Pentomycin Suspension for Injection

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Benzylpenicillin procaine ; Dihydrostreptomycin sulphate

זמין מ:

Univet Limited

קוד ATC:

QJ01CE09

INN (שם בינלאומי):

Benzylpenicillin procaine ; Dihydrostreptomycin sulphate

כמות:

200, 200 milligram(s)/millilitre

טופס פרצבטיות:

Suspension for injection

סוג מרשם:

POM: Prescription Only Medicine as defined in relevant national legislation

קבוצה תרפויטית:

Cattle, Pigs, Sheep

איזור תרפויטי:

procaine benzylpenicillin

סממני תרפויטית:

Antibacterial

מצב אישור:

Authorised

תאריך אישור:

1987-10-01

מאפייני מוצר

Health Products Regulatory Authority
08 May 2018
CRN000XVX
Page 1 of 6
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Pentomycin Suspension for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Procaine benzylpenicillin
200 mg
Dihydrostreptomycin
200 mg
(as dihydrostreptomycin sulphate)
EXCIPIENTS
Methyl parahydroxybenzoate
1.0 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 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
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
08 May 2018
CRN000XVX
Page 2 of 6
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 on
susceptibility
testing.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS:
Penicillin and cephalosporins may cause hypersensitivity (allergy)
follo