Label: information for the user

CUROSURF 120 mg

Endotracheal and pulmonary instillation suspension

Porcine Pulmonary Surfactant

Read the entire label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor.
• This medication has been prescribed only to you, and you should not give it to others who may have the same symptoms of illness as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this label.

Curosurf is used to treat or prevent Respiratory Distress Syndrome (RDS) in newborns. Most newborns are born with a substance in their lungs called "surfactant". This substance covers the lungs and prevents them from sticking together, thus facilitating normal breathing. However, some children, especially premature children, do not have enough of this surfactant when they are born, which causes RDS. Curosurf is a natural surfactant, which acts in the same way as the newborn's own surfactant, so it will help the newborn to breathe normally until the baby produces surfactant on its own.

Do not use Curosurf 120 mg Suspension for endotracheal and pulmonary instillation

- If you are allergic to porcine pulmonary surfactant or any of the other components of this medication (listed in section 6).

Warnings and precautions

The general condition of the newborn should be stabilized. It is also recommended to correct acidosis, hypotension, anemia, hypoglycemia, and hypothermia.

Children born after a very prolonged period after membrane rupture (more than 3 weeks) may not respond optimally.

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

The administration of Curosurf in preterm newborns with severe hypotension has not been studied.

Children

This medication is only for premature children.

Curosurf 120 mg Suspension for endotracheal and pulmonary instillation interaction with other medicationswith other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription, homeopathic, herbal, 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 medications commonly used in Intensive Care Units for premature children.

Pregnancy and breastfeeding

This medication is only for premature children.

Driving and operating machinery

This is not applicable as this medication is only for premature children.

Curosurf 120 mg Suspension for endotracheal and pulmonary instillation contains sodium

This medication contains less than 23 mg (1 mmol) of sodium per vial, making it essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

Curosurf should only be administered by trained and experienced personnel in the care, resuscitation, and stabilization of premature newborns, and only when there are adequate facilities for ventilation and monitoring of children with Respiratory Distress Syndrome.

Curosurf 120 mg Suspension for Endotracheal Instillation is administered via endotracheal instillation.

The recommended dose in treatment is:

The recommended dose in prevention (prophylaxis) is:

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

No cases of overdose have been described after administration of Curosurf. However, in the unlikely event of an accidental overdose, and only in the presence of clear clinical effects on respiration, ventilation, or oxygenation of the newborn, the largest possible amount of suspension should be aspirated and supportive treatment should be administered, with special attention to electrolyte balance.

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

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

Like all medications, Curosurf 120 mg Suspension for endotracheal instillation may produce adverse effects, although not everyone will experience them.

The following adverse effects have been reported:

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Human Medications, https://www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication

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

Curosurf vials that have not been opened or used and have been at room temperature for up to 24 hours can be returned to the refrigerator for later use. Do not exceed room temperature to refrigerator more than once.

Keep out of reach and sight of children.

Do not use Curosurf after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit empty containers and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medicines. This will help protect the environment.

Composition of Curosurf 120 mg Suspension for Endotracheal Instillation

- The active ingredient is porcine pulmonary surfactant. Each single-dose vial contains 120 mg of porcine pulmonary surfactant.

- The other components are sodium chloride, sodium bicarbonate, and injection water.

Appearance of the Product and Contents of the Package

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

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder of the Marketing Authorization:

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, 10th Floor

08908 L’Hospitalet de Llobregat

Barcelona (Spain)

Responsible for Manufacturing:

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 updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

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This information is intended solely for medical professionals or 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 a blockage of the endotracheal tube by mucus, especially if lung secretions were abundant before administration of the drug. If a blockage of the endotracheal tube by mucus is suspected and aspiration is not possible to eliminate, the endotracheal tube should be replaced immediately.

Administration Method

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

The vial should be gently inverted several times for a few minutes, WITHOUT SHAKING, until the suspension appears homogeneous.

To extract the suspension, follow the instructions carefully:

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

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

Curosurf can be administered in the following different modalities:

1. Disconnecting the child from assisted ventilation:

Disconnect the child temporarily from assisted ventilation and administer1.25 to2.5 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 approximately 1 minute of assisted ventilation with an ambu and then reconnect the child to assisted ventilation under the same conditions as before administration. If additional doses (1.25 ml/kg = 100 mg/kg) are needed, they can be administered in the same way.

1. Without disconnecting the child from assisted ventilation:

Administer1.25 to2.5 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 by passing a catheter through the suction port and within the endotracheal tube. If additional doses (1.25 ml/kg = 100 mg/kg) are needed, they can be administered in the same way.

1. There is a third option of 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, a technique of intubation-extubation is used and after administration of the surfactant and extubation, CPAP nasal (Continuous Positive Airway Pressure = Presión positiva continuain theairway) can be applied.
2. Less Invasive Surfactant Administration (LISA) using a fine catheter

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

To administer the surfactant, a fine catheter with a CE mark for surfactant administration should be used.

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

• Regular monitoring of blood gases after administration, as an immediate increase in PaO2or oxygen saturation is usually observed. To maintain adequate oxygen levels in the blood, it is recommended to perform periodic blood gas analyses, continuous monitoring of transcutaneous PO2or oxygen saturation.
• Monitoring to identify signs of infection. At the first symptoms of neonatal infection, appropriate antibiotic therapy should be administered.
• Avoid sudden changes in PaO2after instillation by immediately adjusting the ventilator. The appearance of intracranial hemorrhages after Curosurf instillation has been associated with a reduction in mean arterial blood pressure and early peaks of arterial oxygenation (PaO2).

AFTER administration of the medication:

• Do not aspirate tracheal secretions for at least 6 hours, unless there is a vital risk;
• It may be necessary:

• • Reducing the peak inspiratory pressure (without waiting for confirmation of blood gas control, if lung expansion improves rapidly);
  • Quickly adjusting the inspiratory oxygen concentration (to avoid hyperoxia, if a rapid increase in arterial oxygen concentration occurs)

STOP treatment with Curosurf in case of:

• Bradycardia, hypotension, and low oxygen saturation: in these situations, appropriate measures should be taken to normalize heart rate. After stabilization, monitoring of the neonate's vital signs should be continued.
• Reflex: if necessary, the inspiratory peak pressure of the ventilator should be increased to eliminate the blockage of the endotracheal tube.

To complete the picture of complications of prematurity, the following disorders can 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, the prolonged use of high oxygen concentrations and mechanical ventilation is associated with the development of bronchopulmonary dysplasia and retinopathy of prematurity.