healthcare professional year planner 2013€¦ · 28 - 29: sts/aats tech-con 2012, fort lauderdale,...
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Healthcare Professional Year Planner 2013
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Australia Day
Canberra Day (ACT)
Adelaide Cup (SA) Labour Day (VIC) Eight Hours Day (TAS)
Good Friday
Easter Saturday May Day (NT) Labour Day (QLD)
AMA National Conference, Melbourne, VIC
AMA National Conference, Melbourne, VIC
Mother’s Day
AMA National Conference, Melbourne, VIC
Foundation Day (WA)
Queen’s Birthday (ex WA) Volunteer’s Day (SA)
Daylight Savings Ends (TAS, ACT, NSW, SA, VIC)
Easter Monday
Easter Tuesday (TAS)
ANZAC Day
Picnic Day (NT)
Father’s Day
Daylight Savings Starts (TAS, ACT, NSW, SA, VIC)
Labour Day (ACT, NSW, SA) Queen’s Birthday (WA)
Melbourne Cup (VIC)
Family & Community Day (ACT)
Christmas Day
Boxing Day (ex SA) Proclamation Day (SA)
New Year’s Day
New Year’s Day Holiday
Labour Day (WA)
January events 06 - 07: IPS/CTO Live 2012, Seoul, Korea
11 - 15: APMEC 2012, Singapore
12 - 14: AsiaPCR/Sing Live 2012, Suntec City, Singapore
19 - 21: CACVS 2012, Paris, France
28 - 29: STS/AATS Tech-Con 2012, Fort Lauderdale, FL, USA
29 - 30: STS AM 2012, Fort Lauderdale, FL, USA
February events 01 - 03: International Stroke Conference 2012, New Orleans, LA, USA
03 - 05: APCHF 2012, Chiang Mai, Thailand
06 - 11: 15th Annual Comprehensive Review & Update of Perioperative Echo, San Diego, CA, USA
08 - 09: CT CON 2012, Kolkata, India
12 - 15: ICDDT 2012, Dubai, UAE
18 - 21: 12th Annual International Symposium on Congenital Heart Disease, St Petersburg, FL, USA
22 - 26: Cardiology 2012, Orlando, FL, USA
23 - 25: 9th International Chronic Total Occlusion Summit, New York, NY, USA
March events 01 - 03: The International Conference on Heart & Brain 2012, Paris, France
11 - 14: ACC Rockies 2012, Banff, AB, Canada
11 - 16: Annual Update on Cardiopulmonary Bypass 2012, Aspen, CO, USA
13 - 16: EPI/NPAM 2012, San Diego, CA, USA
15 - 18: CIT 2012, Beijing, China
19 - 23: Cardiology Review Course 2012, London, England, UK
22 - 23: Basic and Clinical Aspects of Plaque Progression, Melbourne, VIC
22 - 25: Familial Hypercholesterolaemia and Genetic Dyslipidaemia Satellite Meeting 2012, Manly Beach, NSW
April events 12 - 14: HVSA/SHVD 2012, New York City, NY, USA
18 - 20: ATVB 2012, Chicago, IL, USA
18 - 21: World Congress of Cardiology 2012, Dubai, UAE
19 - 21: ACP Internal Medicine 2012, New Orleans, LA, USA
19 - 22: 18th Annual Interventional Cardiology Fellows Course, Miami, FL, USA
25 - 27: TCTAP 2012, Seoul, Korea
25 - 28: ESCVS 2012, Dubrovnik, Croatia
26 - 27: Aortic Symposium 2012, New York, NY, USA
May events 03 - 05: EuroPRevent 2012, Dublin, Ireland
06 - 09: RACP 2012, Brisbane, QLD
08 - 15: AMA (NSW) Clinical Conference Galapagos Islands
09 - 11: QCOR 2012, Atlanta, GA, USA
09 - 12: SCAI 2012, Las Vegas, NV, USA
15 - 18: ESC EuroPCR 2012, Paris, France
16 - 20: MSDA 2012, Marrakesh, Morocco
17 - 20: Global Congress for CIP and Child Health 2012, Moscow, Russia
18 - 23: ATS 2012, San Francisco, CA, USA
19 - 22: Heart Failure Congress 2012, Belgrade, Serbia
19 - 22: 2012 ASH ASM, New York, NY, USA
22 - 25: ESC (Stroke) 2012, Lisbon, Portugal
June events 02 - 05: IVBM 2012, Wiesbaden, Germany
07 - 09: ASCI 2012, Bangkok, Thailand
08 - 12: ADA 2012 SS, Philadelphia, PA, USA
13 - 15: Endovascular Cardiac Complications 2012, Dusseldorf, Germany
13 - 16: Cardiostim 2012, Nice, France
28 - 30: WTSA AM 2012, Maui, HI, USA
30 Jun - 02-Jul: CIPP XI, Bangkok, Thailand
July events 05 - 08: 15th Annual Cardiothoracic Update & Tee Board Review, Hilton Head Island, SC, USA
23 - 26: BCVS 2012, New Orleans, LA, USA
27 - 30: IAC World Congress on Heart Disease ASS 2012, Toronto, ON, Canada
August events 13 - 15: ACRA 2012, Brisbane, QLD
15 - 16: ANZET12, Brisbane, QLD
16 - 19: CSANZ 2012, Brisbane, QLD
25 - 29: ESC Congress 2012, Munich, Germany
27 - 29: ANZSN ASM 2012, Auckland, NZ
September events 10 - 12: Population Health Congress 2012, Adelaide, SA
27 - 29: CSVS 2012, Quebec City, QC, Canada
29 Sep - 04 Oct: Hypertension 2012, Sydney, NSW
October events 04 - 06: APHRS 2012, Taipei, Taiwan
10 - 13: World Stroke Congress 2012, Brasilia, Brazil
20 - 23: Acute Cardic Care 2012, Istanbul, Turkey
30 Oct - 04 Nov: ASN Kidney Week 2012, San Diego, CA, USA
November events 01 - 04: ATCSA 2012, Sabah, Malaysia
02 - 04: CCT 2012, Kobe, Japan
11 - 15: WCIM2012, Santiago, Chile
14 - 17: ICCVA/NZA ASM 2012, Auckland, NZ
14 - 18: GSA ASM 2012, San Diego, CA, USA
December events
Australian School Term DatesTerm 1 Term 2 Term 3 Term 4
NSW 27 Jan - 5 Apr 23 Apr - 29 Jun 16 Jul - 21 Sep 8 Oct - 21 Dec
VIC 1 Feb - 30 Mar 16 Apr - 29 Jun 16 Jul - 21 Sep 8 Oct - 21 Dec
QLD 23 Jan - 30 Mar 10 Apr - 22 Jun 9 Jul - 21 Sep 8 Oct - 14 Dec
TAS 14/15 Feb - 1 Jun 18 Jun - 7 Sep 24 Sep - 20 Dec –
ACT 3 Feb - 13 Apr 30 Apr - 6 Jul 23 Jul - 28 Sep 15 Oct - 21 Dec
NT 31 Jan - 5 Apr 16 Apr - 22 Jun 23 Jul - 28 Sep 8 Oct - 13 Dec
SA 30 Jan - 5 Apr 23 Apr - 29 Jun 16 Jul - 21 Sep 8 Oct - 14 Dec
WA 30 Jan - 5 Apr 23 Apr - 6 Jul 23 Jul - 28 Sep 15 Oct - 18 Dec
DECEMBER 2011 JANUARY 2013
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PBS status and Product Information can be found on
the back of this planner.This planner is designed to be used
within your practice in order to comply with Edition 16 of the Medicines Australia Code of Conduct.
