Parvoduk
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
15-04-2019
Produktets egenskaber
(SPC)
15-04-2019
Offentlige vurderingsrapport
(PAR)
15-04-2019
Aktiv bestanddel:
live attenuated Muscovy duck parvovirus
Tilgængelig fra:
Merial
ATC-kode:
QI01BD03
INN (International Name):
live attenuated Muscovy duck parvovirus
Terapeutisk gruppe:
Ducks
Terapeutisk område:
Immunologicals for aves, duck parvovirus, Live viral vaccines
Terapeutiske indikationer:
Active immunisation of ducks to prevent mortality1 and to reduce weight loss and lesions of duck parvovirosis and Derzsy's disease.1In absence of maternally derived antibodies.
Produkt oversigt:
Revision: 2
Autorisation status:
Withdrawn
Autorisation dato:
2014-04-11
Indlægsseddel
Medicinal product no longer authorised
17
_ _
B. PACKAGE LEAFLET
Medicinal product no longer authorised
18
PACKAGE LEAFLET:
PARVODUK CONCENTRATE AND SOLVENT FOR SUSPENSION FOR INJECTION FOR
MUSCOVY DUCKS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
MERIAL
29 avenue Tony Garnier
69007 Lyon,
FRANCE
Manufacturer responsible for batch release:
MERIAL
Laboratory of Lyon Porte des Alpes
Rue de l’Aviation,
69800 Saint Priest
FRANCE
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Parvoduk concentrate and solvent for suspension for injection for
Muscovy ducks
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Each reconstituted dose of 0.2 ml contains:
Active substance:
Live attenuated Muscovy duck parvovirus strain GM 199
...................... 2.6–4.8 log
10
CCID
50
*
* Cell culture infectious dose 50%.
Concentrate and solvent for suspension for injection.
The concentrate is opalescent and homogeneous.
The solvent is clear and colourless.
4.
INDICATION(S)
Active immunisation of Muscovy ducks to reduce weight loss and lesions
of Muscovy duck
parvovirosis and Derzsy’s disease and, in the absence of maternally
derived antibodies, to also
prevent mortality.
Onset of immunity: 11 days after the primary vaccination course
Duration of immunity: 26 days after the primary vaccination course
The demonstrated duration of immunity protects the birds during the
period when they are most
susceptible to Muscovy duck parvovirosis and Derzsy’s disease.
Medicinal product no longer authorised
19
5.
CONTRAINDICATIONS
Do not use in birds in lay.
6.
ADVERSE REACTIONS
None.
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.
7.
TARGET SPECIES
Muscovy ducks.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
For subcutaneous use.
Administer one dose of 0.2 ml by s
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Produktets egenskaber
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Parvoduk concentrate and solvent for suspension for injection for
Muscovy ducks
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each reconstituted dose of 0.2 ml contains:
ACTIVE SUBSTANCE:
Live attenuated Muscovy duck parvovirus strain GM 199
............................... 2.6–4.8 log
10
CCID
50
*
* Cell culture infectious dose 50%.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate and solvent for suspension for injection.
The concentrate is opalescent and homogeneous.
The solvent is clear and colourless.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Muscovy ducks.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of Muscovy ducks to reduce weight loss and lesions
of Muscovy duck
parvovirosis and Derzsy’s disease and, in the absence of maternally
derived antibodies, to also
prevent mortality.
Onset of immunity: 11 days after the primary vaccination course
Duration of immunity: 26 days after the primary vaccination course
The demonstrated duration of immunity protects the birds during the
period when they are most
susceptible to Muscovy duck parvovirosis and Derzsy’s disease.
4.3
CONTRAINDICATIONS
Do not use in birds in lay.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Medicinal product no longer authorised
3
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The entire flock should be vaccinated to lower the risk of any
circulation of the vaccine strain and
virus recombination.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Not applicable.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Do not use in birds in lay (see section 4.3).
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No information is avail
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