국가: 뉴질랜드
언어: 영어
출처: Medsafe (Medicines Safety Authority)
Sunitinib malate 50.1mg equivalent to sunitinib 37.5mg;
Pfizer New Zealand Limited
37.5 mg
Capsule
Active: Sunitinib malate 50.1mg equivalent to sunitinib 37.5mg Excipient: Croscarmellose sodium Gelatin Ink Iron oxide yellow Magnesium stearate Mannitol Povidone Sodium laurilsulfate Titanium dioxide
Prescription
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
2020-10-30
SUNITINIB PFIZER 1 SUNITINIB PFIZER _Sunitinib malate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SUNITINIB PFIZER. 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 PFIZER 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 PFIZER IS USED FOR SUNITINIB PFIZER is used in the treatment of renal cell carcinoma, a type of kidney cancer. SUNITINIB PFIZER 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 PFIZER slows down the growth of these cells. SUNITINIB PFIZER 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 PFIZER HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another purpose. SUNITINIB PFIZER is only available with a doctor's prescription. It is not addictive. _USE IN CHILDREN _ The safety and efficacy of SUNITINIB PFIZER have not been established in children. BEFORE YOU TAKE SUNITINIB PFIZER _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE SUNITINIB PFIZER IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO SUNITINIB (THE ACTIVE INGREDIENT IN SUNITINIB PFIZER) 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 SUNITINIB PFIZER AFTER THE EXPIRY DATE PRINTED ON THE PACK. DO NOT USE SUNITINIB PFIZER IF THE PACKAGING SHOWS SIG 전체 문서 읽기
Version: pfdsuntc10821 Supersedes: N/A Page 1 of 32 NEW ZEALAND DATA SHEET 1. PRODUCT NAME SUNITINIB PFIZER (sunitinib 12.5 mg capsules) SUNITINIB PFIZER (sunitinib 25 mg capsules) SUNITINIB PFIZER (sunitinib 37.5 mg capsules) SUNITINIB PFIZER (sunitinib 50 mg capsules) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient of SUNITINIB PFIZER is sunitinib malate. SUNITINIB PFIZER 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 SUNITINIB PFIZER 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. Not all strengths may be marketed. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SUNITINIB PFIZER is indicated for the treatment of advanced renal cell carcinoma. SUNITINIB PFIZER is indicated for the treatment of gastrointestinal stromal tumour (GIST) after failure of imatinib mesilate treatment due to resistance or intolerance. SUNITINIB PFIZER is indicated for the treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic NET). Version: pfdsuntc10821 Supersedes: N/A Page 2 of 32 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE For GIST and mRCC, the recommended dose of SUNITINIB PFIZER 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 pancreati 전체 문서 읽기