Spiolto Respimat solution for inhalation 2.5mkg + 2.5mkg / dose, 4.5ml inhaler + cartridge

The drug SPIOLTO RESPIMAT, taken once a day, is indicated for long-term maintenance therapy in patients with chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, to reduce airway obstruction and concomitant shortness of breath; reducing the frequency of exacerbations; improving exercise tolerance and quality of life.

The recommended therapeutic dose is two inhalations of the spray from the RESPIMAT inhaler (5 ?g / therapeutic dose of tiotropium bromide and 5 ?g / therapeutic dose of olodaterol) once a day, at the same time of day (see instructions for use). In elderly patients, you can use the drug SPIOLTO RESPIMAT at the recommended dose. In patients with mild to moderate hepatic impairment, SPIOLTO RESPIMAT can be used at the recommended dose. There are no data on the use of olodaterol in patients with severe hepatic impairment.

In patients with impaired renal function, you can use the drug SPIOLTO RESPIMAT at the recommended dose.

Patients with moderate and severe renal insufficiency, using the drug SPIOLTO RESPIMAT, should be under close medical supervision.

One inhalation dose contains:

Active substance: olodaterol - 0.0025 mg (respectively, olodaterol hydrochloride 0.002736 mg) and tiotropium 0.0025 mg (respectively, tiotropium bromide monohydrate 0.003124 mg)

Excipients: benzalkonium chloride solution 0.002200 mg (correspondingly benzalkonium chloride 0.001100 mg). disodium edetate 0.001100 mg. hydrochloric acid 1M to pH 2.9. purified water to 11.05 mg.

The drug SPIOLTO RESPIMAT is contraindicated in patients with hypersensitivity to olodaterol, tiotropium bromide or to any component of the drug.

The drug SPIOLTO RESPIMAT is contraindicated in patients who have previously experienced hypersensitivity to atropine or its derivatives, for example ipratropium and oxitropia.

The drug SPIOLTO RESPIMAT is not recommended for use in children under 18 years of age (due to the lack of data on efficacy and safety).

Carefully

In patients with acute-angle glaucoma, prostatic hyperplasia and bladder neck obstruction.

In patients with cardiovascular diseases, incl. coronary insufficiency, cardiac arrhythmias, lengthening of the QT interval, hypertrophic obstructive cardiomyopathy. arterial hypertension, thyrotoxicosis, convulsions. In patients with a history of such diseases as: myocardial infarction or hospitalization due to heart failure (during the previous year), life-threatening arrhythmia, paroxysmal tachycardia with a heart rate> 100.

In patients with unusual reactions to sympathomimetic amines.

Tradename:

Spiolto Respimat

International non-proprietary or group name:

olodaterol + tiotropium bromide

Dosage form:

metered dose solution for inhalation

Composition:

One inhalation dose contains:

Active substance: olodaterol - 0.0025 mg (respectively, olodaterol hydrochloride 0.002736 mg) and tiotropium 0.0025 mg (respectively, tiotropium bromide monohydrate 0.003124 mg)

Excipients: benzalkonium chloride solution 0.002200 mg (correspondingly benzalkonium chloride 0.001100 mg). disodium edetate 0.001100 mg. hydrochloric acid 1M to pH 2.9. purified water to 11.05 mg.

Description

Transparent, colorless solution.

Pharmacotherapeutic group:

Combined bronchodilator (beta2-long-acting adrenomimetic + m - anticholinergic)

ATX code: R03AL06

Pharmacological properties

Olodaterol, a long-acting beta2-adrenergic agonist, and tiotropium bromide-m-anticholinergic blocker provide complementary bronchodilation. as a result of a different mechanism of action of active substances and different localization of target receptors in the lungs. Olodaterol has a high affinity and selectivity for beta2-adrenergic receptors. Activation of beta2-adrenergic receptors in the airways leads to the stimulation of intracellular adenylate clase. which is involved in the synthesis of cyclic 3.5-adenosiimonophosphate (cAMP). An increase in cAMP levels causes bronchodilation. relaxing the smooth muscle cells of the airways. Olodaterol is a selective long-acting beta2-adrenergic receptor agonist with a rapid onset of action and long-term (at least 24 hours) preservation of the effect.

