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Clinical particulars
Target species
Cattle
Indications for use, specifying the target species
Combiclav Injection has a 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) Treats:
Cattle:
Respiratory infections
Soft tissue infections (e.g. joint/navel ill, abscesses etc.)
Metritis
Mastitis.
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.
Contraindications
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
The product should not be administered to rabbits, guinea pigs, hamsters or gerbils. Caution is advised in its use in other very small herbivores.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
Official and local antimicrobial policies should be taken into account when the product is used.
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local epidemiological information.
Avoid use of the product in herds where no β-lactamase producing Staphylococci strains 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.
Care should be taken to avoid contaminating the remaining contents of a vial with water.
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.
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.
Care should be taken to avoid accidental self-injection.
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 in breathing are more serious symptoms and require urgent medical attention.
Wash hands after use.
Adverse reactions (frequency and seriousness)
Use of the product may occasionally result in pain on injection and/or local tissue reaction.
Use during pregnancy, lactation or lay
The product may be used safely in pregnant animals.
Interaction with other medicinal products and other forms of interaction
None known.
Amount(s) to be administered and administration route
For 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. After injection, massage the injection site. Use a completely dry sterile needle and syringe. Swab the septum before removing each dose.
For Combined Therapy the following minimum treatment regime should be followed:
Combiclav Injection
Combiclav LC Intramammary
8.75 mg/kg bodyweight (7.0 mg amoxicillin, 1.75 mg clavulanic acid) i.e. 1 ml/20 kg bodyweight.
One syringe gently infused into the teat of the infected quarter
24 hours
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12 hours
Description: arrowdown
8.75 mg/kg bodyweight (7.0 mg amoxicillin, 1.75 mg clavulanic acid) i.e. 1 ml/20 kg bodyweight.
One syringe gently infused into the teat of the infected quarter
24 hours
Description: arrowdown
12 hours
Description: arrowdown
8.75 mg/kg bodyweight (7.0 mg amoxicillin, 1.75 mg clavulanic acid) i.e. 1 ml/20 kg bodyweight.
One syringe gently infused into the teat of the infected quarter
Where necessary Combiclav Injection may be administered for an additional two days for a total of 5 daily injections.
To ensure the correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Potentiated penicillin is of a low order of toxicity and is well tolerated by the parenteral route. Apart from occasional injection site reactions, which may occur at the recommended dose, no other adverse effects are to be expected from an accidental overdose.
Withdrawal period(s)
Meat and offal: 42 days.
Milk: 60 hours