DIANEAL PD-2 Peritoneal Dialysis Solution

DIANEAL PD-2 Peritoneal Dialysis Solution
BAR CODE LOCATION (FOR POSITION ONLY)
REFER TO PARA. 5.2 FOR ACTUAL LOCATION
ULTRABAG System For Continuous Ambulator y Per itoneal Dialysis (CAPD)
For intraper itoneal administration only
D I A N E A L P D - 2 p e r i t o n e a l d i a l y s i s s o l u t i o n s a r e s t e r i l e, n o n py r o g e n i c s o l u t i o n s i n
U LT R A B AG C o n t a i n e r s fo r i n t r a p e r i t o n e a l a d m i n i s t r a t i o n o n l y. T h ey c o n t a i n n o
bacteriostatic or antimicrobial agents.
Ionic Concentration
(mEq/L)
5.08
mg
346
DIANEAL PD-2
Peritoneal Dialysis
Solution with
2.5% Dextrose
2.5
g
538
mg
448
mg
25.7
mg
5.08
mg
396
DIANEAL PD-2
Peritoneal Dialysis
Solution with
4.25% Dextrose
4.25
g
538
mg
448
mg
25.7
mg
5.08
mg
485
pH
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
2500
2000
2000
3000
FNB9865
FNB9866
FNB9868
132
3.5
0.5
96
40
1500
2000
2500
2000
2000
3000
FNB9875
FNB9876
FNB9878
132
3.5
0.5
96
40
1500
2000
2500
2000
2000
3000
FNB9895
FNB9896
FNB9898
Dextrose Hydrous, USP
(D-Glucopyranose monohydrate)
Sodium Lactate
The plastic container “Y” set is fabricated from polyvinyl chlor ide (PL-146 Plastic).
Exposure to temperatures above 25°C/77°F dur ing transpor t 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
ex p i ra t i o n p e r i o d . T h e a m o u n t o f wa t e r t h a t c a n p e r m e a t e f r o m i n s i d e t h e s o l u t i o n
container into the over pouch is insufficient to affect the solution significantly. Solutions
in contact with the plastic container may leach out cer tain chemical components from
the plastic in ver y small amounts; however, biological testing was suppor tive of the
safety of the plastic container mater ials.
Code
Lactate
25.7
mg
Chloride
448
mg
Container
Size
(mL)
Magnesium
Magnesium Chloride, USP
(MgCl2 • 6H2O)
538
mg
Fill
Volume
(mL)
Calcium
Calcium Chloride, USP
(CaCl2 • 2H2O)
1.5
g
How Supplied
Sodium
Sodium Lactate
(C3H5NaO3)
DIANEAL PD-2
Peritoneal Dialysis
Solution with
1.5% Dextrose
OSMOLARITY
(mOsmol/L)(calc)
Sodium Chloride, USP
(NaCl)
Composition/100 mL
Dextrose, Hydrous, USP
*PPD15064*
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.
C o m p o s i t i o n , c a l c u l a t e d o s m o l a r i t y, p H a n d i o n i c c o n c e n t ra t i o n s a r e s h ow n i n t h e
following table.
Description
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 per itoneal dialysis fluid through a conduit
into the peritoneal cavity. Toxic substances and metabolites, present in high concentration
in the blood, cross the per itoneal membrane into the dialyzing fluid. Dextrose in the
dialyzing fluid is used to produce a solution hyperosmolar to the plasma, creating an
o s m o t i c gra d i e n t w h i c h fa c i l i t a t e s f l u i d r e m ova l f r o m t h e p a t i e n t ’s p l a s m a i n t o t h e
per itoneal 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
ser um potassium level or hypokalemia, the addition of potassium chlor ide (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 ser um CO 2 and decreases in ser um magnesium levels. The decrease in
magnesium levels did not cause clinically significant hypomagnesemia.
