Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
ISOPRENALINE HYDROCHLORIDE
International Medication Systems
20 Microgram/ML
Solution for Inj/Inf
1977-09-08
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Isoprenaline Minijet , solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Isoprenaline Hydrochloride 20 micrograms per ml. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Solution for injection or infusion The container is specially designed for use with the IMS Minijet injector supplied. The product may also be diluted (see 6.6). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the short term, emergency treatment of heart block, severe bradycardia and the temporary control of Stokes-Adams syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Widely ranging doses have been used successfully. The dose/infusion rate should be adjusted according to response. ECG should be monitored during treatment. _Adults_: initial bolus of 20mcg then subsequent doses of 10-200mcg by intravenous injection. or 0.5-10mcg/minute by intravenous infusion. _Children_: initial bolus of 10mcg then subsequent doses of 5-100mcg by intravenous injection. or 0.25-5mcg/minute by intravenous infusion. 4.3 CONTRAINDICATIONS Contraindications are relative, as Isoprenaline is only intended for short term emergency treatment. Known hypersensitivity, recent myocardial infarction, pre-existing tachyarrhythmias. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Isoprenaline should be administered with caution in elderly patients, patients with diabetes or hyperthyroidism or who are otherwise hyper-responsive to sympathomimetic drugs, and patients suffering from cardiovascular disease such as ischaemic heart disease, arrhythmia or tachycardia, occlusive vascular disease including arteriosclerosis, those on digitalis, hypertension or aneurysms. Anginal pain may be precipitated. IRISH MEDICINES BOARD ___________________________________________________________ Lugege kogu dokumenti