Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Retinol palmitate; Colecalciferol; Dl-alfa tocoferol; Ascorbic acid; Pyridoxine hydrochloride; Cyanocobalamin; Folic acid; Dexpanthenol; Biotin; Nicotinamide; Cocarboxylase tetrahydrate; Riboflavin sodium phosphate
Baxter Healthcare Limited
A11BA
Retinol palmitate; Colecalciferol; Dl-alfa tocoferol; Ascorbic acid; Pyridoxine hydrochloride; Cyanocobalamin; Folic acid; Dexpanthenol; Biotin; Nicotinamide; Cocarboxylase tetrahydrate; Riboflavin sodium phosphate
N/A
Powder for solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Multivitamins, plain
Marketed
1993-01-04
1a BE-30-02-826 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CERNEVIT Powder for Solution for Injection or Infusion Read all of this leaflet carefully before this medicine is given to you because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. In this leaflet: 1. What CERNEVIT is and what it is used for 2. What you need to know before CERNEVIT is given 3. How CERNEVIT is given 4. Possible side effects 5. How to store CERNEVIT 6. Contents of the pack and other information Throughout this leaflet CERNEVIT Powder for Solution for Injection or Infusion will be called CERNEVIT. 1 What CERNEVIT is and what it is used for CERNEVIT is a sterile powder for solution for injections or infusion. It contains 12 vitamins (see section 6). CERNEVIT is used to give your daily requirement of vitamins straight into your blood. It is used when you cannot take enough food by your mouth. It is usually given with other things such as nutrition solutions and minerals. 2 What you need to know before CERNEVIT is given You will not be given CERNEVIT if: • you are allergic (hypersensitive) to the active substance or any of the ingredients of this medicine, especially vitamin B1 or soya protein or peanut protein (see Section 6, Contents of the pack and other information), • you have too much of one of the vitamins in CERNEVIT stored in your body (called ‘hypervitaminosis’). Do not have CERNEVIT if any of the above applies to you. If you are not sure talk to your doctor, nurse or pharmacist. BE-30-03-043 2a Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given CERNEVIT if: Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cernevit, Powder for Solution for Injection or Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder contains: Excipients: Each vial contains 24mg sodium and less than 112.5mg soya oil. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion Orange-yellow sterile cake of lyophilised powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Supply of vitamins corresponding to the daily needs of adults and children over 11 years requiring multi-vitamin supplementation by the parenteral route when oral nutrition is contraindicated, impossible or insufficient (e.g. due to malnutrition, gastrointestinal malabsorption, parenteral nutrition, etc). Retinol Palmitate (Vit A) 3500 IU Colecalciferol (Vit D 3 ) 220 IU DL tocopherol (Vit E) 10.20 mg - corresponding to -tocopherol 11.200 IU Ascorbic acid (Vit C) 125 mg Cocarboxylase tetrahydrate 5.80 mg - corresponding to Thiamine (Vit B 1 ) 3.510 mg Riboflavin dihydrated sodium phosphate (Vit B 2 ) 5.67 mg - corresponding to Riboflavin 4.14 mg Pyridoxine hydrochloride (Vit B 6 ) 5.50 mg - corresponding to Pyridoxine 4.53 mg Cyanocobalamin (Vit B 12 ) 6 micrograms Folic acid 414 micrograms Dexpanthenol 16.15 mg - corresponding to pantothenic acid 17.25 mg D-Biotin 69 micrograms Nicotinamide 46 mg 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_ _ _ _0_ _1_ _/_ _0_ _8_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ Les hele dokumentet