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SODIUM CHLORIDE 0.45% Solution for Infusion (2018)

Αναφορές

Βιβλιογραφική αναφορά

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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. &nbsp; 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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