Evalon (vaccine against coccidiosis in chickens) – Labelling - QI01AN01

Updated on site: 09-Feb-2018

Ravimi nimetus: Evalon
ATC: QI01AN01
Toimeaine: vaccine against coccidiosis in chickens
Tootja: Laboratorios Hipra, S.A.

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Cardboard box

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Evalon suspension and solvent for oral spray for chickens.

2.STATEMENT OF ACTIVE SUBSTANCES

Each dose (0.007 ml) of undiluted vaccine contains:

 

Eimeria acervulina, strain 003.........................................

332–450

Eimeria brunetti, strain 034 .............................................

213–288

Eimeria maxima, strain 013 .............................................

196–265

Eimeria necatrix, strain 033.............................................

340–460

Eimeria tenella, strain 004 ...............................................

276–374

 

 

 

3.

PHARMACEUTICAL FORM

 

Suspension and solvent for oral spray.

4.PACKAGE SIZE

One vial of 1,000 doses and one vial with 50 ml of HIPRAMUNE T (solvent). One vial of 5,000 doses and one vial with 250 ml of HIPRAMUNE T (solvent). One vial of 10,000 doses and one vial with 500 ml of HIPRAMUNE T (solvent).

5.TARGET SPECIES

Chickens.

6.INDICATION(S)

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

Coarse spray.

Read the package leaflet before use.

8.WITHDRAWAL PERIOD(S)

Withdrawal period: Zero days.

9.SPECIAL WARNING(S), IF NECESSARY

Read package leaflet before use.

10.EXPIRY DATE

EXP {month/year}

Once diluted use within 10 hours.

11.SPECIAL STORAGE CONDITIONS

Store and transport refrigerated. Do not freeze.

12. SPECIAL 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. 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/2/16/194/001

EU/2/16/194/002

EU/2/16/194/003

17.MANUFACTURER’S BATCH NUMBER

Batch {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vaccine vial of 1,000 or 5,000 doses

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Evalon suspension for oral spray for chickens.

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

Each dose (0.007 ml) of undiluted vaccine contains:

 

Eimeria acervulina, strain 003.........................................

332–450

Eimeria brunetti, strain 034 .............................................

213–288

Eimeria maxima, strain 013 .............................................

196–265

Eimeria necatrix, strain 033.............................................

340–460

Eimeria tenella, strain 004 ...............................................

276–374

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

1,000 doses

5,000 doses

4.ROUTE(S) OF ADMINISTRATION

Oral use.

To be mixed with the solvent. Read the package leaflet before use.

5.WITHDRAWAL PERIOD(S)

Withdrawal period: Zero days.

6.BATCH NUMBER

Batch {number}

7.EXPIRY DATE

EXP {month/year}

Once diluted use within 10 hours.

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE

Vaccine vial of 10,000 doses

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Evalon suspension for oral spray for chickens.

2. STATEMENT OF ACTIVE SUBSTANCES

 

Each dose (0.007 ml) of undiluted vaccine contains:

 

 

Eimeria acervulina, strain 003.........................................

332–450

 

Eimeria brunetti, strain 034 .............................................

213–288

 

Eimeria maxima, strain 013 .............................................

196–265

 

Eimeria necatrix, strain 033.............................................

340–460

 

Eimeria tenella, strain 004 ...............................................

276–374

 

 

 

 

 

 

3.

PHARMACEUTICAL FORM

 

 

 

 

 

 

 

Suspension for oral spray.

 

 

 

 

 

4.

PACKAGE SIZE

 

 

10,000 doses

 

 

 

 

 

5.

TARGET SPECIES

 

 

 

 

 

 

Chickens.

 

6. INDICATION(S)

7. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

Coarse spray.

To be mixed with the solvent. Read the package leaflet before use.

8. WITHDRAWAL PERIOD(S)

Withdrawal period: Zero days.

9. SPECIAL WARNING(S), IF NECESSARY

Read package leaflet before use.

10. EXPIRY DATE

EXP {month/year}

Once diluted use within 10 hours.

11. SPECIAL STORAGE CONDITIONS

Store and transport refrigerated. Do not freeze.

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

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”

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/2/16/194/003

17. MANUFACTURER’S BATCH NUMBER

Batch {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Solvent vial of 50 ml, 250 ml or 500 ml

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

HIPRAMUNE T, solvent for Evalon

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

50 ml

250 ml

500 ml

3. ROUTE(S) OF ADMINISTRATION

4.STORAGE CONDITIONS

Store and transport refrigerated. Do not freeze.

5.BATCH NUMBER

Batch {number}

6.EXPIRY DATE

EXP {month/year}

7.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

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