Импланты для подкожного введения: гель для заполнения мягких тканей на основе гиалуроновой кислоты BioHyalux® Deep Dermis 1 мл (1 шприц 1 мл, 2 иглы 27G х 1/2")

Страна: Беларусь

Язык: русский

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

Доступна с:

Bloomage Biotechnology Corp. Ltd., КИТАЙ

класс:

изделия медицинского назначения

Производитель:

Bloomage Biotechnology Corp. Ltd.

Дата Авторизация:

2023-08-01

Характеристики продукта

July. 2021
WellKang Ltd (www.CE-marking.eu)
Enterprise Hub, NW Business Complex,
1 Beraghmore Road, Derry, BT48 8SE,
Northern Ireland, UK
Trade name
BioHyalux
®
Generic name
Hyaluronan Soft Tissue Filling Gel
Description
BioHyalux
®
is
a
colorless,
transparent,
viscoelastic,
biodegradable,
non-pyrogenic
and sterile gel, supplied in a prefilled glass
syringe. BioHyalux
®
consists of cross-linked
sodium hyaluronate from biofermentation and
formulated to a concentration of 20 mg/ml,
suspended in a physiological buffer pH 7.
Sodium hyaluronate is a natural polymer of
repeating
disaccharide
units
of
N-acetyl-D-glucosamine
and
sodium
glucuronate linked by glycosidic bonds, which
is widely istributed in the extracellular matrix
in
both
animals
and
human. After
slightly
cross-linking, it also has good biocompatibility.
BioHyalux
®
is supplied in a disposable glass
syringe with a luer-lock fitting. The syringe is
equipped with a plunger stopper, finger grip
and
plunger
rod
and
packed
in
a
blister
together with two sterile needles, 27 G×1/2’’.
Indications
BioHyalux
®
is intended to be used for a facial
tissue augmentation for mid-to-deep dermal
implantation for the correction of moderate to
serve facial wrinkles and folds.
INSTRUCTION FOR USE
1
2
Specification
Content:
Sodium hyaluronate, cross-linked: 20 mg/ml
Physiological
sodium
chloride
phosphate
buffer: q.s.
pH:
6.8 - 7.5
Volume:
1.0 ml
One
package
of
BioHyalux
®
contains
a
syringe and two sterile 27 G needles.
Mode of action
After injection, BioHyalux
®
integrates into the
tissue naturally, and acts by adding volume to
dermal tissue, thereby restoring wrinkles and
folds to the desired correction.
Pre-treatment guidance
Before the treatment, the suitability of patient
for
treatment
should
be
assessed.
The
patient should be informed the indications,
precautions,
warnings,
and
potential
side-effects.
According to the depth of injection and the
administered
quantity,
a
linear
threading
technique, a serial puncture technique, or a
combination of the two can be