Vitamins B+C Intravenous High Potency concentrate for solution for infusion

Please refer to the Summary of Product Characteristics (SmPC) before prescribing.

Name and active ingredient: Vitamins B+C Intravenous High Potency concentrate for solution for infusion.

Each presentation (carton) contains pairs of 5 ml ampoules.

Each pair of ampoules to be used in treatment is labelled Vitamins B+C Ampoule 1 and Vitamins B+C Ampoule 2.

Each Ampoule 1 (5ml) contains: Thiamine hydrochloride (Vitamin B1) 250mg, Riboflavin (as Phosphate sodium) (Vitamin B2) 4mg and Pyridoxine hydrochloride (Vitamin B6) 50mg.

Each Ampoule 2 (5ml) contains: Ascorbic acid (Vitamin C) 500mg, Nicotinamide (Vitamin B3) 160mg Glucose (as monohydrate) 1000mg.

Indications: Indicated in adults and children for rapid therapy of severe depletion or malabsorption of the water soluble vitamins B and C: alcoholism where a severe depletion of thiamine can lead to Wernicke’s encephalopathy, after acute infections, post-operatively, in psychiatric states and also used to maintain levels of vitamin B and C in patients on chronic intermittent haemodialysis.

Posology and method of administration: Adults and elderly: Alcoholism, where a severe depletion of thiamine can lead to Wernicke’s encephalopathy: 2 to 3 pairs of 5ml ampoules (1 pair = ampoule 1 + ampoule 2) diluted with 50ml to 100ml 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: 1 pair of 5ml ampoules diluted with 50ml to 100ml infusion solution (physiological saline or glucose 5%) administered over 30 minutes twice daily for up to 7 days.

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

Paediatric Population: Vitamins B+C Intravenous High Potency concentrate for solution for infusion is rarely indicated for administration to children; however, suitable doses are as follows: Under 6 years - quarter of the adult dose, 6 to 10 years- third of the adult dose, 10 to 14 years - half to two thirds of the adult dose and 14 years and over - as for the adult dose.

Method of administration: Dilute before use.

Vitamins B+C Intravenous High Potency concentrate for solution for infusion should be administered by drip infusion. (See SmPC section section 4.2).

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

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 Vitamins B+C, such rare occurrence of serious allergic reactions should not preclude the use of Vitamins B+C 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 Vitamins B+C 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 Vitamins B+C Intravenous High Potency is administered.

To minimise the risk of such events with Vitamins B+C Intravenous High Potency, 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 product is administered intravenously as intended – reports of unintentional intramuscular administration 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.

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

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 of the SmPC).

The potential risk for humans is unknown.

Caution should be exercised when prescribing to pregnant women.

Adverse reactions: 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”. (see section 4.8 of the SmPC).

Presentation: Concentrate for solution for infusion.

Ampoule 1: Clear yellow solution.

Ampoule 2: Clear colorless to pale yellow solution.

Pack Size: 6 pairs of 5ml ampoules.

Kent Pharma List Price: £138.04.

Legal Classification: POM.

MA Holder: Demo Pharma UK Limited.

MA Number: PL 55035/0019.

Distributed by Kent Pharma UK Ltd.

Date of preparation: Jan 2025.

UK25/001 SmPC June 2024.

Adverse events should be reported.

Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Adverse events should also be reported to Kent Pharma UK Ltd on 01233 506574 or medical@kent-athlone.com.

For a copy of the SmPC or further medical information, please contact: medical@kent-athlone.com.

Additional information available on request.