Ostenil® line

®
Ostenil line
®
Decrease Joint Pain
Improve Joint Function
A Swiss pharmaceutical company with more than 30 years experience
in hyaluronic acid-based products.
In-house ISO certified manufacturing
facilities of sterile injectables
in Vouvry, Switzerland.
Over 1 million pre-filled syringes
produced every year for intraarticular injections with Swiss
quality and unique know-how.
OSTENIL® pre-filled syringes contain
highly purified sodium hyaluronate
obtained by fermentation.
Restoring synovial balance in small joints
- HA obtained from bacterial fermentation
- HA 1% (10 mg/1 ml)
- Molecular weight:1-2 million Daltons
- 1 ml pre-filled syringe
- Terminal sterilisation for optimal safety:
the content and the outer surface of
the syringe are sterile.
Ostenil Mini
10 mg / 1 ml
• Cycle of 1-3 injections into small joints such
as those in the hand, foot, facet joints and the
temporomandibular joint.
• A single injection of OSTENIL® MINI
is as effective as an injection of steroid
in patients with rhizarthrosis.2
• OSTENIL® MINI improves joint mobility and
pain-free activity in the treatment of hallux
rigidus.1
• In temporomandibular joint disorders,
an injection of OSTENIL® MINI reduces
pain and improves joint function.3
1
2
3
Pons M et al. Foot Ankle Int 2007;28(1):38-42
Tourret LJ et al. Presented at the 10th World Congress on Osteoarthritis. December 8-11, 2005; poster P157.
Oliveras-Moreno JM et al. J Oral Maxillofac Surg 2008;66:2243-46
Designed for long-term relief in OA
- HA obtained from bacterial fermentation
- HA 1% (20 mg/2 ml)
- Molecular weight:1-2 million Daltons
- 2 ml pre-filled syringe
- Terminal sterilisation for optimal
safety: the content and the
outer surface of the syringe
are sterile.
• Treatment cycle of 3-5 weekly injections
into large joints.
• OSTENIL® provides long-lasting pain relief
and improves function in knee OA patients,
with excellent tolerability.4
Ostenil
20 mg / 2 ml
• OSTENIL® reduces pain and improves
function in patients with advanced OA
of the shoulder, who either refuse or are
considered medically unfit for shoulder
replacement surgery.6
• In patients suffering from hip OA, a
treatment cycle of 3 weekly injections of
OSTENIL® is effective in reducing pain over
12 months compared to lidocaine.5
4
5
6
Dreiser RL et al. Ann Rheum Dis 2012;71(Suppl3):584
Tsvetkova E et al. Ann Rheum Dis 2010;69(Suppl3):281
Funk L et al. Presented at the 9th World Conference of the Osteoarthritis Research Society International 2004; poster P338
®
Flexible treatment scheme with high dose HA 2%
- HA obtained from bacterial fermentation
- HA 2% (40 mg/2 ml)
- Molecular weight:1-2 million Daltons
- Mannitol 0.5% (10 mg/2 ml)
- 2 ml pre-filled syringe
- Terminal sterilisation for optimal
safety: the content and the outer
surface of the syringe are sterile.
• Mannitol-stabilised high dose HA 2%.
Mannitol acts as a free radical
scavenger which protects HA
from rapid depolymerisation.7
• The formulation offers the possibility of
increasing the intervals between injections.8
7
8
9
Mendoza G et al. Carbohydr Res 2007; 342: 96-102
Data on file
Borras-Verdera et al. Rev Esp Cir Ortop Traumatol 2012; 56(4): 274-80
Ostenil Plus
40 mg / 2 ml
• Sustained efficacy with reduced number of injections (1-3).8
• One injection of OSTENIL® PLUS reduces
pain and improves function in knee OA over
a period of at least 6 months.9
The healthy synovial
joint is in a state of
balance or homeostasis.
The hyaluronan in
the joint space is
continuously replaced,
but its concentration
and molecular weight
profile remain constant.
In osteoarthritis,
homeostasis is lost and
the hyaluronan in the
joint space becomes
depolymerised and
fragmented.10
The synovial fluid becomes less
viscous and its lubricating, shockabsorbing and filtering abilities
are reduced.11
The coating of hyaluronan over the
surface of the joint breaks down,
leaving the cartilage and synovium
exposed to mechanical and
inflammatory damage.12
Loss of homeostasis
in the osteoarthritic joint
The synovium becomes inflamed. As a result, it grows
more permeable to inflammatory molecules, which are
therefore able to enter the joint in increased numbers.12
Mensitieri M et al. J Mat Sci Mat Med 1995;6:130-7.
