Restylane SubQ

Restylane ® SubQ INSTRUCTIONS

Composition:

• Hyaluronic acid, stabilized  20 mg / ml
• Phosphate-buffered saline   qs

Information :

Restylane SubQ is a gel, a sterile transparent hyaluronic acid stabilized non-animal origin.
Restylane SubQ is placed into a glass syringe with luer-lock fitting. Each lethal injection
moist heat sterilized in containers and packed in special boxes. This product is for single use
only. The number of units per package and the volume in each syringe contained, as in sentence
Outside of the package. A patient record label is part of the syringe label. The label must be attached to the
Patient records to ensure traceability of products.

Purpose

Restylane SubQ is to be used for facial tissue augmentation. It is recommended for use
Shape facial contours, such as cheek or chin is obvious. Depth of injection
may by injection into the subcutaneous adipose tissue for administration vary supraperiostal
Depending on the location of the treatment. Restylane SubQ is injected by a doctor with
Know-how in the correction of volume defects on the face.

Operation :

Restylane SubQ is a filler that adds volume to the network so that it is supported (dermal)
Network form the contours of the face, to the desired level of correction. Volume and lift
Capacity of hyaluronic acid from the ability to handle large amounts of water to attract the derived
improved by the stabilization. Restylane SubQ experience in the time isovolemic
Degradation, which means that the product maintains volume even during mining.

Warning

• Restylane SubQ is for subcutaneous and / or administrative supraperiostal determined.

• Do not inject intravascularly. The medical device injection injection accidentally

• Blood vessels, which can potentially lead to vascular occlusion, ischemia and necrosis. To ensure that the Needle is not in the blood vessels, aspiration with a syringe before the injection 
• Not in patients with bleeding disorders or in patients with thrombolysis or Anticoagulants.

• Keep out again Restylane SubQ.

• Not available with other products prior to injection equipment mix. Vigilance General considerations relevant to injectable medicine products

• Injection procedure associated with the risk of infection. Aseptic technique and standard Should practice to prevent cross infection to be observed.

• Caution should be exercised when treating areas close to permanent Implants.

• Knowledge of the anatomical site of treatment and special attention is needed to avoid Perforation or compression of the vessels and other vulnerable structures. If a pointed needle is used This is important.

• Caution should be exercised when treating an area with limited collateral circulation be because to an increased risk of ischemia.

• Do not use where there is active disease such as inflammation, infection or tumors in or near intended site of treatment.

• Injection procedure can lead to reactivation of latent herpes virus infection or subclinical.

• Patients with substances that affect platelet function are, such as aspirin and nonsteroidal anti-inflammatory drugs can increase the experience for each injection bruising or bleeding Injection site.

• Patients with the expectation reached no suitable candidates for treatment.

• Do not use the product if the packaging is damaged. Relevant to the use of Restylane SubQ certain considerations

• Do not inject Restylane SubQ in an area where other injectable implants are available, except for other products from the Restylane range of products. Are not injected Restylane SubQ in an area where non-injectable implants have been used.

• Patients should minimize exposure of the treated area to strong sunlight or extreme cold in subsided, at least until the first swelling and redness