Procapen Injector 3 g intramammary suspension for cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Benzylpenicillin procaine monohydrate

Available from:

aniMedica GmbH

ATC code:

QJ51CE09

INN (International Name):

Benzylpenicillin procaine monohydrate

Dosage:

3 g/syringe

Pharmaceutical form:

Intramammary suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle

Therapeutic area:

procaine benzylpenicillin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2015-03-27

Summary of Product characteristics

Health Products Regulatory Authority
11 May 2018
CRN000TXF
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Procapen Injector 3 g 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 the 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-susceptible staphylococci and streptococci.
4.3 CONTRAINDICATIONS
Do not use in the cases of
- infections with β-lactamase-producing pathogens
- hypersensitivity to penicillins, other substances of the β-lactam
group, procaine or
to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
11 May 2018
CRN000TXF
Page 2 of 6
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.
Official, national and regional antimicrobial policies should be taken
into account
when the product is used.
Use of the product deviating from the instructions given in the SPC
may increase the
prevalence of bacteria resistant to benzylpenicillin and may decrease
the
effectiveness of treatment with other beta lactam antimicrobials
(penicillins and
cephalosporins) due to the potential for cross-resistance.
The feeding of waste milk containing residues of penicillin to calves
should be
avoided up to the end of the milk withdrawal period (except during the
c