Ena Farma - Sanatatea articulatiilor tale

OSTENIL PLUS.

INSTRUCTIONS FOR USE
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, sodium monohydrogenphosphate, sodium dihydrogenphosphate, mannitol and water for injection.

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.

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. 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.

Side effects:
Local secondary phenomena such as pain, feeling 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.

Interactions with other products:
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.

Dosage and administration:
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 remains unbroken. Take the pre-filled syringe out of the sterile pack. Before usage of the pre-filled syringe the tamperevident seal has to be tilted up. As a result the crosspieces of the tamperevident seal break and the cap can be removed together with the tip cap (see pictures). Attach a suitable needle (for example 18 to 25 G) and secure it by turning slightly. If present remove the air bubble from the syringe prior to injection.

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 shockabsorbing 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.
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 and package size:
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: April 2009

OSTENIL

INSTRUCTIONS FOR USE
Sodium hyaluronate 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, sodium monohydrogenphosphate, sodium dihydrogenphosphate, water for injection.

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 one of the constituents.

Precautions:
Caution should be exercised in patients with known hypersensitivity to drugs. The general precautions for intra-articular injections should be observed. OSTENIL® should be injected accurately into the joint cavity. 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 prefilled syringe or sterile pack are damaged. 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.

Side effects:
Local secondary phenomena such as pain, feeling of heat, redness and swelling may occur in the joint treated with OSTENIL®. Application of an ice pack for five to ten minutes onto the treated joint will reduce the incidence of these events.

Interactions with other products:
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.

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 from the sterile pack. Before administration break off the tamper-evident seal of the pre-filled syringe removing the tip-cap with it (see illustration). Attach a suitable needle (e. g. a 19 to 21 G needle) and secure it to the syringe by turning slightly. Remove any air bubble, if present, before injection.

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 shockabsorbing 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 and package size:
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: October 2009

OSTENIL MINI.

INSTRUCTIONS FOR USE

Sodium hyaluronate 1.0 %. Viscoelastic solution for injection into small joints. Sterile by moist heat.

Composition:
1 ml isotonic solution contains 10.0 mg sodium hyaluro nate from fermentation and sodium chloride, sodium monohydrogenphosphate, sodium dihydrogenphosphate, water for injection.

Indications:
Pain and restricted mobility in degenerative and traumatic changes of small synovial 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 proximal joint of the big toe and the temporomandibular joint. In the treatment of bigger joints, for example the knee, hip or shoulder, OSTENIL® prefilled syringes of 20 mg/2.0 ml should be used.

Contra-indications:
OSTENIL® mini should not be used in patients with ascertained hypersensitivity to one of the constituents.

Precautions for use:
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® mini should be injected accurately into the joint cavity, if necessary under imaging control. Avoid injec tions 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 re commended in these cases. Do not use if the pre-filled syringe or sterile pack are damaged. 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.

Side effects:
Local secondary phenomena such as pain, feeling of heat, redness and swelling/joint effusion may occur in the joint treated with OSTENIL® mini. Application of an ice pack for five to ten minutes onto the treated joint will reduce the incidence of these events. In isolated cases the occurrence of side effects may be due to the intra-articular injection itself.

Interactions with other products:
Avoid using OSTENIL® mini with instruments sterilised with quarternary ammonium salts solutions. No information on the incompatibility of OSTENIL® mini 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.

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 intra-articular cortico steroid 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 remains unbroken. 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 25 G) and secure it by turning slightly. If present remove the air bubble from the syringe prior to injection.

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 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.

Presentation and package size:
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: November 2009

VISCOSEAL®

INSTRUCTIONS FOR USE

Sodium hyaluronate from fermentation 0.5 %. Synovial fluid substitute. 10 ml mono-use container in a sterile sachet. Sterile by moist heat.

Composition:
1 ml isotonic solution contains 5.0 mg sodium hyaluronate from fermentation, sodium chloride, sodium monohydrogenphosphate, sodium dihydrogenphosphate and water for injections.

Indication:
To relieve pain, improve mobility and promote joint recovery by flushing out irrigating solution and substituting the synovial fluid following arthroscopic procedures or joint lavage.

Directions for use:
The contents and outer surface of the VISCOSEAL® mono-use container are sterile as long as the sachet remains unbroken. VISCOSEAL® should be used at the end of the arthroscopy after completion of the normal irrigating procedure. Remove the container from the sachet. Twist off the cap and remove the air bubble by squeezing the container. Attach its Luer tip to a portal already placed in the joint. Introduce VISCOSEAL® into the joint cavity by squeezing the container. This will help to wash out the remaining irrigating solution.

