Phospholipid fraction from bovine lung (surfactant).
The active substance is: Phospholipid fraction from bovine lung.
1 vial with 54 mg contains: 50.76-60.00 mg phospholipid fraction from bovine lung (powder), equivalent to a content of 66 μmole of 54 mg total phospholipids as freeze-dried powder.
1 vial with 108 mg contains: 101.52-120.0 mg phospholipid fraction from bovine lung (powder), equivalent to a content of 132 μmole or 108 mg total phospholipids as freeze-dried powder.
The other ingredients: 1 pre-filled syringe with 1.2 mL or 2.4 mL solvent contains: Sodium chloride, sodium hydrogen carbonate, water for injections.
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, are recommended.
Pharmacologic classification: (Natural) Lung Surfactant.
Preventive use in neonates with a high risk of respiratory distress syndrome (RDS).
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 are recommended.
Overdosage has not been yet reported. In the unlikely event of inadvertent overdose, it is recommended to aspirate the applied quantity of liquid applied as much as possible if there is a clinical deterioration. Symptomatic therapy should be given where necessary.
Hypersensitivity to phospholipid fraction from bovine lung or any of the other ingredients.
Very common: more than 1 treated patient out of 10.
Common: 1 to 10 treated patients out of 100.
Uncommon: 1 to 10 treated patients out of 1,000.
Rare: 1 to 10 treated patients out of 1,000.
Very rare: less than 1 treated patient out of 10,000.
Not known: frequency cannot be estimated from the available data.
No substance-related interactions are known so far. No negative effects have been seen from Alveofact therapy following administration of ambroxol infusion concentrate or glucocorticoids to the mother prevent respiratory distress syndrome.
The benefits and risks of Alveofact therapy for congenital infections in premature neonates have not yet been adequately elucidated. The acute effect may be reduced if connatal pneumonia is suspected.
Pulmonary function may also deteriorate in the event of concomitant underdevelopment of the lung (prolonged deficiency of amniotic fluid due to ruptured membranes or congenital renal function impairment).
Do not store the powder and the solvent above 30°C.
Do not freeze the powder, the solvent of the reconstituted suspension.
R07AA02 - natural phospholipids ; Belongs to the class of lung surfactants. Used in the treatment of respiratory diseases.
Lyo powd for susp (vial) 45 mg/mL (pre-filled syringe w/ 1.2 mL solvent) x 1's