Land: Nýja-Sjáland
Tungumál: enska
Heimild: Medsafe (Medicines Safety Authority)
Sunitinib malate 33.4mg equivalent to 25 mg sunitinib;
Pfizer New Zealand Limited
Sunitinib malate 33.4 mg (equivalent to 25 mg sunitinib)
25 mg
Capsule
Active: Sunitinib malate 33.4mg equivalent to 25 mg sunitinib Excipient: Croscarmellose sodium Gelatin Iron oxide black Iron oxide red Iron oxide yellow Magnesium stearate Mannitol Povidone Propylene glycol Shellac Sodium hydroxide Sodium laurilsulfate Titanium dioxide
Blister pack, 28 capsules
Prescription
Prescription
Pfizer Asia Pacific Pte Ltd
SUTENT is indicated for the treatment of advanced renal cell carcinoma.
Package - Contents - Shelf Life: Blister pack, Aluminium/polyvinyl chloride(PVC)/polychlorotriflouroethylene(PCTFE, Aclar) - 28 capsules - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 28 capsules - 36 months from date of manufacture stored at or below 25°C
2006-07-10
SUTENT ® 1 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 BALLOO Lestu allt skjalið
Version: pfdsutec11219 Supersedes: pfdsutec10818 Page 1 of 31 NEW ZEALAND DATA SHEET 1. PRODUCT NAME SUTENT (sunitinib 12.5 mg capsules) SUTENT (sunitinib 25 mg capsules) SUTENT (sunitinib 37.5 mg capsules) SUTENT (sunitinib 50 mg capsules) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient of SUTENT is sunitinib malate. SUTENT capsules contain sunitinib malate equivalent to 12.5 mg, 25 mg, 37.5 mg or 50 mg sunitinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM SUTENT is supplied as a hard gelatin capsule for oral administration. 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 the treatment of advanced renal cell carcinoma. SUTENT is indicated for the treatment of gastrointestinal stromal tumour (GIST) after failure of imatinib mesilate treatment due to resistance or intolerance. SUTENT is indicated for the treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic NET). Version: pfdsutec11219 Supersedes: pfdsutec10818 Page 2 of 31 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE For GIST and mRCC, the recommended dose of SUTENT is 50 mg taken orally once daily for 4 consecutive weeks followed by a 2 week rest period (Schedule 4/2) to comprise a complete cycle of 6 weeks. For pancreatic NET, the recommended dose of SUTENT is 37.5 mg taken orally once daily without a scheduled rest period. If Lestu allt skjalið