Duacler Genuine (Duacler Genuine)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspPowder for inhalation dosed.
Composition:One metered dose contains:
Active substances: aklidinium bromide micronized (calculated for aclidinium) 0.400 mg (0.343 mg) * and formoterol fumarate dihydrate micronized 0.012 mg **. Excipient: lactose monohydrate 1 1.588 mg.
* The delivered dose of aclidinium bromide is 396 μg, which corresponds to 340 μg of validity. ** Delivered dose of formoterol fumarate dihydrate - 11.8 μg.
Description:Inhaler: The inhaler is white with an orange protective cap, with an orange metering button and a fixed sliding cover with a cartridge containing 60 doses of the drug and a dose counter.
Contents of the cartridge: A white or almost white, finely dispersed, free flowing powder that does not contain visible conglomerates or foreign particles.
Pharmacotherapeutic group:Bronchodilator combined (β2-adrenomimetic selective + m-holinoblokator)
ATX: & nbsp
  • Formoterol and aclidinium bromide
    • Pharmacodynamics:Mechanism of action
    The drug Duacryl Genuary contains two bronchodilators: aclidinium. antagonist long-acting muscarinic receptors (also called anticholinergic), and formoterol, a long acting agonist β2 -adrenergic receptors.The combination of these substances with different mechanisms of action provides an additive effect compared with the use of individual components. Due to the difference in the density of muscarinic and β2adrenoreceptors in the central and peripheral airways, muscarinic receptor antagonists are more effective in relaxing the central airways, and agonists β2-adrenergic receptors - peripheral respiratory tract; Thus, the use of combination therapy can enhance the beneficial effect on lung function.
    Aklidinium is a competitive, selective antagonist of muscarinic receptors with a longer binding time to M3 receptors than cM2 receptors. M3-receptors serve as mediators for contracting the smooth muscles of the respiratory tract. Inhalation aklidinium bromide acts locally in the lungs as an antagonist of M3receptors of the smooth muscles of the respiratory tract and causes bronchodilation. The use of akladinia in patients with chronic obstructive pulmonary disease (COPD) also causes a decrease in the severity of symptoms, the improvement of the health-related health condition,reducing the frequency of exacerbations and improving the tolerance of exercise. Because the aklidinium bromide rapidly destroyed in blood plasma, the amount of systemic anticholinergic side effects is low.
    Formoterol is a potent selective agonist β2adrenoreceptors. Bronchodilation is achieved by relaxing the smooth muscles of the respiratory tract due to increased levels of cyclic adenosine monophosphate after activation of adenylate cyclase. In addition to improving lung function, formoterol reduces the severity of symptoms and improves the quality of life in patients with COPD.
    Clinical studies have shown that Duacler Genuine provides a clinically significant improvement in lung function (estimated by volume of forced expiration in 1 second (OFB1)) for more than 12 hours after admission.
    Duacryl Genuine has a quick onset of action - within 5 minutes after the first inhalation compared to placebo. The onset of the action of Duacler Genuine was comparable to the effect of the rapid agonist pz-adrenergic receptors. formoterol, in a dose of 12 mcg. Maximum bronchodilation (maximum OFB1) compared with the baseline level was achieved from the first day (304 ml) and was maintained during the entire period of therapy lasting more than 6 months (326 ml).
    Electrophysiology of the heart
    There was no clinically significant effect of Duacler Genuine on the parameters of the electrocardiogram (ECG), including the QT interval, compared with obdiny, formoterol and placebo, as well as the heart rate during daily monitoring by Holter.
    Clinical efficacy
    A Phase III clinical study program involving approximately 4,000 patients with a clinical diagnosis of moderate to severe COPD included two 6-month randomized trials with placebo and active control (ACLIFORM-COPD and AUGMENT), a 6-month extended phase of the AUGMENT study, and an additional 12 -month randomized, controlled trial.
    In long-term safety studies, Duacler Genuine showed consistent efficacy with a duration of application of more than 1 year, without signs of hahifilaxia.
    Effect on lung function
    Duacler Genuine (340 μg + 11.8 μg / dose twice a day) provided a clinically significant improvement in lung function (assessed by OFB1 forced life capacity of lungs and inspiratory capacity) compared with placebo.Clinically significant bronchodilator effect was achieved within 5 minutes after taking the first dose of the drug and was maintained throughout the inter-dose interval.
    In the ACLIFORM-COPD study, Duacler Genuine provides an improvement OFB1 1 hour after taking the dose compared with placebo and aclidinium, by 299 mL and 125 mL, respectively (p <0.0001 in both comparisons), and an improvement in the residual OFB1 compared with placebo and formoterol, 143 ml and 85 ml. respectively (p <0.0001 in both comparisons). The AUGMENT study improved OFB1 1 hour after taking the dose compared with placebo and aclidinium, were 284 ml and 108 ml, respectively (p <0.0001 in both comparisons), and an improvement in the residual OFB1 compared with placebo and formoterol, was 130 ml (p <0.0001) and 45 ml (p = 0.01), respectively.
    Relieving symptoms and improving health due to illness
