HERCEPTIN 600 MG 5 ML S.C.

Šalis: Izraelis

kalba: anglų

Šaltinis: Ministry of Health

Veiklioji medžiaga:

TRASTUZUMAB

Prieinama:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

ATC kodas:

L01FD01

Vaisto forma:

SOLUTION FOR INJECTION

Sudėtis:

TRASTUZUMAB 600 MG / 5 ML

Vartojimo būdas:

S.C

Recepto tipas:

Required

Pagaminta:

HOFFMANN LA ROCHE LTD, SWITZERLAND

Gydymo sritis:

TRASTUZUMAB

Terapinės indikacijos:

Breast cancerMetastatic breast cancerHerceptin is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): - as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments. - in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. - in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. - in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.Early breast cancerHerceptin is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC). - following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) . - following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. - in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. - in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameterHerceptin should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay .

Leidimo data:

2020-10-31

Pakuotės lapelis

Roche Pharmaceuticals (Israel) Ltd
6
Hacharash St.
P.O.B. 6391
Hod Hasharon 4524079
Tel. + 972-9-9737777
Fax + 972-9-9737850
טסוגוא
2018
HERCEPTIN
®
(
TRASTUZUMAB
)
600 MG/5ML
S.C
SOLUTION FOR SUBCUTANEOUS INJECTION
_ _
,ה/רקי ת/חקור ,ה/רקי ה/אפור
מ"עב )לארשי( הקיטבצמרפ שור תרבח
תשקבמ
םינוכדע רפסמ לע םכעידוהל
לש אפורל ןולעב
רישכתה
רה
ס
ןיטפ
600
/ג"מ
5
ל"מ
C
.
S
כדע קר םיניוצמ וז העדוהב .
םינוכדעו םייתוהמ םינו
.הרמחה םיווהמ רשא
יוותהה
ה
מושרה
ה
ל רישכת
:לארשיב
Metastatic breast cancer
Herceptin is indicated for the treatment of adult patients with HER2
positive
metastatic breast cancer (MBC):
-
as monotherapy for the treatment of those patients who have received
at least
two chemotherapy regimens for their metastatic disease. Prior
chemotherapy
must have included at least an anthracycline and a taxane unless
patients are
unsuitable for these treatments. Hormone receptor positive patients
must also
have failed hormonal therapy, unless patients are unsuitable for these
treatments.
-
in combination with paclitaxel for the treatment of those patients who
have not
received chemotherapy for their metastatic disease and for whom an
anthracycline is not suitable.
-
in combination with docetaxel for the treatment of those patients who
have not
received chemotherapy for their metastatic disease
.
-
in combination with
an aromatase inhibitor for the treatment of postmenopausal
patients with hormone-receptor positive MBC, not previously treated
with
trastuzumab.
Early breast cancer
Herceptin is indicated for the treatment of adult patients with HER2
positive early
breast cancer (EBC).
- following surgery, chemotherapy (neoadjuvant or adjuvant) and
radiotherapy (if
applicable).
-
following adjuvant chemotherapy with doxorubicin and cyclophosphamide,
in
combination with paclitaxel or docetaxel.
-
in combination with adjuvant chemotherapy consisting

Prekės savybės

Herceptin 600mg/5ml S.C PI Ver 9.0
HERCEPTIN
®
600 MG/5ML S.C.


TRASTUZUMAB
Solution for injection
1.
NAME OF THE MEDICINAL PRODUCT
Herceptin 600 mg solution for injection in vial
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of 5 mL contains 600 mg of trastuzumab, a humanised IgG1
monoclonal antibody produced
by mammalian (Chinese hamster ovary) cell suspension culture and
purified by affinity and ion
exchange chromatography including specific viral inactivation and
removal procedures.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for subcutaneous injection
Clear to opalescent solution, colourless to yellowish.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Breast cancer
_Metastatic breast cancer _
Herceptin is indicated for the treatment of adult patients with HER2
positive metastatic breast cancer
(MBC):
-
as monotherapy for the treatment of those patients who have received
at least two chemotherapy
regimens for their metastatic disease. Prior chemotherapy must have
included at least an
anthracycline and a taxane unless patients are unsuitable for these
treatments. Hormone receptor
positive patients must also have failed hormonal therapy, unless
patients are unsuitable for these
treatments.
-
in combination with paclitaxel for the treatment of those patients who
have not received
chemotherapy for their metastatic disease and for whom an
anthracycline is not suitable.
-
in combination with docetaxel for the treatment of those patients who
have not received
chemotherapy for their metastatic disease.
-
in combination with an aromatase inhibitor for the treatment of
postmenopausal patients with
hormone-receptor positive MBC, not previously treated with
trastuzumab.
2
_Early breast cancer _
Herceptin is indicated for the treatment of adult patients with HER2
positive early breast cancer
(EBC).
-
following surgery, chemotherapy (neoadjuvant or adjuvant) and
radiotherapy (if applicable) (see
section 5.1).
-
following adjuvant chemotherapy with doxorubicin and cy