Balazs EA, Denlinger JL. J. Rheumatol 1993;20(Suppl 39):3-9.
12
Pelletier JP, Martel-Pelletier J. J Rheumatol 1993;20(Suppl 39):19-24.
13
Abatangelo G et al. Clin Orthop 1989;241:278-85.
14
Peyron JG. Osteoarthritis Cartilage, 1993;1:85-7.
15
Abatangelo G et al. Eur J Cell Biol 1998;49(Suppl 28):18.
16
Kvam BJ et al. Exp Cell Res 1995;218:79-86.
17
Presti D, Scott JE. Cell Biochem Funct 1994; 12:281-8.
18
Frizziero L et al. Clin Exp Rheumatol 1998;16:441-9.
19
Partsch G et al. Z Rheumatol 1989;48:123-8.
20
Karatay S et al. Ann Clin Lab Sci 2004;34:330-5.
21
Gotoh S et al. Ann Rheum Dis 1993;52:817-22.
22
Miyazaki K et al. Pharmacometrics 1984;28:1123-35.
23
Homandberg GA et al. Osteoarthritis Cartilage 1997;5:309-19.
24
Jubb RW et al. Ann Rheum Dis 2001; 60(Suppl 1):46.
25
Listrat V et al. Osteoarthritis Cartilage 1997;5:153-60.
26
Yasui T et al. Biomed Res 1992;13:343-8.
10
11
The articular cartilage is
gradually destroyed.13
Osteoarthritis is accompanied
by symptoms of pain,
inflammation and reduced mobility
The administration of exogenous hyaluronan increases
the viscosity of the synovial fluid, restoring its lubricating,
shock-absorbing and filtering properties.10,14
In addition, it re-establishes the protective coating
of hyaluronan over the inner surface of the joint and
increases the scavenging of free radicals.15,16,17
Exogenous hyaluronan
restores synovial balance
As a result of these changes, hyaluronan reduces
inflammation of the synovium.18-20
By masking the nociceptors, pain is also alleviated.11,21,22
Evidence exists suggesting that exogenous hyaluronan may slow the destruction of cartilage
®
23-26
GB
GB
Viscoelastic solution for injection into small joints
Instructions for Use
OSTENIL® mini
Sodium hyaluronate from fermentation 1.0 %. Viscoelastic solution for ­injection into small joints. Sterile by moist heat.
Composition:
1 ml isotonic solution contains 10.0 mg sodium hyaluro­nate and sodium chloride, disodium phosphate, sodium dihydrogen phosphate, water for i­njections.
Indications:
Pain and restricted mobility in degenerative and traumatic changes of small s­ ynovial joints, for example, the facet joints
of the lumbar spine, the saddle joint of the thumb, the interphalangeal joints of the fingers and toes, the p­ roximal joint
of the big toe and the temporomandibular joint. In the t­ reatment of larger joints, for example the knee, hip or shoulder,
OSTENIL® ­pre-filled syringes of 20 mg/2.0 ml should be used.
Contra-indications:
OSTENIL® mini should not be used in patients with ascertained h­ yper­sensitivity to any of its constituents.
Interactions:
No information on the incompatibility of OSTENIL® mini with other solutions for intraarticular use is available to date.
The concomitant use of an oral analgesic or anti-inflammatory drug during the first few days of treatment may be
helpful for the patient.
Undesirable effects:
Local secondary phenomena such as pain, feeling of heat, redness and s­ welling/joint effusion may occur in the joint
treated with OSTENIL® mini. Application of an ice pack onto the treated joint for five to ten minutes will reduce the
incidence of these events.
Dosage and administration:
Inject OSTENIL® mini into the affected joint once a week for a total of 1–3 injections. Several joints may be treated at
the same time. Depending on the severity of the joint disease the beneficial effects of a treatment cycle may last at
least six months. Repeat treatment cycles may be administered as required. In case of joint effusion it is advisable to
reduce the effusion by aspiration, rest, application of an ice pack and/or intraarticular cortico­steroid injection. Treatment
with OSTENIL® mini can be started two to three days later.
The contents and outer surface of the OSTENIL® mini pre-filled syringe are sterile as long as the sterile pack is intact.
Take the pre-filled s­ yringe out of the sterile pack, unscrew the Luer lock cap from the syringe, attach a s­ uitable ­needle
(for example 19 to 25 G) and secure it by turning slightly. Remove any air bubble, if present, before injection.
Precautions:
Caution should be exercised in patients with known hypersensitivity to drugs. The general precautions for intraarticular
injections should be observed, including measures to avoid joint infections. OSTENIL® mini should be ­injected accurately into the joint cavity, if necessary under imaging control. Avoid injec­tions into blood vessels or surrounding tissues!
