Država: Peru
Jezik: španjolski
Izvor: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas)
ACETATO DE GOSERELINA;
ASTRAZENECA PERU S.A.
L02AE03
ACETATE, GOSERELIN;
IMPLANTE
POR PASTILLA
SUBCUTANEA
Caja de cartón conteniendo un sobre de tereftalato de polietileno/hoja de aluminio/polietileno con un implante en jeringa prelle
Con receta médica
ASTRAZENECA UK LIMITED; REINO UNIDO
Goserelina
Presentación: Caja de cartón conteniendo un sobre estéril de teraftalato de polietileno/hoja de aluminio/polietileno, con un implante inyectable en una cámara de copolímero estireno butadieno, en una jeringa prellenada de polietileno de alta densidad blanco con funda protectora de aguja.
VIGENTE
2023-03-13
ZOLADEX 3.6MG IMPLANT 1. NAME OF THE MEDICINAL PRODUCT Zoladex 3.6 mg, implant 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Goserelin acetate (equivalent to 3.6 mg goserelin). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Implant, pre-filled syringe 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS (i) Treatment of prostate cancer in the following settings (see also section 5.1): In the treatment of metastatic prostate cancer where Zoladex has demonstrated comparable survival benefits to surgical castrations (see section 5.1) In the treatment of locally advanced prostate cancer, as an alternative to surgical castration where Zoladex has demonstrated comparable survival benefits to an anti-androgen (see section 5.1) As adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced prostate cancer where Zoladex has demonstrated improved disease-free survival and overall survival (see section 5.1) As neo-adjuvant treatment prior to radiotherapy in patients with high- risk localised or locally advanced prostate cancer where Zoladex has demonstrated improved disease-free survival (see section 5.1) As adjuvant treatment to radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression where Zoladex has demonstrated improved disease-free survival (see section 5.1) (ii) Advanced breast cancer in pre and perimenopausal women suitable for hormonal manipulation. (iii) Zoladex 3.6 mg is indicated as an alternative to chemotherapy in the standard of care for pre/perimenopausal women with oestrogen receptor (ER) positive early breast cancer. (iv) Endometriosis: In the management of endometriosis, Zoladex alleviates symptoms, including pain, and reduces the size and number of endometrial lesions. (v) Endometrial thinning: Zoladex is indicated for the prethinning of the uterine endometrium prior to endometrial ablation or resection. (vi) Uterine fibroids: In conjunction with iron therapy in the haematological Pročitajte cijeli dokument