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ADRENALINE (EPINEPHRINE) INJECTION BP 1:1000 FOR ANAPHYLAXIS

Active substance(s): ADRENALINE ACID TARTRATE

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Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

D00854

Adrenaline (Epinephrine) Injection BP
(1:1000) for Anaphylaxis
Adrenaline
Because of your condition 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 for
the treatment of serious shock produced by a severe allergic
(hypersensitive) reaction or collapse.

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.

Children: Volume of 1:1000 adrenaline to administer is shown in
brackets.
Children over 12 years:
500 micrograms given by injection into the muscle (intramuscular)
(0.5ml i.e. same as adult dose).
300 micrograms (0.3ml if the child is small or prepubertal).
Children 6 to 12 years: 300 micrograms (0.3 ml).
Children 6 months to 6 years: 150 micrograms (0.15ml)
Children under 6 months: 150 micrograms (0.15ml)
Repeat the intramuscular dose if there is no improvement in the
patients condition. Further doses can be given at 5 minute intervals
according to the patient’s response.
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, 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 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
• subarachnoid 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)

Take special care with Adrenaline (Epinephrine) Injection BP
(1:1000) if you are:
• suffering from high blood pressure.
• pregnant or breastfeeding.
• diabetic.

In patients with Parkinson’s disease Adrenaline (Epinephrine) may
increase rigidity (stiffness) and tremors (shaking).

If any of the above apply to you or your child please tell your doctor
before you are given this medicine.

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.

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
BP (1:1000) include:
• antihistamines (drugs used to treat allergic reactions or allergies).
• drugs 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).
• entacapone (for the treatment of Parkinson’s disease).
• antipsychotics (for the treatment of schizophrenia and other
psychiatric disorders).
Pregnancy & breast-feeding
If you are pregnant or are breast-feeding, your doctor will advise
you whether you can be given Adrenaline (Epinephrine) Injection
BP (1:1000) as an emergency treatment.
Effects on the ability to drive and use machines
Using Adrenaline (Epinephrine) Injection BP (1:1000) will not affect
your ability to drive or operate machinery.
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
Your doctor, nurse or paramedic will administer adrenaline into a
muscle (intramuscular)
In emergencies it may be necessary to administer an adrenaline
solution slowly into a vein (intravenous). Your doctor will decide
the correct dosage for you and when and how the injection should
be administered.

After being given this product, you may experience slight pain,
minor bruising/bleeding or some left over liquid where you have
been injected.

If 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 reach and sight of children.
Your doctor, nurse or paramedic will check that the expiry date on
the label has not been passed before administering Adrenaline
(Epinephrine) Injection BP (1:1000) to you. The expiry date refers to
the last day of the month.
Adrenaline (Epinephrine) is sensitive to light; therefore the
Adrenaline (Epinephrine) Injection BP (1:1000) 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 BP
(1:1000) if you notice 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)
1mg per ml.
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 with a needle.
Marketing Authorisation Holder:
Aurum Pharmaceuticals Ltd.
Bampton Road, Romford, RM3 8UG, United Kingdom
Manufacturer:
Martindale Pharmaceuticals Ltd.
Bampton Road, Romford, RM3 8UG, United Kingdom
This leaflet was last approved in: June/2009
Product License Number: PL 12064/0058

Elderly: There are no specific dosage regimes for adrenaline
injection in elderly patients. However, adrenaline should be given
with great caution in these patients who may be more susceptible
to cardiovascular side effects of Adrenaline.
Continued overleaf

D00854

Dosage:
Adults: 500 micrograms (0.5 ml) of 1:1000 adrenaline solution
given by injection into the muscle (intramuscular)

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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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