OXALIPLATIN ACCORD oxaliplatin 50 mg/10 mL concentrated injection vial

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

oxaliplatin, Quantity: 50 mg

थमां उपलब्ध:

Accord Healthcare Pty Ltd

फार्मास्यूटिकल फॉर्म:

Injection, concentrated

रचना:

Excipient Ingredients: water for injections

प्रशासन का मार्ग:

Intravenous Infusion

पैकेज में यूनिट:

1 vial

प्रिस्क्रिप्शन प्रकार:

(S4) Prescription Only Medicine

चिकित्सीय संकेत:

Oxaliplatin, in combination with fluorouracil and folinic acid, is indicated for: Adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of the primary tumour; Treatment of advanced colorectal cancer.

उत्पाद समीक्षा:

Visual Identification: A clear, colourless solution in a clear glass vial. When examined under suitable conditions of visibility it should be practically free from visible particles.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2021-04-30

सूचना पत्रक

Oxaliplatin Accord – version 2.0
1
OXALIPLATIN ACCORD
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I BEING GIVEN OXALIPLATIN ACCORD?
Oxaliplatin Accord contains the active ingredient oxaliplatin.
Oxaliplatin Accord is used to treat cancer of the large intestine
and rectum (colorectal cancer). It is used in combination with other
anti-cancer drugs; fluorouracil and folinic acid. Oxaliplatin
Accord is not recommended in children.
For more information, see Section 1. Why am I using Oxaliplatin
Accord?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN OXALIPLATIN ACCORD?
Do not use if you have ever had an allergic reaction to Oxaliplatin,
any of the ingredients listed at the end of the CMI or other
platinum compound.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become
pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I am
given Oxaliplatin Accord?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines and Oxaliplatin may interfere with each other and may
affect how well each medicine works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW WILL I BE GIVEN OXALIPLATIN ACCORD?
Oxaliplatin Accord will be given to you by a doctor or a nurse as an
infusion into one of your veins.
More instructions can be found in Section 4. How will I be given
Oxaliplatin Accord?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN OXALIPLATIN ACCORD?
THINGS YOU
SHOULD DO
•
Be sure to keep all your doctor's appointments
•
Tell your doctor if you do not feel well between courses of
oxaliplatin
•
If you suffer from persistent or severe diarrhoea or vomiting, contact
your doctor urgently for
treatment advice
•
Tell your doctor if you notice any bruising or abnormal bleeding
•
Avoid cold foods and drin

उत्पाद विशेषताएं

Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
OXALIPLATIN ACCORD (OXALIPLATIN) CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Oxaliplatin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxaliplatin
Accord,
concentrated
injection
is
presented
in
vials
containing
50
mg/10
mL
and
100 mg/20 mL oxaliplatin.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Oxaliplatin Accord, concentrated injection is a clear, colourless
solution in a clear glass vial.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Oxaliplatin in combination with fluorouracil and folinic acid is
indicated for:
•
Adjuvant treatment of stage III (Duke's C) colon cancer after complete
resection of the primary
tumour
•
Treatment of advanced colorectal cancer
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
In combination with fluorouracil and folinic acid the recommended dose
for the treatment of advanced
colorectal cancer is 85 mg/m
2
intravenously repeated every two weeks.
In combination with fluorouracil and folinic acid the recommended dose
for adjuvant treatment is 85
mg/m
2
intravenously repeated every two weeks for 12 cycles (6 months).
DOSAGE MODIFICATION
Prior to each treatment cycle, patients should be evaluated for
toxicity and the dose of oxaliplatin adjusted
accordingly.
_NEUROLOGICAL TOXICITY _
If acute neurological reactions occur e.g. acute pharyngolaryngeal
dysaesthesia, increase the oxaliplatin
infusion time from 2 hours to 6 hours. This decreases C
max
by 30% and may lessen acute toxicities.
If sensory loss or paraesthesia persists longer than 7 days or
interferes with function (grade 2 toxicity),
reduce oxaliplatin dose by 25%.
If sensory loss or paraesthesia interferes with activities of daily
living (grade 3 toxicity), oxaliplatin
should be discontinued.
_HAEMATOLOGICAL TOXICITY _
If haematological toxicity (neutrophils <1.5x10
9
/L or platelets <75x10
9
/L) is present before starting
treatment or prior to the next course:
•
Delay treatment until neutrophil count is ≥1.5x10
9
/L and platele