Durolane 3 mL

Durolane

Injectable – Viscosupplement

Intra-articular Hyaluronic Acid Injection

CE Marked medical device / medicinal product (depending on jurisdiction) manufactured in Sweden.
Complies with applicable quality and safety standards for intra Articular hyaluronic acid viscosupplements in markets where marketed.

CE Marked medical device / medicinal product (depending on jurisdiction) manufactured in Sweden.
Complies with applicable quality and safety standards for intra Articular hyaluronic acid viscosupplements in markets where marketed.

Intra-articular Hyaluronic Acid Injection

Description

Durolane 3 mL is a single-injection intra-articular hyaluronic acid (sodium hyaluronate) treatment indicated for the symptomatic relief of pain in osteoarthritis. It contains 60 mg of non-animal stabilized hyaluronic acid (NASHA) in a 3 mL prefilled syringe (20 mg/mL) and is injected directly into the affected joint, most commonly the knee. Durolane supplements the viscoelastic properties of synovial fluid, improving lubrication and shock absorption to reduce pain and improve joint function. Clinical data show that a single injection can provide pain relief for up to 6 months in many patients who have not responded adequately to conservative non-pharmacological therapy or simple analgesics.

Bnefits

Single-injection treatment, avoiding the need for multi-injection regimens while providing long-lasting relief.
Contains 60 mg of non-animal stabilized hyaluronic acid (NASHA) with high molecular weight and viscoelasticity for effective joint lubrication.
Clinically proven to relieve pain and improve function in mild to moderate osteoarthritis of the knee and other indicated joints.
Pain relief can last for up to 6 months for many patients, reducing the frequency of intra-articular procedures.
Non-animal origin hyaluronic acid minimises risk of avian protein sensitivity.
Pre-filled, ready-to-use sterile syringe simplifies preparation and helps ensure accurate dosing.
Well-established safety profile with mostly transient, local post-injection reactions.

Indications

Symptomatic treatment of mild to moderate osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy and simple analgesics.
Symptomatic treatment of mild to moderate hip osteoarthritis (in markets where approved for hip).
Symptomatic treatment of mild to moderate osteoarthritis pain in ankle, fingers and toes (in markets where these indications are approved).
Relief of pain following joint arthroscopy in the presence of osteoarthritis, when injected within 3 months of the procedure (where approved in local product information).

Composition

Non-animal stabilized hyaluronic acid (NASHA) (sodium hyaluronate) 20 mg/mL, total 60 mg in 3 mL.
Phosphate-buffered saline (PBS) vehicle.
pH-adjusting and tonicity agents as per manufacturer’s specification (no added preservatives).

Formulation

Sterile, transparent, viscoelastic gel for intra-articular injection.
Concentration: 20 mg/mL sodium hyaluronate (NASHA).
Volume: 3 mL per prefilled syringe (total 60 mg HA).
Non-pyrogenic, single-use preparation for intra-articular administration.

Packaging

One 3 mL single-use glass syringe with Luer-lock fitting, prefilled with Durolane gel.
Syringe supplied in a sterile blister pack inside an outer carton.
Needle (18–22 G) is not supplied and must be provided separately by the healthcare professional.
Carton labelled with product name, strength (60 mg/3 mL), batch number, expiry date and manufacturer details.

Usage

For intra-articular use only; must be administered by a trained healthcare professional under aseptic conditions.
Inspect the syringe before use; do not use if the blister or syringe is damaged or if the gel is discoloured or contains particulate matter.
Remove any joint effusion from the target joint prior to injection.
Attach an appropriate sterile needle (18–22 G) to the Luer-lock fitting and expel any air from the syringe.
Inject the full contents (3 mL) into the joint cavity using a suitable intra-articular approach that avoids damage to adjacent structures.
Do not inject intravascularly, extra-articularly, or into synovial tissues or the joint capsule.
After injection, advise the patient to avoid strenuous or prolonged weight-bearing activities (longer than about one hour) for 48 hours.
Discard the syringe and any unused product immediately after use; do not resterilise or reuse.

Contraindications

Hypersensitivity or allergy to sodium hyaluronate (hyaluronic acid) preparations or any component of the product.
Infection or severe inflammation in the joint to be treated (e.g. septic arthritis).
Skin disease or infection at or near the planned injection site.
Known hypersensitivity to proteins from birds (avian proteins) in markets where avian-related sensitivity is listed as a contraindication.
Do not inject into joints other than those indicated in the local product information.

Adverse Effects

Transient pain, swelling, warmth or stiffness in the injected joint.
Joint effusion or increased joint swelling following injection.
Injection-site reactions including redness, bruising or discomfort.
Less common: pain in limb, bursitis, synovitis, Baker’s cyst, paraesthesia around the joint.
Very rare: infection in the joint (septic arthritis) or severe inflammatory reaction; such events require prompt medical evaluation and treatment.
As with any intra-articular procedure, there is a small risk of bleeding, injury to structures, or allergic reaction.

Storage Conditions

Store in the original packaging at 0–30 °C (32–86 °F).
Short-term temperature spikes up to 40 °C (104 °F) are permitted for a maximum of 24 hours.
Protect from freezing; do not use if the product has been frozen.
Refrigeration is not required.
Keep out of the reach of children.
Use before the expiry date printed on the packaging.

Duration

A single 3 mL intra-articular injection per affected joint constitutes one treatment course and may provide symptom relief for up to approximately 6 months. If symptoms recur, repeat injection cycles are generally considered after at least 6 months, according to clinical judgement and local prescribing information.

Onset

Many patients experience improvement in pain and joint function within 2 weeks of injection, with maximum benefit typically developing over several weeks and potentially lasting up to 6 months.