For further information about the code visit: www.medicinesaustralia.com.au
DISCLAIMER: WHILST ALL POSSIBLE CARE IS TAKEN TO ENSURE THAT THE CONTENTS OF THIS PLANNER ARE CORRECT AT TIME OF PRINTING WE CANNOT GUARANTEE ITS ACCURACY OR BE HELD RESPONSIBLE FOR ERRORS, OR FOR CANCELLATIONS OR CHANGES OF DATES, VENUES ETC. SPONSORSHIP OF THIS PLANNER DOES NOT IMPLY
PRODUCT INDORSEMENT BY EITHER CARBINE MEDIA
Notes
Before prescribing review Product and PBS Information which can be found on the back of this planner.
Novartis Pharmaceuticals Australia Pty Limited ABN 18 004 244 160. 54 Waterloo Road, North Ryde NSW 2113. Ph (02) 9805 3555. ® Registered Trademark. VEX0253. NOEX4763. 08/11.
References: 1. SPIRIVA Approved Product Information. 2. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease: executive summary. Updated 2009. Available at www.goldcopd.com (accessed August 2010). Boehringer Ingelheim Pty Ltd, ABN 52 000 452 308. 78 Waterloo Road, North Ryde NSW 2113. Pfizer Australia Pty Ltd, ABN 50 008 422 348, 38-42 Wharf Road, West Ryde NSW 2114. Spiriva® was developed by Boehringer Ingelheim and is being co-promoted by Boehringer Ingelheim and Pfizer Australia. ®Registered trademark Boehringer Ingelheim. AUS/SPI-11034. SPR0034/AMA P4677 08/11
† Diagnosis of COPD, symptomatic despite prn reliever therapy2
Before prescribing review Product and PBS Information which can be found on the back of this calendar.
COPD MAINTENANCE THERAPY † right from the start † 1,2
Before prescribing review Product and PBS Information which can be found on the back of this planner.
1-4
References: 1. Warrington S et al. Eur J Clin Pharmacol 2006; 62: 685–91. 2. Warrington S et al. Aliment Pharmacol Ther 2007; 25: 511–7. 3. PARIET Approved Product Information. 4. Horn J. Aliment Pharmacol Ther 2004; 20 Suppl 6: 11–9. 5. Adachi K et al. Aliment Pharmacol Ther 2000; 14(10): 1259–66. 6. Hu YM et al. Acta Pharmacol Sin 2005; 26(3): 384–8. 7. Keane WF et al. J Clin Pharmacol 1999; 39(9): 927–33. 8. Laurent AL et al. Clin Geriatr 1999; 7: 27–33. Janssen-Cilag Pty Ltd, ABN 47 000 129 975, 1-5 Khartoum Road, Macquarie Park NSW 2113. ® PARIET is a registered trademark of Eisai R&D Management Co. Ltd for rabeprazole oral tablets. JCPA5161. 09/11. Ward6.
In addition to reducing acid consistently,1-4 PARIET has consistent pharmacokinetics across patient populations (elderly, renal impairment, CYP2C19 genotypes)3-8
Before prescribing review Product and PBS Information which can be found on the back of this planner
References: 1. Physiotens Approved Product Information, 2011. 2. Sharma AM et al. J Hum Hypertens 2004;18(9):669–75. 3. Waters J et al. J Clin Bas Cardiol 1999;2:219–224. 4. Schacter M et al. Int J Clin Pract 2003;57(6):479–82. 5. Frei M et al. J Cardiovasc Pharmacol 1994;24(Suppl.1):S25–8. Further information is available from Abbott Australasia Pty Ltd., 32–34 Lord Street Botany NSW 2019. Call 1800 225 311. PHYSIOTENS® is a registered trademark of Abbott Australasia. AU-PHY-2011-33a
The add-on that adds up.1-5
Now available at a high dose: 640μg/day1
Before prescribing, please review Product and PBS Information which can be found on the back of this planner.
Further information and full PI available from Nycomed Pty Ltd: ABN 71095610870, Ground Floor, 2 Lyonpark Road, North Ryde NSW 2113. Phone 1800 675 957. Reference: 1. Alvesco Approved Product Information. Alvesco® is a registered trademark of Nycomed GmbH. EMVALV0012B 08/11 AUS/PR/ALV/03/08-2011
Before prescribing please review Product and PBS Information found on the reverse side of this planner
Janssen-Cilag Pty Ltd, ABN47000129975, 1-5 Khartoum Road, Macquarie Park NSW 2113. INVEGA® is the registered trademark of Johnson & Johnson USA. INV11aug25-2NE/McCann Healthcare INV0002 09/11.
Before prescribing review Product and
PBS Information which can be found on the back of this planner.
Novartis Pharmaceuticals Australia Pty Limited ABN 18 004 244 160. 54 Waterloo Road, North Ryde NSW 2113. Ph (02) 9805 3555. ® Registered Trademark. VEX0253. NOEX4763. 08/11.
REFERENCE: 1. Mobic Approved Product Information. Boehringer Ingelheim Pty Ltd, 78 Waterloo Road, North Ryde NSW 2113. ABN 52 000 452 308. ® Registered Trademark. BIMOB0023
Saturday’s big game proudly supported by
Reduce OA Pain.1 Increase Movement.1
Before prescribing review Product and PBS Information which can be found on the back of this planner.
