PERJETA

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

PERTUZUMAB

Διαθέσιμο από:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

Φαρμακολογική κατηγορία (ATC):

L01FD02

Φαρμακοτεχνική μορφή:

CONCENTRATE FOR SOLUTION FOR INFUSION

Σύνθεση:

PERTUZUMAB 420 MG / 14 ML

Οδός χορήγησης:

I.V

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

HOFFMANN LA ROCHE LTD, SWITZERLAND

Θεραπευτική ομάδα:

PERTUZUMAB

Θεραπευτική περιοχή:

PERTUZUMAB

Θεραπευτικές ενδείξεις:

Early breast cancer Perjeta is indicated for use in combination with trastuzumab and chemotherapy for: • The neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. • the adjuvant treatment of patients with HER2-positive early breast cancer (node positive) at high risk of recurrence .Metastatic Breast CancerPerjeta is indicated for use in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

Ημερομηνία της άδειας:

2018-01-31

Φύλλο οδηγιών χρήσης

Page 1 of 2
Perjeta
®
Vials 420mg/14ml
יאמ
2019
/14ML
420MG
®
PERJETA הט'גרפ
420
/ ג"מ
14 ל"מ
PERTUZUMAB
CONCENTRATE FOR SOLUTION FOR INFUSION
_ _
,ה/רקי ת/חקור ,ה/רקי ה/אפור
מ"עב )לארשי( הקיטבצמרפ שור תרבח
תשקבמ
םינוכדע רפסמ לע םכעידוהל
לש אפורל ןולעב
רישכתה
הט'גרפ
םינוכדע קר םיניוצמ וז העדוהב .
.הרמחה םיווהמ רשא םינוכדעו םייתוהמ
יוותהה תו
ה
מושר
תו
ל רישכת
:לארשיב
METASTATIC BREAST CANCER:
Perjeta is indicated in combination with trastuzumab and docetaxel for
the treatment
of patients with HER2 positive metastatic breast cancer who have not
received prior
anti-HER2 therapy or chemotherapy for metastatic disease.
EARLY BREAST CANCER:
Perjeta is indicated for use in combination with trastuzumab and
docetaxel for the
neoadjuvant treatment of patients with HER2-positive, locally
advanced,
inflammatory, or arly stage breast cancer (either greater than 2 cm in
diameter or
node positive) as part of a complete treatment regimen for early
breast cancer.
This indication is based on demonstration of an improvement in
pathological
complete response rate. No data are available demonstrating
improvement in
event-free survival or overall.
Perjeta is indicated for use in combination with trastuzumab and
chemotherapy for
the adjuvant treatment of patients with HER2-positive early breast
cancer at high
risk of recurrence (positive nodes).
:רבסה
יתחת וק םע טסקט
.ןולעל ףסוהש טסקט ןייצמ
הצוח וק םע טסקט
.ןולעה ןמ רסוהש טסקט ןייצמ
.תואירבה דרשמ י"ע רשואש יפכ אפורל ןולעב
ןייעל שי ףסונ עדימל
ןכדועמה ןולעה
חלשנ
לבקל ןתינו ,תואירבה דרשמ רתאבש תופורתה
רגאמב םוסרפל
ו
ספדומ
י"ע
שור :םושירה לעבל היינפ
ד.ת ,מ"עב )לארשי( הקיטבצמרפ
6391
ןורשה

Αρχείο Π.Χ.Π.

EMEA/H/C/0002547/II/0066 (05.2023) 1 Perjeta PI_Ver 9.0
PERJETA_PI_VER 9.0
PERJETA
®
_PERTUZUMAB_
Concentrate for solution for infusion
1.
NAME OF THE MEDICINAL PRODUCT
Perjeta 420 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 14 ml vial of concentrate contains 420 mg of pertuzumab at a
concentration of 30 mg/ml.
After dilution, one ml of solution contains approximately 3.02 mg of
pertuzumab for the initial dose and
approximately 1.59 mg of pertuzumab for the maintenance dose (see
section 6.6).
Pertuzumab is a humanised IgG1 monoclonal antibody produced in
mammalian (Chinese hamster ovary)
cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear to slightly opalescent, colourless to pale yellow, liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Early breast cancer
Perjeta is indicated for use in combination with trastuzumab and
chemotherapy for the neoadjuvant treatment
of patients with HER2-positive, locally advanced, inflammatory, or
early stage breast cancer (either greater
than 2 cm in diameter or node positive) as part of a complete
treatment regimen for early breast cancer.
Perjeta is indicated for use in combination with trastuzumab and
chemotherapy for the adjuvant treatment of
patients with HER2-positive early breast cancer at high risk of
recurrence (positive nodes).
Metastatic Breast Cancer
Perjeta is indicated in combination with trastuzumab and docetaxel for
the treatment of patients with HER2
positive metastatic breast cancer
_ _
who have not received prior anti-HER2 therapy or chemotherapy for
metastatic disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Perjeta should only be initiated under the supervision of a physician
experienced in the administration of
anti-cancer agents. Perjeta should be administered by a healthcare
professional prepared to manage
anaphylaxis and in an environment where full resuscitation facilities
are immediately avai