Properties
What is it?
International Nonproprietary Name - Mometasone, Azelastine Pharmacological group: Topical anti-inflammatory preparations Composition Each 1 ml contains: Active ingredients: Mometasone furoate (European Pharmacopoeia) – 0.5 mg Azelastine hydrochloride (British Pharmacopoeia) – 1.4 mg Inactive ingredient (preservative): Benzalkonium chloride (KF) – 0.2 mg Other inactive ingredients: Glycerin, Microcrystalline cellulose, Carboxymethylcellulose sodium, Sorbitol solution, Sodium citrate hydrate, Citric acid hydrate, Disodium edetate hydrate, Purified water, Cold mint #F-P396, Thaumatin, Polysorbate 80 Description: White or almost white opaque suspension nasal spray solution in a single-dose opaque plastic container. Indication: Allergic rhinitis occurring throughout the year Dosage and administration Adults and children 12 years and older: Twice daily, one spray in each nostril. (One spray delivers 100 mg of suspension containing 0.05 mg of mometasone furoate and 0.14 mg of azelastine hydrochloride. The total daily dose is 0.2 mg of mometasone furoate and 0.56 mg of azelastine hydrochloride.) To achieve maximum therapeutic effect with reduced risk of adverse reactions, it is important to use the correct dose and obtain proper information on dosage and administration before starting treatment. When using for the first time, it is necessary to check that the solution sprays well. Hold the bottle as shown in Figure 2, press the pump with your index and middle fingers about 10 times to check if the solution sprays uniformly, if you have not used it for more than 14 days, and spray twice for testing. If spraying does not occur well, clean the nozzle head with water and use after drying. Always shake well before use and use according to the image and procedure below. 1. Shake the container well and remove the violet cap. 2. After blowing your nose, tilt your head, close one nostril with a finger, and hold the container as shown in Figure 2 (hold the container with your thumb and palm and press the pump with your index and middle fingers), insert the nozzle head deep into the other nostril that is not closed and spray as shown in Figure 3. Press the pump once for a good spray. * To avoid direct spraying into the nose, spray into the left nostril with the right hand and into the right nostril with the left hand. 3. After spraying, inhale gently through your nose and exhale through your mouth. 4. Spray similarly into the other nostril that was closed, inhale gently through your nose and exhale through your mouth. 5. Finally, replace the violet cap. Maintaining container cleanliness To ensure proper functioning of Nazaflex nasal spray, it is important to maintain its cleanliness by periodically cleaning the container. Under no circumstances should the nozzle hole be punctured. 1. Remove the violet cap, lift the white nozzle slightly upwards, and remove the nozzle (Figure 4). 2. Clean the violet cap and nozzle with cold tap water, especially the nozzle head, wipe off moisture and dry. 3. Reinsert the pump into the nozzle, replace the violet cap, and store. 4. Before use, spray as for test activation to check that the solution is dispensed uniformly. Adverse events that occurred in more than one case without a causal relationship to the test preparation when taking the combination preparation of mometasone furoate and azelastine hydrochloride (N=115): Respiratory: Hemoptysis, pharyngolaryngeal pain, wet cough Nervous system: Headache, somnolence Infection: Nasopharyngitis Gastrointestinal: Halitosis, diarrhea, stomatitis Trauma: Burns (20), sprains, wounds