Curosurf 120

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

CUROSURF 120 mg

Endotracheopulmonary instillation suspension

Porcine Pulmonary Surfactant

Read this entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor, even if they are adverse effects not listed in this leaflet.

Leaflet contents:

1. What Curosurf 120 mg Suspension for endotracheal instillation is and what it is used for
2. What you need to know before using Curosurf 120 mg Suspension for endotracheal instillation
3. How to use Curosurf 120 mg Suspension for endotracheal instillation
4. Possible adverse effects
5. Storage of Curosurf 120 mg Suspension for endotracheal instillation
6. Package contents and additional information

1. What Curosurf 120 mg Intratracheal and Pulmonary Instillation Suspension is and what it is used for

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 coats the lungs and prevents them from sticking together, thus facilitating normal breathing. However, some infants, especially premature infants, do not have sufficient amounts of this surfactant at birth, which leads to RDS. Curosurf is a natural surfactant that works in the same way as the surfactant naturally produced by newborns, helping the infant to breathe normally until the baby can produce surfactant on its own.

2. What you need to know before starting to use Curosurf 120 mg Endotracheal Pulmonary Instillation Suspension

Do not use Curosurf 120 mg Endotracheal Pulmonary Instillation Suspension

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

Warnings and precautions

The newborn's general condition should be stabilised. It is also recommended to correct acidosis, hypotension, anaemia, hypoglycaemia and hypothermia.

Infants born after a very prolonged rupture of membranes (longer than 3 weeks) may not respond optimally.

Surfactant administration may reduce the severity of RDS but does not eliminate entirely the mortality and morbidity associated with prematurity, as these infants may have other associated complications. After administration of Curosurf, a depression of cerebral electrical activity, lasting 2-10 minutes, has been observed, the clinical significance of which is not fully understood.

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

Children

This medicine is intended solely for use in preterm infants.

Interaction of Curosurf 120 mg Endotracheal Pulmonary Instillation Suspension with other medicines

Inform your doctor or pharmacist if you are using or have recently used any 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 any of them.

Nevertheless, no interactions have been observed between Curosurf and the medicines commonly used in neonatal intensive care units.

Pregnancy and breastfeeding

This medicine is intended solely for use in preterm infants.

Driving and use of machinery

Not applicable, as this medicine is intended solely for use in preterm infants.

Curosurf 120 mg Endotracheal Pulmonary Instillation Suspension contains sodium

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

3. How to use Curosurf 120 mg Suspension for endotracheal instillation

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

Curosurf must only be administered by trained and experienced personnel in the care, resuscitation, and stabilization of preterm newborn infants, and only when adequate facilities are available for ventilation and monitoring of infants with Respiratory Distress Syndrome (RDS).

Curosurf 120 mg Suspension for endotracheal instillation is administered via endotracheal route.

The recommended dose for treatment is:

• 200 mg/kg (1.25–2.5 mL/kg), given as a single dose or divided into two doses of 100 mg/kg, the first of which should be administered immediately after diagnosis of RDS and the second after approximately 12 hours.
• If considered necessary, an additional dose of 100 mg/kg may be administered after an interval of 12 hours in newborns who still 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 may be given 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 instillation than you should

Cases of overdose following administration of Curosurf have not been reported. However, in the unlikely event of accidental overdose, and only if clear clinical effects on the neonate's respiration, ventilation, or oxygenation occur, the largest possible amount of the suspension should be aspirated and supportive treatment provided, with special attention to fluid and electrolyte balance.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

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

4. Possible adverse effects

Like all medicines, Curosurf 120 mg Endotracheal Pulmonary Instillation Suspension may cause adverse effects, although not everyone experiences them.

These adverse effects include:

• Infections and infestations: sepsis (serious infection)
• Nervous system disorders: intracranial hemorrhage
• Respiratory disorders: presence of air in the pleura (pneumothorax), pulmonary hemorrhage, chronic lung disease (bronchopulmonary dysplasia), breathing difficulty (apnea), oxygen toxicity (hyperoxia), bluish discoloration of the skin and mucous membranes (cyanosis).
• Cardiac disorders: abnormally slow heart rate (bradycardia).
• Vascular disorders: low blood pressure (hypotension).
• Investigations: reduced oxygen saturation, abnormal electroencephalogram.
• Injuries, poisonings, and procedural complications: complications of endotracheal intubation.

