Bimprocil 300 mg/ml suspension for injection for cattle, sheep and pigs

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Benzylpenicillin procaine

Dostępny od:

Bimeda Animal Health Limited

Kod ATC:

QJ01CE09

INN (International Nazwa):

Benzylpenicillin procaine

Dawkowanie:

300 milligram(s)/millilitre

Forma farmaceutyczna:

Suspension for injection

Typ recepty:

POM: Prescription Only Medicine as defined in relevant national legislation

Dziedzina terapeutyczna:

procaine benzylpenicillin

Status autoryzacji:

Authorised

Data autoryzacji:

2021-06-18

Charakterystyka produktu

Health Products Regulatory Authority
18 June 2021
CRN009PWK
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bimprocil 300 mg/ml suspension for injection for cattle, sheep and
pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Benzylpenicillin procaine 300 mg
(corresponding to 175.8 mg of benzylpenicillin)
EXCIPIENTS
Methyl Parahydroxybenzoate E218 2.0 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suspension for injection.
An off-white suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, sheep and pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of acute systemic infections caused by bacteria
susceptible to benzylpenicillin.
4.3 CONTRAINDICATIONS
Do not inject intravenously.
Do not use in known cases of hypersensitivity to penicillin,
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 very small herbivores such as guinea pigs, gerbils and
hamsters.
Do not use in the presence of β-lactamase producing pathogens.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Complete cross-resistance has been shown between benzylpenicillin
procaine and other penicillins.
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 penicillins and cephalosporins due to the potential
for cross-resistance.
The feeding of waste milk containing resi