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Summary of Product Characteristics SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Nitro "Pohl" Infus voor perfusorpompsystemen 1 mg/ml, oplossing voor infusie 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution for infusion contains 1 mg of glyceryl trinitrate (trinitrine), 1 ampoule of 5 ml contains 5 mg trinitrine, 1 ampoule of 10 ml contains 10 mg trinitrine, 1 ampoule of 25 ml contains 25 mg trinitrine, 1 vial of 50 ml contains 50 mg trinitrine. Excipient: glucose monohydrate (0.05 g/ml) For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion, clear and colourless solution 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Surgery/anaesthesia: Prevention of myocardial ischemia during coronary interventions. Cardiology: 1. Left ventricular heart failure, in particular during the acute phase of the myocardial infarction. 2. Unstable angina pectoris 4.2 Posology and method of administration General: It is recommended to start with a low dose of 5 µg/min and increase it gradually every 5 minutes. The dosage must be determined by the patient’s individual requirement and depending on the required response and possible adverse effects, including increased heart rate and hypotension. The dosages determined for individual patients may differ by a factor of 10. In most cases the dosage ranges from 5 - 200 µg/min. Careful clinical monitoring and measurement of blood pressure are necessary for correct adjustment of the infusion rate. 1 4.3 Contraindications Glyceryl trinitrate must not be used in patients with: - hypersensitivity to glyceryl trinitrate and/or nitro compounds in general or for one of the other (inactive) ingredients; - increased intracranial pressure (head injury or cerebral haemorrhage); - insufficient cerebral perfusion; - constrictive pericarditis or pericardial tamponade; - hypotension, with or without cardiogenic shock (systolic blood pressure below 90 mmHg); - uncorrected hypovolemia; - toxic pulmonary oedema. Concurrent use of phosphodiesterase-5-inhibitors (e.g. sildenafil, vardenafil and tadalafil). 4.4 Special warnings and precautions for use During continuous infusion of glyceryl trinitrate, reduction in its activity (tachyphylaxis) must be considered. Tolerance development and occurrence of cross intolerance to other nitro compounds have been reported. Increase of dosage may be necessary. Administration must not be discontinued abruptly. In order to avoid attenuation or loss of effect, high continuous dosage should be avoided. In individual patients the necessary dose to reach the required reduction in blood pressure may differ significantly. Therefore continuous monitoring of the blood pressure is necessary. The hypotensive effect of glyceryl trinitrate occurs almost immediately after administration. The effect also quickly disappears if the infusion is discontinued or the dose is reduced. In case of left ventricular failure use of the product is not safe unless the effect on cardiac filling pressure can be measured by means of a balloon catheter in the pulmonary artery. A severe drop in the arterial blood pressure of more than 20 mmHg, an increase in the heart rate of more than 20 beats/min or a reduction in filling pressure below normal values is an imperative indication to reduce or discontinue infusion of glyceryl trinitrate because it reduces coronary perfusion. Infusion of glyceryl trinitrate should not be given if systolic pressure is below 13,3 kPa (= 100 mm Hg) and/or diastolic pressure is below 8,0 kPa (= 60 mm Hg), since severe hypotension may occur. Intravenous infusion of glyceryl trinitrate in patients with myocardial infarction without cardial decompensation may cause undesirable reduction in left ventricular filling pressure and reduction in cardiac output. In addition to direct measuring of left ventricular filling pressure, careful monitoring of heart rate and arterial blood pressure is imperative. In treating diabetic patients one should avoid using glucose as dilution solution and bear in mind that Nitro "Pohl" Infus voor perfusorpompsystemen 1 mg/ml, oplossing voor infusie contains 5 % glucose. To be used exclusively in perfusor pump systems: the use of PVC tubings for infusion should be avoided (See 6.2 Incompatibilities). Caution is recommended in patients with restricted cardiac outflow, e.g. hypertrophic obstructive cardiomyopathy, aorta stenosis and mitral valve stenosis. 