Flolan 1.5mg powder and solvent (pH12) for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Epoprostenol sodium

Available from:

pH12) for solution for infusion vials (GlaxoSmithKline UK Ltd

ATC code:

B01AC09

INN (International Name):

Epoprostenol sodium

Dosage:

1.5mg

Pharmaceutical form:

Powder and solvent for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02080100; GTIN: 5000123114504

Patient Information leaflet

1
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
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.

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 to you, DON’T USE FLOLAN until you
have checked with your doctor.
2
WARNINGS AND PRECAUTIONS
Talk to your doctor bef

Summary of Product characteristics

OBJECT 1
FLOLAN 1.5 MG POWDER AND SOLVENT FOR SOLUTION
FOR INFUSION (WITH PH 12 SOLVENT)
Summary of Product Characteristics Updated 13-Oct-2017 |
GlaxoSmithKline UK
1. Name of the medicinal product
Flolan 1.5 mg powder and solvent for solution for infusion
2. Qualitative and quantitative composition
Epoprostenol 1.5 mg powder for solution for infusion:
Each vial contains epoprostenol sodium equivalent to 1.5 mg
epoprostenol.
One ml of reconstituted concentrate solution contains epoprostenol (as
epoprostenol sodium) 30,000
nanogram (1.5 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.
Powder 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 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).
4.2 Posology and method of administration
Posology
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
resuscitation equipment.
A short-term dose-ranging procedure administered via either a
peripheral or central venous line is
required to determine the long-term infusion rate. The infusion rate
is in