Sileo (dexmedetomidine hydrochloride) – Labelling - QN05CM18

Updated on site: 09-Feb-2018

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

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Carton (1 pre-filled syringe)

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Sileo 0.1 mg/ml oromucosal gel for dogs dexmedetomidine hydrochloride

2.STATEMENT OF ACTIVE AND OTHER SUBSTANCES

1 ml: Dexmedetomidine hydrochloride 0.1 mg

3.PHARMACEUTICAL FORM

Oromucosal gel

4.PACKAGE SIZE

1 x 3 ml oral syringe

5.TARGET SPECIES

Dogs

6.INDICATION(S)

7.METHOD AND ROUTE(S) OF ADMINISTRATION

For oromucosal use.

Read the package leaflet before use.

QR code to be included + www.sileodog.com

8.WITHDRAWAL PERIOD

9.SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10.EXPIRY DATE

EXP: {month/year}

Once opened use within 4 weeks.

Once opened use by...

11.SPECIAL STORAGE CONDITIONS

Replace cap after use.

Return the oral syringe to the outer carton immediately after each use.

12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED 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

Orion Corporation

Orionintie 1

FI-02200 Espoo

FINLAND

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/15/181/001 (1 x 3 ml oral syringe)

17.MANUFACTURER’S BATCH NUMBER

Lot

Instructions for opening the package:

1.

2.

3.

1.Push to break white seal.

2.Push to break yellow seal.

3.Push yellow seal and pull open

Text on the seals:

Push

Pull

On the inner part of the carton:

When closing, make sure that the pictures of the dogs are aligned and that the carton is closed properly.

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Carton (3 x 1, 5 x 1, 10 x 1 and 20 x 1 pre-filled syringes)

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Sileo 0.1 mg/ml oromucosal gel for dogs dexmedetomidine hydrochloride

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

1 ml: Dexmedetomidine hydrochloride 0.1 mg

3. PHARMACEUTICAL FORM

Oromucosal gel

4. PACKAGE SIZE

3 packs of (3 ml) oral syringes

5 packs of (3 ml) oral syringes

10 packs of (3 ml) oral syringes

20 packs of (3 ml) oral syringes

5. TARGET SPECIES

Dogs

6. INDICATION(S)

7. METHOD AND ROUTE(S) OF ADMINISTRATION

For oromucosal use.

Read the package leaflet before use.

8. WITHDRAWAL PERIOD

9. SPECIAL WARNING(S), IF NECESSARY

Read the package leaflet before use.

10. EXPIRY DATE

EXP: {month/year}

11. SPECIAL STORAGE CONDITIONS

12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED 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. This multipack is not intended to be supplied directly to the animal owner.

(for 5 x 1, 10 x 1 and 20 x 1 multipacks only)

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/2/15/181/002 (3 (1 x 3 ml) oral syringes)

EU/2/15/181/003 (5 (1 x 3 ml) oral syringes)

EU/2/15/181/004 (10 (1 x 3 ml) oral syringes)

EU/2/15/181/005 (20 (1 x 3 ml) oral syringes)

17. MANUFACTURER’S BATCH NUMBER

Lot

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Oral syringe

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Sileo 0.1 mg/ml oromucosal gel

dexmedetomidine HCl

2.QUANTITY OF THE ACTIVE SUBSTANCE(S)

Dexmedetomidine hydrochloride 0.1 mg/ml

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

3 ml

4.ROUTE(S) OF ADMINISTRATION

Oromucosal use.

5.WITHDRAWAL PERIOD

6.BATCH NUMBER

Lot

7.EXPIRY DATE

EXP: {month/year}

8.THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

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