NALOXONE 400 MICROGRAMS/ML SOLUTION FOR INJECTION

Active substance: NALOXONE HYDROCHLORIDE DIHYDRATE

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806/12614951/0214

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 because
it contains important information for you.

–  eep this leaflet. You may need to read it again.
K
– 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:

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
1. What Naloxone 400 micrograms/
into breast milk and it has not been established
ml solution for injection/infusion is whether infants who are breast-fed are affected
by Naloxone 400 micrograms/ml solution for inand what it is used for
jection/infusion. Therefore, breast-feeding is not
Naloxone 400 micrograms/ml solution for injec- recommended for 24 hours after treatment
tion/infusion is a drug used to counter the effects
of opioid overdose, for example morphine overdose. Driving and using machines
Naloxone 400 micrograms/ml solution for injec- After receiving Naloxone 400 micrograms/ml sotion/infusion is used for reversal of unwanted ef- lution for injection/infusion for the reversal of the
fects of opioids for countering life-threatening effects of opioids you must not take part in road
depression of the central nervous system and res- traffic, operate machinery or engage in any other
physically or mentally demanding activity for at
piratory system (breathing difficulties).
Naloxone 400 micrograms/ml solution for injec- least 24 hours since the effects of opioids may
tion/infusion is also used to diagnose an acute possibly recur.
opioid overdose or intoxication.
Naloxone 400 micrograms/ml solution for
If a woman was given analgetic drugs dur- injection/infusion contains sodium
ing labour, a newborn child can be treated with
Naloxone 400 micrograms/ml solution for injec- This medicinal product contains 3.8 mmol (88.5
tion/infusion for reversal of unwanted effects of mg) sodium per maximum daily dose. Please tell
opioids, e.g. if he/she suffers from breathing prob- your doctor, if you are on low sodium diet, he/she
will take it into account.
lems or depression of central nervous system.
1.  hat Naloxone 400 micrograms/ml solution
W
for injection/infusion is and what it is used for
2.  hat you need to know before Naloxone 400
W
micrograms/ml solution for injection/infusion
is administered to you
3.  ow Naloxone 400 micrograms/ml solution for
H
injection/infusion is administered
4.  ossible side effects
P
5.  ow to store Naloxone 400 micrograms/ml soH
lution for injection/infusion
6. Contents of the pack and other information

3. How Naloxone 400 micrograms/
2. What you need to know before
ml solution for injection/infusion is
Naloxone 400 micrograms/ml soluadministered
tion for injection/infusion is administered to you
The recommended doses given to you are

Naloxone 400 micrograms/ml solution for Reversal of the unwanted effects of opioids
Adults:  – 0.2 mg, if necessary additional in0.1
injection/ must not be administered
jections of 0.1 mg may be given

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

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.

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.

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12.02.14 09:07

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

940

GB/IE___806
Naloxone 400 micrograms/ml
GIF – GA
806/12614951/0214
Standort Jaen
Font size: 9 pt.
G 130733

806/12614951/0214

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):
• Fast heart beat
Uncommon (may affect up to 1 in 100 people):
•  hanges in the way your heart beats, slow heart
C
rate
Rare (may affect up to 1 in 1,000 people):
• Seizures

940

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
• Fibrillation, cardiac arrest
• Fluids on the lungs (pulmonary oedema)

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
Other side effects include:
Postal address:
Very common (may affect more than 1 in 10 peo- 34209 Melsungen
Germany
ple):
• Nausea
Phone: +49 5661/71-0
Fax: +49 56 61/71-45 67
Common (may affect up to 1 in 10 people):
• Dizziness, headache
Manufacturer:
• ncreased or decreased blood pressure (you may hameln pharmaceuticals gmbh
I
have a headache or feel faint)
Langes Feld 13, 31789 Hameln,
• Vomiting
Germany
• f a too large dose is given after an operation,
I
you may become excited and feel pain (because Tel.: +49 5151/581-0
the painkilling effects of the medicines you Fax: +49 5151/581-258
were given will have been counteracted as well and
as the effects on your breathing).
B. Braun Medical S. A.
Carretera de Terrassa, 121
Uncommon (may affect up to 1 in 100 people)
• nvoluntary trembling or quivering (tremor), 08191 Rubí (Barcelona), Spain
I
sweating
This medicinal product is authorised in the ­ ember
M
• Diarrhoea, dry mouth
States of the EEA under the following names:
• Over breathing (hyperventilation)
• rritation of vessel wall has been reported after Austria
I
Naloxon B. Braun 0,4 mg/ml
i.v. administration; local irritation and inflamInjektions-/Infusionslösung
mation have been reported after i.m. adminisBelgium
Naloxon B. Braun 0,4 mg/
tration.
ml oplossing voor injectie/
Rare (may affect up to 1 in 1,000 people):
infusie
• Tension
Denmark
Naloxon B. Braun injekVery rare (may affect up to 1 in 10,000 people):
tions-/infusionsvæske,
•  iscoloration and lesions of the skin (erythema
D
opløsning
multiforme)
Finland
Naloxon B. Braun 0,4 mg/ml
If you get any side effects, talk to your doctor
injektio-/infuusioneste, liuos
or pharmacist. This includes any possible side
Germany
Naloxon B. Braun 0,4 mg/ml
effects not listed in this leaflet.
Injektions-/Infusionslösung
Greece
Naloxon B. Braun 0,4 mg/ml
5.  ow to store Naloxone 400 micro­
H
ενέσιμο διάλυμα/διάλυμα για
grams/ml solution for injection/­
έγχυση
infusion
Iceland
Naloxon B. Braun 0,4 mg/
Keep this medicine out of the sight and reach of
ml stungulyf/­nnrennslislyf,
i
children.
lausn
This medicine must not be administered after the
Naloxone 400 micrograms/
expiry date, which is stated on the ampoule label Ireland
ml solution for injection/
and the carton. The expiry date refers to the last
infusion
day of that month.
Keep the ampoules in the outer carton in order to Italy
Naloxone B. Braun 0,4 mg/
protect from light.
ml soluzione iniettabile/per
Store below 25°C.
infusione
Store diluted solutions below 25°C.
Luxembourg
Naloxon B. Braun 0,4 mg/ml
Do not throw away any medicines via wastewater
Injektions-/Infusionslösung
or household waste. Ask your pharmacist how to
Norway
Naloxon B. Braun 0,4 mg/ml
throw away medicines you no longer use. These
injeksjonsvæske/infusjonsmeasures will help protect the environment.
væske, oppløsning
Portugal
Naloxona B. Braun 0,4 mg/
6. Contents of the pack and other
ml solução injetável/para
information
perfusão
What Naloxone 400 micrograms/ml
Spain
Naloxona B. Braun 0,4 mg/
s
­ olution for injection/infusion contains
ml solución para inyección/
perfusión
The active substance is naloxone hydrochloride.
Each ampoule with 1 ml contains 0.4 mg naloxone Sweden
Naloxon B. Braun 0,4 mg/ml
hydrochloride (as naloxone hydrochloride dihyinjektions-/­nfusionsvätska,
i
drate).
lösning
The other ingredients are sodium chloride, hydro- The Netherlands Naloxon HCl B. Braun 0,4
chloric acid diluted (for pH adjustment) and water
mg/ml, oplossing voor injecfor injections.
tie/infusie
United Kingdom Naloxone 400 micrograms/
ml solution for injection/
infusion
This leaflet was last revised in August 2013.
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-molecularweight 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

12.02.14 09:07

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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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