CUROSURF 120

Introduction

Package Leaflet: Information for the User

CUROSURF 120 mg

Suspension for Endotracheal Administration

Porcine Pulmonary Surfactant

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the Package Leaflet:

1. What Curosurf 120 mg Suspension for Endotracheal Administration is and what it is used for
2. What you need to know before you use Curosurf 120 mg Suspension for Endotracheal Administration
3. How to use Curosurf 120 mg Suspension for Endotracheal Administration
4. Possible side effects
5. Storage of Curosurf 120 mg Suspension for Endotracheal Administration
6. Contents of the pack and other information

1. What Curosurf 120 mg Suspension for Endotracheal Administration is and what it is used for

Curosurf is used to treat or prevent Respiratory Distress Syndrome (RDS) in newborn babies. Most newborn babies are born with a substance in their lungs called "surfactant". This substance coats the lungs and prevents them from sticking together, making it easier to breathe. However, some babies, especially premature babies, do not have enough of this surfactant when they are born, which causes RDS. Curosurf is a natural surfactant that works in the same way as the baby's own surfactant, helping the baby to breathe normally until they can produce surfactant on their own.

2. What you need to know before you use Curosurf 120 mg Suspension for Endotracheal Administration

Do not use Curosurf 120 mg Suspension for Endotracheal Administration

• If you are allergic to porcine pulmonary surfactant or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

The baby's general condition should be stabilized. It is also recommended to correct acidosis, hypotension, anemia, hypoglycemia, and hypothermia.

Babies born after a very prolonged period after rupture of membranes (more than 3 weeks) may not respond optimally.

Administration of surfactant may decrease the severity of RDS but does not completely eliminate the mortality and morbidity associated with prematurity, as these babies have other complications. After administration of Curosurf, a depression of cerebral electrical activity has been detected, lasting 2-10 minutes, whose impact is not well known.

Curosurf has not been studied in preterm babies with severe hypotension.

Children

This medicine is only for premature babies.

Interaction of Curosurf 120 mg Suspension for Endotracheal Administration with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription, homeopathic medicines, herbal remedies, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

However, no interactions have been observed between Curosurf and the medicines commonly used in Intensive Care Units for premature babies.

Pregnancy and breastfeeding

This medicine is only for premature babies.

Driving and using machines

This is not applicable as this medicine is only for premature babies.

Curosurf 120 mg Suspension for Endotracheal Administration contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per vial, so it is considered essentially "sodium-free".

3. How to use Curosurf 120 mg Suspension for Endotracheal Administration

Follow exactly the administration instructions of this medicine given by your doctor. If you are in doubt, consult your doctor again.

Curosurf should only be administered by trained personnel with experience in the care, resuscitation, and stabilization of preterm newborn babies, and only when there are adequate facilities for ventilation and monitoring of babies with Respiratory Distress Syndrome.

Curosurf 120 mg Suspension for Endotracheal Administration is administered via the endotracheal route.

The recommended dose for treatment is:

• 200 mg/kg (1.25-2.5 ml/kg), administered as a single dose or divided into 2 doses of 100 mg/kg, the first of which should be administered immediately after diagnosis of RDS and the second after 12 hours.
• If necessary, an additional dose of 100 mg/kg can be administered after an interval of 12 hours in newborn babies who continue to require assisted ventilation and supplemental oxygen. The maximum total dose is 300-400 mg/kg.

The recommended dose for prevention (prophylaxis) is:

• 100-200 mg/kg (1.25-2.5 ml/kg), administered as soon as possible after birth (preferably within the first 15 minutes) as a single dose.
• If necessary, an additional dose of 100 mg/kg can be administered 6-12 hours after the first dose and repeated 12 hours later if signs of RDS persist and assisted ventilation is still required. The maximum total dose is 300-400 mg/kg.

If you use more Curosurf 120 mg Suspension for Endotracheal Administration than you should

No cases of overdose have been reported after administration of Curosurf. However, in the unlikely event of an accidental overdose, and only if there are clear clinical effects on respiration, ventilation, or oxygenation of the newborn, as much of the suspension as possible should be aspirated and supportive treatment should be administered, with special attention to hydroelectrolytic balance.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you have any other questions about the use of this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Curosurf 120 mg Suspension for Endotracheal Administration can cause side effects, although not everybody gets them.

These side effects include:

• Infections and infestations: sepsis (severe infection)
• Nervous system disorders: intracranial hemorrhage
• Respiratory disorders: presence of air in the pleura (pneumothorax), pulmonary hemorrhage, chronic lung disease (bronchopulmonary dysplasia), difficulty breathing (apnea), oxygen intoxication (hyperoxia), bluish discoloration of the skin and mucous membranes (cyanosis).
• Cardiac disorders: abnormal slowing of heart rate (bradycardia).
• Vascular disorders: low blood pressure (hypotension).
• Investigations: reduction of oxygen saturation, abnormal electroencephalogram.
• Traumatic injuries, poisonings, and complications of therapeutic procedures: complication of endotracheal intubation.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for human use medicines, https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Curosurf 120 mg Suspension for Endotracheal Administration

Store in a refrigerator (2-8°C), protected from light.

Unopened and unused vials of Curosurf that have been at room temperature for up to 24 hours can be returned to the refrigerator for later use. Do not move from room temperature to refrigerator more than once.

Keep out of the reach and sight of children.

Do not use Curosurf after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy's SIGRE collection point. If you are in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Curosurf 120 mg Suspension for Endotracheal Administration

• The active substance is porcine pulmonary surfactant. Each single-dose vial contains 120 mg of porcine pulmonary surfactant.
• The other ingredients are sodium chloride, sodium bicarbonate, and water for injection.

Appearance of the product and contents of the pack

A pack containing a 5 ml glass vial with 1.5 ml of sterile surfactant suspension (80 mg/ml) of white to yellowish color; the stopper is made of chlorobutyl rubber and the cap is made of plastic and aluminum.

Marketing authorization holder and manufacturer

Marketing authorization holder:

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, Planta 10

08908 L’Hospitalet de Llobregat

Barcelona (Spain)

Manufacturer:

CHIESI FARMACEUTICI, S.p.A.

Via San Leonardo 96 - Via Palermo, 26/A

43122 Parma (Italy)

This leaflet was approved in October 2016.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

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This information is intended only for healthcare professionals

Method of use

BEFORE using CUROSURF

Aspirate the endotracheal tube before instillation to reduce the risk of obstruction, as if ventilation parameters vary significantly during or immediately after instillation, it is possible that there is an obstruction of the endotracheal tube by mucus, especially if pulmonary secretions were abundant before administration of the medicine. If an obstruction of the endotracheal tube by mucus is suspected and cannot be eliminated by aspiration, the endotracheal tube should be replaced immediately.

Method of administration

Warm the vial to room temperature by simply holding it in your hand for a few minutes.

Gently invert the vial several times for a few minutes, WITHOUT SHAKING, until the suspension appears homogeneous.

To extract the suspension, carefully follow the instructions below:

1. Locate the notch (FLIP UP) on the colored plastic cap.
2. Lift the notch and pull upwards.
3. Pull the plastic cap with the aluminum portion downwards.
4. And 5) Remove the entire ring by tearing off the aluminum wrapper.

1. Remove the rubber stopper.
2. Extract the contents using a sterile needle and syringe and administer CUROSURF following the most appropriate modality described below.

CUROSURF can be administered according to the following different modalities:

1. Disconnecting the baby from assisted ventilation:

Disconnect the baby momentarily from assisted ventilation and administer 1.25 to 2.5 ml/kg (100-200 mg/kg) of the suspension as a single bolus, directly into the lower part of the trachea through the endotracheal tube. Maintain assisted ventilation with a bag for approximately one minute and then reconnect the baby to assisted ventilation under the same conditions as before administration. If additional doses are needed (1.25 ml/kg = 100 mg/kg), they can be administered in the same way.

1. Without disconnecting the baby from assisted ventilation:

Administer 1.25 to 2.5 ml/kg (100-200 mg/kg) of the suspension as a single bolus, directly into the lower part of the trachea through a catheter passed through the suction port and into the endotracheal tube. If additional doses are needed (1.25 ml/kg = 100 mg/kg), they can be administered in the same way.

1. There is a third option for administration through intubation of the newborn to administer the surfactant. The doses are the same as those indicated in sections a and b. In this case, an intubation-extubation technique is used, and after administration of the surfactant and extubation, nasal CPAP (Continuous Positive Airway Pressure) can be applied.
2. Less Invasive Surfactant Administration (LISA) using a thin catheter

In premature babies who breathe spontaneously, Curosurf can also be administered through the Less Invasive Surfactant Administration (LISA) technique using a thin catheter. The doses are the same as those indicated in the administration modalities mentioned in sections a, b, and c. A small-diameter catheter is placed in the trachea of babies on CPAP, ensuring continuous spontaneous breathing, with direct visualization of the vocal cords by laryngoscopy. Curosurf is instilled in a single bolus over 0.5-3 minutes. After instillation of Curosurf, the tube is immediately removed. CPAP treatment should be maintained throughout the process.

For surfactant administration, a thin catheter with a CE mark for surfactant administration should be used.

DURING treatment, regardless of the administration modality adopted, the following is recommended:

• Frequent monitoring of blood gases after administration, as an immediate increase in PaO2 or oxygen saturation is usually observed. To maintain adequate oxygen values in the blood, it is recommended to periodically perform blood gas analyses, continuous monitoring of transcutaneous PO2, or oxygen saturation.
• Monitoring to identify signs of infection. At the first symptoms of neonatal infection, appropriate antibiotic therapy should be administered.
• Avoiding sudden changes in PaO2 after instillation by immediately adjusting the ventilator. The occurrence of intracranial hemorrhages after Curosurf administration has been associated with a reduction in mean arterial blood pressure and early peaks of arterial oxygenation (PaO2).

AFTER administration of the medicine:

• Do not aspirate tracheal secretions for at least 6 hours, unless there is a vital risk;
• it may be necessary:
• • a reduction of the peak inspiratory pressure (without waiting for confirmation of blood gas control, if lung expansion improves rapidly);
  • a rapid adjustment of the inspired oxygen concentration (to avoid hyperoxia, if there is a rapid increase in arterial oxygen concentration)

INTERRUPT therapy with CUROSURF in case of:

• bradycardia, hypotension, and low oxygen saturation: in these situations, measures should be taken to normalize heart rate. After stabilization, monitoring of the newborn's vital signs should continue.
• reflux: if necessary, the peak inspiratory pressure of the ventilator should be increased to eliminate the obstruction of the endotracheal tube

To complete the picture of complications of prematurity, the following disorders may occur, directly related to the severity of the disease and the use of mechanical ventilation, necessary for reoxygenation: pneumothorax, interstitial pulmonary emphysema, and pulmonary hemorrhage.

Finally, prolonged use of high oxygen concentrations and mechanical ventilation is associated with the development of bronchopulmonary dysplasia and retinopathy of prematurity.