NOAH Compendium

Printed from NOAH Compendium (https://www.noahcompendium.co.uk). (c) Copyright NOAH Compendium 2024. All Rights Reserved.
Date: Saturday, May 18, 2024 14:19

Release 2.30
Nobivac® Myxo RHD lyophilisate and solvent for suspension for injection in rabbits
 
Species: Rabbits
Therapeutic indication: Immunological veterinary medical products: For rabbits
Active ingredient: Vaccine Antigens
Product:Nobivac® Myxo RHD lyophilisate and solvent for suspension for injection in rabbits
Product index: Nobivac® Myxo RHD
Withdrawal notes: Rabbit: Zero days
Incorporating:
Qualitative and quantitative composition
Each dose of reconstituted vaccine contains:
Active substance: Live myxoma vectored RHD virus strain 009: ≥103.0 and ≤106.1 FFU*.
*Focus Forming Units.
Excipients: For the full list of excipients, see section “Pharmaceutical Particulars”.
Pharmaceutical form
Lyophilisate and solvent for suspension for injection.
Lyophilisate: off-white or cream-coloured pellet.
Solvent: clear colourless solution.
Reconstituted product: off-pink or pink coloured suspension.
Clinical particulars
Target species
Rabbits.
Indications for use
For active immunisation of rabbits from 5 weeks of age onwards to reduce mortality and clinical signs of myxomatosis and to prevent mortality due to rabbit haemorrhagic disease (RHD) caused by classical RHD virus strains.
Onset of immunity: 3 weeks.
Duration of immunity: 1 year.
Contraindications
None.
Special warnings for each target species
None.
Special precautions for use
Vaccinate only healthy rabbits.
Rabbits that have been vaccinated previously with another myxomatosis vaccine, or that have experienced natural myxomatosis infection in the field, may not develop a proper immune response against rabbit haemorrhagic disease following vaccination.
Operator warnings
None.
Adverse reaction
A transient temperature increase of 1 - 2 °C can commonly occur. A small, non-painful swelling (maximum 2 cm diameter) at the injection site is commonly observed within the first two weeks after vaccination. The swelling will resolve completely by 3 weeks after vaccination.
In pet rabbits, in very rare cases, local reactions at the injection site such as necrosis, scabs, crusts or hair loss may occur. In very rare cases serious hypersensitivity reactions, which may be fatal, may occur after vaccination. In very rare cases the appearance of mild clinical signs of myxomatosis may occur within 3 weeks of vaccination. Recent or latent infection with field myxoma virus seems to play a role in this to a certain extent.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
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.
Use during pregnancy or lactation
Pregnancy:
Studies involving the use of the vaccine during early pregnancy were inconclusive, therefore vaccination is not recommended during the first 14 days of pregnancy.
Fertility:
No safety study on the reproductive performance has been conducted in male rabbits (bucks). Therefore, the vaccination of breeding bucks is not recommended.
Interactions
No 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.
Amounts to be administered and administration route
After reconstitution, administer 1 dose of vaccine by subcutaneous injection to rabbits from 5 weeks of age onwards.
Revaccinate annually.
Ensure that the lyophilisate is completely reconstituted before use.
Single dose vial Reconstitute a single dose vial of vaccine with 1 ml of Nobivac Myxo RHD solvent and inject the total contents of the vial.
Multi-dose vial
Solvent volume
Number of vials of freeze-dried vaccine to be added
Injection volume
Total number of rabbits that can be vaccinated
10 ml
1
0.2 ml
50
50 ml
5
0.2 ml
250
For proper reconstitution of the multidose vial, use the following procedure:
Add 1-2 ml of Nobivac Myxo RHD solvent to the 50 dose vaccine vial(s) and ensure that the lyophilisate is fully dissolved.
Withdraw the reconstituted vaccine concentrate from the vial(s) and inject it back into the Nobivac Myxo RHD solvent vial.
Ensure that the resulting vaccine suspension in the Nobivac Myxo RHD solvent vial is properly mixed.
Use the vaccine suspension within 4 hours of reconstitution. Any reconstituted vaccine remaining at the end of this time should be discarded.
Overdose
In addition to the adverse reactions observed after single dose vaccination, a mild swelling of the local lymph nodes may be observed within the first 3 days after overdose vaccination.
Withdrawal period
Zero days.
Pharmacological particulars
ATCvet code: QI08AD.
Pharmacotherapeutic group
Live viral vaccine,
To stimulate immunity against myxoma virus and rabbit haemorrhagic disease virus. The vaccine strain is a myxoma virus expressing the capsid protein gene of rabbit haemorrhagic disease virus. As a consequence rabbits are immunised against both myxoma virus and rabbit haemorrhagic disease virus. After infection with virulent myxoma virus some vaccinated animals may develop a few very small swellings, especially on hairless places of the body, which quickly form scabs.The scabs usually disappear within 2 weeks after the small swellings have been observed. These scabs are only observed in animals with active immunity and have no influence on the general health, appetite or behaviour of the rabbit.
Pharmaceutical particulars
Excipients
Lyophilisate:
Hydrolysed gelatine
Pancreatic digest of casein
Sorbitol
Disodium phosphate dihydrate
Solvent:
Disodium phosphate dihydrate
Potassium dihydrogen phosphate
Water for injections
Major incompatibilities
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the vaccine.
Shelf life
Shelf-life of the lyophilisate as packaged for sale: 2 years.
Shelf-life of the solvent as packaged for sale: 1 ml and 10 ml glass vials: 4 years.
50 ml PET vials: 2 years.
Shelf-life after reconstitution according to directions: 4 hours.
Special precautions for storage
Lyophilisate: Store in a refrigerator (2 °C - 8 °C). Do not freeze. Protect from light.
Solvent (50 ml PET vial): Store in a refrigerator (2 °C - 8 °C). Do not freeze.
Solvent (1 ml and 10 ml glass vial): No special precautions for storage. Do not freeze.
Immediate packaging
Lyophilisate: Glass vial of 1 or 50 doses with a halogenobutyl rubber stopper and aluminium cap.
Solvent: Glass vial of 1 ml or 10 ml, or polyethylene terephthalate (PET) bottle of 50 ml with a halogenobutyl rubber stopper and aluminium cap.
Packaging:
Plastic box with 5 x 1 dose vial of vaccine and 5 x 1 ml vial of solvent.
Plastic box with 25 x 1 dose vial of vaccine and 25 x 1 ml vial of solvent.
Cardboard box with 10 x 50 doses vial of vaccine + cardboard box with 10 x 10 ml vial of solvent.
Cardboard box with 10 x 50 doses vial of vaccine + 2 x cardboard boxes each containing 1 x 50 ml vial of solvent.
Not all pack sizes may be marketed.
Disposal
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Marketing Authorisation Holder (if different from distributor)
UK(NI): Intervet International B.V., The Netherlands
Marketing Authorisation Number
UK(GB): Vm 01708/5049
UK(NI): EU/2/11/132/001 – 004
Significant changes
Date of the first authorisation or date of renewal
7 September 2011
Date of revision of the text
UK(GB): March 2021
UK(NI): 18 March 2021
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Nobivac Myxo-RHD 5x1ds+5x1ml:
GTIN:08713184114730