MYOCET 50 MG

Country: Israel

Bahasa: Inggeris

Sumber: Ministry of Health

Bahan aktif:

DOXORUBICIN HYDROCHLORIDE

Boleh didapati daripada:

MEDISON PHARMA LTD

Kod ATC:

L01DB01

Borang farmaseutikal:

POWDER,DISPERSION AND SOLVENT FOR CONCENTRATE FOR DISPERSION FOR INFUSION

Komposisi:

DOXORUBICIN HYDROCHLORIDE 50 MG VIALS

Laluan pentadbiran:

I.V

Jenis preskripsi:

Required

Dikeluarkan oleh:

GP-PHARM POLIGON INDUSTIRAL ELS VINYETS-ELS FOGARS, SPAIN

Kumpulan terapeutik:

DOXORUBICIN

Kawasan terapeutik:

DOXORUBICIN

Tanda-tanda terapeutik:

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

Tarikh kebenaran:

2016-01-31

Risalah maklumat

– )תוחיטב עדימ ( הרמחה לע העדוה
אפורל ןולע
:ךיראת
30.12.2013
:תילגנאב רישכת םש
MYOCET
:םושיר רפסמ
145-22-33081-00
מ"עב המראפ ןוסידמ :םושירה לעב םש
ןולעב םייונישה
בוהצ עקר לע םינמוסמ
אפורל ןולעב
םי/שקובמה םי/יונישה לע םיטרפ
ןולעב קרפ
יחכונ טסקט
שדח טסקט
4.8
UNDESIRABLE
EFFECTS
SKIN AND SUBCUTANEOUS TISSUE
DISORDERS
Alopecia
Very
Comm
on
Comm
on
Rash
Comm
on
Not
known
Nail
disorder
Comm
on
Uncom
mon
Pruritus
Uncom
mon
Uncom
mon
Folliculitis
Uncom
mon
Uncom
mon
Dry skin
Uncom
mon
Not
known
SKIN AND SUBCUTANEOUS TISSUE
DISORDERS
Alopecia
Very
Comm
on
Comm
on
Rash
Comm
on
Not
known
Palmar-
plantar
erythrodysa
esthesia
syndrome
Not
known
Not
known
Nail
disorder
Comm
on
Uncom
mon
Pruritus
Uncom
mon
Uncom
mon
Folliculitis
Uncom
mon
Uncom
mon
Dry skin
Uncom
mon
Not
known
ב"צמ
ובש ,ןולע
םינמוסמ
תורמחהה
תושקובמה
לע
עקר
בוהצ
.
םייוניש
םניאש
רדגב
תורמחהה
ונמוס
ןולעב
עבצב
הנוש
.
רבעוה
ראודב
ינורטקלא
ךיראתב
30.12.2013

Ciri produk

1
PHYSICIAN PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Myocet 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 is supplied as a three-vial system:
Myocet doxorubicin HCl is a red lyophilised powder.
Myocet liposomes is a white to off-white, opaque and homogeneous
dispersion.
Myocet buffer is a clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Myocet, 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 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 is administered in combination with cyclophosphamide (600
mg/m
2
) the initial
recommended dose of Myocet is 60-75 mg/m
2
every three weeks.
_Elderly patients _
Safety and efficacy of Myocet 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 in this population was comparable to that observed in patients
less than 65 years old.
_Patients with impaired hepatic function _
As metabolism and excretion of doxorubicin occurs primarily by the
hepatobiliary route, evaluation of
hepatobiliary function should be performed before and during therapy
with Myocet.
2
Based on limited data in patients with liver metastases, it is
recommende