OSTEB-M [Sodium hyaluronate + MSM] 1.6% + 5% solution for intra-articular injection
OSTEB-М
Sodium hyaluronate (sodium salt of hyaluronic acid) 1.6% (48 mg) +
Methylsulfonylmethane (MSM) 5% (150 mg) 1 pre-filled syringe with a volume of 3
ml for intra-articular administration
OSTEB-M acts as a substitute for synovial fluid in
joints affected by degenerative or mechanical osteoarthritis, causing pain or limited
mobility.
DESCRIPTION
OSTEB-M is a CE-marked medical device compliant with
MDD 93/42/CEE, containing 16 mg/ml of hyaluronic acid obtained by fermentation
and without chemical modification, and MSM.
OSTEB-M is a clear, sterile, apyrogenic and viscoelastic
solution supplied in a 3 ml syringe. Hyaluronic acid is a natural
polysaccharide present in many human tissues, especially in the synovial fluid,
and acts on the joints as a lubricant for cartilage and ligaments, as well as a
shock absorber. Many studies have shown that injections of hyaluronic acid into
joints affected by osteoarthritis restore the viscosity and elasticity of the
synovial fluid, which leads to a decrease in pain and improved joint mobility.
JOYFLEX PROAKJN acts only in the joint into which it is injected, without any
systemic effect.
COMPOSITION
Sodium hyaluronate, MSM, sodium chloride, sodium
dihydrogen phosphate dehydrate, sodium dibasic phosphate dodecahydrate, water
(water for injection).
WARNINGS -
PRECAUTIONS FOR USE:
OSTEB-M is only suitable for intra-articular
injections and should only be administered by a physician who has undergone
special training in intra-articular injection techniques.
Before use, check the integrity of the syringe and the
expiration date. The product should not be administered in the presence of an
infected or severely inflamed joint. Infiltration should be avoided in case of
infection at the site or inflammatory skin conditions in the immediate vicinity
of the injection site. Since there is no clinical experience with sodium
hyaluronate in children, treatment with OSTEB-M is not recommended in these
cases. After intra-articular injection, it is advisable to advise the patient
to avoid physical activity that requires stress on the joints and to resume
normal activity after a few days.
OSTEB-M is a single-use product, the quality and
sterility of which are guaranteed only if the syringe is tightly sealed. Any
residue should be discarded and not reused. Do not use the product if the
packaging has already been opened or damaged. The assembled syringe must be
discarded immediately after use, regardless of whether the solution has been
completely injected. After use, dispose of in accordance with applicable
national practice.
INCOMPATIBILITIES:
There is an incompatibility between sodium hyaluronate
and quaternary ammonium compounds such as benzalkonium chloride solutions.
Therefore, contact of OSTEB-M with these substances should be avoided.
SIDE EFFECT
After the injection of OSTEB-M, some temporary side
effects may occur, such as pain, stiffness, warmth, redness or swelling. These
secondary effects can be relieved by applying ice to the treated joint. These
effects usually disappear after a short time. If symptoms persist, consult a
doctor. Any other unwanted side effects associated with the injection of
OSTEB-M should be reported to the doctor.
METHODS OF USE:
Before injecting OSTEB-M, remove joint effusion; the
same needle must be used for effusion removal and OSTEB-M injection. Remove the
protective cap of the syringe, paying particular attention to avoiding contact
with the orifice. Screw the 18 to 22 G needle securely into the Luer lock
collar following the instructions below. Before injection, the injection site
should be treated with an appropriate disinfectant. Inject OSTEB-M using
aseptic technique. Inject only into the joint cavity. According to medical
prescription, an initial cycle of 3 weekly treatments is recommended, possibly
with subsequent maintenance sessions.
INSTRUCTIONS FOR ASSEMBLY OF THE SYRINGE NEEDLE:
A. Carefully unscrew the syringe tip cap, being
especially careful to avoid contact with the opening.
B. Gently grasp the needle guard and place the needle
onto the luer lock, tightening it firmly until you feel slight counter pressure
to ensure a tight seal and prevent fluid leakage during insertion.
STORAGE:
Store at 2–25°C (36–77°F) in a dry place. Protect from
light, heat and cold. Keep out of reach of children.
CONTENTS OF THE PACK:
1 pre-filled syringe containing 3 ml of apyrogenic gel, sterilized together with instructions for use in a cardboard box.