Quad Panel Square (120x120mm) Major Panel Landscape (240x120mm)
Full Banner Landscape (792x60mm)
Double Panel Landscape (120x60mm)
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Examples shown on this planner front are ads from 2012 planners. Size & format may vary, so please check your artwork specifi cations email. Read on to fi nd more specifi c information about Medicine’s Australia requirements.
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Australian Professional Year PlannersArtwork Specifi cations & guidelines
Exforge PBS Information: Restricted Benefit. Hypertension in a patient who is not adequately controlled with either of the drugs in the combination.
Please review TGA Approved Product Information before prescribing. TGA Approved Product Information available on request. EXFORGE (valsartan/amlodipine besylate). Indication: Treatment of hypertension. Treatment should not be initiated with this fixed dose combination. Dosage and administration: Recommended dose is one film-coated tablet per day (5 mg amlodipine and 80 mg valsartan, or 5 mg amlodipine and 160 mg valsartan, or 10 mg amlodipine and 160 mg valsartan, or 5 mg amlodipine and 320 mg valsartan, or 10 mg amlodipine and 320 mg valsartan). Contraindications: Hypersensitivity to the active substances (valsartan and amlodipine), dihydropyridine derivatives, or to any of the excipients; Severe hepatic impairment; biliary cirrhosis and cholestasis; Severe renal impairment (GFR <30 mL/min/1.73 m2) and patients undergoing dialysis; Pregnancy. Precautions: Risk of hypotension in sodium- and/or volume-depleted patients. Risk of increased angina in patients with severe obstructive coronary artery disease. Beta-blocker withdrawal should be gradual. Caution in patients with mild to moderate renal impairment. No data available in patients with unilateral or bilateral renal artery stenosis, stenosis to a solitary kidney or after recent kidney transplantation. Caution in patients with mild to moderate hepatic impairment without cholestatis. Special caution in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Caution should be observed when initiating therapy in patients with heart failure or post-myocardial infarction. Caution should be observed with the triple combination of an ACE-inhibitor, beta blocker and valsartan. When administered simultaneously with NSAIDs, attenuation of the antihypertensive effect may occur. Concomitant use of an angiotensin II receptor blocker and an ACE inhibitor may increase the risk of hyperkalaemia, renal failure, hypotension and syncope*. Caution when driving or operating machines. Avoid use in women planning to become pregnant and while breast-feeding. Not recommended in patients below 18 years of age. Interactions: Caution and monitoring of serum potassium levels when used concomitantly with potassium supplements, potassium sparing diuretics, salt substitutes containing potassium, or other drugs that may increase potassium level. Side effects: Most common: Nasopharyngitis, influenza, headache, oedema peripheral, oedema, fatigue, flushing, asthenia, hot flush. Rare/serious: Hypersensitivity. Additional or potentially serious adverse experiences reported in clinical trials with amlodipine monotherapy: Vomiting, gastritis, gingival hyperplasia, gynaecomastia, leucopenia, myalgia, pancreatitis, hepatitis, thrombocytopenia, vasculitis. In a long-term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA III and IV heart failure of nonischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo. Myocardial infarction or increased angina and arrhythmia (including ventricular tachycardia and atrial fibrillation) have also been reported. These adverse events may not be distinguishable from the natural history of the underlying disease. Additional potentially serious adverse experiences reported in clinical trials with valsartan monotherapy are: Neutropenia. Heart failure patients: >50% increases in creatinine in 3.9% of valsartan-treated patients compared to 0.9% of placebo-treated patients. >20% increases in serum potassium in 10% of valsartan-treated patients compared to 5.1% of placebo-treated patients. >50% increases in BUN in 16.6% of valsartan-treated patients compared to 6.3% of placebo-treated patients. Post-myocardial infarction patients: doubling of serum creatinine in 4.2% of valsartan-treated patients, 4.8% of valsartan plus captopril-treated patients, and 3.4% of captopril-treated patients. Elevated liver enzymes have also been reported in post-marketing surveillance. >20% decreases in haemoglobin and haematocrit observed in 0.4% and 0.8% respectively, of valsartan patients compared with 0.1% and 0.1% in placebo-treated patients (exf030611m.doc). PBS Dispensed Price: 5/80mg (28 tablets) $29.22; 5/160mg (28 tablets) $33.00; 10/160mg (28 tablets) $39.85; 5/320mg (28 tablets) $37.73; 10/320mg (28 tablets) $44.11.
*Please note changes in Product Information
Exforge HCT PBS Information: Restricted Benefit. Hypertension in a patient who is not adequately controlled with any of the two drugs in the combination.
Please review TGA Approved Product Information before prescribing. TGA Approved Product Information available on request.EXFORGE HCT (valsartan/amlodipine besylate/hydrochlorothiazide). Indication: Exforge HCT is indicated ONLY as substitution therapy for the treatment of hypertension in patients whose blood pressure is already adequately controlled on the triple combination of amlodipine, valsartan and hydrochlorothiazide taken either as three single component formulations or as dual-component formulation with a single-component formulation, all components at the same dose level. Treatment should not be initiated with these fixed-dose combinations. Dosage and administration: Recommended dose: one tablet per day. If blood pressure is not controlled on one of the three possible dual combination therapies, then any third monotherapy must be first added as an individual therapy until dose titration is complete and BP control established before the triple fixed-dose combination may be introduced. If a patient’s blood pressure is uncontrolled at one of the lower dosage of the combination, dose titration must be carried out with the separately administered components. Contraindications: Hypersensitivity to the active substances, dihydropyridine derivatives, other sulfonamide-derived drugs, or to any of the excipients; Severe hepatic impairment; biliary cirrhosis and cholestasis; Severe renal impairment (GFR <30 mL/min/1.73 m2), anuria and patients undergoing dialysis; Refractory hypokalaemia, hyponatraemia, hypercalcaemia and symptomatic hyperuricaemia; Pregnancy. Precautions: Risk of hypotension in sodium- and/or volume-depleted patients. Risk of increased angina in patients with severe obstructive coronary artery disease. Beta-blocker withdrawal should be gradual. Caution in patients with mild to moderate renal impairment or systemic lupus erythematosus. No long-term data available in patients with unilateral or bilateral renal artery stenosis, stenosis to a solitary kidney or after recent kidney transplantation. Caution in patients with mild to moderate hepatic impairment without cholestatis. As with all other vasodilators, special caution