Macrolane VRF 20 - 20 ML / 10ML

Macrolane VRF 20 / 30

Composition

Each ml contains:

Hyaluronic acid, stabilized - 20mg/ml

Phosphate buffered saline – q.s

Description:

Macrolane Volume Restoration Factor gels, Macrolane VRF 20 and VRF 30 are sterile, transparent gels of stabilized hyaluronic acid of non-animal origin. The products have a PH of 6.0-7.5. Macrolane VRF 20 and VRF 30 are designed for deep tissue implantation and differ with respect to the physical structure of the gel. Macrolane VRF 20 and VRF 30 are supplies in plastic syringes with luer-look. Each syringe is terminally moist heat sterilized in its packaging and packed in a paper carton. The products are for single use only. The volume contained in each syringes is as stated on the outer package. A patient record label is a part of the syringe label and extra labels are included in the package. These labels are to be attached to patient records to ensure traceability of the product.

Intended use:

Macrolane VRF 20 and VRF 30 are intended to be used for volume restoration and contouring of body surfaces. The products are not intended for facial tissue augmentation. In general, deep subcutaneous administration is recommended. For both products sufficient tissue cover and support are important parameters to achieve a good esthetic treatment outcome. A minimum of 1cm skin thickness, including subcutaneous fat, is usually required to attain good results. The choice between Macrolane VRF 20 and VRF 30 is based on the assessment f tissure cover as determined by skin fold measures. Macrolane VRF 30 is intended in areas where skin fold thickness is greater. The injection should be made by physicians who have thorough knowledge of the anatomy of the treatment site and are experienced with injection techniques in the relevant area. The treatment facility must be suitable for performance of aseptic procedures.

Mode of Action.

Macrolane gels act by adding volume to the tissue, thereby restoring and enhancing body contours. The product will be degraded over time.

*Do not inject intravascularly. As for the injectable medical devices, inadvertent injection into blood vessels could potentially lead to vascular occlusion, ischemia and necrosis.

      *Do not use in patients with bleeding disorders or in patient who are taking thrombolytics or anticoagulants.

*Macrolane should not be used in the breast as the product may interfere with the reading of mammograms.
*Do not use in the hands and penis because the benefit risk has not been adequately investigated in prospective clinical studies.
*Do not use in patients previously treated with NASHA gel products and who in connection therewith, have experienced delay inflammatory reactions or implant complications that requited medical treatment.
*Do not use during pregnancy or lactation
*Do not resterillize Macrolane gels as this damages the product
*Do not mix with other products.

Precautions
*Implantation of medical devices is associated with a risk of infection, Aseptic technique and standard practice to prevent perioperative infections are to be observed. Soft tissue infections following injection treatment have been observed.
*Special caution should be exercised when treating areas in close proximity to permanent implant or vulnerable structures such as nerves, vessels and viscera.
*Do not use where there is a condition, in or near the intended treatment size that might increase the risk for development of adverse events following treatment, eg. Inflammation, infections or tumours.
*Patients who are using substances that affect platelet functions, such as aspirin and non steroidal anti inflammatory drugs may as with any injection, experience increased bruising or bleeding at injections sites.
*Patients with unattainable expectations are not suitable candidates for treatment.
*Scarring might occur at the insertion site. Some patients are known to have a higher risk for scarring, e.g. previous history of keloid formation or darker skin type
*Do not use the product if the package is damaged

Post treatment advice

To avoid a possible risk of local product mobility the patient should be advised to avoid massaging the treatment site or applying pressure to the area for at least 2 weeks following the injection. Activities that can be associated with excessive movements such as jogging and jumping should also be avoided during this time period. The use of supportive clothing for at least 2 weeks after injection treatment may be useful. To reduce possible risk of infection, the patient should be advised to keep the injection site dry for a few days after treatment. After the first treatment, additional injections of macrolane gel may be necessary to achieve and maintain the desired aesthetic result. Individual variability exists.

Shelf life and storage

The expiry date is indicated on package. Store up to 25degree Celsius. Protect from freezing and sunlight.