PERJETA CONCENTRATE FOR SOLUTION FOR INFUSION 420MG14ML

Država: Singapur

Jezik: engleski

Izvor: HSA (Health Sciences Authority)

Aktivni sastojci:

Pertuzumab

Dostupno od:

ROCHE SINGAPORE PTE. LTD.

ATC koda:

L01XC13

Doziranje:

30 mg/ml

Farmaceutski oblik:

INFUSION, SOLUTION CONCENTRATE

Sastav:

Pertuzumab 30 mg/ml

Administracija rute:

INTRAVENOUS

Tip recepta:

Prescription Only

Proizveden od:

Roche Diagnostics GmbH

Status autorizacije:

ACTIVE

Datum autorizacije:

2014-02-05

Uputa o lijeku

1 
PERJETA
® 
Pertuzumab 

1. 
NAME OF THE MEDICINAL PRODUCT 
Perjeta concentrate for solution for infusion 420mg/14ml 

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  3.36 mg
of pertuzumab for 
the initial dose and 1.68 mg
of pertuzumab for the maintenance dose 
(see section 6.4). 

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 
Perjeta  is indicated for  use  in combination with trastuzumab  and 
docetaxel  for the treatment of adult  patients with HER2-positive 
metastatic or locally recurrent unresectable
breast cancer,_  _who have 
not received previous anti-HER2 therapy or chemotherapy for their 
metastatic disease. 

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 
Perjeta is subject to restricted medical prescription and therapy 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 service is 
immediately available. 

Patients treated with Perjeta must have
HER2-positive tumour status, 
defined as a score of 3+ by immunohistochemistry (IHC) and/or a ratio 
of 
≥ 2.0 by in situ hybridisation (ISH) assessed by a validated
test. 
To
ensure accurate and reproducible results, 

Svojstava lijeka

1
Please visit www.roche.com.sg/pharma/perjeta for a printable version
of this leaflet.
INF-PER-2021 02
PERJETA
®
Pertuzumab
1.1
NAME OF THE MEDICINAL PRODUCT
Perjeta concentrate for solution for infusion 420mg/14ml
1.2
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 3.36 mg of pertuzumab for
the initial
dose and 1.68 mg of pertuzumab for the maintenance dose (see section
4.2).
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 4.3.
1.3
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear to slightly opalescent, colourless to pale yellow, liquid.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATIONS
Metastatic Breast Cancer (MBC)
Perjeta is indicated for use in combination with Herceptin and
docetaxel for the
treatment of adult patients with HER2-positive metastatic or locally
recurrent
unresectable breast cancer, who have not received previous anti-HER2
therapy
or chemotherapy for their metastatic disease.
Early Breast Cancer
Perjeta is indicated for use in combination with Herceptin 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. 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
survival.

adjuvant treatment of patients with HER2-positive early breast cancer
at
high risk of recurrence (see section 3.1.2).
2.2
POSOLOGY AND METHOD OF ADMINISTRATION
General
Perjeta is subject to restricted medical prescription and therapy
should only be
initiated under the supervision of a physician experienced in the
adm