MEGAPEN - STREP INJECTION

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

PROCAINE BENZYL PENICILLIN (LECITHIN COATED), DIHYDROSTREPTOMYCIN SULFATE

Disponibil de la:

Franklin Pharmaceuticals Ltd.

Codul ATC:

QJ01RA

INN (nume internaţional):

PROCAINE BENZYL PENICILLIN (LECITHIN COATED), DIHYDROSTREPTOMYCIN SULFATE

Dozare:

20/20

Forma farmaceutică:

Suspension for Injection

Tip de prescriptie medicala:

POM

Grupul Terapeutică:

Bovine

Zonă Terapeutică:

Combinations of antibacterials

Indicații terapeutice:

Antibacterial

Statutul autorizaţiei:

Authorised

Data de autorizare:

1987-10-01

Caracteristicilor produsului

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
________________________________________________________________________________________________________________________
_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