CAELYX

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

DOXORUBICIN HYDROCHLORIDE

Disponível em:

J-C HEALTH CARE LTD

Código ATC:

L01DB01

Forma farmacêutica:

LIPOSOME CONCENTRATE FOR SOLUTION FOR INFUSION

Composição:

DOXORUBICIN HYDROCHLORIDE 2.0 MG/ML

Via de administração:

I.V

Tipo de prescrição:

Required

Fabricado por:

JANSSEN PHARMACEUTICA N.V.,BELGIUM

Grupo terapêutico:

DOXORUBICIN

Área terapêutica:

DOXORUBICIN

Indicações terapêuticas:

First or second line therapy of aids related kaposis sarcoma in patients with low cd 4 counts and extensive mucocutaneous or visceral disease The treatment of patients with metastatic carcinoma of the ovary who are refractory to both paclitaxel and platinium-based chemotherapy regimens and who may also be refractory to topotecan. Refractory is defined as a patient having progressive disease while on treatment or within 6 months of completing treatmnt. As monotherapy for patients with metastatic breast cancer where there is an increased cardiac risk. In combination with bortezomib for the treatment of progressive multiplemyeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.

Data de autorização:

2013-06-30

Folheto informativo - Bula

Kibbutz Shefayim, 6099000
ISRAEL
Phone: [phone] Fax: [phone]
טסוגוא
2018
ה/דבכנ ה/אפור
ת/חקור
/דבכנ
ה
וננוצרב
איבהל
םכתעידיל
תא
םינוכדעה
ןולעב
אפורל
לש
רישכתה
:
CAELYX
L
/M
MG
.0
2
DOXORUBICIN HYDROCHLORIDE
היוותהל רשואמה
:
Caelyx is indicated
- As monotherapy for patients with metastatic breast cancer, where
there is an increased
cardiac risk.
- The treatment of patients with metastatic carcinoma of the ovary who
are refractory to both
paclitaxel and platiniumbased chemotherapy regimens and who may also
be refractory to
topotecan. Refractory is defi ned as a patient having progressive
disease while on treatment, or
within 6 months of completing treatment.
- 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
and extensive mucocutaneous or visceral disease.
אפורל ןולעב םייתוהמה םייונישה
םיעיפומ
:םיאבה םיפיעסב
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of Caelyx contains 2 mg doxorubicin hydrochloride in a
pegylated liposomal
formulation
Caelyx, a liposome formulation, is doxorubicin hydrochloride
encapsulated in liposomes with
surfacebound 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
Contains less than 1 mmol sodium (23 mg) per dose, and is essentially
‘sodium-free’.
For a full list of excipients, see section 6.1.
4.3 CONTRAINDICATION
Hypersensitivity to the active substance , peanut or soya, or to any
of the excipients listed in
section 6.1.
Caelyx should not

Características técnicas

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CAELYX_NOV_2019
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1. NAME OF THE MEDICINAL PRODUCT
Caelyx
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of Caelyx contains 2 mg doxorubicin hydrochloride in a
pegylated liposomal formulation
Caelyx, a liposome formulation, is doxorubicin hydrochloride
encapsulated in liposomes with surfacebound
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
Contains less than 1 mmol sodium (23 mg) per dose, and is essentially
‘sodium-free’.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Liposome Concentrate for solution for infusion
The suspension is sterile, translucent and red
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Caelyx is indicated:
- As monotherapy for patients with metastatic breast cancer, where
there is an increased cardiac risk.
- The treatment of patients with metastatic carcinoma of the ovary who
are refractory to both paclitaxel and platiniumbased
chemotherapy regimens and who may also be refractory to topotecan.
Refractory is defined as a patient having progressive
disease while on treatment, or within 6 months of completing
treatment.
- 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 and extensive mucocutaneous or
visceral disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Caelyx should only be administered under the supervision of a
qualified oncologist specialized in the administration of
cytotoxic agents.
Caelyx exhibits unique pharmacokinetic properties and must not be used
interchangeably with other formulations of
doxorubicin hydrochlorid