DIANEAL PD-2 Peritoneal Dialysis Solution · · 2010-11-07DIANEAL PD-2 Peritoneal Dialysis...
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DIANEAL PD-2 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 PD-2 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 PD-2 peritoneal dialysis solution with 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 ➀ Description DIANEAL PD-2 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 and integrated "Y" set and drain container for infusion and drainage of DIANEAL PD-2 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. Dextrose Hydrous, USP (D-Glucopyranose monohydrate) Sodium Lactate DIANEAL PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose 538 mg 1.5 g 448 mg 2.5 g 538 mg 448 mg 4.25 g 538 mg 448 mg 25.7 mg 25.7 mg 25.7 mg 5.08 mg 5.08 mg 5.08 mg 346 396 485 5.2 (4.0 to 6.5) 5.2 (4.0 to 6.5) 5.2 (4.0 to 6.5) 132 3.5 0.5 96 40 1500 2000 FNB9865 2000 2000 FNB9866 2500 3000 FNB9868 132 3.5 0.5 96 40 1500 2000 FNB9875 2000 2000 FNB9876 2500 3000 FNB9878 132 3.5 0.5 96 40 1500 2000 FNB9895 2000 2000 FNB9896 2500 3000 FNB9898 Calcium Chloride, USP (CaCl 2 • 2H 2 O) 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) DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose How Supplied DIANEAL PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose Sodium Lactate (C 3 H 5 NaO 3 ) Calcium
Transcript of DIANEAL PD-2 Peritoneal Dialysis Solution · · 2010-11-07DIANEAL PD-2 Peritoneal Dialysis...
DIANEAL PD-2 Peritoneal Dialysis SolutionULTRABAG System For Cont inuous Ambulator y Per i toneal Dia lys is (CAPD)For in t raper i toneal adminis t rat ion only
The p las t ic conta iner “Y” se t i s fabr ica ted f rom po lyv iny l ch lo r ide (PL-146 P las t ic ) .Exposure to temperatures above 25°C/77°F dur ing t ranspor t and s torage wi l l lead tominor losses in mo is tu re con ten t . H igher tempera tures lead to grea ter losses. I t i sun l ike ly that these minor losses wi l l lead to c l in ica l ly s ign i f i cant changes wi th in theexp i ra t ion per iod . The amount o f water tha t can per meate f rom ins ide the so lu t ioncontainer into the over pouch is insuf f ic ient to af fect the solut ion s igni f icant ly. Solut ionsin contact wi th the p last ic conta iner may leach out cer ta in chemical components f romthe p las t ic in ver y smal l amounts ; however, b io log ica l tes t ing was suppor t ive o f thesafety of the p last ic conta iner mater ia ls.
Cl in ica l PharmacologyPeritoneal dialysis is a procedure for removing toxic substances and metaboli tes normallyexcreted by the kidneys, and for aiding in the regulat ion of f lu id and electrolyte balance.The procedure is accompl ished by inst i l l ing per i toneal d ia lys is f lu id through a condui tinto the per itoneal cavity. Toxic substances and metaboli tes, present in high concentrationin the blood, c ross the per i toneal membrane in to the d ia lyz ing f lu id . Dext rose in thedia lyz ing f lu id is used to produce a so lu t ion hyperosmolar to the p lasma, creat ing anosmot ic grad ien t wh ich fac i l i t a tes f lu id remova l f rom the pa t ien t ’s p lasma in to theper i tonea l cav i ty. A f te r a per iod o f t ime (dwel l t ime) , the f lu id i s d ra ined by grav i tyf rom the cavi ty.The so lu t ion does no t con ta in po tass ium. In s i tua t ions in wh ich there i s a nor ma lserum potass ium leve l o r hypoka lemia , the add i t ion o f po tass ium ch lo r ide (up to aconcent ra t ion of 4 mEq/L) may be ind icated to prevent severe hypokalemia. Addi t ionof potassium chlor ide should be made af ter carefu l evaluat ion of serum and tota lbody potassium and only under the d i rect ion of a physic ian.Cl in ica l s tud ies have demonstrated that the use of th is so lut ion resul ted in s ign i f icantincreases in serum CO2 and decreases in serum magnes ium leve ls. The decrease inmagnesium levels d id not cause c l in ica l ly s ign i f icant hypomagnesemia.
