Bovalto Respi 4 Suspension For Injection For Cattle
Issued: February 2016
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:
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.
Aluminium hydroxide 8.0 mg
Quillaja saponin (Quil A) 0.4 mg
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
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
4.4 Special warnings for each target species
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.
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.
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
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
Quillaja saponin (Quil A)
Water of injection
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
8. MARKETING AUTHORISATION NUMBER
9. DATE OF FIRST AUTHORISATION
10. DATE OF REVISION OF THE TEXT
Page 5 of 5