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*
➀
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.
➁
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
by: LW
➂
�� =W Baxter Healthcare SA, Singapore Branch ��=�� =��I=��=��=�� =�� =��=�� !=�� =��=��=�� =�� =�� !K
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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 �
�� !� 2.5% �� !" (2.5mEq/L) �� !"�� !" �� !"# 022299 �
�� !� 4.25% �� !" (2.5mEq/L) �� !"�� !" �� !"# 022298 �
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
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PPD-15224.pm6c 04/09/2003, 10:48 AM3
by: LW
④
�� !" Baxter Healthcare SA, Singapore Branch�� !" 2 Woodlands Industrial Park D,
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PPD-15224.pm6c 04/10/2003, 9:34 AM4
