Synulox Ready-To-Use Suspension for Injection is an off-white suspension containing 35 mg/ml clavulanic acid as Potassium clavulanate and 140 mg/ml amoxicillin as Amoxicillin trihydrate.

Synulox Ready-To-Use Suspension for Injection has a notably broad spectrum of bactericidal activity against the bacteria commonly found in cattle, pigs and small animals.

(a) In vitro Synulox is active against a wide range of clinically important bacteria including:

(b) Clinically, Synulox has been shown to be effective in treating a wide range of diseases including:

The recommended dosage rate is 8.75 mg/kg bodyweight (7.0 mg amoxicillin, 1.75 mg clavulanic acid), equivalent to 1 ml of suspension per 20 kg bodyweight.

Treatment should be administered once daily for 3 to 5 days.

Shake the vial well before use. Inject by the subcutaneous or intramuscular route in dogs and cats, and by the intramuscular route only in cattle and pigs. After injection, massage the injection site.

The suspension is not suitable for intravenous or intrathecal administration. Great care should be taken to avoid contaminating the remaining contents of the vial with water (see 'Pharmaceutical precautions').

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 Suspension for Injection can be administered in combination with Synulox Lactating Cow Intramammary Suspension using the following minimum treatment regime:

In common with all other penicillins, Synulox should not be administered to rabbits, guinea pigs, hamsters or gerbils. Caution is advised in its use in any other very small herbivores.

Very rarely, the use of the product may result in pain on injection and/or local tissue reactions.

Allergic reactions (allergic skin reactions, anaphylaxis) may occasionally occur. If allergic reactions occur, the product should be discontinued immediately. Appropriate symptomatic treatment should be initiated.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

Use of the product may occasionally result in pain on injection and/or local tissue reaction.

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.

Milk for human consumption must not be taken during treatment. Milk for human consumption may only be taken only from cows after 60 hours from the last treatment.

Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 42 days from the last treatment. Pigs may be slaughtered for human consumption only after 31 days from the last treatment.

Do not store above 25°C.

This product does not contain an antimicrobial preservative. Following withdrawal of the first dose, use the product within 28 days. Discard unused material.

Swab the septum before removing each dose.

Clavulanic acid is moisture sensitive. It is very important, therefore, that a completely dry needle and syringe is used when extracting suspension for injection in order to avoid contaminating the remaining contents of the vial with drops of water.

Contamination will result in obvious beads of dark brown discolouration corresponding to the introduced water droplets. Material affected in this way should not be used as it may have significantly reduced potency.

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

Keep out of the sight and reach of children.

For animal treatment only.

Packs containing 6 x 100 ml and 12 x 40 ml vials.

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 body.

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

Synulox RTU may be used in pregnant animals, subject to observance of the withholding time for milk and meat intending for human consumption.