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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

Excipients with known effect:

This medicinal product contains approximately 3.4mmol (or 79mg) sodium per dose (1 pair of 5ml ampoules). To be taken into consideration by patients on a controlled sodium diet.

This medicinal product contains approximately 6.8mmol (or 158mg) sodium per dose (1 pair of 10ml ampoules). To be taken into consideration by patients on a controlled sodium diet.

For the full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Solution for injection

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Pabrinex 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, where a severe depletion of thiamine can lead to W ernicke’s encephalop athy

•    after acute infections

•    post-operatively

•    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.

Adults and elderly :

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.

* or equivalent volume of 5ml and/or 10ml ampoules

Psychosis following narcosis or E.C. T; toxicity from acute infections

10ml of the mixed 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

10ml of the mixed 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

Pabrinex Intravenous High Potency, Solution for Injection is rarely indicated for administration to children; however, suitable doses are as follows:

quarter of the adult dose

third of the adult dose

half to two thirds of the adult dose

as for the adult dose

Method of administration

Pabrinex Intravenous High Potency, Solution for Injection should be administered by drip infusion. Equal volumes of the contents of ampoules number 1 and 2 should be added to 50ml to 100ml physiological saline or 5% glucose and infused over 30 minutes (see sections 6.3 and 6.6).

4.3 Contraindications

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

4.4 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 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, 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 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.

4.5 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 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.

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    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

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

ATC code: A11EB

5.2    Pharmacokinetic properties

Not supplied.

5.3 Preclinical 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

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

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

Before opening:

24 months.

After opening:

Chemical and physical in-use stability of intravenous high potency vitamins B and C has been demonstrated in the following intravenous infusion fluids for the number of hours stated in the table below, at room temperature:

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.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

The diluted solutions should not be frozen.

6.4    Special precautions for storage

Do not store above 25°C. Keep the container in the outer carton. Do not freeze. For storage conditions after dilution of the medicinal product, see section 6.3.

6.5    Nature and contents of container

Pabrinex Intravenous High Potency, Solution for Injection is supplied in pairs of amber glass ampoules of 5ml or 10ml. Packs contain either, six or ten pairs of 5ml ampoules, or five pairs of 10ml ampoules.

Not all pack sizes may be marketed.

6.6    Special precautions for disposal

Compatibility of intravenous high potency vitamins B and C has been demonstrated with the following infusion fluids:

•    Glucose 5%

•    Physiological saline (sodium chloride 0.9%)

•    Glucose 4.3% with sodium chloride 0.18%

•    Glucose 5% with potassium chloride 0.3%

•    Sodium lactate M/6

Please refer to section 6.3 for details regarding storage following dilution in each of these fluids.

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

7    MARKETING AUTHORISATION HOLDER

Archimedes Pharma UK Limited

Galabank Business Park

Galashiels

TD11QH

United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 12406/0003

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

27/10/1993 / 20/11/2003

10    DATE OF REVISION OF THE TEXT

22/06/2016