Active substanceSalmeterol + FluticasoneSalmeterol + Fluticasone
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  • Dosage form: & nbspPowder for inhalation dosed.
    Composition:Per one capsule:

    Active substance:

    50 μg + 100 μg

    50 μg + 250 μg

    50 μg + 500 μg

    Salmeterol xinafoate

    72.5 μg

    72.5 μg

    72.5 μg

    (in terms of salmeterol)

    50 μg

    50 μg

    50 μg

    Fluticasone propionate


    Excipients:

    100 μg

    250 mcg

    500 μg

    Sodium benzoate

    2.0 mg

    2.0 mg

    2.0 mg

    Lactose Monohydrate


    Capsules, gelatinous

    up to 12.0 mg

    up to 12.0 mg

    up to 12.0 mg

    Capsule body:

    - azorubin

    -

    -

    0,0016%

    - diamond black

    -

    -

    0,0958 %

    - proprietary blue

    -

    -

    0,1643 %

    - quinoline yellow

    -

    -

    1,1496%

    - titanium dioxide

    2%

    2%

    1,3333 %

    - gelatin

    up to 100 %

    up to 100%

    up to 100 %

    Capsule cap:

    - indigotine

    -

    0,3 %

    -

    - iron oxide yellow

    -

    1,7143%

    -

    - azorubin

    -

    -

    0,0016%

    - diamond black

    -

    -

    0,0958 %

    - proprietary blue

    -

    -

    0,1642%

    - quinoline yellow

    -

    -

    1,1496%

    - titanium dioxide

    2%

    1 %

    1,3333 %

    - gelatin

    up to 100%

    up to 100%

    up to 100%

    Description:Dosage of 50 μg + 100 μg: hard gelatin capsules No. 3, white body, white lid.
    Dosage of 50 μg + 250 μg: hard gelatin capsules No. 3, white body, lid green.
    Dosage of 50 μg + 500 μg: hard gelatin capsules No. 3, green body, lid green.
    The contents of capsules are white or almost white powder.
    Pharmacotherapeutic group:Bronchodilator combined (beta2-adrenomimetic selective + glucocorticosteroid local).
    ATX: & nbsp

    R.03.A.K   Sympathomimetics in combination with corticosteroids or other drugs, excluding anticholinergic drugs