As no ­clinical ­evidence is available on the use of hyaluronic acid in children, pregnant and lactating women or in inflammatory joint diseases such as rheumatoid arthritis or Bechterew disease, treatment with OSTENIL® mini is not
re­commended in these cases. Do not use if the pre-filled syringe or s­terile pack are damaged. Any solution not used
immediately after opening must be discarded. Otherwise the sterility is no longer guaranteed. Store between 2 °C and
25 °C! Do not use after the expiry date indicated on the box. Keep out of the reach of children.
Characteristics and mode of action:
Synovial fluid, which is viscoelastic due to the presence of hyaluronic acid, is found in all synovial joints where it ensures
normal, painless movement due to its lubricating and shock-absorbing properties. It is also responsible for the nutrition
of the cartilage. In degenerative joint disorders such as osteoarthritis, the viscoelasticity of the synovial fluid is markedly reduced thereby decreasing its lubricating and shock-absorbing functions. This increases mechanical ­loading of the
joint and cartilage destruction which ultimately results in pain and restricted mobility of the affected joint.
Supplementing this synovial fluid with intraarticular injections of highly purified hyaluronic acid can ameliorate the viscoelastic properties of synovial fluid. This improves its lubricating and shock-absorbing functions and reduces mechanical
­overload of the joint. As a rule this results in a decrease in pain and an improvement in joint mobility which may last for
several months after a t­reatment cycle.
Presentation:
One pre-filled syringe of 10 mg/1.0 ml OSTENIL® mini in a sterile pack.
OSTENIL® mini is a medical device. To be used by a physician only.
Last revision date: March 2011
Viscoelastic solution for injection into the joint cavity
Instructions for Use
OSTENIL®
Sodium hyaluronate from fermentation 1.0 %. Viscoelastic solution for injection into the joint cavity. Sterile by moist
heat.
Composition:
1 ml isotonic solution contains 10.0 mg sodium hyaluronate and sodium chloride, disodium phosphate, sodium dihydrogen phosphate, water for injections.
Indications:
Pain and restricted mobility in degenerative and traumatic changes of the knee joint and other synovial joints.
Contra-indications:
OSTENIL® should not be used in patients with ascertained hypersensitivity to any of its constituents.
Interactions:
No information on the incompatibility of OSTENIL® with other solutions for intra-articular use is available to date. The
concomitant use of an oral analgesic or anti-inflammatory drug during the first few days of treatment may be helpful for
the patient.
Undesirable effects:
Local secondary phenomena such as pain, feeling of heat, redness and swelling/joint effusion may occur in the joint
treated with OSTENIL®. Application of an ice pack onto the treated joint for five to ten minutes will reduce the incidence
of these events.
Dosage and administration:
Inject OSTENIL® into the affected joint once a week for a total of 3–5 injections. Several joints may be treated at
the same time. Depending on the severity of the joint disease the beneficial effects of a treatment cycle of five
intra-articular injections will last at least six months. Repeat treatment cycles may be administered as required.
In case of joint effusion it is advisable to reduce the effusion by aspiration, rest, application of an ice pack and/or
intra-articular corticosteroid injection. Treatment with OSTENIL® can be started two to three days later.
The content and the outer surface of the OSTENIL® pre-filled syringe are sterile as long as the sterile pack is intact. Take
the pre-filled syringe out of the sterile pack, unscrew the Luer lock cap from the syringe, attach a suitable needle
(for example 19 to 21 G) and secure it by turning slightly. Remove any air bubble, if present, before injection.
Precautions:
Caution should be exercised in patients with known hypersensitivity to drugs. The general precautions for intra-articular
injections should be observed, including measures to avoid joint infections. OSTENIL® should be injected accurately into
the joint cavity, if necessary under imaging control. Avoid injections into blood vessels or surrounding tissues! As no
clinical evidence is available on the use of hyaluronic acid in children, pregnant and lactating women or in inflammatory
joint diseases such as rheumatoid arthritis or Bechterew disease, treatment with OSTENIL® is not recommended in these
cases. Do not use if the pre-filled syringe or sterile pack are damaged. Any solution not used immediately after opening
must be discarded. Otherwise the sterility is no longer guaranteed. Store between 2 °C and 25 °C! Do not use after the
expiry date indicated on the box. Keep out of the reach of children.
