Thursday, October 20, 2016

Hyalgan






Hyalgan


(Sodium hyaluronate)


Solution for intra-articular injection, 20mg/2ml, prefilled syringe


Please read this leaflet carefully. It tells you about your medicine. Keep the leaflet in a safe place because you may want to read it again. If you have any questions or are unsure about anything, please ask your doctor.


If any of the side effects gets serious, or if you notice any side effects not listed in the leaflet, please tell your doctor.


In this leaflet:


1. What Hyalgan is and what it’s used for

2. Things to consider before you have Hyalgan injection

3. How you will be given the injection

4. Possible side effects

5. How Hyalgan should be stored

6. Further information




What Hyalgan is and what it’s used for


Hyalgan is an injection. It is a sterile solution which provides 20mg of the active ingredient, sodium hyaluronate, in 2ml of liquid. Each pre-filled syringe is used only once.


Hyalgan is used to treat people who have painful knees because they have osteoarthritis. Hyalgan injections help to reduce the pain and make it easier to move.


Osteoarthritis is a disease which affects the joints making them painful and difficult to move. The joints may swell up and change shape.


Sodium hyaluronate is found naturally in the joints. It acts as a lubricant and shock absorber. It also plays a number of other important roles in normal joint function. In people with osteoarthritis in their knees the hyaluronic acid in the knee joints has broken down making the knees painful and difficult to move.




Things to consider before you have Hyalgan injection


Are there any reasons why I shouldn’t have the Hyalgan injection?



Some people must not have this injection. You should tell your doctor before you are given Hyalgan injection if:


  • You think that you may be allergic to sodium hyaluronate or to any or the other ingredients in the product listed in Section 6.

  • You know that you are allergic to any other avian (bird) proteins such as in feathers or droppings (sodium hyaluronate is of avian origin).

  • You have any infection in the knee joint.

  • You have any infection or disease in the area of skin around the joint being treated.


You should also ask yourself these questions before having the injection.


Are you pregnant or breast-feeding?


Is your knee joint swollen or inflamed?



If the answer to any of the questions is YES, tell your doctor or nurse because the injection may not be suitable for you.



Other special warnings


Try to rest, with as little exercise as possible, for the first 48 hours after the injection into your knee. You should certainly try to avoid any strenuous or prolonged activity, and you should even try to avoid standing for too long. You can then start to return to normal activity after this 48 hour rest.


Hyalgan should not affect your ability to drive or operate machinery.





How you will be given the injection


Your doctor will give you the injection of Hyalgan directly into the affected knee. Before you have the injection he or she will examine the knee carefully and will remove any excess fluid from the joint if necessary. The excess fluid is usually removed by inserting a needle into the knee joint and drawing it off using a syringe. This syringe is then disconnected from the needle, leaving the needle in place.


The syringe containing the Hyalgan is then connected to the needle and the Hyalgan injected into the knee joint.



A usual course of treatment is to have an injection into the knee once a week for five weeks. Your doctor will tell you when you should have your injections.


The course of injections can be repeated, but only after an interval of at least 6 months.


Hyalgan is intended to be given to adults, including the elderly. It is not recommended for children.



Information for the doctor or nurse


Hyalgan is supplied ready to use. The syringe is for single use only and the contents must be administered immediately once the container is opened. The solution may only be used if it is clear. Hyalgan should not be mixed with, or given at the same time as, any other medicines that are to be injected into the knee and must not be diluted. It must not be used with disinfectants called quaternary ammonium salts.




Hyalgan Side Effects


Although Hyalgan is suitable for most people like all medicines it can sometimes cause side effects.


There is very slight risk of an allergic reaction to Hyalgan, particularly in those people who have an allergy to bird proteins. In a very few cases Hyalgan may cause a severe shock-like reaction.



Tell the doctor or nurse straightaway if you get any allergic reactions such as



  • skin rashes or itching,


  • swelling of the face, lips or tongue,


  • coughing, wheezing or breathlessness,


either while you are having the injection or any time later.


With Hyalgan you may experience some pain, swelling, fluid in the knee, heat or redness after injection. This does not usually last very long and can be treated by resting the affected knee and cooling it with an ice pack.


If any of these symptoms do not disappear or do not improve within 1 to 4 days, go back to your doctor.


If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor.




How Hyalgan should be stored


All medicines should be kept out of the reach and sight of children.


Hyalgan should be stored in its original packaging in order to protect from light.


Store below 25ÂșC.


Do not freeze. Hyalgan should not be used if the package has been opened or damaged.


Hyalgan should not be used after the expiry date which is printed on the package.


Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.




Further information


Each pre-filled syringe contains 20 mg of the active ingredient sodium hyaluronate in 2 ml of liquid. The liquid also contains other ingredients sodium chloride, disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and water for injections.


The syringes are for single use only. A pack contains 1 prefilled syringe.


The product licence holder and manufacturer is



Fidia Farmaceutici S.p.A.

Via Ponte della Fabbrica 3/A

35031 Abano Terme (Padova)

Italy


Hyalgan is distributed in the UK by



IPG Pharma Ltd

Swadlincote

DE11 8LN

UK




This leaflet was last approved in July 2009


If you would like any more information, or would like the leaflet in a different format, please contact +39 049 8232761






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