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ADRENALINE INJECTION 1MG IN 10ML IN A PREFILLED SYRINGE

Active substance: ADRENALINE ACID TARTRATE

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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.
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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.
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.
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 pre-filled syringe
contains 10ml of the solution.
Marketing Authorisation Holder: Manufacturers:
Aurum Pharmaceuticals Ltd.
Martindale Pharmaceuticals Ltd.
Bampton Road
Bampton Road
Romford, RM3 8UG
Romford, RM3 8UG
United Kingdom
United Kingdom

Agila Specialties Polska Sp.z.oo

10 Daniszewska Str.

03-230 Warsaw, Poland
This leaflet was last revised in April 2013
Product License Number: PL 12064/0006

Continued overleaf

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100mm Measurement Verification Bar

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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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