Restylane Dosage/Direction for Use

Needle: The size and the length of the cannula will affect the force needed to extrude the gel. If a thinner cannula is used the resistance during injection may be too high resulting in an increased risk for leakage or separation of the cannula and syringe. The same considerations are applicable for needles.
Restylane: Disposable sterile 29G TW (thin wall) needles are provided. In case a replacement needle is required a needle within the range of 29-30G should be used.
Alternatively, a sterile blunt cannula 27-28G can be used.
Restylane Defyne: It is important to use a sterile, appropriate needle or blunt cannula. Suitable needles (27G x ½" Ultra thin wall) are supplied with the syringe in the blister pack. As an alternative, a blunt thin walled cannula with a recommended size of 27G can be used.
Restylane Kysse: It is important to use a sterile, appropriate needle or blunt cannula. Suitable needles (30G x ½" Ultra thin wall) are supplied with the syringe in the blister pack. As an alternative, a blunt thin walled cannula with a recommended size of 25-27G can be used.
Restylane Lyft: Disposable sterile 27G TW (thin wall) needles are provided. In case a replacement needle is required a 27G needle should be used.
Alternatively, a sterile blunt cannula 23-25G can be used.
Restylane Refyne: It is important to use a sterile, appropriate needle or blunt cannula. Suitable needles (30G x ½" Ultra thin wall) are supplied with the syringe in the blister pack. As an alternative, a blunt thin walled cannula with a recommended size of 27G can be used.
Restylane Volyme: It is important to use a sterile, appropriate needle or blunt cannula. Suitable needles (27G x ½" Ultra thin wall) are supplied with the syringe in the blister pack. As an alternative, a blunt thin walled cannula with a recommended size of 27G or wider can be used.
Assembly of needle to syringe: Restylane/Restylane Lyft: 1. Put on sterile gloves.
2. Use the thumb and forefinger to hold firmly around both the syringe-barrel and the luer-lock adapter part of the closure system.
3. With the other hand, take hold of the tip cap at the end of the closure system and bend (do not rotate) until the cap disconnects and can be pulled off (tamper proof seal will be broken).
4. Do not touch the syringe tip to keep it sterile.
5. Open the needle and grasp the needle shield.
6. Assure to hold both the syringe barrel and the luer-lock adapter.
7. To facilitate proper assembly, both push and rotate the needle firmly clockwise.
8. Make sure the needle is screwed on all the way so that the needle shield touches the luer lock adapter.
9. To remove the needle shield, hold the syringe and the luer lock adapter. With the other hand hold the needle shield and pull straight out. Do not rotate.
Strict aseptic technique must be followed. Improper assembly may result in separation of the needle and syringe during injection.
Restylane Defyne/Restylane Kysse/Restylane Refyne/Restylane Volyme: Use surgical gloves, remove the cap from the needle and unscrew the tip cap from the syringe. Hold firmly around the syringe barrel and grasp the needle shield with the other hand. Screw the needle tight onto the syringe by simultaneously pushing and rotating firmly until the needle is completely locked. To ensure proper assembly, minimize the gap between the needle shield and the syringe.
Remove the needle shield just before injection by pulling it straight out. Do not rotate.
Note: Improper assembly may cause leakage or needle disconnection.
Assembly instruction applies to both needle and blunt cannula.
Treatment Procedure: Restylane/Restylane Lyft: The patient shall be informed about the indications, expected result, precautions and potential adverse events. The patient's need for pain relief should be assessed. For optimal patient comfort, topical or local anaesthesia is recommended when treating wrinkles (Restylane) or when shaping the contours of the face and correcting folds (Restylane Lyft). For lip augmentation, anaesthesia through a nerve block can be used.
Clean the treatment site thoroughly with a suitable antiseptic solution.
To avoid breakage of the needle or cannula, do not attempt to bend it before or during treatment. If the needle gets bent, discard it and complete the procedure with a replacement needle.
Before injecting, remove the air by pressing the rod carefully until a small droplet is visible at the tip of the needle.
When using a needle, aspiration prior to injection is recommended. Inject slowly while pulling the needle backwards.
Injection should stop just before the needle is pulled out from the skin to prevent material from leaking out from the injection site.
As an alternative to the needle, a blunt cannula can be used. After preparation as described previously, an entry point is made in the skin, e.g. with a sharp needle of appropriate size. Inject slowly. During injection, it is recommended to keep the side hole of the cannula facing downwards, away from the skin surface, to ensure that the flow of the gel is maintained at the correct tissue depth.
Do not apply excessive pressure to the syringe at any time. Presence of scar tissue may impede advancement of the cannula/needle. If resistance is encountered the cannula/needle should be partially withdrawn and repositioned or fully withdrawn and checked for function.
It is recommended to change needle/cannula for each new treatment site.
At each treatment session a maximum dosage of 2 mL per treatment site is recommended.
Defects should be fully corrected, but not overcorrected, at each treatment session.
The correction site should be massaged to conform to the contour of the surrounding tissues.
If the treated area is swollen directly after the injection, an ice pack can be applied on the site for a short period. Ice should be used with caution if the area is still numb from anaesthetic to avoid thermal injury.
If there is pronounced skin laxity, it is recommended that the product be injected on two or more separate occasions.
After the first treatment, additional implantations of the product may be necessary to achieve the desired level of correction. Periodic follow-up injections help sustain the desired degree of correction.
Restylane Defyne/Restylane Kysse/Restylane Refyne/Restylane Volyme: Inform the patient about the treatment procedure and expected results. Ensure the patient receives appropriate post-treatment care instructions and is made aware of signs and symptoms of potential complications.
Cleanse the area to be treated with an antiseptic and allow it to dry before injection.
To avoid breakage of the needle/cannula, do not attempt to bend it before or during treatment. If the needle gets bent, discard it and complete the procedure with a replacement needle.
Before injecting the product, depress the plunger rod carefully until a small droplet is visible at the tip of the needle/cannula.
Align the bevel of the needle by turning the syringe on its axis.
If a blunt cannula is used, an entry point is made in the skin, for example with a sharp needle of appropriate size. During injection, keep the side hole of the cannula facing downwards, away from the skin surface.
Aspiration is recommended prior to injection in order to reduce the risk of inadvertent injection into a blood vessel.
Inject the gel slowly by gently pressing down on the plunger rod with the thumb or palm of the hand. Do not apply excessive pressure to the syringe at any time. Presence of scar tissue may impede advancement of the needle/cannula. If resistance is encountered the needle/cannula should be partially withdrawn and repositioned or fully withdrawn and checked for function.
Choose from a variety of injection techniques, i.e. serial puncture, linear threading or cross-hatching (linear threading or cross-hatching for Restylane Volyme). It is recommended to change needle/cannula for each new treatment site.
Defects should be fully corrected, but not overcorrected, at each treatment session. Gently massage the treated area after injection.
If "blanching" of the skin is observed, the injection should be stopped immediately and the whitened area should be massaged gently until it returns to a normal colour before continuing with the injection.
If the treated area is swollen directly after the injection, an ice pack with adequate protective cloth can be applied on the site for a short period. Ice should be used with caution if the area is still numb from anaesthetic to avoid thermal injury.
Additional treatments may be necessary to achieve and maintain the desired level of correction.