Summary of medicine characteristics - Parvoduk
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each reconstituted dose of 0.2 ml contains:
Active substance:...............................2.6–4.8 log™ CCID50*
Live attenuated Muscovy duck parvovirus strain GM 199 * 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 PARTICULARS4.1 Target species
Muscovy ducks.
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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
4.8 Interaction with other medicinal products and other forms of interaction
4.8 Interaction with other medicinal products and other forms of interactionNo information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
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4.9 Amounts to be administered and administration route
Subcutaneous use.
Administer one dose of 0.2 ml by subcutaneous injection according to the following vaccination scheme:
Firstvaccination: at 1 day of age. Second vaccination: at 17 days of age.
the vial of antigen concentrate. Insert t
Shake the vial of antigen concentrate. Insert the trocar provided with the bag of solvent through the closures of both the glass vial and the solvent bag to connect them. Transfer the content of the glass vial into the bag of solvent. Then remove the trocar from both containers. Gently shake the bag to mix the antigen concentrate with the solvent. After mixing, connect the bag to a high-speed, automated or semi-automated injection system. The vaccine is then ready to use.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions were observed after the administration of an overdose (10 x the dose).
- 4.11 Withdrawal period(s)
Zero days.
- 5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: live viral vaccines, duck parvovirus.
ATCvet code: QI01BD03.
The vaccine contains a live attenuated Muscovy duck parvovirus. It induces an active and specific immunity against Muscovy duck parvovirosis and Derzsy’s disease in the vaccinated birds.
Eleven genetic markers (nucleotides) in the VP1 gene allow differentiation of the Parvoduk vaccine strain from the field strains of duck and goose parvovirus, as shown below:
| Position on VP 1 gene | 8 | 19 | 132 | 649 | 957 | 1769 | 1790 | 1858 | 1933 | 2100 | 2198 |
| Parvoduk | A | G | T | C | T | A | T | C | G | A | i G |
| Duck Parvovirus | C | A | C | G | C | C | C | A | A | C | A |
| Goose Parvovirus | C | T | C | G | C | C | C | A | A | *« T | A |
The vaccine strain can be found in the spleen for at least 35 days.
In ducklings free of maternally derived antibodies a single vaccination at day 1 will lead to an onset of immunity after 14 days.
A small occasional impact on growth cannot be excluded upon vaccination of day-old ducklings free
of maternally derived antibodies.
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Concentrate:
Casein hydrolysate
Aluminium hydroxide
Solvent:
Sodium chloride
Potassium chloride
Potassium dihydrogen phosphate Disodium phosphate dehydrate Water for injections.
6.2 Major 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 : 2 years
Shelf life after dilution according to directions: 4 hours.
6.4 Special precautions for storage
Store and transport refrigerated (2° C – 8° C).
Do not freeze.
Protect from light.
Solvent :
Store below 25 °C.
Do not freeze.
Protect from light.
- 6.5 Nature and composition of immediate packaging
Antigen concentrate :
Type I glass vials with butyl elastomer closure.
Cardboard box of 10 vials of 500 doses.
Cardboard box of 1 vial of 2,500 doses.
Solvent :
Polypropylene bags with butyl elastomer closure and trocar.
Cardboard box of 10 bags of 500 doses.
Cardboard box of 1 bag of 2,500 doses.
- 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
7. MARKETING AUTHORISATION HOLDER
MERIAL
29, avenue Tony Garnier
69007 Lyon
FRANCE
8. MARKETING AUTHORISATION NUMBERS
EU/2/14/162/001–002
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 11/04/2014
Date of last renewal: