Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
THIAMINE HYDROCHLORIDE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, NICOTINAMIDE, ASCORBIC ACID, GLUCOSE (AS MONOHYDRATE)
Archimedes Pharma UK Limited
A11EB
THIAMINE HYDROCHLORIDE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, NICOTINAMIDE, ASCORBIC ACID, GLUCOSE (AS MONOHYDRATE)
N/A
Solution for Inj/Inf
Product subject to prescription which may not be renewed (A)
Vitamin B-complex with vitamin C
Authorised
1997-08-20
PHARMACODE POSITION GUIDE DOES NOT PRINT PHARMACODE POSITION GUIDE DOES NOT PRINT PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PABRINEX INTRAVENOUS HIGH POTENCY, SOLUTION FOR INFUSION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Please keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or nurse. - If you get any side effects talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Pabrinex Intravenous is and what it is used for 2. What you need to know before you are given Pabrinex Intravenous 3. How Pabrinex Intravenous is given 4. Possible side effects 5. How to store Pabrinex Intravenous 6. Contents of the pack and other information 1. WHAT PABRINEX INTRAVENOUS IS AND WHAT IT IS USED FOR Pabrinex Intravenous High Potency Solution for Infusion (‘Pabrinex Intravenous’) provides additional thiamine hydrochloride, riboflavin, pyridoxine hydrochloride and nicotinamide (B vitamins); ascorbic acid (vitamin C); and glucose to correct deficiencies that may have occurred: • in alcoholism • through unbalanced diet (malnutrition) or • poor absorption (malabsorption) of the water soluble vitamins B and C. Vitamins B and C are important for a number of bodily functions including releasing energy from food and in the formation of healthy skin, bones and teeth. This medicine will be given to you by a healthcare professional by drip infusion into a vein. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PABRINEX INTRAVENOUS YOU MUST NOT BE GIVEN PABRINEX INTRAVENOUS: • if you are allergic to any of the ingredients of this medicine (listed in section 6) • if you have a history of sensitivity to vitamins B and/or C WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before you are given Pabrinex Intravenous. Pabrinex Intravenous should be given with extreme caution if you have: • ever had a mild alle Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pabrinex Intravenous High Potency Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each presentation (carton) contains 5 ml ampoules. Each pair of ampoules to be used in treatment is labelled Pabrinex No 1 and Pabrinex No 2. Each No. 1 ampoule (5 ml) contains: Thiamine Hydrochloride 250 mg Riboflavin (as Phosphate Sodium) 4 mg Pyridoxine Hydrochloride 50 mg Each No. 2 ampoule (5 ml) contains: Ascorbic Acid 500 mg Nicotinamide 160 mg Glucose (as monohydrate) 1000 mg Excipients with known effect: This medicinal product contains approximately 3.4 mmol (or 79 mg) sodium per dose (1 pair of 5 ml 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 infusion Ampoule No 1 Yellow coloured solution in an amber glass ampoule Ampoule No 2 Yellow coloured solution in an amber glass ampoule 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pabrinex is indicated in adults 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 Wernicke’s encephalopathy. Wernicke’s encephalopathy may also occur as a consequence of other medical conditions. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _3_ _0_ _/_ _0_ _3_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _5_ _6_ _8_ _4_ _p_ _a_ _g_ _e_ _ Прочитайте повний документ