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    3. Zafiron capsules containing powder for inhalation 12mkg 60 pcs with an inhaler — Made in Poland by Adamed — Free Delivery

    Zafiron capsules containing powder for inhalation 12mkg 60 pcs with an inhaler — Made in Poland by Adamed — Free Delivery


    Brand: ADAMED
    Product Code: Zafiron
    Availability: In Stock
    $36.89
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    Indications.

    • Prevention and treatment of bronchospasm in patients with bronchial asthma;
    • prevention of bronchospasm caused by allergens, cold air or exercise;
    • prevention and treatment of violations of bronchial patency in patients with chronic obstructive pulmonary disease (COPD), incl. with chronic bronchitis and emphysema.

    Contraindications

    Hypersensitivity to formoterol or other components of the preparation.
    Interaction with other medicinal products and other types of interactions.
    The simultaneous use of Zafiron and preparations such as quinidine, disopyramide, procainamide, phenothiazines, antihistamines and tricyclic antidepressants, MAO inhibitors, macrolides or preparations that extend the QT interval requires caution, since their effect on the cardiovascular preparation. , preparations that increase the QT interval increase the risk of ventricular arrhythmias).
    The simultaneous use of other sympathomimetic agents can aggravate the side effects of Zafiron.
    The simultaneous use of xanthine derivatives, steroids or diuretics may enhance the potential hypokalemic effect of beta2-adrenostimulants.
    Hypokalemia can increase the tendency to irregular heart rhythm in patients with digitalis glycosides.
    Patients taking painkillers in the form of halogenated hydrocarbons at the same time are at risk of cardiac arrhythmias.
    Beta-blockers can weaken or block the action of Zafiron. In this regard, Zafiron should not be used in conjunction with beta-blockers (including eye drops), unless there is another alternative.

    Features of the application.

    The lowest possible dose of Zafiron, which provides a therapeutic effect, should be selected in accordance with the individual needs of the patient. Do not exceed the maximum recommended dose (see method of administration and dose).
    Anti-inflammatory treatment.
    During the treatment of patients with asthma, the preparation Zafiron, a long-acting beta2-adrenostimulant (LABA), should be used only as an adjuvant used together with inhaled corticosteroids, in patients whose asthma is not adequately controlled with inhaled corticosteroids or patients in whom an exacerbation of the disease gives rise to treatment with inhaled corticosteroids and a beta2-adrenostimulant of prolonged action.
    In children from 6 to 12 years old, the use of a complex preparation containing inhaled corticosteroids and a long-acting beta2-adrenostimulant is recommended, except for cases when the use of separate inhaled corticosteroids and a long-acting beta2-adrenostimulant is required.
    Do not use Zafiron together with other long-acting beta2-adrenostimulants. During the treatment of patients with asthma, Zafiron should be used as an adjuvant preparation for patients whose asthma is not adequately controlled by other means (for example, inhaled corticosteroids in small and medium doses) or in patients in whom an exacerbation of the disease gives rise to treatment with two preparations used in maintenance therapy, including with the help of the preparation  Zafiron.
    For patients who are not receiving anti-inflammatory treatment, it should be started simultaneously with the start of the use of Zafiron. Patients should be advised to continue anti-inflammatory therapy after starting the use of Zafiron, even if there is an improvement in their condition.
    If asthma symptoms improve, a gradual dose reduction of Zafiron may be considered. It is important to regularly monitor the patient's condition during the dose reduction period. The lowest effective dose of Zafiron should be used.
    Exacerbation of asthma.
    Clinical studies using the preparation Zafiron indicate a more frequent occurrence of severe exacerbations of asthma in patients taking Zafiron than in patients receiving placebo, in particular in children aged 5 to 12 years. These studies do not allow an accurate determination of the difference in the number of cases of asthma exacerbation between the study groups.
    If symptoms persist or the number of doses of Zafiron needed to control symptoms of the disease increases, this usually indicates a worsening of the underlying disease and a need to see a doctor for basic asthma therapy.
    You should not start treatment with Zafiron, as well as increase the dosage during an exacerbation of asthma.
    Do not use Zafiron to relieve acute asthma symptoms.
     In case of an asthma attack, a fast acting beta2-adrenostimulant should be used. The patient should be informed of the urgent need for medical attention in case of a sudden exacerbation of asthma.
    The need for frequent administration of the preparation (i.e., prophylactic treatment), for example, with corticosteroids and long-acting beta2-adrenostimulants) in order to prevent exercise-induced bronchospasm several times a week, despite supportive therapy, may be a symptom of insufficient control. reviewing asthma treatment and assessing patient compliance with doctor's recommendations
    Associated diseases.
    Zafiron should be used with extreme caution and under medical supervision, especially in terms of compliance with the recommended dose: ischemic heart disease; violation of heart rhythm and conduction, especially with AV block of the III degree; severe heart failure or severe uncompensated heart failure, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm, pheochromocytoma, hypertrophic obstructive cardiomyopathy; thyrotoxicosis; known or suspected prolongation of the QT interval (QT corrected> 0.44 sec).
    Due to the hyperglycemic effect inherent in β2-adrenostimulants, patients with diabetes mellitus, additional monitoring of blood glucose is recommended.
    Hypokalemia.
    The consequence of therapy with β2-adrenostimulants may be the development of potentially serious hypokalemia. Since this effect of the preparation can be enhanced by hypoxia and concomitant treatment, special care should be taken in patients with severe bronchial asthma. In these cases, regular monitoring of serum potassium levels is recommended.
    Paradoxical bronchospasm.
    As with other inhalation therapy, when using Zafiron, one should take into account the possibility of developing paradoxical bronchospasm. In this case, the preparation should be discontinued immediately and an alternative cure should be prescribed.
    The preparation contains lactose, therefore, patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not use the preparation.
    Application during pregnancy or lactation.
    The safety of using Zafiron during pregnancy and lactation has not yet been established.
    In animal studies, formoterol caused miscarriages and also decreased early postpartum survival and birth weight.
    The use of the preparation during pregnancy should be avoided unless there is a safer alternative preparation. Formoterol, like other beta2-adrenostimulants, can slow down the labor process as a result of tocolytic action.
    It is not known whether formoterol passes into breast milk. The substance is found in the milk of female rats during lactation. Women should stop breastfeeding for the period of treatment.
    The ability to influence the reaction rate when driving vehicles or other mechanisms.
    In case of dizziness, tremors, convulsions during treatment, you should not drive vehicles or work with complex mechanisms.

