SYNULOX LACTATING COW INTRAMAMMARY SUSPENSION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
07-12-2016
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Active ingredient:
AMOXICILLIN (EQUIVALENT TO AMOXICILLIN TRIHYDRATE PH. EUR.), CLAVULANIC ACID (EQUIVALENT TO POTASSIUM CLAVULANATE PH. EUR.), PREDNISOLONE
Available from:
Zoetis Ireland Limited
ATC code:
QJ51RV01
INN (International Name):
AMOXICILLIN (EQUIVALENT TO AMOXICILLIN TRIHYDRATE PH. EUR.), CLAVULANIC ACID (EQUIVALENT TO POTASSIUM CLAVULANATE PH. EUR.), PRE
Dosage:
200/50
Pharmaceutical form:
intramammary Suspension
Prescription type:
POM
Therapeutic group:
Bovine
Therapeutic area:
Antibacterials and corticosteroids
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
2014-11-28
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Synulox Lactating Cow Intramammary suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Intramammary suspension.
Pale cream/buff coloured oily suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (lactating cows).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For use in clinical cases of mastitis including cases associated with infections with the following pathogens:
Straphylococci (including -lactamase producing strains)
Streptococci (including _S.agalactiae, S.dysgalactiae _and _S.uberis_)
_Escherichia coli _(including -lactamase producing strains)
4.3 CONTRAINDICATIONS
Do not use in animals which are known to be hypersensitive to -lactamase antibiotics.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not use in cases associated with _Pseudomonas_.
Active substances
One syringe (3g) contains:
Amoxicillin trihydrate
equivalent to amoxicillin
200 mg
Potassium clavulanate
equivalent to clavulanic acid 50 mg
Prednisolone
10 mg
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 22/11/2016_
_CRN 7024907_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Swab teat end with appropriate disinfectant before treatment.
RECOMMENDATIONS FOR PRUDENT USE
The product should be used for treatment of clinical mastitis only.
Use of the product should be based on local (regional, farm level) epidemiological information about susceptibility of
the target bacteria and take into account official and local antimicrobial policies.
The use of the product should preferably be based on susceptibility tests.
Avoid use of the product in
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