NITROLINGUAL Sublingual spray (2018)
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Περιεχόμενα
Name of the medicinal product
Nitrolingual Pumpspray.
Qualitative and quantitative composition
Each metered dose contains 400 micrograms glyceryl trinitrate. Excipients: contains 9.6 mg anhydrous ethanol per metered dose. For the full list of excipients, see section 6.1.
Pharmaceutical form
Sublingual spray.
Therapeutic indications
For the treatment and prophylaxis of angina pectoris and the treatment of variant angina.
Posology and method of administration
Posology Adults and older people At the onset of an attack or prior to a precipitating event: one or two 400 microgram metered doses sprayed under the tongue. If symptoms do not resolve, this may be repeated ...
Contraindications
Hypersensitivity to the active substance, other nitrates or to any of the excipients listed in 6.1. Acute circulatory shock including hypovolaemic shock. Cardiogenic shock, unless a sufficiently high left ...
Special warnings and precautions for use
Any lack of effect may be an indicator of early myocardial infarction. As with all glyceryl trinitrate preparations, use in patients with incipient glaucoma should be avoided. Glyceryl trinitrate should ...
Interaction with other medicinal products and other forms of interaction
Consistent with their known effects on the nitric oxide/cyclic guanosine monophosphate (cGMP) pathway, phosphodiesterase type 5 inhibitors (e.g. sildenafil, vardenafil and tadalafil) have been shown to ...
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 (see section 5.3). Pregnancy Animal studies did not ...
Effects on ability to drive and use machines
Since hypotension, dizziness and syncope have been reported following treatment with glyceryl trinitrate, caution is recommended in patients performing skilled tasks, such as driving and operating machinery. ...
Undesirable effects
Undesirable effects are listed below by system organ class and frequency. Frequencies are defined as follows: very common ≥1/10 (≥10%); common ≥1/100 and <1/10 (≥1% and <10%); uncommon ≥1/1000 and <1/100 ...
Overdose
Signs and symptoms encountered with overdose are generally similar to those events reported during treatment use although the magnitude and/or severity of the reactions may be more pronounced (see Adverse ...
Pharmacodynamic properties
Glyceryl trinitrate relieves angina pectoris by reduction of cardiac work and dilation of the coronary arteries. In this way, not only is there a lessening in arterial oxygen requirement but the amount ...
Pharmacokinetic properties
The pharmacokinetics of glyceryl trinitrate are complex; venous plasma levels of the drug show wide and variable fluctuations and are not predictive of clinical effect. In a human pharmacodynamic study, ...
Preclinical safety data
None stated.
List of excipients
Medium-chain triglycerides Ethanol (absolute) Glycerol monocaprylocaprate Peppermint oil Sodium (S)-lactate (S)-lactic acid
Incompatibilities
Not known.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Glass bottle with or without red plastic coating, fitted with metering pump. Each bottle contains 6.3 g, 12.1 g, 13.2 g, 15.4 g solution (equivalent to about 75, 180, 200 or 250 doses). Nitrolingual Pumpspray ...
Special precautions for disposal and other handling
See Administration section. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
G. Pohl-Boskamp GmbH & CO KG., Kieler Strasse 11, 25551 Hohenlockstedt, Germany
Marketing authorization number(s)
PL 04719/0005
Date of first authorization / renewal of the authorization
28 November 2005
Date of revision of the text
21<sup>st</sup> September 2018
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