Pazenir

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

paclitaxel

Saatavilla:

ratiopharm GmbH

ATC-koodi:

L01CD01

INN (Kansainvälinen yleisnimi):

paclitaxel

Terapeuttinen ryhmä:

Antineoplastic agents

Terapeuttinen alue:

Breast Neoplasms

Käyttöaiheet:

Pazenir 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.Pazenir 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.

Tuoteyhteenveto:

Revision: 7

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2019-05-06

Pakkausseloste

40
B. PACKAGE LEAFLET
41
PACKAGE LEAFLET: INFORMATION FOR THE USER
PAZENIR 5 MG/ML POWDER FOR DISPERSION 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 Pazenir is and what it is used for
2.
What you need to know before you are given Pazenir
3.
How to use Pazenir
4.
Possible side effects
5.
How to store Pazenir
6.
Contents of the pack and other information
1.
WHAT PAZENIR IS AND WHAT IT IS USED FOR
WHAT PAZENIR IS
Pazenir 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 Pazenir.
WHAT PAZENIR IS USED FOR
Pazenir 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).
•
Pazenir 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�

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Pazenir 5 mg/ml powder for dispersion for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg of paclitaxel formulated as albumin bound
nanoparticles.
After reconstitution, each ml of dispersion contains 5 mg of
paclitaxel formulated as albumin bound
nanoparticles.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for dispersion for infusion.
The reconstituted dispersion 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
Pazenir 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).
Pazenir in combination with gemcitabine is indicated for the
first-line treatment of adult patients with
metastatic adenocarcinoma of the pancreas.
Pazenir 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
Pazenir 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 Pazenir 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 < 500
cells/mm
3
for a week or longer) or
severe sensory neuropathy during Pazenir therapy should have the dose
reduced to 220 mg/m
2
for
subsequent courses. Following recurrence of severe neutropenia or
severe sensory neuropathy,
3
additional dose reduction should be made to 180 mg