ARELIX Tablet (2017)
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Περιεχόμενα
Name of the medicinal product
Arelix 6mg Tablets.
Qualitative and quantitative composition
Each tablet contains 6 mg piretanide. For full list of excipients, see Section 6.1.
Pharmaceutical form
Tablet. Yellow-white, oblong scored tablets imprinted on one side with the Hoechst logo and having the identifying code ARE imprinted on the unscored side. The tablet can be divided into equal halves. ...
Therapeutic indications
Arelix is a diuretic for the management of fluid retention and treatment of mild to moderate hypertension.
Posology and method of administration
Adults Oedema The usual initial adult dose is 6mg daily, adjusted according to response to a maximum of 30mg. An initial dose of 3mg may be sufficient in some patients. Hypertension The usual initial adult ...
Contraindications
Arelix must not be used in the following circumstances: hypersensitivity to piretanide or sulphonamide derivatives or any of the excipients renal failure with anuria coma and hepatic pre-coma severe hypokalaemia ...
Special warnings and precautions for use
hypotension patients with manifest or latent diabetes mellitus (regular blood sugar checks) patients with gout (regular check of serum levels of uric acid) patients with obstructed urinary flow (e.g. prostatic ...
Interaction with other medicinal products and other forms of interaction
Based on experience with diuretics, the following interactions should be taken into consideration: The nephrotoxic effects of certain antibiotics (e.g. aminoglycosides, cephalosporins, polymyxins) and ...
Pregnancy and lactation
Arelix must not be used during the first trimester of pregnancy. There is insufficient experience to assess the safety of its use in the later phases of pregnancy. Arelix must not be administered to breast-feeding ...
Effects on ability to drive and use machines
Treatment with this medicinal product requires regular medical checks. In individual cases reduced mental alertness may impair the ability to drive or operate dangerous machinery. This is most likely at ...
Undesirable effects
The adverse reactions for piretanide are listed below. The frequencies for these reactions are unknown. <u>Blood and lymphatic system disorders:</u> thrombocytopenia, leucopenia, haemoconcentration <u> ...
Overdose
Symptoms of intoxication Severe diuresis with the risk of dehydration and, during prolonged use, hypokalaemia. The rapid water and electrolyte loss can lead to a state of delirium. A sudden flood of urine ...
Pharmacodynamic properties
Piretanide is a loop diuretic.
Pharmacokinetic properties
Piretanide is readily absorbed from the gastrointestinal tract. The diuretic effect begins about 30 minutes after administration and lasts about 4-6 hours.
Preclinical safety data
Not applicable.
List of excipients
Maize starch Microcrystalline cellulose Magnesium stearate Colloidal anhydrous silica
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from light.
Nature and contents of container
Aluminium/PVC blister packs of 20 or 100 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Sanofi-Aventis Ireland Ltd., T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland
Marketing authorization number(s)
PA0540/030/003
Date of first authorization / renewal of the authorization
Date of first authorisation: 12 May 1983 Date of last renewal: 07 October 2010
Date of revision of the text
March 2017
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