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Convenia

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Summary for the public


What is Convenia?

Convenia contains cefovecin, an antibiotic which is given by injection (under the skin). It is used for dogs and cats.

There are two vials in each pack of Convenia, one vial containing a powder, and one vial containing the diluent. The powder is dissolved in the diluent before use to make up a solution for injection.


What is Convenia used for?

Convenia is used to treat infections caused by certain specific bacteria (see the SPC for further details). It is generally given as a single injection, and the effect of the injection lasts for up to 14 days. Depending on the infection concerned, the injection can be repeated if necessary (up to three times).

Convenia is used in dogs to treat skin and soft tissue infections; these are infections on the skin and in the layers just below the skin, such as wounds, abscesses and pyoderma (a skin infection with a rash and pustules). It is also used in dogs to treat urinary tract infections caused by certain specific bacteria.

Convenia is used in cats to treat skin and soft tissue infections, such as wounds and abscesses. It is also used in cats to treat urinary tract infections caused by certain specific bacteria. 


How does Convenia work?

The active substance in Convenia is cefovecin which belongs to a class of antibiotics called third generation cephalosporins. All these cephalosporin antibiotics, including cefovecin, kill bacteria by disrupting the building of the bacterial cell walls, so the bacteria die and the infection is cured. Like other antibiotics, cefovecin is not effective against all types of bacteria.

Cefovecin differs from other similar cephalosporin antibiotics as it stays in the dog’s or cat’s body for a very long time after it has been injected. One injection lasts for up to 14 days.


How has Convenia been studied?

Data from laboratory studies with different bacteria showed that cefovecin was effective against the bacteria specified in the product information (SPC and package leaflet).

Convenia has been studied in dogs with skin and soft tissue infections (where it was compared to another antibiotic containing amoxicillin and clavulanic acid) and in dogs with urinary tract infections (where it was compared to another cephalosporin antibiotic, cefalexin).

Convenia has also been studied in cats with skin and soft tissue infections (where it was compared to another antibiotic containing amoxicillin and clavulanic acid), and in a small study in cats with urinary tract infections, where it was compared with cefalexin. The studies measured the rate at which the infections were cured.


What benefit has Convenia shown during the studies?

In all studies, Convenia was as effective in curing the infection as the comparator antibiotic. Convenia has the benefit of a long duration of activity.


What is the risk associated with Convenia?

No side-effects have been reported with Convenia to date. However, it should not be used in dogs or cats which have shown an allergy to any cephalosporin or penicillin-type antibiotics.

Convenia should also not be used in dogs or cats of less than 8 weeks old, or in dogs or cats with severe kidney problems (renal dysfunction).

It would be dangerous to use Convenia in other animals such as guinea pigs and rabbits (it is not licensed for use in these species). As no studies have been made in breeding animals with Convenia and it has an exceptionally long duration in the body, Convenia should not be used in pregnant or lactating dogs or cats. Treated animals should not be used for breeding for 12 weeks after the last injection of Convenia.


What are the precautions for the person who gives the medicine or comes into contact with the animal?

Cephalosporin and penicillin antibiotics can cause allergies in humans, and sometimes these allergies can be very serious. Convenia should therefore not be handled by anyone who is hypersensitive (allergic) to such antibiotics, or by anyone who has been advised not to work with them. Anyone allergic to penicillins or cephalosporins should also avoid contact with litter used by dogs or cats treated with Convenia.

Convenia should be handled with care and all the recommended precautions be taken to avoid exposure to the product. If any symptoms occur after accidental exposure to Convenia, for example a skin rash, then the advice of a doctor should be sought immediately. Swelling of the face, lips or eyes, or any difficulty breathing are more serious symptoms and require urgent medical attention.


