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Date: Wednesday, April 30, 2025 8:18

Release 3.203
Yurvac RHD emulsion for injection for rabbits (NI)
 
Species: Rabbits
Therapeutic indication: Immunological veterinary medical products: For rabbits
Active ingredient: Vaccine Antigens
Product:YURVAC RHD emulsion for injection for rabbits
Product index: YURVAC RHD
Incorporating:
Presentation
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 ml dose contains:
Active substance:
Recombinant RHDV2 virus capsid protein RP*≥ 0.7
* Relative potency (ELISA test)
Adjuvant:
Light mineral oil 104.125 mg
Excipients:
Qualitative composition of excipients and other constituents Polysorbate 80: 0.03 g, Sorbitan mono-oleate, Sodium chloride, Potassium chloride, Disodium phosphate dodecahydrate, Potassium dihydrogen phosphate, Water for injections
White homogeneous emulsion.
Uses
Target species
Rabbits, including pet (dwarf) rabbits
Indications for use for each target species
For active immunisation of rabbits from 30 days of age onwards to reduce mortality of rabbit haemorrhagic disease (RHD) caused by classical RHD virus (RHDV) and variant strains (RHDV2), including highly virulent strains.
Onset of immunity: 7 days for RHDV2, 14 days for RHDV.
Duration of immunity: 1 year
Dosage and administration
Administration routes and dosage
Subcutaneous use.
Primary vaccination:
Administer one dose (0.5 ml) subcutaneously to rabbits from 30 days of age onwards.
Revaccination:
Revaccinate annually with one dose (0.5 ml) by subcutaneous injection.
Allow the vaccine to reach room temperature before use.
Shake well before administration.
Contra-indications, warnings, etc
Contraindications
None.
Special warnings
Vaccinate healthy animals only.
Special precautions for use
Special precautions for safe use in the target species:
Pregnant does should be handled gently to avoid stress and risk of abortion.
No safety study on the reproductive performance has been conducted in male rabbits (bucks).
Special precautions to be taken by the person administering the veterinary medicinal product to animals
To the user:
This veterinary medicinal product contains mineral oil. Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.
To the physician:
This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this veterinary medicinal product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Special precautions for the protection of the environment:
Not applicable.
Other precautions
Not applicable.
Adverse events
Rabbits, including pet (dwarf) rabbits:
Very common (>1 animal/10 animals treated): Elevated temperature1, Injection site inflammation2
1 The highest individual rectal temperature increase was 1.15 ºC which returned to normal values 24 hours later.
2 Inflammation (< 2 cm) at the injection can be observed. These local reactions gradually reduce and disappear without need for treatment.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Can be used during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
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.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
No adverse reactions other than those mentioned above were observed after the administration of a 5-fold dose.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Pharmaceutical precautions
IMMUNOLOGICAL INFORMATION
ATCvet code: QI08AV.
The vaccine is intended to stimulate active immunity against RHDV and RHDV2.
The active substance of the vaccine is the recombinant RHDV2 capsid protein, which auto-assembles into virus like particles (VLPs).
PHARMACEUTICAL PARTICULARS
Major incompatibilities
Do not mix with any other veterinary medicinal product
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 1 year.
Shelf life after first opening the immediate packaging: 10 hours.
Special precautions for storage
Store and transport refrigerated (2 ºC - 8 ºC).
Do not freeze.
Protect from light.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Legal category
Legal category: POM-V
Packaging quantities
Nature and composition of immediate packaging
Type I colourless glass vials with 0.5 ml (1 dose) or 5 ml (10 doses).
The vials are closed with a rubber stopper and an aluminium cap.
Type I colourless polyethylene terephthalate (PET) vials with 20 ml (40 doses) or 100 ml (200 doses).
The vials are closed with a rubber stopper and an aluminium cap.
Pack sizes:
Cardboard box of 10 glass vials of 1 dose (0.5 ml).
Cardboard box of 1 glass vial of 10 doses (5 ml).
Cardboard box of 1 PET vial of 40 doses (20 ml).
Cardboard box of 1 PET vial of 200 doses (100 ml).
Not all pack sizes may be marketed.
Marketing Authorisation Holder (if different from distributor)
NAME OF THE MARKETING AUTHORISATION HOLDER
Laboratorios Hipra SA
Further information

Marketing Authorisation Number
MARKETING AUTHORISATION NUMBER
Vm 17533/5020
Significant changes
GTIN
GTIN description:YURVAC RHD NORTHERN IRELAND 1 DS*10
GTIN:8427711307013
GTIN description:YURVAC RHD NORTHERN IRELAND 10 DS
GTIN:8427711307037
GTIN description:YURVAC RHD NORTHERN IRELAND 40 DS
GTIN:8427711307020