BUMETANIDE Tablet (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Bumetanide 1 mg Tablets.
Qualitative and quantitative composition
Each tablet contains 1 mg of bumetanide. Excipient with known effect: Contains 134 mg lactose (as lactose monohydrate). For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White, flat, bevelled-edged, scored, tablet marked BU/1 on one side and G on the reverse, approx. diameter 8 mm. The score line is only to facilitate breaking for ease of swallowing and not to ...
Therapeutic indications
Bumetanide is indicated for the treatment of oedema associated with e.g. congestive heart failure, renal dysfunction including nephrotic syndrome and cirrhosis of the liver in adults. In oedema of renal ...
Posology and method of administration
Posology Most patients require a daily dose of 1 mg given as a single morning or early evening dose. Depending on the patients response, a second dose can be given 6-8 hours later. In refractory cases, ...
Contraindications
Hypersensitivity to the active substance, sulfonamides or to any of the excipients listed in section 6.1. Oliguria. Anuria. Increase in blood urea.Although bumetanide can be used to induce diuresis in ...
Special warnings and precautions for use
Sudden changes in cardiovascular pressure-flow relationships, leading to circulatory collapse, can occur particularly in the elderly if the oedema is eliminated too rapidly. It is important to remember ...
Interaction with other medicinal products and other forms of interaction
The following combinations with bumetanide are considered potentially hazardous: Bumetanide should not be administered concurrently with lithium, as diuretics reduce the clearance rate of lithium leading ...
Pregnancy and lactation
Pregnancy Although tests in animals have shown no teratogenic effects, there are no data on its effect on pregnant humans. Therefore it is advisable to avoid taking this drug during the first trimester. ...
Effects on ability to drive and use machines
Bumetanide has no known effect on the ability to drive or operate machinery.
Undesirable effects
Adverse effects are listed by system organ class and frequency: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1000), very rare (<1/10,000) and ...
Overdose
Signs and symptoms If overdose has occurred or is suspected symptoms should be those caused by excessive diuresis. Management Steps should be taken to empty the stomach either by emesis or gastric lavage. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Diuretics, high-ceiling diuretics, sulfonamides, plain ATC code: C03CA02 Mechanism of action Bumetanide is a potent loop diuretic with a rapid onset and a short duration of action. ...
Pharmacokinetic properties
Absorption Following oral administration, bumetanide is rapidly and almost completely absorbed from the gastro-intestinal tract with the bioavailability reported as between 80 and 95%. Distribution It ...
Preclinical safety data
Bumetanide has been extensively evaluated in a wide range of animal toxicity tests. Studies in rats and mice have shown it to have a relatively low acute toxicity. No toxic effects were seen in rats at ...
List of excipients
Lactose monohydrate Maize starch Maize starch, pregelatinised Cellulose, microcrystalline Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
PVC/PVdC/Al calendar blister packs: 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168 and 180 tablets. High density polyethylene containers with tamper-evident polypropylene ...
Special precautions for disposal and other handling
None.
Marketing authorization holder
Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts, EN6 1TL
Marketing authorization number(s)
PL 04569/0433
Date of first authorization / renewal of the authorization
30/08/2006
Date of revision of the text
07/12/2018
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