dianeal low calcium peritoneal dialysis solution - .low calcium peritoneal dialysis solution. it

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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 25C/77F 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, impa