Pabrinex Intravenous High Potency Solution for Injection or Infusion.

For a full list of excipients, see section 6.1.

Solution for injection or infusion.

Ampoule No 1

Yellow coloured solution in an amber glass ampoule

Ampoule No 2

Yellow coloured solution in an amber glass ampoule

In the management of alcoholism for rapid therapy of severe depletion or malabsorption of the water soluble vitamins B and C where a severe depletion of thiamine can lead to Wernicke's encephalopathy. Wernicke's encephalopathy may also occur as a consequence of other medical conditions.

Facilities for resuscitation and for treating anaphylactic reactions should be available whenever Pabrinex Intravenous High Potency is administered.

The preferred method of administration of Pabrinex Intravenous High Potency is by drip infusion.

The contents of each pair of ampoules should be diluted with 50 to 100ml physiological saline or 5% glucose and infused over 30 minutes (see “Special Precautions and Storage” section).

Alternatively the contents of each pair of ampoules (total 10ml) are drawn up into a syringe to mix them just before use, then injected slowly, over a period of not less than 30 minutes, into a vein.

Adults:

Wernicke's encephalopathy may occur as a consequence of other medical conditions. In these situations the requirements of thiamine may be different to those for patients who suffer with alcoholism.

Elderly: As for adults.

Known hypersensitivity to any of the active constituents or to the excipients

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

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

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

However animal studies are insufficient with respect to effects on pregnancy/ and-or/ embryonal/foetal development/ and-or/ parturition/ and-or/ postnatal development (see section 5.3). The potential risk for humans is unknown.

Caution should be exercised when prescribing to pregnant women.

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.

Adverse reactions reported as possibly associated to Pabrinex 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

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

Pabrinex Intravenous High Potency contains vitamins B₁, B₂, B₆, nicotinamide and vitamin C.

ATC code: A11EB

Not supplied.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.

Edetic acid

Sodium hydroxide

Water for Injections

None reported.

2 years.

Once mixed or diluted, it should be used immediately.

Do not store above 25°C. Protect from light. Do not freeze.

For storage conditions after dilution of the medicinal product, see section 6.3.

Pabrinex Intravenous High Potency is supplied in pairs of 5ml amber Type I glass ampoules in packs of 10 pairs.

The two 5ml ampoules (a No. 1 and a No. 2) each containing sterile yellow coloured aqueous solutions are to be mixed prior to administration. If it is necessary to administer Pabrinex Intravenous High Potency in infusion, the mixed solution should be further diluted in physiological saline or 5% glucose.

In common with all parenteral products each ampoule should be visually inspected prior to administration.

Archimedes Pharma UK Limited

250 South Oak Way

Green Park

Reading

Berkshire

RG2 6UG

UK

PA 0757/007/001

Date of first authorisation: 20 August 1987

Date of last renewal: 20 August 2007

® Pabrinex is a registered trade mark