in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Like other thiazide, Hydrochlorothiazide can cause hypokalaemia, which may favour the onset of digitalis-induced cardiac arrhythmias. Caution in patients with hypokalaemia, hyponatraemia, hypocalcaemia or symptomatic hyperuricaemia. Disturbance of serum electrolyte balance (monitoring recommended), glucose tolerance and serum levels of cholesterol, triglycerides and uric acid. Caution should be observed when initiating therapy in patients with heart failure or post-myocardial infarction. Caution should be observed with the triple combination of an ACE-inhibitor, beta blocker and valsartan. Caution when driving or operating machines. Avoid use in patients with primary aldosteronism; chronic heart failure or other conditions with stimulation of the renin-angiotensin-aldosterone-system. Photosensitivity: it is recommended to protect exposed areas to the sun or to artificial UVA. Risk of acute angle-closure glaucoma. Caution in patients with allergy in asthma. Avoid use in women planning to become pregnant and while breast-feeding. Not recommended in patients below 18 years of age. Interactions: Monitoring when used concomitantly with lithium; Caution when used concomitantly with drugs that may increase potassium levels; Concomitant treatment with NSAIDs and Cox-2 inhibitors may decrease antihypertensive effects. Caution if combined with other antihypertensives, curare derivatives, NSAIDs, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G, antiarrhythmics, antidepressants, antipsychotics, antiepileptics, salicylic acid derivatives, digoxin, antidiabetic agents, allopurinol, amantadine, diazoxide, cytotoxic drugs, anticholergenic agents, methyldopa, cholestyramine, vitamin D, calcium salts, carbamazepine and cyclosporin. Side effects: Most common: Nasopharyngitis, influenza, headache, oedema peripheral, oedema, fatigue, flushing, asthenia, dyspepsia, vertigo, tachycardia, palpitations, orthostatic hypotension, cough, pharyngolaryngeal pain, diarrhoea, nausea, abdominal pain, constipation, dry mouth, rash, erythema, joint swelling, back pain, arthralgia; Rare adverse reactions but potentially serious: Hypersensitivity, syncope, hypotension; Potentially serious adverse experiences reported with amlodipine monotherapy: Leucopenia, pancreatitis, hepatitis, thrombocytopenia, vasculitis, peripheral neuropathy, angioedema, erythema multiforme. In a long-term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA III and IV heart failure of nonischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo. Risk of myocardial infarction or increased angina and arrhythmia (including ventricular tachycardia and atrial fibrillation) have also been reported. These adverse events may not be distinguishable from the natural history of the underlying disease; Potentially serious adverse experiences reported with valsartan monotherapy: Neutropenia; Potentially serious adverse experiences reported with hydrochlorothiazide monotherapy: Most common adverse reactions: Hypokalaemia and rise in blood lipids, hypomagnesaemia, hyperuricaemia, hyponatraemia, urticaria and other forms of rash, decreased appetite, mild nausea and vomiting, orthostatic hypotension, impotence. Less common adverse reactions but potentially serious: Jaundice, cardiac arrhythmias, blood dyscrasias, vasculitis, lupus erythematosus, toxic epidermal necrolysis, erythema multiforme, pancreatitis, pneumonitis, pulmonary oedema, skin rash with or without difficulties in breathing (hypersensitivity reactions), hypochloraemic alkalosis, hypercalcaemia, severe or persistent vomiting or diarrhea, thrombocytopenia with or without purpura, agranulocytosis, leucopenia, pancytopenia, bone marrow depression, hemolytic or aplastic anaemia, renal failure or renal disorder, acute angle-closure glaucoma. (exh060611m.doc). PBS Dispensed Price: 5/160/12.5mg (28 tablets) $35.07; 5/160/25mg (28 tablets) $37.14; 10/160/12.5mg (28 tablets) $41.79; 10/160/25mg (28 tablets) $43.59; 10/320/25mg (28 tablets) $47.72. Novartis Pharmaceuticals Australia Pty Limited ABN 18 004 244 160. 54 Waterloo Road, North Ryde NSW 2113. Ph (02) 9805 3555. ® Registered Trademark. VEX0253. NOEX4763. 08/11.
*Please note changes in Product Information
PBS Information: Authority required (STREAMLINED). Refer to PBS Schedule to full authority information.
Please see TGA approved Product Information before prescribing. Approved Product Information available on request. GALVUS® (vildagliptin).
Indication: Treatment of diabetes mellitus type 2 in persons 18 years of age and older, as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes with one of metformin, a sulfonylurea or pioglitazone when diet, exercise and the single agent do not result in adequate glycaemic control. Dosage and administration: 50 mg daily (morning) or 100 mg daily in two divided doses of 50 mg (morning and evening) in dual combination with metformin or a thiazolidinedione (TZD); 50 mg daily (morning) in combination with a sulfonylurea (SU). Galvus is not recommended in paediatric patients. Contraindications: Hypersensitivity to vildagliptin or to any of the excipients. Precautions: Not for type 1 diabetes mellitus or diabetic ketoacidosis. Not recommended in moderate or severe renal impairment, or in patients with End Stage Renal Disease (ESRD) on haemodialysis. Not recommended in patients with hepatic impairment including patients with a pre-treatment ALT or AST>2.5X the upper limit of normal; liver function tests (LFT) to be performed prior to treatment initiation, at three-month intervals during the first year and periodically thereafter; withdrawal of therapy is recommended if an increase in AST or ALT of 3X upper limit normal or greater persist; following withdrawal of treatment and LFT normalisation, treatment should not be reinitiated. Not recommended in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Pregnancy: should not be used unless the potential benefit justifies the potential risk to the foetus. Breast-feeding: should not be used Interactions: vildagliptin has a low potential for drug interactions. No clinically relevant interactions with other oral antidiabetics (glibenclamide, pioglitazone, metformin), amlodipine, digoxin, ramipril, simvastatin, valsartan or warfarin were observed after co-administration with vildagliptin. Adverse reactions: Common: dizziness, headache, tremor, asthenia, weight increase, oedema peripheral. Rare cases of angioedema. Rare cases of hepatic dysfunction (including hepatitis). Post-marketing experience: Rare: hepatitis (reversible with drug discontinuation) * – Unknown: urticaria, pancreatitis*. (gal050511m.doc). PBS dispensed price: GALVUS® 50 mg x 60 tablets $97.24.
*Please note changes to the Product Information.
PBS Information: Authority required (STREAMLINED). Refer to PBS Schedule to full authority information.
Please see TGA approved Product Information before prescribing. Approved Product Information available on request. GALVUMET® (vildagliptin/metformin hydrochloride).
WARNING: Life-threatening lactic acidosis can occur due to accumulation of metformin. Risk factors include renal impairment, old age and the use of high doses of metformin above 2000 mg per day.
