Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gemcitabine hydrochloride
Pfizer Ltd
L01BC05
Gemcitabine hydrochloride
2gram
Powder for solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010300; GTIN: 5015997274919
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER GEMCITABINE 200 MG POWDER FOR SOLUTION FOR INFUSION GEMCITABINE 1 G POWDER FOR SOLUTION FOR INFUSION GEMCITABINE 2 G POWDER FOR SOLUTION FOR INFUSION GEMCITABINE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, nurse or pharmacist. - If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Gemcitabine Powder for Solution for Infusion is and what it is used for 2. What you need to know before you use Gemcitabine Powder for Solution for Infusion 3. How to use Gemcitabine Powder for Solution for Infusion 4. Possible side effects 5. How to store Gemcitabine Powder for Solution for Infusion 6. Contents of the pack and other information 1. WHAT GEMCITABINE POWDER FOR SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR Gemcitabine Powder for Solution for Infusion belongs to a group of medicines called ‘cytotoxics’. These medicines kill dividing cells, including cancer cells. Gemcitabine may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer you have. Gemcitabine Powder for Solution for Infusion is used in the treatment of a number of types of cancer including: 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 GEMCITABINE POWDER FOR SOLUTION FOR INFUSION YOU SHOULD NOT BE GIVEN GEMCITABINE POWDER FOR SOLUTION FOR INFUSION If you are allergic to gemcitabine or any of the other ingredients of this medicine (listed in section 6). If you are breast-feeding. Tell the doctor if you think any of the above applies to you. WARNINGS AND PRECAUTIONS Before the firs Διαβάστε το πλήρες έγγραφο
OBJECT 1 GEMCITABINE 200 MG POWDER FOR SOLUTION FOR INFUSION GEMCITABINE 1 G POWDER FOR SOLUTION FOR INFUSION GEMCITABINE 2 G POWDER FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 12-Jun-2017 | Hospira UK Ltd 1. Name of the medicinal product Gemcitabine 200mg Powder for Solution for Infusion Gemcitabine 1g Powder for Solution for Infusion Gemcitabine 2g Powder for Solution for Infusion 2. Qualitative and quantitative composition One vial contains gemcitabine hydrochloride, equivalent to 200 mg gemcitabine. One vial contains gemcitabine hydrochloride, equivalent to 1 g gemcitabine. One vial contains gemcitabine hydrochloride, equivalent to 2 g gemcitabine. After reconstitution, the solution contains 38 mg/ml gemcitabine (as hydrochloride). Excipients Each 200 mg vial contains approximately 3.5 mg (0.15 mmol) sodium. Each 1 g vial contains approximately 17.5 mg (0.75 mmol) sodium. Each 2 g vial contains approximately 35 mg (1.5 mmol) sodium. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Powder for solution for infusion (powder for infusion) White to off-white plug or powder. 4. Clinical particulars 4.1 Therapeutic indications BLADDER CANCER: Locally advanced or metastatic bladder cancer, in combination with cisplatin. PANCREATIC CANCER: Locally advanced or metastatic adenocarcinoma of the pancreas. NON-SMALL CELL LUNG CANCER: First-line treatment of patients with locally advanced or metastatic non-small cell lung cancer, in combination with cisplatin. Gemcitabine monotherapy can be considered in elderly patients or those with performance status 2. OVARIAN CANCER: 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. BREAST CANCER: Unresectable, locally recurrent or metastatic breast cancer, in combination with paclitaxel, in patients experiencing a relapse after adjuvant/neoadjuvant chemotherapy. T Διαβάστε το πλήρες έγγραφο