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SURVANTA 25MG/ML SUSPENSION

Active substance(s): BERACTANT

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• If any vial is not used within
8 hours of re-warming to room
temperature it should be thrown
away. Vials should not be returned
to the refrigerator once warmed.

Package leaflet: Information
for the Parent/Guardian

Survanta
25 mg/ml
Suspension
®

Medicines should not be
disposed of via wastewater or
household waste.
6. Contents of the pack and
other information

Beractant

IMPORTANT
INFORMATION

What Survanta contains

!

-The active substance is beractant
which is a mixture containing
phospholipids (25 mg/ml), free
fatty acids (1.4 -3.5 mg/ml),
triglycerides (0.5 -1.75 mg/ml) and
protein (0.1 -1.0 mg/ml).

Read all of this leaflet
carefully before this
medicine is given because
it contains important
information for you.

-The other excipients are sodium
chloride, sodium hydroxide,
hydrochloric acid, palmitic acid,
dipalmitoyl phosphatidylcholine,
tripalmitin and water.
What Survanta looks like
-It is a sterile off-white to light
brown suspension and is
supplied in a single use glass
vial containing 8 ml (200 mg
phospholipids). Packs of 1, 3, and
10 vials are available.*
*Not all pack sizes may be marketed.
Marketing Authorisation Holder:
AbbVie Ltd.,
Maidenhead, SL6 4UB. UK
Manufacturer:
AbbVie Logistics B.V.
Zuiderzeelaan 53
8017 JV Zwolle
The Netherlands
This leaflet was last revised in:
July 2015
List 1039-53

Keep this leaflet; you may
need to read it again.
If you have any
questions, please ask
your doctor or nurse.

LIST NO.
COMMOD.
NO.
PPLS
VERSION
CR NO.
LABEL
EDITOR
DATE
PREPARED
DRAWING
NUMBER

1039-53
03-B190
1
0001146-2015
Dorr
8/5/15
SB-6010-0

CYCLE

1

ARTIST

BO

AbbVie Label
Control Approval
Approved by
Date
Not valid unless final
proofs carry Label Control
Approval signature

Color Separations
PMS Black
PMS2768 C
PMS 185 C

What is in this leaflet
1. What Survanta is and what
it is used for
2. What you need to know
before Survanta is used
3. How to use Survanta
4. Possible side effects
5. How to store Survanta
6. Contents of the pack and
other information
1. What Survanta is and what
it is used for
Survanta contains the active
substance beractant which is a
natural surfactant extracted from
cow’s lungs (see section 6) to help
your child breathe.
Your baby will be/has been given
Survanta because he or she is at
risk of developing, or is suffering
from, a condition called Respiratory
Distress Syndrome (hyaline
membrane disease) which may
cause severe breathing difficulties.
Survanta is indicated for treatment
of Respiratory Distress Syndrome
(RDS) in newborn premature
infants with a birth weight of 700 g
or greater and who have had tube
inserted and are on a mechanical
ventilator to help them breathe.
Survanta is also used for the
treatment of premature babies,
when the pregnancy has lasted
for less than 32 weeks, at risk of
developing RDS.

03-B 190

(Prepared by
AbbVie Graphics)

Respiratory Distress Syndrome
occurs in some babies, particularly
premature babies, who lack a
substance usually produced in the
lungs known as surfactant. This
surfactant lines the inside of the
lungs, stopping them from sticking
together, so that the baby can
breathe normally.
Survanta as a natural surfactant
acts in a similar way to your baby’s
own surfactant helping your baby
to breathe normally.
2. What you need to know
before Survanta is used
Your baby will only be given
Survanta if the equipment
for ventilation and monitoring
babies with Respiratory Distress
Syndrome is available.
After being given Survanta, your
baby will continue to be monitored
by the doctor or nurse to ensure
that the right amount of oxygen is
being given.
During the dosing procedure,
occasional episodes of slow
heartbeat (bradycardia) and/ or
oxygen reduction in the circulation
have been reported. If these
occur, dosing will be stopped and
appropriate measures to relieve
the condition will be started. After
stabilisation, the dosing procedure
will be resumed.
3. How Survanta is used
The dosage of Survanta varies for
each child depending on their body
weight. The usual dose is 100 mg
Survanta per kg body weight. The
doctor will calculate the right dose.
Usually the first dose will be given as
soon as possible after birth (usually
within 15 minutes) or as soon as
possible after Respiratory Distress
Syndrome has been diagnosed
(usually within 8 hours of birth).
The dose of Survanta will be
administered to your baby via a
tube already in place in your baby’s
windpipe. Do not be concerned if
your baby is disconnected from its
ventilator while Survanta is being
administered. To make sure that
Survanta reaches all parts of your
baby’s lungs, the dose is split into
smaller doses and your baby’s
position altered before each part of
the dose is given.