Why has Convenia been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Convenia exceed the risks for the treatment of dogs and cats with certain specified skin, soft tissue and urinary tract infections and recommended that Convenia should be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Convenia

The European Commission granted a marketing authorisation valid throughout the European Union, for Convenia to Pfizer Ltd on 19 June 2006. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: Convenia
EMEA Product number: EMEA/V/C/000098
Active substance: cefovecin
INN or common name: Cefovecin
Species: DogsCats
ATCvet Code: QJ01DD91
Marketing Authorisation Holder: Pfizer Limited
Revision: 5
Date of issue of Market Authorisation valid throughout the European Union: 19/06/2006
Contact address:
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom



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    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Convenia 80 mg/ml powder and solvent for solution for injection for dogs and cats
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    Each 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 vial of diluent contains :
    Excipients:
    13 mg/ml benzyl alcohol
    10.8 ml water for injection
    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
    For a full list of excipients, see section 6.1.
    3.
    PHARMACEUTICAL FORM
    Powder and solvent for solution for injection.
    The powder is off-white to yellow and the diluent (solvent) is a clear, colourless liquid.
    4.
    CLINICAL PARTICULARS
    4.1
    Target species
    Dogs and cats.
    4.2
    Indications for use, specifying the target species
    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, -haemolytic Streptococci , Escherichia coli and/or Pasteurella
    multocida .
    For the treatment of urinary tract infections associated with Escherichia coli and/or Proteus spp.
    2
    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 4.5 ‘Special Precautions for Use’.)
    Cats:
    For the treatment of skin and soft tissue abscesses and wounds associated with Pasteurella multocida ,
    Fusobacterium spp., Bacteroides spp., Prevotella oralis ,  haemolytic Streptococci and/or Staphylococcus
    pseudintermedius .
    For the treatment of urinary tract infections associated with Escherichia coli .
    4.3
    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.
    4.4
    Special warnings
    None.
    4.5
    Special precautions for use
    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 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.
    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.
    3
    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.
    4.6 Adverse reactions (frequency and seriousness)
    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.
    4.7 Use during pregnancy, lactation or lay
    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.
    4.8 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 effects.
    4.9
    Amounts to be administered and administration route
    Skin and soft tissue infections in dogs:
    A single subcutaneous injection of 8 mg/kg bodyweight (1 ml per 10 kg bodyweight). 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 of 8 mg/kg bodyweight (1 ml per 10 kg bodyweight). 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/kg bodyweight (1 ml per 10 kg bodyweight).
    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.
    4
    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 ensure a correct dosage, body weight should be determined as accurately as possible to avoid
    underdosing.
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    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.
    4.11 Withdrawalperiod(s)
    Not applicable.
    5.
    PHARMACOLOGICAL PROPERTIES
    Pharmacotherapeutic group: Antibacterials for systemic use (cephalosporins).
    ATCvet code: QJ01DD91.
    5.1
    Pharmacodynamic properties
    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.
    In-vitro activity against these pathogens as well as against other skin and urinary tract pathogens collected
    during a European (Denmark, France, Germany, Italy and United Kingdom) MIC survey (1999 – 2000)
    and during European (France, Germany, Spain and United Kingdom) clinical efficacy and safety field
    studies (2001 – 2003) are listed below. Periodontal isolates were collected during a European (France and
    Belgium) clinical efficacy and safety field study (2008).
    5
     
