Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
palbociclib, Quantity: 100 mg
Pfizer Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; silicon dioxide; crospovidone; magnesium stearate; succinic acid; titanium dioxide; hypromellose; triacetin; iron oxide yellow; indigo carmine aluminium lake
Oral
21
(S4) Prescription Only Medicine
IBRANCE is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: ? an aromatase inhibitor as initial endocrine-based therapy ? fulvestrant in patients who have received prior therapy.
Visual Identification: Oval, green, film-coated tablet with Pfizer debossed on one side and PBC 100 debossed on other side.; Container Type: Blister Pack; Container Material: Other plastic laminate/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Registered
2020-06-16
IBRANCE ® I B R A N C E ® 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 IBRANCE? IBRANCE contains the active ingredient palbociclib. IBRANCE is used to treat advanced breast cancer. For more information, see Section 1. Why am I using IBRANCE? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE IBRANCE? Do not use if you have ever had an allergic reaction to palbociclib 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 IBRANCE? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines and IBRANCE may interfere with each other. It is important you tell your doctor or pharmacist if you are taking any medicines used to treat fungal or bacterial infections, HIV/AIDS infections, hepatitis C, tuberculosis, certain heart conditions or high blood pressure, epilepsy/seizures and depression and sleep disorders. 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 IBRANCE? • IBRANCE is a tablet and is taken by mouth. • Your doctor will advise how much IBRANCE to use depending on your medical condition. • Detailed instructions on how to take IBRANCE are provided in the 'Instructions for Use' leaflet inside the pack. More instructions can be found in Section 4. How do I use IBRANCE? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING IBRANCE? THINGS YOU SHOULD DO • Remind any doctor, pharmacist or dentist you visit that you are using IBRANCE. • Check with your doctor before you receive any vaccines. • Use a reliable method of contraception during treatment with IBRANCE. • It is important to tell your doctor if you get symptoms of an infection. THINGS YOU SHOULD NOT DO • Прочетете целия документ
Version: pfpibrac10620 Supersedes: pfpibrac11119 Page 1 of 35 AUSTRALIAN PRODUCT INFORMATION – IBRANCE® (PALBOCICLIB) 1. NAME OF THE MEDICINE Palbociclib 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each IBRANCE tablet contains palbociclib 75 mg, 100 mg or 125 mg. Each IBRANCE capsule contains palbociclib 75 mg, 100 mg or 125 mg. EXCIPIENTS WITH KNOWN EFFECT IBRANCE capsules contain lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM IBRANCE is supplied as hard capsules or a film-coated tablets for oral administration. 75 mg strength: Opaque, hard capsule with a light orange body (printed “PBC 75” in white) and a light orange cap (printed “Pfizer” in white). Round, light purple, film-coated tablet debossed with “Pfizer” on one side and “PBC 75” on the other side. 100 mg strength: Opaque, hard capsule with a light orange body (printed “PBC 100” in white) and a caramel cap (printed “Pfizer” in white). Oval, green, film-coated tablet debossed with “Pfizer” on one side and “PBC 100” on the other side. 125 mg strength: Opaque, hard capsule with a caramel body (printed “PBC 125” in white) and a caramel cap (printed “Pfizer” in white). Oval, light purple, film-coated tablet debossed with “Pfizer” on one side and “PBC 125” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS IBRANCE is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: • an aromatase inhibitor as initial endocrine-based therapy • fulvestrant in patients who have received prior therapy. Version: pfpibrac10620 Supersedes: pfpibrac11119 Page 2 of 35 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE The recommended dose of IBRANCE is a 125 mg capsule or tablet taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. When coadministered with pal Прочетете целия документ