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.
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