CHAN PEN STREP SUSPENSION FOR INJECTION

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

BENZYLPENICILLIN PROCAINE, DIHYDROSTREPTOMYCIN SULPHATE

Commercializzato da:

Chanelle Pharmaceuticals Manufacturing Limited

Codice ATC:

QJ01RA01

INN (Nome Internazionale):

BENZYLPENICILLIN PROCAINE, DIHYDROSTREPTOMYCIN SULPHATE

Dosaggio:

200/200 Mg/Ml

Forma farmaceutica:

Suspension for Injection

Tipo di ricetta:

POM

Gruppo terapeutico:

Bovine, Ovine, Porcine

Area terapeutica:

Penicillins, combinations with other antibacterials

Indicazioni terapeutiche:

Antibacterial

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2000-08-18

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Chan Pen Strep Suspension for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, sheep, pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infections caused by bacteria sensitive to penicillin and dihydrostreptomycin in cattle, sheep and pigs.
4.3 CONTRAINDICATIONS
Not to be administered to animals known to be sensitive to penicillin.
Not to be used when it is known that penicillinase-producing staphylococcus organisms are present.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Occasionally in sucking and fattening pigs administration of products containing procaine penicillin may cause a transient pyrexia,
vomiting, shivering, listlessness and incoordinations.
In pregnant sows and gilts a vulval discharge which could be associated with abortion has been reported.
The maximum dose volume recommended at any one site for cattle is 20 ml.
Each ml contains:
ACTIVE SUBSTANCE
Procaine Benzylpenicillin
200 mg
Dihydrostreptomycin Sulphate (as dihydrostreptomycin sulphate)
200 mg
EXCIPIENT
Sodium formaldehyde sulfoxylate
0.432 mg
Methyl Parahydroxybenzoate
1 mg
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 09/06/2015_
_CRN 7021129_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Not for use in lactating ewes producing milk for human consumption.
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 (regiona