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SPC, UK: MUSE 250 microgram urethral stick (2009)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Meda Pharmaceuticals
Διεύθυνση :
Sky Way House, Parsonage Road, Takeley, Bishop's Stortford, CM22 6PU
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Δωρεάν εγγραφή

Name of the medicinal product

MUSE 250 microgram urethral stick.

Qualitative and quantitative composition

Each urethral stick contains 250 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 250 micrograms. ...

Contraindications

MUSE is contraindicated in men with any of the following conditions: Hypersensitivity to the active substance or to any of the excipients. Abnormal penile anatomy (stenosis of the distal urethra, severe ...

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. Incorrect insertion of MUSE may cause urethral abrasion and minor ...

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 PGE1 already present in the semen. A condom barrier should therefore be used during sexual intercourse if the female partner is pregnant ...

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 events in treatment with MUSE are presented in the table below. (Very common> 1/10; Common> 1/100, <1/10; Uncommon>1/1000, <1/100; Rare>1/10000, <1/1000; Very rare ...

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 E1, the actions of which include vasodilatation of blood vessels in the erectile tissues of ...

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 E1 increased foetal resorption, presumably due to maternal stress. High concentrations of alprostadil (400 microgram/ml) had no effect on human sperm motility or viability ...

List of excipients

Macrogol 1450

Incompatibilities

Not applicable.

Shelf life

18 months. 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

Meda Pharmaceuticals Ltd 249 West George Street Glasgow G2 4RB UK Trading as: Meda Pharmaceuticals Ltd Skyway House Parsonage Road Takeley Bishops Stortford CM22 6PU UK

Marketing authorization number(s)

PL 15142/0030

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

11 November 2009