Tuesday, October 18, 2016

Flolan 0.5mg Injection






Flolan 0.5 mg injection



epoprostenol



Please read this leaflet carefully. Keep it safe as you may want to read it again.



This leaflet is a summary of information about Flolan 0.5 mg injection. If you want to know more about your illness or your medicine, ask your pharmacist or doctor.




What is in Flolan?


Flolan is supplied as a sterile white to off-white powder in vials containing 500 micrograms of the active ingredient epoprostenol, as the sodium salt.


There are some inactive ingredients in Flolan, these are glycine, sodium chloride, mannitol and sodium hydroxide.



Before Flolan is used it is dissolved in a sterile diluent called GlaxoSmithKline Glycine Buffer Diluent. This contains the inactive ingredients glycine, sodium chloride, sodium hydroxide and Water for Injections.




Who makes Flolan?



GlaxoSmithKline Manufacturing S.p.A.

Strada Provinciale Asolana 90

43056 San Polo di Torrile

Parma

Italy


makes Flolan and



GlaxoSmithKline UK

Stockley Park West

Uxbridge

Middlesex

UB11 1BT


is licensed to sell it in the UK.




What is Flolan for?


Flolan belongs to a group of drugs called anticoagulants. It is used during renal dialysis to stop your blood from clotting.




Is it alright for me to have Flolan?


This medicine suits most people, but there are a few people who, in some cases it may not be suitable for.


Ask yourself these questions to check whether it is right for you:


  • Do you have a bleeding tendency?

  • Have you previously had an allergic reaction to Flolan, epoprostenol or any of the other ingredients listed above?

  • Are you pregnant, trying to become pregnant or breast-feeding?

  • Are you currently taking any medicine to prevent blood clots such as heparin, warfarin, aspirin or other anti-inflammatory pain killers (NSAIDs)?

  • Are you currently taking any medicines that are used to treat high blood pressure, angina, heart failure, or any other heart or circulation problem?

If the answer to any of these questions is "YES", or if you are not sure, please tell your doctor before you are given Flolan.




How is Flolan given?


Flolan will be given as an infusion (drip) either intravascularly (into a blood vessel) or into the blood supplying the dialyser. The dose of Flolan is based on your body weight in kilograms.


Your doctor will decide on the dose and duration of Flolan therapy which is right for you. The usual starting dose is 4 nanograms of the active ingredient per kilogram of body weight per minute.


There is no specific information available on the dose of Flolan in children or elderly people.



Can an overdose of Flolan be given?


The effects of Flolan are monitored carefully and appropriate action can be taken promptly in the unlikely event that you receive too much. Receiving too much Flolan may cause very low blood pressure, which may possibly cause you to faint. If you think that you have been given too much Flolan, tell your nurse or doctor.





Does Flolan have side effects?


Flolan can cause side effects in some people. If you experience any of the following while you are receiving it please tell your doctor at once:


  • redness or flushing of the face

  • headaches

  • feeling sick and vomiting

  • abdominal discomfort

  • a dry mouth

  • tiredness

  • chest pain and tightness

  • reddening and pain at the infusion site

  • speeding up or slowing of the heart beat, quickening of the pulse or lowering of blood pressure (e.g. feeling faint on standing)

  • paling of the skin

  • sweating

  • jaw pain

  • chills, fever, shivers, confusion and rapid breathing (septicaemia)

  • anxiety, nervousness and agitation

You may also experience lower levels of certain blood cells (platelets) used in the clotting process. Sometimes this may be noticeable as bruising or bleeding from the gums or nose.


Tell your doctor if you notice any other side effects from your medicine which are not mentioned here.




Storing Flolan


  • Flolan should be stored in a dry safe place below 25°C and protected from light until it is given. It should not be frozen and should be kept out of reach and sight of children.

  • The doctor or nurse will check that the expiry date on the label has not passed.


Leaflet last updated: September 2006


Flolan is a registered trademark of the GlaxoSmithKline group of companies


© 2006 GlaxoSmithKline group of companies




10000000029558





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