Hyalgan

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HYALURONIC ACID

Available from:

Fidia Farmaceutici S.p.A Via Ponte della Fabbrica 3/A, 35031 Abano Terme, Padova, Italy

ATC code:

M09AX01

INN (International Name):

HYALURONIC ACID 10 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

HYALURONIC ACID 10 mg/ml

Prescription type:

POM

Therapeutic area:

OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM

Authorization status:

Withdrawn

Authorization date:

2006-11-28

Summary of Product characteristics

Page 1 of 4 

SUMMARY OF THE PRODUCT CHARACTERISTICS 

1.  TRADE NAME OF THE MEDICINAL PRODUCT 
 HYALGAN®

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 

2.1  Each pre-filled syringe contains: 20 mg/2ml of
hyaluronic acid sodium salt (Hyalectin
®) 

See section 6.1 for details of excipients 

3. PHARMACEUTICAL 
FORM 

Hyalgan is a sterile solution for intra-articular injection for
single use only. 

4. CLINICAL 
PARTICULARS 

4.1. Therapeutic indications 

Traumatic and degenerative joint disease. Adjuvant in
orthopaedic surgery. 

4.2. Posology and method of administration 
2 ml of Hyalgan (20mg) administered
intra-articularly once a week for 5 weeks or as directed 
by the physician. Treatment may be repeated, usually, at 6 up to
12-month intervals. 

4.3. Contra-indications 

Individual hypersensitivity to any of its components.  
Hyalgan cannot be used in patients who are allergic to avian
proteins, feathers, and eggs 
products. 

4.4. Special warnings and special precautions for use 
It is necessary to follow a correct technique
of intra-articular injection in accurately aseptic 
conditions. See also item 6.6. 
Particular attention must be paid in case of patients with an infection close
to the injection 
path, in order to avoid the possibility of
developing bacterial arthritis. 

Remove joint effusion, if present, before injecting Hyalgan.  

Patients should be carefully examined prior to administration
to determine signs of acute 
inflammation and the physician should evaluate whether Hyalgan
treatment should be 
initiated when objective signs of inflammation are present. 

A healthcare professional must instruct the patient to rest for 48
hours following the 
administration of the product, doing
as little exercise as possible and avoiding standing for 
long periods of time. Subsequently, they may gra