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CUROSURF 120 MG / VIAL ENDOTRACHEOPULMONARY INSTILLATION SUSP, CUROSURF 240 MG / VIAL ENDOTRACHEOPULMONARY INSTILLATION SUSP - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - CUROSURF 120 MG / VIAL ENDOTRACHEOPULMONARY INSTILLATION SUSP, CUROSURF 240 MG / VIAL ENDOTRACHEOPULMONARY INSTILLATION SUSP

C

Information Leaflet for Parents or Carers

g Curosurf 120mg ® / vial Endotracheopul­monary Instillation Suspension

° Curosurf 240mg ® / vial Endotracheopul­monary Instillation Suspension

Phospholipid fraction from porcine lung

Please read this leaflet carefully as it provides a summary of the information available on your baby’s medicine. If you have any questions or are not sure about anything, then please ask the doctor treating your baby.

What is in this leaflet

1. What Curosurf is and what it is used for

  • 2. How Curosurf is used

3. Possible side effects

4. How to store Curosurf

5. Contents of the pack and other information

1. what curosurf is and what it is used for

Curosurf is used to treat or prevent Respiratory Distress Syndrome (RDS) in newborn babies. Most babies are born with a substance in their lungs known as ‘surfactant’. This substance lines the lungs and stops them from sticking together and so makes normal breathing possible. Some babies, however, particularly premature babies, do not have enough of this surfactant when they are born, which causes RDS. Curosurf is a natural surfactant, which works in the same way as your baby’s own surfactant would have done and, therefore, will help your baby to breathe normally until your baby produces his or her own surfactant.

Your baby may have other problems as well as RDS which may need other treatments.

  • 2. How Curosurf is used

Dosage:

Your doctor will decide the right dose for your baby, depending on your baby’s weight. If your baby is being given Curosurf to prevent Respiratory Distress Syndrome (RDS) it is important that Curosurf is given within 15 minutes after birth. If your baby is being given Curosurf to treat RDS, it is important that Curosurf is given as soon as possible after RDS has been diagnosed. If your baby needs another dose of Curosurf, it will be given 12 hours later. If necessary, a third dose may be given 12 hours after that.

Method of administration:

The doctor or nurse will give Curosurf to your baby in the incubator. They will warm the Curosurf liquid to room temperature, and then using a syringe they will give it to your baby through tubes or thin catheter into the baby’s windpipe. They may disconnect your baby from the ventilator for a few minutes to do this.

Please read the back of this leaflet ->

3. possible side effects

All medicines can cause side effects although not everybody gets them. Possible side effects are listed below according to their frequency. If you are not sure what the side effects below are ask your doctor to explain them to you.

Uncommon (affecting less than 1 in 100 people) Rare (affecting less than 1 in 1,000 people)

  • infection slower heart rate
  • bleeding in the brain low blood pressure
  • air in the chest cavity caused by lesions in the lungs chronic lung disease
  • decrease in oxygen around the body

The following side effects have also been reported:

  • increased amount of oxygen in the body
  • blue colour of skin or gums, caused by too little oxygen
  • stopping of breathing
  • complication with placement of the tubes into the lungs
  • abnormal reading of the brain activity

If you think any of the above side effects become serious, or noticed any other side effect not mentioned in this leaflet, contact your doctor immediately.

During the administration of Curosurf with a thin catheter some mild and transitory adverse events have been seen: bradycardia, apnoea, decreased oxygen saturation, froth at the mouth, coughing, choking and sneezing.

Reporting of side effects

If your baby gets 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 via

UK: Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store.

Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: ; E-mail:.

Malta: ADR Reporting Website:

By reporting side effects you can help provide more information on the safety of this medicine.

4. how to store curosurf

  • Keep this medicine out of the sight and reach of children.
  • Store in a refrigerator at 2°C to 8°C in the original package in order to protect from light. However, before it is given to your baby it will be warmed to room temperature.
  • Unopened unused vials of Curosurf that have warmed to room temperature can be returned to refrigerated storage within 24 hours for future use. Do not warm to room temperature and return to refrigerated storage more than once.
  • Do not use Curosurf after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
  • Use each vial once, and then throw away anything that is left over. The hospital will make sure that any unused Curosurf will be disposed of safely.

5. contents of the pack and other information

What Curosurf contains: The active substance is a mixture of fats and proteins which come from pig lung. The other ingredients are sodium chloride, sodium hydrogen carbonate and water for injections.

