Mamyzin 269.5mg/ml Powder and Solvent for Suspension for Injection for Cattle

Summary of Product characteristics

                                Revised: October 2017
AN: 01604/2016
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Mamyzin 269.5 mg/ml Powder and Solvent for Suspension for Injection
for
cattle.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5g vial contains:
Penethamate hydriodide
5 million IU
Each 10g vial contains:
Penethamate hydriodide
10 million IU
Each 15ml and 30ml vial of solvent contains:
methyl parahydroxybenzoate, as preservative
1.5mg/ml
Each ml of the reconstituted product contains 269.5 mg of penethamate
hydriodide.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder and solvent for suspension for injection
Powder vial: White to off-white crystalline powder
Solvent vial: Clear solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, dairy
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Bovine mastitis caused by penicillin sensitive organisms.
4.3
CONTRAINDICATIONS
Do not use in animals known to be hypersensitive to penicillin.
Do not administer by intravenous injection.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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Revised: October 2017
AN: 01604/2016
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
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 (regional, farm level) epidemiological information about
susceptibility of
the target bacteria.
Official, national and regional antimicrobial policies should be taken
into
account when the product is used.
Use of the product deviating from the instructions given in the SPC
may
increase the prevalence of bacteria resistant to benzylpenicillin and
may
decrease the effectiveness of treatment with other beta-lactams due to
the
potential for cross-resistance.
Special Precautions to be taken by the person administering the
medicinal
product to animals
Penicillins and cephalosporins may cause hypersensitivity (allergy)
following
injection, inhalation, ingestion or skin conta
                                
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