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buy to inject derma veil in patients
WHAT IS DERMA VEIL? Derma Veil is a lyophilized low viscosity, non-toxic, bioabsorbable and biodegradable tissue reconstructive material with the following characteristics: – Injectable single use medical device incorporated as a hydrophilic matrix.
Its active principle is composed of glycolic acid (GA) bound to the polymeric column of polylactic acid [PURASORB Poly (L-lactide)] both of which are homogeneously dispersed throughout and their rate of release is controlled by diffusion, prolonging a sustained repairing action through the slow dissolution of the compound.
– Immunologically inactive, biocompatible and absorbable and is degraded by hydrolysis.
The degradation begins first by water diffusion in the material, initially at the more amorphous zones, followed by hydrolysis, material fragmentation and finally, a more extensive hydrolysis along with phagocytosis, diffusion and metabolization.
buy to inject derma veil in patients
Elimination occurs primarily through the respiratory tract.
Each box of Derma Veil contains 2 vials and an Instruction for Use leaflet.
The vials are made of transparent borosilicate glass, sealed with a siliconized halobutyl stopper secured by an aluminum ring with a “flip off” plastic cap.
The vial has 10 mL capacity and contains 236.
14 mg of a lyophilized, sterile, pyrogen free, crystalline white powder of asymmetric micro-particles (40 to 60 m) made of: – POLYLACTIC ACID a biocompatible, biodegradable synthetic polymer for medical applications, [PURASORB Poly (L-lactide)] – GLYCOLIC ACID a biocompatible, biodegradable, high purity hydroxyacetic acid monomer for medical applications, – CARBOXY METHYL CELLULOSE SODIUM (USP), – MANNITOL (USP), – POLYSORBATE 80 (NF), INTENDED USE: Derma Veil is applied by subdermal injection to treat moderate to severe facial fat loss (lipoatrophy) caused by degenerative changes that occur due to illness or advanced age.
Its application triggers a foreign body reaction promoting a glucosaline biosynthesis that increases cellular interactions favoring the production of new collagen.
The process generates histological changes that provide greater fullness to the cutaneous tegument.
These functions provide reconstruction to collapsed areas while diminishing skin depressions such as wrinkles, creases and minor scars.
– The treatment requires a minimum of two sessions separated by 3 weeks (20 days).
– Derma Veil is activated prior to use by adding preferably 8mL of Physiological Saline Solution (0.
91% w/v of NaCl, about 300 mOsm) or 8mL of Sterile Water for Injection (pyrogen and preservative free) Once activated, the formula becomes a suspension of relative viscosity.
Derma Veil should be injected using a sterilized 26G (0. buy to inject derma veil in patients
45mm x 13mm) needle.
STORAGE: Keep Derma Veil in dry storage, away from humidity and light, at a temperature between 15 C (59 F) and 30 C (86 F).
Refrigeration is not necessary.
CONTRAINDICATIONS: – Derma Veil should not to be used in patients with hypersensitivity or allergy to any of the components in the formula.
– Derma Veil should not to be used in patients with a history or presence of severe allergies.
– Derma Veil should not to be used if a dermatological condition or an active inflammatory process or infection is present – The safety of Derma Veil for use in women who are pregnant, suspected of being pregnant or who are lactating has not been established – Do not inject Derma Veil in woman’s breast region due to potential imaging interference during diagnostic procedures – Do not inject Derma Veil in patients who have a history or susceptibility to hypertrophic scarring or keloid formation.
– Do not inject Derma Veil in patients with bleeding disorders or patients who are using medications that can prolong bleeding, such as Heparin, Plavix or aspirin – Do not use Derma Veil if other fillers /implants have been used within six (6) months prior to a programmed treatment and never
inject derma veil in patients