Country: Philippines
Language: English
Source: FDA (Food And Drug Administration)
Phospholipid Fraction from Bovine Lung
Glorious Dexa Mandaya, Inc.; Distributor: Glorious Dexa Mandaya, Inc.
Phospholipid Fraction from Bovine Lung
45 mg/mL (54 mg/1.2 mL)
Lyophilized Powder for Suspension for Intratracheal Administration
Blister pack x 10's (Box of 100's), 1 Glass Type I Vial containing Powder and 1 Pre filled Syringe with 1.2 mL Solvent (0.45%
BAG Health Care GmbH, Germany
Lyophilized Powder for Suspension for Intratracheal Administration
2021-05-11
SUMMARY OF PRODUCT CHARACTERISTICS ALVEOFACT ® 45 mg/ml LYOMARK PHARMA 10140026e 1 1. NAME OF THE MEDICINAL PRODUCT Alveofact ® 45 mg/ml 54 mg, powder and solvent for preparation of a suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Phospholipid fraction from bovine lung (surfactant) 1 vial with 54 mg contains 50.76 to 60.00 mg of a phospholipid fraction (powder) from cattle lung, equivalent to a content of 66 µmol or 54 mg total phospholipids as freeze-dried powder. 1 vial with 108 mg contains 101.52 to 120.00 mg of a phospholipid fraction (powder) from cattle lung, equivalent to a content of 132 µmol or 108 mg total phospholipids as freeze-dried powder. For a full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Powder and solvent for preparation of a suspension White poweder and a clear, colourless solvent (pH 7.3 8.3). The pH of the reconstituted suspension is 6.0 – 7.5. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alveofact is used in neonates. Preventive use in premature neonates with a high risk of respiratory distress syndrome (RDS). 4.2. POSOLOGY AND METHOD OF ADMINISTRATION A single dose of 1.2 ml Alveofact per kg body weight (equivalent to 54 mg total phospholipids per kg body weight) and application _within the first hour after birth_ is recommended_._ Depending on the need for ventilation the following dosing scheme should be applied: - Starting dose 54 mg: up to three subsequent applications of 54 mg - Starting dose 108 mg: up to one subsequent application of 108, or up to two subsequent applications with 54 mg, The total dose should not exceed 216 mg total phospholipids per kg body weight within the first 5 days of life. _ _ Treatment with Alveofact powder is given _only by endotracheopulmonary _ _instillation_. _ _ _INSTRUCTION _ _FOR _ _THE _ _RECONSTITUTION _ _OF _ _THE POWDER_: There are two options: Option 1 – with vial adapter Option 2 – with cannula OPTION 1 – WITH VIAL ADAPTER Caution: The syringe and vial adapter remain connected to the v Read the complete document