Sevoflurane Baxter, 100%, inhalation vapour, liquid

Section 6.5 Changes in red and deletion shown crossed through.

250 ml aluminium bottles, lined with an internal epoxyphenolic resin protective lacquer. The bottles are closed with:
- plastic screw-on caps with a polytetrafluoroethylene (PTFE) laminate inner liner or
- an integrated crimped-on valve closure with stainless steel, nylon, ethylene-propylene copolymer (EPDM) and polyethylene product contact components.
250 ml aluminium bottles, lined with an internal epoxyphenolic resin protective lacquer, and plastic screw-on caps with a polytetraflurorethylene (PTFE) laminate inner liner.

Pack sizes of 1 and 6 bottles.

Not all pack sizes may be marketed.

Section 6.6 Changes in red and deletion shown crossed through.

Sevoflurane should be administered with a vaporiser calibrated specifically for sevoflurane. Filling occurs directly from the bottle via an integrated valve or, in case of a bottle without integrated valve, and with the use of an filling system with a key which is appropriate adaptor designed specifically to fit the for the sevoflurane special vaporiser or other filling systems suitable for the sevoflurane special vaporiser. Only vaporisers demonstrated to be compatible with this medicinal product should be used for administration. Sevoflurane has been found to undergo degradation in the presence of strong Lewis acids that may be formed on metal or glass surfaces under harsh conditions, and the use of vaporisers that contain such strong Lewis acids, or that may form them under conditions of normal use, must be avoided.
Carbon dioxide absorbents should not be allowed to dry out when inhalational anaesthetics are being administered. If the CO2 absorbent is suspected to be desiccated it should be replaced

Section 10 - Date change March 2015 to November 2017

Section 6.5 Changes in red and deletion shown crossed through.

250 ml aluminium bottles, lined with an internal epoxyphenolic resin protective lacquer. The bottles are closed with:
- plastic screw-on caps with a polytetrafluoroethylene (PTFE) laminate inner liner or
- an integrated crimped-on valve closure with stainless steel, nylon, ethylene-propylene copolymer (EPDM) and polyethylene product contact components.
250 ml aluminium bottles, lined with an internal epoxyphenolic resin protective lacquer, and plastic screw-on caps with a polytetraflurorethylene (PTFE) laminate inner liner.

Pack sizes of 1 and 6 bottles.

Not all pack sizes may be marketed.

Section 6.6 Changes in red and deletion shown crossed through.

Sevoflurane should be administered with a vaporiser calibrated specifically for sevoflurane. Filling occurs directly from the bottle via an integrated valve or, in case of a bottle without integrated valve, and with the use of an filling system with a key which is appropriate adaptor designed specifically to fit the for the sevoflurane special vaporiser or other filling systems suitable for the sevoflurane special vaporiser. Only vaporisers demonstrated to be compatible with this medicinal product should be used for administration. Sevoflurane has been found to undergo degradation in the presence of strong Lewis acids that may be formed on metal or glass surfaces under harsh conditions, and the use of vaporisers that contain such strong Lewis acids, or that may form them under conditions of normal use, must be avoided.
Carbon dioxide absorbents should not be allowed to dry out when inhalational anaesthetics are being administered. If the CO2 absorbent is suspected to be desiccated it should be replaced

Section 10 - Date change March 2015 to November 2017

None provided

None provided