MEDSURGE ALFENTANIL alfentanil (as hydrochloride) 1 mg/2 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

alfentanil hydrochloride, Quantity: 1.09 mg (Equivalent: alfentanil, Qty 1 mg)

Available from:

Medsurge Pharma Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium hydroxide; water for injections; sodium chloride

Administration route:

Intravenous

Units in package:

10, 1, 5

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

Alfentanil Injection is indicated for intravenous use by specialist anaesthetists and their trainees as:,? an analgesic supplement given by incremental intravenous boluses or continuous infusion; and,? an anaesthetic induction agent where in patients undergoing in-patient surgery, when endotracheal intubation and controlled ventilation are to be used.,Because of its rapid onset and short duration of action, intravenous alfentanil (as hydrochloride) is particularly suited as a narcotic analgesic for short procedures and outpatients, provided that the patients are maintained under appropriate post-operative surveillance. However, intravenous alfentanil (as hydrochloride) is also useful as an analgesic supplement for procedures of medium to long duration, since periods of very painful stimuli can be easily overcome by administration of small increments of alfentanil (as hydrochloride) or by adapting the infusion rate.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2019-10-21

Patient Information leaflet

CMI EDITION 2.0 NOVEMBER 2020
1 ALFENTANIL
_ALFENTANIL HYDROCHLORIDE (EQUIVALENT TO 0.5 MG/ML ALFENTANIL) _
CONSUMER MEDICINE INFORMATION
WARNING
LIMITATIONS OF USE
Alfentanil injection 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
Alfentanil injection 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
Alfentanil injection 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 Alfentanil
injection 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 ALFENTANIL INJECTION
USING ALFENTANIL INJECTION 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
Alfentanil injection.
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
of
the
common
questions
about
Alfentanil
injection.
It does not contain all the information.
It does not take the place of talking to
your doctor, anaesthetist or pharmacist.
All medicines have risks and benefits.
Your pharmacist or doctor has weighed
the risks of you being given Alfentanil
injection
against
the
benefits
they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING
GIVEN THIS MEDICINE

Summary of Product characteristics

ALFENTANIL INJECTION
_ _
PRODUCT INFORMATION
Edition 3.0 July 2021
Page
1
of
19
AUSTRALIAN PRODUCT INFORMATION
MEDSURGE ALFENTANIL (ALFENTANIL (AS HYDROCHLORIDE))
SOLUTION FOR INJECTION
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, Alfentanil
injection 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 _
Alfentanil injection 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 Alfentanil injection.
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 on Alfentanil
injection.
1
NAME OF THE MEDICINE
Alfentanil hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alfentanil hydrochloride 0.54 mg/mL equivalent to 0.5 mg/mL
alfentanil.
ALFENTANIL INJECTION
_ _