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:

Cross Vetpharm Group Limited

ATC code:

QJ01RA01

INN (International Name):

PROCAINE BENZYLPENICILLIN, DIHYDROSTREPTOMYCIN SULFATE

Dosage:

200/200 Mg/Ml

Pharmaceutical form:

Suspension for Injection

Prescription type:

POM

Therapeutic group:

Bovine, Ovine, Porcine

Therapeutic area:

Penicillins, combinations with other antibacterials

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2006-03-03

Summary of Product characteristics

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.
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 04/08/2016_
_CRN 7024181_
_page number: 1_
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