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NALOXONE 400 MICROGRAMS/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): NALOXONE HYDROCHLORIDE / NALOXONE HYDROCHLORIDE / NALOXONE HYDROCHLORIDE

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You should not be given Naloxone Injection:
• if you are allergic to naloxone hydrochloride or any
of the other ingredients contained in Naloxone Injection
(see list under heading ‘What Naloxone Injection
contains’ in section 6)

To diagnose or treat an opioid overdose Adults
An initial dose of 400 micrograms to 2mg of Naloxone
Injection may be given into a vein. This may be repeated at
two to three minute intervals until your breathing improves.
If it does not improve after 10mg Naloxone Injection has
been given you may not have an opioid overdose.

If the above statement applies to you, you should tell
your doctor or nurse
Speak to your doctor before you are given Naloxone
Injection if you:
• have problems with your heart or blood vessels
• are taking medicines that can affect the normal functioning
of the heart (e.g. cyclic antidepressants – used to treat
depression, bipolar disorder, anxiety, and other mood
disorders, calcium channel blockers - used to treat
high blood pressure, angina, Raynaud’s phenomenon and
abnormal heart rhythms, beta-blockers - used to treat
angina, heart failure and high blood pressure, digoxin –
used to treat heart failure).
• are dependent on opioids
• are being treated with methadone
• have recently taken a large dose of an opioid
• have recently been given an opioid for pain (e.g. during
or after an operation)

After an operation Adults
The usual dose is 1.5 - 3.0 micrograms per kg body weight
given into a vein. Additional doses may be given every two
minutes until your breathing is under control but you are still
free of pain. Further doses into the muscle may be needed
within one to two hours, depending on the interval since the
last opioid administration and the amount and type (i.e. long
or short acting) of drug used.
Use in children
The usual initial dose in children is 5-10 micrograms
per kg body-weight given into a vein. A subsequent dose of
100 micrograms per kg body weight may be administered.
Naloxone Injection may be administered into a muscle or
under the skin in divided doses.

The following information is intended for healthcare
professionals only:
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Naloxone 400 micrograms/ml Solution for Injection or Infusion

in the desired degree of clinical improvement,
a subsequent dose of 100 micrograms per body weight
may be administered. Naloxone may be administered
intramuscularly or subcutaneously in divided doses.

4.2 Posology and method of administration
Naloxone injection is for intravenous (iv), intramuscular (im)
or subcutaneous (sc) injection.

4.4 Special warnings and precautions for use
Patients who have responded satisfactorily to naloxone
should be kept under observation. Repeated doses may be
necessary since the duration of action of some opioids may
exceed that of naloxone. Naloxone is not effective against
respiratory depression caused by non-opioid drugs.

Intravenous Infusion (iv)
In situations where one of the longer acting opioids is
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
known or suspected to be the cause of the symptoms,
Each 1ml contains naloxone hydrochloride (dihydrate) 0.44mg IV infusion of naloxone is recommended to produce
This is equivalent to 0.40mg/ml of anhydrous naloxone
sustained antagonism to the opioid (without antagonism
hydrochloride
of pain relief) rather than repeated injection.
For full list of excipients, see section 6.1
Naloxone may be diluted for intravenous infusion in normal
3 PHARMACEUTICAL FORM
saline (0.9%) or 5% dextrose in water or saline.
Solution for injection or Infusion
Mixtures should be used within 24 hours. Any remaining
A clear, colourless solution free from particulate matter.
unused solution must then be discarded. The rate of
4 CLINICAL PARTICULARS
administration should be titrated in accordance with the
4.1 Therapeutic indications
patient’s response.
Naloxone is indicated for the treatment of respiratory
4.3 Contraindications
depression induced by natural and synthetic opioids.
Naloxone should not be given to patients who are known to
It may also be used for the diagnosis of suspected acute
be hypersensitive to it.
opioid overdosage.

