Gemcitabine Koanaa Pdr for Soln for Infusion 1000mg

国: マルタ

言語: 英語

ソース: Malta Medicines Authority

有効成分:

GEMCITABINE HYDROCHLORIDE

から入手可能:

Koanaa Healthcare Limited 4th Floor, Cavendish House, 369 Burnt Oak, Broadway, Edgware, HA85AW, Middlesex, United Kingdom

ATCコード:

L01BC05

INN（国際名）:

GEMCITABINE HYDROCHLORIDE 1000 mg

医薬品形態:

POWDER FOR SOLUTION FOR INFUSION

構図:

GEMCITABINE HYDROCHLORIDE 1000 mg

処方タイプ:

POM

治療領域:

ANTINEOPLASTIC AGENTS

認証ステータス:

Withdrawn

承認日:

2016-10-28

情報リーフレット

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
GEMCITABINE KOANAA 200 MG POWDER FOR SOLUTION FOR INFUSION
GEMCITABINE KOANAA 1000 MG POWDER 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 Koanaa is and what it is used for
2.
What you need to know before you use Gemcitabine Koanaa
3.
How to use Gemcitabine Koanaa
4.
Possible side effects
5.
How to store Gemcitabine Koanaa
6.
Contents of the pack and other information
1. WHAT GEMCITABINE KOANAA IS AND WHAT IT IS USED FOR
Gemcitabine Koanaa 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 Koanaa is used in the treatment of the following types of
cancers:
•
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 KOANAA
_ _
DO NOT USE GEMCITABINE KOANAA
•
if you are allergic (hypersensitive) to gemcitabine or any of the
other ingredients of
gemcitabine (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 gemcitab

製品の特徴

Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Gemcitabine Koanaa 200mg Powder for Solution for Infusion
Gemcitabine Koanaa 1000 mg Powder for Solution for Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 200 mg gemcitabine (as hydrochloride).
Each vial contains 1000 mg gemcitabine (as hydrochloride).
After reconstitution the solution contains 38 mg/ml gemcitabine (as
hydrochloride), (see section
6.6).
Excipients
Each 200 mg vial contains 3.5 mg (<1 mmol) sodium.
Each 1,000 mg vial contains 17.5 mg (<1 mmol) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion (powder for infusion)
White to off-white lyophilized powder or cake.
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. Prior chemotherapy should have
included an anthracycline
unless clinically contraindicated.
Page 2 of 17
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Gemcitabine should only be prescribed by a physician qualified in the
use of anti-canc