PABRINEX INTRAMUSCULAR HIGH POTENCY

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 Adults and elderly:

The contents of one pair of ampoules (7ml) twice daily for up to 7 days.

Paediatric population:

Pabrinex Intramuscular High Potency 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 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.

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 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 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. 4% of the WHO recommended maximum daily intake of 2 g sodium for an adult. 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)

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