Curosurf

Package Leaflet: Information for Parents and Carers

Curosurf, 80 mg/ml, Suspension for Inhalation and Endotracheal Administration

(Poractant alfa)
Phospholipid fraction from pig lungs

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If the patient experiences any side effects, including those not listed in this package leaflet, tell the doctor or nurse. See section 3.

Table of Contents:

• 1. What is Curosurf and what is it used for
• 2. How to use Curosurf
• 3. Possible side effects
• 4. How to store Curosurf
• 5. Package contents and other information

1. WHAT IS CUROSURF AND WHAT IS IT USED FOR

Curosurf is used to treat and prevent respiratory distress syndrome (RDS) in newborn babies. In most newborns, a substance called surfactant is present in the lungs. This substance covers the alveoli, prevents them from sticking together, and allows for normal breathing. However, some newborns, especially premature babies, are born with a surfactant deficiency, which leads to RDS. Curosurf is a natural surfactant that works in the same way as the surfactant produced by newborns, helping them to breathe normally until they start producing their own natural surfactant.
Newborns may also have other conditions that require different treatment.

2. HOW TO USE CUROSURF

Dosage:

The doctor will choose the correct dose of the medicine, depending on the child's weight. If the child is given Curosurf to prevent RDS, the medicine should be administered within 15 minutes of birth. If the child is given Curosurf to treat RDS, the medicine should be administered as soon as the condition is diagnosed. If the child needs an additional dose of Curosurf, it is given 12 hours after the first dose. If necessary, a third dose can be given after another 12 hours. The use of Curosurf in premature babies with liver or kidney failure has not been studied.

Method of administration:

Curosurf is administered to the child in an incubator by a doctor or nurse. The medicine is warmed to room temperature and then administered using a syringe through an endotracheal tube into the child's trachea. This may require temporarily disconnecting the child from the ventilator. A less invasive method of surfactant administration through a thin catheter (LISA - Less Invasive Surfactant Administration) may also be used.

Curosurf contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per vial, which means it is considered "sodium-free".

3. POSSIBLE SIDE EFFECTS

Like all medicines, Curosurf can cause side effects, although not everybody gets them. Possible side effects are listed below by frequency of occurrence:
In case of doubts about side effects, consult a doctor.
Uncommon(occurring in less than 1 in 100 patients):
Rare(occurring in less than 1 in 1000 patients):

• infection
• bleeding into the brain
• air in the chest cavity
• slow heart rate
• low blood pressure
• chronic lung disease
• decreased oxygen levels in the body

Additionally, the following side effects have been reported:

• increased oxygen levels in the body
• blue discoloration of the skin or gums due to oxygen deficiency
• respiratory arrest
• complications due to the insertion of tubes into the lungs
• decreased brain activity

During the administration of Curosurf through a thin catheter, some mild and short-term side effects have been reported: bradycardia, apnea, decreased oxygen saturation, foam on the mouth, coughing, choking, and sneezing.

Reporting side effects

If any side effects occur, including those not listed in this package leaflet, tell the doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

4. HOW TO STORE CUROSURF

• Store the medicine out of sight and reach of children.
• Store in a refrigerator at a temperature between 2°C and 8°C, in the original packaging to protect from light. Before administration to the child, warm to room temperature.
• Unopened and unused vials of Curosurf that have been warmed to room temperature can be returned to the refrigerator within 24 hours for later use. The medicine should not be warmed to room temperature and returned to the refrigerator more than once.
• Do not use this medicine after the expiry date stated on the carton and vial. The expiry date refers to the last day of the month stated.
• Use one container once and discard the remainder. The hospital should ensure the safe disposal of unused Curosurf.
• Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

5. PACKAGE CONTENTS AND OTHER INFORMATION

What Curosurf contains

• -The active substance is a mixture of lipids and proteins obtained from pig lung alveoli.
• Other ingredients are: sodium chloride, water for injection, sodium hydrocarbonate (for pH adjustment).

What Curosurf looks like and package contents

Curosurf is a sterile suspension. It is available in single-dose glass vials of 5 ml, containing 1.5 ml (120 mg) or 3 ml (240 mg) of phospholipid fraction from pig lung alveoli. Each milliliter of sterile suspension contains 80 mg of phospholipid fraction from pig lung alveoli. One package contains 2 vials of 1.5 ml suspension or 1 vial of 3 ml suspension of Curosurf.
Not all pack sizes may be marketed.

Marketing authorization holder:

Chiesi Farmaceutici S.p.A, Via Palermo 26/A, 43122 Parma, Italy.

Manufacturer:

Chiesi Farmaceutici S.p.A, Via San Leonardo 96 - Via Palermo 26/A, 43122 Parma, Italy.
Chiesi Pharmaceuticals GmbH, Gonzagagasse 16/16, A-1010 Vienna, Austria.
To obtain more detailed information, please contact the representative of the marketing authorization holder in Poland:
Chiesi Poland Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw
tel.: (22) 620 14 21, fax: (22) 652 37 79, e-mail: info-pl@chiesi.com
Date of last revision of the package leaflet:

Please read the information on the back of the package leaflet

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How to open the product?

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• 1) Find the notch on the colored, plastic cap,
• 2) Lift the cap at the notch and pull it upwards,
• 3) Pull down the plastic part of the cap along with its aluminum part,
• 4) and 5) Remove the entire cap by pulling the aluminum ring
• 6) and 7) Remove the rubber stopper before withdrawing the contents of the vial.

For single use only. Any unused suspension remaining in the vial should be discarded.
Do not store unused suspension for later use.
Any remaining unused product or waste materials should be disposed of in accordance with regulations.

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