Patient leaflet - Convenia
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
Convenia 80 mg/ml powder and solvent for solution for injection for dogs and cats
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
Manufacturer responsible for batch release:
Haupt Pharma Latina S.r.l.
S.S. 156 Km 47,600
04100 Borgo San Michele
Latina
ITALY
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Convenia 80 mg/ml powder and solvent for solution for injection for dogs and cats cefovecin
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each 23 ml vial of lyophilised powder contains :
Active substance:
852 mg cefovecin (as sodium salt)
Excipients:
19.17 mg methyl parahydroxybenzoate (E218)
2.13 mg propyl parahydroxybenzoate (E216)
Each 19 ml vial of diluent contains :
Excipients:
13 mg/ml benzyl alcohol
10.8 ml water for injections
Each 5 ml vial of lyophilised powder contains :
Active substance:
340 mg cefovecin (as sodium salt)
Excipients:
7.67 mg methyl parahydroxybenzoate (E218)
0.85 mg propyl parahydroxybenzoate (E216)
Each 10 ml vial of diluent contains :
Excipients:
13 mg/ml benzyl alcohol
4.45 ml water for injections
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 (E218)
0.2 mg/ml propyl parahydroxybenzoate (E216)
12.3 mg/ml benzyl alcohol
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4. INDICATION(S)
For use only for the following infections requiring 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, p 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 12 ‘Special Warnings – For the animal’.)
Cats :
For the treatment of skin and soft tissue abscesses and wounds associated with Pasteurella multocida , Fusobacterium spp., Bacteroides spp., Prevotella oralis , p haemolytic Streptococci and/or Staphylococcus pseudintermedius.
For the treatment of urinary tract infections associated with Escherichia coli.
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5. CONTRAINDICATIONS
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.
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6. ADVERSE REACTIONS
Gastrointestinal signs, including emesis, diarrhoea and/or anorexia have been observed on very rare occasions.
Neurological signs (ataxia, convulsion or seizure) and injection site reactions have been reported in very rare cases after the use of the product.
Hypersensitivity reactions (e.g. anaphylaxis, dyspnoea, circulatory shock) may occur very rarely. If such a reaction occurs, appropriate treatment should be administered without delay (see also 12 Special precautions for use in animals).
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
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7. TARGET SPECIES
Dogs and cats.
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Dogs and cats: 8 mg cefovecin/kg body weight (1 ml/10 kg body weight).
Dosing Table:
| Animal Weight (Dogs and Cats) | Volume to be Administered |
| 2.5 kg | 0.25 ml |
| 5 kg | 0.5 ml |
| 10 kg | 1.0 ml |
| 20 kg | 2.0 ml |
| 40 kg | 4.0 ml |
| 60 kg | 6.0 ml |
To reconstitute, withdraw the required volume of the supplied diluent from its vial (for 23 ml vial containing 852 mg of lyophilised powder reconstitute using 10 ml of diluent, or for 5 ml vial containing 340 mg of lyophilised powder reconstitute using 4 ml of diluent) 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.
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9. ADVICE ON CORRECT ADMINISTRATION
To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Pyoderma is often secondary to an underlying disease. It is, therefore, advisable to determine the underlying cause and to treat the animal accordingly.
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10. WITHDRAWAL PERIOD(S)
Not applicable.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Do not use this veterinary medicinal product after the expiry date which is 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 reconstitution:
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Store in the original package in order to protect from light.
After reconstitution:
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Store in the original package in order to protect from light.
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12. SPECIAL WARNING(S)
Special precautions for use in animals:
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.
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.
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.
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.
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.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required. These measures should help to protect the environment.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED