Curosurf

Package Leaflet: Information for Parents and Carers

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Curosurf, 80 mg/ml (120 mg/1.5 ml), suspension for intratracheal and intra-bronchial use

(Poractant alfa)
Fraction of phospholipids from pig lungs

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell the doctor or nurse. See section 3.

Table of Contents of the Leaflet:

• 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. Contents of the pack 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 newborns. 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 have other conditions that require different treatment.

2. HOW TO USE CUROSURF

Dosage:

The doctor will choose the appropriate 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 possible after diagnosis. 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 disconnecting the child from the ventilator for a few minutes.
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 the medicine is considered "sodium-free".

3. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine 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(occur in less than 1 in 100 patients):

• infection
• bleeding into the brain
• air in the chest cavity caused by lung damage

Rare(occur in less than 1 in 1000 patients):

• slow heart rate
• low blood pressure
• chronic lung disease
• decreased oxygen levels in the body

The following side effects have also 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 you experience any side effects, including any side effects not listed in this leaflet, tell the doctor 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 Warszawa, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of the medicine.

4. HOW TO STORE CUROSURF

• Keep the medicine out of sight and reach of children.
• Store in a refrigerator (2°C - 8°C). Store 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 no longer required. This will help protect the environment.

5. CONTENTS OF THE PACK AND OTHER INFORMATION

What Curosurf contains

• The active substance is a mixture of lipids and proteins obtained from pig lung alveoli.
• The other ingredients are: sodium chloride, water for injections.

What Curosurf looks like and what the pack contains

Curosurf is a sterile suspension. It is available in single-dose glass vials containing 1.5 ml (120 mg) of phospholipid fraction from pig lung alveoli. Each ml of sterile suspension contains 80 mg of phospholipid fraction from pig lung alveoli. One pack contains 2 vials of 1.5 ml Curosurf suspension.
For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

CHIESI FARMACEUTICI SpA
Via Palermo 26/A, 43122 Parma, Italy

Manufacturer:

CHIESI FARMACEUTICI SpA
Via Palermo 26/A, 43122 Parma, Italy
CHIESI FARMACEUTICI S.p.A
Via San Leonardo 96, 43122 Parma, Italy
CHIESI PHARMACEUTICALS GmbH
Gonzagagasse 16/16, 1010 Vienna, Austria

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Romania, the country of export: 272/2007/01

Parallel import authorization number: 85/19

Date of leaflet approval:12.02.2024
[Information about the trademark]

Please read the information on the back of the leaflet

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How to open the product?

• 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 together 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 should be disposed of in accordance with regulations.