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Instructions for use

Please read this important safety notice, that takes precedence over the Instructions for Use, before using LQD® Spray.

Dear patient,

Please read the following instructions for use carefully as it contains important information that you should follow when using this medical device. Please contact your healthcare professional if you have any questions.

A specific bottle size is required to ensure that the product can be easily used. For this reason, the bottle containing 7 ml solution is partially filled. This is not a defect.

The LQD® dressing contains chitosan-FH02™ in an aqueous solution with a skin-neutral pH. After drying, the spray forms a thin, elastic, transparent film, which is removed as part of standard wound cleaning or remains on the wound until removal during natural skin renewal. As a spray, the product is also suitable for treating wounds that are difficult to reach and/or uneven.

Chitosan consists of the sugar components glucosamine and n-acetylglucosamine, which also occur naturally in the human body, and therefore has excellent biocompatibility. The chitosan-FH02™ used in LQD® is produced in a form to promote maximum wound healing properties. Studies support the performance and tolerance of LQD®.

APPLICATION

The wound should be cleaned according to current best practice. Before using for the first time, pump the spray nozzle about 5 times until it emits a uniform mist. The system is then ready for each subsequent use. If possible, hold the wound in a horizontal position and spray LQD® evenly at a distance of approximately 10 cm. Allow the spray film to dry uncovered for at least 2 minutes. If necessary, the wound may be covered with an appropriate secondary dressing. Please replace the cap after use to prevent the spray nozzle from sticking.


INDICATIONS

LQD® dressing is used for the external, local treatment of chronic wounds (such as leg ulcers), secondary wound healing disorders, acute wounds and epidermal and superficial partial thickness burns.


FREQUENCY OF USE

LQD® can be used as a primary wound dressing for each change of dressing.


NOTES ON APPLICATION

LQD® is not fully effective if used with hydrogels or hydrocolloid dressings or if applied to heavily exuding wounds. Heavy fibrin coatings and necrotic tissue must be removed (debridement) before treatment with LQD®.


CONTRAINDICATIONS

None known.


SIDE EFFECTS

In rare cases, a transient mild burning sensation and temporary skin redness may occur when administered. There are no known allergic reactions to medical devices containing chitosan. In the event of very rarely documented allergic reactions to products that contain chitosan, there is no definite causal relationship with the ingredient chitosan. Intolerance reactions cannot be excluded with absolute certainty.


WARNINGS/ PRECAUTIONS

Make sure that the pump head does not come into contact with the wound.

As a precaution, LQD® should not be used if the bottle or pump system is damaged.

For external use only.

Do not spray in eyes.

Keep out of sight and reach of children.

There is no information available regarding the use of LQD® by pregnant women or nursing mothers.


STORAGE AND EXPIRY DATE

The expiry date is specified on the label and on the packaging.

Store LQD® at room temperature (15–25°C).

The special pump head system allows the contents to remain sterile for further use once opened.

Use within 12 weeks of opening.


COMPOSITION

Sterile chitosan-acetate solution 0.75%. Contains no preservatives.


DOSAGE FORM AND CONTENTS

Pump spray bottle with 7/12/20 ml solution. Note: To ensure better handling, the 7 ml solution is filled into a larger bottle and is therefore partially filled.


MANUFACTURER

Medoderm GmbH Friedrich-Koenig-Str. 3 55129 Mainz, Germany

 


DATE OF INSTRUCTION FOR USE

July 2018


EXPLANATIONS OF THE SYMBOLS USED

Manufacturer
Expiry date: year-month
Lot number
Sterile as a result of aseptic processing
Caution, observe accompanying documents
Temperature limit for storage
Use within 12 weeks of opening