NALOXONE SXP naloxone hydrochloride (as dihydrate) 400 microgram/1 mL solution for injection ampoule

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

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

متاح من:

Southern XP IP Pty Ltd

الشكل الصيدلاني:

Injection

تركيب:

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

طريقة التعاطي:

Intravenous, Subcutaneous, Intramuscular

الوحدات في الحزمة:

5 x 1 mL ampoules, 10 x 1 mL ampoules

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

Naloxone is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, codeine, morphine and heroin, and the mixed opioid agonist-antagonist analgesics such as pentazocine. Naloxone is also indicated for the diagnosis of suspected acute opioid overdosage.

ملخص المنتج:

Visual Identification: The solution is a clear, colourless solution.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

الوضع إذن:

Registered

تاريخ الترخيص:

2020-03-05

نشرة المعلومات

NALOXONE SXP
1
NALOXONE SXP
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 BEING GIVEN NALOXONE SXP?
NALOXONE SXP contains the active ingredient naloxone hydrochloride
dihydrate. NALOXONE SXP is used to reverses the effect
of opium-like substances such as morphine, heroin and codeine.
For more information, see Section 1. Why am I being given NALOXONE
SXP?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN NALOXONE SXP?
You should not be given NALOXONE SXP if you have ever had an allergic
reaction to this medicine 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 am
given NALOXONE SXP?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with NALOXONE SXP 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 AM I GIVEN NALOXONE SXP?
•
NALOXONE SXP Injection is given as an injection into a muscle, under
the skin or as a slow injection into a vein.
•
NALOXONE SXP Injection should only be given by a doctor or nurse. Your
doctor will decide on the dose.
•
In emergency situations, NALOXONE SXP may be given by paramedical
staff, such as an ambulance attendant.
•
More instructions can be found in Section 4. How am I given NALOXONE
SXP?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN NALOXONE SXP?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist that you visit that you have
been given NALOXONE SXP.
•
Tell your doctor if you are pregnant, intending to become pregnant or
are breastfeeding.
•
Tell your doctor if you have heart disease, lung disease, drug
addiction, kidney disease or liver disease.
•
If you feel light-

خصائص المنتج

1
AUSTRALIAN PRODUCT INFORMATION – NALOXONE SXP
(NALOXONE HYDROCHLORIDE DIHYDRATE) INJECTION
1
NAME OF THE MEDICINE
Naloxone hydrochloride dihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains naloxone hydrochloride (as dihydrate) 400
microgram in 1 mL. The
preparation has a pH of approximately 3.5.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Naloxone Hydrochloride Injection is a sterile, clear, colourless
solution, free from
visible particulates.
Naloxone is a semi-synthetic opioid antagonist which differs
structurally from
oxymorphone only in that the methyl group on the nitrogen atom of
oxymorphone is
replaced by an allyl group.
Naloxone hydrochloride dihydrate is 17-allyl-4,5
α-epoxy-3,14-dihydroxymorphinan-6-
one
hydrochloride.
Naloxone hydrochloride dihydrate occurs as a white to slightly
off-white powder
and is soluble in water, dilute acids and strong alkalis and is
slightly soluble in
alcohol. It is practically insoluble in ether or chloroform.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Naloxone is indicated for the complete or partial reversal of opioid
depression,
including respiratory depression, induced by natural and synthetic
opioids including
propoxyphene,
methadone, codeine, morphine and heroin, and the mixed opioid
agonist-antagonist analgesics such as pentazocine. Naloxone is also
indicated for the
diagnosis of suspected acute opioid overdosage.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
USE IN ADULTS
OPIOID OVERDOSAGE – KNOWN OR SUSPECTED:
An initial dose of 400 microgram (0.4 milligram) to 2 milligram of
naloxone
hydrochloride may be administered intravenously.
This dose may be repeated at
2 to 3 minute intervals, if necessary. If no response is seen after a
total of 10 milligram
has been administered, the diagnosis of opioid-induced or partial
opioid-induced
toxicity should be questioned. If the intravenous route is not
available, the
medicine
may be administered by intramuscular or subcutaneous injection.