Methadone Injection BP

Quốc gia: New Zealand

Ngôn ngữ: Tiếng Anh

Nguồn: Medsafe (Medicines Safety Authority)

Thành phần hoạt chất:

Methadone hydrochloride 10 mg/mL

Sẵn có từ:

AFT Pharmaceuticals Ltd

INN (Tên quốc tế):

Methadone hydrochloride 10 mg/mL

Liều dùng:

10 mg/mL

Dạng dược phẩm:

Solution for injection

Thành phần:

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

Các đơn vị trong gói:

Vial, glass, Type I, 10 dose units

Lớp học:

Class B3 Controlled Drug

Loại thuốc theo toa:

Class B3 Controlled Drug

Sản xuất bởi:

Siegfried Ltd

Chỉ dẫn điều trị:

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.

Tóm tắt sản phẩm:

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

Ngày ủy quyền:

1986-11-26

Đặc tính sản phẩm

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