Opioid overdosage (known or suspected)
Adults:
An initial dose of 400 micrograms to 2mg of naloxone
may be administered intravenously. If the desired degree
of counteraction and improvement in respiratory function
is not obtained it may be repeated at two to three minute
intervals. If no response is observed after 10mg of naloxone
being administered the diagnosis of opioid-induced or
partial opioid induced toxicity should be questioned.
Intramuscular or subcutaneous administration may be
necessary if dosing by the intravenous route is not feasible.
Post-operative Use:
When naloxone is used post-operatively, the dose should
be titrated for each patient in order to obtain respiratory
response while maintaining analgesia. An intravenous
dose of 1.5 - 3.0 micrograms/kg body weight is usually
sufficient, but a full two minutes should be allowed between
each 100 microgram increment of naloxone administered.
Further intramuscular doses may be needed within one
to two hours, depending on the interval since the last
opioid administration and the amount and type (i.e. long or
short acting) of drug used. Alternatively, naloxone may be
administered as an intravenous infusion (see below).
Children:
The usual initial dose in children is 5-10 micrograms per kg
body-weight given intravenously. If this does not result

Cautions: cardiovascular disease or concomitant cardio
toxic drugs as serious adverse cardiovascular effects
have been reported (see section 4.8 Undesirable effects);
physical dependence on opioids (including patients being
treated with methadone), or after large doses of opioids,
as naloxone may precipitate acute withdrawal syndrome
(see section 4.8 Undesirable effects).
Naloxone may antagonise the analgesic effects of the
opioids in the control of postoperative pain.
4.5 Interaction with other medicinal products and other
forms of interaction
Naloxone should be used with caution in patients who are
opioid dependent (including patients being treated with
methadone), as it may precipitate an acute withdrawal
syndrome.
Naloxone reverses the analgesic effects of opioid analgesics
(e.g. nalbupine, pentazocine) and opioid agonist analgesics
(e.g. alfentanil, fentanyl, remifentanil).
4.6 Pregnancy and lactation
Naloxone crosses the placenta; adequate and well-controlled
studies in humans have not been done, therefore naloxone,
like all drugs, should be used with caution during pregnancy.
Risk-benefit must be considered before naloxone is

281
Pharma
Code

820382

26/01/2017
Date

English
Language

3

UK
Market

Proof No.

8.5pt (Main Body)
Min. Point Size

matt.pirie-scott

150 x 460mm
Size

Proof By

W-LFT001

Profile

103077/4
Item Code

Artwork No.

Wockhardt Travel Direction

Patients treated with Naloxone Injection must be kept under
observation as repeated doses may be needed.

Pharmacode: 281

2. BEFORE YOU ARE GIVEN NALOXONE
INJECTION

MPS Read Direction

Alternatively, under certain circumstances Naloxone
Injection may be given over a period of time as an infusion
into a vein via a drip. Your doctor or nurse will dilute
Naloxone Injection in water or a salt solution prior to giving
you an infusion.

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Your nurse or doctor will give you your injection. Your
injection may be given into a muscle, vein or just under the
skin.

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.

Nalaxone Injection is used to treat very shallow breathing
caused by opioid use. It may also be used to diagnose
opioid use.

3. HOW NALOXONE INJECTION SHOULD BE
GIVEN

Clearly mark any amendments on one proof and return to MPS

The active ingredient in Naloxone Injection is naloxone
hydrochloride which belongs to a group of medicines called
opioid antagonists. These drugs reverse the actions of opioids.
Opioids are used as pain killers (e.g. codeine, morphine).
However some of them are abused by drug addicts (e.g.
heroin).

Naloxone Injection contains sodium chloride
This medicinal product contains less than 1 mmol sodium
(23mg) per ampoule, i.e. it is essentially ‘sodium-free’.

artwork.leicester@multipkg.com

1. WHAT NALOXONE INJECTION IS AND WHAT
IT IS USED FOR

Driving and using machines
Naloxone Injection does not affect the ability to drive or
operate machinery.

Naloxone leaflet

In this leaflet:
1. What Naloxone Injection is and what it is used for
2. Before you are given Naloxone Injection
3. How Naloxone Injection should be given
4. Possible side effects
5. How to store Naloxone Injection
6. Contents of the pack and other information

You should speak to your doctor if you are breast-feeding or
wish to breast-feed whilst being given Naloxone Injection.

Description

The name of your medicine is Naloxone 400 Micrograms/ml
Solution for Injection or Infusion. In the rest of this leaflet it
is called Naloxone Injection.

