Имплантаты инъекционные интрадермальные: имплантат JALUPRO HMW

Страна: Беларусь

Язык: русский

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

Доступна с:

Professional Derma SA, ШВЕЙЦАРИЯ

класс:

изделия медицинского назначения

Производитель:

Professional Derma SA

Дата Авторизация:

2021-01-28

Характеристики продукта

INJECTABLE FOR INTRADERMAL IMPLANT.
THE PRODUCT IS INTENDED FOR THE EXCLUSIVE
USE OF MEDICAL STAFF. DO NOT USE THE PRODUCT FOR
APPLICATIONS DIFFERENT FROM THOSE BEING INDICATED IN
THIS ILLUSTRATIVE SHEET.
COMPOSITION
- Sodyum Hyaluronate
- Water for injection
- Glycine
- L-Proline
- L-Lysine monohydrochloride
- L-Leucine
DESCRIPTION
JALUPRO is a sterile reabsorbable injectable solution
which acts:
- as
a
tissue
lubricant
which
can
be
used
for
minimizing evidence of skin wrinkles of the face,
acting as a filler.
- as adjuvant in the physical or chemical treatments
such as peeling, laser therapy and dermoabrasion.
PACKAGING
The box contains:
- 2 sterile vials (A) of 30 mg (Sodyum Hyaluronate)
- 2 sterile bottles (B) of 100 mg (freeze-dried mixture
of amino acids).
INDICATION OF USE
JALUPRO is an implantable medical device, made
in
conformity
with
Regulation
93/42/CEE
MDD
and is intended for the correction of defects in the
following areas of the face: nose-labial creases;
increase of the lips; crow’s-feet; wrinkles at the sides
of the lips; acne scars; glabella wrinkles; frontal
wrinkles; increase of the cheek bones.
It can be used to coincide with physical or chemical
treatments
such
as
peeling,
laser
therapy
and
dermoabrasion.
INSTRUCTIONS FOR USE
The packaging contains two vials (A) of 30 mg of
sterile Sodyum Hyaluronate and two bottles (B) of 100
mg of a mixture of freeze-dried amino acids. For the
use, employ sterile syringes, the measure of the needle
is chosen by the physician who carry out the implant.
Before intradermal administration, the product must
be reconstituted and the freeze-dried powder (bottle
B) dissolved with the solution contained in the vial
(vial A), obtaining a clear and particles free solution.
According to the purpose of the treatment, inject the
obtained solution following the procedures described
in
the
next
paragraph
“precautions
for
use”
or
according the technique chosen by the physician.
PRECAUTIONS FOR USE
Before starting the implant, the area to be subjected
to the treatment