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Date: Sunday, June 26, 2022 18:12

Description: Animalcare_UK_2SpotCol_RGB_vertical_Logo
Release 2.179
Cephacare Flavour Tablets
 
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Antimicrobials: Oral preparations: Tablets
Active ingredient: Cephalexin monohydrate
Product:Cephacare Flavour 50mg, 250mg, 500mg and 1000mg Tablets
Product index: Cephacare Flavour Tablets
Incorporating:Cephacare Flavour 50mg, 250mg, 500mg and 1000mg Tablets
Qualitative and quantitative composition
Each tablet contains:
Active substance:
50mg, 250mg, 500 mg and 1000mg cefalexin as cefalexin monohydrate.
Excipients:
For a full list of excipients, see pharmaceutical particulars
Pharmaceutical form
Cephacare flavour 50 mg tablets for cats and dogs
Tablets. Beige, round biconvex tablets. The tablets should not be divided.
Cephacare flavour 250 mg and 500mg tablets for dogs
Tablets. Beige, flat tablets with a break mark on one side.
Cephacare Flavour 1000mg Tablets for Dogs
Tablets. Brown speckled oblong tablet, with one side flat and other side spherical with break mark on both sides. The tablets can be divided into halves.
Clinical particulars
Indication for use and target species
Cephacare flavour 50 mg tablets for cats and dogs :
Target species
Cats and dogs. Indications for use, specifying the target species
In dogs: Treatment of infections of the respiratory tract, gastro-intestinal tract, urogenital tract, the skin and localised infections in soft tissue caused by bacteria sensitive to cefalexin.
In cats: Treatment of infections of the respiratory tract, urogenital tract, the skin and localised infections in soft tissue caused by bacteria sensitive to cefalexin.
Cephacare flavour 250mg, 500 mg & 1000mg tablets for dogs:
Target species
Dogs Indications for use, specifying the target species
Treatment of infections of the respiratory tract, gastro-intestinal tract, urogenital tract, the skin and localised infections in soft tissue caused by bacteria sensitive to cefalexin.
Contraindications
Do not use in cases of known 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 rabbits, gerbils, guinea pigs and hamsters.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies. Use of the 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 penicillins, due to the potential for cross resistance. In the case of an allergic reaction, treatment should be withdrawn. As with other antibiotics which are excreted mainly by the kidneys, unnecessary accumulation may occur in the body when renal function is impaired. In cases of known renal insufficiency the dose should be reduced, antimicrobials known to be nephrotoxic should not be administered concurrently and the product should be used only according to a risk/benefit assessment by the responsible veterinarian.
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 product if you know you are sensitised or if you have been advised not to be in contact with such substances. Handle this 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. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands after use.
Adverse reactions (frequency and seriousness)
Transient episodes of soft faeces and vomiting have been observed in cats when given products containing cefalexin. Treatment should be discontinued if vomiting and diarrhoea develop. Vomiting has been observed occasionally in dogs when given products containing cefalexin.
Use during pregnancy, lactation or lay
The safety of the product has not been demonstrated in studies in pregnant or lactating dogs and cats. Use only in accordance with a risk/benefit assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
The bactericidal activity of cephalosporins is reduced by concomitant administration of bacteriostatic acting compounds (macrolides, sulphonamides and tetracyclines). Nephrotoxicity can be increased when 1st generation cephalosporins are combined with polypeptide antibiotics, aminoglycosides and some diuretics (furosemide). Concomitant use with such active substances should be avoided.
Amounts to be administered and administration route
For oral administration.
Dogs: A dose of 15 mg/kg twice daily is recommended, to be doubled where appropriate. Treatment for five days is recommended. Any increase in dose or duration of use should be according to a risk/benefit assessment by the prescribing veterinarian (e.g. in cases of chronic pyoderma).
Cats: A dose of 15 mg/kg twice daily for 5 days is recommended. Tablets may be added to food if necessary. To avoid underdosing, the bodyweight should be accurately determined.
Overdose (symptoms, emergency procedures, antidotes), if necessary
The administration of cefalexin has been shown to produce no serious side-effects at many times the recommended dose rate.
Withdrawal period(s)
Not applicable.
Pharmacological particulars
Pharmacotherapeutic group:
Antibacterials for systemic use, other beta-lactam antibacterials, first-generation cephalosporins.
ATCvet code: QJ01DB01.
Pharmacodynamic properties
Cefalexin is a semi-synthetic bactericidal antibiotic belonging to the cephalosporin group which acts by interference with bacterial cell wall formation.
Cefalexin is active against a wide range of Gram-positive and Gram-negative bacteria. The following micro-organisms have been shown to be sensitive to cefalexin in vitro: Staphylococcus spp (including penicillin-resistant strains), Streptococcus spp, Corynebacterium spp, Pasteurella multocida, Escherichia coli, Micrococcus spp, Moraxella spp.
Cefalexin is resistant to the action of staphylococcal penicillinase and is therefore active against the strains of Staphylococcus aureus that are insensitive to penicillin (or related antibiotics such as ampicillin or amoxycillin) because of production of penicillinase.
Cefalexin is also active against the majority of ampicillin-resistant E.coli.
Pharmacokinetic particulars
Following oral administration, cefalexin is rapidly and almost completely absorbed. Peak plasma concentrations (Cmax= 14.38 μg/ml) are achieved within approximately 2 hours (Tmax= 2.1 hours) in the cat. Peak plasma concentrations in the dog (Cmax= 17.49 μg/ml) are achieved within approximately 1.5 hours (Tmax= 1.55). In both species, cefalexin is excreted in the urine in high concentrations and has an elimination half life (T1/2) of approximately 2.5–3 hours.
Pharmaceutical particulars
List of excipients
Lactose monohydrate
Potato starch
Magnesium stearate
Beef flavour
Incompatibilities
Not applicable.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Return any ½ tablet to the blister pack and use within 24 hours or within 48 hours for 1000mg tablet.
Special precautions for storage
Do not store above 25°C.
Store in a dry place.
Keep the blister in the outer carton.
Nature and composition of immediate packaging
Cephacare flavour tablets are supplied in blister packs each containing 10 tablets, in cardboard boxes containing 20, 100 or 250 tablets.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
50 mg: UK (GB) Vm 10347/4025, UK (Northern Ireland) Vm 10347/4025
250 mg: UK (GB) Vm 10347/4026, UK (Northern Ireland) Vm 10347/4026
500 mg: UK (GB) Vm 10347/4027, UK (Northern Ireland) Vm 10347/4027
1000 mg: UK (GB) Vm 10347/4040, UK (Northern Ireland) Vm 10347/4040
Significant changes
Date of the first authorisation or date of renewal
Cephacare flavour 50 mg tablets for cats and dogs:
19 December 2008
Cephacare flavour 250 mg and 500mg tablets for dogs:
19 December 1998
Cephacare Flavour 1000mg Tablets for Dogs:
02 February 2017
Date of revision of the text
Cephacare flavour 50 mg, 250mg and 500mg tablets for cats and dogs :
July 2018
Cephacare Flavour 1000mg Tablets for Dogs:
February 2019

Any other information
Legal category
Legal category: POM-V
GTIN
GTIN description:Cephacare 50mg- ESPT-100 tablet pack
GTIN:5055037402223
GTIN description:Cephacare 250mg- ESPT- 100 tablet pack
GTIN:5055037402230
GTIN description:Cephacare 500mg- ESPT- 100 tablet pack
GTIN:5055037402247
GTIN description:Cephacare 1000mg- ESPT- 100 tablet pack
GTIN:5055037402254