Introduction

Pfizer

Company name: Pfizer Limited

Address: Ramsgate Road

Sandwich

Kent CT13 9NJ

Telephone: 0845 300 8034 (Out of hours: 01304 616161)

Fax: 01737 332521

Email: UKVetLine@pfizer.com

Website: www.only4vets.co.uk

Presentation

Synulox Lactating Cow Intramammary Suspension is a pale cream/buff coloured oily suspension containing clavulanic acid, amoxicillin and prednisolone in a non-irritant base designed to disperse rapidly in milk. It is presented in syringes containing 50 mg of clavulanic acid as Potassium clavulanate, 200 mg of amoxicillin as Amoxicillin trihydrate and 10 mg of Prednisolone in 3 g of suspension.

Uses

Synulox Lactating Cow is specially formulated for the treatment of bovine mastitis. It has a notably broad spectrum of bactericidal activity against the bacteria commonly isolated from the bovine udder.

The prednisolone in Synulox Lactating Cow has an anti-inflammatory action which helps to reduce the potentially destructive swelling and inflammation associated with mastitis, without affecting the white cell response to infection.

In vitro Synulox is active against a wide range of clinically important bacteria, including the following organisms, which are commonly associated with bovine mastitis:

Staphylococci (including beta-lactamase-producing strains),

Streptococci (including S. agalactiae, S. dysgalactiae and S. uberis),

A. pyogenes and other minor members of the Corynebacteria spp.

Escherichia coli (including beta-lactamase producing strains). In addition, it is active in vitro against many less common udder pathogens including: Bacillus cereus, Bacteroides (including β-lactamase producing strains) Campylobacter spp., Klebsiellae and Pasteurellae.

Clinically, Synulox Lactating Cow has been shown to be an effective routine treatment for mastitis in lactating cows. Cases responding successfully to treatment include infections with the following major pathogens:

Staphylococci (including β-lactamase producing strains),

Streptococci (including S. agalactiae, S. dysgalactiae, and S. uberis),

Escherichia coli (including β-lactamase-producing strains).

Dosage and administration

Dosage

A course of 3 syringes per affected quarter–one syringe every 12 hours.

Administration

After milking, clean and disinfect the teat end thoroughly with surgical spirit. Insert the syringe nozzle into the teat orifice and apply gentle and continuous pressure until the suspension is expressed. The treated quarter(s) may be milked out at the next normal milking time, but the milk should be discarded.

Combined Therapy for the treatment of bovine mastitis. In the situation where systemic treatment as well as intramammary treatment is necessary, Synulox Ready-To-Use Injection can be administered in combination with Synulox Lactating Cow Intramammary using the following minimum treatment regime.

Synulox RTU

Synulox LC

8.75 mg/kg bodyweight (7.0 mg amoxicillin, 1.75 mg clavulanic acid) i.e. 1 ml/20 kg bodyweight

and then 24 hours later

One syringe gently infused into the teat of the infected quarter

and then 12 hours later

One syringe gently infused into the teat of the infected quarter

and then 12 hours later

8.75 mg/kg bodyweight (7.0 mg amoxicillin, 1.75 mg clavulanic acid) i.e. 1 ml/20 kg bodyweight

and then 24 hours later

8.75 mg/kg bodyweight (7.0 mg amoxicillin, 1.75 mg clavulanic acid) i.e. 1 ml/20 kg bodyweight

Where necessary, Synulox RTU Injection may be administered for an additional two days for a total of 5 daily injections.

One syringe gently infused into the teat of the infected quarter

Contra-indications, warnings, etc

During the course of treatment the situation should be reviewed frequently by close veterinary supervision.

Milk for human consumption must not be taken from a cow during treatment. With cows milked twice daily, milk for human consumption may only be taken from 60 hours (i.e. at the 5th milking) after the last treatment.

Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 7 days from the last treatment.

With other milking routines, the basis of the veterinary surgeon's advice should be that milk may be taken for human consumption only after the same period from the last treatment (e.g. with three times a day milking and the product administered twice per day, milk for human consumption may only be taken at the 6th milking).

Combined Therapy: When using Synulox LC Intramammary and Synulox RTU in combination, animals must not be slaughtered for human consumption during treatment. Cows may not be slaughtered for human consumption until 42 days after the last treatment. Milk must not be taken for human consumption during treatment. Milk for human consump-tion may be taken only from cows after 60 hours from the last treatment of Synulox RTU following the minimum dosage regime described in Dosage and Administration.

Operator warnings

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.

Pharmaceutical precautions

Store in a dry place. Do not store above 25°C.

Keep out of the reach of children. For animal treatment only.

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Legal category

POM-V

Packaging Quantities

Cartons of 12 and 24 syringes.

Further information

Synulox is a novel concept in antibiotic therapy. Resistance to many antibiotics is caused by beta-lactamase enzymes which destroy the antibiotic before it can act on the bacteria themselves. The clavulanate in Synulox counteracts this defence mechanism by inactivating the beta-lactamases, thus rendering the bacteria sensitive to amoxicillin's rapid bactericidal effect, at concentrations readily attainable in the udder.

Synulox is effective against Klebsiella infections found in veterinary practice, but it is not indicated for cases involving Pseudomonas species.