Fentanyl (AstraZeneca)

Država: Nova Zelandija

Jezik: angleščina

Source: Medsafe (Medicines Safety Authority)

Aktivna sestavina:

Fentanyl citrate 78.125 µg/mL equivalent to to 50 µg/mL of fentanyl

Dostopno od:

Juno Pharmaceuticals NZ Limited

INN (mednarodno ime):

Fentanyl citrate 78.125 µg/mL (equiv. to 50 µg/mL of fentanyl)

Odmerek:

50 mcg/mL

Farmacevtska oblika:

Solution for injection

Sestava:

Active: Fentanyl citrate 78.125 µg/mL equivalent to to 50 µg/mL of fentanyl Excipient: Citric acid Sodium chloride Sodium citrate dihydrate Sodium hydroxide as 2M solution for pH adjustment Water for injection

Enote v paketu:

Polyamp, 2mL, 10 dose units

Razred:

Class B3 Controlled Drug

Tip zastaranja:

Class B1 Controlled Drug

Izdeluje:

Mallinckrodt Chemical Inc

Povzetek izdelek:

Package - Contents - Shelf Life: Polyamp, 2mL - 10 dose units - 18 months from date of manufacture stored at or below 25°C - Polyamp, 10m - 10 dose units - 18 months from date of manufacture stored at or below 30°C - Syringe, 2mL - 5 dose units - 18 months from date of manufacture stored at or below 30°C - Vial, glass, 20mL - 5 dose units - 24 months from date of manufacture stored at or below 30°C

Datum dovoljenje:

1989-11-23

Lastnosti izdelka

F
ENTANYL
Data Sheet 080517
DATA SHEET
1.
PRODUCT NAME
F
ENTANYL
I
NJECTION
Fentanyl citrate 50 µg/mL, solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2ml ampoule contains 100 micrograms of Fentanyl as Fentanyl
citrate.
Each 10ml ampoule contains 500 micrograms of Fentanyl as Fentanyl
citrate.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Injection: a clear, colourless, particle-free solution, pH 4.0-7.5,
and containing fentanyl
50µg/mL (as citrate).
Fentanyl is chemically identified as N-(1-phenethyl-4-piperidyl)
propionanilide citrate, MW
528.61.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short duration analgesia during pre-medication, induction and
maintenance of anaesthesia,
and in the immediate post-operative period.
Opioid analgesic supplement to general and regional anaesthesia.
Combination with a neuroleptic as an anaesthetic pre-medication for
the induction of
anaesthesia, and as an adjunct in the maintenance of general and
regional anaesthesia.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dosage should be individualised according to age, bodyweight, physical
status, underlying
pathological condition, use of other medicines, type of anaesthesia to
be used and the surgical
procedure involved (see also section 4.4 Special Warnings and
Precautions for Use).
F
ENTANYL
I
NJECTION
contains no antimicrobial agent. It should be used only once and any
residue discarded.
ADULTS
PREMEDICATION
(To be appropriately modified in the elderly, debilitated and those
who receive other
depressant medicines): 50 to 100 µg (1 to 2 mL) may be administered
intramuscularly 30 to
60 minutes prior to surgery.
F
ENTANYL
Data Sheet 080517
2
ADJUNCT TO GENERAL ANAESTHESIA
Induction: 50 to 100 µg (1 to 2 mL) IV initially, repeat at two to
three minute intervals until
desired effect is achieved. A reduced dose of 25 to 50 µg (0.5 to 1
mL) is recommended in
elderly and poor risk patients.
MAINTENANCE
25 to 50 µg (0.5 to 1 mL) IV or IM when movement and/or changes in
vital signs i