Rinomaris Advance nasal spray 0.5mg/ml 10ml №1

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Rinomaris Advance spray naz. 0.5mg/ml in vial 10ml in pack. No. 1
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Transparent, colorless solution Main active ingredient Xylometazoline Release form Dosed nasal spray Dosage 0.5 mg / ml in vial. 10 ml Special instructions In the following cases, before starting the use of this medicinal product, a careful assessment of the risk-benefit ratio is required: use of monoamine oxidase (MAO) inhibitors (MAOIs), tricyclic antidepressants or other drugs that increase blood pressure; use of alpha or beta blockers; increased intraocular pressure, especially when angle-closure glaucoma; the presence of severe cardiovascular diseases (eg, coronary heart disease, hypertension); the presence of pheochromocytoma; the presence of prostatic hyperplasia; the presence of porphyria; the presence of metabolic disorders (eg, hyperthyroidism, diabetes). Due to the risk of atrophy of the nasal mucosa, the use of this medicinal product in patients with chronic inflammation of the nasal cavity is allowed only under medical supervision. Prolonged use of sympathomimetic decongestants or their use in doses exceeding the recommended ones can cause reactive congestion of the nasal mucosa. The reactive effect can lead to airway obstruction and thus cause frequent or prolonged use of the drug. As a result, chronic congestion (rhinitis medicamentosa) and atrophy of the nasal mucosa (ozena) can occur. To maintain at least partial nasal breathing in less severe cases, first consider discontinuing the use of the sympathomimetic in one nostril, and then, after the disappearance of symptoms, in the other. Pharmacological action Pharmacodynamics Mechanism of action Xylometazoline, an imidazoline derivative, is a sympathomimetic drug with alpha-adrenergic activity. It has a vasoconstrictive effect, reduces swelling of the mucous membrane and neighboring parts of the pharynx, facilitates breathing, and promotes the separation of mucus. Its action occurs after 5-10 minutes and lasts for about 10 hours. Hyaluronic acid maintains moisture in the nasal mucosa. Pharmacokinetics The action of xylometazoline occurs within 5-10 minutes, the effect persists for about 10 hours. With intranasal administration, there may be absorption of the drug in an amount sometimes sufficient for systemic effects, for example, on the central nervous system and the cardiovascular system. Data from pharmacokinetic studies in humans are not available. Preclinical safety data The results of standard preclinical pharmacological safety studies and genotoxic studies indicate that there is no particular risk to humans. Relevant repeated dose toxicity studies, carcinogenicity studies, reproductive toxicity studies and embryotoxicity studies have not been conducted. Indications for use Symptomatic treatment of nasal congestion caused by sinusitis and rhinitis. RINOMARIS ADVANCE, nasal spray, 0.5 mg/ml is indicated for the treatment of children aged 2 to 12 years. Dosage and administration Children from 2 to 12 years old: 1 injection in each nostril up to 3 times a day. Do not use in infants and children under 2 years of age. The efficacy and safety of RINOMARIS ADVANCE nasal spray 0.5 mg/ml in children under 2 years of age has not been established. Do not use RINOMARIS ADVANCE at doses higher than those recommended. Duration of treatment: RINOMARIS ADVANCE should not be used for more than 5 consecutive days. Prolonged, excessive use may cause reactive flushing and recurrence of symptoms. Always consult a physician before use in children. The course of treatment can be repeated after a break of several days. Prolonged use of RINOMARIS ADVANCE may lead to atrophy of the nasal mucosa. In this regard, in the case of chronic diseases, the present medicinal product should be used only under the supervision of a physician. Method of application: This medicinal product is intended for nasal administration. Before the first application, several test sprays (5 times) into the air should be made to achieve dose uniformity. If the product has not been used for several days, at least one test spray into the air must be made to achieve dose uniformity. After use, the sprayer should be carefully wiped with a dry, clean paper towel and closed with a protective cap. For hygiene reasons and to prevent the spread of infections, each vial is for individual use only. Use during pregnancy and lactation Pregnancy There are no relevant studies of the effects on the fetus, epidemiological data on the effects on the fetus are not available. Therefore xylometazoline should not be used during pregnancy. Breast-feeding period This medicinal product should not be used during breast-feeding as it is not known whether it is excreted in breast milk. Reproductive function It is not known whether xylometazoline affects reproductive function. Influence on the ability to drive vehicles or potentially dangerous mechanisms Xylometazoline in doses exceeding those recommended may affect the ability to drive vehicles or equipment. Precautions Careful assessment of the risk-benefit ratio is required before starting the use of this medicinal product: use of monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants or other drugs that increase blood pressure; use of alpha or beta blockers; increased intraocular pressure, especially with angle-closure glaucoma; the presence of severe cardiovascular disease (eg, coronary heart disease, hypertension); the presence of pheochromocytoma; the presence of prostatic hyperplasia; the presence of porphyria; the presence of metabolic disorders (eg, hyperthyroidism, diabetes). funds in patients with chronic inflammation of the nasal cavity is allowed only under medical supervision. Prolonged use of sympathomimetic decongestants or their use in doses exceeding the recommended ones can cause reactive congestion of the nasal mucosa. The reactive effect can lead to airway obstruction and thus cause frequent or prolonged use of the drug. As a result, chronic congestion (rhinitis medicamentosa) and atrophy of the nasal mucosa (ozena) can occur. To maintain at least partial nasal breathing in less severe cases, first consider discontinuing the use of the sympathomimetic in one nostril, and then, after the disappearance of symptoms, in the other. Interaction with other drugs In view of the possible hypertensive effect of xylometazoline, this drug should not be used in combination with antihypertensive drugs (for example, methyldopa). Perhaps a complex interaction with ?