Target species:
Cattle (lactating cows).
Indications for use, specifying the target species
For the treatment of clinical mastitis caused by the following bacteria susceptible to the combination of amoxicillin and clavulanic acid:
•Staphylococci (including β-lactamase producing strains)
•Streptococci (including S. agalactiae, S. dysgalactiae and S. uberis)
•Escherichia coli (including β-lactamase producing strains)
Contraindications
Do not use in cases of hypersensitivity to the active substances, or to any of the excipients.
Special Warnings for each target species
Do not use in cases associated with Pseudomonas
Special precautions for use
Special precautions for use in animals
Swab teat end before treatment, with cleaning towels provided.
Recommendations for prudent use
The product should be used for treatment of clinical mastitis only.
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 (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Official, national and regional antimicrobial policies should be taken into account when the product is used.
The combination of amoxicillin and clavulanic acid should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.
Avoid use of the product in herds where no β-lactamase producing staphylococci strains have been isolated. E.coli mastitis with mild to moderate clinical signs, a non-antimicrobial approach should be the first option. Veterinarians should strive to use narrow spectrum antibiotics if possible. Inappropriate use of the product may increase the prevalence of bacteria resistant to β-lactam antibiotics and may decrease the effectiveness of treatment with β-lactam antibiotics, due to the potential for cross-resistance. Most of the ESBLs and AmpC β-lactamases producing E.coli strains may not be inhibited by the combination of amoxicillin/clavulanic acid.
The feeding of waste milk containing residues of antibiotics to calves should be avoided up to the end of the milk withdrawal period, except during colostral phase, because it could select antimicrobial resistant bacteria within the intestinal microbiota of the calf and increase the faecal shedding of these bacteria.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This product may cause skin and eye irritation. Avoid contact with the skin and eyes. In the event of skin or eye contact rinse with plenty of clean water.
The cleaning towels supplied with the product contain isopropyl alcohol, which many cause skin or eye irritation in some people.
The wearing of gloves is recommended during administration of the product and when handling the cleaning towels.
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.
Other precautions
Due to the endocrine-disrupting potential of prednisolone, the product may be dangerous to fish and other aquatic organisms. Consequently treated animals should not have access to watercourses during the first 12 hours after treatment.
Adverse reactions (frequency and seriousness)
In very rare cases, immediate hypersensitivity reactions may occur (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy, lactation or lay
No special precautions
Interaction with other medicinal products and other forms of interaction
None known
Amounts to be administered and administration route
Intramammary use.
The syringe must only be used once. Partly emptied syringes due to the unsuccessful use should be discarded.
The content of one syringe should be infused gently into the teat of the infected quarter every 12 hours after each of three consecutive milkings.
Milk out the infected quarters. After thoroughly cleaning and disinfecting the teat and teat orifice with the cleaning towels provided, gently infuse the contents of one syringe into each affected quarter. Disperse the product by gentle massage of the teat and udder of the affected animal.
In cases of infections caused by Staphylococcus aureus, a longer course of antibacterial therapy may be required. Therefore overall treatment length must be at the veterinarian’s discretion but should be long enough to ensure complete resolution of intramammary infection.
Combined therapy for the treatment of bovine mastitis. In the situation where systemic treatment as well as intramammary treatment is necessary, especially in cases of serious clinical mastitis Combiclav Injection can be administered in combination with this product.
For Combined Therapy the following minimum treatment regime should be followed:
Potentiated Penicillin Injection | Potentiated Penicillin Intramammary Suspension for Lactating Cows |
Intramuscular injection at a dose rate of 8.75 mg/kg bodyweight (7,0 amoxicillin and 1,75 mg clavulanic acid) which corresponds to 1 ml of product/20 kg bodyweight daily for 3 days as follows: 8.75 mg/kg bodyweight (7.0 mg amoxicillin, 1.75 mg clavulanic acid) i.e. 1 ml/20 kg bodyweight | The content of one syringe should be infused gently into the teat of the infected quarter every 12 hours after each of three consecutive milkings as follows: One syringe gently infused into the teat of the infected quarter |
24 hours | | 12 hours | |
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 | | 12 hours | |
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 Potentiated Penicillin Injection may be administered for an additional two days for a total of 5 daily injections. | |
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions are to be expected from an accidental overdose
Withdrawal period
Meat & Offal: 7 days
Milk: 84 hours
Combined Therapy:
When using this product and Combiclav Injection in combination:
Meat and offal: 42 days
Milk: 84 hours
From the last treatment of Combiclav Injection following the minimum posology regime.