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NALOXONE 400 MICROGRAMS/ML SOLUTION FOR INJECTION

Active substance: NALOXONE HYDROCHLORIDE DIHYDRATE

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806/12614951/0514

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

Naloxone 400 micrograms/ml
solution for injection/infusion
naloxone hydrochoride

940

Read all of this leaflet carefully before this medicine is administered to you ­ ecause
b
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.
-  his medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
T
even if their signs of illness are the same as yours.
- f you get any side effects, talk to your doctor or pharmacist. This includes any possible side efI
fects 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

1.  hat Naloxone 400 micrograms/ml
W
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 was given analgetic 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 central nervous system.

2.  hat you need to know before
W
Naloxone 400 micrograms/ml
solution for injection/infusion is
administered to you
Naloxone 400 micrograms/ml solution
­
for injection/infusion must not be
a
­ dministered

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
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.
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

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 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.

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

• f you are allergic (hypersensitive) to naloxone Reversal of the unwanted effects of opioids
I
hydrochloride or to any of the ingredients of Adults:  – 0.2 mg, if necessary additional
0.1
this medicine (listed in section 6).
injections of 0.1 mg may be given
Children: 
0.01 – 0.02 mg per kg body weight, if
Warnings and precautions
necessary additional injections of the
Talk to your doctor or pharmacist before
same dose may be given
Naloxone 400 micrograms/ml solution for injecDiagnosis of opioid overdose or intoxication
tion/infusion is administered to you.
Adults:  – 2 mg, if necessary the injections
0.4
Special care will be taken
can be repeated at intervals of 2 – 3
• f you are physically dependent to opioids
I
minutes. The maximum dose of 10 mg
(for example morphine) or have received high
should not be exceeded.
doses of these drugs (you may get strong with- Children: 
0.01 mg per kg body weight, if necesdrawal symptoms after receiving Naloxone 400
sary an additional injection of 0.1 mg
micrograms/ml solution for injection/infusion
per kg may be given
because of a too rapid reversal of the opioid efReversal of the unwanted effects of opioids in
fect; these symptoms may be high blood pressure, palpitations, severe difficulties in breath- neonates whose mothers have received opioids
0.01 mg per kg body weight, if necessary addiing or cardiac arrest).
• f you have any heart or circulation problems tional injections may be given
I
(because side effects like high or low blood For reversal of the unwanted effects of opioids
pressure, palpitations or severe difficulties in (in adults, children and also in neonates) patients
breathing may appear more likely).
are monitored to ensure that the desired effect
of Naloxone 400 micrograms/ml solution for inOther medicines and Naloxone 400
jection/infusion occurs. Additional doses may be
m
­ icrograms/ml solution for injection/
given every 1 – 2 hours if necessary.
infusion
In elderly patients with heart or circulation probTell your doctor or pharmacist if you are taking or lems or in those receiving medicines that can
produce heart or circulation disorders (e.g. cohave recently taken any other medicines.
• f you are taking painkilling medication like caine, methamphetamine, cyclic antidepressants,
I
buprenorphine. The painkilling effect may calcium channel blockers, beta-blockers, digoxin)
even become stronger while you are treated Naloxone 400 micrograms/ml solution for injecwith Naloxone 400 micrograms/ml solution tion/infusion will be used with caution since serifor injection/infusion. However, the reversal of ous side effects such as fast heart beat (ventricuunwanted effects, like respiratory depression lar tachycardia) and fibrillation have occurred.
caused by buprenorphine is limited.
If you have the impression that the effect of
• f you are taking sedatives, as Naloxone 400 Naloxone 400 micrograms/ml solution for injecI
micrograms/ml solution for injection/infusion tion/infusion is too strong or too weak, talk to
may possibly have a less rapid effect.
your doctor.
• f you are taking any medication that may afI
fect your heart or circulation (e.g. antihyper- Method of administration
tensive drugs e.g. clonidine), even those not Naloxone 400 micrograms/ml solution for injecprescribed.
tion/infusion will be given to you always by intravenous or intramuscular injection (into a vein
Naloxone 400 micrograms/ml solution
or into a muscle) or, after dilution, as intravenous
for injection/infusion with alcohol
infusion (over a longer period). Naloxone 400
Please inform your doctor if you drank alcohol. micrograms/ml solution for injection/infusion
In patients with multi-intoxication (with opio- will be given by your anaesthetist or experienced
ids and sedatives or alcohol) Naloxone 400 mi- physician.
crograms/ml solution for injection/infusion may If you have any further questions on the use of
have a less rapid effect.
this product, ask your doctor or pharmacist.

