Narcan 3.6 mg Nasal Spray, solution in a single dose container

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Naloxone hydrochloride dihydrate

Boleh didapati daripada:

Emergent Operations Ireland Limited

Kod ATC:

V03AB; V03AB15

INN (Nama Antarabangsa):

Naloxone hydrochloride dihydrate

Dos:

3.6 milligram(s)

Borang farmaseutikal:

Nasal spray, solution in single-dose container

Jenis preskripsi:

Product subject to prescription which may not be renewed (A)

Kawasan terapeutik:

Antidotes; naloxone

Status kebenaran:

Not marketed

Tarikh kebenaran:

2018-03-23

Risalah maklumat

Revision: 02
1
October 2020
PACKAGE LEAFLET: INFORMATION FOR THE USER
NARCAN 1.8 MG NASAL SPRAY, SOLUTION IN SINGLE DOSE CONTAINER.
NARCAN 3.6 MG NASAL SPRAY, SOLUTION IN SINGLE DOSE CONTAINER.
naloxone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet (See section 4).
WHAT IS IN THIS LEAFLET
1.
What Narcan is and what it is used for
2.
What you need to know before you are given Narcan
3.
How Narcan is to be given
4.
Possible side effects
5.
How to store Narcan
6.
Contents of the pack and other information
1.
WHAT NARCAN IS AND WHAT IT IS USED FOR
This medicine contains the active substance naloxone. Narcan
temporarily reverses the effects of
opioids such as heroin, methadone, fentanyl, oxycodone, buprenorphine
and morphine.
Narcan is a nasal spray used for the emergency treatment of opioid
overdose or possible opioid
overdose in adults.
SIGNS AND SYMPTOMS OF AN OPIOID OVERDOSE
includes:

breathing problems

extreme sleepiness

extremely small pupils in the eye

not responding to a loud noise or touch
IF YOU ARE AT RISK OF AN OPIOID OVERDOSE YOU SHOULD ALWAYS CARRY
NARCAN WITH YOU.
Narcan works
for a short time only to reverse the effects of opioids while you wait
for emergency medical attention.
It is not a substitute for emergency medical care. Narcan is intended
for use by appropriately trained
individuals.
Always tell your friends and family that you carry Narcan with you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NARCAN
YOU SHOULD NOT BE GIVEN NARCAN
-
if you are allergic
to naloxone or any of the other ingredients of this medicine (listed
in section
6).
WARNINGS AND PRECAUTIONS
_ _
Narcan will be supplied to you only after you or the person who will
be giving the medicine to you
have been t

Ciri produk

Health Products Regulatory Authority
23 March 2021
CRN00C3YS
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Narcan 3.6 mg Nasal Spray, solution in a single dose container
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.1 mL dose contains naloxone hydrochloride dihydrate equivalent
to 3.6 mg naloxone.
_Excipient with known effect_
Benzalkonium chloride 0.01 mg per dose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal Spray, solution in single dose container.
A clear or colourless or slightly yellow, buffered solution intended
for nasal administration
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Narcan is intended for emergency reversal of respiratory and/or
central nervous system depression induced by or suspected to
be induced by opioids (natural or synthetic), in healthcare settings
and in non-medical settings by appropriately trained
individuals.
Narcan is indicated for use in adults only.
Narcan is not a substitute for emergency medical care.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Narcan may be made available once the prescriber has assessed the
suitability and competence of an individual to administer
naloxone in the appropriate circumstances.
Narcan may need to be used in a non-medical setting. Therefore, the
prescriber as per local
clinical guidance should take appropriate steps to ensure that the
patient thoroughly understands the indications and use of
Narcan.
The choice of a 1.8 mg or 3.6 mg dose depends on the specific
particulars of each case and the following factors should be
taken into account: the type and amount of opioid which has been
taken, patient co-morbidities and concomitant drug or
alcohol usage. In opioid-dependent patients expected to be at risk of
severe opioid withdrawal, Narcan 1.8 mg should be
administered. Subjects believed to have taken high potency opioids
such as fentanyl should be administered the 3.6 mg dose,
as they may require larger doses of Narcan in order to achieve a
response. In cases where