MINIMAL INFORMATIONS OF THE SPC 1. NAME OF THE MEDICINAL PRODUCT  Cyramza 10 mg/ml concentrate for solution for infusion    2. QUALITATIVE AND QUANTITATIVE COMPOSITION  One ml of concentrate for solution for infusion contains 10 mg ramucirumab.  Each 10 ml vial contains 100 mg of ramucirumab. Each 50 ml vial contains 500 mg of ramucirumab.   Ramucirumab is a human IgG1 monoclonal antibody produced in murine (NS0) cells by recombinant DNA technology.  Excipient with known effect  Each 10 ml vial contains approximately 17 mg sodium. Each 50 ml vial contains approximately 85 mg sodium. For the full list of excipients, see section 6.1.   3. PHARMACEUTICAL FORM  Concentrate for solution for infusion (sterile concentrate).  The concentrate is a clear to slightly opalescent and colourless to slightly yellow solution, pH 6.0.    4. CLINICAL PARTICULARS  4.1 Therapeutic indications  Gastric cancer  Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy (see section 5.1).   Cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate (see section 5.1).  Colorectal cancer  Cyramza, in combination with FOLFIRI (irinotecan, folinic acid, and 5‑fluorouracil), is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine.  Non-small cell lung cancer  Cyramza in combination with erlotinib is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer with activating epidermal growth factor receptor (EGFR) mutations (see section 5.1).  Cyramza in combination with docetaxel is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with disease progression after platinum-based chemotherapy.  Hepatocellular carcinoma  Cyramza monotherapy is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have a serum alpha fetoprotein (AFP) of ≥ 400 ng/ml and who have been previously treated with sorafenib.  4.2 Posology and method of administration  Ramucirumab therapy must be initiated and supervised by physicians experienced in oncology.  Posology  Gastric cancer and gastro-oesophageal junction (GEJ) adenocarcinoma  Cyramza in combination with paclitaxel The recommended dose of ramucirumab is 8 mg/kg on days 1 and 15 of a 28 day cycle, prior to paclitaxel infusion. The recommended dose of paclitaxel is 80 mg/m² administered by intravenous infusion over approximately 60 minutes on days 1, 8 and 15 of a 28 day cycle. Prior to each paclitaxel infusion, patients should have a complete blood count and blood chemistry performed to evaluate hepatic function. Criteria to be met prior to each paclitaxel infusion are provided in Table 1.   Table 1: Criteria to be met prior to each paclitaxel administration

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