dianeal low calcium peritoneal dialysis solution - baxter · low calcium peritoneal dialysis...

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DIANEAL Low Calcium Peritoneal Dialysis Solution ULTRABAG System For Continuous Ambulatory Peritoneal Dialysis (CAPD) For intraperitoneal administration only The plastic container “Y” set is fabricated from polyvinyl chloride (PL-146 Plastic). Exposure to temperatures above 25 °C/77 °F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the solution container into the overpouch is insufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Clinical Pharmacology Peritoneal dialysis is a procedure for removing toxic substances and metabolites normally excreted by the kidneys, and for aiding in the regulation of fluid and electrolyte balance. The procedure is accomplished by instilling peritoneal dialysis fluid through a conduit into the peritoneal cavity. Toxic substances and metabolites, present in high concentration in the blood, cross the peritoneal membrane into the dialyzing fluid. Dextrose in the dialyzing fluid is used to produce a solution hyperosmolar to the plasma, creating an osmotic gradient which facilitates fluid removal from the patient’s plasma into the peritoneal cavity. After a period of time, (dwell time), the fluid is drained by gravity from the cavity. The solution does not contain potassium. In situations in which there is a normal serum potassium level or hypokalemia, the addition of potassium chloride (up to a concentration of 4 mEq/L) may be indicated to prevent severe hypokalemia. Addition of potassium chloride should be made after careful evaluation of serum and total body potassium and only under the direction of a physician. Clinical studies have demonstrated that the use of this solution resulted in significant increases in serum CO 2 and decreases in serum magnesium levels. The decrease in magnesium levels did not cause clinically significant hypomagnesemia. Indications and Usage DIANEAL Low Calcium peritoneal dialysis solutions in ULTRABAG containers are indicated for use in chronic renal failure patients being maintained on continuous ambulatory peritoneal dialysis when nondialytic medical therapy is judged to be inadequate. Contraindications None known. Warnings Not for Intravenous Injection. Use aseptic technique. Contamination of Luer lock connector may result in peritonitis. An improper clamping sequence may result in infusion of air into the peritoneum. Peritoneal dialysis should be done with great care, if at all, in patients with a number of conditions, including disruption of the peritoneal membrane or diaphragm by surgery or trauma, extensive adhesions, bowel distention, undiagnosed abdominal disease, abdominal wall infection, hernias or burns, fecal fistula or colostomy, tense ascites, obesity, large polycystic kidneys, recent aortic graft replacement, lactic acidosis, and severe pulmonary disease. When assessing peritoneal dialysis as the mode of therapy in such extreme situations, the benefits to the patient must be weighed against the possible complications. An accurate fluid balance record must be kept and the weight of the patient carefully monitored to avoid over or under hydration with severe consequences, including congestive heart failure, volume depletion, and shock. Excessive use of DIANEAL Low Calcium peritoneal dialysis solution with 3.5 % or 4.25% dextrose during a peritoneal dialysis treatment can result in significant removal of water from the patient. Stable patients undergoing maintenance peritoneal dialysis should have routine periodic evaluation of blood chemistries and hematologic factors, as well as other indicators of patient status. If the resealable rubber plug on the medication