    R.03.A.K.06   Salmeterol and fluticasone

    Pharmacodynamics:Saltikazon ® is a combination of two active ingredients: salmeterol xinafoate and fluticasone propionate, which have different mechanisms of action. Salmeterol prevents the occurrence of symptoms of bronchospasm, fluticasone improves pulmonary function and prevents exacerbation. Salticasone®-native thanks to a convenient dosing regimen can be an alternative for patients who simultaneously receive a beta agonist2-adrenoceptors and inhaled glucocorticosteroid (GCS), using different inhalers.
    Salmeterol is a selective long-acting (up to 12 hours) beta agonist2adrenoreceptors, which in its structure has a long side chain that binds to the outer domain of the receptor.
    Pharmacological properties of salmeterol provide protection against histamine-induced bronchoconstriction and prolonged bronchodilation (duration of at least 12 hours) than beta agonists2adrenoreceptors of short action.
    Salmeterol is a strong and long-acting inhibitor of the release from the human lung tissue of the mediators of mast cells, such as histamine, leukotrienes and prostaglandin D2.
    Salmeterol depresses the early and late phases of the response to inhaled allergens. The inhibition of the late phase of the response persists for more than 30 hours after taking a single dose, while the bronchodilator effect is no longer present. Single administration of salmeterol weakens the hyperreactivity of the bronchial tree. This indicates that salmeterol in addition to bronchodilator activity
    has an additional effect, not associated with the expansion of the bronchi, the clinical significance of which has not been fully established.This mechanism of action is different from the anti-inflammatory effect of GCS.
    Fluticasone belongs to the group of SCS for topical application and when inhaled at the recommended doses has a pronounced anti-inflammatory and anti-allergic effect in the lungs, which leads to a decrease in clinical symptoms, a decrease in the frequency of exacerbations of bronchial asthma. Fluticasone does not cause undesirable phenomena that are observed during systemic administration of glucocorticosteroids.
    With prolonged use of inhalation fluticasone, the daily secretion of hormones in the adrenal cortex remains within normal limits, both in adults and in children, even when the maximum recommended doses are used. After transferring patients receiving other inhaled GCS to fluticasone, the daily secretion of adrenal cortex hormones gradually improves, despite the previous and current recurrent use of oral steroids. This indicates the restoration of adrenal function against the background of inhalation application of fluticasone. With prolonged use of fluticasone, the reserve function of the adrenal cortex also remains within the normal range,as evidenced by a normal increase in cortisol production in response to appropriate stimulation (it must be borne in mind that the residual decrease in adrenal reserve caused by previous therapy may persist for a long time).
    Pharmacokinetics:There is no evidence that when combined inhalation salmeterol and fluticasone affect the pharmacokinetics of each other, and therefore the pharmacokinetic characteristics of each component of the Salticasone®-native preparation can be considered separately.
    Suction
    Salmeterol acts locally, in the lung tissue, so its content in the blood plasma is not an indicator of therapeutic effects. Data on its pharmacokinetics are very limited due to technical problems: when inhaled in therapeutic doses, its maximum concentration in the blood plasma is extremely low (about 200 pg / ml and below). After regular inhalation of salmeterol in the blood, it is possible to detect hydroxynaphthoic acid, the equilibrium concentrations of which are about 100 ng / ml. These concentrations are 1000 times lower than the equilibrium concentrations observed in the toxicity studies.No adverse effects were observed with prolonged regular use (for more than 12 months) in patients with airway obstruction.
    Absolute bioavailability of inhalation fluticasone in healthy people varies depending on the inhaler used: it is 5.5% when administered with salmeterol and fluticasone with an inhaler. In patients with bronchial asthma and chronic obstructive pulmonary disease (COPD), lower concentrations of fluticasone in the blood plasma are observed. Systemic absorption occurs mainly through the lungs. At first it is faster, but then its speed slows down. Part of the inhalation dose can be swallowed, but this part contributes minimally to systemic absorption due to the low solubility of fluticasone in water and due to its pre-systemic metabolism; bioavailability from the gastrointestinal tract is less than 1%. As the inhalation dose increases, a linear increase in the concentration of fluticasone in the blood plasma is observed. Distribution
