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Etrivex for Galderma layout and print prep

Press Ad / Leavepiece / Roller Banner

THE ONLY STEROID SCALP PSORIASIS TREATMENT

THAT SHAMPOOS OUT 15 MINUTES AFTER APPLICATION

Etrivex Shampoo Abbreviated Prescribing Information (UK & IRE)

Presentation: 500 micrograms/g clobetasol propionate shampoo. Indications: Topical treatment

of moderate scalp psoriasis in adults. Dosage and Administration: For cutaneous use on

the scalp. Applied directly on to dry scalp once daily and left for 15 minutes before rinsing.

Treatment duration should be limited to 4 weeks. Not recommended for use below 18 years

of age. Contraindications: Hypersensitivity to active substance or any of the excipients. Skin

areas affected by bacterial, viral, fungal or parasitic infections and specifi c skin diseases (skin

tuberculosis, skin diseases caused by lues). Must not be applied to eyes or to ulcerous wounds.

Not for use in children under 2 years. Precautions and Warnings: Topical corticosteroids should

be used with caution due to post treatment rebound relapses, tachyphylaxis & local or systemic

toxicity. Abrupt discontinuation can lead to acute adrenal insuffi ciency, especially in children. If

Etrivex shampoo is used in children and adolescents below 18 years of age, treatment should

be reviewed weekly. Etrivex shampoo is only intended for the treatment of scalp psoriasis and

should not be used to treat other skin areas. In particular, the face, eyelids, intertriginous areas

(axillae and genitoanal regions) and other erosive skin surfaces. If Etrivex shampoo does enter the

eye, the affected eye should be rinsed with copious amounts of water. Pregnancy and Lactation:

Should not be used during pregnancy or lactation unless clearly necessary. Undesirable Effects:

During clinical development the most commonly reported adverse drug reaction was skin

discomfort (5% incidence), with no serious drug-related adverse events reported. Adverse events

related to treatment were: Common (≥1/100, <1/10): Skin discomfort, Acne/folliculitis Eye stinging/

burning. Uncommon (≥1/1000, <1/100): Local signs of irritation, Pruritus, Urticaria, Telangiectasia,

Skin atrophy. Prolonged use of topical corticosteroids/treatment of extensive areas/use of large

amounts can result in suffi cient systemic absorption to produce the features of hypercortisolism

(Cushing syndrome) or of Hypothalamus-Pituitary-Adrenal (HPA) axis suppression. Risk of HPA axis

suppression is low due to short contact nature of Etrivex shampoo. No HPA axis suppression was

observed during clinical trials. Prolonged and/or intensive treatment with potent corticosteroids

may cause local atrophic changes, such as local skin atrophy, striae, telangiectasia, erythema,

purpura, contact dermatitis. During development of Etrivex Shampoo no skin thinning was

observed. When applied to the face, very potent corticosteroids can induce perioral dermatitis,

skin atrophy or worsen rosacea. There are reports of pigmentation changes, acne, pustular

eruptions and hypertrichosis with topical corticosteroids. Prescribers should consult the summary

of product characteristics in relation to other side-effects. Packaging Quantities and Cost: 125ml

UK £14.32, IRE €16.08. MA Number: PL 10590/0052 PA 590/23/1. Legal Category: POM. Full

prescribing information is available from: Galderma (UK) Ltd, Meridien House, 69-71 Clarendon

Road, Watford, Herts, WD17 1DS, Telephone: +44 (0) 1923 208950 Fax: +44 (0) 1923 208998.

Date of Revision: November 2012.

Adverse events should be reported. Reporting forms and information can be found at

www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Galderma (UK) Ltd.

Reference:

1. Tan J, Thomas R, Wang B et al. Short-Contact Clobetasol Propionate Shampoo 0.05%

Improves Quality of Life in Patients With Scalp Psoriasis. Cutis 2009; 83: 157-64.