Per itoneal dialysis should be done with great care, if at all, in patients with a number
of conditions, including disruption of the per itoneal membrane or diaphragm by surger y
or trauma, extensive adhesions, bowel distention, undiagnosed abdominal disease,
abdominal wall infection, her nias or bur ns, fecal fistula or colostomy, tense ascites,
obesity, large polycystic kidneys, recent aor tic graft replacement, lactic acidosis, and
severe pulmonar y disease. When assessing per itoneal 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
m o n i t o r e d t o avo i d ove r o r u n d e r hy d ra t i o n w i t h s eve r e c o n s e q u e n c e s, i n c l u d i n g
congestive hear t 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 r ubber plug on the medication por t is missing or par tially removed,
do not use product.
After removing over pouch, check for minute leaks by squeezing container fir mly. 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 por t. 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, par tial or complete
obstruction of draining may occur. Manipulation of the connector frangible closure in
the tubing may free the fibrin obstr uction.
Indications and Usage
Precautions
DIANEAL PD-2 per itoneal dialysis solutions in ULTRABAG containers are indicated
for use in chronic renal failure patients being maintained on continuous ambulator y
per itoneal dialysis when nondialytic medical therapy is judged to be inadequate.
General: Do not administer unless solution is clear.
Aseptic technique must be used throughout the procedure and at its ter mination in
order to reduce the possibility of infection.
Significant losses of protein, amino acids and water soluble vitamins may occur dur ing
per itoneal dialysis. Replacement therapy should be provided as necessar y.
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
Clinical Pharmacology
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.
➀
PPD-15223.pm6c
5
04/02/2003, 4:15 PM
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.
dialysis fluid or 1 to 2 exchanges of DIANEAL PD-2 4.25 per itoneal dialysis fluid are
usually administered in combination with DIANEAL PD-2 1.5 peritoneal dialysis fluid,
and 3 to 5 exchanges a day are conducted continuously. Infusion volume, duration of
dwell, and frequency of treatment should be appropriately selected based on the
condition, blood chemistr y, body fluid imbalance, age and body weight of the individual
patient to be treated. Infusion/drainage rate is usually 300 ml/minute or less.
Laborator y tests:
S e r u m e l e c t r o l y t e s, m a g n e s i u m , b i c a r b o n a t e l eve l s a n d f l u i d b a l a n c e s h o u l d b e
per iodically monitored.
Carcinogenesis, mutagenesis, impair ment of fer tility:
Long ter m animal studies with DIANEAL PD-2 peritoneal dialysis solution have not been
performed to evaluate the carcinogenic potential, mutagenic potential or effect on fer tility.
Directions for Use
Pregnancy: Teratogenic Effects
P r e g n a n c y C a t e g o r y C. A n i m a l r e p r o d u c t i o n s t u d i e s h ave n o t b e e n c o n d u c t e d w i t h
D I A N E A L P D - 2 p e r i t o n e a l d i a l y s i s s o l u t i o n . I t i s a l s o n o t k n ow n w h e t h e r D I A N E A L
PD-2 peritoneal dialysis solution can cause fetal har m when administered to a pregnant
woman or can affect reproduction capacity. DIANEAL PD-2 peritoneal dialysis solution
should be given to a pregnant woman only if clearly needed.
1. Te a r ove r p o u c h d ow n s i d e a t a s l i t a n d r e m ove t h e s o l u t i o n . C h e ck fo r m i n u t e
leaks by squeezing container fir mly.
2. Remove the protector from outlet por t at the bottom of the container.
3. Attach administration set, according to the direction accompanying the set.
4. Suspend the container from eyelet suppor t in the upper par t of the bag.
5. Instill/drain the dialysis fluid in the ULTRABAG in the procedure described below.
Nursing mothers:
C a u t i o n s h o u l d b e exe r c i s e d w h e n D I A N E A L P D - 2 p e r i t o n e a l d i a l y s i s s o l u t i o n i s
administered to a nursing woman.