    There is no data on the distribution of salmeterol.
    Fluticasone has a large volume of distribution in the equilibrium state (about 300 liters) and has a relatively high degree of binding to blood plasma proteins (91%).
    Metabolism
    There is evidence that salmeterol Extensively metabolized under the action of the CYP3A4 isoenzyme of the cytochrome P450 system to a-hydroxysalmeterol by aliphatic oxidation.
    Fluticasone is rapidly eliminated from the blood, mainly as a result of metabolism under the action of the CYP3A4 isoenzyme of the cytochrome P450 system to the inactive carboxyl metabolite. Caution should be exercised while using known inhibitors of CYP3A4 and fluticasone, since in such situations, an increase in the latter's plasma content is possible.
    Excretion
    There is no data on salmeterol excretion.
    The distribution of fluticasone is characterized by rapid clearance from the blood plasma (1150 ml / min) and a final elimination half-life of approximately 8 hours. Renal clearance of unchanged fluticasone is negligible (<0.2%), in the form of a metabolite with urine, less than 5% of the dose is excreted.
    Indications:Salticasone® - the native is intended for regular treatment of bronchial asthma if combined beta therapy is indicated2-adrenomimetikom long-acting and inhaled glucocorticosteroid:
    - Patients with insufficient control of the disease against a background of continuous monotherapy with inhaled glucocorticosteroids with periodic use of beta2short-acting adrenomimetics;
    - Patients with adequate disease control on the background of inhaled glucocorticosteroid therapy and beta2-adrenomimetikom long-acting;
    - as a starting maintenance therapy in patients with persistent asthma in the presence of indications for the appointment of glucocorticosteroids to achieve control of the disease.
    Salticasone®-native is intended for maintenance therapy in COPD in patients with forced expiratory volume (FEV1) <60% of the proper values ​​(before the inhalation of the bronchodilator) and repeated exacerbations in the history, in which the expressed symptoms of the disease persist despite regular therapy with bronchodilators.
    Contraindications:- Hypersensitivity to the components of the drug.
    - Age to 18 years.
    Carefully:Like all other inhaled preparations containing glucocorticosteroids, Salticasone-nasv should be used with caution in patients with acute or latent pulmonary tuberculosis.
    Salticasone ® - the native should be used with caution in thyrotoxicosis, fungal, viral or bacterial infections of the respiratory system.
    When taking any drugs group of sympathomimetics, especially when the therapeutic dose is exceeded, it is possible to develop cardiovascular events such as an increase in systolic blood pressure and heart rate. For this reason, Salticasone®-the native should be administered with caution to patients with cardiovascular diseases (coronary heart disease (CHD), idiopathic hypertrophic subaortic stenosis, uncontrolled arterial hypertension, prolongation of the QT interval on the ECG), including arrhythmias such as supraventricular tachycardia and extrasystole, ventricular extrasystole, atrial fibrillation.
    Salticasone® - the native should be administered with caution to patients with hypokalemia, since all sympathomimetic preparations at dosages higher than therapeutic ones can cause a transient decrease in potassium concentration (K+) in the blood plasma.
    Salticasone ® - the native should be used with caution in individuals with an allergic reaction to lactose and milk protein in the anamnesis (residual amounts of protein may be included in lactose), since it is possible to partially swallow the drug when inhaled (the drug contains lactose).
    Any inhaled GCS can cause systemic effects, especially with prolonged use in high doses. Therefore, the drug should be used with caution in glaucoma, cataracts, osteoporosis.
    There are very few reports of an increase in the concentration of glucose in the blood, so patients with diabetes should use Saltikazon ® - native with caution.
    Pregnancy and lactation:Pregnant women and women during breastfeeding should be prescribed Salticasan ® - native only if the expected benefit to the mother exceeds any possible risk to the fetus or child.