Characteristics and mode of action:
Synovial fluid, which is viscoelastic due to the presence of hyaluronic acid, is found in all synovial joints, particularly the
large weight bearing joints, where it ensures normal, painless movement due to its lubricating and shock-absorbing
properties. It is also responsible for the nutrition of the cartilage. In degenerative joint disorders such as osteoarthritis,
the viscoelasticity of the synovial fluid is markedly reduced thereby decreasing its lubricating and shock-absorbing
functions. This increases mechanical loading of the joint and cartilage destruction which ultimately results in pain
and restricted mobility of the affected joint. Supplementing this synovial fluid with intra-articular injections of highly
purified hyaluronic acid can ameliorate the viscoelastic properties of synovial fluid. This improves its lubricating and
shock-absorbing functions and reduces mechanical overload of the joint. As a rule this results in a decrease in pain and
an improvement in joint mobility which may last for several months after a treatment cycle of five intra-articular
injections.
Presentation:
One pre-filled syringe of 20 mg/2.0 ml OSTENIL® in a sterile pack. Three pre-filled syringes of 20 mg/2.0 ml OSTENIL®
in sterile packs. Five pre-filled syringes of 20 mg/2.0 ml OSTENIL® in sterile packs.
OSTENIL® is a medical device. To be used by a physician only.
Last revision date: August 2011
®
%. Viskoelastische Lösung zur
hte Hitze.
Sodium hyaluronate from fermentation 1.0 %. Viscoelastic solution for
injection into the joint cavity. Sterile by moist heat.
Hyaluronate de sodium obtenu par fermentation 1,0 %. Solution viscoélastique
pour injection dans la cavité articulaire. Stérile par vapeur d’eau.
Hialuronato sódico obtenido por fermentación 1,0 %. Solución viscoelástica
para inyección en la cavidad articular. Estéril por calor húmedo.
Natriumhyaluronat sowie Naatriumdihydrogenphosphat und
Composition:
1 ml isotonic solution contains 10.0 mg sodium hyaluronate and sodium
chloride, disodium phosphate, sodium dihydrogen phosphate, water for
injections.
Composition :
1 ml de solution isotonique contient 10,0 mg de hyaluronate de sodium ainsi
que du chlorure de sodium, du phosphate disodique, du phosphate
monosodique et de l’eau pour préparation injectable.
Composición:
Cada ml de la solución isotónica contiene 10,0 mg de hialuronato sódico,
cloruro sódico, monohidrogenofosfato de sodio, dihidrogenofosfato de sodio
y agua para inyectables.
Indications:
Pain and restricted mobility in degenerative and traumatic changes of the
knee joint and other synovial joints.
Indications :
Douleur et diminution de la mobilité dans les altérations dégénératives et
traumatiques de l’articulation du genou et des autres articulations synoviales.
Indicaciones:
Dolor y limitación de la movilidad en cambios degenerativos y traumáticos de
la articulación de la rodilla y otras articulaciones sinoviales.
ähigkeit bei degenerativen und
s und anderer Synovialgelenke.
berempfindlichkeit gegen einen GB
:
®
OSTENIL
mit anderen
tic
solution
for intraintonicht
thebekannt
joint cavity
ng
geworden.
nehmenden schmerzstillenden
während der ersten Behandn.
Contra-indications:
OSTENIL® should not be used in patients with ascertained hypersensitivity to
GBone of the constituents.
Contre-indications :
OSTENIL® ne devrait pas être utilisé chez les patients avec des antécédents
Fd’hypersensibilité à l’un des constituants.
:
Viscoelastic solution for injection into AInteractions
the
joint
ce jour,
aucune cavity
donnée n’est Solución
disponible sur
l’incompatibilité para
d’OSTENIL
viscoelástica
Interactions:
®
No information on the incompatibility
of OSTENIL
with otherpour
solutions
Solution
viscoélastique
injection
dans
la cavité
for intra-articular use is available
to date. The
concomitant
use articulaire
of an oral
analgesic or anti-inflammatory drug during the first few days of treatment
may be helpful for the patient.
®
inyección
en la cavidad
articular
avec d’autres solutions à usage
intra-articulaire.
La prise simultanée
d’analgésiques ou d’une médication anti-inflammatoire par voie orale
pendant les premiers jours de traitement peut être utile au patient.
Contraindicaciones:
OSTENIL® no debe emplearse en pacientes con hipersensibilidad conocida
Ea alguno de sus componentes.
Interacciones:
Hasta la fecha no se dispone de ninguna información sobre la incompatibilidad de OSTENIL® con otras soluciones para uso intraarticular. El empleo
concomitante de un analgésico oral o una medicación antiinflamatoria durante los primeros días de tratamiento puede ser una ayuda para el paciente.
Instructions for Use
OSTENIL Plus
Sodium hyaluronate from fermentation 2.0 %. Viscoelastic solution for ­injection into the joint cavity. Sterile by moist
heat.