    Shortness of breath and other symptoms
    The Duacler Genuine drug provided a clinically significant improvement in dyspnea (assessed by the transient dyspnea index (TDI)), with an increase
    TDI index after 6 months of therapy compared with placebo by 1.29 units in the ACLIFORM-COPD study (p <0.0001) and by 1.44 units in the AUGMENT study (p <0.0001).
    A combined analysis of these two studies showed that the use of Duaclir Genuine is associated with a statistically significant improvement in the TDI index compared with akledinii (by 0.4 units, p = 0.016) or formoterol (by 0.5 units: p = 0.009).
    Duacler Genuine improved the daily symptoms of COPD. particularly shortness of breath, chest symptoms, coughing and sputum separation (estimated using the general E-RS index), and the overall severity of nocturnal symptoms, early morning symptoms and symptoms limiting activity in the early morning hours compared with placebo, acupuncture and formoterol, but this improvement was not always statistically significant. The combination of aclidinia / formoterol did not show a statistically significant decrease in the average number of nocturnal awakenings due to COPD, compared with placebo or formoterol.
    Quality of life due to health
    In the AUGMENT study, Duacler Genuine provided a statistically significant improvement in the health status associated with the disease (assessed using the St. George's Respiratory Response System (SGRQ)), with an improvement in the overall SGRQ index by 4.35 units compared with placebo (p <0.0001 ).In the ACLIFORM-COPD study, there was only a slight decrease in the overall SGRQ index compared with placebo due to an unexpected response to placebo (p = 0.598), and the percentage of patients achieving clinically significant improvement from baseline was 55.3% in the duacryl group Januir and 53.2% in the placebo group (p = 0.669).
    The combined analysis of the data from these two studies showed a greater improvement in the overall SGRQ index with Duacler Genuer compared with formoterol (-1.7 units, p = 0.018) or by akolidinium (-0.79 units, p = 0.273).
    Reduction in the frequency of exacerbation of COPD
    In a combined analysis of the efficacy of two 6-month studies, a statistically significant 29% decrease in the incidence of moderate or severe exacerbations (requiring antibiotic or corticosteroid therapy or leading to hospitalization) was observed with Duaclear Genuine compared with placebo (frequency per patient per year: 0.29 vs. 0.42, respectively, p = 0.036), as well as an increase in time to the first exacerbation of moderate or severe exacerbation compared with placebo (hazard ratio 0.70; = 0.027).
    Use of emergency medicine
    Duacler Genuine reduced the need for an emergency medicine for more than 6 months compared with placebo (by 0.9 inhalations / day (p <0.0001)), by accidence (0.4 inhalations / day (p <0.001)) and formoterol (by 0.2 inhalations / day (p = 0.062)).
    Pharmacokinetics:The pharmacokinetics of aclidinium and formoterol for inhalation in combination did not differ significantly from those observed with the use of individual components.
    Absorption
    After a single inhalation of Duacler Genuer, aclidinium and formoterol quickly absorbed into blood plasma with a maximum concentration within 5 minutes after inhalation in healthy volunteers and within 24 minutes after inhalation in patients with COPD. The maximum equilibrium concentrations of aclidinium and formoterol in patients with COPD who received Duacler Genuer twice daily for 5 days were reached within 5 minutes after the inhalation and were 128 pg / ml and 17 pg / ml, respectively.
    Distribution
    The total number of injected into the lungs through the injector of Genuine Accidence was approximately 30% of the metered dose. The binding of aclidinium to plasma proteins in vitro most likely corresponds to the binding of metabolites to proteins, due to the rapid hydrolysis of aclidinium in the blood plasma.Binding to plasma proteins was 87% for the metabolite of the carboxylic acid and 15% for the alcohol metabolite. The main protein of blood plasma, which binds aclidinium. is atbumine.
    The binding of formoterol to plasma proteins is 61% -64% (34%, mainly albumin). There was no saturation of the binding sites in the concentration range achieved when the drug was administered in therapeutic doses.
    Biotransformation
    Aklidinium is rapidly and intensively hydrolyzed to a pharmacologically inactive alcohol derivative and a carboxylic acid derivative. There is a chemical (non-enzymatic) and enzymatic hydrolysis under the action of esterases. The main esterase involved in hydrolysis in humans is butyrylcholinesterase. The concentration of the acid metabolite in the blood plasma after inhalation is approximately 100 times higher than the concentration of the alcohol metabolite and the unchanged active substance.
    Low absolute bioavailability of aclidinium in case of inhalation (<5%) is due to its intensive systemic and presystemic hydrolysis both in the lungs and in oral administration.Biotransformation with the participation of cytochrome P450 isoenzymes (CYP450) plays an insignificant role in the overall metabolic clearance of aclidinium. In vitro studies have shown that aclodynia at a therapeutic dose or its metabolites do not inhibit or induce any isoenzymes of CYP450 and do not inhibit esterases (carboxyl esterase, acetylcholinesterase and butyrylcholinesterase). It has also been established in vitro that aclidinium or its metabolites are not substrates or inhibitors of P-glycoprotein.
