Restylane

Restylane/Restylane Lyft: Hyaluronic acid, stabilized 20 mg/mL; Phosphate buffered saline q.s. ad 1 mL.
Restylane/Restylane Lyft is a sterile, transparent, biodegradable gel of stabilized hyaluronic acid of non-animal origin. It is supplied in a glass syringe. The contents of the syringe are sterilized using moist heat. The product is for single use only. To ensure traceability the patient record label (part of the syringe label) should be attached to patient records.
Restylane: Disposable 29G TW (thin wall) needles sterilized using ethylene oxide are provided.
Restylane Lyft: Disposable 27G TW (thin wall) needles sterilized using ethylene oxide are provided.
Restylane Defyne/Restylane Kysse/Restylane Refyne/Restylane Volyme: Cross-linked hyaluronic acid 20 mg/mL; Lidocaine hydrochloride 3 mg/mL; Phosphate buffered saline pH 7 qs ad 1 mL.
Restylane Defyne/Restylane Kysse/Restylane Refyne/Restylane Volyme is a sterile, biodegradable, transparent gel of non-animal cross-linked hyaluronic acid with the addition of lidocaine hydrochloride 3 mg/mL. The gel is supplied in a prefilled plastic syringe. The contents of the syringe are sterilized using moist heat. The product is for single use only. To ensure traceability the package includes patient record labels that should be attached to patient records.
Restylane Defyne/Restylane Volyme: The syringe is packaged individually in a blister, with two 27G x ½" Ultra thin wall needles. The needles have been sterilized using irradiation.
Restylane Kysse: The syringe is packaged individually in a blister, with two 30G x ½" Ultra thin wall needles. The needles have been sterilized using ethylene oxide.
Restylane Refyne: The syringe is packaged individually in a blister, with two 30G x ½" Ultra thin wall needles. The needles have been sterilized using irradiation.

Mode of action: Restylane/Restylane Lyft: This product is a filler that adds volume to the tissue, thereby restoring the skin contours or enhancing the lips to the desired level of correction. The volume and the lifting capacity originate from the ability of stabilized hyaluronic acid to bind water.
Restylane Kysse: The product adds volume to the tissue thereby enhancing the lips to the desired level. The volume and lifting capacity originate from the ability of cross-linked hyaluronic acid to bind water.
Restylane Defyne/Restylane Refyne/Restylane Volyme: The product adds volume to the tissue thereby restoring the skin contours of the face to the desired level. The volume and lifting capacity originate from the ability of cross-linked hyaluronic acid to bind water.
Performance: Restylane: In a randomised controlled multicentre study with Restylane for the correction of nasolabial folds, 74% of subjects maintained a clinically significant improvement up to at least 6 months after treatment.
In a prospective, multicentre and evaluator-blinded study with Restylane, subjects were initially treated for correction of both nasolabial folds and randomly assigned to retreatment of one nasolabial fold at 4.5 months and the contralateral fold at 9 months. Results demonstrated initial improvement to be consistent up to 18 months. At 18 months, 97% of subjects were reported with a clinical significant improvement. In an extension phase to the study, subjects had both nasolabial folds treated at study start, i.e. 18 months after initial treatment. Results demonstrated continued improvement up to 36 months. At 36 months, 100% of subjects were reported with a clinical significant improvement.
Results from a randomised controlled multicentre study with Restylane for the correction of nasolabial folds showed 74% of subjects to have a maintained clinically significant improvement 18 months after the initial treatment. The treatment regimen included a retreatment at 9 months.
Restylane Defyne: Two randomized controlled multicentre studies with Restylane Defyne for the correction of moderate to severe nasolabial folds both showed maintained effectiveness for a majority of subjects up to at least 48 weeks after initial treatments. In an open-labelled multicentre study to assess performance and tolerance of Restylane Defyne in facial rejuvenation, most subjects were reported with sustained improvement up to at least 6 months in areas including nasolabial folds, marionette lines, and tear troughs. In another open-labelled multicentre study with Restylane Defyne, subjects were assessed for perception of naturalness during contraction following correction of wrinkles and folds in the lower face. Results showed that 98% of subjects had maintained naturalness for at least up to 6 months.
Restylane Kysse: In a randomized controlled study with Restylane Kysse used for lip injections, the aesthetic improvement was sustained for at least 24 weeks. In another randomized controlled study, aesthetic improvement was demonstrated in both lips in a majority of subjects (≥80.0 %) at Month 6 and in more than a third of subjects (≥39.3 %) at Month 12.
Restylane Lyft: In a controlled multicentre study with Restylane Lyft for the correction of nasolabial folds 79% of the subjects maintained a clinically significant improvement 48 weeks after treatment.
In a controlled multicentre study with Restylane Lyft with lidocaine for cheek augmentation and correction of age-related midface contour deficiencies a significant improvement up to 12 months for the correction of midface deficiencies was demonstrated.
In a randomized controlled 12 months follow-up study, Restylane Lyft and Restylane Lyft with lidocaine were comparable in terms of aesthetic efficacy.
Restylane Refyne: In a randomized controlled multicentre study with Restylane Refyne for correction of moderate nasolabial folds, a majority of subjects maintained a clinically significant improvement up to at least 36 weeks. In another randomized controlled multicentre study with Restylane Refyne for correction of moderate to severe nasolabial folds, effectiveness was maintained up to at least 48 weeks after initial injection. In an open-labelled multicentre study to assess performance and tolerance of Restylane Refyne in facial rejuvenation, most subjects were reported with sustained improvement up to at least 6 months in areas including nasolabial folds, marionette lines, and tear troughs. In another open-labelled multicentre study with Restylane Refyne, subjects were assessed for perception of naturalness during contraction following correction of wrinkles and folds in the lower face. Results showed that 98% of subjects had maintained naturalness for at least up to 6 months.
Restylane Volyme: In an open-labelled multicentre study with Restylane Volyme for full face correction of volume loss, all subjects showed an improvement from baseline in full face volume loss 3 weeks after the last injections, and after 18 months, more than two-thirds were still improved. In another open-labelled multicentre study to assess performance and tolerance of Restylane Volyme in facial rejuvenation, a majority of subjects were reported with maintained cheek volume up to at least 6 months.

