Dianeal Low Calcium Peritoneal Dialysis Resolution

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Generic Title: dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride and magnesium chloride
Dosage Kind: injection, answer

Medically reviewed by Medicine.com. Final up to date on Jan 22, 2021.

Dianeal Low Calcium Peritoneal Dialysis Resolution Description

Dianeal® Low Calcium peritoneal dialysis options are sterile, nonpyrogenic options in UltraBag™ containers for intraperitoneal administration solely. They include no bacteriostatic or antimicrobial brokers. UltraBag™ containers are designed with an built-in “Y” set and drain container for infusion and drainage of Dianeal® Low Calcium when disconnection of the “Y” set from the switch set throughout dwell is desired.

Composition, calculated osmolarity, pH and ionic concentrations are proven within the following desk.

Composition/100mL OSMOLARITY (mOsmol/L) (calc) pH Ionic Focus (mEq/L) How Equipped
Dextrose, Hydrous, USP Sodium Chloride, USP (NaCl) Sodium Lactate (C3H5NaO3) Calcium Chloride, USP (CaCl2·2H2O) Magnesium Chloride, USP (MgCl2·H2O) Sodium Calcium Magnesium Fill Chloride Lactate Fill Quantity
(mL)
Container
(mL)
Code NDC
Dianeal®Low Calcium Peritoneal Dialysis Resolution with 1.5% Dextrose 1.5 g 538 mg 448 mg 18.3 mg 5.08 mg 344 5.2
(4.0 to six.5)
132 2.5 0.5 95 40 1500
2000
2500
3000
2000
2000
3000
5000
5B9765
5B9766
5B9768
5B9757
0941-0424-51
0941-0424-52
0941-0424-53
0941-0424-55
Dianeal®Low Calcium Peritoneal Dialysis Resolution with 2.5% Dextrose 2.5 g 538 mg 448 mg 18.3 mg 5.08 mg 395 5.2
(4.0 to six.5)
132 2.5 0.5 95 40 1500
2000
2500
3000
2000
2000
3000
5000
5B9775
5B9776
5B9778
5B9758
0941-0430-51
0941-0430-52
0941-0430-53
0941-0430-55
Dianeal®Low Calcium Peritoneal Dialysis Resolution with 4.25% Dextrose 4.25 g 538 mg 448 mg 18.3 mg 5.08 mg 483 5.2
(4.0 to six.5)
132 2.5 0.5 95 40 1500
2000
2500
3000
2000
2000
3000
5000
5B9795
5B9796
5B9798
5B9759
0941-0433-51
0941-0433-52
0941-0433-53
0941-0433-55

The plastic container tubing set is fabricated from polyvinyl chloride (PL 146® Plastic). Publicity to temperatures above 25°C/77°F throughout transport and storage will result in minor losses in moisture content material. Increased temperatures result in higher losses. It’s unlikely that these minor losses will result in clinically vital adjustments throughout the expiration interval. The quantity of water that may permeate from inside the answer container into the overpouch is inadequate to have an effect on the answer considerably. Options involved with the plastic container could leach out sure chemical elements from the plastic in very small quantities; nevertheless, organic testing was supportive of the security of the plastic container supplies.

Dianeal Low Calcium Peritoneal Dialysis Resolution – Medical Pharmacology

Peritoneal dialysis is a process for eradicating poisonous substances and metabolites usually excreted by the kidneys, and for aiding within the regulation of fluid and electrolyte steadiness.

The process is achieved by instilling peritoneal dialysis fluid by means of a conduit into the peritoneal cavity. Poisonous substances and metabolites, current in excessive focus within the blood, cross the peritoneal membrane into the dialyzing fluid. Dextrose within the dialyzing fluid is used to provide an answer hyperosmolar to the plasma, creating an osmotic gradient which facilitates fluid elimination from the affected person’s plasma into the peritoneal cavity. After a time frame, (dwell time), the fluid is drained by gravity from the cavity.

The answer doesn’t include potassium. In conditions in which there’s a traditional serum potassium degree or hypokalemia, the addition of potassium chloride (as much as a focus of 4 mEq/L) could also be indicated to stop extreme hypokalemia. Addition of potassium chloride ought to be made after cautious analysis of serum and whole physique potassium and solely underneath the path of a doctor.

