Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GLYCERYL TRINITRATE
UCB (Pharma) Ireland Limited
1 Mg/Ml
Solution for Infusion
2009-12-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nitrocine 1 mg/ml solution for infusion, ampoule 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ampoules containing 10 mg glyceryl trinitrate in 10 ml (1 mg/ml). For a full list of excipients see Section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion Clear colourless and odourless isotonic sterile solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Surgery_ Nitrocine is indicated for: _Unresponsive congestive heart failure:_ Nitrocine may be used to treat unresponsive congestive heart failure secondary to acute myocardial infarction. _Unstable angina:_ Nitrocine may be used to treat unstable angina which is refractory to treatment with beta blockers and sublingual nitrates. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND ELDERLY The dose of Nitrocine should be adjusted to meet the individual needs of the patient. The recommended dosage range is 10 - 200 mcg/min but up to 400 mcg/min may be necessary during some surgical procedures. CHILDREN The safety and efficacy of Nitrocine has not yet been established in children. SURGERY A starting dose of 25 mcg/min is recommended for the control of hypertension, or to produce hypotension during surgery. This may be increased by increments of 25 mcg/min at 5 minute intervals until the blood pressure is stabilised. Doses between 10 - 200 mcg/min are usually sufficient during surgery, although doses of up to 400 mcg/min have been required in some cases. The treatment of perioperative myocardial ischaemia may be started with a dose of 15 - 20 mcg/min, with subsequent increments of 10 - 15 mcg/min until the required effect is obtained. 1. The rapid control of hypertension during cardiac surgery. 2. Reducing blood pressure and maintaining controlled hypotension Read the complete document