Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
MOMETASONE FUROATE (AS MONOHYDRATE); OLOPATADINE AS HYDROCHLORIDE
K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL
R01AD59
NASAL SPRAY, SUSPENSION
MOMETASONE FUROATE (AS MONOHYDRATE) 25 MCG/DELIVERED DOSE; OLOPATADINE AS HYDROCHLORIDE 600 MCG/DELIVERED DOSE
NASAL
Required
GLENMARK PHARMACEUTICALS S.R.O, CZECH REPUBLIC
MOMETASONE, COMBINATIONS
Ryaltris is indicated in adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis.
2023-10-19
Ryaltris Nasal Spray Active substance olopatadine (as hydrochloride) 600 mcg mometasone furoate (as monohydrate) 25 mcg - For information regarding inactive ingredients: see section 2 – “Important information about some of the ingredients of the medicine” and section 6 – “Additional information”. - Read the entire leaflet carefully before using the medicine . This leaflet contains concise information about the medicine. If you have additional questions, refer to the doctor or the pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. 1. What is the medicine intended for? Ryaltris is used to treat the symptoms of moderate to severe seasonal allergic rhinitis (also called hay fever) and perennial rhinitis in adults and adolescents 12 Therapeutic class: To treat nasal congestion or to prevent and treat allergic rhinitis Ryaltris contains two active substances: mometasone furoate and olopatadine. - Mometasone furoate belongs to a group of medicines called corticosteroids (steroids) which reduce inflammation, often found in allergic rhinitis. - Olopatadine belongs to a group of medicines called antihistamines. Antihistamines work by preventing the effects of substances such as histamine that the body produces as part of an allergic reaction - thus reducing symptoms of allergic rhinitis. - 2. Before using the medicine Do not use this medicine if: - if you are allergic to mometasone furoate, olopatadine or any of the other ingredients of this medicine (listed in section 6). - if you have an untreated infection in your nose. Use of Ryaltris during an untreated infection in your nose, such as herpes, can worsen the infection. You should wait until the infection is resolved before you start using the nasal spray. - if you have recently had an operation on y Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ryaltris Nasal Spray, suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One delivered dose (the dose that leaves the actuator) contains mometasone furoate monohydrate equivalent to 25 microgram mometasone furoate and olopatadine hydrochloride equivalent to 600 micrograms olopatadine. Excipient with known effect Each actuation contains 0.02 mg benzalkonium chloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nasal Spray, Suspension. White, homogeneous suspension free of lumps. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Ryaltris is indicated in adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis. 4.2 Posology and method of administration Posology Adults and adolescents (12 years and older) The usual recommended dose is two actuations in each nostril twice daily (morning and evening). Children below 12 years Ryaltris is not recommended for use in children below 12 years of age as safety and efficacy has not been established in this age group. Elderly No dose adjustment is required in this population. Renal and hepatic impairment There are no data in patients with renal and hepatic impairment, however no dose adjustment is expected to be required in these populations considering the absorption, metabolism and elimination of the active substances (see section 5.2). Method of administration Ryaltris is for nasal use only. Prior to administration of the first dose, shake container well and actuate the pump 6 times (until a uniform spray is obtained). If the pump is not used for 14 days or longer, re-prime the pump with 2 actuations until a uniform spray is observed, before next use. Shake container for minimum 10 seconds before each use. After using the spray, wipe the nozzle carefully with a clean handkerchief or tissue and replace the cap, to avoid that the nozzle gets blocked. The bottle should be discarded after the labelled Прочитайте повний документ