Riik: Singapur
keel: inglise
Allikas: HSA (Health Sciences Authority)
Pertuzumab
ROCHE SINGAPORE PTE. LTD.
L01XC13
30 mg/ml
INFUSION, SOLUTION CONCENTRATE
Pertuzumab 30 mg/ml
INTRAVENOUS
Prescription Only
Roche Diagnostics GmbH
ACTIVE
2014-02-05
1 PERJETA ® Pertuzumab 1. NAME OF THE MEDICINAL PRODUCT Perjeta concentrate for solution for infusion 420mg/14ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One 14 ml vial of concentrate contains 420 mg of pertuzumab at a concentration of 30 mg/ml. After dilution, one ml of solution contains 3.36 mg of pertuzumab for the initial dose and 1.68 mg of pertuzumab for the maintenance dose (see section 6.4). Pertuzumab is a humanised IgG1 monoclonal antibody produced in mammalian (Chinese hamster ovary) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear to slightly opalescent, colourless to pale yellow, liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Perjeta is indicated for use in combination with trastuzumab and docetaxel for the treatment of adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer,_ _who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Perjeta is subject to restricted medical prescription and therapy should only be initiated under the supervision of a physician experienced in the administration of anti-cancer agents. Perjeta should be administered by a healthcare professional prepared to manage anaphylaxis and in an environment where full resuscitation service is immediately available. Patients treated with Perjeta must have HER2-positive tumour status, defined as a score of 3+ by immunohistochemistry (IHC) and/or a ratio of ≥ 2.0 by in situ hybridisation (ISH) assessed by a validated test. To ensure accurate and reproducible results, Lugege kogu dokumenti
1 Please visit www.roche.com.sg/pharma/perjeta for a printable version of this leaflet. INF-PER-2021 02 PERJETA ® Pertuzumab 1.1 NAME OF THE MEDICINAL PRODUCT Perjeta concentrate for solution for infusion 420mg/14ml 1.2 QUALITATIVE AND QUANTITATIVE COMPOSITION One 14 ml vial of concentrate contains 420 mg of pertuzumab at a concentration of 30 mg/ml. After dilution, one ml of solution contains 3.36 mg of pertuzumab for the initial dose and 1.68 mg of pertuzumab for the maintenance dose (see section 4.2). Pertuzumab is a humanised IgG1 monoclonal antibody produced in mammalian (Chinese hamster ovary) cells by recombinant DNA technology. For the full list of excipients, see section 4.3. 1.3 PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear to slightly opalescent, colourless to pale yellow, liquid. 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATIONS Metastatic Breast Cancer (MBC) Perjeta is indicated for use in combination with Herceptin and docetaxel for the treatment of adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. Early Breast Cancer Perjeta is indicated for use in combination with Herceptin and chemotherapy for the: neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. This indication is based on demonstration of an improvement in pathological complete response rate. No data are available demonstrating improvement in event-free survival or overall survival. adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence (see section 3.1.2). 2.2 POSOLOGY AND METHOD OF ADMINISTRATION General Perjeta is subject to restricted medical prescription and therapy should only be initiated under the supervision of a physician experienced in the adm Lugege kogu dokumenti