BECONASE Aqueous suspension for intranasal inhalation (2021)
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Περιεχόμενα
1. Name of the medicinal product
Beconase Aqueous Nasal Spray.
2. Qualitative and quantitative composition
Beclometasone Dipropionate 50μg (as monohydrate, micronised). <u>Excipient with known effect:</u> Benzalkonium Chloride. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Aqueous suspension for intranasal inhalation via metered dose atomising pump.
4.1. Therapeutic indications
Beconase Aqueous Nasal Spray is indicated for the prophylaxis and treatment of perennial and seasonal allergic rhinitis including hayfever, and vasomotor rhinitis. Beclometasone dipropionate has a potent ...
4.2. Posology and method of administration
Beconase Aqueous Nasal Spray is for administration by the intranasal route only. <u>Adults and children over six years of age:</u> The recommended dosage is two sprays into each nostril twice daily (400 ...
4.3. Contraindications
Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
4.4. 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 ...
4.5. Interaction with other medicinal products and other forms of interaction
Beclomethasone is less dependent on CYP3A metabolism than some other corticosteroids, and in general interactions are unlikely; however the possibility of systemic effects with concomitant use of strong ...
4.6. Pregnancy and lactation
Pregnancy There is inadequate evidence of safety in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine ...
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) ...
4.9. Overdose
The only harmful effect that follows inhalation of large amounts of the drug over a short time period is suppression of Hypothalamic-Pituitary-Adrenal (HPA) function. No special emergency action need be ...
5.1. Pharmacodynamic properties
Following topical administration beclometasone 17,21-dipropionate (BDP) produces potent anti-inflammatory and vasoconstrictor effects. BDP is a pro-drug with weak corticosteroid receptor binding affinity. ...
5.2. Pharmacokinetic properties
Absorption Following intranasal administration of BDP in healthy males, the systemic absorption was assessed by measuring the plasma concentrations of its active metabolite B-17-MP, for which the absolute ...
5.3. Preclinical safety data
No clinically relevant findings were observed in preclinical studies.
6.1. List of excipients
Avicel RC 591 (Microcrystalline Cellulose and Carboxymethylcellulose Sodium) US NF Anhydrous Dextrose BP Benzalkonium Chloride BP Phenylethyl Alcohol USP Polysorbate 80 BP Purified Water BP
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
24 months when not stored above 30°C.
6.4. Special precautions for storage
Beconase Aqueous Nasal Spray should not be stored above 30°C. Keep container in the outer carton.
6.5. Nature and contents of container
A 25ml amber neutral glass bottle fitted with a metering atomising pump, or a 30ml polypropylene bottle fitted with a tamper-resistant metering atomising pump. The pumps are manufactured by: Valois S.A. ...
6.6. Special precautions for disposal and other handling
Refer to Patient Information Leaflet.
7. Marketing authorization holder
Glaxo Wellcome UK Ltd., Trading as GlaxoSmithKline UK, 980 Great West Road, Brentford, Middlesex, TW8 9GS
8. Marketing authorization number(s)
PL 10949/0104
9. Date of first authorization / renewal of the authorization
12th April 2003
10. Date of revision of the text
10 June 2021
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