PI

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Archimedes Pharma UK Ltd either by phone to 0118 931 5094 or e-mail to drugsafety@archimedespharma.com.

Abbreviated Prescribing Information. Please refer to the full Summary of Product Characteristics before prescribing.

PABRINEX® Vitamins B and C High Potency Injection as Pabrinex Intravenous High Potency (IVHP) solution for injection.

Presentation: Pabrinex IVHP is presented as a pair of ampoules, ampoule number 1 and ampoule number 2. Pabrinex IVHP is two 5ml ampoules (total 10ml). The contents of a pair of ampoules are mixed immediately prior to use. Each pair of ampoules contains: thiamine hydrochloride 250mg, riboflavin 4mg, pyridoxine hydrochloride 50mg, ascorbic acid 500mg and nicotinamide 160mg. In addition, Pabrinex IVHP contains 1000mg of anhydrous glucose.

Indications: Rapid therapy of severe depletion or malabsorption of the water-soluble vitamins B and C, particularly in alcoholism, where severe depletion of thiamine can lead to Wernicke’s encephalopathy, after acute infections, post-operatively and psychiatric states. Pabrinex IVHP is also used to maintain levels of vitamins B and C in patients on chronic intermittent haemodialysis.

Dosage and Administration: Adults: Severe depletion or malabsorption of the water-soluble vitamins B and C, particularly in alcoholism, where severe depletion of thiamine can lead to Wernicke’s encephalopathy: The contents of 2 to 3 pairs of ampoules every eight hours or at the discretion of the physician. For toxicity from acute infections: The contents of 1 pair of ampoules twice daily for up to 7 days. For patients on haemodialysis: The contents of 1 pair of ampoules once every 2 weeks at the end of dialysis. The contents of each pair of ampoules should be diluted with 50ml to 100ml physiological saline or glucose 5% and infused over 30 minutes. Elderly: As for adults. Children: Pabrinex is rarely indicated for administration to children; for further information refer to full SmPC.

Contraindications: Known hypersensitivity to any of the active constituents.

Warnings and Precautions: Parenteral administration 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 is administered. Pabrinex IVHP is only for intravenous administration.

Interactions: The content of pyridoxine may interfere with the effects of concurrent levodopa therapy.

Pregnancy and Lactation: No adverse effects have been noted at recommended doses when used as clinically indicated. However the potential risk for humans is unknown. Caution should be exercised when prescribing to pregnant women.

Undesirable Effects: Occasionally, hypotension and mild paraesthesia from continued high doses of thiamine; occasionally mild ache at local site of injection.

Special Precautions for Storage: Pabrinex IVHP: Do not store above 25°C. Pabrinex should be stored in its outer carton. For storage after mixing ampoules or dilution please refer to full SmPC. In common with all parenteral products each ampoule should be visually inspected prior to administration and should not be used if particulates are present.

Legal category: POM.

Marketing Authorisation Holder: Archimedes Pharma UK Limited, 250 South Oak Way, Green Park, Reading, Berkshire, RG2 6UG, UK.

Marketing Authorisation Number: Pabrinex IVHP: PL12406/0003

Pack Quantities and basic NHS price: Pabrinex IVHP as 10 pairs of ampoules: £22.53

Date of API preparation: December 2012.

For further information please contact: Archimedes Pharma UK Ltd, 250 South Oak Way, Green Park, Reading, Berkshire, RG2 6UG, UK.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Archimedes Pharma UK Ltd either by phone to 0118 931 5094 or e-mail to drugsafety@archimedespharma.com.

Abbreviated Prescribing Information. Please refer to the full Summary of Product Characteristics before prescribing.

PABRINEX® Vitamins B and C High Potency Injection as Pabrinex Intramuscular High Potency (IMHP) solution for injection.

Presentation: Pabrinex is presented as a pair of ampoules, ampoule number 1 and ampoule number 2. Pabrinex IMHP is one 5ml ampoule and one 2ml ampoule (total 7ml). The contents of a pair of ampoules are mixed immediately prior to use. Each pair of ampoules contains: thiamine hydrochloride 250mg, riboflavin 4mg, pyridoxine hydrochloride 50mg, ascorbic acid 500mg and nicotinamide 160mg. In addition, Pabrinex IMHP contains benzyl alcohol.

Indications: Rapid therapy of severe depletion or malabsorption of the water-soluble vitamins B and C, particularly in alcoholism, after acute infections and post-operatively.

Dosage and Administration: Pabrinex IMHP: The contents of 1 pair of ampoules twice daily for up to 7 days. The contents of each pair of ampoules should be drawn up into a syringe to mix just before use and injected slowly, high into the gluteal muscle 5cm below the iliac crest. Elderly: As for adults. Children: Pabrinex is rarely indicated for administration to children; for further information refer to full SmPC.

Contraindications: Known hypersensitivity to any of the active constituents.

Warnings and Precautions: 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 is administered. Pabrinex IMHP is only for intramuscular administration.

Interactions: The content of pyridoxine may interfere with the effects of concurrent levodopa therapy.

Pregnancy and Lactation: No adverse effects have been noted at recommended doses when used as clinically indicated.

Undesirable Effects: Occasionally, hypotension and mild paraesthesia from continued high doses of thiamine; occasionally mild ache at local site of injection.

Special Precautions for Storage: Pabrinex IMHP: Store in a refrigerator at 2°C to 8°C. Pabrinex should be stored in its outer carton. For storage after mixing ampoules or dilution please refer to full SmPC In common with all parenteral products each ampoule should be visually inspected prior to administration and should not be used if particulates are present.

Legal category: POM.

Marketing Authorisation Holder: Archimedes Pharma UK Limited, 250 South Oak Way, Green Park, Reading, Berkshire, RG2 6UG, UK.

Marketing Authorisation Number: Pabrinex IMHP: PL12406/0004.

Pack Quantities and basic NHS price: Pabrinex IMHP as 10 pairs of ampoules: £22.53

Date of API preparation: December 2012.

For further information please contact: Archimedes Pharma UK Ltd, 250 South Oak Way, Green Park, Reading, Berkshire, RG2 6UG, UK.