NASACORT Nasal Spray suspension (2018)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
Nasacort Allergy 55 micrograms/dose Nasal Spray suspension.
2. Qualitative and quantitative composition
The active component of Nasacort Allergy or Triamcinolone Nasal Spray is triamcinolone acetonide. Each bottle of Nasacort Allergy or Triamcinolone Nasal Spray contains 3.575 mg triamcinolone acetonide ...
3. Pharmaceutical form
Nasal Spray suspension. It is an unscented, thixotropic suspension of microcrystalline triamcinolone acetonide in an aqueous medium.
4.1. Therapeutic indications
Nasacort Allergy or Triamcinolone Nasal Spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis.
4.2. Posology and method of administration
Patients aged 18 years and over: the recommended dose is 220 micrograms as 2 sprays in each nostril once daily. Once symptoms are controlled patients can be maintained on 110 micrograms (1 spray in each ...
4.3. Contraindications
Hypersensitivity to any of the ingredients of this preparation or an infection in the nose contraindicates its use.
4.4. Special warnings and precautions for use
If there is any reason to suppose that adrenal function is impaired, care must be taken while transferring patients from systemic steroid treatment to Nasacort Allergy or Triamcinolone Nasal Spray. Patients ...
4.5. Interaction with other medicinal products and other forms of interaction
Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the ...
4.6. Pregnancy and lactation
Pregnancy Nasacort Allergy or Triamcinolone Nasal Spray should only be used in pregnancy on medical advice. There are no adequate and well-controlled studies in pregnant women with Nasacort Allergy or ...
4.7. Effects on ability to drive and use machines
Nasacort Allergy or Triamcinolone Nasal Spray has no known effect on the ability to drive and operate machines.
4.8. Undesirable effects
The adverse events reported in clinical trials with Nasacort Allergy or Triamcinolone Nasal Spray most commonly involved the mucous membranes of the nose and throat. The following frequency rating has ...
4.9. Overdose
Like any other nasally administered corticosteroid, acute overdosing with Nasacort Allergy or Triamcinolone Nasal Spray is unlikely in view of the total amount of active ingredient present. In the event ...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: nasal corticosteroid ATC code: R01AD Mechanism of action Triamcinolone acetonide is a more potent derivative of triamcinolone and is approximately 8 times more potent than prednisone. ...
5.2. Pharmacokinetic properties
Single dose intranasal administration of 220 micrograms of Nasacort Allergy or Triamcinolone Nasal Spray in normal adult subjects and in adult patients with allergic rhinitis demonstrated minimal absorption ...
5.3. Preclinical safety data
In pre-clinical studies, only the effects typical of glucocorticosteroids were observed Like other corticosteroids, triamcinolone acetonide has been shown to be teratogenic in rats and rabbits. Teratogenic ...
6.1. List of excipients
Microcrystalline cellulose Carmellose sodium (Avicel CL-611) Polysorbate 80 Purified water Anhydrous glucose Benzalkonium chloride Edetate sodium Hydrochloric acid or sodium hydroxide (for pH adjustment) ...
6.2. Incompatibilities
None known.
6.3. Shelf life
The shelf-life of Nasacort Allergy or Triamcinolone Nasal Spray is 24 months. The shelf life after the bottle is first opened is 1 month.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
Nasacort Allergy or Triamcinolone Nasal Spray is contained in a 20 ml high density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. Each bottle of Nasacort Allergy or Triamcinolone ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK or trading as: sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
8. Marketing authorization number(s)
PL 04425/0605
9. Date of first authorization / renewal of the authorization
17 October 1997
10. Date of revision of the text
28 August 2018
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