Composition:
1 ml isotonic solution (pH 7.3) contains 20.0 mg sodium hyaluronate from fermentation and sodium chloride, disodium
phosphate, sodium dihydrogenphosphate, mannitol and water for injections.
Indications:
Pain and restricted mobility in degenerative and traumatic changes of the knee joint and other synovial joints.
Contra-indications:
OSTENIL Plus should not be used in patients with ascertained hypersensitivity to one of the constituents.
Interactions:
No information on the incompatibility of OSTENIL Plus with other solutions for intra-articular use is available to date.
The concomitant use of an oral analgesic or anti-inflammatory drug during the first few days of treatment may be
helpful for the patient.
Side effects:
Local secondary phenomena such as pain, sensation of heat, redness and ­swelling may occur in the joint treated with
OSTENIL Plus. Application of an ice pack for five to ten minutes onto the treated joint will reduce the incidence of these
events.
Directions for use:
Inject OSTENIL Plus into the affected joint once a week for a total of 1–3 injections. Several joints may be treated at
the same time. Repeat treatment cycles may be administered as required. In case of joint effusion it is advisable to
reduce the effusion by aspiration, rest, application of an ice pack and/or intra-articular corticosteroid injection. Treatment
with OSTENIL Plus can be started two to three days later.
The content and the outer surface of the OSTENIL Plus pre-filled syringe are sterile as long as the sterile pack is intact.
Take the pre-filled syringe out of the sterile pack, unscrew the Luer lock cap from the syringe, attach a suitable needle
(for example 18 to 25 G) and secure it by turning slightly. Remove any air bubble, if present, before injection.
Precautions:
Caution should be exercised in patients with known hypersensitivity to drugs. The general precautions for intra-articular
injections should be observed, including measures to avoid joint infections. OSTENIL Plus should be injected accurately
into the joint cavity, if necessary under imaging control. Avoid ­injections into blood vessels or surrounding tissues! As no
clinical evidence is available on the use of hyaluronic acid in children, pregnant and lactating women or in inflammatory
joint diseases such as rheumatoid arthritis or Bechterew disease, treatment with OSTENIL Plus is not recommended in
these cases. Do not use if the pre-filled syringe or sterile pack are damaged. Any solution not used immediately after
opening must be discarded. Otherwise the sterility is no longer guaranteed. Store between 2 °C and 25 °C! Do not use
after the expiry date indicated on the box. Keep out of the reach of children!
Characteristics and mode of action:
Synovial fluid, which is viscoelastic due to the presence of hyaluronic acid, is found in all synovial joints, particularly the
large weight bearing joints, where it ensures normal, painless movement due to its lubricating and shock-absorbing
properties. It is also responsible for the nutrition of the cartilage. In degenerative joint disorders such as osteoarthritis,
the viscoelasticity of the synovial fluid is markedly reduced thereby decreasing its lubricating and shock-absorbing functions. This increases mechanical loading of the joint and cartilage destruction which ultimately results in pain and
restricted mobility of the affected joint. Supplementing this synovial fluid with intra-articular in­jections of highly purified
hyaluronic acid can ameliorate the viscoelastic properties of synovial fluid. This improves its lubricating and shockabsorbing functions and reduces mechanical overload of the joint. As a rule this results in a decrease in pain and an
improvement in joint mobility which may last for several months after a treatment cycle.
OSTENIL Plus is a transparent solution of natural and highly purified sodium hyaluronate obtained by fermentation and
is devoid of animal protein. OSTENIL Plus also contains mannitol, a free radical scavenger, which helps to stabilise the
chains of sodium hyaluronate. In biocompatibility studies, OSTENIL Plus was found to be particularly safe.
Presentation:
One pre-filled syringe of 40 mg / 2.0 ml OSTENIL Plus in a sterile pack.
OSTENIL Plus is a medical device. To be used by a physician only.
Last revision date:Présentation
December: 2010
Una jeringa prellenada de 20 mg/2,0 ml OSTENIL en un paquete estéril.
Side
Effets secondaires :
Efectos secundarios:
® effects:
Local secondary phenomena such as pain, feeling of heat, redness and
Des manifestations locales telles que douleur, chaleur, rougeur et gonflement
En la articulación tratada con OSTENIL®, pueden producirse fenómenos
USE
INSTRUCCIONES
PARA ELtraitée
USO par OSTENIL®.
swelling may MODE
occur in theD’EMPLOI
joint treated with OSTENIL®. Application of an ice
peuvent apparaître
au niveau de l’articulation
locales secundarios como dolor, sensación de calor, enrojecimiento e inflamaam
behandelten Gelenk lokale
Batch
number
®
®
ción. La aplicación de una bolsa de hielo
durante
cinco a diez minutos sobre
fühl, Rötungen und Schwellunpack for five to
ten minutes onto the treated joint will reduce the incidence of
L’application OSTENIL
d’une poche à glace pendant 5 à 10 minutes au niveau de la
OSTENIL
la articulación tratada reducirá la incidencia de estos síntomas.
auf das behandelte
Gelenk für solution these
zone traitée réduira
l’incidence
ces effets.