4. Possible side effects
Like all medicines, Survanta can
be associated with side effects
although not everybody gets them.
The following side effects with
Survanta are serious and will be
managed by your baby’s Doctor as
necessary during dosing.
Very common: affecting more
than 1 in 10:
• Bleeding in the brain. The
occurrence of this side effect is
no different to what would be
expected in untreated babies of
the same age.
Common: affecting less than 1 in 10
• Cases of bleeding in the lungs.
Other Side effects:
Uncommon: affecting less
than 1 in 100
• Blockage of the breathing tube
that has been inserted into your
baby’s windpipe.
If you have any questions about
your baby’s treatment which are
not answered by this leaflet, ask
the doctor.
Reporting of side effects
If you get any side effects, talk to
your doctor or nurse. This includes
any possible side effects not listed
in this leaflet. You can also report
side effects directly (see details
below). By reporting side effects you
can help provide more information
on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
www.medicinesauthority.gov.mt/
adrportal
5. How to store Survanta

The dose may be repeated up to
three times at six hourly intervals
within 48 hours. Survanta will be
warmed to room temperature
before administration to your baby.

Keep out of the sight and reach
of children.
• 
Survanta should not be used after
the expiry date shown on the label.
• 
Survanta should have been stored
in a refrigerator and protected
from light; however before it
is given to your baby it will be
warmed to room temperature.
• Survanta must not be frozen.
Any product that has been
frozen by mistake should be
thrown away.
• 
Each vial of Survanta is for single
use only. Used vials with medicine
left in them should be thrown away.

2

3

(Prepared by
AbbVie Graphics)
LIST NO.
COMMOD.
NO.
PPLS
VERSION
CR NO.
LABEL
EDITOR
DATE
PREPARED
DRAWING
NUMBER

1039-53
03-B190
1
0001146-2015
Dorr
8/5/15
SB-6010-0

CYCLE

1

ARTIST

BO

AbbVie Label
Control Approval
Approved by
Date
Not valid unless final
proofs carry Label Control
Approval signature

Color Separations
PMS Black
PMS2768 C
PMS 185 C

0 3 - B 191
0 3 - B 191

Survanta® Beractant

INSTRUCTIONS FOR USE

Survanta® Beractant

(Prepared by
AbbVie Graphics)

1251 - 1300

5.2

1901 - 1950

7.8

1301 - 1350

5.4

1951 - 2000

8.0

Method of Administration
Survanta should be administered by intratracheal
instillation (ie: drug should be conducted into
the lungs via an endotracheal tube) using a
5 Fr catheter. The tip of the catheter should lie at
the end of the endotracheal tube. Infants should
not be intubated solely for the administration
of Survanta.
Survanta should be warmed to room
temperature before administration (see
Special Precautions for Use).
Before administering Survanta in infants on
mechanical ventilation, set the respiratory
frequency at 60/minute - with inspiration
time 0.5s and Fi02 at 1.0. Inspiratory pressure
needs no change at this point.
To ensure distribution of Survanta throughout
the lungs, each dose is divided into fractional
doses. Each dose can be administered as
either two half-doses or four quarter-doses.
Each fractional dose is administered with the
infant in different positions as given below.
Between each position the infant should be
ventilated for 30 seconds.
For Four quarter-doses, the recommended
positions are:
Right Lateral Position with the head
lowered (i.e. head and body slanting down
at an angle of approximately 15°).
Left Lateral Position with the head lowered
(i.e. head and body slanting down at an
angle of approximately 15°).
Right Lateral Position with the head
elevated (i.e. head and body slanting up at
an angle of approximately 15°).
Left Lateral Position with the head elevated
(i.e. head and body slanting up at an angle
of approximately 15°).
For administration of each quarter dose,
the ventilator is disconnected, the catheter
inserted, the dose administered then the
ventilator reconnected.
Between each quarter dose the infant is
ventilated for 30 seconds.
See illustrations below for recommended position
Right lateral position
with the head
lowered, i.e., head
and body slanting
down.
Left lateral position
with the head
lowered, i.e. head
and body slanting
down.

