Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
epoprostenol sodium, Quantity: 0.531 mg (Equivalent: epoprostenol, Qty 0.5 mg)
Sun Pharma ANZ Pty Ltd
Injection, powder for
Excipient Ingredients: sucrose; sodium hydroxide; glycine
Intravenous
1 vial
(S4) Prescription Only Medicine
Epoprostenol SUN is indicated for the long-term treatment, via continuous intravenous infusion, in WHO functional Class III or Class IV patients with idiopathic pulmonary arterial hypertension, familial pulmonary arterial hypertension and pulmonary arterial hypertension associated with the scleroderma spectrum of diseases.
Visual Identification: White to off white lyophilized cake or powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-07-13
1 AUSTRALIAN PRODUCT INFORMATION EPOPROSTENOL SUN (EPOPROSTENOL) POWDER FOR INJECTION 1 NAME OF THE MEDICINE Epoprostenol sodium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION EPOPROSTENOL SUN for Injection is formulated for intravenous administration. EPOPROSTENOL SUN 500 µg powder for injection: Each vial contains 531 µg epoprostenol sodium equivalent to 500 µg epoprostenol. EPOPROSTENOL SUN 1.5 mg powder for injection: Each vial contains 1.593 mg epoprostenol sodium equivalent to 1.5 mg epoprostenol. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Powder for injection for intravenous infusion. Sterile white to off-white lyophilised cake or powder. The reconstituted solution of EPOPROSTENOL SUN has a pH of 12.0 to 13.2 and is increasingly unstable at a lower pH (see Instructions for use/handling). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EPOPROSTENOL SUN is indicated for the long-term treatment, via continuous intravenous infusion, in WHO functional Class III or Class IV patients with: • Idiopathic pulmonary arterial hypertension • Familial pulmonary arterial hypertension • Pulmonary arterial hypertension associated with the scleroderma spectrum of diseases. 4.2 DOSE AND METHOD OF ADMINISTRATION GENERAL EPOPROSTENOL SUN must be reconstituted before use. Any further dilution must be 2 performed using the recommended solutions. Infusion sets with an in-line 0.22 micron filter must be used (see Instructions for use/handling). Epoprostenol reconstituted solution (pH 12.0 to 13.2) must not be used with any preparation or administration materials containing polyethylene terephthalate (PET) or polyethylene terephthalate glycol (PETG) (see SECTION 6.2 INCOMPATIBILITIES). Suitable ambulatory pumps to be used for the administration of EPOPROSTENOL SUN include: • CADD-Legacy® 1 • CADD-Legacy® PLUS Manufactured by Smiths Medical. Other pumps may be used depending on suitability. Pump accessories found compatible with the administration of EPOPROSTENOL SUN incl Belgenin tamamını okuyun