Χώρα: Ισραήλ
Γλώσσα: Αγγλικά
Πηγή: Ministry of Health
EPOPROSTENOL AS SODIUM
GLAXO SMITH KLINE (ISRAEL) LTD
B01AC09
POWDER FOR SOLUTION FOR INFUSION
EPOPROSTENOL AS SODIUM 1.5 MG/VIAL
I.V
Required
GLAXO SMITH KLINE MANUFACTURING SPA,ITALY
EPOPROSTENOL
EPOPROSTENOL
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
2015-01-31
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 Διαβάστε το πλήρες έγγραφο
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 Διαβάστε το πλήρες έγγραφο