© 2012 Galderma (UK) Ltd. CLO/004/0212a February 2013

BEAUTIFULLY SIMPLE500 micrograms/g Shampoo

(clobetasol propionate)

AN EFFECTIVE TREATMENT

[the science bit]

- containing the very potent corticosteroid clobetasol

propionate 0.05%

- with a short contact formulation to minimise the

incidence of side effects

THAT FITS INTO PATIENTS’ ROUTINES

[the scented bit]

- applied once-daily to dry hair

- left on the scalp for 15 minutes

- turns into a shampoo in the shower where it is simply

rinsed off, cleansing like a regular shampoo

81% of patients found Etrivex to be

better than previous treatments1

THE ONLY STEROID SCALP PSORIASIS TREATMENT

THAT SHAMPOOS OUT 15 MINUTES AFTER APPLICATION

BEAUTIFULLY SIMPLE

500 micrograms/g Shampoo

(clobetasol propionate)

Adverse events should be reported. Reporting forms and

information can be found at www.mhra.gov.uk/yellowcard.

Adverse events should also be reported to Galderma (UK) Ltd.

© 2012 Galderma (UK) Ltd. CLO/011/0613 June 2013

Prescribing information can be found at this stand

Visipaque Journals / Reports for GE typesetting, layout,photoshop & print prep

5

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Contents

Section 1Section 1references

Next section

Previous section

SPCPrescribing information

Second generation, low osmolar contrast media (LOCM)20,21

▲ non-ionic LOCMThe carboxyl group is replaced by side chains with a non-dissociating hydrophilic

hydroxyl group. This results in a non-ionic CM with an osmolality less than half that

of HOCM yet still hyperosmolar to blood by a factor of >2 to 3.

▲ ionic LOCMConsisting of two benzene rings (i.e. a dimer) and one ionised carboxyl group, these

CM have an osmolality similar to that of non-ionic LOCM.

Third generation, isosmolar contrast media (IOCM)20,21

These CM have two tri-iodinated benzene rings with a high number of hydroxyl

groups in all side chains. They are isosmolar with plasma at all available iodine

concentrations.

Visipaque (iodixanol) is a non-ionic dimer. It is the only CM for intravascular use that

has a similar physiological osmolality as blood (290 mOsm/kg H2O) at all available

iodine concentrations.1

Figure 2: Osmolality ranges of different contrast media at 37ºC in relation to

blood (mOsm/kg H2O) at the most commonly used concentrations in diagnostic

and interventional procedures (300-400 mgl/ml)

IOCM

LOCM

HOCM

425

290

blood

Visipaque290

915

Osmolality of LOCM

1870

2130+

Osmolality of HOCM

0

500

1000

3000

Osmolality (mOsm/kg H2O)

2

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ContentsNext section

SPC

Prescribing information

Introduction

3Section 1 Visipaque – designed to help manage risk in patients vulnerable to contrast-related reactions 4

Physiochemical properties of contrast media 4

CM impact on blood cell morphology 6

CM impact on endothelial cell morphology 7

CM impact on blood rheology

8

CM impact on renal function

9

- osmotic effects

9

- tubular toxicity

10

- haemodynamic effects

10

CM impact on cardiac function

11

- osmotic effects

12

- electrolyte effects

12

- electrophysiological effects of Visipaque in animal studies

14

- haemodynamic effects of Visipaque in animal studies 15

CM impact on patient comfort

16

References

18Section 2 Visipaque – proven to help manage renal risk in patients vulnerable to contrast-induced nephropathy

20

The incidence of contrast-induced nephropathy 20

Risk factors for CIN

21

The consequences of CIN

22

Early clinical studies suggesting osmolality is key 24

Head-to-head studies with Visipaque 25

Intra-arterial studies

25

– versus the LOCM iohexol

25

– versus the ionic LOCM ioxaglate 26

– versus the LOCM ioversol

27

– versus the LOCM iopromide

28

– versus the LOCM iopamidol

30

– versus the LOCM iomeprol

32

Intravenous CT studies

34

– versus the LOCM iopromide

34

– versus the LOCM iopamidol

35

– versus the LOCM iomeprol

35

Meta-analyses examining the incidence of CIN 36

Comparison of results with previous meta-analysis 38

Comparison of studies included with previousmeta-analysis

38

Identifying patients at risk of CIN 39

References

43Section 3 Visipaque – proven to help manage cardiac risk in patients vulnerable to contrast-related reactions

