FLOLAN FOR INFUSION 0.5 mgvial

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

EPOPROSTENOL

Διαθέσιμο από:

GLAXOSMITHKLINE PTE LTD

Φαρμακολογική κατηγορία (ATC):

B01AC09

Δοσολογία:

0.5 mg/vial

Φαρμακοτεχνική μορφή:

INJECTION, POWDER, FOR SOLUTION

Σύνθεση:

EPOPROSTENOL 0.5 mg/vial

Οδός χορήγησης:

INTRAVASCULAR

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

GLAXOSMITHKLINE MANUFACTURING S.P.A. (Powder)

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

1988-07-04

Φύλλο οδηγιών χρήσης

 
CONFIDENTIAL 

1 
FLOLAN
TM

EPOPROSTENOL SODIUM 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Vials containing sterile, freeze-dried epoprostenol sodium
equivalent to 500 micrograms 
or 1.5 mg epoprostenol. 
Epoprostenol was formerly known as prostacyclin. 
PHARMACEUTICAL FORM 
Powder and solvent for solution for infusion. 
CLINICAL PARTICULARS 
INDICATIONS 
RENAL DIALYSIS 
_FLOLAN_ is indicated for use in renal dialysis when use of heparin
carries a high risk of 
causing or exacerbating bleeding or when heparin is otherwise
contraindicated. 
DOSAGE AND ADMINISTRATION 
_FLOLAN_  lyophilised powder must be reconstituted before use.
Any further dilution must 
be performed using only the recommended solutions. The final
infusion solution must be 
filtered with a sterile 0.22 micron or 0.20 micron filter prior to or
during administration 
_(see Instructions for Use/Handling). _
POPULATIONS 
x 
ADULTS 
RENAL DIALYSIS  
_FLOLAN_ is suitable for continuous infusion only, either
intravascularly or into the blood 
supplying the dialyser. 
The following schedule of infusion has been found effective in
adults: 
prior to dialysis: 4 nanograms/kg/min intravenously for 15 minutes 
during dialysis: 4 nanograms/kg/min into the arterial inlet of the
dialyser. 
The infusion should be stopped at the end of dialysis. 
The recommended dose for renal dialysis should be exceeded
only with careful 
monitoring of patient blood pressure. 

CONFIDENTIAL 

2 
x 
CHILDREN 
There is no specific information on the use of _FLOLAN_ for renal
dialysis or pulmonary 
hypertension in children. 
x 
ELDERLY 
There is no specific information on the use of _FLOLAN_ in patients
over 65 for renal 
dialysis or pulmonary hypertension.  In general, dose selection
for an elderly patient 
should be made carefully, reflecting the greater frequency of
decreased hepatic, renal (in 
the case of pulmonary hypertension) or cardiac function and

Αρχείο Π.Χ.Π.

1
FLOLAN
EPOPROSTENOL SODIUM WITH STERILE DILUENT (PH 12)
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vials containing sterile, freeze-dried epoprostenol sodium equivalent
to 0.5 mg or 1.5 mg
epoprostenol.
PHARMACEUTICAL FORM
Powder and solvent for solution for infusion.
_Freeze-dried powder _
•
Vials containing sterile, freeze-dried epoprostenol sodium equivalent
to 0.5 mg
epoprostenol, or
•
Vials containing sterile, freeze-dried epoprostenol sodium equivalent
to 1.5 mg
epoprostenol.
The powder is white or off-white.
_Solvent _
•
Sterile diluent
Vials containing 50 mL sterile diluent to reconstitute freeze-dried
powder: clear,
colourless solution (pH 11.7 – 12.3).
CLINICAL PARTICULARS
INDICATIONS
RENAL DIALYSIS
_FLOLAN_
is indicated for use in renal dialysis when use of heparin carries a
high risk of
causing or exacerbating bleeding or when heparin is otherwise
contraindicated.
DOSAGE AND ADMINISTRATION
_FLOLAN_
lyophilised powder must be reconstituted before use. Any further
dilution must
be performed using only the recommended solutions. The final infusion
solution must be
filtered with a sterile 0.22 micron or 0.20 micron filter prior to or
during administration
(see
_ Instructions for Use/Handling_
)
_. _
2
_FLOLAN_
prepared with sterile diluent (pH 12) must not be used with any
preparation or
administration materials containing polyethylene terephthalate (PET)
or polyethylene
terephthalate glycol (PETG; see
_Incompatibilities_
).
POPULATIONS
•
ADULTS
RENAL DIALYSIS
_FLOLAN_
is suitable for continuous infusion only, either intravascularly or
into the blood
supplying the dialyser.
The following schedule of infusion has been found effective in adults:
prior to dialysis: 4 nanograms/kg/min intravenously for 15 minutes
during dialysis: 4 nanograms/kg/min into the arterial inlet of the
dialyser
The infusion should be stopped at the end of dialysis.
The recommended dose for renal dialysis should be exceeded only with
careful
monitoring of patient blood pressure.
•
CHILDREN
There is no specific information