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OP-1 IMPLANT
1
OP-1 IMPLANT
_eptotermin alfa (rch) _
CONSUMER MEDICINES INFORMATION
_ _
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about OP-1
IMPLANT.
It does not contain all the available
information.
It does not take the place of talking
to your doctor.
All medicines have benefits and
risks. Your doctor has weighed the
risks of your treatment with OP-1
IMPLANT against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TREATMENT WITH OP-1 IMPLANT,
ASK YOUR DOCTOR.
KEEP THIS LEAFLET. You may need
to read it again.
WHAT OP-1 IMPLANT IS
USED FOR
OP-1 IMPLANT contains the active
ingredient eptotermin alfa (rch).
It is used to treat long bone non-
union (such as broken arms or legs
that have not healed) that were
caused by an injury. OP-1
IMPLANT is a powder that is mixed
with sterile saline solution (
sodium
chloride solution for injection
(0.9% w/v)
) to form a paste which
is then placed between the broken
ends of the bone during surgery. It
works by promoting new bone
formation.
There are many different types of
treatments for long bone non-
union. Your doctor, however, may
have prescribed OP-1 IMPLANT
for another purpose. Ask your
doctor if you have any questions
why OP-1 IMPLANT has been
prescribed for you.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN OP-1
IMPLANT
_WHEN YOU MUST NOT BE GIVEN IT _
DO NOT USE OP-1 IMPLANT IF YOU
HAVE AN ALLERGY TO:
• any medicine containing
eptotermin alfa
• collagen
• any other bone morphogenetic
proteins
If you are not sure whether this
applies to you, check with your
doctor
DO NOT USE OP-1 IMPLANT IF
YOUR ARE PREGNANT.
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製品の特徴
- 1 -
PRODUCT INFORMATION
- 2 -
NAME OF THE MEDICINE
Non-proprietary name
eptotermin alfa (rch)
CAS number
129805-33-0
DESCRIPTION
OP-1 IMPLANT is comprised of eptotermin alfa (common name human recombinant
bone morphogenetic protein, hrBMP-7 or osteogenic protein-1, OP-1) formulated
with bovine collagen. The active form of eptotermin alfa is a dimer comprised of two
glycosylated monomers (18 kDa) linked by a disulphide bond.
Each vial of OP-1 IMPLANT contains 3.3 mg of eptotermin alfa (sourced from a
Chinese Hamster ovary cell line) and 1000 mg bovine collagen (sourced from bovine
diaphyseal bone, primarily Type 1) as a lyophilised powder. The powder is to be
reconstituted with 2-3 mL sterile Sodium Chloride Solution for Injection (0.9% w/v)
prior to use.
PHARMACOLOGY
_Pharmacological actions _
OP-1 IMPLANT is an osteoinductive and osteoconductive medicinal product.
Eptotermin alfa initiates bone formation through the induction of cellular
differentiation in mesenchymal cells which are recruited to the implant site from bone
marrow, periosteum and muscle. Once bound at the cell surface, eptotermin alfa
induces a cascade of cellular events leading to the formation of chondroblasts and
osteoblasts which play a key role in the bone formation process. The collagen matrix
is insoluble and consists of particles with a size range of 75-425 µm. This provides
an appropriate bioresorbable scaffold for the anchorage dependent cell proliferation
and differentiation processes induced by eptotermin alfa. The matrix is also
osteoconductive and it
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