Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
CHROMIC CHLORIDE HEXAHYDRATE; CUPRIC CHLORIDE DIHYDRATE ; FERRIC CHLORIDE HEXAHYDRATE ; MANGANESE CHLORIDE TETRAHYDRATE ; POTASSIUM IODIDE ; SODIUM FLUORIDE; SODIUM MOLYBDATE DIHYDRATE ; SODIUM SELENITE ANHYDROUS ; ZINC CHLORIDE
Fresenius Kabi Limited
B05XA31
CHROMIC CHLORIDE HEXAHYDRATE; CUPRIC CHLORIDE DIHYDRATE ; FERRIC CHLORIDE HEXAHYDRATE ; MANGANESE CHLORIDE TETRAHYDRATE ; POTASSIUM IODIDE ; SODIUM FLUORIDE; SODIUM MOLYBDATE DIHYDRATE ; SODIUM SELENITE ANHYDROUS ; ZINC CHLORIDE
N/A
Concentrate for Soln for Inf
Intravenous infusion
Ampoule (polypropylene) 20 x 10 ml
Product subject to prescription which may not be renewed (A)
Fresenius Kabi Norge AS
Electrolytes in combination with other drugs
electrolytes in combination with other drugs
To meet basal to moderately increased requirements of trace elements in intravenous nutrition
Not Marketed
2015-03-27
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ADDITRACE N CONCENTRATE FOR SOLUTION FOR INFUSION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE 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 or pharmacist. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Additrace N is and what it is used for 2. What you need to know before you receive Additrace N 3. How you are given Additrace N 4. Possible side effects 5. How to store Additrace N 6. Contents of the pack and other information 1. WHAT ADDITRACE N IS AND WHAT IT IS USED FOR Additrace N is a medicine that contains trace elements. Trace elements are tiny amounts of chemicals that your body needs to work normally. Additrace N is given intravenously (into a vein) when you can not eat normally. This medicine is usually used as part of a balanced intravenous diet, together with proteins, fat, carbohydrates, salts and vitamins. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE ADDITRACE N _ _ YOU SHOULD NOT RECEIVE ADDITRACE N: - if you are allergic (hypersensitive) to any of the ingredients of this medicine (listed in section 6). IF YOU DEVELOP A RASH OR OTHER ALLERGIC REACTIONS (LIKE ITCHING, SWOLLEN LIPS OR FACE, OR SHORTNESS OF BREATH), INFORM YOUR DOCTOR IMMEDIATELY. WARNINGS AND PRECAUTIONS Talk to your doctor if you have problems with the way your liver and/or kidney work. Your doctor may want to do regular blood tests to check your condition. OTHER MEDICINES AND ADDITRACE N Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. PREGNANCY AND BREAST-FEEDING If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. DRIVING AND USING MACHINES Additrace N has no effect on driving or usin Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Additrace N concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear solution, almost colourless. Osmolality: approx. 3100 mosm/kg water pH: 2.5 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS To meet basal to moderately increased requirements of trace elements in intravenous nutrition. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Dosage is dependent on age, weight and any degree of deficiency of the patient and must be decided on an individual basis. 1 ampoule of 10 ml contains: Chromic chloride hexahydrate 53.3 microgram Copper chloride dihydrate 1.02 milligram Ferric chloride hexahydrate 5.40 milligram Manganese chloride tetrahydrate 198 microgram Potassium iodide 166 microgram Sodium fluoride 2.10 milligram Sodium molybdate dihydrate 48.5 microgram Sodium selenite anhydrous 173 microgram Zinc chloride 10.5 milligram _The active ingredients in 10 ml of Additrace N correspond to:_ Cr 0.2 µmol 10 µg Cu 6 µmol 380 µg Fe 20 µmol 1.1 mg Mn 1 µmol 55 µg I 1 µmol 130 µg F 50 µmol 950 µg Mo 0.2 µmol 19 µg (as Mo 6+ ) Se 1 µmol 79 µg (as Se 4+ ) Zn 77 µmol 5 mg The content of sodium and potassium in 10 ml corresponds to: Sodium 1.0 mg 52 µmol Potassium 39 µg 1 µmol For the full list of excipients, see section 6.1. 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_ _/_ _1_ _1_ _/_ _2_ _0_ _1_ _7_ _C_ Læs hele dokumentet