Right lateral position
with the head
elevated, i.e. head
and body slanting up.

7.4
7.6

Left lateral position
with the head
elevated, i.e., head
and body slanting up.

1801 - 1850
1851 - 1900

For Two half-doses, the recommended
positions are:

4.8
5.0

With the infant supine, the head and body
turned approximately 45° to the right.

1151 - 1200
1201 - 1250

With the infant supine, the head and body
turned approximately 45° to the left.

7.0
7.2

When two half-doses of Survanta are being
administered there are 2 alternative methods
of administration:
Instillation with disconnection from the
ventilator.

1701 - 1750
1751 - 1800

Each half dose is administered by
disconnecting the endotracheal tube from
the ventilator, inserting the catheter and
administering the half dose. Between the
half doses, the ventilator is reconnected for
30 seconds.
Alternatively,
Instillation without disconnection from the
ventilator (through a suction port connector)

4.4
4.6

The first half dose is administered by
inserting the catheter through a suction
port connector without disconnection from
the ventilator. There should be at least 30
seconds between the half doses during
which time the catheter is retracted from
the endotracheal tube but not removed
from the connector. The catheter is then
reinserted into the endotracheal tube and
the second half dose administered. The
catheter is then withdrawn completely.

1051 - 1100
1101 - 1150

Control arterial blood gas values and
the inspiratory oxygen concentration,
and check for changes in ventilatory
parameters immediately after finishing the
dosing with Survanta.

6.6
6.8

Treatment: The first dose of Survanta
should be applied as soon as possible after
occurrence of RDS, preferably by 8 hours
of age.

1601 - 1650
1651 - 1700

Prophylaxis: The first dose of Survanta
should be administered as soon as possible
after birth, preferably within 15 minutes.

4.0
4.2

The dosage for repeat doses of Survanta
is also 100 mg phospholipids per kg and
is based on the infant’s birth weight. The
need for additional doses of Survanta
should be determined by evidence of
continuing respiratory distress. Dose no
sooner than 6 hours after the previous
dose. Up to 3 additional doses may be
given in the first 48 hours.
Undesirable Effects
Intracranial haemorrhage has been observed
in patients who received either beractant
or placebo. The incidence of intracranial
haemorrhage in all patients is similar to
that reported in the literature in this patient
population. Pulmonary haemorrhage
has also been reported. Blockage of the
endotracheal tube by mucous secretions has
been reported. No other serious adverse
reactions have been reported.

951 - 1000
1001 - 1050

These are presented in the following table:

6.2
6.4

Adverse
Reactions

1501 - 1550
1551 - 1600

System
Frequency
Organ Class

3.6
3.8

Intracranial
haemorrhage

851 - 900
901 - 950

Very
common

6.0

Vascular
disorders

1451 - 1500

Pulmonary
haemorrhage

3.4

Common

801 - 850

Respiratory

5.6
5.8

Blockage of
Surgical
endotracheal
and Medical Uncommon
tube by mucous
Procedures
secretions
The following frequency categories are
used: Very common (>1/10); common (>1/100,
<1/10); uncommon (>1/1,000, <1/100).

1351 - 1400
1401 - 1450

No antibody production to Survanta proteins
has been observed.

3.0
3.2

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after
authorisation of the medicinal product is
important. It allows continued monitoring
of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked
to report any suspected adverse reactions
direct to:

701 - 750
751 - 800

United Kingdom
Yellow Card Scheme:
Website: www.mhra.gov.uk/yellowcard.

Total
Dosage
(ml)

Malta
ADR Reporting
Website:www.medicinesauthority.gov.mt/
adrportal
Overdose
If an excessively large dose of Survanta is
given, observe the infant for signs of acute
airway obstruction. Treatment should
be symptomatic and supportive. Rales and
moist breath sounds can transiently occur
after Survanta is given, and do not indicate
overdosage. Endo-tracheal suctioning or other
remedial action is not required unless clear-cut
signs of airway obstruction are present.
Pharmaceutical Precautions
This drug should not be used after the expiry
date falls due (see vial label for expiry date).
Remaining amounts of Survanta should be
disposed of.
Survanta must be protected from light and
stored under refrigeration at 2 - 8 °C. DO NOT
FREEZE. Any inadvertently frozen product
should be discarded.
Survanta should be inspected visually for
discolouration prior to administration. The
colour of Survanta is off-white to light brown.

