Land: Verenigd Koninkrijk
Taal: Engels
Bron: myHealthbox
cisplatin.
Cipla (EU) Limited
L01XA01
cisplatin.
1mg/ml
Concentrate for solution for infusion
intravenously by infusion
10, 50, 100 ml type I amber glass vial
POM - Prescription Only Medicine
S&D Pharma CZ
Other antineoplastic agents, Pla
for the treatment of: • advanced or metastatic testicular cancer • advanced or metastatic ovarian cancer • advanced or metastatic bladder carcinoma • advanced or metastatic squamous cell carcinoma of the head and neck • advanced or metastatic non-small cell lung carcinoma • advanced or metastatic small cell lung carcinoma
Authorised
2015-03-06
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CISPLATIN 1MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION cisplatin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor or your pharmacist • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. The name of your medicine is ‘Cisplatin 1 mg/ml concentrate for solution for infusion’ but in the rest of the leaflet it will be called “Cisplatin Injection”. WHAT IS IN THIS LEAFLET 1.What Cisplatin Injection is and what it is used for 2.What you need to know before you are given Cisplatin Injection 3.How you are given Cisplatin Injection 4.Possible side effects 5.How to store Cisplatin Injection 6.Contents of the pack and other information 1. WHAT CISPLATIN INJECTION IS AND WHAT IT IS USED FOR Cisplatin forms part of a group of medicines called cytostatics, which are used in the treatment of cancer. Cisplatin can be used alone but more commonly cisplatin is used in combination with other cytostatics. Cisplatin is used to treat cancers of the testis, ovary, urinary bladder, head and neck, and lung. Cisplatin is used to treat cervical cancer in combination with radiotherapy. Your doctor will be able to provide you with more information 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CISPLATIN INJECTION DO NOT TAKE CISPLATIN INJECTION: • If you are allergic (hypersensitive) to cisplatin or other platinum compounds or to any of the other ingredients of this medicine (listed in section 6), • If you have kidn Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cisplatin 1 mg/ml concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of concentrate for solution for infusion contains 1 mg of cisplatin. One vial of 10 ml of concentrate for solution for infusion contains 10 mg of cisplatin One vial of 50 ml of concentrate for solution for infusion contains 50 mg of cisplatin One vial of 100 ml of concentrate for solution for infusion contains 100 mg of cisplatin Excipient with known effect: Each ml of solution contains 3.5 mg of sodium. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, colourless to pale yellow solution in an amber glass vial, which is practically free from particles. The pH is between 3.5 to 6.5 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cisplatin is intended for the treatment of: • advanced or metastatic testicular cancer • advanced or metastatic ovarian cancer • advanced or metastatic bladder carcinoma • advanced or metastatic squamous cell carcinoma of the head and neck • advanced or metastatic non-small cell lung carcinoma • advanced or metastatic small cell lung carcinoma Cisplatin is indicated in combination with radiotherapy in the treatment of cervical carcinoma. Cisplatin can be used as monotherapy and in combination therapy 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and children _ The cisplatin dosage depends on the primary disease, the expected reaction, and on whether cisplatin is used for monotherapy or as a component of combination chemotherapy. The dosage directions are applicable for both adults and children. For monotherapy, the following two dosage regimen Lees het volledige document