Before the first treatment session, it is recommended to contact the local Galderma representative or Restylane distributor for more information about injection techniques and training opportunities. This product is only intended to be administered by authorized personnel in accordance with local legislation.
Restylane: This product is intended to be used for facial tissue augmentation. It is recommended to be used for the correction of wrinkles and for lip enhancement. It should be injected into the middle part of the dermis layer or in the submucosal layer of the lip. For facial areas with limited soft tissue support and soft tissue cover, e.g. the periorbital region, injection into the subcutaneous fatty tissue or supraperiostal administration are recommended.
Restylane Defyne: The product is intended to augment the volume of facial tissues. It is recommended to be used for correction of severe wrinkles, or to redefine the shape of the lips, cheeks or tear troughs. Depending on the area to be treated and the tissue support, the product should be injected in the mid to deep dermis, submucosal layer of the lips, subcutis or supraperiostic zone. Lidocaine is added to the formulation to diminish the pain resulting from the injection during the treatment.
Restylane Kysse: The product is intended to restore or augment the volume of the lips. It should be injected into the submucosal layer of the lip. Lidocaine is added to the formulation to diminish the pain resulting from the injection during the treatment.
Restylane Lyft: This product is intended to be used for facial tissue augmentation. It is recommended to be used for shaping the contours of the face, the correction of folds and for lip enhancement. It should be injected into deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds, or in the submucosal layer of the lip. For cheek augmentation, correction of age-related midface contour deficiencies and facial areas with limited soft tissue support and soft tissue cover, e.g. the periorbital region, injection into the subcutaneous fatty tissue or supraperiostal administration are recommended.
Restylane Refyne: The product is intended to augment the volume of facial tissues. It is recommended to be used for correction of moderate wrinkles, or to redefine the shape of the lips, cheeks or tear troughs. Depending on the area to be treated and the tissue support, the product should be injected in the mid to deep dermis, submucosal layer of the lips, subcutis or supraperiostic zone. Lidocaine is added to the formulation to diminish the pain resulting from the injection during the treatment.
Restylane Volyme: The product is intended to augment the volume of facial tissues. It is recommended to be used for the correction of facial volume, for instance cheeks and chin. Depending on the area to be treated and the tissue support, the product should be injected into the supraperiostic zone or subcutis. Lidocaine is added to the formulation to diminish the pain resulting from the injection during the treatment.

