SUMMARY OF PRODUCT CHARACTERISTICS

Hiprabovis Somni/Lkt Emulsion for Injection for Cattle

Active substances:

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid	ELISA > 2.8 (*)/dose
Inactivated Histophilus somni Bailie strain	MAT > 3.3 (**)/dose

(*) A minimum of 80 % of vaccinated rabbits show ELISA value of > 2.0; the mean ELISA is >2.8.

(**) A minimum of 80 % of vaccinated rabbits show a log₂MAT value of ≥ 3.0; the mean log₂MAT >3.3.

Adjuvant:

Liquid paraffin 18.2 mg/dose

Excipients:

Thiomersal 0.2 mg/dose

For the full list of excipients, see section 6.1.

Emulsion for injection.

Ivory-coloured homogeneous emulsion.

Cattle from 2 months of age.

To reduce the clinical signs and lung lesions caused by Mannheimia haemolyticaserotype A1 and Histophilus somniin calves from 2 months of age.

Onset of immunity:

3 weeks.

Duration of protection:

Not demonstrated.

Do not vaccinate unhealthy animals.

Do not use in case of hypersensitivity to the active substances, to the adjuvant or to any of the excipients.

None.

Do not use in animals which are underweight for their age.

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 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 veterinary medicinal 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 ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.

Very common: A transient rise in temperature (up to 2 ºC) after each vaccination can occur but this resolves after 4 days. Vaccinated animals might show a local swelling at the injection site of 1 to 7 cm after administration of the vaccine. This swelling will have disappeared or be clearly reduced in size by 14 days post vaccination however in some cases swelling may persist for up to 4 weeks after the second administration.

Common: Mild apathy, anorexia and/or depression may be observed after each injection but these resolve within 4 days.

Very rare: Anaphylactic-type reactions may occur in some sensitive animals. In such cases, appropriate symptomatic treatment such as antihistamines or cortisone or in more severe cases adrenaline should be given.

The frequency of adverse reactions is defined using the following convention:

• very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment).

• common (more than 1 but less than 10 animals in 100 animals).

• very rare (less than 1 animal in 10,000 animals, including isolated reports).

Pregnancy:

Do not use during pregnancy.

Lactation:

Do not use during lactation.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

For subcutaneous use.

Cattle: 2 ml / animal.

Recommended vaccination scheme:Administer one dose (2 ml) per calf, at 2 months of age. This 2 ml dose should be repeated after 21 days. Vaccinate calves by subcutaneous injection in the prescapular area. It is preferable to administer the second dose on alternate sides.

The vaccine should be allowed to warm to a temperature between 15 - 20C before administration. Shake before use. Avoid the introduction of contamination during use. Use only sterile needles and syringes for administration.

Vaccination is recommended to be used before stress periods(shipping, allotments…). The vaccination scheme should be completed 3 weeks before such periods. Protection has not been demonstrated if vaccination scheme is completed earlier than 3 weeks before stress periods.

No effects other than those mentioned in section 4.6 were observed after administration of twice the recommended dose.

Zero days.

Pharmacotherapeutic group:Immunologicals for bovidae, cattle, inactivated bacterial vaccines.

ATCVet Code:QI02AB.

To stimulate active immunity against Mannheimia haemolytica A1 and Histophilus somni.

Thiomersal.

Liquid paraffin.

Sorbitan monooleate.

Polysorbate 80.

Sodium alginate.

Calcium chloride, dihydrate.

Simeticone.

Water for injections.

Polymyxin B.

Do not mix with any other veterinary medicinal product.

Shelf life of the veterinary medicinal product as packaged for sale: 18 months.

Shelf life after first opening the immediate packaging: 10 hours.

Store and transport refrigerated (2 C – 8 C).

Do not freeze.

Protect from light.

The container consists of 20 ml (10 doses) Type I colourless glass vials and 100 ml (50 doses) Type II colourless glass vials, Type I rubber stoppers and aluminium caps.

Package sizes:

• Cardboard box with one glass vial of 10 doses with a rubber stopper and aluminium cap.

• Cardboard box with one glass bottle of 50 doses with a rubber stopper and aluminium cap.

Not all pack sizes may be marketed.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Laboratorios Hipra, S.A.

Avda. la Selva, 135

17170 Amer (Girona)

Spain

Vm17533/4005

Date:15 May 2007

Date:November 2014

Approved: 15 December 2014