PoractantAlfa CUROSURF

Indication

Dose

  • the dosage depends on the severity of the clotting disturbance
    1.5 ml of suspension (80 mg/ml)
  • on the location and extent of the bleeding and on the clinical condition of the patients.
    3 ml of suspension (80 mg/ml)


PoractantAlfa CUROSURF

World’s Leading Surfactant

COMPOSITION:

One 1.5 ml vial contains: Active ingredient: phospholipidic fraction from pig lung 120 mg. Excipients: sodium chloride, water for injections. One 3 ml vial contains: Active ingredients: phospholipidic fraction from pig lung 240 mg.Excipients: sodium chloride, water for injections.

HOW SUPPLIED:

One monodose vial of 1.5 ml of suspension (80 mg/ml). Two monodose vials of 1.5 ml of suspension (80 mg/ml). One monodose vial Of 3 ml of suspension (80 mg/ml)

PHARMACO-THERAPEUTIC CATEGORY:

Pulmonary surfactant consisting of natural phospholipids.

THERAPEUTIC INDICATIONS:

No Specific contraindications are known yet.

CONTRAINDICATIONS:

the dosage depends on the severity of the clotting disturbance, on the location and extent of the bleeding and on the clinical condition of the patients.

PRECAUTIONS FOR USE:

Curosurf should only be administered in hospital, by those trained and experienced in the care and resuscitation of preterm infants,having available suitable equipment for ventilation and monitoring of babies with RDS.

Particular precaution should be paid in babies born following very prolonged rupture of the membranes, more than 3 weeks, with possible pulmonary hypoplasia and a not optimal reponse to the exogenous surfactant. The baby general conditions should be stablised. Correction of acidosis, hypotension, anaemia, hyphoglycaemia and hypothermia is also recommended.

INTERACTIONS:

Not known.

SPECIAL WARNINGS:

The drug administration is occasionally followed by obstruction of the endotracheal tube with mucus; bradycardia, hypotension, oxygen desaturation have been rarely reported. These events require interruption of therapy and adoption of suitable measures. After stabilization, the patient can be still treated under suitable monitoring. After administration, chest expansion may rapidly improve, making it necessary to promptly reduce the inspiratory pressure peak, without waiting for confirmation from haemo-gas analysis. Prophylaxis with surfactant should only be performed where adequate neonatal intensive care facilities are available and according to the following recommendations:

-infant less than 26 weeks gestational age:

prophylaxis is recommended:

-infant between 26 and 28 weeks gestational age:

(a) no course of antenatal corticosteroids: immediate prophylaxis is recommended;

(b) with antenatal corticosteroids: surfactant should be administered only if RDS develops.

Considering the risk factor associated to the gestational age lower than 28 Weeks, prophylaxis is also recommended with two or more of the following risk factors for RDS: perinatal asphyxia; need for intubation at birth; maternal diabetes; multiple pregnancies; male sex; familiar predisposition for RDS; Cesarean section;

-infant of 29 weeks gestational age or more:

surfactant should be administered only if RDS develops.

Infants being treated with exogenous surfactant, due to the improved pulmonar functionality, can also be treated with nasal continuous positive airway pressure (nCPAP), in equipped facilities.

Surfactant administration can be expected to reduce the severity of RDS or the risk of its occurrence, but cannot be expected to completely eliminate mortality and morbidity associated with preterm birth, as preterm babies may be exposed to other complications due to their immaturity.

POSOLOGY AND METHOD OF ADMINISTRATION: RESCUE TREATMENT:

the recommended dose is a single dose of 100- 200 mg/kg (1.25-2.5 ml/kg) of body weight. It is possible to administer additional requiring assisted ventilation and supplementary oxygen (maximum total dose: 300-400 mg/kg). It is recommended to start treatment as soon as possible after diagnosing RDS.

PROPHYLAXIS:

a single dose of 100-200 mg/kg (1.25-2.5 ml/kg) should be administered as soon as possible (within 15 minutes) after birth. Further doses of 100 mg/kg can be given 6-12 hours after the first dose, and then at 12 hours intervals in case of occurrence of RDS requiring mechanical ventilation (max. total dose: 300-400 mg/kg).

METHOD OF ADMINISTRATION:

a single dose of 100-200 mg/kg (1.25-2.5 ml/kg) should be administered as soon as possible (within 15 minutes) after birth. Further doses of 100 mg/kg can be given 6-12 hours after the first dose, and then at 12 hours intervals in case of occurrence of RDS requiring mechanical ventilation (max. total dose: 300-400 mg/kg).

The suspension should be withdrawn from the vial by using a sterile needle and syringe, and directly administered, via the intratracheal tube, as a single dose into the lower part of trachea, or as two halved doses in the main right and left bronchial tubes, respectively.

Perform approximately one minute of hand-bagging with the same percentage Of oxygen as before administration, in order to favour a uniform distribution. Reconnect then the baby to the ventilator, whose parameters must be suitably adjusted to the clinical response and to changes of blood gases. Further doses that may be required are administered in the same manner. Babies not requiring assisted ventilation can be disconnected from the ventilator after Curosurf administration.

It is recommended to frequently control blood gases, as, after administration, an immediate increase of PaO2 or oxygen saturation is generally observed. It is however advisable to continuously monitor transcutaneous PO2 or oxygen saturation to avoid hyperoxia.

OVERDOSE:

There have been no reports of overdosage following the administration of Curosurf. However, in the unlikely event of accidental overdose, and only if there are clear clinical effects on the infant’s respiration, ventilation or oxygenation, as much of the suspension as possible should be aspirated and the baby should be managed with supportive treatment, with particular attention to fluid and electrolyte balance.

UNDESIRABLE EFFECTS:

Pulmonary haemorrhage, the incidence of which increases the more immature is the infant, is a rare and sometimes fatal complication of preterm delivery. No evidence exists of any increased risk of this event following the administration of Curosurf. Cases of bradycardia, hypotension, oxygen, desaturation (see Special Warnings and Precautions For Use), transient depression of electrical cerebral activity have been rarely reported. Do not use beyond the expiry date reported on the pack. Keep out of the reach of children.

SPECIAL PRECAUTIONS FOR STORAGE:

:The product must be Stored at +2 to +80C and protected from light, until the moment of use. Do not use any residual quantity in the vials after the first aspiration. Warmed vials should not be returned to the refrigerator.