Alveofact inhalation vapour

Marketed by Dexa Medica

Ingredients in every vial

Phospholipid fraction from bovine lung (surfactant) 54 mg

Each package contains

1 vial of 54 mg

Other details

Dosage form:Inhalation vapour; powder
Flavour None

W.H.O. classification

ATC Level 1 R - Respiratory system
ATC Level 2 R07 - Other Respiratory System Products in ATC
ATC Level 3 R07A - Other Respiratory System Products in ATC

Warnings

Pregnancy

CONSULT YOUR DOCTORSafety of this item for use during pregnancy has not been established. Please consult your doctor.

Lactation

CONSULT YOUR DOCTORSafety of this item for use during lactation has not been established. Please consult your doctor.

Alcohol

CONSULT YOUR DOCTORSafety of this item for use with alcohol has not been established. Please consult your doctor.

Machinery

CONSULT YOUR DOCTORSafety of this item for use while operating heavy machinery has not been established. Please consult your doctor.

Available in

Indonesia
The Philippines

Dosage information

NEONATUS
Each dose of Alveofact is 54 mg of total phospholipids per kg body weight (1.2 ml per kg body weight).

Prevention:
A single dose of Alveofact and application within the first hour after birth are recommended.

Treatment:
Alveofact should be administered early in the course of RDS i.e preferably less than 6 hours of age. Treatment with Alveofact is given only by endotracheopulmonary instillation. A ready prepared catheter (e.g. umbilical catheter or gastric tube) is inserted through the positioned tracheal tube and the catheter opening positioned at the level of the tip of the tube. Using a syringe, the single dose of 1.2 ml Alveofact per kg body weight (corresponding to 54 mg total phospholipids per kg body weight) is administered as an intratracheal bolus via this catheter. Additional injections of air are used to help ensure that instillation is complete. Upon removal of the catheter, the patient is reconnected to the respirator. To promote the equal distribution of Alveofact, the patient may be gently turned from side to side every few seconds.

Duration of treatment:
Depending on the need for ventilation and on the initial dose, the following dosing scheme should be applied:
– Initial dose 54 mg: up to three subsequent applications of 54 mg.
– Initial dose 108 mg: up to one dose of 108 mg or up to two doses of 54 mg.
The total dose should not exceed 216 mg total phospholipids per kg body weight within the first 2 days of life.

Indication

For treatment of respiratory distress syndrome (RDS) in neonates