Glucose 40% W/V Solution For Injection
Revised: April 2015
AN: 01579/2014
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SUMMARY OF PRODUCT CHARACTERISTICS |
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1. |
NAME OF THE VETERINARY MEDICINAL PRODUCT |
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Glucose 40% w/v Solution for Injection |
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2. |
QUALITATIVE AND QUANTITATIVE COMPOSITION |
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Active substanceQualitative composition Glucose (anhydrous) Excipients For a full list of excipients, see section 6.1. |
Quantitative composition 40.00 % w/v |
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3. |
PHARMACEUTICAL FORM |
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Solution for injection. A clear, sterile, aqueous solution. |
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4. |
CLINICAL PARTICULARS |
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4.1 |
Target species |
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Cattle and sheep. |
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4.2 |
Indications for use, specifying the target species |
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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. |
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4.3 |
Contraindications |
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Do not give by subcutaneous injection. |
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4.4 |
Special warnings for each target species |
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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. |
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4.5 |
Special precautions for use |
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i. |
Special precautions for use in animals |
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This product does not contain an antimicrobial preservative. Any solution remaining in the vial following withdrawal of the required dose should be discarded. |
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ii. |
Special precautions for the person administering the veterinary medicinal product to animals |
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Care should be taken to avoid accidental self-injection. Wash hands after use. |
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4.6 |
Adverse reactions (frequency and seriousness) |
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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. |
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4.7 |
Use during pregnancy, lactation or lay |
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Not contraindicated. |
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4.8 |
Interaction with other medicinal products and other forms of interaction |
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None known (supplementary treatment can be provided as appropriate). |
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4.9 |
Amount(s) to be administered and administration route |
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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. |
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4.10 |
Overdose (symptoms, emergency procedures, antidotes), if necessary |
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See 4.6 regarding renal crisis; no treatment specified. |
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4.11 |
Withdrawal periods |
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Cattle and sheep: Meat: zero days Milk: zero hours |
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5. |
PHARMACOLOGICAL PROPERTIES |
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Pharmacotherapeutic group: |
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Blood substitutes and perfusion solutions, I.V. solutions, Solutions for parenteral nutrition |
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ATC Vet Code: |
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QB05BA03 |
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5.1 |
Pharmacodynamic properties |
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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 %. |
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5.2 |
Pharmacokinetic properties |
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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. |
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6. |
PHARMACEUTICAL PARTICULARS |
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6.1 |
List of excipients |
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Water for injections |
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6.2 |
Incompatibilities |
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None known. |
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6.3 |
Shelf life |
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Shelf life of the veterinary medicinal product as packaged for sale: 1 year. |
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6.4 |
Special precautions for storage |
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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. |
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6.5 |
Nature and composition of immediate packaging |
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400 ml type II amber glass bottle, fitted with a grey rubber stopper and push off polypropylene cap. |
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6.6 |
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate |
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Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. |
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7. |
MARKETING AUTHORISATION HOLDER |
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Dechra Limited Dechra House Jamage Industrial Estate Talke Pits Stoke-on-Trent Staffordshire ST7 1XW |
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8. |
MARKETING AUTHORISATION NUMBER |
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Vm 10434/4047 |
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9. |
DATE OF FIRST AUTHORISATION |
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Date: 20 April 1994 |
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10. |
DATE OF REVISION OF THE TEXT |
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Date: April 2015 |
APPROVED 
30/04/15
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