Myocet liposomal (previously Myocet)

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

doxorubicin hydrochloride

Saadav alates:

Teva B.V.

ATC kood:

L01DB01

INN (Rahvusvaheline Nimetus):

doxorubicin

Terapeutiline rühm:

Antineoplastic agents

Terapeutiline ala:

Breast Neoplasms

Näidustused:

Myocet liposomal, in combination with cyclophosphamide, is indicated for the first-line treatment of metastatic breast cancer in adult women.

Toote kokkuvõte:

Revision: 24

Volitamisolek:

Authorised

Loa andmise kuupäev:

2000-07-13

Infovoldik

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
MYOCET LIPOSOMAL 50 MG POWDER, DISPERSION AND SOLVENT FOR CONCENTRATE
FOR DISPERSION FOR
INFUSION
Liposomal 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, pharmacist 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 Myocet liposomal is and what it is used for
2.
What you need to know before you are given Myocet liposomal
3.
How Myocet liposomal is given
4.
Possible side effects
5.
How to store Myocet liposomal
6.
Contents of the pack and other information
1.
WHAT MYOCET LIPOSOMAL IS AND WHAT IS IT USED FOR
Myocet liposomal contains a medicine called “doxorubicin”, which
damages tumour cells. This type
of medicine is called “chemotherapy”. The medicine is contained
inside very small droplets of fat
called “liposomes”.
Myocet liposomal is used in adult women for the first-line treatment
of breast cancer that has spread
(“metastatic breast cancer”). It is used with another medicine
called “cyclophosphamide”. Please also
read the patient information leaflet carefully that comes with that
medicine.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MYOCET LIPOSOMAL
DO NOT HAVE MYOCET LIPOSOMAL:
•
if you are allergic to doxorubicin or any of the other ingredients of
this medicine (listed in section
6).
Do not have Myocet liposomal if this applies to you. If you are not
sure, talk to your doctor or nurse
before having Myocet liposomal.
WARNING AND PRECAUTIONS
Talk to your doctor or nurse before having Myocet liposomal.
Check with your doctor or nurse b

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Myocet liposomal 50 mg powder, dispersion and solvent for concentrate
for dispersion for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Liposome–encapsulated doxorubicin–citrate complex corresponding to
50 mg doxorubicin
hydrochloride (HCl).
Excipient(s) with known effect: The reconstituted medicinal product
contains approximately 108 mg
sodium for a 50 mg doxorubicin HCl dose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder, dispersion and solvent for concentrate for dispersion for
infusion
Myocet liposomal is supplied as a three-vial system as follows:
Vial 1 - doxorubicin HCl is a red lyophilised powder.
Vial 2 - liposomes is a white to off-white, opaque and homogeneous
dispersion.
Vial 3 - buffer is a clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Myocet liposomal, in combination with cyclophosphamide, is indicated
for the first line treatment of
metastatic breast cancer in adult women.
_ _
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The use of Myocet liposomal should be confined to units specialised in
the administration of cytotoxic
chemotherapy and should only be administered under the supervision of
a physician experienced in the
use of chemotherapy.
Posology
When Myocet liposomal is administered in combination with
cyclophosphamide (600 mg/m
2
) the
initial recommended dose of Myocet liposomal is 60-75 mg/m
2
every three weeks.
_Older people _
Safety and efficacy of Myocet liposomal have been assessed in 61
patients with metastatic breast
cancer, age 65 and over. Data from randomised controlled clinical
trials show that the efficacy and
cardiac safety of Myocet liposomal in this population was comparable
to that observed in patients less
than 65 years old.
_Patients with hepatic impairment _
As metabolism and excretion of doxorubicin occurs primarily by the
hepatobiliary route, evaluation of
hepatobiliary function should be performed before and durin