Kraj: Armenia
Język: angielski
Źródło: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
gemcitabine (gemcitabine hydrochloride)
EBEWE Pharma Ges. m.b.H. Nfg. KG
L01BC05
gemcitabine (gemcitabine hydrochloride)
10mg/ml
concentrate for solution for i/v infusion
glass vial 100ml
Prescription
Registered
2022-02-02
11784209-04 WHAT IS IN THIS LEAFLET 1. What Gemcitabin Ebewe is and what it is used for 2. What you need to know before you use Gemcitabin Ebewe 3. How to use Gemcitabin Ebewe 4. Possible side effects 5. How to store Gemcitabin Ebewe 6. Contents of the pack and other information 1. WHAT GEMCITABIN EBEWE IS AND WHAT IT IS USED FOR Gemcitabin Ebewe belongs to a group of medicines called “cytotoxics”. These medicines kill dividing cells, including cancer cells. Gemcitabin Ebewe may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer. Gemcitabin Ebewe is used in the treatment of the following types of cancer: • non-small cell lung cancer (NSCLC), alone or together with cisplatin • pancreatic cancer. • breast cancer, together with paclitaxel. • ovarian cancer, together with carboplatin. • bladder cancer, together with cisplatin. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE GEMCITABIN EBEWE DO NOT USE Gemcitabin Ebewe: - if you are allergic (hypersensitive) to gemcitabine or any of the other ingredients of this medicine (listed in section 6) - if you are breast-feeding. WARNINGS AND PRECAUTIONS Before the first infusion you will have samples of your blood taken to check if your liver and kidneys are working well enough for you to receive this medicine. Before each infusion you will have samples of your blood taken to check if you have enough blood cells to receive Gemcitabin Ebewe. Your doctor may decide to change the dose or delay treating you depending on your general condition and if your blood cell counts are too low. Periodically you will have samples of your blood taken to check how well your kidneys and liver are working. Talk to your doctor, nurse or hospital pharmacist before using Gemcitabin Ebewe If you have, or have previously had liver disease, heart disease, vascular disease or problems with your kidneys talk to your doctor or hospital pharmacist as you may not be able to receive Gemcitabin Ebewe. If you have recently had, or are going to have radi Przeczytaj cały dokument
1. NAME OF THE MEDICINAL PRODUCT Gemcitabin Ebewe 10 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 11.4 mg gemcitabine hydrochloride which corresponds to 10 mg of the active ingredient gemcitabine. Each vial contains 10 mg/ml gemcitabine (as hydrochloride). Each 20 ml vial contains 200 mg gemcitabine (as hydrochloride). Each 50 ml vial contains 500 mg gemcitabine (as hydrochloride). Each 100 ml vial contains 1000 mg gemcitabine (as hydrochloride). Excipients with known effect 20 ml vial: sodium (as sodium acetate trihydrate and sodium hydroxide) 21.49 mg (0.93 mmol). 50 ml vial: sodium (as sodium acetate trihydrate and sodium hydroxide) 53.74 mg (2.34 mmol). 100 ml vial: sodium (as sodium acetate trihydrate and sodium hydroxide) 107.47 mg (4.67 mmol). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion Product description: clear, colourless or almost colourless solution. Free from visible particles. pH: 5.0 – 6.0 Osmolality: 121.7 mOsmol/kg 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gemcitabine is indicated for the treatment of locally advanced or metastatic bladder cancer in combination with cisplatin. Gemcitabine is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. Gemcitabine, in combination with cisplatin is indicated as first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Gemcitabine monotherapy can be considered in elderly patients or those with performance status 2. Gemcitabine is indicated for the treatment of patients with locally advanced or metastatic epithelial ovarian carcinoma, in combination with carboplatin, in patients with relapsed disease following a recurrence-free interval of at least 6 months after platinum-based, first-line therapy. Gemcitabine, in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or meta Przeczytaj cały dokument