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BTVPUR AlSap 2-4 - summary of medicine characteristics

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Summary of medicine characteristics - BTVPUR AlSap 2-4

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

BTVPUR AlSap 2–4 suspension for injection for sheep


2. QUALITATIVE AND QUANTITATIVE COMPOSITION

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose of 1ml of vaccine contains:


Active substances:

Bluetongue virus serotype 2 antigen....­.............­.............­.............­.............­....

Bluetongue virus serotype 4 antigen....­.............­.............­.............­.............­...

* Cell culture infectious dose 50% equivalent to titre prior to inactivation


Adjuvants:Adjuvants:

Aluminium hydroxide

Saponin

**Haemolytic units


For the full list of excipients, see section 6.1.


3. PHARMACEUTICAL FORM


Suspension for injection.


4. CLINICAL PARTICULARS

4.1 Target species


Sheep


2.7 mg, 30 HU**


6.8–9.5 CCID50*

.7.1–8.5 CCID50*


4.2 Indications for use, specifying the target species


Active immunisation of sheep to prevent viraemia* and to reduce clinical signs caused by bluetongue


virus serotypes 2 and 4.

*(below the level of detection indicating no infectious viru



validated RT-PCR method at 3.68 log10 RNA copies/ml, ission)


Onset of immunity has been demonstrated 3 and 5 weeks after the primary vaccination course for serotype 4 and serotype 2, respectively.


The duration of im

None.

4.4

4.3 Co

ns


is 1 year after primary vaccination course.


arnings for each target species

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


4.5 Special precautions for use

Special precautions for use in animals

Vaccinate healthy animals only.

24 cm2) for a


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

Not applicable.

4.6 Adverse reactions (frequency and seriousness)

4.6 Adverse reactions (frequency and seriousness)

Vaccination may be followed by a small local swelling at the injection site (at short period (at most 14 days).

.1 °C, may occur


A transient increase in body temperature, normally not exceeding an average o within 24 hours after vaccination.

  • 4.7 Use during pregnancy, lactation or lay


Can be used during pregnancy and lactation.

The safety and the efficacy of the vaccine have not been establis reeding 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 Competent Authorities on the current vaccination policies against bluetongue virus (BTV).

4.8 Interaction with other medicinal productsther forms of interaction

4.8 Interaction with other medicinal productsther 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 decided on a case by case basis.


4.9 Amounts to be administered and


Subcutaneous use.


Apply usual aseptic procedures Shake gently immediately befor injection. The entire content same procedure. Avoid multi


Administer one dose of 1 m



route

use. Avoid bubble formation, as this can be irritating at the site of e bottle should be used immediately after broaching and during the ial broaching.


cutaneously according to the following vaccination scheme:


RevaccinaRevaccina

Annual.


Primary vaccination


nth of age in naive animals (or from 2.5 months of age in young animals born



4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary 4.11 Withdrawal periodZero days.5. IMMUNOLOGICAL PROPERTIESPharmacotherapeutic group: inactivated bluetongue virus vaccine for sheep. ATCvet code QI04AA02.The vaccine contains inactivated bluetongue virus serotypes 2 and 4 with alumini saponin adjuvants. It induces an active and specific immunity against bluetongue vi and 4 in the vaccinated animals.ydroxide and erotypes 26. PHARMACEUTICAL PARTICULARS6.1 List of excipientsSilicon antifoam Phosphate buffer Glycine buffer Aluminium hydroxide Saponin.6.2 IncompatibilitiesDo not mix with any other veterinary medicinal pr6.3 Shelf lifeShelf life of the veterinary medicinal pro Shelf life after first opening the immedia

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary 4.11 Withdrawal periodZero days.5. IMMUNO­LOGICAL PROPERTIESPhar­macotherapeutic group: inactivated bluetongue virus vaccine for sheep. ATCvet code QI04AA02.The vaccine contains inactivated bluetongue virus serotypes 2 and 4 with alumini saponin adjuvants. It induces an active and specific immunity against bluetongue vi and 4 in the vaccinated animals.ydroxide and erotypes 26. PHARMACEUTICAL PARTICULARS6.1 List of excipientsSilicon antifoam Phosphate buffer Glycine buffer Aluminium hydroxide Saponin.6.2 In­compatibiliti­esDo not mix with any other veterinary medicinal pr6.3 Shelf lifeShelf life of the veterinary medicinal pro Shelf life after first opening the immedia

Store and transport refrigerated Do not freeze.

Protect from light.



6.4 Special precautions for st


ackage for sale: 18 months. ging: use immediately.

6.5 Nature and composition of immediate packaging

Polypropylene bottle of 50 or 100 ml with butyl elastomer closure.

Box of 10 bottl

Box of 1 bottl

Box of 10


es (1 × 100 ml).

0 doses (10 × 100 ml). doses (1 × 50 ml).

f 50 doses (10 × 50 ml).

Box of 1 bottle o


Type I glass bottle of 10 ml with butyl elastomer 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

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

F THE AUTHORISATION


Any unused veterinary medicinal product or waste materials derived from such veterinary me 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)

9. DATE OF FIRST AUTHORISATION/REN

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European

Medicines Agency ).