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Lithium Chloride 0.15 Mmol/Ml Solution For Injection

PACKAGE LEAFLET: INFORMATION FOR THE USER Lithium Chloride 0.15 mmol/ml Solution for Injection

Lithium chloride

Read all of this leaflet, carefully, before you have this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, please ask your doctor or nurse.

If you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

In this leaflet:

1    What Lithium Chloride Solution for Injection is and what it is used for

2    Before you have Lithium Chloride Solution for Injection

3    How Lithium Chloride Solution for Injection is used

4    Possible side effects

5    How Lithium Chloride Solution for Injection is stored

6    Further information

1    WHAT LITHIUM CHLORIDE SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR

What Lithium Chloride Solution for Injection is

Lithium Chloride 0.15 mmol/ml Solution for Injection is a clear liquid made up of lithium chloride and sterile water. Lithium chloride occurs naturally, and is normally present in very small amounts both in drinking water and in your body.

What it is used for

•    The injection is used with heart monitoring equipment called the LiDCO System and is given to you by a doctor or nurse, in hospital, for diagnosis only.

•    The System measures how much blood your heart is pumping per minute (your 'cardiac output'). By knowing this, your doctors will have more of the information needed to improve the performance of your heart and of your blood circulation.

2    BEFORE YOU HAVE LITHIUM CHLORIDE SOLUTION FOR INJECTION Do not have Lithium Chloride Solution for Injection:

•    if you are allergic to medicines containing lithium;

•    if you are already taking lithium to treat certain mental health conditions;

•    if you weigh less than 40 kilos (6 st. 4 lbs);

•    if you are in the first three months of pregnancy;

•    if you are taking muscle-relaxing medicines. These medicines interfere with the results obtained by the LiDCO System.

Tell your doctor if you think any of these apply to you. Your doctor will decide whether the LiDCO System is suitable for measuring your cardiac output or whether other methods would be more appropriate.

Taking other medicines

At the doses recommended for these Lithium Chloride injections, there are no known interactions with other medicines. Please tell your doctor, however, if you are taking or have taken recently any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, or think you may be pregnant. This injection must not be given during the first three months of pregnancy.

You are allowed to breast-feed when you have been given this injection.

If you are pregnant or breast-feeding, ask your doctor or pharmacist for advice before using any medicine.

Driving and using machinery

There are no known effects on driving and using machinery.

3 HOW LITHIUM CHLORIDE SOLUTION FOR INJECTION IS USED

This solution is used only with the LiDCO System, and only in hospital. It is given to you by a doctor or nurse, through an injection into a vein.

How this injection works

When the solution has been injected:

•    It mixes with the blood in your heart.

•    Your heart pumps this blood, with a trace of the lithium chloride, out into your arteries.

•    A small blood sample is then taken from an artery, through a small tube to the LiDCO System's sensor.

•    The sensor measures the amount of lithium chloride in your blood.

•    The system's computer then works out how much blood your heart is pumping per minute.

Dosage:

•    Usual dose: 0.5 - 2.0 ml of solution

•    Maximum single dose: 2.0 ml of solution

•    Maximum total dose: 20 ml of solution.

To obtain accurate results, you may need more than one dose of lithium chloride solution. If so, there should be a gap of at least five minutes between each dose.

If you have more Lithium Chloride Solution than you should

Because this injection is given to you only by trained medical staff, it is very unlikely you will be given more than you should.

If, however, you showed any signs of having more lithium chloride than you should, this injection would be stopped.

If you have any further questions about having this product, please ask your doctor or nurse.

4    POSSIBLE SIDE EFFECTS

The dose of lithium chloride used in the measurement of cardiac output is very small and produces no known side effects. However, if you notice anything which you think may be a side effect, tell your doctor or nurse immediately.

Please remember: the expected benefits of your medicine will usually be greater than the risk of suffering harmful side effects.

5    HOW LITHIUM CHLORIDE SOLUTION FOR INJECTION IS STORED

Lithium Chloride Solution for Injection is stored in the hospital according to the following instructions:

•    store out of reach and sight of children;

•    do not store above 25°C;

•    do not use after the expiry date shown on the bottom of the carton and on the ampoule label. (The expiry date refers to the last date of that month);

•    store in the original container.

Only use if the solution is free from particles. Any unused solution in the ampoule should be disposed of immediately. Solution drawn off into the reservoir syringe can be used for three hours, after which it should be disposed of.

6 FURTHER INFORMATION What Lithium Chloride Solution for Injection contains:

The active substance is: lithium chloride The other substance is: water for injections

What Lithium Chloride Solution for Injection looks like and contents of the pack:

It is a clear solution contained in a glass ampoule. Each ampoule contains 10 ml solution. The product is supplied in cartons of five ampoules.

Marketing Authorisation Holder

LiDCO Ltd 16 Orsman Road London N1 5QJ United Kingdom

Manufacturer

South Devon Healthcare NHS Foundation Trust

Torbay Pharmaceutical Manufacturing Unit

Kemmings Close

Paignton

Devon TQ4 7TW

United Kingdom

This leaflet was last approved in April 2014

Ref. CM 40-044-116/16