45

Impact on cardiac electrical activity 45

Impact on cardiac mechanical performance 46

Impact on heart rate

47

Low potential for major adverse cardiac events 48

References

52Section 4 Visipaque – proven to help minimisepatient discomfort

53

References

58Section 5 Visipaque – potential cost effi cacy for high-risk patients

59

The burden of CIN

59

The cost-effi cacy/cost-saving potential of Visipaque 60

References

64Section 6 Visipaque – proven in everyday procedures 65

Computed tomography

65

Paediatric radiology

68

Immediate (acute) and late (delayed) hypersensitivity reactions

69

Case histories

71

References

86Section 7 Visipaque – Summary of Product Characteristics 87

Visipaque – Prescribing information 97

Contents

GE Healthcare

Contents

SPC


Product monograph

Isosmolar Visipaque:

Helping to manage risk in patients vulnerable to cardio-renal contrast-related adverse reactions1

6

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Contents

Section 1

Section 1references

Next section

Previous section

SPC


CM impact on blood cell morphologySignifi cant changes in red blood cell morphology may occur when cells are

incubated in CM. The normal discoid shape of red blood cells can be lost with the

appearance of multiple short membrane projections (echinocytes or burr cells) or

multiple sharp projections of variable length (acanthocytes or spur cells).22While echinocyte formation may be largely dependent on the chemotoxicity of CM,

spur cell formation is thought to be mainly caused by water being drawn from red

blood cells with subsequent shrinkage of the cell membrane producing a

dessicocyte. Dessicocyte formation as a result of red blood cell dehydration is

proportional to CM osmolality.22

Both dessicocyte and echinocyte formation are associated with a rigidifi cation of

blood cells. Since plasticity is essential for circulation and the smooth fl ow of red

blood cells through small capillaries, capillary perfusion and, consequently, a

tissue’s oxygen supply, may be adversely affected by such changes in

morphology.22,23

Jung et al added Visipaque, isotonic saline, iohexol, iopromide or iomeprol to the

plasma of healthy volunteers that they then incubated at 37ºC for 5 minutes.

Visipaque clearly differed from the other CM with a signifi cantly greater fraction of

normal erythrocytes, while the LOCM did not differ signifi cantly from each other in

this respect.23

A similar study comparing the effects of Visipaque with those of the LOCM

iopromide and iopamidol was conducted by Kerl et al.22 In vitro red blood cell

morphology was found to be less affected by isosmolar Visipaque than by the

LOCM iopromide and iopamidol.

Figure 3: Prevalence of normal erythrocytes following incubation in 40% solutions23IOCM:

LOCM:

iopromide370 mgI/ml

iomeprol350 mgI/ml

20 40 60 80% normal red cells

iohexol350 mgI/ml

Visipaque320 mgI/ml

0

Adapted from Jung23Reproduced permission from IOS press.

73%

12%

22%

21%

Product monograph

Celgene Corporate layout, photoshop & print prep

Thinking long term for patients with multiple myeloma

We believe that multiple myeloma shouldn’t stop her from starting


We believe that multiple myeloma shouldn’t stop him from starting


We believe that multiple myeloma shouldn’t stop him from starting

Press Ads

Elaprase – Spike goes to the hospital layout & print prep

Hard Back Book

Fostair design and layout

Press Ads

Fostair layout and print prep

Breast milk is the best,

there’s no doubt about it.

Its composition is complex, containing

antibodies and unique components that

even scientists have not yet discovered.

But there’s also a lot th

at we do know

about breast milk, and it’s

with the latest

research that we have reformulated our

First Infant M

ilk, to make it closer to

breast milk than any other fo

rmula.Drop for drop, we’re closer to breast milk than any other formula1-7

Press Ad / Mailer

Simponi layout, artwork & interactive

interactive powerpoint

Bayer Brand Book layout and artwork

Ready for take off

Adempas® global brand identity 2013

Version 3.0

HomeHome

1.0 Introduction to Adempas® brand 03

1.1 The aims of the brand book 041.2 Choosing the brand name 051.3 The competitive landscape 061.4 The Adempas® brand vision and strategy 071.5 The Adempas® brand strategy activities 081.6 The Adempas® brand benefi t edge 091.7 The Adempas® brand personality 10

