Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
TESTOSTERONE
GlaxoSmithKline (Ireland) Limited
TESTOSTERONE
2.5 Mg/day
Transdermal Patch
Withdrawn
2008-02-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Andropatch 2.5 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Andropatch 2.5 mg System contains 12.2 mg testosterone. Each Andropatch 2.5 mg System delivers _in-vivo _approximately 2.5 mg of testosterone over 24 hours across skin of average permeability. Active surface area is 7.5 cm 2 . For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal patch. Circular, self-adhesive patch with “TDPS-2” and the company logo printed on opposite sides of a central drug reservoir. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Andropatch is indicated for testosterone replacement therapy in use for conditions associated with a deficiency or absence of endogenous testosterone, as seen in primary and secondary hypogonadism. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults and elderly: _The usual dose is two 2.5mg Andropatch Systems applied nightly (approximately 10pm) and worn for 24hours, providing approximately 5mg testosterone per day. The dose can be adjusted up to 7.5mg nightly or down to one 2.5mg system nightly depending on the serum testosterone measured in the morning after application. Measurement of serum testosterone should be repeated taking care to ensure proper system adhesion and correct time of application before the dose is adjusted. Three systems per day may be required for men with a higher body weight (>130kg). Treatment in non-virilised patients may be initiated with one system applied nightly. The dose should be adjusted as appropriate. The duration of treatment and frequency of testosterone measurements is determined by the physician. The adhesive side of the Andropatch System should be applied to a clean, dry area of the skin on the back, abdomen, upper a Prečítajte si celý dokument