Country: Ավստրալիա
language: անգլերեն
source: Department of Health (Therapeutic Goods Administration)
sunitinib malate, Quantity: 66.824 mg (Equivalent: sunitinib, Qty 50 mg)
Accelagen Pty Ltd
Capsule, hard
Excipient Ingredients: iron oxide black; Gelatin; iron oxide red; mannitol; iron oxide yellow; pregelatinised maize starch; titanium dioxide; magnesium stearate; croscarmellose sodium; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; Shellac; ethanol absolute; ammonia; potassium hydroxide
Oral
28 hard capsules, 30 hard capsules
(S4) Prescription Only Medicine
Sunitinib MSN 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: Hard gelatin capsules with caramel opaque body imprinted with "9" and caramel opaque cap imprinted with "MS" in white ink, free from physical defects.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2022-07-22
Sunitinib MSN* 1 SUNITINIB MSN CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING SUNITINIB MSN? Sunitinib MSN contains the active ingredient sunitinib. Sunitinib MSN is used in treatment of renal cell carcinoma, treatment of gastrointestinal stromal tumour (GIST) and treatment of pancreatic neuroendocrine tumours. For more information, see Section 1. Why am I using Sunitinib MSN? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE SUNITINIB MSN? Do not use if you have ever had an allergic reaction to sunitinib or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Sunitinb MSN? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Sunitinib MSN and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE SUNITINIB MSN? • Follow all directions given to you by your doctor carefully. More instructions can be found in Section 4. How do I use Sunitinib MSN? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING SUNITINIB MSN? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Sunitinib MSN. • Make sure you follow your doctor’s instructions and keep all appointments. • Use a proven method of birth control to prevent pregnancy while being treated with Sunitinib MSN and for at least 4 weeks after finishing treatment with Sunitinib MSN. • Tell your doctor immediately if you become pregnant while taking Sunitinib MSN. • Tell your doctor if you are going to have surgery, an operation or dental treatment while taking Sunitinib MSN. • If you are about to be started on any new medicine, remind your docto read_full_document
Sunitinib MSN hard capsule PI Ver 1.0 1 AUSTRALIAN PRODUCT INFORMATION – SUNITINIB MSN (SUNITINIB) HARD CAPSULES 1. NAME OF THE MEDICINE Sunitinib. 2. QUALITIATIVE AND QUANTITATIVE COMPOSITION Each Sunitinib MSN capsule contains sunitinib malate equivalent to sunitinib 12.5 mg, 25 mg, 37.5 mg or 50 mg. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Capsule. Sunitinib MSN 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 orange opaque cap and body (12.5 mg), orange opaque body and caramel opaque cap (25 mg), yellow opaque cap and body (37.5 mg) and caramel opaque 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: Size "4" hard gelatin capsules with orange opaque body imprinted with "6" and orange opaque cap imprinted with "MS" in white ink, free from physical defects. 25 mg strength: Size "3" hard gelatin capsules with orange opaque body imprinted with "7" and caramel opaque cap imprinted with "MS" in white ink, free from physical defects. 37.5 mg strength: Size "3" hard gelatin capsules with yellow opaque body imprinted with "8" and yellow opaque cap imprinted with "MS" in black ink, free from physical defects. 50 mg strength: Size "2" hard gelatin capsules with caramel opaque body imprinted with "9" and caramel opaque cap imprinted with "MS" in white ink, free from physical defects. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sunitinib MSN 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). 4.2 DOSE AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the administration of anti read_full_document