    Method of administration and dosage.

    Zafiron is intended for inhalation use in adults and children over 6 years old.
    Adults.
    Bronchial asthma.
    1-2 capsules for inhalation (12-24 mcg) 2 times a day. The maximum recommended daily dose for maintenance therapy is 48 mcg / day. If necessary, you can additionally use 1–2 capsules per day in order to reduce the manifestation of symptoms. If the need for additional doses occurs more often than 2 days a week, treatment should be reviewed, as this may indicate a worsening of the underlying disease.
    Chronic obstructive pulmonary disease.
    1-2 capsules for inhalation (12-24 mcg) 2 times a day.
    The maximum daily dose for maintenance therapy is 48 mcg / day.
    Prevention of bronchospasm caused by exercise, allergens or cold air.
    Inhale the contents of 1 capsule (12 mcg) 15 minutes before exercise or suspected contact with an allergen. Patients with severe bronchial asthma may require the use of 2 capsules for inhalation (24 μg) per day.
    Children from 6 years old.
    Bronchial asthma.
    1 capsule for inhalation (12 mcg) 2 times a day.
    The maximum recommended daily dose is 24 mcg / day.
    Prevention of bronchospasm caused by exercise, allergens or cold air.
    The contents of 1 capsule (12 mcg) should be inhaled 15 minutes before loading or prior to expected contact with an allergen.

