SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

BOVALTO Respi 4 suspension for injection for cattle

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One dose (2 ml) contains:

Active substances:

Inactivated bovine respiratory syncytial virus, strain BiO-24 RP 1*

Inactivated bovine parainfluenza 3 virus, strain Bio-23 RP 1*

Inactivated bovine viral diarrhoea virus, strain BiO-25 RP 1*

InactivatedMannheimia haemolytica, serotype A1 strain DSM 5283 RP 1*

*) Relative potency (RP)in comparison with the reference serum obtained after vaccination of guinea pigs with a vaccine batch that has successfully passed the challenge test in the target animals.

Adjuvants:

Aluminium hydroxide 8.0 mg

Quillaja saponin (Quil A) 0.4 mg

Excipients:

Thiomersal 0.2 mg

Formaldehyde 1.0 mg at most

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Suspension for injection.

Appearance: Pinkish liquid with sediment.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle.

4.2 Indications for use, specifying the target species

For active immunisation of cattle in the absence of maternally derived antibodies against:

- parainfluenza 3 virus, to reduce virus excretion due to infection

- bovine respiratory syncytial virus, to reduce virus excretion due to infection

- bovine viral diarrhoea virus, to reduce virus excretiondue to infection

- Mannheimiahaemolyticaserotype A1, to reduce clinical signs and lung lesions.

Onset of immunity (demonstrated by challenge):

3 weeks after primary vaccination

Duration of immunity (demonstrated by challenge):

6 months after primary vaccination

4.3 Contraindications

None.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals

Vaccinate only healthy animals.

Safety and efficacy studies were performed in sero-negative calves.The efficacy of the vaccination has not been demonstrated in presence of antibodies. The level of antibody response may be reduced by the presence of maternal antibodies.In the presence of maternal antibodies, timing of initial vaccination of calves should be planned accordingly.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

In case of accidental self- injection, seek medical advice immediately and show the package insert or label to the physician.

4.6 Adverse reactions (frequency and seriousness)

Following vaccination a localised swelling may be very commonly observed at the injection site. This swelling could reach up to 7 cm in diameter, and usually progressively reduces and disappears within 6 weeks after vaccination.

Commonly, there may be a transient slight increase in body temperature which was higher after the second injection (1.5°C at most) lasting up to 3 days after vaccination.

Anaphylactic-type reactions may very rarely occur after vaccination. In such cases, appropriate symptomatic treatment should be administered.

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

- very common (more than 1 in 10 animals displaying adverse reactions during

the course of one treatment)

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

- uncommon (more than 1 but less than 10 animals in 1,000 animals)

- rare (more than 1 but less than 10 animals in 10,000 animals)

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

4.7 Use during pregnancy, lactation or lay

Do not use during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

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.

4.9 Amounts to be administered and administration route

Dosage – 2 ml administered subcutaneously.

Warm before use to a temperature of 15 to 25 °C and shake the contents of the vial.

Primary vaccination

Calves can be vaccinated from 2 weeks of age.

Calves from non-immune dams: 2 injections 3 weeks apart from 2 weeks of age

Where the immune status of the dam is unknown,the vaccine scheme should be adapted at the discretion of the veterinarian.

Revaccination

Administer a single dose 6 months after completion of the primary vaccination scheme.

The revaccination was demonstrated by measurement of the serological response. The efficacy of the revaccination has not been assessed by challenge.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No adverse effects other than those mentioned in section 4.6. (Adverse Reactions ) were observed. Local reactions after subcutaneous administration of a double dose were larger (up to 10 cm in diameter) than after the recommended dose.

4.11 Withdrawal periods

Zero days.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Immunologicals for cattle; inactivated viral and bacterial vaccines.

ATCvet code: QI02AL.

The vaccine induces an active immunity against bovine respiratory syncytial virus, parainfluenza 3 virus, bovine viral diarrhoea virus and Mannheimia haemolytica.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Aluminium hydroxide

Thiomersal

Formaldehyde

Quillaja saponin (Quil A)

Water of injection

Sodium chloride

6.2 Incompatibilities

Do not mix with any other veterinary medicinal product.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale:

Glass vials: 2 years.

Plastic vials: 15 months.

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

6.4. Special precautions for storage

Store and transport in a refrigerator (2 °C – 8 °C).

Do not freeze. Protect from light.

6.5 Nature and composition of immediate packaging

Translucent plastic bottle of 10, 50 or 100 mLwith chlorobutyl elastomer closure (5, 25 or 50 doses)

Box of 1 bottle of 5 doses (10 ml)

Box of 10 bottles of 5 doses (10 x 10 ml)

Box of 1 bottle of 25 doses (50 ml)

Box of 1 bottle of 50 doses (100 ml)

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

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

7. MARKETING AUTHORISATION HOLDER

Merial Animal Health Limited

PO Box 327, Sandringham House

Harlow Business Park

Harlow

Essex

CM19 5TG

8. MARKETING AUTHORISATION NUMBER

Vm 08327/4274

9. DATE OF FIRST AUTHORISATION

17 February2016

10. DATE OF REVISION OF THE TEXT

February2016

Approved: 17/02/2016