Naloxone Hydrochloride 400 micrograms/ml Solution for Injection or Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

NALOXONE HYDROCHLORIDE

Available from:

Mercury Pharmaceuticals (Ireland) Ltd

ATC code:

V03AB; V03AB15

INN (International Name):

NALOXONE HYDROCHLORIDE

Dosage:

400 microgram(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion

Prescription type:

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

Therapeutic area:

Antidotes; naloxone

Authorization status:

Marketed

Authorization date:

1989-10-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
NALOXONE HYDROCHLORIDE 400 MICROGRAMS/ML SOLUTION FOR
INJECTION/INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 pharmacist.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
The
name
of
your
medicine
is
Naloxone
Hydrochloride
400
micrograms/ml
solution
for
injection/infusion, it will be called Naloxone Injection for ease here
after.
WHAT IS IN THIS LEAFLET:
1.
What Naloxone Injection is and what it is given for
2.
What you need to know before you are given Naloxone Injection
3.
How Naloxone Injection is given to you
4.
Possible side effects
5.
How to store Naloxone Injection
6.
Contents of the pack and other information
1.
WHAT NALOXONE INJECTION IS AND WHAT IT IS GIVEN FOR
Naloxone belongs to a group of medicines known as opioid
antagonist. Opioid medicines are strong
painkillers such as
morphine
and codeine.
In
high doses
these
painkillers can
result
in
side
effects
which
cause
difficulty
in
breathing
and
drowsiness.
These effects can be reversed by an opioid antagonist
(blocks the effects of opioids).
Naloxone Injection may be used:
•
to reverse the depressant effects on breathing caused by opioid
painkillers
•
to help determine whether a patient has taken or received an overdose
of opioid drugs
•
to reverse the depressant effects on breathing and on other parts of
the brain and spinal cord in
newborn babies (resulting from the use of opioid painkillers in the
mother during childbirth).
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NALOXONE INJECTION
YOU SHOULD NOT BE GIVEN NALOXONE INJECTION
•
if you are allergic to Naloxone hydrochloride or any of the other
ingredients of this medicine
(listed in Section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before you are g

Summary of Product characteristics

Health Products Regulatory Authority
11 October 2023
CRN00D7RR
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Naloxone Hydrochloride 400 micrograms/ml Solution for Injection or
Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml ampoule of solution contains naloxone hydrochloride
dihydrate equivalent to 400 micrograms (0.4 mg) naloxone
hydrochloride.
Excipient with known effect
Each 1 ml of solution contains 3.55 mg sodium
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the reversal of opioid depression, including respiratory
depression, caused by natural or synthetic opioids, the
agonist-antagonists nalbuphine and pentazocine, or dextropropoxyphene.
Naloxone may also be used for the diagnosis of
suspected opioid overdosage. Naloxone may be used to reverse
respiratory and other CNS depression in the neonate, resulting
from administration of narcotic analgesics to the mother during
labour.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Opioid overdosage (known or suspected).
_Adults_
An initial dose of 400 to 2000 micrograms (0.4 mg to 2 mg) of naloxone
may be given intravenously and may, if required, be
repeated at 2 to 3 minute intervals. The diagnosis of opioid-related
toxicity should be reconsidered if there is still failure to
respond after a total of 10 mg of naloxone has been administered. If
intravenous administration is impracticable, naloxone may
be administered by the intramuscular or subcutaneous route.
The duration of action of some opioids (including dextropropoxyphene,
dihydrocodeine and methadone) may exceed that of
naloxone. In these circumstances, an intravenous infusion of naloxone
will provide sustained antagonism of the opioid and
obviate the need for repeated injections. Naloxone may be diluted for
intravenous infusion in 0.9% (normal) saline or 5%
dextrose in water or saline. Addition of 2 mg of naloxone to 50