Synulox Lactating Cow Intramammary Suspension
Revised: June 2014
AN: 00247/2014
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE VETERINARY MEDICINAL PRODUCT
SYNULOX LACTATING COW Intramammary Suspension
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients:
One syringe (3 g) contains:
Amoxicillin trihydrate equivalent to amoxicillin 200 mg
Potassium clavulanate equivalent to clavulanic acid 50 mg
Prednisolone 10 mg
For a full list of excipients see section 6.1.
PHARMACEUTICAL FORM
Intramammary suspension.
Pale cream/buff coloured oily suspension.
CLINICAL PARTICULARS
Target species
Cattle (lactating cows).
Indications for use, specifying the target species
For use in clinical cases of
mastitis including cases associated with infections with the
following pathogens:
Staphylococci (including b-lactamase producing strains)
Streptococci (including S. agalactiae, S.
dysgalactiae andS. uberis)
Escherichia coli(including
b-lactamase producing
strains)
Contraindications
Do not use in animals which are known to be hypersensitive to b-lactamase antibiotics.
Special warnings for each target species
Do notuse in cases associated with Pseudomonas.
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 herds where no β-lactamase producing Staphylococcistrains have been isolated. Veterinarians should strive to use narrow spectrum antibiotics if possible. Inappropriate use of the product may increase the prevalence of bacteria resistant to ß-lactam antibiotics and may decrease the effectiveness of treatment with ß-lactam antibiotics, due to the potential for cross-resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.
Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.
Handle this product with great care to avoid exposure, taking all recommended precautions.
If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing, are more serious symptoms and require urgent medical attention.
Wash hands after use.
Adverse reactions (frequency and seriousness)
None known.
Use during pregnancy, lactation or lay
No special precautions.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
Before the infusion is made, the teat end should be cleaned and disinfected.
The contents of one syringe should be infused into each affected quarter via the teat canal, immediately after milking, at 12 hour intervals for three consecutive milkings.
In cases of infections caused by Staphylococcus aureus, a longer course of antibacterial therapy may be required. Therefore overall treatment length must be at the veterinarian’s discretion but should be long enough to ensure complete resolution of intramammary infection.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions are to be expected from an accidental overdose.
Withdrawal periods
Meat and offal: 7 days.
Milk: 84 hours. With cows milked twice daily, milk for human consumption may only be taken from the 7thmilking after the last treatment. Where any other milking routine is followed, milk may be taken for human consumption only after the same period from the last treatment (e.g. with 3 times a day milking, milk may be taken for human consumption at the 11thmilking).
PHARMACOLOGICAL PROPERTIES
Amoxicillin is a broad spectrum bactericidal b-lactam antibiotic. Clavulanic acid inactivates b-lactamases. This combination is effective against b-lactamase producing organisms.
Prednisolone is an anti-inflammatory corticosteroid.
In vitro, clavulanic acid and amoxicillin in combination are active
against a wide range of clinically important bacteria including the
following organisms which are commonly associated with bovine
mastitis:
Staphylococci (including b-lactamase producing strains)
Streptococci (including S.
agalactiae, S. dysgalactiae and
S. uberis)
Arcanobacteria (including A.
pyogenes)
Escherichia coli (including b-lactamase producing strains)
PHARMACEUTICAL PARTICULARS
List of excipients
Calcium Sodium Aluminosilicate (dried)
Mineral Oil (Formula A)
Formula A:
Emulsifying Wax
White Soft Paraffin
Liquid Paraffin Light
Incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
Special precautions for storage
Do not store above 25°C.
Store in a dry place.
Nature and composition of immediate packaging
Low density polyethylene syringes packed in cartons containing 3, 12, 24 or 300 syringes. Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
MARKETING AUTHORISATION HOLDER
Zoetis UK Limited
5th Floor, 6 St. Andrew Street
London
EC4A 3AE
MARKETING AUTHORISATION NUMBER
Vm:42058/4143
DATE OF FIRST AUTHORISATION
Date:11 December 1986
DATE OF REVISION OF THE TEXT
Date:June 2014
26 June 2014
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