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Date: Monday, February 26, 2024 7:50

Release 2.102
Colvasone 0.2% w/v Solution for Injection
 
Species: Cats, Cattle, Dogs, Horses and other equidae
Therapeutic indication: Pharmaceuticals: Anti-inflammatory preparations: Injections: Steroids
Active ingredient: Dexamethasone
Product:Colvasone 0.2% w/v Solution for Injection
Product index: Colvasone Injection
Cattle - milk: 84 hours
Cattle - meat: 21 days
Withdrawal notes: Horses: Do not use in horses intended for human consumption
Incorporating:
Qualitative and quantitative composition
Active Substance:
Dexamethasone Sodium Phosphate
2 mg/ml
Excipients:
Benzyl alcohol
20mg/ml
For a full list of excipients, see section Pharmaceutical Particulars
Pharmaceutical form
Solution for injection.
A clear, colourless solution.
Clinical particulars
Target species
Horses, Cattle, Dogs, Cats
Indications for use, specifying the target species
Dexamethasone is a synthetic corticosteroid with a potent anti-inflammatory action.
Colvasone can be used for:
Intravenous therapy in cases where emergency treatment is indicated, particularly shock and circulatory collapse, fog fever, acute mastitis and burns.
Acetonaemia (ketosis) in cattle. Dexamethasone has a marked glucogenic action.
Inflammatory conditions in all species: the product will suppress inflammation and is indicated in the treatment of arthritis, laminitis, dermatitis etc.
Contraindications
Systemic corticosteroid therapy is generally contra-indicated in patients with renal disease and diabetes mellitus.
Special Warnings for each target species
Use of the product in horses could induce laminitis and therefore careful observations should be made during treatment.
Special precautions for use
Special precautions for use in animals
Anti-inflammatory corticosteroids such as dexamethasone, are known to exert a wide range of side-effects. Whilst single high doses are generally well tolerated, they may induce severe side-effects in long term use and when esters possessing a long duration of action are administered. Dosage in medium to long term use should therefore generally be kept to the minimum necessary to control symptoms.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This product contains dexamethasone which can cause allergic reactions in some people. People with known hypersensitivity to dexamethasone should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the carton to the physician.
Pregnant women should not handle this veterinary medicinal product.
Wash hands after use.
Adverse reactions (frequency and seriousness)
Steroids themselves, during treatment, may cause Cushingoid symptoms involving significant alteration of fat, carbohydrate, protein and mineral metabolism e.g. redistribution of body fat, muscle weakness and wastage and osteoporosis may result. During therapy effective doses suppress the Hypothalamo-Pituitary-Adrenal axis. Following cessation of treatment, symptoms of adrenal insufficiency extending to adrenocortical atrophy can arise and this may render the animal unable to deal adequately with stressful situations. Consideration should therefore be given to means of minimising problems of adrenal insufficiency following the withdrawal of treatment, e.g. a gradual reductions of dosage (for further discussion see standard texts).
Systemically acting corticosteroids may cause polyuria, polydipsia and polyphagia, particularly during the early stages of therapy. Some corticosteroids may cause sodium and water retention and hypokalaemia in long term use.
Systemic corticosteroids have caused deposition of calcium in the skin (calcinosis cutis). Corticosteroids may delay wound healing and the immunosuppressant actions may weaken resistance to or exacerbate existing infections.
Gastrointestinal ulceration has been reported in animals treated with corticosteroids and gastrointestinal ulceration may be exacerbated by steroids in patients given non-steroidal anti-inflammatory drugs and in corticosteroid-treated animals with spinal cord trauma. Steroids may cause enlargement of the liver (hepatomegaly) with increased serum hepatic enzymes.
In very rare cases, hypersensitivity reactions might occur.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals treated displaying adverse reaction(s))
common (more than 1 but less than 10 animals in 100 animals treated)
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated)
very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy, lactation or lay
Corticosteroids are not recommended for use in pregnant animals. Administration in early pregnancy is known to have caused foetal abnormalities in laboratory animals. Administration in late pregnancy may cause early parturition or abortion.
Interaction with other medicinal products and other forms of interaction
In the presence of bacterial infection, antibacterial drug cover is usually required when steroids are used. In the presence of viral infections, steroids may worsen or hasten the progress of the disease.
Amounts to be administered and administration route
By intravenous or intramuscular injection.
Normal aseptic precautions should be observed.
Recommended Dosage Schedule:
Horses and cattle:
1 ml per 25 kg bodyweight
Dogs and cats:
1 ml per 10 kg bodyweight
e.g.
Horses
500 kg
20 ml
Cattle
400 kg
16 ml
Dogs
10 kg
1 ml
Cats
5 kg
0.5 ml
To ensure accuracy of dosing, a suitably graduated syringe must be used when treating small animals.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Exacerbation of effects described in section, "Adverse reactions (frequency and seriousness)". No treatment specified.
Withdrawal periods
Cattle (meat): 21 days.
Cattle (milk): 84 hours.
Do not use in horses intended for human consumption.
Treated horses may never be slaughtered for human consumption.
The horse must have been declared as not intended for human consumption under national horse passport legislation.
Pharmacological particulars
Pharmacotherapeutic group: Corticosteroids for systemic use, plain; Glucocorticoids
ATC Vet Code: QH02AB02
Pharmacodynamic properties
Dexamethasone is a potent synthetic glucocorticoid which is 30-35 times as potent as cortisol as an anti-inflammatory agent. The mechanism by which corticosterioids exert their effect at the cellular level remains unclear however several mechanisms have been proposed. There is evidence that corticosteroids are able to de-repress transcription of DNA to mRNA in the target cell nucleus. Other mechanisms proposed for the action of corticosteroids include boosting of cellular levels of cyclic AMP made possible by steroid inhibition of phosphodiesterases which would otherwise metabolise cyclic AMP. Some of the anti-inflammatory activity of corticosteroids could be due to inhibition of prostaglandin synthesis by suppression of the release of arachidonate, the prostaglandin precursor, from cell membranes.
Pharmaceutical particulars
List of excipients
Benzyl Alcohol
Sodium Phosphate Dodecahydrate
Sodium Phosphate
Disodium Edetate Dihydrate
Water for injection
Major Incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Shelf life after first opening the immediate packaging: 28 days
Special precautions for storage
Do not store above 25°C.
Following withdrawal of the first dose, use the product within 28 days.
Discard unused material.
Nature and composition of immediate packaging
50 ml Amber Type II glass vials sealed with bromobutyl rubber bungs with aluminium overseals.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Norbrook Laboratories Limited, Station Works, Newry, Co. Down, BT35 6JP Northern Ireland
Marketing Authorisation Number
Vm 02000/4009
Significant changes
Date of the first authorisation or date of renewal
30 June 1994
Date of revision of the text
March 2022
Any other information
Nil.
Legal category
Legal category: POM-V
GTIN
GTIN description:Colvasone Injection: 50ml
GTIN:5023534001003