Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
sunitinib malate, Quantity: 66.8 mg (Equivalent: sunitinib, Qty 50 mg)
Pfizer Australia Pty Ltd
sunitinib malate
Capsule
Excipient Ingredients: sodium lauryl sulfate; titanium dioxide; croscarmellose sodium; Shellac; povidone; magnesium stearate; sodium hydroxide; Gelatin; iron oxide black; iron oxide red; propylene glycol; mannitol; iron oxide yellow
Oral
28 capsules
(S4) Prescription Only Medicine
SUTENT 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).
Visual Identification: Capsule with caramel cap and body containing yellow to orange granules, printed with white ink "Pfizer" on the cap and "STN 50 mg" on the body.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2008-02-26
SUTENT ® _Sunitinib malate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SUTENT. 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 SUTENT 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 SUTENT IS USED FOR SUTENT is used in the treatment of renal cell carcinoma, a type of kidney cancer. SUTENT 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. SUTENT slows down the growth of these cells. SUTENT 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 SUTENT HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another purpose. SUTENT is only available with a doctor's prescription. It is not addictive. _USE IN CHILDREN_ The safety and efficacy of SUTENT have not been established in children. BEFORE YOU TAKE SUTENT _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE SUTENT IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO SUNITINIB (THE ACTIVE INGREDIENT IN SUTENT) OR 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 SUTENT AFTER THE EXPIRY DATE PRINTED ON THE PACK. DO NOT USE SUTENT IF THE PACKAGING SHOWS SIGNS OF TAMPERING. _BEFORE YOU START TO TAKE IT_ YOU MUST TELL YOUR DOCTOR IF: • YOU HAVE HIGH BLOOD PRESSURE • YOU HAVE OR HAVE HAD AN ANEURYSM (ABNORMAL BALLOON- LIKE SWELLING Lue koko asiakirja
Version: pfpsutec11019 Supersedes: pfpsutec10219 Page 1 of 35 AUSTRALIAN PRODUCT INFORMATION – SUTENT ® (SUNITINIB MALATE) 1. NAME OF THE MEDICINE Sunitinib malate. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each SUTENT capsule contains sunitinib malate equivalent to sunitinib 12.5 mg, 25 mg, 37.5 mg or 50 mg. Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 25 mg/mL. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Capsule. SUTENT is supplied as a hard gelatin capsule for oral administration. The capsules are differentiated by size, colour and printing. The hard gelatin capsules consist of Swedish Orange cap and body (12.5 mg), Swedish Orange body and caramel cap (25 mg), yellow cap and body (37.5 mg) and caramel cap and body (50 mg) and are printed with white printing ink (12.5 mg, 25 mg and 50 mg) or black printing ink (37.5 mg). 12.5 mg strength: Hard gelatin capsule with Swedish Orange cap and Swedish Orange body, printed with white ink “Pfizer” on the cap, “STN 12.5mg” on the body. 25 mg strength: Hard gelatin capsule with caramel cap and Swedish Orange body, printed with white ink “Pfizer” on the cap, “STN 25mg” on the body. 37.5 mg strength: Hard gelatin capsule with yellow cap and yellow body, printed with black ink “Pfizer” on the cap, “STN 37.5mg” on the body. 50 mg strength: Hard gelatin capsule with caramel cap and caramel body, printed with white ink “Pfizer” on the cap, “STN 50mg” on the body. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SUTENT 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 Version: pfpsutec11019 Supersedes: pfpsutec10219 Page 2 of 35 • treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreat Lue koko asiakirja