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.

Do not use in patients with a history of hypersensitivity to streptococcal proteins, as the product may contain trace amounts of such material.
Do not use in patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.
Restylane Defyne/Restylane Kysse/Restylane Refyne/Restylane Volyme: Do not use in patients with known hypersensitivity to lidocaine or to amide-type local anaesthetics.

Use at specific sites where there is active disease, such as inflammation (skin eruption such as cysts, pimples, rashes or hives), infection or tumours, in or near the intended treatment site should be avoided until the underlying process has been controlled.
This product must not be injected intramuscularly or intravascularly. Localized superficial necrosis and scarring may occur after injection in or near vessels, such as the nose and glabellar area. It is thought to result from the injury, obstruction, or compromise of blood vessels. Special caution should be taken if the patient has undergone a prior surgical procedure in the planned treatment area. Areas with limited collateral blood flow has an increased risk of ischemia. Aspiration prior to injection is recommended.
Unintentional introduction of soft tissue fillers into the vasculature in the face may lead to embolisation, occlusion of the vessels, ischemia, necrosis or infarction at the implant site or in the area supplied by the blood vessels affected. Rare but serious adverse events include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral haemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if any of the following symptoms occurs, including changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and possibly evaluation by an appropriate health care practitioner specialist should an intravascular injection occur.
Patients with bleeding disorders or patients using substances that affect platelet function, thrombolytics or anticoagulants may, as with any injection, experience increased bruising or bleeding at injection site.
This product should not be mixed with other products prior to injection.

Health care practitioners are encouraged to discuss all potential risks of soft tissue injection with their patients prior to treatment and ensure that patients are aware of signs and symptoms of potential complications.
This product should only be used by health care practitioners who have appropriate training, experience, and knowledge about the anatomy at and around the site of injection in order to minimize the risks of potential complications (perforation or compression of vessels, nerves and other vulnerable structures).
Injection procedures are associated with a risk of infection. Aseptic technique and standard practice to prevent cross-infections are to be followed.
Avoid injecting into areas in close proximity to permanent implants, as this could aggravate latent adverse events or interfere with the aesthetic outcome of the treatment. Limited data is available on injecting into an area where a non-permanent implant other than hyaluronic acid has been placed.
Injection procedures can lead to reactivation of latent or subclinical herpes viral infections.
This product should be used with caution in patients on immunosuppressive therapy.
Patients with unattainable expectations are not suitable candidates for treatment.
This product is packaged for single use. Do not resterilize.
Do not use the product if package is opened or damaged, or if the expiry date or lot number is illegible.
Patients should avoid excessive sun, UV lamp exposure and extreme temperatures at least until any initial swelling and redness has resolved.
If laser treatment, chemical peeling or any other procedure based on active dermal response is performed after treatment with this product there is a theoretical risk of eliciting an inflammatory reaction at the implant site. This also applies if the product is administered before the skin has healed completely after such a procedure.
The safety for use during pregnancy, in breastfeeding females or in patients under 18 years has not been established.
Individual variation and treatment area may affect the bio-degradation of this product, in rare cases product remnants have been detected in tissue when the clinical effect has returned to baseline.
Restylane/Restylane Defyne/Restylane Lyft/Restylane Refyne/Restylane Volyme: Injection too superficially, or in facial areas with limited soft tissue support or soft tissue cover, or thin skin, such as the periorbital area, may result in contour irregularities and palpable lumps and/or bluish discolouration.
Injection in the lower periorbital region in patients with pre-existing pigmented dark lower eyelid circles and pre-existing tendency toward oedema formation may be associated with prominent discolouration and excessive swelling due to fluid build-up.
Post inflammatory pigmentation changes may occur after dermal filler injections in people with dark skin (Fitzpatrick Type IV-VI).
Restylane Defyne/Restylane Kysse/Restylane Refyne/Restylane Volyme: Do not use the product if the contents of the syringe are cloudy.
Considerations should be given to the total dose of lidocaine administered if dental block or topical administration of lidocaine is used concurrently. High doses of lidocaine (more than 400 mg) can cause acute toxic reactions manifesting as symptoms affecting the central nervous system and cardiac conduction.
Lidocaine should be used with caution in patients receiving other local anaesthetics or agents structurally related to amide-type local anaesthetics e.g., certain anti-arrhythmics, since the systemic toxic effects can be additive.
Lidocaine should be used with caution in patients with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.
Restylane Defyne/Restylane Refyne/Restylane Volyme: This product should be used with caution in patients with a tendency to form hypertrophic scars or any other healing disorders.
At each treatment session a maximum dosage of 2 mL per treatment site is recommended.
Restylane Kysse: At each treatment session a maximum dosage of 1.5 mL per treatment site is recommended.
Injection too superficially may result in contour irregularities and palpable lumps and/or bluish discolouration.

