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NALOXONE 400 MICROGRAMS/ML SOLUTION FOR INJECTION/INFUSION

Active substance: NALOXONE HYDROCHLORIDE DIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

hameln

Read all of this leaflet carefully before this medicine is administered to you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms
are the same as yours.
- If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

Naloxone 400 micrograms/ml solution for injection/infusion
- naloxone hydrochloride -

In this leaflet:
1.
What Naloxone 400 micrograms/ml solution for
injection/infusion is and what it is used for
2.
Before Naloxone 400 micrograms/ml solution for
injection/infusion is administered to you
3.
How Naloxone 400 micrograms/ml solution for
injection/infusion is administered
4. Possible side effects
5. How to store Naloxone 400 micrograms/ml solution for
injection/infusion
6. Further information
1. WHAT NALOXONE 400 MICROGRAMS/ML
SOLUTION FOR INJECTION/INFUSION IS AND
WHAT IT IS USED FOR
Naloxone 400 micrograms/ml solution for injection/
infusion is a drug used to counter the effects of opioid
overdose, for example morphine overdose.
Naloxone 400 micrograms/ml solution for injection/
infusion is used for reversal of unwanted effects of
opioids for countering life-threatening depression of
the central nervous system and respiratory system
(breathing difficulties).
Naloxone 400 micrograms/ml solution for injection/
infusion is also used to diagnose an acute opioid
overdose or intoxication.
If a woman has been given analgesic drugs during
labour, a newborn child can be treated with Naloxone
400 micrograms/ml solution for injection/infusion for
reversal of unwanted effects of opioids, e.g. if he/she
suffers from breathing problems or depression of the
central nervous system.
2. BEFORE NALOXONE 400 MICROGRAMS/
ML SOLUTION FOR INJECTION/INFUSION IS
ADMINISTERED TO YOU
Naloxone 400 micrograms/ml solution for injection/
infusion must not be administered
- If you are allergic (hypersensitive) to naloxone
hydrochloride or to any of the ingredients of this
medicinal product.
Take special care with Naloxone 400 micrograms/ml
solution for injection/infusion and tell your doctor
- If you are physically dependent on opioids (for
example morphine) or have received high doses of
these drugs (you may get strong withdrawal symptoms
after receiving Naloxone 400 micrograms/ml solution
for injection/infusion because of a rapid reversal of
the opioid effect; these symptoms may be high blood
pressure, palpitations, severe difficulties in breathing
or cardiac arrest).
- If you have any heart or circulation problems
(because side effects like high or low blood pressure,
palpitations or severe difficulties in breathing may
appear more likely).
Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
- If you are taking painkilling medication like
buprenorphine. The painkilling effect may even
become stronger while you are treated with Naloxone
400 micrograms/ml solution for injection/infusion.
However, the reversal of unwanted effects, like
respiratory depression caused by buprenorphine is
limited.
- you are taking sedatives, as Naloxone
If
400 micrograms/ml solution for injection/infusion may

