Osigraft
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
27-07-2016
Charakterystyka produktu
(SPC)
27-07-2016
Sprawozdanie z oceny publicznego
(PAR)
27-07-2016
Składnik aktywny:
eptotermin alfa
Dostępny od:
Olympus Biotech International Limited
Kod ATC:
M05BC02
INN (International Nazwa):
eptotermin alfa
Grupa terapeutyczna:
Drugs for treatment of bone diseases, Bone morphogenetic proteins
Dziedzina terapeutyczna:
Tibial Fractures
Wskazania:
Treatment of nonunion of tibia of at least 9 month duration, secondary to trauma, in skeletally mature patients, in cases where previous treatment with autograft has failed or use of autograft is unfeasible.
Podsumowanie produktu:
Revision: 13
Status autoryzacji:
Withdrawn
Data autoryzacji:
2001-05-17
Ulotka dla pacjenta
18
B. PACKAGE LEAFLET
Medicinal product no longer authorised
19
PACKAGE LEAFLET: INFORMATION FOR THE USER
OSIGRAFT 3.3 MG POWDER FOR SUSPENSION FOR IMPLANTATION
eptotermin alfa
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, ask your doctor.
-
If any of the side effects gets serious, or if you notice any side
effect not listed in this leaflet,
please tell your doctor.
IN THIS LEAFLET:
1.
What Osigraft is and what it is used for
2.
Before you use Osigraft
3.
How to use Osigraft
4.
Possible side effects
5
How to store Osigraft
6.
Further information
1.
WHAT OSIGRAFT IS AND WHAT IT IS USED FOR
Osigraft 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.
Osigraft is implanted in adult patients with fractures of the tibia
which have failed to heal for at least 9
month duration in cases where treatment with autograft (transplanted
bone from your hip) has failed or
should not be used.
2.
BEFORE YOU USE OSIGRAFT
DO NOT USE OSIGRAFT
-
if you are allergic to eptotermin alfa or collagen, the other
ingredient of Osigraft (see section 6).
-
if you are an adolescent and your skeleton is not yet fully formed
(still growing).
-
if you are a child (below 18 years old)
-
if you have an autoimmune disease (disease arising from or directed
against your own tissues),
including rheumatoid arthritis, systemic lupus erythematosus,
scleroderma, Sjögren’s syndrome
and dermatomyositis/ polymyositis.
-
if you have active infection at the site of non-union (inflammation
and drainage at the site of
injury) or active systemic infection.
-
if your doctor determines that you have inadequate skin coverage (at
the fracture site) and
inadequate blood supply at your site of surgery.
-
for vertebral (spine) fractures.
-
for treating non-union resulting from pathological (disease-related)
fractures, metabolic bone
disea
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Osigraft 3.3 mg powder for suspension for implantation
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 3.3 mg of eptotermin alfa*
*Produced in Chinese hamster ovary (CHO) cells by recombinant DNA
technology
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for suspension for implantation.
White to off-white granular powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of non-union of tibia of at least 9 month duration,
secondary to trauma, in skeletally mature
patients, in cases where previous treatment with autograft has failed
or use of autograft is unfeasible.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Osigraft should be used by an appropriately qualified surgeon.
The recommended dose is one single administration in adults. Depending
on the size of the bone
defect, more than one 1 g vial of Osigraft may be required. The
recommended maximum dose should
not exceed 2 vials since efficacy in the treatment on non-unions
requiring higher doses has not been
established.
Paediatric population
Osigraft is contraindicated in children and adolescents (less than 18
years old) and the skeletally
immature (see section 4.3).
Method of administration:
Intraosseous use.
The reconstituted product is administered by direct surgical placement
at the non-union site in contact
with the prepared bone surface. The surrounding soft tissues are then
closed around the implant.
Experience from controlled clinical trials is limited to stabilisation
of the fracture by intramedullary
nailing.
1.
Using sterile technique, remove the vial from its packaging.
2.
Lift the plastic flip-top and remove the crimp from the vial.
Handle the crimp with care. The edges of the crimp are sharp and may
cut or damage gloves.
3.
Using your thumb, pry up the edge of the stopper. Once the vacuum is
broken, remove the vial
stopper while holding the vial upright to prevent loss
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