Restylane

Restylane

Manufacturer:

Galderma

Distributor:

Forewide
/
DCH Auriga - Healthcare
Concise Prescribing Info
Contents
Restylane/Restylane Lyft Hyaluronic acid, stabilized 20 mg/mL. Restylane Defyne/Restylane Kysse/Restylane Refyne/Restylane Volyme Cross-linked hyaluronic acid 20 mg/mL, lidocaine HCl 3 mg/mL. Restylane Lyps Lidocaine Hyaluronic acid, stabilized 20 mg/mL, lidocaine HCl 3 mg/mL
Indications/Uses
Restylane Facial tissue augmentation. Correction of wrinkles & for lip enhancement. Restylane Defyne Augment vol of facial tissues. Correction of severe wrinkles; redefinition of the shape of the lips, cheeks or tear troughs. Restylane Kysse Restoration or augmentation of vol of the lips. Restylane Lyft Facial tissue augmentation. Shaping of the contours of the face, correction of folds & for lip enhancement. Restylane Lyps Lidocaine Lip enhancement. Restylane Refyne Augment vol of facial tissues. Correction of moderate wrinkles; redefinition of the shape of the lips, cheeks or tear troughs. Restylane Volyme Augment vol of facial tissues. Correction of facial vol, for instance cheeks & chin.
Dosage/Direction for Use
Restylane Max 2 mL/treatment site at each treatment session. Inj into the middle part of the dermis layer or in the submucosal layer of the lip. For facial areas w/ limited soft tissue support & cover (eg, periorbital region), inj into the SC fatty tissue or supraperiostal administration. In case of skin laxity, inj on ≥2 separate occasions. After the 1st treatment, additional implantations may be necessary to achieve desired level of correction. Restylane Defyne/Restylane Refyne Max 2 mL/treatment site at each treatment session. Inj into the mid to deep dermis, submucosal layer of the lips, subcutis or supraperiostic zone. Restylane Kysse Max 1.5 mL/treatment site at each treatment session. Administered by submucosal inj. Restylane Lyft Max 2 mL/treatment site at each treatment session. Inj into the deep layer of the dermis &/or surface layer of the subcutis or in the submucosal layer of the lip. For facial areas w/ limited soft tissue support & cover (eg, periorbital region), inj into the SC fatty tissue or supraperiostal administration. In case of skin laxity, inj on ≥2 separate occasions. After the 1st treatment, additional implantations may be necessary to achieve desired level of correction. Restylane Lyps Lidocaine Max 1.5 mL for each lip at each treatment session. Administered by submucosal inj. After the 1st treatment, additional implantations may be necessary to achieve desired level of correction. Restylane Volyme Max 2 mL/treatment site at each treatment session. Inj into the supraperiostic zone or subcutis.
Contraindications
Hypersensitivity to hyaluronic acid filler. Restylane Defyne/Restylane Kysse/Restylane Lyps Lidocaine/Restylane Refyne/Restylane Volyme Hypersensitivity to lidocaine or to amide-type local anaesth. Restylane Defyne/Restylane Kysse/Restylane Refyne/Restylane Volyme Patients w/ porphyria.
Special Precautions
Observe aseptic technique & standard practice to prevent cross-infections. Do not inj intravascularly. Do not inj IM (for Restylane/Restylane Lyft/Restylane Lyps Lidocaine). In case of blanching of overlying skin, stop inj immediately & massage the area until it returns to normal color. Do not use in patients w/ bleeding disorders or in patients who are taking thrombolytics or anticoagulants. Special caution when treating areas in close proximity to permanent implant. Do not use in case of active disease eg, inflammation, infection or tumours, in or near the intended treatment site. Risk of reactivation of latent or subclinical herpes viral infections. Concomitant use w/ substances that affect platelet function eg, aspirin & NSAIDs. Do not inj into an area where an implant other than hyaluronic acid has been placed. Visible lumps &/or bluish discoloration if injected too superficially. Avoid excessive sun or extreme cold at least until any initial swelling & redness has resolved. Theoretical risk of inflammation at the implant site if laser treatment, chemical peeling or any other procedure based on active dermal response is performed after implantation; or if the product is administered before skin has completely healed after such a procedure. Has not been tested in pregnant or breastfeeding women or in childn. Restylane/Restylane Lyft/Restylane Defyne/Restylane Refyne/Restylane Volyme Special caution when treating areas w/ limited collateral circulation; facial areas w/ limited soft tissue support or cover eg, periorbital area. Patients w/ pre-existing pigmented dark lower eye lid circles, thin skin & pre-existing tendency toward edema formation are not suitable candidates for treatment of the lower periorbital region. Restylane Defyne/Restylane Kysse/Restylane Refyne/Restylane Volyme Patients on immunosuppressants are not suitable candidates for treatment. Patients w/ tendency to form hypertrophic scars or any other healing disorders. Restylane Defyne/Restylane Kysse/ Restylane Lyps Lidocaine/Restylane Refyne/Restylane Volyme Consider total dose of lidocaine administered if dental block or topical administration of lidocaine is concurrently used. Concomitant use w/ other local anaesth or agents structurally related to amide-type local anaesth. Patients w/ epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction. Do not use in childn. Restylane Volyme Not indicated for inj other than into the supraperiostic zone or subcutis.
Adverse Reactions
Inj-related reactions eg, bruising, erythema, itching, swelling, pain or tenderness at the implant site.
Drug Interactions
Do not mix w/ other products prior to inj. Restylane Defyne/Restylane Kysse/ Restylane Lyps Lidocaine/Restylane Refyne/Restylane Volyme Lidocaine: Potential additive systemic toxic effects w/ other local anaesth or agents structurally related to amide-type local anaesth.
MIMS Class
Other Dermatologicals
ATC Classification
D11AX - Other dermatologicals ; Used in the treatment of dermatological diseases.
Presentation/Packing
Form
Restylane injectable gel
Packing/Price
1's
Form
Restylane Defyne injectable gel
Packing/Price
1's
Form
Restylane Kysse injectable gel
Packing/Price
1's
Form
Restylane Lyft injectable gel
Packing/Price
1's
Form
Restylane Lyps Lidocaine injectable gel
Packing/Price
1's
Form
Restylane Refyne injectable gel
Packing/Price
1's
Form
Restylane Volyme injectable gel
Packing/Price
1's
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