Sevohale (known as Sevocalm) (sevoflurane) – Labelling - QN01AB08

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Carton box

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Sevohale 100% v/v Inhalation vapour, liquid for dogs. sevoflurane

2.STATEMENT OF ACTIVE SUBSTANCES

Sevoflurane 100% v/v

3.PHARMACEUTICAL FORM

Inhalation vapour, liquid

4.PACKAGE SIZE

250 ml

6 x 250 ml

5.TARGET SPECIES

Dogs

6.INDICATION(S)

For induction and maintenance of anaesthesia.

7.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Administer by inhalation using a vaporiser calibrated for sevoflurane.

8.WITHDRAWAL PERIOD

9.SPECIAL WARNING(S), IF NECESSARY

Do not use in dogs with known hypersensitivity to sevoflurane or other halogenated anaesthetic agents.

Do not use in pregnant and lactating bitches.

Do not use in dogs with a known or suspected genetic susceptibility to malignant hyperthermia. Do not use in dogs less than 12 weeks of age.

For operator warnings - read the package leaflet before use.

10.EXPIRY DATE

EXP {month/year}

11.SPECIAL STORAGE CONDITIONS

Do not store above 25 °C.

Do not refrigerate.

Keep the bottle tightly closed.

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

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea,

Co. Galway,

IRELAND

16.MARKETING AUTHORISATION NUMBER(S)

EU/2/16/196/001 (250 ml)

EU/2/16/196/002 (6 x 250 ml)

17.MANUFACTURER’S BATCH NUMBER

BN{number}

PARTICULARS TO APPEAR ON THE INNER PACKAGE

Bottle label

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Sevohale 100% v/v Inhalation vapour, liquid for dogs. sevoflurane

2. STATEMENT OF ACTIVE SUBSTANCES

100% v/v sevoflurane

3. PHARMACEUTICAL FORM

Inhalation vapour, liquid

4. PACKAGE SIZE

250 ml

5. TARGET SPECIES

Dogs

6. INDICATION(S)

For induction and maintenance of anaesthesia.

7. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

8. WITHDRAWAL PERIOD

9. SPECIAL WARNING(S), IF NECESSARY

Do not use in pregnant and lactating bitches or in dogs less than 12 weeks of age. For operator warnings – read the package leaflet before use.

10. EXPIRY DATE

EXP {month/year}

11. SPECIAL STORAGE CONDITIONS

Do not store above 25 °C.

Do not refrigerate.

Keep the bottle tightly closed.

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

Read the package leaflet before use.

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

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea,

Co. Galway,

IRELAND

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/16/196/001 (250 ml)

EU/2/16/196/002 (6 x 250 ml)

17. MANUFACTURER’S BATCH NUMBER

BN{number}