Medical research have demonstrated using this answer resulted in vital will increase in serum CO2 and reduces in serum magnesium ranges. The lower in magnesium ranges didn’t trigger clinically vital hypomagnesemia.

Indications and Utilization for Dianeal Low Calcium Peritoneal Dialysis Resolution

Dianeal® Low Calcium peritoneal dialysis options in UltraBag™ containers are indicated to be used in persistent renal failure sufferers being maintained on steady ambulatory peritoneal dialysis when nondialytic medical remedy is judged to be insufficient.

Contraindications

None recognized.

Warnings

Not for Intravenous Injection.

Use aseptic approach. Contamination of Luer lock connector could lead to peritonitis.

An improper clamping sequence could lead to infusion of air into the peritoneum.

Peritoneal dialysis ought to be performed with nice care, if in any respect, in sufferers with quite a few circumstances, together with disruption of the peritoneal membrane or diaphragm by surgical procedure or trauma, in depth adhesions, bowel distention, undiagnosed stomach illness, stomach wall an infection, hernias or burns, fecal fistula or colostomy, tense ascites, weight problems, massive polycystic kidneys, current aortic graft alternative, lactic acidosis, and extreme pulmonary illness. When assessing peritoneal dialysis because the mode of remedy in such excessive conditions, the advantages to the affected person have to be weighed in opposition to the doable problems.

An correct fluid steadiness document have to be stored and the load of the affected person rigorously monitored to keep away from over or underneath hydration with extreme penalties, together with congestive coronary heart failure, quantity depletion, and shock.

Extreme use of Dianeal® Low Calcium peritoneal dialysis answer with 4.25% dextrose throughout a peritoneal dialysis therapy can lead to vital elimination of water from the affected person.

Steady sufferers present process upkeep peritoneal dialysis ought to have routine periodic analysis of blood chemistries and hematologic components, in addition to different indicators of affected person standing.

If the resealable rubber plug on the medicine port is lacking or partially eliminated, don’t use product.

After eradicating overpouch, examine for minute leaks by squeezing container firmly. If leaks are discovered, discard the answer as a result of the sterility could also be impaired.

After the pull ring has been faraway from the outlet, examine for damaged connector frangible seal as evidenced by steady fluid circulation from port. Just a few drops of answer throughout the connector or protector cap could also be current. If a steady stream or droplets of fluid are famous, discard answer as a result of sterility could also be impaired.

Throughout answer drainage, fibrin strands could also be noticed within the answer and will grow to be hooked up to the connector frangible closure. In occasional cases, partial or full obstruction of draining could happen. Manipulation of the connector frangible closure within the tubing could free the fibrin obstruction.

Precautions

Normal:

Don’t administer except answer is obvious.

Aseptic approach have to be used all through the process and at its termination with a purpose to cut back the potential for an infection.

Important losses of protein, amino acids and water soluble nutritional vitamins could happen throughout peritoneal dialysis. Substitute remedy ought to be offered as obligatory.

When prescribing the answer for use for a person affected person, consideration ought to be given to the potential interplay between the dialysis therapy and remedy directed at different present diseases. For instance, speedy potassium elimination could create arrhythmias in cardiac sufferers utilizing digitalis or related medicine; digitalis toxicity could also be masked by elevated potassium or magnesium, or by hypocalcemia. Correction of electrolytes by dialysis could precipitate indicators and signs of digitalis extra. Conversely, toxicity could happen at suboptimal dosages of digitalis if potassium is low or calcium excessive. Azotemic diabetics require cautious monitoring of insulin necessities throughout and following dialysis with dextrose containing options.

Laboratory checks:

Serum electrolytes, magnesium, bicarbonate ranges and fluid steadiness ought to be periodically monitored.

Carcinogenesis, mutagenesis, impairment of fertility:

Research to guage the carcinogenic or mutagenic potential of this product, or its potential to have an effect on fertility adversely, haven’t been carried out.

Being pregnant:

Teratogenic Results
Being pregnant Class C.

Animal copy research haven’t been performed with Dianeal® Low Calcium peritoneal dialysis answer. It’s also not recognized whether or not Dianeal® Low Calcium peritoneal dialysis answer could cause fetal hurt when administered to a pregnant lady or can have an effect on copy capability. Dianeal® Low Calcium peritoneal dialysis answer ought to be given to a pregnant lady provided that clearly wanted.

