DBL™ Fentanyl

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

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

Disponible des:

Pfizer New Zealand Limited

Designació comuna internacional (DCI):

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

Dosis:

50 mcg/mL

formulario farmacéutico:

Solution for injection

Composición:

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

Unidades en paquete:

Ampoule, glass, 10mL, 5 dose units

clase:

Class B3 Controlled Drug

tipo de receta:

Class B1 Controlled Drug

Fabricat per:

Macfarlan Smith Ltd

Resumen del producto:

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

Data d'autorització:

1990-10-17

Fitxa tècnica

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