BTVPUR AlSap 1 - summary of medicine characteristics

Summary of medicine characteristics - BTVPUR AlSap 1

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

BTVPUR AlSap 1 suspension for injection for sheep and cattle.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose of 1 ml contains:

Active substances:

Inactivated Bluetongue Virus Serotype 1..................

(*) Antigen content (VP2 protein) by immuno-assay

Adjuvants:Adjuvants:

. Al3+ (as hydroxide) 2.7 mg

. Saponin 30 HU

( ) Haemolytic units

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Homogeneous milky white suspension for injection.

4. CLINICAL PARTICULARS4.1 Target species

Sheep and cattle

4.2 Indications for use, specifying the target species

Active immunisation of sheep and bluetongue virus serotype 1.

prevent viraemia* and to reduce clinical signs caused by

*(below the level of detection by the validated RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission)

Onset of immunity has been demonstrated 3 weeks after the primary vaccination course.

The duration of immunity for cattle and sheep is 1 year after the primary vaccination course.

4.3 Contraindi

None.

4.4 Sp

arnings for each target species

If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination. The level of efficacy for other species may differ from that observed in sheep and cattle.

4.5 Special precautions for use

Special precautions for use in animals

Vaccinate healthy animals only.

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

32 cm2 in

ally not

None

4.6 Adverse reactions (frequency and seriousness)

In very rare cases it has been observed a small local swelling at the injection site ( cattle and 24 cm2 in sheep) which becomes residual 35 days later (< 1 cm2).

In very rare cases it has been observed a transient increase in body temperature, exceeding an average of 1.1 °C, may occur within 24 hours after vaccinatio

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).
– 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

Can be used during pregnancy in ewes. Can be used during pregnancy and lactation in cows

The safety and the efficacy of the vaccine have not been established in breeding males. In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national C against Bluetongue Virus (BTV).

nt Authorities on the current vaccination policies

4.8 Interaction with other med

roducts 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

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 vial broaching.

Administer one dose of 1 ml subcutaneously according to the following vaccination scheme:

ary vaccination

- First injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals born to immune cattle).Second injection: after 3-4 weeks• Annual.4.10 Overdose (symptoms, emergency procedures, antidotes), if necessaryVery rare and transient apathy can be observed after the administration of a double-dose of the vaccine. No other adverse reactions except those mentioned in section 4.6 were observed.4.11 Withdrawal periodZero days.5. IMMUNOLOGICAL PROPERTIESPharmacotherapeutic group: bluetongue virus vaccine, ATCvet code QI04AA02 (sheep) and QI02AA08 (cattle).The vaccine contains inactivated Bluetongue Virus Serotype 1 with aluminium hydroxide and saponin adjuvants. It induces an active and specific immunity against bluetongue virus serotype 1 in the vaccinated animal.6. PHARMACEUTICAL PARTICULARS6.1 List of excipientsAluminium hydroxideSaponinSilicon antifoam Phosphate buffer Glycine buffer6.2 IncompatibilitiesDo not mix with any other veterinary medicinal product.6.3 Shelf lifeShelf life of the veterinary medicinal product as package for sale (100 ml bottle): 2 years Shelf life of the veterinary medicinal product as package for sale (50 ml bottle): 2 years Shelf life of the veterinary medicinal product as package for sale (10 ml bottle): 18 months Shelf life after first opening the immediate packaging: use immediately6.4 Sprecautions for storage

6.5 Nature and composition of immediate packaging

Polypropylene bottle of 50 or 100 ml with butyl elastomere closure

Box of 1 bottle of 100 doses (1 × 100 ml)

Box of 10 bottles of 100 doses (10 × 100 ml)

Box of 1 bottle of 50 doses (1 × 50 ml)

Box of 10 bottles of 50 doses (10 × 50 ml)

Type I glass bottle of 10 ml with butyl elastomere closure

Box of 1 bottle of 10 doses (1 × 10 ml)

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 products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

MERIAL

29, avenue Tony Garnier

69007 Lyon

FRANCE

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/10/112/001

EU/2/10/112/002

EU/2/10/112/003

EU/2/10/112/004

EU/2/10/112/005

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of the first authorisation:

Date of the last renewal: