Suplasyn solution for injection

País: Armenia

Idioma: inglés

Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes activos:

hyaluronic acid (sodium hyaluronate)

Disponible desde:

Mylan Institutional

Código ATC:

M09AX01

Designación común internacional (DCI):

hyaluronic acid (sodium hyaluronate)

Dosis:

20mg/2ml

formulario farmacéutico:

solution for injection

Unidades en paquete:

(1) 2ml pre-filled syringe

tipo de receta:

Prescription

Estado de Autorización:

Registered

Fecha de autorización:

2017-12-08

Ficha técnica

_ _
SMPC FOR SUPLASYN
®
20MG/2ML
1.
NAME OF THE DRUG
Suplasyn
®
Sterile Sodium Hyaluronate Solution
2.
QUANTITIVE AND QUALITIVE COMPOSITION
Each syringe contains: 20mg Hyaluronic acid sodium salt. Excipients
qs. 2ml
For full list of excipients see section 6.1.
3.
DOSAGE FORM
2mL Syringe, containing 2mL solution for intraarticular injection
4.
CLINICAL CHARACTERISTICS
4.1 INDICATIONS
Suplasyn® is indicated for the symptomatic treatment of
osteoarthritis. Suplasyn® has been
shown to be beneficial in osteoarthritis for the management of pain
and improvement in
physical function of joints. Depending upon joint size, up to 2ml may
be administrated intra-
articulary. Use strict aseptic technique. More than one joint may be
treated at the same time.
Discard any unused portion of the syringe. To use the prefilled
syringe, remove the Luer
lock cap, attach a suitable cannula (recommended is 21-25G depending
on joint) and secure
it by turning slightly.
Hyaluronic
acid
is
the
prototype
of
a
wide
range
of
saccharide
biopolymers
(glycosaminoglycan sot mucopolysaccharides), important components of
all extracellular
tissue structures, including cartilage and synovial fluid. The active
substance of Suplasyn®
is a hyaluronic acid of defined molecular chain length with a high
degree of purity. The
introduction of Suplasyn® into the synovial space will assist in the
normalization of the
joint following arthrocentesis.
4.2 USAGE FORMS AND DOSAGE
Suplasyn® is supplied as 2ml solution in a pre-filled syringe. The
recommended schedule is
1 injection per week for 3 weeks, but up to 6 may be given depending
on patient’s
condition.
4.3 WARNINGS
Do not inject intra-vascularly.
The patients should rest 24-48 hours after the injection and avoid any
strenuous activity over
the full course of the treatment.
Avoid
using
Suplasyn
®
with
instruments
sterilised
with
quaternary
ammonium
salts
solutions.
_ _
For Single Use Only.
4.4 PRECAUTIONS
Transient short duration pain may occur following intra-articular
introduction. The affected
join