BUDESONIDE 64 Aqueous Nasal Spray (2017)
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Περιεχόμενα
Name of the medicinal product
Budesonide 64 micrograms/actuation, Aqueous Nasal Spray.
Qualitative and quantitative composition
The delivered (metered) dose of 0.05 ml nasal spray, suspension contains 64 micrograms of budesonide. Excipient (s) with known effect: 0.06 mg of potassium sorbate/0.05 ml nasal spray, suspension For the ...
Pharmaceutical form
Nasal spray, suspension. White homogeneous suspension.
Therapeutic indications
Treatment and prevention of signs and symptoms of seasonal and perennial allergic rhinitis. Treatment of signs and symptoms of nasal polyps.
Posology and method of administration
Posology For nasal use only. The dosage should be determined individually. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. The duration of the therapy ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary ...
Interaction with other medicinal products and other forms of interaction
Budesonide has not been observed to interact with any drug used for the treatment of rhinitis. Concomitant administration of oral ketoconazole 200 mg once daily and oral budesonide (3 mg single dose) increased ...
Pregnancy and lactation
Pregnancy Results from prospective epidemiological studies and from worldwide post marketing experience indicate no increased risk for overall congenital malformations from the use of inhaled or intranasal ...
Effects on ability to drive and use machines
Budesonide nasal spray suspension has no influence on the ability to drive or use machines.
Undesirable effects
When patients are transferred from systemic corticosteroid (oral or parenteral) to Budesonide nasal spray suspension, undesirable effects outside the nasal area which were previously under control by systemic ...
Overdose
An acute overdose with Budesonide nasal spray suspension is unlikely even if all the sprays contained in the bottle are administered all at once. Administration of doses higher than recommended (see section ...
Pharmacodynamic properties
Pharmacotherapeutic group: Decongestants and other nasal preparations for topical use, Corticosteroids ATC Code: R01AD05 Budesonide is a glucocorticosteroid with a strong topical anti-inflammatory effect ...
Pharmacokinetic properties
Absorption The systemic availability of budesonide from RHINOCORT AQUA, with reference to the metered dose, is 33%. In adults, the maximal plasma concentration after administration of 256 micrograms budesonide ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans at therapeutic doses based on studies of chronic toxicity, genotoxicity and carcinogenicity. Glucocorticosteroids including budesonide have produced ...
List of excipients
Dispersible cellulose (Microcrystalline cellulose and carboxymethylcellulose sodium, (89:11, w/w)) Polysorbate 80 Potassium sorbate E202 Glucose, anhydrous Disodium edetate Hydrochloric acid, concentrated ...
Incompatibilities
Not applicable.
Shelf life
2 years. After first opening: 3 months.
Special precautions for storage
Do not store above 30°C. Do not freeze. For storage conditions after first opening of the medicinal product, see section 6.3
Nature and contents of container
Amber type III glass bottle fitted with a plastic nasal spray pump and polypropylene nasal applicator: pack size of 1 x120 (1 10 ml) doses, 3 120 (3 10 ml) doses, 10 120 (10 10 ml) doses Not all pack ...
Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom
Marketing authorization number(s)
PL 04416/0784
Date of first authorization / renewal of the authorization
30<sup>th</sup> July 2009
Date of revision of the text
12/06/2017
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