Land: Malta
Taal: Engels
Bron: Malta Medicines Authority
GLYCERYL TRINITRATE
G. Pohl-Boskamp GmbH & Co. KG Kieler Strasse 11, D-25551, Hohenlockstedt, Germany
C01DA02
GLYCERYL TRINITRATE 0.4 mg
SUBLINGUAL SPRAY
GLYCERYL TRINITRATE 0.4 mg
POM
CARDIAC THERAPY
Withdrawn
2006-10-10
Us er information, pleas e read carefully! G . P OHL -B OS K A MP G mbH & C o., K ieler S traß e 1 1, D-25551 Hohenlockstedt, G ermany Active ingredient: glyceryl trinitrate C ompos ition: 1 puff of the s pray contains 0.4 mg glyceryl trinitrate. Other cons tituents : medium-chain triglycerides, medium-chain partial glycerides, absolute ethanol, peppermint oil. Indications : Ð Treatment of all forms of episodic cardiac pain (relief of angina pectoris attacks); Ð As a prophylactic measure immediately prior to physical exertion or other situations known from experience to be capable of triggering episodic cardiac pain (prophylaxis of angina pectoris); Ð Acute cardiac infarction; Ð Acute left-heart failure (acute myocardial insufficiency, with acutely impaired left ventricular function); Ð C atheter-induced coronary spasms during coronary angiography. C ontraindications : G lyceryl trinitrate must not be used in patients with: Ð Hypersensitivity to one of the components of the drug; Ð Acute circulatory failure (shock, circulatory collapse); Ð S evere hypotension (systolic blood pressure below 90 mm Hg); Ð C ardiogenic shock, unless intra-aortic counterpulsation or positively inotropic drugs ensure an adequately high left-ventricular end-diastolic pressure; Ð Myocardial disorders, with a reduction of the heart volume (hypertrophic obstructive cardiomyopathy); Ð C onstrictive pericarditis; Ð P ericardial tamponade; Ð P atients with primary pulmonary hypertens ion (high blood pres s ure in the pulmonary circulation of unknown causation), since a possible increase in the blood supply to hypoventilated alveolar regions (hypoventilated regions of the lungs) can lead to hypoxaemia (reduction in the oxygen concentration in the arterial blood). T his applies in parti Lees het volledige document
Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT NITROLINGUAL ® Spray 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient of NITROLINGUAL ® Spray is glyceryl trinitrate (nitroglycerin). It is an organic nitrate, an ester of nitric acid with the following structural formula: CH 2 -O-NO 2 ⏐ CH -O-NO 2 ⏐ CH 2 -O-NO 2 Relative molecular weight: 227.1 One spray dose of 48 mg contains 0.40 mg of glyceryl trinitrate. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Sublingual spray 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS - Arrestation of angina pectoris attacks; - As a prophylactic measure immediately prior to physical exertion or other situations known from experience to be capable of triggering episodic cardiac pain (prophylaxis of angina pectoris); - Acute cardiac infarction; - Acute left-heart failure (acute myocardial insufficiency, with acutely impaired left ventricular function); - Catheter-induced coronary spasms during coronary angiography. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Unless otherwise prescribed, at the onset of an angina pectoris attack or immediately preceding situations known from experience to provoke an angina pectoris attack depending on the severity of the attack administer 0.4 mg - 0.8 mg of glyceryl trinitrate, corresponding to 1 - 2 spray doses. Page 2 of 8 In acute left ventricular failure and acute myocardial infarction depending on the severity administer 0.4 mg - 1.2 mg of glyceryl trinitrate, corresponding to 1 - 3 spray doses while continually monitoring the circulatory conditions (systolic blood pressure above 100 mm Hg). If there is no response, the same dose can be administered again Lees het volledige document