Beta2-adrenergic receptors are present not only in smooth muscle cells, but also in many other cells, including epithelial and endothelial cells of the lungs and heart. The exact function of beta2-receptors in the heart is not fully understood, but their presence indicates the possibility of effects on the heart even of highly selective beta2-adrenergic agonists.

Tiotropium bromide is a long-acting muscarinic receptor antagonist, often referred to in clinical practice as an m-holpnoblocking agent. The drug has the same affinity for the Ml - M5 subtypes of muscarinic receptors. The induction of MZ receptors in the respiratory tract results in relaxation of smooth muscles.

The bronchodilating effect is dose-dependent and persists for at least 24 hours. The significant duration of action is probably associated with a very slow dissociation of the drug from the MZ receptors; the half-dissociation period is significantly longer than that of ipratropium bromide. With the inhalation method of administration, tiotropium bromide, as an N-quaternary ammonium derivative, has a local selective effect (on the bronchi), while in therapeutic doses it does not cause systemic m-cholioblocking side effects.

Dissociation from M2 receptors occurs faster than from MZ receptors, which indicates the predominance of selectivity for the MZ subtype of receptors over M2 receptors.

High affinity for receptors and slow dissociation of the drug from the connection with receptors cause a pronounced and long-term bronchodilatory effect in patients with chronic obstructive pulmonary disease (COPD).

Bronchodilation that develops after inhalation of tiotropium bromide is primarily due to local (in the respiratory tract), and not systemic action.

In the course of clinical studies, it was found that the drug SPIOLTO RESPIMAT, used once a day, in the morning led to a rapid (within 5 minutes after the first dose) improvement in lung function. The effect of the drug SPIOLTO RESPIMAT was superior to the effect of tiotropium bromide at a dose of 5 ?g and olodaterol at a dose of 5 ?g, used as monotherapy (forced expiratory volume in 1 second (FEV1) increased when SPIOLTO RESPIMAT was taken by 0.058 L: when taking thiotropium on thiotropium l; when taking olodaterol - by 0.125 l.

When using the drug SPIOLTO RESPIMAT, compared with the use of tiotropium bromide and olodaterol as monotherapy, a more significant bronchodilating effect was achieved, and the peak volumetric expiratory flow rate in the morning and evening hours also increased.

The use of the drug SPIOLTO RESPIMAT led to a decrease in the risk of exacerbations of COPD compared with placebo.

SPIOLTO RESPIMAT significantly improved inspiratory capacity compared to tiotropium bromide, olodaterol, or placebo used as monotherapy.

SPIOLTO RESPIMAT significantly improved exercise tolerance time compared to placebo.

Pharmacokinetics

The pharmacokinetics of the combined drug SPIOLTO RESPIMAT is equivalent to the pharmacokipetics of olodaterol and tiotroppa bromide used separately. Olodaterol and tiotropium bromide have linear pharmacokinetics. A steady state of olodaterol pharmacokinetics was achieved after 8 days when applied once a day, and the degree of effect increased 1.8 times compared with a single dose. The steady state pharmacokinetics of tiotropia bromide when applied once a day was achieved after 7 days.

Suction

Olodaterol is rapidly absorbed, after inhalation of the drug, the maximum plasma concentration is usually reached within 10-20 minutes. In healthy volunteers after inhalation of the drug, the absolute bioavailability of olodaterol was about 30%. whereas the absolute bioavailability of olodaterol after oral administration of the drug in the form of a solution was below 1%. Thus, the systemic effect of olodaterol after inhalation is mainly realized by absorption in the lungs, and the contribution of the swallowed part of the dose to the systemic effect is insignificant.

After inhalation of a solution of tiotropia bromide, about 33% of the inhalation dose enters the systemic circulation. Absolute oral availability is 2-3%. The maximum plasma concentration is observed 5-7 minutes after inhalation.

Distribution

Plasma protein binding of olodaterol is approximately 60%. and the volume of distribution is 1110 liters.

The binding of tiotropium bromide to plasma proteins is 72%: the volume of distribution is 32 l / kg. Preclinical studies have shown that tiotropia bromide does not cross the blood-brain barrier.