Hialuronato
sódicodeobtenido
por fermentación 1,0 %. Solución viscoelástica
mentation
1.0 %. Viscoelastic
for events. Hyaluronate de sodium obtenu par fermentation 1,0 %. Solution viscoélastique
solcher
Begleiterscheinungen.
para
inyección
en
la
cavidad
articular.
Estéril
por
calor
húmedo.
rile
by moist
heat.
pour
injection
dans
la
cavité
articulaire.
Stérile
par
vapeur
d’eau.
Directrices de uso:
Directions for use:
Dosage et administration :
®
®
Inyectar OSTENIL® en el interior de la articulación afectada una vez a la
ndung:
Inject OSTENIL
Injecter OSTENIL
into the affected
joint once a week for a total of 3–5
dans l’articulation atteinte une fois par semaine, pour un
Composición:
Composition
:
injections. Several
joints
may be
treated atcontient
the same
on the
total de 3 à 5Cada
injections.
peuvent 10,0
être traitées
semana con un total de 3–5 inyecciones. Pueden tratarse varias articulaciones
en
Abständen
in das
erkrankte and sodium
ml de Plusieurs
la soluciónarticulations
isotónica contiene
mg de simulhialuronato sódico,
10.0
mg sodium
hyaluronate
1 ml de
solution
isotonique
10,0time.
mg Depending
de hyaluronate
de sodium ainsi
jointdudisease
the beneficial
effects
a treatmentdisodique,
cycle of five
tanément. Encloruro
fonctionsódico,
du degré
de sévérité de l’affection
articulaire,
les effets de sodio
al mismo tiempo. Dependiendo de la gravedad de la patología articular, los
gleichzeitig
behandeltphosphate,
werden. water severity
monohidrogenofosfato
de sodio,
dihidrogenofosfato
sodium
dihydrogen
for of theque
chlorure
de sodium,
du ofphosphate
du phosphate
intra-articularmonosodique
injections willetlast
leastpour
six months.
Repeat
treatment cycles
bénéfiques d’un
cycle
traitement de 5 injections intra-articulaires se
efectos beneficiosos de un ciclo de tratamiento de cinco inyecciones intraann der Effekt einer Behandlung
y agua
paradeinyectables.
deatl’eau
préparation
injectable.
may be administered as required. In case of joint effusion it is advisable to
prolongeront au minimum 6 mois. Il est possible de répéter les cycles de
articulares durará como mínimo seis Expiry
meses.date
Pueden administrarse ciclos de
onate anhalten. Wiederholte
Indicaciones:
Indications :
reduce the effusion by aspiration, rest, application of an ice pack and /or
traitement si nécessaire. En cas d’épanchement articulaire, il est conseillé de
tratamiento repetidos según se precise. En caso de derrame articular, se
. Bei Vorliegen eines GelenkDolor y limitación de la movilidad en cambios degenerativos y traumáticos de
degenerative and traumatic changes of the
Douleur et diminution de la mobilité dans les ®altérations dégénératives et
intra-articular corticosteroid injection. Treatment with OSTENIL can be started
réduire l’épanchement par aspiration, repos, application d’une poche à glace
recomienda reducir el derrame mediante aspiración, reposo, aplicación de una
die Ruhigstellung des Gelenks
la articulación de la rodilla y otras articulaciones sinoviales.
nts.
traumatiques de l’articulation du genou et des autres articulations synoviales.
et/ou injection intra-articulaire d’un corticostéroïde. Le traitement avec
bolsa de hielo y/o inyección intraarticular de corticosteroides. El tratamiento
der die intra-artikuläre Verabtwo to three days later.
Contraindicaciones:
Contre-indications :
OSTENIL® pourra
con OSTENIL® puede iniciarse dos o tres días más tarde.
wei bis drei Tage danach wird
alors reprendre deux à trois jours après.
