PACLITAXEL EBEWE paclitaxel 300 mg/50 mL concentrated injection vial

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

paclitaxel, Quantity: 300 mg

Dostępny od:

Sandoz Pty Ltd

Forma farmaceutyczna:

Injection, concentrated

Skład:

Excipient Ingredients: PEG-35 castor oil; ethanol

Droga podania:

Intravenous

Sztuk w opakowaniu:

50 mLx1 vial

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

Primary treatment of ovarian cancer in combination with a platinum agent. Treatment of metastatic ovarian cancer and breast cancer, after failure of standard therapy. Treatment of non-small cell lung cancer (NSCLC). 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 overexpress HER-2 and who have not received previous chemotherapy for their previous metastatic disease.

Podsumowanie produktu:

Visual Identification: clear concentraed solution for infusion; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status autoryzacji:

Licence status A

Data autoryzacji:

2005-02-14

Ulotka dla pacjenta

PACLITAXEL EBEWE
®
1
PACLITAXEL EBEWE
®
_paclitaxel _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Paclitaxel 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 risks and
benefits. Your doctor has weighed
the risks of you taking Paclitaxel
Ebewe against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
YOUR DOCTOR OR PHARMACIST CAN
PROVIDE YOU WITH MORE INFORMATION
ABOUT PACLITAXEL EBEWE.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT PACLITAXEL EBEWE
IS USED FOR
This medicine is used to treat:
•
Ovarian cancer
•
Breast cancer
•
Non-small cell lung cancer
(NSCLC).
This medicine belongs to a group of
medicines called antineoplastic or
cytotoxic medicines. You may also
hear of these being called
chemotherapy medicines.
It works by killing cancer cells and
stopping them from growing and
multiplying.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor’s prescription
_._
BEFORE YOU ARE GIVEN
PACLITAXEL EBEWE
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU MUST NOT BE GIVEN PACLITAXEL
EBEWE IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
paclitaxel
•
any of the ingredients listed at the
end of this leaflet
•
any medicines containing PEG-35
castor oil such as ciclosporin
injection or teniposide injection
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
YOU MUST NOT BE GIVEN THIS
MEDICINE IF YOU HAVE A VERY LOW
WHITE BLOOD CELL (WBC) COUNT.
TELL YOUR DOCTOR IF YOU HAVE AN
INFECTION OR HIGH TEMPERATURE.
Your d

Charakterystyka produktu

201222-paclitaxel-ebewe-pi
Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION
PACLITAXEL EBEWE
® (PACLITAXEL) CONCENTRATED INJECTION
1.
NAME OF THE MEDICINE
Paclitaxel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL of Paclitaxel Ebewe
®
concentrated injection contains 6 mg of paclitaxel.
_Excipient with known effect:_
Ethanol.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Injection, concentrated.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Primary treatment of ovarian cancer in combination with a platinum
agent.
Treatment of metastatic ovarian cancer and metastatic breast cancer,
after failure of standard
therapy.
Treatment of non-small cell lung cancer (NSCLC).
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 overexpress HER-2 and who have not
received previous
chemotherapy for their metastatic disease.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
Product is for single use in one patient only.
All
patients
must be
premedicated before
paclitaxel
is
administered to
prevent
severe
hypersensitivity reactions (see Section 4.4 Special warnings and
precautions for use). Such
premedication may consist of dexamethasone 20 mg orally (or its
equivalent), approximately
12 and 6 hours prior to starting the paclitaxel infusion; promethazine
25 mg or 50 mg
intravenously or other suitable H1-antagonist, 30 minutes prior to
starting the paclitaxel
infusion; and cimetidine 300 mg or ranitidine 50 mg by intravenous
infusion over 15 minutes,
starting 30 minutes prior to the paclitaxel infusion.
Repeat courses of Paclitaxel Ebewe Injection Concentrate should not be
administered to
patients with solid tumors until the neutrophil count is at least 1.5
x 10
9
cells/L and the platelet
count is at least 100 x 10
9
cells/L. Patients who experience severe neutropenia (< 0.5 x 10
9
cells/L) or severe