Country: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
sunitinib, Quantity: 50 mg
Sandoz Pty Ltd
Capsule
Excipient Ingredients: Gelatin; titanium dioxide; croscarmellose sodium; magnesium stearate; microcrystalline cellulose; iron oxide red; povidone; mannitol; propylene glycol; butan-1-ol; isopropyl alcohol; ethanol; Shellac; strong ammonia solution; sulfuric acid
Oral
28
(S4) Prescription Only Medicine
? treatment of advanced renal cell carcinoma (RCC),? treatment of gastrointestinal stromal tumour (GIST) after failure of imatinib mesilate treatment due to resistance or intolerance,? treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic NET).
Visual Identification: Gelatin capsules with caramel cap and caramel body, printed with white ink 50 mg on the body and containing yellow to orange granules; 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 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2020-11-26
SUNITINIB SANDOZ ® 1 SUNITINIB SANDOZ ® _sunitinib _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Sunitinib Sandoz. 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 Sunitinib Sandoz against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT SUNITINIB SANDOZ IS USED FOR Sunitinib Sandoz is used in the treatment of renal cell carcinoma, a type of kidney cancer. Sunitinib Sandoz is used to treat gastrointestinal stromal tumour (GIST). GIST is a cancer of the stomach and bowels. It is caused by the uncontrolled growth of cells in the wall of the stomach or bowel. Sunitinib Sandoz slows down the growth of these cells. Sunitinib Sandoz is also used to treat pancreatic neuroendocrine tumours. This is a rare cancer in the cells of the pancreas that release hormones. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY SUNITINIB SANDOZ HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another purpose. Sunitinib Sandoz is only available with a doctor's prescription. It is not addictive. _USE IN CHILDREN_ _ _ The safety and efficacy of Sunitinib Sandoz have not been established in children. BEFORE YOU TAKE SUNITINIB SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE SUNITINIB SANDOZ IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO • SUNITINIB (THE ACTIVE INGREDIENT IN SUNITINIB SANDOZ) • ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET . 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 • rash, itching or hives on the skin. DO NOT USE SUNITINIB SANDOZ AFTER THE EXPIRY DATE PRINTED ON THE PACK. DO NOT USE SUNITINIB SANDOZ IF T সম্পূর্ণ নথি পড়ুন
200424-sunitinib-sandoz-pi Page 1 of 34 AUSTRALIAN PRODUCT INFORMATION SUNITINIB SANDOZ ® (SUNITINIB) 1. NAME OF THE MEDICINE Sunitinib. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Sunitinib Sandoz ® 12.5 mg capsule contains sunitinib 12.5 mg. Each Sunitinib Sandoz ® 25 mg capsule contains sunitinib 25 mg. Each Sunitinib Sandoz ® 37.5 mg capsule contains sunitinib 37.5 mg. Each Sunitinib Sandoz ® 50 mg capsule contains sunitinib 50 mg. _Excipient with known effect: _ mannitol. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Capsule. Sunitinib Sandoz is supplied as a hard gelatin capsule for oral administration. Sunitinib Sandoz 12.5 mg capsules are gelatin capsules with orange cap and orange body, printed with white ink “12.5 mg” on the body and containing yellow to orange granules. Sunitinib Sandoz 25 mg capsules are gelatin capsules with caramel cap and orange body, printed with white ink “25 mg” on the body and containing yellow to orange granules. Sunitinib Sandoz 37.5 mg capsules are gelatin capsules with yellow cap and yellow body, printed with black ink “37.5 mg” on the body and containing yellow to orange granules. Sunitinib Sandoz 50 mg capsules are gelatin capsules with caramel cap and caramel body, printed with white ink “50 mg” on the body and containing yellow to orange granules. _Not all strengths may be marketed in Australia. _ 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS Sunitinib Sandoz is indicated for: • treatment of advanced renal cell carcinoma (RCC) • treatment of gastrointestinal stromal tumour (GIST) after failure of imatinib mesilate treatment due to resistance or intolerance • treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic NET). 200424-sunitinib-sandoz-pi Page 2 of 34 4.2. D OSE AND METHOD OF ADMINISTRATION DOSAGE Therapy should be initiated by a physician experienced in the administration of anti-cancer agents. Sunitinib Sandoz may be taken with or without f সম্পূর্ণ নথি পড়ুন