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Adrenaline Injection Bp 1mg In 1ml (1:1000)

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PACKAGE LEAFLET: INFORMATION FOR THE USER


Adrenaline (Epinephrine) Injection BP 1:1000


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It may not be possible for you to read this leaflet before you are given Adrenaline (Epinephrine) Injection BP 1:1000.

•    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 BP 1:1000 is, and what it is used for

2.    Before Adrenaline (Epinephrine) Injection BP 1:1000 is given

3.    How Adrenaline (Epinephrine) Injection BP 1:1000 is given

4.    Possible side effects

5.    Storing Adrenaline (Epinephrine) Injection BP 1:1000

6.    Further information

1.    What Adrenaline (Epinephrine) Injection BP 1:1000 is, and what it is used for

•    Adrenaline (Epinephrine) belongs to a group of medicines used to restart your heart if it has stopped

•    It can be used for the treatment of serious shock produced by a severe allergic reaction or collapse

•    It may also be used if you have severe asthma

2.    Before Adrenaline (Epinephrine) Injection

BP 1:1000 is given

You should not be given Adrenaline (Epinephrine) Injection BP 1:1000 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 BP 1:1000 if you are:

•    suffering from high blood pressure

•    pregnant or breastfeeding

•    diabetic

f 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 ecently taken any other medicines, including medicines obtained without a prescription.

Medicines that may interact with Adrenaline (Epinephrine) njection BP 1:1000 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 or 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)

•    antipsychotics (for the treatment of serious mental disorders)

Pregnancy & breast-feeding

f you are pregnant or are breast-feeding, your doctor will advise you whether you can have Adrenaline (Epinephrine) njection BP 1:1000 as an emergency treatment.

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, which 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 BP 1:1000 is given

Depending on why you are being given adrenaline 1:1000 injection, the doctor, nurse or paramedic will give the injection either into a vein (intravenous), into a bone (intraosseous), into a muscle (intramuscular) or under the skin (subcutaneous).

Your doctor will decide the correct dose and the best way to give it to you.

Adrenaline must not be injected into the fingers, toes, ears, nose or genital area. Intramuscular injection in the buttocks should be avoided.

When there is either uncontrolled beating of the heart, or if the heart has stopped working:

Adults and children over 12 years:

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. To give this dose, your doctor will need to use a different strength of adrenaline injection.

_Continued overleaf


When treating life threatening allergic reactions (acute anaphylaxis):

Adrenaline (Epinephrine) 1:1000 injection will be given into your muscle to treat an allergic reaction.

Adults and children over 12 years:

500 micrograms (0.5ml of Adrenaline 1:1000 injection) into the muscle

Children 6 - 12 years:

300 micrograms (0.3ml of Adrenaline 1:1000 injection) into the muscle

Children 6 months to 6 years:

150 micrograms (0.15ml of Adrenaline 1:1000 injection) into the muscle

Children less than 6 months:

150 micrograms (0.15ml of Adrenaline 1:1000 injection) into the muscle

To treat severe asthma:

300 micrograms (0.3ml of Adrenaline 1:1000 injection) given under the skin. This may be repeated up to a total of 3 doses at 20 minute intervals.

If you are given more Adrenaline (Epinephrine) Injection BP 1:1000 than you should

As this medicine will be given to you whilst you are in hospital, t 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

_ike all medicines Adrenaline (Epinephrine) Injection BP 1:1000 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. The 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)

•    ECG changes

n patients with Parkinson's disease, Adrenaline (Epinephrine) may increase rigidity (stiffness) and tremors (shaking).

After being given this product, you may experience slight oain, 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.

f any of the side effects become serious or you notice any other effects not mentioned in this leaflet, please tell your doctor or nurse.

5.    Storing Adrenaline (Epinephrine) Injection BP 1:1000

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 BP 1:1000 to you. The expiry date efers to the last day of that month.

Adrenaline (Epinephrine) is sensitive to light, therefore Adrenaline (Epinephrine) Injection BP 1:1000 must always be kept in the original outer carton.

Do not store above 25°C and do not freeze.

You should not be given Adrenaline (Epinephrine) Injection 3P 1:1000 if it has been used or shows signs of visible damage.

6.    Further Information

What Adrenaline (Epinephrine) Injection BP 1:1000 contains

The active ingredient is Adrenaline (Epinephrine) as acid tartrate.

Each 1ml solution for injection contains 1mg of adrenaline (epinephrine) as the acid tartrate.

The other ingredients are Sodium Chloride, Sodium Metabisulphite and Water for Injections. Dilute Hydrochloric acid may be added to adjust the acidity.

What Adrenaline (Epinephrine) Injection BP 1:1000 looks like and contents of the pack Adrenaline (Epinephrine) Injection BP 1:1000 is a clear colourless solution supplied in a pre-filled syringe. Each prefilled syringe contains 1ml of the solution.

Marketing Authorisation Manufacturer:

Holder:

Aurum Pharmaceuticals Ltd. Martindale Pharmaceuticals 3ampton Road, Romford, Bampton Road, Romford RM38UG RM38UG United Kingdom United Kingdom

This leaflet was last revised in: April 2013 Product License Number: PL 12064/0024

Bampton Road, Harold Hill, Romford RM3 8UG, United Kingdom

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100mm Measurement Verification Bar


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