- and ?-blockers, leading to hypotension or hypertension, tachycardia or bradycardia. Concomitant use of xylometazoline with monoamine oxidase inhibitors (eg, drugs such as tranylcycpromine), tricyclic antidepressants, or other drugs with a potential hypertensive effect (eg, doxapram, ergotamine, oxytocin) may cause an increase in blood pressure as a result of the effect of these drugs on cardiovascular system. Therefore, use in combination with these drugs is not recommended. Contraindications Hypersensitivity to xylometazoline hydrochloride or any of the components of the drug. Condition after transsphenoidal hypophysectomy or any surgical intervention on the dura mater. Dry inflammation of the nasal mucosa (rhinitis sicca). Children’s age up to 2 years. Composition Per 1 ml of solution: RINOMARIS® ADVANCE, nasal spray 0.5 mg / ml (children’s form) Active substances: Xylometazoline hydrochloride 0.5 mg Excipients: Purified water of the Adriatic Sea 261.5600 mg .4024 mg Purified water 743.4370 mg Overdose Overdose can occur with nasal and oral administration. In children, an overdose can cause severe depression of the functions of the central nervous system. The clinical picture of intoxication with imidazoline derivatives may be unclear due to the alternation of periods of increased activity and periods of suppression of the functions of the central nervous system, cardiovascular and respiratory systems. In case of overdose, especially in children, central nervous system disorders can often be observed, accompanied by convulsions and coma, bradycardia, apnea, and hypertension, which may be followed by hypotension. Excitation of the central nervous system has such manifestations as a feeling of fear, anxiety, hallucinations and convulsions. Depression of the central nervous system manifests itself as a decrease in body temperature, lethargy, drowsiness and coma. May have symptoms such as miosis, mydriasis, sweating, fever, pallor, cyanosis, apnea, and palpitations. In the case where the effect on the central nervous system dominates, nausea, vomiting, tachycardia, bradycardia, cardiac arrhythmias, cardiac arrest, hypertension, shock-like hypotension, respiratory failure and apnea can be observed. In case of an overdose as a result of the administration of a large amount of the agent, it is necessary to immediately apply activated charcoal (adsorbent), sodium sulfate (laxative) and, if possible, gastric lavage due to the possibility of rapid absorption of xylometazoline. In case of severe overdose, hospitalization in the intensive care unit and resuscitation is necessary. A non-selective alpha-adrenergic antagonist such as phentolamine can be used as an antidote to lower blood pressure. The use of vasoconstrictive agents is contraindicated. If necessary, take measures to alleviate the febrile state, conduct anticonvulsant therapy, use oxygen for breathing. Adverse reactions are listed below, taking into account the system organ class according to the MedDRA dictionary (SOC) and the frequency of their development. The frequency of development is defined as follows: Very often (greater than or equal to 1/10) Often (greater than or equal to 1/100 – less than 1/10) Infrequently (greater than or equal to 1/1,000 – less than 1/100) Rarely (greater than or equal to 1/100 – less than 1/100) 1/10000 – less than 1/1000) Very rare (less than 1/10000) The frequency is unknown (cannot be determined from the available data). SOK – Frequency – Adverse reactions Immune system disorders – Infrequently – Systemic allergic reactions (angioneurotic edema, rash, itching). Mental disorders – Very rarely – Hyperexcitability, insomnia, fatigue / drowsiness (mainly in children). Nervous system disorders – Very rare – Hallucinations (mainly in children), headache, dizziness, convulsions (mainly in children). Cardiac disorders – Rare – Palpitations, tachycardia. Cardiac disorders – Very rare – Arrhythmia. Vascular disorders – Rare – Hypertension. Respiratory, thoracic and mediastinal disorders – Common – Feeling of soreness or burning in the nose or throat, sneezing, dryness of the nasal mucosa. Respiratory, thoracic and mediastinal disorders – Uncommon – Increased swelling of the nasal mucosa after discontinuation of treatment, epistaxis. Respiratory, thoracic and mediastinal disorders – Very rare – Apnea in children and neonates. Gastrointestinal disorders – Rare – Nausea. Pediatric patients The results of several clinical studies indicated the safety of the use of xylometazoline in children. Data from clinical trials and case reports suggest that adverse reactions in children are similar in frequency, type, and severity to adverse reactions in adults. Most adverse events in children have been observed following an overdose of xylometazoline. These include irritability, insomnia, sleepiness/drowsiness, hallucinations, and seizures. In young children and newborns, there have been cases of uneven (intermittent) breathing. It should be noted that prolonged, frequent use or use of xylometazoline in high doses contributes to a burning sensation or dryness of the nasal mucosa, as well as to the development of reactive congestion with rhinitis medicamentosa. This effect can be observed as early as 5 days of treatment, and in the case of continued use, it can lead to long-term damage to the mucous membrane with the formation of crusts (rhinitis sicca). In the event of the listed side effects, as well as reactions not listed in the package insert, you should consult a doctor. It is important to report suspected adverse reactions after registration of the medicinal product in order to ensure continuous monitoring of the risk-benefit ratio of the medicinal product. Medical staff are encouraged to report any suspected adverse drug reactions and drug inefficiencies to the Republican Unitary Enterprise Center for Expertise and Testing in Healthcare, website rceth.by. Storage conditions Store at a temperature not exceeding 25 ° C, out of the reach of children. Buy Rinomaris Advance nasal spray 0.5 mg / ml 10 ml No. 1 Price for Rinomaris Advance nasal spray 0.5 mg / ml 10 ml No. 1 ,5mg/ml 10ml №1