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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Procaine benzylpenicillin; Dihydrostreptomycin sulfate

Available from:

Bimeda Animal Health Limited

ATC code:

QJ01RA01

INN (International Name):

Procaine benzylpenicillin; Dihydrostreptomycin sulfate

Dosage:

200, 200 milligram(s)/millilitre

Pharmaceutical form:

Suspension for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

penicillins, combinations with other antibacterials

Authorization status:

Authorised

Authorization date:

2006-03-03

Summary of Product characteristics

Health Products Regulatory Authority
03 May 2019
CRN009112
Page 1 of 4
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
​
200
​mg
​
Dihydrostreptomycin
​
200
​mg
​
(as dihydrostreptomycin sulphate)
​
​
​
​
​
​
EXCIPIENTS
​
​
​
Methyl parahydroxybenzoate
​
1.0
​mg
​
Sodium formaldehyde sulfoxylate
​
0.423
​mg
​
​
​
​
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.
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.
Health Products Regulatory Authority
03 May 2019