NITRONAL Solution for infusion (2018)
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Περιεχόμενα
Name of the medicinal product
Nitronal.
Qualitative and quantitative composition
Glyceryl trinitrate 1 mg/ml.
Pharmaceutical form
Solution for infusion.
Therapeutic indications
Unresponsive congestive heart failure, including that secondary to acute myocardial infarction. Refractory unstable angina pectoris and coronary insufficiency, including Prinzmetals angina. Control of ...
Posology and method of administration
For intravenous use. Nitronal should be administered by means of a micro-drip set infusion pump or similar device which permits maintenance of constant infusion rate. Adults and the elderly The dose should ...
Contraindications
Hypersensitivity to nitrates or any of the excipients. Acute circulatory failure (shock, circulatory collapse). Hypotensive shock. Severe hypotension (systolic blood pressure below 90 mmHg). Arterial hypoxaemia. ...
Special warnings and precautions for use
Caution should be exercised in patients with severe liver or renal disease, hypothermia, hypothyroidism. Nitronal should not be given by bolus injection. Nitronal contains glucose monohydrate (49mg/ml). ...
Interaction with other medicinal products and other forms of interaction
Glyceryl trinitrate may potentiate the action of other hypotensive drugs, and the hypotensive and anticholinergic effects of tricyclic anti-depressants. It may also slow the metabolism of morphine-like ...
Fertility, pregnancy and lactation
Fertility Animal studies did not indicate harmful effects with respect to fertility. However, the relevance of these animal findings to man is unknown. Pregnancy For glyceryl trinitrate no clinical data ...
Effects on ability to drive and use machines
Even when used as directed, this drug may affect the ability to drive or operate machinery. This can occur in particular at the beginning of the treatment, with an increase of the dosage, when changing ...
Undesirable effects
Adverse reactions are listed below in descending order by frequency of occurrence. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Very common (≥1/10), ...
Overdose
Symptoms of overdose Signs and symptoms of overdose are generally similar to the described adverse reactions: e.g. drop in blood pressure with orthostatic regulatory disturbances, reflex tachycardia and ...
Pharmacodynamic properties
Glyceryl trinitrate exerts a spasmolytic action on smooth muscle, particularly in the vascular system. The predominant effect is an increase in venous capacitance resulting in marked diminution of both ...
Pharmacokinetic properties
It is important that the dose of Nitronal be titrated against the individual clinical response. After intravenous administration, glyceryl trinitrate is widely distributed in the body with an estimated ...
Preclinical safety data
None, of relevance to the prescriber, which are not given elsewhere in this document.
List of excipients
Glucose Water for injections Hydrochloric acid
Incompatibilities
Glyceryl trinitrate is adsorbed onto administration systems composed of polyvinyl chloride, see 6.6.
Shelf life
Shelf life Ampoules: 4 years. Vial: 2 years. The diluted solution should be administered as soon as possible; it is stable for up to 24 hours in the recommended infusion system.
Special precautions for storage
Do not store above 25°C. Store in the original container.
Nature and contents of container
Cartons of 10 ampoules or single vials. Amber glass ampoule (containing 5ml or 25ml). Clear glass vial (containing 50ml).
Special precautions for disposal and other handling
Nitronal need not be diluted before use but can be diluted with Dextrose Injection BP, Sodium Chloride and Dextrose Injection BP, 0.9% Sodium Chloride Injection BP or other protein-free infusion solution, ...
Marketing authorization holder
G. Pohl-Boskamp GmbH & CO KG., Kieler Strasse 11, 25551 Hohenlockstedt, Germany
Marketing authorization number(s)
PL 04719/0006
Date of first authorization / renewal of the authorization
24 June 2010
Date of revision of the text
31 January 2018
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