PRIMOPEN 300 mg/ml suspension for injection for cattle, pigs and horses

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Benzylpenicillin procaine monohydrate

Предлага се от:

FATRO S.p.A.

АТС код:

QJ01CE09

INN (Международно Name):

Benzylpenicillin procaine monohydrate

дозиране:

300 milligram(s)/millilitre

Лекарствена форма:

Suspension for injection

Вид предписание :

POM: Prescription Only Medicine as defined in relevant national legislation

Терапевтична област:

procaine benzylpenicillin

Статус Оторизация:

Authorised

Дата Оторизация:

2020-09-18

Данни за продукта

Health Products Regulatory Authority
18 September 2020
CRN00990Z
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
PRIMOPEN 300 mg/ml suspension for injection for cattle, pigs and
horses
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Benzylpenicillin (procaine) monohydrate
(corresponding to 170 mg benzylpenicillin)
300 mg
EXCIPIENTS:
Sodium formaldeyde sulfoxylate
Sodium methyl parahydroxybenzoate (E219)
2.50 mg
1.15 mg
Disodium edetate
0.55 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
White to almost white, homogeneous suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, pigs and horses.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infections caused by penicillin-sensitive
bacteria.
4.3 CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substance,
cephalosporins, procaine or to any of the excipients.
Do not use in rabbits, guinea pigs, hamsters or gerbils.
Do not use intravenously.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The product will not be effective against beta lactamase producing
organisms.
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.
Health Products Regulatory Authority
18 September 2020
CRN00990Z
Page 2 of 5
Special precautions to be taken by the person ad