Inductos
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
18-10-2021
Summary of Product characteristics
(SPC)
18-10-2021
Public Assessment Report
(PAR)
15-06-2017
Active ingredient:
dibotermin alfa
Available from:
Medtronic BioPharma B.V.
ATC code:
M05BC01
INN (International Name):
dibotermin alfa
Therapeutic group:
Drugs for treatment of bone diseases
Therapeutic area:
Tibial Fractures; Fracture Fixation, Internal; Spinal Fusion
Therapeutic indications:
Inductos is indicated for single level lumbar interbody spine fusion as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least 6 months of non operative treatment for this condition.Inductos is indicated for the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary unreamed nail fixation.
Product summary:
Revision: 23
Authorization status:
Authorised
Authorization date:
2002-09-09
Patient Information leaflet
40
B. PACKAGE LEAFLET
41
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
INDUCTOS 1.5 MG/ML POWDER, SOLVENT AND MATRIX FOR IMPLANTATION MATRIX
dibotermin alfa
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 InductOs is and what it is used for
2.
What you need to know before you receive InductOs
3.
How InductOs is given
4.
Possible side effects
5.
How to store InductOs
6.
Contents of the pack and other information
1.
WHAT INDUCTOS IS AND WHAT IT IS USED FOR
InductOs contains the active substance, dibotermin alfa. It is a copy
of a protein called bone
morphogenetic protein 2 (BMP-2), which is produced naturally by the
body and helps with the
formation of new bone tissue.
InductOs may be used either in lower back spine fusion surgery or to
repair fractures of the shin bone.
_ _
_Lower back spine fusion surgery_
If you have a lot of pain from a damaged disc in your lower back, and
other treatments have not
proven effective, you may be considered for lower back spine fusion
surgery. InductOs is used instead
of taking a bone graft from your hip; this avoids the problems and
pain that can be caused by an
operation to collect the bone graft.
When used in lower back fusion surgery, InductOs is used in
combination with a medical device,
which corrects the position of your spine. If you have any question
about the medical device, please
ask your doctor.
_Fractures of the shin bone_
If you have broken your shin bone, InductOs is used, to help your
fracture heal and to reduce the need
for additional surgeries. It is used in addition to standard treatment
and care of shin bone fractures.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE INDUCTOS
YOU SHOULD NOT RECEIVE INDUCTOS
•
if you a
Read the complete document
Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1
NAME OF THE MEDICINAL PRODUCT
InductOs 1.5 mg/ml powder, solvent and matrix for implantation matrix
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 4 mg (4 mg pack) or 12 mg (12 mg pack) dibotermin
alfa. After reconstitution,
InductOs contains 1.5 mg/ml dibotermin alfa.
Dibotermin alfa (recombinant human Bone Morphogenetic Protein-2;
rhBMP-2) is a human protein
derived from a recombinant Chinese Hamster Ovary (CHO) cell line.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder, solvent and matrix for implantation matrix.
The powder is white. The solvent is a clear colourless liquid. The
matrix is white.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
InductOs is indicated for single-level lumbar interbody spine fusion
as a substitute for autogenous
bone graft in adults with degenerative disc disease who have had at
least 6 months of non-operative
treatment for this condition.
_ _
InductOs is indicated for the treatment of acute tibia fractures in
adults, as an adjunct to standard care
using open fracture reduction and intramedullary unreamed nail
fixation.
See section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
InductOs should be used by an appropriately qualified surgeon.
Posology
InductOs must be prepared exactly in accordance with the directions
for preparation (see section 6.6).
The appropriate dose is determined by the volume of wetted matrix
required for the intended
indication.
If the surgical setting requires that only a portion of the product is
needed, the wetted matrix should be
cut to the desired size, and the unused portion must be discarded.
3
_Dosing table for InductOs 4 mg pack _
INDUCTOS WETTED
MATRICES
(4 MG PACK)
DIMENSIONS OF
WETTED MATRIX
VOLUME OF
WETTED MATRIX
CONCENTRATION OF
WETTED MATRIX
DIBOTERMIN
ALFA DOSE
1 matrix
2.5 cm x 5 cm
1.3 cm
3
1.5 mg/cm
3
2 mg
2 matrices
2 x (2.5 cm x 5 cm)
2.7 cm
3
1.5 mg/cm
3
4 mg
_ _
_Dosing table for InductOs 12 mg pack _
PORTION OF INDUCTOS
WETTED MATRIX
(12 M
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