Product Description:

1. What this product is and what it is used for

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

Domine can be used in adults:

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. What you need to know before you use this product

Do not use Domine

If you are allergic to dopamine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
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
Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Domine

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.

Children

The safety and efficacy of dopamine in children has not been established.

Other medicines and Domine

Tell your doctor if you have been taking, have recently taken or might take any other medicine, 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 (anti-depressant medicines)
Phenytoin (a medicine used to treat epilepsy)
Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

Dominecontains sodiummetabisulfite and sodium

Domine contains sodium metabisulfite. Each 5 ml of Domine 200 mg/5 ml Concentrate for Solution for Infusion contains 45 mg sodium metabisulfite which, rarely, may cause severe hypersensitivity (severe allergy) reactions and bronchospasm (breathing difficulties).

Domine contains sodium. Each 5 ml of Domine 200 mg/5 ml Concentrate for Solution for Infusion contains 10.925 mg sodium. This medicine contains less than 1 mmol (23 mg) sodium per 5 ml, that is to say essentially ‘sodium-free’.

3. How to use this product.

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.

Your doctor will work out the recommended 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 use moreDominethan you should

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.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

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

Uncommon:

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 even to black) (gangrene)
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:

Common:

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)
Narrowing of blood vessels (which may cause the skin to become cold and to turn pale or to have a bluish colour)
Feeling or being sick
Headache
Uncommon:

High blood pressure (you may get headaches or your doctor may monitor for this)
Abnormalities in the ECG (a tracing of electrical currents in the heart)
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.

5. How to store this product

Keep this medicine out of the sight and reach of children.

Store below 30°C.

Store in the original package in order to protect from light.

Prepared infusions should be used immediately, however, if this is not possible, they can be stored for up to 24 hours at room temperature provided they have been prepared in a way to exclude microbial contamination.

Do not use this medicine after the expiry date which is stated on the package after “EXP”. The expiry date refers to the last day of that month.

Do not use this medicine if you notice an opaque, cloudy or discoloured solution.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.