    Formoterol is excreted mainly through metabolism. The main route is direct glucuronization with O-demethylation followed by conjugation with glucuronide. In the O-demethylation of formoterol, the isozymes CYP2D6, CYP2C19, CYP2C9 and CYP2A6 are involved. In therapeutically significant concentrations formoterol does not inhibit the CYP450 isoenzymes.
    Excretion
    After inhalation of Duacler Genuine 340 μg + 11.8 μg / dose, the final half-life of aclidinium and formoterol is approximately 5 hours and 8 hours, respectively.
    After intravenous administration of 400 μg of radionuclide-labeled aclidinium to healthy volunteers, about 1% of the administered dose was excreted unchanged in urine.Up to 65% of the dose was excreted in the form of metabolites with urine and up to 33% in the form of metabolites with feces. After inhalation of 200 μg and 400 μg of aclidinium in healthy volunteers and patients with COPD, excretion of unchanged aclidinia in the urine was very low (approximately 0.1% of the administered dose), which indicates that renal clearance plays an insignificant role in the overall clearance of aclidinium from blood plasma .
    The bulk of the administered dose of formoterol was metabolized in the liver, followed by excretion by the kidneys. After inhalation, 6% to 9% of the delivered dose of formoterol is excreted unchanged in the urine or in the form of conjugates of formoterol.
    Special populations of patients
    Elderly patients
    Studies of the pharmacokinetics of the combination of aclidinia / formoterol in elderly patients have not been conducted. Because elderly patients do not need to adjust the dose of drugs of aclidinium or formoterol, adjusting the dosage is also not necessary when using the combination of aclidinia / formoterol.
    Patients with impaired renal and hepatic function
    Data on the features of the combination of aclidinia / formoterol in patients with impaired renal or hepatic function are absent.Since patients with impaired renal or hepatic function do not require a dose adjustment of the medication or formoterol, adjusting the dosage is also not necessary when using the combination of aclidinia / formoterol.
    Indications:Duacler Genuine is indicated as a supporting bronchodilator therapy to alleviate the symptoms of chronic obstructive pulmonary disease in adults.
    Contraindications:- Hypersensitivity to aclidinium bromide, formoterol or lactose.
    - Children under 18 years of age (efficacy and safety not established).
    - Galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
    Carefully:Myocardial infarction suffered during the previous 6 months, unstable angina, first-time arrhythmia during the previous 3 months, hospitalization for the previous 12 months for heart failure of III and IV NYHA functional classes or other severe cardiovascular diseases, QTc interval (by the method of Bazetta)> 470 ms, concomitant therapy with drugs prolonging the QTc interval, convulsive disorders.thyrotoxicosis, pheochromocytoma, symptomatic prostatic hyperplasia, urinary retention, angle-closure glaucoma, hypokalemia.
    Pregnancy and lactation:Pregnancy
    There are no data on the use of Duacler Genuer in pregnant women.
    In animal studies, fetotoxicity was noted only at doses far exceeding the maximum dose of aclidinium in humans, and undesirable effects in studies of reproductive toxicity only at very high system exposures of formoterol.
    During pregnancy, Duaclin Genuine should only be used when the expected benefit exceeds potential risks.
    Breastfeeding period
    It is not known whether aclidinium (and / or its metabolites) is secreted or formoterol with breast milk. Because preclinical studies have shown that small amounts of ascidinium (and / or its metabolites) and formoterol permeate milk, during breastfeeding, Duacler Genuine should be used only when the expected benefit for a woman exceeds the potential risk to the baby.
    Fertility
    Preclinical studies revealed a slight decrease in fertility only when administered at doses significantly exceeding the maximum dose of acodinium and formoterol in humans. It is unlikely that the use of Duacler Genuer at the recommended dose will affect fertility in humans.
    Dosing and Administration:For inhalation use.
    The recommended dose is one inhalation of the drug Duacler Genuine 340 μg +11.8 μg / dose 2 times a day.
    In case of missed dose, the missed dose should be taken as soon as possible and the next dose taken at the usual time. Do not take a double dose in order to compensate for missed.
    Elderly patients
    Correction of the dose of the drug in elderly patients is not required (see the section "Pharmacokinetics").
    Impaired renal function
    Correction of the dose of the drug in patients with impaired renal function is not required (see the section "Pharmacokinetics").
    Impaired liver function
    Correction of the dose of the drug in patients with impaired liver function is not required (see the section "Pharmacokinetics").
    Children
    Duacryl Genuine is not suitable for use in children and adolescents under the age of 18 years with COPD.
    Mode of application
    Patients should be trained in the principles of proper application of the drug.
    Instructions for proper use of Duacler Genuine
    Before the first use, open the sealed bag in the direction of the arrows, remove the Januarter nebulizer and familiarize yourself with its components. Pack and sachet with desiccant are recyclable.

