CUROSURF 120 mg/vial Endotracheopulmonary instillation, suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Porcine lung surfactant

Available from:

Chiesi Limited

ATC code:

R07AA; R07AA02

INN (International Name):

Porcine lung surfactant

Dosage:

120 milligram(s)

Pharmaceutical form:

Endotrachpulm Inst, Susp

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Lung surfactants; natural phospholipids

Authorization status:

Marketed

Authorization date:

1994-09-08

Patient Information leaflet

Information Leaflet for Parents or Carers
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 war

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
CUROSURF 120 mg/vial Endotracheopulmonary instillation, suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 120 mg (1.5ml) of phospholipid fraction from porcine
lung (Poractant alfa).
Composition per ml of suspension: phospholipid fraction from porcine
lung 80mg/ml, equivalent to about 74mg/ml of
total phospholipids and 0.9mg/ml of low molecular weight hydrophobic
proteins.
CUROSURF is a natural surfactant, prepared from porcine lungs,
containing almost exclusively polar lipids, in
particular phosphatidylcholine (about 70% of the total phospholipid
content) and about 1% of specific low molecular
weight hydrophobic proteins SP-B and SP-C.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Endotracheopulmonary instillation, suspension.
A white to yellow sterile suspension for endotracheopulmonary
instillation in single dose vials.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of Respiratory Distress Syndrome (RDS) or hyaline
membrane disease in newborn babies with birth
weight over 700g.
Prophylactic use in premature infants between 24 and 31 weeks
estimated gestational age at risk from RDS or with
evidence of surfactant deficiency where the mother had not received
appropriate ante-natal corticosteroids.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
4.1.1
POSOLOGY
4.2.1.1 RESCUE TREATMENT
The recommended starting dose is 100-200mg/kg (1.25-2.5ml/kg),
administered in a single dose as soon as possible
after diagnosing RDS.
Additional doses of 100mg/kg (1.25ml/kg), each at about 12-hourly
intervals, may also be administered if RDS is
considered to be the cause of persisting or deteriorating respiratory
status of the infants (maximum total dose of 300-
400mg/kg).
4.2.1.2 PROPHYLAXIS
A single dose of 100 to 200mg/kg should be administered as soon as
possible after birth (preferably within 15 minutes).
Further doses of 100mg/kg can be given 6 to 12 hours after the first
dose and then 12 hours la