VITAMIN E Oral suspension (2016)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Vitamin E Suspension 100mg/ml.
Qualitative and quantitative composition
Each 5ml of suspension contains 500mg of DL-alpha-tocopheryl acetate. Excipients with known effect: Each 5ml of suspension contains 1 g of sucrose and 400 mg of polyethoxylated castor oil. For the full ...
Pharmaceutical form
Oral suspension.
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: ...
Contraindications
Use in patients with a known hypersensitivity to Vitamin E. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not ...
Special warnings and precautions for use
Vitamin E has been reported to increase bleeding tendency in vitamin-K deficient patients or those taking anticoagulant treatments, it is therefore recommended to monitor the prothrombin time and international ...
Interaction with other medicinal products and other forms of interaction
Vitamin E may increase the risk of haemorrhage in patients taking anticoagulants (see section 4.4). Vitamin E may increase the risk of thrombosis in patients taking oestrogens (see 4.4 above).
Pregnancy and lactation
There is no evidence of the safety of high doses of vitamin E in pregnancy nor is there evidence from animal work that it is free from hazard, therefore do not use in pregnancy especially in the first ...
Effects on ability to drive and use machines
None known.
Undesirable effects
Diarrhoea and abdominal pain may occur with doses greater than 1g daily. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. ...
Overdose
Transient gastro-intestinal disturbances have been reported with doses greater than 1g daily and where necessary, general supportive measures should be employed.
Pharmacodynamic properties
Pharmacotherapeutic group: Other plain vitamin preparations ATC code: A11HA03 The exact role of vitamin E in the animal organism has not yet been established. Vitamin E is known to exert an important physiological ...
Pharmacokinetic properties
Vitamin E is absorbed from the gastrointestinal tract. Most of the vitamin appears in the lymph and is then widely distributed to all tissues. Most of the dose is slowly excreted in the bile and the remainder ...
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of excipients
Polyethoxylated castor oil Benzoic acid E210 Sorbic acid Sucrose Glycerol Purified water Raspberry flavour containing: Propylene glycol E1520 Natural flavourings Purified water
Incompatibilities
None.
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 ...
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.
Marketing authorization holder
Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, UK
Marketing authorization number(s)
PL 16853/0117
Date of first authorization / renewal of the authorization
8<sup>th</sup> March 1993
Date of revision of the text
17/05/16
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
