RHINOLAST Nasal spray (2022)
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Περιεχόμενα
1. Name of the medicinal product
Rhinolast Nasal Spray.
2. Qualitative and quantitative composition
Azelastine Hydrochloride 0.1% w/v.
3. Pharmaceutical form
Nasal spray.
4.1. Therapeutic indications
For the treatment of both seasonal allergic rhinitis (e.g. hayfever) and perennial allergic rhinitis in patients aged 6 years and over.
4.2. Posology and method of administration
Route of application is topical nasal mucosa. Adults One application (0.14 ml) in each nostril twice daily (0.56 mg of azelastine hydrochloride). Elderly There have been no specific studies in the elderly. ...
4.3. Contraindications
Proven allergy against azelastine hydrochloride.
4.4. Special warnings and precautions for use
None.
4.5. Interaction with other medicinal products and other forms of interaction
No specific interactions have been studied.
4.6. Pregnancy and lactation
At high oral doses in animals, 500 times the proposed oral human daily dose, foetal death, growth retardation and an increased incidence of skeletal abnormalities occurred during reproduction toxicity ...
4.7. Effects on ability to drive and use machines
None.
4.8. Undesirable effects
The following frequencies of undesirable effects were reported: Commonly (1-10%), a substance-specific bitter taste may be experienced after administration (often due to incorrect method of application, ...
4.9. Overdose
The results of animal studies show that toxic doses can produce CNS symptoms, e.g. excitation, tremor, convulsions. Should these occur in humans, symptomatic and supportive treatment should be instigated ...
5.1. Pharmacodynamic properties
Azelastine, a phthalazinone derivative of novel structure, is classified as a potent long acting anti-allergic compound with particularly strong H1 antagonist properties. Data from animal studies show ...
5.2. Pharmacokinetic properties
After repeated nasal application (0.14 mg) into each nostril twice daily, the plasma levels of azelastine were about 0.26 ng/ml. The levels of the active metabolite desmethylazelastine were detected at ...
5.3. Preclinical safety data
Nothing relevant.
6.1. List of excipients
Hypromellose Disodium edetate Citric acid Disodium phosphate dodecahydrate Sodium chloride Purified water
6.2. Incompatibilities
None.
6.3. Shelf life
Three years unopened.
6.4. Special precautions for storage
Do not store below 8°C. Do not refrigerate.
6.5. Nature and contents of container
Polyethylene bottle with polypropylene cap and polyethylene seal containing either 10 ml or 20 ml. Glass bottle with screw closure and polypropylene seal containing 10 ml, 20 ml or 22 ml. Glass bottle ...
6.6. Special precautions for disposal and other handling
<u>For separate bottle and pump:</u> Open the bottle by unscrewing the cap. Place the spray pump nozzle in the bottle and screw the pump onto the bottle. Remove the protective cap. Before first using, ...
7. Marketing authorization holder
Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
8. Marketing authorization number(s)
PL 46302/0140
9. Date of first authorization / renewal of the authorization
14<sup>th</sup> August 2009
10. Date of revision of the text
January 2022
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