CaniLeish (Leishmania infantum excreted secreted...) – Labelling - QI070AO

Updated on site: 08-Feb-2018

Medication name: CaniLeish
ATC: QI070AO
Substance: Leishmania infantum excreted secreted proteins
Manufacturer: Virbac S.A

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Box of 1 vial of lyophilisate and 1 vial of solvent

Box of 1 vial of lyophilisate, 1 vial of solvent, 1 syringe and 1 needle. Box of 3 vials of lyophilisate and 3 vials of solvent

Box of 5 vials of lyophilisate and 5 vials of solvent

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

CaniLeish lyophilisate and solvent for suspension for injection for dogs

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

L. infantum Proteins (ESP) ≥ 100 µg

3.PHARMACEUTICAL FORM

Lyophilisate and solvent for suspension for injection.

4.PACKAGE SIZE

1 dose.

3 doses.

5 doses.

5.TARGET SPECIES

Dogs.

6.INDICATION

7.METHOD AND ROUTE OF ADMINISTRATION

Subcutaneous use.

Read the package leaflet before use.

8.WITHDRAWAL PERIOD

9.SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10.EXPIRY DATE

EXP: {month/year}

Use immediately after reconstitution.

11.SPECIAL STORAGE CONDITIONS

Store and transport refrigerated.

Protect from light.

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

Read the package leaflet before use.

13.THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR

RESTRICTIONS REGARDING SUPPLY AND USE, if applicable

For animal treatment only. To be supplied on veterinary subscription.

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

VIRBAC

1ère avenue – 2065 m – L.I.D. 06516 Carros

France

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/11/121/001

EU/2/11/121/002

EU/2/11/121/003

EU/2/11/121/004

17.MANUFACTURER’S BATCH NUMBER

Batch: {number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Box of 10 vials of lyophilisate and 10 vials of solvent

Box of 15 vials of lyophilisate and 15 vials of solvent

Box of 25 vials of lyophilisate and 25 vials of solvent

Box of 30 vials of lyophilisate and 30 vials of solvent

Box of 50 vials of lyophilisate and 50 vials of solvent

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

CaniLeish lyophilisate and solvent for suspension for injection for dogs

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Each dose of 1 ml vaccine contains:

L. infantum Proteins (ESP) ≥ 100 µg

3. PHARMACEUTICAL FORM

Lyophilisate and solvent for suspension for injection.

4. PACKAGE SIZE

10 doses.

15 doses.

25 doses.

30 doses.

50 doses.

5. TARGET SPECIES

Dogs.

6. INDICATION(S)

Read the package leaflet before use.

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Subcutaneous use.

Read the package leaflet before use.

8. WITHDRAWAL PERIOD

9. SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10. EXPIRY DATE

EXP: {month/year}

Use immediately after reconstitution.

11. SPECIAL STORAGE CONDITIONS

Store and transport refrigerated.

Protect from light.

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

Read the package leaflet before use.

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

VIRBAC

1ère avenue – 2065 m – L.I.D. 06516 Carros

France

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/11/121/005

EU/2/11/121/006

EU/2/11/121/007

EU/2/11/121/008

EU/2/11/121/009

17. MANUFACTURER’S BATCH NUMBER

Batch: {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial with 1 dose of lyophilisate

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

CaniLeish lyophilisate

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

L. infantum ESP ≥ 100 µg

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

1 dose

4.ROUTE(S) OF ADMINISTRATION

SC

5.WITHDRAWAL PERIOD

6.BATCH NUMBER

Batch: {number}

7.EXPIRY DATE

EXP: {month/year}

Use immediately after reconstitution.

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial with 1 dose of solvent

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

CaniLeish solvent

2. QUANTITY OF THE ACTIVE SUBSTANCE(S)

Sodium chloride 9 mg/ml (0.9%)

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

1 ml

4. ROUTE(S) OF ADMINISTRATION

5. WITHDRAWAL PERIOD

Not applicable.

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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