LITHIUM CHLORIDE

15 mmol/ml Solution for Injection. e. 0 ml of lithium chloride injection. 2 mM. 2 mM are allowable but the measurement may be less accurate. e. e. 5 ml of the injection. An interval of at least 5 minutes should be allowed before a subsequent lithium cardiac output determination is attempted.

15 mmol/ml Solution for Injection are based on the assumption that the patient weight is in excess of 40 kg. Please note that a single LiDCO determination within the target dilution curve peak range is sufficient to give a cardiac output reading with the same precision and accuracy as the mean of three thermodilution determinations.

3 mmol (2 ml) lithium chloride. The cumulative dose of lithium chloride should not exceed 3 mmol. Method of Administration THIS PRODUCT SHOULD ONLY BE USED IN ACCORDANCE WITH THE LiDCO SYSTEM USER'S MANUAL SUPPLIED WITH THE MONITORING EQUIPMENT AND SHOULD ONLY BE USED IN MEDICAL AND SURGICAL INTENSIVE CARE UNITS, OPERATIVE SUITES AND ACCIDENT AND EMERGENCY UNITS Lithium chloride is for single patient use only and should be used immediately upon opening the ampoule.

The lithium chloride may be withdrawn from the ampoule into a closed reservoir syringe system supplied by LiDCO and as described in the LiDCO System User’s Manual. Any unused solution remaining in the closed reservoir syringe system must be discarded after three (3) hours.

The lithium dose is administered by intravenous injection via a central venous catheter

No undesirable effects related to lithium chloride are expected at the proposed posology.

4 Special warning and precautions for use This medicinal product must only be used in conjunction with the LiDCO System 1. Follow the dose recommendations. 5 mM. 2. All injections of lithium chloride should be recorded in the patient notes.

3. A minimum of 5 minutes should be left between sequential LiDCO System determinations of cardiac output. 4. Waste blood should not be returned to the patient. The waste blood may clot in the bag and/or pick up contaminant material/particles from contact with the Flow Through Cell assembly wick material.

5. g. vecuronium bromide, atracurium besylate and pancuronium bromide. These agents interfere with the performance of the lithium electrode and concurrent use must be avoided. 6. Lithium sensors are affected by other chemicals notably: detergents/surfactants and solvents.

Occasional problems have been noted with contaminants present in saline infusion products such as saline bags. 7. The use of the LiDCO System requires the bolus administration of lithium chloride and saline followed by arterial blood sampling.

Only medical staff appropriately qualified for the administration of intravenous fluids and peripheral arterial catheter use should use the system. Usual care should be taken to avoid: patient infection, catheter or line disconnection, arterial or venous blood loss and air embolism.

8. The concurrent use of: electrocautery, electrosurgery, defibrillation and X-ray machinery will cause transient interference with the LiDCO System Monitor trace. Determinations should not be performed during such periods. No such interference is known to occur with infrared irradiation, or equipment generating radiofrequency irradiation.

9 In cases of intracardiac shunt (such as myocardial infarction with interventricular septum rupture), the cardiac output measurement will be distorted when measured by the LiDCO System, as it would by the thermodilution method. An alternative method for cardiac output determination should be considered in such cases.

15 mmol/ml Solution for Injection is contraindicated: • In patients currently under lithium therapy for control of bipolar disorder. • In patients less than 40 kg in weight. • In the first trimester of pregnancy. 6. Hypersensitivity to lithium compounds.