During the administration of Dopacard, as with any parenteral catecholamine, the rate of administration and duration of therapy should be adjusted according to the patient's response as determined by heart rate and rhythm (ECG), blood pressure, urine flow and, if possible, measurement of cardiac output.

It is recommended that the infusion of Dopacard is reduced gradually rather than withdrawn abruptly.

The duration of therapy is dependent upon the patient's overall response to treatment. Extended therapy beyond 48 hours has not been fully eva luated.

Special instructions for the preparation of Dopacard infusion solutions:

Dopacard must be diluted before use. For instructions on dilution of the product before administration, see section 6.6.

4.3 Contraindications

 Known sensitivity to dopexamine hydrochloride or excipients (disodium edetate).

Use in patients who are receiving monoamine oxidase inhibitors (MAOIs) or have received such treatment within the past 14 days.

Phaeochromocytoma.

Thrombocytopenia.

Use in patients with left ventricular outlet obstruction such as hypertrophic obstructive cardiomyopathy or aortic stenosis. In such patients, positive inotropic activity may increase left ventricular outflow obstruction and sudden vasodilatation may cause hypotension.

Use in patients with uncorrected hypovolaemia.

4.4 Special warnings and precautions for use

 Correction of hypovolaemia must be achieved before the administration of Dopacard. Hypovolaemia should also be corrected during therapy as vasodilatation occurs due to treatment.

Care should be exercised so as to restrict the sodium and fluid load during administration of Dopacard.

Dopacard should not be administered to patients with severe hypotension or a markedly reduced systemic vascular resistance until specific resuscitative measures have been taken to restore blood pressure to a clinically acceptable level.

In patients with a marked reduction in systemic vascular resistance, Dopacard should not be used as a direct substitute for pressor agents or other inotropes.

As with other catecholamines, Dopacard should be administered with caution to patients with a clinical history of ischaemic heart disease especially following acute myocardial infarction or recent episodes of angina pectoris as a tachycardia may increase myocardial oxygen demand and further exacerbate myocardial ischaemia.

As has been observed with some other β2-adrenergic agonists, a small reversible fall in circulating platelet numbers has been observed in some patients. No adverse effects attributable to alterations in platelet count have been seen in clinical trials.

Care must be exercised when administering Dopacard in the presence of hypokalaemia or hyperglycaemia. In common with other β2-agonists, Dopacard depresses plasma potassium and raises plasma glucose. These effects are minor and reversible. Monitoring of potassium and glucose is advisable in patients likely to be at risk from such changes, e.g., diabetics, patients with myocardial infarction or patients being treated with