Country: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
erlotinib hydrochloride, Quantity: 109.27 mg
Sandoz Pty Ltd
Tablet, film coated
Excipient Ingredients: lactose monohydrate; magnesium stearate; sodium starch glycollate type A; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; sodium bicarbonate; methacrylic acid copolymer
Oral
30 tablets
(S4) Prescription Only Medicine
Non-small cell lung cancer Erlotinib Sandoz 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 Sandoz is indicated for maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFRmutations who have not progressed on first-line chemotherapy.,Erlotinib Sandoz 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 Sandoz in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
Visual Identification: White to yellowish, round, biconvex, film-coated tablets with '100' engraved on one side. The diameter of the tablet is ~ 8.9 mm; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2020-10-28
[MEDICINE NAME] ® ™ 1 ERLOTINIB SANDOZ ® _erlotinib hydrochloride _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Erlotinib Sandoz tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Erlotinib Sandoz tablets against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ERLOTINIB SANDOZ IS USED FOR Erlotinib Sandoz contains the active ingredient erlotinib. Erlotinib Sandoz is used for the treatment of non-small cell lung cancer (NSCLC). It can be given before or after initial chemotherapy if your cancer has specific mutations in a protein called epidermal growth factor receptor (EGFR). It can also be given later on when initial chemotherapy has not worked. Erlotinib Sandoz is also used in combination with gemcitabine for the treatment of pancreatic cancer. Erlotinib Sandoz belongs to a group of medicines called anti-neoplastic (or anti-cancer) agents which are used to treat cancer. Erlotinib Sandoz prevents the activity of the EGFR protein. This protein is known to be involved in the growth and spread of cancer cells. Your doctor may have prescribed Erlotinib Sandoz for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ERLOTINIB SANDOZ HAS BEEN PRESCRIBED FOR YOU. Erlotinib Sandoz is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE ERLOTINIB SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ERLOTINIB SANDOZ IF: 1. YOU HAVE HAD AN ALLERGIC REACTION TO ERLOTINIB OR ANY INGREDIENTS LISTED AT THE END OF THIS LEAFLET Some symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body Lestu allt skjalið
200902-erlotinib sandoz-pi Page 1 of 23 AUSTRALIAN PRODUCT INFORMATION ERLOTINIB SANDOZ ® (ERLOTINIB (AS HYDROCHLORIDE)) 1. NAME OF THE MEDICINE Erlotinib (as hydrochloride) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Erlotinib Sandoz 25 mg film-coated tablet contains erlotinib hydrochloride equivalent to 25 mg of erlotinib. Each Erlotinib Sandoz 100 mg film-coated tablet contains erlotinib hydrochloride equivalent to 100 mg of erlotinib. Each Erlotinib Sandoz 150 mg film-coated tablet contains erlotinib hydrochloride equivalent to 150 mg of erlotinib. _Excipients with known effect: _ lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Erlotinib Sandoz 25 mg film-coated tablets are white to yellowish, round biconvex, film-coated tablets with ‘25’ engraved on one side. The diameter of the tablet is ~ 6.1 mm. Erlotinib Sandoz 100 mg film-coated tablets are white to yellowish, round biconvex, film- coated tablets with ‘100’ engraved on one side. The diameter of the tablet is ~ 8.9 mm. Erlotinib Sandoz 150 mg film-coated tablets are white to yellowish, round biconvex, film- coated tablets with ‘150’ engraved on one side. The diameter of the tablet is ~ 10.5 mm. _Not all strengths may be marketed in Australia._ 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS NON-SMALL CELL LUNG CANCER Erlotinib Sandoz 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 Sandoz 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 Sandoz 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 Sandoz in combination with gemcitabine is indicated for th Lestu allt skjalið