Имплантаты для подкожного введения: имплантат инъекционный Teosyal PureSense Redensity 2, 2 х 1 мл (гель гиалуроновой кислоты с лидокаином)

Страна: Беларусь

Язык: русский

Источник: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Доступна с:

Teoxane S.A., ШВЕЙЦАРИЯ

класс:

изделия медицинского назначения

Производитель:

Teoxane S.A.

Дата Авторизация:

2020-10-02

Характеристики продукта

EN - INSTRUCTIONS FOR USE
DESCRIPTION
TEOSYAL
RHA®
1
is
a
sterile,
transparent,
non-pyrogenic,
viscoelastic
gel
of
both
crosslinked
and
non-crosslinked
hyaluronic acid of non-animal origin and contains 0.3 % by
mass of lidocaine hydrochloride, for its anaesthetic properties.
Each box contains two pre-filled syringes of TEOSYAL RHA® 1.
For each syringe, the box contains two sterile 30G1/2” needles
and two traceability labels (one to be given to the patient, and
one to be kept by the doctor in the patient medical record). The
volume of each syringe is indicated on the cardboard box as well
as on each syringe.
COMPOSITION
Hyaluronic acid
15 mg/mL
Lidocaine hydrochloride
0.3% by mass
Phosphate buffer pH 7.3
q.s. ad 1 mL
INDICATIONS
Therapeutic indications of TEOSYAL® products:
Reconstructive
surgery,
filling
of
depressions
due
to
scars,
reconstruction
of
volumes
lost
by
lipoatrophy
in
patient
undergoing HIV treatment.
Aesthetic indications of TEOSYAL® products:
Modification of aged skin: restoration of volumes, filling of skin
depression and wrinkles, restoration of skin hydration.
TEOSYAL RHA® 1 is indicated for the even filling of fine superficial
wrinkles (such as perioral rhytids, upper lip border and philtrum),
skin cracks and lines, as well as for the correction of withered
skin marked by signs of ageing on the face, neck and neckline.
It is also indicated for skin folds (including circles under the
eyes).
Lidocaine hydrochloride is a local anaesthetic agent designed to
reduce the sensation of pain.
MODE OF ACTION
Hyaluronic acid is a major constituent of the ground substance of
the dermal extracellular matrix. A genuine molecular sponge, its
helicoidal structure enables it to trap up to a thousand times its
weight in water. It is widely distributed in cutaneous tissues and
hydrates the skin, though its content diminishes with age. As the
skin becomes thinner and fragile, initial skin fracture lines appear.
For the correction of fine lines/wrinkles affecting a withered
skin marked by signs of ageing (exc