Biotransformation

Olodaterol is largely metabolized by direct glucuronidation and O-demethylation followed by conjugation. Of the six identified metabolites, only one unconjugated demethylated derivative binds to beta2 receptors (SOM 1522). however, this metabolite is not detected in plasma after prolonged inhalation use of the drug at the recommended therapeutic dose or at doses exceeding the therapeutic dose by 4 times. Cytochrome P450 (isoenzymes CYP2C9. CYP2C8 and, to a small extent, CYP3A4) is involved in O-demethylation of olodaterol. The isoforms of uridpndiphoephatglncosyl transferase are involved in the formation of olodaterol glucuronides. UGT2B7, UGT1A1, 1A7 and 1A9.

The degree of biotransformation of tiotropium bromide is negligible. This is confirmed by the fact that after intravenous administration of tiotropium bromide to young healthy volunteers, 74% of tiotropium bromide is excreted unchanged by the kidneys. Tiotropium bromide is an ester that is cleaved into ethanol-M-methylscopine and dithienyl glycolic acid; these compounds do not bind to muscarinic receptors.

In vitro studies have shown that some of the drug (<20% of the dose after intravenous administration) is metabolized by oxidation by cytochrome P450 (CYP2D6 and ZL4), followed by conjugation with glutathone and the formation of various metabolites.

Withdrawal

The total clearance of olodaterol in healthy volunteers is 872 ml / min. and renal clearance 173 ml / min. The terminal half-life after intravenous administration of olodatsrol is 22 hours, while the terminal half-life after inhalation is approximately 45 hours. It follows that in the latter case, excretion is more dependent on absorption.

Total isotope-labeled dose of olodatsrol. excreted through the kidneys (including the parent compound and all metabolites) was 38% after intravenous administration. after oral administration 9%. The total isotope-labeled dose released through the nights of unchanged olodatsrol was 19% after intravenous administration. The total isotope-labeled dose excreted through the intestine was 53% after intravenous administration and 84% after oral administration.

More than 90% of the drug dose was eliminated after intravenous administration within 5 days and after oral administration within 6 days. 11 after inhalation use of the drug, the excretion of unchanged olodaterol by the kidneys during the dosing interval in healthy volunteers during the period of steady state pharmacokpnetics was 5-7% of the dose.

Tiotropium bromide after intravenous administration is mainly excreted by the kidneys unchanged (74%). The total clearance after intravenous administration of tiotropium bromide to young healthy volunteers is 880 ml / min. After inhalation of the solution in patients with COPD, renal excretion is 18.6% (0.93 ?g). the remaining unabsorbed part is excreted through the intestines. The renal clearance of tiotropium bromide exceeds that of creatinine. which indicates its kaialtsy secretion. The terminal half-life of tiotropium bromide after inhalation is from 27 to 45 hours.

Pharmacokinetics in elderly patients

Clinical studies have shown that, despite the effect of age, sex and body weight on the systemic effects of olodaterol, dose adjustment is not required.

In old age, there is a decrease in renal clearance of tiotropium (347 ml / min in patients with COPD under the age of 65 years and 275 ml / min in patients with COPD over 65 years of age). However, this did not lead to an increase in the AUCo-6, ss and Cmax.ss values.

Race

Comparison of pharmacokinetic data obtained in clinical studies of olodaterol. revealed a trend towards higher systemic exposure to olodaterol in patients from Japan and other patients of the Asian race compared to patients from the euro! eoid race. In clinical studies of olodaterol. used in doses that exceeded the recommended therapeutic dose by two times, no safety concerns were established in patients of the Caucasian and Asian races.

Patients with impaired renal function

In patients with severe renal failure (creatinine clearance (CC) <30 ml / min), systemic exposure to olodaterol increased by an average of 1.4 times. This increase in exposure does not raise safety concerns given the experience gained from the use of olodaterol in clinical trials.

After inhalation of tiotropium once a day during the period of steady state pharmacokpnetics in patients with COPD and mild renal failure (creatinine clearance 50-80 ml / min), there was a slight increase in AUC0-6.ss values ??by 1.8-30% and Cmax. ss compared with patients with normal renal function (creatinine clearance> 80 ml / min). Patients with COPD claim renal failure secondary to severe (creatinine clearance <50 mL / min) intravenous administration of tiotropium bromide resulted in a twofold increase in the total exposure of tiotropium bromide (AUC0-4 value increased by 82%, while the value Cmax increased by 52% ) compared with patients with normal renal function. A similar increase in plasma concentration was observed after inhalation of dry powder.