Indication: As an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes whose diabetes is not adequately controlled on metformin hydrochloride alone or who are already treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. Treatment of type 2 diabetes should not be initiated with this fixed-dose combination. Dosage and administration: Starting dose should be on the patient’s current regimen of vildagliptin and/or metformin hydrochloride: 50/500, 50/850 or 50/1000 twice daily. Do not exceed the maximum recommended daily dose of vildagliptin (100 mg). Should be given with meals. To minimise the risk of lactic acidosis, only one strength of Galvumet should be prescribed and used at any one time. Patients should also be advised to discard their previous metformin medication when initiated on Galvumet. Contraindications: Hypersensitivity to vildagliptin or metformin hydrochloride or to any of the excipients. Renal disease or dysfunction. Congestive heart failure. Acute or chronic metabolic acidosis including diabetic ketacidosis. Temporarily discontinuation recommended in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials. Precautions: Not for type 1 diabetes or diabetic ketoacidosis. Caution with concomitant use of medications that may affect renal function or metformin hydrochloride disposition. Renal function should be assessed and verified as normal before initiating Galvumet. Not recommended in patients with hepatic impairment including patients with a pre-treatment ALT or AST >2.5X the upper limit of normal; liver function tests (LFT) to be performed prior to treatment initiation, at three-month intervals during the first year and periodically thereafter; withdrawal of therapy is recommended if an increase in AST or ALT of 3X upper limit normal or greater persist; following withdrawal of treatment and LFT normalisation, treatment should not be reinitiated. Not recommended in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Risk of lactic acidosis. Not recommended in paediatric patients. Discontinue treatment in case of hypoxemia. Temporary discontinuation in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials or surgical procedure. Excessive alcohol intake to be avoided. Risk of decreased vitamin B12 serum levels. Risk of hypoglycaemia. May be temporarily withheld in case of loss of glycaemic control. Pregnancy (Category C): Should not be used unless the potential benefit justifies the potential risk to the foetus. Breast-feeding: Should not be used. Interactions: Vildagliptin has a low potential for drug interactions. No clinically relevant interactions with other oral antidiabetics (glibenclamide, pioglitazone, metformin), amlodipine, digoxin, ramipril, simvastatin, valsartan or warfarin were observed after co-administration with vildagliptin. Interactions with metformin hydrochloride: furosemide, nifedipine, glyburide, cationic drugs, drugs tending to produce hyperglycaemia, alcohol. Adverse reactions: Vildagliptin: Common: dizziness; Uncommon: headache, constipation, oedema peripheral; Rare: angioedema, hepatic dysfunction (including hepatitis); Metformin: Very common: nausea, vomiting, diarrhoea, abdominal pain, loss of appetite; Common: metallic taste; Very rare: decrease of vitamin B12 absorption, lactic acidosis, liver function test abnormalities, hepatitis, skin reactions such as erythema, pruritus and urticaria. Other effects with vildagliptin and metformin: Common: headache, tremor, dizziness. Post-marketing experience: Rare: hepatitis (reversible with drug discontinuation)* – Unknown: pancreatitis, urticaria. (gam050511m). PBS dispensed price: GALVUMET® x 60 tablets: 50/500 mg $97.79; 50/850 mg $100.22; 50/1000 mg $101.20.
*Please note changes to the Product Information.Novartis Pharmaceuticals Australia Pty Limited, ABN 18 004 244 160. 54 Waterloo Road, North Ryde NSW 2113. ® Registered Trademark. GMT0451. NOGA4762. 08/11.
Exforge HCT PBS Information: Restricted Benefit. Hypertension in a patient who is not adequately controlled with any of the two drugs in the combination.
Please review TGA Approved Product Information before prescribing. TGA Approved Product Information available on request.EXFORGE HCT (valsartan/amlodipine besylate/hydrochlorothiazide). Indication: Exforge HCT is indicated ONLY as substitution therapy for the treatment of hypertension in patients whose blood pressure is already adequately controlled on the triple combination of amlodipine, valsartan and hydrochlorothiazide taken either as three single component formulations or as dual-component formulation with a single-component formulation, all components at the same dose level. Treatment should not be initiated with these fixed-dose combinations. Dosage and administration: Recommended dose: one tablet per day. If blood pressure is not controlled on one of the three possible dual combination therapies, then any third monotherapy must be first added as an individual therapy until dose titration is complete and BP control established before the triple fixed-dose combination may be introduced. If a patient’s blood pressure is uncontrolled at one of the lower dosage of the combination, dose titration must be carried out with the separately administered components. Contraindications: Hypersensitivity to the active substances, dihydropyridine derivatives, other sulfonamide-derived drugs, or to any of the excipients; Severe hepatic impairment; biliary cirrhosis and cholestasis; Severe renal impairment (GFR <30 mL/min/1.73 m2), anuria and patients undergoing dialysis; Refractory hypokalaemia, hyponatraemia, hypercalcaemia and symptomatic hyperuricaemia; Pregnancy. Precautions: Risk of hypotension in sodium- and/or volume-depleted patients. Risk of increased angina in patients with severe obstructive coronary artery disease. Beta-blocker withdrawal should be gradual. Caution in patients with mild to moderate renal impairment or systemic lupus erythematosus. No long-term data available in patients with unilateral or bilateral renal artery stenosis, stenosis to a solitary kidney or after recent kidney transplantation. Caution in patients with mild to moderate hepatic impairment without cholestatis. As with all other vasodilators, special caution in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Like other thiazide, Hydrochlorothiazide can cause hypokalaemia, which may favour the onset of digitalis-induced cardiac arrhythmias. Caution in patients with hypokalaemia, hyponatraemia, hypocalcaemia or symptomatic hyperuricaemia. Disturbance of serum electrolyte balance (monitoring recommended), glucose tolerance and serum levels of cholesterol, triglycerides and uric acid. Caution should be observed when initiating therapy in patients with heart failure or post-myocardial infarction. Caution should be observed with the triple combination of an ACE-inhibitor, beta blocker and valsartan. Caution when driving or operating machines. Avoid use in patients with primary aldosteronism; chronic heart failure or other conditions with stimulation of the renin-angiotensin-aldosterone-system. Photosensitivity: it is recommended to protect exposed areas to the sun or to artificial UVA. Risk of acute angle-closure glaucoma. Caution in patients with allergy in asthma. Avoid use in women planning to become pregnant and while breast-feeding. Not