Alfentanil

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Alfentanil hydrochloride 0.544 mg/mL equivalent to alfentanil 0.5mg/mL

Available from:

Medsurge Pharma Limited

Dosage:

1 mg/2mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Alfentanil hydrochloride 0.544 mg/mL equivalent to alfentanil 0.5mg/mL Excipient: Sodium chloride Sodium hydroxide Water for injection

Prescription type:

Class B3 Controlled Drug

Therapeutic indications:

Alfentanil injection is indicated in adults and children aged above one year for use as: · an opioid analgesic in general or regional anaesthesia for both short (bolus injections) and long (bolus, supplemented by increments or by continuous infusion) surgical procedures. · an anaesthetic induction agent. Due to its rapid and short-lasting action, Alfentanil injection is particularly suited as an opioid analgesic for short procedures and outpatient surgery. It is also useful as an analgesic supplement for procedures of medium and long duration, since periods of very painful stimuli can easily be overcome by small increments of Alfentanil injection or by adapting its infusion rate.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, type I colourless, 2 mL - 1 dose units - 48 months from date of manufacture stored at or below 25°C 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) - Ampoule, glass, type I colourless, 2 mL - 5 dose units - 48 months from date of manufacture stored at or below 25°C 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) - Ampoule, glass, type I colourless, 2 mL - 10 dose units - 48 months from date of manufacture stored at or below 25°C 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2019-11-25

Patient Information leaflet

NZ CMI EDITION 1.0 AUGUST 2020
1
ALFENTANIL
_ALFENTANIL HYDROCHLORIDE _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Medsurge Alfentanil
injection.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was last
updated on the date listed on the final
page. More recent information on the
medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK TO
YOUR PHARMACIST OR DOCTOR TO OBTAIN
THE MOST UP-TO-DATE INFORMATION ON
THE MEDICINE.
Those updates may contain important
information about the medicine and its
use of which you should be aware.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you having Alfentanil injection
against the benefits they expect it will
give you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to
read it again.
WHAT ALFENTANIL
INJECTION IS USED FOR
Alfentanil injection is a drug used to
relieve pain and produce anaesthesia.
It can be used as a premedication
before an operation, or with a general
anaesthetic during an operation.
Alfentanil injection belongs to a group
of medicines called opioid analgesics.
Alfentanil injection works by
changing the messages that are sent to
the brain about pain.
Your doctor will have explained why
you are being given Alfentanil
injection.
Follow all directions given to you by
your doctor carefully. They may differ
from the information contained in this
leaflet.
Ask your doctor if you have any
questions about why this medicine has
been prescribed for you. Your doctor
may have prescribed it for another
purpose.
BEFORE YOU ARE GIVEN
ALFENTANIL INJECTION
_WHEN _
_YOU _
_MUST _
_NOT _
_USE _
_ALFENTANIL INJECTION _
_ _
_ _
ALFENTANIL
INJECTION
SHOULD
NOT
BE
USED FOR PAIN RELIEF AFTER SURGERY HAS
TAKEN PLACE.
ALFENTANIL
INJECTION
SHOULD
NOT
BE
USED
IF
YOU
HAVE
AN
ALLERGY,
INTOLERANCE OR HYPERSENSITIVITY TO:
•
alf

Summary of Product characteristics

ALFENTANIL X MG/Y ML
NEW ZEALAND DATA SHEET
New Zealand Data Sheet Edition 4.0 – October 2022
Page 1 of 13
NEW ZEALAND DATA SHEET
1 PRODUCT NAME
Alfentanil 1 mg/2 mL MEDSURGE
Alfentanil 5 mg/10 mL MEDSURGE
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of Alfentanil solution for injection contains 0.544 mg of
alfentanil hydrochloride, equivalent
to 0.5 mg/mL alfentanil base.
It is available as a sterile solution of alfentanil hydrochloride
equivalent to 0.5 mg/mL alfentanil with
9.0 mg sodium chloride in water for injection to 1 mL.
Each 2 mL ampoule contains 1.0 mg of alfentanil (as hydrochloride).
Each 10 mL ampoule contains 5.0 mg of alfentanil (as hydrochloride).
Excipient(s) with known effect: sodium chloride 9.0 mg/mL.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Solution for injection
Medsurge Alfentanil injection is a clear colourless solution.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Alfentanil injection is indicated in adults and children aged above
one year for use as:
• an opioid analgesic in general or regional anaesthesia for both
short (bolus injections) and long
(bolus, supplemented by increments or by continuous infusion) surgical
procedures.
• an anaesthetic induction agent.
Due to its rapid and short-lasting action, Alfentanil injection is
particularly suited as an opioid
analgesic for short procedures and outpatient surgery. It is also
useful as an analgesic supplement for
procedures of medium and long duration, since periods of very painful
stimuli can easily be overcome
by small increments of Alfentanil injection or by adapting its
infusion rate.
4.2
Dose and method of administration
Alfentanil injection should be administered intravenously. Other
routes of administration have not
been evaluated.
The dosage of Alfentanil injection should be individualised according
to age, body weight, physical
status, underlying pathological condition, use of other medicines,
type of anaesthesia and type and
duration of the surgical procedure