Pro Penstrep Suspension for Injection for Cattle, Sheep and Pigs

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Benzylpenicillin procaine ; Dihydrostreptomycin sulfate

Prieinama:

Interchem Ireland Ltd

ATC kodas:

QJ01RA01

INN (Tarptautinis Pavadinimas):

Benzylpenicillin procaine ; Dihydrostreptomycin sulfate

Dozė:

200, 200 milligram(s)/millilitre

Vaisto forma:

Suspension for injection

Recepto tipas:

POM: Prescription Only Medicine as defined in relevant national legislation

Farmakoterapinė grupė:

Cattle, Pigs, Sheep

Gydymo sritis:

penicillins, combinations with other antibacterials

Terapinės indikacijos:

Antibacterial

Autorizacija statusas:

Authorised

Leidimo data:

2012-02-10

Prekės savybės

Health Products Regulatory Authority
22 December 2017
CRN000V54
Page 1 of 6
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Pro Penstrep Suspension for Injection for Cattle, Sheep and Pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Procaine benzylpenicillin
200
mg
Dihydrostrepomycin
200
mg
(as dihydrostreptomycin sulphate)
EXCIPIENTS:
Methyl parahydroxybenzoate (E218)
1.0
mg
Sodium formaldehyde sulfoxylate
0.432 mg
For the full list of excipents, see section 6.1
3 PHARMACEUTICAL FORM
Suspension for injection. A white to off-white aqueous 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
dihydrostreptomcyin 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
22 December 2017
CRN000V54
Page 2 of 6
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Occasionally in sucking and fattening pigs in 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 cephal