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CUROSURF® QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: - Phospholipidic fraction of porcine lung, 120 mg Excipients: - Sodium
chloride: 13.5 mg
Active substance: - Phospholipidic fraction of porcine lung, 240 mg Excipients: - Sodium
chloride: 27 mg CUROSURF®, is a natural surfactant prepared from porcine lung, containing almost exclusively phospholipids, particularly, phosphatidylcholine (about 70% of the total content in phospholipids and about 1% of specific hydrophobic proteins of low molecular weight: SP-B and SP-C. PHARMACEUTICAL
FORM PHARMACOTHERAPEUTIC
CLASS NAME
OR DESIGNATION OF THE RESPONSIBLE FOR THE M.A. THERAPEUTIC INDICATIONS
CONTRAINDICATIONS
AND SIDE EFFECTS Pulmonary haemorrhage is an event whose incidence increases the more premature is the baby and constitutes a rare and sometimes fatal complication of premature labor. There is no evidence that supports the increase of the risk of this complication after the administration of CUROSURF®. No other side effects were reported. DRUG
INTERACTIONS AND OTHER FORMS OF INTERACTION SPECIAL
PRECAUTIONS FOR USE Babies born after a very prolonged rupture of the membranes (more than 3 weeks), may not show an optimal response to the treatment. The general state of the baby should be stabilized. It is also recommended to correct acidosis, hypotension, anaemia, hypoglycaemia and hypothermia. The administration of surfactant is expected to reduce the severity of RIS or the risk of its occurrence, but we cannot expect that it completely eliminates mortality and morbility associated with preterm birth, since premature babies may be exposed to other complications due to their immaturity. After the administration of CUROSURF®, it has been registered a transient depression of cerebral-electrical activity (with the duration of about 2 to 10 minutes) whose impact is yet unknown. EFFECTS
ON PREGNANT WOMEN, BREAST-FEEDING WOMEN, CHILDREN, ELDERLY PATIENTS AND
PATIENTS WITH SPECIAL PATHOLOGIES EFFECTS
ON THE ABILITY TO DRIVE OR TO USE MACHINES LIST
OF EXCIPIENTS USUAL
POSOLOGY, WITH REFERENCE TO MAXIMUM DOSE It
is advisable to start treatment as soon as possible, after the diagnostic
of RIS. Prophylaxis: A single dose of 100-200 mg/Kg as soon as possible (within 15 minutes), after birth. Complementary doses of 100 mg/kg may be administered 6 to 12 hours after the first dose and, afterwards, in intervals of 12 hours, in case of the occurrence of RIS needing mechanical ventilation (maximum total dose: 300 – 400 mg/kg). ADMINISTRATION
MODE AND ROUTE Before
its use, the vial should be warmed up at 37ºC, keeping it in an incubator
for about 1 hour or in a water-bath for about three minutes; gently, without
agitating, invert the vial one or two times in order to obtain an uniform
suspension. Disconnect the baby from the ventilator for a few moments and administer 1.25 to 2.5 ml/kg of suspension in a single dose bolus, directly in the lower trachea, through the endotracheal tube. Next, the baby should be manually ventilated for about one minute and then connected to the ventilator. Additional doses (1.25 ml/kg) eventually necessary are administered in the same way. CUROSURF® may also be distributed into the lungs with the help of the ventilator instead of using manual ventilation. After the administration of CUROSURF®, it is necessary to closely and frequently monitor arterial gases, since it is normally observed an immediate increase of PaO2 or oxygen saturation. However, it is advisable to continuously monitor transcutaneous PO2 or the oxygen saturation, in order to prevent hyperoxia. Newborns who do not need assisted ventilation should be extubated following the administration of CUROSURF®. INDICATION
OF THE MOST FAVOURABLE MOMENT FOR THE ADMINISTRATION OF THE MEDICINE DURATION
OF THE AVERAGE TREATMENT WHEN IT SHOULD BE LIMITED INDICATION
OF HOW TO DISCONTINUE THE TREATMENT WHEN ITS DISCONTINUATION CAUSES WITHDRAWAL
EFFECTS MEASURES
TO ADOPT IN CASE OF OVERDOSAGE AND/OR INTOXICATION, EMERGENCY SYMPTOMS
AND ANTIDOTES However, in the improbable case of accidental overdosage, and only when there is evidence of clinical effects in the baby’s breathing, ventilation or oxygenation, the surplus suspension must be aspirated as much as possible, and the baby treated with support therapy, paying particular attention to the electrolytic balance of the fluids. ADVICE
TO THE PATIENT SPECIAL
PRECAUTIONS FOR STORAGE AND INDICATION OF VISIBLE SIGNS OF DETERIORATION,
IF THEY EXIST DATE OF THE REVISION OF THE LEAFLET : February 2004. |