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ADRENALINE INJECTION 1MG IN 10ML IN A PREFILLED SYRINGE

Active substance(s): ADRENALINE ACID TARTRATE / ADRENALINE ACID TARTRATE / ADRENALINE ACID TARTRATE

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D03713
PACKAGE LEAFLET: INFORMATION FOR THE USER

Adrenaline (Epinephrine) Injection 1:10,000
Because of your condition it may not be possible for
you to read this leaflet before you are given Adrenaline
(Epinephrine) Injection 1:10,000.
The leaflet will be kept for you as you may wish to read it later.
• If you have 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:
1. What Adrenaline (Epinephrine) Injection 1:10,000 is, and
what it is used for
2. Before Adrenaline (Epinephrine) Injection 1:10,000 is
given
3. How Adrenaline (Epinephrine) Injection 1:10,000 is given
4. Possible side effects
5. Storing Adrenaline (Epinephrine) Injection 1:10,000
6. Further information

1. What Adrenaline (Epinephrine) Injection
1:10,000 is, and what it is used for
• Adrenaline (Epinephrine) belongs to a group of medicines
used for the treatment of serious shock produced by a
severe allergic (hypersensitive) reaction or collapse
• It may also be used to restart your heart if it has stopped

2. Before Adrenaline (Epinephrine) Injection
1:10,000 is given
You should not be given Adrenaline (Epinephrine)
Injection 1:10,000 if you are:
• allergic (hypersensitive) to any of the ingredients in this
injection
• suffering from any form of heart disease
• in shock (other than that caused by a sudden life
threatening reaction)
• suffering from brain damage or hardening of the arteries
in the brain
• suffering from glaucoma (increased pressure in the eye)
• having or are about to have an operation under general
anaesthetic
• in the second stage of labour
Take special care with Adrenaline (Epinephrine) Injection
1:10,000 if you are:
• suffering from high blood pressure
• pregnant or breastfeeding
• diabetic
If any of the above applies to you or your child, please tell the
doctor before this medicine is given.
Taking other medicines
Please tell your doctor or nurse if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.
Medicines that may interact with Adrenaline (Epinephrine)
Injection 1:10,000 include:
• antihistamines (drugs used to treat allergic reactions or
allergies)
• drugs used to treat high blood pressure, heart conditions,
depression or thyroid problems
• ergot alkaloids (drugs used to treat migraine)
• insulin oral hypoglycaemics (drugs used to treat diabetes)
• oxytocin (used in childbirth to stimulate contractions of the
uterus)
• doxapram (given as an injection in hospitals to help severe
breathing problems)
• entacapone (for the treatment of Parkinson’s disease)
• antipsychotics (for the treatment of serious mental
disorders)
Pregnancy & breast-feeding
If you are pregnant or are breast-feeding, your doctor will
advise you whether you can have Adrenaline (Epinephrine)
Injection 1:10,000 as an emergency treatment.
Effects on the ability to drive and use machines
Having Adrenaline (Epinephrine) Injection 1:10,000 will not
affect your ability to drive or use machines.
Important information about some of the ingredients in
this medication
The product also contains Sodium Metabisulphite which may
cause allergic (hypersensitive) type reactions in some people
and can lead to breathing difficulties or collapse. People with
a history of asthma or allergies are most likely to experience
these problems.

3. How Adrenaline (Epinephrine) Injection
1:10,000 is given
Your doctor, nurse or paramedic will give Adrenaline
(Epinephrine) Injection 1:10,000 to you either into a vein
(intravenous) or into a bone (intraosseous). Your doctor will
decide the correct amount for you, and when and how this
should be given.
Adrenaline must not be injected into the fingers, toes, ears,
nose or genital area. Intramuscular injection in the buttocks
should be avoided.
This medicinal product is not intended to deliver
volumes of less than 2ml.
Adults and children over 12 years:
When there is either uncontrolled beating of the heart, or
if the heart has stopped working:
1mg adrenaline is given either into the vein or into a bone
every 3-5 minutes until the heart starts to work. Once
the heart is working, further doses may be given but this
depends on your blood pressure. Intravenous doses of 50
micrograms are usually sufficient for most patients.
When the heart stops following cardiac surgery:
Following cardiac surgery, your doctor will give adrenaline
1:10,000 into the vein in doses of up to 100 micrograms.
Heart Resuscitation:
In heart resuscitation, the recommended dose is 1mg into
the vein.
Continued overleaf

