Dezrinit Nazal Spray. scrapper. 50mkg / 18g dose 140doz vial 1 piece

$8.57

Dezrinit Nazal Spray. scrapper. 50mkg / 18g dose 140doz vial 1 piece

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SKU: 2020128274 Categories: , Tags: ,

Description

Composition
Active substance:
mometasone furoate monohydrate (calculated as mometasone furoate), 0.052 mg (0.050 mg);
Excipients:
Avicel RC-591 [microcrystalline cellulose, sodium carmellose] 2.00 mg; glycerol 2.10 mg;
benzalkonium chloride solution of 500 g / l 0.04 mg; Polysorbate 80 0.01 mg; citric acid monohydrate 0.20 mg; Sodium citrate dihydrate 0.28 mg; water for injection qs 100.00 mg.
Description:
The milky white suspension without agglomerates placed in a white plastic bottle equipped with a dosing device and a transparent polypropylene cap.
Product form:
Nasal spray metered dose, 50 .mu.g / dose.
10 g (60 doses) or 18 g (140 doses) suspension in white polyethylene bottles, equipped with a metering device and a plastic cap.
1 bottle (10 g) and 1, 2, 3 bottles (18 g), together with instructions for use in a cardboard package.
Contraindications
Hypersensitivity to Mometasone or any of the components; infancy (with seasonal and perennial allergic rhinitis – up to 2 years, with an acute sinusitis, acute exacerbations of chronic sinusitis or – up to 12 years, with nasal polyposis – 18 years); recent surgery or trauma to the nasal mucosal damage of the nasal cavity – to healing wounds (because of the inhibitory effect of corticosteroids on the healing process).
Carefully
The drug Dezrinit should be used with caution in tuberculosis infection (active or latent) of the respiratory tract, untreated fungal, bacterial, systemic viral infections or infections caused by Herpes simplex eye disease (as an exception, perhaps the appointment of the drug in these infections as directed by a physician), the presence of untreated local infection in a process involving the mucosa of the nasal cavity.
Dosage
50 ug / dose
Indications
– seasonal and perennial allergic rhinitis in adults, adolescents and children from 2 years of age;
– acute sinusitis or acute exacerbation of chronic sinusitis in adults (including the elderly) and adolescents 12 years of age – as an auxiliary therapeutic agent in the treatment of antibiotics;
– acute rhinosinusitis with mild to moderate symptoms without signs of serious bacterial infections in patients aged 12 years or more.
– preventive treatment of seasonal allergic rhinitis, moderate and severe in adults and adolescents from 12 years (recommended for 2-4 weeks before the expected start of the season dusting);
– nasal polyposis, followed by a violation of nasal breathing and sense of smell, in adults (18 years).
Interaction with other drugs
The simultaneous use of mometasone loratadine does not alter the concentration of loratadine or its major metabolite in plasma, the plasma was not determined even in the presence of mometasone minimum concentration. In these studies, mometasone furoate in plasma was not detected (sensitivity of determination at 50 pg / ml).
In an application with SYP3A inhibitors, including kobitsistat-containing preparations, the risk of systemic side effects increases. Avoid their simultaneous use, except in cases where the potential benefit to the patient exceeds the potential risk of systemic side effects of corticosteroids. In the case of a joint application, it is necessary to control the development of systemic side effects of corticosteroids in patients.
Overdose
Prolonged use of corticosteroids at high doses, as well as simultaneous application of several corticosteroids may inhibition function gipotalamogipofizarno-adrenal system. Due to the low systemic bioavailability of the drug (
pharmachologic effect
Pharmacological group:
topical glucocorticosteroid
Pharmacodynamics:
Mometasone is a synthetic glucocorticosteroid (GCS) for topical application. It has anti-inflammatory and anti-allergic effect.
The local anti-inflammatory effect of the drug manifested when used at doses at which there is no systemic effects.
Inhibits the release of inflammatory mediators. Increases lipomodulin production, an inhibitor of phospholipase A, which causes the decrease of arachidonic acid release and, accordingly, suppression of the synthesis of the arachidonic acid metabolism products – cyclic endoperoxides, prostaglandins. Prevents the accumulation of neutrophils boundary, which reduces the inflammatory exudation and production of lymphokines inhibits the migration of macrophages, reduces the processes of infiltration and granulation. Reduces inflammation by reducing the formation of chemotactic substance (effect on later reactions allergies), inhibits the development of immediate allergic reaction (due to inhibition of the formation of arachidonic acid metabolites and reducing the release of mast cell mediators of inflammation).
In studies with provocative tests with the application of antigens on nasal mucosa high anti-inflammatory activity of the drug has been demonstrated, both early and late stages of an allergic reaction.
When compared with placebo installed reducing histamine and eosinophil activity and a decrease (compared to baseline), number of eosinophils, neutrophils and epithelial cell proteins.
Pharmacokinetics:
Intranasal application of systemic bioavailability of mometasone furoate is