Weight
(grammes)

POM

Total
Weight
Dosage
(grammes)
(ml)

1

ARTIST

BO

PMS Color

PL 41042/0003

The dosing chart below shows the total
dosage for a range of birth weights.

SB-5995-0

CYCLE

Color Separations

Legal Category:

Each vial of Survanta is for single use. Used
vials with residual drug should be discarded.
Survanta should be inspected visually for
discolouration prior to administration. The
colour of Survanta is off-white to light brown.
Some settling may occur during storage.
If this occurs, gently invert the vial several
times (DO NOT SHAKE) to redisperse.
Interactions with Other Medications
None known to date.
Dosage Instructions
Unless otherwise prescribed, 4 ml suspension
per kg birth weight is the normal dose to be
administered via the trachea (intratracheal
administration).
Higher doses should not be used.

Dorr
8/7/15

Date

MA 532/00301

Survanta is stored refrigerated (2-8°C).
Before administration, Survanta should be
warmed by standing at room temperature
for 20 minutes or warmed in the hand for 8
minutes. ARTIFICIAL WARMING METHODS
SHOULD NOT BE USED.
Discard each vial if not used within 8 hours
of warming to room temperature. Vials
should not be returned to the refrigerator
once warmed.

1

Not valid unless final
proofs carry Label Control
Approval signature

Product Licence
Number (UK):

During the dosing procedure, transient
episodes of bradycardia and/or oxygen
desaturation have been reported. If
these occur, dosing should be stopped
and appropriate measures to alleviate
the condition should be initiated. After
stabilisation the dosing procedure should
be resumed.

0001146-2015

Approved by

Marketing Authorisation
Number (Malta):

Marked improvements in oxygenation may
occur within minutes of the administration
of Survanta. Therefore, frequent and
careful monitoring of systemic oxygenation
is essential to avoid hyperoxia. Following
Survanta administration, monitoring of the
arterial blood gases, the fraction of inspired
oxygen and ventilatory change is required to
ensure appropriate adjustments.

CR NO.
LABEL
EDITOR
DATE
PREPARED

03-B191

AbbVie Label
Control Approval

Marketing Authorisation AbbVie Ltd.,
Holder:
Maidenhead,

SL6 4UB.

UK

This leaflet was last revised in July 2015

Special Precautions for Use:
Survanta should only be administered
with adequate facilities for ventilation and
monitoring of babies with RDS.

1039 (53)

DRAWING
NUMBER

03-B191

Description and Composition
Survanta is a sterile, non-pyrogenic pulmonary
surfactant intended for intratracheal use only.
It is a bovine lung extract containing
phospholipids, neutral lipids, fatty acids and
surfactant associated proteins to which have
been added dipalmitoyl phosphatidylcholine,
palmitic acid and tripalmitin.
The resulting composition provides:
phospholipids 25 mg/ml (including
11.0 - 15.5 mg/ml disaturated
phosphatidylcholine)
triglycerides 0.5 - 1.75 mg/ml
free fatty acids 1.4 - 3.5 mg/ml
protein less than 1.0 mg/ml
It is suspended in 0.9% sodium chloride (Ph Eur)
solution. It also contains sodium hydroxide and
hydrochloric acid.
Each millilitre of Survanta contains 25 mg
phospholipids. It is an off-white to light
brown liquid supplied in single-use glass
vials containing 8 ml (200 mg phospholipids).
Properties
Endogenous pulmonary surfactant lowers
surface tension on alveolar surfaces during
respiration and stabilises the alveoli against
collapse at resting transpulmonary pressures.
Deficiency of pulmonary surfactant causes
Respiratory Distress Syndrome (RDS) in
premature infants. Survanta replenishes
surfactant and restores surface activity to
lungs of these infants.
Therapeutic Indications
Survanta is indicated for the treatment of
Respiratory Distress Syndrome (RDS) in
newborn premature infants with birth weight
of 700 g or greater who are intubated and
receiving mechanical ventilation. Survanta is
also indicated for the prophylactic treatment
of premature infants <32 weeks gestational
age at risk of developing RDS.
Contraindications
No specific contraindications for Survanta
have been defined by the clinical studies.
Warnings and Precautions

LIST NO.
COMMOD.
NO.
PPLS
VERSION

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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