Summary of medicine characteristics - Fatrovax RHD
SUMMARY OF PRODUCT CHARACTERISTICS
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1. NAME OF THE VETERINARY MEDICINAL PRODUCT
FATROVAX RHD suspension for injection for rabbits
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (0.5 ml) contains:
Active substances :
Rabbit haemorrhagic disease virus 1 (RHDV1) VP1a* >1 RP
Rabbit haemorrhagic disease virus 2 (RHDV2) VPlab* >1 RP
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* recombinant capsid protein
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* * Relative potency: ELISA by comparison with a reference serum in vaccinated mice
Adjuvant:
Aluminium hydroxide (as Al3+) 0.83 mg
Excipients:
Thiomersal 0.05 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Suspension for injection
Whitish aqueous suspension with soft white sedimentation.
4. CLINICAL PARTICULARS4.1 Target species
Rabbits, including pet (dwarf) rabbits
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4.2 Indications for use, specyfing the target species
For active immunisation of rabbits from the age of 28 days to reduce mortality, infection, clinical signs and organ lesions of rabbit haemorrhagic disease caused by RHDV1 and RHDV2.
Onset of immunity: 1 week (7 days) after vaccination.
Duration of immunity: 1 year.
4.3 Contraindications
None.
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4.4 Special warnings for each target species
Vaccinate healthy animals only.
The possible interference of MDAs cannot be excluded at the recommended age for vaccination.
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4.5 Special precautions for use
Special precautions for use in animals
Pregnant does should be handled with special care to avoid stress and risk of abortion.
The safety of reproductive performance in male rabbits was not evaluated.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
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4.6 Adverse reactions (frequency and seriousness)
A very small transient nodule (maximum 5.2 mm diameter) at the site of injection may commonly be visible or palpable in the first week post vaccination, in laboratory trials. In the repeated dose laboratory trials, upon necropsy small nodules in the subcutis at the injection site were commonly observed.
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
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4.7 Use during pregnancy, lactation or lay
Can be used during pregnancy.
4.8 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.
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4.9 Amounts to be administered and administration route
Subcutaneous use.
Vaccination schedule: Administer the first dose (0.5 ml) at 28 days of age.
Revaccination: every 12 months.
Vaccination using the single-dose presentation (0.5 ml)
The pre-filled glass syringes needs to be attached to the needle included in the packaging. Administer one dose by subcutaneous injection.
Vaccination using multi-dose presentations (50 doses (25 ml) or 200 doses (100 ml))
The elastomer stoppers of the polypropylene bottles need to be punctured with a needle (attached to a syringe) to extract the appropriate volume for vaccination (0.5 ml per animal). Administer one dose by subcutaneous injection.
Before use allow the vaccine to reach room temperature.
Shake well before use to resuspend the sediment.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In dwarf rabbits, small transient nodules at the injection site were commonly noted after administration of a 2X dose that completely disappeared in the first two weeks.
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4.11 Withdrawal period(s)
Zero days.
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5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Immunologicals for rabbits, inactivated viral vaccines, rabbit haemorrhagic disease virus.
ATCVet Code: QI08AA01.
To stimulate active immunity against RHDV1 (classical strain) and RHDV2 (new variant).
The active substances of the vaccine are two recombinant proteins: rabbit haemorrhagic disease virus 1 VP1a (capsid protein VP1 and VP2 of strain Ast89) and rabbit haemorrhagic disease virus 2 VP1ab (chimera of strains Ast89 and N11), which auto-assemble into viruslike particles (VLPs).
6. PHARMACUTICAL PARTICULARS6.1 List of excipients
Aluminium hydroxide
Thiomersal
Sodium dihydrogen phosphate dihydrate
Disodium phosphate dodecahydrate
Sodium chloride
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: 9 months.
Shelf life after first opening the immediate packaging: 10 hours.
6.4 Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Protect from light.
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6.5 Nature and composition of the immediate packaging
Multi-dose presentations: Polypropylene bottles of 25 or 100 ml containing 50 or 200 doses with elastomer stopper type I and aluminium cap.
Single dose presentation: Type I glass syringes of 0.5 ml containing a single dose with elastomer stopper and sterile disposable needles.
Pack sizes:
Paperboard box of 5 pre-filled syringes of 1 dose (5 × 0.5 ml) with sterile disposable needles for each in a protective cover.
Cardboard box of 1 polypropylene bottle of 50 doses.
Cardboard box of 1 polypropylene bottle of 200 doses.
Not all pack sizes may be marketed.
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6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
7. MARKETING AUTHORISATION HOLDER
FATRO S.p.A.
Via Emilia 285
40064 Ozzano dell’Emilia (BO)
ITALY
E-mail:
8. MARKETING AUTHORISATION NUMBER(S)
EU/2/21/275/001–003
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation:16/08/2021