    No. of
    Isolates
    Cefovecin MIC ( g/ml)
    Bacterial Pathogen
    Origin
    Min
    Max
    MIC 50 1 MIC 90 2
    Staphylococcus
    pseudintermedius
    Dog
    Cat
    226
    44
    0.06
    0.06
    8
    8
    0.12
    0.12
    0.25
    0.25
     haemolytic
    Streptococcus spp.
    Dog
    Cat
    52
    34
    0.06
    0.06
    16
    1
    0.06
    0.06
    0.12
    0.12
    Coagulase negative
    Staphylococcus spp. 4
    Cat
    16
    0.12
    32
    0.25
    8
    Staphylococcus
    aureus 3, 4
    Dog 4
    Cat 4
    16
    20
    0.5
    0.5
    1
    >32
    1
    1
    1
    16
    Coagulase positive
    Staphylococcus spp. 3, 4
    Dog 4
    Cat 4
    24
    0.12
    >32
    0.25
    0.5
    Escherichia coli
    Dog
    Cat
    167
    93
    0.12
    0.25
    >32
    8
    0.5
    0.5
    1
    1
    Pasteurella multocida
    Dog
    Cat
    47
    146
    0.06
    0.06
    0.12
    2
    0.06
    0.06
    0.12
    0.12
    Proteus spp.
    Dog
    Cat 4
    52
    19
    0.12
    0.12
    8
    0.25
    0.25
    0.12
    0.5
    0.25
    Dog 4
    Cat 4
    29
    10
    0.12
    0.25
    >32
    8
    1
    2
    >32
    4
    Enterobacter spp. 4
    Dog 4
    Cat 4
    Klebsiella spp. 4
    11
    0.25
    1
    0.5
    1
    Prevotella spp.
    (2003 survey)
    Dog 4
    Cat
    25
    50
    0.06
    0.06
    8
    4
    0.25
    0.25
    2
    0.5
    Fusobacterium spp.
    Cat
    23 0.06
    2
    0.12
    1
    Bacteroides spp.
    Cat
    24 0.06
    8
    0.25
    4
    Prevotella spp.
    (periodontal 2008)
    Dog
    29 0.008
    4
    0.125
    1
    Porphyromonas spp. Dog 272 0.008 1 0.031 0.062
    1 Lowest concentration, which completely inhibits visible growth of at least 50 % of isolates
    2 Lowest concentration, which completely inhibits visible growth of at least 90 % of isolates
    3
    Some of these pathogens (e.g. S. aureus ) exhibited natural in vitro resistance to cefovecin
    4
    The clinical significance of these in vitro data has not been demonstrated.
    Resistance to cephalosporins results from enzymatic inactivation (-lactamase production), from reduced
    permeability by porin mutations or change in efflux, or by selection of low-affinity penicillin-binding
    proteins. 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. or 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 Staphylococcus 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.
    6
     
