Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
erlotinib hydrochloride, Quantity: 163.9 mg (Equivalent: erlotinib, Qty 150 mg)
Cipla Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; sodium starch glycollate type A; magnesium stearate; sodium lauryl sulfate; titanium dioxide; hypromellose; hyprolose; macrogol 400
Oral
30 Tablet
(S4) Prescription Only Medicine
Non-small cell lung cancer ERLOTINIB CIPLA is indicated for the first-line treatment of patients with advanced (Stage IIIB) or metasttic (Stega IV) non-small cell lung cancer (NSCLC) with activating EGFR mutations. ERLOTINIB CIPLA is indicated for matintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutations who have not progressed on first-line chemotherapy. ERLOTINIB CIPLA is also indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer after failure of prior chemotherapy.,Pancreatic cancer ERLOTINIB CIPLA in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
Visual Identification: White, round, biconvex film-coated tablet debossed with C3 on one side and plain on the other; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2021-04-30
ERLOTINIB CIPLA 1 ERLOTINIB CIPLA CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING ERLOTINIB CIPLA? Erlotinib Cipla contains the active ingredient erlotinib. Erlotinib Cipla is used for the treatment of non‐small cell lung cancer (NSCLC). It is also used in combination with gemcitabine for the treatment of pancreatic cancer. For more information, see Section 1. Why am I using Erlotinib Cipla? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ERLOTINIB CIPLA? Do not use if you have ever had an allergic reaction to erlotinib or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Erlotinib Cipla? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Erlotinib Cipla and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE ERLOTINIB CIPLA? • The usual dose for non‐small‐cell lung cancer one 150 mg tablet each day and pancreatic cancer in combination with gemcitabine is one 100 mg tablet each day. • Do not take Erlotinib Cipla with food. Take Erlotinib Cipla exactly as your doctor has prescribed. More instructions can be found in Section 4. How do I use Erlotinib Cipla? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING ERLOTINIB CIPLA? THINGS YOU SHOULD DO • Tell all doctors, dentists and pharmacists who are treating you that you are taking Erlotinib Cipla. Tell your doctor if you become pregnant while taking Erlotinib Cipla. • Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. • Tell your doctor if you feel the tablets are not helping your condition. • Be sure to keep all of your a Preberite celoten dokument
AUSTRALIAN PRODUCT INFORMATION - ERLOTINIB CIPLA (ERLOTINIB (AS HYDROCHLORIDE)) FILM-COATED TABLETS 1. NAME OF THE MEDICINE Erlotinib (as hydrochloride) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Erlotinib Cipla film coated tablets are available in 3 dosage strengths containing erlotinib hydrochloride equivalent to 25 mg, 100 mg or 150 mg of erlotinib. Excipients with known effect Each 25 mg film-coated tablet contains 17.333 mg lactose monohydrate. Each 100 mg film-coated tablet contains 69.333 mg lactose monohydrate. Each 150 mg film-coated tablet contains 104.000 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Erlotinib Cipla 25 mg film-coated tablets are white, round, biconvex film coated tablets debossed with ‘C1’ on one side and plain on the other. Dimensions- thickness: 2.40 mm – 3.0 mm; diameter: 5.30 mm – 5.70 mm. Erlotinib Cipla 100 mg film-coated tablets are white, round, biconvex film coated tablets debossed with ‘C2’ on one side plain on the other. Dimensions- thickness: 3.90 mm – 4.50 mm; diameter: 8.80 mm – 9.20 mm. Erlotinib Cipla 150 mg film-coated tablets are white, round, biconvex film coated tablets debossed with ‘C3’ on one side plain on the other. Dimensions- thickness: 4.40 mm – 5.00 mm; diameter: 10.30 mm – 10.70 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Non-small cell lung cancer Erlotinib Cipla is indicated for the first-line treatment of patients with advanced (Stage IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) with activating EGFR mutations. Erlotinib Cipla is indicated for maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutations who have not progressed on first-line chemotherapy. Erlotinib Cipla is also indicated for the treatment of patients with locally advanced or metastatic non- small cell lung cancer after failure of prior chemotherapy. Pancreatic cancer Erlotinib Cipla in com Preberite celoten dokument