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Date: Saturday, April 20, 2024 13:03

Release 4.145
Cephorum ® 500mg Film Coated Tablets for dogs
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Antimicrobials: Oral preparations: Tablets
Active ingredient: Cephalexin
Product:Cephorum® Film Coated Tablets 500 mg for dogs
Product index: Cephorum Tablets 500 mg
Incorporating:
Presentation
White to yellowish, elongated, film-coated tablet scored on both sides, each containing cefalexin monohydrate Ph. Eur. equivalent to 500 mg anhydrous cefalexin.
Uses
Cephorum® Tablets 500 mg are indicated for oral antibiotic therapy in dogs.
When susceptible organisms are present, Cephorum® Tablets 500 mg are indicated for the treatment of bacterial skin infections, and urinary-tract infections caused by Klebsiella pneumoniae.
Dosage and administration
The recommended dose rate is 15 mg/kg bodyweight twice daily. In severe or acute conditions the dose may be safely doubled or given at more frequent intervals.
Treatment for five days is recommended but this may be extended or shortened at the discretion of the veterinary surgeon.
To ensure a correct dosage body weight should be determined as accurately as possible to avoid under-dosing.
Contra-indications, warnings, etc
Use of Cephorum® Tablets 500 mg should be based on susceptibility testing and take in to account official and local antimicrobial policies. Cephorum® Tablets 500 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.
Adverse reactions: Hypersensitivity to cephalexin is very rare.
Symptoms of overdose include nausea, vomiting, epigastric distress, diarrhoea and haematuria. Treatment should be symptomatic.
Although laboratory and clinical studies have shown no evidence of teratogenicity, caution should be exercised when prescribing for pregnant animals. Small quantities of cefalexin are found in the milk of lactating animals.
Keep out of reach of children. For animal treatment only.
User precautions: 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 TVM UK Animal Health.
Pharmaceutical precautions
Do not store above 25°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 1.1 mg titanium dioxide (E171) per tablet.
Legal category
Legal category: POM-V
Packaging quantities
Blister packs of 100 tablets and 140 tablets
Cephalexin is a broad spectrum cephalosporin antibiotic with bacteriocidal activity against a wide range of Gram-positive and Gram-negative bacteria. The following have been shown to be sensitive to cefalexin in vitro: Staphylococcus spp (including penicillin resistant strains) Streptococcus spp, Corynebacterium spp, Pasteurella multocida, Escherichia coli, and Klebsiella spp.
Cefalexin is acid stable, well absorbed following oral administration either with or without food, and is excreted by renal tubular secretion and glomerular filtration. The elimination half life in the dog is approximately 90 minutes.
Marketing Authorisation Number
Vm 46275/4000
Significant changes
GTIN
GTIN description:Cephorum 500mg Tablet (100 count unit)
GTIN:05013073000698
GTIN description:Cephorum 500mg (pack of 126 x 100)
GTIN:05013073000704
GTIN description:Cephorum 500mg Tablet (unit)
GTIN:05013073000674
GTIN description:Cephorum 500mg (pack of 126)
GTIN:05013073000681