VITAMIN E Oral suspension Ref.[7395] Active ingredients: Vitamin E

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, UK

Therapeutic indications

For the correction of Vitamin E deficiency occurring in malabsorption disorders ie. cystic fibrosis, chronic cholestasis and abetalipoproteinaemia.

Posology and method of administration

Route of administration

For oral use.

Adults (including the elderly)

For the treatment of malabsorption disorders the following doses should be administered:

Cystic fibrosis: 100-200mg/day.

Abetalipoproteinaemia: 50-100mg/kg/day.

Children

For the treatment of cystic fibrosis a dose of 50mg/day should be given to children less than 1 year and 100mg/day to children 1 year and over.

The adult dosage should be used for the treatment of abetalipoproteinaemia (50-100mg/kg/day).

Infants with vitamin E deficiency which is secondary to chronic cholestasis may be treated with doses of 150-200mg/kg/day.

For instructions on dilution of Vitamin E before administration, see section 6.6.

Overdose

Transient gastro-intestinal disturbances have been reported with doses greater than 1g daily and where necessary, general supportive measures should be employed.

Shelf life

Shelf life

Unopened: Two years.

After first opening: One month (The product will be stable after opening for the normal duration of treatment providing the cap is replaced after use and the recommended storage conditions on the label are observed).

Special precautions for storage

Store below 25°C.

Nature and contents of container

100ml Amber glass bottles with an HDPE child resistant and tamper evident cap with a polypropylene inner and EPE wad.

Special precautions for disposal and other handling

No special requirements.

Vitamin E Suspension may be diluted with Syrup BP but should be used immediately and not stored.

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