possibly have a less rapid effect.
- If you are taking any medication that may affect your
heart or circulation (e.g. antihypertensive drugs e.g.
clonidine), even those not prescribed.
Using Naloxone 400 micrograms/ml solution for
injection/infusion with food and drink
Please inform your doctor if you drank alcohol. In patients
with multi-intoxication (with opioids and sedatives or
alcohol) Naloxone 400 micrograms/ml solution for
injection/infusion may have a less rapid effect.
Pregnancy and breast-feeding
There is no sufficient information available regarding
the use of Naloxone 400 micrograms/ml solution for
injection/infusion in pregnant women. During pregnancy,
your doctor will assess the benefit of Naloxone
400 micrograms/ml solution for injection/infusion against
possible risks to the embryo or to the foetus.
It is not known whether Naloxone 400 micrograms/ml
solution/infusion for injection passes into breast milk
and it has not been established whether infants who are
breast-fed are affected by Naloxone 400 micrograms/ml
solution for injection/infusion. Therefore, breast-feeding
should be avoided for 24 hours after treatment. Ask your
doctor for advice before taking any medicine.
Driving and using machines
After receiving Naloxone 400 micrograms/ml solution
for injection/infusion for the reversal of the effects of
opioids you must not drive a vehicle, operate machinery
or engage in any other physically or mentally demanding
activity for at least 24 hours as the effects of opioids may
possibly recur.
Important information about some of the ingredients
of Naloxone 400 micrograms/ml solution for
injection/infusion
This medicinal product contains 3.8 mmol (88.5 mg)
sodium per maximum daily dose. Please tell your doctor,
if you are on a low sodium diet, he/she will take it into
account.
3. HOW
NALOXONE
400
MICROGRAMS/ML
SOLUTION
FOR
INJECTION/INFUSION
IS
ADMINISTERED
The usual doses given to you are
Reversal of the unwanted effects of opioids
Adults:
0.1-0.2 mg, if necessary additional injections
of 0.1 mg may be given
Children: 0.01-0.02 mg per kg body weight, if
necessary additional injections of the same
dose may be given
Diagnosis of opioid overdose or intoxication
Adults:
0.4-2 mg, if necessary the injections can
be repeated at intervals of 2-3 
minutes.
The maximum dose of 10 mg should not be
exceeded.
Children: 0.01 mg per kg body weight, if necessary an
additional injection of 0.1 mg per kg may be
given
Reversal of the unwanted effects of opioids in neonates
whose mothers have received opioids
0.01 mg per kg body weight, if necessary additional
injections may be given:
For reversal of the unwanted effects of opioids (in adults,
children and also in neonates) patients are monitored
to ensure that the desired effect of Naloxone 400
micrograms/ml solution for injection/infusion occurs.
Additional doses may be given every 1-2 hours if
necessary.

--------------------------------------------------------------------------------------------------------------------The following information is intended for medical or
healthcare professionals only:

hameln

Naloxone 400 micrograms/ml solution for injection/infusion
Shelf-life after first opening
After first opening the medicinal product should be used
immediately.
Shelf-life after dilution
Chemical and physical in-use stability has been
demonstrated for 24 hours below 25°C.

From the microbiological point of view, the dilutions
should be used immediately. If not used immediately,
in-use storage times and conditions prior to use are the
responsibility of the user and would normally not be longer
than 24 hours at 2 to 8°C, unless dilution has taken place
in controlled and validated aseptic conditions.

In elderly patients with heart or circulation problems or
in those receiving medicines that can produce heart or
circulation disorders (e.g. cocaine, methamphetamine,
tricyclic antidepressants, calcium channel blockers, betablockers, digoxin) Naloxone 400 micrograms/ml solution
for injection/infusion will be used with caution since
serious side effects such as fast heart beats (ventricular
tachycardia and fibrillation) have occurred.
If you have the impression that the effect of Naloxone
400 micrograms/ml solution for injection/infusion is too
strong or too weak, talk to your doctor.
Method of administration
Naloxone 400 micrograms/ml solution for injection/
infusion will be given to you always by intravenous or
intramuscular injection (into a vein or into a muscle) or,
after dilution, as an intravenous infusion (over a longer
period). Naloxone 400 micrograms/ml solution for
injection/infusion will be given by your anaesthetist or an
experienced physician.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Naloxone 400 micrograms/ml solution
for injection/infusion can cause side effects, although not
everybody gets them.
The frequency of side effects is classified into the
following categories:
Very common

