Herceptin powder for concentrate for solution for infusion

Država: Armenija

Jezik: engleski

Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivni sastojci:

trastuzumab

Dostupno od:

F. Hoffmann-La Roche AG Wurmisweg

ATC koda:

L01XC03

INN (International ime):

trastuzumab

Doziranje:

440mg

Farmaceutski oblik:

powder for concentrate for solution for infusion

Jedinice u paketu:

(1) glass vial and solvent in vial 20ml

Tip recepta:

Prescription

Status autorizacije:

Registered

Datum autorizacije:

2019-12-12

Uputa o lijeku

10238528_NP9357.indd 1
3/18/21 1:35 PM
Artwork
Creator
Date
Version
Signature
Proofreader
Date
Signature
Perigord / MAH
18 Mar 2021
1
Genisys-No.
10238528
make-up code:
FE
Type size:
8 pt
Printing colour:
Pantone Black
Format:
450x500 mm
folded: 47x60 mm
Drawing Norm:
NP9357
17.08.10
10.114 - 3
HERCEPTIN
®
Trastuzumab
These symptoms can be treated with an analgesic/antipyretic such as
meperidine or paracetamol, or an antihistamine such as
diphenhydramine.
Serious reactions have been treated successfully with supportive
therapy
such as oxygen, beta-agonists and corticosteroids. In rare cases,
these
reactions are associated with a clinical course culminating in a fatal
outcome.
The majority of the LVEF decreases noted in BO18255 study were
asymptomatic, with the exception of one patient in the Herceptin-
containing arm whose LVEF decrease coincided with cardiac failure.
TABLE 2
SUMMARY OF LVEF CHANGE FROM BASELINE (BO18255 STUDY)
Patients who are experiencing dyspnoea at rest due to complications of
advanced malignancy or co-morbidities may be at increased risk of a
fatal
infusion reaction. Therefore, these patients should not be treated
with
Herceptin.
ANTINEOPLASTIC AGENT
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Antineoplastic agent.
ATC code: L01 XC03.
1.2
TYPE OF DOSAGE FORM
Powder for concentrate for solution for infusion.
Herceptin is a white to pale yellow lyophilized powder.
1.3
ROUTE OF ADMINISTRATION
Intravenous infusion.
1.4
STERILE / RADIOACTIVE STATEMENT
Sterile product.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient: _
trastuzumab.
_Dosage preparations: _
150 mg single-dose vials, and 440 mg multidose
vials containing powder for concentrate for solution for infusion.
Reconstituted Herceptin concentrate contains 21 mg/ml of trastuzumab.
_Excipients: _
As registered locally.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATIONS
BREAST CANCER
_Metastatic Breast Cancer (MBC)_
_ _
Herceptin is indicated for the treatment of patients with metastatic
breast
cancer who have

Svojstava lijeka

December 2020
Ro 45-2317
Summary of Product Characteristics FE/English
Herceptin
1
December 2020
Summary of Product Characteristics FE
HERCEPTIN
®
Trastuzumab
ANTINEOPLASTIC AGENT
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Antineoplastic agent.
ATC code: L01 XC03.
1.2
TYPE OF DOSAGE FORM
Powder for concentrate for solution for infusion.
Herceptin is a white to pale yellow lyophilized powder.
1.3
ROUTE OF ADMINISTRATION
Intravenous infusion.
1.4
STERILE / RADIOACTIVE STATEMENT
Sterile product.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient: _trastuzumab.
_Dosage preparations: _150 mg single-dose vials, and 440 mg multidose
vials containing powder
for concentrate for solution for infusion. Reconstituted Herceptin
concentrate contains 21 mg/ml
of trastuzumab.
_Excipients: _As registered locally.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATIONS
BREAST CANCER
_Metastatic Breast Cancer (MBC) _
Herceptin is indicated for the treatment of patients with metastatic
breast cancer who have
tumors that overexpress HER2:
a)
as monotherapy for the treatment of those patients who have received
one or more
chemotherapy regimens for their metastatic disease.
b)
in combination with paclitaxel or docetaxel for the treatment of those
patients who have not
received chemotherapy for their metastatic disease.
December 2020
Ro 45-2317
Summary of Product Characteristics FE/English
Herceptin
2
December 2020
Summary of Product Characteristics FE
c)
in combination with an aromatase inhibitor for the treatment of
patients with hormone-
receptor-positive metastatic breast cancer.
_Early Breast Cancer (EBC) _
_ _
Herceptin is indicated for the treatment of patients with
HER2-positive early breast cancer

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.

i