Hyaluronic Sodium Salt 1.5% Solution for intra-articular Injection Taj Pharma

Hyaluronic Sodium Salt 1.5% Solution for intra-articular Injection Taj Pharma.

Composition

a) Hyaluronic Sodium Salt 1.5% Solution for intra-articular Injection
Each 2mL of Solution for injection contains:
Sodium Hyaluronate                        30mg
Excipients                                          q.s.

b) Hyaluronic Sodium Salt 1.5% Solution for intra-articular Injection
Each 4mL of Solution for injection contains:
Sodium Hyaluronate                          60mg
Excipients                                           q.s.

Description

Clear, colorless, viscoelastic solution in pre-filled syringe system.

Clinical Pharmacology

Sodium hyaluronate is a high molecular weight polysaccharide, composed of sodium glucoronate and N-acetylglucosamine which forms a repeating disaccharide unit by linking alternately beta 1-3 and beta 1-4 glycosidic bonds.

Sodium hyaluronate is used intra-articularly to treat osteoarthritis. To remain healthy all cartilage, regardless of type, need proteoglycans found in all connective tissues to attract and maintain water molecules. Sodium hyaluronate is a polysaccharide that is distributed widely in the extracellular matrix of connective tissue (vitreous and aqueous humor of the eye, synovial fluid, skin, and umbilical cord) in humans. It composes one of four main groups of glycosaminoglycans, which, because of sulfate or carboxyl groups, are highly negatively charged and thus hydrophilic. In osteoarthritic joints, the synovial fluid becomes more abundant but less viscous, and the concentration of hyaluronic acid decreases. Visco-supplementation is intra-articular injection of sodium hyaluronate into osteoarthritic joints to restore the rheological properties of synovial fluid and possibly promote synthesis of more sodium hyaluronate.

Indication and Usages

Degenerative osteoarthritis, shoulder periarthritis

Dosage and Administration

In adults, Sterile Sodium Hyaluronate Solution injection is administered by intra-articular injection directly into the affected joint once a week for three weeks, consecutively. Frequency of injection can be adjusted according to symptoms and severity. Sterile Sodium Hyaluronate Solution should be injected directly into synovial space, using aseptic precautions.

Contraindications

Known hypersensitivity (allergy) to sodium hyaluronate preparation.

Active knee joint infection or skin disease at injection site.

Warnings and Precautions

Sterile Sodium Hyaluronate Solution should be administered with caution in patients with liver disease or prior history of it.

  1. Anaphylactoid and allergic reactions have been reported with sodium hyaluronate.
  2. Sterile Sodium Hyaluronate Solution should be given only after the treatment of inflammation caused by degenerative osteoarthritis of the joint.
  3. Transient inflammations have been reported in the knee following intraarticular sodium injection in some patients with inflammatory arthritis such as rheumatoid arthritis or gouty arthritis.
  4. Patient should be advised to avoid strenuous activities or weight-bearing activity after administration of sodium hyaluronate injection for at least 48 hrs. as a preventive measure against local pain.
  5. Effectiveness of a single cycle of less than 3 injections has not been established.
  6. Safety and effectiveness of the intra-articular sodium hyaluronate injection concomitantly with other intra articular injection have not been established.
  7. Since pain can be caused by the leakage of Sterile Sodium Hyaluronate Solution out of articular cavity, it should be administered accurately into the articular cavity.

Special Populations

  1. Pregnant and nursing women

Sterile Sodium Hyaluronate Solution should be cautiously administered to pregnant women or if likely to become pregnant. Should be used during pregnancy if the potential benefits justify the potentials risks to the fetus.

Sterile Sodium Hyaluronate Solution is excreted into the breast milk in animal tests; nursing should be avoided during the administration of Sterile Sodium Hyaluronate Solution.

  1. Pediatric patients
  • Safety and efficacy have not been established.
  1. Geriatric patients
  • Administration should be made carefully.

Precautions in Usage

  1. In case of no symptomatic improvement following administration, Sterile Sodium Hyaluronate Solution is restricted to three injections.
  2. Remove joint effusion, if present, before injecting Sterile Sodium Hyaluronate Solution.
  3. Sterile Sodium Hyaluronate Solution should not be injected into the blood vessel.
  4. Sterile Sodium Hyaluronate Solution is not for ophthalmologic use.
  5. Do not use if rubber cap of the syringe is damaged.
  6. The syringe contents are for single use only.
  7. Sterile Sodium Hyaluronate Solution is viscous, hence a 22-23G needle is recommended for injection.

Drug Interactions

Do not use concomitantly with disinfectants containing quaternary ammonium salts because hyaluronic acid can precipitate in their presence.

Side Effects

  1. Shock: Since symptoms of shock (indistinct frequency) may occur, careful observation should be made. In case abnormalities are noticed, administration should be discontinued and proper measures should be taken.
  2. Hypersensitivity: Edema (face, eyelid, etc.), facial flare, rarely rash, urticarial, pruritus may occur. In case these symptoms occur, administration should be discontinued and appropriate measures should be taken.
  3. Articular site injected: Occasionally pain (mainly transient pain after injection), swelling, rarely edema, flare, sense of heat, and sense of local oppression may occur.
  4. Others: Nausea, vomiting and fever may occur.

If you experience any side effects, talk to your doctor or pharmacist or report side effects directly via the national pharmacovigilance program of India by calling on 1800 180 3024.

By reporting side effects, you can help provide more information on the safety of this product.

Directions for Use

Sterile Sodium Hyaluronate Solution is administered by intra-articular injection once a week (1 week apart) for a total of 3 injections. Injection of subcutaneous lidocaine or similar local anesthetic may be recommended prior to injection of Sterile Sodium Hyaluronate Solution.

Each pre-filled syringe is intended for single use only. Discard any unused portion of the drug. Use a separate syringe for each knee if bilateral treatment is being given.

Shelf Life

3 years (36 months)

Storage

Store in hermetic container between 2°C to 8°C.

Do not freeze. Protect from light. Keep out of reach of children.

How Supplied

2 mL x 1 Pre-filled syringe

Manufactured in India by:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at: Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

 

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Taj Generics (Taj Pharma) provides a wide range of products to the Indian market, including an extensive range of generics and specialty products; Our products cover a vast array of therapeutic categories, and we offer an extensive range of dosage forms and delivery systems including oral solids, controlled-release, steriles, injectables, topicals, liquids, transdermals, semi-solids and high-potency products. Our Generics portfolio offers over 1500 products in the major therapeutic areas of gastro-intestinal, cardiovascular, pain management, oncology, anti-infectives, paediatrics and dermatology.