Keytruda

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Pembrolizumab 50mg

Dostupné z:

Merck Sharp & Dohme (New Zealand) Limited

INN (Medzinárodný Name):

Pembrolizumab 50 mg

Dávkovanie:

50 mg

Forma lieku:

Powder for infusion

Zloženie:

Active: Pembrolizumab 50mg Excipient: Histidine Histidine hydrochloride monohydrate Polysorbate 80 Sucrose

Typ predpisu:

Prescription

Výrobca:

AstraZeneca Pharmaceuticals LP

Terapeutické indikácie:

Melanoma KEYTRUDA is indicated as monotherapy for the treatment of unresectable or metastatic melanoma in adults. KEYTRUDA® is indicated for the adjuvant treatment of patients with melanoma with lymph node involvement who have undergone complete resection.

Prehľad produktov:

Package - Contents - Shelf Life: Vial, glass, Type I with bromobutyl rubber stopper and flip-off seal - 50 mg - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 96 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze). includes time between reconstitution and dilution 6 hours diluted stored at or below 25°C. includes time between reconstitution and dilution

Dátum Autorizácia:

2015-04-24

Príbalový leták

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 called
melanoma.
•
a kind of lung cancer called
non-small cell lung cancer.
•
a kind of cancerin 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 renal
cell carcinoma in adults.
KEYTRUDA contains the active
substance pembrolizumab.
Adults get KEYTRUDA when their
cancer has spread or cannot be taken
out by surgery.
KEYTRUDA may be given in
combination with other anti-cancer
medicines. It is important that you
also read the Consumer Medicine
Information for these other
medicines. If you have any questions
about these medicines, please ask
your doctor.
KEYTRUDA works by helping your
immune system fight your cancer.
Ask your doctor if you have any
questions about why KEYTRUDA
has been prescribed for you.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
KEYTRUDA
KEYTRUDA CAN BE USED IN
CHILDREN BELOW 18 YEARS OF AGE WITH
CLASSICAL

Súhrn charakteristických

Page 1 of 73
NEW ZEALAND DATA SHEET
1 PRODUCT NAME
KEYTRUDA
_P_
®
_P_
50 mg powder for solution for infusion.
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
KEYTRUDA 50 MG POWDER FOR SOLUTION FOR INFUSION
One vial contains 50 mg of pembrolizumab.
After reconstitution, 1 mL of solution contains 25 mg of
pembrolizumab.
KEYTRUDA 100 MG/4 ML (25 MG/ML) CONCENTRATE FOR SOLUTION FOR INFUSION
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 powder for solution for infusion is a sterile,
preservative-free, white to off-white
lyophilized powder. It is reconstituted and diluted for intravenous
infusion.
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
_P_
®
_P_
(pembrolizumab) is indicated as monotherapy for the treatment of
unresectable
or metastatic melanoma in adults.
KEYTRUDA
®
is indicated for the adjuvant treatment of patients with melanoma with
lymph
node involvement who have undergone complete resection.
Page 2 of 73
_ _
_ _
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 pat