Procactive 300 mg/ml Suspension for Injection for Cattle, Sheep and Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Procaine Benzylpenicillin

Available from:

Laboratorios SYVA S.A.U

ATC code:

QJ01CE09

INN (International Name):

Procaine Benzylpenicillin

Pharmaceutical form:

Suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Pigs, Sheep

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2019-03-26

Summary of Product characteristics

Issued: June 2022
AN: 00288/2021
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Procactive 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.
Issued: June 2022
AN: 00288/2021
Page 2 of 7
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 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 i