Материал вискоэластичный: изделие офтальмологическое вискохирургическое (вискоэластик) Healon EndoCoat стерильное 0,85 мл в одноразовом стеклянном шприце

Страна: Беларусь

Язык: русский

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

Доступна с:

Johnson & Johnson Surgical Vision, Inc., СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ

класс:

изделия медицинского назначения

Производитель:

Johnson & Johnson Surgical Vision

Дата Авторизация:

2021-01-28

Характеристики продукта

© Johnson & Johnson Surgical Vision, Inc. 2018
EN
Z311181 Rev. B
Revision Date: 10/2018
Healon
®
EndoCoat Ophthalmic
Viscosurgical Device
Healon
®
EndoCoat Ophthalmic
Viscosurgical Device
Graphics
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FOR INTRAOCULAR USE AS A SURGICAL AID IN ANTERIOR SEGMENT SURGERY
ONLY.
DESCRIPTION
Healon
®
EndoCoat Ophthalmic Viscosurgical Device (OVD) is a sterile
non-pyrogenic solution of highly
purified sodium hyaluronate with dispersive rheological properties.
Healon
®
EndoCoat OVD contains 30
mg/ml of sodium hyaluronate. The concentration is adjusted to yield a
viscosity of approximately 50,000
centipoise when dissolved in a physiological buffered salt solution.
The solution has an osmolality of
approximately 320 milliosmoles/kg.
CHARACTERISTICS
Sodium hyaluronate is
a linear polysaccharide
composed of repeating
disaccharides of
sodium glucuronate and
N-acetylglucosamine found
throughout the tissues
of the body with high
concentrations in the vitreous
humour, synovial fluid, and
umbilical cord. It has a role
in regulating the interactions
between adjoining tissues.
Sodium hyaluronate can
also act as a viscoelastic space filler, maintaining a separation
between tissues. Sodium hyaluronate
does not interfere with the normal wound healing process. Sodium
hyaluronate is also present in the
capsular material of certain bacteria. Those bacteria may be cultured
by a fermentation process to yield
sodium hyaluronate. Sodium hyaluronate extracted and purified from
different sources can have different
molecular weights but has the same molecular structure. The sodium
hyaluronate in Healon
®
EndoCoat
OVD is a highly purified extract of a bacterial fermentation and is
tolerated well in the eye. It has a
molecular weight of approximately 800,000 Daltons, is non-antigenic
(1,2,3), and non-pyrogenic.
INDICATIONS
Healon
®
EndoCoat OVD is used in ophthalmic surgical procedures of the anterior
segment, including:
•
Cataract surgery with an intraocular lens
•
Cataract surgery without an intrao