MEGAPEN - STREP INJECTION

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

PROCAINE BENZYL PENICILLIN (LECITHIN COATED), DIHYDROSTREPTOMYCIN SULFATE

Fáanlegur frá:

Franklin Pharmaceuticals Ltd.

ATC númer:

QJ01RA

INN (Alþjóðlegt nafn):

PROCAINE BENZYL PENICILLIN (LECITHIN COATED), DIHYDROSTREPTOMYCIN SULFATE

Skammtar:

20/20

Lyfjaform:

Suspension for Injection

Gerð lyfseðils:

POM

Meðferðarhópur:

Bovine

Lækningarsvæði:

Combinations of antibacterials

Ábendingar:

Antibacterial

Leyfisstaða:

Authorised

Leyfisdagur:

1987-10-01

Vara einkenni

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
IRISH MEDICINES BOARD
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_Date Printed 28/04/2011_
_CRN 7010620_
_page number: 1_
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 product. Use gloves when administering the product. Seek medicinal advice if symptoms
such as skin rash, swelling of face, lips etc occurs.
Penicillin and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin
contact. Hypersensitivity to penicillin may lead t