Combiclav Injection

Name:

 Combiclav Injection

Category:

 Intramammaries

Region:

 United Kingdom

Combiclav Injection is an off-white suspension containing amoxicillin 140 mg/ml as amoxicillin trihydrate Ph. Eur. and clavulanic acid 35 mg/ml as potassium clavulanate Ph. Eur. in an oily base.

Combiclav Injection has a notably broad spectrum of bactericidal activity against the bacteria commonly found in cattle.

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

Gram-positive: Staphylococci (including beta-lactamase producing strains), Streptococci, Corynebacteria, Clostridia, Bacillus anthracis, Actinomyces bovis.

Gram-negative: Escherichia coli (including beta-lactamase producing strains), Salmonella spp, (including beta-lactamase producing strains), Campylobacter spp, Klebsiella spp, Proteus spp, Pasteurella spp, Fusobacterium necrophorum, Bacteroides (including beta-lactamase producing strains), Haemophilus spp, Moraxella spp and Actinobacillus lignieresi.

(b) Combiclav Injection is effective against bacteria which cause a wide range of diseases:

In cattle these include:
Respiratory infections
Soft tissue infections (e.g. joint/navel ill, abscesses etc.)
Metritis
Mastitis

By intramuscular injection at a dosage rate of 8.75 mg/kg bodyweight (1 ml per 20 kg bodyweight) daily for 3-5 days.

Shake the vial well before use. Use a completely dry sterile needle and syringe. Swab the septum before removing each dose. After injection, massage the injection site.

The suspension is not suitable for intravenous or intrathecal administration.

Combined therapy for the treatment of bovine mastitis: In the situation where systemic treatment as well as intramammary treatment is necessary, Combiclav Injection can be administered in combination with Combiclav Lactating Cow Intramammary Suspension using the following minimum treatment regime:

The product should not be administered to rabbits, guinea pigs, hamsters or gerbils. Caution is advised in its use in other very small herbivores.

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

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.

Milk for human consumption must not be taken during treatment. Milk for human consumption may be taken from treated cattle only 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.

Do not store above 25ºC.

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

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

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

POM-V

Vm 02000/4238

50 ml and 100 ml multidose vials.

MANUFACTURED BY:
Norbrook Laboratories Limited
Station Works
Newry
Co. Down, BT35 6JP

DISTRIBUTED BY:
Norbrook Laboratories (GB) Limited
The Green
Great Corby
Carlisle
Cumbria, CA4 8LR

Resistance to many antibiotics is caused by beta-lactamase enzymes which destroy the antibiotic before it can act on the bacteria themselves. The clavulanic acid in Combiclav Injection 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.

FOR ANIMAL TREATMENT ONLY.