Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
SODIUM CHLORIDE ; GLUCOSE MONOHYDRATE
Maco Pharma (UK) Ltd
B05BB02
SODIUM CHLORIDE ; GLUCOSE MONOHYDRATE
%w/v
Solution for Infusion
Product subject to prescription which may not be renewed (A)
electrolytes with carbohydrates
Marketed
2001-12-03
WHAT IS IN THIS LEAFLET 1. What Sodium Chloride 0.18%w/v Glucose 4%w/v Solution for Infusion is and what it is used for 2. What you need to know before you are given Sodium Chloride 0.18%w/v Glucose 4%w/v Solution for Infusion 3. How Sodium Chloride 0.18%w/v Glucose 4%w/v Solution for Infusion is given 4. Possible side effects 5. How to store Sodium Chloride 0.18%w/v Glucose 4%w/v Solution for Infusion 6. Contents of the pack and other information 1. WHAT SODIUM CHLORIDE 0.18%W/V GLUCOSE 4%W/V SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR Sodium Chloride 0.18%w/v Glucose 4%w/v Solution for Infusion is a clear, colourless to faintly straw-coloured solution of sodium chloride and glucose in water. The solution is stored in a sealed flexible plastic bag. Glucose sodium chloride solution is given to replace fluid loss from the body. Glucose is a simple sugar, which provides a source of energy. Sodium chloride (salt) helps to maintain the correct balance of fluid in and around the body’s cells and tissues. Glucose sodium chloride solution may be given alone but may be given with other medicines added. You will be given glucose sodium chloride solution in hospital by a doctor or nurse. The solution should be used in children only in specialist paediatric units under expert medical supervision, to maintain the correct balance of fluids and salts. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SODIUM CHLORIDE 0.18%W/V GLUCOSE 4%W/V SOLUTION FOR INFUSION YOU MUST NOT BE GIVEN this solution if you have: • an ALLERGY to sodium chloride, glucose or any of the other ingredients • if you are having regular treatment for abnormal fluid levels • after ischaemic stroke • within 24 hours of head injury, or • if you have abnormal levels of hydration with low sodium salt levels. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse if you: • have HEART FAILURE, KIDNEY PROBLEMS, HIGH BLOOD PRESSURE, LIVER DISEASE, or OEDEMA (swelling) • have DIABETES MELLITUS • have PRE-ECLAMPSIA of pregnancy • are receiving SAL Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sodium Chloride 0.18% w/v Glucose 4%w/v Solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 0.18% w/v sodium chloride and 4% w/v anhydrous glucose (as glucose monohydrate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Infusion Sterile non-pyrogenic infusion solution, colourless to faintly straw-coloured without visible particles. pH 3.5 - 6.5 Osmolality: 290mOsm/kg H 2 O (approx). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For use in prophylactic and replacement therapy requiring the use of glucose and sodium chloride. Paediatric Population This product should only be used in paediatric specialist settings (such as renal, hepatic and cardiac units, high dependency units and intensive care units) for intravenous fluid therapy requiring the use of 0.18% sodium chloride and 4% glucose to maintain fluid and electrolyte balance. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ The volume of glucose sodium chloride 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 typically betwee 500ml and 3000ml per 24 hours but are subject to clinical and laboratory assessment in each case. Paediatric Population Use of 0.18% sodium chloride and 4% glucose should be restricted to specialist paediatric settings such as renal, hepatic and cardiac units, high dependency units and intensive care units. The dosage depends on the age, weight, clinical and biological (acid-base balance) conditions of the patient, concomitant therapy and should be determined by the consulting specialist. Monitoring: Adequate urine flow must be ensured and careful monitoring of fluid balance, plasma and urinary electrolyte concentrations are essential. Active component Per 500ml Per 1000ml Sodium chloride 0.9g Na+ 15 mmol C1- 15 mmol 1.8g Na+ 30 mmol C1- 30 mmol Glucose monohydrate 22.0g equivalent to 20.0 Прочитайте повний документ