NALOXONE 400 MICROGRAMS/ML SOLUTION FOR INJECTION

Active substance: NALOXONE HYDROCHLORIDE DIHYDRATE

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806/LLD002/21/07

Package leaflet:
Information for the Patient
B. Braun Melsungen AG · 34209 Melsungen · Germany

Naloxone
400 micrograms/ml
solution for injection
naloxone hydrochoride
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 gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Naloxone is and what it is used for
2. Before Naloxone is administered to you
3. How Naloxone is administered
4. Possible side effects
5. How to store Naloxone
6. Further information

Driving and using machines
After receiving Naloxone for the reversal of the
effects of opioids you must not drive, 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.
Important information about some of the ingredients of Naloxone
This medicinal product contains 3.8 mmol (88.5 mg)
sodium per maximum daily dose of 10 mg naloxone
hydrochloride. Please tell your doctor if you are on a
low sodium diet, he/she will take it into account.

3. How Naloxone is administered

Take special care with Naloxone 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 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 be more likely).

In elderly patients with heart or circulation problems or in those receiving medicines that can produce heart or circulation disorders (e.g. cocaine,
methamphetamine, cyclic antidepressants, calcium
channel blockers, beta-blockers, digoxin) Naloxone
should be used with caution since serious side
effects such as fast heart beat (ventricular tachycardia) and fibrillation have occurred.
If you have the impression that the effect of Naloxone is too strong or too weak, talk to your doctor.

Method of administration
Naloxone will be given to you always by intravenous or intramuscular injection (into a vein or
into a muscle) or, after dilution, as intravenous infuTaking other medicines
Please tell your doctor or pharmacist if you are tak- sion (over a longer period). Naloxone will be given
ing or have recently taken any other medicines, by your anaesthetist or experienced physician.
including medicines obtained without a prescrip- If you have any further questions on the use of this
product, ask your doctor or pharmacist.
tion.
- If you are taking painkilling medication like
buprenorphine, as the painkilling effect may
become stronger while you are treated with 4. Possible side effects
Naloxone. However, the reversal of unwanted
effects, like respiratory depression caused by Like all medicines, Naloxone can cause side effects,
although not everybody gets them.
buprenorphine is limited.
- If you are taking sedatives, as Naloxone may posThe frequency of side effects is classified into the
sibly have a less rapid effect.
- If you are taking any medication that may affect following categories:
your heart or circulation (e.g. antihypertensive
Very common in more than 1 in 10 patients
drugs e.g. clonidine), even those not prescribed.
Using Naloxone with food and drink
Please inform your doctor if you drink alcohol. In
patients with multi-intoxication (with opioids and
sedatives or alcohol) Naloxone may have a less
rapid effect.
Pregnancy and breast-feeding
There is no sufficient information available regarding the use of Naloxone in pregnant women. During
pregnancy, your doctor will outweigh the benefit of
Naloxone against possible risks to the embryo or to
the foetus.
It is not known whether Naloxone passes into
breast milk and it has not been established whether
infants who are breast-fed are affected by Naloxone. Therefore, breast-feeding should be avoided
for 24 hours after treatment. Ask your doctor for
advice before taking any medicine.

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 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, difficult breathing,
Quincke’s oedema (localised swelling causing large hives)), allergic
shock.

B|BRAUN

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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 nec1. What is and what it is used for
essary additional injections of the same
dose may be given
Naloxone is a drug used to counter the effects of
opioid overdose, for example morphine overdose.
Diagnosis of opioid overdose or intoxication
Naloxone is used for reversal of unwanted effects of Adults: 0.4 – 2 mg, if necessary the injections can
be repeated at intervals of 2 – 3 minutes.
opioids for countering life-threatening depression
The maximum dose of 10 mg should not
of the central nervous system and respiratory sysbe exceeded.
tem (breathing difficulties).
Naloxone is used to diagnose an acute opioid over- Children: 0.01 mg per kg body weight, if necessary
an additional injection of 0.1 mg per kg
dose or intoxication.
may be given
Naloxone is used for reversal of depression of the
central nervous system and respiratory system
(breathing difficulties) in the newborn child whose Reversal of the unwanted effects of opioids in
neonates whose mothers have received opioids
mothers have received opioids.
0.01 mg per kg body weight, if necessary additional
injections may be given
2. Before Naloxone is administered to you
For reversal of the unwanted effects of opioids (in
adults, children and also in neonates) patients are
Naloxone must not be administered
- If you are allergic (hypersensitive) to naloxone monitored to ensure that the desired effect of
hydrochloride or to any of the ingredients of this Naloxone occurs. Additional doses may be given
every 1 – 2 hours if necessary.
medicinal product.

