Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
PEMBROLIZUMAB
MERCK SHARP & DOHME ISRAEL LTD
L01XC18
POWDER FOR SOLUTION FOR INFUSION
PEMBROLIZUMAB 50 MG/VIAL
I.V
Required
MERCK SHARP & DOHME CORP., USA
PEMBROLIZUMAB
- Melanoma:Keytruda (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic melanoma.- Non-Small Cell Lung Cancer:• KEYTRUDA, in combination with pemetrexed and carboplatin, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) negative for EGFR or ALK genomic tumor aberrations.• KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of patients with metastatic squamous NSCLC. • Keytruda, as a single agent, is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 [Tumor Proportion Score (TPS) ≥50%)] as determined by a validated test. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on or after platinum-containing chemotherapy and an approved therapy for these aberrations prior to receiving Keytruda.• Keytruda, as a single agent, is indic
2015-02-12
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) 1986 This medicine can be supplied upon physician’s prescription only KEYTRUDA ® 50 MG POWDER FOR SOLUTION FOR INTRAVENOUS INFUSION Each vial contains: Pembrolizumab 50 mg KEYTRUDA ® 100 MG/4 ML CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION Each vial contains: Pembrolizumab 100 mg For a list of inactive ingredients see section 6.1 "What KEYTRUDA contains". READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about KEYTRUDA. If you have any further questions, refer to your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their medical condition seems similar to yours. 1. WHAT KEYTRUDA IS AND WHAT IT IS USED FOR? KEYTRUDA is a prescription medicine used to treat: skin cancer called melanoma. KEYTRUDA may be used when your melanoma has spread or cannot be removed by surgery (advanced melanoma). lung cancer called non-small cell lung cancer (NSCLC). KEYTRUDA may be used when your lung cancer: o has spread (advanced NSCLC) AND, o tests positive for “PD-L1” AND, you have not received chemotherapy to treat your advanced NSCLC and your tumor does not have an abnormal “EGFR” or “ALK” gene, OR you have received chemotherapy that contains platinum to treat your advanced NSCLC, and it did not work or it is no longer working, AND if your tumor has an abnormal “EGFR” or “ALK” gene, you have also received an EGFR or ALK inhibitor medicine and it did not work or is no longer working. head and neck squamous cells cancer (HNSCC). KEYTRUDA may be used when your HNSCC: o has returned or spread (advanced HNSCC) AND o you have received chemotherapy that contains platinum to treat your advanced HNSCC, and it did not work or is no longer working. cancer called classical Hodgkin lymphoma (cHL) in adults and children when: o you have tried a treatment and it did Pročitajte cijeli dokument
KEYTRUDA ® 50 MG (PEMBROLIZUMAB) KEYTRUDA ® 100 MG/4 ML (PEMBROLIZUMAB) POWDER FOR SOLUTION FOR INTRAVENOUS INFUSION CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 MELANOMA KEYTRUDA (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic melanoma _[see Clinical Studies (14.1)]_. 1.2 NON-SMALL CELL LUNG CANCER KEYTRUDA, in combination with pemetrexed and carboplatin, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) negative for EGFR or ALK genomic tumor aberrations _[see Clinical Studies (14.2)]_. KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first- line treatment of patients with metastatic squamous NSCLC _[see Clinical Studies (14.2)]_. KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 [Tumor Proportion Score (TPS) ≥50%)] as determined by a validated test. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on or after platinum- containing chemotherapy and an approved therapy for these aberrations prior to receiving KEYTRUDA _[see Clinical Studies (14.2)]_. _ _ KEYTRUDA, as a single agent, is indicated for the treatment of patients with advanced NSCLC whose tumors express PD-L1 as determined by a validated test, with disease progression on or after platinum containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on approved therapy for these aberrations prior to receiving KEYTRUDA _[see Clinical Studies _ _(14.2)]_. 1.3 HEAD AND NECK CANCER KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy _[see _ _Clinical Studies (14.3)]_. 1.4 CLASSICAL HODGKIN LYMPHOMA KEYTRUDA is indicated for the treatment Pročitajte cijeli dokument