SODIUM CHLORIDE 0.45% Solution for Infusion (2018)
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Περιεχόμενα
Name of the medicinal product
Sodium Chloride 0.45% Solution for Infusion.
Qualitative and quantitative composition
Sodium Chloride: 4.5 g/l Each ml contains 4.5 mg sodium chloride. Na<sup>+</sup> Cl<sup>-</sup> mmol/l 77 77 mEq/l 77 77 154 mOsm/l (approx.) pH: 4.5-7.0 For the full list of excipients, see ...
Pharmaceutical form
Solution for infusion. Clear solution, free from visible particles.
Therapeutic indications
Sodium Chloride 0.45% Solution for Infusion is indicated for the treatment of hypertonic extracellular dehydration or hypovolaemia in cases where the intake of fluids and electrolytes by normal routes ...
Posology and method of administration
Posology Adults, older people, Adolescents and Children Fluid balance, serum electrolytes and acid-base balance should be monitored before and during administration, with particular attention to serum ...
Contraindications
The solution is contra-indicated in patient presenting: Hyponatraemia, hypochloraemia, Extracellular hyperhydration or hypervolaemia, Severe renal insufficiency (with oliguria/anuria), Fluid and sodium ...
Special warnings and precautions for use
Electrolyte balance Hyponatraemia/Hypernatraemia The infusion of solutions with sodium concentrations <0.9% may result in hyponatraemia. High volume infusion must be used under specific monitoring in patients ...
Interaction with other medicinal products and other forms of interaction
Interaction related to the presence of sodium: Corticoids/Steroids and carbenoxolone, which are associated with the retention of sodium and water (with oedema and hypertension), see section 4.4 special ...
Pregnancy and lactation
There are no adequate data from the use Sodium Chloride 0.45% Solution for Infusion in pregnant or lactating women. The physician should carefully consider the potential risks and benefits for each specific ...
Effects on ability to drive and use machines
There is no information on the effects of Sodium Chloride 0.45% Solution for Infusion on the ability to operate an automobile or other heavy machinery.
Undesirable effects
the following undesirable effects have been reported to have occurred during or following infusion of Sodium Chloride 0.45% Solution for Infusion. System Organ Class Symptoms (LLT terms MedDRA) <u>Metabolism ...
Overdose
An excessive volume of Sodium Chloride 0.45% Solution for Infusion may lead to: hypo- and hypernatremia (which can lead to CNS manifestations, including seizures, coma, cerebral oedema and death) and ...
Pharmacodynamic properties
Pharmacotherapeutic group: "Electrolyte solutions" ATC code: B05XA03 Sodium Chloride 0.45% Solution for Infusion is a hypotonic solution, with an approximate osmolarity of 154 mOsm/l. The pharmacodynamic ...
Pharmacokinetic properties
Sodium and Chloride are mainly distributed in blood and extracellular compartiments (Na<sup>+</sup>: 142 mmol/l – Cl<sup>-</sup>: 103 mmol/l). Sodium is predominantly excreted by the kidney with a renal ...
Preclinical safety data
Preclinical safety data of this solution for infusion in animals are not relevant since its constituents are physiological components of animal and human plasma. Toxic effects are not to be expected under ...
List of excipients
Water for Injections
Incompatibilities
Incompatibility of the medicinal product to be added to the solution in Viaflo container must be assessed before addition. Those additives known to be incompatible should not be used. In the absence of ...
Shelf life
<u>500 ml bags:</u> 3 years. <u>In-use shelf-life:</u> From a microbiological point of view, the diluted product must be used immediately. If not used immediately, in-use storage times and conditions prior ...
Special precautions for storage
No special precautions for storage.
Nature and contents of container
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 polyamide/polypropylene. Bag size: 500 ...
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 0.45% Solution for Infusion ...
Marketing authorization holder
Baxter Healthcare Ltd, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
Marketing authorization number(s)
PL 00116/0404
Date of first authorization / renewal of the authorization
27/10/2010
Date of revision of the text
Dec 2018
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