NASONEX Nasal Spray, Suspension (2017)
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Περιεχόμενα
Name of the medicinal product
NASONEX 50 micrograms/actuation Nasal Spray, Suspension.
Qualitative and quantitative composition
Mometasone furoate (as the monohydrate) 50 micrograms/actuation. Excipient with known effect: This medicinal product contains 0.02 mg of benzalkonium chloride per actuation. For the full list of excipients, ...
Pharmaceutical form
Nasal Spray, Suspension. White to off-white opaque suspension.
Therapeutic indications
NASONEX Nasal Spray is indicated for use in adults and children 3 years of age and older to treat the symptoms of seasonal allergic or perennial rhinitis. NASONEX Nasal Spray is indicated for the treatment ...
Posology and method of administration
After initial priming of the NASONEX Nasal Spray pump, each actuation delivers approximately 100 mg of mometasone furoate suspension, containing mometasone furoate monohydrate equivalent to 50 micrograms ...
Contraindications
Hypersensitivity to the active substance, mometasone furoate, or to any of the excipients listed in section 6.1. NASONEX Nasal Spray should not be used in the presence of untreated localised infection ...
Special warnings and precautions for use
Immunosuppression NASONEX Nasal Spray should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, or in untreated fungal, bacterial, or ...
Interaction with other medicinal products and other forms of interaction
(See 4.4 Special warnings and special precautions for use with systemic corticosteroids) A clinical interaction study was conducted with loratadine. No interactions were observed. Co-treatment with CYP3A ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of mometasone furoate in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). As with other nasal corticosteroid ...
Effects on ability to drive and use machines
None known.
Undesirable effects
Summary of the safety profile Epistaxis was generally self-limiting and mild in severity, and occurred at a higher incidence compared to placebo (5%), but at a comparable or lower incidence when compared ...
Overdose
Symptoms Inhalation or oral administration of excessive doses of corticosteroids may lead to suppression of HPA axis function. Management Because the systemic bioavailability of NASONEX Nasal Spray is ...
Pharmacodynamic properties
Pharmacotherapeutic group: Decongestants and Other Nasal Preparations for Topical Use-Corticosteroids ATC code: R01AD09 Mechanism of action Mometasone furoate is a topical glucocorticosteroid with local ...
Pharmacokinetic properties
Absorption Mometasone furoate, administered as an aqueous nasal spray, has a systemic bioavailability of <1% in plasma, using a sensitive assay with a lower quantitation limit of 0.25 pg/ml. Distribution ...
Preclinical safety data
No toxicological effects unique to mometasone furoate exposure were demonstrated. All observed effects are typical of this class of compounds and are related to exaggerated pharmacologic effects of glucocorticoids. ...
List of excipients
Dispersable cellulose (microcrystalline cellulose and carmellose sodium) Glycerol Sodium citrate Citric acid monohydrate Polysorbate 80 Benzalkonium chloride Purified water
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years. Use within 2 months of first use.
Special precautions for storage
Do not store above 25°C. Do not freeze.
Nature and contents of container
NASONEX Nasal Spray is contained in a white, high density polyethylene bottle, that contains 10 g (60 actuations) or 18 g (140 actuations) of product formulation, supplied with a metered-dose, manual polypropylene ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK
Marketing authorization number(s)
PL 00025/0587
Date of first authorization / renewal of the authorization
10 April 1997 / 5 March 2008
Date of revision of the text
1 December 2017
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