Alfentanil 500 micrograms/ml solution for injection/infusion

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Alfentanil

Tilgængelig fra:

AS Kalceks

ATC-kode:

N01AH02

INN (International Name):

Alfentanil

Dosering:

500 microgram(s)/millilitre

Lægemiddelform:

Solution for injection/infusion

Terapeutisk område:

alfentanil

Autorisation status:

Marketed

Autorisation dato:

2019-09-13

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALFENTANIL 500 MICROGRAMS/ML SOLUTION FOR INJECTION/INFUSION
Alfentanil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor or nurse.
−
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Alfentanil is and what it is used for
2.
What you need to know before you are given Alfentanil
3.
How Alfentanil will be given
4.
Possible side effects
5.
How to store Alfentanil
6.
Contents of the pack and other information
1.
WHAT ALFENTANIL IS AND WHAT IT IS USED FOR
Alfentanil contains the active substance alfentanil hydrochloride
(hereinafter referred to as alfentanil). It
belongs to a group of medicines called ‘opioid anaesthetics’.
Alfentanil is a strong painkiller (analgesic)
used in hospitals. It has a fast onset and short duration of action,
and is therefore used for anaesthesia in
surgical procedures and investigations.
This medicine is used in adults:
•
as analgesic for initiating and/or maintaining general anaesthesia.
This medicine is used in newborns, infants, children and adolescents:
•
as analgesic together with a sleeping medicine (hypnotic) to induce
anaesthesia;
•
as analgesic in connection with general anaesthesia during surgical
procedures of both short and
long duration.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ALFENTANIL
YOU SHOULD NOT BE GIVEN ALFENTANIL
−
if you are allergic to alfentanil hydrochloride, other opioids or any
of the other ingredients of this
medicine (listed in section 6).
If you are not sure if any of the above applies to you, talk to your
doctor or nurse before you are given
this medicine.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before being given Alfentanil if you:
‒
have muscle weakness (myasthenia gravis);
‒
h

Produktets egenskaber

Health Products Regulatory Authority
11 July 2023
CRN00D4ZK
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alfentanil 500 micrograms/ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution contains alfentanil hydrochloride equivalent to
500 micrograms alfentanil.
Each 2 ml ampoule contains alfentanil hydrochloride equivalent to 1 mg
alfentanil.
Each 10 ml ampoule contains alfentanil hydrochloride equivalent to 5
mg alfentanil.
Excipient with known effect: sodium (see section 4.4).
Each 2 ml ampoule contains 7.1 mg of sodium.
Each 10 ml ampoule contains 35.4 mg of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear, colourless solution free from visible particles.
pH of solution is 4.0 - 6.0.
Osmolality is 270 ‑ 310 mOsmol/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Alfentanil is indicated in adults as:
• an analgesic for induction of anaesthesia and/or maintenance of
general anaesthesia.
Alfentanil is indicated for use in neonates, infants, children and
adolescents less than 18 years of age as:
• an opioid analgesic together with a hypnotic to induce
anaesthesia;
• an opioid analgesic in connection with general anaesthesia during
surgical procedures of both short and long duration.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage of alfentanil should be individualised according to age,
body weight, physical status, underlying pathological
conditions, use of other drugs and type of surgery and anaesthesia.
_ADULT PATIENTS_
The usual recommended dosage regimen is given in Table 1.
TABLE 1THE USUAL RECOMMENDED DOSAGE REGIMEN
_Adults_
_Initial_
_Supplemental_
Spontaneous respiration
500 mcg (1 ml)
250 mcg (0.5 ml)
Assisted ventilation
30‑50 mcg/kg
15 mcg/kg

_Short procedures and outpatient surgery_
Health Products Regulatory Authority
11 July 2023
CRN00D4ZK
Page 2 of 11
In spontaneously breathing patients, the initial bolus dose should be