Je was op zoek naar: bivirkningsmønsteret (Deens - Engels)

for børn på 2 år og derover er bivirkningsmønsteret som for voksne.
in children 2 years of age and older, the nature of the safety profile is similar to that seen in adults.

herudover var bivirkningsmønsteret generelt det samme hos antistof-positive og antistof-negative patienter.
otherwise, the pattern of adverse events was generally similar for antibody positive and negative patients.

skønt bivirkningsmønsteret taler imod, at det forhøjede østrogenniveau spiller en rolle, vides det, at myokardiet har androgenreceptorer og kan tænkes at blive påvirket ved længerevarende androgen deprivation.
whilst the pattern of adverse events argues against a role for raised oestrogen levels, it is known that the myocardium has androgen receptors, and it might be affected by long-term androgen deprivation.

den foreslåede intermitterende behandling på 20 dage efterfulgt af en 10- dages behandlingsfri periode kan muligvis dæmpe effekten på prolaktinindholdet, men det vides ikke, om den vil få indflydelse på bivirkningsmønsteret.
the proposed intermittent treatment of 20 days, followed by a 10 day period of non-treatment, may temper this effect on the prolactin level, but it is unknown whether this measure has any effect on the adverse event pattern.

desuden tyder de på, at der ikke er nogen ugunstig indflydelse på tromboemboliske hændelser i opfølgningsperioden (hvilket underbygges af, at bivirkningsmønsteret ikke er konsistent med hormonale virkninger).
the requested additional analyses of the epc trial data confirm an increased risk for deaths coded as heart failures (however, with no overall excess risk in the cardiovascular system), an increased risk of urogenital symptoms (including gynaecomastia and breast pain) mainly during the first year of intake, and further indicate the absence of an adverse effect on thromboembolic events during the follow-up (supported by a pattern of events inconsistent with hormonal effects).

- anbefalinger om lægelig overvågning af brysterne og intermitterende doseringsplan (20 dage efterfulgt af 10 dage uden behandling) for at mindske risikoen for hyperprolaktinæmi med henblik på at øge sikkerheden for brysterne (det vides dog ikke, om denne foranstaltning har nogen virkning på det iagttagne bivirkningsmønster knyttet til hyperprolaktinæmi, således mammahypertrofi, galaktorré og risici for patienter med prolaktinafhængige tumorer som f. eks. hypofyse- prolaktinom og brystcancer).
-recommendations of medical breast monitoring and intermittent schedule (20 days followed by a 10- day period of non-treatment) to reduce the risk of hyperprolactinemia, aimed to improve the breast safety (however, it is unknown whether this measure has any effect on the observed adverse event pattern related to hyperprolactinemia like breast enlargement, galactorrhoea and risk for patients with prolactin-dependent tumours such as pituitary gland prolactinoma and breast cancer).