देश: यूरोपीय संघ
भाषा: अंग्रेज़ी
स्रोत: EMA (European Medicines Agency)
Rabbit hemorrhagic disease virus 2 VP1AB, Rabbit hemorrhagic disease virus VP1A
Fatro S.p.A
QI08AA01
Rabbit haemorrhagic disease vaccine (inactivated, recombinant)
Rabbits
Immunologicals for leporidae
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.
Authorised
2021-08-16
18 B. PACKAGE LEAFLET 19 PACKAGE LEAFLET: FATROVAX RHD SUSPENSION FOR INJECTION FOR RABBITS 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: FATRO S.p.A., Via Emilia 285, 40064 Ozzano dell’Emilia (BO), ITALY 2. NAME OF THE VETERINARY MEDICINAL PRODUCT FATROVAX RHD suspension for injection for rabbits 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Each dose (0.5 ml) contains: Active substances: Rabbit haemorrhagic disease virus 1 (RHDV1) VP1a* ≥1 RP** Rabbit haemorrhagic disease virus 2 (RHDV2) VP1ab* ≥1 RP** * recombinant capsid protein ** Relative potency: ELISA test by comparison with a reference serum in vaccinated mice Adjuvant: Aluminium hydroxide (as Al 3+ ) Preservative: Thiomersal Whitish aqueous suspension with soft white sedimentation easily resuspendable. 4. INDICATION(S) 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. 5. CONTRAINDICATIONS None. 20 6. ADVERSE REACTIONS A very small transient nodule 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: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - 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 repor पूरा दस्तावेज़ पढ़ें
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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) VP1ab* ≥1 RP** * recombinant capsid protein ** Relative potency: ELISA by comparison with a reference serum in vaccinated mice ADJUVANT: Aluminium hydroxide (as Al 3+ ) 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 PARTICULARS 4.1 TARGET SPECIES Rabbits, including pet (dwarf) rabbits 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. 3 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. 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. 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 necrop पूरा दस्तावेज़ पढ़ें