Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: 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, vial 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 50 mg glyceryl trinitrate in 50 ml (1mg/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: 1.The rapid control of hypertension during cardiac surgery. 2.Reducing blood pressure and maintaining controlled hypotension during surgical procedures. 3.Controlling myocardial ischaemia during and after cardiovascular surgery. _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 সম্পূর্ণ নথি পড়ুন