Stronghold (selamectin) – Labelling - QP54AA05

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

CARTON LABEL, 15 mg (3 and 15 pipettes)

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Stronghold 15 mg spot-on solution for cats and dogs < 2.5 kg Selamectin

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Selamectin 15 mg

3.PHARMACEUTICAL FORM

Spot-on solution.

4.PACKAGE SIZE

3 pipettes

15 pipettes

0.25 ml

5.TARGET SPECIES

Cats and dogs weighing 2.5 kg or less

6.INDICATION(S)

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Spot-on 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}

11.SPECIAL STORAGE CONDITIONS

Do not store above 30 °C. Store in the unopened foil package in a dry place.

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

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/99/014/001 (3 pipettes)

EU/2/99/014/012 (15 pipettes)

17.MANUFACTURER’S BATCH NUMBER

Lot {number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

CARTON LABEL, 30 mg, 60 mg, 120 mg, 240 mg, 360 mg (3 and 6 pipettes)

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Stronghold 30 mg spot-on solution for dogs 2.6–5.0 kg

Stronghold 60 mg spot-on solution for dogs 5.1–10.0 kg

Stronghold 120 mg spot-on solution for dogs 10.1–20.0 kg

Stronghold 240 mg spot-on solution for dogs 20.1–40.0 kg

Stronghold 360 mg spot-on solution for dogs 40.1–60.0 kg

Selamectin

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Selamectin 30 mg

Selamectin 60 mg

Selamectin 120 mg

Selamectin 240 mg

Selamectin 360 mg

3. PHARMACEUTICAL FORM

Spot-on solution.

4. PACKAGE SIZE

3 pipettes

6 pipettes

0.25 ml

0.5 ml

1.0 ml

2.0 ml

3.0 ml

5. TARGET SPECIES

Dogs weighing 2.6–5.0 kg.

Dogs weighing 5.1–10.0 kg.

Dogs weighing 10.1–20.0 kg.

Dogs weighing 20.1–40.0 kg.

Dogs weighing 40.1–60.0 kg.

6. INDICATION(S)

7. METHOD AND ROUTE(S) OF ADMINISTRATION

Spot-on 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}

11. SPECIAL STORAGE CONDITIONS

Do not store above 30 °C. Store in the unopened foil package in a dry place.

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

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/99/014/003 (30 mg - 3 pipettes)

EU/2/99/014/007 (30 mg - 6 pipettes)

EU/2/99/014/004 (60 mg - 3 pipettes)

EU/2/99/014/009 (60 mg - 6 pipettes)

EU/2/99/014/005 (120 mg - 3 pipettes)

EU/2/99/014/010 (120 mg - 6 pipettes)

EU/2/99/014/006 (240 mg - 3 pipettes)

EU/2/99/014/011 (240 mg - 6 pipettes)

EU/2/99/014/015 (360 mg - 3 pipettes)

EU/2/99/014/016 (360 mg - 6 pipettes)

17. MANUFACTURER’S BATCH NUMBER

Lot {number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

CARTON LABEL, 45 mg, 60 mg (3 and 6 pipettes)

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Stronghold 45 mg spot-on solution for cats 2.6–7.5 kg Stronghold 60 mg spot-on solution for cats 7.6–10.0 kg Selamectin

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Selamectin 45 mg

Selamectin 60 mg

3. PHARMACEUTICAL FORM

Spot-on solution.

4. PACKAGE SIZE

3 pipettes

6 pipettes

0.75 ml

1.0 ml

5. TARGET SPECIES

Cats weighing 2.6–7.5 kg.

Cats weighing 7.6–10.0 kg.

6. INDICATION(S)

7. METHOD AND ROUTE(S) OF ADMINISTRATION

Spot-on 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}

11. SPECIAL STORAGE CONDITIONS

Do not store above 30 °C. Store in the unopened foil package in a dry place.

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

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/99/014/002 (3 pipettes)

EU/2/99/014/008 (6 pipettes)

EU/2/99/014/013 (3 pipettes)

EU/2/99/014/014 (6 pipettes)

17. MANUFACTURER’S BATCH NUMBER

Lot {number}

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOIL LABEL, 15 mg, 30 mg, 45 mg, 60 mg, 120 mg, 240 mg, 360 mg

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Stronghold 15 mg spot-on for cats and dogs < 2.5 kg

Stronghold 30 mg spot-on for dogs 2.6–5.0 kg

Stronghold 45 mg spot-on for cats 2.6–7.5 kg

Stronghold 60 mg spot-on for cats 7.6–10.0 kg

Stronghold 60 mg spot-on for dogs 5.1–10.0 kg

Stronghold 120 mg spot-on for dogs 10.1–20.0 kg

Stronghold 240 mg spot-on for dogs 20.1–40.0 kg

Stronghold 360 mg spot-on for dogs 40.1–60.0 kg

Selamectin

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

15 mg selamectin

30 mg selamectin

45 mg selamectin

60 mg selamectin

120 mg selamectin

240 mg selamectin

360 mg selamectin

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

4.ROUTE(S) OF ADMINISTRATION

Spot-on use

5.WITHDRAWAL PERIOD

6.BATCH NUMBER

Lot {number}

7.EXPIRY DATE

EXP {month/year}

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

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