PACLITAXEL ACCORD paclitaxel 300 mg/50 mL concentrated injection vial

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

paclitaxel, Quantity: 300 mg

Prieinama:

Accord Healthcare Pty Ltd

INN (Tarptautinis Pavadinimas):

Paclitaxel

Vaisto forma:

Injection, concentrated

Sudėtis:

Excipient Ingredients: PEG-35 castor oil; ethanol absolute

Vartojimo būdas:

Intravenous Infusion

Vienetai pakuotėje:

1

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

- Primary treatment of ovarian cancer in combination with a platinum agent. - Treatment of metastatic carcinoma of the ovary after failure of standard therapy. - Treatment of metastatic carcinoma of the breast after failure of standard therapy. - Adjuvant treatment of node-positive breast cancer administered sequentially to doxorubicin and cyclophosphamide. - Treatment of metastatic cancer of the breast, in combination with trastuzumab (Herceptin), in patients who have tumours that over-express HER-2 and who have not received previous chemotherapy for their metastatic disease. - in combination with gemcitabine (Gemzar), 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. - for the treatment of non-small cell lung cancer (NSCLC).

Produkto santrauka:

Visual Identification: A clear, colorless to slightly yellow solution in a clear glass vial with flip off seal.; 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

Autorizacija statusas:

Licence status A

Leidimo data:

2016-02-02

Pakuotės lapelis

Paclitaxel Accord - version 5
1
PACLITAXEL 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 USING PACLITAXEL ACCORD?
Paclitaxel Accord contains the active ingredient paclitaxel.
Paclitaxel Accord is used to treat cancer of the ovary, the breast,
and non small cell cancer of the lung. Paclitaxel Accord may be used
alone or in combination with other anticancer agents.
For more information, see Section 1. Why am I using Paclitaxel Accord?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PACLITAXEL ACCORD?
Do not use if you are allergic to paclitaxel, other medicines similar
to paclitaxel called taxanes, any of the ingredients listed at
the end of this leaflet or any medicines containing PEG-35 castor oil.
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’m
given Paclitaxel Accord?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Paclitaxel Accord and affect how it
works.
See Section 3. What if I am taking other medicines?
in the full CMI.
4.
HOW DO I USE PACLITAXEL ACCORD?
Paclitaxel Accord is an injection and will be given to you by your
doctor.
More instructions can be found in Section 4. How is Paclitaxel Accord
given?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PACLITAXEL ACCORD?
THINGS YOU
SHOULD DO
•
Tell any other doctors, nurses, surgeons, dentists or pharmacists who
treat you that you are taking this
medicine
•
Tell your doctor immediately If you or your partner become pregnant
while taking this medicine
•
Tell your doctor if you experience any of the side effects listed in
the CMI
•
Keep all of your doctor's appointments so that your progress can be
checked
•
You should wear sun protection after receiving treatment
THINGS YOU
SHOULD NOT

Prekės savybės

Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
PACLITAXEL ACCORD (PACLITAXEL) CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Paclitaxel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL contains 6 mg paclitaxel.
1 vial of 5 mL concentrated injection for infusion contains 30 mg
paclitaxel.
1 vial of 16.7 mL concentrated injection for infusion contains 100 mg
paclitaxel.
1 vial of 50 mL concentrated injection for infusion contains 300 mg
paclitaxel.
Excipients with known effect: absolute ethanol (49.5% v/v). For the
full list of excipients, see
SECTION
6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Paclitaxel Accord Concentrate for Intravenous Infusion is supplied as
a nonaqueous solution intended
for dilution with 0.9% Sodium Chloride Injection or 5% Glucose
Injection prior to intravenous infusion.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
1.
Paclitaxel is indicated for the primary treatment of ovarian cancer in
combination with a platinum
agent.
2.
Paclitaxel is indicated for the treatment of metastatic carcinoma of
the ovary after failure of standard
therapy.
3.
Paclitaxel is indicated for the treatment of metastatic carcinoma of
the breast after failure of
standard therapy.
4.
Paclitaxel
is
indicated
for
adjuvant
treatment
of
node-positive
breast
cancer
administered
sequentially to doxorubicin and cyclophosphamide.
5.
Paclitaxel is indicated for the treatment of metastatic cancer of the
breast, in combination with
trastuzumab (Herceptin
®
), in patients who have tumours that over-express HER-2 and who have
not received previous chemotherapy for their metastatic disease.
6.
Paclitaxel, in combination with gemcitabine (Gemzar
®
), 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.
7.
Paclitaxel is indicated for the treatment of non-small cell lung
cancer (NSCLC).
4.2
D
OSE AND METHOD OF ADMINISTRATI