OSTENIL MINI 1% Injection/Intraarticular

What is OSTENIL MINI 1%

OSTENIL MINI 1% is a sterile, viscoelastic solution containing 10 mg/mL of sodium hyaluronate, designed for intra-articular injection into small synovial joints. It is presented in a 1 mL pre-filled syringe and is used to alleviate pain and improve mobility in degenerative and traumatic joint conditions, such as osteoarthritis.

• Generic Name: Sodium Hyaluronate
• Form: Intra-articular Injection
• Concentration: 1% (10 mg/mL)
• Volume: 1 mL per pre-filled syringe
• Indications: Relief of pain and improvement of joint function in small synovial joints affected by degenerative or traumatic changes.

OSTENIL MINI is particularly suitable for small joints such as the thumb's saddle joint, finger joints, toe joints, and temporomandibular joint. It is produced via biofermentation, ensuring high purity and biocompatibility without animal-derived components.

How to use OSTENIL MINI 1%

OSTENIL MINI 1% should be administered by a qualified healthcare professional under aseptic conditions. The injection is performed directly into the affected joint cavity.

• Preparation: Bring the syringe to room temperature before use. Ensure the sterile pack is intact before opening.
• Needle Attachment: Remove the Luer lock cap from the syringe and attach a suitable sterile needle (e.g., 19 to 25 G), securing it by turning slightly.
• Air Removal: Eliminate any air bubbles present in the syringe before injection.
• Injection Site: Disinfect the skin over the joint thoroughly. If joint effusion is present, aspirate the excess fluid before injecting OSTENIL MINI.
• Post-Injection Care: Advise the patient to avoid strenuous activities or prolonged weight-bearing on the treated joint for 48 hours post-injection.

The number of injections per treatment cycle may vary based on the severity of the joint condition and the patient's response to therapy.

Mode of Action OSTENIL MINI 1%

Sodium hyaluronate, the active component in OSTENIL MINI 1%, is a natural polysaccharide found in synovial fluid. In osteoarthritic joints, the concentration and molecular weight of hyaluronic acid decrease, leading to reduced viscoelasticity and joint lubrication.

• Restores Synovial Fluid Viscosity: Enhances the viscoelastic properties of synovial fluid, improving lubrication and shock absorption within the joint.
• Reduces Pain: By restoring the normal function of synovial fluid, it decreases mechanical stress on the joint tissues, leading to pain relief.
• Improves Mobility: Enhanced joint lubrication facilitates smoother joint movements, thereby improving mobility.
• Protects Cartilage: May inhibit cartilage degradation by reducing inflammatory mediators and mechanical stress.

These effects contribute to the alleviation of symptoms associated with osteoarthritis and other degenerative joint conditions.

OSTENIL MINI 1% Interactions OSTENIL MINI 1%

OSTENIL MINI 1% has minimal systemic absorption, reducing the potential for systemic drug interactions. However, certain precautions should be observed:

• Disinfectants: Avoid using disinfectants containing quaternary ammonium salts (e.g., benzalkonium chloride) on the skin prior to injection, as they may precipitate hyaluronic acid.
• Concurrent Intra-articular Therapies: The safety and efficacy of concurrent use with other intra-articular injections have not been established.
• Oral Analgesics/NSAIDs: May be used concomitantly to manage pain during the initial days of treatment.

Always inform the healthcare provider of all medications and treatments the patient is receiving to ensure safe administration.

Dosage of OSTENIL MINI 1%

The dosage regimen for OSTENIL MINI 1% should be tailored to the individual patient's needs and the severity of the joint condition.

• Standard Dosage: Inject 1 mL of OSTENIL MINI into the affected joint once a week.
• Treatment Duration: A course of 1 to 3 injections is typical, depending on clinical response.
• Multiple Joints: Several joints may be treated simultaneously if necessary.
• Repeat Treatment: Depending on the patient's response, treatment cycles may be repeated at intervals of at least six months.

Prior to injection, any joint effusion should be aspirated, and standard aseptic techniques must be followed during administration.

Possible side effects of OSTENIL MINI 1%

OSTENIL MINI 1% is generally well-tolerated. However, some patients may experience mild to moderate side effects, primarily localized to the injection site.

• Common Side Effects:
  • Pain or discomfort at the injection site
  • Swelling or joint effusion
  • Redness or warmth in the treated area
• Less Common Side Effects:
  • Itching or rash at the injection site
  • Joint stiffness or decreased mobility
• Rare Side Effects:
  • Allergic reactions, including anaphylaxis
  • Infection at the injection site

Most side effects are transient and resolve without intervention. Patients should be advised to report any persistent or severe symptoms to their healthcare provider promptly.

OSTENIL MINI 1% Contraindications OSTENIL MINI 1%

OSTENIL MINI 1% should not be used in the following situations:

• Hypersensitivity: Known allergy to sodium hyaluronate or any component of the product.
• Infection or Skin Disease: Presence of infections or skin diseases at the injection site.
• Joint Infections: Active infections within the joint cavity.
• Pregnancy and Lactation: Not recommended due to insufficient data on safety.
• Pediatric Use: Safety and efficacy have not been established in children.

Careful assessment of the patient's medical history and current condition is essential before initiating treatment with OSTENIL MINI.

Storage of OSTENIL MINI 1%

Proper storage of OSTENIL MINI 1% is crucial to maintain its sterility and effectiveness.

• Temperature: Store at room temperature, not exceeding 25°C (77°F).
• Packaging: Keep the pre-filled syringe in its original sterile packaging until use.
• Protection: Protect from light and do not freeze.
• Shelf Life: Refer to the expiration date indicated on the packaging. Do not use beyond this date.
• Handling: Do not use if the packaging is damaged or if the solution is cloudy or contains particles.

Ensure the product is kept out of reach of children and is only used by qualified healthcare professionals.