    There is insufficient data on the use of salmeterol and fluticasone during pregnancy and during breastfeeding.
    Pregnancy
    The reproductive toxicity of salmeterol and fluticasone was studied during preclinical studies. Excessive systemic concentration of active betag-adrenomimetic and GCS affects the fetus.
    Extensive experience in the clinical use of drugs of this class indicates that with the use of therapeutic doses, the described effects are not clinically significant. Salmeterol and fluticasone do not possess genotoxicity.
    Breastfeeding period
    The concentration of salmeterol and fluticasone in the blood plasma after inhaling the drug in therapeutic doses is extremely low, so their concentration in breast milk should be the same low. This is confirmed by studies in animals in the milk of which low concentrations of salmeterol and fluticasone were measured. There is no data on the concentration of salmeterol and fluticasone in breast milk of women during breastfeeding.
    Dosing and Administration:Salticasone® - the native is only for inhalation.
    The patient should be informed that to obtain the optimal effect the drug should be used regularly, even in the absence of clinical symptoms of bronchial asthma and COPD.
    The physician should regularly evaluate the effectiveness of the patient's treatment.
    Determining the duration of the course of therapy and changing the dose of the drug is possible only on the advice of a doctor.
    Bronchial asthma
    The dose of Salticasone ® - the native should be reduced to the lowest dose, which provides effective control of the symptoms.
    If taking Saltikazon ® - the native twice a day provides control over the symptoms,in the dose reduction to minimally effective, it is possible to reduce the frequency of taking the drug up to 1 time per day.
    The patient should be prescribed a form of Salticasone ®, a native that contains a dose of fluticasone, corresponding to the severity of his disease.
    If therapy with inhaled glucocorticosteroids does not provide adequate control over the disease, then their replacement with Salticasan®-native in a dose therapeutically equivalent to the dose administered by GCS can improve the control of the course of bronchial asthma. In patients who can monitor the course of bronchial asthma solely with inhaled glucocorticosteroids, replacing them with Salticasone®-native can reduce the dose of GCS needed to control the course of the disease. If the patient does not receive appropriate therapy, taking only inhaled glucocorticosteroids, then replacing them with Salticasone®-native preparation in a dose therapeutically equivalent to that administered by GCS can improve the control of the course of bronchial asthma.
    Recommended doses:
    One inhalation (50 μg salmeterol and 100 μg fluticasone propionate) 2 times a day, or
    one inhalation (50 μg salmeterol and 250 μg fluticasone propionate) 2 times a day, or
    one inhalation (50 μg salmeterol and 500 μg fluticasone propionate) 2 times a day.
    In adults, when the dose is doubled against the background of the use of any form of production of the preparation Saltikazona®-native for 14 days, the same safety and tolerability as with regular use of the drug for one inhalation twice a day is maintained. Dose can be doubled in those cases where patients need additional short-term (up to 14 days) therapy with inhaled corticosteroids.
    Chronic obstructive pulmonary disease (COPD)
    For adult patients, the maximum recommended dose is 1 inhalation (50 μg salmeterol and 500 μg fluticasone) 2 times a day.
    Special patient groups
    There is no need to reduce the dose of Salticasone ® - the drug in elderly patients, as well as in patients with impaired renal or hepatic function.
    Instructions for inhalation
    In order to ensure the correct use of the drug, it should be used only with the Inhaler CDM® inhaler. Inhaler powder "Inhaler CDM®" is a plastic device with a movable upper part and with a retractable compartment for a capsule, about 6 cm high.
    Capsules are for inhalation use only and are not intended for ingestion. Remove the capsule from the cell pack immediately before use.
    Instructions for the use of the inhaler "Inhaler CDM®"
    "Inhaler CDM®" is a single-dose inhaler that allows to dose and inhale the drug in very small doses.
    Saltkazone® - natv gets into the patient's airways along with air streams when performing an active inspiration through the mouthpiece.
    Inhaler CDM® is very simple to use. Follow the step-by-step instructions below:
    Step 1.
    Remove the transparent cap from the Inhaler CDM® device, as shown in Fig. 1.

