Clomicalm (clomipramine) – Labelling - QN06AA04

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

CARDBOX

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Clomicalm 5 mg tablets for dogs

Clomipramine hydrochloride

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Clomipramine hydrochloride 5 mg (equivalent to 4.5 mg Clomipramine)

3.PHARMACEUTICAL FORM

Tablets.

4.PACKAGE SIZE

30 tablets

5.TARGET SPECIES

Dog

6.INDICATION

As an aid in the treatment of separation-related disorders in combination with behavioural modification techniques.

7.METHOD AND ROUTE OF ADMINISTRATION

For oral use.

Clomicalm is administered twice daily at a dose of 1-2 mg/kg clomipramine to give a total daily dose of 2 - 4 mg/kg according to the following table:

Body weight

Clomicalm 5 mg

 

 

1.25-2.5 kg

½ tablet

>2.5-5 kg

1 tablet

 

 

Read the package leaflet before use.

8.WITHDRAWAL PERIOD

Not applicable

9.SPECIAL WARNINGS, IF NECESSARY

To be used under veterinary supervision. Read the package leaflet before use.

10.EXPIRY DATE

EXP {month/year}

11.SPECIAL STORAGE CONDITIONS

Store in the original container.

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

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

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 REACH AND SIGHT OF CHILDREN”

Keep out of the reach and sight of children. Accidental ingestion should be regarded as serious.

15.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke

RG24 9NL

UNITED KINGDOM

16.MARKETING AUTHORISATION NUMBER

EU/2/98/007/001

17.MANUFACTURER’S BATCH NUMBER

Lot {number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

CARDBOX

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Clomicalm 20 mg tablets for dogs

Clomipramine hydrochloride

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Clomipramine hydrochloride 20 mg (equivalent to 17.9 mg Clomipramine)

3. PHARMACEUTICAL FORM

Tablets.

4. PACKAGE SIZE

30 tablets

5. TARGET SPECIES

Dog

6. INDICATION

As an aid in the treatment of separation-related disorders in combination with behavioural modification techniques.

7. METHOD AND ROUTE OF ADMINISTRATION

For oral use.

Clomicalm is administered twice daily at a dose of 1-2 mg/kg clomipramine to give a total daily dose of 2 - 4 mg/kg according to the following table:

Body weight

Clomicalm 20 mg

 

 

> 5-10 kg

½ tablet

>10-20 kg

1 tablet

 

 

Read the package leaflet before use.

8. WITHDRAWAL PERIOD

Not applicable

9. SPECIAL WARNINGS, IF NECESSARY

To be used under veterinary supervision. Read the package leaflet before use.

10. EXPIRY DATE

EXP {month/year}

11. SPECIAL STORAGE CONDITIONS

Store in the original container.

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

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

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 REACH AND SIGHT OF CHILDREN”

Keep out of the reach and sight of children. Accidental ingestion should be regarded as serious.

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke

RG24 9NL

UNITED KINGDOM

16. MARKETING AUTHORISATION NUMBER

EU/2/98/007/002

17. MANUFACTURER’S BATCH NUMBER

Lot {number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

CARDBOX

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Clomicalm 80 mg tablets for dogs

Clomipramine hydrochloride

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Clomipramine hydrochloride 80 mg (equivalent to 71.7 mg Clomipramine)

3. PHARMACEUTICAL FORM

Tablets.

4. PACKAGE SIZE

30 tablets

5. TARGET SPECIES

Dog

6. INDICATION

As an aid in the treatment of separation-related disorders in combination with behavioural modification techniques.

7.METHOD AND ROUTES OF ADMINISTRATION

For oral use.

Clomicalm is administered twice daily at a dose of 1-2 mg/kg clomipramine to give a total daily dose of 2-4 mg/kg according to the following table:

Body weight

Clomicalm 80 mg

 

 

>20-40 kg

½ 5 tablet

>40-80 kg

1 tablet

 

 

Read the package leaflet before use.

8. WITHDRAWAL PERIOD

Not applicable

9. SPECIAL WARNINGS, IF NECESSARY

To be used under veterinary supervision. Read the package leaflet before use.

10. EXPIRY DATE

EXP {month/year}

11. SPECIAL STORAGE CONDITIONS

Store in the original container.

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

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

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 REACH AND SIGHT OF CHILDREN”

Keep out of the reach and sight of children. Accidental ingestion should be regarded as serious.

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke

RG24 9NL

UNITED KINGDOM

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/98/007/003

17. MANUFACTURER’S BATCH NUMBER

Lot {number}

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE

BOTTLE

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Clomicalm 5 mg tablets for dogs

Clomipramine hydrochloride

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Clomipramine hydrochloride 5 mg (equivalent to 4.5 mg Clomipramine)

3.PACKAGE SIZE

30 tablets

4.METHOD AND ROUTE OF ADMINISTRATION

For oral use.

1-2 mg clomipramine/kg bw twice daily.

Read the package leaflet before use.

5.SPECIAL WARNINGS, IF NECESSARY

To be used under veterinary supervision. Read the package leaflet before use.

6.EXPIRY DATE

EXP {month/year}

7.SPECIAL STORAGE CONDITIONS

Store in the original container.

8. 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.

9.THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”

Keep out of the reach and sight of children. Accidental ingestion should be regarded as serious.

10.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke

RG24 9NL

UNITED KINGDOM

11.MARKETING AUTHORISATION NUMBER

EU/2/98/007/001

12.MANUFACTURER’S BATCH NUMBER

Lot {number}

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE

BOTTLE

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Clomicalm 20 mg tablets for dogs

Clomipramine hydrochloride

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Clomipramine hydrochloride 20 mg (equivalent to 17.9 mg Clomipramine)

3. PACKAGE SIZE

30 tablets

4. METHOD AND ROUTE OF ADMINISTRATION

For oral use.

1-2 mg clomipramine/kg bw twice daily.

Read the package leaflet before use.

5. SPECIAL WARNINGS, IF NECESSARY

To be used under veterinary supervision. Read the package leaflet before use.

6. EXPIRY DATE

EXP {month/year}

7. SPECIAL STORAGE CONDITIONS

Store in the original container.

8. 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.

9. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”

Keep out of the reach and sight of children.Accidental ingestion should be regarded as serious.

10. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke

RG24 9NL

UNITED KINGDOM

11. MARKETING AUTHORISATION NUMBER

EU/2/98/007/002

12. MANUFACTURER’S BATCH NUMBER

Lot {number}

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE

BOTTLE

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Clomicalm 80 mg tablets for dogs

Clomipramine hydrochloride

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Clomipramine hydrochloride 80mg (equivalent to 71.7 mg Clomipramine)

3. PACKAGE SIZE

30 tablets

4. METHOD AND ROUTE OF ADMINISTRATION

For oral use.

1-2 mg clomipramine/kg bw twice daily.

Read the package leaflet before use.

5. SPECIAL WARNINGS, IF NECESSARY

To be used under veterinary supervision. Read the package leaflet before use.

6. EXPIRY DATE

EXP {month/year}

7. SPECIAL STORAGE CONDITIONS

Store in the original container.

8. 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.

9. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”

Keep out of the reach and sight of children.Accidental ingestion should be regarded as serious.

10. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke

RG24 9NL

UNITED KINGDOM

11. MARKETING AUTHORISATION NUMBER

EU/2/98/007/003

12. MANUFACTURER’S BATCH NUMBER

Lot {number}

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