Patient leaflet - Innovax-ND-IBD
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
Innovax-ND-IBD concentrate and solvent for suspension for injection for chickens
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer responsible for batch release :
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
THE NETHERLANDS
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Innovax-ND-IBD concentrate and solvent for suspension for injection for chickens
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of the reconstituted vaccine (0.2 ml for subcutaneous use or 0.05 ml for in ovo use) contains:
Cell-associated live recombinant turkey herpesvirus (strain HVP360), expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus: 103.3 – 104.6 PFU1.
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1 PFU – plaque forming units.
Concentrate and solvent for suspension for injection.
Cell concentrate: off-red to red cell concentrate.
Solvent: clear, red solution.
4.
INDICATION(S)
For active immunisation of one-day-old chicks or 18–19 day-old embryonated chicken eggs:
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– to reduce mortality and clinical signs caused by Newcastle disease (ND) virus,
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– to prevent mortality and to reduce clinical signs and lesions caused by infectious bursal disease (IBD) virus,
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– to reduce mortality, clinical signs and lesions caused by Marek’s disease (MD) virus.
Onset of immunity:
ND: 4 weeks of age, IBD: 3 weeks of age, MD: 9 days.
Duration of immunity:
ND: 60 weeks, IBD: 60 weeks, MD: entire risk period.
5. CONTRAINDICATIONS
None.
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6. ADVERSE REACTIONS
None known.
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.
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7. TARGET SPECIES
Chickens and embryonated chicken eggs.
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
After dilution, administer 1 dose of 0.2 ml vaccine per chicken by subcutaneous injection in the neck or 1 dose of 0.05 ml per egg by in ovo injection.
9.
ADVICE ON CORRECT ADMINISTRATION
The bag of vaccine should be gently swirled frequently during vaccination to guarantee that the vaccine suspension remains homogenous and that the correct vaccine virus titre is administered (e.g. during long vaccination sessions).
Preparation of the vaccine:
The usual aseptic precautions should be applied to all preparation and administration procedures.
The handling of liquid nitrogen should take place in a well-ventilated area.
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1. Use solvent for cell associated poultry vaccines for reconstitution.
For subcutaneous use reconstitute the vaccine according to the table below:
| Solvent bag | Number of vaccine ampoules for subcutaneous use |
| Bag of 400 ml solvent | 1 ampoule containing 2000 doses |
| Bag of 800 ml solvent | 2 ampoules containing 2000 doses |
| Bag of 800 ml solvent | 1 ampoule containing 4000 doses |
| Bag of 1200 ml solvent | 3 ampoules containing 2000 doses |
| Bag of 1600 ml solvent | 4 ampoules containing 2000 doses |
| Bag of 1600 ml solvent | 2 ampoules containing 4000 doses |
When this product is mixed with Nobilis Rismavac, both should be diluted in the same solvent bag in the same way (400 ml of solvent for each 2,000 doses of both products or 800 ml of solvent for each 4,000 doses of both products).
For in ovo use reconstitute the vaccine according to the table below:
| Solvent bag | Number of vaccine ampoules for in ovo use |
| Bag of 400 ml solvent | 4 ampoules containing 2000 doses |
| Bag of 400 ml solvent | 2 ampoules containing 4000 doses |
| Bag of 800 ml solvent | 8 ampoules containing 2000 doses |
| Bag of 800 ml solvent | 4 ampoules containing 4000 doses |
| Bag of 1200 ml solvent | 12 ampoules containing 2000 doses |
| Bag of 1200 ml solvent | 6 ampoules containing 4000 doses |
| Bag of 1600 ml solvent | 16 ampoules containing 2000 doses |
| Bag of 1600 ml solvent | 8 ampoules containing 4000 doses |
The solvent must be clear, red coloured, without sediment and at room temperature (15–25 °C) at the time of mixing.
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2. Preparation of the vaccine shall be planned before the ampoules are taken from the liquid nitrogen and the exact amount of vaccine ampoules and amount of solvent needed shall be calculated first. There is no information available on the number of doses on the ampoules once they are removed from the cane, so special care has to be taken to ensure that the mix-ups of ampoules with different number of doses is avoided and the correct solvent is used.
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3. Before withdrawing the ampoules from the liquid nitrogen container, protect hands with gloves, wear long sleeves and use a facemask or goggles. When removing an ampoule from the cane, hold in the palm of a gloved hand away from the body and the face.
