SURVANTA beractant (as phospholipids) 200mg/8mL suspension vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Beractant, Quantity: 25 mg/mL

Available from:

Abbvie Pty Ltd

Pharmaceutical form:

Suspension

Composition:

Excipient Ingredients: colfosceril palmitate; tripalmitin; palmitic acid; sodium chloride; phosphatidyl choline; water for injections

Administration route:

Intratracheal

Units in package:

1 x 8mL vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Prevention and treatment ("rescue") of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants.

Product summary:

Visual Identification: Off-white to light brown liquid.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

1994-03-18

Patient Information leaflet

SURVANTA
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about your baby being given this medicine, speak to your doctor,
nurse or pharmacist.
1.
WHY IS THE DOCTOR GIVING SURVANTA TO MY BABY?
Survanta contains the active ingredient beractant. Survanta is used to
replace the natural fluid in a baby's lungs which may be
missing if the baby is premature.
For more information, see Section 1. Why is the doctor giving Survanta
to my baby? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE MY BABY IS GIVEN SURVANTA?
Talk to the doctor if you have any concerns about your baby being
given Survanta.
For more information, see Section 2. What should I know before my baby
is given Survanta? in the full CMI.
3.
WHAT IF MY BABY IS RECEIVING OTHER MEDICINES?
Survanta is used in newborn, premature infants; therefore, there is no
information on whether it may interfere with other medicines,
or that other medicines may interfere with it.
See Section 3. What if my baby is receiving other medicines? in the
full CMI.
4.
HOW IS SURVANTA GIVEN?
•
Survanta is given directly into the windpipe.
•
It is given by highly specialised doctors in hospitals with the
facilities to care for premature babies.
More information can be found in Section 4. How is Survanta given? in
the full CMI.
5.
WHAT SHOULD I KNOW ABOUT USING SURVANTA?
THINGS YOU
SHOULD DO
•
Make sure you understand the risks and benefits of your baby being
given Survanta
•
Tell the baby's doctor if you have taken steroids in the last few
weeks of your pregnancy.
THINGS YOU
SHOULD NOT DO
•
Survanta is given by highly specialised doctors and medical teams;
therefore, there are no particular
instructions for you or your baby during treatment.
DRIVING
OR USING
MACHINES
•
Survanta is for premature babies; therefore, there is no information
available regarding its use and driving
or operating machinery.
DRINKING
ALCOHOL
•
Survanta is used for pr

Summary of Product characteristics

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AUSTRALIAN PRODUCT INFORMATION – SURVANTA
®
(BERACTANT) INTRATRACHEAL SUSPENSION
1
NAME OF THE MEDICINE
Beractant.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Survanta® (beractant) is a sterile, non-pyrogenic pulmonary
surfactant intended for intratracheal use
only. It is a natural bovine lung extract containing phospholipids,
neutral lipids, fatty acids, and
surfactant-associated
proteins
to
which
colfosceril
palmitate
(dipalmitoyl
phosphatidylcholine),
palmitic acid and tripalmitin are added to standardise the composition
and to mimic the surface-
tension lowering properties of natural lung surfactant. It is
dispersed in 0.9% sodium chloride
solution and heat-sterilised. Survanta contains no preservatives. It
contains two, hydrophobic, low
molecular weight, surfactant-associated proteins commonly known as
SP-B and SP-C. It does not
contain the hydrophilic, large molecular weight surfactant-associated
protein known as SP-A.
Each mL of Survanta contains beractant equivalent to 25 mg of
phospholipids (200 mg phospholipids
/ 8mL) suspended in 0.9% sodium chloride solution.
3
PHARMACEUTICAL FORM
Survanta (beractant) intratracheal suspension is an off-white to light
brown liquid supplied in single-
use glass vials.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Survanta is indicated for prevention and treatment ("rescue") of
Respiratory Distress Syndrome
(RDS) (hyaline membrane disease) in premature infants.
PREVENTION
In premature infants less than 1250 g birthweight, or with evidence of
surfactant deficiency, give
Survanta as soon as possible, preferably within 15 minutes of birth.
RESCUE
To treat infants with RDS confirmed by X-ray and requiring mechanical
ventilation, give Survanta as
soon as possible, preferably by 8 hours of age.
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Page 2 of 16
NOTE: Results from clinical studies suggest that little benefit is
likely to be gained from giving
Survanta to infants who have completed a prenatal course of
corticosteroids, unless th