Country: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
vismodegib, Quantity: 150 mg
Roche Products Pty Ltd
Vismodegib
Capsule, hard
Excipient Ingredients: purified talc; iron oxide red; Gelatin; sodium starch glycollate; microcrystalline cellulose; titanium dioxide; iron oxide black; Shellac; lactose monohydrate; povidone; magnesium stearate; sodium lauryl sulfate
Oral
28 capsules
(S4) Prescription Only Medicine
ERIVEDGE is indicated for the treatment of adult patients with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma where surgery and/or radiation therapy are not appropriate.
Visual Identification: Hard gelatin capsule, with a pink opaque body with 150mg printed in black ink and a grey opaque cap with VISMO printed in black ink.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2013-12-03
ERIVEDGE ® pronounced "EH-rih-vedge" _vismodegib_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Erivedge capsules. It does not contain all the available information. It does not take the place of talking to your pharmacist or doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Erivedge against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR PHARMACIST OR DOCTOR. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ERIVEDGE IS USED FOR Erivedge contains the active ingredient vismodegib. Erivedge belongs to a group of medicines called anti-neoplastic (or anti-cancer) agents. Erivedge 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 other parts of the body (called "metastatic" basal cell carcinoma) or • 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. Surgery and radiation treatment may not be appropriate because; • surgery will change the shape of a body part (cause deformity) • with surgery, you may lose the use of a body part such as an eye or ear • the cancer has returned after previous surgeries and further surgery isn't likely to be successful • radiation was previously unsuccessful or you are not suitable for radiation. Erivedge works by controlling a key protein involved in this type of cancer. Erivedge may slow or stop the cancer cells from growing, or may kill them. As a result, your skin cancer may shrink. Research undertaken in the development of Erivedge utilised cell lines derived from human embryos. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have given it for another reason. This medicine is not addictive. This medicine is available only with সম্পূর্ণ নথি পড়ুন
AUSTRALIAN PRODUCT INFORMATION – ERIVEDGE ® (VISMODEGIB) Erivedge 200326 1 1. NAME OF THE MEDICINE Vismodegib 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Erivedge 150 mg hard capsule For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Erivedge 150 mg capsules are hard gelatin capsules, with a pink opaque body with “150mg” printed in black ink and a grey opaque cap with “VISMO” printed in black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Erivedge is indicated for the treatment of adult patients with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma where surgery and/or radiation therapy are not appropriate. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE The recommended daily dose of Erivedge is 150 mg. Erivedge should be taken once a day, with or without food. Capsules must be swallowed whole with water and must not be opened or crushed under any circumstances. Erivedge should be continued until disease progression or until unacceptable toxicity. In patients where treatment is discontinued prior to progression, patients should be monitored for disease recurrence or worsening of disease. MISSED DOSE If a dose of Erivedge is missed, patients should be instructed not to take the missed dose but to resume dosing with the next scheduled dose. SPECIAL POPULATIONS Elderly Patients No dose adjustment is required in patients > 65 year years of age (see section 4.4 Special warnings and precautions for use). Paediatric Patients The safety and efficacy of Erivedge in children and adolescents (<18 years) have not been established. Erivedge 200326 2 Patients with Renal Impairment No dose adjustment is required in patients with renal impairment (see section 5.2 Pharmacokinetic properties). Very limited data is available in patients with severe renal impairment. Patients with severe renal impairment should be carefully monitored for adverse reactions. Patients with Hepatic Impairment No dose adjustment is required in patients with hepatic i সম্পূর্ণ নথি পড়ুন