recommended in patients below 18 years of age. Interactions: Monitoring when used concomitantly with lithium; Caution when used concomitantly with drugs that may increase potassium levels; Concomitant treatment with NSAIDs and Cox-2 inhibitors may decrease antihypertensive effects. Caution if combined with other antihypertensives, curare derivatives, NSAIDs, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G, antiarrhythmics, antidepressants, antipsychotics, antiepileptics, salicylic acid derivatives, digoxin, antidiabetic agents, allopurinol, amantadine, diazoxide, cytotoxic drugs, anticholergenic agents, methyldopa, cholestyramine, vitamin D, calcium salts, carbamazepine and cyclosporin. Side effects: Most common: Nasopharyngitis, influenza, headache, oedema peripheral, oedema, fatigue, flushing, asthenia, dyspepsia, vertigo, tachycardia, palpitations, orthostatic hypotension, cough, pharyngolaryngeal pain, diarrhoea, nausea, abdominal pain, constipation, dry mouth, rash, erythema, joint swelling, back pain, arthralgia; Rare adverse reactions but potentially serious: Hypersensitivity, syncope, hypotension; Potentially serious adverse experiences reported with amlodipine monotherapy: Leucopenia, pancreatitis, hepatitis, thrombocytopenia, vasculitis, peripheral neuropathy, angioedema, erythema multiforme. In a long-term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA III and IV heart failure of nonischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo. Risk of myocardial infarction or increased angina and arrhythmia (including ventricular tachycardia and atrial fibrillation) have also been reported. These adverse events may not be distinguishable from the natural history of the underlying disease; Potentially serious adverse experiences reported with valsartan monotherapy: Neutropenia; Potentially serious adverse experiences reported with hydrochlorothiazide monotherapy: Most common adverse reactions: Hypokalaemia and rise in blood lipids, hypomagnesaemia, hyperuricaemia, hyponatraemia, urticaria and other forms of rash, decreased appetite, mild nausea and vomiting, orthostatic hypotension, impotence. Less common adverse reactions but potentially serious: Jaundice, cardiac arrhythmias, blood dyscrasias, vasculitis, lupus erythematosus, toxic epidermal necrolysis, erythema multiforme, pancreatitis, pneumonitis, pulmonary oedema, skin rash with or without difficulties in breathing (hypersensitivity reactions), hypochloraemic alkalosis, hypercalcaemia, severe or persistent vomiting or diarrhea, thrombocytopenia with or without purpura, agranulocytosis, leucopenia, pancytopenia, bone marrow depression, hemolytic or aplastic anaemia, renal failure or renal disorder, acute angle-closure glaucoma. (exh060611m.doc). PBS Dispensed Price: 5/160/12.5mg (28 tablets) $35.07; 5/160/25mg (28 tablets) $37.14; 10/160/12.5mg (28 tablets) $41.79; 10/160/25mg (28 tablets) $43.59; 10/320/25mg (28 tablets) $47.72. Novartis Pharmaceuticals Australia Pty Limited ABN 18 004 244 160. 54 Waterloo Road, North Ryde NSW 2113. Ph (02) 9805 3555. ® Registered Trademark. VEX0253. NOEX4763. 08/11.
*Please note changes in Product Information
PBS Information: Authority required (STREAMLINED). Refer to PBS Schedule to full authority information.
Please see TGA approved Product Information before prescribing. Approved Product Information available on request. GALVUMET® (vildagliptin/metformin hydrochloride).
WARNING: Life-threatening lactic acidosis can occur due to accumulation of metformin. Risk factors include renal impairment, old age and the use of high doses of metformin above 2000 mg per day.
Indication: As an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes whose diabetes is not adequately controlled on metformin hydrochloride alone or who are already treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. Treatment of type 2 diabetes should not be initiated with this fixed-dose combination. Dosage and administration: Starting dose should be on the patient’s current regimen of vildagliptin and/or metformin hydrochloride: 50/500, 50/850 or 50/1000 twice daily. Do not exceed the maximum recommended daily dose of vildagliptin (100 mg). Should be given with meals. To minimise the risk of lactic acidosis, only one strength of Galvumet should be prescribed and used at any one time. Patients should also be advised to discard their previous metformin medication when initiated on Galvumet. Contraindications: Hypersensitivity to vildagliptin or metformin hydrochloride or to any of the excipients. Renal disease or dysfunction. Congestive heart failure. Acute or chronic metabolic acidosis including diabetic ketacidosis. Temporarily discontinuation recommended in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials. Precautions: Not for type 1 diabetes or diabetic ketoacidosis. Caution with concomitant use of medications that may affect renal function or metformin hydrochloride disposition. Renal function should be assessed and verified as normal before initiating Galvumet. Not recommended in patients with hepatic impairment including patients with a pre-treatment ALT or AST >2.5X the upper limit of normal; liver function tests (LFT) to be performed prior to treatment initiation, at three-month intervals during the first year and periodically thereafter; withdrawal of therapy is recommended if an increase in AST or ALT of 3X upper limit normal or greater persist; following withdrawal of treatment and LFT normalisation, treatment should not be reinitiated. Not recommended in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Risk of lactic acidosis. Not recommended in paediatric patients. Discontinue treatment in case of hypoxemia. Temporary discontinuation in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials or surgical procedure. Excessive alcohol intake to be avoided. Risk of decreased vitamin B12 serum levels. Risk of hypoglycaemia. May be temporarily withheld in case of loss of glycaemic control. Pregnancy (Category C): Should not be used unless the potential benefit justifies the potential risk to the foetus. Breast-feeding: Should not be used. Interactions: Vildagliptin has a low potential for drug interactions. No clinically relevant interactions with other oral antidiabetics (glibenclamide, pioglitazone, metformin), amlodipine, digoxin, ramipril, simvastatin, valsartan or warfarin were observed after co-administration with vildagliptin. Interactions with metformin hydrochloride: furosemide, nifedipine, glyburide, cationic drugs, drugs tending to produce hyperglycaemia, alcohol. Adverse reactions: Vildagliptin: Common: dizziness; Uncommon: headache, constipation, oedema peripheral; Rare: angioedema, hepatic dysfunction (including hepatitis); Metformin: Very common: nausea, vomiting, diarrhoea, abdominal pain, loss of appetite; Common: metallic taste; Very rare: decrease of vitamin B12 absorption, lactic acidosis, liver function test abnormalities, hepatitis, skin reactions such as erythema, pruritus and urticaria. Other effects with vildagliptin and metformin: Common: headache, tremor, dizziness. Post-marketing experience: Rare: hepatitis (reversible with drug discontinuation)* – Unknown: pancreatitis, urticaria. (gam050511m). PBS dispensed price: GALVUMET® x 60 tablets: 50/500 mg $97.79; 50/850 mg $100.22; 50/1000 mg $101.20.