    Read the instructions carefully before using the Januire nebulizer.
    How to use Duaclear Genuine
    General information
    To use the Januire nebulizer after removing the cap, you need to do 2 steps:
    Step 1: Press and RELEASE orange button and exhale completely, but not in the inhaler.
    Step 2: Tightly grasp the mouthpiece and STRONG and DEEP inhale through an inhaler.
    After inhalation, do not forget to put on the protective cap.
    Start application
    - When you are about to take a dose of the drug, remove the protective cap, lightly squeezing the arrows on each side and pulling the cap outward (see Figure 1).

    - Make sure that the mouthpiece does not block anything.
    - Keep the inhaler in Geneva horizontally mouthpiece towards you, with an orange button facing straight up (see Figure 2).

    STEP 1: CLICK orange button to the full depth and then RELEASE her (see Figures 3 and 4).
    DO NOT KEEP THE ORANGE BUTTON PRESSED.

    Stop and check: make sure the dose is ready for inhalation
    - Make sure that the color control window turns green (see Figure 5).
    - The green color of the control window confirms that the drug is ready for inhalation.

    IF THE WINDOW OF COLOR CONTROL REMAINS RED, CLICK AND RELEASE THE ORANGE BUTTON MORE TIMES (SEE STEP 1).
    - Before you bring the inhaler to your mouth, exhale completely. Do not exhale into the inhaler.
    STEP 2:
    - Tightly grasp the mouthpiece of the inhaler Jenwair and STRONG and DEEP inhale through the mouthpiece (see Figure 6).
    -This strong, deep breath delivers the drug through the inhaler into the lungs.

