4.1. Therapeutic indications

This medicine is indicated in adults and children for 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

• after acute infections

• post-operatively

• in psychiatric states

Also used to maintain levels of vitamin B and C in patients on chronic intermittent haemodialysis.

4.2. Posology and method of administration

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.

Psychosis following narcosis or E.C.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

This medicine is rarely indicated for administration to children; however, suitable doses are as follows:

Under 6 years

quarter of the adult dose

6 - 10 years

third of the adult dose

10 - 14 years

half to two thirds of the adult dose

14 years and over

as for the adult dose

Method of administration

Dilute before use.

This medicine should be administered by drip infusion. Equal volumes of the contents of ampoules number 1 and 2 should be added to 50 ml to 100 ml physiological saline or 5% glucose and infused over 30 minutes (see sections 6.3 and 6.6).

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Although potentially serious allergic adverse reactions such as anaphylactic shock may occur rarely during, or shortly after, parenteral administration of this medicine, such rare occurrence of serious allergic reactions should not preclude the use of this medicine 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 this medicine 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 this medicine is administered. To minimise the risk of such events with this medicine 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.

4.5. Interaction with other medicinal products and other forms of interaction

The content of pyridoxine may interfere with the effects of concurrent levodopa therapy.

4.6. Fertility, pregnancy and lactation

No adverse effects have been reported at recommended doses when used as clinically indicated.

Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). The potential risk for humans is unknown.

Caution should be exercised when prescribing to pregnant women.

4.7. Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However given the nature of the product, no effects are anticipated.

4.8. Undesirable effects

Adverse reactions reported as possibly associated to this medicine 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

In the unlikely event of over dosage, treatment is symptomatic and supportive.