Ind icat ions and UsageDIANEAL PD-2 per i tonea l d ia lys is so lu t ions in ULTRABAG conta iners a re ind ica tedfor use in chron ic rena l fa i lu re pat ien ts be ing main ta ined on cont inuous ambula tor yper i toneal d 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 toneal d ia lys is should be done wi th great care, i f a t a l l , in pat ients wi th a numberof condi t ions, inc luding disrupt ion of the per i toneal membrane or d iaphragm by surgeryor t rauma, ex tens ive adhes ions, bowel d is ten t ion , und iagnosed abdomina l d isease,abdomina l wa l l in fec t ion , hern ias or bur ns, feca l f i s tu la or co los tomy, tense asc i tes,obesi ty, large polycyst ic k idneys, recent aor t ic graf t rep lacement , lact ic ac idos is, andsevere pulmonar y d isease. When assessing per i toneal d ia lys is as the mode of therapyin such ex t reme s i tua t ions, the benef i ts to the pat ien t must be we ighed aga ins t thepossible compl icat ions.An accurate f lu id ba lance record must be kept and the weight o f the pat ient carefu l lymon i to red to avo id ove r o r under hyd ra t i on w i th seve re consequences, i nc lud ingcongest ive hear t fa i lure, vo lume deplet ion, and shock.Excessive use of DIANEAL PD-2 per i toneal dialysis solut ion with 4.25% dextrose dur inga per i toneal dialysis treatment can result in signif icant removal of water from the patient.Stable pat ients undergoing maintenance per i toneal dialysis should have rout ine per iodicevaluat ion of blood chemistr ies and hematologic factors, as wel l as other indicators ofpat ient s tatus.I f the resealable rubber p lug on the medicat ion por t is miss ing or par t ia l ly removed,do not use product .A f te r remov ing over pouch, check fo r m inu te leaks by squeez ing conta iner f i rm ly. I fleaks are found, d iscard the solut ion because the ster i l i ty may be impaired.After the pull r ing has been removed from the outlet, check for broken connector frangiblesea 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 wi th inthe connector or protector cap may be present . I f a cont inuous s t ream or drop le ts o ff lu id are noted, d iscard solut ion because ster i l i ty may be impaired.Dur ing solut ion drainage, f ibrin strands may be observed in the solut ion and may becomeattached to the connector f rangible c losure. In occasional instances, par t ia l or completeobst ruct ion o f dra in ing may occur. Manipu la t ion o f the connector f rang ible c losure inthe tubing may f ree the f ibr in obstruct ion.
Precaut ionsGeneral : Do not adminis ter unless solut ion is c lear.Asept ic techn ique must be used th roughout the procedure and a t i t s te r minat ion inorder to reduce the possib i l i ty of in fect ion.Signi f icant losses of prote in, amino acids and water soluble 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 given to the potent ial interact ion between the dialysis t reatment and therapy directedat other exist ing i l lnesses. For example, rapid potassium removal may create arrhythmiasin card iac pat ients us ing d ig i ta l is or s imi lar drugs; d ig i ta l is tox ic i ty may be masked bye levated potass ium or magnes ium, or by hypoca lcemia. Correc t ion o f e lec t ro ly tes by
BAR CODE LOCATION (FOR POSITION ONLY)REFER TO PARA. 5.2 FOR ACTUAL LOCATION
*PPD15064*
➀
Descr ip t ionDIANEAL PD-2 per i tonea l d ia lys is so lu t ions a re s te r i l e , nonpyrogen ic so lu t ions inU LT R A B AG C o n t a i n e r s fo r i n t ra p e r i t o n e a l a d m i n i s t ra t i o n o n l y. T h ey c o n t a i n n obacter iostat ic or ant imicrobia l agents.
ULTRABAG conta iners are des igned wi th and in tegra ted "Y" se t and dra in conta inerfo r in fus ion and dra inage o f DIANEAL PD-2 when d isconnect ion o f the "Y" se t f romthe t ransfer set dur ing dwel l is desi red.Compos i t ion , ca lcu la ted osmola r i t y, pH and ion ic concen t ra t ions a re shown in thefo l lowing table.
Dextrose Hydrous, USP(D-Glucopyranose monohydrate)
Sodium Lactate
DIANEAL PD-2Peritoneal DialysisSolution with2.5% Dextrose
538mg
1.5g
448mg
2.5g
538mg
448mg
4.25g
538mg
448mg
25.7mg
25.7mg
25.7mg
5.08mg
5.08mg
5.08mg
346
396
485
5.2(4.0to
6.5)
5.2(4.0to
6.5)
5.2(4.0to
6.5)
132 3.5 0.5 96 40 1500 2000 FNB98652000 2000 FNB98662500 3000 FNB9868
132 3.5 0.5 96 40 1500 2000 FNB98752000 2000 FNB98762500 3000 FNB9878
132 3.5 0.5 96 40 1500 2000 FNB98952000 2000 FNB98962500 3000 FNB9898
Cal
cium
Chl
orid
e, U
SP(C
aCl 2
• 2H
2O)
Dex
trose
, Hyd
rous
, USP
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)
DIANEAL PD-2Peritoneal DialysisSolution with1.5% Dextrose
How Supplied
DIANEAL PD-2Peritoneal DialysisSolution with4.25% Dextrose
Sodi
um L
acta
te(C
3H5N
aO3)
Cal
cium
PPD-15223.pm6c 04/02/2003, 4:15 PM5
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dia lys is may prec ip i ta te s igns and symptoms of d ig i ta l is excess. Converse ly, tox ic i tymay occur at suboptimal dosages of digital is i f potassium is low or calcium high. Azotemicdiabet ics require careful monitor ing of insul in requirements dur ing and fol lowing dialysiswi th dextrose conta in ing solut ions.
