ABRAXANE

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

PACLITAXEL

Disponível em:

NEOPHARM SCIENTIFIC LTD

Código ATC:

L01CD01

Forma farmacêutica:

POWDER FOR SUSPENSION FOR INFUSION

Composição:

PACLITAXEL 100 MG/VIAL

Via de administração:

I.V

Tipo de prescrição:

Required

Fabricado por:

CELGENE DISTRIBUTION B.V., THE NETHERLANDS

Área terapêutica:

PACLITAXEL

Indicações terapêuticas:

Abraxane 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. Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas. Abraxane 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.

Data de autorização:

2016-04-14

Folheto informativo - Bula

דבכנ ת/חקור ,ה/אפור
ה/
,
א
ןסקרב
ךות ןתמל יוריעל ףיחרת תנכהל הקבא
-
ידירו
ABRAXANE Powder for Suspension for I.V Infusion

ה
ולע
ן
אפורל
כדוע
ן
ב
ראוני
2019

וז העדוהב
הרמחה םיווהמה םייונישה םיניוצמ
ןכו
הרמחה םניאש םיפסונ םייוניש

הצוח וקב ןמוסמ רסוהש טסקט ,יתחת וקב
ןמוסמ ףסוותהש טסקט
רמוחה
ליעפה
:
Paclitaxel 100 mg/vial
רישכתל רשואמה היוותהה חסונ ןלהל
:
Abraxane 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.
Abraxane in combination with gemcitabine is indicated for the
first-line treatment of adult patients
with metastatic adenocarcinoma of the pancreas.
Abraxane 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.
וכדעה םינ
רקיעה
םיי ןולעב אפורל
שענ
ו
יעסב
םיפ
אבה
םי
:
4.6
FERTILITY, PREGNANCY AND LACTATION
…..
Pregnancy
There are very limited data on the use of paclitaxel in human
pregnancy. Paclitaxel is suspected to cause serious birth
defects when administered during pregnancy. Studies in animals have
shown reproductive toxicity (see section 5.3).
Women of childbearing potential should have a pregnancy test prior to
starting treatment with Abraxane. Abraxane
should not be used in pregnancy, and in women of childbearing
potential not using effective contraception, unless the
clinical condition of the mother requires treatment with paclitaxel.
Breast-feeding
Paclitaxel and/or its metabolites were excreted into the milk of
lactating rats (see section 5.3). It is not known if
paclitaxel is excreted in human milk. Because of po

Características técnicas

1
1.
NAME OF THE MEDICINAL PRODUCT
Abraxane
®
5 mg/ml powder for suspension for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg of paclitaxel formulated as albumin bound
nanoparticles.
After reconstitution, each ml of suspension contains 5 mg of
paclitaxel formulated as albumin bound
nanoparticles.
Excipients with known effect
Each ml of concentrate contains 0.183 mmol sodium, which is 4.2 mg of
sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for suspension for infusion.
The reconstituted suspension 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
Abraxane 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).
Abraxane in combination with gemcitabine is indicated for the
first-line treatment of adult patients with
metastatic adenocarcinoma of the pancreas.
Abraxane 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
Abraxane 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
2
_Breast cancer _
The recommended dose of Abraxane 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 Abraxane therapy should have the dose
reduced to 220 mg/m
2
for
subsequent courses. Following recurrence of severe neutropenia or
sev