Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
sodium chloride, magnesium sulfate heptahydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium hydrogen carbonate
KRKA d.d.
R01AX10
sodium chloride, magnesium sulfate heptahydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium hydrogen carbonate
8,8mg/ml+2,5mg/ml+1,8mg/ml+0,5mg/ml+0,1mg/ml
spray nasal
plastic container with pump dispenser 30ml (667 doses /1 dose - 45mg/)
OTC
Registered
2015-07-03
1.3.1 SeptoAqua SPC, Labeling and Package Leaflet AM SmPCPIL065827_1 23.07.2015 – Updated: 23.07.2015 Page 1 of 5 1. NAME OF THE MEDICINAL PRODUCT SEPTOAQUA FOR ADULTS SEPTOAQUA FOR CHILDREN nasal spray, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of nasal spray, solution contains: Sodium chloride 8.8 mg Magnesium sulphate heptahydrate 2.5 mg Magnesium chloride hexahydrate 1.8 mg Calcium chloride dihydrate 0.5 mg Sodium hydrogen carbonate 0.1 mg SeptoAqua isotonic sterile solution contains purified water with mineral salts: sodium chloride, magnesium sulphate heptahydrate, magnesium chloride hexahydrate, calcium chloride dihydrate and sodium hydrogen carbonate, which ensure the following amounts of ions in 1 ml of solution: chlorides (Cl - ) at least 5.50 mg sodium (Na + ) at least 2.50 mg magnesium (Mg 2+ ) at least 0.35 mg sulphates (SO 4 2- ) at least 0.60 mg calcium (Ca 2+ ) at least 0.08 mg hydrogen carbonates (HCO 3 - ) at least 0.03 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nasal spray, solution. The solution is clear, colorless liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SeptoAqua contains an isotonic sterile solution of mineral salts, which rinses, moisturises and cleans the nasal mucous membrane, and helps to soften and remove dirt particles from the nasal mucous membrane. It is also recommended for thinning the thick nasal secretions in colds and allergies. For everyday cleaning of the nasal mucous membrane, it can be used in adults, the elderly, children and babies. It is also suitable for pregnant women and nursing mothers. Septoaqua for adults/ Septoaqua for children nasal spray, solution is recommended: - in acute and chronic inflammatory diseases of the nasal cavity, paranasal sinuses, and nasopharynx (also in pregnancy and breast-feeding); - in the period before and after nasal surgery; - in allergic and vasomotor rhinitis (especially in people who have or are prone to increased sensitivity to medicines) (also in pregnancy and breast Прочитать полный документ