Pregnancy and breast-feeding
You should speak to your doctor before being given
Naloxone Injection if you are pregnant or wish to become
pregnant. Pregnant women who are opioid dependent must
consult their doctor before being given Naloxone Injection as
there is a chance that the newborn child could experience
withdrawal symptoms as well as the mother. You should not
generally receive Naloxone Injection just before delivery of
your baby.

Wockhardt UK Limited

Read all of this leaflet carefully before you start using
this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- 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 nurse. See section 4.

If you have any doubts about whether you should be given
this medicine then discuss matters with your doctor.
Measure bar should be 150mm at 100% scale

Naloxone 400 micrograms/ml Solution for
Injection or Infusion
Naloxone Hydrochloride (dihydrate)

Please check with your doctor if you are taking or
have been given any of the following (or any other
medication):
• o pioid or opioid-like pain killers, such as pentazocine,
nalbupine, fentanyl, alfentanil or remifentanil
• opioids for any other reason (e.g. heroin)
• methadone

Keyline (non-printing)

Please inform your doctor or nurse if you are taking or have
recently taken any other medicines or drugs, including those
you may have bought yourself without a prescription.

Process Black

Colours Used

Taking other medicines
Taking another medicine while you are being given
Naloxone Injection can affect how it or the other medicine
works.

Customer

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Keyline (non-printing)

Problems with your nervous system
• tingling hands and feet
• trembling
• fits
Psychiatric disorders
• changes in behaviour including violent behaviour
• nervousness
• restlessness
• excitement
• irritability
Problems with your digestive tract
• feeling sick
• being sick

administered to a pregnant woman who is known or
suspected to be opioid dependent because naloxone may
precipitate withdrawal in the foetus as well as the mother.
It is not generally advisable to give naloxone just prior to
delivery as blocking endogenous endorphins may affect the
ability of the foetus to withstand the stress of delivery.
It is not known if naloxone is distributed into breast milk.
Problems in humans have not been documented.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Cardiac disorders: atrial and ventricular dysrhythmias,
including atrial premature contractures, ventricular
tachycardia and fibrillation, asystole, hypotension,
hypertension, left ventricular failure and cardiac arrest.
Gastrointestinal disorders: Nausea and vomiting.
General disorders and administration site conditions: Opioid
withdrawal symptoms- sweating, yawning, rhinorrhoea,
sneezing, muscle tremor, weakness, anxiety, irritability,
restlessness, nausea, vomiting, diarrhoea, abdominal
and muscle cramps, piloerection, increases in heart rate
(tachycardia), blood pressure and temperature (fever).
Acute withdrawal syndrome may include, but is not limited
to the above listed signs and symptoms. Acute withdrawal
effects after naloxone have only been reported in individuals
physically dependent on opioids or after large doses of opioids.

Manufacturer: CP Pharmaceuticals Ltd, Ash Road North,
Wrexham, LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name
Naloxone 400 micrograms/ml
Solution for Injection or Infusion

Reference number
29831/0148

This is a service provided by the Royal National Institute of
Blind People.
This leaflet was last revised in 01/2017.

103077/4

5.2 Pharmacokinetic properties
Naloxone acts within two minutes of intravenous injection
and usually within three to five minutes of subcutaneous
or intramuscular injection. The plasma half life is
approximately one to two hours.
5.3 Preclinical safety data
Animal toxicity and reproductive studies have not revealed
any mutagenic, carcinogenic, teratogenic or embryotoxic
effects, nor impaired fertility.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride
Water for injections
Sodium hydroxide
Hydrochloric acid
6.2 Incompatibilities
Naloxone is stable in the range pH 2.5-5.0, but should not
be added to infusion solutions with an alkaline pH. It is not
compatible with solutions containing bisulphate, sulphites,
or long chain/high molecular weight anions.
6.3 Shelf life
24 months
6.4 Special precautions for storage
Do not store above 25°C
Store in the original container

Nervous system disorders: tingling/numbness of the
extremities, trembling and generalised convulsions.

6.5 Nature and contents of container
1ml clear glass ampoules Type 1 (Ph.Eur)
Packs of 3, 10 or 50 ampoules

Psychiatric disorders: behavioural changes, including violent
behaviour, nervousness, restlessness, excitement, irritability.

