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- AREMED 1 FILM-COATED TABLET 1MG [SIN14001P]
AREMED 1 FILM-COATED TABLET 1MG [SIN14001P]
Active ingredients: AREMED 1 FILM-COATED TABLET 1MG
Product Info
AREMED 1 FILM-COATED TABLET 1MG
[SIN14001P]
Product information
Active Ingredient and Strength | ANASTROZOLE - 1 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | REMEDICA LTD - CYPRUS |
Registration Number | SIN14001P |
Licence Holder | GOLDPLUS UNIVERSAL PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | L02BG03 |
Indications
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.
Dosage and method of administration
Posology
The recommended dose of Aremed for adults including the elderly in one 1 mg tablet once a day.
Special populations
Paediatric population:
Aremed is not recommended for use in children and adolescents due to insufficient data on safety and efficacy.
Renal impairment:
No dose change is recommended in patients with mild or moderate renal impairment.
Hepatic impairment:
No dose change is recommended in patients with mild hepatic disease.
Method of administration
Oral administration.
Contraindications
Aremed is contra-indicated in:
premenopausal women.
pregnant or breast-feeding women.
patients with severe renal impairment (creatinine clearance <20ml/min).
patients with moderate or severe hepatic disease.
hypersensitivity to the active substance(s) or to any of the excipients listed in section List of excipients.
concurrent oestrogen-containing therapies.
concurrent tamoxifen therapy.
