PROBENCIL 300 mg/ml suspension for injection for cattle and pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Benzylpenicillin procaine

Available from:

MEVET S.A.U.

ATC code:

QJ01CE09

INN (International Name):

Benzylpenicillin procaine

Dosage:

300 milligram(s)/millilitre

Pharmaceutical form:

Suspension for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

procaine benzylpenicillin

Authorization status:

Authorised

Authorization date:

2019-05-03

Summary of Product characteristics

2
1
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NAME OF THE VETERINARY MEDICINAL PRODUCT
PROBENCIL 300 mg/ml suspension for injection for cattle and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Procaine Benzylpenicillin …………………………….. 300 mg
EXCIPIENTS:
Sodium methyl parahydroxybenzoate (E219) ………… 1.25 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
White suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of systemic infections in cattle and pigs caused by
bacteria sensitive to penicillin:
4.3
CONTRAINDICATIONS
Do not inject intravenously.
Do not use in cases of hypersensitivity to penicillins,
cephalosporins, procaine or to any of the
excipients.
Do not use in case of severe renal dysfunction with anuria and
oliguria.
Do not use in the presence of β-lactamase producing pathogens.
Do not use in very small herbivores such as guinea pigs, gerbils and
hamsters.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Administer by deep injection only
The 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.
3
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
penicillins and cephalosporins due to the potential for
cross-resistance.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Penicillin and cephalosporins may cause hypersensitivity (allergy)
following injection, inhal