Nursing moms:

Warning ought to be exercised when Dianeal® Low Calcium peritoneal dialysis answer is run to a nursing lady.

Pediatric use:

Security and effectiveness in kids haven’t been established.

Adversarial Reactions

Adversarial reactions to peritoneal dialysis embody mechanical and answer associated issues in addition to the outcomes of contamination of apparatus or improper approach in catheter placement. Stomach ache, bleeding, peritonitis, subcutaneous an infection across the peritoneal catheter, catheter web site an infection, catheter blockage, issue in fluid elimination, and ileus are among the many problems of the process. Resolution associated adversarial reactions could embody peritonitis, electrolyte and fluid imbalances, hypovolemia, hypervolemia, hypotension, hypertension, disequilibrium syndrome, allergic signs, and muscle cramping.

Dianeal Low Calcium Peritoneal Dialysis Resolution Dosage and Administration

Dianeal® Low Calcium options are supposed for intraperitoneal administration solely.

It is strongly recommended that grownup sufferers being positioned on steady ambulatory peritoneal dialysis ought to be appropriately skilled in a program which is underneath supervision of a doctor. Coaching supplies can be found from Baxter Healthcare Company, Deerfield, IL, 60015 USA to facilitate this coaching.

Parenteral drug merchandise ought to be inspected visually for particulate matter and discoloration previous to administration each time answer and container allow.

The frequency of therapy, formulation, change quantity, period of dwell, and size of dialysis ought to be chosen by the doctor accountable for and supervising the therapy of the person affected person.

To keep away from the chance of extreme dehydration and hypovolemia and to reduce the lack of protein, it’s advisable to pick out the peritoneal dialysis answer with the bottom degree of osmolarity in step with the fluid elimination necessities for that change.

Heating the dialysis answer to 37°C (98.6°F) could lower discomfort.

Components could also be incompatible. Don’t retailer answer containing components.

Roughly two liters of dialysis answer are instilled into the peritoneal cavity of adults and the peritoneal entry gadget is then clamped. The answer stays within the cavity for dwell instances of 4 to eight hours throughout the day and eight to 12 hours in a single day. On the conclusion of every dwell interval, the entry gadget is opened, the answer drained and contemporary answer instilled. The process is repeated 3 to five instances per day, 6 to 7 days per week. Resolution change frequency ought to be individualized for ample biochemical and fluid quantity management. Nearly all of exchanges will make the most of 1.5% or 2.5% dextrose containing peritoneal dialysis options, with 4.25% dextrose containing options getting used when additional fluid elimination is required. Affected person weight is used because the indicator of the necessity for fluid elimination.

DIRECTIONS FOR USE

Use aseptic approach.

For full system preparation, see instructions accompanying ancillary gear.

Preparation for Administration

1. Collect provides.

2. Tear the container overpouch firmly down the facet from high slit and take away. Some opacity of the plastic because of moisture absorption throughout the sterilization course of could also be noticed. That is regular and doesn’t have an effect on the answer high quality or security. The opacity ought to diminish regularly.

3. Place container on work station.

4. Uncoil tubing.

5. Examine the affected person connector to make sure the pull ring is hooked up. Don’t use if pull ring shouldn’t be hooked up to the connector.

6. Examine tubing and drain container for presence of answer. If answer is famous, discard items.

NOTE: Small water droplets are acceptable.

7. Squeeze container to examine for leaks and damaged answer frangible. Be aware answer circulation previous the frangible. Discard if container or answer frangible leaks, as a result of sterility could also be impaired.

If Supplemental Medicine is Prescribed:

1. Examine container to make sure resealable rubber medicine port is in place. Discard if rubber injection port shouldn’t be hooked up to container port.

2. Placed on a masks.

3. Put together medicine port in accordance with aseptic approach.

4. Utilizing a syringe with a 1 inch lengthy, 19 to 25 gauge needle, puncture resealable medicine port and inject medicine.

5. Place container with medicine port going through upward. Squeeze and faucet medicine port to empty answer. Combine answer by vigorously agitating container.

