País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
SODIUM CHLORIDE; GLUCOSE MONOHYDRATE
Baxter Healthcare Limited
B05XA31
SODIUM CHLORIDE; GLUCOSE MONOHYDRATE
0.18/4 %w/v
Solution for Infusion
Product subject to prescription which may not be renewed (A)
electrolytes in combination with other drugs
Marketed
2007-08-24
Read all of this leaflet carefully before you are given 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. See section 4. This medicine is called Sodium chloride 0.18% w/v & Glucose 4% w/v Solution for Infusion BP, but will be referred to as Sodium chloride 0.18 & Glucose 4 Infusion throughout the remainder of this leaflet. What is in this leaflet: 1. What Sodium chloride 0.18 & Glucose 4 Infusion is and what it is used for 2. What you need to know before you are given Sodium chloride 0.18 & Glucose 4 Infusion 3. How you will be given Sodium chloride 0.18 & Glucose 4 Infusion 4. Possible side effects 5. How to store Sodium chloride 0.18 & Glucose 4 Infusion 6. Contents of the pack and other information 1. What Sodium chloride 0.18 & Glucose 4 Infusion is and what it is used for Sodium chloride 0.18 & Glucose 4 Infusion is a solution of the following substances in water: • sugar (glucose) • sodium chloride (salt). Glucose is one of the body’s sources of energy. This solution for infusion provides 200 kilocalories per litre. Sodium and chloride are chemical substances found in the blood. Sodium chloride 0.18 & Glucose 4 Infusion is used: • as a source of carbohydrate (sugar). • to treat a loss of body water (dehydration) and chemicals (e.g. by heavy sweating, kidney disorders) • to treat you, if the volume of blood in your blood vessels is low (hypovolaemia). 2. What you need to know before you are given Sodium chloride 0.18 & Glucose 4 Infusion Do NOT receive Sodium chloride 0.18 & Glucose 4 Infusion if you are suffering from any of the following conditions • when you know you are allergic to the product • when there is too much fluid in the spaces around the cells of the body (extracellular hyperhydration) • when there is a larger volume Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 0.18%w/v Sodium Chloride and 4.0% w/v Glucose Intravenous Infusion BP, (Viaflo Container) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium chloride: 1.80 g/l Glucose (as monohydrate): 40.00 g/l Each ml contains 1.8 mg sodium chloride and 40 mg glucose (as monohydrate). mmol/l (approx): Na+: 30 Cl - : 30 approximately: 668 kJ/l (or 160 kcal) For a full list of excipients, see section 6.1 . 3 PHARMACEUTICAL FORM Solution for infusion Sterile, non-pyrogenic, clear, colourless, aqueous Solution for Infusion. pH: 3.5-5.5 and osmolarity (approx): 284 m0sm/l 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sodium Chloride 0.18 % and Glucose 4% solution is used in the following indications: Dehydration treatment due to a moderated loss of sodium and chloride (vomiting, diarrhoea, renal disorders, overuse of diuretics) in cases where a source of energy is required (particularly starvation). 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 The choice of the specific sodium chloride and glucose concentration, dosage, volume, rate and duration of administration depends on the age, weight, clinical condition of the patient and concomitant therapy. It should be determined by a physician. For patients with electrolyte and glucose abnormalities and for paediatric patients, consult a physician experienced in intravenous fluid therapy. Rapid correction of hyponatraemia and hypernatraemia is potentially dangerous (risk of serious neurologic complications). _ADULTS, OLDER PATIENTS AND ADOLESCENTS (AGE 12 YEARS AND OVER):_ The Recommended dosage is 500 ml to 3 L/24h Administration rate The infusion rate is usually 40 ml/kg/24h and should not exceed the patient’s gl Leer el documento completo