port is missing or partially removed, do not use product. After removing overpouch, check for minute leaks by squeezing container firmly. If leaks are found, discard the solution because the sterility may be impaired. After the pull ring has been removed from the outlet, check for broken connector frangible seal as evidenced by continuous fluid flow from port. A few drops of solution within the connector or protector cap may be present. If a continuous stream or droplets of fluid are noted, discard solution because sterility may be impaired. During solution drainage, fibrin strands may be observed in the solution and may become attached to the connector frangible closure. In occasional instances, partial or complete obstruction of draining may occur. Manipulation of the connector frangible closure in the tubing may free the fibrin obstruction. Precautions General: Do not administer unless solution is clear. Aseptic technique must be used throughout the procedure and at its termination in order to reduce the possibility of infection. Significant losses of protein, amino acids and water soluble vitamins may occur during peritoneal dialysis. Replacement therapy should be provided as necessary. When prescribing the solution to be used for an individual patient, consideration should be given to the potential interaction between the dialysis treatment and therapy directed at other existing illnesses. For example, rapid potassium removal may create arrhythmias in cardiac patients using digitalis or similar drugs; digitalis toxicity may be masked by elevated potassium or magnesium, or by hypocalcemia. Correction of electrolytes by dialysis may precipitate signs and symptoms of digitalis excess. Conversely, toxicity may occur at suboptimal dosages of digitalis if potassium is low or calcium high. Azotemic diabetics require careful monitoring of insulin requirements during and following dialysis with dextrose containing solutions. Laboratory tests: Serum electrolytes, magnesium, bicarbonate levels and fluid balance should be periodically monitored. Description DIANEAL Low Calcium peritoneal dialysis solutions are sterile, nonpyrogenic solutions in ULTRABAG containers for intraperitoneal administration only. They contain no bacteriostatic or antimicrobial agents. ULTRABAG containers are designed with an integrated "Y" set and drain container for infusion and drainage of DIANEAL Low Calcium when disconnection of the "Y" set from the transfer set during dwell is desired. Composition, calculated osmolarity, pH and ionic concentrations are shown in the following table. Sodium Lactate Dextrose Hydrous, USP (D-Glucopyranose monohydrate) 538 mg 1.5 g 448 mg 2.5 g 538 mg 448 mg 3.5 g 538 mg 448 mg 18.3 mg 18.3 mg 18.3 mg 5.08 mg 5.08 mg 5.08 mg 344 395 445 5.2 (4.0 to 6.5) 5.2 (4.0 to 6.5) 5.2 (4.0 to 6.5) 132 2.5 0.5 95 40 1500 2000 FNB9775 2000 2000 FNB9776 2500 3000 FNB9778 132 2.5 0.5 95 40 2500 3000 FNB9788 Calcium Chloride, USP (CaCl 2 • 2H 2 O) Sodium Lactate (C 3 H 5 NaO 3 ) Dextrose, Hydrous, USP Sodium Chloride, USP (NaCl) Magnesium Chloride, USP (MgCl 2 • 6H 2 O) OSMOLARITY (mOsmol/L)(calc) Sodium pH Lactate Magnesium Chloride Fill Volume (mL) Container Size (mL) Code Composition/100 mL Ionic Concentration (mEq/L) 4.25 g 538 mg 448 mg 18.3 mg 5.08 mg 483 5.2 (4.0 to 6.5) How Supplied 132 2.5 0.5 95 40 1500 2000 FNB9765 2000 2000 FNB9766 2500 3000 FNB9768 132 2.5 0.5 95 40 1500 2000 FNB9795 2000 2000 FNB9796 2500 3000 FNB9798 Calcium DIANEAL Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose DIANEAL Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose DIANEAL Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 3.5% Dextrose DIANEAL Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose

