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1. Pabrinex Intravenous High Potency Solution For Injection
2. Pabrinex Intravenous High Potency Solution For Injection

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT

Pabrinex Intravenous High Potency, Solution for injection

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each presentation (carton) contains either 5ml or 10ml ampoules. Each pair of ampoules to be used in treatment is labelled Pabrinex No 1 and Pabrinex No 2.

Each No 1 ampoule contains:	5ml ampoule	10ml ampoule
Thiamine Hydrochloride	250mg	500mg
Riboflavin (as Phosphate Sodium)	4mg	8mg
Pyridoxine Hydrochloride	50mg	100mg
Each No 2 ampoule contains:	5ml ampoule	10ml ampoule
Ascorbic Acid	500mg	1000mg
Nicotinamide	160mg	320mg
Anhydrous Glucose	1000mg	2000mg

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Solution for injection

4. CLINICAL PARTICULARS

4.1 Therapeutic Indications

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 and 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

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

1)    The preferred method of administration of Pabrinex Intravenous High Potency is by drip infusion. Equal volumes of the contents of ampoules number 1 and 2 should be added to 50ml to 100ml physiological saline or glucose 5% and infused over 30 minutes (see “Special Precautions for Storage” section).

2)    For a combined injection volume of not more than 10ml (e.g. the contents of one 5ml ampoule number 1 and one 5ml ampoule number 2) the contents of the ampoules are drawn up into a syringe to mix them just before use, then injected slowly, over a period of 10 minutes, into a vein.

Adults:

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

10ml solution from Ampoule Number 1	PLUS	10ml solution from Ampoule Number 2
OR
15ml solution from Ampoule Number 1	PLUS	15ml solution from Ampoule Number 2

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.

Elderly: as for adults.

Children: Pabrinex Intravenous 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

4.3 Contraindications

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.

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 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.

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 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

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

5.1    Pharmacodynamic properties

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

ATC code: A11EB

5.2    Pharmacokinetic properties

Not supplied.

5.3    Pre-clinical safety data

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.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Edetic acid Sodium hydroxide Water for Injections

Incompatibilities

If it is necessary to administer Pabrinex Intravenous High Potency in infusion, it is recommended that Pabrinex IV HP is administered in physiological saline or glucose 5%.

6.3    Shelf life

24 months.

6.4    Special precautions for storage

Do not store above 25°C. Keep the container in the outer carton. Do not freeze.

Storage of diluted Pabrinex Intravenous High Potency

The stability of Pabrinex Intravenous High Potency in intravenous infusion fluids, at room temperature, is as follows:

Intravenous infusion fluid	In the light
Glucose 5%	7 hours
Physiological saline (sodium chloride 0.9%)	7 hours
Glucose 4.3% with sodium chloride 0.18%	4 hours
Glucose 5% with potassium chloride 0.3%	4 hours
Sodium lactate M/6	7 hours

Although no further specific data are available, the solutions are expected to be stable for longer periods when protected from light. Store diluted solutions at 2°C to 8°C if not used immediately. Do not freeze.

6.5 Nature and contents of container

Pabrinex Intravenous High Potency is supplied in pairs of amber glass ampoules of 5ml or 10ml. Pack sizes contain ten pairs of 5ml or five pairs of 10ml ampoules.