HAXL ONE 20 mg/ml prefilled syringe, 1 ST

The HAXL ONE 20 mg/ml pre-filled syringe for the intra-articular treatment of your knee osteoarthritis. High-purity, cross-linked 2% sodium hyaluronate for improved joint function and reduced pain. Class III medical device.

The single-use syringe for the treatment of knee osteoarthritis with cross-linked 2% hyaluronic acid

• Cross-linked hyaluronic acid as a single injection (one-shot treatment)
• Effective in relieving pain and improving mobility and quality of life
• Well-tolerated, as it contains no animal proteins

Hyaluronic acid therapy with HAXL ONE 

HAXL ONE is a modern hyaluronic acid therapy that is injected directly into the affected knee joint in a single injection (one-shot therapy). The hyaluronic acid in HAXL ONE has been cross-linked using innovative SARE Technology® to create a particularly stable structure with a high buffering effect and long-lasting joint lubrication. 

The result: a targeted and effective treatmentthat noticeably relieves pressure on the knee joint – for greater mobility and quality of life!

The distinctive features of SARE Technology® 

HAXL ONE is based on the innovative SARE Technology® and combines two distinctive features: the hybridisation of hyaluronic acid chains of varying lengths and the cross-linking of the individual molecules.

• Hybridisation: The combination of hyaluronic acid chains of varying lengths results in what is known as a hybrid structure. This molecular diversity enables optimal adaptation to the demands of the knee joint.
• Cross-linking: Cross-linking binds the hyaluronic acid molecules together using a special cross-linking agent. This creates a dense and uniform network, which gives the gel a particularly stable structure. This structure makes the hyaluronic acid more resistant to degradation processes and supports both uniform lubrication and targeted cushioning of the knee joint.

Indications

HAXL One is intended for intra-articular injection into the synovial space of the knee joint, to restore the viscosity of the synovial fluid in patients with knee osteoarthritis whose joint function is impaired by a loss of viscosity and who have responded inadequately to non-pharmacological measures and simple analgesics.

Dosage form

Pre-filled syringe

Administration

HAXL One must be administered by a qualified specialist via an intra-articular injection, in accordance with all rules of aseptic technique and injection procedure. HAXL One is injected using a suitable sterile needle. The manufacturer recommends the use of a 19G needle. A single injection of HAXL One is recommended. The exact dose is at the discretion of the treating doctor. Any remaining product must be disposed of appropriately.

1. Before injection, the area to be treated must be carefully disinfected and the product brought to room temperature. 
2. Remove the sterile barrier and take the syringe out of the blister pack. 
3. Remove the Luer-Lock cap from the syringe without touching the tip, so that it remains sterile. 
4. Attach a suitable sterile needle to the syringe. The manufacturer recommends using a 19G needle. Before use, check that the needle is correctly locked onto the syringe’s Luer-Lock adapter. 
5. If necessary, remove any air from the syringe. 
6. Inject into the synovial space of the affected knee joint, observing aseptic injection procedures. 
7. Dispose of the used syringe and any unused material after the injection. The exact dose is at the discretion of the treating doctor. The recommended dose is 3–4 ml for each knee joint.

Warnings & Precautions: HAXL One must be injected strictly intra-articularly, in accordance with the rules of aseptic injection techniques. The product must be administered using sterile Luer-Lock needles. Do not inject into blood vessels or surrounding tissue. To avoid pain following the injection, it is recommended that the treated joint be rested for 48 hours after the injection. The product must not be used if the packaging is damaged or the expiry date has passed. This medical device is intended for single use only. Do not reuse, as there is a risk of infection. Do not re-sterilise; re-sterilisation may affect the physico-chemical properties of the medical device and compromise its efficacy and safety. The syringe and needle used must be disposed of in a suitable container. Keep out of the reach of children.

Ingredients

• HAXL One consists of highly purified sodium hyaluronate, pharmacopoeia-grade salts and water for injection.
• Composition (mg/ml): Cross-linked sodium hyaluronate 20, disodium phosphate dodecahydrate 0.6, sodium dihydrogen phosphate dihydrate 0.05, sodium chloride 8, water for injections q.s.