Sevohale (known as Sevocalm) (sevoflurane) – Labelling - QN01AB08
Updated on site: 09-Feb-2018
Ravimi nimetus: | Sevohale (known as Sevocalm) |
ATC: | QN01AB08 |
Toimeaine: | sevoflurane |
Tootja: | Chanelle Pharmaceuticals Manufacturing Limited |
Liigid: Koerad
Artikli sisu
- 1. NAME OF THE VETERINARY MEDICINAL PRODUCT
- 2. STATEMENT OF ACTIVE SUBSTANCES
- 3. PHARMACEUTICAL FORM
- 4. PACKAGE SIZE
- 5. TARGET SPECIES
- 6. INDICATION(S)
- 7. METHOD AND ROUTE(S) OF ADMINISTRATION
- 8. WITHDRAWAL PERIOD
- 9. SPECIAL WARNING(S), IF NECESSARY
- 10. EXPIRY DATE
- 11. SPECIAL STORAGE CONDITIONS
- 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
- 13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
- 14. THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
- 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
- 16. MARKETING AUTHORISATION NUMBER(S)
- 17. MANUFACTURER’S BATCH NUMBER
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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.
- Sevoflo - sevoflurane
Retseptiravimite loetelu. Toimeaine: "Sevoflurane"
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.
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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)
- Rheumocam - Chanelle Pharmaceuticals Manufacturing Limited
Retseptiravimite loetelu. Tootja: "Chanelle Pharmaceuticals Manufacturing Limited"
EU/2/16/196/002 (6 x 250 ml)
17.MANUFACTURER’S BATCH NUMBER
BN{number}
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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.
- Sevoflo - QN01AB08
Retseptiravimite loetelu. ATC kood: "QN01AB08"
10. EXPIRY DATE
EXP {month/year}
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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}