Convenia 80 mg/ml powder and solvent for solution for injection for dogs and cats

Convenia 80 mg/ml powder and solvent for solution for injection for dogs and cats

Species: Cats, Dogs Therapeutic indication: Pharmaceuticals: Antimicrobials: Injections Active ingredient: Cefovecin Product:Convenia® 80 mg/ml powder and solvent for soloution for injection for cats and dogs Product index: Convenia

Presentation

Convenia is presented as a vial of lyophilised powder supplied with a vial of diluent containing the following:

When reconstituted according to label instructions, the solution for injection contains: 80.0 mg/ml cefovecin (as sodium salt) 1.8 mg/ml methyl parahydroxybenzoate 0.2 mg/ml propyl parahydroxybenzoate 12.3 mg/ml benzyl alcohol

Uses

Convenia is indicated for use only for the following infections which require prolonged treatment. The antimicrobial activity of Convenia 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 gingival and periodontal tissues associated with Porphyromonas spp. and Prevotella spp. 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.

Dosage and administration

Dogs and cats: 8 mg cefovecin/kg bodyweight (1 ml/10 kg bodyweight). Dosing Table:

To reconstitute, withdraw 10 ml of the supplied diluent from its vial and add to the vial containing the lyophilised powder. Shake the vial until the powder is seen to have fully dissolved. Skin and soft tissue infections in dogs: A single subcutaneous injection. 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/kg bodyweight (1 ml per 10 kg bodyweight). Skin and soft tissue abscesses and wounds in cats: A single subcutaneous injection. 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. To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.

Contra-indications, warnings, etc

Do not use in cases of hypersensitivity to cephalosporin or penicillin antibiotics. Do not use in small herbivores (including guinea pigs and rabbits). Do not use in dogs and cats less than 8 weeks old. On very rare occasions gastrointestinal signs, including emesis and/or diarrhoea have been observed. In very rare cases neurological signs and injection site reactions have been reported after use. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. It is prudent to reserve third generation cephalosporins for the treatment of clinical conditions, which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials or first generation cephalosporins. Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies. The fundamental requirement of the treatment of periodontal disease is mechanical and/or surgical intervention by the veterinarian. The safety of Convenia in dogs and cats has not been established during pregnancy and lactation. Treated animals should not be used for breeding for 12 weeks after the last administration. The safety of Convenia 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 drugs. 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. 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 effects. 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. In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products. User warnings: 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

Pharmaceutical precautions

Do not use after the expiry date stated on the carton. Shelf-life after reconstitution according to directions: 28 days. As with other cephalosporins, the colour of the reconstituted solution may darken during this period. However, if stored as recommended, potency is not affected. Before and after reconstitution: Store in a refrigerator (2°C to 8°C). Do not freeze. Store in the original package in order to 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. Keep out of the sight and reach of children. For animal treatment only.

Legal category

Legal category: POM-V

Packaging quantities

The product is available in a single pack of either 5 ml or 20 ml, composed of a vial containing the freeze-dried powder, and a second vial containing the diluent. Reconstitution yields either 4 ml or 10 ml of solution for injection. Not all pack sizes may be marketed.

Further information

Cefovecin is a third generation cephalosporin with a broad-spectrum of activity against Gram-positive and Gram-negative bacteria. It differs from other cephalosporins in that it is highly protein bound and has a long duration of activity. As with all cephalosporins, the action of cefovecin results from the inhibition of bacterial cell wall synthesis; cefovecin has bactericidal activity. Cefovecin exhibits in vitro activity against Staphylococcus pseudintermedius and Pasteurella multocida which are associated with canine and feline skin infections. Anaerobic bacteria such as Bacteroides spp. and Fusobacterium spp. collected from feline abscesses were shown to be susceptible. Porphyromonas gingivalis and Prevotella intermedia collected from canine periodontal disease were also shown to be susceptible. In addition, cefovecin exhibits in-vitro activity against Escherichia coli which is associated with canine and feline urinary tract infections. Resistance to cephalosporins results from enzymatic inactivation (β-lactamase production) or from other mechanisms. Resistance may be chromosomal or plasmid-encoded and may be transferred if associated with transposons or plasmids. Cross resistance with other cephalosporins and other beta-lactam antibacterial agents can be observed. When applying a proposed microbiological breakpoint of S < 2 μg/ml, no resistance to cefovecin was detected in Pasteurella multocida, Fusobacterium spp or Porphyromonas spp. field isolates. When applying a proposed microbiological breakpoint of I < 4 μg/ml, cefovecin resistance in S. pseudintermedius and beta-haemolytic Streptococci isolates was less than 0.02% and 3.4% in Prevotella intermedia isolates. The percentage of cefovecin resistant isolates in E. coli, Prevotella oralis, Bacteroides spp. and Proteus spp. were 2.3%, 2.7%, 3.1% and 1.4%, respectively. The percentage of cefovecin resistant isolates in coagulase negative Staphylococci spp. (e.g. S. xylosus, S. schleiferi, S. epidermidis) is 9.5%. Pseudomonas spp., Enterococcus spp, and Bordetella bronchiseptica isolates are inherently resistant to cefovecin. Cefovecin has unique pharmacokinetic properties with extremely long elimination half-lives in both dogs and cats.

Marketing Authorisation Number

EU/2/06/059/001-2

GTIN

GTIN description:1 x 10 ml: GTIN:05414736011011 GTIN description:1 x 4 ml: GTIN:05414736022543