HYALGAN PREFILLED SYRINGE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

HYALURONATE SODIUM

Available from:

Fidia Farmaceutici S.p.A.

ATC code:

M09AX01

INN (International Name):

HYALURONATE SODIUM

Dosage:

20mg/2ml Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

hyaluronic acid

Authorization status:

Marketed

Authorization date:

1999-04-01

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hyalgan solution for intra-articular injection, 20 mg/2 ml, prefilled
syringe.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 20 mg/2 ml of Sodium hyaluronate.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for intra-articular injection.
Clear, viscous solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the sustained relief of pain in osteoarthritis of the knee.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS (INCLUDING THE ELDERLY)
The contents of one pre-filled syringe (20 mg/2mL) to be injected into
the affected joint once a week to a total of five
injections, using a standard technique. No adjustment of dose is
required in elderly patients.
This can be repeated at not less than 6 monthly intervals.
CHILDREN
At present there is not enough evidence to recommend a dosage regimen
for use in children.
Intra-articular injection of Hyalgan should be made using precise,
anatomical localisation into the joint cavity of the
knee to be treated. The injection site in the knee is determined by
that location which is easier to reach. Usually a lateral
approach can be followed, but in some cases a medial approach is
preferable. Strict aseptic precautions should be
observed during the administration in order to avoid the possibility
of developing infections in the injection site. The
solution in the pre-filled syringe is ready for use and requires only
a sterile disposable needle. To ensure sterility the
injection site must be carefully cleansed with antiseptic. Care should
be taken to expel any trapped air bubbles from the
syringe containing Hyalgan prior to administration.
Joint effusion, if present, should be aspirated by arthrocentesis
prior to injection of Hyalgan.
The arthrocentesis should be made using a 20 gauge needle and the
joint should be aspirated to almost dryness, but not
to degree that would compromise the accuracy of the subsequent Hyalgan
injection. An appropriate exami