Naloxone Hydrochloride Minijet 400 micrograms/ml Solution for injection

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

NALOXONE HYDROCHLORIDE

Dostupné z:

DLRC Pharma Services Limited

ATC kód:

V03AB; V03AB15

INN (Medzinárodný Name):

NALOXONE HYDROCHLORIDE

Dávkovanie:

400 microgram(s)/millilitre

Forma lieku:

Solution for injection

Terapeutické oblasti:

Antidotes; naloxone

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

1988-04-18

Príbalový leták

PATIENT INFORMATION LEAFLET: NALOXONE
HYDROCHLORIDE
MINIJET,
400 MICROGRAMS/ML SOLUTION FOR INJECTION
NALOXONE HYDROCHLORIDE
READ
ALL OF THIS LEAFLET CAREFULLY BEFORE
Y
OU
ARE GIVEN THIS
MEDICINE.
•
K
eep
t
his
leafle
t.
Y
ou
ma
y
need
t
o
r
ead
it
ag
ain
•
If
y
ou
ha
ve
an
y
fur
t
her
q
ues
tions,
ask
y
our
doctor or
nur
se
In this leaflet, Naloxone Hydrochloride
Mini
-
jet 400 micrograms/ml
solution
for
injection
will be called
N
alo
x
one.
IN THIS
LEAFLE
T
:
1. What Naloxone is
f
or
2. Before you are given
N
alo
x
one
3. How Naloxone will be given to
y
ou
4. Possible side
ef
fects
5. How to store
N
alo
x
one
6. Further
information.
1.
WHAT NALOXONE IS FOR
Naloxone
belongs
to
a
group
of
medicines
called “opioid antagonists.”
It
count
er
acts
strong
painkillers (opiates).
Naloxone
is
used
to
restore
the
body’s
breathing
if it has been affected by
s
tr
ong
painkillers (usually opioids such as
morphine,
heroin, methadone etc.) which may have
been
given during an operation for
e
x
am
ple.
It is also used for the same reason after
an
overdose
of these
drugs
has
been
taken,
or
when an overdose of opioids is
suspect
ed.
As Naloxone is only used in
medical
emergencies,
the injection will be given by
a
doctor or nurse
in a
hospit
al.
2.
BEFORE YOU ARE GIVEN
N
ALO
X
ONE
DO NOT USE NALOXONE
IF:
•
You are allergic to
N
alo
x
one
•
Y
ou
ar
e
aller
gic
t
o
an
y
of
t
he
o
t
her
ingredients in Naloxone (see section
6)
If
t
his
applies
t
o
y
ou
t
alk
t
o
y
our
doctor
or
nur
se.
CHECK
WITH YOUR DOCTOR BEFORE YOU ARE
GIV
EN
NALOXONE
IF:
•
You are addicted to heroin or similar
dr
ugs
•
You have heart or circulation
pr
oblems
•
Y
ou
ar
e
pr
egnant,
planning
pr
egnancy
or
br
eas
t-feeding
•
You have just had an
oper
ation
TELL
YOUR DOCTOR IF YOU ARE TAKING ANY OF
T
HE
FOLLOWING MEDICINES:
•
Medicines that may affect your
hear
t
•
An
y
o
t
her
medicine,
including
medicines
obtained without a
pr
escr
ip
tion.
PREGNANCY AND
BR
EAST-F
EEDING
T
ell
y
our
doctor
if
y
ou
ar
e
pr
egnant,
tr
ying
t
o
become pregnant

Súhrn charakteristických

Health Products Regulatory Authority
29 May 2019
CRN008TLL
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Naloxone Hydrochloride Minijet 400 micrograms/ml Solution for
injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 400 micrograms naloxone hydrochloride as naloxone
hydrochloride dihydrate.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection (injection)
A clear, colourless, solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Naloxone is indicated for the treatment of respiratory depression
induced by natural and synthetic opioids, such as codeine,
diamorphine, levorphanol, methadone, morphine, concentrated opium
alkaloid hydrochlorides and propoxyphene. It is also
useful for the treatment of respiratory depression caused by opioid
agonist/antagonists nalbuphine and pentazocine.
Naloxone is also used for the diagnosis of suspected acute opioid
overdose.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Naloxone hydrochloride may be administered by IV, IM or SC injection
or IV infusion.
Adults:
Naloxone may be diluted for intravenous infusion in normal saline or
5% dextrose solutions. The addition of 2 mg of naloxone
in 500 ml of either solution provides a concentration of 4
micrograms/ml. Infusion should be commenced as soon as
practicable after preparation of the mixture in order to reduce
microbiological hazards. Preparations not used within 24 hours
should be discarded.
The rate of administration should be titrated in accordance with the
patient’s response. Parenteral drug products should be
inspected visually for particulate matter and discolouration prior to
administration whenever solution and container permit.
Naloxone hydrochloride may be used postoperatively to reverse central
depression resulting from the use of opioids during
surgery. The usual dosage is 100 - 200 micrograms IV given at 2 to 3
minute intervals to obtain optimum respiratory response
while maintaining adequate analgesia. Additional doses may be