Ceporex Injection

CatsCattleDogs

Ceporex Injection Data Sheet

Presentation
Ceporex Injection is an oily suspension of sodium cefalexin equivalent to 18% w/v cefalexin Ph.Eur.

Uses
Ceporex Injection is indicated for antibiotic therapy in cattle, cats and dogs. Cefalexin 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 cefalexin in vitro:

Staphylococcus spp. (including penicillin-resistant strains)

Streptococcus spp.Actinomyces bovis
Corynebacterium spp.Haemophilus spp.
Pasteurella spp.Erysipelothrix rhusiopathiae
Escherichia coliClostridium spp.
Proteus spp.Salmonella spp.
Micrococcus spp.Fusobacterium spp.
Moraxella spp.Peptostreptococcus spp.
Actinobacillus lignieresiPeptococcus spp.

When susceptible organisms are present, Ceporex Injection is indicated in the treatment of infections of the respiratory tract, urogenital tract, the skin and localised infections in soft tissues in dogs and cats. In dogs it may also be effective in the treatment of the gastrointestinal tract.
Trials have shown Ceporex Injection to be of particular value in treating the following:
Cattle: Metritis, foot infections, wounds and abscesses and in the treatment of septicaemic mastitis to supplement intramammary therapy.

Dosage and administration
In the presence of water hydrolysis of cefalexin occurs. It is important, therefore, that a dry syringe is used when extracting suspension for injection to avoid contaminating the remaining contents of the vial with drops of water.
Before withdrawal of a dose the vial should be shaken to re-suspend the contents.

Dogs and cats
The recommended dose is 10 mg/kg once daily for up to 5 days. Any variation should be at the prescribing veterinary surgeons discretion, e.g. in severe or acute conditions. The following is intended as a guide:

AnimalWeightDose Volume
Cats: up to4.5kg0.25ml
Dogs: Small5-9.0kg
0.25–0.5 ml
   medium9.0kg-27.0 kg
0.5–1.5 ml
   large27.0-54.0 kg
1.5–3.0 ml
Ceporex Injection may be administered by either the subcutaneous or intramuscular route. After administration massage the injection site. Ceporex Injection is not suitable for intravenous or intrathecal administration.

Large animals
The recommended dose for cattle is 7 mg/kg once daily for up to 5 days.
SpeciesDose rateDose Volume
Cattle7 mg/kg1ml/25kg
Ceporex Injection should be administered by the intramuscular route. It is not suitable for intravenous administration.
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.

Contra-indications, warnings, etc
Hypersensitivity to cefalexin is rare. However, Ceporex Injection should not be administered to animals which are known to be hypersensitive to cefalexin.

Operator warnings
Penicillin and cephalosporins may cause sensitisation (allergy) following injection, inhalation, ingestion or skin contact. Sensitivity to penicillin may lead to cross sensitivity to cephalosporins 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 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.
Use of the product may result in localised tissue reaction.
Wash hands after use.
Overdose:
Administration of Cefalexin at up to twice the recommended dose in cattle and at up to three times the recommended dose in dogs and cats does not produce any adverse effects.
For animal treatment only
Keep out of the reach and sight of children
 
Large animals
Withdrawal period for cows' milk - zero hours.
Animals for human consumption must not be slaughtered during treatment. Withdrawal periods for animals for human consumption when treated with Ceporex Injection at the recommended dosage are as follows:
Cattle: 19 days after last treatment.

Pharmaceutical precautions
Protect from light. Do not store above 30°C.
Shake well before use. 
After withdrawal of the first dose, use the product within 28 days. When the container is broached for the first time, use the in-use shelf life which is specified on the packaging to calculate the date on which any remaining product should be discarded. This discard date should be written in the space provided on the label. Discard unused material.

Disposal
Dispose of used packaging in the household refuse. Unused product should be returned to the veterinary surgeon. Do not mix with any other veterinary product.

Legal category
POM-V

Packaging Quantities
Multidose vials 100 ml.

Further information

Cefalexin is rapidly absorbed after injection. Peak blood concentrations are generally achieved within one hour of administration. Cefalexin is excreted in the urine in high concentration.
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.
 
Marketing authorisation number
Vm 00201/4139.