Cefabactin 50/250 mg - dogs and cats

Cefabactin 500/1000 mg - dogs

For the treatment of:

- Respiratory tract infections, especially bronchopneumonia, caused by Staphylococcus aureus, Streptococcus spp., Escherichia coli and Klebsiella spp.

- Urinary tract infections caused by Escherichia coli, Proteus spp. and Staphylococcus spp.

- Skin infections in cats caused by Staphylococcus spp. and Streptococcus spp. and skin infections in dogs caused by Staphylococcus spp.

Do not use in cases of hypersensitivity to the active substance, to other cephalosporins, to other substances of the β-lactam group or to any of the excipients.

Do not use in known cases of resistance to cephalosporins or penicillins.

Do not use in rabbits, guinea pigs, hamsters and gerbils.

Due to the likely variability (time, geographical) in the occurrence of cefalexin resistant bacteria, bacteriological sampling and susceptibility testing are recommended.

The product should only be used based on susceptibility testing of the bacteria isolated from the animals. If this is not possible, therapy should be based on local epidemiological information.

Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.

Use of the product deviating from the instructions given in this datasheet may increase the prevalence of bacteria resistant to cefalexin and may decrease the effectiveness of treatment with other beta-lactam antibiotics due to the potential for cross-resistance.

In case of chronic renal insufficiency the dose should be reduced or the dosage interval should be increased.

The tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals.

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillin may lead to cross-reactions to cephalosporin and vice versa. Allergic reactions to these substances may occasionally be serious. Do not handle this veterinary medicinal product if you know you are sensitised or if you have been advised not to be in contact with such substances.

Handle this veterinary medicinal product with great care to avoid exposure, taking all recommended precautions. If you develop symptoms following exposure such as skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty breathing are more serious symptoms and require urgent medical attention.

To avoid accidental ingestion of the product by a child, divided or unused tablets should be returned to the open blister pocket and placed back in the outer carton.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Wash hands after use.

Mild and transient vomiting and diarrhoea have been observed very commonly in cats even at the lowest recommended dosage regime. The symptoms were reversible in most cats without symptomatic treatment. Vomiting has been observed occasionally in dogs treated with products containing cefalexin. As with other antibiotics, diarrhoea can occur. In case of recurring vomiting and/or diarrhoea, the treatment should be discontinued and the advice of the attending veterinarian sought. Lethargy can occur very rarely.

Hypersensitivity can occur rarely. In cases of hypersensitivity reactions the treatment should be discontinued.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)

- common (more than 1 but less than 10 animals in 100 animals)

- uncommon (more than 1 but less than 10 animals in 1,000 animals )

- rare (more than 1 but less than 10 animals in 10,000 animals)

- very rare (less than 1 animal in 10,000 animals, including isolated reports).

Laboratory studies in rats and mice have not produced any evidence of teratogenic effects.

The safety of the veterinary medicinal product in dogs and cats has not been established during pregnancy and lactation. Use only accordingly to the benefit/risk assessment by the responsible veterinarian.

In order to ensure efficacy, the veterinary medicinal product should not be used in combination with bacteriostatic antibiotics (macrolides, sulfonamides and

tetracyclines). Concurrent use of first generation cephalosporins with aminoglycoside antibiotics or some diuretics such as furosemide can enhance nephrotoxicity risks.

For oral administration.

The recommended dose is 15-30 mg cefalexin per kg body weight twice a day, during at least 5 consecutive days. An extended course of treatment may be prescribed by the responsible veterinarian in cases of, for example, urinary tract infections or bacterial dermatitis.

To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.

The following table is intended as a guide to dispensing the product at a dose rate of 15 mg cefalexin per kg body weight twice a day.

Tablets can be divided into 2 or 4 equal parts to ensure accurate dosing. Place the tablet on a flat surface, with its scored side facing up and the convex (rounded) side facing the surface.

Halves: press down with your thumbs on both sides of the tablet.

Quarters: press down with your thumb in the middle of the tablet.

No other known side effects than those under Adverse reactions.

In the event of overdose, treatment should be symptomatic