Dexdomitor (dexmedetomidine hydrochloride) – Labelling - QN05CM18

Updated on site: 09-Feb-2018

Medication name: Dexdomitor
ATC: QN05CM18
Substance: dexmedetomidine hydrochloride
Manufacturer: Orion Corporation

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

BOX

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

DEXDOMITOR 0.1 mg/ml solution for injection

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

1 ml contains:

0.1 mg dexmedetomidine hydrochloride equivalent to 0.08 mg dexmedetomidine

3.PHARMACEUTICAL FORM

Solution for injection

4.PACKAGE SIZE

15 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

Not applicable.

9.SPECIAL WARNING(S), IF NECESSARY

10.EXPIRY DATE

EXP: month/year

Shelf life after first opening: 3 months at 25°C.

11.SPECIAL STORAGE CONDITIONS

Do not freeze.

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

Any unused product or waste materials derived from such veterinary medicinal products 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 SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of children.

15.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/02/033/003

17.MANUFACTURER’S BATCH NUMBER

Batch:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS/ MULTI PACKAGE

VIAL/MULTI PACKAGE

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

DEXDOMITOR 0.1 mg/ml solution for injection

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

0.1 mg/ml dexmedetomidine hydrochloride

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

15 ml, 10 x 15 ml

4.ROUTE(S) OF ADMINISTRATION

Dogs: IM, IV

Cats: IM

5.WITHDRAWAL PERIOD

Not applicable.

6.BATCH NUMBER

Batch:

7.EXPIRY DATE

EXP: month/year

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

BOX

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

DEXDOMITOR 0.5 mg/ml solution for injection

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

1 ml contains:

0.5 mg dexmedetomidine hydrochloride equivalent to 0.42 mg dexmedetomidine

3. PHARMACEUTICAL FORM

Solution for injection

4. PACKAGE SIZE

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

Not applicable.

9. SPECIAL WARNING(S), IF NECESSARY

10. EXPIRY DATE

EXP: month/year

Shelf life after first opening: 3 months at 25°C.

11. SPECIAL STORAGE CONDITIONS

Do not freeze.

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

Any unused product or waste materials derived from such veterinary medicinal products 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 SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of children.

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/02/033/001-002

17. MANUFACTURER’S BATCH NUMBER

Batch:

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS/ MULTI PACKAGE

VIAL/MULTI PACKAGE

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

DEXDOMITOR 0.5 mg/ml solution for injection

2. QUANTITY OF THE ACTIVE SUBSTANCE(S)

0.5 mg/ml dexmedetomidine hydrochloride

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

10 ml, 10 x 10 ml

4. ROUTE(S) OF ADMINISTRATION

Dogs: intravenous or intramuscular use

Cats: intramuscular use

5. WITHDRAWAL PERIOD

Not applicable.

6. BATCH NUMBER

Batch:

7. EXPIRY DATE

EXP: month/year

8. THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

Comments