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by: LW

DIANEAL Low Calcium Peritoneal Dialysis SolutionULTRABAG System For Continuous Ambulatory Peritoneal Dialysis (CAPD)For intraperitoneal administration only

The plast ic container “Y” set is fabr icated f rom polyv iny l chlor ide (PL-146 Plast ic) . Exposureto temperatures above 25°C/77°F dur ing t ranspor t and s torage wi l l lead to minor losses inmoisture content . Higher temperatures lead to greater losses. I t is unl ike ly that these minorlosses wi l l lead to c l in ica l ly s ign i f icant changes wi th in the expi rat ion per iod. The amount ofwater that can per meate f rom ins ide the solut ion container in to the overpouch is insuf f ic ientto af fect the solut ion s igni f icant ly. Solut ions in contact wi th the p last ic conta iner may leachout cer ta in chemical components f rom the p last ic in ver y smal l amounts; however, b io logicaltest ing was suppor t ive of the safety of the p last ic conta iner mater ia ls.

Cl in ica l PharmacologyPer i toneal d ia lys is is a procedure for removing tox ic substances and metabol i tes normal lyexcre ted by the k idneys, and for a id ing in the regu la t ion o f f lu id and e lec t ro ly te ba lance.The procedure is accompl ished by inst i l l ing per i toneal d ia lys is f lu id through a condui t in tothe per i tonea l cav i ty. Tox ic substances and metabo l i tes, p resent in h igh concent ra t ion inthe b lood, cross the per i toneal membrane in to the d ia lyz ing f lu id . Dextrose in the d ia lyz ingf lu id is used to produce a solut ion hyperosmolar to the plasma, creat ing an osmot ic gradientwhich fac i l i ta tes f lu id removal f rom the pat ient ’s p lasma in to the per i toneal cav i ty. Af ter aper iod of t ime, (dwel l t ime), the f lu id is dra ined by gravi ty f rom the cavi ty.The so lu t ion does not conta in po tass ium. In s i tua t ions in wh ich there is a nor mal serumpotass ium leve l or hypokalemia, the addi t ion o f potass ium ch lor ide (up to a concent ra t ionof 4 mEq/L) may be indicated to prevent severe hypokalemia. Addit ion of potassium chlorideshould be made af ter carefu l eva luat ion o f serum and to ta l body potass ium and on lyunder the d i rect ion of a physic ian.Clinical studies have demonstrated that the use of this solution resulted in signif icant increasesin serum CO2 and decreases in serum magnesium levels. The decrease in magnesium levelsd id not cause c l in ica l ly s ign i f icant hypomagnesemia.

Ind icat ions and UsageDIANEAL Low Calc ium per i toneal d ia lys is so lu t ions in ULTRABAG conta iners are ind icatedfor use in chronic renal fai lure pat ients being maintained on cont inuous ambulatory per i toneald ia lys is when nondia ly t ic medical therapy is judged to be inadequate.

Contra ind icat ionsNone known.

WarningsNot for In t ravenous In ject ion.Use asept ic technique. Contaminat ion of Luer lock connector may resul t in per i toni t is.An improper c lamping sequence may resul t in in fus ion of a i r in to the per i toneum.Per i tonea l d ia lys is shou ld be done wi th great care, i f a t a l l , in pat ien ts w i th a number o fcond i t ions, inc lud ing d is rup t ion o f the per i tonea l membrane or d iaphragm by surger y o rt rauma, extens ive adhesions, bowel d is tent ion, undiagnosed abdominal d isease, abdominalwa l l in fec t ion , her n ias o r burns, feca l f i s tu la o r co los tomy, tense asc i tes, obes i ty, la rge

polycyst ic k idneys, recent aor t ic gra f t rep lacement , lac t ic ac idos is, and severe pu lmonar ydisease. When assessing peritoneal dialysis as the mode of therapy in such extreme situations,the benef i ts to the pat ient must be weighed against the possible compl icat ions.An accurate f luid balance record must be kept and the weight of the patient careful ly monitoredto avoid over or under hydrat ion with severe consequences, including congest ive hear t fai lure,volume deplet ion, and shock.Excess ive use o f DIANEAL Low Calc ium per i tonea l d ia lys is so lu t ion wi th 3 .5 % or 4 .25%dext rose dur ing a per i tonea l d ia lys is t rea tment can resu l t in s ign i f i cant remova l o f waterf rom the pat ient .S table pa t ien ts undergo ing main tenance per i tonea l d ia lys is shou ld have rou t ine per iod icevaluat ion of blood chemistr ies and hematologic factors, as wel l as other indicators of pat ientstatus.I f the resealable rubber p lug on the medicat ion por t is miss ing or par t ia l ly removed, do notuse product .A f te r remov ing over pouch, check fo r minute leaks by squeez ing conta iner f i rmly. I f leaksare found, d iscard the solut ion because the ster i l i ty may be impaired.Af ter the pu l l r ing has been removed f rom the out le t , check for broken connector f rangiblesea l as ev idenced by cont inuous f lu id f low f rom por t . A few drops o f so lu t ion w i th in theconnector or protector cap may be present . I f a cont inuous s t ream or drop le ts o f f lu id arenoted, d iscard solut ion because ster i l i ty may be impaired.Dur ing so lu t ion dra inage, f ib r in s t rands may be obser ved in the so lu t ion and may becomeat tached to the connector f rang ible c losure. In occas iona l ins tances, par t ia l o r comple teobst ruc t ion o f d ra in ing may occur. Manipu la t ion o f the connector f rang ible c losure in thetubing may f ree the f ibr in obstruct ion.

