Zaltrap

Quốc gia: New Zealand

Ngôn ngữ: Tiếng Anh

Nguồn: Medsafe (Medicines Safety Authority)

Thành phần hoạt chất:

Aflibercept 25 mg/mL;  

Sẵn có từ:

sanofi-aventis new zealand limited

INN (Tên quốc tế):

Aflibercept 25 mg/mL

Liều dùng:

25 mg/mL

Dạng dược phẩm:

Concentrate for infusion

Thành phần:

Active: Aflibercept 25 mg/mL   Excipient: Citric acid Dibasic sodium phosphate heptahydrate Hydrochloric acid Monobasic sodium phosphate monohydrate Polysorbate 20 Sodium chloride Sodium citrate dihydrate Sodium hydroxide Sucrose Water for injection

Loại thuốc theo toa:

Prescription

Sản xuất bởi:

Regeneron Pharmaceuticals Inc

Chỉ dẫn điều trị:

Zaltrap in combination with irinotecan-fluoropyrimidine-based chemotherapy is indicated in adults with metastatic colorectal cancer previously treated with an oxaliplatin-containing regimen.

Tóm tắt sản phẩm:

Package - Contents - Shelf Life: Vial, glass, single dose, Type I, clear, with brobobutyl rubber sealing disk, 8ml - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 8 hours opened stored at or below 25°C protect from light

Ngày ủy quyền:

2013-10-03

Tờ rơi thông tin

ZALTRAP
®
1
ZALTRAP
®
_(ZAL-TRAP) _
_Aflibercept (rch) (a-flib-er-cept) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Zaltrap.
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 taking Zaltrap
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR.
Keep this leaflet as you may need to
read it again.
WHAT ZALTRAP IS USED
FOR
Zaltrap is used to treat advanced
large bowel cancer (that is, cancer in
the colon or rectum) in combination
with chemotherapy agents.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Zaltrap contains the active ingredient
aflibercept.
Zaltrap is an anti-cancer medicine
that blocks the growth of blood
vessels that provide nutrients and
oxygen to cancer cells. This prevents
the growth of the cancer cells.
Your doctor may have prescribed
Zaltrap for another purpose.
This medicine is only available with
a doctor's prescription.
Zaltrap is not addictive.
BEFORE YOU ARE GIVEN
ZALTRAP
DO NOT RECEIVE ZALTRAP IF YOU ARE
ALLERGIC TO ZALTRAP OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Some symptoms of an allergic
reaction include: skin rash, hives,
itching or redness of the skin;
shortness of breath, wheezing or
difficulty breathing; or swelling of
the face, lips, tongue or other parts of
the body.
ZALTRAP SHOULD NOT BE USED IN YOUR
EYE, SINCE IT MAY SEVERELY DAMAGE
IT.
DO NOT RECEIVE ZALTRAP:
•
AFTER THE EXPIRY DATE (EXP)
PRINTED ON THE VIAL.
•
IF THE PACKAGING IS DAMAGED OR
SHOWS SIGNS OF TAMPERING.
TELL YOUR DOCTOR IF YOU ARE
PREGNANT OR ARE PLANNING ON
HAVING A BABY.
Do not use Zaltrap if you are
pregnant unless otherwise advised by
your doctor. Zaltrap may harm your
unborn baby.
Your doctor will advise you about
using effective contraception during
treatment with Zaltrap an

Đặc tính sản phẩm

PRODUCT INFORMATION
Zaltrap 100mg/4mL and 200mg/8mL Injection, Concentrated
zaltrap-ccdsv4-dsv3-12apr16
Page 1 of 29
NEW ZEALAND DATA SHEET
ZALTRAP
®
NAME OF MEDICINE
INTERNATIONAL NON-PROPRIETARY NAME
Aflibercept (rch)
CHEMICAL STRUCTURE
Aflibercept is a recombinant protein consisting of sequences derived
from human vascular
endothelial growth factor (VEGF) receptor extracellular domains fused
to the Fc portion of human
immunoglobulin G1 (IgG1).
The extracellular domain sequences come from two different VEGF
receptors, VEGFR1 (also
known as Flt-1) and VEGFR2 (also known as KDR or Flk-1). Each of the
VEGF receptors are
composed of seven immunoglobulin (Ig) domains in their extracellular
regions, with Ig domains 2
and 3 contributing the majority of the binding energy for VEGF.
Thus the amino acid sequence structure of aflibercept comprises Ig
domain 2 from VEGFR1,
fused to Ig domain 3 from VEGFR2, which is in turn fused to the Fc
domain of IgG1.
There are no extraneous linker sequences between any of the peptide
domains. The presumptive
Ig domain structure of aflibercept is provided in Figure 1. FIGURE 1 - STRUCTURE OF AFLIBERCEPT
AFLIBERCEPT
2
2
3
3
I g G 1
1
2
3
4
5
6
7
1
2
3
4
5
6
7
V E G F R 1
V E G F R
VEGF Trap
PRODUCT INFORMATION
Zaltrap 100mg/4mL and 200mg/8mL Injection, Concentrated
zaltrap-ccdsv4-dsv3-12apr16
Page 2 of 29
MOLECULAR FORMULA
Aflibercept molecular formula (without glycosylation) is C
4318
H
6788
N
1164
O
1304
S
32
.
MOLECULAR WEIGHT
115 kDa
CHEMICAL NAME
1. Vascular endothelial growth factor receptor type VEGFR-1 (synthetic
human immunoglobulin
domain 2 fragment) fusion protein with vascular endothelial growth
factor receptor type VEGFR-
2 (synthetic human immunoglobulin domain 3 fragment) fusion protein
with immunoglobulin G1
(synthetic Fc fragment), dimer.
2. des-432-lysine-[human vascular endothelial growth factor receptor
1-(103-204)-peptide
(containing Ig-like C2-type 2 domain) fusion protein with human
vascular endothelial growth
factor receptor 2- (206-308)-peptide (containing Ig-li