Fentanyl

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Fentanyl citrate 78.5 µg/mL equivalent to 50 µg/mL fentanyl

Tilgjengelig fra:

Boucher & Muir (NZ) Ltd t/a Mercury Pharma (NZ)

INN (International Name):

Fentanyl citrate 78.5 µg/mL (equivalent to 50 µg/mL fentanyl)

Dosering :

50 mcg/mL

Legemiddelform:

Solution for injection

Sammensetning:

Active: Fentanyl citrate 78.5 µg/mL equivalent to 50 µg/mL fentanyl Excipient: Sodium chloride Sodium hydroxide Water for injection

Enheter i pakken:

Ampoule, glass, Type 1, 10mL, 10 dose units

Klasse:

Class B3 Controlled Drug

Resept typen:

Class B1 Controlled Drug

Produsert av:

Macfarlan Smith Ltd

Indikasjoner:

Fentanyl Injection is indicated for: · analgesic action of short duration during anaesthetic periods, premedication, induction and maintenance, and in the immediate post-operative period (recovery room) as the need arises; · use as a narcotic analgesic supplement in general and regional anaesthesia; · administration with a neuroleptic such as droperidol injection as an anaesthetic premedication, for the induction of anaesthesia, and as an adjunct in the maintenance of general and regional anaesthesia.

Produkt oppsummering:

Package - Contents - Shelf Life: Ampoule, glass, Type 1, 10mL - 10 dose units - 3 years from date of manufacture stored at or below 25°C - Ampoule, glass, Type 1, 2mL - 10 dose units - 3 years from date of manufacture stored at or below 25°C

Autorisasjon dato:

2010-06-01

Informasjon til brukeren

1
FENTANYL INJECTION
Consumer Medicine Information
FENTANYL INJECTION
_ _
_FENTANYL _
_50 MICROGRAMS/ML INJECTION _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you are given Fentanyl
Injection.
This leaflet answers some common questions about Fentanyl Injection.
It does not contain all
the available information. The most up-to-date Consumer Medicine
Information can be
downloaded from www.medsafe.gov.nz.
Reading this leaflet does not take the place of talking to your doctor
or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you receiving
Fentanyl Injection against the benefits this medicine is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT RECEIVING FENTANYL INJECTION ASK YOUR
DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR MEDICINE.
You may need to read it again.
WHAT FENTANYL INJECTION IS USED FOR
Fentanyl Injection is used to provide short-term pain relief and to
help anaesthesia when you
have an operation. It can be given with droperidol injection which is
a tranquilliser.
Fentanyl Injection contains a medicine called fentanyl. It belongs to
a group of medicines
known as opioid analgesics. Fentanyl relieves pain by blocking the
nerves in the brain that
recognise pain messages from the body.
Your doctor may have prescribed fentanyl for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN
PRESCRIBED FOR YOU.
Fentanyl Injection is only available with a doctor’s prescription.
Fentanyl may be addictive. Addiction is unlikely in patients who
receive it under medical
supervision.
2
FENTANYL INJECTION
You may be at more risk of addiction if:
• You or someone in your family have a history of drug and alcohol
abuse or mental
illness
• You require repeated injections of Fentanyl Injection
• You need increasingly larger doses of Fentanyl Injection to
control your pain.
BEFORE YOU ARE GIVEN FENTANYL INJECTION
Fentanyl Injection is not suitable for everyone.
_WHEN YOU MUST NOT BE GIVEN FENTANYL INJECTION _

Preparatomtale

1
FENTANYL
FENTANYL CITRATE SOLUTION FOR INJECTION 50 MICROGRAMS/ML
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
FENTANYL
50 micrograms/mL Solution for Injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fentanyl Injection contains fentanyl 50 micrograms/mL as citrate.
Each 2 mL ampoule contains 100 micrograms of fentanyl as fentanyl
citrate.
Each 10 mL ampoule contains 500 micrograms of fentanyl as fentanyl
citrate.
EXCIPIENT(S) WITH KNOWN EFFECT:
Sodium 9.0 mg/mL
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Fentanyl Injection 50 mcg/mL is a clear, colourless solution and is
available in 2 mL and 10
mL clear glass ampoules.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fentanyl Injection is indicated in adults and children aged above two
years for:
•
analgesic action of short duration during anaesthetic periods,
premedication, induction
and maintenance, and in the immediate post-operative period (recovery
room) as the
need arises;
•
use as an opioid analgesic supplement in general and regional
anaesthesia;
•
administration with a neuroleptic such as droperidol injection as an
anaesthetic
premedication, for the induction of anaesthesia, and as an adjunct in
the maintenance
of general and regional anaesthesia.
2
FENTANYL
FENTANYL CITRATE SOLUTION FOR INJECTION 50 MICROGRAMS/ML
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
Dosage should be individualised. Some of the factors to be considered
in determining the
dose are: age, body weight, physical status, underlying pathological
condition, use of other
medicines, type of anaesthesia to be used, and the surgical procedure
involved.
_USUAL DOSAGE IN ADULTS_
1.
PREMEDICATION
(To be appropriately modified in the elderly, debilitated and those
who
have received other depressant medicines)
50 to 100 micrograms (1 to 2 mL) may be administered intramuscularly
30 to 60
minutes
prior to surgery.
2.
ADJUNCT TO GENERAL ANAESTHESIA
INDUCTION
- 50 to 100 micrograms (1 to 2 mL) may be administered initially
intravenously
and may be repeated at 2 to 3-m