FUROSEMIDE Solution for injection (2018)
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Περιεχόμενα
Name of the medicinal product
Furosemide 20mg/2ml Solution for Injection. Furosemide 50mg/5ml Solution for Injection. Furosemide 250mg/25ml Solution for Injection.
Qualitative and quantitative composition
Each 1ml of solution contains 10mg of Furosemide B.P. Excipient(s) with known effect: Sodium. For the full list of excipients, see section 6.1.
Pharmaceutical form
Colourless or almost colourless sterile solution intended for parenteral administration to human beings.
Therapeutic indications
Furosemide is a potent diuretic and is recommended for use when prompt and effective diuresis is required. Furosemide Injection 20mg/2ml and 50mg/5ml are appropriate for use in emergencies or where oral ...
Posology and method of administration
Posology Furosemide Injection 20mg/2ml and 50mg/5ml are for intramuscular or for intravenous administration and must always be given slowly. Furosemide Injection 250mg/25ml is for slow intravenous administration. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to amiloride, sulphonamides or sulphonamide derivatives. Hypovolaemia and dehydration (with ...
Special warnings and precautions for use
Conditions requiring correction before furosemide is started (see also section 4.3) Hypotension. Hypovolaemia. Severe electrolyte disturbances – particularly hypokalaemia, hyponatraemia and acid-base disturbances. ...
Interaction with other medicinal products and other forms of interaction
General The dosage of concurrently administered cardiac glycosides, diuretics, anti-hypertensive agents, or other drugs with blood-pressure-lowering potential may require adjustment as a more pronounced ...
Pregnancy and lactation
Pregnancy Furosemide crosses the placental barrier and should not be given during pregnancy unless there are compelling medical reasons. It should only be used for the pathological causes of oedema which ...
Effects on ability to drive and use machines
Reduced mental alertness, dizziness and blurred vision have been reported, particularly at the start of treatment, with dose changes and in combination with alcohol. Patients should be advised that if ...
Undesirable effects
Undesirable effects can occur with the following frequencies: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000, including ...
Overdose
Features Overdose can cause massive diuresis resulting in dehydration, volume depletion and electrolyte disturbances with consequent hypotension and cardiac toxicity. High doses have the potential to cause ...
Pharmacodynamic properties
Pharmacotherapeutic Group: High-ceiling diuretic sulfonamides, loop diuretics ATC code: C03CA01 Mechanism of action The principle renal action of furosemide is to inhibit active chloride transport in the ...
Pharmacokinetic properties
Absorption Approximately 65% of the dose is absorbed after oral administration. The plasma half-life is biphasic with a terminal elimination phase of about 1½ hours. Furosemide is a weak carboxylic acid ...
Preclinical safety data
No further information other than that which is contained in other sections of the Summary of Product Characteristics.
List of excipients
Sodium Chloride B.P. Sodium Hydroxide B.P. Water for Injections B.P.
Incompatibilities
Furosemide may precipitate solutions of low pH, and therefore dextrose solutions are not suitable infusion fluids for furosemide injection. The injection solution should not be mixed with other drugs in ...
Shelf life
3 years (36 months). If only part used, discard the remaining solution.
Special precautions for storage
Keep in outer carton. Do not store above 25°C. Do not refrigerate or freeze.
Nature and contents of container
2ml, 5ml & 25ml One point cut (OPC) amber glass ampoules, glass type 1 Ph.Eur. packed in cardboard cartons to contain 10 2ml or 10 5ml or 10 25ml ampoules. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Mercury Pharma International Ltd, 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland
Marketing authorization number(s)
PL 2848/0103
Date of first authorization / renewal of the authorization
24/09/1990 / 18/06/2003
Date of revision of the text
30/01/2018
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