국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Thiamine hydrochloride; Pyridoxine hydrochloride; Riboflavin sodium phosphate
Kyowa Kirin International UK NewCo Ltd
A11EB
Thiamine hydrochloride; Pyridoxine hydrochloride; Riboflavin sodium phosphate
50mg/1ml ; 10mg/1ml ; 800microgram/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF:
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PABRINEX® INTRAVENOUS HIGH POTENCY, SOLUTION FOR INJECTION (Vitamins B & C Injection) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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. – If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET : 1. What Pabrinex Intravenous injection is and what it is used for 2. What you need to know before you are given Pabrinex Intravenous injection 3. How Pabrinex Intravenous injection is given 4. Possible side effects 5. How to store Pabrinex Intravenous injection 6. Contents of the pack and other information 1. WHAT PABRINEX INTRAVENOUS INJECTION IS AND WHAT IT IS USED FOR 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. Pabrinex Intravenous High Potency, Solution for injection (‘Pabrinex’) provides additional vitamins B and C to correct deficiencies that may have occurred, for example: in alcoholism after infections after operations in certain psychiatric states. The product is also used to maintain levels of vitamins B and C in patients who are on long-term intermittent haemodialysis. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PABRINEX INTRAVENOUS INJECTION YOU MUST NOT BE GIVEN PABRINEX INTRAVENOUS INJECTION: 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 before taking Pabrinex Intravenous injection. Pabrinex Intravenous injection should be given with extreme caution if you have: ever had a mild allergic reaction (sneezing or mild asthma) to any previous injections of vitamin B1 (thiamine). This could mean that you 전체 문서 읽기
OBJECT 1 PABRINEX INTRAVENOUS HIGH POTENCY INJECTION Summary of Product Characteristics Updated 06-Feb-2017 | Kyowa Kirin Ltd 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 250mg 500mg Riboflavin (as Phosphate Sodium) 4mg 8mg Pyridoxine Hydrochloride 50mg 100mg EACH NO 2 AMPOULE CONTAINS: 5ML AMPOULE 10ML AMPOULE Ascorbic Acid 500mg 1000mg Nicotinamide 160mg 320mg Glucose (as Monohydrate) 1000mg 2000mg Excipients with known effect: This medicinal product contains approximately 3.4 mmol (or 79mg) sodium per dose (1 PAIR OF 5ML ampoules). To be taken into consideration by patients on a controlled sodium diet. This medicinal product contains approximately 6.8 mmol (or 158mg) sodium per dose (1 PAIR OF 10ML 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 injection 4. Clinical particulars 4.1 Therapeutic indications Pabrinex is indicated in adults and children 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 • after acute infections • post-operatively • 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. _Adults and elderly:_ _RAPID THERAPY OF SEVERE DEPLETION OR MALABSORPTION OF THE WATER SOLUBLE VITAMINS B AN 전체 문서 읽기