Pabrinex Intravenous High Potency, Solution for injection
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:Thiamine Hydrochloride
Riboflavin (as Phosphate Sodium)
Each No 2 ampoule contains:Ascorbic Acid
For a full list of excipients, see section 6.1.
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.
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.
|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|
|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|
|5ml Ampoule Number 1||PLUS||5ml Ampoule Number 2|
|10ml of the mixed ampoules diluted with 50ml to 100ml infusion solution (physiological saline or glucose 5%) administered over 15 to 30 minutes twice daily for up to 7 days.
|5ml Ampoule Number 1||PLUS||5ml Ampoule Number 2|
|10ml of the mixed ampoules diluted with 50ml to 100ml infusion solution (physiological saline or glucose 5%) administered over 15 to 30 minutes once every two weeks at the end of dialysis.
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 dose6 - 10 years third of the adult dose10 - 14 years half to two thirds of the adult dose14 years and over as for the adult dose|
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
Reporting of suspected adverse reactions
|SYSTEM ORGAN CLASS (SOC)||FREQUENCY||ADVERSE REACTION|
|Immune system disorders||Unknown
||Hypersensitivity (including anaphylaxis, rash and urticaria)
|Nervous system disorders||Unknown
|General disorders and administration site conditions||Unknown
||Injection site reactions (including pain and swelling)
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
In the unlikely event of overdosage, treatment is symptomatic and supportive.
Pabrinex Intravenous High Potency contains vitamins B1, B2, B6, nicotinamide, vitamin C and glucose.
ATC code: A11EB
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.
Water for Injections
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%.
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
|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
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.
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.
In common with all parenteral products each ampoule should be visually inspected prior to administration and should not be used if particulates are present.
Archimedes Pharma UK Limited
250 South Oak Way
Date of first authorisation: October 1993
Date of the latest renewal: October 2003