Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

1. NAME OF THE MEDICINAL PRODUCT

 Dopacard 10mg/ml

Concentrate for solution for infusion

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each 5 ml ampoule contains 50 mg dopexamine hydrochloride (10 mg/ml).

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

 Concentrate for solution for infusion

Colourless liquid

4. CLINICAL PARTICULARS

4.1 Therapetic indications

 Dopacard is indicated for short term administration (experience in clinical studies has included administration for up to 48h) to patients who require peripheral vasodilator (afterload reduction), renal vasodilator and mild positive inotropic therapy in the treatment of heart failure such as may be associated with exacerbation of chronic heart failure or with cardiac surgery. Dopexamine should only be used in specialist units in which adequate facilities are available for patient surveillance and monitoring of responses.

4.2 Posology and method of administration

 Dosage

The dosage required is variable and must be determined for each patient by dose titration. Patients who are acutely ill with a high sympathetic drive may require and tolerate lower doses than those with severe chronic disease.

Adults and the elderly:

Infusion should begin at a dose of 0.5 microgram/kg/min and may be increased to 1 microgram/kg/min and then in increments (0.5-1 microgram/kg/min) up to 6 micrograms/kg/min at not less than 15 minute intervals according to the patient's haemodynamic and clinical response. Smaller increments (0.5 microgram/kg/min) may be justified in certain patients according to haemodynamic and clinical response.

Children.

The safety and efficacy of Dopacard for use in children have not been established.

Administration

Dopacard should only be administered intravenously by infusion through a cannula or catheter in a central or large peripheral vein. Contact with metal parts in infusion apparatus should be minimised. A device which provides accurate control of the rate of flow is essential.

Central administration:

Dopacard can be administered via a cannula or catheter sited in a central vein. The concentration of the infusion solution for administration via this route must not exceed 4 mg/ml.

Peripheral administration.

Dopacard can be admini