REMIFENTANIL VIATRIS 1mg remifentanil (as hydrochloride) powder for injection vial

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

remifentanil hydrochloride, Quantity: 1.097 mg (Equivalent: remifentanil, Qty 1 mg)

थमां उपलब्ध:

Alphapharm Pty Ltd

INN (इंटरनेशनल नाम):

Remifentanil hydrochloride

फार्मास्यूटिकल फॉर्म:

Injection, powder for

रचना:

Excipient Ingredients: hydrochloric acid; glycine

प्रशासन का मार्ग:

Intravenous Infusion, Intravenous

पैकेज में यूनिट:

5 vials, 1 vial

प्रिस्क्रिप्शन प्रकार:

(S8) Controlled Drug

चिकित्सीय संकेत:

REMIFENTANIL Viatris 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.

उत्पाद समीक्षा:

Visual Identification: White to off-white powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

प्राधिकरण का दर्जा:

Licence status A

प्राधिकरण की तारीख:

2012-10-15

सूचना पत्रक

REMIFENTANIL
ALPHAPHARM
_contains the active ingredient remifentanil (as hydrochloride)_
CONSUMER MEDICINE INFORMATION
WARNING
LIMITATIONS OF USE
REMIFENTANIL ALPHAPHARM 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
REMIFENTANIL ALPHAPHARM 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
REMIFENTANIL ALPHAPHARM 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 REMIFENTANIL ALPHAPHARM 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 REMIFENTANIL ALPHAPHARM
Using REMIFENTANIL ALPHAPHARM 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 diffi-
culties and sedation. You must not drink alcohol while using
REMIFENTANIL ALPHAPHARM.
WHAT IS IN THIS LEAFLET
This leaflet contains answers to some
common questions about
REMIFENTANIL ALPHAPHARM.
It does not contain all the information
available on REMIFENTANIL
ALPHAPHARM.
It does NOT take the place of talking
to your doctor or your pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
REMIFENTANIL ALPHAPHARM
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
T

उत्पाद विशेषताएं

AUSTRALIAN PRODUCT INFORMATION
REMIFENTANIL ALPHAPHARM
_remifentanil (as hydrochloride) powder for injection _
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, Remifentanil
Alphapharm 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 _
Remifentanil Alphapharm 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 Remifentanil Alphapharm.
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 Remifentanil Alphapharm.
1
NAME OF THE MEDICINE
Remifentanil (as hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each REMIFENTANIL ALPHAPHARM powder for injection vial contains 1 mg,
2 mg or 5 mg of
remifentanil (as hydrochloride) as the active ingredient.
Fo