COBACTAN 2.5% 100ML – Cefquinoma 25 mg, Solution for injection

COBACTAN 2.5% 100ML

COMPOSITION:
1 ml product contains:
Active substance:
Cefquinoma 25 mg
(equivalent to cefquinoma sulfate 29.64 mg)

INDICATIONS:
Treatment of bacterial infections in pigs and cattle caused by Gram positive and Gram negative microorganisms sensitive to cefquinoma.
Cattle:
Lactating cows:
– treatment of respiratory tract infections caused by Pasteurella multocida and Pasteurella haemolitica.
– treatment of interdigital dermatitis, acute interdigital necrosis and infectious necrosis of the bulletin.
– treatment of acute mastitis produced by E. coli with general manifestations.

Calves:

– treatment of sepsis caused by E. coli.
Pigs (adult pigs):
– treatment of bacterial infections of the respiratory system caused by Pasteurella multocida, Haemophilus parasuis, Actinobacillus pleuropneumoniae, Streptococcus suis and other microorganisms sensitive to cefquinoma.
– treatment of MMA complex involving E. coli, Staphylococcus spp., Streptococcus spp. and other microorganisms sensitive to cefquinoma.
Piglets:
– treatment of meningitis caused by Streptococcus suis.
– treatment of arthritis caused by Streptococcus spp., E. coli and other microorganisms sensitive to cefquinoma.

CONTRAINDICATIONS:
Do not use in case of known hypersensitivity to the active substance, to other cephalosporins, to other substances of the beta–lactam group or to any of the excipients. Do not administer to animals with a body weight of less than 1.25 kg. Do not administer to birds (including laying hens) due to the risk of developing antimicrobial resistance in humans. Do not use in rabbits, guinea pigs, hamsters and gerbils.

SIDE EFFECTS:
Slight localized tissue reactions may be observed when this product is administered. They disappear after 15 days from the date of administration of the product.
Hypersensitivity reactions rarely occur to cephalosporins. In case of hypersensitivity reactions, treatment should be discontinued.

TARGET SPECIES:
Cattle (lactating cows and calves) and pigs (adult pigs and piglets).

METHOD OF ADMINISTRATION:
Route of administration: by intramuscular injections. The recommended injection site is into the muscle tissue in the middle of the neck.
Cattle (lactating cows): For the treatment of respiratory tract infections caused by Pasteurella multocida and P. haemolitica, 1 mg cefquinoma/kg body weight (2 ml Cobactan 2.5%/50 kg body weight) once a day, for 3–5 consecutive days. For the treatment of interdigital dermatitis, acute interdigital necrosis and infectious necrosis of the bulletin, 1 mg cefquinoma/kg body weight (2 ml Cobactan 2.5%/50 kg body weight) is administered once a day for 3–5 consecutive days. For the treatment of acute mastitis caused by systemic E. coli, 1 mg cefquinoma/kg body weight (2 ml Cobactan 2.5%/50 kg body weight) is administered once a day for 2 consecutive days.
Calves: For the treatment of sepsis caused by E. coli, 2 mg cefquinoma/kg body weight (4 ml Cobactan 2.5%/50 kg body weight) is administered once a day for 3–5 consecutive days.
Pigs (adult pigs): For the treatment of diseases of the respiratory system, 2 mg cefquinoma/kg body weight (4 ml Cobactan 2.5%/25 kg body weight) is administered once a day for 3 consecutive days. For the treatment of MMA complex, 2 mg cefquinoma/kg body weight (4 ml Cobactan 2.5%/25 kg body weight) is administered once a day for 2 consecutive days.
Piglets: For the treatment of meningitis, 2 mg cefquinoma/kg body weight (4 ml Cobactan 2.5%/25 kg body weight) is administered once a day for 2 consecutive days. For the treatment of arthritis, 2 mg cefquinoma/kg body weight (4 ml Cobactan 2.5%/25 kg body weight) is given once a day for 2 consecutive days. For the treatment of epidermatitis, 2 mg cefquinoma/kg body weight (4 ml Cobactan 2.5%/25 kg body weight) is administered once a day for 2 consecutive days. Studies recommend that the following injections be given at different sites.

