Depo-Medrone V 40 mg/ml Suspension for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Methylprednisolone acetate

Available from:

Zoetis Belgium S.A.

ATC code:

QH02AB04

INN (International Name):

Methylprednisolone acetate

Dosage:

40 milligram(s)/millilitre

Pharmaceutical form:

Suspension for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats, Dogs, Non food-producing horses

Therapeutic area:

methylprednisolone

Therapeutic indications:

Corticosteroid

Authorization status:

Authorised

Authorization date:

2014-01-06

Summary of Product characteristics

Health Products Regulatory Authority
17 August 2017
CRN000TZ7
Page 1 of 8
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Depo-Medrone V 40 mg/ml Suspension for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active Substance
Methylprednisolone acetate 40.0 mg
Excipients
Myristyl-gamma-picolinium chloride 0.2 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suspension for injection.White aqueous suspension
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dog, cat and horse
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Injectable corticosteroid in dogs, cats and horses.
For the treatment of, or as part of a therapeutic regime for,
inflammatory and allergic
conditions in dogs and cats such as allergic or non-specific
inflammatory dermal
conditions, musculoskeletal conditions, ocular/otic inflammatory
conditions and
other inflammatory/allergic conditions that are likely to respond to
corticosteroid
therapy e.g. autoimmune disorders. For the treatment of, or as part of
a therapeutic
regime for, musculo-skeletal conditions in horses.
4.3 CONTRAINDICATIONS
1.
Not to be given intravenously. The technique of aspiration should be
employed, as appropriate, to avoid intravascular
administration. Intrasynovial, intratendinous or other injections of
corticosteroids for local effect are contra-indicated in the presence
of
acute infectious conditions.
Health Products Regulatory Authority
17 August 2017
CRN000TZ7
Page 2 of 8
2.
Do not mix with any other product for injection at the same site.
3.
Systemic corticosteroid therapy is generally contra-indicated in
patients
with arrested tuberculosis, peptic ulcer, renal disease, diabetes
mellitus and
Cushing’s syndrome.
4.
The product is contraindicated for the treatment of laminitis in
horses.
5.
Do not administer to pregnant animals.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
It is important that treatment of working or racing animals is
followed by a period of
rest to allow resolution of the clinical condition.
4.5 SPECIAL PRECAUTIONS