Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DOPAMINE HYDROCHLORIDE
Hospira UK Limited
C01CA04
DOPAMINE HYDROCHLORIDE
40 Mg/Ml
Concentrate for Soln for Inf
Product subject to prescription which may not be renewed (A)
Adrenergic and dopaminergic agents
Authorised
1986-05-21
PACKAGE LEAFLET: INFORMATION FOR THE USER DOPAMINE HYDROCHLORIDE 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 Hydrochloride Sterile Concentrate is and what it is used for 2. Before Dopamine Hydrochloride Sterile Concentrate is used 3. How Dopamine Hydrochloride Sterile Concentrate is used 4. Possible side effects 5. How Dopamine Hydrochloride Sterile Concentrate is stored 6. Further information 1. WHAT DOPAMINE HYDROCHLORIDE 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 Hydrochloride 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 HYDROCHLORIDE STERILE CONCENTRATE IS USED DOPAMINE HYDROCHLORIDE 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 • if you have shown signs of hypersensitivity (severe allergy) to dopamine or sodium metabisulphite in the past If possi Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dopamine Hydrochloride 40 mg/ml Sterile Concentrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 40 mg dopamine hydrochloride Each 5 ml ampoule contains 200 mg of dopamine hydrochloride Excipients: Each ampoule contains 50mg sodium metabisulphite (E223) equivalent to 10mg per ml. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion (Sterile concentrate) 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:- a) Acute hypotension or shock associated with myocardial infarction, endotoxic septicaemia, trauma and renal failure. b) As an adjunct after open heart surgery, where there is persistent hypotension after correction of hypovolaemia. c) 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. 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 mcg/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 5mcg/kg/min and increased gradually in 5 to 10mcg/kg/min increments up to 20 to 50mcg/kg/min as needed. If doses in excess of 50mcg/kg/min are required, it is advisable to check urine output frequently. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Read the complete document