    - During inspiration you will hear "CLICK", indicating the proper use of the Januire nebulizer.
    - In order to take the whole dose, continue to inhale even after you have heard "CLICK" inhaler.
    - Take the Jaguar inhaler out of your mouth and hold your breath for so long that it feels comfortable, then exhale slowly through your nose.
    Note. Some patients, depending on individual characteristics, can feel a slight sweetish or bitter taste when inhaled. Do not take an extra dose if you do not feel any taste after inhalation.
    Stop and check: make sure you have properly inhaled
    - Make sure that the control window has become red (see Figure 7). This is confirmed by the fact that you performed the full dose inhalation correctly.
    The inhalation was carried out correctly.

    IF THE WINDOW OF THE COLOR CONTROL IS REMAINING GREEN, YOU NEED TO EVERYTHING UP AND DEEP INTO THE MUNDSTOCK (SEE STEP 2).
    - If the control window still does not change color to red, then perhaps you forgot to release the orange button before inhaling or could not breathe in properly. If so, try again.
    Make sure that you HAVE RELEASED orange button, and STRONG a deep breath through the mouthpiece.
    Note. If after several attempts you did not manage to properly administer the inhalation, contact your doctor.
    - As soon as the control window turns red, put the protective cap on the mouthpiece (see figure 8).

    When do you need a new Genuarter inhaler?
    - The Januera Inhaler is equipped with a dose indicator that shows how many doses are left in the inhaler. The dose indicator slowly falls, reflecting intervals of 10 (60, 50, 40, 30, 20, 10, 0) (see Figure A). Each Genuarter inhaler contains at least 60 doses of the drug.
    When the indicator doses tape with red stripes appear (see. Figure A), it means that the drug is finished and must purchase a new inhaler Dzhenueyr.

    Note. If your Januarter inhaler is damaged or the cap is lost, you need to replace the inhaler. The genewoman does not need to be cleaned. However, if necessary, this should be done with a dry cloth or paper napkin on the outside of the mouthpiece.
    NEVER use water to clean the Januar nebulizer, as this can damage the drug.
    How do you know that your Januarine inhaler is empty?
    - When the figure 0 (zero) appears in the middle of the dose indicator, all doses remaining in the inhaler should be continued.
    - When the last dose, the orange button is not fully return to its upper position, and will remain locked in the center position (see Figure B). It will be prepared for inhalation.

    Even when the orange button is locked.You, however, will be able to take the last dose. After that, the Januarter nebulizer can not be used again, and you will need to start using the new Januarter nebulizer.
    Side effects:The following safety information is based on the experience of Duacler Genuine (in the recommended therapeutic dose up to 12 months) and its individual components.
    Security Profile Overview
    The undesirable reactions associated with the use of Duaclear Genuine are similar to those observed with the use of its individual components. Because Duacler Genuine contains aclidinium and formoterol, then against the background of its application can expect the undesirable reactions described for these components.
    The most frequently observed undesirable reactions with Duacler Genuer were nasopharyngitis (7.9%) and headache (6.8%).
    List of unwanted reactions in the form of a table
    The frequency of adverse reactions is based on an estimate of the overall reaction rates observed with the use of the drug Duacler Genuine 340 μg + 11.8 μg / dose as part of a pooled analysis of randomized, placebo-controlled Phase III clinical trials lasting at least 6 months.
    The frequency of unwanted reactions is presented using the following notation: very often (≥ 1/10); often (≥ 1/100 to <1/10); infrequently (≥ 1/1000 to <1/100); rarely (≥ 1/10000 to <1/1000); very rarely (<1/10000) and frequency, unspecified (can not be estimated from available data).

