Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
GLYCERYL TRINITRATE
UCB (Pharma) Ireland Limited
GLYCERYL TRINITRATE
1 Mg/Ml
Solution for Infusion
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
Abreißperforation Abreißperforation NOTE: ARTWORK STUDIO CHECKS AND APPROVES TECHNICAL ACCURACY AND PRE-PRESS SUITABILITY OF THIS ARTWORK ONLY. ENSURE THE ARTWORK HAS BEEN THOROUGHLY CHECKED FOR TEXTUAL ACCURACY AND HAS BEEN APPROVED AS SUCH! Aesica Pharmaceuticals GmbH Packaging Technology & Artwork Services Alfred-Nobel-Straße 10 40789 Monheim, Germany ARTWORK STUDIO Date Operator Approver PT Approval Dispatched to Schlüter Manufacturing Site ARTWORK INFORMATION Fontsize Bodytext 8 pt Linespacing 9 pt Technical Changes Product Name Nitrocine Print Colours Techn. Colours Aesica Id.-No. 4015108 GBR/IRL BLACK external Id.-No. Dimensions 140 x 520 mm Operator Sorek Creation Date 31.01.2012 Amended by Sorek Modific. Date 28.02.2012 Edition No. 02 VPT-Pool/Technik/ABV_SOP_Vorgaben/Freigabefeld/Freigabefeld_Aesica_08/2011 UNRESPONSIVE CONGESTIVE HEART FAILURE: The recommended starting dose is 20-25mcg/min. This may be decreased to 10mcg/min, or increased in steps of 20-25mcg/min every 15-30 minutes until the desired effect is obtained. UNSTABLE ANGINA: An initial dose of 10mcg/min is recommended with increments of 10mcg/min being made at approximately 30 minute intervals according to the needs of the patient. Patients with severe anginal syndromes must be treated with a posology of 33-133µg/min. For patients in a hypertensive crisis: infuse 33- 133µg/min while constantly monitoring blood pressure and heart rate. ADMINISTRATION Refer to compatibilities at the end of this leaflet. Nitrocine ® can be administered undiluted by slow intravenous infusion using a syringe pump incorporating a glass or rigid plastic syringe. Alternatively, Nitrocine may be administered intravenously as an admixture using a suitable vehicle such as Sodium Chloride Injection B.P. or Dextrose Injection B.P. In case of dilution, Nitrocine must be mixed under aseptic conditions immediately after opening. ADMIXTURE PREPARATION: Admixtures are prepared by replacing a given v Přečtěte si celý dokument
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_ 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. _Elderly_ There is no evidence that a posology adjustment is required in the elderly _Paediatric population_ 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 stabilized. 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 hypertensi Přečtěte si celý dokument