Medine.co.uk

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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