Gemcitabine 38 mg/ml Concentrate for Solution for Infusion

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Gemcitabine hydrochloride

Disponível em:

Fresenius Kabi Deutschland GmbH

Código ATC:

L01BC; L01BC05

DCI (Denominação Comum Internacional):

Gemcitabine hydrochloride

Dosagem:

38 milligram(s)/millilitre

Forma farmacêutica:

Concentrate for solution for infusion

Área terapêutica:

Pyrimidine analogues; gemcitabine

Status de autorização:

Marketed

Data de autorização:

2015-01-16

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
GEMCITABINE 38 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
GEMCITABINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- 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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Gemcitabine is and what it is used for
2. What you need to know before you use Gemcitabine
3. How to use Gemcitabine
4. Possible side effects
5. How to store Gemcitabine
6. Contents of the pack and other information
1. WHAT GEMCITABINE IS AND WHAT IT IS USED FOR
Gemcitabine belongs to a group of medicines called “cytotoxics”.
These medicines kill dividing cells,
including cancer cells.
This medicine may be given alone or in combination with other
anti-cancer medicines, depending on
the type of cancer.
This medicine 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 GEMCITABINE
DO NOT USE
GEMCITABINE:
-
if you are allergic 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
gemcitabine. 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

Características técnicas

Health Products Regulatory Authority
15 January 2024
CRN00F1DX
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gemcitabine 38 mg/ml Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate for solution for infusion contains gemcitabine
hydrochloride, equivalent to 38 mg gemcitabine.
The quantitative composition of each presentation is provided in the
table below:
Presentation
Strength
Quantity of gemcitabine
(as hydrochloride)
Volume of Solution
200 mg/5.26 ml
38 mg/ml
200 mg
5.26 ml
1000 mg/26.3 ml
38 mg/ml
1000 mg
26.3 ml
2000 mg/52.6 ml
38 mg/ml
2000 mg
52.6 ml
Excipient with known effect:
3.16 mg/ml to 3.74 mg/ml (0.14 mmol/ml to 0.16 mmol/ml) sodium.
30% v/v (310.8 mg/ml) propylene glycol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless to light straw colored solution free from visible
particles.
pH: 7.0 to 9.0
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
metastatic breast cancer who have relapsed following
adjuvant/neoadjuvant chemotherapy. P