*Please note changes to the Product Information.Novartis Pharmaceuticals Australia Pty Limited, ABN 18 004 244 160. 54 Waterloo Road, North Ryde NSW 2113. ® Registered Trademark. GMT0451. NOGA4762. 08/11.
Exforge PBS Information: Restricted Benefit. Hypertension in a patient who is not adequately controlled with either of the drugs in the combination.
Please review TGA Approved Product Information before prescribing. TGA Approved Product Information available on request. EXFORGE (valsartan/amlodipine besylate). Indication: Treatment of hypertension. Treatment should not be initiated with this fixed dose combination. Dosage and administration: Recommended dose is one film-coated tablet per day (5 mg amlodipine and 80 mg valsartan, or 5 mg amlodipine and 160 mg valsartan, or 10 mg amlodipine and 160 mg valsartan, or 5 mg amlodipine and 320 mg valsartan, or 10 mg amlodipine and 320 mg valsartan). Contraindications: Hypersensitivity to the active substances (valsartan and amlodipine), dihydropyridine derivatives, or to any of the excipients; Severe hepatic impairment; biliary cirrhosis and cholestasis; Severe renal impairment (GFR <30 mL/min/1.73 m2) and patients undergoing dialysis; Pregnancy. Precautions: Risk of hypotension in sodium- and/or volume-depleted patients. Risk of increased angina in patients with severe obstructive coronary artery disease. Beta-blocker withdrawal should be gradual. Caution in patients with mild to moderate renal impairment. No data available in patients with unilateral or bilateral renal artery stenosis, stenosis to a solitary kidney or after recent kidney transplantation. Caution in patients with mild to moderate hepatic impairment without cholestatis. Special caution in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Caution should be observed when initiating therapy in patients with heart failure or post-myocardial infarction. Caution should be observed with the triple combination of an ACE-inhibitor, beta blocker and valsartan. When administered simultaneously with NSAIDs, attenuation of the antihypertensive effect may occur. Concomitant use of an angiotensin II receptor blocker and an ACE inhibitor may increase the risk of hyperkalaemia, renal failure, hypotension and syncope*. Caution when driving or operating machines. Avoid use in women planning to become pregnant and while breast-feeding. Not recommended in patients below 18 years of age. Interactions: Caution and monitoring of serum potassium levels when used concomitantly with potassium supplements, potassium sparing diuretics, salt substitutes containing potassium, or other drugs that may increase potassium level. Side effects: Most common: Nasopharyngitis, influenza, headache, oedema peripheral, oedema, fatigue, flushing, asthenia, hot flush. Rare/serious: Hypersensitivity. Additional or potentially serious adverse experiences reported in clinical trials with amlodipine monotherapy: Vomiting, gastritis, gingival hyperplasia, gynaecomastia, leucopenia, myalgia, pancreatitis, hepatitis, thrombocytopenia, vasculitis. In a long-term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA III and IV heart failure of nonischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo. Myocardial infarction or increased angina and arrhythmia (including ventricular tachycardia and atrial fibrillation) have also been reported. These adverse events may not be distinguishable from the natural history of the underlying disease. Additional potentially serious adverse experiences reported in clinical trials with valsartan monotherapy are: Neutropenia. Heart failure patients: >50% increases in creatinine in 3.9% of valsartan-treated patients compared to 0.9% of placebo-treated patients. >20% increases in serum potassium in 10% of valsartan-treated patients compared to 5.1% of placebo-treated patients. >50% increases in BUN in 16.6% of valsartan-treated patients compared to 6.3% of placebo-treated patients. Post-myocardial infarction patients: doubling of serum creatinine in 4.2% of valsartan-treated patients, 4.8% of valsartan plus captopril-treated patients, and 3.4% of captopril-treated patients. Elevated liver enzymes have also been reported in post-marketing surveillance. >20% decreases in haemoglobin and haematocrit observed in 0.4% and 0.8% respectively, of valsartan patients compared with 0.1% and 0.1% in placebo-treated patients (exf030611m.doc). PBS Dispensed Price: 5/80mg (28 tablets) $29.22; 5/160mg (28 tablets) $33.00; 10/160mg (28 tablets) $39.85; 5/320mg (28 tablets) $37.73; 10/320mg (28 tablets) $44.11.
*Please note changes in Product Information
PBS Information: Authority required (STREAMLINED). Refer to PBS Schedule to full authority information.
Please see TGA approved Product Information before prescribing. Approved Product Information available on request. GALVUS® (vildagliptin).
Indication: Treatment of diabetes mellitus type 2 in persons 18 years of age and older, as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes with one of metformin, a sulfonylurea or pioglitazone when diet, exercise and the single agent do not result in adequate glycaemic control. Dosage and administration: 50 mg daily (morning) or 100 mg daily in two divided doses of 50 mg (morning and evening) in dual combination with metformin or a thiazolidinedione (TZD); 50 mg daily (morning) in combination with a sulfonylurea (SU). Galvus is not recommended in paediatric patients. Contraindications: Hypersensitivity to vildagliptin or to any of the excipients. Precautions: Not for type 1 diabetes mellitus or diabetic ketoacidosis. Not recommended in moderate or severe renal impairment, or in patients with End Stage Renal Disease (ESRD) on haemodialysis. Not recommended in patients with hepatic impairment including patients with a pre-treatment ALT or AST>2.5X the upper limit of normal; liver function tests (LFT) to be performed prior to treatment initiation, at three-month intervals during the first year and periodically thereafter; withdrawal of therapy is recommended if an increase in AST or ALT of 3X upper limit normal or greater persist; following withdrawal of treatment and LFT normalisation, treatment should not be reinitiated. Not recommended in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Pregnancy: should not be used unless the potential benefit justifies the potential risk to the foetus. Breast-feeding: should not be used Interactions: vildagliptin has a low potential for drug interactions. No clinically relevant interactions with other oral antidiabetics (glibenclamide, pioglitazone, metformin), amlodipine, digoxin, ramipril, simvastatin, valsartan or warfarin were observed after co-administration with vildagliptin. Adverse reactions: Common: dizziness, headache, tremor, asthenia, weight increase, oedema peripheral. Rare cases of angioedema. Rare cases of hepatic dysfunction (including hepatitis). Post-marketing experience: Rare: hepatitis (reversible with drug discontinuation) * – Unknown: urticaria, pancreatitis*. (gal050511m.doc). PBS dispensed price: GALVUS® 50 mg x 60 tablets $97.24.
