Summary of Product Characteristics
last updated on the eMC:
10/03/2008
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SPC
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Pabrinex Intramuscular High Potency Injection
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Go to top of the page | Pabrinex Intramuscular High Potency | |
Go to top of the page | Each No. 1 (5ml) ampoule contains:Thiamine Hydrochloride BP | 250mg | Riboflavin (as Phosphate Sodium BP) | 4mg | Pyridoxine Hydrochloride BP | 50mg |
Each No. 2 (2ml) ampoule contains:Ascorbic acid BP | 500mg | Nicotinamide BP | 160mg |
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Go to top of the page | Injection for intramuscular use: two (5ml, 2ml) amber glass ampoules containing sterile aqueous solutions which are to be mixed prior to administration. | |
Go to top of the pageGo to top of the page | Rapid therapy of severe depletion or malabsorption of the water soluble vitamins B and C, particularly in alcoholism, after acute infections, post-operatively and in psychiatric states. | |
Go to top of the page | Pabrinex is also available as an Intravenous High Potency Injection. Therefore before administration ensure that both the Summary of Product Characteristics and ampoule labels refer to the INTRAMUSCULAR injection.The contents of one ampoule number 1 and one ampoule number 2 of Pabrinex Intramuscular High Potency (total 7ml) 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.Adults: The contents of one pair of ampoules (7ml) twice daily for up to 7 days.Elderly: As for adults.Children: Pabrinex Intramuscular High Potency is rarely indicated for administration to children, however suitable doses are as follows:Under 6 years | one quarter of the adult dose | 6-10 years | one third of the adult dose | 10-12 years | one half to two thirds of the adult dose | 14 years and over | as for the adult dose |
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Go to top of the page | Known hypersensitivity to any of the active constituents. | |
Go to top of the page | Repeated injections of preparations containing high concentrations of vitamin B1 (thiamine) may give rise to anaphylactic shock. Mild allergic reactions such as sneezing or mild asthma are warning signs that further injections may give rise to anaphylactic shock. Facilities for treating anaphylactic reactions should be available whenever Pabrinex Intramuscular High Potency is administered. Not for intravenous use. | |
Go to top of the page | The content of pyridoxine may interfere with the effects of concurrent levodopa therapy. | |
Go to top of the page | No adverse effects have been noted at recommended doses when used as clinically indicated. | |
Go to top of the pageGo to top of the page | Occasionally, hypotension and mild paraesthesia from continued high doses of thiamine; occasionally mild ache at local site of injection. | |
Go to top of the page | In the unlikely event of overdosage, treatment is symptomatic and supportive. | |
Go to top of the pageGo to top of the page | Pabrinex Intramuscular High Potency contains vitamins B1, B2, B6, nicotinamide and vitamin C.ATC code: A11EB | |
Go to top of the pageGo to top of the page | 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. | |
Go to top of the pageGo to top of the page | Edetic acidSodium hydroxideBenzyl alcoholWater for Injections | |
Go to top of the pageGo to top of the pageGo to top of the page | Store in a refrigerator at 2°C to 8°C. Do not freeze. | |
Go to top of the page | Pabrinex Intramuscular High Potency is supplied in pairs of (5ml and 2ml) amber glass ampoules in packs of 10 pairs. | |
Go to top of the pageGo to top of the page | Archimedes Pharma UK Ltd250 South Oak WayGreen ParkReadingBerkshireRG2 6UGUK | |
Go to top of the pageGo to top of the page | October 1993/ October 2003 | |
Go to top of the pageGo to top of the page | POM.® Pabrinex is a registered trade mark | | | | SPC0507 |
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More information about this product
Link to this document from your website: http://emc.medicines.org.uk/medicine/6570/SPC/Pabrinex Intramuscular High Potency Injection/