GEMCITABINE ACTAVIS 200 gemcitabine 200 mg (as hydrochloride) powder for injection vial

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

gemcitabine hydrochloride, Quantity: 228 mg (Equivalent: gemcitabine, Qty 200 mg)

Tilgjengelig fra:

Medis Pharma Pty Ltd

INN (International Name):

Gemcitabine hydrochloride

Legemiddelform:

Injection, powder for

Sammensetning:

Excipient Ingredients: mannitol; sodium hydroxide; sodium acetate trihydrate

Administreringsrute:

Intravenous Infusion

Enheter i pakken:

1 X 10 mL vial

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Treatment of patients with locally advanced or metastatic non-small cell lung cancer. Treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. Treatment of patients with FU refractory pancreatic cancer. Treatment of patients with bladder cancer, alone or in combination with cisplatin. Treatment, in combination with paclitaxel, 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. Treatment, in combination with carboplatin, of patients with recurrent epithelial ovarian carcinoma, who have relapsed >six months following platinum based therapy.

Produkt oppsummering:

Visual Identification: White or almost white lyophilisate; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

2009-07-28

Informasjon til brukeren

GEMCITABINE ACTAVIS/130307/CMI-1
1
GEMCITABINE ACTAVIS
_contains the active ingredient gemcitabine (as hydrochloride) _
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about GEMCITABINE
ACTAVIS.
It does not contain all of 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 being given
GEMCITABINE ACTAVIS against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with your
medicine. You may need to read it
again.
What GEMCITABINE
ACTAVIS is used for
GEMCITABINE ACTAVIS is used to
treat patients with:

lung cancer

cancer of the pancreas

bladder cancer

breast cancer

ovarian cancer.
GEMCITABINE ACTAVIS works by
killing cancer cells and preventing
cancer cells from growing and
multiplying. GEMCITABINE ACTAVIS
belongs to a group of medicines
called antineoplastic or cytotoxic
medicines. You may also hear of
these being called chemotherapy
medicines.
Your doctor may have prescribed
GEMCITABINE ACTAVIS for another
reason. Ask your doctor if you have
any questions about why
GEMCITABINE ACTAVIS has been
prescribed for you.
GEMCITABINE ACTAVIS may be used
in combination with other
cytotoxic medicines to treat
cancer.
Before you are given
GEMCITABINE ACTAVIS
_WHEN YOU MUST NOT TAKE IT _
YOU MUST NOT BE GIVEN
GEMCITABINE ACTAVIS IF YOU ARE
ALLERGIC TO MEDICINES CONTAINING
GEMCITABINE
OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
YOU MUST NOT BE GIVEN
GEMCITABINE ACTAVIS IF YOU
HAVE:

liver problems

kidney problems.
YOU MUST NOT BE GIVEN
GEMCITABINE ACTAVIS IF THE
EXPIRY DATE (EXP.) PRINTED ON THE
PACK HAS PASSED.
YOU MUST NOT BE GIVEN
GEMCITABINE ACTAVIS IF THE
PACKAGING IS TORN OR SHOWS SIGNS
OF TAMPERING.
_BEFORE YOU START TO TAKE IT _
TELL YOUR DOCTOR IF YOU ARE
ALLERGIC TO ANY OTHER MEDICINES,
FOODS, DYES OR PRES

Preparatomtale

Gemcitabine Actavis
POWDER FOR INJECTION
PRODUCT INFORMATION
NAME OF THE MEDICINE
Gemcitabine (as hydrochloride). The chemical name for gemcitabine
hydrochloride is 4-Amino-1-
(2-Deoxy-2,2-difluoro-ß-D-_erythro_-pentofuranosyl)pyrimidin-2(1_H_)-one
hydrochloride.
Its
structural formula is:
C
9
H
11
F
2
N
3
O
4
.HCl
Molecular weight: 299.7
CAS No.: 122111-03-9.
DESCRIPTION
Gemcitabine hydrochloride is a white or almost white powder, which is
soluble in water. The pH
value is 2 to 3 in aqueous solution at 10 mg/mL, and the pKa is 3.6.
GEMCITABINE ACTAVIS comes in three strengths of powder for injection
and contains either 200
mg, 1000 mg or 2000 mg of gemcitabine (as hydrochloride). It also
contains mannitol, sodium
acetate and sodium hydroxide may be added to adjust pH 3.0 ± 0.2.
PHARMACOLOGY
Gemcitabine exhibits significant cytotoxic activity against a variety
of cultured murine and human
tumour cells. It exhibits cell phase specificity, primarily killing
cells undergoing DNA synthesis (S-
phase) and, under certain conditions blocking progression of cells
through the GI/S-phase
boundary.
_In vitro_, the
cytotoxic
action
of gemcitabine is both concentration and time
dependent.
In animal tumour models, the antitumour activity of gemcitabine is
schedule dependent. When
administered daily gemcitabine causes death in animals with minimal
antitumour activity.
However, when an every third or fourth day dosing schedule is used,
gemcitabine can be given at
non-lethal doses and have excellent antitumour activity against a
broad range of mouse tumours.
Mechanism of Action: Gemcitabine (dFdC) is metabolised intracellularly
by nucleoside kinase to
the active diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides.
The cytotoxic action of
gemcitabine appears to be due to inhibition of DNA synthesis by two
actions of dFdCDP and
dFdCTP.
First,
dFdCDP
inhibits
ribonucleotide
reductase
which
is
uniquely
responsible
for
catalysing the reactions that generate the deoxynucleoside
triphosphates for DNA synthesis.
Inhibition of th