Country: Սինգապուր
language: անգլերեն
source: HSA (Health Sciences Authority)
AZELASTINE HCl
MYLAN PHARMACEUTICALS PTE. LTD.
R01AC03
1 mg/ml
SPRAY
AZELASTINE HCl 1 mg/ml
NASAL
Prescription Only
MEDA Manufacturing GmbH
ACTIVE
1996-04-30
MEDA PHARMA GMBH & CO. KG 61352 Bad Homburg Germany PATIENT INFORMATION LEAFLET, PLEASE READ CAREFULLY! AZEP ® NASAL SPRAY Active ingredient: azelastine hydrochloride COMPOSITION Active ingredient: Each spray puff (equivalent to 0.14 ml solution) contains 0.14 mg of azelastine hydrochloride Other ingredients: Hypromellose, disodium edetate dihydrate, citric acid, dibasic sodium phosphate dodeca- hydrate, sodium chloride, purified water INDICATIONS For the symptomatic treatment of seasonal allergic rhinitis (hay fever) and non-seasonal (perennial) allergic rhinitis. CONTRAINDICATIONS Azep Nasal Spray must not be used in patients with known hypersensitivity to Azelastine hydrochloride, or EDTA, nor in children under 6 years of age. PREGNANCY AND LACTATION Although doses far in excess of the therapeutic range tested in laboratory animals failed to generate any evidence of a teratogenic effect of the drug, current medical concepts discourage use of Azep Nasal Spray in the first trimester of pregnancy. Nasal Spray should not be used by nursing mothers, because there is insufficient evidence of the safety of the drug during lactation. SIDE EFFECTS In rare cases irritations of the inflamed nasla mucosa can occur on spraying, e.g. stinging, itching and sneezing. In isolated cases patients can experience nosebleeding. Improper administration (with head reclined back; see Dosage instruction and how to use) may procduce a bitter taste which may lead occasionally to nausea. INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. DOSAGE, METHOD O read_full_document
MEDA PHARMA GMBH & CO. KG 61352 Bad Homburg Germany PATIENT INFORMATION LEAFLET, PLEASE READ CAREFULLY! AZEP ® NASAL SPRAY Active ingredient: azelastine hydrochloride COMPOSITION Active ingredient: Each spray puff (equivalent to 0.14 ml solution) contains 0.14 mg of azelastine hydrochloride Other ingredients: Hypromellose, disodium edetate dihydrate, citric acid, dibasic sodium phosphate dodeca- hydrate, sodium chloride, purified water INDICATIONS For the symptomatic treatment of seasonal allergic rhinitis (hay fever) and non-seasonal (perennial) allergic rhinitis. CONTRAINDICATIONS Azep Nasal Spray must not be used in patients with known hypersensitivity to Azelastine hydrochloride, or EDTA, nor in children under 6 years of age. PREGNANCY AND LACTATION Although doses far in excess of the therapeutic range tested in laboratory animals failed to generate any evidence of a teratogenic effect of the drug, current medical concepts discourage use of Azep Nasal Spray in the first trimester of pregnancy. Nasal Spray should not be used by nursing mothers, because there is insufficient evidence of the safety of the drug during lactation. SIDE EFFECTS In rare cases irritations of the inflamed nasla mucosa can occur on spraying, e.g. stinging, itching and sneezing. In isolated cases patients can experience nosebleeding. Improper administration (with head reclined back; see Dosage instruction and how to use) may procduce a bitter taste which may lead occasionally to nausea. INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. DOSAGE, METHOD OF ADMINISTRATION AND DURATION OF TREATMENT Unless otherwise prescribed, spray once into each nostril twice daily (equivalent to a daily dose of 0.56 mg of azelastine hydrochloride). Spray with head held upright (see How to use Azep Nasal Spray). Azep Nasal Spray may be used until symptoms clear up, but treatment should not be continued for more than 6 consecutive months. AZEP NASENSPRAY Tropon-Nr.: T5003226 EPE TypoData: 56-54394-R Schriftgrösse: 8 pt F read_full_document