Administration:

1. Placed on masks and wash arms.

2. Insure affected person switch set is closed.

3. Break connector frangible (blue) by greedy the tubing above the highest of the frangible and pulling ahead and backward till the frangible separates from base. See Figures 1 and a pair of.

4. Take away pull ring from the affected person connector.

5. Take away disconnect cap from affected person switch set. Instantly connect affected person switch set connector to the affected person connector by twisting the connector till firmly secured.

6. Clamp answer line.

7. Break answer frangible (inexperienced) by greedy the tubing above the highest of the frangible and pulling ahead and backward till the frangible separates. See Figures 3 and 4.

8. Cling the brand new answer container.

9. Place the drainage container beneath the extent of the peritoneum.

10. Open switch set clamp to empty answer from peritoneum. Warning: Throughout answer drainage, fibrin strands could grow to be hooked up to the connector frangible closure. Manipulation of the connector frangible closure within the tubing could free any fibrin obstruction that happens.

11. Shut switch set line clamp after drainage is full.

12. Open answer line clamp and permit the brand new answer to circulation into the drainage container for five seconds to prime line.

13. Clamp drain line.

14. Open switch set clamp and permit the answer to circulation into the peritoneum.

15. Shut switch set clamp when infusion is full.

16. Put together a brand new disconnect cap following the instructions accompanying the cap.

17. Disconnect the affected person switch set from the UltraBag™ and fix a brand new disconnect cap to the switch set.

Administration Process for the UltraBag™ Container Alternate

(The Steps Discuss with the Corresponding Administration Steps)

How is Dianeal Low Calcium Peritoneal Dialysis Resolution Equipped

Dianeal® Low Calcium peritoneal dialysis options in UltraBag™ containers can be found in nominal measurement versatile containers as proven within the desk within the DESCRIPTION part.

All Dianeal® Low Calcium peritoneal dialysis options have overfills that are declared on container labeling.

Freezing of options could happen at temperatures beneath 0°C (32°F). Enable to thaw naturally in ambient circumstances and completely combine contents by shaking.

Publicity of pharmaceutical merchandise to warmth ought to be minimized. Keep away from extreme warmth. It is strongly recommended the product be saved at room temperature (25°C/77°F).

Baxter Healthcare Company
Deerfield, IL 60015 USA

Printed in USA

©Copyright 1992, Baxter Healthcare Company. All rights reserved.

07-19-26-995
2002/02

*BAR CODE POSITION ONLY
071926995

PRINCIPAL DISPLAY PANEL

Container Label

5B9766
NDC 0941-0424-52

2000 mL
(APPROX 80 mL EXCESS)

Baxter Brand

Dianeal
Low Calcium (2.5 mEq/L)
Peritoneal Dialysis Resolution
with 1.5% Dextrose

EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM
LACTATE 18.3 mg CALCIUM CHLORIDE USP 5.08 mg
MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5)

mEq/L SODIUM – 132 CALCIUM – 2.5 MAGNESIUM – 0.5
CHLORIDE – 95 LACTATE – 40
OSMOLARITY – 344 mOsmol/L (CALC)

STERILE NONPYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY
UNDER THE DIRECTION OF A PHYSICIAN

READ PACKAGE INSERT FOR FULL INFORMATION

FOR INTRAPERITONEAL ADMINISTRATION ONLY

DOSAGE AS DIRECTED BY A PHYSICIAN

CAUTIONS SQUEEZE AND INSPECT INNER BAG
WHICH MAINTAINS PRODUCT STERILITY DISCARD
IF LEAKS ARE FOUND

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

Rx ONLY

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT
ROOM TEMPERATURE (25° C/77°F) UNTIL READY TO
USE
AVOID EXCESSIVE HEAT SEE INSERT

