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PRENOXAD 1MG/ML INJECTION

Active substance(s): NALOXONE HYDROCHLORIDE

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Package leaflet: information for the user D02111

Prenoxad Injection
Naloxone Hydrochloride 1mg/1ml Solution for Injection
TM

Because of your condition it may not be possible for you to read this
leaflet before you are given Prenoxad Injection. The leaflet has been
provided to you to give some information that you should have and to
assist the person who is helping you.
You may wish to read it later.
• If you have any further questions, please ask your doctor or nurse
• If any of the side effects become serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or nurse

In this leaflet:

If the patient does not appear to be breathing normally:
1

Call 999 immediately and ask for an ambulance.

Instructions for patient administration

q
2

Give basic life support by giving the patient 30 chest compressions
and 2 rescue breaths if possible.

q
3

1

2

Give 0.4ml of Prenoxad Injection (to first or next black line)
into the outer thigh or upper arm muscle.

q
4 Give 3 cycles of 30 chest compressions and 2 rescue breaths if possible.

1. What Prenoxad Injection is and what it is used for
2. Before Prenoxad Injection is given
3. How Prenoxad Injection will be given
4. Possible side effects
5. Storing Prenoxad Injection
6. Contents of the Pack and other information

q
5

Repeat steps 3 and 4 until the ambulance arrives
or the patient is breathing normally.

When the patient is breathing normally move them to the recovery position (lying
on their side, mouth open and pointing towards the ground). Watch continuously.

1. What Prenoxad Injection is and what it is used for.
Prenoxad Injection contains the medicine naloxone. Naloxone belongs to a
group of medicines that reverse the action of opioid drugs e.g. diamorphine
(heroin), methadone, dextropropoxyphene, nalbuphine, pentazocine.
This medicine is used to:
• reverse the action of opioid drugs e.g. if you have been given or taken an
overdose of these drugs.
• If you are at risk of an opioid overdose you should always carry your Prenoxad
Injection with you. It is designed as an emergency rescue treatment but you
should still get medical attention as soon as possible.

2. Before Prenoxad Injection is given
This medicine is often used in circumstances where it is necessary to act
very rapidly. You should not be injected with this medicine unless it is in
the circumstances that were explained when you were given the Prenoxad
Injection.
Prenoxad Injection will only be made available once the prescriber has assessed
the suitability and ability of a client or a representative to administer naloxone in
the appropriate circumstances
You should not be given Prenoxad Injection if:
• you are allergic (hypersensitive) to Naloxone or to any other ingredients in this
medicine, listed in section 6 of this leaflet.
Before giving you the Prenoxad Injection your prescriber will have
considered whether special care needs to be taken if:
• you have kidney or liver problems
• you have heart problems
If you have any of these problems you should make your doctor aware or remind him.
Taking other medicines
If you are able, you must tell your doctor if you are taking or have recently
taken any medicines, including those obtained without a prescription.
Pregnancy and breast-feeding
Prenoxad Injection should not be used if you are pregnant or breast-feeding
unless it is absolutely essential.
Driving or using machines
Please speak to your doctor before driving or using machines.
Prenoxad Injection contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 2ml dose, i.e. it is
essentially ‘sodium- free’

3. How Prenoxad Injection will be given
You or the person instructed by your doctor and clinic will give 0.4ml of the
injection solution at any one time, into the outer thigh muscle or upper arm
muscle (intramuscularly). The number of times injections of 0.4ml will be
repeated will depend on your individual need and response to the treatment.
The pack contains two needles. The second needle is provided in case the
first needle is damaged or gets contaminated because for example you have
dropped it on the floor.
Adults
Known or suspected opioid overdose:

If medical assistance has not arrived after you have used up the contents of
one syringe and you have a second syringe available then this may be used
using the same procedure as with the first. Use of the second syringe in the
same way as the first does not present a safety hazard.
Prenoxad Injection is for single patient use only and any unused injection
solution should be discarded as instructed in section 5
If you are given more or less Prenoxad Injection than you should have
If you think you have been given too much or too little tell your doctor or the
ambulance crew at the scene of the overdose.
Like all medicines Prenoxad Injection can cause side effects, although not
everybody gets them.
Possible side effects include:
Very common (incidence >1 in 10): nausea
Common (incidence greater than 1 in 100 but less than 1 in 10): dizziness,
headache, faster beating of the heart, increased blood pressure, vomiting.
Uncommon (incidence greater than 1 in 1000 but less than in 100): tremor,
sweating, irregular heartbeat, decreased heart rate, diarrhoea, dry mouth, local
irritation, inflammation, faster or deeper breathing
Rare (incidence greater than 1 in 10000 and less than 1 in 1000): seizure,
tension
Very rare (incidence less than 1 in 10000): allergic reactions (urticaria,
rhinitis, dyspnoea, swelling, anaphylactic shock, cardiac arrest, redness of the
skin with blisters or ulcers
Frequency unknown: fever, nervousness restlessness, irritability, runny nose,
sneezing, yawning, piloerection, weakness, shivering, death
If any of the side effects become serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or nurse

5. Storing Prenoxad Injection

Give 0.4ml of Prenoxad Injection (to first black line) into the outer
thigh or upper arm muscle.

