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HSA Approval

ZOLADEX LA DEPOT INJECTION 10.8 mg/syringe

SIN09793P

ZOLADEX LA DEPOT INJECTION 10.8 mg/syringe

ZOLADEX LA DEPOT INJECTION 10.8 mg/syringe

June 4, 1998

ASTRAZENECA SINGAPORE PTE LTD

ASTRAZENECA SINGAPORE PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantASTRAZENECA SINGAPORE PTE LTD
Licence HolderASTRAZENECA SINGAPORE PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INJECTION

**4.2 Posology and method of administration** 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. 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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). For correct administration of ZOLADEX LA 10.8mg, see instructions on instruction card (see Section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Adult Men:** One 10.8mg depot of ZOLADEX LA 10.8mg injected subcutaneously into the anterior abdominal wall, every 3 months (see Section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Adult Women:** One depot of ZOLADEX LA 10.8mg injected subcutaneously into the anterior abdominal wall, every 12 weeks. **Elderly:** No dosage adjustment is necessary in the elderly. **Renal Impairment:** No dosage adjustment is necessary for patients with renal impairment. **Hepatic Impairment:** No dosage adjustment is necessary for patients with hepatic impairment. **Children:** Not indicated for use in children.

SUBCUTANEOUS

Medical Information

**4.1 Therapeutic indications** 1. **Prostate cancer:** ZOLADEX LA 10.8mg is indicated in the management of prostate cancer suitable for hormonal manipulation. 2. **Endometriosis:** 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. 3. **Uterine fibroids:** 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. 4. **Breast cancer:** ZOLADEX LA 10.8mg is indicated in the management of estrogen-receptor-positive breast cancer in premenopausal women.

**4.3 Contraindications** Known hypersensitivity to the active substance, to other LHRH analogues, or to any excipients of this product. Pregnancy and lactation (see Section 4.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

L02AE03

goserelin

Manufacturer Information

ASTRAZENECA SINGAPORE PTE LTD

ASTRAZENECA UK LTD

Active Ingredients

GOSERELIN

10.8 mg/syringe

Goserelin

Documents

Package Inserts

143CZO~1.PDF

Approved: September 16, 2021

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ZOLADEX LA DEPOT INJECTION 10.8 mg/syringe - HSA Approval | MedPath