UltraBag CONTAINER PL 146 PLASTIC

BAXTER DIANEAL ULTRABAG AND PL 146 ARE

TRADEMARKS OF BAXTER INTERNATIONAL INC

BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

US PAT NOS 4340049 4346703

4439188 4573980

Low Calcium 1.5% Dextrose

Carton Label

5B9766

6-2000ML IN 2000ML
ULTRABAGTM CONT

1.5%

DIANEAL® LOW CALCIUM 1.5% DEX
PERITONEAL DIALYSIS SOLUTION

EXP
XXXXX

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

LOT
XXXXX

PRIMARY BAR CODE

(01) 50309410424525

DIANEAL LOW CALCIUM WITH DEXTROSE
dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride injection, answer
Product Data
Product Kind HUMAN PRESCRIPTION DRUG LABEL Merchandise Code (Supply) NDC:0941-0424
Route of Administration INTRAPERITONEAL DEA Schedule
Energetic Ingredient/Energetic Moiety
Ingredient Title Foundation of Power Power
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 1.5 g in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 538 mg in 100 mL
SODIUM LACTATE (LACTIC ACID and SODIUM CATION) SODIUM LACTATE 448 mg in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 18.3 mg in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 5.08 mg in 100 mL
Inactive Elements
Ingredient Title Power
WATER
Packaging
# Merchandise Code Bundle Description
1 NDC:0941-0424-51 1500 mL in 1 BAG
2 NDC:0941-0424-52 2000 mL in 1 BAG
3 NDC:0941-0424-53 2500 mL in 1 BAG
4 NDC:0941-0424-55 3000 mL in 1 BAG
Advertising Data
Advertising Class Utility Quantity or Monograph Quotation Advertising Begin Date Advertising Finish Date
NDA NDA020183 12/04/1992
DIANEAL LOW CALCIUM WITH DEXTROSE
dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride injection, answer
Product Data
Product Kind HUMAN PRESCRIPTION DRUG LABEL Merchandise Code (Supply) NDC:0941-0430
Route of Administration INTRAPERITONEAL DEA Schedule
Energetic Ingredient/Energetic Moiety
Ingredient Title Foundation of Power Power
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 2.5 g in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 538 mg in 100 mL
SODIUM LACTATE (LACTIC ACID and SODIUM CATION) SODIUM LACTATE 448 mg in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 18.3 mg in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 5.08 mg in 100 mL
Inactive Elements
Ingredient Title Power
WATER
Packaging
# Merchandise Code Bundle Description
1 NDC:0941-0430-51 1500 mL in 1 BAG
2 NDC:0941-0430-52 2000 mL in 1 BAG
3 NDC:0941-0430-53 2500 mL in 1 BAG
4 NDC:0941-0430-55 3000 mL in 1 BAG
Advertising Data
Advertising Class Utility Quantity or Monograph Quotation Advertising Begin Date Advertising Finish Date
NDA NDA020183 12/04/1992
DIANEAL LOW CALCIUM WITH DEXTROSE
dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride injection, answer
Product Data
Product Kind HUMAN PRESCRIPTION DRUG LABEL Merchandise Code (Supply) NDC:0941-0433
Route of Administration INTRAPERITONEAL DEA Schedule
Energetic Ingredient/Energetic Moiety
Ingredient Title Foundation of Power Power
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 4.25 g in 100 mL
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 538 mg in 100 mL
SODIUM LACTATE (LACTIC ACID and SODIUM CATION) SODIUM LACTATE 448 mg in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 18.3 mg in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 5.08 mg in 100 mL
Inactive Elements
Ingredient Title Power
WATER
Packaging
# Merchandise Code Bundle Description
1 NDC:0941-0433-51 1500 mL in 1 BAG
2 NDC:0941-0433-52 2000 mL in 1 BAG
3 NDC:0941-0433-53 2500 mL in 1 BAG
4 NDC:0941-0433-55 3000 mL in 1 BAG
Advertising Data
Advertising Class Utility Quantity or Monograph Quotation Advertising Begin Date Advertising Finish Date
NDA NDA020183 12/04/1992
Labeler – Baxter Healthcare Company (005083209)
Institution
Title Handle ID/FEI Operations
Baxter Healthcare Company 059140764 ANALYSIS(0941-0424, 0941-0430, 0941-0433), LABEL(0941-0424, 0941-0430, 0941-0433), MANUFACTURE(0941-0424, 0941-0430, 0941-0433), PACK(0941-0424, 0941-0430, 0941-0433), STERILIZE(0941-0424, 0941-0430, 0941-0433)
Institution
Title Handle ID/FEI Operations
Baxter Healthcare Company 194684502 ANALYSIS(0941-0424, 0941-0430, 0941-0433)

Baxter Healthcare Company

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