Nobilis Influenza H5N2 (inactivated whole avian influenza virus...) – Labelling - QI01AA23

Updated on site: 09-Feb-2018

Medication name: Nobilis Influenza H5N2
ATC: QI01AA23
Substance: inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86)
Manufacturer: Intervet International BV

Article Contents

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

CARDBOARD BOX 250ml; 500ml

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Nobilis Influenza H5N2 emulsion for injection for chickens

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

One dose of 0.5 ml contains:

Inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86), inducing an HI titre of ≥6.0 log2 as tested according to the potency test.

Adjuvant:

Liquid light paraffin 234.8 mg

3.PHARMACEUTICAL FORM

Emulsion for injection

4.PACKAGE SIZE

250 ml

500 ml

5.TARGET SPECIES

Chickens

6.INDICATION(S)

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular or subcutaneous use (0.25 to 0.5 ml, depending on the age).

Read the package leaflet before use.

8.WITHDRAWAL PERIOD

Withdrawal period: zero days.

9.SPECIAL WARNING(S), IF NECESSARY

Accidental self-injection is dangerous.

Read the package leaflet before use.

10.EXPIRY DATE

EXP {month/year}

Once broached, use within 8 hours.

11.SPECIAL STORAGE CONDITIONS

Store and transport refrigerated. Do not freeze.

12.SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

Disposal: read package leaflet.

13.THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable

For animal treatment only.

The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Avian Influenza.

14.THE WORDS “KEEP OUT OF THE SIGHTAND REACH OF CHILDREN”

Keep out of the sight and reach of children.

15.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer

The Netherlands

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/06/061/001-004

17.MANUFACTURER’S BATCH NUMBER

Lot {number}

MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING

BOTTLE LABEL 250ml/500ml

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Nobilis Influenza H5N2 emulsion for injection

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

One dose of 0.5 ml contains:

Inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86), inducing an HI titre of ≥6.0 log2 as tested according to the potency test.

Adjuvant:Liquid light paraffin 234.8 mg

3.CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES

250 ml

500 ml

4.ROUTE(S) OF ADMINISTRATION

Intramuscular or subcutaneous use.

Read the package leaflet before use.

5.WITHDRAWAL PERIOD

Withdrawal period: Zero days.

6.BATCH NUMBER

Lot {number}

7.EXPIRY DATE

EXP {month/year}

Once broached, use within 8 hours.

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

Comments