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Date: Sunday, June 16, 2024 7:05

Release 2.60
Ceporex® 180 mg/ml Suspension for injection for cattle, cats and dogs
 
Species: Cats, Cattle, Dogs
Therapeutic indication: Pharmaceuticals: Antimicrobials: Injections
Active ingredient: Sodium Cefalexin
Product:Ceporex® 180 mg/ml Suspension for injection for cattle, cats and dogs
Product index: Ceporex®
Cattle - milk: Zero hours
Cattle - meat: 19 days
Incorporating:
Qualitative and quantitative composition
Active constituents: mg/ml
Cefalexin sodium
equivalent to Cefalexin 180
For the full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Suspension for injection
A white to cream coloured mobile suspension
Clinical particulars
Target Species
Cattle, cats and dogs.
Indications for use
The product is indicated for antibiotic therapy in cattle, cats and dogs. Cefalexin is a broad spectrum cefalosporin 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 coli
Clostridium spp.
Proteus spp.
Salmonella spp.
Micrococcus spp.
Fusobacterium spp.
Moraxella spp.
Peptostreptococcus spp.
Actinobacillus lignieresi
Peptococcus spp.


When susceptible organisms are present, the product 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 infections of the gastrointestinal tract.
Trials have shown the product to be of particular value in treating metritis, foot infections, wounds and abscesses and in the treatment of septicaemic mastitis to supplement intramammary therapy in cattle.
Contraindications
Hypersensitivity to cefalexin is very rare, however, it should not be administered to animals which are known to be hypersensitive.
Special warnings for each target species
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.
Special precautions for use
Not suitable for intravenous or intrathecal administration.
Operator warnings
Care should be taken to avoid accidental self-injection. In the case of accidental self-injection, seek medical advice immediately.
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. Wash hands after use.
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.
Adverse Reactions
Use of the product may result in localised tissue reaction.
Allergic reactions across all target species have been reported very rarely in spontaneous reports.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy or lactation
None.
Interactions
Concurrent use of cephalosporins with potentially nephrotoxic substances (e.g. aminoglycosides, polymyxin antibiotics) or diuretic substances (e.g. furosemide) may increase possible nephrotoxic effects. Also see section ‘Special warnings for each target species’.
Amounts to be administered and administration route
Before withdrawal of a dose the vial should be shaken to re-suspend the contents.
This product does not contain an antimicrobial preservative. Use a dry needle and syringe. Swab the septum before removing each dose.
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:
Weight
Dose Volume
Cats: up to
4.5 kg
0.25 ml
Dogs: small
5-9.0 kg
0.25-0.5 ml
medium
9.0-27.0 kg
0.5-1.5 ml
large
27.0-54.0 kg
1.5-3.0 ml

The product may be administered by either the subcutaneous or intramuscular route. After administration massage the injection site.
Cattle: The recommended dose for cattle is 7 mg/kg (1ml/25kg) once daily for up to 5 days.
The product should be administered by the intramuscular route.
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.
Withdrawal periods
Cattle - 19 days
Cattle (milk) – Zero hours
Animals for human consumption must not be slaughtered during treatment.
Pharmacological particulars
ATC Vet Code: QJ01DB01
Pharmacodynamic properties
Cefalexin is a semi-synthetic bactericidal antibiotic belonging to the cefalosporin group which acts by interference with bacterial cell wall formation.
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 Properties
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.
Pharmaceutical particulars
Excipients
Caster Oil, hydrogenated
Triglycerides, medium chain
Major incompatibilities
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.
Shelf life
Shelf life of the veterinary product as packaged for sale 3 years.
Shelf life following withdrawal of the first dose, 28 days
Special precautions for storage
Do not store above 30°C. Protect from light.
Following withdrawal of the first dose, use the product within 28 days.
Immediate packaging
Colourless, multidose 100ml Type I or Type II glass vial, sealed with a bromobutyl rubber closure and an aluminium cap with tear-off lid.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. Do not mix with any other veterinary product.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK: Vm 01708/4590
Significant changes
Date of the first authorisation or date of renewal
23 December 1992.
Date of revision of the text
March 2022.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Ceporex inj 1x100ml:
GTIN:5017363002102