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4. When withdrawing a cane of ampoules from the canister in the liquid nitrogen container, expose
only the ampoule(s) to be used immediately. It is recommended to handle a maximum of 5 ampoules (from one cane only) at a time. After removing the ampoule(s), the remaining ampoules should be put back immediately into the canister in the liquid nitrogen container.
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5. Thaw the content of the ampoule(s) rapidly by immersing the ampoule in clean water at 25
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27 °C. Gently swirl the ampoule(s) to disperse the contents. In order to protect cells, it is important that the ampoule content is mixed, immediately after thawing, with the solvent. Dry the ampoule, then break the ampoule at its neck and immediately proceed as described below.
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6. Gently withdraw the contents of the ampoule into a sterile syringe, fitted with an 18 gauge needle.
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7. Insert the needle through the stopper of the solvent bag, and then slowly and gently add the contents of the syringe to the solvent. Gently swirl and invert the bag to mix the vaccine. Withdraw a small quantity from the solvent bag into the syringe and rinse the ampoule. Inject the remaining contents of the ampoule gently into the solvent bag. Remove the syringe and invert the bag (6–8 times) to mix the vaccine.
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8. The vaccine is now ready for use.
After adding the contents of the ampoule to the solvent, the ready to use product is a clear, red coloured suspension for injection.
Control of correct storage:
To allow a check on correct storage and transport the ampoules are placed upside down in the liquid nitrogen containers. If frozen content is situated in the tip of the ampoule, this indicates that the content has been thawed and must not be used.
10.
WITHDRAWAL PERIOD(S)
Zero days.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Cell concentrate: Store and transport frozen in liquid nitrogen (below –140 °C).
Solvent: Store below 30 °C.
Container: Store liquid nitrogen container securely in an upright position in a clean, dry and well-ventilated room separated from the hatching/chicken room.
Shelf life after reconstitution according to directions: 2 hours.
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12. SPECIAL WARNING(S)
Special warnings for each target species: Vaccinate healthy animals only.
Special precautions for use in animals :
As this is a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys. Safety trials have shown that the strain is safe for turkeys. However, precautionary measures have to be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
The handling of liquid nitrogen should take place in a well-ventilated area.
Innovax-ND-IBD is a virus suspension packed in glass ampoules and stored in liquid nitrogen. Before withdrawing ampoules from the liquid nitrogen canister, protective equipment consisting of gloves, long sleeves and a facemask or goggles should be worn. In order to prevent serious wounds, by either the liquid nitrogen or the ampoules when removing an ampoule from the canister, hold the palm of (gloved) hand holding the ampoule away from the body and face. Care should be exercised to prevent contaminating the hands, eyes and clothing with the ampoule content. CAUTION: The ampoules have been known to explode on exposure to sudden temperature changes. Do not thaw in hot water or icecold water. Thaw the ampoules in clean water at 25–27 °C.
Lay :
The safety of the veterinary medicinal product has not been established during lay.
Interaction with other medicinal products and other forms of interaction:
Safety and efficacy data are available which demonstrate that Innovax-ND-IBD can be mixed in the same solvent and administered by the subcutaneous route with Nobilis Rismavac. For this mixed use, an onset of immunity of 5 days has been demonstrated for MD.
Safety and efficacy data are available which demonstrate that Nobilis ND Clone 30 or Nobilis ND C2 can be administered to day-old chicks that are vaccinated either by the subcutaneous or in ovo route with Innovax-ND-IBD. For such associated use, an onset of immunity of 3 weeks (when used with Nobilis ND Clone 30) and 2 weeks (when used with Nobilis ND C2), has been demonstrated for ND. Safety and efficacy data are available which demonstrate that Nobilis IB Ma5 or Nobilis IB 4–91 can be administered to day-old chicks that are vaccinated either by the subcutaneous or in ovo route with the vaccine.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. 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.
Overdose (symptoms, emergency procedures, antidotes):
No symptoms were observed after the administration of a 10-fold dose of vaccine when applied subcutaneously. A 3-fold overdose was tested in ovo , which was regarded as safe. No information is available on the safety or possible adverse reactions following a 10-fold overdose applied in ovo.
Incompatibilities:
Do not mix with any other veterinary medicinal product except Nobilis Rismavac and the solvent supplied for use with the veterinary medicinal product.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED