Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
sonidegib phosphate, Quantity: 280.8 mg (Equivalent: sonidegib, Qty 200 mg)
Sun Pharma ANZ Pty Ltd
sonidegib phosphate
Capsule, hard
Excipient Ingredients: colloidal anhydrous silica; magnesium stearate; purified water; Gelatin; lactose monohydrate; titanium dioxide; iron oxide red; sodium lauryl sulfate; poloxamer; crospovidone; butylated hydroxytoluene; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; Shellac; sulfuric acid
Oral
30
(S4) Prescription Only Medicine
Odomzo is indicated for the treatment of adult patients with:,- Locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy.,- Metastatic BCC
Visual Identification: Opaque pink capsule,cap imprinted in black ink with NVR, body imprinted in black ink with SONIDEGIB 200MG, containing white powder with granules; Container Type: Bottle; Container Material: HDPE; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2017-10-17
ODOMZO ® ™v3.0 1 ODOMZO ® _sonidegib _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ODOMZO. 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 ODOMZO against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ODOMZO IS USED FOR ODOMZO contains the active ingredient sonidegib. ODOMZO belongs to a group of medicines called anti-neoplastic (or anti-cancer) medicines. It works by blocking cancer cells from growing and making new cells. ODOMZO is used to treat adults with a type of skin cancer called advanced basal cell carcinoma. It is used when the cancer: has spread to surrounding areas (called "locally advanced" basal cell carcinoma) and your doctor has decided that treatment with surgery or radiation is not appropriate. has spread to other parts of the body (called "metastatic" basal cell carcinoma). Surgery and radiation treatment may not be appropriate because: surgery will change the shape of a body part (cause deformity) e.g. face, neck surgery may cause you to lose the use of a body part such as an eye or ear the cancer has returned after previous surgery and further surgery may not work or is not possible radiation was previously not successful or it is not suitable for you to have radiation. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE ODOMZO _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ODOMZO IF YOU ARE YOU ARE PREGNANT, THINK YOU MAY BE PREGNANT, OR ARE PLANNING TO BECOME PREGNANT DURING THE COURSE OF TREATMENT Прочитайте повний документ
1 ODOMZO v4.5 AUSTRALIAN PRODUCT INFORMATION ODOMZO Sonidegib 200 mg capsule 1. NAME OF THE MEDICINE Sonidegib 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard gelatin capsule of ODOMZO contains 200 mg - sonidegib (as diphosphate). Excipient with known effects: Each capsule contains lactose monohydrate 38.60 mg. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Hard gelatin capsule. Size #00, Coni-snap, opaque pink capsule, cap imprinted in black ink with “NVR,” body imprinted in black ink with “SONIDEGIB 200MG,” containing white to practically white powder with granules. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ODOMZO is indicated for the treatment of adult patients with: • Locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy. • Metastatic BCC. 4.2 DOSE AND METHOD OF ADMINISTRATION GENERAL TARGET POPULATION The recommended dose of ODOMZO is 200 mg taken orally once daily on an empty stomach, at the same time each day. ODOMZO should be taken at least 1 hour before, or two hours after a meal. ODOMZO capsules must be swallowed whole. They must not be chewed or crushed. If a dose is missed, the recommended dose of ODOMZO should be taken within 6 hours after the missed dose. If more than 6 hours have passed, the patient should be instructed not to take the missed dose. The patient should continue treatment with the next prescribed dose. Continue treatment as long as clinical benefit is observed or until unacceptable toxicity develops. 2 ODOMZO v4.5 DOSE MODIFICATIONS IN: RENAL IMPAIRMENT Sonidegib has not been studied in patients with renal impairment. Based on the available data, sonidegib elimination via the kidney is negligible. A population pharmacokinetic analysis did not find significant influence of renal function on the apparent clearance (CL/F) of sonidegib suggesting that dose adjustment is not necessary in patients with renal impairment (see SECTION 5 PHARMACOLOGICAL PROPERTIES). H Прочитайте повний документ