1 Dosing Considerations FOR INTRATRACHEAL ADMINISTRATION ONLY. 3 Administration using conventional administration methods). Before administering Curosurf assure proper placement and patency of the endotracheal tube. At the discretion of the clinician, the endotracheal tube may be suctioned before administering Curosurf.
The infant should be allowed to stabilize before proceeding with dosing. 3 Administration using LISA method). Curosurf should be administered by or under the supervision of clinicians experienced in intubation, ventilation management and general care of premature infants.
Marked improvements in oxygenation may occur within minutes of administration of Curosurf. Therefore, frequent and careful clinical observation and arterial or transcutaneous monitoring of systemic oxygenation are essential to avoid hyperoxia, which could cause an increased incidence of intracranial haemorrhage.
If oxygen saturation is in excess of 95 %, FiO2 should be promptly reduced until it reaches 90 - 95 % and, if necessary, peak ventilator inspiratory pressure reduced. Failure to reduce ventilatory inspiratory pressure rapidly can result in lung distension and fatal pulmonary air leaks.
Assisted ventilation should not be Serious Warnings and Precautions Curosurf is intended for Intratracheal use only (see DOSAGE AND ADMINISTRATION). Curosurf should only be administered by those trained and experienced in the care and resuscitation of preterm infants.
Prior to administering Curosurf, the infant’s general conditions should be stabilized (see INDICATIONS, WARNINGS AND PRECAUTIONS: General and Monitoring and Laboratory Tests sections below). The administration of exogenous surfactants, including Curosurf, can rapidly affect oxygenation and lung compliance; therefore, frequent clinical and laboratory assessments are needed to determine modifications to oxygen concentration and ventilator settings (see WARNINGS AND PRECAUTIONS: Monitoring and Laboratory Tests section below).
Administration of Curosurf may cause bradycardia, hypotension, endotracheal tube blockage, apnea, airway obstruction, and oxygen desaturation. Sto p administration and take appropriate measures to alleviate such conditions. Dosing may proceed after the patient is stable (see WARNINGS AND PRECAUTIONS).
Curosurf® Product Monograph Page 7 of 32 abruptly stopped so as not to increase the risk of apnoea. Transient episodes of bradycardia, hypotension, endotracheal tube blockage, apnea, airway obstruction, and oxygen desaturation have occurred during the dosing procedure of Curosurf by endotracheal tube or thin tube (LISA technique).
These events require interrupting the administration of Curosurf and taking the appropriate measures to alleviate the condition. After stabilization, dosing may resume with appropriate monitoring. Infants whose ventilation becomes markedly impaired during or shortly after dosing may have mucous plugging of the endotracheal tube, particularly if pulmonary secretions were prominent prior to drug administration.
Suctioning of all infants prior to dosing ma y lessen the probability of mucous plugs obstructing the endotracheal tube. If endotracheal tube obstruction from such plugs is suspected, and suctioning is unsuccessful in removing the obstruction, the blocked endotracheal tube should be replaced immediat ely.
5 mL/kg (200 mg/kg) birth weight. This dose may be determined from the Curosurf dosing chart below. This dose is administered into each main bronchus via a feeding tube to ensure proper distribution (and not into the lower trachea). 25 mL/kg (100 mg/kg) birth weight each may be administere d, using the same technique described for the initial dose.
Repeat doses should be administered, at approximately 12-hour intervals, in infants who remain intubated and in whom RDS is considered responsible for their persisting or deteriorating respiratory status. The maximum recommended total dose (sum of the initial and up to two repeat doses) is 5 mL/kg (300 -400 mg/kg).
3 Administration Curosurf should be inspected visually for discoloration prior to administration. The color of Curosurf is white to creamy white. A slight color change, towards yellow, may occur on aging without denoting product degradation.
Before use, the vial should be slowly warmed to room temperature (by holding it in an incubator for about one hour or in a thermostated bath for about three minutes), and gently turned upside- down, in order to obtain a uniform suspension.
DO NOT SHAKE. See STORAGE, STABILITY AND DISPOSAL, and SPECIAL HANDLING INSTRUCTIONS. Use with conventional administration Curosurf is administered intratracheally by instillation through a 5 French […]