    Class of organ system

    The term preferred use

    Frequency

    Infectious and parasitic diseases

    Nasopharyngitis3

    Urinary tract infection1

    Sinusitis2

    Tooth abscess1

    Often

    Immune system disorders

    Hypersensitivity4

    Rarely

    Angioedema4

    Anaphylactic reaction4

    Unspecified

    frequencies

    Disorders from the metabolism and nutrition

    Hypokalemia3

    Infrequently

    Hyperglycaemia3

    Infrequently

    Disorders of the psyche

    Insomnia2

    Anxiety2

    Often

    Excitation3

    Infrequently

    Disturbances from the nervous system

    Headache3

    Dizziness3 Tremor2

    Often

    Disturbance of taste3

    Infrequently

    Disturbances on the part of the organ of sight

    Blurred vision2

    Infrequently

    Heart Disease

    Tachycardia2

    Interval lengthening QTc on the ECG2 Heart palpitations3

    Infrequently

    Angina pectoris4

    Unspecified

    frequencies

    Disturbances from the respiratory system, chest and mediastinal organs

    Cough3

    Often

    Dysphonia2 Throat irritation3

    Infrequently

    Bronchospasm, including paradoxical4

    Rarely

    Disorders from the gastrointestinal tract

    Diarrhea3Nausea3 Dry mouth2

    Often

    Stomatitis3

    Infrequently

    Disturbances from the skin and subcutaneous tissues

    Rash3

    Itchy skin3

    Infrequently

    Disturbances from musculoskeletal and connective tissue

    Myalgia2

    Muscle spasms2

    Often

    Disorders from the kidneys and urinary tract

    Retention of urine3

    Infrequently

    General disorders and disorders at the site of administration

    Peripheral edema3

    Often

    Laboratory and instrumental data

    Increased activity of creatine phosphokinase in the blood1

    Often

    Increased blood pressure3

    Infrequently

    1 Undesirable reactions observed with the use of Duacler Genuine, but not specified in the instructions for its individual components.

    2Undesirable reactions observed with the use of Duacler Genuine. and specified in the instruction of at least one of its individual components.

    3Undesirable reactions indicated in the instruction of at least one of the individual components, but with the use of the drug Duacler Genuine 340 μg + 11.8 mcg / dose observed with a lower or comparable frequency than with placebo.

    4Undesirable reactions indicated in the instruction of at least one of the individual components, but not observed with the use of the drug Duacler Genuine 340 μg + 11.8 μg / dose; the frequency category of development is indicated in accordance with the "Side-effect" section of the instruction for individual components.

