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NALOXONE 400 MICROGRAMS/ML SOLUTION FOR INJECTION

Active substance(s): NALOXONE HYDROCHLORIDE DIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
B. Braun Melsungen AG · 34209 Melsungen, Germany

Naloxone 400 micrograms/ml
solution for injection/infusion
naloxone hydrochoride
Read all of this leaflet carefully before this medicine is administered to you b­ ecause 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.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:
1. What Naloxone 400 micrograms/ml solution for injection/infusion is and
what it is used for
2. What you need to know 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. Contents of the pack and other information

Naloxone 400 micrograms/ml solution for injection/infusion
contains sodium
This medicinal product contains 3.8 mmol (88.5 mg) sodium per maximum
daily dose. Please tell your doctor, if you are on low sodium diet, he/she will
take it into account.

3. How Naloxone 400 micrograms/ml solution for
injection/infusion is administered
The recommended 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
1. What Naloxone 400 micrograms/ml solution for
given
­injection/infusion is and what it is used for
Children: 0.01 – 0.02 mg per kg body weight, if necessary additional injecNaloxone 400 micrograms/ml solution for injection/infusion is a drug used
tions of the same dose may be given
to counter the effects of opioid overdose, for example morphine overdose.
Diagnosis of opioid overdose or intoxication
Naloxone 400 micrograms/ml solution for injection/infusion is used for reAdults: 0.4 – 2 mg, if necessary the injections can be repeated at interversal of unwanted effects of opioids for countering life-threatening devals of 2 – 3 minutes. The maximum dose of 10 mg should not be
pression of the central nervous system and respiratory system (breathing
exceeded.
difficulties).
Children: 0.01 mg per kg body weight, if necessary an additional injection
Naloxone 400 micrograms/ml solution for injection/infusion is also used to
of 0.1 mg per kg may be given
diagnose an acute opioid overdose or intoxication.
If a woman was given analgetic drugs during labour, a newborn child can Reversal of the unwanted effects of opioids in neonates whose mothers
be treated with Naloxone 400 micrograms/ml solution for injection/infu- have received opioids
sion for reversal of unwanted effects of opioids, e.g. if he/she suffers from 0.01 mg per kg body weight, if necessary additional injections may be given
breathing problems or depression of central nervous system.
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
2. What you need to know before Naloxone
Naloxone 400 micrograms/ml solution for injection/infusion occurs. Addi400 micrograms/ml solution for injection/infusion is
tional doses may be given every 1 – 2 hours if necessary.
administered to you
In elderly patients with heart or circulation problems or in those receiving medicines that can produce heart or circulation disorders (e.g. cocaine,
Naloxone 400 micrograms/ml s­ olution for injection/infusion
methamphetamine, cyclic antidepressants, calcium channel blockers, betamust not be ­administered
• If you are allergic (hypersensitive) to naloxone hydrochloride or to any of blockers, digoxin) Naloxone 400 micrograms/ml solution for injection/infusion will be used with caution since serious side effects such as fast heart
the ingredients of this medicine (listed in section 6).
beat (ventricular tachycardia) and fibrillation have occurred.
Warnings and precautions
If you have the impression that the effect of Naloxone 400 micrograms/ml
Talk to your doctor or pharmacist before Naloxone 400 micrograms/ml solusolution for injection/infusion is too strong or too weak, talk to your doctor.
tion for injection/infusion is administered to you.
Special care will be taken
• If you are physically dependent to 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 too 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).

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 intravenous infusion (over a longer period).
Naloxone 400 micrograms/ml solution for injection/infusion will be given by
your anaesthetist or 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, this medicine can cause side effects, although not everybody gets them.
It may be difficult to know what side effects Naloxone 400 micrograms/
Tell your doctor or pharmacist if you are taking or have recently taken any ml solution for injection/infusion has, because it is always given after other
other medicines.
drugs have also been used.
• If you are taking painkilling medication like buprenorphine. The painkilling effect may even become stronger while you are treated with Naloxone The following side effects may be serious. If any of the follow400 micrograms/ml solution for injection/infusion. However, the reversal ing side effects occur, consult a doctor immediately:
of unwanted effects, like respiratory depression caused by buprenorphine Common (may affect up to 1 in 10 people):
is limited.
• Fast heart beat
• If you are taking sedatives, as Naloxone 400 micrograms/ml solution for Uncommon (may affect up to 1 in 100 people):
injection/infusion may possibly have a less rapid effect.
• Changes in the way your heart beats, slow heart rate
• If you are taking any medication that may affect your heart or circulation
Rare (may affect up to 1 in 1,000 people):
(e.g. antihypertensive drugs e.g. clonidine), even those not prescribed.
• Seizures
Naloxone 400 micrograms/ml solution for injection/infusion
Very rare (may affect up to 1 in 10,000 people):
with alcohol
• Allergic reactions (nettle rash, nasal catarrh or a cold, difficult breathing,
Please inform your doctor if you drank alcohol. In patients with multi-intoxQuincke’s oedema (giant swelling)), allergic shock
ication (with opioids and sedatives or alcohol) Naloxone 400 micrograms/ml • Fibrillation, cardiac arrest
solution for injection/infusion may have a less rapid effect.
• Fluids on the lungs (pulmonary oedema)

Other medicines and Naloxone 400 ­micrograms/ml solution for
injection/infusion

Pregnancy and breast-feeding

Other side effects include:

If you are pregnant or breast-feeding, think you may be pregnant or are Very common (may affect more than 1 in 10 people):
planning to have a baby, ask your doctor or pharmacist for advice before • Nausea
taking this medicine.

