- Approval Id
- 488c52b137ee2ab0
- Drug Name
- ZOLADEX LA DEPOT INJECTION 10.8 MG/SYRINGE
- Product Name
- ZOLADEX LA DEPOT INJECTION 10.8 MG/SYRINGE
- Approval Number
- SIN09793P
- Approval Date
- 1998-06-04
- Registrant
- ASTRAZENECA SINGAPORE PTE LTD
- Licence Holder
- ASTRAZENECA SINGAPORE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p>Caution should be taken while inserting ZOLADEX LA 10.8mg into the anterior abdominal wall due to the proximity of underlying inferior epigastric artery and its branches.</p>
<p>Use extra care when administering ZOLADEX LA 10.8mg to patients with a low body mass index and/or who are receiving full anticoagulation medication (see Section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>For correct administration of ZOLADEX LA 10.8mg, see instructions on instruction card (see Section 6.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Adult Men:</strong> One 10.8mg depot of ZOLADEX LA 10.8mg injected subcutaneously into the anterior abdominal wall, every 3 months (see Section 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Adult Women:</strong> One depot of ZOLADEX LA 10.8mg injected subcutaneously into the anterior abdominal wall, every 12 weeks.</p>
<p><strong>Elderly:</strong> No dosage adjustment is necessary in the elderly.</p>
<p><strong>Renal Impairment:</strong> No dosage adjustment is necessary for patients with renal impairment.</p>
<p><strong>Hepatic Impairment:</strong> No dosage adjustment is necessary for patients with hepatic impairment.</p>
<p><strong>Children:</strong> Not indicated for use in children.</p>
- Route Of Administration
- SUBCUTANEOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<ol class="roman-enclosed">
<li><p><strong>Prostate cancer:</strong> ZOLADEX LA 10.8mg is indicated in the management of prostate cancer suitable for hormonal manipulation.</p></li>
<li><p><strong>Endometriosis:</strong> ZOLADEX LA 10.8mg is indicated in the management of endometriosis including alleviation of symptoms, such as pain, and reduction in the size and number of endometrial lesions.</p></li>
<li><p><strong>Uterine fibroids:</strong> ZOLADEX LA 10.8mg is indicated in the management of fibroids including shrinkage of lesions, improvement in the patient’s haematological status and reduction of symptoms, such as pain. It can be used as an adjunct to surgery to facilitate the operative technique and reduce operative blood loss.</p></li>
<li><p><strong>Breast cancer:</strong> ZOLADEX LA 10.8mg is indicated in the management of estrogen-receptor-positive breast cancer in premenopausal women.</p></li>
</ol>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Known hypersensitivity to the active substance, to other LHRH analogues, or to any excipients of this product.</p>
<p>Pregnancy and lactation (see Section 4.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- L02AE03
- Atc Item Name
- goserelin
- Pharma Manufacturer Name
- ASTRAZENECA SINGAPORE PTE LTD
- Company Detail Path
- /organization/astrazeneca-singapore-pte-ltd
