SUBLIMAZE fentanyl 500 microgram/10mL (as citrate) injection ampoule

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

fentanyl citrate, Quantity: 78.5 microgram/mL (Equivalent: fentanyl, Qty 50 microgram/mL)

זמין מ:

Piramal Critical Care Pty Ltd

טופס פרצבטיות:

Injection, solution

הרכב:

Excipient Ingredients: water for injections; sodium chloride

מסלול נתינה (של תרופות):

Intravenous, Intramuscular

יחידות באריזה:

5 X 10 mL

סוג מרשם:

(S8) Controlled Drug

סממני תרפויטית:

SUBLIMAZE is indicated for analgesic action of short duration during anaesthetic periods, premedication, induction and maintenance, and in the immediate post-operative period (recovery room) as the need arises; use as a narcotic analgesic supplement in general and regional anaesthesia; administration with a neuroleptic such as droperidol injection as an anaesthetic premedication, for the induction of anaesthesia, and as an adjunct in the maintenance of general and regional anaesthesia.

leaflet_short:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

מצב אישור:

Registered

תאריך אישור:

1994-03-07

עלון מידע

SUBLIMAZE
®
INJECTION
1
SUBLIMAZE
® INJECTION
_Fentanyl _
CONSUMER MEDICINE INFORMATION
WARNING
LIMITATIONS OF USE
SUBLIMAZE should only be used when your doctor decides that other
treatment options are not able to effectively manage
your pain or you cannot tolerate them.
HAZARDOUS AND HARMFUL USE
SUBLIMAZE poses risks of abuse, misuse and addiction which can lead to
overdose and death. Your doctor will monitor
you regularly during treatment.
LIFE THREATENING RESPIRATORY DEPRESSION
SUBLIMAZE can cause life-threatening or fatal breathing problems
(slow, shallow, unusual or no breathing), even when
used as recommended. These problems can occur at any time during use,
but the risk is higher when first starting
SUBLIMAZE and after a dose increase, if you are older, or have an
existing problem with your lungs. Your doctor will
monitor you and change the dose as appropriate.
USE OF OTHER MEDICINES WHILE USING SUBLIMAZE
Using SUBLIMAZE with other medicines that can make you feel drowsy
such as sleeping tablets (e.g. benzodiazepines),
other pain relievers, antihistamines
, antidepressants, antipsychotics, gabapentinoids (e.g. gabapentin and
pregabalin),
cannabis and alcohol may result in severe drowsiness, decreased
awareness, breathing problems, coma and death. Your
doctor will minimise the dose and duration of use; and monitor you for
signs and symptoms of breathing difficulties and
sedation. You must not drink alcohol while using SUBLIMAZE.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SUBLIMAZE
injection. It does not contain all 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 receiving SUBLIMAZE against
the benefits this medicine is expected
to have for you.
If you have any concerns about
receiving SUBLIMAZE, ask your
doctor or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT SUBLIMAZE IS
USED FOR
SUBLIMAZE injection is used to

מאפייני מוצר

1
SUBLIMAZE
AUSTRALIAN
PRODUCT
INFORMATION
–
SUBLIMAZE
(FENTANYL
CITRATE) INJECTION
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, SUBLIMAZE
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 _
SUBLIMAZE 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
SUBLIMAZE. 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 SUBLIMAZE.
1
NAME OF THE MEDICINE
Fentanyl citrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SUBLIMAZE injection contains fentanyl 50 micrograms per mL (as
fentanyl citrate).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
SUBLIMAZE solution for injection is a clear colourless so