SODIUM CHLORIDE 0.9% Solution for infusion (2018)
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Περιεχόμενα
Name of the medicinal product
Sodium Chloride 0.9% Intravenous Infusion BP.
Qualitative and quantitative composition
Sodium chloride: 9.0 g/l Each ml contains 9 mg sodium chloride. mmol/l: Na<sup>+</sup>: 154 Cl<sup>-</sup>: 154 pH: 4,5-7 For the full list of excipients: see section 6.1.
Pharmaceutical form
Solution for infusion. Clear solution, free from visible particles.
Therapeutic indications
Sodium Chloride 0.9% intravenous infusion is indicated for: Treatment of isotonic extracellular dehydration Treatment of sodium depletion Vehicle or diluent of compatible drugs for parenteral administration. ...
Posology and method of administration
Posology Adults, older people and children Doses may be expressed in terms of mEq or mmol of sodium, mass of sodium, or mass of sodium salt (1 g NaCl = 394 mg, 17.1 mEq or 17.1 mmol of Na and Cl). Fluid ...
Contraindications
The solution is contra-indicated in patient presenting hypernatraemia or hyperchloraemia. The contra-indications related to the added medicinal product should be considered.
Special warnings and precautions for use
Fluid balance/renal function Use in patients with (severe) renal impairment Sodium Chloride 0.9% should be administered with particular caution to patients with or at risk of severe renal impairment. In ...
Interaction with other medicinal products and other forms of interaction
Drugs leading to an increased vasopressin effect The below listed drugs increase the vasopressin effect, leading to reduced renal electrolyte free water excretion and may increase the risk of hospital ...
Fertility, pregnancy and lactation
There are no adequate data from the use of Sodium Chloride 0.9% in pregnant or lactating women. The physician should carefully consider the potential risks and benefits for each specific patient before ...
Effects on ability to drive and use machines
No studies have been conducted on the influence of Sodium Chloride 0.9% on the ability to operate an automobile or other heavy machinery.
Undesirable effects
The following adverse reactions have been reported in post-marketing experience. The frequency of the adverse drug reactions listed in this section cannot be estimated from the available data. Nervous ...
Overdose
General adverse effects of sodium excess in the body include nausea, vomiting, diarrhea, abdominal cramps, thirst, reduced salivation and lacrimation, sweating, fever, tachycardia, hypertension, renal ...
Pharmacodynamic properties
Pharmacotherapeutic group: "Other IV Solution Additives" ATC code: B05XX Sodium Chloride 0.9% intravenous infusion is an isotonic solution, with an approximate osmolarity of 308 mOsm/l. The pharmacodynamic ...
Pharmacokinetic properties
Sodium is predominantly excreted by the kidney, but there is extensive renal reabsorption. Small amounts of sodium are lost in the faeces and sweat.
Preclinical safety data
The safety of sodium chloride in animals is not relevant in view of its presence as a normal component in animal and human plasma.
List of excipients
Water for Injections
Incompatibilities
As with all parenteral solutions compatibility of the additives with the solution must be assessed before addition. In the absence of compatibility studies, this solution must not be mixed with other medicinal ...
Shelf life
<u>Shelf life as packaged:</u> 50 ml bag: 15 months. 100 ml bag: 2 years. 250 and 500 ml bags: 2 years. 1000 ml bags: 3 years. <u>In-use shelf life: Additives.</u> Chemical and physical stability of any ...
Special precautions for storage
50 and 100 ml bags: Do not store above 30°C. 250, 500 and 1000 ml bags: This medicinal product does not require any special storage conditions.
Nature and contents of container
Bag sizes: 50, 100, 250, 500 or 1000 mL The bags known as Viaflo are composed of polyolefin/polyamide co-extruded plastic (PL-2442). The bags are overwrapped with a protective plastic pouch composed of ...
Special precautions for disposal and other handling
Please see section 4.2 for information regarding the method of administration. Before adding a drug, verify it is soluble and stable in water at the pH range of the Sodium Chloride 0.9% Intravenous Infusion ...
Marketing authorization holder
Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk IP24 3SE, United Kingdom
Marketing authorization number(s)
PL 00116/0334
Date of first authorization / renewal of the authorization
Date of first authorisation: 10 May 2001 Date of latest renewal: 19 March 2006
Date of revision of the text
Dec 2018
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