Biolevox HA 2,2% 1 pre-filled syringe 2ml

The intra-articular injection procedure can only be performed by a doctor

100,00 

Availability: 17 in stock

Biolevox HA 2,2% 1 pre-filled syringe 2ml

SKU 9640 Categories ,

Biolevox HA 2.2% Sodium hyaluronate 44 mg in the form of intra-articular gel. A medical device intended for intra-articular injection to increase the viscosity of synovial fluid.

Indications

  • Pain and limited joint mobility resulting from post-traumatic or degenerative changes (osteoporosis).

Action

  • Biolevox HA 2.2% intra-articular gel 1 pre-filled syringe with pH 6.8-7.4 contains sodium hyaluronate of high molecular weight, obtained by bacterial fermentation, of non-animal origin. The product has been sterilized and is non-pyrogenic. The product is intended for intra-articular injection to increase the viscosity of synovial fluid.
  • Sodium hyaluronate is responsible for the viscosity and elasticity of synovial fluid. Thanks to its lubricating and shock-absorbing properties, it enables painless, physiological movement in the joint. In addition, it supplies joint cartilage with nutrients.
  • Replenishment of synovial fluid by intra-articular injection of sodium hyaluronate improves the elasticity and viscosity of synovial fluid. In this way, after the first intra-articular injection, joint mobility improves and the level of pain resulting from damage to articular cartilage is reduced.

Contraindications

Biolevox HA 2.2% intra-articular gel medical device should not be used in patients:

  • with known hypersensitivity to any of the product ingredients
  • with septic arthritis
  • with dermatosis at the site of the planned injection
  • taking anticoagulants

Due to the lack of sufficient clinical data, the product should not be used in children.

Warnings

  • This is a medical device. Use it according to the instructions for use or label.
  • All precautions should be followed during the procedure to prevent the occurrence of septic arthritis.
  • The product is intended only for intra-articular injection.
  • Do not use agents containing quaternary ammonium salts to disinfect the skin before injection, because sodium hyaluronate may precipitate in their presence.
  • Do not use the product if the sterile pre-filled syringe is damaged.
  • Do not use the product after the expiry date.
  • The product cannot be re-sterilized.
  • The pre-filled syringe is intended for use in one patient during one treatment.

Use

  • Medical device Biolevox HA 2.2% intra-articular gel 1 pre-filled syringe intended only for intra-articular injection administered by a doctor.
  • Disinfect the skin at the site of the planned injection. Remove the pre-filled syringe from the packaging, remove the Luer-lock clamp from the syringe and screw on the appropriate sterile needle (21G). Remove any air bubbles before injecting.
  • The therapy consists of a series of three intra-articular injections, administered at weekly intervals.
  • The effects of therapy last for at least six months. The therapy cycle can be repeated if necessary.

Interactions

  • To date, no data have been submitted regarding complications or side effects resulting from reactions of the product with other intra-articular solutions.
  • Use during pregnancy and breastfeeding
  • Due to the lack of sufficient clinical data, Biolevox HA 2.2% intra-articular gel should not be used in women during pregnancy and lactation.

Side effects

  • Biocompatibility tests confirmed the high safety of the product. Temporary symptoms such as pain, redness and swelling may occur at the injection site. These symptoms can be alleviated by cooling the injection site for 5-10 minutes after application using a cooling compress.
  • In case of pain, the simultaneous use of oral analgesics and anti-inflammatory drugs may be beneficial.
  • If side effects occur, consult a doctor.

Storage

  • Store at temperatures from 2°C to 25°C. Protect from moisture and sunlight.
  • Keep out of the reach of children.

Ingredients – 1 ml contains:

  • Sodium hyaluronate 22,000 mg
  • Sodium chloride 8,500 mg
  • Disodium hydrogen phosphate 0.563 mg
  • Sodium dihydrogen phosphate 0.045 mg
  • Water for injection q.s.

Producer: Biovico Sp. z o. o.

Weight 1 kg
Producer

Synvisc

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