Megapen - Strep Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Procaine benzylpenicillin; Dihydrostreptomycin sulphate

Available from:

Franklin Pharmaceuticals Ltd.

ATC code:

QJ01RA

INN (International Name):

Procaine benzylpenicillin; Dihydrostreptomycin sulphate

Dosage:

200, 200 milligram(s)/millilitre

Pharmaceutical form:

Suspension for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle

Therapeutic area:

Combinations of antibacterials

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1987-10-01

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Megapen - Strep Injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Suspension for injection.
A white aqueous solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Bovine.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and control of infections caused by bacteria
sensitive to procaine penicillin or dihydrostreptomycin
sulphate.
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active
ingredients.
Do not administer by the intravenous route.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
Each ml contains:
Active substances
Procaine Benzylpenicillin
200 mg
Dihydrostreptomycin Sulphate
200 mg
Excipient
Methyl Parahydroxybenzoate
1.0 mg
Sodium Formaldehyde Sulfoxylate
1.48 mg
For a full list of excipients, see section 6.1
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4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use of the product should be based on susceptibility testing of the
bacteria isolated from the animal. If this is not
possible, therapy should be based on local (regional, farm level)
epidemiological information about susceptibility of the
target bacteria.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Avoid direct contact with p