2.0 Adempas® identity toolkit 11

2.1 Our brand mark components 122.2 The brand mark: Adempas® wings 132.3 The brand mark: Adempas® primary brand mark 142.4 The brand mark: Secondary logo suite 152.5 The brand mark: Clear space and minimum size 162.6 The brand mark: How not to use the logo 172.7 The brand mark: Adempas® non-Latin logo 18

2.8 Typography: Our primary typeface FS Albert 192.9 Typography: FS Albert typeface 202.10 Typography: FS Albert Pro typeface 212.11 Typography: Our secondary typeface Helvetica 22

2.12 Color: Introduction 232.13 Color: Primary color palette 242.14 Color: Secondary color palette 252.15 Color: Secondary color palette specifi cations 26

2.16 The brand mark: Exceptions + Examples 27-28

2.17 Photography: Introduction 292.18 Photographic style: Guidance for shooting 30

your own backgrounds 2.19 Photographic style: Creating a story within 31

the shot

2.20 Graphics: Introduction 322.21 Graphics: Charts, graphs and diagrams 33-35 2.22 Graphics: Infographics 36

3.0 Applying our brand 37

International grids:3.1 A4 Clinical front cover 383.2 A4 Promotional front cover 393.3 A4 Clinical inside spreads 403.4 A4 Inside spreads: Watermark 413.5 A4 Clinical back cover 423.6 A5 Clinical front cover 433.7 A5 Promotional front cover 443.8 A5 Clinical inside spreads 453.9 A5 Clinical back cover 46

US grids:3.10 A4 US Clinical front cover 473.11 A4 US Promotional front cover 483.12 A4 US Clinical inside spreads: Watermark 49-503.13 A4 US Clinical back cover 51

4.0 Microsoft® Offi ce templates 52

4.1 Marketing PowerPoint: Adempas® 53-544.2 Microsoft® Word document: Templates 554.3 Promotional Powerpoint: Adempas® 56

5.0 Adempas® campaign 57

5.1 Adempas® campaign: Imagery 58-595.2 Adempas® campaign: How to use the 60

photographic toolkit5.3 Adempas® campaign: Guidance on 61

master ad headlines

6.0 Adempas® promotional printed examples 62

Nurse and physician: 6.1 A4 Promotional sales aid front cover 636.2 A4 Promotional sales aid introduction spread 646.3 A4 Promotional sales aid inside spread 656.4 A5 Promotional leave piece front cover 666.5 A5 Promotional leave piece introduction spread 67

6.6 A5 Promotional leave piece inside spread 68

6.7 Promotional journal adverts: Single page 696.8 Promotional journal adverts: DPS 70

6.9 PIs A4 back cover 716.10 PIs A5 back cover 72

7.0 Adempas® clinical printed examples 73

Nurse and physician: 7.1 A4 Clinical front cover 747.2 A4 Clinical inside spread 757.3 A4 Clinical documents of more than 20 pages 76

8.0 Adempas® branded and unbranded 77

8.0 Patient communication: Silhouettes 8.1 Branded A5 patient leave piece front cover 788.2 Branded A5 patient leave piece inside spread 798.3 Unbranded A5 Silhouettes with campaign imagery 808.4 Unbranded A5 Silhouette imagery checklist 818.5 Unbranded A5 Patient leavepiece front cover 828.6 Unbranded A5 Patient leavepiece inside spread 838.7 Unbranded Caregiver communication: Silhouettes 848.8 Unbranded A5 Caregiver brochure front cover 858.9 Unbranded A5 Caregiver brochure inside spread 86

9.0 Adempas® events, exhibitions and symposia 87

9.1 Event stand examples 889.2 Pull-up banner and lectern examples 899.3 Event collateral examples 909.4 Symposia Introduction 919.5 Symposia Examples 92-93

Contents

Adempas Global Brand Identity | 2014 1

Adempas Global Brand Identity | 2014

28

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2.16 The brand mark | Exceptions + Examples

A personalizedtreatmentHow to take Adempas®You are unique. Adempas® therapy is tailored at the start of treatment with your

