Pabrinex Intramuscular High Potency Injection

Pabrinex IM 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

• after acute infections

• post-operatively

• in psychiatric states.

Pabrinex is also available as an Intravenous High Potency, Solution for Injection. Therefore before administration ensure that both the Summary of Product Characteristics and ampoule labels refer to the INTRAMUSCULAR injection.

Posology

Method of administration

The contents of one ampoule number 1 and one ampoule number 2 of Pabrinex Intramuscular High Potency (total 7 ml) are drawn up into a syringe to mix them just before use, then injected slowly high into the gluteal muscle, 5cm below the iliac crest.

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

Although potentially serious allergic adverse reactions such as anaphylactic shock may occur rarely during, or shortly after, parenteral administration of Pabrinex Intramuscular, such rare occurrence of serious allergic reactions should not preclude the use of Pabrinex Intramuscular in patients who need treatment by this route of administration. Initial warning signs of a reaction to Pabrinex Intramuscular 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 Intramuscular High Potency is administered.

This medicine is for injection into a muscle 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.

This medicinal product contains approximately 67 mg sodium per 7 ml dose (1 pair of ampoules), equivalent to 3.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

This medicine contains approximately 139 mg benzyl alcohol in each 7 ml dose (1 pair of ampoules) which is equivalent to 19.9 mg/ml:

• Benzyl alcohol may cause allergic reactions.

• Intravenous administration of benzyl alcohol has been associated with serious adverse events and death in neonates ("gasping syndrome"). The minimum amount of benzyl alcohol at which toxicity may occur is not known.

• Increased risk due to accumulation in young children.

• High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis)

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

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.

None stated.

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

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.

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

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

Pharmacotherapeutic group: Vitamin B-complex with vitamin C, ATC code: A11EB

None 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

Benzyl alcohol

Water for Injections

None stated.

24 months.

Store in a refrigerator at 2° C to 8° C. Keep the container in the outer carton. Do not freeze.

Pabrinex Intramuscular High Potency is supplied in pairs of (5ml and 2ml) amber glass ampoules in packs of 10 pairs.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.