Alfapen-Strep Suspension for Injection

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Benzylpenicillin procaine ; Dihydrostreptomycin sulphate

Предлага се от:

Alfa Med Limited

АТС код:

QJ01RA01

INN (Международно Name):

Benzylpenicillin procaine ; Dihydrostreptomycin sulphate

дозиране:

200, 200 milligram(s)/millilitre

Лекарствена форма:

Suspension for injection

Вид предписание :

POM: Prescription Only Medicine as defined in relevant national legislation

Терапевтична група:

Cattle, Pigs, Sheep

Терапевтична област:

penicillins, combinations with other antibacterials

Терапевтични показания:

Antibacterial

Статус Оторизация:

Authorised

Дата Оторизация:

1999-08-23

Данни за продукта

Health Products Regulatory Authority
04 September 2018
CRN008DJ6
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Alfapen-Strep Suspension for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES:
Benzylpenicillin Procaine
200 mg
Dihydrostreptomycin
200 mg
(as dihydrostreptomycin sulphate)
EXCIPIENTS:
Methyl parahydroxybenzoate (E218)
1 mg
Sodium formaldehyde sulfoxylate
0.432 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suspension for Injection.
A white to off-white suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, sheep, pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infections caused by bacteria sensitive to
penicillin and
dihydrostreptomycin in cattle, sheep and pigs.
4.3 CONTRAINDICATIONS
Do not administer to animals known to be sensitive to penicillin.
Do not use when it is known that penicillinase-producing
staphylococcus organisms
are present.
Health Products Regulatory Authority
04 September 2018
CRN008DJ6
Page 2 of 7
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Occasionally in sucking and fattening pigs administration of products
containing
procaine penicillin may cause a transient pyrexia, vomiting,
shivering, listlessness and
incoordination.
In pregnant sows and gilts a vulval discharge which could be
associated with
abortion has been reported.
The maximum dose volume recommended at any one site for cattle is 20
ml.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use of this 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.
Whenever possible the product should only be used on the basis of
susceptibility
testing.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
Penicillin and cephalosp