    Step 2.
    Hold the device firmly with one hand, with the index finger and the thumb of the other hand, open the capsule compartment, as shown in Fig. 2. To do this, press the index finger on "PUSH" in the moving part of the inhaler "Inhaler CDM®", sliding it in the opposite direction.

    Step 3.
    Hold the device with one hand, insert the capsule with the drug into the compartment of the compartment (Figure 3).

    Step 4.
    Make sure that the capsule is correctly inserted into the socket (Figure 4).

    Step 5.
    While holding the Inhaler CDM® in the vertical position, close the compartment by pressing the thumb in the opposite direction until it stops,until you hear a click (Figure 5).

    Step 6.
    Hold the device "Inhaler CDM®" strictly vertically (Figure 6).

    Step 7.
    Bring it to the working state, as shown in Fig. 7. To do this, press firmly onto the mouthpiece so that the arrow on the body disappears from the bottom of the device to the top line. Then release the mouthpiece to return it to its original position. Thus, you will pierce the capsule, opening access to the drug in the lumen of the mouthpiece.

    Step 8.
    Caution: exhale before inhalation (Fig. 8). Do not exhale through the mouthpiece!

    Step 9.
    Gently squeeze the mouthpiece of the Inhaler CDM® device with your teeth, tightly grasp it with your lips and draw a deep and strong breath through your mouth (Figure 9). You will hear a vibrating sound inside the capsule compartment, emitted by the capsule while rotating and dispersing the drug. Hold your breath for about 10 seconds or longer, as far as possible. Remove the inhaler from the mouth. Make a slow exhalation. Then breathe normally.
    The mouthpiece should not be chewed and clenched with teeth!
    Repeat steps 6-9 again, to ensure that the dose of the drug is inhaled.

