Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
VERAPAMIL HYDROCHLORIDE
Abbott Laboratories Ireland Ltd
VERAPAMIL HYDROCHLORIDE
2.5 Mg/Ml
Solution for Inj/Inf
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
ISOPTIN 2.5MG/ML SOLUTION FOR INJECTION OR INFUSION (verapamil hydrochloride) IMPORTANT INFORMATION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE ISOPTIN 2.5MG/ML SOLUTION FOR INJECTION OR INFUSION BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet as you may need to read it again. This leaflet provides a summary of the information currently available on Isoptin 2.5mg/ml Solution for Injection or Infusion. For further information or advice ask your doctor or ward pharmacist. This medicine is for you only and should never be given to anyone else, even if they appear to have the same symptoms as you. Tell your doctor or pharmacist if you experience any side effects. See Section 4. LEAFLET CONTENTS: 1. What is Isoptin 2.5mg/ml Solution for Injection or Infusion and what is it used for? 2. What you need to know before you receive Isoptin 2.5mg/ml Solution for Injection or Infusion 3. How will you receive Isoptin 2.5mg/ml Solution for Injection or Infusion? 4. Possible side effects 5. How should Isoptin 2.5mg/ml Solution for Injection or Infusion be stored? 6. Further information 1. WHAT IS ISOPTIN 2.5MG/ML SOLUTION FOR INJECTION OR INFUSION AND WHAT IS IT USED FOR? Isoptin 2.5mg/ml Solution for Injection or Infusion belongs to a group of medicines called calcium channel blockers. Calcium channel blockers change the amount of calcium getting into the muscle cells in your heart and blood vessels. This can change the strength and speed with which your heart beats. It also opens up the blood vessels so blood can be pumped around the body more easily. This helps more oxygen to get to your heart muscle and can lower your blood pressure. Isoptin 2.5mg/ml Solution for Injection or Infusion is used to treat abnormal hear Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Isoptin 2.5mg/ml Solution for Injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1ml of solution contains 2.5mg of verapamil hydrochloride. Each ampoule contains 2ml of solution containing 5ml of verapamil hydrochloride. Excipients: contains 17 mg of sodium under the sodium chloride form. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection or infusion A clear, colourless, sterile, aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Verapamil hydrochloride is indicated in adults, neonates, infants, children and adolescents for the treatment of : Tachycardias, such as paroxysmal supraventricular tachycardia, atrial fibrillation/flutter with tachyarrhythmia (except in WPW syndrome, see Section 4.3, Contra-indications), supraventricular extrasystoles, ventricular extrasystoles if due to myocardial ischaemia. Severe angina not responsive to oral therapy. Severe hypertension and hypertensive crisis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ADULTS:_ The recommended intravenous doses of verapamil hydrochloride are as follows: _INITIAL DOSE_: 5 mg initially, given slowly (over approximately 2 minutes), keeping the patient under constant observation and if possible under ECG and blood pressure monitoring. _REPEAT DOSE_: If the therapeutic effect is not achieved, a further 5 mg may be injected after 5 to 10 minutes. Drip infusion to maintain the therapeutic effect: 5-10 mg/hour in physiological saline, glucose, laevulose or similar solutions (pH 6.5) on average up to a total dose of 100 mg/day. SPECIAL POPULATIONS _PAEDIATRIC POPULATION_ THE SAFETY AND EFFICACY OF VERAPAMIL HYDROCHLORIDE INJECTION HAVE BEEn ESTABLISHED IN NEONATES, INFANTS, CHILDREN AND ADOLESCENTS: New Lugege kogu dokumenti