Perjeta

Maa: Uusi-Seelanti

Kieli: englanti

Lähde: Medsafe (Medicines Safety Authority)

Aktiivinen ainesosa:

Pertuzumab 420mg equivalent to 30 mg/mL

Saatavilla:

Roche Products (NZ) Ltd

INN (Kansainvälinen yleisnimi):

Pertuzumab 420 mg (= 30 mg/mL)

Annos:

420 mg/14mL

Lääkemuoto:

Concentrate for infusion

Koostumus:

Active: Pertuzumab 420mg equivalent to 30 mg/mL Excipient: Glacial acetic acid Histidine Polysorbate 20 Sucrose Water for injection

Kpl paketissa:

Vial, glass, 14 mL

luokka:

Prescription

Prescription tyyppi:

Prescription

Valmistaja:

Genentech Inc

Käyttöaiheet:

Metastatic Breast Cancer Perjeta is indicated in combination with trastuzumab and docetaxel for patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for their metastatic disease.

Tuoteyhteenveto:

Package - Contents - Shelf Life: Vial, glass, - 14 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Valtuutus päivämäärä:

2012-12-12

Pakkausseloste

Perjeta

CMI 200217
1
CONSUMER MEDICINE INFORMATION
PERJETA
®
PERTUZUMAB (RCH)
420 mg in 14 mL concentrate for intravenous infusion
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Perjeta. It does not
contain all the available
information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you being given Perjeta
against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet. You may need to read it again.
WHAT PERJETA IS GIVEN FOR
Perjeta contains an active ingredient called pertuzumab.
Perjeta belongs to a group of medicines known as anti-neoplastic (or
anti-cancer) agents. There are
many different classes of anti-neoplastic agents. Perjeta belongs to a
class called monoclonal
antibodies.
Monoclonal antibodies are proteins made in a laboratory. These
proteins are designed to recognise
and bind to other unique proteins in the body.
Perjeta recognises and attaches to a protein called human epidermal
growth factor receptor 2 (HER2).
HER2 is found in large amounts on the surface of some cancer cells.
When Perjeta attaches to HER2
cancer cells it may kill them or slow/stop the cancer cells from
growing.
Perjeta can be used to treat breast cancer before surgery
(neoadjuvant), after surgery (adjuvant) or
metastatic (spreading) breast cancer. It is only used for patients
whose tumour has tested positive to
HER2.
For metastatic breast cancer Perjeta is used with Herceptin
(trastuzumab) and the chemotherapy
medicine, docetaxel. When Perjeta is used before or after surgery, it
is used with Herceptin and
chemotherapy medicines.
Perjeta

CMI 200217
2
For further information about Herceptin and other chemotherapy
medicines please ask your doctor,
nurse or pharmacist for the Consumer Medicine Information (CMI)
leaflets for these medicines.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY PERJETA HAS BEEN
PRES

Valmisteyhteenveto

perjeta20210310
1 NEW ZEALAND DATA SHEET
1. PRODUCT NAME
Perjeta 420 mg concentrate for solution for infusion.
2
. QUALITATIVE AND QUANTITATIVE COMPOSITION
Perjeta is supplied as a single-use vial containing 14 mL of
preservative-free concentrate
solution. Each vial contains 420 mg of pertuzumab (30 mg/mL) with the
following excipients:
sucrose, polysorbate 20, histidine and acetic acid, glacial.
Perjeta is a recombinant humanized monoclonal antibody. The antibody
is based upon the
human IgG1 kappa framework sequence, with a molecular weight of ~
148kDa and composed
of two light chains consisting of 214 amino acid residues and two
heavy chains consisting of
448 or 449 amino acid residues.
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear to opalescent, colourless to slightly brownish solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_EARLY BREAST CANCER _
Perjeta is indicated in combination with trastuzumab and chemotherapy
for the:
•
neoadjuvant treatment of patients with HER2-positive, early stage
(either > 2 cm in
diameter or node positive), inflammatory or locally advanced breast
cancer as part of a
complete treatment regimen for early breast cancer
•
adjuvant treatment of patients with HER-2 positive early breast cancer
at high risk of
recurrence.
_METASTATIC BREAST CANCER _
Perjeta is indicated in combination with trastuzumab and docetaxel for
patients with HER2-
positive
metastatic
breast
cancer
who
have
not
received
prior
anti-HER2
therapy
or
chemotherapy for their metastatic disease.
4.2 DOSE AND METHOD OF ADMINISTRATION
GENERAL
Substitution by any other biological medicinal product requires the
consent of the prescribing
physician. In order to prevent medication errors, it is important to
check the vial labels to ensure
that the drug being prepared and administered is Perjeta.
DO NOT ADMINISTER PERJETA AS AN IV PUSH OR BOLUS.
perjeta20210310
2
DETECTION OF HER2 PROTEIN OVEREXPRESSION OR HER2 GENE AMPLIFICATION
Patients can only be treated with Perjeta in combination wit