NALOXONE HYDROCHLORIDE INJECTION SDZ PRESERVATIVE FREE SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

NALOXONE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE DIHYDRATE)

Sẵn có từ:

SANDOZ CANADA INCORPORATED

Mã ATC:

V03AB15

INN (Tên quốc tế):

NALOXONE

Liều dùng:

0.4MG

Dạng dược phẩm:

SOLUTION

Thành phần:

NALOXONE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE DIHYDRATE) 0.4MG

Tuyến hành chính:

INTRAMUSCULAR

Các đơn vị trong gói:

1 ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

OPIATE ANTAGONISTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0108981002; AHFS:

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2019-08-01

Đặc tính sản phẩm

Page 1 of 11
PRODUCT MONOGRAPH
PR
NALOXONE HYDROCHLORIDE INJECTION SDZ
PRESERVATIVE FREE
NALOXONE HYDROCHLORIDE DIHYDRATE
0.4 mg/mL
THERAPEUTIC CLASSIFICATION
Opioid Antagonist
Sandoz Canada Inc.
Date of Preparation: March 27, 2012
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Control No: 154041
Naloxone Hydrochloride Injection SDZ
Preservative Free 0.4 mg/ml Page 2 of 11
NALOXONE HYDROCHLORIDE INJECTION SDZ
PRESERVATIVE FREE
0.4 mg/mL
THERAPEUTIC CLASSIFICATION
Opioid Antagonist
CLINICAL PHARMACOLOGY
Naloxone hydrochloride prevents or reverses the effects of opioids,
including respiratory
depression, sedation, and hypotension. Also, it can reverse the
psychosomimetic and
dysphoric effects of agonist-antagonists such as pentazocine. Naloxone
hydrochloride is
an essentially pure opioid antagonist, i.e. it does not possess the
agonistic or morphine-
like properties characteristic of other opioid antagonists; naloxone
does not produce
respiratory depression, psychosomimetic effects or pupillary
constriction. In the absence
of opioids or agonistic effects of other opioid antagonists it
exhibits essentially no
pharmacologic activity. Naloxone has not been shown to produce
tolerance or to cause
physical or psychological dependence. In the presence of physical
dependence on opioids
naloxone will produce withdrawal symptoms.
While the mechanism of action of naloxone is not fully understood, the
preponderance of
evidence suggests that naloxone antagonizes the opioid effects by
competing for the same
receptor sites.
Following parenteral administration naloxone is rapidly distributed in
the body. It is
metabolized in the liver, primarily by glucuronide conjugation, and
excreted in urine.
INDICATIONS AND CLINICAL USE
Naloxone is indicated for the complete or partial reversal of opioid
depression, including
respiratory depression induced by opioids, including natural and
synthetic opioids,
propoxyphene, methadone and the agonist-antagonist analgesics
nalbuphine, pentazocine
and butorphanol. Naloxone is also indicated for