Keytruda

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Pembrolizumab 25 mg/mL;  ;  

Mevcut itibaren:

Merck Sharp & Dohme (New Zealand) Limited

INN (International Adı):

Pembrolizumab 25 mg/mL

Doz:

25 mg/mL

Farmasötik formu:

Concentrate for infusion

Kompozisyon:

Active: Pembrolizumab 25 mg/mL     Excipient: Histidine Histidine hydrochloride monohydrate Polysorbate 80 Sucrose Water for injection

Reçete türü:

Prescription

Tarafından üretildi:

AstraZeneca Pharmaceuticals LP

Terapötik endikasyonlar:

Melanoma KEYTRUDA® (pembrolizumab) is indicated as monotherapy for the treatment of unresectable or metastatic melanoma in adults. KEYTRUDA® is indicated for the adjuvant treatment of adult and paediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma who have undergone complete resection.

Ürün özeti:

Package - Contents - Shelf Life: Vial, glass, Type I, 4 mL fill, closed with bromobutyl stopper, polypropylene cap and aluminium flip-off seal - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Do not shake. 96 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) 6 hours diluted stored at or below 25°C - Vial, glass, Type I , 4 mL fill, closed with a chlorobutyl stopper, polypropylene cap and aluminium flip-off seal - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Do not shake. 96 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) 6 hours diluted stored at or below 25°C

Yetkilendirme tarihi:

2016-03-31

Bilgilendirme broşürü

KEYTRUDA
®
1
KEYTRUDA
®
_pembrolizumab _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about KEYTRUDA. It
does not contain all the available
information.
It does not take the place of talking to
your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using KEYTRUDA
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT KEYTRUDA IS
USED FOR
KEYTRUDA is used to treat:
•
a kind of skin cancer in adults
and children called melanoma.
•
a kind of lung cancer called
non-small cell lung cancer.
•
a kind of cancer in adults and
children called classical
Hodgkin lymphoma.
•
a kind of cancer called
urothelial carcinoma,
including bladder cancer.
•
a kind of head and neck
cancer called head and neck
squamous cell carcinoma.
•
a kind of cancer in adults and
children that can occur in any
part of the body and is shown
by a laboratory test to be
microsatellite instability-high
(MSI-H) or mismatch repair
deficient (dMMR).
It is not known if
KEYTRUDA is safe and
effective in children with
MSI-H or dMMR cancer of
the brain or spinal cord
(central nervous system
cancers).
•
a kind of cancer called colon
or rectal cancer in adults that
is shown by a laboratory test
to be MSI-H or dMMR.
•
a kind of cancer called renal
cell carcinoma in adults.
•
a kind of uterine cancer called
endometrial carcinoma in
adult women.
•
a kind of cancer called
oesophageal carcinoma in
adults.
•
a kind of skin cancer called
cutaneous squamous cell
carcinoma.
•
a kind of cancer called
cervical cancer in adult
women.
•
a kind of cancer called triple-
negative breast cancer in
adults.
KEYTRUDA contains the active
substance pembrolizumab.
Adults get KEYTRUDA when their
cancer has spread or cannot be taken
out by surgery.
People get KEYTRUDA after they
had surgery to remove melanoma,
non-small cell lung can

Ürün özellikleri

Page 1 of 111
Proprietary
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
KEYTRUDA
_P_
®
_P_
100 mg/4 mL (25 mg/mL) concentrate for solution for infusion.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
CAS No.: 1374853-91-4
One vial contains 100 mg of pembrolizumab in 4 mL of solution.
Pembrolizumab
is
a
selective
humanized
monoclonal
antibody
designed
to
block
the
interaction between PD-1 and its ligands, PD-L1 and PD-L2.
Pembrolizumab is an IgG4 kappa
immunoglobulin
with
an
approximate
molecular
weight
of
149 kDa.
Pembrolizumab
is
produced in Chinese hamster ovary cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
KEYTRUDA concentrate for solution for infusion is a sterile,
preservative-free, clear to slightly
opalescent, colourless to slightly yellow solution.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Melanoma
KEYTRUDA
®
(pembrolizumab) is indicated as monotherapy for the treatment of
unresectable
or metastatic melanoma in adults.
KEYTRUDA
®
is indicated for the adjuvant treatment of adult and paediatric (12
years and
older) patients with Stage IIB, IIC, or III melanoma who have
undergone complete resection.
Non-small cell lung cancer (NSCLC)
KEYTRUDA
_P_
®
_P_
, in combination with pemetrexed and platinum chemotherapy, is
indicated for
the first-line treatment of patients with metastatic non-squamous
non-small cell lung
carcinoma (NSCLC), with no EGFR or ALK genomic tumour aberrations.
KEYTRUDA
®
, in combination with carboplatin and either paclitaxel or
nab-paclitaxel, is
indicated for the first-line treatment of patients with metastatic
squamous NSCLC.
KEYTRUDA
_P_
®
_P_
as monotherapy is indicated for the first-line treatment of patients
with NSCLC
expressing PD-L1 [tumour proportion score (TPS) ≥1%] as determined
by a validated test,
with no EGFR or ALK genomic tumour aberrations, and is
•
stage III
where patients
are
not
candidates for
surgical
resection
or
definitive
chemoradiation, or
•
metastatic.
KEYTRUDA
_P_
®
_P_
as monotherapy i