PH healthcare professional to provide optimized care for you

Adempas® is taken orally as a tablet three times a day and is

available in the following doses:1

The Adempas® starting dose is 1mg three times a day,

taken with or without food1 You should take each tablet 6-8 hours apart1

Adempas® enables personalized oral dosing to help meet

your individual needs1

Full titration starting information can be found under the flap of the last page

0.5mg 1mg 1.5mg 2mg 2.5mg

1mgTID

TID

TDS1.5mg

Starting dose

Maximum dose

0.5mgTID

Day 1

Week 2

Week 4

Week 6

Week 8

Step 1Assess patient baseline

and initiate dosingStep 2

Assess patient suitability to titrate

up, down or remain on doseStep 3





Assess patient suitability to maintain their

individual dose and continue treatment

BP

BP

BP

BP

Increase dose by 0.5mg if systolic blood pressure is greater than or

equal to 95mmHg

Patient assessment:Measure blood pressure and look for

signs and symptoms of hypotension.

Monitor treatment-related side effectsThe established individual dose should be continued

unless signs and symptoms of hypotension occur

If a tablet is missed, treatment should be continued

with the next tablet as planned

Where treatment is interrupted for three days or

more, it should be restarted at 1mg for two weeks and

then treatment continued according to the titration

scheme describedTID: 3 x daily

Reduce dose by 0.5mg if systolic blood pressure is less than 95mmHg

and patient shows signs and symptoms of hypotension

Maintain dose if systolic blood pressure is

less than 95mmHg and patient shows no

signs and symptoms of hypotension

BP

TID

2mg

TID

2.5mg

How Adempas® is takenHow to start your patients on Adempas® and titrate them

to an individualized dose

2.5mg 75%

2mg 15%

1.5mg 5%

1mg 3%

0.5mg 2%

An example of how the packaging colours are used in the titration diagram and to indicate the various

doses in HCP and patient material

Adempas Global Brand Identity | 2014 19

HomeHome

ABCDEFGHIJKLMNOPQRSTUVWXYZabcdefghijklmnopqrstuvwxyz0123456789

AaType is the clothing that dresses words, giving them character, emphasis and personality.• FS Albert’s a charismatic face.

• Warm, sensitive, with personality.

• A friendly, approachable sans serif font; shapely and fl exible.

• It is clean, highly legible and a contemporary representation of the brand values.

2.8 Typography | Our primary typeface FS Albert


25

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The secondary color palette for Adempas®

comprises of eight colors and can easily

accommodate different audiences and media

needs with a combination of strong, rich colors

and lighter, more subtle tones, as illustrated

in section 2.14.

Secondary color palette

The eight colors that form the secondary

palette can be tinted to produce variations.

These colors can be used to represent

competitor products in data visualization

and information graphics.

The colors aren’t connected with specifi c

businesses, divisions, products or services.

They are there for everyone to use.

White type should NEVER be reversed out

of less than a 50% tint of any color.

2.14 Color | Secondary color palette


26

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2.15 Color | Secondary color palette specifi cationsColor specifi cationsThe respective Pantone references, CMYK

and RGB values are shown below.

100%

70%

50%

20%

Pantone 7406 CC 0M

18Y 100K

0R 255G 207B

1

Pantone 1807 C C 0M

100Y 96K 28R

181G 18B 27

Pantone 242 C C 10M

100Y 0K

49R 130G

0B 83

Pantone 511 C C 60M

100Y 45K 30R

98G 27B 75

Pantone 7460 C C 100M

0Y 0K 5R

0G 165B 227

Pantone 315 C C 100M

0Y 12K 43R 0G

114B 143

Pantone 548 C C 100M 24Y 0K

64R 0G

68B 106

Pantone 7490 C C 45M 0Y

80K 35R

103G 145B 70

interactive pdf

iPad & Web page built in Indesign

Breast milk

Non-nutritional bioactive components

Rich in alpha-protein

SN-2 palmitate rich fat

Prebiotic effect

For more information please contact:

By email: [email protected]

By telephone: 07901717058

paul cleavely - portfoliohr

Documents

skin areas

treatment of scalp psoriasis

skin discomfort

treatment duration

used concentrations

blood mosmkg h2o

osmolality similar

erosive skin surfaces