2 4.5 Interaction with other medicinal products and other forms of interaction Concomitant use of Nitro "Pohl" Infus voor perfusorpompsystemen 1 mg/ml, oplossing voor infusie and other vasodilating antihypertensives, ß-blockers, calcium antagonists, ACE- inhibitors, diuretics, tricyclic antidepressants, sapropterin and alcohol may cause increased hypotensive effect. In patients who are treated simultaneously with organic nitrates (e.g. isosorbide dinitrate and isosorbide- 5-mononitrate) it may be necessary to increase the dosage of glyceryl trinitrate in order to achieve the desired effect. The vasodilating effect of organic nitrates is potentiated by phosphodiesterase-5-inhibitors (e.g. sildenafil, vardenafil and tadalafil). This might cause life threatening cardiovascular complications in susceptible patients. Concomitant use of organic nitrates and phosphodiesterase-5-inhibitors should be avoided. 4.6 Pregnancy and lactation Pregnancy There are no adequate data from the use of Nitro "Pohl" Infus voor perfusorpompsystemen 1 mg/ml, oplossing voor infusie in pregnant women. Animal studies are insufficient with respect to effects on pregnancy or embryofoetal development or parturition or postnatal development (see section 5.3). The potential for human is unknown. Intravenous administration may show reversible pharmacological effects, including isolated case reports of a reduction in fetal heart rate. Nitro "Pohl" Infus voor perfusorpompsystemen 1 mg/ml, oplossing voor infusie is not recommended during pregnancy except for acute situations. Lactation It is not known whether glyceryl trinitrate is excreted in human milk. Lactation is not recommended during use of Nitro "Pohl" Infus voor perfusorpompsystemen 1 mg/ml, oplossing voor infusie, because of possible pharmacological effects in the infant. 4.7 Effects on ability to drive and use machines Even when used according to the instructions, the drug may effect the ability to drive and to operate machinery. This may occur particularly at the start of the treatment, when the dosage is increased, when changing to another medicinal product or when used in combination with alcohol. Because of the fact that Nitro "Pohl" Infus voor perfusorpompsystemen 1 mg/ml, oplossing voor infusie is used exclusively in a clinical setting and closely monitored circumstances, the above effects will not occur in practice. 3 4.8 Undesirable effects Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), not known (cannot be estimated from the available data). Nervous system disorders: Common: headache1 Vascular disorders: Uncommon: drop in blood pressure with subsequent heart rate increase2, orthostatic hypotension, facial flushing, collapse cardiovascular with bradycardia and syncope Not known: ischaemia3 Gastrointestinal disorders: Uncommon: nausea, vomiting Skin and subcutaneous tissue disorders: Uncommon: allergic skin reaction Very rare: exfoliative dermatitis 1 May occur at the start of treatment, usually subsides with continuous use. 2 A dose-dependent reduction in blood pressure and heart rate increase may occur. In case of severe reduction in blood pressure, the infusion must be discontinued. If this does not result in spontaneous recovery, it may become necessary to take cardiovascular measures, e.g. raising the patient’s legs or volume replacement. A large drop in blood pressure may lead to a paradoxical exacerbation of angina pectoris symptoms. 3 Transient hypoxaemia may occur as a result of relative redistribution of the blood flow due to hypoventilation of alveolar tissues. In patients with coronary heart disease this may lead to ischaemia. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*. 4.9 Overdose a) Symptoms of overdose Reduction in blood pressure with orthostatic regulatory disturbances, reflex tachycardia and headache, weakness, dizziness, drowsiness, diminution of consciousness, flushes, nausea, vomiting and diarrhoea may occur. At high doses (more than 20 mg/kg body weight) occurrence of methaemoglobinemia, cyanosis, dyspnoea and tachypnoea, due to the formation of nitrite ions during metabolism of glyceryl trinitrate. At very high doses an increase in intracranial pressure with cerebral symptoms (convulsions) may occur. b) Treatment in case of overdose Place the patient in recumbent position with the legs raised; the vital parameters should be monitored in intensive-care setting and corrected if necessary. 4 Volume replacement should be performed in case of severe hypotension and/or shock; in exceptional cases, intravenous infusion of norepinephrine and/or dopamine should be given as a cardiovascular treatment. Administration of epinephrine and related substances is contra-indicated. Methaemoglobinemia may be treated with intravenous methylthionine
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