Страна: Велика Британія
мова: англійська
Джерело: VMD (Veterinary Medicines Directorate)
Infectious bovine rhinotraceitis virus
MSD Animal Health UK Limited
QI02AA03
Infectious bovine rhinotraceitis virus
Suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle
Inactivated Viral Vaccine
Authorized
2006-07-19
Amended pages: October 2023 AN: 01481/2023 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Bovilis IBR marker inac suspension for injection for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml contains: ACTIVE SUBSTANCE: Inactivated bovine herpesvirus type 1 (BHV-1) strain GK/D (gE¯) * : 60 ELISA units ** . * gE¯: glycoprotein E negative ** inducing 6.1 - 11.1 log 2 virus neutralising units in mouse potency test ADJUVANT: Aluminium-phosphate and -hydroxide (Al 3+ ) 6.0 - 8.8 mg EXCIPIENT: Formaldehyde 0.6 - 1.0 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Pink turbid suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of cattle to reduce the intensity and duration of clinical signs (pyrexia) induced by an infection with bovine herpesvirus type 1 (BHV-1) as well as to reduce the replication and nasal excretion of the field virus. Onset of immunity: - 3 weeks Duration of immunity:- 6 months The schedule using Bovilis IBR marker live for primary vaccination and revaccination after 6 months with Bovilis IBR marker inac, will result in protective immunity that lasts for 12 months. Amended pages: October 2023 AN: 01481/2023 Page 2 of 5 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Efficacy has not been demonstrated in the face of maternally derived antibodies. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Vaccinate only healthy animals. Special precautions to be taken by the person administering the veterinary medicinal product to animals In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the physician. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) A local reaction at the injection site may occur in very rare cases. Hypersensitivity reactions can occur in very rare cases. In such cases an appr Прочитайте повний документ