Methadone Injection BP

国家: 新西兰

语言: 英文

来源: Medsafe (Medicines Safety Authority)

有效成分:

Methadone hydrochloride 10 mg/mL

可用日期:

AFT Pharmaceuticals Ltd

INN（国际名称）:

Methadone hydrochloride 10 mg/mL

剂量:

10 mg/mL

药物剂型:

Solution for injection

组成:

Active: Methadone hydrochloride 10 mg/mL Excipient: Water for injection

每包单位数:

Vial, glass, Type I, 10 dose units

类:

Class B3 Controlled Drug

处方类型:

Class B3 Controlled Drug

厂商:

Siegfried Ltd

疗效迹象:

Methadone Injection is used as an analgesic for the relief of moderate to severe pain. Single doses of methadone have a less marked sedative action than morphine.

產品總結:

Package - Contents - Shelf Life: Vial, glass, Type I - 10 dose units - 36 months from date of manufacture stored at or below 25°C

授权日期:

1986-11-26

产品特点

Page 1 of 14
WARNINGS
NEW ZEALAND DATA SHEET
LIMITATIONS OF USE
Because of the risks associated with the use of opioids, Methadone
Injection BP 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
Methadone Injection BP 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 Methadone
Injection BP. 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
benzodiazepines,
gabapentinoids,
antihistamines,
tricyclic
antidepressants,
antipsychotics,
cannabis
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 Methadone
Injection BP.
1.
METHADONE INJECTION BP 10 MG/ML SOLUTION FOR INJECTION
Methadone hydrochloride 10 mg/mL solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 10 mg of methadone hydrochloride.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, col