    5.2
    Pharmacokinetic particulars
    Cefovecin has unique pharmacokinetic properties with extremely long elimination half-lives in both dogs
    and cats.
    In dogs, when cefovecin was administered as a single subcutaneous dose of 8 mg/kg bodyweight,
    absorption was rapid and extensive; peak plasma concentration at 6 hours was 120 g/ml and
    bioavailability approximately 99 %. Peak concentrations in tissue cage fluid of 31.9 μg/ml were measured
    2 days after administration. Fourteen days after administration, the mean cefovecin concentration in
    plasma was 5.6 μg/ml. Plasma protein binding is high (96.0 % to 98.7 %) and the volume of distribution is
    low (0.1 l/kg). Elimination half-life is long – approximately 5.5 days. Cefovecin is primarily eliminated
    unchanged via the kidneys. At fourteen days after administration, urine concentrations were 2.9 μg/ml.
    In cats, when cefovecin was administered as a single subcutaneous dose of 8 mg/kg bodyweight,
    absorption was rapid and extensive; peak plasma concentration at 2 hours was 141 g/ml and
    bioavailability approximately 99 %. Fourteen days after administration the mean cefovecin concentration
    in plasma was 18 g/ml. Plasma protein binding is high (more than 99 %) and the volume of distribution
    is low (0.09 l/kg). Elimination half-life is long – approximately 6.9 days. Cefovecin is primarily
    eliminated unchanged via the kidneys. At ten and fourteen days after administration, urine concentrations
    were 1.3 g/ml and 0.7 g/ml, respectively. Following repeated administrations at the recommended dose,
    elevated concentrations of cefovecin were observed in plasma.
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Methyl parahydroxybenzoate (E218)
    Propyl parahydroxybenzoate (E216)
    Benzyl alcohol
    Sodium citrate
    Citric acid
    Sodium hydroxide (for pH adjustment)
    Hydrochloric acid (for pH adjustment)
    Water for injection
    6.2 Incompatibilities
    In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other
    veterinary medicinal products.
    6.3 Shelf life
    Shelf-life of the veterinary medicinal product as packaged for sale: 36 months.
    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.
    6.4 Special precautions for storage
    Before reconstitution:
    Store in a refrigerator (2 C – 8 C). Do not freeze.
    Store in the original package in order to protect from light.
    7
    After reconstitution:
    Store in a refrigerator (2 C – 8 C). Do not freeze.
    Store in the original package in order to protect from light.
    6.5 Nature and composition of immediate packaging
    Powder:
    Type I glass vial with butyl rubber stopper sealed with an aluminium flip-off seal.
    Diluent:
    Type I glass vial with chlorobutyl rubber stopper sealed with an aluminium flip-off seal.
    Pack size: 1 vial of powder and 1 vial of diluent.
    6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
    materials derived from the use of such products
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    products should be disposed of in accordance with local requirements.
    7.
    MARKETING AUTHORISATION HOLDER
    Pfizer Limited
    Ramsgate Road
    Sandwich
    Kent CT13 9NJ
    UK
    8.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/06/059/001
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    19/06/2006
    10.
    DATE OF REVISION OF THE TEXT
    Detailed information on this veterinary medicinal product is available on the website of the European
    Medicines Agency (EMA) http://www.ema.europa.eu/
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    Not applicable.
    8
    ANNEX II
    A.
    MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
    BATCH RELEASE
    B.
    CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    C.
    CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    WITH REGARD TO SAFE AND EFFECTIVE USE
    D.
    STATEMENT OF THE MRLs
    9
    A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturer(s) responsible for batch release
    Haupt Pharma Latina S.r.l.
    S.S. 156 Km 47,600
    04100 Borgo San Michele
    Latina
    Italy
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    To be supplied only on veterinary prescription.
    The holder of this marketing authorisation must inform the European Commission about the marketing
    plans for the medicinal product authorised by this decision.
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
    REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
    Not applicable.
    D.
    STATEMENT OF THE MRLs
    Not applicable.
    10
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    11
    A. LABELLING
    12
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    OUTER CARTON (CONTAINING LYOPHILISED POWDER VIAL AND DILUENT VIAL)
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Convenia 80 mg/ml powder and solvent for solution for injection for dogs and cats
    Cefovecin
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    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
    3.
    PHARMACEUTICAL FORM
    Powder and solvent for solution for injection.
    4.
    PACKAGE SIZE
    10 ml (after reconstitution)
    5.
    TARGET SPECIES
    Dogs and cats.
    6.
    INDICATION(S)
    For certain skin, soft tissue, urinary tract and severe periodontal infections. Read the package leaflet
    before use.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Read the package leaflet before use.
    8.
    WITHDRAWAL PERIOD
    13
     
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    10. EXPIRY DATE
    EXP:
    After reconstitution, use within 28 days.
    Discard date:
    11. SPECIAL STORAGE CONDITIONS
    Store in a refrigerator (2 C – 8 C).
    Do not freeze.
    Store in the original package in order to protect from light (before and after reconstitution).
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE
    MATERIALS, IF ANY
    Dispose of waste material in accordance with local requirements.
    13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only - to be supplied only on veterinary prescription.
    14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Pfizer Limited
    Ramsgate Road
    Sandwich
    Kent CT13 9NJ
    UK
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/06/059/001
    17. MANUFACTURER’S BATCH NUMBER
    Batch: {number}
    14
     
    PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
    LABEL (LYOPHILISED POWDER VIAL)
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Convenia 80 mg/ml powder for solution for injection for dogs and cats
    2.
    CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    10 ml (after reconstitution)
    Each vial contains 852 mg cefovecin.
    3.
    ROUTE(S) OF ADMINISTRATION
    For subcutaneous use.
    Read the package leaflet before use.
    4.
    BATCH NUMBER
    Batch: {number}
    5.
    EXPIRY DATE
    EXP: {mm/yyyy}
    After reconstitution, use within 28 days.
    Discard date:
    6.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    15
     
    PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
    LABEL (DILUENT VIAL)
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Diluent for Convenia
    2.
    QUANTITY OF OTHER SUBSTANCES
    13 mg/ml benzyl alcohol in water for injections.
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
    10 ml
    4.
    ROUTE(S) OF ADMINISTRATION
    Read the package leaflet before use.
    5.
    BATCH NUMBER
    Batch: {number}
    6.
    EXPIRY DATE
    EXP: {mm/yyyy}
    16
     
