Flolan 0.5mg Injection

Nchi: Malta

Lugha: Kiingereza

Chanzo: Malta Medicines Authority

Viambatanisho vya kazi:

EPOPROSTENOL SODIUM

Inapatikana kutoka:

Glaxo Wellcome UK Limited

ATC kanuni:

B01AC09

INN (Jina la Kimataifa):

EPOPROSTENOL SODIUM

Dawa fomu:

POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

Tungo:

EPOPROSTENOL SODIUM 0.5 mg

Dawa ya aina:

POM

Eneo la matibabu:

ANTITHROMBOTIC AGENTS

Idhini hali ya:

Authorised

Idhini ya tarehe:

2006-08-14

Taarifa za kipeperushi

Page 1 of 11
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLOLAN 0.5 MG POWDER AND SOLVENT FOR SOLUTION FOR INFUSION
FLOLAN 1.5 MG POWDER AND SOLVENT FOR SOLUTION FOR INFUSION
Flolan 0.5 mg powder for solution for infusion
Flolan 1.5 mg powder for solution for infusion
Epoprostenol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Flolan is and what it is used for
2.
What you need to know before you use Flolan
3.
How to use Flolan
4.
Possible side effects
5.
How to store Flolan
6.
Contents of the pack and other information
1.
WHAT FLOLAN IS AND WHAT IT IS USED FOR
WHAT FLOLAN IS
Flolan contains the active substance epoprostenol which belongs to a
group of medicines called
prostaglandin, which stops blood from clotting and widens the blood
vessels.
WHAT FLOLAN IS USED FOR

Flolan is used to treat a lung condition called ‘pulmonary arterial
hypertension’. This is where
the pressure is high in the blood vessels in the lungs. Flolan widens
the blood vessels to lower
the blood pressure in the lungs.

Flolan is used to prevent blood clotting during kidney dialysis in
emergency situations when
heparin cannot be used.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FLOLAN
DO NOT USE FLOLAN

IF YOU ARE ALLERGIC to Flolan or any of the other ingredients of this
medicine (listed in section 6).

if you have HEART FAILURE.
3

if you start to develop a build-up of fluid in your lungs causing
breathlessness after starting this
treatment.
If you think any of these apply

Tabia za bidhaa

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SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 19
1.
NAME OF THE MEDICINAL PRODUCT
Flolan 0.5 mg powder and solvent for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Epoprostenol 0.5mg powder for solution for infusion:
Each vial contains epoprostenol sodium equivalent to 0.5 mg
epoprostenol.
One ml of reconstituted concentrate solution contains epoprostenol (as
epoprostenol sodium)
10,000 nanogram (0.5 mg epoprostenol in 50 ml of solvent).
Excipients with known effect:
The amount of sodium present in the reconstituted concentrate solution
equals 73 mg
approximately.
The amount of sodium present in the powder for solution for infusion
equals 3 mg approximately
per vial.
The amount of sodium present in the solvent for parenteral use equals
70 mg approximately per
vial.
For a full list of excipents, see section 6.1
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for infusion.
-
White or off-white freeze dried powder
Solvent for parenteral use:
-
Clear, colourless solution (pH 11.7 – 12.3)
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Flolan is indicated for:
Pulmonary Arterial Hypertension
Flolan is indicated for the treatment of pulmonary arterial
hypertension (PAH) (idiopathic or
heritable PAH and PAH associated with connective tissue diseases) in
patients with WHO
Functional Class III-IV symptoms to improve exercise capacity (see
section 5.1).
Renal Dialysis
Flolan is indicated for use in haemodialysis in emergency situations
when use of heparin carries a
high risk of causing or exacerbating bleeding or when heparin is
otherwise contraindicated (see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Pulmonary Arterial Hypertension
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Epoprostenol is only indicated for continuous infusion by intravenous
route._ _
Treatment should only be initiated and monitored by a physician
experienced in the treatment of
pulmonary arterial hypertension.
_Short-term (acute) dose ranging: _
This procedure should be conducted in a hospital with adequate
resuscit