DIPEN 100ML SUSPENSION FOR INJECTION FOR CATTLE, SHEEP AND PIGS
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
19-08-2016
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Ingredient activ:
PROCAINE BENZYLPENICILLIN, DIHYDROSTREPTOMYCIN SULFATE
Disponibil de la:
Cross Vetpharm Group Limited
Codul ATC:
QJ01RA01
INN (nume internaţional):
PROCAINE BENZYLPENICILLIN, DIHYDROSTREPTOMYCIN SULFATE
Dozare:
200/200 Mg/Ml
Forma farmaceutică:
Suspension for Injection
Tip de prescriptie medicala:
POM
Grupul Terapeutică:
Bovine, Ovine, Porcine
Zonă Terapeutică:
Penicillins, combinations with other antibacterials
Indicații terapeutice:
Antibacterial
Statutul autorizaţiei:
Authorised
Data de autorizare:
2006-03-03
Caracteristicilor produsului
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
________________________________________________________________________________________________________________________
_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
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