Letifend (recombinant protein Q from Leishmania...) – Labelling - QI07A

Updated on site: 21-Sep-2017

Ravimi nimetus: Letifend
ATC: QI07A
Toimeaine: recombinant protein Q from Leishmania infantum MON-1
Tootja: Laboratorios LETI, S.L.U.

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Plastic box

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

LETIFEND, lyophilisate and solvent for solution for injection for dogs.

2.STATEMENT OF ACTIVE SUBSTANCES

Per dose of 0.5 ml:

Recombinant Protein Q from Leishmania infantum MON-1 ≥ 36.7 EU

3.PHARMACEUTICAL FORM

Lyophilisate and solvent for solution for injection.

4.PACKAGE SIZE

1 vial of lyophylisate and 1 vial of solvent (1 dose)

4 vials of lyophylisate and 4 vials of solvent (4 doses) 5 vials of lyophylisate and 5 vials of solvent (5 doses)

10 vials of lyophylisate and 10 vials of solvent (10 doses) 20 vials of lyophylisate and 20 vials of solvent (20 doses) 25 vials of lyophylisate and 25 vials of solvent (25doses) 50 vials of lyophylisate and 50 vials of solvent (50 doses)

100 vials of lyophylisate and 100 vials of solvent (100 doses)

5.TARGET SPECIES

Dogs.

6.INDICATION(S)

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous use.

Read the package leaflet before use.

8.WITHDRAWAL PERIOD(S)

9.SPECIAL WARNING(S), IF NECESSARY

10.EXPIRY DATE

EXP {mm/yyyy}

Once reconstituted use immediately.

11.SPECIAL STORAGE CONDITIONS

Store in a refrigerator.

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 LETI, S.L. unipersonal C/ Del Sol 5,

Polígono Industrial Norte Tres Cantos

28760 Madrid SPAIN

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/16/195/001

 

 

 

 

 

 

1 dose

EU/2/16/195/002

 

4 doses

 

 

 

EU/2/16/195/003

5 doses

 

 

EU/2/16/195/004

10 doses

 

 

EU/216/195/005

20 doses

 

EU/2/16/195/006

25 doses

 

EU/2/16/195/007

50 doses

 

EU/2/16/195/008

100 doses

 

17.MANUFACTURER’S BATCH NUMBER

Lot {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial of lyophilisate

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

LETIFEND lyophilisate for dogs

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

Recombinant Protein Q from L. infantum MON-1

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

1 dose

4.ROUTE(S) OF ADMINISTRATION

SC

5.WITHDRAWAL PERIOD(S)

6.BATCH NUMBER

Lot {number}

7.EXPIRY DATE

EXP {mm/yyyy}

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Vial of solvent

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

LETIFEND solvent for dogs

2. QUANTITY OF THE ACTIVE SUBSTANCE(S)

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

0.8 ml

4. ROUTE(S) OF ADMINISTRATION

5. WITHDRAWAL PERIOD(S)

6. BATCH NUMBER

Lot {number}

7. EXPIRY DATE

EXP {mm/yyyy}

8. THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only

Kommentaarid