Alfentanil

Pajjiż: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

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

Disponibbli minn:

Medsurge Pharma Limited

Dożaġġ:

1 mg/2mL

Għamla farmaċewtika:

Solution for injection

Kompożizzjoni:

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

Tip ta 'preskrizzjoni:

Class B3 Controlled Drug

Indikazzjonijiet terapewtiċi:

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.

Sommarju tal-prodott:

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)

Data ta 'l-awtorizzazzjoni:

2019-11-25

Karatteristiċi tal-prodott

ALFENTANIL X MG/Y ML
NEW ZEALAND DATA SHEET
New Zealand Data Sheet Edition 2.0 – November 2021
Page 1 of 13
NEW ZEALAND DATA SHEET
1 PRODUCT NAME
Alfentanil 1 mg/2 mL MEDICIANZ
Alfentanil 5 mg/10 mL MEDICIANZ
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of Alfentanil solution for injection contains 0.544 mg/mL of
alfentanil hydrochloride, equivalent to
0.5 mg/mL of 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
Medicianz 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