DEPO-MEDRONE V 40 MG/ML SUSPENSION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
11-08-2015
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Active ingredient:
METHYLPREDNISOLONE ACETATE
Available from:
Zoetis Ireland Limited
ATC code:
QH02AB04
INN (International Name):
METHYLPREDNISOLONE ACETATE
Dosage:
40 Mg/Ml
Pharmaceutical form:
Suspension for Injection
Prescription type:
POM
Therapeutic group:
Canine, Equine Non Food, Feline
Therapeutic area:
Methylprednisolone
Therapeutic indications:
Corticosteroid
Authorization status:
Authorised
Authorization date:
2014-01-06
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 27/07/2015_
_CRN 7021331_
_page number: 1_
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.
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 contraindi
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