*Please note changes to the Product Information.
Australian Professional Year PlannersArtwork Specifi cations & guidelines
Examples shown on this planner back are examples of Product Information & PBS Status from 2012 planners. Read on to fi nd more specifi c information
about about Medicine’s Australia requirements.
References: 1. SPIRIVA Approved Product Information. 2. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease: executive summary. Updated 2009. Available at www.goldcopd.com (accessed August 2010). Boehringer Ingelheim Pty Ltd, ABN 52 000 452 308. 78 Waterloo Road, North Ryde NSW 2113. Pfizer Australia Pty Ltd, ABN 50 008 422 348, 38-42 Wharf Road, West Ryde NSW 2114. Spiriva® was developed by Boehringer Ingelheim and is being co-promoted by Boehringer Ingelheim and Pfizer Australia. ®Registered trademark Boehringer Ingelheim. AUS/SPI-11034. SPR0034/AMA P4677 08/11
† Diagnosis of COPD, symptomatic despite prn reliever therapy2
Before prescribing review Product and PBS Information which can be found on the back of this calendar.
COPD MAINTENANCE THERAPY † right from the start † 1,2
Australian approved name should appear 1.5mm min on the lower case ‘e’ in sans serif font, 0 kerning, auto leading.
Company details should appear 1.5mm min on the lower case ‘e’ in sans serif font, 0 kerning, auto leading.
This statement referring practitioner to PI & PBS info should appear 3mm min on the lower case ‘e’ in sans serif font,
0 kerning, auto leading. Black text in white box with black border as shown.
Qualifying Statement should appear 3mm min on the lower case ‘e’ in sans serif font, 0 kerning, auto leading.
File specifications:Artwork should be supplied as a High Quality PDF using high resolution CMYK images and True Type Fonts where possible. Hard copy proofs would also
be appreciated in order to check the file’s accuracy.
If supplying JPEG & TIFF images they should be 300dpi at 100% document size. Any EPS files created using vector images from Illustrator, Freehand etc. should have type converted to paths.
No bleed is required & a border should be applied where there is no solid edge around the document i.e. ads can’t float & 1pt black border will be added by Carbine Media if necessary. Trim marks are appreciated but not essential. Please note that sizes & formats do vary and the order form should be
checked paying special attention to the ‘Landscape’ , ‘Portrait’ or ‘Square’ orientation.
Artwork must conform to current Medicine’s Australia Guidelines. For further information see: www.medicinesaustralia.com.au
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Exforge PBS Information: Restricted Benefit. Hypertension in a patient who is not adequately controlled with either of the drugs in the combination.
Please review TGA Approved Product Information before prescribing. TGA Approved Product Information available on request. EXFORGE (valsartan/amlodipine besylate). Indication: Treatment of hypertension. Treatment should not be initiated with this fixed dose combination. Dosage and administration: Recommended dose is one film-coated tablet per day (5 mg amlodipine and 80 mg valsartan, or 5 mg amlodipine and 160 mg valsartan, or 10 mg amlodipine and 160 mg valsartan, or 5 mg amlodipine and 320 mg valsartan, or 10 mg amlodipine and 320 mg valsartan). Contraindications: Hypersensitivity to the active substances (valsartan and amlodipine), dihydropyridine derivatives, or to any of the excipients; Severe hepatic impairment; biliary cirrhosis and cholestasis; Severe renal impairment (GFR <30 mL/min/1.73 m2) and patients undergoing dialysis; Pregnancy. Precautions: Risk of hypotension in sodium- and/or volume-depleted patients. Risk of increased angina in patients with severe obstructive coronary artery disease. Beta-blocker withdrawal should be gradual. Caution in patients with mild to moderate renal impairment. No data available in patients with unilateral or bilateral renal artery stenosis, stenosis to a solitary kidney or after recent kidney transplantation. Caution in patients with mild to moderate hepatic impairment without cholestatis. Special caution in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Caution should be observed when initiating therapy in patients with heart failure or post-myocardial infarction. Caution should be observed with the triple combination of an ACE-inhibitor, beta blocker and valsartan. When administered simultaneously with NSAIDs, attenuation of the antihypertensive effect may occur. Concomitant use of an angiotensin II receptor blocker and an ACE inhibitor may increase the risk of hyperkalaemia, renal failure, hypotension and syncope*. Caution when driving or operating machines. Avoid use in women planning to become pregnant and while breast-feeding. Not recommended in patients below 18 years of age. Interactions: Caution and monitoring of serum potassium levels when used concomitantly with potassium supplements, potassium sparing diuretics, salt substitutes containing potassium, or other drugs that may increase potassium level. Side effects: Most common: Nasopharyngitis, influenza, headache, oedema peripheral, oedema, fatigue, flushing, asthenia, hot flush. Rare/serious: Hypersensitivity. Additional or potentially serious adverse experiences reported in clinical trials with amlodipine monotherapy: Vomiting, gastritis, gingival hyperplasia, gynaecomastia, leucopenia, myalgia, pancreatitis, hepatitis, thrombocytopenia, vasculitis. In a long-term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA III and IV heart failure of nonischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo. Myocardial infarction or increased angina and arrhythmia (including ventricular tachycardia and atrial fibrillation) have also been reported. These adverse events may not be distinguishable from the natural history of the underlying disease. Additional potentially serious adverse experiences reported in clinical trials with valsartan monotherapy are: Neutropenia. Heart failure patients: >50% increases in creatinine in 3.9% of valsartan-treated patients compared to 0.9% of placebo-treated patients. >20% increases in serum potassium in 10% of valsartan-treated patients compared to 5.1% of placebo-treated patients. >50% increases in BUN in 16.6% of valsartan-treated patients compared to 6.3% of placebo-treated patients. Post-myocardial infarction patients: doubling of serum creatinine in 4.2% of valsartan-treated patients, 4.8% of valsartan plus captopril-treated patients, and 3.4% of captopril-treated patients. Elevated liver enzymes have also been reported in post-marketing surveillance. >20% decreases in haemoglobin and haematocrit observed in 0.4% and 0.8% respectively, of valsartan patients compared with 0.1% and 0.1% in placebo-treated patients (exf030611m.doc). PBS Dispensed Price: 5/80mg (28 tablets) $29.22; 5/160mg (28 tablets) $33.00; 10/160mg (28 tablets) $39.85; 5/320mg (28 tablets) $37.73; 10/320mg (28 tablets) $44.11.
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