    How to use the inhaler

    1. Remove the nozzle cover from the inhaler.
    2. Hold the lower part of the inhaler and open it by turning the tip (upper part) in the direction of the arrow.
    3. Place the capsule in the capsule-shaped chamber located at the bottom of the inhaler. The capsule should be removed from the package immediately before use.
    4. Rotate the tip to the closed position.
    5. Press all the way down the button at the bottom of the inhaler at the same time (only once!) While holding the inhaler in an upright position.
    ATTENTION! At this point, the capsule may disintegrate and small pieces of gelatin may enter the mouth or throat. The capsule consists of food grade gelatin. The probability of the capsule disintegration will be minimal if it is pierced no more than once, the storage conditions are observed and if the capsule is unpacked immediately before use.
    6. Take a deep breath.
    7. Take the tip in your mouth and throw your head back a little, clamp the tip with your mouth and take a few quick, even and deep breaths. At this moment, the capsule begins to rotate in the inhaler chamber, and the powder scatters, which is accompanied by a characteristic sound. If this sound does not appear, the capsule is stuck in the chamber. In this case, you need to open the inhaler and release the capsule. It is forbidden to try to release the capsule by repeatedly pressing the buttons.
    8. Hearing a characteristic sound (buzzing), you need to hold your breath as much as possible without discomfort, and pull the inhaler out of your mouth. Exhale. Then open the inhaler and check if there is any powder left in the capsule. If powder remains, repeat steps 6-8.
    9. Open the inhaler, remove the empty used capsule, turn the tip to the closed position and put on the nozzle cap.
    Nebulizer cleaning: To remove powder residues, wipe the tip and capsule chamber with a dry cloth or soft, clean brush.
    Children.
    Do not use formoterol in children under 6 years of age due to the lack of sufficient clinical experience in this group of patients.

    Overdose.

    Symptoms: an overdose of Zafiron can lead to phenomena characteristic of the excessive action of other β2-adrenostimulants, such as nausea, vomiting, headache, tremors, drowsiness, palpitations, tachycardia, ventricular arrhythmias, metabolic acidosis, hypokalemia, hypercardiogram, arterial hypertension.
    Treatment: Supportive and symptomatic therapy is indicated. In serious cases, hospitalization is necessary.
    The use of beta-blockers may be considered, but only with extreme caution, since the use of these agents can cause bronchospasm.
    In case of severe intoxication, the concentration of electrolytes (for example, potassium) in the blood serum and the acid-base balance should be monitored.

    Adverse reactions.

    Severe exacerbation of asthma.
    Placebo-controlled clinical trials in which formoterol was used for at least 4 weeks indicate a more frequent occurrence of severe exacerbations of asthma in patients taking formoterol (0.9% for a dose of 10-12 mcg twice a day, 1.9% in case of dose
    24 μg 2 times a day than in patients receiving placebo (0.3%), in particular in children from 6 to 12 years old.
    Experience of use in young and adult patients with asthma.
    In two large-scale controlled trials conducted over 12 weeks with the aim of registering a preparation containing formoterol on the American market, which included 1095 patients aged 12 years and older, severe asthma exacerbations (exacerbations of asthma that required hospitalization) occurred more often in in the case of taking formoterol at a dose of 24 mcg twice a day (9/271, 3.3%) than in the case of taking formoterol at a dose of 12 mcg twice a day (1/275, 0.4%), taking placebo (2/277 , 0.7%) or albuterol (2/277, 0.7%).
    In the next clinical study, which dealt with the above-mentioned observations, 2085 patients were included. Severe asthma-related side effects were compared in the higher and lower dose groups. The results obtained in this 16-week study did not reveal a clear association between the occurrence of this effect and the dose of formoterol. The percentage of patients with severe exacerbations of asthma in this study was slightly higher with formoterol than with placebo (in three groups with a double-blind method: formoterol at a dose of 24 μg twice a day (2/527, 0.4%), formoterol in a dose of 12 mcg twice a day (3/527, 0.6%) and placebo (1/514, 0.2%) and in the group with a known preparation : formoterol at a dose of 12 mcg twice a day and up to two additional doses per day (1 / 517.0.2%).
    Experience of use in children from 6 to 12 years old with asthma
    The safety of a preparation containing formoterol at a dose of 12 mcg twice a day, a preparation at a dose of 24 mcg twice a day, and placebo was compared in one large, multicenter, randomized, double-blind clinical trial conducted for 52 weeks in group 1 from 6 to 12 years ) with asthma, who need daily intake of bronchodilators and anti-inflammatory preparations. Severe exacerbations of asthma occurred more often in children who received formotreol at a dose of 24 mcg twice a day (11/171, 6.4%) or formotreol at a dose of 12 mcg twice a day (8/171, 4.7%) than in children who received placebo (0/176, 0.0%).
    The frequency of occurrence is defined as follows: very often (˃1 / 10), often (˃ 1/100, <1/10), sometimes (˃ 1/1000, <1/100), rarely (˃ 1/10000, <1 / 1000) and very rarely (<1/10000).
    Best before date.
    2 years.

    Storage conditions.

    Store in its original packaging out of the reach of children at a temperature not exceeding 25 ºС.

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