Convenia (cefovecin) – Package leaflet - QJ01DD91

PACKAGE LEAFLET FOR:

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

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

2.NAME OF THE VETERINARY MEDICINAL PRODUCT

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

3.STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each 20 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 15 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)

0.2mg/ml propyl parahydroxybenzoate (E216)

12.3mg/ml benzyl alcohol

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, 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 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, β haemolytic Streptococci and/or Staphylococcus pseudintermedius.

For the treatment of urinary tract infections associated with Escherichia coli.

5.CONTRAINDICATIONS

Do not use in case 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.

6.ADVERSE REACTIONS

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 the use of the product.

If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

7.TARGET SPECIES

Dogs and cats.

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 of the required volume of the supplied diluent from its vial (for 20 ml vial containing 852 mg of lyophilised powder reconstitue using 10 ml of diluent, or for 5 ml vial containing 340 mg of lyophilised powder reconstitue 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.

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.

10.WITHDRAWAL PERIOD

Not applicable.

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.

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.

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.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

14.DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).

15.OTHER 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 g/ml, no resistance to cefovecin was detected in Pasteurella multocida, Fusobacterium spp. and

Porphyromonas spp. field isolates. When applying a proposed microbiological breakpoint of I ≤ 4 g/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.

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 respectively. Not all pack sizes may be marketed.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

België/Belgique/Belgien

Lietuva

Zoetis Belgium SA

Oriola Vilnius UAB

Tél/Tel.: +32 (0) 800 99 189

Tel: +370 610 05088

Република България

Luxembourg/Luxemburg

Zoetis Belgium SA

Zoetis Belgium SA

Teл: +359 2 4775791

Tél/Tel.: +352 8002 4026

Česká republika

Magyarország

Zoetis Česká republika, s.r.o.

Zoetis Hungary Kft.

Tel: +420 257 101 111

Tel: +361 224 5222

Danmark

Malta

Orion Pharma Animal Health

Agrimed Limited

Tlf: +45 86 14 00 00

Tel: +356 21 465 797

Deutschland

Nederland

Zoetis Deutschland GmbH

Zoetis B.V.

Tel: +49 30 330063 0

Tel: +31 (0)10 714 0900

Eesti

Norge

Oriola Vilnius UAB

Orion Pharma Animal Health

Tel: +370 610 05088

Tlf: +47 40 00 41 90

Ελλάδα

Österreich

Zoetis Hellas S.A.

Zoetis Österreich GmbH

Τηλ.: +30 210 6791900

Tel: +43 1 2701100 110

España

Polska

Zoetis Spain, S.L.

Zoetis Polska Sp. z o.o.

Tel: +34 91 4191900

Tel: +48 22 2234800

France

Portugal

Zoetis France

Zoetis Portugal, Lda.

Tél: +33 (0)810 734 937

Tel: +351 21 042 72 00

Hrvatska

România

Zoetis B.V., Podružnica Zagreb za promidžbu

Zoetis România SRL

Tel: +385 1 644 1460

Tel: +40 21 202 3083

Ireland

Slovenija

Zoetis Belgium SA

Zoetis B.V., Podružnica Zagreb za promidžbu

Tel: +353 (0) 1 256 9800

Tel: +385 1 644 1460

Ìsland

Slovenská republika

Icepharma hf.

Zoetis Česká republika, s.r.o.

Sími: +354 540 80 00

Tel: +420 257 101 111

Italia

Suomi/Finland

Zoetis Italia S.r.l.

Zoetis Finland Oy

Tel: +39 06 3366 8133

Puh/Tel: +358 (0)9 4300 40

Kύπρος

Sverige

Zoetis Hellas S.A.

Orion Pharma Animal Health

Τηλ.: +30 210 6791900

Tel: +46 (0)8 623 64 40

Latvija

United Kingdom

Oriola Vilnius UAB

Zoetis UK Limited

Tel: +370 610 05088

Tel: +44 (0) 845 300 8034

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