COLVASONE VETERINARY

Šalis: Izraelis

kalba: anglų

Šaltinis: Ministry of Health

Veiklioji medžiaga:

DEXAMETHASONE SODIUM PHOSPHATE

Prieinama:

COMEX LTD., ISRAEL

Vaisto forma:

SOLUTION FOR INJECTION

Sudėtis:

DEXAMETHASONE SODIUM PHOSPHATE 2 MG/ML

Vartojimo būdas:

I.V, I.M

Recepto tipas:

Required

Pagaminta:

NORBROOK LABORATORIES LTD, IRELAND

Terapinės indikacijos:

In hosrses, dogs, cats and Cattle . Dexametahsone is a synthetic corticosteroid with a potent anti-inflammatory action. Colvasone can be used for: 1. Intravenous therapy in cases where emergency treatment is indicated, particulaly shock and circulatory collapse, acute mastitis and burns. 2. Inflammatory conditions in all species: the product will suppress inflammation and is indicated in the treatment of arthritis, laminitis, dermatitis etc. 3. Acetonaemia (ketosis) in cattle. Dexamethasone has a marked glucogenic action.

Leidimo data:

2019-11-30

Pakuotės lapelis

THIS LEAFLET HAS BEEN REVIEWED AND APPROVED 05/2019
SUMMARY OF PRODUCT CHARACTERISTICS
VETERINARY USE ONLY - PRESCRIPTION ONLY MEDICINE
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Colvasone Veterinary, 2mg/ml, Solution for injection
I.M, I.V injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Dexamethasone Sodium Phosphate 2mg
For a full list of excipients, see section 13 “further
information”
3.
INDICATIONS FOR USE
Dexamethasone is a synthetic corticosteroid with a potent anti-
inflammatory action.
Colvasone can be used for:
(1) Intravenous therapy in cases where emergency treatment is
indicated, particularly shock and circulatory collapse, acute
mastitis and burns.
(2) Inflammatory conditions: the product will suppress
inflammation and is indicated in the treatment of arthritis,
laminitis, dermatitis etc..
(3) Acetonaemia (ketosis) in cattle. Dexamethasone has a
marked glucogenic action
PHARMACOTHERAPEUTIC GROUP:
corticosteroids
4.
CONTRAINDICATIONS
Systemic corticosteroid therapy is generally contra-indicated in
patients with renal disease and diabetes mellitus.
5.
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.

Prekės savybės

THIS LEAFLET HAS BEEN REVIEWED AND APPROVED 05/2019
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Colvasone veterinary
I.M, I.V Solution for injection
2.
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 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
A clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses
Cattle
Dogs
Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dexamethasone is a synthetic corticosteroid with a potent anti-
inflammatory action.
Colvasone can be used for:
(1) Intravenous therapy in cases where emergency treatment is
indicated, particularly shock and circulatory collapse, acute mastitis
and burns.
(2) Acetonaemia (ketosis) in cattle. Dexamethasone has a marked
glucogenic action.
(3) Inflammatory conditions in all species: the product will suppress
inflammation and is indicated in the treatment of arthritis,
laminitis,
dermatitis etc.
4.3
CONTRAINDICATIONS
Systemic corticosteroid therapy is generally contra-indicated in
patients
with renal disease and diabetes mellitus.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Use of the product in horses could induce laminitis and therefore
careful observations should be made during treatment.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
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.
ii.
Special precautions to be taken by the person administering
the veterinary medicinal product to animals
In case of accidental self-injection, seek medical advice
immediately and show the carton to the p