RAPIFEN alfentanil 1mg/2mL (as hydrochloride) injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

alfentanil hydrochloride, Quantity: 0.544 mg/mL

Available from:

Piramal Critical Care Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; water for injections

Administration route:

Intravenous

Units in package:

5 X 2mL

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

Indications: RAPIFEN is indicated for intravenous use by specialist anaesthetists and their trainees as 1. An analgesic supplement given by incremental intravenous boluses or continuous infusion; and 2. 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 RAPIFEN 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 RAPIFEN 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 RAPIFEN 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: 5 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1994-10-14

Patient Information leaflet

RAPIFEN
®
CMI AU
1
RAPIFEN
®
_Alfentanil Hydrochloride Injection (equivalent to 0.5 mg/mL
alfentanil) _
CONSUMER MEDICINE INFORMATION
WARNING
LIMITATIONS OF USE
RAPIFEN 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
RAPIFEN 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
RAPIFEN 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 RAPIFEN 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 RAPIFEN
USING RAPIFEN 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
RAPIFEN.
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
RAPIFEN. It does not contain all the
information that is known about
RAPIFEN.
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
RAPIFEN 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. YOU MAY NEED TO
READ IT AGAI

Summary of Product characteristics

1
RAPIFEN
AUSTRALIAN
PRODUCT
INFORMATION
–
RAPIFEN
(ALFENTANIL
HYDROCHLORIDE) INJECTION
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, RAPIFEN
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 _
RAPIFEN 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 RAPIFEN. 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 RAPIFEN.
1
NAME OF THE MEDICINE
Alfentanil hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of RAPIFEN contains alfentanil hydrochloride equivalent to
0.5mg alfentanil with 9.0mg
sodium chloride in water for injection to 1mL.
3
PHARMACEUTICAL FORM
RAPIFEN solution for injection is a sterile, clear and colourless
sol