Precautions:
The general precautions for arthroscopic procedures should be observed. VISCOSEAL® should be instilled accurately into the joint cavity. As VISCOSEAL® does not contain preservatives, any solution not used immediately after opening should be discarded. Do not use if the mono-use container or sterile sachet are damaged. 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.

Side effects:
No undesirable effects are expected with VISCOSEAL® when used in the approved indication and at the dosage prescribed. The contra-indications must be considered.

Contra-Indications:
Known hypersensitivity to any of the constituents of the product.

Interactions:
No information on the incompatibility of VISCOSEAL® with other solutions for intra-articular use is available to date.

Characteristics and mode of action:
Arthroscopy is a common procedure to visualise, diagnose and treat problems inside a joint. The joint is normally irrigated with solutions such as saline or Ringer lactate before and during arthroscopy in order to allow a clear view of the operation site and to rinse out debris. There is evidence that the presence of these solutions in the joint after irrigation may be detrimental to the cartilage. Furthermore, during the procedure the synovial fluid, which has particular viscoelastic and protective properties due to its hyaluronic acid content, is washed from the joint. Therefore, although the intervention may result in a long-term improvement of joint function, in the short-term patients may suffer from postarthroscopy complaints like pain, swelling and impaired mobility of the joint. VISCOSEAL® has been developed to relieve these symptoms and promote joint recovery. It contains a highly purified specific fraction of hyaluronic acid pro duced by fermentation and is devoid of animal protein. Flushing VISCOSEAL® through the joint cavity will help remove the remaining irrigating solution and efficiently coat all surfaces of the joint. The VISCOSEAL® left in the joint will act as a lubricant and a shock absorber and its macromolecular meshwork will prevent the free passage of inflammatory cells and molecules through the joint cavity. In addition, hyaluronic acid is able to promote wound healing.

Presentation and package size:
1 x 10 ml mono-use container of VISCOSEAL® in a sterile sachet.
To be used by a physician only.
Last revision date: November 2009

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ARTROSCOPIA, UN EXAMEN PARACLINIC

Artroscopia este o investigatie invaziva care permite vizualizarea foarte buna a spatiului articular cu ajutorulul artroscopului. Artroscopul este format dintr-un endoscop cu fibra optica, instrument care se introduce direct in articulatie printr-o mica incizie subcutanata. Artroscopia ofera medicului posibilitatea de a inspecta suprafetele articulare si tesutul moale din jur: ligamentele si cartilajele.
Introducerea instrumentelor endoscopice permite nu numai examinarea in scop diagnostic a interiorului articulatiei, dar si tratarea leziunilor articulare sau indepartarea corpilor straini liberi din spatiul articular, fara a traumatiza sever tesuturile invecinate, cat si urmarirea evolutiei unei afectiuni articulare sau monitorizarea eficientei tratamentului. Artroscopia se aplica la nivelul articulatiilor mari, dar in principal la nivelul calcaiului, genunchiului si umarului. Se poate folosi pentru vizualizarea soldului, cotului sau articulatiei pumnului.

Se introduce in articulatie, printr-o mica incizie, un tub subtire prevazut cu o camera video si o sursa de lumina. Imaginile obtinute sunt marite si pot fi urmarite pe un monitor. De asemenea, sunt prelevate mostre de tesut pentru efectuarea biopsiei. Daca este folosita si ca metoda terapeutica va mai fi necesara introducerea prin mici incizii a unor instrumente suplimentare.
Ca si procedurile chirurgicale deschise, artroscopia ofera o buna vizualizare a articulatiei, insa spre deosebire de acestea prezinta urmatoarele beneficii:
- este mai putin traumatizanta fiind mai putin dureroasa
- este mai ieftina
- permite recuperarea rapida
- poate fi efectuata in ambulator, fara sa necesite spitalizarea pacientului.

EFICACITATEA ADMINISTRARII VISCOSEAL-ULUI DUPA OPERATIA DE ARTROSCOPIE:
Avanseaza recuperarea articulatiei prin scoaterea din interioar a solutiei irigatoare si inlocuirea lichidului sinovial. Reduce durerea post-operatorie refacand stratul protector din membrana sinoviala, oferind mobilitate articulatiei prin proprietatile sale lubrefiante, de elasticitate si vascozitate datorita acidului hialuronic obtinut prin fermentatie bacteriana.

VISCOSEAL ESTE UN PRODUS UNIC IN LUME FOLOSIT DUPA OPERATIA DE ARTROSCOPIE

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