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NALOXONE 400 MICROGRAMS/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): NALOXONE HYDROCHLORIDE

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2. BEFORE YOU ARE GIVEN NALOXONE
INJECTION
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)
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, betablockers - 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
• h ave recently been given an opioid for pain
(e.g. during or after an operation)

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
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml contains naloxone hydrochloride (dihydrate)
0.44mg
This is equivalent to 0.40mg/ml of anhydrous naloxone
hydrochloride
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection or Infusion
A clear, colourless solution free from particulate matter.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Naloxone is indicated for the treatment of respiratory
depression induced by natural and synthetic opioids.
It may also be used for the diagnosis of suspected acute
opioid overdosage.
4.2 Posology and method of administration
Naloxone injection is for intravenous (iv), intramuscular (im)
or subcutaneous (sc) injection.
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).

Your nurse or doctor will give you your injection. Your
injection may be given into a muscle, vein or just under the
skin.
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.
Patients treated with Naloxone Injection must be kept under
observation as repeated doses may be needed.
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.
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.

Children:
The usual initial dose in children is 5-10 micrograms per kg
body-weight given intravenously. If this does not result
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.
Intravenous Infusion (iv)
In situations where one of the longer acting opioids is
known or suspected to be the cause of the symptoms,
IV infusion of naloxone is recommended to produce
sustained antagonism to the opioid (without antagonism
of pain relief) rather than repeated injection.
Naloxone may be diluted for intravenous infusion in normal
saline (0.9%) or 5% dextrose in water or saline.
Mixtures should be used within 24 hours. Any remaining
unused solution must then be discarded. The rate of
administration should be titrated in accordance with the
patient’s response.
4.3 Contraindications
Naloxone should not be given to patients who are known to
be hypersensitive to it.
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.
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).

Pharma
Code

02/10/2015
Date

Artwork No.

601321

2

Language

Proof No.

English

Market

elkie.bramall

8.5pt (main body)

UK

150 x 460mm
Size

Min. Point Size

W-LFT001

Profile

Proof By

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

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

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.

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’.

Clearly mark any amendments on one proof and return to MPS

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.

artwork.leicester@multipkg.com

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

103077/3

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

Item Code

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.

Naloxone common leaflet

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.

Description

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.

Wockhardt UK Limited

If you have any doubts about whether you should be given
this medicine then discuss matters with your doctor.

308

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

Measure bar should be 150mm at 100% scale

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

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

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.

Keyline (non-printing)

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

Process Black

5. HOW TO STORE NALOXONE INJECTION
Colours Used

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.
Problems with your nervous system
• tingling hands and feet
• trembling
• fits

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

Reference number

Naloxone 400 micrograms/ml
Solution for Injection or Infusion

29831/0148

This is a service provided by the Royal National Institute
of Blind People.
This leaflet was last revised in September 2015.

Psychiatric disorders
• changes in behaviour including violent behaviour
• nervousness
• restlessness
• excitement
• irritability
Problems with your digestive tract
• feeling sick
• being sick
If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please contact your
doctor or nurse immediately.
4.6 Pregnancy and lactation
Naloxone crosses the placenta; adequate and wellcontrolled 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 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.
Nervous system disorders: tingling/numbness of the
extremities, trembling and generalised convulsions.
Psychiatric disorders: behavioural changes, including
violent behaviour, nervousness, restlessness, excitement,
irritability.
Respiratory, thoracic and mediastinal disorders: Pulmonary
oedema and dyspnoea.
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.

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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
6.5 Nature and contents of container
1ml clear glass ampoules Type 1 (Ph.Eur)
Packs of 3, 10 or 50 ampoules
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
Wockhardt UK Ltd
Ash Road North, Wrexham, LL13 9UF
United Kingdom.
8 MARKETING AUTHORISATION NUMBER(S)
PL 29831/0148
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
15 June 2007
10 DATE OF REVISION OF THE TEXT
May 2008

Pharma
Code

02/10/2015
Date

601321

2

Language

Proof No.

English

Market

elkie.bramall

8.5pt (main body)

UK

150 x 460mm
Size

Min. Point Size

W-LFT001

Profile

103077/3
Item Code

Proof By

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

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

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.

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

Naloxone common 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. C
 ONTENTS 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.

Clearly mark any amendments on one proof and return to MPS

Other symptoms include:
Lack of pain control
•  Naloxone Injection might prevent your opioid pain killer
from working properly

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

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

This medicine should not be stored above 25°C.

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

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.
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:

308

4. POSSIBLE SIDE EFFECTS

Artwork No.

If you are given more Naloxone Injection than
you should
A doctor or nurse will give you this medicine. If you think
that you have been given too much, inform your doctor or
nurse.

Expand view ⇕

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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