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PHYSIONEAL 40 DEXTROSE SOLUTION 4.25% W/V/ 42.5 MG/ML [SIN12437P]

Active ingredients: PHYSIONEAL 40 DEXTROSE SOLUTION 4.25% W/V/ 42.5 MG/ML

Last updated 26 October 2025

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Product Info
4.2 Posology and method of administration

Product Info

PHYSIONEAL 40 DEXTROSE SOLUTION 4.25% W/V/ 42.5 MG/ML

[SIN12437P]

Product information

Active Ingredient and Strength

CALCIUM CHLORIDE DIHYDRATE (IN SMALL BAG A) - 0.507 G/L
DEXTROSE MONOHYDRATE (IN SMALL BAG A) - 117.14 G/L
MAGNESIUM CHLORIDE HEXAHYDRATE (IN SMALL BAG A) - 0.14 G/L
SODIUM BICARBONATE (IN LARGE BAG B) - 3.29 G/L
SODIUM CHLORIDE (IN LARGE BAG B) - 8.43 G/L
SODIUM LACTATE (IN LARGE BAG B) - 2.63 G/L

Dosage Form

SOLUTION, STERILE

Manufacturer and Country

VANTIVE MANUFACTURING LIMITED - IRELAND
VANTIVE MANUFACTURING PTE. LTD. - SINGAPORE

Registration Number

SIN12437P

Licence Holder

VANTIVE PTE. LTD.

Forensic Classification

GENERAL SALE LIST

Anatomical Therapeutic Chemical (ATC) code

B05DB

4.1 Therapeutic indications
PHYSIONEAL 40 is indicated for:

  • peritoneal dialysis for the treatment of acute and chronic renal failure with manifestations of severe water retention and severe electrolyte imbalance.

  • intoxication with dialyzable substances where adequate alternate treatments are not available.

Bicarbonate/lactate based PHYSIONEAL 40 peritoneal dialysis solutions with a physiological pH are indicated in patients in whom solutions based on lactate buffer only, with a low pH, cause abdominal inflow pain or discomfort.

4.2 Posology and method of administration

  • PHYSIONEAL 40 is intended for intraperitoneal administration only. Not for intravenous administration.

  • Peritoneal dialysis solutions may be warmed to 37°C (98.6°F) to enhance patient comfort. However, only dry heat (for example, heating pad, warming plate) should be used. Solutions should not be heated in water or in a microwave oven due to the potential for patient injury or discomfort.

  • The solution should be warmed in the overpouch to body temperature before use.

  • After removal of the overpouch, immediately break the interchamber frangible pin to mix the two solutions. Wait until the upper chamber has completely drained into the lower chamber. Mix gently by pushing with both hands on the lower chamber walls. The intraperitoneal solution must be infused within 24 hours after mixing.

  • Aseptic technique should be employed throughout the peritoneal dialysis procedure.

  • The mode of therapy, frequency of treatment, exchange volume, duration of dwell and length of dialysis should be selected by the physician.

  • To avoid the risk of severe dehydration, hypovolemia and to minimise the loss of proteins, it is advisable to select the peritoneal dialysis solution with the lowest level of osmolarity consistent with fluid removal requirements for each exchange. PHYSIONEAL 40 Dextrose 4.25% w/v Solution for Peritoneal Dialysis is a high osmotic pressure fluid and using it for all exchanges may cause dehydration.

  • The average frequency is 4 to 5 times a day. The fill volume depends on body size, usually from 2.0 to 2.5 liters.

  • So far, there are no data from clinical studies in pediatric patients. In this patient category the benefits of PHYSIONEAL 40 have therefore to be balanced versus the risk of side effects.

  • More than 30% of the patients in the clinical trials were older than 65. The evaluation of the results obtained for this group does not show any difference to the rest of the patients.

4.3 Contraindications
PHYSIONEAL 40 is contraindicated for use in patients with:

  • Uncorrectable mechanical defects that prevent effective PD or increase the risk of infection.

  • Documented loss of peritoneal function or extensive adhesions that compromise peritoneal function.