GEMZAR 1 GR

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

GEMCITABINE AS HYDROCHLORIDE

MAH:

ELI LILLY ISRAEL LTD

ATC_code:

L01BC

pharmaceutical_form:

LYOPHILIC POWDER FOR CONCENTRATED INFUSION

composition:

GEMCITABINE AS HYDROCHLORIDE 1 G/VIAL

administration_route:

I.V

prescription_type:

Required

manufactured_by:

LILLY FRANCE S.A.S., FRANCE

therapeutic_group:

PYRIMIDINE ANALOGUES

therapeutic_indication:

Palliative treatment of patients with locally advanced or metastatic non-small cell lung cancer and locally advanced or metastatic adenocarcinoma of the pancreas and for patients with 5-FU refractory pancreatic cancer. Gemcitabine is indicated for the treatment of patients with bladder cancer at the invasive stage. Breast cancer: 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. Ovarian cancer: Gemcitabine in combination with carboplatin is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma whom have relapsed at least six months after platinum - based therapy.

authorization_date:

2012-07-17

PIL

העדוה
העדוה
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לע
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עדימ
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ל
אפור
אפור
ךיראת
07
-
OCT-2014
םש
רישכת
תילגנאב
רפסמו
:םושירה
GEMZAR 200 MG
רפסמ
:םושיר
103-72-28801-00/01
GEMZAR 1000 MG
רפסמ :םושיר
103-73-2880100/201
םש
לעב
םושירה :
ילא
יליל
לארשי
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
SPECIAL WARNINGS AND
SPECIAL PRECAUTIONS
FOR USE
תפסות
4.4 SPECIAL WARNINGS AND PRECAUTIONS
FOR USE
Posterior reversible encephalopathy
syndrome
Reports of posterior reversible
encephalopathy syndrome (PRES) with
potentially severe consequences have been
reported in patients receiving gemcitabine as
single agent or in combination with other
chemotherapeutic agents. Acute hypertension
and seizure activity were reported in most
gemcitabine patients experiencing PRES, but
other symptoms such as headache, lethargy,
confusion and blindness could also be
present. Diagnosis is optimally confirmed by
magnetic resonance imaging (MRI). PRES
was typically reversible with appropriate
supportive measures. Gemcitabine should be
permanently discontinued and supportive
measures implemented, including blood
pressure control and anti-seizure therapy, if
PRES develops during therapy.
ADVERSE EVENTS
תפסות
4.8 UNDESIRABLE EFFECTS
NERVOUS SYSTEM DISORDERS
Very rare
-
Posterior reversible encephalopathy
syndrome
(see section 4.4.)
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SPC

X GEMZVL F 05
1.
TRADE NAME OF THE MEDICINAL PRODUCT
GEMZAR 1,000 mg powder for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains gemcitabine hydrochloride equivalent to 1,000 mg
gemcitabine.
After reconstitution, the solution contains 38 mg/ml of gemcitabine.
_Excipients: _
Each 1,000 mg vial contains 17.5 mg (<1 mmol) sodium.
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion.
White to off-white plug or powder.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Non-Small Cell Lung Cancer: _
Gemcitabine is indicated for the palliative treatment of patients with
locally advanced
or metastatic non-small cell lung cancer.
_Breast cancer: _
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.
_Pancreatic Cancer: _
Gemcitabine is indicated for the treatment of patients with locally
advanced or
metastatic adenocarcinoma of the pancreas and for patients with 5-FU
refractory
pancreatic cancer.
_Bladder Cancer: _
Gemcitabine is indicated for the treatment of patients with bladder
cancer at the
invasive stage.
Page
1
of
21
X GEMZVL F 05
_Ovarian cancer:_
Gemcitabine in combination with carboplatin, is indicated for the
treatment of
patients with recurrent epithelial ovarian carcinoma who have relapsed
at least six
months after platinum-based therapy.
4.2_ _
POSOLOGY AND METHOD OF ADMINISTRATION
Gemcitabine should only be prescribed by a physician qualified in the
use of anti-
cancer chemotherapy.
Recommended posology:
_ _
_Non-Small Cell Lung Cancer:_
_Single-agent use: _
Adults: The recommended dose of gemcitabine is 1,000 mg/m
2
,
given by 30 minute intravenous infusion. This should be repeated once
weekly for
three weeks, followed by a one week rest period. This four week cycle
i