Eravac (Inactivated rabbit haemorrhagic disease...) – Labelling - QI08AA01

Updated on site: 21-Sep-2017

Nafn lyfs: Eravac
ATC: QI08AA01
Efni: Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2)
Framleiðandi: Laboratorios Hipra, S.A.

PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE

PACKAGE

CARTON

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

ERAVAC emulsion for injection for rabbits

2.STATEMENT OF ACTIVE SUBSTANCES

Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037 ≥70% cELISA40 ≥70 % of vaccinated rabbits shallgive cELISA antibody titres equal to or higher than 40.

3.PHARMACEUTICAL FORM

Emulsion for injection.

4.PACKAGE SIZE

10 doses (5 ml).

40 doses (20 ml).

5.TARGET SPECIES

Rabbits

6.INDICATION(S)

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous use.

Read the package leaflet before use.

8.WITHDRAWAL PERIOD(S)

Withdrawal period: Zero days.

9.SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

Accidental injection is dangerous.

10.EXPIRY DATE

EXP {month/year}

Once broached use immediately.

11.SPECIAL STORAGE CONDITIONS

Store and transport refrigerated.

Do not freeze.

Keep the bottle in the outer carton in order to protect from light.

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

Disposal: read the package leaflet.

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

For animal treatment only.

To be supplied only on veterinary prescription.

14.THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of children.

15.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Laboratorios Hipra S.A. Avda. la Selva, 135 17170 Amer (Girona) SPAIN

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/16/199/001-002

17.MANUFACTURER’S BATCH NUMBER

Batch{number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial label (10 or 40 doses)

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

ERAVAC emulsion for injection for rabbits

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

Inactivated RHDV2, strain V-1037: ≥70% cELISA40

≥70 % of vaccinated rabbits shall give cELISA antibody titres equal to or higher than 40.

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

10 doses (5 ml).

40 doses (20 ml).

4.ROUTE(S) OF ADMINISTRATION

SC

5.WITHDRAWAL PERIOD(S)

6.BATCH NUMBER

Batch{number}

7.EXPIRY DATE

EXP {month/year}

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

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