HERCEPTIN 440 MG I.V

Riik: Iisrael

keel: inglise

Allikas: Ministry of Health

Toimeaine:

TRASTUZUMAB

Saadav alates:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

ATC kood:

L01FD01

Ravimvorm:

SOLUTION FOR INFUSION

Koostis:

TRASTUZUMAB 440 MG/ML

Manustamisviis:

I.V

Retsepti tüüp:

Required

Valmistatud:

HOFFMANN LA ROCHE, SWITZERLAND

Terapeutiline rühm:

TRASTUZUMAB

Terapeutiline ala:

TRASTUZUMAB

Näidustused:

Herceptin is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress HER2: 1. As a single agent for the treatment of those patients who have received one or more chemotherapy regiments for their metastatic disease. 2. In combination with Paclitaxel or Docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. 3. Herceptin in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive metastatic breast cancer. Early breast cancer (EBC) :Herceptin is indicated to treat patients with HER2-positive early breast cancer following surgery and chemotherapy (neoadjuvant or adjuvant) either alone or in combination with chemotherapy excluding Anthracyclines. Herceptin should only be used in patients whose tumors have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.HER2 metastatic gastric cancer (mGC)Herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.Herceptin should only be used in patients with metastatic gastric cancer whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory FISH+ result, or IHC 3+, as determined by an accurate and validated assay

Loa andmise kuupäev:

2014-05-31

Infovoldik

1
Herceptin 440mg I.V. Ver 8.0
HERCEPTIN
® 440 MG I.V.
r
Trastuzumab
Powder and solvent for concentrate for solution for intravenous
infusion
1.
NAME OF THE MEDICINAL PRODUCT
Herceptin
®
440 mg I.V., powder and solvent for concentrate for solution for
intravenous infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 multidose vial contains 440 mg of trastuzumab. Trastuzumab is, 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.
1 vial of solvent contains Water for Injection containing 1.1% benzyl
alcohol (Bacteriostatic Water for
Injection).
The reconstituted Herceptin solution contains 21 mg/ml of trastuzumab.
For a full list of excipients, (see section 6.1).
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Herceptin is a white to pale yellow lyophilised powder.
The solvent is a clear, colourless liquid.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Metastatic Breast Cancer (MBC)
Herceptin is indicated for the treatment of patients with metastatic
breast cancer who have tumours
that overexpress HER2;
1.
As a single agent, for the treatment of those patients who have
received one or more
chemotherapy regimens for their metastatic disease.
2.
In combination with Paclitaxel or Docetaxel for the treatment of those
patients who have not
received chemotherapy for their metastatic disease.
3.
In combination with an aromatase inhibitor for the treatment of
postmenopausal patient with
hormone-receptor positive metastatic breast cancer.
Early Breast Cancer (EBC)
Herceptin is indicated to treat patients with HER2 positive early
breast cancer following surgery and
chemotherapy (neoadjuvant or adjuvant) either alone or in combination
with chemotherapy excluding
anthracyclines.
2
Herceptin should only be used in patients whose tumours have either
HER2 overexpression or HER2
gene amplification as determined by an accurat

Toote omadused

1
Herceptin 440mg I.V. Ver 10
HERCEPTIN
® 440 MG I.V.
Trastuzumab
Powder and solvent for concentrate for solution for intravenous
infusion
1.
NAME OF THE MEDICINAL PRODUCT
Herceptin
®
440 mg I.V., powder and solvent for concentrate for solution for
intravenous infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 multidose vial contains 440 mg of trastuzumab. Trastuzumab is, 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.
1 vial of solvent contains Water for Injection containing 1.1% benzyl
alcohol (Bacteriostatic Water for
Injection).
The reconstituted Herceptin solution contains 21 mg/ml of trastuzumab.
For a full list of excipients, (see section 6.1).
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Herceptin is a white to pale yellow lyophilised powder.
The solvent is a clear, colourless liquid.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Metastatic Breast Cancer (MBC)
Herceptin is indicated for the treatment of patients with metastatic
breast cancer who have tumours
that overexpress HER2;
1.
As a single agent, for the treatment of those patients who have
received one or more
chemotherapy regimens for their metastatic disease.
2.
In combination with Paclitaxel or Docetaxel for the treatment of those
patients who have not
received chemotherapy for their metastatic disease.
3.
In combination with an aromatase inhibitor for the treatment of
postmenopausal patient with
hormone-receptor positive metastatic breast cancer.
Early Breast Cancer (EBC)
Herceptin is indicated to treat patients with HER2 positive early
breast cancer following surgery and
chemotherapy (neoadjuvant or adjuvant) either alone or in combination
with chemotherapy excluding
anthracyclines.
Herceptin should only be used in patients whose tumours have either
HER2 overexpression or HER2
gene amplification as determined by an accurate and