BluTaVo 3 (50ml) 50 doses POM-V ( Fridge)

Product Description

1. NAME OF THE VETERINARY MEDICINAL PRODUCT BULTAVO 3 suspension for injection for sheep and cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml dose contains: Active substances: Inactivated bluetongue virus serotype 3 (strain Bio-93:BTV3) ............................. ≥ 10 ELISA units* *The amount of inactivated antigen was determined using an ELISA method. Adjuvants: Aluminium hydroxide ................................................................................................. 2.25 – 2.75 mg Quillaja saponin (Quil A).......................................................................................................... 0.2 mg Excipients: Qualitative composition of excipients and other constituents Quantitative composition if that information is essential for proper administration of the veterinary medicinal product Formaldehyde 35% ≤ 0.7 mg Thiomersal 0.085 – 0.115 mg Sodium chloride Water for injections White to pinkish liquid with sediment present. 3. CLINICAL INFORMATION

3.1 Target species Sheep and cattle. 3.2 Indications for use for each target species Sheep: Active immunisation to reduce viraemia and to prevent clinical signs and mortality caused by bluetongue virus serotype 3. Onset of immunity: 3 weeks after the primary vaccination course. Duration of immunity: not established. Cattle: Active immunisation against bluetongue virus serotype 3. Onset of immunity: not established. Duration of immunity: not established.

Administration routes and dosage Apply usual aseptic procedures. Shake gently immediately before use. Avoid bubble formation, as this can be irritating at the site of injection. The entire content of the bottle should be used immediately after broaching and during the same procedure. Avoid multiple broaching of vials. Before use the vaccine should be warmed to 15-25°C. Administer one dose of 1 ml, subcutaneously in sheep, intramuscularly in cattle, according to the following vaccination scheme: Primary vaccination In sheep: one injection from 1 month of age in naive animals. In cattle: - 1 st injection: from 1 month of age in naive animals. - 2 nd injection: 3 weeks after the first injection. Revaccination Not established

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