    Step 10.
    After the inhalation, open the capsule compartment, remove the empty capsule, and then close it, as shown in Fig. 5.
    Attention:
    When carrying out inhalation, try not to cover the holes located on the sides of the mouthpiece. This can interfere with the free movement of air within the inhaler, thereby reducing the dispersion of the contents of the capsule.
    Do not press on the mouthpiece when inhaled. This can block the movement of the capsule.
    Always close the Inhaler CDM® cap tightly after use, this will keep the mouthpiece clean.
    Regularly (once a week), you should clean the mouthpiece from the outside with a dry cloth.
    Side effects:All the undesirable reactions presented below are characteristic for the active substances - salmeterol and fluticasone alone. Additional side effects with simultaneous use of the two components of the drug are not noted. The incidence of adverse reactions is estimated as follows: arising "very often" -> 10%; "often" -> 1% and - <10%, "infrequently" -> 0.1% - <1%, "rarely" -> 0.01 - <0.1%, "very rarely" - <0, 01%, including individual messages, "frequency unknown" (the frequency can not be calculated from the available data).Infectious and parasitic diseases: often - candidiasis of the mouth and pharynx, pneumonia (in patients with COPD); rarely - esophageal candidiasis.
    Immune system disorders: infrequently - skin reactions of hypersensitivity (including skin rash), dyspnea; rarely - anaphylactic reactions, angioedema, mainly edema of the face and oropharynx, bronchospasm.
    Disorders from the endocrine system: rarely - Cushing's syndrome, Cushing's symptoms, suppression of adrenal function, reduction of bone mineral density.
    Disorders from the metabolism and nutrition: infrequently hyperglycemia; very rarely - hypokalemia.
    Disorders of the psyche: infrequently - anxiety, sleep disturbances; rarely - changes in behavior, including increased activity and irritability, frequency is unknown - depression.
    Impaired nervous system: very often - headache; infrequently - a tremor.
    Disorders from the side of the organ of vision: infrequently - cataract; rarely - glaucoma.
    Heart Disease: infrequently - heart palpitations, tachycardia, atrial fibrillation; rarely - arrhythmia, including ventricular extrasystole, supraventricular tachycardia and extrasystole.
    Disturbances from the respiratory system, chest and mediastinal organs: often hoarseness and / or dysphonia; infrequent - pharynx irritation; rarely paradoxical bronchospasm.
    Disorders from the gastrointestinal tract: very rarely - abdominal pain, nausea, vomiting; infrequently - a change in taste sensations (dysgeusia).
    Disturbances from the skin and subcutaneous tissues: infrequently - bruises.
    Disturbances from the musculoskeletal and connective tissue: often - muscle spasms, arthralgia, the frequency is unknown - myalgia, fractures of bones.
    Overdose:It is not recommended to administer the drug at doses exceeding those specified in the section "Method of administration and dose". It is very important to regularly review the dosage regimen of the drug and reduce the dose to the lowest recommended dose, which provides effective control over the disease ("Method of administration and dose").
    Symptoms
    Expected symptoms and signs of a salmeterol overdose are typical for excessive beta2-adrenergic stimulation and include tremor, headache, tachycardia, increased systolic blood pressure, and hypokalemia.
    Acute overdose of fluticasone during inhalation administration can provoke a temporary suppression of the hypothalamic-pituitary-adrenal system. Usually this does not require taking any emergency measures, since the normal function of the adrenal glands is restored within a few days.
    When taking the drug in doses above the recommended for a long period of time, a significant suppression of the function of the adrenal cortex is possible. Rare cases of acute adrenal crisis, which occurred mainly in children who received doses of a combination of salmeterol with fluticasone above those recommended for a long time (several months or years) are described. Acute adrenal crisis is manifested by hypoglycemia, accompanied by confusion and / or convulsions. Situations that can serve as triggers for an acute adrenal crisis include trauma, surgery, infection, or any rapid reduction in the dose of inhaled fluticasone, which is part of the Salticasone®-native preparation.
    Treatment
    There is no specific treatment for an overdose of salmeterol and fluticasone.In case of an overdose, supportive therapy should be followed and the patient's condition monitored. In chronic overdose, it is recommended to monitor the reserve function of the adrenal cortex.
    Interaction:Because of the risk of developing bronchospasm, selective and nonselective beta-blockers should be avoided, unless they are extremely necessary for the patient.
    In normal situations, fluticasone inhalations are accompanied by low concentrations of it in the blood plasma due to intensive metabolism in the "first" passage and high systemic clearance under the influence of the CYP3A4 isoenzyme of the cytochrome P450 system in the intestine and liver. Due to this, clinically important interactions involving fluticasone are unlikely.
    Ritonavir, a highly active inhibitor of the CYP3A4 isoenzyme, can cause a dramatic increase in plasma concentrations of fluticasone, which significantly reduces serum cortisol concentrations. There have been reports of clinically significant drug interactions in patients who simultaneously received fluticasone (intranasally or by inhalation) and ritonavir. These interactions caused systemic side effects peculiar to SCS, such as Cushing's syndrome and suppression of adrenal function. Given this, simultaneous use of fluticasone and ritonavir should be avoided, unless the potential benefit to the patient exceeds the risk of systemic side effects of GCS. Other inhibitors of the isoenzyme CYP3A4 cause negligible (erythromycin) and insignificant (ketoconazole) an increase in the level of fluticasone in the blood plasma, at which the concentrations of serum cortisol are practically not reduced. Despite this, caution should be exercised while using fluticasone and strong inhibitors of CYP3A4 (eg, ketoconazole), since such combinations do not exclude the possibility of an increase in plasma fluticasone concentration, which can potentially increase the systemic effects of fluticasone.
    When investigating the interaction of drugs, it was found that the use of ketoconazole as a concomitant systemic therapy significantly increases the concentration of salmeterol in blood plasma (an increase in Cmax 1.4 times and AUC 15 times).This can lead to an elongation of the QTc interval. Caution should be exercised when co-administration of strong inhibitors of CYP3A4 (eg, ketoconazole) and salmeterol.
