LASIX Solution for injection or infusion (2021)
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Περιεχόμενα
1. Name of the medicinal product
Lasix 20mg/2ml Solution for Injection or Infusion.
2. Qualitative and quantitative composition
Furosemide 20mg in 2ml aqueous solution. For excipients, see 6.1.
3. Pharmaceutical form
Solution for Injection or Infusion. Clear, colourless aqueous solution.
4.1. Therapeutic indications
Lasix is used for the management of fluid retention and for the management of mild to moderate hypertension, either alone or as an adjunct.
4.2. Posology and method of administration
<u>General:</u> The dose used must be the lowest that is sufficient to achieve the desired effect. <u>Route of administration:</u> intramuscular or intravenous Furosemide is given intravenously only when ...
4.3. Contraindications
Patients with hypovolaemia or dehydration, anuria or renal failure with anuria not responding to furosemide, renal failure as a result of poisoning by nephrotoxic or hepatotoxic agents or renal failure ...
4.4. Special warnings and precautions for use
Too vigorous diuresis may cause orthostatic hypotension or acute hypotensive episodes. Where indicated, steps should be taken to correct hypotension or hypovolaemia before commencing therapy. Regular monitoring ...
4.5. Interaction with other medicinal products and other forms of interaction
The concomitant administration of this preparation with cardiac glycosides or hypotensive agents may necessitate adjustment of the dosage of those drugs. The harmful effects of nephrotoxic drugs on the ...
4.6. Pregnancy and lactation
Furosemide crosses the placental barrier. It must not be given during pregnancy unless there are compelling medical reasons. Treatment during pregnancy requires monitoring of foetal growth. Furosemide ...
4.7. Effects on ability to drive and use machines
Reduced mental alertness may impair ability to drive or operate dangerous machinery.
4.8. Undesirable effects
The frequencies are derived from literature data referring to studies where furosemide is used in a total of 1387 patients, at any dose and in any indication. When the frequency category for the same ADR ...
4.9. Overdose
The clinical picture in acute or chronic overdose depends primarily on the extent and consequences of electrolyte and fluid loss, e.g. hypovolaemia, dehydration, haemoconcentration, cardiac arrhythmias ...
5.1. Pharmacodynamic properties
The evidence from many experimental studies suggests that furosemide acts along the entire nephron with the exception of the distal exchange site. The main effect is on the ascending limb of the loop of ...
5.2. Pharmacokinetic properties
Furosemide is a weak carboxylic acid which exists mainly in the dissociated form in the gastrointestinal tract. Furosemide is rapidly but incompletely absorbed (60-70%)on oral administration and its effect ...
5.3. Preclinical safety data
Not Applicable.
6.1. List of excipients
Water for Injection Sodium hydroxide (E524) Sodium chloride Lasix 20 mg injection contains approximately 0.14 mmol Na<sup>+</sup> / ml
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Keep the vials in the outer carton.
6.5. Nature and contents of container
Type I, PhEur glass ampoules in packs of 5 2ml glass ampoules.
6.6. Special precautions for disposal and other handling
Injections of Lasix must not be mixed with any other preparations. Lasix is a solution with a pH of about 9 with no buffering capacity. Therefore, the active ingredient may precipitate at lower pH values. ...
7. Marketing authorization holder
Sanofi-aventis Ireland Ltd., T/A SANOFI, Citywest Business Campus, Dublin 24
8. Marketing authorization number(s)
PA 540/52/2
9. Date of first authorization / renewal of the authorization
1<sup>st</sup> April 1977 / 1<sup>st</sup> January 2006
10. Date of revision of the text
August 2021
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