The AMH concentration is to be expressed in pmol/L and is to be rounded off to the nearest integer. The maximum daily dose for the first treatment cycle is 12 micrograms.įor calculation of the REKOVELLE dose, the body weight is to be measured without shoes and overcoat just prior to start of stimulation. The dose is to be rounded off to the nearest 0.33 micrograms to match the dosing scale on the injection pen. For women with AMH ≥15 pmol/L the daily dose decreases from 0.19 to 0.10 micrograms/kg by increasing AMH concentration (Table 1). For women with AMH <15 pmol/L the daily dose is 12 micrograms, irrespective of body weight. The individual daily dose is to be maintained throughout the stimulation period. assay used in clinical development trials), or alternatively the ACCESS AMH Advanced from Beckman Coulter or LUMIPULSE G AMH from Fujirebio (see section 4.4). #THE LAST OF US PART 2 1.08 PLUS#within the last 12 months) measured by the following diagnostic tests: ELECSYS AMH Plus immunoassay from Roche (i.e. The dose should be based on a recent determination of AMH (i.e. The dosing regimen is specific for REKOVELLE and the microgram dose cannot be applied to other gonadotropins.įor the first treatment cycle, the individual daily dose will be determined on the basis of the woman's serum anti-Müllerian hormone (AMH) concentration and her body weight. REKOVELLE is dosed in micrograms (see section 5.1). aims to achieve an adequate number of oocytes retrieved and reduce the interventions to prevent ovarian hyperstimulation syndrome (OHSS). The posology of REKOVELLE is individualised for each patient and aims to obtain an ovarian response which is associated with a favourable safety/efficacy profile, i.e. Treatment should be initiated under the supervision of a physician experienced in the treatment of fertility problems. Date of first authorisation/renewal of the authorisation
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