Abraxane
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
19-06-2023
Summary of Product characteristics
(SPC)
19-06-2023
Active ingredient:
Paclitaxel 100mg (nanoparticle albumin-bound);
Available from:
Celgene Limited
INN (International Name):
Paclitaxel 100 mg (nanoparticle albumin-bound)
Dosage:
100 mg
Pharmaceutical form:
Powder for injection
Composition:
Active: Paclitaxel 100mg (nanoparticle albumin-bound) Excipient: Albumin
Units in package:
Vial, glass, 50 mL Type I 20 mm with bromobutyl rubber stopper and flip-cap aluminium crimp seal, 1 dose unit
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
ScinoPharm Taiwan Ltd
Therapeutic indications:
Abraxane is indicated for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy.
Product summary:
Package - Contents - Shelf Life: Vial, glass, 50 mL Type I 20 mm with chlorobutyl rubber stopper and flip-cap aluminium crimp seal - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Should be used immediately but can be stored if required - Vial, glass, 50 mL Type I 20 mm with bromobutyl rubber stopper and flip-cap aluminium crimp seal - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Should be used immediately but can be stored if required
Authorization date:
2009-06-11
Patient Information leaflet
20221215_ABX_CMI_AUNZ
1
ABRAXANE
_Paclitaxel (pak-li-TAX-el) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ABRAXANE.
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 being given
ABRAXANE against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR. YOUR DOCTOR OR PHARMACIST
CAN PROVIDE YOU WITH MORE
INFORMATION ABOUT ABRAXANE.
KEEP THIS LEAFLET
You may need to read it again.
WHAT ABRAXANE IS
USED FOR
This medicine is used to treat:
•
Breast cancer
•
Lung Cancer
•
Pancreatic Cancer
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 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
ABRAXANE
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU MUST NOT BE GIVEN
ABRAXANE IF YOU HAVE AN ALLERGY
TO:
•
any medicine containing
paclitaxel
•
any of the ingredients listed at the
end of this leaflet
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 doctor may decide to delay
your treatment until the infection is
gone. A mild illness, such as a cold,
is not usually a reason to delay
treatment.
YOU MUST NOT BE GIVEN THIS
MEDICINE IF YOU HAVE SEVERE LIVER
DAMAGE.
Read the complete document
Summary of Product characteristics
20230518_ABX_PI_NZ
1
PRODUCT INFORMATION
ABRAXANE (NANOPARTICLE ALBUMIN-BOUND PACLITAXEL)
1
NAME OF THE MEDICINE
nanoparticle albumin-bound paclitaxel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ABRAXANE (nanoparticle albumin-bound paclitaxel) powder for injection
(suspension) is an
albumin nanoparticle form of paclitaxel
with a mean particle size of approximately 130 nanometres.
Paclitaxel exists in the nanoparticles in a non-crystalline, amorphous
state. Each vial of ABRAXANE
contains paclitaxel and human albumin in the ratio of 1:9. The
paclitaxel is contained within
nanoparticles that consist of a majority of paclitaxel bound to human
albumin.
Each single-use vial contains the following: Paclitaxel 100 mg
ABRAXANE is free of solvents.
The reconstituted medicinal product contains approximately 85 mg
sodium per vial when
reconstituted with 0.9% sodium chloride.
The active agent in ABRAXANE is paclitaxel, a natural product with
antitumour activity. Paclitaxel
is obtained from
_Taxus media_
.
Excipient(s) with known effect
Not applicable. For the full list of excipients, see
_SECTION 6.1 LIST OF EXCIPIENTS. _
_ _
3
PHARMACEUTICAL FORM
ABRAXANE is supplied as a white to yellow, sterile, lyophilised powder
in a 50 mL glass vial.
Paclitaxel is a white to off-white crystalline powder with a molecular
weight of 853.91. It is highly
lipophilic, insoluble in water.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
METASTATIC BREAST CANCER
ABRAXANE is indicated for the treatment of metastatic carcinoma of the
breast after failure of
anthracycline therapy.
NON-SMALL CELL LUNG CANCER
ABRAXANE, in combination with carboplatin, is indicated for the
first-line treatment of non-small
cell lung cancer in patients who are not candidates for potentially
curative surgery and/or radiation.
METASTATIC ADENOCARCINOMA OF THE PANCREAS
ABRAXANE, in combination with gemcitabine, is indicated for the
first-line treatment of patients
with metastatic adenocarcinoma of the pancreas.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The reconstituted s
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