CHAN PEN STREP SUSPENSION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
12-06-2015
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Active ingredient:
BENZYLPENICILLIN PROCAINE, DIHYDROSTREPTOMYCIN SULPHATE
Available from:
Chanelle Pharmaceuticals Manufacturing Limited
ATC code:
QJ01RA01
INN (International Name):
BENZYLPENICILLIN PROCAINE, DIHYDROSTREPTOMYCIN SULPHATE
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:
2000-08-18
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Chan Pen Strep Suspension for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
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
Not to be administered to animals known to be sensitive to penicillin.
Not to be used 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 incoordinations.
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.
Each ml contains:
ACTIVE SUBSTANCE
Procaine Benzylpenicillin
200 mg
Dihydrostreptomycin Sulphate (as dihydrostreptomycin sulphate)
200 mg
EXCIPIENT
Sodium formaldehyde sulfoxylate
0.432 mg
Methyl Parahydroxybenzoate
1 mg
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 09/06/2015_
_CRN 7021129_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Not for use in lactating ewes producing milk for human consumption.
Use of the 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 (regiona
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