MUSE Urethral Stick (2018)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
MUSE 500 microgram urethral stick.
Qualitative and quantitative composition
Each urethral stick contains 500 micrograms alprostadil. For a full list of excipients, see section 6.1.
Pharmaceutical form
Urethral Stick. MUSE is a sterile, single-use transurethral system for the delivery of alprostadil to the male urethra. Alprostadil is suspended in macrogol and is formed into a urethral stick (1.4 mm ...
Therapeutic indications
Treatment of erectile dysfunction of primarily organic etiology. Adjunct to other tests in the diagnosis and management of erectile dysfunction.
Posology and method of administration
Use in Adults Treatment of erectile dysfunction Initiation of therapy: a medical professional should instruct each patient on the correct use of MUSE. The recommended starting dose is 500 micrograms. ...
Contraindications
MUSE is contraindicated in the following patients: Patients who have a known hypersensitivity to the active substance or to any of the excipients. Patients with anatomical deformation of the penis, such ...
Special warnings and precautions for use
Underlying treatable medical causes of erectile dysfunction should be diagnosed and treated prior to initiation of treatment with MUSE. Painful erection is more likely to occur in patients with anatomical ...
Interaction with other medicinal products and other forms of interaction
Systemic interactions are unlikely because of the low levels of alprostadil in the peripheral venous circulation, however the presence of medication affecting erectile function may influence the response ...
Pregnancy and lactation
MUSE may add small amounts of alprostadil to the naturally occurring PGE<sub>1</sub> already present in the semen. A condom barrier should therefore be used during sexual intercourse if the female partner ...
Effects on ability to drive and use machines
Patients should be cautioned to avoid activities, such as driving or hazardous tasks, where injury could result if hypotension or syncope were to occur after MUSE administration. In patients experiencing ...
Undesirable effects
The most frequently reported adverse effect following treatment with MUSE was pain in the penis. In most cases, pain was assessed as mild or moderate. Penile fibrosis, including angulation, fibrotic nodules, ...
Overdose
Overdosage has not been reported with MUSE. Symptomatic hypotension, persistent penile pain and in rare instances, priapism may occur with alprostadil overdosage. Patients should be kept under medical ...
Pharmacodynamic properties
ATC Code: G04BE01 (Drugs used in erectile dysfunction) Alprostadil is chemically identical to prostaglandin E<sub>1</sub>, the actions of which include vasodilatation of blood vessels in the erectile tissues ...
Pharmacokinetic properties
Approximately 80% of the alprostadil delivered by MUSE is absorbed through the urethral mucosa within 10 minutes. The half-life is less than 10 minutes and peripheral venous plasma concentrations are low ...
Preclinical safety data
In rats, high doses of prostaglandin E<sub>1</sub> increased foetal resorption, presumably due to maternal stress. High concentrations of alprostadil (400 microgram/ml) had no effect on human sperm motility ...
List of excipients
Macrogol 1450
Incompatibilities
Not applicable.
Shelf life
Shelf life: 2 years. From a microbiological point of view, the product should be used immediately after opening the foil pouch.
Special precautions for storage
Store at 2°-8°C (in a refrigerator). Store in the original package. Unopened pouches may be kept out of the refrigerator by the patient, at a temperature below 30°C, for up to 14 days prior to use.
Nature and contents of container
MUSE is supplied as cartons of 1, 2, 3, 6 or 10 foil pouches, with each pouch containing one delivery system. Not all pack sizes may be marketed. The pouches are composed of aluminium foil/laminate. The ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Marketing authorization number(s)
PL 46302/0183
Date of first authorization / renewal of the authorization
Date of first authorization: 24 November 1997 Date of latest renewal: 10 October 2007
Date of revision of the text
May 2018
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