Spironolactone Ceva (spironolactone) – Labelling - QC03DA01

Updated on site: 21-Sep-2017

Namn på medicinering: Spironolactone Ceva
ATC: QC03DA01
Ämne: spironolactone
Tillverkare: Ceva Sante Animale

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Cardboard box of 1 bottle of 30 tablets

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Spironolactone Ceva 10 mg tablets for dogs

Spironolactone Ceva 40 mg tablets for dogs

Spironolactone Ceva 80 mg tablets for dogs

Spironolactone.

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Spironolactone 10 mg

Spironolactone 40 mg

Spironolactone 80 mg

3.PHARMACEUTICAL FORM

Tablet

4.PACKAGE SIZE

30 tablets

5.TARGET SPECIES

Dogs

6.INDICATION(S)

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral 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 within 2 months after first opening the bottle.

11.SPECIAL STORAGE CONDITIONS

Store partially used tablets in the original bottle.

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

Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne

France

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/07/074/007

EU/2/07/074/008

EU/2/07/074/009

17.MANUFACTURER’S BATCH NUMBER

Lot: {number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Cardboard box - 10 mg tablets, 40 mg tablets and 80 mg tablets

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Spironolactone Ceva 10 mg tablets for dogs

Spironolactone Ceva 40 mg tablets for dogs

Spironolactone Ceva 80 mg tablets for dogs

Spironolactone.

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Spironolactone 10 mg

Spironolactone 40 mg

Spironolactone 80 mg

3. PHARMACEUTICAL FORM

Tablet

4. PACKAGE SIZE

30 tablets

180 tablets

5. TARGET SPECIES

Dogs

6. INDICATION(S)

7. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral 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}

Partially used tablets to be used within 7 days.

11. SPECIAL STORAGE CONDITIONS

Store partially used tablets in the original blister.

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

Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne

France

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/07/074/001 (3 blisters of 10 tablets)

EU/2/07/074/002 (18 blisters of 10 tablets)

EU/2/07/074/003 (3 blisters of 10 tablets)

EU/2/07/074/004 (18 blisters of 10 tablets)

EU/2/07/074/005 (3 blisters of 10 tablets)

EU/2/07/074/006 (18 blisters of 10 tablets)

17. MANUFACTURER’S BATCH NUMBER

Lot: {number}

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE

Bottle of 30 tablets

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Spironolactone Ceva 10 mg tablets for dogs

Spironolactone Ceva 40 mg tablets for dogs

Spironolactone Ceva 80 mg tablets for dogs

spironolactone

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

spironolactone 10 mg spironolactone 40 mg spironolactone 80 mg

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

30 tablets

4.ROUTE(S) OF ADMINISTRATION

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.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blister - 10 mg tablets, 40 mg tablets and 80 mg tablets

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Spironolactone Ceva 10 mg tablets for dogs

Spironolactone Ceva 40 mg tablets for dogs

Spironolactone Ceva 80 mg tablets for dogs

Spironolactone

2.NAME OF THE MARKETING AUTHORISATION HOLDER

CEVA

3.EXPIRY DATE

EXP: {month/year}

4.BATCH NUMBER

Lot:

5.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

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