    B. PACKAGE LEAFLET
    17
    PACKAGE LEAFLET
    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:
    Pfizer Limited
    Ramsgate Road
    Sandwich
    Kent CT13 9NJ
    UK
    Manufacturing authorisation holder 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 VETERINARY THE 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 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 vial of diluent contains :
    Excipients:
    13 mg/ml benzyl alcohol
    10.8 ml water for injection
    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
    18
    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,  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 ,  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 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).
    19
    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 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.
    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 reach and sight of children.
    Do not use after the expiry date stated on the carton.
    Shelf-life after reconstitution according to directions: 28 days.
    20
     
    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)
    For the animal:
    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.
    For the user:
    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:
    21
    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 (EMA)
    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 (-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.
    22
    Cefovecin has unique pharmacokinetic properties with extremely long elimination half-lives in both dogs
    and cats.
    The product is available in a single pack size composed of a vial containing the freeze-dried powder, and a
    second vial containing the diluent. Reconstitution yields 10 ml of solution for injection.
    For any information about this veterinary medicinal product, please contact the local representative of the
    marketing authorisation holder.
    België/Belgique/Belgien
    Pfizer Animal Health s.a.,
    Tél.: +32 (0)2 554 62 11
    Luxembourg
    Pfizer Animal Health s.a.,
    Tél: + 32 (0)2 554 62 11
    Република България
    Pfizer Luxembourg SARL
    Tel: + 359 2 970 41 71
    Magyarország
    Pfizer Kft.
    Tel: +361 488 3695
    Česká republika
    Pfizer Animal Health
    Tel: +420 283 004 111
    Malta
    Agrimed Limited
    Tel: +356 21 465 797
    Danmark
    Orion Pharma Animal Health
    Tlf: +45 49 12 67 65
    Nederland
    Pfizer Animal Health B.V.,
    Tel: +31 (0)10 4064 600
    Deutschland
    Pfizer GmbH
    Tel: +49 (0) 30-5500 5501
    Norge
    Orion Pharma Animal Health
    Tlf: +47 40 00 41 90
    Eesti
    Pfizer Animal Health
    Tel: +370 5 269 17 96
    Österreich
    Pfizer Corporation Austria Ges.m.b.H,
    Tel: +43 (0)1 52 11 57 20
    Ελλάδα
    Pfizer Hellas A.E.
    Τηλ.: +30 210 6785800
    Polska
    Pfizer Trading Polska Sp. z.o.o.
    Tel: +48 22 335 61 00
    España
    Pfizer S.L.
    Tel: +34 91 4909900
    Portugal
    Laboratórios Pfizer, Lda.
    Tel: +351 21 423 55 00
    France
    Pfizer
    Tél: +33 (0)1 58 07 46 00
    Romania
    Pfizer Romania SRL
    Tel: + 0040 21 207 28 93
    Ireland
    Pfizer Healthcare Ireland, trading as:
    Pfizer Animal Health
    Tel: + 353 (0) 1 467 6500
    Slovenija
    Pfizer Luxemburg SARL
    Tel: +386 (0) 1 52 11 670
    Ìsland
    Icepharma hf.
    Tlf: +354 540 80 00
    Slovenská republika
    Pfizer Luxembourg SARL o.z.
    Tel: + 421 2 3355 5500
    23
    Italia
    Pfizer Italia S.r.l.,
    Tel: +39 06 3318 2933
    Suomi/Finland
    Pfizer Oy Animal Health,
    Puh/Tel: +358 (0)9 4300 40
    Kύπρος
    Pfizer Hellas A.E.
    Τηλ.: +30 210 6785800
    Sverige
    Orion Pharma Animal Health
    Tlf: +46 (0)8 623 64 40
    Latvija
    Pfizer Animal Health
    Tel: +370 5 269 17 96
    United Kingdom
    Pfizer Ltd
    Tel: +44 (0) 1304 616161
    Lietuva
    Pfizer Animal Health
    Tel.: +370 5 269 17 96
    24


    Source: European Medicines Agency


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