    The derivatives of xanthine, GCS and diuretics increase the risk of hypokalemia (especially in patients with exacerbation of bronchial asthma, hypoxia). Monoamine oxidase inhibitors and tricyclic antidepressants increase the risk of developing side effects from the cardiovascular system.
    Salticasone® - native is compatible with cromoglycic acid.
    Special instructions:Salticasone® - the native is not intended to alleviate acute symptoms, since in such cases, a rapid and short-acting inhalation bronchodilator (for example, salbutamol). Patients should be informed that they always have on hand a drug to stop acute symptoms. The combination of salmeterol with fluticasone can be used for initial maintenance therapy in patients with persistent asthma (daily occurrence of symptoms or daily use of an agent for arresting seizures) in the presence of indications for prescribing glucocorticosteroids and when determining their approximate dosage.
    The more frequent use of short-acting bronchodilators to relieve symptoms indicates a worsening of control over the disease, and in such situations the patient should consult a doctor.
    The sudden and increasing deterioration in the control of bronchial asthma poses a potential threat to life, and in such situations, the patient should also consult a doctor. The doctor should consider the possibility of prescribing a higher dose of GCS. If the dose of Salticasone ®, the native does not provide adequate control over the disease, the patient should also consult a doctor.
    Patients with bronchial asthma can not abruptly stop treatment with Saltikazon ® - native because of the risk of developing exacerbation, the dose of the drug should be reduced gradually under the supervision of a doctor.
    In patients with COPD, the withdrawal of the drug may be accompanied by symptoms of decompensation and requires the supervision of a physician. There is evidence of an increase in the incidence of pneumonia in patients with COPD receiving a combination of salmeterol with fluticasone. Doctors should be aware of the possibility of developing pneumonia in COPD, as the clinical picture of pneumonia and exacerbations of COPD are often similar.
    Any inhaled GCS can cause systemic reactions, especially with prolonged use in high doses; but the likelihood of such symptoms is much lower than when treated with oral GCS. Possible systemic reactions include Cushing syndrome, Cushingoid features, suppression of adrenal function, reduction of bone mineral density, cataract and glaucoma. Therefore, in the treatment of bronchial asthma, it is important to reduce the dose to the lowest dose, which provides effective control over the disease.
    In emergency and planned situations that can cause stress, it is always necessary to remember the possibility of suppressing the function of the adrenal gland and be ready to use the GCS.
    When carrying out resuscitation measures or surgical interventions, it is required to determine the degree of adrenal insufficiency.
    Due to the possibility of suppression of the adrenal glands, patients transferred from oral GCS to inhalation therapy with fluticasone should be treated with extreme caution and regularly monitor their function as the adrenal cortex. When transferring patients from receiving systemic GCS to inhalation therapy, allergic reactions (for example, allergic rhinitis, eczema), which were suppressed by systemic SCS, may appear.In such situations it is recommended to carry out symptomatic treatment with antihistamines and / or topical preparations, including SCS for topical application.
    After the initiation of treatment with inhaled fluticasone, systemic GCS should be discontinued gradually, patients should carry a special patient card containing an indication of the possible need for additional administration of SCS in stressful situations.
    In patients with exacerbation of bronchial asthma, hypoxia, it is necessary to monitor the concentration of potassium ions in the plasma.
    There are very few reports of an increase in the concentration of glucose in the blood, and this should be borne in mind when appointing a combination of salmeterol with fluticasone in patients with diabetes mellitus.
    There is evidence of a clinically significant drug interaction between fluticasone and ritonavir leading to systemic effects of GCS, including Cushing's syndrome and suppression of adrenal function. Therefore, it is recommended that joint use of fluticasone and ritonavir should be avoided, unless the potential benefit to the patient exceeds the risk associated with systemic effects of GCS.
    When taking salmeterol, the risk of serious unwanted reactions from the respiratory system or death in patients of African American origin is presumably higher than in other patients. The importance of pharmacogenetic factors or other causes is unknown.
    Like other inhaled medications, Salticasan® - the native can cause a paradoxical bronchospasm, manifested by the increase of dyspnea immediately after application. In this case, rapid and short-acting inhalation bronchodilator should be immediately applied, Salticasin®-native should be discarded, the patient should be examined and alternative therapy should be started, if necessary.
    There are reports of adverse reactions associated with the pharmacological action of beta2antagonists, such as a subjective feeling of palpitations. However, these reactions are of a short-term nature, and their severity decreases with regular therapy.
    Effect on the ability to drive transp. cf. and fur:There is no evidence of the effect of the drug on the ability to drive vehicles and other mechanisms. When taking the drug Saltikazon ® - the native can develop such adverse reactions as a headache,tremor and muscle spasms, so you need to be careful when driving vehicles and working with mechanisms, as well as when engaging in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.
    When these undesirable phenomena appear, one should refrain from performing these activities.
    Form release / dosage:The powder for inhalation is dosed, 50 μg + 100 μg, 50 μg + 250 μg, 50 μg + 500 μg.
    Packaging:10 capsules per circuit cell packaging made of aluminum foil and laminated aluminum foil.
    For 3 or 6 contour packagings with or without an inhalation device, the instructions for use are placed in a cardboard box.
    Storage conditions:In the dark place at a temperature of no higher than 25 ° C.
    Keep out of the reach of children.
    Shelf life:2 years. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-003400
    Date of registration:31.12.2015
    Expiration Date:31.12.2020
    The owner of the registration certificate:NATIVA, LLC NATIVA, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp2016-12-17
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