Precaut ionsGeneral : Do not adminis ter unless solut ion is c lear.Asept ic technique must be used throughout the procedure and at i ts terminat ion in order toreduce the possib i l i ty of in fect ion.S ign i f i can t losses o f p ro te in , amino ac ids and water so luble v i tamins may occur dur ingper i toneal d ia lys is. Replacement therapy should be prov ided as necessar y.When prescr ib ing the solut ion to be used for an indiv idual pat ient , considerat ion shouldbe g iven to the potent ia l in teract ion between the d ia lys is t reatment and therapy d i rected ato ther ex is t ing i l lnesses. For example, rap id potass ium removal may create ar rhy thmias incardiac pat ients using dig i ta l is or s imi lar drugs; d ig i ta l is tox ic i ty may be masked by e levatedpotass ium or magnes ium, or by hypoca lcemia . Cor rec t ion o f e lec t ro ly tes by d ia lys is mayprecipitate signs and symptoms of digital is excess. Conversely, toxicity may occur at suboptimaldosages of d ig i ta l is i f potass ium is low or ca lc ium h igh. Azotemic d iabet ics requi re carefu lmonitoring of insulin requirements during and following dialysis with dextrose containing solutions.

Laborator y tests:Serum elect ro ly tes, magnesium, b icarbonate levels and f lu id balance should be per iodica l lymoni tored.

BAR CODE LOCATION (FOR POSITION ONLY)REFER TO PARA. 5.2 FOR ACTUAL LOCATION

*PPD15063*

Descr ip t ionDIANEAL Low Calc ium per i toneal d ia lys is so lu t ions are s ter i le, nonpyrogenic so lu t ions inULTRABAG containers for intraper i toneal administrat ion only. They contain no bacter iostat icor ant imicrobia l agents.

ULTRABAG conta iners a re des igned w i th an in tegra ted "Y" se t and d ra in con ta iner fo rin fus ion and dra inage o f DIANEAL Low Calc ium when d isconnect ion o f the "Y" se t f romthe t ransfer set dur ing dwel l is desi red.Composi t ion, calculated osmolar i ty, pH and ionic concentrat ions are shown in the fo l lowingtable.

Sodium LactateDextrose Hydrous, USP

(D-Glucopyranose monohydrate)

538 mg

1.5g

448 mg

2.5 g

538 mg

448 mg

3.5 g

538 mg

448 mg

18.3 mg

18.3 mg

18.3 mg

5.08 mg

5.08 mg

5.08 mg

344

395

445

5.2(4.0to

6.5)

5.2(4.0to

6.5)

5.2(4.0to

6.5)

132 2.5 0.5 95 40 1500 2000 FNB97752000 2000 FNB97762500 3000 FNB9778

132 2.5 0.5 95 40 2500 3000 FNB9788

Cal

cium

Chl

orid

e,U

SP (C

aCl 2

• 2H

2O)

Sodi

um L

acta

te

(C3H

5NaO

3)

Dex

trose

, Hyd

rous

,U

SP

Sodi

um C

hlor

ide,

USP

(NaC

l)

Mag

nesi

um C

hlor

ide,

USP

(MgC

l 2 •

6H2O

)

OSM

OLA

RITY

(mO

smol

/L)(c

alc)

Sodi

um

pH Lact

ate

Mag

nesi

um

Chl

orid

e

FillVolume

(mL)

ContainerSize(mL)

Code

Composition/100 mL Ionic Concentration (mEq/L)

4.25g

538 mg

448 mg

18.3 mg

5.08 mg

4835.2(4.0to

6.5)

