Product Details - CEPOREX® ORAL DROPS

Reg. No. 83/568 (Act 101/1965)
Ceporex Oral Drops are presented as granules for reconstitution with water to give 10ml of orange-coloured, sweetened suspension containing 100 mg cephalexin in each ml.
Pharmacological action:
Cephalexin is a broad spectrum cephalosporin antibiotic with bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria.
Indications:
Ceporex Oral Drops are indicated for oral antibiotic therapy in cats and small dogs. Cephalexin is a broad spectrum cephalosporin antibiotic with bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria.
The following micro-organisms have been shown to be sensitive to cephalexin in vitro:
Staphylococcus spp. (including penicillin-resistant strains).
Streptococcus spp.
Corynebacterium spp.
Pasteurella multocida
Escherichia coliProteus spp.
Micrococcus spp.
Moraxella spp.
When susceptible organisms are present, Ceporex Oral Drops may be effective in the treatment of infections of the respiratory tract, urogenital tract, the skin and localized infections.
Contraindications:
There are no contra-indications.
Hypersensitivity to cephalexin is very rare, however, Ceporex Oral Drops should not be administered to animals which are known to be hypersensitive to cephalexin.
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.
Dosage and directions for use:
Ceporex Oral Drops are prepared by adding 6 ml of ordinary drinking water to the granules and mixing thoroughly . Shake well before each withdrawal from the bottle. Ceporex Oral Drops are well accepted by cats and dogs and may be administered directly into the mouth , or added to food.
The recommended dose rate is 10 to 15 mg/kg bodyweight (which is 1,0 to 1,5 ml Ceporex Oral Drops per 10 kg bodyweight) twice daily. In severe or acute infections 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 veterinarian.
The following is intended as a guide:
Dogs: 5 kg and less bodymass: 0,5 to 1,0 ml drops twice daily.
6 kg to 10 kg bodymass: 1,0 to 1,5 ml drops twice daily.
11 kg to 20 kg bodymass: 1,5 to 3 ml drops twice daily.
Cats: Average dose rate: 0,5 ml drops twice daily.
Further information: Cephalexin is rapidly, and almost completely, absorbed after oral administration. Effective blood levels are generally achieved within two hours of dosing. Cephalexin is excreted in the urine in high concentration.
Cephalexin 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. Cephalexin is also active against the majority of ampicillin-resistant E.coli.
The administration of cephalexin has been shown to produce no serious side-effects at many times the recommended dose rate.
For larger breeds of dogs Ceporex 250mg tablets may be a more suitable dosage form.
Side effects and special precautions:
None.
Known signs of overdosage and its treatment:
Not known.
Identification:
Orange-coloured sweetened granules.
Presentation:
Ceporex Oral Drops are presented in bottles as granules for reconstitution with water to give 10 ml of orange-coloured, sweetened suspension containing 100 mg cephalexin in each ml. The dropper is calibrated to deliver either 0,5 ml or 1,0 ml (50 mg or 100 mg).
Storage instructions:
Store at room temperature (below 25°C). Protect from light.
When reconstituted the drops retain their potency for 10 days when kept in a cool place, preferably a refrigerator.
Before each withdrawal the bottle should be thoroughly shaken.
Keep out of reach of children and uninformed persons.
Registration holders:
Schering-Plough Animal Health
Co. Reg. No. 1934/005207/07
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