GEMCITABINE MEDAC 1500 MG

Negara: Israel

Bahasa: Inggris

Sumber: Ministry of Health

Bahan aktif:

GEMCITABINE AS HYDROCHLORIDE

Tersedia dari:

TZAMAL BIO-PHARMA LTD

Kode ATC:

L01BC05

Bentuk farmasi:

POWDER FOR SOLUTION FOR INFUSION

Komposisi:

GEMCITABINE AS HYDROCHLORIDE 1500 MG

Rute administrasi :

I.V

Jenis Resep:

Required

Diproduksi oleh:

MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH, GERMANY

Kelompok Terapi:

GEMCITABINE

Area terapi:

GEMCITABINE

Indikasi Terapi:

Palliative treatment of patients with locally advanced or metastatic non-small cell lung cancer and locallyadvanced or metastatic adenocarcinoma of the pancreas and for patients with 5-FU refractory pancreaticcancer.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 locallyrecurrent 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 epithelialovarian carcinoma whom have relapsed at least six months after platinum - based therapy.

Tanggal Otorisasi:

2015-05-31

Selebaran informasi

טסוגוא
2019
ה/דבכנ ת/חקור ,ה/אפור
,
:ןודנה
Gemcitabine medac 200 mg
-
ןיבטיצמג
קאדמ
200
ג"מ
g
0 m
00
1
Gemcitabine medac
-
ןיבטיצמג
קאדמ
0
0
0
1
ג"מ
mg
0
0
5
1
Gemcitabine medac
-
ןיבטיצמג
קאדמ
0
0
15
ג"מ
ליעפ ביכרמ
:
Gemcitabine medac 200 mg: 200mg Gemcitabine
Gemcitabine medac 100 mg: 1000 mg Gemcitabine
Gemcitabine medac 150 mg: 1500 mg Gemcitabine
ןונימ תרוצ
:
Powder For Solution For Infusion
תויוותה
תורשואמ
:
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.
תרבח
מצ
ויב ל
-
המראפ
מ"עב
תשקבמ
עידוהל
םכ
לע
ה
םינוכדע
םיאבה
ןולעב
אפורל
ה לש
רישכת
.
תועצמאב תנמוסמ הרמחה
תחת וק
י
ש ,
ועמשמ
הל רושקה עדימ תפסות איה ות
הרמח
.
4.2
Posology and method of administration
Recommended posology:
Cisplatin has been used at doses between 75-100 mg/ m
2
once every 3 or 4 weeks
Paediatric population (<18 years)
Gemcitabine is not recommended for use in children under 18 years of
age
due to insufficient data on safety and efficacy.
Posterior reversible encephalopathy syndrome
Reports of posterior reversible encephalopathy syn

Karakteristik produk

GEM_PI_PI_app_TZ_04.2021
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Gemcitabine medac 200 mg
Gemcitabine medac 1000 mg
Gemcitabine medac 1500 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains gemcitabine hydrochloride equivalent to 200 mg
gemcitabine.
One vial contains gemcitabine hydrochloride equivalent to 1,000 mg
gemcitabine.
One vial contains gemcitabine hydrochloride equivalent to 1,500 mg
gemcitabine.
After reconstitution, the solution contains 38 mg/ml of gemcitabine.
Excipients with known effect
Each 200 mg vial contains 3.5 mg (< 1 mmol) sodium.
Each 1,000 mg vial contains 17.5 mg (< 1 mmol) sodium.
Each 1,500 mg vial contains 26.3 mg (> 1 mmol) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion
White to off-white 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.
GEM_PI_PI_app_TZ_04.2021
_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 qual