Anticipated injection-related reactions: Injection-related reactions (including bruising, erythema, itching, swelling, pain or tenderness at the implant site) might occur after treatment.
Restylane: Typically resolution is spontaneous within a few days after injection into the skin, and within one week after injection of the lips.
Restylane Lyft: These injection-related reactions consist mainly of mild to moderate inflammatory symptoms that resolve spontaneously within a few days or up to 2 weeks.
Restylane Defyne/Restylane Kysse/Restylane Refyne/Restylane Volyme: Typically, resolution is spontaneous within one week after injection.
Post marketing adverse event reporting: Vascular compromise may occur due to an inadvertent intravascular injection or as a result of vascular compression associated with implantation of any injectable product. This may manifest as blanching, discolouration, necrosis or ulceration at the implant site or in the area supplied by the blood vessels affected; or rarely as ischemic events in other organs due to embolisation. Rare but serious cases of ischemic events associated with temporary or permanent vision impairment, blindness, cerebral ischemia or stroke have been reported following facial aesthetic treatments.
Symptoms of inflammation at the implant site commencing either shortly after injection or after a delay of up to several weeks have been reported. In case of unexplained inflammatory reactions infections should be excluded and treated if necessary since inadequately treated infections may progress into complications such as abscess formation. Treatment using only oral corticosteroids without concurrent antibiotic treatment is not recommended.
The prolonged use of any medication, e.g., corticosteroids or antibiotics in treatment of adverse events has to be carefully assessed, since this may carry a risk for the patient. In case of persistent or recurrent inflammatory symptoms, consider removal of the product by aspiration/drainage, extrusion or enzymatic degradation (use of hyaluronidase has been described in scientific publications). Before any removal procedure is performed, the swelling may be reduced by using, e.g., NSAID for 2-7 days or a short course of corticosteroids for less than 7 days, in order to more easily palpate any remaining product.
For patients who have experienced clinically significant reactions, a decision for retreatment should take into consideration the cause and significance of previous reactions.
For reporting of adverse events contact the local Galderma representative or distributor for this product.
Restylane: The following post marketing adverse events have been reported from worldwide sources after treatment with Restylane or Restylane Lidocaine (non-exhaustive list). The frequency of reporting is based on the number of estimated treatments performed with the products.
1/1 000 - 1/10 000: Swelling/oedema with immediate onset and onset up to several weeks after treatment, Mass/induration.
1/10 000 - 1/100 000: Short duration of effect, Erythema, Pain/tenderness, Bruising/bleeding, Deformity/asymmetry, Papules/nodules, Infection/abscess including pustule, cellulitis and purulent discharge, Discolouration/hyperpigmentation, Ischemia/necrosis including livedo reticularis, pallor and vascular occlusion, Other injection site reactions and skin reactions including burning sensation, exfoliation, irritation, discomfort, dryness and warmth, Inflammation, Hypersensitivity/angioedema, Eye disorders including dry eyes, eye irritation, eye pain, eye swelling, eyelid ptosis, increased lacrimation and visual impairment such as blindness, blurred vision and reduced visual acuity, Neurological symptoms including facial nerve paralysis, hypoaesthesia and paraesthesia, Pruritus, Extrusion of device, Scar/scab/skin atrophy.
<1/100 000: Device dislocation, Granuloma/foreign body reaction, Reactivation of herpes infection, Rash, Blisters/vesicles, Capillary disorders such as telangiectasia, Discharge/extravasation, Acne, Urticaria, Dermatitis, Muscle disorders including muscle twitching and muscular weakness, Encapsulation, Dermatophytosis, Other dermatological events including localised alopecia and skin wrinkling, Non-dermatological events including anxiety, arthralgia, asthenia, depression, dizziness, dysphagia, dyspnoea, fatigue, headache, malaise, pyrexia, influenza like illness, insomnia, sinusitis and nausea.
