Cepedex (dexmedetomidine hydrochloride) – Labelling - QN05CM18

Updated on site: 21-Sep-2017

Namn på medicinering: Cepedex
ATC: QN05CM18
Ämne: dexmedetomidine hydrochloride
Tillverkare: CP-Pharma Handelsgesellschaft mbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Cardboard box (0.1 mg/ml)

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Cepedex 0.1 mg/ml solution for injection for dogs and cats dexmedetomidine hydrochloride

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

 

1 ml contains:

 

 

Dexmedetomidine hydrochloride

0.1 mg

(equivalent to dexmedetomidine

0.08 mg)

 

 

 

 

 

 

 

3.

PHARMACEUTICAL FORM

 

 

 

 

 

 

 

 

Solution for injection

 

 

 

 

 

 

4.

PACKAGE SIZE

 

 

5 ml

 

 

 

 

 

 

10 ml

 

 

 

 

 

 

5 x 10

ml

 

 

 

 

 

 

 

5.

TARGET SPECIES

 

 

 

 

 

 

Dogs and cats

 

6.INDICATION(S)

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Dogs: intravenous or intramuscular use

Cats: intramuscular use

Read the package leaflet before use.

8.WITHDRAWAL PERIOD

9.SPECIAL WARNINGS, IF NECESSARY

Read the package leaflet before use

10.EXPIRY DATE

EXP:

Shelf-life after first opening the container: 56 days.

Once broached use by:

11.SPECIAL STORAGE CONDITIONS

12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL 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

CP Pharma Handelsgesellschaft mbH

Ostlandring 13, 31303 Burgdorf

Germany

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/16/200/001 (5 ml)

EU/2/16/200/002 (10 ml)

EU/2/16/200/003 (5 x 10 ml)

17.MANUFACTURER'S BATCH NUMBER

Lot.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Glass vials of 5 or 10 ml (0.1 mg/ml)

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Cepedex 0.1 mg/ml injection dexmedetomidine hydrochloride

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

0.1 mg/ml

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

5 ml

10 ml

4. ROUTE(S) OF ADMINISTRATION

Dogs: IM, IV

Cats: IM

5. WITHDRAWAL PERIOD

6.BATCH NUMBER

Lot {number}

7.EXPIRY DATE

EXP {month/year}

Once broached use by

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Cardboard box (0.5 mg/ml)

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Cepedex 0.5 mg/ml solution for injection for dogs and cats dexmedetomidine hydrochloride

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

 

1 ml contains:

 

 

Dexmedetomidine hydrochloride

0.5 mg

(equivalent to dexmedetomidine

0.42 mg)

 

 

 

 

 

3.

PHARMACEUTICAL FORM

 

 

 

 

 

 

Solution for injection

 

 

 

 

4.

PACKAGE SIZE

 

 

5 ml

 

 

 

 

10 ml

 

 

 

5 x 10 ml

20 ml

5. TARGET SPECIES

Dogs and cats

6. INDICATION(S)

7. METHOD AND ROUTE(S) OF ADMINISTRATION

Dogs: intravenous or intramuscular use

Cats: intramuscular use

Read the package leaflet before use.

8. WITHDRAWAL PERIOD

9. SPECIAL WARNINGS, IF NECESSARY

Read the package leaflet before use

10. EXPIRY DATE

EXP:

Shelf-life after first opening the container: 56 days.

Once broached use by:

11. SPECIAL STORAGE CONDITIONS

12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL 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

CP-Pharma Handelsges. mbH

Ostlandring 13, 31303 Burgdorf

Deutschland

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/16/200/004 (5 ml)

EU/2/16/200/005 (10 ml)

EU/2/16/200/006 (5 x 10 ml)

EU/2/16/200/007 (20 ml)

17. MANUFACTURER'S BATCH NUMBER

Lot.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Glass vials of 5, 10 or 20 ml (0.5 mg/ml)

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Cepedex 0.5 mg/ml injection dexmedetomidine hydrochloride

2. QUANTITY OF THE ACTIVE SUBSTANCE(S)

0.5 mg/ml

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

5 ml

10 ml

20 ml

4. ROUTE(S) OF ADMINISTRATION

Dogs: IM, IV

Cats: IM

5. WITHDRAWAL PERIOD

6. BATCH NUMBER

Lot {number}

7. EXPIRY DATE

EXP {month/year}

Once broached use by

8. THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

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