Herceptin solution for s/c injection

Negara: Armenia

Bahasa: Inggris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

trastuzumab

Tersedia dari:

F. Hoffmann-La Roche Ltd.

Kode ATC:

L01XC03

INN (Nama Internasional):

trastuzumab

Dosis:

600mg/5ml

Bentuk farmasi:

solution for s/c injection

Unit dalam paket:

glass vial 6ml

Jenis Resep:

Prescription

Status otorisasi:

Registered

Tanggal Otorisasi:

2018-12-24

Selebaran informasi

Artwork
Creator
Date
Version
Signature
Proofreader
Date
Signature
Perigord / MAH
19 Feb 2020
1
Genisys-No.
10223299
make-up code:
FE
Type size:
7.5 pt
Printing colour:
Pantone Black
Format:
450x500 mm folded: 47x60 mm
Drawing Norm:
NP9357 17.08.10 10.114
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
_Intravenous (IV) formulation (Herceptin IV): _
Powder for concentrate for
solution for infusion.
_Subcutaneous (SC) formulation (Herceptin SC): _
Solution for injection.
1.3
ROUTE OF ADMINISTRATION
_Herceptin IV: _
Intravenous infusion.
_Herceptin SC: Solution for injection._
1.4
STERILE / RADIOACTIVE STATEMENT
Sterile product.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient:_
trastuzumab.
HERCEPTIN IV
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.
HERCEPTIN SC_:_
600 mg/5 ml fixed dose vial containing solution for injection (do not
reconstitute or dilute).
_Excipients:_
Herceptin SC contains recombinant human hyaluronidase
(rHuPH20), an enzyme used to increase the dispersion and absorption of
co-administered drugs when administered subcutaneously.
All other excipients described as registered locally.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATIONS
_HERCEPTIN IV AND HERCEPTIN SC:_
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.
c) in combination with an aromatase inhibitor for the treatment of
patients w

Karakteristik produk

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 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.
_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 cyclophosphamide,
in combination with
paclitaxel or docetaxel.
3
-
in combina