3

Call 999 and ask for an ambulance.

5

Peel back the backing paper from the needle packet
and remove the needle in its protective sheath.

6

The service that prescribed the product should be contacted so that they
can advise you how to dispose of unused expired product or left over used
product, including used and unused needles. Following use any left over
product, including used and unused needles, may be given to the attending
ambulance crew. Medicines should not be disposed of via drains or household
waste.
Store in the original box to protect from light.
Do not store above 25°C. If the injection is discoloured it should not be used.

With the needle still in its sheath, screw the blue
fitting on to the syringe.

Gently twist the needle sheath and remove it from
the syringe.

6. Contents of the Pack and other information

q

2

Unscrew the clear plastic top from the syringe.

You should not be given Prenoxad Injection after the expiry
date which is printed on the box and syringe label. The doctor, nurse or
pharmacist will check the expiry date on the box and syringe label before
giving the pack to you.

Product Licence Number: PL 12064/0125
Date of last revision: November 2012
Instructions for administration to patients may be found overleaf

Move the patient into the recovery position, lying on their side,
mouth open and pointing towards the ground.

4

Keep out of the sight and reach of children.

q

1

3

The box contains 1 syringe of Prenoxad and two
needles.

4. Possible side effects

What Prenoxad Injection contains.
The active substance is Naloxone Hydrochloride 1mg per ml.
The other ingredients are Sodium Chloride, Water for Injection and Dilute
Hydrochloric Acid.
What Prenoxad Injection looks like and contents of the pack.
The injection is supplied in a 2ml prefilled syringe containing 2ml of a
clear, colourless solution together with two needles. The syringe and needles
are contained in a yellow box.
Marketing Authorisation Holder: Manufacturer:
Aurum Pharmaceutical Ltd
Martindale Pharmaceuticals Ltd.
Bampton Road
Bampton Road
Harold Hill
Harold Hill
Romford, RM3 8UG
Romford, RM3 8UG
United Kingdom
United Kingdom

Prenoxad Injection should only be given where it is known or suspected that an
opioid overdose has occurred.
The following procedure should be followed:
See overleaf for diagrams to help the person give the injections.
If the patient is breathing normally but is unrousable
or unconscious:

Remove the clear film wrapping by pulling the tear
strip on the side of the box. Twist the outer plastic
box as shown to break the tamper evident seals and
open.

7

To inject someone who has overdosed, hold the
syringe like a pen.

q

4 Give further intramuscular injections of 0.4ml Prenoxad Injection (to next
black line) into the outer thigh or upper arm muscle every 2–3 minutes until
the ambulance arrives or the patient regains consciousness.

8

Insert the needle into the patient’s outer thigh or
upper arm, through clothing if necessary, and inject
first dose (0.4ml). Withdraw the needle and syringe
after each dose.

3

Stay with person until
ambulance arrives

2

Recovery position

BREATHING

1

RECOVERY POSITION

Repeat 3 cycles of
30 chest compressions
then 2 rescue
breaths if possible

If no change after 2-3 minutes

Inject 0.4ml Prenoxad
(to next black line)
Inject 0.4ml Prenoxad
(to first black line)

Call 999
30 chest compressions
then 2 rescue breaths

Inject 0.4ml naloxone
(to first black line)
Call 999

NOT BREATHING

Open airway:
Tilt head back gently
and lift chin

Shout for help and
approach with care

Recovery position

BREATHING

Inflict pain
Put in bath or shower
Walk them about
Use other drugs such
as stimulants
• Leave them alone

DO






DO NOT
Person unconscious
and unresponsive

Action on finding a potential overdose

D02111

100mm Measurement Verification Bar

DEVELOPMENT ARTWORK
Component Code: D02111
Paper size: 200 x 400mm
Version Control Date

By

Version A Created 17/02/12 AC
Version B

22/02/12 AC

Version C

05/04/12 AC

Version D

18/04/12 HM

Version E

26/04/12 AC

Version F

26/04/12 AC

Version G

21/05/12 AC

Version H

22/05/12 AC

Version I

28/05/12 AC

Version J

31/05/12 AC

Version K

11/06/12 AC

Version L

14/06/12 AC

Version M

28/06/12 AC

Version N

28/06/12 AC

Version O

01/10/12 AC

Version P

30/10/12 AC

Version Q

31/10/12 AC

Version R

31/10/12 AC

Version S

02/11/12 AC

Version T

16/11/12 AC

Version U

23/11/12 AC

Version V

26/11/12 AC

Version W

27/11/12 AC

Version X

03/12/12 AC

Version Y
Version Z
Grand Fromage Creative Ltd
60 Churchill Square, Kings
Hill
West Malling, Kent ME19 4YU
t:+44 (0)1732 54 34 94
f:+44 (0)1732 54 34 04
e:studio@grand-fromage.co.uk

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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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