Target species
Dogs and cats.
Indications for use for each target species
For use only for the following infections which require prolonged treatment. The antimicrobial activity of the veterinary medicinal product following a single injection lasts for up to 14 days.
Dogs:
For the treatment of skin and soft tissue infections including pyoderma, wounds and abscesses associated with Staphylococcus pseudintermedius, β‑haemolytic Streptococci, Escherichia coli and/or Pasteurella multocida.
For the treatment of urinary tract infections associated with Escherichia coli and/or Proteus spp.
As adjunctive treatment to mechanical or surgical periodontal therapy in the treatment of severe infections of the gingiva and periodontal tissues associated with Porphyromonas spp. and Prevotella spp. (see also section ‘Special precautions for safe use in the target species’).
Cats:
For the treatment of skin and soft tissue abscesses and wounds associated with Pasteurella multocida, Fusobacterium spp., Bacteroides spp., Prevotella oralis, β-haemolytic Streptococci and/or Staphylococcus pseudintermedius.
For the treatment of urinary tract infections associated with Escherichia coli.
Contraindications
Do not use in cases of hypersensitivity to cephalosporin or penicillin antibiotics or to any of the excipients.
Do not use in small herbivores (including guinea pigs and rabbits).
Do not use in dogs and cats less than 8 weeks old.
Special warnings
Cross-resistance has been shown between cefovecin and other cephalosporins and other ß-lactam antibiotics. Use of the veterinary medicinal product should be carefully considered when susceptibility testing has shown resistance to cephalosporins or ß-lactams because its effectiveness may be reduced.
Special precautions for use
Special precautions for safe use in the target species:
Use of the product should be based on identification and susceptibility testing of the target pathogen(s). If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at local/regional level. Use of the product should be in accordance with official, national and regional antimicrobial policies.
An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG category) should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.
The product selects for resistant strains such as bacteria carrying extended-spectrum beta-lactamases (ESBL) and may constitute a risk to human health if these strains disseminate to humans.
The fundamental requirement of the treatment of periodontal disease is mechanical and/or surgical intervention by the veterinarian.
The safety of the veterinary medicinal product has not been assessed in animals suffering from severe renal dysfunction.
Pyoderma is often secondary to an underlying disease. It is, therefore, advisable to determine the underlying cause and to treat the animal accordingly.
Caution should be exercised in patients that have previously shown hypersensitivity reactions to cefovecin, other cephalosporins, penicillins, or other medicinal products. If an allergic reaction occurs, no further administrations of cefovecin should be administered and appropriate therapy for beta-lactam hypersensitivity should be instituted. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures, including oxygen, intravenous fluids, intravenous antihistamine, corticosteroids, and airway management, as clinically indicated. Veterinarians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.
Occasionally, cephalosporins have been associated with myelotoxicity, thereby creating a toxic neutropenia. Other haematological reactions seen with cephalosporins include neutropenia, anaemia, hypoprothrombinemia, thrombocytopenia, prolonged prothrombin time (PT) and partial thromboplastin time (PTT), platelet dysfunction.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross sensitivity to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.
Do not handle this product if you know you are sensitised or if you have been advised not to work with such preparations.
Handle this product with care to avoid exposure, taking all recommended precautions.
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 in breathing are more serious symptoms and require urgent medical attention.
If you know you are allergic to penicillins or cephalosporins, avoid contact with contaminated litter. In the event of contact, wash skin with soap and water.
Special precautions for the protection of the environment:
Not applicable
Adverse events
Dogs and cats:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Injection site reaction, Digestive tract disorder (e.g. diarrhoea, emesis, anorexia), Hypersensitivity reaction (e.g. anaphylaxis, circulatory shock, dyspnoea)1, Neurological signs (e.g. ataxia, convulsion, seizure) |
1Appropriate treatment should be administered without delay.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Fertility:
Treated animals should not be used for breeding for 12 weeks after the last administration.
Interaction with other medicinal products and other forms of interaction
Concurrent use of other substances that have a high degree of protein binding (e.g. furosemide, ketoconazole, or non-steroidal anti-inflammatory drugs (NSAIDs)) may compete with cefovecin binding and thus may cause adverse events.
Administration routes and dosage
Subcutaneous use.
Skin and soft tissue infections in dogs:
A single subcutaneous injection of 8 mg cefovecin/kg body weight (1 ml of the veterinary medicinal product per 10 kg body weight). If required, treatment may be repeated at 14-day intervals up to a further three times. In accordance with good veterinary practice, treatment of pyoderma should be extended beyond complete resolution of clinical signs.
Severe infections of the gingival and periodontal tissues in dogs:
A single subcutaneous injection of 8 mg cefovecin/kg body weight (1 ml of the veterinary medicinal product per 10 kg body weight).
Skin and soft tissue abscesses and wounds in cats:
A single subcutaneous injection of 8 mg cefovecin/kg body weight (1 ml of the veterinary medicinal product per 10 kg body weight). If required, an additional dose may be administered 14 days after the first injection.
Urinary tract infections in dogs and cats:
A single subcutaneous injection of 8 mg cefovecin/kg body weight (1 ml of the veterinary medicinal product per 10 kg body weight).
To reconstitute, withdraw the required volume of the supplied solvent from its vial (for 23 ml vial containing 978,65 mg of lyophilised powder reconstitute using 10 ml of solvent, or for 5 ml vial containing 390,55 mg of lyophilised powder reconstitute using 4 ml of solvent) and add to the vial containing the lyophilised powder. Shake the vial until the powder is seen to have fully dissolved.
The reconstituted solution is clear and practically free from particles. It is light yellow to reddish brown in colour.
As with other cephalosporins, the colour of the reconstituted solution may darken. However, if stored as recommended, potency is not affected.
Dosing table
Animal weight (dogs and cats) | Volume to be administered |
2.5 kg | 0.25 ml |
5 kg | 0.5 ml |
10 kg | 1 ml |
20 kg | 2 ml |
40 kg | 4 ml |
60 kg | 6 ml |
To ensure a correct dosage, body weight should be determined as accurately as possible.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Repeated dosing (eight administrations) in 14-day intervals at five times the recommended dose was tolerated well in young dogs. Slight and transient injection site swellings were observed after the first and second administration. A single administration of 22.5 times the recommended dose caused transient oedema and discomfort at the injection site.
Repeated dosing (eight administrations) in 14-day intervals at five times the recommended dose was tolerated well in young cats. A single administration of 22.5 times the recommended dose caused transient oedema and discomfort at the injection site.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Not applicable.