PROCAPEN INJECTOR 3 G INTRAMAMMARY SUSPENSION FOR CATTLE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PROCAINE PENICILLIN G

Available from:

aniMedica GmbH

ATC code:

QJ51CE09

INN (International Name):

PROCAINE PENICILLIN G

Dosage:

3 Grams

Pharmaceutical form:

intramammary Suspension

Prescription type:

POM

Therapeutic group:

Bovine

Therapeutic area:

Procaine penicillin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2015-03-27

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Procapen Injector 3g intramammary suspension for cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml intramammary syringe contains:
ACTIVE SUBSTANCE:
Benzylpenicillin, procaine monohydrate
3.0 g
(equivalent to 1.7 g benzylpenicillin)
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Intramammary suspension
White to yellowish suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (lactating cows)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For treatment of udder infection in lactating cows caused by
benzylpenicillin-sensitive staphylococci and streptococci.
4.3 CONTRAINDICATIONS
Do not use in the case of
- infections with
-lactamase-forming pathogens.
- known hypersensitivity to penicillin, cephalosporins or procaine or
one of the excipients of the product.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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4.5 SPECIAL PRECAUTIONS FOR USE
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.
Use of the product deviating from the instructions given in the SPC
may inc