Država: Malezija
Jezik: angleščina
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PIG LUNG SURFACTANT (PHOSPHOLIPID
PHARMAFORTE (MALAYSIA) SDN. BHD.
PIG LUNG SURFACTANT (PHOSPHOLIPID
1.5ml mL
CHIESI FARMACEUTICI SPA
CUROSURF ® 1.5ML SUSPENSION _Consumer Medication Information Leaflet (RiMUP)_ (Suspension containing phospholipid fraction from porcine lung(poractant alfa) 1 WHAT IS IN THIS LEAFLET - What Curosurf ® is used for - How Curosurf ® works - Before you use Curosurf ® - How to use Curosurf ® - While you are using Curosurf ® - Side effects - Storage and disposal of Curosurf ® - Product description - Manufacturer and product registration holder - Date of revision WHAT CUROSURF ® IS USED FOR Curosurf ® contained active substance, poractant-alfa extracted from pig’s lung. It is used to treat or prevent Respiratory Distress Syndrome (RDS) in newborn babies. Most babies are born with a substance in their lungs known as ‘surfactant’. This substance lines the lungs and stops them from sticking together and so makes normal breathing possible. Some babies, however, particularly premature babies, do not have enough of this surfactant when they are born, which causes RDS. Curosurf ® is a natural surfactant, which works in the same way as your baby’s own surfactant would have done and, therefore, will help your baby to breathe normally until your baby produces his or her own surfactant. HOW CUROSURF® WORKS Curosurf ® is a p ulmonary surfactant consisting of natural phospholipids extracted from pig’s lung. - It was developed to replace deficiency of endogenous pulmonary surfactant by intratracheal administration of exogenous surfactant. - It acts by lowering surface tension of premature babies lung which is essential to stabilise premature lung and to avoid collapse at end- expiration so that adequate gas exchange is maintained throughout the ventilatory cycle. BEFORE YOU USE CUROSURF® WHEN YOU MUST NOT USE IT DO NOT USE CUROSURF®: - If you are allergic (hypersensitive) to the active substance or any excipients of Curosurf® BEFORE YOU START TO USE IT Your baby will only be given Curosurf ® if the equipment for ventilation and monitoring babies with Respiratory Distress Syndrome is available. After being gi Preberite celoten dokument
1. CLINICAL PARTICULARS Curosurf 80 mg/ml suspension for endotracheobronchial instillation. Active ingredient: One 1.5 ml vial contains 120mg of phospholipid fraction from porcine lung (poractant alfa). One 3.0ml vial contains 240mg of phospholipid fraction from porcine lung (poractant alfa) CUROSURF® is a natural surfactant prepared from the alveolar surface of porcine lungs, mainly containing phospholipids, especially phosphatidylcholine (70% approx. of the total phospholipid content) and 1-2% approximately of surfactant specific hydrophobic low-molecular weight proteins SP-B and SP-C. Lung surfactant is a mixture of substances, chiefly phospholipids and specific proteins that coats the internal surface of lung alveoli lowering the surface tension. This action is essential to stabilise alveoli, avoiding 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 named Respiratory Distress Syndrome (RDS) of Hyaline Membrane Disease (HMD). In premature babies, RDS is the major cause of mortality and morbidity in the first days of life being also responsible for long term respiratory and neurologic sequelae. CUROSURF® has been developed to replace the deficiency of endogenous pulmonary surfactant by administration of exogenous surfactant into the lower airways. The tensioactive properties of CUROSURF® favour its uniform distribution into the lungs and spreading at the air- liquid interface in the alveoli. Both physiological and therapeutical effects of CUROSURF® in surfactant deficiency have been extensively documented in various animal patterns. In premature rabbit foetuses obtained by hysterectomy and immediately sacrificed, the administration of CUROSURF® caused a marked improvement in lung expansion. In premature rabbits ventilated with 100% O2 there was a dramatic improvement of tidal volume and lung-thorax compliance compared to the control animals, after administration of Preberite celoten dokument