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Avodart 0.5mg soft capsules (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης GlaxoSmithKline UK
Διεύθυνση Stockley Park West, Uxbridge, Middlesex, UB11 1BT
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Δωρεάν εγγραφή

Name of the medicinal product

Avodart 0.5 mg soft capsules.

Qualitative and quantitative composition

Each capsule contains 0.5 mg dutasteride. For a full list of excipients, see section 6.1.

Pharmaceutical form

Capsules, soft. The capsules are opaque, yellow, oblong soft gelatin capsules imprinted with GX CE2 on one side in red ink.

Therapeutic indications

Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH). Reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of BPH. ...

Posology and method of administration

Avodart can be administered alone or in combination with the alpha-blocker tamsulosin (0.4mg) (see sections 4.4, 4.8 and 5.1). Adults (including elderly) The recommended dose of Avodart is one capsule ...

Contraindications

Avodart is contraindicated in: women and children and adolescents (see section 4.6). patients with hypersensitivity to dutasteride, other 5-alpha reductase inhibitors soya, peanut or any of the other excipients. ...

Special warnings and precautions for use

Combination therapy should be prescribed after careful benefit risk assessment due to the potential increased risk of adverse events (including cardiac failure) and after consideration of alternative treatment ...

Interaction with other medicinal products and other forms of interaction

For information on the decrease of serum PSA levels during treatment with dutasteride and guidance concerning prostate cancer detection, please see section 4.4. Effects of other drugs on the pharmacokinetics ...

Pregnancy and lactation

Avodart is contraindicated for use by women. Fertility Dutasteride has been reported to affect semen characteristics (reduction in sperm count, semen volume, and sperm motility) in healthy men (see section ...

Effects on ability to drive and use machines

Based on the pharmacodynamic properties of dutasteride, treatment with dutasteride would not be expected to interfere with the ability to drive or operate machinery.

Undesirable effects

AVODART AS MONOTHERAPY Approximately 19% of the 2167 patients who received dutasteride in the 2 year Phase III placebo-controlled trials developed adverse reactions during the first year of treatment. ...

Overdose

In volunteer studies of Avodart, single daily doses of dutasteride up to 40 mg/day (80 times the therapeutic dose) have been administered for 7 days without significant safety concerns. In clinical studies, ...

Pharmacodynamic properties

Pharmacotherapeutic group: testosterone-5-alpha-reductase inhibitors ATC code: G04CB02 Dutasteride reduces circulating levels of dihydrotestosterone (DHT) by inhibiting both type 1 and type 2, 5α-reductase ...

Pharmacokinetic properties

Absorption Following oral administration of a single 0.5 mg dutasteride dose, the time to peak serum concentrations of dutasteride is 1 to 3 hours. The absolute bioavailability is approximately 60%. The ...

Preclinical safety data

Current studies of general toxicity, genotoxicity and carcinogenicity did not show any particular risk to humans. Reproduction toxicity studies in male rats have shown a decreased weight of the prostate ...

List of excipients

Capsule contents: Mono- and diglycerides of caprylic/capric acid Butylhydroxytoluene (E321) Capsule shell: Gelatin Glycerol Titanium dioxide (E171) Iron oxide yellow (E172) Triglycerides, medium chain ...

Incompatibilities

Not applicable.

Shelf life

4 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

Blisters of opaque PVC/PVDC film containing 10 soft gelatin capsules packed into containers of 10, 30, 60 and 90 capsules. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Dutasteride is absorbed through the skin, therefore contact with leaking capsules must be avoided. If contact is made with leaking capsules, the contact area should be washed immediately with soap and ...

Marketing authorization holder

GlaxoSmithKline UK Limited 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom Trading as: GlaxoSmithKline UK Ltd Stockley Park West Uxbridge Middlesex UB11 1BT

Marketing authorization number(s)

19494/0006

Date of first authorization / renewal of the authorization

17 January 2003 / 13 February 2008

Date of revision of the text

13th April 2012
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