Procapen Injector 3g Intramammary Suspension for Cattle

Summary of Product characteristics

                                Revised: June 2018
AN: 00908/2016
Page 1 of 6
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 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.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Revised: June 2018
AN: 00908/2016
Page 2 of 6
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 colostral
phase), because it
could select antimicrobial-resistant bacteria within the intestina
                                
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