Procactive 300 mg/ml Suspension for injection for cattle, sheep and pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Benzylpenicillin Procaine Monohydrate

Available from:

Laboratorios SYVA, S.A.U

ATC code:

QJ01CE09

INN (International Name):

Benzylpenicillin Procaine Monohydrate

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

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
_ _
Procactive 300 mg/ml suspension for injection for cattle, sheep and
pigs.
In France: Procactive suspension for injection in cattle, sheep and
pigs.
In Belgium and Netherlands, Norway and Sweden: Peniyet vet 300 mg/ml
suspension for injection for
cattle, sheep and pigs.
In Greece, Denmark and Finland: Syvacillin vet 300 mg/ml suspension
for injection for cattle, sheep
and pigs.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each ml contains:
ACTIVE SUBSTANCE:
Benzylpenicillin procaine monohydrate…………….300 mg
(corresponding to 170.40 mg benzylpenicillin)
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, sheep and pigs (weighing more than 25 kg).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
_ _
For the treatment of systemic infections in cattle, sheep and pigs
(weighing more than 25 kg) caused
by or associated with bacteria susceptible to benzylpenicillin.
4.3
CONTRAINDICATIONS
Do not inject intravenously.
Do not use in known cases of hypersensitivity to penicillins,
cephalosporins, procaine or to any of the
excipients.
Do not use in cases 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
Complete cross-resistance has been shown between benzylpenicillin
procaine and other penicillins.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The product is not to be used in pigs weighing less than 25 kg
bodyweight.
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
infor