NARCAN naloxone hydrochloride (as dihydrate) 400 microgram/1 mL injection ampoule

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

naloxone hydrochloride dihydrate, Quantity: 440 microgram (Equivalent: naloxone hydrochloride?, Qty 400 microgram)

Dostępny od:

Phebra Pty Ltd

Forma farmaceutyczna:

Injection

Skład:

Excipient Ingredients: water for injections; sodium chloride; hydrochloric acid

Droga podania:

Intramuscular, Intravenous, Subcutaneous

Sztuk w opakowaniu:

10 x 1mL

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

Narcan is indicated for the complete or partial reversal of narcotic depression, including respiratory depression, induced by opioids including natural and synthetic narcotics, propoxyphene, methadone and the narcotic antagonist analgesics: nalbuphine, pentazocine and butorphanol. Narcan is also indicated for the diagnosis of suspected acute opioid overdosage.

Podsumowanie produktu:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status autoryzacji:

Registered

Data autoryzacji:

1997-10-02

Ulotka dla pacjenta

Narcan® Injection V04
1
NARCAN® INJECTION
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING NARCAN INJECTION?
Narcan Injection contains the active ingredient naloxone
hydrochloride. Narcan Injection is used to reverse the effects of
opium-
like substances such as morphine, heroin, and codeine.
For more information, see Section 1. Why am I using Narcan Injection?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NARCAN INJECTION?
Do not use if you have ever had an allergic reaction to Narcan
Injection or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Narcan Injection? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Narcan Injection and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE NARCAN INJECTION?
•
Narcan Injection must only give by a doctor or nurse. They will decide
what dose and how long you will receive it for. This
depends on your medical condition and other factors.
More instructions can be found in Section 4. How do I use Narcan
Injection? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NARCAN INJECTION?
THINGS YOU SHOULD DO
•
If you become pregnant while being given Narcan Injection, tell your
doctor immediately.
•
Remind any doctor, dentist, pharmacist or nurse you visit that you
have been given
Narcan Injection
•
Before surgery, tell the surgeon or anaesthetist that you have been
given this medicine.
•
Tell your doctor if you are about to have any blood tests.
•
Tell your doctor if you are on a salt restricted diet.
DRIVING OR USING MACHINES
•
Do not drive or operate machinery for at least

Charakterystyka produktu

PRODUCT INFORMATION
NARCAN
® INJECTION
Australian Product Information - Narcan
®
Injection
Page 1 of 11
Version 05
NARCAN
®
(NALOXONE HYDROCHLORIDE) INJECTION
1
NAME OF THE MEDICINE
Naloxone hydrochloride dihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Narcan Injection is available as naloxone hydrochloride (as dihydrate)
400 micrograms in 1 mL of water for
injections.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Narcan Injection is available as a clear colourless sterile solution
for intravenous, intramuscular, and subcutaneous
administration
in a
clear glass ampoule.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Narcan Injection 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 narcotic-
antagonist analgesics: nalbuphine, pentazocine and butorphanol. Narcan
Injection is also indicated for the
diagnosis of suspected acute opioid overdosage.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Narcan Injection may be administered intravenously, intramuscularly,
or subcutaneously. The most rapid onset of
action is achieved by intravenous administration and it is recommended
in emergency situations.
Since the duration of action of some opioids may exceed that of Narcan
Injection the patient should be kept under
continued surveillance, and repeated doses of Narcan Injection should
be administered, as necessary.
Use in one patient on one occasion only and discard. Contains no
antimicrobial preservative.
INTRAVENOUS INFUSION
Narcan Injection may be diluted for intravenous infusion in normal
saline (sodium chloride solution) or 5% glucose
solutions. The addition of 2 mg of Narcan Injection in 500 mL of
either solution provides a concentration of 4
micrograms/mL. Mixtures should be used within 24 hours. After 24
hours, the remaining unused solution must be
discarded. The rate of administration should be titrated in accordance
wit