Reporting of 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products, https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Curosurf 120 mg Suspension for endotracheal instillation

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

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

Keep out of the reach and sight of children.

Do not use Curosurf after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Curosurf 120 mg Suspension for endotracheal instillation

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

Appearance of the product and contents of the pack

Pack containing a colorless glass vial with a capacity of 5 ml, which contains 1.5 ml of sterile pulmonary 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 summary of product characteristics was approved in October 2016.

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

This information is intended exclusively for physicians or healthcare professionals

Instructions for use

BEFORE using CUROSURF

Aspirate the endotracheal tube before instillation to reduce the risk of obstruction, as changes in ventilatory parameters during or immediately after instillation may indicate endotracheal tube blockage by mucus, especially if pulmonary secretions were abundant prior to drug administration. If mucus obstruction of the endotracheal tube is suspected and cannot be cleared by suctioning, the endotracheal tube must be replaced immediately.

Method of administration

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

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

To withdraw 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 off the plastic cap with the aluminum portion facing downwards.

4. and 5) Remove the entire ring by tearing off the aluminum seal.

5. Remove the rubber stopper.

6. Withdraw the contents using a sterile needle and syringe and administer CUROSURF according to the most appropriate method described below.

CUROSURF can be administered using the following different methods:

1. Disconnecting the infant from mechanical ventilation:

Temporarily disconnect the infant from mechanical 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 trachea via the endotracheal tube. Provide manual ventilation with an ambu bag for approximately one minute, then reconnect the infant to mechanical ventilation under the same conditions as before administration. If additional doses (1.25 ml/kg = 100 mg/kg) are required, they may be administered in the same manner.

1. Without disconnecting the infant from mechanical ventilation:

Administer 1.25 to 2.5 ml/kg (100–200 mg/kg) of the suspension as a single bolus directly into the lower trachea by passing a catheter through the suction port and into the endotracheal tube. If additional doses (1.25 ml/kg = 100 mg/kg) are required, they may be administered in the same manner.

1. A third administration option involves intubation of the newborn to deliver 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 surfactant administration and extubation, nasal CPAP (Continuous Positive Airway Pressure) may be applied.
2. Less Invasive Surfactant Administration using a thin catheter (LISA)

In spontaneously breathing preterm infants, Curosurf can also be administered via the Less Invasive Surfactant Administration (LISA) technique using a thin catheter. The doses are the same as those indicated in the administration methods described in sections a, b, and c. A small-diameter catheter is inserted into the trachea of infants on CPAP, ensuring continuous spontaneous breathing, with direct visualization of the vocal cords by laryngoscopy. Curosurf is instilled as a single bolus over 0.5–3 minutes. After instillation, the catheter is immediately removed. CPAP treatment must be maintained throughout the procedure.

For surfactant administration, a CE-marked thin catheter intended for surfactant delivery must be used.

DURING treatment, regardless of the administration method used, the following is recommended:

• Frequent blood gas monitoring after administration, as an immediate increase in PaO₂ or oxygen saturation is typically observed. To maintain adequate blood oxygen levels, periodic blood gas analyses or continuous monitoring of transcutaneous PO₂ or oxygen saturation is recommended.
• Monitoring for signs of infection. Appropriate antibiotic therapy should be initiated at the first signs of neonatal infection.
• Avoid sudden changes in PaO₂ after instillation by promptly adjusting the ventilator settings. Intracranial hemorrhage following CUROSURF instillation has been associated with a reduction in mean arterial blood pressure and early peaks in arterial oxygenation (PaO₂).

AFTER administration of the medicinal product:

• Do not aspirate tracheal secretions for at least 6 hours, unless there is a life-threatening situation;
• The following adjustments may be necessary:
  • Reduction of peak inspiratory pressure (without waiting for blood gas confirmation) if lung expansion improves rapidly;
  • Rapid adjustment of the inspired oxygen concentration (to avoid hyperoxia) if a rapid increase in arterial oxygen levels occurs.

DISCONTINUE CUROSURF therapy in case of:

• Bradycardia, hypotension, and low oxygen saturation: in these situations, appropriate measures should be taken to normalize heart rate. After stabilization, continue monitoring the neonate's vital signs.
• Reflux: if necessary, increase the peak inspiratory pressure of the ventilator until endotracheal tube obstruction is resolved.

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

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