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ADRENALINE INJECTION BP 1 IN 1000

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Date of Approval:

PROOF

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1

To be implemented by:

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28/02/2012

Product Description:

Originated by

Date:

Tech Approved

Adrenaline Injection

Jitendra

28/02/2012

No

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Revised by

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Leaflet

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IAD050901/LF/1

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CRF No.:

B Braun

IAD050901LF Adrenaline Epinephrine Inj UK v1_1 QA.CRF.022.2012

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UK

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9.5pt Swiss 721BT

148 x 420mm

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PATIENT INFORMATION LEAFLET

Adrenaline (Epinephrine) 1:1,000
Solution for Injection
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 pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
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 pharmacist.
The name of your medicine is Adrenaline (Epinephrine) 1:1,000 Solution for Injection.
It will be referred to as Adrenaline Injection for ease hereafter.
In this leaflet:
1. What Adrenaline Injection is and what it is used for
2. Before you are given Adrenaline Injection
3. How Adrenaline Injection is given to you
4. Possible side effects
5. How to store Adrenaline Injection
6. Further information
1. WHAT ADRENALINE INJECTION IS AND WHAT IT IS USED FOR
Adrenaline belongs to a class of drugs called sympathomimetic agents. Adrenaline
Injection may be used to rapidly relieve severe allergic reactions to drugs or other
substances causing allergy. It may also be used in the emergency treatment of shock
due to a severe allergic reaction.
2. BEFORE YOU ARE GIVEN ADRENALINE INJECTION
You should not be given this medicine:
• if you know you are allergic to adrenaline, or to any of the other ingredients (see
Section 6 of this leaflet)
• when you are in labour
• if you have severe heart disease particularly if it is associated with an increased heart
rate
• you are suffering from any infection, disease or tumour of the brain
• you have atherosclerosis which is a narrowing, and hardening of the body's blood
vessels (your doctor will advise you).
Adrenaline injection should not be used in areas such as fingers, toes, ears, nose or
penis, as the blood supply to these areas might become inadequate.
Speak to your doctor if one of these applies to you before you are given this medicine.
Take special care and tell your doctor if:
• you are elderly
• you suffer from any heart problem, particularly if it affects the heart rate or if you
suffer from chest pain
• you have problems with your brain eg. stroke, brain damage or blood vessel disease
• you have an overactive thyroid, diabetes or glaucoma (high pressure in the eye)
• you have phaeochromocytoma (a tumour on the adrenal gland)
• you have low blood levels of potassium or high blood levels of calcium
• you have a tumour on your prostate gland or kidney disease
• you are in shock or have lost a lot of blood
• you are going to have a surgery under general anaesthesia
• you are suffering from high blood pressure.
Taking other medicines:
Tell your doctor or midwife before you are given this medicine if you are taking or have
recently taken any other medicines, including medicines obtained without a
prescription.
A large number of drugs can interact with Adrenaline Injection which can significantly
alter their effects. These drugs include:
• monoamine oxidase inhibitors (MAOI) or tricyclic antidepressants both used for
depression
• guanethidine, used for the rapid control of blood pressure
• diuretics (“water tablets”)
• inhaled general anaesthetics, such as halothane
• medicines to raise or lower your blood pressure including betablockers, e.g.
propranolol, atenolol, bisoprolol, phentolamine
• anti -diabetic drugs like insulin or oral hypoglycaemic agents (e.g glipizide)
• aminophylline and theophylline (medicines to help you breathe)
• corticosteroids (medicines used to treat inflammatory conditions in your body such
as asthma or arthritis)
• antihistamines (for example: diphenhydramine), used for the treatment of allergies
• medicines used to treat mental illness like chlorpromazine, pericyazine or
fluphenazine
• medicines used to treat an underactive thyroid gland
• oxytocin (used to induce labor at term and to control bleeding after delivery)
• any cough or cold remedies (sympathomimetics).

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continued overleaf

If you are already taking one of these medicines, speak to your doctor before you
receive Adrenaline Injection.
Pregnancy and breastfeeding:
Tell your doctor before you are given this medicine if you are pregnant, think you may
be pregnant or are planning to become pregnant. Adrenaline should only be used
during pregnancy and breastfeeding if considered essential by your doctor.
Please tell your doctor or nurse before being given this injection if you are breast
feeding, this injection should not be used by nursing (breast feeding) mothers.
Driving and using machines:
You should not drive or use machinery if you are affected by the administration of
Adrenaline (epinephrine) 1 in 1000 injection.
Important information about some of the ingredients of Adrenaline Injection:
This medicine contains sodium metabisulphite, a preservative. This may rarely cause
severe allergic (hypersensitivity) reactions and wheezing. This medicinal product
contains less than 1mmol sodium (23mg) per dose (essentially ‘sodium-free’).
3. HOW ADRENALINE INJECTION IS GIVEN TO YOU
Adrenaline may be injected either into a muscle or into the tissue just beneath the
skin. It will be administered by a trained healthcare professional. Your doctor will
decide the most suitable dosage for your particular case according to your age and
physical circumstances. Depending on the response further doses may be needed,
usually at 5 minute intervals. If you have any concerns or questions about how much
of this medicine you have received, speak to your doctor immediately.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Adrenaline Injection can sometimes cause side effects, although
not everyone gets them.
All medicines can cause allergic reactions although serious allergic reactions
are rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids,
face or lips, rash or itching (especially affecting your whole body) should be
reported to a doctor immediately.
Other side effects include:
• headache, dizziness
• feelings of anxiety or fear or restlessness
• trembling
• insomnia, confusion, irritability
• abnormal mood or behaviour
• a dry mouth or producing too much saliva
• weakness or sweating
• changes in the rhythm and speed of the heart
• high blood pressure
• coldness of the arms or legs
• breathlessness
• reduced appetite, feeling sick or being sick
• repeated injections may damage tissues at the site of the injection
• difficulty of not being able to pass water
• metabolic acidosis (an imbalance of certain constituents in your blood) may occur
• there may be some tissue damage at the site of injection after repeated injections of
adrenaline
• increase in tremors and rigidity in patients suffering from a condition called parkinsonian
syndrome
• bleeding in the head
• paralysis of one half of the body
• increased sugar levels in the blood
• breakdown of fat in the body.
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 pharmacist.
5. HOW TO STORE ADRENALINE INJECTION
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and
ampoule label after “Exp”. The expiry date refers to the last day of that month.
Do not store above 25˚C.
Keep the container in the outer carton in order to protect from light.
The solution should not be used if it is discoloured in any way.
This medicine should not be mixed with any other drugs.
The solution must not be stored in contact with metals e.g. needles or metal parts of
syringes, as dissolved metal ions may cause swelling at the site of the injection.
If only part of an ampoule is used, the remaining solution should be discarded.
6. FURTHER INFORMATION
The active substance is adrenaline. Each 1ml contains 1mg adrenaline (epinephrine)
as the acid tartrate.
The other ingredients are sodium metabisulphite (E223), sodium chloride, sodium
hydroxide or hydrochloric acid in water for injections..
What Adrenaline Injection looks like and contents of pack
Adrenaline Injection is a clear colourless, aqueous, sterile solution for injection,
available in 1ml glass ampoules, packed in boxes containing 10 ampoules.
Marketing authorization holder
Antigen International Limited, Roscrea, Co. Tipperary, Ireland.
Manufacturer
B. Braun Melsungen AG, Mistelweg 2, 12357 Berlin, Germany.
This leaflet was last revised in March 2012
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IAD050901/LF/1

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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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