CUROSURF poractant alfa 120mg/1.5mL intratracheal suspension vial

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

Poractant alfa, Quantity: 80 mg/mL

제공처:

Chiesi Australia Pty Ltd

약제 형태:

Suspension

구성:

Excipient Ingredients: sodium chloride; water for injections; sodium bicarbonate

관리 경로:

Intratracheal

패키지 단위:

1.5mL equivalent to 120mg of active

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

For the treatment (rescue) of Respiratory Distress Syndrome (RDS) in premature infants and prophylactic use in infants at risk of RDS.

제품 요약:

Visual Identification: White to cream white suspension in clear glass vials.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius

승인 상태:

Licence status A

승인 날짜:

2005-02-28

환자 정보 전단

Curosurf CMI v 4.0 September 2021
1
CONSUMER MEDICINE INFORMATION
CUROSURF
® (PORACTANT ALFA) INTRATRACHEAL SUSPENSION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about CUROSURF. It does not
contain all the
available information. It does not take the place of talking to your
doctor.
All medicines have risks and benefits. Your doctor has weighed the
risks of your baby receiving
CUROSURF against the benefits expected from treatment.
If you have any concerns about your baby being given this medicine,
ask your doctor or
pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
WHAT CUROSURF IS USED FOR
CUROSURF is used to treat babies suffering from or at risk of a
condition called respiratory
distress syndrome (RDS). Most babies are born with a substance known
as surfactant in their
lungs. This substance lines the lungs and stops them from sticking
together and so makes normal
breathing (respiration) possible. Some babies, however, particularly
premature babies, are born
without surfactant and this causes RDS.
CUROSURF is a natural surfactant obtained from pigs which works in the
same way as human
surfactant. It will therefore help your baby to breathe normally until
your baby produces their own
surfactant.
CUROSURF helps to treat and prevent RDS but cannot be expected to help
with other problems
which are sometimes associated with premature birth.
CUROSURF is available only with a doctor's prescription.
HOW CUROSURF IS GIVEN
CUROSURF is instilled directly into your baby’s trachea or bronchi.
CUROSURF is given by a
doctor or nurse who is trained and experienced in the care of pre-term
babies.
Your baby’s doctor will decide what dose should be given and how
long your baby will receive
CUROSURF. This depends on your baby’s weight and other factors, such
as how premature your
baby is.
Each vial of CUROSURF is used once only and the remaining suspension
is discarded.
WHILE YOUR BABY IS BEING GIVEN CUROSURF
The administration of CUROSURF to your baby can affect the abil

제품 특성 요약

CUROSURF Product Information
CUROSURF v9.0
1
AUSTRALIAN PRODUCT INFORMATION - CUROSURF
®
(PORACTANT ALFA) SUSPENSION
1
NAME OF THE MEDICINE
poractant alfa
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CUROSURF (poractant alfa) Intratracheal Suspension is a sterile,
non-pyrogenic
pulmonary surfactant intended for intratracheal or intrabronchial
administration. It is an
extract of natural porcine lung surfactant consisting of 99% polar
lipids (mainly
phospholipids) and about 1% hydrophobic low molecular weight proteins
(surfactant
associated proteins SP-B and SP-C). It is suspended in 0.9% sodium
chloride solution.
Each millilitre of surfactant mixture contains 80 mg of total
phospholipids (including
54 mg of phosphatidylcholine of which 30.5 mg is dipalmitoyl
phosphatidylcholine) and
1 mg of protein including 0.3 mg of SP-B.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Suspension for intrathecal administration.
CUROSURF is a white to creamy white suspension of poractant alfa.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CUROSURF is indicated for the treatment (rescue) of Respiratory
Distress Syndrome
(RDS) in premature infants and for prophylactic use in infants at risk
of RDS.
4.2
DOSE AND METHOD OF ADMINISTRATION
FOR INTRATHCEAL ADMINISTRATION ONLY
The clinician administering CUROSURF must be experienced in neonatal
intensive care,
including endotracheal intubation, mechanical ventilation and
cardiorespiratory and
oxygen monitoring.
CUROSURF is administered intratracheally by instillation through a 5
French end-hole
catheter and briefly disconnecting the endotracheal tube from the
ventilator.
Alternatively, CUROSURF may be administered through the secondary
lumen of a dual
lumen endotracheal tube without interrupting mechanical ventilation,
or in the delivery
room through temporary placement of an ET tube followed by CPAP.
Before administering CUROSURF, ensure proper placement and patency of
the
endotracheal tube. At the discretion of the clinician, the
endotrach