What is Curosurf used for?

For the treatment, including early rescue of Respiratory Distress Syndrome (RDS) or hyaline membrane disease in newborn babies. Prophylactic use in premature infants requiring intubation for stabilisation at risk from RDS or with evidence of surfactant deficiency.

What pharmaceutical form is Curosurf available in?

Curosurf: Zawiesina do stosowania dotchawiczego i dooskrzelowego 80 mg/ml

What are the side effects of Curosurf?

Undesirable side effects observed during treatment in clinical trials and integrated with those collected during post-marketing experience are listed in the table below according to System Organ Class (showed with the MedDRA Preferred Term) and to the following frequency: very common (≥ 1/10); common (≥1/100 and <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). System organ Class Adverse Reaction F

Who should NOT take Curosurf?

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. No specific contraindications are yet known.

What precautions should be taken with Curosurf?

The vial should be warmed to room temperature , before use, and gently turned upside down, without shaking, in order to obtain a homogeneous suspension. The suspension should be withdrawn from the vial using a sterile needle and syringe. In order to draw the suspension, carefully follow the instructions below: 1) Locate the notch (FLIP UP) on the coloured plastic cap. 2) Lift the notch and pull upwards 3) Pull the plastic cap with the aluminium portion downwards 4) and 5) Remov

What ATC class does Curosurf belong to?

Curosurf: ATC R07AA02. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Curosurf

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

Pharmacotherapeutic group: Other respiratory, Lung surfactants, ATC code: R07AA02 Lung surfactant is a mixture of substances, mainly phospholipids and specific proteins, lining the internal surface of alveoli and capable of lowering pulmonary surface tension. This surface tension lowering activity is essential to stabilise alveoli, and to avoid collapse at end-expiration so that adequate gas exchange is maintained throughout the ventilatory cycle. Deficiency of lung surfactant, from whatever cause, leads to severe respiratory failure which in preterm babies is known as respiratory distress syndrome (RDS) or hyaline membrane disease (HMD).‍‍‍‍‍‍‍ RDS is a major cause of acute mortality and acute morbidity in the preterm baby and may also be responsible for long term respiratory and neurologic sequelae. CUROSURF was developed to replace this deficiency of endogenous pulmonary surfactant by intratracheal administration of exogenous surfactant. The surface properties of CUROSURF favour its uniform distribution in the lungs and spreading at the air-liquid interfaces in the alveoli. The physiological and therapeutic effects of CUROSURF in surfactant deficiency have been documented extensively in various animal models. In immature rabbit foetuses obtained by hysterectomy and immediately sacrificed the administration of CUROSURF caused a marked improvement in lung expansion. In premature newborn rabbits ventilated with 100% oxygen there was a dramatic improvement of tidal volume and lung-thorax compliance compared to the control animals, after administration of CUROSURF via a tracheal cannula. Also in premature newborn rabbits, treatment with CUROSURF (maintaining a standardised tidal volume of about 10ml/kg), increased the compliance of the lung- thorax system to a level similar to that of mature newborn animals. Clinical efficacy and safety A spontaneous clinical trial ( NINSAPP) has compared the administration of Curosurf with the LISA technique and the standard one ( intubation, administration and mechanical ventilation) in two groups of preterms newborns with RDS and gestational age between 23 and 27 weeks ( LISA group: N.108 , control group: N. 105 ). LISA technique was not inferior to the standard one on the primary end-point (survival without bronchopulmonary dysplasia at 36 gestational weeks). On the secondary end-points LISA was superior in increasing survival without major complications and in reducing the frequency of other morbidities associated with prematurity. The need of mechanical ventilation was significantly reduced with LISA.

Curosurf

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