Colvasone 2 mg/ml Solution for injection

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Dexamethasone sodium phosphate

Tillgänglig från:

Norbrook Laboratories (Ireland) Limited

ATC-kod:

QH02AB02

INN (International namn):

Dexamethasone sodium phosphate

Dos:

2 milligram(s)/millilitre

Läkemedelsform:

Solution for injection

Receptbelagda typ:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapiområde:

dexamethasone

Bemyndigande status:

Authorised

Tillstånd datum:

1989-10-01

Produktens egenskaper

Health Products Regulatory Authority
24 January 2019
CRN008TFG
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Colvasone 2 mg/ml Solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active Substance
Dexamethasone Sodium Phosphate
2
mg
Excipient
Benzyl Alcohol
20
mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless, sterile 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 potent
anti-inflammatory action.
Colvasone can be used for:
1)Intravenous therapy in cases where emergency treatment is indicated,
particularly
shock and circulatory collapse, fog fever, acute mastitis and burns.
2)Acetonaemia (ketosis) in cattle. Colvasone has a marked glucogenic
action.
3)Inflammatory conditions in all species: Colvasone will suppress
inflammation and is
indicated in the treatment of arthritis, dermatitis etc.
Health Products Regulatory Authority
24 January 2019
CRN008TFG
Page 2 of 5
4.3 CONTRAINDICATIONS
Do not use 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
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. In the
presence of bacterial infection, antibacterial drug cover is usually
required when
steroids are used.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETER