国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
SODIUM CHLORIDE
Maco Pharma (UK) Ltd
B05BB01
SODIUM CHLORIDE
0.9 %w/v
Solution for Infusion
Product subject to prescription which may not be renewed (A)
electrolytes
Marketed
1999-05-31
WHAT IS IN THIS LEAFLET 1. What 0.9% Sodium Chloride Intravenous Infusion Solution is and what it is used for 2. What you need to know before you are given 0.9% Sodium Chloride Intravenous Infusion Solution 3. How 0.9% Sodium Chloride Intravenous Infusion Solution is given 4. Possible side effects 5. How to store 0.9% Sodium Chloride Intravenous Infusion Solution 6. Contents of the pack and other information 1. WHAT 0.9% SODIUM CHLORIDE INTRAVENOUS INFUSION SOLUTION IS AND WHAT IT IS USED FOR 0.9% Sodium Chloride Intravenous Infusion Solution is a clear colourless to faintly straw- coloured solution of sodium chloride in water. The solution is stored in a sealed flexible plastic bag. Sodium chloride (salt) helps to maintain the correct balance of fluid in and around the body’s cells and tissues. Sodium chloride infusions are given to add water to tissues which are dehydrated and to help to restore the normal salt balance. Sodium chloride infusions may be given alone but may be given with other medicines added. You will be given sodium chloride infusions in hospital by a doctor or nurse. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN 0.9% SODIUM CHLORIDE INTRAVENOUS INFUSION SOLUTION YOU MUST NOT BE GIVEN SODIUM CHLORIDE INFUSIONS IF YOU: • have an ALLERGY to sodium chloride or any of the other ingredients. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse if you: • have HEART FAILURE, CARDIO-PULMONARY DISEASE, KIDNEY PROBLEMS, HIGH BLOOD PRESSURE, LIVER DISEASE, or OEDEMA (swelling) • have HIGH SERUM LEVELS OF SODIUM (“hypernatraemia”) • have PRE-ECLAMPSIA of pregnancy • are receiving drugs which may increase SODIUM RETENTION • are VERY YOUNG or ELDERLY. OTHER MEDICINES AND 0.9% SODIUM CHLORIDE INTRAVENOUS INFUSION SOLUTION Tell your doctor if you are taking or have recently taken any other medicines. PREGNANCY, BREAST-FEEDING AND FERTILITY If you are pregnant or breast-feeding, or think you may be pregnant, ask your doctor for advice before being given this medicine. DRIVING AND USING MACHIN 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 0.9% Sodium Chloride Intravenous Infusion Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium Chloride 9g per litre. _For a full list of excipients, see Section 6.1._ 3 PHARMACEUTICAL FORM Solution for infusion. Colourless to faintly straw-coloured solution without visible particles in bags, individually overwrapped. pH 5. Osmolarity approx 300mOsm/kgH 2 O. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 0.9% isotonic saline solution is indicated: o for fluid replacement and provision of extracellular ions in near physiological concentration in conditions of extracellular-volume depletion, dehydration and electrolyte imbalance such as sodium depletion o as an isotonic medium for intravenous administration of medicinal products known to be compatible with 0.9% sodium chloride. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For intravenous infusion under medical supervision. Single use only. The pathophysiological response to dehydration, to electrolyte loss and to sodium chloride infusion will vary with the age of the patient being treated and this should be taken into account during rehydration therapy. Fluid replacement therapy should be administered with caution to very young and elderly patients. The volume of isotonic saline solution needed to replenish fluid deficits varies with age, body weight, complementary treatment and severity of the clinical condition. The dose and rate of administration are subject to clinical and laboratory assessment in each case. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ 完全なドキュメントを読む