80 mg/ml instillation liquid for respiratory, suspension 
porcine lunglipider and protein

1. What Curosurf is and what it is used for

Curosurf contains the active substance porcine lung lipids and protein, which is a surfactant. Surfactant is a substance that is formed in the lungs and prevents them from collapsing. Some newborns, especially premature babies, do not have enough of this substance and this causes shortness of breath (RDS).

Curosurf is used to treat newborns who have or are at risk of developing shortness of breath.

The drug is used to improve the breathing of newborns until they can produce enough of their own surfactant.

2. What you need to know before your child is given Curosurf

Curosurf should not be given

  • if your child is allergic to porcine lung lipids and protein or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Curosurf cannot be expected to completely rule out mortality or morbidity because premature infants can have other types of complications.

Current clinical treatment guidelines for the treatment of respiratory distress syndrome will be followed by healthcare professionals.

Before treatment, the doctor will stabilize the child’s general condition, among other things by correcting the blood’s pH value, blood pressure, blood value, blood sugar, and body temperature. Even during the treatment of your child, the healthcare staff will monitor these values, blood gases, and signs of infection. Before treatment, mucus can be sucked up from the baby’s airways to avoid blocking the tube used to dispense the medicine.

If your child’s condition does not respond adequately to treatment or deteriorates rapidly, your doctor will investigate possible complications before giving the next dose. For example. the tube used to dispense the medicine may have been blocked by mucus, especially if the child had a lot of mucus before the medicine was given, however, the doctor will avoid sucking mucus from the child’s airways for at least 6 hours from dosing the medicine to prevent the medicine from being removed. Your doctor will consider stopping treatment with Curosurf if the following conditions occur:

  • Reflux (reflux of the drug)
  • Slow pulse
  • Low blood pressure
  • Decreased oxygen concentration in the blood
  • Respiratory arrest

There is no information on the effects of insertion doses other than 100 and 200 mg/kg, more frequent dosing than intervals of 12 hours, or dosing of Curosurf started later than 15 hours after diagnosis of respiratory distress syndrome.

Special patient groups

The safety and efficacy of Curosurf have not been established in patients with renal or hepatic impairment.

Curosurf treatment of premature infants with severe hypotension has not been studied.

3. How Curosurf is given

Information for healthcare professionals can be found at the end of the package leaflet.

Administration

Curosurf should only be given by staff trained for and with experience in the care, resuscitation, and stabilization of premature babies.

Curosurf is intended to be given into the airways using a catheter.

Dosage

For preventive use, a dose of 1.25-2.50 ml/kg (100-200 mg/kg) body weight is given as soon as possible after birth (preferably within 15 minutes). An additional dose of 1.25 ml/kg (100 mg/kg) can be given 6-12 hours after the first dose and then 12 hours later to children who have persistent signs of shortness of breath and need respiratory therapy. Maximum total dose : 3.75-5.0 ml / kg (300-400 mg / kg).

In the treatment of respiratory distress syndrome, the starting dose of 1.25-2.5 ml/kg (100-200 mg/kg) is recommended, as soon as possible after a diagnosis of respiratory distress syndrome. An additional dose of 1.25 ml/kg (100 mg/kg), at 12-hour intervals, may be given if the respiratory distress syndrome is considered to be the cause of permanent impairment or deterioration of the lung function of the child. Maximum total dose : 3.75-5.0 ml / kg (300-400 mg / kg).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon (may affect up to 1 in 100 people):

  • severe infection ( sepsis )
  • bleeding in the brain ( intracranial hemorrhage)
  • lung collapse

Rare (may affect up to 1 in 1,000 people):

  • slow pulse
  • low blood pressure
  • chronic lung disease (bronchopulmonary dysplasia)
  • pulmonary hemorrhage
  • decreased oxygen saturation (a measure of oxygen supply in the blood)

Has been reported (occurs in an unknown number of users).

  • an abnormal increase in the amount of oxygen in tissues and organs (hyperoxia)
  • bluish discoloration of the skin and mucous membranes ( neonatal cyanosis)
  • respiratory arrest ( apnea )
  • Abnormal brain activity (measured by EEG )
  • Complications after lowering the dosing tube into the airways

Respiratory arrest and severe infection may occur as a result of the newborn’s immaturity.

In the clinical studies conducted to date, small signs of increased frequency of PDA (a congenital heart defect characterized by a persistent open connection, between the pulmonary artery and the carotid artery, which normally closes shortly after birth) in the newborn have been reported after treatment with Curosurf.

When Curosurf has been given via a thin catheter, some mild and transient side effects have been observed: decreased oxygen saturation, respiratory arrest, slow pulse, froth in the mouth, cough, airway obstruction, and sneezing.

5. How to store Curosurf

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (2 – 8 ° C). Store in the original package. Sensitive to light.

Unopened, unused vials that have been warmed to room temperature can be returned to the refrigerator within 24 hours for future use. The vial may only be warmed to room temperature and returned to the refrigerator once.

Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substances are porcine lung lipids and protein. 1 ml Curosurf contains porcine lung lipids and 80 mg protein.
  • The other ingredients are sodium chloride, water for injections, and sodium bicarbonate (for pH adjustment).

What the medicine looks like and the contents of the pack

White to yellow suspension

Colorless glass vials (1.5 ml and 3 ml) with plastic and aluminum cap and chlorobutyl rubber stopper

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Chiesi Farmaceutici SpA, via Palermo 26 / A, 43122 Parma, Italy

Manufacturer

Chiesi Farmaceutici SpA, Via San Leonardo 96 – Via Palermo 26 / A, 43122 Parma, Italy

Muhammad Nadeem

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