Oxaliplatin Juno oxaliplatin 50mg/10mL concentrated injection vial

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

oxaliplatin, Quantity: 50 mg

Dostupné z:

Juno Pharmaceuticals Pty Ltd

INN (Medzinárodný Name):

Oxaliplatin

Forma lieku:

Injection, concentrated

Zloženie:

Excipient Ingredients: water for injections

Spôsob podávania:

Intravenous Infusion

Počet v balení:

1

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

Oxaliplatin is indicated for adjuvant treatment of stage III (Duke?s C) colon cancer, in combination with fluoropyrimidine agent.,Oxaliplatin in combination with fluorouracil and folinic acid is indicated for the treatment of advanced colorectal cancer.,Oxaliplatin in combination with capecitabine, with or without bevacizumab, is indicated for the treatment of patients with metastatic colorectal cancer.,Oxaliplatin in combination with epirubicin and either capecitabine or fluorouracil, is indicated for: the treatment of patients with advanced oesophagogastric cancer

Prehľad produktov:

Visual Identification: a sterile, colourless, clear, aqueous solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizácia:

Licence status A

Dátum Autorizácia:

2016-05-24

Príbalový leták

Oxaliplatin Juno Concentrated Injection
1
OXALIPLATIN JUNO
CONCENTRATED INJECTION
SOLUTION FOR INFUSION
_Contains the active ingredient oxaliplatin _
CONSUMER MEDICINE INFORMATION
_ _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about oxaliplatin. It does
not contain all the available information. It does not take
the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on
the last page. More recent information on this medicine may
be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not understand in this leaflet,
•
if you are worried about taking your medicine, or
•
to obtain the most up-to-date information.
You can also download the most up- to-date leaflet from
www.apotex.com.au.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using this medicine against the benefits they
expect it will have for you.
Pharmaceutical companies cannot give you medical advice or an
individual diagnosis.
Keep this leaflet. You may want to read it again.
WHAT THIS MEDICINE IS USED FOR
The name of your medicine is Oxaliplatin Juno concentrated injection
solution for infusion. It contains the active ingredient
oxaliplatin.
It is used to treat cancer of the oesophagus/stomach, large intestine
and rectum (colorectal cancer). Oxaliplatin is used in
combination with other anti-cancer drugs; capecitabine, bevacizumab,
epirubicin, fluorouracil (FU), and/or folinic acid.
Cancer cells are normal cells which have changed so that they grow in
an uncontrolled way. Oxaliplatin works by interfering
with cancer cell growth. Because of the similarities between cancer
cells and normal cells, anti-cancer drugs often have
unwanted effects on the body.
Your doctors have decided to treat you with oxaliplatin because they
believe that the benefit of oxaliplatin treatment will be
greater than the unwanted effects.
Many of the side effects from anti-cancer drugs are predictable and
can be prevented or lessened.

Súhrn charakteristických

1
AUSTRALIAN PRODUCT INFORMATION
OXALIPLATIN JUNO (OXALIPLATIN) CONCENTRATED
INJECTION SOLUTION FOR INFUSION
1
NAME OF THE MEDICINE
Oxaliplatin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of concentrated injection solution for infusion contains 50
mg/10 mL, 100 mg/20 mL
or 200 mg/40 mL oxaliplatin, as the active ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Concentrated injection solution for infusion: A sterile, colourless,
clear, aqueous solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oxaliplatin is indicated for adjuvant treatment of stage III (Duke’s
C) colon cancer, in
combination with fluoropyrimidine agent.
Oxaliplatin in combination with fluorouracil and folinic acid is
indicated for the treatment of
advanced colorectal cancer.
Oxaliplatin in combination with capecitabine, with or without
bevacizumab, is indicated for the
treatment of patients with metastatic colorectal cancer.
Oxaliplatin in combination with epirubicin and either capecitabine or
fluorouracil, is indicated
for: the treatment of patients with advanced oesophagogastric cancer.
4.2
DOSE AND METHOD OF ADMINISTRATION
Oxaliplatin Juno concentrated injection solution for infusion is for
intravenous infusion.
DOSAGE
In combination with fluorouracil and folinic acid for adjuvant
treatment of colon cancer, the
recommended dose of oxaliplatin is 85 mg/m
2
intravenously repeated every two weeks for 12
cycles (6 months).
In combination with capecitabine for adjuvant treatment of colon
cancer, the recommended
dose of oxaliplatin is 130 mg/m
2
, administered as an intravenous infusion over 2 hours on day
1 of a three week cycle. For the recommended doses of capecitabine see
section 5.1
PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS.
In combination with fluorouracil and folinic acid for the treatment of
advanced colorectal cancer,
the recommended dose of oxaliplatin is 85 mg/m
2
intravenously repeated every two weeks.
In combination with capecitabine with or without bevacizumab