Administration:
Pediatr ic use:
Safety and effectiveness in children have not been established.
Adverse Reactions
Adverse reactions to peritoneal dialysis include mechanical and solution related problems
as well as the results of contamination of equipment or improper technique in catheter
placement. Abdominal pain, bleeding, per itonitis, subcutaneous infection around the
peritoneal catheter, catheter site infection, catheter blockage, difficulty in fluid removal,
a n d i l e u s a r e a m o n g t h e c o m p l i c a t i o n s o f t h e p r o c e d u r e. S o l u t i o n r e l a t e d a d ve r s e
r e a c t i o n s m ay i n c l u d e p e r i t o n i t i s , e l e c t r o l y t e a n d f l u i d i m b a l a n c e s, hy p ovo l e m i a ,
hyper volemia, hypotension, hyper tension, disequilibr ium syndrome, allergic symptoms,
and muscle cramping.
Use aseptic technique.
Preparation for Administration
1. Remove the cap of the connection tube on the patient side.
2. Connect the connection tube connector of the ULTRABAG to the tip of connection
tube on the patient side.
3. Drain intraper itoneal waste fluid via the waste fluid bag.
4. After drainage, clamp the connection tube on the patient side, and open the seal
of the outlet on the fluid bag of dialysis solution.
5. Wash the circuit with about 100 ml of a fresh dialysis fluid (for 10 seconds) and
pour into the waste fluid tube.
6. Subsequently, clamp the waste fluid tube and release the clamp of the connection
tube on the patient side to instill the fresh dialysis fluid intraper itoneally.
7. After infusion, detach the connection tube on the patient side from the connection
tube connector of the ULTRABAG.
8. Attach the cap to the tip of the connection tube on the patient side to complete
the replacement procedure.
Dosage and Administration
The solution is used for dialysis therapy by instilling into the peritoneal cavity.
Typically, 1.5 to 2 L of dialysis solution is instilled into the peritoneal cavity of adults
and dwelled for 4 to 8 hours. After the effect is considered to be obtained, the fluid is
drained. This procedure is regarded as one cycle. In the case where the excessive
body fluid is 1 kg/day or less, 3 to 4 exchanges a day with only DIANEAL PD-2 1.5
per itoneal dialysis fluid are conducted continuously. In the case where the excessive
body fluid is 1 kg/day or greater, 1 to 4 exchanges with DIANEAL PD-2 2.5 per itoneal
Manufactured by
Baxter Healthcare SA, Singapore Branch
2 Woodlands Industrial Park D Singapore 738750
(An affiliate of Baxter Healthcare Corporation USA)
Printed in Singapore
PPD-15-223
Iss. February 2003
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“Baxter” DIANEAL PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose (In ULTRABAG Container)
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Ionic Concentration
(mEq/L)
5.08
mg
346
DIANEAL PD-2
Peritoneal Dialysis
Solution with
2.5% Dextrose
2.5
g
538
mg
448
mg
25.7
mg
5.08
mg
396
DIANEAL PD-2
Peritoneal Dialysis
Solution with
4.25% Dextrose
4.25
g
538
mg
448
mg
25.7
mg
5.08
mg
485
5.2
(4.0
to
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5.2
(4.0
to
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Container
Size
(mL)
Code
Magnesium
25.7
mg
Fill
Volume
(mL)
Calcium
Magnesium Chloride, USP
(MgCl2 • 6H2O)
448
mg
How Supplied
Sodium
Calcium Chloride, USP
(CaCl2 • 2H2O)
538
mg
pH
Sodium Lactate
(C3H5NaO3)
1.5
g
OSMOLARITY
(mOsmol/L)(calc)
Sodium Chloride, USP
(NaCl)
Composition/100 mL
Dextrose, Hydrous, USP
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132
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➂
PPD-15223.pm6c
3
04/02/2003, 4:12 PM
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④
PPD-15223.pm6c
4
04/09/2003, 10:36 AM