B|BRAUN
12614951_Naloxon_Jaen_GIF_148x420mm_GB+IE_806.indd 1

14.05.14 11:17

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Dokument =  48 x 420 mm (bxh)
1
2 Seiten
Lätus

940

GB/IE___806
Naloxone 400 micrograms/ml
GIF – GA
806/12614951/0514
Standort Jaen
Font size: 9 pt.
G 130733

806/12614951/0514

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/ml solution for injection/infusion has, because it is always given after
other drugs have also been used.

940

The following side effects may be serious.
If any of the following side effects occur,
consult a doctor immediately:
Common (may affect up to 1 in 10 people):
•  ast heart beat
F
Uncommon (may affect up to 1 in 100 people):
•  hanges in the way your heart beats, slow
C
heart rate
Rare (may affect up to 1 in 1,000 people):
•  eizures
S
Very rare (may affect up to 1 in 10,000 people):
•  llergic reactions (nettle rash, nasal catarrh or
A
a cold, difficult breathing, Quincke’s oedema
(giant swelling)), allergic shock
•  ibrillation, cardiac arrest
F
•  luids on the lungs (pulmonary oedema)
F

Other side effects include:

Very common (may affect more than 1 in 10 people):
•  ausea
N
Common (may affect up to 1 in 10 people):
•  izziness, headache
D
• ncreased or decreased blood pressure (you
I
may have a headache or feel faint)
•  omiting
V
• f a too large dose is given after an operation,
I
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)
• nvoluntary trembling or quivering (tremor),
I
sweating
•  iarrhoea, dry mouth
D
•  ver breathing (hyperventilation)
O
• rritation of vessel wall has been reported after
I
i.v. administration; local irritation and inflammation have been reported after i.m. administration.
Rare (may affect up to 1 in 1,000 people):
•  ension
T
Very rare (may affect up to 1 in 10,000 people):
•  iscoloration and lesions of the skin (erythema
D
multiforme)

Reporting of side effects:

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 via:
United Kingdom:  ellow Card Scheme www.mhra.
Y
gov.uk/yellowcard.
Ireland: IMB Pharmacovigilance, Earlsfort Terrace,

IRL - Dublin 2; Tel: +353 1 6764971;
Fax: +353 1 6762517. Website: www.imb.ie;
e-mail: imbpharmacovigilance@imb.ie
By reporting side effects you can help provide
more information on the safety of this medicine.

5.  ow to store Naloxone 400
H
m
­ icrograms/ml solution for
i
­njection/infusion

6. Contents of the pack and other

information
What Naloxone 400 micrograms/ml
s
­ olution for injection/infusion contains

The active substance is naloxone hydrochloride.
Each ampoule with 1 ml 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
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.

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:
Austria
Naloxon B. Braun 0,4 mg/ml
Injektions-/Infusionslösung
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
Naloxona B. Braun 0,4 mg/ml
Portugal
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
Naloxone 400 micrograms/ml
United
solution for injection/infusion
Kingdom

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.
This leaflet was last revised in May 2014.

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 highmolecular-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.

B|BRAUN

12614951_Naloxon_Jaen_GIF_148x420mm_GB+IE_806.indd 2

B. Braun Melsungen AG
34209 Melsungen
Germany

14.05.14 11:17

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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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