VANTONEX CONCENTRATE FOR

Adults and elderly:

Rapid therapy of severe depletion or malabsorption of the water soluble vitamins B and C, particularly in alcoholism, where a severe depletion of thiamine can lead to Wernicke's encephalopathy 10 ml solution from Ampoule Number 1 PLUS 10 ml solution from Ampoule Number 2 OR 15 ml solution from Ampoule Number 1 PLUS 15 ml solution from Ampoule Number 2 2 to 3 pairs of 5 ml ampoules (1 pair = ampoule 1 + ampoule 2) diluted with 50 ml to 100 ml infusion solution (physiological saline or glucose 5%) and administered over 30 minutes every 8 hours, or at the discretion of the physician.

T; toxicity from acute infections 5 ml Ampoule Number 1 PLUS 5 ml Ampoule Number 2 1 pair of 5 ml ampoules diluted with 50 ml to 100 ml infusion solution (physiological saline or glucose 5%) administered over 30 minutes twice daily for up to 7 days.

Haemodialysis 5 ml Ampoule Number 1 PLUS 5 ml Ampoule Number 2 1 pair of 5 ml ampoules diluted with 50 ml to 100 ml infusion solution (physiological saline or glucose 5%) administered over 30 minutes once every two weeks at the end of dialysis.

Paediatric population Vantonex concentrate for solution for infusion is rarely indicated for administration to children; however, suitable doses are as follows: Under 6 years 6 - 10 years 10 - 14 years 14 years and over quarter of the adult dose third of the adult dose half to two thirds of the adult dose as for the adult dose Method of administration Dilute before use.

Vantonex concentrate for solution for infusion should be administered by drip infusion. 6).

Adverse reactions reported as possibly associated to Vantonex are presented in the following table by MedDRA System Organ Class (SOC), Preferred Term and frequency.

The following frequency categories are used:

Very common (>1/10); Common (>1/100, <1/10); Uncommon (>1/1,000, <1/100); Rare (>1/10,000, <1/1,000); Very rare (<1/10,000), including isolated reports. Post-marketing adverse reactions are reported voluntarily from a population with an unknown rate of exposure.

Therefore, it is not possible to estimate the true incidence of adverse reactions and the frequency is “unknown”. Tabulated summary of adverse reactions SYSTEM ORGAN CLASS (SOC) FREQUENCY ADVERSE REACTION Immune system disorders Unknown Hypersensitivity (including anaphylaxis, rash and urticaria) Nervous system disorders Unknown Paraesthesia Vascular disorders Unknown Hypotension General disorders and administration site conditions Unknown Injection site reactions (including pain and swelling) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store.

Although potentially serious allergic adverse reactions such as anaphylactic shock may occur rarely during, or shortly after, parenteral administration of Vantonex, such rare occurrence of serious allergic reactions should not preclude the use of Vantonex in patients who need treatment by this route of administration particularly those at risk of Wernicke's encephalopathy - for whom treatment with parenteral thiamine is essential.

Initial warning signs of a reaction to Vantonex are sneezing or mild asthma and those treating patients need to note that the administration of further injections to such patients may give rise to anaphylactic shock. Facilities for treating anaphylactic reactions should be available whenever Vantonex is administered.

To minimise the risk of such events with Vantonex, this medicinal product should be administered by infusion over a period of 30 minutes. This medicine is for injection into a vein only and should not be given by any other route Care should be taken to ensure that the route of administration used (intramuscular or intravenous) is that intended – reports of unintentional administration by the wrong route have been received; these incidents have not been associated with serious adverse reactions.

In common with all parenteral products each ampoule should be visually inspected prior to administration and should not be used if particulates are present.

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