Krajina: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
ASCORBIC ACID
Pascoe Pharmazeutische Präparate GmbH Schiffenberger Weg 55 35394 Giessen , Germany
A11GA01
ASCORBIC ACID 7.5 g
CONCENTRATE FOR SOLUTION FOR INFUSION OR INJECTION
ASCORBIC ACID 7.5 g
POM
VITAMINS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2020-11-04
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER ASCORBIC ACID PASCOE 150 MG/ML CONCENTRATE FOR SOLUTION FOR INJECTION / INFUSION ascorbic acid 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. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion _ _ is and what it is used for 2. What you need to know before you use Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion 3. How to use Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion 4. Possible side effects 5. How to store Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion 6. Contents of the pack and other information 1. WHAT ASCORBIC ACID PASCOE 150 MG/ML CONCENTRATE FOR SOLUTION FOR INJECTION / INFUSION_ _IS AND WHAT IT IS USED FOR Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion is intended for the treatment of clinical vitamin C deficiency states not amenable to dietary supply or intake of vitamin C preparations. Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion contains the essential active substance ascorbic acid (vitamin C) that cannot be produced internally by the human body. Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion is indicated in adults. Page 2 of 6 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ASCORBIC ACID PASCOE 150 MG/ML CONCENTRATE FOR SOLUTION FOR INJECTION / INFUSION DO NOT USE ASCORBIC ACID PASCOE 150 MG/ML CONCENTRAT Prečítajte si celý dokument
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 vial with 50 ml concentrate for solution for injection/infusion contains: 7.5 g ascorbic acid Excipient with known effect: Sodium hydrogen carbonate (50 ml of the concentrate contains 972 mg sodium). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for injection/infusion. Clear, light yellow solution. The pH ranges from 6.2 to 7.0. The osmolality is 1500-1700 mOsmol/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of clinical vitamin C deficiency states not amenable to dietary supply or oral replacement therapy. Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _ _ _Adults: _ The usual dose is 0.5 to 1.0 g ascorbic acid (corresponding to 3.3 – 6.7 ml concentrate). Severe trauma or surgery can require daily dosages of at least 3 g ascorbic acid to restore normal plasma levels. Depending on the disease situation, up to 7.5 g ascorbic acid (50 ml concentrate) per day may be used for infusion. _ _ _Paediatric population: _ Children under 12 years of age should not receive more than 5-7 mg ascorbic acid/kg body weight per day. High doses of Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion are contraindicated in children under 12 years (see section 4.3). No data are available on the use of Ascorbic Acid Pascoe 150 mg/ml Concentrate for solution for injection / infusion in adolescents. Method of administration For slow intravenous injection or infusion after dilution. Page 2 of 7 For instructions on dilution prior to administration, see section 6.6. The injection/infusion therapy must be performed by a physician. The duration of use depends on the course of the illness and the results of laboratory tests. _Inst Prečítajte si celý dokument