Sedadex (dexmedetomidine hydrochloride) – Labelling - QN05CM18

PARTI CULARS TO APPEAR ON THE O UTER PA CKAGE

Cardboard box

1.NAME OF THE VETER INARY M EDICINAL PRODUCT

Sedadex 0.1 mg/ml olution for injection for dogs and cats dexmed etomidine hy drochloride

2.S TATEMENT OF ACTI VE AND OTHER SUB STANCES

	1 ml con tains:
	Dexmedetomidine hydrochloride			0.1 mg
	(equivalent to dexm detomidine			0.08 mg)
3.		P HARMACE UTICAL FORM
	Solution for injectio n
4.		P ACKAGE S IZE
	10 ml

5.TARGET SPECIES

Dogs and cats

6.I DICATIO N(S)

7.M ETHOD AND ROUTE (S) OF ADMINISTRA TION

Dogs: intravenous o intramuscular use

Cats: intramuscular use

Read the package le aflet before se.

8.W ITHDRAW AL PERIO D

9.S PECIAL WARNINGS, IF NECES SARY

Read the package le aflet before se.

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

Le Vet Beheer B.V.

Wilgenweg 7

3421 TV Oudewater

The Netherlands

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/16/198/001

17.MANUFACTURER'S BATCH NUMBER

Lot.

MINIMUM PART CULARS O APPEA R ON SMALL IMMED IATE PAC KAGING NITS Glass vial of 10 ml

1. NAME OF THE VETER INARY M EDICINAL PRODUCT

Sedadex 0.1 mg/ml injection dexmed etomidine hy drochloride

2.QUANTITY OF THE A CTIVE SUB STANCE( S)

0.1 mg/ ml

3. CONTENTS BY WEIG HT, BY VO LUME OR BY NUMB ER OF DOS ES

10 ml

4. ROUTE(S) O F ADMINISTRATIO

Dogs: I M, IV

Cats: IM

5.W ITHDRAW AL PERIO D

6.BATCH NU MBER

Lot {nu mber}

7.EXPIRY DATE

EXP {month/year}

Once br oached use b y

8.THE WORDS “FOR AN IMAL TRE ATMENT ONLY”

For anim al treatment only.

PARTI CULARS TO APPEAR ON THE O UTER PA CKAGE

Cardboard box

1. NAME OF THE VETER INARY M EDICINAL PRODUCT

Sedadex 0.5 mg/ml olution for injection for dogs and cats dexmed etomidine hy drochloride

2. S TATEMENT OF ACTI VE AND OTHER SUB STANCES

	1 ml con tains:
	Dexmedetomidine hydrochloride			0.5 mg
	(equivalent to dexm detomidine			0.42 mg)
3.		P HARMACE UTICAL FORM
	Solution for injectio n
4.		P ACKAGE S IZE
	10 ml

5. TARGET SPECIES

Dogs and cats

6. I DICATIO N(S)

7. M ETHOD AND ROUTE (S) OF ADMINISTRA TION

Dogs: intravenous o intramuscular use

Cats: intramuscular use

Read the package le aflet before se.

8. W ITHDRAW AL PERIO D

9. S PECIAL WARNINGS, IF NECES SARY

Read the package le aflet before se.

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

Le Vet Beheer B.V.

Wilgenweg 7

3421 TV Oudewater

The Netherlands

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/16/198/002

17. MANUFACTURER'S BATCH NUMBER

Lot.

MINIMUM PART CULARS O APPEA R ON SMALL IMMED IATE PAC KAGING NITS Glass vial 10 ml

1. NAME OF THE VETER INARY M EDICINAL PRODUCT

Sedadex 0.5 mg/ml injection dexmed etomidine hy drochloride

2. QUANTITY OF THE A CTIVE SUB STANCE( S)

0.5 mg/ ml

3. CONTENTS BY WEIG HT, BY VO LUME OR BY NUMB ER OF DOS ES

10 ml

4. ROUTE(S) O F ADMINISTRATIO

Dogs: I , IM

Cats: IM

5. W ITHDRAW AL PERIO D

6. BATCH NU MBER

Lot {nu mber}

7. EXPIRY DATE

EXP {month/year}

Once br oached use b y

8. THE WORDS “FOR AN IMAL TRE ATMENT ONLY”

For anim al treatment only.