Sodium Hyaluronate Mini 0.3% injection is used to treat knee pain caused by osteoarthritis (OA) in patients who have already been treated with pain relievers (e.g., acetaminophen) and other treatments that did not work well.
Sodium Hyaluronate Mini 0.3% is similar to a substance that occurs naturally in the joints. It works by acting like a lubricant and shock absorber in the joints and helps the joints to work properly.
Sodium Hyaluronate Mini 0.3% is to be administered only by or under the immediate supervision of your doctor.
Sodium Hyaluronate Mini 0.3% indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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* Sores in the mouth, when applied to the skin as a gel.
* Eye surgery and corneal transplant, when injected by an eye surgeon.
Osteoarthritis, when injected into the joint by a healthcare provider. Despite being approved by the FDA for treatment of osteoarthritis by injection, results vary. Some people report a moderate improvement in joint stiffness and pain decrease with Sodium Hyaluronate Mini 0.3% treatment, but this is not always the case. Whether Sodium Hyaluronate Mini 0.3% might delay or lessen progressive joint damage with long-term use is unknown. Adjunctive therapy in: * Healing skin wounds and burns.
* Detached retina and other eye injuries.
* Preventing the effects of aging.
How should I use Sodium Hyaluronate Mini 0.3%?
Use Sodium Hyaluronate Mini 0.3% as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Sodium Hyaluronate Mini 0.3%. Talk to your pharmacist if you have questions about this information.
Sodium Hyaluronate Mini 0.3% is given as an injection into the knee joint at your doctor's office, hospital, or clinic.
Sodium Hyaluronate Mini 0.3% is usually given as a series of injections 1 week apart for a total of 3 to 5 injections depending upon the particular product you are using. You may not experience relief until you have received several injections.
Do not use Sodium Hyaluronate Mini 0.3% if it contains particles, is cloudy or discolored, or if the vial or syringe is cracked or damaged.
Do not use disinfectants containing ammonium salts to prepare the skin for injection because side effects may occur.
Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
If you miss a dose of Sodium Hyaluronate Mini 0.3%, contact your doctor to establish a new dosing schedule.
Ask your health care provider any questions you may have about how to use Sodium Hyaluronate Mini 0.3%.
Uses of Sodium Hyaluronate Mini 0.3% in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Sodium Hyaluronate Mini 0.3% is used to treat knee pain caused by osteoarthritis (a disorder of joints that causes stiffness, pain and loss of movement due to breakdown of lubricating fluid between joints) when treatment with common painkillers or other physical therapy (exercise, physiotherapy etc.) does not provide adequate relief. It is also used for treatment of mouth sores, prevention of skin aging and during cataract surgery.
Sodium Hyaluronate Mini 0.3% description
Each bottle contains 100 mL soln plus 1 applicator for nasal use and 1 applicator for the use in the ear, sealed in a bag.
Inside the metal bottle, the soln remains isolated and not in contact with the propellant because it is contained within a bag made of nontoxic material. The propellant used is air and it is pressurized within the entire space surrounding the bag inside the metal bottle. The inhalation of Sodium Hyaluronate Mini 0.3% occurs via valve positioned above the bag.
With the system: The air is used like a gas propellant, so Sodium Hyaluronate Mini 0.3% does not damage the ozone layer. It is necessary to use preservatives so the possibility of allergic reaction is reduced. The bottle can be used in any direction so Sodium Hyaluronate Mini 0.3% is practical and easy to use.
Sodium Hyaluronate Mini 0.3% dosage
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No information provided.
How supplied
Sodium Hyaluronate Mini 0.3%® is supplied as a sterile, non-pyrogenic solution in 2 mL vials or 2 mL pre-filled syringes.
Detailed Device Description
Each vial or syringe contains:
Sodium Hyaluronate 20.0 mg
Sodium chloride 17.0 mg
Monobasic sodium phosphate • 2H0 1.2 mg
Water for injection q.s.* to 2.0 mL
*q.s. = up to
Directions For Use
Sodium Hyaluronate Mini 0.3%® is administered by intra-articular injection. A treatment cycle consists of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly intervals. This has been noted in studies reported in the literature in which patients treated with three injections were followed for 60 days.
Precaution: Do not use Sodium Hyaluronate Mini 0.3%® if the package is opened or damaged. Store in the original packaging (protected from light) below 77° F (25° C). DO NOT FREEZE.
Precaution: Strict aseptic administration technique must be followed.
Warning: Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because Sodium Hyaluronate Mini 0.3% can precipitate in their presence.
Inject subcutaneous lidocaine or similar local anesthetic prior to injection of Sodium Hyaluronate Mini 0.3%®.
Precaution: Remove joint effusion, if present, before injection of Sodium Hyaluronate Mini 0.3%®.
Do not use the same syringe for removing joint effusion and for injecting Sodium Hyaluronate Mini 0.3%®.
Take care to remove the tip cap of the syringe and needle aseptically.
Inject Sodium Hyaluronate Mini 0.3%® into the joint through a 20-gauge needle.
Precaution: The vial/syringe is intended for single use. The contents of the vial must be used immediately once the container has been opened. Discard any unused Sodium Hyaluronate Mini 0.3%®. Inject the full 2 mL in one knee only. If treatment is bilateral, a separate vial should be used for each knee.
REFERENCES
1. M. Carrabba et a l., 1991 Sodium Hyaluronate Mini 0.3% sodium salt (Sodium Hyaluronate Mini 0.3%®) in the treatment of patients with osteoarthritis of the knee: a controlled trial versus Orgotein, Final Report, April 1991. Data on file.