This medicinal product contains less than 1 mmol sodium (23mg) per vial, ie. essentially “sodium free”.

What Curosurf looks like and contents of the pack:

It is a sterile suspension and is supplied in single use 5ml glass vials containing either 1.5ml (120mg) or 3ml (240mg) of phospholipid fraction from porcine lung. Each ml of sterile suspension contains 80mg of phospholipid fraction from porcine lung.

Marketing Authorisation Holder:

UK: Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, UK.

Ireland and Malta: Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122 Parma, Italy.

Manufacturer: Chiesi Farmaceutici S.p.A. at 96, Via San Leonardo, 43122 Parma, Italy.

Is this leaflet hard to see or read? Phone for help: 0161 488 5555 (from UK) +44 161 488 5555 (from Ireland and Malta).

This leaflet was last revised in 11/2019

CP001/12

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How to draw the product:



  • 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 aluminium portion downwards

  • 4 and 5. Remove the whole ring by pulling off the aluminium wrapper

  • 6 and 7. Remove the rubber cap to extract content

Sources: Original (products.mhra.gov.uk)

The drug is classified in the ATC tree:

R RESPIRATORY SYSTEM DRUGS

R07 OTHER RESPIRATORY SYSTEM PRODUCTS in ATC

R07A OTHER RESPIRATORY SYSTEM PRODUCTS in ATC

R07AA Lung surfactants

R07AA02 natural phospholipids

Frequently Asked Questions

What is Curosurf used for in newborns?

Curosurf is a medication used to treat respiratory distress syndrome (RDS) in premature infants by replacing natural lung surfactant.

How does Curosurf help babies with lung issues?

Curosurf works by reducing surface tension in the lungs, allowing the air sacs to expand more easily, which helps improve breathing.

Is Curosurf safe for premature infants?

Yes, Curosurf is specifically designed for use in premature infants and has been shown to be safe and effective in clinical studies.

What are the common side effects of Curosurf?

Some common side effects may include temporary changes in heart rate and low blood oxygen levels, but serious side effects are rare.

How is Curosurf administered to the baby?

Curosurf is given through an endotracheal tube directly into the lungs by a healthcare professional.

Can Curosurf be given to full-term infants?

Curosurf is primarily used for premature infants with RDS; its use in full-term infants is not common and should be evaluated by a doctor.

What should I do if my baby has an allergic reaction to Curosurf?

If you notice any signs of an allergic reaction such as difficulty breathing or rash, contact your healthcare provider immediately.

How soon can Curosurf start working after administration?

Curosurf can start improving lung function within minutes after it is administered, but full effects may vary.

Can Curosurf be used multiple times if my baby needs it again?

Yes, if needed, Curosurf can be given more than once; your healthcare provider will determine the appropriate timing.

Will my baby need special care after receiving Curosurf?

Yes, your baby will be closely monitored for lung function and oxygen levels after receiving Curosurf in a NICU setting.

Is there anything I should avoid doing after my baby receives Curosurf?

Avoid unnecessary movements or stressors around your baby; the medical team will provide specific instructions based on your baby's condition.

How can I help support my baby's recovery after treatment with Curosurf?

Providing a calm environment and following medical advice can help support your baby's recovery following treatment with Curosurf.

Are there any long-term effects of using Curosurf on my baby?

Currently, studies show that using Curosurf does not have significant long-term adverse effects when used appropriately.

Can other treatments be combined with Curosurf?

Yes, other treatments like oxygen therapy or mechanical ventilation may be used alongside Curosurf as needed for your baby's care.

How does using natural phospholipids in Curosurf benefit my baby?

Natural phospholipids mimic the body's own surfactant, helping to improve lung function effectively and safely.

Can I ask about the ingredients of Curosurf before it's administered to my baby?

Absolutely! You should feel comfortable asking your healthcare provider about all ingredients and their functions before treatment.

What if my baby does not respond well to the initial dose of Curosurf?

If there’s insufficient improvement, your doctor may reassess the treatment plan and consider additional doses or alternative therapies.

How does premature birth affect my baby's need for Curosurf?

Premature babies often lack sufficient surfactant due to underdeveloped lungs, making them more likely to need therapies like Curosurf.

Where can I find more information about RDS and its treatments like Curosurf?

Reliable information can be found through reputable health organizations or directly from your baby's healthcare provider.

Is there a dedicated support line for parents whose babies receive treatments like Curosurf?

Many hospitals have support services or helplines for parents; ask your baby's care team for resources available to you.