Caelyx pegylated liposomal

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

doxorubicin hydrochloride

Saatavilla:

Baxter Holding B.V.

ATC-koodi:

L01DB

INN (Kansainvälinen yleisnimi):

doxorubicin

Terapeuttinen ryhmä:

Antineoplastic agents

Terapeuttinen alue:

Sarcoma, Kaposi; Multiple Myeloma; Ovarian Neoplasms; Breast Neoplasms

Käyttöaiheet:

Caelyx pegylated liposomal is indicated:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk;for treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen;in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant;for treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (

Tuoteyhteenveto:

Revision: 36

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

1996-06-20

Pakkausseloste

31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE USER
CAELYX PEGYLATED LIPOSOMAL 2 MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
doxorubicin hydrochloride
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 pharmacist.
-
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 pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Caelyx pegylated liposomal is and what it is used for
2.
What you need to know before you use Caelyx pegylated liposomal
3.
How to use Caelyx pegylated liposomal
4.
Possible side effects
5
How to store Caelyx pegylated liposomal
6.
Contents of the pack and other information
1.
WHAT CAELYX PEGYLATED LIPOSOMAL IS AND WHAT IT IS USED FOR
Caelyx pegylated liposomal is an antitumour agent.
Caelyx pegylated liposomal is used to treat cancer of the breast in
patients at risk for heart problems.
Caelyx pegylated liposomal is also used to treat cancer of the ovary.
It is used to kill cancer cells,
shrink the size of the tumour, delay the growth of the tumour, and
extend your survival.
Caelyx pegylated liposomal is also used in combination with another
medicine, bortezomib, to treat
multiple myeloma (a cancer of the blood) in patients who have received
at least 1 prior therapy.
Caelyx pegylated liposomal is also used to produce an improvement in
your Kaposi’s sarcoma
including flattening, lightening and even shrinkage of the cancer.
Other symptoms of Kaposi’s
sarcoma, such as swelling around the tumour, may also improve or
disappear.
Caelyx pegylated liposomal contains a medicine which is able to
interact with cells in such a way as to
selectively kill cancer cells. The doxorubicin hydrochlor

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Caelyx pegylated liposomal 2 mg/ml concentrate for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of Caelyx pegylated liposomal contains 2 mg doxorubicin
hydrochloride in a pegylated
liposomal formulation.
Caelyx pegylated liposomal is doxorubicin hydrochloride encapsulated
in liposomes with
surface-bound methoxypolyethylene glycol (MPEG). This process is known
as pegylation and protects
liposomes from detection by the mononuclear phagocyte system (MPS),
which increases blood
circulation time.
Excipients with known effect
Contains fully hydrogenated soy phosphatidylcholine (from soyabean)
– see section 4.3.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate)
The dispersion is sterile, translucent and red.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Caelyx pegylated liposomal is indicated:
-
As monotherapy for patients with metastatic breast cancer, where there
is an increased cardiac
risk.
-
For treatment of advanced ovarian cancer in women who have failed a
first-line platinum-based
chemotherapy regimen.
-
In combination with bortezomib for the treatment of progressive
multiple myeloma in patients
who have received at least one prior therapy and who have already
undergone or are unsuitable
for bone marrow transplant.
-
For treatment of
AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4
counts
(< 200 CD4 lymphocytes/mm
3
) and extensive mucocutaneous or visceral disease.
Caelyx pegylated liposomal may be used as first-line systemic
chemotherapy, or as second line
chemotherapy in AIDS-KS patients with disease that has progressed
with, or in patients intolerant to,
prior combination systemic chemotherapy comprising at least two of the
following agents: a vinca
alkaloid, bleomycin and standard
_ _
doxorubicin (or other anthracycline).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Caelyx pegylated liposomal should on