RECOMMENDATIONS ON CORRECT ADMINISTRATION:
Shake the bottle well before use. This veterinary medicinal product does not contain an antimicrobial preservative.
Dab the stopper before extracting each dose. Use only sterile needles and syringes. To allow the correct administration of the desired volume, a properly graduated syringe can be used. This is especially important when injecting small volumes, for example, for the treatment of piglets. The lid can be safely pricked up to 25 times. 50 ml bottles are recommended to be used for treating piglets. When treating groups of animals, use a single extraction needle.

WAITING TIME:
The use for human consumption of meat and milk from animals during the treatment period shall not be permitted.
Meat and offal: cattle (lactating cows and calves): 5 days; pigs: 3 days.
Milk: cattle (lactating cows): one day.

SPECIAL PRECAUTIONS FOR STORAGE:

RECOMMENDATIONS ON CORRECT ADMINISTRATION:
Shake the bottle well before use. This veterinary medicinal product does not contain an antimicrobial preservative.
Dab the stopper before extracting each dose. Use only sterile needles and syringes. To allow the correct administration of the desired volume, a properly graduated syringe can be used. This is especially important when injecting small volumes, for example, for the treatment of piglets. The lid can be safely pricked up to 25 times. 50 ml bottles are recommended to be used for treating piglets. When treating groups of animals, use a single extraction needle.

WAITING TIME:
The use for human consumption of meat and milk from animals during the treatment period shall not be permitted.
Meat and offal: cattle (lactating cows and calves): 5 days; pigs: 3 days.
Milk: cattle (lactating cows): one day.

SPECIAL PRECAUTIONS FOR STORAGE:

Keep out of sight and reach of children. Store at a temperature lower than 250C. Protect from light. Do not use this veterinary product after the expiry date which is stated on the label. Shelf life after the first opening of the immediate packaging: 28 days.

SPECIAL WARNINGS:
Cobactan 2.5% is selected for resistant strains, such as bacteria carrying extended-spectrum beta lactamase (ESBL), which can pose a risk to human health if these strains spread to humans, for example, through food. For this reason, Cobactan 2.5% should be reserved for the treatment of clinical conditions that have responded poorly, or are expected to respond poorly (refers to very acute cases when treatment must be initiated without bacteriological diagnosis), for first-line treatment.The use of the product must be based on testing the susceptibility of the bacteria isolated from the animal. If this is not possible, treatment should be based on local epidemiological data. Official, national and regional antimicrobial policies must be taken into account when the product is used. Use of the product outside the instructions provided in the SmPC may increase the prevalence of cefquinoma-resistant bacteria and reduce the effectiveness of treatment with other cephalosporins and penicillins, due to the possibility of cross-resistance.
Cobactan 2.5% is intended for the individual treatment of animals. Do not use for disease prevention or as part of group treatment programs.Group treatment should be strictly limited to ongoing disease outbreaks in accordance with the approved conditions of use. Penicillins and cephalosporins can cause hypersensitivity (allergies) following injection, inhalation, ingestion, or skin contact. Hypersensitivity to penicillins can lead to cross–sensitivity to cephalosporins and vice versa. Occasionally, allergic reactions to these substances can be serious.
1. Do not handle this product if you know you are allergic, or if you have been advised not to work with such preparations.
2. Handle the product with great care, taking all recommended precautions, to avoid exposure. Wash your hands after use.

3. If symptoms such as rashes appear after exposure, seek medical advice and present this warning. Swelling of the face, lips and eyelids or shortness of breath are more serious symptoms and require emergency medical intervention.
There is no information available indicating toxicity in cows and sows. Studies in laboratory animals have shown no effects on reproduction or teratogenic potential.
Use in accordance with the benefit/risk balance assessment carried out by the responsible veterinarian. To ensure efficacy, the veterinary medicinal product should not be used in combination with bacteriostatic antibiotics.
Studies in animals with doses up to 10 times higher than the recommended dose were well tolerated by cattle and pigs.
In the absence of compatibility studies, this veterinary medicinal product should not be mixed with other veterinary medicinal products.

SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED PRODUCT OR WASTE, AS APPROPRIATE:
Medicines should not be disposed of in wastewater or household waste. Ask your veterinarian or pharmacist about how to dispose of medicines that are no longer needed. These measures contribute to environmental protection.

DIMENSION:
Bottle x 100 ml