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 BP | 250mg | 500mg |
Riboflavin (as Phosphate Sodium BP) | 4mg | 8mg |
Pyridoxine Hydrochloride BP | 50mg | 100mg |
Each No 2 ampoule contains: | 5ml ampoule | 10ml ampoule |
Ascorbic Acid BP | 500mg | 1000mg |
Nicotinamide BP | 160mg | 320mg |
Anhydrous Glucose BP | 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 | ||
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Psychosis following narcosis or E.C.T; toxicity from acute infections | ||
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Haemodialysis | ||
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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.
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, 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 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
Occasionally, hypotension and mild paraesthesia from continued high doses of thiamine; occasionally mild ache at local site of injection.
4.9 Overdose
In the unlikely event of overdosage, 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
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:
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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.
6.6 Special Precautions For Disposal And Other Handling
In common with all parenteral products each ampoule should be visually inspected prior to administration and should not be used if particulates are present.
7. Marketing Authorisation Holder
Archimedes Pharma UK Limited
250 South Oak Way
Green Park
Reading
Berkshire
RG2 6UG
UK
8. Marketing Authorisation Number(S)
PL 12406/0003
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of first authorisation: October 1993
Date of the latest renewal: October 2003
10. Date Of Revision Of The Text
22 July 2010
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