Gemcitabine Ebewe

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Gemcitabine hydrochloride 11.39 mg/mL equivalent to gemcitabine 10 mg/mL;  

Available from:

Sandoz New Zealand Limited

INN (International Name):

Gemcitabine hydrochloride 11.39 mg/mL (equivalent to gemcitabine 10 mg/mL)

Dosage:

10 mg/mL

Pharmaceutical form:

Concentrate for injection

Composition:

Active: Gemcitabine hydrochloride 11.39 mg/mL equivalent to gemcitabine 10 mg/mL   Excipient: Sodium acetate trihydrate Sodium hydroxide Water for injection

Units in package:

Vial, glass, Type I colourless glass with bromobutyl stopper, 20 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Dr Reddy's Laboratories Limited

Therapeutic indications:

Non-Small Cell Lung Cancer: Gemcitabine Ebewe, alone or in combination with cisplatin, is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer.

Product summary:

Package - Contents - Shelf Life: Vial, glass, Type I colourless glass with bromobutyl stopper - 20 mL - 24 months from date of manufacture stored at or below 25°C. Do not refrigerate or freeze - Vial, glass, Type I colourless glass with bromobutyl stopper - 50 mL - 24 months from date of manufacture stored at or below 25°C. Do not refrigerate or freeze - Vial, glass, Type I colourless glass with bromobutyl stopper - 100 mL - 24 months from date of manufacture stored at or below 25°C. Do not refrigerate or freeze

Authorization date:

2007-11-05

Patient Information leaflet

Gemcitabine Ebewe
Gemcitabine_Ebewe_CMI_v2_Dec 2014 Page 1 of 4
GEMCITABINE EBEWE
gemcitabine hydrochlori
de
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Gemcitabine Ebewe.
It does not contain all the
available information. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have benefits
and risks. Your doctor has
weighed the risks of you taking
gemcitabine against the
benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET
You may need to read it again.
It is important to remember
that Gemcitabine Ebewe is a
PRESCRIPTION ONLY
MEDICINE.
Gemcitabine Ebewe will only
be given to you by specially
trained personnel in a hospital
environment.
WHAT GEMCITABINE EBEWE IS
USED FOR
Gemcitabine belongs to the
group of medicines called
antineoplastics or cytotoxic
medicines. It is typically used
to treat patients with lung
cancer, cancer of the pancreas,
bladder cancer, cancer of the
breast or ovarian cancer. It
works by killing cancer cells
and preventing cancer cells
from growing and multiplying.
Gemcitabine may also be used
to treat other conditions as
determined by your doctor.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
GEMCITABINE EBEWE HAS BEEN
PRESCRIBED FOR YOU.
Gemcitabine Ebewe may also
be used in combination with
other cytotoxic medicines to
treat cancer.
BEFORE YOU ARE GIVEN
GEMCITABINE EBEWE
TELL YOUR DOCTOR OR HEALTH
CARE PROFESSIONAL IF YOU HAVE
ANY OF THE FOLLOWING
CONDITIONS OR IF YOU HAVE EVER
EXPERIENCED ANY OF THESE
CONDITIONS. _ _
_WHEN YOU MUST NOT BE GIVEN _
_THIS MEDICINE: _
YOU MUST NOT BE GIVEN THIS
MEDICINE IF YOU HAVE HAD AN
ALLERGIC REACTION TO
GEMCITABINE EBEWE OR TO ANY
OF THE INGREDIENTS LISTED AT THE
END OF THIS LEAFLET (see
PRODUCT DESCRIPTION).
Symptoms of an allergic
reaction may include rashes,
itching and redness of the skin
and swelling of the tongue or
face.
YOU MUST NOT BE GIVEN THIS
MEDICINE

Summary of Product characteristics

230320-Gemcitabine Ebewe-ds
Page 1 of 21
NEW ZEALAND DATA SHEET
GEMCITABINE EBEWE (GEMCITABINE HYDROCHLORIDE) INJECTION
VIALS
1.
PRODUCT NAME
Gemcitabine Ebewe injection vials
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gemcitabine Ebewe containing 10 mg/mL gemcitabine hydrochloride in
vial containing 200
mg, 500 mg or 1000 mg of gemcitabine.
Gemcitabine is a white to off-white solid. Gemcitabine is an acidic
compound. The free base
is soluble in water, slightly soluble in methanol, and practically
insoluble in ethanol and polar
organic solvents.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Gemcitabine Ebewe is a sterile, clear, colourless, solution for
intravenous use.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
_Non-Small Cell Lung Cancer:_
Gemcitabine Ebewe, alone or in combination with cisplatin, is
indicated for the first line treatment of patients with locally
advanced or metastatic non-small
cell lung cancer.
_Pancreatic Cancer:_
Gemcitabine Ebewe is indicated for treatment of patients with locally
advanced or metastatic adenocarcinoma of the pancreas. Gemcitabine
Ebewe is indicated for
patients with 5-FU refractory pancreatic cancer. Patients treated with
Gemcitabine Ebewe may
derive improvement in survival, significant clinical benefit, or both.
_Bladder Cancer:_
gemcitabine is indicated for the treatment of patients with bladder
cancer.
_Breast Cancer:_
Gemcitabine Ebewe, in combination with paclitaxel, is indicated for
the first
line treatment of patients with unresectable, locally recurrent or
metastatic breast cancer who
have relapsed following adjuvant/neoadjuvant chemotherapy, containing
anthracycline, unless
clinically contraindicated.
_Ovarian Cancer:_
Gemcitabine Ebewe in combination with carboplatin, is indicated for
the
treatment of patients with recurrent epithelial ovarian carcinoma who
have relapsed following
platinum-based therapy.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_STANDARD DOSING _
NON-SMALL CELL LUNG CANCER: (SINGLE-A