Pregnancy and breast-feeding
Special safety trials of mometasone during pregnancy and lactation was conducted.
As with other nasal corticosteroids, Dezrinit drug should be used during pregnancy and lactation only if the expected benefit of its use outweighs the potential risk to the fetus and newborn. Neonates whose mothers used corticosteroids during pregnancy should be carefully evaluated for possible hypoadrenalism.
Conditions of supply of pharmacies
Prescription.
side effects
Adverse events associated with the drug (> 1%), identified during clinical trials in patients with allergic rhinitis or nasal polyposis and during the post-registration of the drug, regardless of the indications for use are shown below in “The incidence of adverse reactions.” Adverse reactions listed in accordance with the classification system-organ class MedDRA. Within each system organ class, adverse reactions are classified according to frequency of occurrence.
Epistaxis, they were usually mild and stops on its own,
the frequency of their occurrence was slightly greater than with placebo (5%)
but equal to or smaller than the appointment other intranasal corticosteroids, which were used as active controls (some of them incidence of nasal bleeding was up to 15%). The incidence of all other adverse events was comparable to the incidence with placebo.
The overall incidence of adverse events in patients treated with respect nasal polyposis was comparable to the incidence in patients with allergic rhinitis.
The overall incidence of adverse events in patients treated for acute rhinosinusitis, was comparable to the incidence in patients with allergic rhinitis and with placebo.
In applying intranasal corticosteroids may develop systemic side effects, especially with prolonged use of nasal corticosteroids at high doses (see. “Special instructions” section).
The frequency of adverse reactions set as follows: very often (> 1/10); common (> 1/100,
special instructions
As with any treatment, patients treated with mometasone in the formulation – nasal spray metered for several months or longer must undergo periodic medical examination for possible changes in the nasal mucosa.
Should be monitored for patients receiving intranasal corticosteroids for a long time. Perhaps the development of growth retardation in children. In case of growth retardation in children is necessary to reduce the dose of intranasal corticosteroids to the lowest, which effectively control the symptoms. In addition, the patient should be referred for consultation to the pediatrician.
In the case of local fungal infection of the nose or throat may require discontinuation of therapy with mometasone in the formulation – nasal spray dosage and carrying out special treatment. Continuing for a long time, stimulation of the nasal mucosa and pharynx may also serve as a basis for cessation of treatment in the dosage form of mometasone – nasal spray metered.
In a placebo-controlled clinical trials in children when dosage form in mometasone – nasal spray metered applied in a daily dose of 100 mg for one year, growth retardation in children were noted.
Prolonged treatment with mometasone in a dosage form – nasal spray characteristics suppression of the hypothalamic-pituitary-adrenal system were observed.
Patients who go to treatment with mometasone in the formulation – nasal spray dosage corticosteroids after prolonged therapy with systemic action, require special attention. Cancel systemic corticosteroids in these patients may lead to failure of the adrenal glands function, subsequent recovery which may take up to several months. If signs of adrenal insufficiency should resume receiving systemic corticosteroids and other necessary measures.
In applying intranasal corticosteroids may develop systemic side effects, especially with prolonged use at high doses. The likelihood of developing these effects is significantly less than with oral corticosteroids.
Systemic side effects may differ both in individual patients, and depending on the used glucocorticosteroid preparation.
Potential systemic effects include Cushing’s syndrome, features kushingoida, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely a range of psychological or behavioral effects including psychomotor hyperactivity, sleep disorders, anxiety,
depression or aggression (particularly in children).
During the transition from the treatment of glucocorticoid systemic effects to the mometasone treatment in the formulation – nasal spray dosage in some patients may experience initial withdrawal symptoms of systemic corticosteroids (eg, pain in the joints and / or muscles, fatigue and depression), despite the decrease in severity of symptoms associated with lesions of the nasal mucosa. In the case of these symptoms should resume receiving systemic corticosteroids and other necessary measures. The transition from the local system can also identify glucocorticosteroids already existed, but the masked systemic therapy with glucocorticosteroids allergic diseases such as allergic conjunctivitis and eczema.
Patients undergoing treatment with glucocorticosteroids have potentially reduced immune reactivity and be alerted to elevated for their risk of infection in the event of contact with sick certain infectious diseases (e.g., chicken pox, measles), and the need for medical consultation if such contact occurred .
