GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Glucose solution for Peritoneal dialysis BP (1.5%)
B. Glucose solution for Peritoneal dialysis BP (2.5%)
C. Glucose solution for Peritoneal dialysis BP (4.25%)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Glucose solution for Peritoneal dialysis BP (1.5%)
Composition:
Each 1000ml contains:
Glucose BP……………………………………15g
Sodium lactate solution USP
Equivalent to Sodium Lactate…………………… 3.925g
Sodium Chloride BP…………………………………… 5.786g
Calcium Chloride dihydrate BP…………………… 257.3mg
Magnesium chloride hexahydrate BP………… 101.7g
Water for Injection BP………………………………q.s.

B. Glucose solution for Peritoneal dialysis BP (2.5%)
Composition:
Each 1000ml contains: Glucose BP……………………………………25g
Sodium lactate solution USP
Equivalent to Sodium Lactate…………………… 4.48g
Sodium Chloride BP…………………………………… 5.38g
Calcium Chloride dihydrate BP…………………… 0.257g
magnesium chloride hexahydrate BP………… 0.0508g
Water for Injection BP………………………………q.s.


C. Glucose solution for Peritoneal dialysis BP (4.25%)
Composition:
Each 1000ml contains:
Glucose BP……………………………………42.5g
Sodium lactate solution USP
Equivalent to Sodium Lactate…………………… 4.48g
Sodium Chloride BP…………………………………… 5.38g
Calcium Chloride dihydrate BP…………………… 0.257g
magnesium chloride hexahydrate BP………… 0.0508g
Water for Injection BP………………………………q.s.

THERAPEUTIC INDICATIONS:

Glucose solution for Peritoneal dialysis BP is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of end-stage renal disease.

DIRECTION OF USE:

To be used with Non-pyrogenic I.V. administration set with aseptic technique.
For I.V. use only.

CAUTION & WARNING:

CAUTION: Even Invisible damage to bottle during transit, Storage or handling may result in contamination. Do not use if contamination is found leaking on squeezing, content not clear or contains visible solid particle.
WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store in moisture barrier overwrap and in carton until ready to use.
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Dosage: As directed by the Physician.

Glucose solution for Peritoneal dialysis BP 2.5% Technical Specification:

Product Name:Glucose solution for Peritoneal dialysis BP 2.5%
Brand Name:Generics
Strength:1.5%, 2.5%, 4.25%
Dosage Form:I.V. Infusion Bottle (LVP)
Packing:1000mL,2000mL,3000mL IV Bottle
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Intravenous Nutritional Product
Indication: Glucose solution for Peritoneal dialysis BP is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of end-stage renal disease.
Storage:Store in moisture barrier overwrap and in carton until ready to use.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Glucose solution for Peritoneal dialysis BP (2.5%)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Glucose solution for Peritoneal dialysis BP (2.5%)
    Composition:
    Each 1000ml contains:
    Glucose BP……………………………………25g
    Sodium lactate solution USP
    Equivalent to Sodium Lactate…………………… 4.48g
    Sodium Chloride BP…………………………………… 5.38g
    Calcium Chloride dihydrate BP…………………… 0.257g
    Magnesium chloride hexahydrate BP………… 0.0508g
    Water for Injection BP………………………………q.s.

THERAPEUTIC INDICATIONS:

Glucose solution for Peritoneal dialysis BP is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of end-stage renal disease.

DIRECTION OF USE:

To be used with Non-pyrogenic I.V. administration set with aseptic technique.

For I.V. use only.

CAUTION & WARNING:

CAUTION: Even Invisible damage to bottle during transit, Storage or handling may result in contamination. Do not use if contamination is found leaking on squeezing, content not clear or contains visible solid particle.

WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store in moisture barrier overwrap and in carton until ready to use.

STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.

Keep medicine out of reach of children.
FOR HUMAN USE ONLY

Dosage: As directed by the Physician.