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Pregnancy
There is no adequate information available regarding the use of Naloxone
400 micrograms/ml solution for injection/infusion in pregnant women.
During pregnancy, your doctor will outweigh the benefit of Naloxone 400
micrograms/ml solution for injection/infusion against possible risks to the
unborn baby. Naloxone 400 micrograms/ml solution for injection/infusion
can cause withdrawal symptoms in the newborn baby.

2289
806/12621911/0116

PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT

Breastfeeding
It is not known whether Naloxone 400 micrograms/ml solution for injection/
infusion 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 is not recommended
for 24 hours after treatment

Naloxone
400 micrograms/ml
solution for
injection/infusion

Driving and using machines

naloxone hydrochoride

After receiving Naloxone 400 micrograms/ml solution for injection/infusion
for the reversal of the effects of opioids you must not take part in road
traffic, operate machinery or engage in any other physically or mentally
demanding activity for at least 24 hours since the effects of opioids may
possibly recur.

12621911_Naloxone_GIF_GA_neu_GB-IE_806__L04.indd 1

B|BRAUN
B. Braun Melsungen AG
34209 Melsungen
Germany

2289

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schwarz
Dokument = 210 x 447 mm
2 Seiten
Lätus
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GB/IE___806
806/12621911/0116
Naloxone 400 micrograms/ml
L04
GIF (GA)
Standort Jaen
Font size: 9 pt.
G 151462

Common (may affect up to 1 in 10 people):
• Dizziness, headache
• Increased or decreased blood pressure (you may have a headache or feel
faint)
• Vomiting
• If a too large 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 well as the effects on your breathing).
Uncommon (may affect up to 1 in 100 people)
• Involuntary trembling or quivering (tremor), sweating
• Diarrhoea, dry mouth
• Over breathing (hyperventilation)
• Irritation of vessel wall has been reported after i.v. administration; local
irritation and inflammation have been reported after i.m. administration.
Rare (may affect up to 1 in 1,000 people):
• Tension
Very rare (may affect up to 1 in 10,000 people):
• Discoloration and lesions of the skin (erythema multiforme)

Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
B. Braun Melsungen AG
Carl-Braun-Straße 1, 34212 Melsungen, Germany
Postal address:
34209 Melsungen, Germany
Phone: +49 5661/71-0, Fax: +49 5661/71-4567
Manufacturer:
hameln pharmaceuticals gmbh
Langes Feld 13, 31789 Hameln, Germany
Tel.: +49 5151/581-0, Fax: +49 5151/581-258
and
B. Braun Medical S.A.
Carretera de Terrassa, 121
08191 Rubí (Barcelona), Spain
This medicinal product is authorised in the Member States of the EEA under
the following names:

Reporting of side effects:

Austria

Naloxon B. Braun 0,4 mg/ml Injektions-/Infusionslösung

If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet.
You can also report side effects directly (see details below).
By reporting side effects you can help provide more information on the
safety of this medicine.
United Kingdom:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland:
HPRA Pharmacovigilance, Earlsfort Terrace,
IRL - Dublin 2; Tel: +353 1 6764971;
Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie

Belgium

Naloxon B. Braun 0,4 mg/ml oplossing voor injectie/
infusie

Denmark

Naloxon B. Braun injektions-/infusionsvæske, opløsning

Finland

Naloxon B. Braun 0,4 mg/ml injektio-/infuusioneste,
liuos

Germany

Naloxon B. Braun 0,4 mg/ml Injektions-/Infusionslösung

Greece

Naloxon B. Braun 0,4 mg/ml ενέσιμο διάλυμα/διάλυμα
για έγχυση

Iceland

Naloxon B. Braun 0,4 mg/ml stungulyf/innrennslislyf,
lausn

Ireland

Naloxone 400 micrograms/ml solution for injection/
infusion

Italy

Naloxone B. Braun 0,4 mg/ml soluzione iniettabile/per
infusione

Luxembourg

Naloxon B. Braun 0,4 mg/ml Injektions-/Infusionslösung

Norway

Naloxon B. Braun 0,4 mg/ml injeksjons-/infusjonsvæske,
oppløsning

Portugal

Naloxona B. Braun 0,4 mg/ml solução injetável/para
­perfusão

Spain

Naloxona B. Braun 0,4 mg/ml solución para inyección/­
perfusión

Sweden

Naloxon B. Braun 0,4 mg/ml injektions-/infusionsvätska,
lösning

The Netherlands

Naloxon HCl B. Braun 0,4 mg/ml, oplossing voor
­injectie/infusie

5. How to store Naloxone 400 ­micrograms/ml solution for
­injection/infusion
Keep this medicine out of the sight and reach of children.
This medicine 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.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and other information
What Naloxone 400 micrograms/ml s­ olution for injection/infusion contains

Naloxone 400 micrograms/ml solution for injection/
United
The active substance is naloxone hydrochloride.
infusion
Kingdom
Each ampoule with 1 ml contains 0.4 mg naloxone hydrochloride (as
naloxone hydrochloride dihydrate).
This leaflet was last revised in 06/2015.
The other ingredients are sodium chloride, hydrochloric acid diluted (for pH
adjustment) and water for injections.

What Naloxone 400 micrograms/ml s­ olution 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 ml solution for
injection/infusion.
Pack sizes: 5 and 10 ampoules
Not all pack sizes may be marketed.

The following information is intended for healthcare professionals only:
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.
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.

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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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