When signs of severe bacterial infection (e.g., fever, and persistent severe pain on one side face or dental pain, swelling in the orbital or periorbital) require immediate medical consultation.
When applied in the formulation of mometasone – nasal spray metered for 12 months did not arise signs of atrophy of nasal mucosa. Furthermore, mometasone furoate tended help normalize histological biopsies at the nasal mucosa.
The efficacy and safety of mometasone has not been studied in the treatment of unilateral polyps, polyps associated with cystic fibrosis and polyps that completely cover the nasal cavity.
In the case of unilateral polyps unusual or irregular shape, particularly ulceration or bleeding, it is necessary to carry out additional medical examination.
It reported visual impairment in systemic and local application of corticosteroids. If the patient has symptoms such as blurred vision or other visual disturbances, consider the direction of the patient to the ophthalmologist to evaluate possible causes which can include cataracts, glaucoma or rare diseases, such as central serous chorioretinopathy (CSR).
Effect on the ability to drive mechanisms and
No data on the influence of drug Dezrinit drug on the ability to drive vehicles or moving machinery.
Storage conditions
Store at a temperature not higher than 25 ° C, do not freeze.
Keep out of the reach of children.
The shelf life of an opened bottle for 2 months.
Dosing and Administration
Intranasally. Injecting a suspension contained in a bottle, performed with a special metering device to the vial.
Before the first application of the preparation is necessary to “calibrate” the dispensing device.
Puncture nasal applicator (nozzle for spraying).
To carry out “calibration” press the dispenser 10 times as long, until there are sprays that indicates readiness for use of the drug.
Tilt your head and inject the drug into each nostril as recommended by the attending physician.
If the drug did not appear for 14 days or longer time, it is necessary to press the dispensing device 2 times as long as the sprays do not appear.
Tilt your head and inject the drug into each nostril as recommended by the attending physician.
Cleaning the dosing device
It is important to regularly clean the metering unit to avoid malfunction. Remove the cap, which protects the unit from dust, and then carefully remove the spray tip. Thoroughly rinse spray nozzle and a cap to protect it from dust in warm water and rinse under tap.
Do not attempt to open the nasal applicator (tip for spraying) with a needle or other sharp object as this will damage the applicator, with the result that you can take the wrong dose.
Dry the cap and nozzle in a warm place. Then attach tip for spraying onto the vial and again fasten the cap to the bottle to protect it from dust. The first application of a nasal spray after cleaning must be repeated “calibration” by pressing the dispensing device 2 times.
Before each use, it is necessary to shake the bottle vigorously.
Treatment of seasonal and perennial allergic rhinitis
Adults (including the elderly) and adolescents from 12 years
Recommended prophylactic and therapeutic dose is 2 injection (50 micrograms each) in each nostril once a day 1 (total daily dose – 200 mg). Upon reaching therapeutic effect for maintenance therapy may reduce the dose of 1 injection into each nasal passage 1 times a day (total daily dose – 100 mg).
If the reduction of symptoms can not be achieved using the drug at the recommended therapeutic dose, the daily dose may be increased to 4 injections into each nasal passage 1 time per day (total daily dose – 400 mg).
After reducing the symptoms recommended dose reduction.
The onset of action of the drug is usually noted clinically within 12 hours after the first application of the preparation.
Children 2-11 years
The recommended therapeutic dose in the treatment of seasonal or perennial allergic rhinitis – 1 injection (50 micrograms of mometasone furoate) in each nostril once a day 1 (total daily dose – 100 mg).
For the use of the drug in young children need adult assistance.
Adjunctive treatment of acute sinusitis, acute or chronic sinusitis
Adults (including the elderly) and adolescents from 12 years
The recommended therapeutic dosage is 2 injection (50 micrograms each) in each nostril two times a day (total daily dose – 400 mg).
If the reduction of symptoms can not be achieved using the drug at the recommended therapeutic dose, the daily dose may be increased to 4 injections in each nostril two times a day (total daily dose – 800 mg). After reducing the symptoms recommended dose reduction.
Treatment of acute rhinosinusitis, with no signs of serious bacterial infection
The recommended dose for adults and adolescents is 2 injections of 50 micrograms into each nostril two times a day (total daily dose 400 mg). With the deterioration of symptoms during treatment should consult a specialist.
Treatment of nasal polyposis
Adults (including the elderly) aged 18
The recommended therapeutic dose of 2 injection (50 micrograms each) in each nostril two times a day (total daily dose – 400 mg).
After reducing the symptoms recommended dose reduction to 2 injections (50 ug each) into each nasal passage 1 time per day (total daily dose – 200 mg).
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

TEVA

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