How Supplied

132 2.5 0.5 95 40 1500 2000 FNB97652000 2000 FNB97662500 3000 FNB9768

132 2.5 0.5 95 40 1500 2000 FNB97952000 2000 FNB97962500 3000 FNB9798

Cal

cium

DIANEAL Low Calcium(2.5mEq/L) PeritonealDialysis Solution with1.5% Dextrose

DIANEAL Low Calcium(2.5mEq/L) PeritonealDialysis Solution with2.5% Dextrose

DIANEAL Low Calcium(2.5mEq/L) PeritonealDialysis Solution with3.5% Dextrose

DIANEAL Low Calcium(2.5mEq/L) PeritonealDialysis Solution with4.25% Dextrose

PPD-15224.pm6c 04/09/2003, 10:46 AM5

by: LW

Carcinogenesis, mutagenesis, impair ment of fer t i l i ty :Long term animal s tud ies wi th DIANEAL Low Calc ium per i toneal d ia lys is so lu t ion have notbeen per fo r med to eva lua te the carc inogen ic po ten t ia l , mutagen ic po ten t ia l o r e f fec t onfer t i l i ty.

Pregnancy: Teratogenic Ef fectsPregnancy Category C. Animal reproduct ion studies have not been conducted wi th DIANEALLow Calc ium per i toneal d ia lysis solut ion. I t is a lso not known whether DIANEAL Low Calc iumper i toneal d ia lys is so lu t ion can cause fe ta l har m when admin is tered to a pregnant womanor can af fect reproduct ion capaci ty. DIANEAL Low Calcium per i toneal d ia lysis solut ion shouldbe g iven to a pregnant woman only i f c lear ly needed.

Nurs ing mothers:Caut ion shou ld be exerc ised when DIANEAL Low Ca lc ium per i tonea l d ia lys is so lu t ion i sadministered to a nurs ing woman.

Pediatr ic use:Safety and ef fect iveness in ch i ldren have not been establ ished.

Adverse React ionsAdverse react ions to per i toneal d ia lys is inc lude mechanica l and so lu t ion re la ted problemsas we l l as the resu l ts o f con tamina t ion o f equ ipment o r improper techn ique in ca the te rplacement. Abdominal pain, bleeding, peri tonit is, subcutaneous infect ion around the per i tonealcatheter, catheter s i te in fect ion, catheter blockage, d i f f icu l ty in f lu id removal , and i leus areamong the compl icat ions of the procedure. Solu t ion re la ted adverse react ions may inc ludeper i ton i t i s, e lec t ro l y te and f l u id imba lances, hypovo lemia , hyper vo lemia , hypo tens ion ,hyper tens ion, d isequi l ibr ium syndrome, a l lerg ic symptoms, and muscle cramping.

Dosage and Adminis t rat ionThe solut ion is used for d ia lys is therapy by inst i l l ing in to the per i toneal cavi ty.Typica l ly, 1 .5 to 2 L of d ia lys is so lu t ion is ins t i l led in to the per i toneal cav i ty o f adul ts anddwel led for 4 to 8 hours. Af ter the ef fect is considered to be obta ined, the f lu id is dra ined.Th is p rocedure i s regarded as one cyc le. In the case where the excess ive body f lu id i s1 kg/day or less, 3 to 4 exchanges a day wi th on ly DIANEAL Low Calc ium 1.5 per i tonea ld ia lys is f lu id a re conduc ted cont inuous ly. In the case where the excess ive body f lu id i s1 kg/day or greater, 1 to 4 exchanges wi th DIANEAL Low Calc ium 2.5 per i tonea l d ia lys isf lu id or 1 to 2 exchanges of DIANEAL Low Calc ium 4.25 per i toneal d ia lys is f lu id are usual lyadminis tered in combinat ion wi th DIANEAL Low Calc ium 1.5 per i toneal d ia lys is f lu id , and 3to 5 exchanges a day are conducted cont inuous ly. In fus ion vo lume, durat ion o f dwel l , and

f requency o f t rea tment shou ld be appropr ia te ly se lec ted based on the cond i t ion , bloodchemistr y, body f lu id imbalance, age and body weight of the indiv idual pat ient to be t reated.Infus ion/dra inage rate is usual ly 300 ml /minute or less.

