Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Sodium bicarbonate
B. Braun Medical Limited
B05XA; B05XA02
Sodium bicarbonate
8.4 percent weight/volume
Solution for infusion
Product subject to prescription which may not be renewed (A)
Electrolyte solutions; sodium bicarbonate
Marketed
1983-04-01
0d0d1d0d0d0d1d1d1d1d0 0d0d1d0d0d0d1d1d1d1d0 201/12262692/0416 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 nurse. • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What 8.4% w/v Sodium Bicarbonate Intravenous Infusion BP is and what it is used for 2. What you need to know before you receive 8.4% w/v Sodium Bicar- bonate Intravenous Infusion BP 3. How to use 8.4% w/v Sodium Bicarbonate Intravenous Infusion BP 4. Possible side effects 5. How to store 8.4% w/v Sodium Bicarbonate Intravenous Infusion BP 6. Contents of the pack and other information 1. WHAT 8.4 % W/V SODIUM BICARBONATE INTRA- VENOUS INFUSION BP IS AND WHAT IT IS USED FOR This medicine contains sodium bicarbonate (bicarbonate of soda), a sub- stance that is able to neutralise acidic substances. 8.4% w/v Sodium Bicarbonate Intravenous Infusion BP is used: • to neutralise excess acidic (= sour) substances in the blood • to render the urine more basic (or alkaline) in the case of poisoning with acidic substances, e.g. phenobarbital or acetylsalicylic acid, in order to accelerate their excretion • to render the urine more basic (or alkaline) in order to make some drug substances, e.g. methotrexate, sulfadiazine, more soluble to improve their excretion in urine to render the urine more basic (or alkaline) in order to prevent blocking of the kidneys by haemoglobin fragments in the case of a massive breakdown of red blood cells (haemolysis). 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE 8.4 % W/V SODIUM BICARBONATE INTRAVENOUS INFUSION BP YOU SHOULD NOT RECEIVE 8.4% W/V SODIUM BICARBONATE INTRA- VENOUS INFUSION BP • if you are allergic to sodium bicarbonate or any of the other ingredients of this medicine (listed in section 6) • if your blood is already too Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 8.4% w/v Sodium Bicarbonate Intravenous Infusion BP 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 100 ml of solution contains: _Active ingredient:_ Sodium Hydrogen Carbonate (Sodium Bicarbonate) 8.4 g _Electrolyte concentrations:_ _mmol/100 ml_ Na + 100 HCO 3 - 100 For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for infusion (Infusion) A clear, colourless, sterile aqueous solution. _Theoretical osmolarity:_ 2000 mOsm/l pH 7.0-8.5 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Correction of metabolic acidosis. • Urine alkalinisation: • as part of the management strategy for enhanced elimination in the case of intoxication with weak organic acids, e.g. phenobarbital or acetylsalicylic acid (depending on the clinical condition, time course of intoxication and type of poison other options to enhance elimination (e.g. dialysis, hemoperfusion, single- dose or repeated-dose activated charcoal) might be considered as well); • in order to improve the solubility of drug substances that are poorly soluble in neutral or acid medium, e.g. methotrexate, sulfadiazine; • in the case of haemolysis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Correction of metabolic acidosis_ Correction of metabolic acidosis should not be effected too rapidly. It is advisable to start administering only half of the calculated dose and adjust further doses according to the actual results of blood gas analysis. The dose depends on the degree of the disorder of the acid-base status. According to the blood gas values the amount to be administered is calculated applying the following formula: # mmol sodium bicarbonate = base deficit × kg body weight × 0.2** 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Đọc toàn bộ tài liệu