The content and the outer
surface of the OSTENIL® pre-filled syringe are sterile
OSTENIL® no debe emplearse en pacientes con hipersensibilidad conocida
OSTENIL® ne devrait pas être utilisé chez les patients avec des antécédents
patients with ascertained hypersensitivity to
Le contenu et la surface externe de la seringue pré-remplie d’OSTENIL®
El contenido y la superficie de la jeringa prellenada de OSTENIL® son estériles
as
®long as the sterile pack is intact. Take the pre-filled syringe out of the sterile
d’hypersensibilité à l’un des constituants.
a alguno de sus componentes.
pack, unscrew the Luer lock cap from the syringe, attach a suitable needle
ist, sind der Inhalt und die
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inyección.
atients with known hypersensitivity to drugs.
injections of highly purified hyaluronic acid can ameliorate the viscoelastic
Dans le cas d’affections dégénératives articulaires telles que l’ostéoarthrose,
gung des Gelenkknorpels mit
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ra-articular injections should be observed,
Précautions :
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properties of synovial fluid. This improves its lubricating and shock-absorbing
la viscoélasticité du®liquide synovial est notablement diminuée, ce qui entraîne
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functions and reduces mechanical overload of the joint. As a rule this results
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elenkschmiere erheblich beeinamortiguadoras de choques. Esto aumenta la carga mecánica de la articulasensibilité connue aux médicaments. Les précautions générales liées aux
los medicamentos. Guardar las precauciones habituales de las inyecciones
if necessary under imaging control. Avoid
in a decrease in pain and an improvement in joint mobility which may last for
augmente la charge mécanique de l’articulation et la destruction du cartilage.
dämpfende Wirkung mindert.
ción y la destrucción del cartílago que finalmente produce dolor y limitación
injections intra-articulaires doivent être prises, y compris les mesures destinées
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urrounding tissues! As no clinical evidence is
several months after a treatment cycle of five intra-articular injections. ®
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nic acid in children, pregnant and lactating
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t diseases such as rheumatoid arthritisPresentation:
or
sées spécifiquement dans la cavité articulaire, si nécessaire sous contrôle
cavidad articular,
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par
des
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ith OSTENIL is not recommended in these
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Verabreichung von hochreiner
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®
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hyaluronique chez l’enfant, la femme enceinte ou allaitante, ou dans les
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after opening must be discarded. Otherwise
ainsi qu’une diminution de la surcharge mécanique de l’articulation. En règle
und stoßdämpfende Wirkung
disminución del dolor y una mejoría de la movilidad articular que puede durar
® affections inflammatoires articulaires telles que l’arthrite rhumatoïde ou la
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eed. Store between 2 °C and 25 °C! Do OSTENIL
not
is
a
medical
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générale, le résultat se traduit par une
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ng des Gelenks verringert. Das
varios meses después de un ciclo de tratamiento de cinco inyecciones intraM. Bechterew, l’administration d’OSTENIL® n’est pas recommandée chez ces
tratamiento con OSTENIL® en estos casos. No utilizar en caso de que la
ated on the box. Keep out of the reach of
amélioration de la mobilité articulaire qui peut durer pendant plusieurs mois
hmerzen und eine Verbesserung
articulares.
Last revision date: October 2010
patients. Ne pas utiliser si la seringue pré-remplie ou l’emballage stérile sont
jeringa prellenada o la envoltura estéril estén deteriorados. Toda solución que
après un cycle de traitement de 5 injections intra-articulaires.
Behandlungszyklus von fünf
endommagés. Toute solution non utilisée immédiatement après ouverture
no sea usada inmediatamente después de haber sido abierta deberá Presentaciones:
ser
action:
anhalten können.
Présentation
:
Una jeringa prellenada de 20 mg/2,0 ml OSTENIL® en un paquete estéril.
doit
être
jetée.
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la
stérilité
n´est
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entre
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et
desechada.
De
lo
contrario
no
se
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esterilidad
de
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misma.
tic due to the presence of hyaluronic acid, is
®
Une seringueConservar
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ml No
OSTENIL
Tres jeringas prellenadas de 20 mg/2,0 ml OSTENIL® en paquetes estériles.
dans undeemballage
25°C ! Ne pas utiliser après la date d’expiration mentionnée sur la boîte. Tenir
entre
y 25 °C.
usar después
la fecha de caducidad
ularly the large weight bearing joints, where
stérile.
Cinco jeringas prellenadas de 20 mg/2,0 ml OSTENIL® en paquetes estériles.
in Sterilverpackung.
hors de portée des enfants.
indicada en la caja. Guardar fuera del alcance de los niños.
vement due to its lubricating and shockTrois seringues pré-remplies de 20 mg/2,0 ml OSTENIL®, individuellement
l in Sterilverpackung.