806/LLD002/21/07

Cardiac disorders
Common:
Fast heart beat.
Uncommon: Changes in the way your heart
beats, slow heart rate.
Very rare:
Fibrillation, cardiac arrest.

What Naloxone looks like and contents of the
pack
Naloxone is a clear and colourless solution in
colourless glass ampoules containing 1 ml solution
for injection.
Pack sizes: 5 and 10 ampoules
Not all pack sizes may be marketed.

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Marketing Authorisation Holder and Manufacturer
Vascular disorders
Common:
Increased or decreased blood pres- Marketing authorisation holder:
sure (you may have a headache or B. Braun Melsungen AG
feel faint).
Carl-Braun-Strasse 1
34212 Melsungen
Respiratory disorders
Germany
Very rare:
Fluids on the lungs (pulmonary
Postal address:
oedema).
34209 Melsungen
Germany
Gastrointestinal disorders
Phone: +49 5661/71-0
Very common: Nausea.
Fax: +49 56 61/71-45 67
Common:
Vomiting.
Uncommon: Diarrhoea, dry mouth.
Manufacturer:
hameln pharmaceuticals gmbh
Skin and subcutaneous tissue disorders
Langes Feld 13, 31789 Hameln
Very rare:
Discoloration and lesions of the skin Germany
(erythema multiforme).
Phone: +49 51 51/5 81-0
Fax: +49 51 51/5 81-258
General disorders and administration site conditions
Common:
If too large a dose is given after an This medicinal product is authorised in the Member
operation, you may become excited States of the EEA under the following names:
and feel pain (because the
painkilling effects of the medicines
Austria
Naloxon B. Braun 0,4 mg/ml
you were given will have been counInjektionslösung
teracted as well as the effects on
Belgium
Naloxon B. Braun 0,4 mg/ml
your breathing).
oplossing voor injectie
Uncommon: Over breathing (hyperventilation),
irritation of the vessel wall has been
Denmark
Naloxon B. Braun
reported after i.v. administration;
Finland
Naloxon B. Braun 0,4 mg/ml
local irritation and inflammation
injektioneste, liuos
have been reported after i.m.
Germany
Naloxon B. Braun 0,4 mg/ml
administration.
Injektionslösung
If any of the side effects gets serious, or if you
Greece
Naloxon B. Braun 0,4 mg/ml
notice any side effects not listed in this leaflet,
ενέσιμο διάλυμα
please tell your doctor or pharmacist.
Ireland
Naloxone 400 micrograms/ml
solution for injection

Keep out of the reach and sight of children.
Naloxone 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.

Italy

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

Luxembourg

Naloxon B. Braun 0,4 mg/ml
Injektionslösung

Norway

Naloxon B. Braun 0,4 mg/ml
injeksjonsvæske, oppløsning

Portugal

Naloxona B. Braun 0,4 mg/ml
solução injectável

Spain

Naloxona B. Braun 0,4 mg/ml
solución inyectable

Sweden

5. How to store Naloxone

Naloxon B. Braun 0,4 mg/ml
injektionsvätska, lösning

The Netherlands Naloxon HCl B. Braun 0,4
mg/ml, oplossing voor injectie
United Kingdom Naloxone 400 micrograms/ml
solution for injection

6. Further information
What Naloxone contains

This leaflet was last approved in
11/2007


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.

The following information is intended for medical For i.v. infusion Naloxone is diluted only with sodium chloride 0.9 % or glucose 5 %. 5 ampoules of
or healthcare professionals only:
Naloxone (2 mg) per 500 ml give 4 µg/ml.
Shelf-life after first opening:
After first opening the medicinal product should be It is recommended that infusions of Naloxone
should not be mixed with preparations containing
used immediately.
bisulphite, metabisulphite, long-chain or high-molecular-weight anions, or solutions with an alkaline
Shelf-life after dilution
Chemical and physical in-use stability has been pH.
demonstrated for 24 hours below 25 °C.
From the microbiological point of view, the dilu- This medicinal product is for single use only.
tions should be used immediately. If not used Please inspect the medicinal product visually prior
immediately, in-use storage times and conditions to use (also after dilution). Use only clear and
prior to use are the responsibility of the user and colourless solutions practically free from particles.
would normally not be longer than 24 hours at 2 to
8 °C, unless dilution has taken place in controlled
and validated aseptic conditions.

B|BRAUN

B. Braun Melsungen AG
34209 Melsungen
Germany

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Nervous system disorders
Common:
Dizziness, headache.
Uncommon: Involuntary trembling or quivering
(tremor), sweating.
Rare:
Seizures, tension.

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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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