Glucose 40% w/v Solution for Injection

Composition

Active substance

Excipients

For a full list of excipients, see section 6.1.

6.1 List of excipients

Water for injections

3

Pharmaceutical form

Solution for injection.

A clear, sterile, aqueous solution.

3

Pharmacological properties

Pharmacotherapeutic group:

Blood substitutes and perfusion solutions, I.V. solutions, Solutions for parenteral nutrition

ATC Vet Code:

QB05BA03

5.1 Pharmacodynamic properties

Glucose is often a constituent of oral and parenteral fluid therapies including those for parenteral nutrition. Solutions of glucose are widely used in the treatment of metabolic diseases in which hypoglycaemia is an important component. Examples of these conditions include, pregnancy toxaemia or twin-lamb disease in sheep, acetonaemia or ketosis in cattle.

Acetonaemia in cattle is also known as ketosis. In sheep, acetonaemia is usually known as pregnancy toxaemia or twin lamb disease. Treatment of acetonaemia is usually very successful in cattle but in sheep the mortality rates, even after treatment, often exceed 50 %.

5.2 Pharmacokinetic properties

Glucose is of critical importance to normal physiology and cellular metabolism. Blood glucose concentrations in healthy animals are closely controlled and in hyperglycaemia the excess blood glucose is normally removed from the circulation. The removal occurs by several routes including renal clearance. The renal threshold of blood glucose is readily exceeded. Intravenous supplementation can only be achieved by use of hypertonic solutions, for example glucose 40 % w/v solution. This glucose solution can make a useful contribution to the energy requirements of the body. However, it is easy to exceed the renal threshold and induce a diuresis.

3

Target species

Cattle and sheep.

3

Indications

For the treatment of primary and secondary hypoglycaemia, acetonaemia and as a source of energy in cattle.

As an aid in the treatment of pregnancy toxaemia in sheep.

3

Dosage

Cattle: 1 ml/kg, by slow intravenous injection. In some cases, a higher dose rate may be required but should only be given on veterinary advice. Treatment may be repeated as necessary.

Sheep: 1 ml/kg to be given by slow intravenous injection. Treatment may be repeated after 6 hours if necessary.

The solution should be warmed to body temperature before use.

Strict aseptic precautions should be observed in preparation of the site of injection.

Do not exceed the recommended dosage.

3

Contraindications

Do not give by subcutaneous injection.

3

Adverse reactions

Rapid intravenous injection of dextrose will cause the renal threshold for glucose to be exceeded, with consequent clinical signs of stress and loss of glucose in the urine. For best results intravenous infusions should be given slowly, preferably at a rate not exceeding 0.5 ml/kg/hour.

3

Warnings

i. Special precautions for use in animals

This product does not contain an antimicrobial preservative. Any solution remaining in the vial following withdrawal of the required dose should be discarded.

ii. Special precautions for the person administering the veterinary medicinal product to animals

Care should be taken to avoid accidental self-injection.

Wash hands after use.

3

Use during pregnancy, lactation or lay

Not contraindicated.

3

Interactions

None known (supplementary treatment can be provided as appropriate).

3

Overdose

See 4.6 regarding renal crisis; no treatment specified.

3

Special warnings

Intravenous injection should be given slowly, preferably not exceeding 0.5 ml/kg/hour.

Do not administer by the subcutaneous route.

When acidosis is severe, and renal failure present, treatment is unlikely to be efficacious.

3

Withdrawal period

Cattle and sheep:

Meat: zero days

Milk: zero hours

3

Incompatibilities

None known.

3

Immediate packaging

400 ml type II amber glass bottle, fitted with a grey rubber stopper and push off polypropylene cap.

3

Storage

Do not store above 25ºC.

Protect from light.

This product does not contain an antimicrobial preservative. Any remaining solution in the bottle following withdrawal of the required dose should be discarded.

3

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 1 year.

3

Disposal of unused product

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

3

Additional information

Vm 36408/4013

9 DATE OF FIRST AUTHORISATION

20 April 1994

10 DATE OF REVISION OF THE TEXT

August 2021

Approved 18 August 2021

3

Registration holder

Alfasan Nederland B.V.

Kuipersweg 9

3449 JA Woerden

The Netherlands

3