    Overdose:The experience of treatment of an overdose of Duacryl Genuine is limited. High doses of Duacler Genuine can lead to an increase in the symptoms and manifestations of anticholinergic and / or β2-adrenergic action; the most frequent of which are: blurred vision, dry mouth, nausea, muscle spasm, tremor, headache, palpitations and hypertension.
    In case of an overdose, discontinue the use of Duaclear Genuine. Supportive and symptomatic therapy is indicated.
    Interaction:Medicines for COPD treatment
    The combined use of Duaclir Genuire with other anticholinergics and / or agonists β2-adrenergic long-acting receptors has not been studied and is not recommended.
    Although no formal studies of the drug interactions of Duacler Genuine were performed in vivo, it was used concomitantly with other drugs for COPD therapy, including β-agonists2-adrenergic short-acting receptors, methylxanthines, as well as oral and inhaled glucocorticosteroids, without clinical signs of drug interaction.
    Metabolic interactions
    In vitro studies, it has been established that the interaction of aclidinium in a therapeutic dose or its metabolites with substrates of P-glycoprotein (P-gp) and drugs metabolized by cytochrome P450 isoenzymes (CYP450) and esterases is not expected. In therapeutically significant concentrations formoterol does not inhibit CYP450 isoenzymes (see section "Pharmacokinetics").
    Drugs that cause hypokalemia
    Concomitant use of methylxanthine derivatives, steroids or potassium-sparing diuretics may enhance the possible hypokatemic effect of agonists β2adrenoreceptors. therefore, use caution when combined with these preparations (see section "Special instructions").
    Blockers of β-adrenergic receptors
    Blockers of β-adrenergic receptors can weaken or level out the effect of agonists β2-adrenergic receptors. If it is necessary to use blockers of β-adrenergic receptors (including in the form of eye drops), the appointment of cardioselective β-adrenergic receptor blockers is preferable, although they should be used with caution.
    Other pharmacodynamic interactions
    Caution should be exercised in the preparation of Duacler Genuine in patients receiving QTc-prolonging drugs such as monoamine oxidase inhibitors, tricyclic antidepressants, antihistamines or macrolides, as they can potentiate the effect of formoterol on the cardiovascular system. Drugs that extend the QTc interval increase the risk of ventricular arrhythmia.
    Special instructions:Bronchial asthma
    The drug Duacler Genuine should not be used for bronchial asthma; clinical studies of the drug Duacler Genuer in bronchial asthma have not been conducted.
    Paradoxical bronchospasm
    In clinical studies, no cases of paradoxical bronchospasm have been observed in the recommended dose of Duaclin Genuera. However, paradoxical bronchospasm was observed in the course of another inhalation therapy. If it occurs, discontinue the use of the drug and consider the possibility of alternative therapy.
    The drug is not intended for relief of acute attacks
    Duacryl Genuine is not indicated for the treatment of acute attacks of bronchoconstriction.
    Influence on the cardiovascular system
    Duacler Genuine should be used with caution in patients who underwent myocardial infarction during the previous 6 months in patients with unstable angina first diagnosed with arrhythmia during the previous 3 months with a QTc interval (calculated by the Basett method)> 470 ms or hospitalized for previous 12 months for heart failure of III and IV functional classes according to the NYHA classification. Because these patients were not included in the clinical studies.
    In individual patients, β-agonists2-adrenoceptors can cause an increase in heart rate and blood pressure, changes in the ECG in the form of flattening of the T wave, depression of the ST segment and prolongation of the QTc interval. If these effects develop, early termination of therapy may be required. The β agonists2long-acting adrenoceptors should be used with caution in patients with a prolonged QTc interval, either currently or in the past, or receiving medications that affect the duration of the QTc interval (see "Interactions with Other Drugs and Other Drug Interactions").
    System Effects
    Duacryl Genuine should be used with caution in patients with severe cardiovascular disorders, convulsive disorders, thyrotoxicosis, and pheochromocytoma.
    When high doses of agonists are used, β2-adrenoceptors may develop metabolic effects in the form of hyperglycemia and hypokalemia. In clinical trials of Phase III, the frequency of a significant increase in blood glucose concentration with the use of Duacler Genuine was low (0.1%) and similar to the placebo group.Hypokalemia is usually transient and does not require additional therapy. In patients with severe COPD, hypokalemia may be potentiated by hypoxia and concomitant therapy (see "Interaction with Other Drugs and Other Drug Interactions"). Hypokalemia may increase the risk of arrhythmia.
    Due to anticholinergic activity, Duacler Genuine should be used with caution in symptomatic prostatic hyperplasia, urinary retention, or angle-closure glaucoma (although direct contact with the eye is very unlikely). Dry mouth, marked against the background of anticholinergic therapy, while retaining for a long time can lead to tooth decay.
    Effect on the ability to drive transp. cf. and fur:The preparation of Duacryl Genuine does not, or to a minor extent, influence the ability to drive vehicles and mechanisms. The development of blurred vision or dizziness can affect the ability to drive vehicles or work with mechanisms.
    Form release / dosage:Powder for inhalation dosed, 340 mcg + 11.8 mcg / dose.
    Packaging:For 60 doses of powder for inhalation in the inhaler.
    1 inhaler in a package of laminated aluminum foil, containing a sachet bag with desiccant. For 1 package with instructions for use in a cardboard box with the control of the first opening.
    Storage conditions:At a temperature of no higher than 30 ° C.
    Keep out of the reach of children.
    Shelf life:2 years.
    After the first opening of the package - 60 days.
    Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-003844
    Date of registration:19.09.2016
    Expiration Date:19.09.2021
    The owner of the registration certificate:AstraZeneca UK LtdAstraZeneca UK Ltd United Kingdom
    Manufacturer: & nbsp
    Representation: & nbspAstraZeneca Pharmaceuticals Ltd.AstraZeneca Pharmaceuticals Ltd.
    Information update date: & nbsp2016-10-11
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