DBL™ Fentanyl

Country: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

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

Fáanlegur frá:

Pfizer New Zealand Limited

INN (Alþjóðlegt nafn):

Fentanyl citrate 78.125 µg/mL (equivalent to 50 µg/mL fentanyl)

Skammtar:

50 mcg/mL

Lyfjaform:

Solution for injection

Samsetning:

Active: Fentanyl citrate 78.125 µg/mL equivalent to 50 µg/mL fentanyl Excipient: Water for injection Active: Fentanyl citrate 78.125 µg/mL Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Water for injection

Einingar í pakka:

Ampoule, glass, 10mL, 5 dose units

Tegund:

Class B3 Controlled Drug

Gerð lyfseðils:

Class B1 Controlled Drug

Framleitt af:

Macfarlan Smith Ltd

Vörulýsing:

Package - Contents - Shelf Life: Ampoule, glass, 10mL - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, 2mL - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light

Leyfisdagur:

1990-10-17

Vara einkenni

Version: pfdfenti10721
Supercedes: pfdfenti10820
Page 1 of 22
NEW ZEALAND DATA SHEET
WARNINGS
_LIMITATIONS OF USE_
Because of the risks associated with the use of opioids, fentanyl
should only be used in
patients for whom other treatment options, including non-opioid
analgesics, are ineffective,
not tolerated or otherwise inadequate to provide appropriate
management of pain (see section
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
_HAZARDOUS AND HARMFUL USE_
Fentanyl poses risks of hazardous and harmful use which can lead to
overdose and death.
Assess the patient’s risk of hazardous and harmful use before
prescribing and monitor the
patient regularly during treatment (see section 4.4 SPECIAL WARNINGS
AND PRECAUTIONS FOR
USE).
_LIFE-THREATENING RESPIRATORY DEPRESSION_
Serious, life-threatening or fatal respiratory depression may occur
with the use of fentanyl.
Be aware of situations which increase the risk of respiratory
depression, modify dosing in
patients at risk and monitor patients closely, especially on
initiation or following a dose
increase (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
_CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS) DEPRESSANTS, _
_INCLUDING ALCOHOL_
Concomitant use of opioids with CNS depressant medicines, such as
other opioid analgesics,
benzodiazepines, gabapentinoids, cannabis, sedatives, hypnotics,
tricyclic antidepressants,
antipsychotics,
antihistamines,
centrally-active
anti-emetics,
general
anaesthetics,
tranquilisers, or other central nervous system (CNS) depressants,
including alcohol, may
result in profound sedation, respiratory depression, coma, and death.
Limit dosages and
durations to the minimum required; and monitor patients for signs and
symptoms of
respiratory depression and sedation. Caution patients not to drink
alcohol while taking
fentanyl (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
1.
PRODUCT NAME
DBL Fentanyl Injection 50 micrograms/mL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL Fentanyl Injection is