6.6 Special precautions for disposal
None

Respiratory, thoracic and mediastinal disorders: Pulmonary
oedema and dyspnoea.

7 MARKETING AUTHORISATION HOLDER
Wockhardt UK Ltd
Ash Road North, Wrexham, LL13 9UF
United Kingdom.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation
of the medicinal product is important. It allows continued
monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
4.9 Overdose
No documented reports of acute overdosage, either
accidental or non-accidental, are available.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Naloxone is a specific narcotic antagonist and finds
particular use in the off-set of respiratory depression
caused by opioids.

8 MARKETING AUTHORISATION NUMBER(S)
PL 29831/0148
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
30/07/1990 / 30/01/1997
10 DATE OF REVISION OF THE TEXT
Jan 2017

103077/4

Pharma
Code

26/01/2017
Date

English
Language

3

UK
Market

Proof No.

8.5pt (Main Body)
Min. Point Size

matt.pirie-scott

150 x 460mm
Size

Proof By

W-LFT001

Profile

103077/4
Item Code

820382

Pharmacode: 281

Marketing Authorisation Holder: Wockhardt UK Ltd,
Ash Road North, Wrexham, LL13 9UF, UK.

MPS Read Direction

The ampoules are available is packs of 3, 10 or 50
ampoules.

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

What Naloxone Injection looks like and contents of the
pack
The injection is a clear, colourless solution in a 1ml clear
glass ampoule.

Naloxone leaflet

What Naloxone Injection contains
The active ingredient in Naloxone Injection is naloxone
hydrochloride. Each 1ml contains 0.44mg naloxone
hydrochloride (dihydrate), equivalent to 0.4 mg/ml of
anhydrous naloxone hydrochloride. The other ingredients
are sodium chloride, water for injections, sodium hydroxide
and hydrochloric acid.

Description

6. CONTENTS OF THE PACK AND OTHER
INFORMATION

Wockhardt UK Limited

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.

Wockhardt Travel Direction

Breathing problems
• difficulty in breathing
• shortness of breath
• fluid in your lungs – symptoms include wheezing or
gasping for breath, feelings of suffocating, or a cough that
produces frothy sputum that may be tinged with blood.

Store the ampoule in the outer carton in order to protect
from light and moisture.

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.

Lack of pain control
• Naloxone Injection might prevent your opioid pain killer
from working properly

This medicine should not be stored above 25°C.

Clearly mark any amendments on one proof and return to MPS

Other symptoms include:

This medicine should not be used if the expiry date on the
ampoule has passed. The expiry date refers to the last day
of that month.

artwork.leicester@multipkg.com

Heart problems
• disturbances of the rhythm of your heart e.g. a faster or
slower heartbeat than usual or an irregular heartbeat
• low blood pressure - symptoms include dizziness, light
headedness, fainting, confusion, palpitations, nausea
• high blood pressure – symptoms include persistent
headache, blurred or double vision, nosebleeds
• heart failure – symptoms include breathlessness, extreme
tiredness, swollen ankles which may extend up the legs
• heart stoppage – symptoms include breathing difficulties
and unconsciousness

Keep this medicine out of the sight and reach of children.

Customer

Opioid withdrawal syndrome. This can occur in patients
who are physically dependent on opioids (including patients
being treated with methadone) and in patients who have
had large doses of opioids. Symptoms include:
• diarrhoea
• feeling sick
• being sick
• abdominal and muscle cramps
• muscle trembling
• weakness
• hair standing on end
• sweating
• anxiety
• irritability
• restlessness
• raised blood pressure
• faster heart beat
• yawning
• “runny” nose
• sneezing
• fever

5. H
 OW TO STORE NALOXONE INJECTION

Measure bar should be 150mm at 100% scale

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
if you experience any of the following symptoms,
contact your doctor or nurse IMMEDIATELY:

281

4. POSSIBLE SIDE EFFECTS

Artwork No.

If you think you have missed a dose of Naloxone
Injection
A doctor or nurse will give you this medicine. If you think
you have missed a dose, inform your doctor or nurse.

Process Black

A doctor or nurse will give you this medicine. If you think
that you have been given too much, inform your doctor or
nurse.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. 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.

Colours Used

If you are given more Naloxone Injection than you
should

Expand Transcript

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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