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
Indications/Uses
Restylane Facial tissue augmentation. Correction of wrinkles & fine line enhancement. Restylane Defyne Augment vol of facial tissues. Shape redefinition of chin & nasolabial fold (NLF). Restylane Kysse Restoration or augmentation of vol of the lips. Restylane Lyft Facial tissue augmentation. Shaping of the contours of the face, correction & enhancement of cheeks, nose, chin, & jawline. Restylane Refyne Augment vol of facial tissues. Correction of NLF, marionette lines, perioral lines. Restylane Volyme Augment vol of facial tissues. Correction of facial vol ie, cheeks & temple.
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 Inj into the mid to deep dermis for correction of NLF, or mid to deep dermis (SC or supraperiostic zone) for chin augmentation. Restylane Kysse Inj into the submucosal layer of the lip. Restylane Lyft 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 Refyne Inj into the mid to deep dermis. 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 Refyne/Restylane Volyme Hypersensitivity to lidocaine or to amide-type local anaesth.
Special Precautions
Observe aseptic technique & standard practice to prevent cross-infections. Do not inj IM or intravascularly. Avoid use at specific sites where there is active disease (eg, inflammation, infection or tumours), in or near the intended treatment until the underlying process has been controlled. Take special caution if patient has undergone prior surgical procedure in the planned treatment area. Increased risk of ischemia in areas w/ limited collateral blood flow. Immediately stop inj in case of changes in vision, signs of stroke, blanching of the skin, or unusual pain during or shortly after the procedure. Increased bruising or bleeding at inj site in patients w/ bleeding disorders or patients using substances that affect platelet function, thrombolytics or anticoagulants. Avoid injecting into areas in close proximity to permanent implants. Risk of contour irregularities & palpable lumps &/or bluish discolouration if injected too superficially, or in facial areas w/ limited soft tissue support or soft tissue cover, or thin skin eg, periorbital area. Risk of reactivation of latent or subclinical herpes viral infections. Caution in patients on immunosuppressive therapy. Avoid excessive sun, UV lamp exposure & extreme temp 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. Safety for use during pregnancy, in breastfeeding females or in patients <18 yr has not been established. Restylane/Restylane Lyft/Restylane Defyne/Restylane Refyne/Restylane Volyme Inj in the lower periorbital region in patients w/ pre-existing pigmented dark lower eyelid circles & pre-existing tendency toward oedema formation may be associated w/ prominent discolouration & excessive swelling due to fluid build-up. Risk of post-inflammatory pigmentation changes after dermal filler inj in people w/ dark skin (Fitzpatrick Type IV-VI). Restylane Defyne/Restylane Refyne/Restylane Volyme Caution in patients w/ tendency to form hypertrophic scars or any other healing disorders. Restylane Defyne/Restylane Kysse/Restylane Refyne/Restylane Volyme Lidocaine: Consider total dose of lidocaine administered if dental block or topical administration of lidocaine is concurrently used. Caution w/ concomitant use of other local anaesth or agents structurally related to amide-type local anaesth. Caution in patients w/ epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.
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 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 Refyne injectable gel
Packing/Price
1's
Form
Restylane Volyme injectable gel
Packing/Price
1's
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