Restylane Defyne: The following post marketing adverse events have been reported from worldwide sources after treatment with Restylane Defyne (non-exhaustive list). The frequency of reporting is based on the number of estimated treatments performed with the product.
1/1 000 - 1/10 000: Swelling/oedema with immediate onset and onset up to several weeks after treatment, Mass/induration.
1/10 000 - 1/100 000: Papules/nodules, Erythema, Pain/tenderness, Device ineffective, Infection/abscess including pustule, cellulitis and purulent discharge, Bruising/bleeding, Inflammation, Discolouration, Other injection site reactions and skin reactions including burning sensation, exfoliation, irritation, discomfort, dryness and warmth, Ischemia/necrosis including livedo reticularis, pallor and vascular occlusion, Granuloma/foreign body reaction, Pruritus, Hypersensitivity/angioedema, Eye disorders including eye contusion, eye irritation, eye pain, eye swelling, eyelid ptosis, and visual impairment such as blurred vision, Device dislocation, Neurological symptoms including facial paralysis, hypoaesthesia and paraesthesia, Rash.
<1/100 000: Scar/skin atrophy, Blisters/vesicles, Reactivation of herpes infection, Deformity/asymmetry, Capillary disorders such as telangiectasia, Dermatitis, Discharge, Urticaria, Acne, Extrusion of device, Non-dermatological events including chills, cutaneous contour deformity, dizziness, headache, malaise, nausea, pyrexia and vomiting, Other dermatological events such as skin pain.
Restylane Kysse: The following post marketing adverse events have been reported from worldwide sources after treatment with Restylane Kysse (non-exhaustive list). The frequency of reporting is based on the number of estimated treatments performed with the product.
1/1 000 - 1/10 000: Swelling/oedema with immediate onset and onset up to several weeks after treatment, Mass/induration, Device ineffective.
1/10 000 - 1/100 000: Papules/nodules, Pain/tenderness, Bruising/bleeding, Ischemia/necrosis including arterial occlusive disease, pallor and ulcer, Erythema, Discolouration/hyperpigmentation, Inflammation, Hypersensitivity/angioedema, Blisters/vesicles, Infection/abscess including pustule and purulent discharge, Other injection site reactions and skin reactions including burning sensation, discomfort and warmth, Pruritus, Neurological symptoms including facial nerve paralysis, hypoaesthesia and paraesthesia.
<1/100 000: Device dislocation, Eye disorders including dry eyes, eye irritation, eye oedema, brow ptosis and increased lacrimation, Rash, Scar/scab/skin atrophy, Capillary disorders such as telangiectasia, Reactivation of herpes infection, Urticaria, Acne, Dermatitis, Discharge/extravasation, Granuloma/foreign body reaction, Non-dermatological events including cutaneous contour deformity, dizziness, dyspnoea and headache, Other dermatological events including dry lips and skin tightness.
Restylane Lyft: The following post marketing adverse events have been reported from worldwide sources after treatment with Restylane Lyft or Restylane Lyft Lidocaine (non-exhaustive list). The frequency of reporting is based on the number of estimated treatments performed with the products.
1/1 000 - 1/10 000: Swelling/oedema with immediate onset and onset up to several weeks after treatment.
1/10 000 - 1/100 000: Short duration of effect, Mass/induration, Pain/tenderness, Erythema, Bruising/bleeding, Infection/abscess including pustule, cellulitis and purulent discharge, Papules/nodules, Inflammation, Other injection site reactions and skin reactions including burning sensation, exfoliation, irritation, discomfort, and warmth, Discolouration/hyperpigmentation, Neurological symptoms including facial nerve paralysis, hypoaesthesia and paraesthesia, Hypersensitivity/angioedema, Non-dermatological events including anxiety, dizziness, dyspnoea, headache, influenza like illness, insomnia, malaise, nausea, pyrexia, and sinusitis.
