Quốc gia: Singapore
Ngôn ngữ: Tiếng Anh
Nguồn: HSA (Health Sciences Authority)
Epoprostenol sodium 1.593mg eqv epoprostenol
JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
B01AC09
INJECTION, POWDER, FOR SOLUTION
Epoprostenol sodium 1.593mg eqv epoprostenol 1.5mg
INTRAVENOUS
Prescription Only
Patheon Italia S.p.A
ACTIVE
2018-01-11
1 1. NAME OF THE MEDICINAL PRODUCT Veletri ® 0.5 mg, Powder for Solution for Infusion Veletri ® 1.5 mg, Powder for Solution for Infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Veletri ® 0.5 mg, Powder for Solution for Infusion Each vial contains 0.531 mg epoprostenol sodium equivalent to 0.5 mg epoprostenol One mL of reconstituted solution contains 0.1 mg epoprostenol (as epoprostenol sodium) (0.5 mg epoprostenol in 5 mL of solvent). Veletri ® 1.5 mg, Powder for Solution for Infusion Each vial contains 1.593 mg epoprostenol sodium equivalent to 1.5 mg epoprostenol One mL of reconstituted solution contains 0.3 mg epoprostenol (as epoprostenol sodium) (1.5mg epoprostenol in 5 mL of solvent). Excipient(s) with known effect: sodium, (0.03 mg for 0.5 mg/vial and 0.09 mg for 1.5 mg/vial) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion White to off-white powder For the pH of the diluted solution see section 4.4 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Veletri ® is indicated for: Pulmonary Arterial Hypertension. Veletri ® 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). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Veletri ® 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 equipment. 2 A short-term dose-ranging procedure administered via either a peripheral or central venous line is required to determine the long-term infusion rate. The infusion is initiated at 2 ng/kg/min and increased by increments of 2 ng/kg/min every 15 min or longer until maximum haemodynamic benefit or dose- Đọc toàn bộ tài liệu