Hi-Flex Inj. solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

hyaluronic acid (sodium hyaluronate)

Available from:

Hankook Korus Pharm Co.

ATC code:

M09AX01

INN (International Name):

hyaluronic acid (sodium hyaluronate)

Dosage:

20mg/2ml

Pharmaceutical form:

solution for injection

Units in package:

(3) pre-filled syringe 2ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-03-17

Patient Information leaflet

leaflet(115X180)mm
HI-FLEX
INJ.
Sodium Hyaluronate 20mg/2ml
INTRA-ARTICULAR INJECTION
[COMPOSITION]
Each syringe contains
Active Ingredient
Sodium hyaluronate - - - - - - - - - - - - - - - - - - - - - - - - - -
- - - - - - - - - - - - - - - - - - - - - - - 20mg/2ml
Excipients: Sodium Chloride, Dibasic Sodium Phosphate, Monobasic
Sodium Phosphate, Water for Injection
[INDICATIONS]
Sodium hyaluronate for intra-articular injection is indicated for the
treatment of pain in osteoarthritis
(OA) of the knee in patients who have failed to respond adequately to
conservative non-pharmacologic
therapy or simple analgesics (e.g., acetaminophen).
[DOSAGE AND ADMINISTRATION]
Sodium hyaluronate for intra-articular injection is administered by
intra-articular injection once a week
(one week apart) for a total of three injections.
Adults : administer 1 syringe per week to the articular cavity of knee
or articular cavity of shoulder
(shoulder joint, intra-subacromial bursa, intra-biceps tendon sheath)
three times continuously in weekly
intervals and increase and decrease the frequency according to
symptoms.
This
medicine
injects
to
intra-articular
cavity
of
knee
therefore
administrate
under
strict
aseptic
operation.
[CONTRAINDICATIONS]
•Do not administer to patients with known hypersensitivity (allergy)
to hyaluronate preparations.
•Do not administer to patients with known hypersensitivity (allergy)
to gram positive bacterial proteins.
•Do not inject Sodium hyaluronate for intra-articular injection in
the knees of patients with infections or
skin diseases in the area of the infection site or joint.
•Do not administer to patients with known systemic bleeding
disorders
[WARNINGS]
•Do not concomitantly use disinfectants containing quaternary
ammonium salts for skin preparation as
hyaluronan can precipitate in their presence.
•Transient increases in inflammation in the injected knee following
Sodium hyaluronate for intra-articular
injection have been reported in some patients with inflammatory
osteoarthritis.
[PRECAUTIONS]