ALFAPEN-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:
PROCAINE BENZYLPENICILLIN, DIHYDROSTREPTOMYCIN
Available from:
Alfa Med Limited
ATC code:
QJ01RA01
INN (International Name):
PROCAINE BENZYLPENICILLIN, DIHYDROSTREPTOMYCIN
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:
1999-08-23
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Alfapen-Strep Suspension for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Suspension for Injection.
A white to off-white suspension.
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
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.
Each ml contains:
ACTIVE SUBSTANCES:
Benzylpenicillin Procaine
200
mg
(Equivalent of 200,000 IU)
Dihydrostreptomycin
200
mg
(as dihydrostreptomycin sulphate)
EXCIPIENTS:
Methyl parahydroxybenzoate (E218)
1
mg
Sodium formaldehyde sulfoxylate
0.432 mg
For a full list of excipients, see section 6.1
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 09/06/2015_
_CRN 7021128_
_page number: 1_
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) epidemiolog
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