Instructions for Use 

Cross-linked sodium hyaluronate viscosupplement 2.0%

DESCRIPTION

HAXL One is a biocompatible hydrogel of crosslinked sodium hyaluronate obtained by biofer-mentation and highly purified, dissolved in a physiological and isotonic buffer. The product is an injectable hydrogel, sterile and apyrogenic, with a low level of endotoxins.

COMPOSITION

HAXL One is formulated with highly purified sodium hyaluronate, pharmacopeia quality salts and water for injection (WFI):

COMPOSITION	(mg/mL)
Sodium hyaluronate cross-linked	20
Disodium phosphate dodecahydrate	0.6
Sodium dihydrogen phosphate dihydrate	0.05
Sodium chloride	8
Water For Injection (WFI)	q.s

CONTENTS OF THE PACK

HAXL One is supplied in a graduated, pre-filled and disposable Type I glass sterile syringe with a Luer-lock system, containing 4.4 mL of solution.

INTENDED USE

HAXL One is intended to be injected intra-articularly in the synovial space of the knee as visco-supplementation medium for synovial fluid when its viscosity has been reduced due to the osteoarthritis process in patients who have not responded adequately to conservative non-pharmacological therapy and simple analgesics.

PROPERTIES

HAXL One reduces the pain and increases the functionality of the affected joint. 
HAXL One provides a lubricant and shock-absortion effect on the affected joint. 
HAXL One improves the quality of life of the patient.

ADMINISTRATION

HAXL One must be administered by intra-articular injection by a qualified clinician following all aseptic procedure and injection technique guidelines. The product can be injected using a hypodermic needle, according to the needs of the specialist. The manufacturer recommends the use of a 19G needle. HAXL One is recommended to be administered in a single session. The amount of product to be administered is at the discretion of the clinician. Discard any unused portion of the syringe.

DIRECTIONS FOR USE

1. Prior to the injection, the area to be treated should be disinfected thoroughly and the product brought to room temperature.
2. Peel off the sterile barrier and remove the syringe from inside.
3. Remove the tip cap of the syringe without touching the syringe tip, in order to maintain its sterility.
4. Attach a suitable (19G is recommended) sterile needle to the tip of the syringe. Verify that the needle is properly locked to the Luer-lock adapter of the syringe before using it.
5. Remove air from the syringe, if necessary.
6. Inject intra-articularly into the synovial space of the affected knee, following aseptic injection procedures.
7. After finishing the treatment session, discard the syringe and the remaining product.

The amount of product to be administered is at the discretion of the specialist, the recommended dose is 3mL to 4mL for each knee joint.

CONTRAINDICATIONS

Do not administer HAXL One to patients with known hypersensitivity (allergy) to hyaluronic acid and / or other components of the product. Do not administer HAXL One to patients with skin infections or disorders at the injection site. Do not administer HAXL One to patients with coagulation defects and / or who are treated with anticoagulant medication. HAXL One should not be administered to pregnant or breastfeeding women. HAXL One should not be administered to children. The use of HAXL One in any joint other than the knee and for other conditions has not been studied.

WARNINGS AND PRECAUTIONS

HAXL One should only be injected into the intra-articular space following aseptic injection procedures. HAXL One should be administered with sterile Luer-lock needles. Do not inject into a blood vessel or surrounding tissues. To avoid pain after the injection, adequate rest of the injection site for 48 hours after the injection is recommended. The product should not be used if the package is damaged or broken. The product should not be used after the expiration date.

The product is for single use. Do not reuse to avoid the risk of infection. Do not re-sterilize as re-sterilization can affect the physico-chemical properties of the product and compromise its effectiveness and safety. The syringe and the used needle should be discarded in a container provided for this purpose.

Keep out of the reach of children.

INTERACTIONS

Do not use with other products that contain quaternary ammonium salts (e.g. benzalkonium chloride) or with any surgical material treated with this type of substance as sodium hyaluronate can precipitate in the presence of these salts. To prevent any possible interaction, coadministration with other intra-articular products should be avoided. There are no known interactions with other local anaesthetics.

ADVERSE EVENTS

Viscoelastic supplementation with hyaluronic acid in joints is safe. Moderate episodes of arthralgia, joint swelling or stiffness, and transient discomfort and / or pain at the injection site following intra-articular injection have occasionally been observed. To a lesser extent, there may be some joint effusion or minor local skin conditions such as erythema or rash.

STORAGE

Store between 5°C and 25°C. Protect from light and avoid freezing.

EXPIRY DATE

Do not use after the date marked on the package.

MANUFACTURED BY & AUTHORIZATION HOLDER

i+Med S.Coop
Parque Tecnológico de Álava 
C/Hermanos Elhuyar, 6
01510 Vitoria-Gasteiz, Álava (SPAIN)
www.imasmed.com

Waste segregation and management in accordance with current legislation.