देश: मलेशिया
भाषा: अंग्रेज़ी
स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ERLOTINIB HYDROCHLORIDE
Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.
ERLOTINIB HYDROCHLORIDE
30 Tablets
DR. REDDY'S LABORATORIES LIMITED
_Consumer Medication Information Leaflet (RiMUP) _ 1 RILTARED 25 (ERLOTINIB FILM-COATED TABLETS 25MG) RILTARED 100 (ERLOTINIB FILM-COATED TABLETS 100MG) RILTARED 150 (ERLOTINIB FILM-COATED TABLETS 150MG) _Contains active ingredient Erlotinib Hydrochloride (25mg, 100mg, 150mg as Erlotinib) _ _ _ WHAT IS IN THIS LEAFLET 1. What Riltared is used for 2. How Riltared works 3. Before you use Riltared 4. How to use Riltared 5. While you are using it 6. Side effects 7. Storage and disposal of Riltared 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of Revision 12. Serial Number 1. WHAT RILTARED IS USED FOR Riltared contains the active ingredient erlotinib hydrochloride Riltared is indicated for adults. This medicine can be prescribed to you if you have non-small cell lung cancer at an advanced stage. It can be prescribed as initial therapy if your cancer cells have specific EGFR mutations. It can also be prescribed if your disease remains largely unchanged after initial chemotherapy, or if previous chemotherapy has not helped to stop your disease. Riltared is also used in combination with gemcitabine for the treatment of pancreatic cancer. This medicine is available only with a doctor's prescription. 2. HOW RILTARED WORKS As a targeted cancer treatment, Riltared targets a specific protein on the surface of the cancer cells called EGFR/ HER1 (epidermal growth factor receptor 1). It slows or blocks the activity of EGFR and may cause the cancer cells to die, with potentially less damage to normal cells. However, the way Riltared works to treat cancer is not fully known. 3. BEFORE YOU USE RILTARED - _WHEN YOU MUST NOT USE IT _ DO NOT TAKE RILTARED IF : 1. you have had an allergic reaction to Riltared or any ingredients listed at the end of this leaflet 2. the package is torn or shows signs of tampering. 3. the expiry date (EXP) printed on the pack has passed. If you take this medicine after the expiry date has passed, it may not work as well. If you are not sure if you should be taking Riltare पूरा दस्तावेज़ पढ़ें
Page 1 of 11 PRESCRIBING INFORMATION RILTARED 25 (ERLOTINIB FILM-COATED TABLETS 25 MG) RILTARED 100 (ERLOTINIB FILM-COATED TABLETS 100 MG) RILTARED 150 (ERLOTINIB FILM-COATED TABLETS 150MG) COMPOSITION _RILTARED 25 (Erlotinib Film-Coated Tablets 25 mg)_ : Each Film-Coated Tablet Contains: Erlotinib Hydrochloride 27.3 mg equivalent to Erlotinib 25 mg _RILTARED 100 (Erlotinib Film-Coated Tablets 100 mg)_ : Each Film-Coated Tablet Contains: Erlotinib Hydrochloride 109.30 mg equivalent to Erlotinib 100 mg _RILTARED 150 (Erlotinib Film-Coated Tablets 150 mg)_ : Each Film-Coated Tablet Contains: Erlotinib Hydrochloride 163.90 mg equivalent to Erlotinib 150 mg PHARMACEUTICAL FORM Film Coated Tablet _RILTARED 25 (Erlotinib Film-Coated Tablets 25 mg)_ : White to off white film coated round tablets with ‘E’ de-bossed on one side and plain on other side. _RILTARED 100 (Erlotinib Film-Coated Tablets 100 mg)_ : White to off white film coated round tablets with ‘E’ de-bossed on one side and ‘100’ on other side. _RILTARED 150 (Erlotinib Film-Coated Tablets 150 mg)_ : White to off white film coated round tablets with ‘E’ de-bossed on one side and ‘150’ on other side. CLINICAL INFORMATION THERAPEUTIC INDICATION Non-small cell lung cancer Riltared is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations. Riltared is indicated for maintenance treatment in patients with locally advanced or metastatic NSCLC with EGFR activating mutations who have not progressed after firstline chemotherapy. Riltared is also indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. Pancreatic Cancer Riltared in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer POSOLOGY AND METHOD OF ADMINISTRATION Standard Dosage _Non-small cell lung cancer _ EGFR mutation testing s पूरा दस्तावेज़ पढ़ें