ALFENTANIL GH injection alfentanil (as hydrochloride) 5 mg/10 mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

alfentanil hydrochloride, Quantity: 5.438 mg

Available from:

Generic Health Pty Ltd

INN (International Name):

alfentanil hydrochloride

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; sodium chloride; hydrochloric acid

Administration route:

Intravenous

Units in package:

10 x 10 mL ampolues, 5 x 10 mL ampoules, 1 x 10 mL ampoule

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

ALFENTANIL GH 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 GH Injection 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 GH Injection 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 GH Injection 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: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2013-11-01

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
ALFENTANIL GH
(ALFENTANIL HYDROCHLORIDE) SOLUTION FOR INJECTION
WARNING
LIMITATIONS OF USE
Alfentanil GH 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 GH 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 GH 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 GH 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 GH
USING ALFENTANIL GH WITH OTHER MEDICINES THAT CAN MAKE YOU FEEL DROWSY
SUCH AS SLEEPING TABLETS
(EG.
BENZODIAZEPINES),
OTHER
PAIN
RELIEVERS,
ANTIHISTAMINES,
ANTIDEPRESSANTS,
ANTIPSYCHOTICS,
GABAPENTINOIDS (EG. 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 GH.
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask
about Alfentanil GH.
It does not contain all the
information that is known about
Alfentanil GH.
It does not take the place of
talking to your doctor,
anaesthetist or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you being
given Alfentanil GH against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT BEING GIVEN THIS
MEDICINE, ASK YOUR DOCTOR,
ANAESTHETIST OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDI

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – ALFENTANIL GH
(ALFENTANIL HYDROCHLORIDE) SOLUTION FOR INJECTION
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, alfentanil
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 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. 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.
1
NAME OF THE MEDICINE
Alfentanil hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alfentanil GH is available as a sterile solution in an ampoule
containing 1 mg/2 mL or 5 mg/10 mL of
alfentanil (as hydrochloride).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FOR