Target species
Cattle, Dogs and Cats.
Indications for use, specifying the target species
Noroclav Injection has a broad-spectrum of bactericidal activity against the bacteria commonly found in cattle, dogs and cats.
(a) In vitro Noroclav 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, Pasteurellae spp, Fusobacterium necrophorum, Bacteroides (including beta-lactamase producing strains), Haemophilus spp, Moraxella spp and Actinobacillus lignieresi.
(b) Noroclav Injection is indicated for the treatment of diseases including:
Cattle:
•Respiratory infections
•Soft tissue infections (e.g. joint/navel ill, abscesses etc.)
•Metritis
•Mastitis.
Dogs and cats:
•Respiratory tract infections
•Urinary tract infections
•Skin and soft tissue infections (e.g. abscesses, pyoderma, anal sacculitis and gingivitis.)
Contraindications
Do not administer to rabbits, guinea pigs, hamsters or gerbils. Caution is advised in its use in other very small herbivores.
Special Warnings
Cross-resistance has been shown between amoxicillin/clavulanic acid and other beta-lactam antibiotics. Use of the veterinary medicinal product should be carefully considered when susceptibility testing has shown resistance to beta-lactam antibiotics because its effectiveness may be reduced.
Special precautions for use
Special precautions for safe use in the target species
Do not use in cases of hypersensitivity to penicillin or other substances of the beta-lactam group.
Use of the product should be based on identification and susceptibility testing of the target pathogen(s). If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at farm level, or at local/regional level.
Use of the product should be in accordance with official, national and regional antimicrobial policies.
An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG category) should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.
Narrow spectrum antibiotic therapy with a lower risk of antimicrobial resistance selection should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.
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)
Cattle, Dogs and Cats: | |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Immediate pain upon injection, Injection site reaction |
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the immediate packaging for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Can be used during pregnancy, subject to observance of the withholding time for milk and the withdrawal time for meat intended for human consumption.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
Intramuscular use: Cattle
Subcutaneous use: Dogs
Intramuscular use and subcutaneous use: Cats
The recommended dosage rate is 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. This veterinary medicinal product does not contain an antimicrobial preservative. Use a completely dry sterile needle and syringe. Swab the septum before removing each dose.
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 vialwith 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.
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
Cattle:
Meat and offal: 42 days
Milk: 80 hours
Animals must not be slaughtered for human consumption during treatment.
Milk for human consumption must not be taken during treatment.