Small Animal Products
Cephorum® - Affordable veterinary licensed cephalexin

Forum Animal Health
Crown House, 2-8 Gloucester Road
Redhill, Surrey RH1 1FH
United Kingdom

Telephone: +44 (0)1737 781416
animalhealth@forumgroup.co.uk

Cephorum® - Affordable veterinary licensed cephalexin

Licensed Veterinary Cephalexin


CEPHORUM® FILM COATED TABLETS
250 MG FOR DOGS

PRESENTATION
White round biconvex film-coated tablets scored on one side with "CX" embossed above the score-line and "250" below the score-line. Each tablet contains cefalexin monohydrate Ph. Eur. The tablets are not divisible.

USES
When susceptible organisms are present, Cephorum® Tablets 250 mg are indicated for the treatment of bacterial skin infections, and urinary-tract infections caused by Klebsiella pneumoniae.

Cephorum® - Affordable veterinary licensed cephalexin

DOSAGE AND ADMINISTRATION
The recommended dose rate is 15 mg/kg bodyweight twice daily by the oral route. In severe or acute conditions the dose may be safely doubled or given at more frequent intervals.

The table below is intended as a guide for the recommended dose of 15 mg cefalexin per kg bodyweight. Any increase in the dose should be calculated case-by-case for the individual animal concerned.

Cephorum® - Affordable veterinary licensed cephalexin
* Two doses per day should be given

Treatment for five days is recommended but this may be extended or shortened at the discretion of the veterinary surgeon.

Any increase in dose or duration of use, and any use in dogs less than 12 kg bodyweight, should be in accordance with a risk/benefit assessment by the responsible veterinarian. To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.

Cephorum® - Affordable veterinary licensed cephalexin

PACKAGING
Cephorum our established leading antibiotic for use in treating susceptible bacterial skin infections in the dog, has undergone a packaging transformation.

The NEW packaging is in blister strips of fourteen tables with 10 strips in each carton. This helps in dispensing and handling at surgery and home.


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CONTRA-INDICATIONS, WARNINGS, ETC

Use of Cephorum® Tablets 250 mg should be based on susceptibility testing and take in to 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 potential cross-resistance.

In case of an allergic reaction, treatment should be withdrawn.

Cephorum® Tablets 250 mg should not be administered to animals which are known to be hypersensitive to cefalexin.

As with other antibiotics which are excreted mainly by the kidneys, 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.

Vomiting and/or diarrhoea have been observed in dogs. In rare cases hypersensitivity can occur. In cases of hypersensitivity reactions the treatment should be stopped.

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

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.

Symptoms of overdose include nausea, vomiting, epigastric distress, diarrhoea and haematuria. Treatment should be symptomatic.

Keep out of reach of children. For animal treatment only.

Special precautions to be taken by the person administering the tablets to animals: Cephalosporins may cause sensitisation (allergy) following injection,inhalation, ingestion or skin contact. Sensitivity to penicillin may lead to cross-sensitivity to cephalosporin and vice versa. Allergic reactions to these substances may occasionally be serious.


  1. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.
  2. Handle this product with great care to avoid exposure, taking all recommended precautions.
  3. 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 breathing are more serious symptoms and require urgent medical attention.

Wash hands after use.

Summary of Products Characteristics is available on request from Forum Animal Health.

PHARMACEUTICAL PRECAUTIONS
Store in a dry place. Do not store above 30°C. Protect from light.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Contains 0.55 mg titanium dioxide (E171) per tablet.

LEGAL CATEGORY
POM-V

PACKAGING QUANTITIES
Container of 250 tablets and blister packs of 100 tablets.

FURTHER INFORMATION
Cefalexin, first generation cephalosporin, inhibits bacterial cell wall synthesis in a manner similar to the penicillins, and is widely considered to be bacteriocidal in action. It is thought that cephalexins act by binding to and inactivating a number of different penicillin-binding proteins (PBPs) located on the inner aspects of the bacterial cell membrane. Cephalosporins are essentially time-dependent antibiotics.

Cefalexin is active against a large spectrum of gram-positive and gram-negative bacteria. The breakpoints for cefalexin are usually defined as S≤ 8 μg/ml, R> 32 μg/ml.

The in vitro activity of cefalexin against bacterial isolates from skin infections in dogs is as follows:

Cephorum® - Affordable veterinary licensed cephalexin

The MIC90 value of cefalexin against Klebsiella pneumoniae isolated from urinary tract infections in dogs is 4 μg/ml.

The most prevalent resistance mechanism among gram-negative bacteria to cefalexin is due to the production of various beta-lactamases (cephalosporinase) that cause inactivation. Resistance in gram-positive bacteria often involves a decreased affinity of the PBPs (penicillinbinding proteins) for beta-lactam drugs. Efflux pumps, extruding the antibiotic from the bacterial cell, and structural changes in porins (reducing passive diffusion of the drug through the cell wall), may contribute to bacterial resistance.

Cross-resistance (involving the same resistance mechanism) exists between antibiotics belonging to the beta-lactam group due to their similar structures. This occurs with betalactamase enzymes, structural changes in porins or variations in efflux pumps. Co-resistance (involving different resistance mechanisms) has been reported in E. coli due to a plasmid with resistance genes.

After oral administration, 60 to 80% of cefalexin is absorbed from the small intestine. The delay reported between administration and beginning of absorption is approximately 20 minutes and differences in mean AUC, Cmax, and Tmax are not significantly affected by food administration concomitant to treatment with cefalexin.

Cephorum® - Affordable veterinary licensed cephalexin

Protein binding is low at 18%. Cefalexin is widely distributed into a variety of tissue fluids, including bile, synovial and pericardial fluid The passage into interstitial tissue, as demonstrated in wound fluid concentration, peritoneal fluid and skin blisters is generally good.

Cefalexin is minimally metabolized and primarily excreted via the renal route, around 70% of an oral dose is excreted into the urine in 24 hours in the dog. It is important to note that cefalexin concentrations obtained in urine are well above plasma concentrations, and similarly concentrations in bile may be up to four times higher.

MARKETING AUTHORISATION NUMBER
Vm 05928/4004.

SIGNIFICANT CHANGES
Forum Animal Health/Cephorum Film Coated
Tablets 250mg for dogs/Dosage
02/10/2012

GTIN (GLOBAL TRADE ITEM NO)
Cephorum 250mg Tablet (unit)
05013073000452
Cephorum 250mg Tablet (pack of 36)
05013073000469

For further information, please contact Forum Animal Health on
+44 (0)1737 781416 or
animalhealth@forumgroup.co.uk

Cephorum® is a registered trade mark of Forum Products Ltd.

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