Children under 12 years:
When there is uncoordinated beating of the heart or the
heart has stopped:
10 micrograms per kilogram of body weight, repeated every
3-5 minutes.
When there is a failure of breathing and blood circulation
around the body:
First and further doses: 10 micrograms per kilogram of body
weight given into a vein or into a bone.
Maximum dose is 1mg. If needed, further doses should
be given every 3-5 minutes. If your doctor is unable to
give adrenaline in any other way, the doctor can inject the
adrenaline into the airway (called the trachea), in a dose of
100 micrograms per kilogram of body weight.
Newborn:
When ventilation and chest compression have not increased
the heart above 60 beats per minute, adrenaline may be given
into the vein in a dose of 10-30 micrograms per kilogram
of body weight. The doctor can give this using a thin tube
through the umbilical cord.
Although not recommended, if necessary, the doctor may
inject the adrenaline into the airway in a dose of 50-100
microgram per kilogram of body weight.
Treating life threatening allergic reactions (acute
anaphylaxis):
Usually, adrenaline is given into a muscle using a different
strength of injection. Adrenaline 1:10,000 can also be given
into the vein by experienced doctors. For adults, if given into
the vein, a dose of 50 micrograms of Adrenaline 1:10,000 will
be used.
If you are given more Adrenaline (Epinephrine) Injection
1:10,000 than you should
As this medicine will be given to you whilst you are in
hospital, it is unlikely that you will be given too little or too
much; however, tell your doctor or nurse if you have any
concerns.

4. Possible side effects
Like all medicines, Adrenaline (Epinephrine) Injection 1:10,000
can cause side effects, although not everybody gets them.
Adrenaline (Epinephrine) solutions may be associated with
some unwanted effects although these are normally related
to higher strengths of the drug. These unwanted effects
include:
• anxiety
• difficulty in breathing
• high blood sugar levels
• high blood pressure
• restlessness
• palpitations (irregular or faster heart beat)
• tremors (shaking)
• weakness
• dizziness
• headache
• coldness of the fingers and toes
• feeling sick (nausea)
• being sick (vomiting)
• sweating
• cerebral haemorrhage (bleeding in the brain which can
cause very severe headaches, stiff neck, fits and loss of
consciousness)
• hemiplegia (paralysis of one side of the body)
• pulmonary oedema (fluid in the lungs)
• ECG changes
In patients with Parkinson’s disease, adrenaline may increase
rigidity (stiffness) and tremors (shaking).
After being given this product, you may experience slight
pain, minor bruising/bleeding or some left over liquid in the
place where you have been injected.
Repeated injection may cause tissue damage in the place
where you have been injected. Tissue damage may also occur
in the extremities (fingers and toes), kidneys and liver.
If any of the side effects gets serious or you notice any other
effects not mentioned in this leaflet, please tell your doctor
or nurse.

5. Storing Adrenaline (Epinephrine) Injection
1:10,000
Keep out of the sight and reach of children.
Your doctor, nurse or paramedic will check that the expiry
date on the label has not passed before giving Adrenaline
(Epinephrine) Injection 1:10,000 to you. The expiry date refers
to the last day of that month.
Adrenaline (Epinephrine) is sensitive to light, therefore
Adrenaline (Epinephrine) 1:10,000 must always be kept in the
original outer carton.
Do not store above 25ºC and do not freeze.
You should not be given Adrenaline (Epinephrine) Injection
1:10,000 if it has been used or shows signs of visible damage.

6. Further Information
What Adrenaline (Epinephrine) Injection 1:10,000
contains
The active ingredient is Adrenaline (Epinephrine) as acid
tartrate.
Each 10ml solution for injection contains 1mg of adrenaline
(epinephrine) as the acid tartrate.
The other ingredients are Sodium Chloride, Citric Acid
Monohydrate, Sodium Citrate Dihydrate, Sodium
Metabisulphite and Water for Injections. Dilute Hydrochloric
acid may be added to adjust the acidity.
What Adrenaline (Epinephrine) Injection 1:10,000 looks
like and contents of the pack
Adrenaline (Epinephrine) Injection 1:10,000 is a clear
colourless solution supplied in a pre-filled syringe. Each prefilled syringe contains 10ml of the solution.
Marketing Authorisation Holder: Manufacturers:
Macarthys Laboratories Ltd
Aurum Pharmaceuticals Ltd.
T/A Martindale Pharma
Bampton Road, Romford,
Bampton Road, Romford,
RM3 8UG, United Kingdom
RM3 8UG, United Kingdom
This leaflet was last revised in June 2017
Product License Number: PL 12064/0006
D03713

100mm Measurement Verification Bar

3713-C

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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