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Hospira

PACKAGE LEAFLET: INFORMATION FOR THE USER

Dopamine 40 mg/ml Sterile Concentrate

In this leaflet:

1.    What Dopamine Sterile Concentrate is and what it is used for

2.    Before Dopamine Sterile Concentrate is used

3.    How Dopamine Sterile Concentrate is used

4.    Possible side effects

5.    How Dopamine Sterile Concentrate is stored

6.    Further information

1. WHAT DOPAMINE STERILE

CONCENTRATE IS AND WHAT IT IS USED FOR

Dopamine is a medicine that stimulates the heart and has effects on the blood vessels.

Dopamine Sterile Concentrate can be used:

•    to treat low blood pressure or shock (reduction of blood flow through the body tissues) after a heart attack, blood poisoning, trauma (injury) or kidney failure

•    in combination with other treatments where low blood pressure occurs after open heart surgery

•    in congestive heart failure (heart failure due to a build up of fluid/blood)

2. BEFORE DOPAMINE STERILE CONCENTRATE IS USED

Dopamine Sterile Concentrate should not be used

•    if you have a tumour that causes an increase in blood pressure

•    if you have an overactive thyroid gland

•    if you have irregular or rapid heartbeats

•    if you have shown signs of hypersensitivity (severe allergy) to dopamine or sodium metabisulphite in the past

If possible, tell your doctor if any of the above applies to you before this medicine is used.

Special care needs to be taken with Dopamine Sterile Concentrate

•    if you have diabetes

•    if you have kidney or liver problems

•    if you have a history of blood circulation problems (you will be monitored for any changes in colour or temperature of your fingers or toes)

If possible, tell your doctor if any of the above applies to you before this medicine is used.

Taking/using other medicines

Special care is needed if you are taking/ using other medicines as some could interact with dopamine, for example:

•    anaesthetics (dopamine should not be used with cyclopropane and halogenated hydrocarbon anaesthetics)

•    alpha- and beta-blockers, e.g. propranolol (medicines which are often used for treating blood pressure and heart disorders)

•    monoamine oxidase inhibitors (antidepressant medicines)

•    phenytoin (a medicine used to treat epilepsy)

If possible, please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding. Your doctor will only use this medicine if the expected benefits outweigh any potential risk to your baby.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Do not drive or use machines if you experience any side effect (e.g. dizziness or difficulty seeing in bright light) which may lessen your ability to do so.

Important information about some of the ingredients of Dopamine Sterile Concentrate

This medicinal product contains sodium metabisulphite which, rarely, may cause severe hypersensitivity (severe allergy) reactions and bronchospasm (breathing difficulties).

This medicinal product contains less than 1 mmol (23 mg) sodium per ampoule, i.e. essentially 'sodium free'.

3. HOW DOPAMINE STERILE CONCENTRATE IS USED

This medicine will be diluted before it is given to you. It will be given as an infusion (drip) into a vein.

Dose

If your blood volume is low, you may be given a transfusion of blood or a plasma expander before dopamine is given.

-dr—

Dopamine 40 mg/ml Sterile Concentrate

The following information is intended for medical or healthcare professionals only

Further to the information included in section 3, practical information on the preparation/ handling of the medicinal product is provided here.

Incompatibilities

Dopamine Sterile Concentrate should not be added to any alkaline intravenous solutions, i.e. sodium bicarbonate. Any solution which exhibits physical or chemical incompatibility through a colour change or precipitate should not be administered.

It is suggested that admixtures containing gentamicin sulphate, cephalothin sodium, cephalothin sodium neutral or oxacillin sodium should be avoided unless all other viable alternatives have been exhausted.

Admixtures of ampicillin and dopamine in 5% glucose solution are alkaline and incompatible and result in decomposition of both drugs. They should not be admixed.

Admixtures of dopamine, amphotericin B in 5% glucose solution are incompatible as a precipitate forms immediately on mixing.

