ULTIVA Remifentanil (as hydrochloride) 2mg powder for injection vial

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

remifentanil hydrochloride, Quantity: 2.194 mg (Equivalent: remifentanil, Qty 2 mg)

Tilgjengelig fra:

Aspen Pharmacare Australia Pty Ltd

Legemiddelform:

Injection, powder for

Sammensetning:

Excipient Ingredients: glycine

Administreringsrute:

Intravenous

Enheter i pakken:

5 x 2mg vial

Resept typen:

(S8) Controlled Drug

Indikasjoner:

Ultiva 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 ventillation are anticipated. For provision of analgesia and sedation in mechanically ventilated intensive care patients.

Produkt oppsummering:

Visual Identification: White to off-white lyophilised powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Registered

Autorisasjon dato:

1998-05-11

Informasjon til brukeren

ULTIVA
®
1
ULTIVA
® FOR INJECTION
_Remifentanil hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about Ultiva. 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 Ultiva
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 ULTIVA IS USED FOR
Ultiva 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.
Ultiva may also be used for patients
in the Intensive Care Unit to maintain
sedation and relieve pain.
Ultiva 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
Ultiva for another reason.
Ask your doctor if you have any
questions about why Ultiva has been
prescribed for you.
As with other opioids, Ultiva can be
addictive. This is unlikely to happen
when Ultiva is only used during your
operation.
BEFORE YOU ARE GIVEN
ULTIVA
_WHEN YOU MUST NOT RECEIVE _
_ULTIVA _
YOU MUST NOT RECEIVE ULTIVA IF YOU
HAVE EVER HAD AN ALLERGIC REACTION
TO REMIFENTANIL HYDROCHLORIDE OR
ANY OF THE INGREDIENTS LISTED AT THE
END OF THIS LEAFLET.
YOU SHOULD NOT RECEIVE ULTIVA IF
YOU ARE ALLERGIC (HYPERSENSITIVE) TO
OTHER PAIN-RELIEVING MEDICINES
WHICH ARE SIMILAR TO FENTANYL AND
WHICH ARE RELATED TO THE CLASS OF
MEDICINES KNOWN AS OPIOIDS.
Symptoms of an allergic reaction
may be mild or severe. They usually
include some or all of the following:
wheezing, swelling of the lips/mouth,
difficulty in breathing, hayfever,
lumpy rash ("hives") or fai

Preparatomtale

1
AUSTRALIAN PRODUCT INFORMATION
ULTIVA (REMIFENTANIL HYDROCHLORIDE) POWDER FOR INJECTION
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, ULTIVA should
only be used in
patients for whom other treatment options, including non-opioid
analgesics, are ineffective,
not tolerated or otherwise inadequate to provide appropriate
management of pain (see
_section 4.4 Special Warnings and Precautions for Use_).
_HAZARDOUS AND HARMFUL USE _
ULTIVA poses risks of hazardous and harmful use which can lead to
overdose and death.
Assess the patient’s risk of hazardous and harmful use before
prescribing and monitor the
patient regularly during treatment (see _section 4.4. Special Warnings
and Precautions for _
_Use_).
_LIFE THREATENING RESPIRATORY DEPRESSION _
Serious, life-threatening or fatal respiratory depression may occur
with the use of ULTIVA.
Be aware of situations which increase the risk of respiratory
depression, modify dosing in
patients at risk and monitor patients closely, especially on
initiation or following a dose
increase (see _section 4.4 Special Warnings and Precautions for Use_).
_CONCOMITANT _
_USE _
_OF _
_BENZODIAZEPINES _
_AND _
_OTHER _
_CENTRAL _
_NERVOUS _
_SYSTEM _
_(CNS) _
_DEPRESSANTS, INCLUDING ALCOHOL _
Concomitant use of opioids with benzodiazepines, gabapentinoids,
antihistamines, tricyclic
antidepressants,
antipsychotics,
cannabis
or
other
central
nervous
system
(CNS)
depressants, including alcohol, may result in profound sedation,
respiratory depression,
coma, and death. Limit dosages and durations to the minimum required;
and monitor
patients for signs and symptoms of respiratory depression and
sedation. Caution patients
not to drink alcohol while taking ULTIVA.
1
NAME OF THE MEDICINE
Remifentanil hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Remifentanil hydrochloride – 1mg, 2mg and 5mg as
remifentanil base.
List of excipients: Glycine, Hydrochloric acid, Sodium hydroxide and
water for injection
For the full list of excip