Laborator y tests:Se r um e lec t ro l y tes, magnes ium, b i ca rbona te l eve l s and f l u i d ba lance shou ld beper iodica l ly moni tored.Carc inogenesis, mutagenesis, impairment of fer t i l i ty :Long term animal studies with DIANEAL PD-2 peri toneal dialysis solut ion have not beenperformed to evaluate the carcinogenic potential, mutagenic potential or effect on fer t i l i ty.
Pregnancy: Teratogenic Ef fectsPregnancy Categor y C. An ima l reproduc t ion s tud ies have no t been conduc ted w i thDIANEAL PD-2 per i tonea l d ia lys is so lu t ion . I t i s a lso no t known whether DIANEALPD-2 per i toneal d ia lysis solut ion can cause fetal harm when administered to a pregnantwoman or can af fect reproduct ion capaci ty. DIANEAL PD-2 per i toneal d ia lys is so lut ionshould be g iven to a pregnant woman only i f c lear ly needed.
Nurs ing mothers:Cau t ion shou ld be exe rc i sed when D IANEAL PD-2 pe r i t onea l d ia l ys i s so lu t i on 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 reactions to per itoneal dialysis include mechanical and solution related problemsas wel l as the resul ts of contaminat ion of equipment or improper technique in catheterp lacement . Abdomina l pa in , bleed ing, per i ton i t i s, subcutaneous in fec t ion around theper i toneal catheter, catheter s i te infect ion, catheter blockage, d i f f icul ty in f lu id removal ,and i leus a re among the compl i ca t ions o f the p rocedure. So lu t ion re la ted adversereac t i ons may inc lude pe r i t on i t i s , e lec t ro l y te and f l u id imba lances, hypovo lemia ,hyper volemia, hypotension, 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 lut ion is inst i l led in to the per i toneal cav i ty of adul tsand dwel led for 4 to 8 hours. Af ter the ef fect is considered to be obta ined, the f lu id isdra ined. Th is p rocedure is regarded as one cyc le. In the case where the excess ivebody f lu id is 1 kg /day or less, 3 to 4 exchanges a day wi th on ly DIANEAL PD-2 1 .5per i toneal d ia lys is f lu id are conducted cont inuous ly. In the case where the excess ivebody f lu id is 1 kg/day or greater, 1 to 4 exchanges wi th DIANEAL PD-2 2.5 per i toneal
d ia lys is f lu id or 1 to 2 exchanges of DIANEAL PD-2 4.25 per i toneal d ia lys is f lu id areusual ly admin is tered in combinat ion wi th DIANEAL PD-2 1.5 per i toneal d ia lys is f lu id ,and 3 to 5 exchanges a day are conducted cont inuously. In fus ion vo lume, durat ion ofdwe l l , and f requency o f t rea tment shou ld be appropr ia te l y se lec ted based on thecondi t ion, blood chemistr y, body f lu id imbalance, age and body weight of the indiv idualpat ient to be t reated. In fus 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 over pouch down s ide a t a s l i t and remove the so lu t ion . Check fo r m inu te
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 solut 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 tube 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 pat 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-15-223 Iss. February 2003
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Dextrose Hydrous, USP(D-Glucopyranose monohydrate)
Sodium Lactate
DIANEAL PD-2Peritoneal DialysisSolution with2.5% Dextrose
538mg
1.5g
448mg
2.5g
538mg
448mg
4.25g
538mg
448mg
25.7mg
25.7mg
25.7mg
5.08mg
5.08mg
5.08mg
346
396
485
5.2(4.0to
6.5)
5.2(4.0to
6.5)
5.2(4.0to
6.5)
132 3.5 0.5 96 40 1500 2000 FNB98652000 2000 FNB98662500 3000 FNB9868
132 3.5 0.5 96 40 1500 2000 FNB98752000 2000 FNB98762500 3000 FNB9878
132 3.5 0.5 96 40 1500 2000 FNB98952000 2000 FNB98962500 3000 FNB9898
Cal
cium
Chl
orid
e, U
SP(C
aCl 2
• 2H
2O)
Dex
trose
, Hyd
rous
, USP
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)
DIANEAL PD-2Peritoneal DialysisSolution with1.5% Dextrose
How Supplied
DIANEAL PD-2Peritoneal DialysisSolution with4.25% Dextrose
Sodi
um L
acta
te(C
3H5N
aO3)
Cal
cium
“Baxter” DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose (In ULTRABAG Container)“Baxter” DIANEAL PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose (In ULTRABAG Container)“Baxter” DIANEAL PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose (In ULTRABAG Container)
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PPD-15223.pm6c 04/02/2003, 4:12 PM3
④
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PPD-15223.pm6c 04/09/2003, 10:36 AM4