Instructions for use and handling

For single use

Discard any unused contents

Do not use if the solution is discoloured

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Your doctor will work out the correct dose of dopamine for you and how often it must be given. The dose will depend upon your medical condition and your size.

The rate of administration will be carefully controlled and adjusted according to your response. During treatment your heart rate, blood pressure and urine output will be measured to check how you are responding.

If you are given too much or too little Dopamine Sterile Concentrate

This medicine will be given to you in a hospital, under the supervision of a doctor. It is unlikely that you will be given too much or too little, however, tell your doctor or nurse if you have any concerns.

4. POSSIBLE SIDE EFFECTS

Like all medicines, dopamine can cause side effects, although not everybody gets them.

If any of the following happen, tell your doctor immediately:

•    severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint

•    pain or poor circulation in your fingers or toes (you may notice a change in skin colour)

•    pain or swelling at the injection site during or immediately after the injection

•    severe palpitations

These are serious side effects. You may need urgent medical attention.

If any of the following happen, tell your doctor as soon as possible:

•    irregular, rapid or slow heart beats

•    chest pain

•    shortness of breath

•    low blood pressure (you may feel dizzy or faint, particularly when standing up or getting out of bed)

•    feeling or being sick

•    headache

•    dilation of the pupil of the eye (mydriasis) which may cause difficulty seeing in bright light

•    goose pimples

Dopamine may lead to changes in your blood chemistry. Your doctor may take blood samples to monitor for these.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via

United Kingdom

Yellow Card Scheme Website:

http://www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW DOPAMINE STERILE CONCENTRATE IS STORED

Keep out of the reach and sight of children

Expiry

This medicine must not be used after the expiry date which is stated on the ampoule and carton after 'EXP'. Where only a month and year is stated, the expiry date refers to the last day of that month.

Storage

The ampoules should be kept in the outer carton, in order to protect from light, and stored at, or below, 30°C.

Prepared infusions should be used immediately, however, if this is not possible they can be stored for up to 48 hours provided they have been prepared in a way to exclude microbial contamination.

Visible signs of deterioration

Only clear, colourless or pale yellow solutions should be used. Opaque, cloudy or discoloured solutions should be discarded.

6. FURTHER INFORMATION

What Dopamine Sterile Concentrate contains

The active substance is dopamine hydrochloride. Each millilitre (ml) of concentrate contains 40 milligrams (mg) of dopamine hydrochloride.

The other ingredients are sodium metabisulphite and Water for Injections. See section 2 for further information about sodium metabisulphite.

What Dopamine Sterile Concentrate looks like and contents of the pack

Dopamine Sterile Concentrate is a clear, colourless or pale yellow concentrate for solution for infusion which comes in glass containers called ampoules.

It may be supplied in packs containing:

•    5 x 200 mg/5 ml ampoules

•    50 x 200 mg/5 ml ampoules Not all packs may be marketed.

Marketing authorisation holder and manufacturer

Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, uK

This leaflet was last revised in 09/2015

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Preparation of infusion solutions

Suggested dilution

Aseptically transfer Dopamine Sterile Concentrate into the IV solution as shown in the following table:

Strength of Concentrate	Volume of concentrate (ml)	IV Solution Volume (ml)	Final Concentration (microgram/ml)
200 mg/5 ml	5	500	400
200 mg/5 ml	5	250	800
200 mg/5 ml	10	250	1600
200 mg/5 ml	20	500	1600

Dopamine hydrochloride can be diluted with:

•    Sodium chloride (0.9%) solution

•    Dextrose (5%), sodium chloride (0.45%) solution

•    Sodium Lactate Intravenous Infusion, Compound (Hartmann's Solution for Injection)

In use storage precautions

Following dilution in the recommended diluents chemical and physical in-use stability has been demonstrated for 48 hours at a temperature not above 25°C.

However, from a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C unless dilution has taken place in controlled and validated aseptic conditions.

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