Download Drug Information Sheet("Kusuri-no-Shiori") Injection Revised: 04

Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 04/2016
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is
important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response,
patients should understand their medication and cooperate with the treatment.
Brand name:Flolan for injection 1.5 mg
Active ingredient:Epoprostenol sodium
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine lowers pulmonary arterial pressure and eases blood flow by dilating blood vessels of the lungs.
It is usually used to treat pulmonary arterial hypertension.
Before using this medicine, be sure to tell your doctor and pharmacist
・If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have: left-heart dysfunction or hypotension.
If you have had: exacerbation of pulmonary edema during dose initiation of this medicine.
・If you are pregnant or breastfeeding.
・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal
effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
・Your dosing schedule prescribed by your doctor is((
to be written by a healthcare professional))
・In general, inject this medicine intravenously and continuously.
・Ask the doctor about the treatment span.
・Do not stop using this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
・Long-term continuous infusion may entail infection from the injection site and sepsis; therefore, be sure to keep the
injection site always clean.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include headache, flush, blood pressure falling, nausea/vomiting,
bradycardia, loss of consciousness, hypotensive shock, decreased urine output, jaw pain, bleeding, diarrhea,
chills/fever/influenza-like symptom, anxiety/nervousness/tremor, pain/neck pain/arthralgia and loss of appetite. If
any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated
in brackets. If any of these symptoms occur, see your doctor immediately.
・dizziness on standing up, bradycardiac (under 50 per minute), shortness of breath [excessive blood pressure
falling, excessive bradycardia]
・pale face, cold sweat, loss of consciousness [a state of shock]
・decreased urine output [decreased urine output]
・palpitation upon exertion, respiratory distress, orthopnea (relieved when sitting upright) [pulmonary edema]
・sweat, weight loss, frequent pulse [hyperthyroidism]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your
doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
・As the reconstitution diluent for Flolan contains no preservative, discard the remainder.
・Because the active ingredient in the reconstituted solution undergoes gradual degradation, store the reconstituted
solution of Flolan in the refrigerator if not used immediately.
・When the reconstituted medicine is stored in a refrigerator, the duration of storage with refrigeration should not
exceed 8 days (192 hours).
・Avoid freezing the reconstitution diluent for Flolan or reconstituted medicine. If the reconstitution diluent for
Flolan or reconstituted medicine is frozen, do not use it even after thawed.
・Use the reconstituted medicine within 72 hours below 25 degrees Celsius, within 48 hours below 30 degrees
Celsius, within 24 hours below 35 degrees Celsius or within 12 hours below 40 degrees Celsius regardless of
whether the reconstituted medicine has been stored with refrigeration until initiation of its use. Protect the
reconstituted medicine from light whenever feasible even during its use.
・Do not use any residual portion of reconstituted solution once use of the reconstituted medicine is started.
For healthcare professional use only
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For further information, talk to your doctor or pharmacist.
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