Opgenra
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
14-07-2016
Fachinformation
(SPC)
14-07-2016
Öffentlichen Beurteilungsberichts
(PAR)
15-07-2016
Wirkstoff:
eptotermin alfa
Verfügbar ab:
Olympus Biotech International Limited
ATC-Code:
M05BC02
INN (Internationale Bezeichnung):
eptotermin alfa
Therapiegruppe:
Drugs for treatment of bone diseases
Therapiebereich:
Spondylolisthesis
Anwendungsgebiete:
Opgenra is indicated for posterolateral lumbar spinal fusion in adult patients with spondylolisthesis where autograft has failed or is contra-indicated.
Produktbesonderheiten:
Revision: 9
Berechtigungsstatus:
Withdrawn
Berechtigungsdatum:
2009-02-19
Gebrauchsinformation
B. PACKAGE LEAFLET
23
Medicinal product no longer authorised
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OPGENRA 3.3 MG POWDER FOR IMPLANTATION SUSPENSION
eptotermin alfa
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See end of section 4 for
how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE ADMINISTERED THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If you get any side effects talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Opgenra is and what it is used for.
2.
What you need to know before you are administered Opgenra.
3.
How to use Opgenra.
4.
Possible side effects.
5
How to store Opgenra.
6.
Contents of the pack and other information.
1.
WHAT OPGENRA IS AND WHAT IT IS USED FOR
Opgenra contains the active substance eptotermin alfa.
Opgenra is a type of medicine known as a bone morphogenetic protein
(BMP). This group of
medicines cause new bone to grow at the location where the surgeon has
placed (implanted) it.
Opgenra is implanted in adult patients with slippage of the spine
(spondylolisthesis) in cases where
treatment with autograft (transplanted bone from your hip) has failed
or must not be used.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE ADMINISTERED OPGENRA
DO NOT USE OPGENRA
-
if you are allergic to eptotermin alfa or to any of the ingredients of
this medicine (see section
6).
-
if you have an autoimmune disease (disease arising from or directed
against your own tissues),
including Crohn’s disease, rheumatoid arthritis, systemic lupus
erythematosus, scleroderma,
Sjögren’s syndrome and dermatomyositis/ polymyositis.
-
if you have an active infection in your spine or have been told that
you have an active internal
(systemic) infection.
-
if y
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Fachinformation
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Opgenra 3.3 mg powder for implantation suspension.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 1g powder with 3.3 mg of eptotermin alfa*.
After reconstitution, Opgenra contains 1 mg/ml eptotermin alfa.
*Eptotermin alfa is human recombinant osteogenic protein 1 (OP-1)
produced in Chinese hamster
ovary (CHO) cell line.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for implantation suspension.
The powder containing the active substance is granular and white to
off-white.
The powder containing the excipient carmellose
(carboxymethylcellulose) is yellowish white.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Opgenra is indicated for posterolateral lumbar spinal fusion in adult
patients with spondylolisthesis
where autograft has failed or is contra-indicated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product should be used by an appropriately qualified
surgeon.
Posology
Opgenra is intended only for single use in each patient. Treatment
requires a single surgery. To fuse a
single level of the lumbar region of the spine, one unit of medicinal
product is used on each side of the
spine. The maximum human dose should not exceed 2 units since efficacy
and safety for spinal fusion
requiring higher doses has not been established.
_Paediatric population _
Opgenra is contraindicated in children (<12 years old), adolescents
(12-18 years old) and the
skeletally immature (see section 4.3).
_Renal/hepatic impairment _
Care should be used when Opgenra is used in patients with renal or
hepatic impairment (see section
4.4).
2
Medicinal product no longer authorised
Method of administration
For intrao
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