Para uso médico exclusivo.
sponsible for the nutrition of the cartilage. In
Caractéristiques et mode d’action :
Características y modo de acción:
emballées dans un emballage stérile.
ml in Sterilverpackung.
h as osteoarthritis, the viscoelasticity of the
Le liquide synovial, dont la viscoélasticité est liée à la présence d’acide hyalEl líquido sinovial, que es viscoelástico debido a la presencia de ácido
Última revisión: Octubre 2010
Cinq seringues pré-remplies de 20 mg/2,0 ml OSTENIL®, individuellement
ced thereby decreasing its lubricating and
uronique, est présent dans toutes les articulations synoviales, et particulièrehialurónico, se encuentra en todas las articulaciones sinoviales, particularmente
emballées dans un emballage stérile.
ncreases mechanical loading of the joint and
ment dans les articulations supportant un poids important, où il permet des
las articulaciones que soportan grandes pesos, donde asegura un movimiento
à un
usageymédical
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mately results in pain and restricted mobility
mouvements normaux et sans douleur grâce à ses propriétés lubrifiantesRéservé
et
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nting this synovial fluid with intra-articular
d’absorption des chocs. Il assure également l’apport nutritionnel du cartilage.
choques.
También
Dernière révision
: Octobre
2010es responsable de la nutrición del cartílago. En alteraciones
luronic acid can ameliorate the viscoelastic
Dans le cas d’affections dégénératives articulaires telles que l’ostéoarthrose,
articulares degenerativas como osteoartritis, la viscoelasticidad del líquido
mproves its lubricating and shock-absorbing
la viscoélasticité du liquide synovial est notablement diminuée, ce qui entraîne
sinovial se reduce notablemente, disminuyendo sus funciones lubricantes y
al overload of the joint. As a rule this results
une réduction des fonctions lubrifiantes et d’absorption des chocs. Ceci
amortiguadoras de choques. Esto aumenta la carga mecánica de la articula®
rovement in joint mobility which may last for
augmente la charge mécanique de l’articulation et la destruction du cartilage.
ción y la destrucción del cartílago que finalmente produce dolor y limitación
®
cycle of five intra-articular injections.
Ces phénomènes ont pour conséquences une mobilité réduite de l’articulation
de la movilidad de la articulación afectada. La suplementación de este líquido
®
atteinte et l’apparition de douleurs. Une supplémentation du liquide synovial
sinovial con inyecciones intraarticulares de ácido hialurónico altamente puripar des injections intra-articulaires d’acide hyaluronique hautement purifié
ficado puede mejorar las propiedades viscoelásticas del líquido sinovial. Esto
2.0 ml OSTENIL® in a sterile pack.
permet
d’améliorer
les
propriétés
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du
liquide
synovial.
On
mejora sus funciones lubricantes y de absorción de choques y reduce
g/2.0 ml OSTENIL® in sterile packs.
observe une amélioration des propriétés lubrifiantes et d’absorption des chocs
la sobrecarga mecánica de la articulación. Como resultado se logra una
/2.0 ml OSTENIL® in sterile packs.
®
ainsi qu’une diminution de la surcharge mécanique
de l’articulation. En règle
disminución del dolor y una mejoría de la movilidad articular que puede durar
e. To be used by a physician only.
générale, le résultat se traduit par une diminution de la douleur et une
varios meses después de un ciclo de tratamiento de cinco inyecciones intra®
amélioration de la mobilité articulaire qui peut durer pendant plusieurs mois
articulares.
après un cycle de traitement de 5 injections intra-articulaires.
Presentaciones:
0406105/7 0762H
Réservé à un usage médical exclusivement.
Dernière révision : Octobre 2010
For single use only
Refer to instruction leaflet
Sterile by moist heat
Don‘t use if the sterile barrier is damaged
TRB Chemedica AG
Richard-Reitzner-Allee 1
85540 Haar/München, Germany
®
Une seringue pré-remplie de 20 mg/2,0 ml OSTENIL® dans un emballage
stérile.
Trois seringues pré-remplies de 20 mg/2,0 ml OSTENIL®, individuellement
emballées dans un emballage stérile.
Cinq seringues pré-remplies de 20 mg/2,0 ml OSTENIL®, individuellement
emballées dans un emballage stérile.
Expiry date
Tres jeringas prellenadas de 20 mg/2,0 ml OSTENIL® en paquetes estériles.
Cinco jeringas prellenadas de 20 mg/2,0 ml OSTENIL® en paquetes estériles.
Para uso médico exclusivo.
Última revisión: Octubre 2010
TRB CHEMEDICA AG
Richard-Reitzner-Allee 1
85540 Haar/München, Germany
TRB CHEMEDICA AG
Richard-Reitzner-Allee 1
85540 Haar/München, Germany
Printed in 10/12
Ostenil line, Designed for
®
long-term relief in OA
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