2. M. Carrabba et a l., 1995. Effectiveness and safety of 1, 3 and 5 injections of 20 mg/2 ml Sodium Hyaluronate Mini 0.3%® in comparison with a placebo and with arthrocentesis only, in the treatment of knee osteoarthritis. European Journal of Rheumatology and Inflammation 15:25-31.
3. M. Dougados et al., 1993. High molecular weight sodium hyaluronate (hyalectin) in osteoarthritis of the knee: a one-year placebo-controlled trial. Osteoarthritis and Cartilage 1:97-103.
4. R. Kotz and G. Kolarz, 1997 published as R. Kotz and G. Kolarz, 1999. Intra-articular Sodium Hyaluronate Mini 0.3%: duration of effect and results of repeated treatment cycles. The American Journal of Orthopedics, 28:5-7.
5. G. Leardini et a l., 1987. Intra-articular sodium hyaluronate (Sodium Hyaluronate Mini 0.3%®) in gonarthrosis. Clinical Trials Journal 24(4):341-350.
6. J.J. Scali, 1995. Intra-articular Sodium Hyaluronate Mini 0.3% in the treatment of osteoarthritis of the knee: a longterm study 15(1 ):57-62.
MANUFACTURED BY: Fidia Farmaceutici S.p. A., Via Ponte della Fabbrica 3/A - 35031 Abano Terme, Padua (PD), Italy. MANUFACTURED FOR: Fidia Pharma USA Inc., Parsippany, NJ 07054. Revised May 2014
To date, there are no reports of incompatibilities (interactions) of Sodium Hyaluronate Mini 0.3% with other solutions for intra-articular administration. The patient may benefit from the concurrent use of oral analgesic and anti-inflammatory agents during the first days of treatment.
Incompatibiliies: There is a known incompatibility between sodium hyaluronate and quaternary ammonium salts eg, benzalkonium chloride which can be used as skin disinfectants. Sodium Hyaluronate Mini 0.3% must therefore never come into contact with such products, nor with medical or surgical equipment treated with these types of products, since Sodium Hyaluronate Mini 0.3% can precipitate in their presence.
Sodium Hyaluronate Mini 0.3%® was investigated in a pivotal clinical investigation conducted in the United States in which there were three arms (164 subjects treated with Sodium Hyaluronate Mini 0.3%®; 168 with placebo; and 163 with naproxen) (refer to Table 1). Common adverse events reported for the Sodium Hyaluronate Mini 0.3%®-treated subjects were gastrointestinal complaints, injection site pain, knee swelling/effusion, local skin reactions (rash, ecchymosis), pruritus, and headache. Swelling and effusion, local skin reactions (ecchymosis and rash), and headache occurred at equal frequency in the Sodium Hyaluronate Mini 0.3%®- and placebo-treated groups. Sodium Hyaluronate Mini 0.3%® treated subjects had 48/164 (29%) incidents of gastrointestinal complaints that were not statistically different from the placebo-treated group. A statistically significant difference in the occurrence of pain at the injection site was noted in the Sodium Hyaluronate Mini 0.3%®-treated subjects: 38/164 (23%) in comparison to 22/168 (13%) in the placebo-treated subjects (p = 0.022). There were 6/164 (4%) premature discontinuations in Sodium Hyaluronate Mini 0.3%®-treated subjects due to injection site pain in comparison to 1/168 ( < 1%) in the placebo-treated subjects. These differences were not statistically significant. Two (2/164, 1.2%) Sodium Hyaluronate Mini 0.3%®-treated subjects and 3/168 (1.8%) placebo-treated subjects were reported to have positive bacterial cultures of effusion aspirated from the treated knee. The two Sodium Hyaluronate Mini 0.3%®-treated subjects and two of the placebo-treated subjects did not exhibit evidence of infection clinically or subsequently and were not treated with antibiotics. One of the placebo-treated subjects was hospitalized and received presumptive treatment for septic arthritis.
Sodium Hyaluronate Mini 0.3%® has been in clinical use in Europe since 1987. Analysis of the adverse events that have been reported with the use of Sodium Hyaluronate Mini 0.3%® in Europe reveals that most of the events are related to local symptoms such as pain, swelling/effusion, and warmth or redness at the injection site. Usually such symptoms disappear within a few days by resting the affected joint and applying ice locally. Only sporadically have these events been more severe and longer lasting. Very rare cases of intra-articular infection have been reported. Strict aseptic technique must be followed in administering Sodium Hyaluronate Mini 0.3%®. Systemic allergic reactions rarely have been recorded. Isolated cases of an anaphylactic or anaphylactic-like reaction have been reported in post-marketing experience and they all resolved. Allergic-type signs and symptoms such as rash, pruritus, and urticaria also are very rare. A few cases of fever were reported. In some instances, they were associated with local reactions, in other cases, no association other than temporal was found with the use of the product.
Adverse experience data from the literature contain no evidence of increased risk relating to retreatment with Sodium Hyaluronate Mini 0.3%®. The frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle. (Carrabba et al., 1995; Carrabba et al., 1991; Kotz and Kolarz, 1999; Scali, 1995).
Sodium Hyaluronate Mini 0.3% gel is contraindicated for use in breast augmentation, or for implantation into bone, tendon, ligament, or muscle,
Sodium Hyaluronate Mini 0.3% gel is contraindicated for patients with a history of known hypersensitivity to avian proteins.
Sodium Hyaluronate Mini 0.3% gel must not be injected into blood vessels. Introduction of Sodium Hyaluronate Mini 0.3% gel into the vasculature may occlude the vessels and could cause infarction or embolization.
Active ingredient matches for Sodium Hyaluronate Mini 0.3%:
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