Country: Malta
Language: English
Source: Medicines Authority
DOPAMINE HYDROCHLORIDE
Hospira UK Limited
C01CA04
DOPAMINE HYDROCHLORIDE
CONCENTRATE FOR SOLUTION FOR INFUSION
DOPAMINE HYDROCHLORIDE 40 mg/ml
POM
CARDIAC THERAPY
Authorised
2006-12-28
H03121 PACKAGE LEAFLET: INFORMATION FOR THE USER DOPAMINE 40 MG/ML STERILE CONCENTRATE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. IN THIS LEAFLET: 1. What Dopamine Sterile Concentrate is and what it is used for 2. Before Dopamine Sterile Concentrate is used 3. How Dopamine Sterile Concentrate is used 4. Possible side effects 5. How Dopamine Sterile Concentrate is stored 6. Further information 1. WHAT DOPAMINE STERILE CONCENTRATE IS AND WHAT IT IS USED FOR Dopamine is a medicine that stimulates the heart and has effects on the blood vessels. DOPAMINE STERILE CONCENTRATE CAN BE USED: • 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. BEFORE DOPAMINE STERILE CONCENTRATE IS USED DOPAMINE STERILE CONCENTRATE SHOULD NOT BE USED • 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 • i f y o u h a v e s h o w n s i g n s o f hypersensitivity (severe allergy) to dopamine or sodium metabisulphite in the past If possible, tell your doctor if any of the above applies to you before this medicine is used. SPECIAL CARE NEEDS TO BE TAKEN WITH DOPAMINE STERILE CONCENTRATE • 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 us Read the complete document
Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dopamine 40 mg/ml Sterile Concentrate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 40 mg dopamine hydrochloride Each 5 ml ampoule of concentrate contains 200 mg dopamine hydrochloride For excipients, see 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion Ampoules containing a clear colourless or pale yellow solution 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Dopamine is indicated for the correction of haemodynamic imbalance present in: 1) Acute hypotension or shock associated with myocardial infarction, endotoxic septicaemia, trauma and renal failure. 2) As an adjunct after open heart surgery where there is persistent hypotension after correction of hypovolaemia. 3) In chronic cardiac decompensation as in congestive failure. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION To be administered by intravenous infusion only after dilution with the appropriate diluents. A suitable metering device is required in the infusion system to control the rate of flow, and this should be adjusted to the optimum patient response and monitored constantly in the light of the individual patient’s response. ADULTS Where appropriate, the circulating blood volume must be restored with a suitable plasma expander or whole blood, prior to administration of dopamine hydrochloride. Begin infusion of dopamine hydrochloride solution at doses of 2.5 microgram/kg/min in patients who are likely to respond to modest increments of heart force and renal perfusion. In more severe cases, administration may be initiated at a rate of 5 microgram/kg/min and increased gradually in 5- to 10 microgram/kg/min increments up to 20 to 50 microgram/kg/min as needed. If doses in excess of 50 microgram/kg/min are required, it is advisable to check urine output frequently. Page 2 of 8 Should urinary flow begin to decrease in the absence of hypotension, reduction of dopamine dosage should be considered. It has been found that more tha Read the complete document