Dipen 100ml Suspension for Injection for cattle, sheep and pigs

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Procaine benzylpenicillin; Dihydrostreptomycin (as the sulfate)

Fáanlegur frá:

Cross Vetpharm Group Limited

ATC númer:

QJ01RA01

INN (Alþjóðlegt nafn):

Procaine benzylpenicillin; Dihydrostreptomycin (as the sulfate)

Skammtar:

200, 200 milligram(s)/millilitre

Lyfjaform:

Suspension for injection

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Meðferðarhópur:

Cattle, Pigs, Sheep

Lækningarsvæði:

penicillins, combinations with other antibacterials

Ábendingar:

Antibacterial

Leyfisstaða:

Authorised

Leyfisdagur:

2006-03-03

Vara einkenni

Health Products Regulatory Authority
21 May 2018
CRN000XW1
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Dipen 100ml Suspension for Injection for cattle, sheep and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Procaine benzylpenicillin 200mg
Dihydrostreptomycin 200mg
(as dihydrostreptomycin sulphate)
EXCIPIENTS
Methyl parahydroxybenzoate 1.0mg
Sodium formaldehyde sulfoxylate 0.432mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suspension for Injection
The product is a white to off-white sterile aqueous suspension for
injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, sheep and 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.
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.
Health Products Regulatory Authority
21 May 2018
CRN000XW1
Page 2 of 6
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 A