<1/100 000: Ischemia/necrosis, Eye disorders including dry eyes, eye irritation, eye pain, eye swelling, eyelid ptosis, increased lacrimation, and visual impairment such as blindness, blurred vision, and reduced visual acuity, Pruritus, Scar/scab/skin atrophy, Device dislocation, Rash, Discharge/extravasation, Granuloma/foreign body reaction, Acne, Blisters/vesicles, Reactivation of herpes infection, Urticaria, Capillary disorders such as telangiectasia, Extrusion of device, Dermatitis, Muscle disorders including muscle twitching and muscular weakness, Encapsulation, Other dermatological events including alopecia, chapped lips, dry skin, and skin wrinkling.
Restylane Refyne: The following post marketing adverse events have been reported from worldwide sources after treatment with Restylane Refyne (non-exhaustive list). The frequency of reporting is based on the number of estimated treatments performed with the product.
1/1 000 - 1/10 000: Swelling/oedema with immediate onset and onset up to several weeks after treatment.
1/10 000 - 1/100 000: Mass/induration, Erythema, Papules/nodules, Bruising/bleeding, Device ineffective, Discolouration/hyperpigmentation, Pain/tenderness, Infection/abscess including pustule and purulent discharge, Inflammation, Ischemia/necrosis including pallor and vascular occlusion, Eye disorders including dry eye, eye pain and visual impairment such as blurred vision, Other injection site reactions and skin reactions including burning sensation, exfoliation, irritation and warmth, Hypersensitivity/angioedema, Pruritus, Device dislocation.
<1/100 000: Blisters/vesicles, Neurological symptoms including hypoaesthesia and paraesthesia, Deformity/asymmetry, Scar/skin atrophy, Rash, Granuloma/foreign body reaction, Acne, Discharge/extravasation, Urticaria, Capillary disorders such as telangiectasia, Dermatitis, Reactivation of herpes infection, Muscle disorders such as muscle twitching, Non-dermatological events including chills, cutaneous contour deformity, dizziness, dyspnoea, headache and sinusitis, Other dermatological events such as chapped lips.
Restylane Volyme: The following post marketing adverse events have been reported from worldwide sources after treatment with Restylane Volyme (non-exhaustive list). The frequency of reporting is based on the number of estimated treatments performed with the product.
1/1 000 - 1/10 000: Swelling/oedema with immediate onset and onset up to several weeks after treatment.
1/10 000 - 1/100 000: Mass/induration, Pain/tenderness, Papules/nodules, Erythema, Device ineffective, Inflammation, Infection/abscess including pustule, cellulitis and purulent discharge, Bruising/bleeding, Hypersensitivity/angioedema including anaphylactic shock, Ischemia/necrosis including pallor, Neurological symptoms including facial nerve paralysis, hypoaesthesia and paraesthesia, Device dislocation, Other injection site reactions and skin reactions including burning sensation and warmth, Eye disorders including eye pain, eyelid oedema, eyelid ptosis and dry eyes, Granuloma/foreign body reaction.
<1/100 000: Discolouration, Deformity/asymmetry, Pruritus, Reactivation of herpes infection, Rash, Blisters/vesicles, Scar/scab/skin atrophy, Acne, Dermatitis, Encapsulation, Urticaria, Non-dermatological events including chills, cutaneous contour deformity, dizziness, feeling hot, headache, influenza like illness, migraine and presyncope, Other dermatological events such as chapped lips.

The syringe, disposable needle/blunt cannula and any unused material must be discarded immediately after the treatment session and must not be reused due to risk for contamination of the unused material and the associated risks including infections. Disposal should be in accordance with accepted medical practice and applicable national, local or institutional guidelines.

Store up to 25°C. Protect from freezing and sunlight.

Other Dermatologicals

D11AX - Other dermatologicals ; Used in the treatment of dermatological diseases.