FLOLAN INFUSION OF EPOPROSTENOL 1500 MCG

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

EPOPROSTENOL AS SODIUM

Tilgængelig fra:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC-kode:

B01AC09

Lægemiddelform:

POWDER FOR SOLUTION FOR INFUSION

Sammensætning:

EPOPROSTENOL AS SODIUM 1.5 MG/VIAL

Indgivelsesvej:

I.V

Recept type:

Required

Fremstillet af:

GLAXO SMITH KLINE MANUFACTURING SPA,ITALY

Terapeutisk gruppe:

EPOPROSTENOL

Terapeutisk område:

EPOPROSTENOL

Terapeutiske indikationer:

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

Autorisation dato:

2015-01-31

Indlægsseddel

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician s prescription only
Flolan infusion of epoprostenol 500 mcg
The vial of powder contains the active ingredient:
epoprostenol (as sodium) 500 mcg
Flolan infusion of epoprostenol 1500 mcg
The vial of powder contains the active ingredient:
epoprostenol (as sodium) 1500 mcg
For the list of the inactive and allergenic ingredients in the
medicine, see section 2
– Important information about some of the ingredients in the
medicine and section
6 – Additional information .
Read the leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions,
refer to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them even if it seems to you that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Flolan is used for the long-term intravenous treatment of a lung
disease called
pulmonary arterial hypertension (PAH) - idiopathic or heritable PAH or
PAH
associated with connective tissue diseases.
In this lung disease, pressure is high in the blood vessels in the
lungs. Flolan
widens the blood vessels to lower the blood pressure in the lungs.
Therapeutic group: Anticoagulant (antithrombotic agent), platelet
aggregation
inhibitor.
Flolan contains the active ingredient epoprostenol which belongs to a
group of
medicines called prostaglandins. This group of medicines stops blood
from clotting
and widens the blood vessels.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
• you are sensitive (allergic) to the active ingredient
(epoprostenol), or to any of
the additional ingredients contained in this medicine (listed in
section 6).
• you have heart failure.
• you 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 un

Produktets egenskaber

1
FLOLAN
INFUSION OF EPOPROSTENOL 500 MCG FLOLAN
INFUSION OF EPOPROSTENOL 1500 MCG
1.
NAME OF THE MEDICINAL PRODUCT
Flolan Infusion of Epoprostenol 500 mcg
Flolan Infusion of Epoprostenol 1500 mcg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Flolan Infusion of Epoprostenol 500 mcg
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).
Flolan Infusion of Epoprostenol 1500 mcg
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 excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for infusion.
Powder for solution for infusion:
-
White to off-white solid
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).
2
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