국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pertuzumab
Roche Products Ltd
L01XC13
Pertuzumab
30mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010500; GTIN: 5000471007206
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PERJETA 420 MG CONCENTRATE FOR SOLUTION FOR INFUSION pertuzumab READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START BEING GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or nurse. If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Perjeta is and what it is used for 2. What you need to know before you are given Perjeta 3. How you are given Perjeta 4. Possible side effects 5. How to store Perjeta 6. Contents of the pack and other information 1. WHAT PERJETA IS AND WHAT IT IS USED FOR Perjeta contains the active substance pertuzumab and is used to treat adult patients with breast cancer when: The breast cancer has been identified to be of the “HER2-positive” form – your doctor will test you for this. The cancer has spread to other parts of the body such as the lungs or liver (metastasised) and has not previously been treated with anticancer medicines (chemotherapy) or other medicines designed to attach to HER2, or else the cancer has come back in the breast after previous treatment. The cancer has not spread to other parts of the body and treatment is going to be given before surgery takes place (treatment before surgery is called neoadjuvant therapy) The cancer has not spread to other parts of the body and treatment is going to be given after surgery (treatment after surgery is called adjuvant therapy) As well as Perjeta you will also receive trastuzumab and medicines called chemotherapy Information about these medicines is described in separate package leaflets. Ask your doctor or nurse to give you information about these other medicines. HOW PERJETA WORKS Perjeta is a type of medicine called a “monoclonal antibody” which attaches itself to specific targets in your body and on the cancer c 전체 문서 읽기
OBJECT 1 PERJETA 420 MG CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 06-Jun-2018 | Roche Products Limited 1. Name of the medicinal product Perjeta 420 mg concentrate for solution for infusion 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 approximately 3.02 mg of pertuzumab for the initial dose and approximately 1.59 mg of pertuzumab for the maintenance dose (see section 6.6). 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 Early breast cancer Perjeta is indicated for use in combination with trastuzumab and chemotherapy in: • the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence (see section 5.1) • the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1) Metastatic breast cancer Perjeta is indicated for use in combination with trastuzumab and docetaxel in 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 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 facilities are immediately available. Posology Patients treated with Perjeta must have HER2-positive tumour status, defined as a s 전체 문서 읽기