Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Rabbit hemorrhagic disease virus
Ceva Animal Health Ltd
QI08AA01
Rabbit hemorrhagic disease virus
Emulsion for injection
POM-V - Prescription Only Medicine – Veterinarian
Rabbits
Inactivated Viral Vaccine
Authorized
2006-09-22
Revised: February 2012 AN: 01636/2011 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT LAPINJECT VHD 2. QUALITATIVE AND QUANTITATIVE COMPOSITION For one dose of vaccine: Calicivirus of rabbit hemorrhagic disease. 1 PD 100 * Strain 3116-AP (suspension of inactivated virus) Mineral oil................................................. 104.125 mg Thiomersal................................................ 0.05 mg Excipient q.s. 1 dose of 0.5 ml * Protective Dose 100% tested in rabbits. For full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Emulsion for injection. 4. CLINICAL PARTICULARS 4.1 TARGET-SPECIES Rabbit. 4.2 INDICATIONS FOR USE For active immunisation of rabbit to prevent mortality caused by RHD virus Onset immunity: 6 days Duration of Immunity: 1 year 4.3 CONTRA-INDICATIONS None. 4.4 SPECIAL PRECAUTIONS FOR USE None 4.5 SPECIAL PRECAUTIONS FOR USE, INCLUDING SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO THE ANIMALS i. Special precautions for use in animals Handle pregnant females with the usual precautions. Revised: February 2012 AN: 01636/2011 Page 2 of 4 ii. Special precautions for the person administering the veterinary medicinal product to animals _To the user: _ This product contains mineral oil. Accidental i n jection /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 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 product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischeamic necrosis and the loss o Read the complete document