in more than 1 in 10 patients

Common

in more than 1 in 100 patients,
but less than 1 in 10 patients

Uncommon

in more than 1 in 1,000 patients,
but less than 1 in 100 patients

Rare

in more than 1 in 10,000 patients,
but less than 1 in 1,000 patients

Very rare

in less than 1 in 10,000 patients,
including isolated reports

It may be difficult to know what side effects Naloxone
400 micrograms/ml solution for injection/infusion has,
because it is always given after other drugs have also
been used.
Immune system disorders
Very rare:
Allergic reactions (nettle rash, nasal
catarrh or a cold, difficulty breathing,
Quincke’s oedema (facial swelling)),
allergic shock.
Nervous system disorders
Common:
Dizziness, headache.
Uncommon:
Involuntary trembling or quivering
(tremour), sweating.
Rare:
Seizures, tension.
Cardiac disorders
Common:
Fast heart beat.
Uncommon:
Changes in the way your heart beats,
slow heart rate.
Very rare:
Fibrillation, cardiac arrest.
Vascular disorders
Common:
Increased or decreased blood
pressure (you may have a headache
or feel faint).
Respiratory disorders
Very rare:
Fluid on the lungs (pulmonary
oedema).
Gastrointestinal disorders
Very common: Nausea.
Common: Vomiting.
Uncommon:
Diarrhoea, dry mouth.
Skin and subcutaneous tissue disorders
Very rare:
Discolouration and lesions of the skin
(erythema multiforme).
General disorders and administration site conditions
Common:
If too large a dose is given after an
operation, you may become excited
and feel pain (because the painkilling
effects of the medicines you were
given will have been counteracted as

Uncommon:

well as the effects on your breathing).
Over breathing (hyperventilation),
irritation of the blood vessel wall has
been reported after i.v. administration;
local irritation and inflammation
have been reported after i.m.
administration.

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.mhra.gov.
uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE NALOXONE 400 MICROGRAMS/
ML SOLUTION FOR INJECTION/INFUSION
Keep out of the reach and sight of children.
Naloxone 400 micrograms/ml solution for injection/
infusion must not be administered after the expiry date,
which is stated on the ampoule label and the carton. The
expiry date refers to the last day of that month.
Keep the ampoules in the outer carton in order to protect
from light.
Store below 25°C.
Store diluted solutions below 25°C.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
to protect the environment.
6. FURTHER INFORMATION
What Naloxone 400 micrograms/ml solution for
injection/infusion contains
The active substance is naloxone hydrochloride.
Each 1 ml ampoule contains 0.4 mg naloxone
hydrochloride (as naloxone hydrochloride dihydrate).
The other ingredients are sodium chloride, hydrochloric
acid diluted (for pH adjustment) and water for injections.
What Naloxone 400 micrograms/ml solution for
injection/infusion looks like and contents of the pack
Naloxone 400 micrograms/ml solution for injection/
infusion is a clear and colourless solution in colourless
glass ampoules containing 1  solution for injection/
ml
infusion.
Pack sizes: 5 and 10 ampoules
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing authorisation holder
hameln pharma plus gmbh
Langes Feld 13, 31789 Hameln, Germany
Manufacturer
hameln pharmaceuticals gmbh
Langes Feld 13, 31789 Hameln, Germany
This medicinal product is authorised in the Member
States of the EEA under the following names:
Denmark

Naloxon Hameln 0,4 mg/ml
injektions- og infusionsvæske,
opløsning

Germany

Naloxon-hameln 0,4 mg/ml
Injektions-/Infusionslösung

Norway

Naloxon Hameln 0,4 mg/ml
injeksjons-/infusjonsvæske,
oppløsning

Sweden

Naloxon Hameln 0,4 mg/ml
injektions-/infusionsvätska, lösning

The Netherlands

Naloxon HCl-hameln 0,4 mg/ml,
oplossing voor injectie/infusie

United Kingdom

Naloxone 400 micrograms/ml
solution for injection/infusion

This leaflet was last approved in 07/2014
xxxxx/29/14

--------------------------------------------------------------------------------------------------------------------For i.v. infusion Naloxone 400 micrograms/ml solution
for injection/infusion is diluted only with sodium chloride
0.9% or glucose 5%. 5 
ampoules of Naloxone 400
micrograms/ml solution for injection/infusion (2 mg) per
500 ml give 4 µg/ml.
It is recommended that infusions of Naloxone
400 micrograms/ml solution for injection/infusion should
not be mixed with preparations containing bisulphite,
metabisulphite, long-chain or high-molecular-weight
anions, or solutions with an alkaline pH.

This medicinal product is for single use only.
Please inspect the medicinal product visually prior to
use (also after dilution). Use only clear and colourless
solutions practically free from particles.

xxxxx/29/14

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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