DBL Remifentanil powder for injection (remifentanil hydrochloride) 2 mg/vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

remifentanil hydrochloride

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

Remifentanil hydrochloride

Authorization status:

Registered

Patient Information leaflet

DBL™ REMIFENTANIL POWDER FOR INJECTION
1
DBL™
REMIFENTANIL POWDER FOR INJECTION
Remifentanil hydrochloride
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about DBL
Remifentanil powder for
injection. It does not contain all
of the available information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you being
given DBL Remifentanil powder
for injection against the benefits
this medicine is expected to
have for you.
If you have any concerns about
being given this medicine, ask your
doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT DBL REMIFENTANIL
POWDER FOR INJECTION IS
USED FOR
DBL Remifentanil powder for
injection is an anaesthetic used
with other anaesthetic
medicines, to produce and/or
maintain heavy sleep during your
operation. If you are a cardiac
patient, it may also be used to help
relieve any pain immediately
following your operation.
DBL Remifentanil powder for
injection may also be used for
patients in the Intensive Care Unit
to maintain sedation and relieve
pain.
DBL Remifentanil powder for
injection belongs to a group of
medicines called opioids. It
differs from other medicines in this
group by its very quick onset and
very short duration of action.
Your doctor may have prescribed
DBL Remifentanil powder for
injection for another reason.
Ask your doctor if you have any
questions about why DBL
Remifentanil powder for injection
has been prescribed for you.
As with other opioids, DBL
Remifentanil powder for injection
can be addictive. This is unlikely
to happen when DBL
Remifentanil powder for injection
is only used during your
operation.
BEFORE YOU ARE GIVEN
DBL REMIFENTANIL
POWDER FOR INJECTION
When you must not receive DBL
Remifentanil powder for injection
You must not receive DBL
Remifentanil powder for injection
if you have ever had an allergic
reaction to remifentanil
hydrochloride or any of the
ingredien

Summary of Product characteristics

Version:pfpremiv11019
Supersedes:
Page 1 of 34
AUSTRALIAN
PRODUCT
INFORMATION
–[
DBL™
REMIFENTANIL
(REMIFENTANIL
HYDROCHLORIDE) POWDER FOR INJECTION]
1.
NAME OF THE MEDICINE
Remifentanil hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Three strengths are available; 1 mg, 2 mg and 5 mg of remifentanil
base (as the hydrochloride
salt).
3.
PHARMACEUTICAL FORM
Powder for Injeciton
DBL™ Remifentanil powder for injection is a sterile, non-pyrogenic,
preservative-free, white
to off-white lyophilised powder for intravenous use.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL™ Remifentanil powder for injection is indicated -
•
As
an
opioid
adjunct
for
use
during
induction
and/or
maintenance
of
general
anaesthesia during surgical procedures including cardiac surgery in
adults.
•
As
an
opioid
adjunct
for
use
during
induction
and/or
maintenance
of
general
anaesthesia during surgical but not cardiac procedures in children
aged 1 to 12 years.
•
For continuation as an analgesic into the immediate post-operative
period under the
close supervision of medically qualified persons trained in the use of
anaesthetic drugs,
during transition to longer acting analgesia following adult cardiac
surgery -
when endotracheal intubation and controlled ventilation are
anticipated.
•
For provision of analgesia and sedation in mechanically ventilated
intensive care
patients.
4.2 DOSE AND METHOD OF ADMINISTRATION
DBL™ Remifentanil powder for injection should be administered only
in a setting fully
equipped for the monitoring and support of respiratory and
cardiovascular function and by
Version:pfpremiv11019
Supersedes:
Page 2 of 34
medically qualified persons specifically trained in the use of
anaesthetic drugs and the
recognition and management of the expected adverse effects of potent
opioids, including
respiratory and cardiac resuscitation. Such training must include
intubation, and assisted
ventilation.
Continuous infusions of remifentanil must be administered by a
calibrated infusion device,
where possible