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ZOLADEX INJECTION • Zoladex 3.6 Injection best price • How to push Zoladex 3.6 Injection • #how_to_inject_Zoladex_3.6 • how many price Zoladex 3.6 Injection • Zoladex 3.6 Injection preview • Zoladex 3.6 Injection video • how do work Zoladex 3.6 Injection • describes you • Patient or Carer • Healthcare Professional • Other Professional • Toggle navigation • emc logo • Zoladex 3.6mg Implant • Back to top • AstraZeneca UK Limited • contact details • Active ingredient • goserelin acetate • Legal Category • POM: Prescription only medicine • • ATC code • L02AE03 • Find similar products • SmPC • • Patient Leaflet • • Product Information • Show table of contents • This information is intended for use by health professionals • 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, in 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 improvement of anaemic patients with fibroids prior to surgery. • (vii) Assisted reproduction: Pituitary downregulation in preparation for superovulation. • 4.2 Posology and method of administration • Posology • Adults • One 3.6 mg depot of Zoladex injected subcutaneously into the anterior abdominal wall, every 28 days. No dosage adjustment is necessary for patients with renal or hepatic impairment, or in the elderly. • Endometriosis should be treated for a period of six months only, since at present there are no clinical data for longer treatment periods. Repeat courses should not be given due to concern about loss of bone mineral density. In patients receiving Zoladex for the treatment of endometriosis, the addition of hormone replacement therapy (a daily oestrogenic agent and a progestogenic agent) has been shown to reduce bone mineral density loss and vasomotor symptoms. • For use in endometrial thinning: four or eight weeks treatment. The second depot may be required for the patient with a large uterus or to allow flexible surgical timing. • For women who are anaemic as a result of uterine fibroids: Zoladex 3.6 mg depot with supplementary iron may be administered for up to three months before surgery. • Assisted reproduction: Zoladex 3.6 mg is administered to downregulate the pituitary gland, as defined by serum estradiol levels similar to those observed in the early follicular phase (approximately 150 pmol/l). This will usually take between 7 and 21 days. • When downregulation is achieved, superovulation (controlled ovarian stimulation) with gonadotrophin is commenced. The downregulation achieved with a depot agonist is more consistent suggesting that, in some cases, there may be an increased requirement for gonadotrophin. At the appropriate stage of follicular development, gonadotrophin is stopped and human chorionic gonadotrophin (hCG) is administered to induce ovulation. Treatment monitoring, oocyte retrieval and fertilisation techniques are performed according to the normal practice of the individual clinic. • Paediatric population • Zoladex is not indicated for use in children. • Method of administration • For correct administration of Zoladex, see
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