Negara: Singapura
Bahasa: Inggris
Sumber: HSA (Health Sciences Authority)
Palbociclib
PFIZER PRIVATE LIMITED
L01XE33
CAPSULE
Palbociclib 75.000mg
ORAL
Prescription Only
Pfizer Manufacturing Deutschland GmbH
ACTIVE
2016-07-21
IBRANCE ® CAP TABLE OF CONTENT _Please click on either of the following links to access the required information: _ PRESCRIBING INFORMATION PATIENT INFORMATION LEAFLET Page 1 of 25 1. NAME OF THE MEDICINAL PRODUCT IBRANCE ® 75 mg, 100 mg, and 125 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 75 mg or 100 mg or 125 mg of palbociclib freebase. Excipients: see Section 6.1 (List of excipients) for the full list of excipients. Palbociclib is a yellow to orange powder with a pKa of 7.4 (the secondary piperazine nitrogen) and 3.9 (the pyridine nitrogen). The palbociclib drug product is provided as hard gelatin, opaque capsules dosage strengths of: 75 mg (Size #2, light orange body/light orange cap) in which the body is printed with “PBC 75” and the cap printed with “Pfizer” in white; 100 mg (Size #1, light orange body/caramel cap) in which the body is printed with “PBC 100” and the cap printed with “Pfizer” in white; and 125 mg (Size # 0, caramel body/caramel cap) in which the body is printed with “PBC 125” and the cap printed with “Pfizer” in white. 3. PHARMACEUTICAL FORM Hard gelatin capsules 75 mg, 100 mg, and 125 mg 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Ibrance is indicated for the treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: Page 2 of 25 - an aromatase inhibitor as initial endocrine-based therapy; or - fulvestrant in patients with disease progression following endocrine therapy. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose of Ibrance is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment (Schedule 3/1) to comprise a complete cycle of 28 days. When co-administered with palbociclib, the aromatase inhibitor should be administered according to the dose reported in the approved prescribing information. When co-administered with palbociclib, the recommen Baca dokumen lengkapnya
1. NAME OF THE MEDICINAL PRODUCT IBRANCE ® 75 mg, 100 mg, and 125 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 75 mg or 100 mg or 125 mg of palbociclib freebase. Excipients: see Section 6.1 (List of excipients) for the full list of excipients. Palbociclib is a yellow to orange powder with a pKa of 7.4 (the secondary piperazine nitrogen) and 3.9 (the pyridine nitrogen). The palbociclib drug product is provided as hard gelatin, opaque capsules dosage strengths of: 75 mg (Size #2, light orange body/light orange cap) in which the body is printed with “PBC 75” and the cap printed with “Pfizer” in white; 100 mg (Size #1, light orange body/caramel cap) in which the body is printed with “PBC 100” and the cap printed with “Pfizer” in white; and 125 mg (Size # 0, caramel body/caramel cap) in which the body is printed with “PBC 125” and the cap printed with “Pfizer” in white. 3. PHARMACEUTICAL FORM Hard gelatin capsules 75 mg, 100 mg, and 125 mg 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Ibrance is indicated for the treatment of patients with 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; or - fulvestrant in patients with disease progression following endocrine therapy. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose of Ibrance is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment (Schedule 3/1) to comprise a complete cycle of 28 days. When co-administered with palbociclib, the aromatase inhibitor should be administered according to the dose reported in the approved prescribing information. When co-administered with palbociclib, the recommended dose of fulvestrant is 500 mg administered intramuscularly on Days 1, 15, 29, and once monthly thereafter. Please refer to the full prescribing information of fulvestrant. Ibrance should be t Baca dokumen lengkapnya