Ostenil/Ostenil Mini/Ostenil Plus

Ostenil/Ostenil Mini/Ostenil Plus

sodium hyaluronate

Manufacturer:

TRB Chemedica

Distributor:

DCH Auriga
Full Prescribing Info
Contents
Sodium hyaluronate.
Description
Ostenil & Ostenil Mini 1 ml isotonic solution contains 10.0 mg sodium hyaluronate and sodium chloride, disodium phosphate, sodium dihydrogen phosphate, water for injections.
Sodium hyaluronate from fermentation 1.0 %. Viscoelastic solution for injection into the joint cavity. Sterile by moist heat.
Ostenil Plus 1 ml isotonic solution (pH 7.3) contains 20.0 mg sodium hyaluronate from fermentation and sodium chloride, disodium phosphate, sodium dihydrogen-phosphate, mannitol and water for injections.
Sodium hyaluronate from fermentation 2.0%. Sterile by moist heat.
Ostenil: Viscoelastic solution for injection into the joint cavity.
Ostenil Mini: Viscoelastic solution for injection into small joints.
Action
Pharmacology: Characteristics and mode of action: Ostenil & Ostenil Plus: 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.
Ostenil Mini: 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 viscoelaticity 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.
Ostenil: 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.
Ostenil Mini: As a rule this results in a decrease in pain and an improvement in joint mobility which may last for several months after the treatment cycle.
Ostenil Plus: As a rule this results in a decrease in pain and an improvement in joint mobility which may last for several months after the 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.
Indications/Uses
Ostenil & Ostenil Plus: Pain and restricted mobility in degenerative and traumatic changes of the knee joint and other synovial joints.
Ostenil Mini: 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.
Dosage/Direction for Use
Ostenil: 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.
Ostenil Mini: 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 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. Remove any air bubble, if present, before injection.
Ostenil Plus: 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 intraarticular 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.
Contraindications
Ostenil/Ostenil Mini/Ostenil Plus should not be used in patients with ascertained hypersensitivity to any of its constituents.
Special Precautions
Caution should be exercised in patients with known hypersensitivity to drugs. As with all invasive joint treatments in very rare cases an infection may occur. Hence, the general precautions for intra-articular injections should be observed, including measures to avoid joint infections. OSTENIL/OSTENIL MINI/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 pregnant and lactating women or in inflammatory joint diseases such as rheumatoid arthritis or Bechterew disease, treatment with OSTENIL/OSTENIL MINI/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 and this may be associated with a risk of infection.
Adverse Reactions
Ostenil & Ostenil Plus: In very rare cases local and general secondary phenomena such as pain, feeling of heat, redness, inflammation, swelling/joint effusion, hypertension, hypotension, shortness of breath, nausea and pruritus may occur during or after the injection of OSTENIL/OSTENIL PLUS.
Ostenil Mini: In very rare cases local and general secondary phenomena such as pain, feeling of heat, redness, swelling/joint effusion may occur during or after the injection of OSTENIL MINI.
Drug Interactions
No information on the incompatibility of OSTENIL/OSTENIL MINI/OSTENIL PLUS 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.
Storage
Store between 2°C and 25°C.
ATC Classification
M09AX01 - hyaluronic acid ; Belongs to the class of other drugs for disorders of the musculo-skeletal system.
Presentation/Packing
Ostenil inj (pre-filled syringe) 20 mg/2 mL x 1's. Ostenil Mini inj 10 mg/mL (pre-filled syringe) x 1's. Ostenil Plus inj 40 mg/2 mL (transparent solution in a pre-filled syringe) x 1's.
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