Direct ions for UseUse asept ic technique.Preparat ion for Adminis t rat ion1. Tear overpouch down s ide at a s l i t and remove the so lut ion. Check for minute leaks by

squeezing conta iner f i rmly.2 . Remove the protector f rom out let por t at the bot tom of the conta iner.3. At tach adminis t rat ion set , according to the d i rect ion accompanying the set .4 . Suspend the conta iner f rom eyelet suppor t in the upper par t of the bag.5. Inst i l l /dra in the d ia lys is f lu id in the ULTRABAG in the procedure descr ibed below.Adminis t rat ion:1. Remove the cap of the connect ion tube on the pat ient s ide.2. Connect the connect ion tube connector o f the ULTRABAG to the t ip o f connect ion tube

on the pat ient s ide.3. Drain in t raper i toneal waste f lu id v ia the waste f lu id bag.4. Af ter dra inage, c lamp the connect ion tube on the pat ient s ide, and open the seal of the

out let on the f lu id bag of d ia lys is so lut ion.5 . Wash the c i rcu i t w i th about 100 ml o f a f resh d ia lys is f lu id ( for 10 seconds) and pour

into the waste f lu id tube.6 . Subsequent ly, c lamp the waste f lu id and re lease the c lamp of the connect ion tube on

the pat ient s ide to inst i l l the f resh d ia lys is f lu id in t raper i toneal ly.7. Af ter in fus ion, detach the connect ion tube on the pat ient s ide f rom the connect ion tube

connector of the ULTRABAG.8. At tach the cap to the t ip o f the connect ion tube on the pa t ien t s ide to comple te the

replacement procedure.

Manufactured byBaxter Healthcare SA, Singapore Branch2 Woodlands Industrial Park D Singapore 738750(An affiliate of Baxter Healthcare Corporation USA)Printed in SingaporePPD-15-224 Iss. February 2003

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PPD-15224.pm6c 04/02/2003, 3:39 PM2

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Sodium LactateDextrose Hydrous, USP

(D-Glucopyranose monohydrate)

“Baxter” DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose (In ULTRABAG Container)“Baxter” DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose (In ULTRABAG Container)“Baxter” DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose (In ULTRABAG Container)

�� !� 1.5% �� !" (2.5mEq/L) �� !"�� !" �� !"# 022297 �

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538 mg

1.5g

448 mg

2.5 g

538 mg

448 mg

3.5 g

538 mg

448 mg

18.3 mg

18.3 mg

18.3 mg

5.08 mg

5.08 mg

5.08 mg

344

395

445

5.2(4.0to

6.5)

5.2(4.0to

6.5)

5.2(4.0to

6.5)

132 2.5 0.5 95 40 1500 2000 FNB97752000 2000 FNB97762500 3000 FNB9778

132 2.5 0.5 95 40 2500 3000 FNB9788

Cal

cium

Chl

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SP (C

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Sodi

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rous

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SP

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USP

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OSM

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pH Lact

ate

Mag

nesi

um

Chl

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FillVolume

(mL)

ContainerSize(mL)

Code

Composition/100 mL Ionic Concentration (mEq/L)

4.25g

538 mg

448 mg

18.3 mg

5.08 mg

4835.2(4.0to

6.5)

How Supplied

132 2.5 0.5 95 40 1500 2000 FNB97652000 2000 FNB97662500 3000 FNB9768

132 2.5 0.5 95 40 1500 2000 FNB97952000 2000 FNB97962500 3000 FNB9798

Cal

cium

DIANEAL Low Calcium(2.5mEq/L) PeritonealDialysis Solution with1.5% Dextrose

DIANEAL Low Calcium(2.5mEq/L) PeritonealDialysis Solution with2.5% Dextrose

DIANEAL Low Calcium(2.5mEq/L) PeritonealDialysis Solution with3.5% Dextrose

DIANEAL Low Calcium(2.5mEq/L) PeritonealDialysis Solution with4.25% Dextrose

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by: LW

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