ULTIVA FOR INJECTION 1 mgvial

País: Singapur

Idioma: inglés

Fuente: HSA (Health Sciences Authority)

Ingredientes activos:

Remifentanil Hydrochloride eqv Remifentanil

Disponible desde:

DCH AURIGA SINGAPORE

Código ATC:

N01AH06

Dosis:

1 mg/vial

formulario farmacéutico:

INJECTION, POWDER, FOR SOLUTION

Composición:

Remifentanil Hydrochloride eqv Remifentanil 1 mg/vial

Vía de administración:

INTRAVENOUS

tipo de receta:

Prescription Only

Fabricado por:

GlaxoSmithKline Manufacturing S.p.A.

Estado de Autorización:

ACTIVE

Fecha de autorización:

1997-11-21

Información para el usuario

 
CONFIDENTIAL 

ULTIVA™ 
 REMIFENTANIL 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
Remifentanil for injection is a sterile, endotoxin-free,
preservative-free, white to off 
white, lyophilised powder, to be reconstituted before use. When
reconstituted as directed, 
solutions of remifentanil for injection are clear and colourless and
contain 1 mg/ml of 
remifentanil_ _base as remifentanil hydrochloride. 
PHARMACEUTICAL FORM 
Lyophilised powder for reconstitution for i.v. administration. 
CLINICAL PARTICULARS 
INDICATIONS 
_ULTIVA _is indicated as an analgesic agent for use during induction
and/or maintenance 
of general anaesthesia during surgical procedures including cardiac
surgery, and also for 
continuation of analgesia into the immediate post-operative period
under close 
supervision, during transition to longer acting analgesia. 
_ULTIVA _is indicated for provision of analgesia and sedation in
mechanically ventilated 
intensive care patients. 
DOSAGE AND ADMINISTRATION 
_ULTIVA _should be administered only in a setting fully equipped for
the monitoring and 
support of respiratory and cardiovascular function and by 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 the establishment and maintenance of a patent airway
and assisted 
ventilation. 
Continuous infusions of _ULTIVA _must be administered by a
calibrated infusion device 
into a fast-flowing i.v. line or via a dedicated i.v. line. This
infusion line should be 
connected at, or close to, the venous cannula and primed, to
minimise the potential dead 
space (_see Instructions for Use/ Handling _for additional
information, including tables 

CONFIDENTIAL 

with examples of infusion rates by body weight to
help titrate _ULTIVA _to the patient's 
anaesthetic needs). 
Care should be taken to avoid ob

Ficha técnica

1
ULTIVA
REMIFENTANIL HYDROCHLORIDE
QUALITATIVE AND QUANTITATIVE COMPOSITION
Remifentanil for injection is a sterile, preservative-free, white to
off white, lyophilised
powder, to be reconstituted before use. When reconstituted as
directed, solutions of
remifentanil for injection are clear and colourless and contain 1
mg/ml of remifentanil
base as remifentanil hydrochloride.
Excipient(s) with known effect:
This medicine contains less than 1 mmol sodium (23 mg) per vial, that
is to say
essentially ‘sodium-free’. (
_See List of Excipients_
”)
PHARMACEUTICAL FORM
Sterile, endotoxin-free non-pyrogenic, preservative-free, white to off
white, lyophilised
CLINICAL PARTICULARS
INDICATIONS
_ULTIVA _
is indicated as an analgesic agent for use during induction and/or
maintenance of
general anaesthesia during surgical procedures including cardiac
surgery, and also for
continuation of analgesia into the immediate post-operative period
under close
supervision, during transition to longer acting analgesia.
_ULTIVA _
is indicated for provision of analgesia and sedation in mechanically
ventilated
intensive care patients.
DOSAGE AND ADMINISTRATION
_ULTIVA _
should be administered only in a setting fully equipped for the
monitoring and
support of respiratory and cardiovascular function and by 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 the establishment and maintenance of a patent airway and
assisted
ventilation.
Continuous infusions of
_ULTIVA _
must be administered by a calibrated infusion device
into a fast-flowing i.v. line or via a dedicated i.v. line. This
infusion line should be
2
connected at, or close to, the venous cannula and primed, to minimise
the potential dead
space (
_see Instructions for Use/ Handling _
for additional information, including tables
with examples of infusion rates by body weight to help titrate
_ULTIVA _
to the patient