- Approval Id
- a4a96ba032f0ec5f
- Drug Name
- AREMED 1 FILM-COATED TABLET 1MG
- Product Name
- AREMED 1 FILM-COATED TABLET 1MG
- Approval Number
- SIN14001P
- Approval Date
- 2011-08-18
- Registrant
- GOLDPLUS UNIVERSAL PTE LTD
- Licence Holder
- GOLDPLUS UNIVERSAL PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>Dosage and method of administration</strong></p>
<p><u>Posology</u><br>
The recommended dose of Aremed for adults including the elderly in one 1 mg tablet once a day.</p>
<p><em>Special populations</em></p>
<p>Paediatric population:<br>
Aremed is not recommended for use in children and adolescents due to insufficient data on safety and efficacy.</p>
<p><em>Renal impairment:</em><br>
No dose change is recommended in patients with mild or moderate renal impairment.</p>
<p><em>Hepatic impairment:</em><br>
No dose change is recommended in patients with mild hepatic disease.</p>
<p><u>Method of administration</u></p>
<p>Oral administration.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Indications</strong></p>
<p>Aremed is indicated for the treatment of advanced breast cancer in postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. Efficacy has not been demonstrated in oestrogen receptor negative patients unless they had a previous positive clinical response to tamoxifen.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p>Aremed is contra-indicated in:</p>
<ul>
<li>premenopausal women.</li>
<li>pregnant or breast-feeding women.</li>
<li>patients with severe renal impairment (creatinine clearance <20ml/min).</li>
<li>patients with moderate or severe hepatic disease.</li>
<li>hypersensitivity to the active substance(s) or to any of the excipients listed in section List of excipients.</li>
<li>concurrent oestrogen-containing therapies.</li>
<li>concurrent tamoxifen therapy.</li>
</ul>
- Atc Code
- L02BG03
- Atc Item Name
- anastrozole
- Pharma Manufacturer Name
- GOLDPLUS UNIVERSAL PTE LTD
