Largen Med


Full Prescribing Info
Bovine lung surfactant.
Newfactan is a white to pale yellowish freeze-dried crystalline lump filled in a colorless and transparent vial. By adding saline solution, it makes yellowish suspension with slightly characteristic odor.
Treatment for neonatal respiratory distress syndrome (RDS) caused by deficiency of pulmonary surfactant. The prognosis of RDS is so poor that it frequently results in neonatal deaths.
Dosage/Direction for Use
Suspend saline solution (120 mg/4 mL) and infuse 120 mg/kg into the trachea.
In order to evenly distribute the drug throughout the entire pulmonary field, infuse the drug in 4 or 5 separate aliquots, and at each infusion, change the position of the body.
Ensure transcutaneous arterial oxygen pressure to be ≥80 mm Hg while bagging with 100% oxygen during the infusion of each aliquot. It is desirable to infuse the initial aliquot within 8 hrs after birth. The dosage level for an additional treatment is 60-120 mg/kg and should be determined according to the condition of the patient.
Direction for Reconstitution: Slowly drip the 4-mL warm saline solution into the Newfactan vial (phospholipid 100 mg) and dissolve the cake completely. Do not shake the vial and just swirl it gently to prevent foaming. In addition, some foaming at the surface may occur during handling and is inherent in the nature of Newfactan.
Aliquot the total volume (4 mL/kg/dose) in 5 different syringes.
Patients with family history of allergic predisposition to bovine lung surfactant.
Special Precautions
Concomitant disease can be suspected when Newfactan is not effective after an administration according to the instructions.
An appropriate evaluation of the cardiovascular conditions and cardiac function as well as adequate treatments, if necessary, should be done.
For an appropriate ventilation condition, immediately after treatment, a long inspiratory phase time (0.7-1 sec), a low frequency of air exchange (30-40 times/min) and some pressure (peak inspiratory pressure of 20 cm H2O, end tidal pressure of 5 cm H2O) are necessary.
If the arterial oxygen tension improves after a treatment, ventilation conditions may be modified; 1st, lower the inhaled oxygen concentration and then adjust the pressure setting, the inspiratory phase time and the frequency of air changes.
An RDS patient has a left to right shunt mediated by the arterial canal from an early stage after birth. Increase in the shunt volume may cause pulmonary congestion and heart failure during the recovery phase, consequently, the efficacy of Newfactan is diminished.
Newfactan therapy should therefore be carefully conducted due to possible occurrence of a patent ductus arteriosus. Particularly, in very premature babies, the treatment for closing the arterial canal is recommended at an early stage after Newfactan therapy.
Additional administration should be made if the inhaled oxygen concentration cannot be reduced to ≤0.4, if the mean intratracheal pressure cannot be reduced to ≤7 cm H2O and if reticular and granular shadows are present in chest x-ray films. In general, only 1 additional dose is administered.
Be careful for an infection in the patient when Newfactan is administered.
Caution For Usage
Aspirate the prepared solution according to the instructions into a syringe fitted with a G26 needle. Connect the syringe to a small sterile tube (3-4 Fr) and infuse the solution into the trachea via an intratracheal tube.
Do not administrate in blood vessels.
Gently spread 4 mL saline solution on Newfactan mixture by using a catheter needle so that bubbles are not formed on its surface. And immediately shake the vial gently so that an even suspension is obtained. If a solution other than saline solution is used, a poor suspension (increase in viscosity and lumps) may be obtained.
Use the suspension after warming it up to body temperature.
Aspirate and remove amniotic fluid and mucus from the trachea before administration.
Use the suspension immediately after the preparation. Any remaining suspension should not be used because it may be contaminated by bacteria (Newfactan contains no preservatives).
Since Newfactan is a lyophilized preparation, the content may be disintegrated under certain physical conditions, but with no alteration in efficacy.
Store below 5°C.
Shelf-Life: 24 months.
ATC Classification
R07AA02 - natural phospholipids ; Belongs to the class of lung surfactants. Used in the treatment of respiratory diseases.
Powd for inj (vial) 30 mg/mL x 4 mL x 1's.
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