Target species
Cefabactin 50 mg and 250 mg: dogs and cats.
Cefabactin 500 mg and 1000 mg: dogs.
Indications for use, specifying the target species
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.
Contraindications
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.
Special warnings for each target species
None.
Special precautions for use in animals
Due to the likely variability (time, geographical) in the occurrence of cefalexin resistant bacteria, bacteriological sampling and susceptibility testing are recommended.
The veterinary medicinal 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.
Use of the veterinary medicinal product should be in accordance with official, national and regional antimicrobial policies.
Use of the veterinary medicinal product deviating from the instructions given in the SPC 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.
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 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 veterinary medicinal 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.
Special precautions for the protection of the environment
Not applicable.
Other precautions
Not applicable.
Adverse reactions (frequency and seriousness)
Dogs:
Rare (1 to 10 animals / 10,000 animals treated): | Hypersensitivity reaction a |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Vomiting b, Diarrhoea b, Lethargy |
a The treatment should be discontinued.
b In case of recurrence, the treatment should be discontinued and the advice of the attending veterinarian sought.
Cats:
Very common (>1 animal / 10 animals treated): | Vomiting a, Diarrhoea a |
Rare (1 to 10 animals / 10,000 animals treated): | Hypersensitivity reaction b |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Lethargy |
a Mild and transient. The symptoms were reversible in most cats without symptomatic treatment.
b The treatment should be discontinued.
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 its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
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 according to the benefit-risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
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.
Amount(s) to be administered and administration route
For oral use.
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 veterinary medicinal product at a dose rate of 15 mg cefalexine per kg body weight twice a day.
ADMINISTRATION TWICE DAILY |
Body weight | Dose mg | Cefabactin 50 mg | Cefabactin 250 mg | Cefabactin 500 mg | Cefabactin 1000 mg |
>0.5 kg - 0.8 kg | 12.5 | ¼ | | | |
>0.8 kg - 1.6 kg | 25 | ½ | | | |
>1.6 kg - 2.5 kg | 37.5 | ¾ | | | |
>2.5 kg - 3.3 kg | 50 | 1 | | | |
>3.3 kg - 5 kg | 75 | 1½ | | | |
>5 kg - 6.6 kg | 100 | 2 | | | |
>6.6 kg - 8 kg | 125 | 2½ | ½ | | |
>8 kg - 10 kg | 150 | 3 | | | |
>10 kg - 12.5 kg | 188 | | ¾ | | |
>12.5 kg - 16.6 kg | 250 | | 1 | ½ | |
>16.6 kg - 20 kg | 313 | | 1¼ | | |
>20 kg - 25 kg | 375 | | 1½ | | |
>25 kg - 29 kg | 438 | | 1¾ | | |
>29 kg - 33 kg | 500 | | 2 | 1 | ½ |
>33 kg - 41 kg | 625 | | | 1¼ | |
>41 kg - 50 kg | 750 | | | 1½ | ¾ |
>50 kg - 58 kg | 875 | | | 1¾ | |
>58 kg - 66 kg | 1000 | | | 2 | 1 |
>66 kg - 83 kg | 1250 | | | | 1¼ |
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.
Halves: press down with your thumbs on both sides of the tablet.
Quarters: press down with your thumb in the middle of the tablet.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No other known side effects than those under Adverse reactions.
In the event of overdose, treatment should be symptomatic.
Withdrawal period(s)
Not applicable.