Abraxane 100mg powder for suspension for infusion vials

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Paclitaxel albumin

Beszerezhető a:

Celgene Ltd

INN (nemzetközi neve):

Paclitaxel albumin

Adagolás:

100mg

Gyógyszerészeti forma:

Powder for suspension for infusion

Az alkalmazás módja:

Intravenous

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 08010500; GTIN: 7640133683133

Betegtájékoztató

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ABRAXANE 5 MG/ML POWDER FOR SUSPENSION FOR INFUSION
paclitaxel
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Abraxane is and what it is used for
2.
What you need to know before you are given Abraxane
3.
How to use Abraxane
4.
Possible side effects
5.
How to store Abraxane
6.
Contents of the pack and other information
1.
WHAT ABRAXANE IS AND WHAT IT IS USED FOR
WHAT ABRAXANE IS
Abraxane contains, as its active substance, paclitaxel attached to the
human protein albumin, in the form
of tiny particles known as nanoparticles. Paclitaxel belongs to a
group of medicines called “taxanes” used
in cancer.

Paclitaxel is the part of the medicine that affects the cancer, it
works by stopping cancer cells from
dividing – this means that they die.

Albumin is the part of the medicine that helps paclitaxel dissolve in
the blood and get across the
walls of the blood vessels into the tumour. This means that other
chemicals that can cause side
effects that can be life threatening are not needed. Such side effects
occur far less with Abraxane.
WHAT ABRAXANE IS USED FOR
Abraxane is used to treat the following types of cancer:
Breast Cancer

Breast cancer which has spread to other parts of the body (this is
called “metastatic” breast cancer).

Abraxane is used in metastatic breast cancer when at least one other
therapy has been tried but has
not worked and you are unsuitable for treatments containing a group of
medicines called
“anthracyclines”.

Peop

Termékjellemzők

OBJECT 1
ABRAXANE 5 MG/ML POWDER FOR SUSPENSION FOR
INFUSION
Summary of Product Characteristics Updated 11-Jun-2018 | Celgene Ltd
1. Name of the medicinal product
Abraxane 5 mg/ml powder for suspension for infusion.
2. Qualitative and quantitative composition
Each vial contains 100 mg of paclitaxel formulated as albumin bound
nanoparticles.
Each vial contains 250 mg of paclitaxel formulated as albumin bound
nanoparticles.
After reconstitution, each ml of suspension contains 5 mg of
paclitaxel formulated as albumin bound
nanoparticles.
Excipients with known effect
Each ml of concentrate contains 0.183 mmol sodium, which is 4.2 mg of
sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for suspension for infusion.
The reconstituted suspension has a pH of 6-7.5 and an osmolality of
300-360 mOsm/kg.
The powder is white to yellow.
4. Clinical particulars
4.1 Therapeutic indications
Abraxane monotherapy is indicated for the treatment of metastatic
breast cancer in adult patients who
have failed first-line treatment for metastatic disease and for whom
standard, anthracycline containing
therapy is not indicated (see section 4.4).
Abraxane in combination with gemcitabine is indicated for the
first-line treatment of adult patients with
metastatic adenocarcinoma of the pancreas.
Abraxane in combination with carboplatin is indicated for the
first-line treatment of non-small cell lung
cancer in adult patients who are not candidates for potentially
curative surgery and/or radiation therapy.
4.2 Posology and method of administration
Abraxane should only be administered under the supervision of a
qualified oncologist in units specialised
in the administration of cytotoxic agents. It should not be
substituted for or with other paclitaxel
formulations.
Posology
_Breast cancer _
The recommended dose of Abraxane is 260 mg/m
2
administered intravenously over 30 minutes every 3
weeks.
_Dose adjustments during treatment of breast cancer_
Patients who experience severe neutropenia (neutrophil count < 5