Convenia
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
08-12-2020
Fachinformation
(SPC)
08-12-2020
Öffentlichen Beurteilungsberichts
(PAR)
28-05-2013
Wirkstoff:
cefovecin (as sodium salt)
Verfügbar ab:
Zoetis Belgium SA
ATC-Code:
QJ01DD91
INN (Internationale Bezeichnung):
cefovecin
Therapiegruppe:
Dogs; Cats
Therapiebereich:
Antibacterials for systemic use
Anwendungsgebiete:
DogsFor 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.CatsFor the treatment of skin and soft-tissue abscesses and wounds associated with Pasteurella multocida, Usobacterium spp., Bacteroides spp., Prevotella oralis, β-haemolytic streptococci and / or Staphylococcus pseudintermedius.For the treatment of urinary-tract infections associated with Escherichia coli.
Produktbesonderheiten:
Revision: 13
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2006-06-19
Gebrauchsinformation
20
B. PACKAGE LEAFLET
21
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:
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 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
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.
22
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
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Convenia 80 mg/ml powder and solvent for solution for injection for
dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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
For the 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.
3
As adjunctive treatment to mechanical or surgical periodontal therapy
in the treatment of severe infections
of the gingiva and periodontal tissues asso
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