Țară: Regatul Unit
Limbă: engleză
Sursă: VMD (Veterinary Medicines Directorate)
Rabbit haemorrhagic disease virus
Laboratorios Hipra SA
QI08AA01
Rabbit haemorrhagic disease virus
Emulsion for injection
POM-V - Prescription Only Medicine – Veterinarian
Rabbits
Inactivated Viral Vaccine
Authorized
2016-09-22
Issued: September 2021 AN: 01737/2020 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ERAVAC emulsion for injection for rabbits. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 0.5 ml contains: ACTIVE SUBSTANCE: Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strainV- 1037……≥70% cELISA40* (*) ≥70 % of vaccinated rabbits shall give cELISA antibody titres equal to or higher than 40. ADJUVANT: Mineral oil…………104.125 mg EXCIPIENTS: Thiomersal…………0.05 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection. Whitish emulsion. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Rabbits 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of rabbits from the age of 30 days to reduce mortality caused by the rabbit haemorrhagic disease type 2 virus (RHDV2). Onset of immunity: 1 week. Duration of immunity: 12 months demonstrated by challenge_ _ 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance, to the adjuvant or to any of the excipients. Issued: September 2021 AN: 01737/2020 Page 2 of 5 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The vaccine provides protection only against RHDV2, cross protection against classical RHDV has not been demonstrated. Vaccinate healthy animals only. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Vaccination is recommended where RHDV2 is epidemiologically relevant. 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 Citiți documentul complet