Patients with impaired liver function

In patients with mild to moderate hepatic impairment, systemic exposure to olodaterol did not change. The systemic effects of olodaterol in patients with severe hepatic impairment have not been studied.

It is assumed that hepatic failure does not significantly affect the pharmacokietics of tiotropium bromide, since tiotropium bromide is predominantly excreted by the kidneys and by non-enzymatic melting of the ether bond with the formation of derivatives that do not have pharmacological activity.

Indications

The drug SPIOLTO RESPIMAT, taken once a day, is indicated for long-term maintenance therapy in patients with chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, to reduce airway obstruction and concomitant shortness of breath; reducing the frequency of exacerbations; improving exercise tolerance and quality of life.

Contraindications

The drug SPIOLTO RESPIMAT is contraindicated in patients with hypersensitivity to olodaterol, tiotropium bromide or to any component of the drug.

The drug SPIOLTO RESPIMAT is contraindicated in patients who have previously experienced hypersensitivity to atropine or its derivatives, for example ipratropium and oxitropia.

The drug SPIOLTO RESPIMAT is not recommended for use in children under 18 years of age (due to the lack of data on efficacy and safety).

Carefully

In patients with acute-angle glaucoma, prostatic hyperplasia and bladder neck obstruction.

In patients with cardiovascular diseases, incl. coronary insufficiency, cardiac arrhythmias, lengthening of the QT interval, hypertrophic obstructive cardiomyopathy. arterial hypertension, thyrotoxicosis, convulsions. In patients with a history of such diseases as: myocardial infarction or hospitalization due to heart failure (during the previous year), life-threatening arrhythmia, paroxysmal tachycardia with a heart rate> 100.

In patients with unusual reactions to sympathomimetic amines.

Pregnancy and breastfeeding

There are no clinical data on the effect of ododagerol / tpotroppa bromide on pregnancy. In preclinical studies using high doses of olodaterol. several times higher than the therapeutic dose, the effects are typical for [32-adrenomimetics. The inhibitory effect of olodaterol on the contractility of the uterus should be taken into account. SPIOLTO RESPIMAT should not be used in pregnant women, unless the potential benefit to the mother outweighs the potential risk to the fetus.

There are no clinical data on the use of olodaterol / tiotropium bromide in women who are breastfeeding. SPIOLTO RESPIMAT should not be used in breastfeeding women, unless the potential benefit to the mother outweighs the potential risk to the baby.

For the period of use of the drug, it is necessary to stop breastfeeding the child.

Method of administration and dosage

The recommended therapeutic dose is two inhalations of the spray from the RESPIMAT inhaler (5 ?g / therapeutic dose of tiotropium bromide and 5 ?g / therapeutic dose of olodaterol) once a day, at the same time of day (see instructions for use). In elderly patients, you can use the drug SPIOLTO RESPIMAT at the recommended dose. In patients with mild to moderate hepatic impairment, SPIOLTO RESPIMAT can be used at the recommended dose. There are no data on the use of olodaterol in patients with severe hepatic impairment.

In patients with impaired renal function, you can use the drug SPIOLTO RESPIMAT at the recommended dose.

Patients with moderate and severe renal insufficiency, using the drug SPIOLTO RESPIMAT, should be under close medical supervision.

Side effect

Adverse reactions were identified on the basis of data obtained during clinical trials of the drug SPIOLTO RESPIMAT

Infections and invasions

Nasopharyngitis;

Metabolic and nutritional disorders

Dehydration:

Nervous system disorders

dizziness, insomnia:

Violations of the organ of vision

increased intraocular pressure, glaucoma: blurred vision;

Cardiovascular disorders

atrial fibrillation, palpitations, tachycardia, supraventricular tachycardia, increased blood pressure;

Respiratory, Chest and Mediastinal Disorders

cough, nosebleeds, pharyngitis, dysphonia, bronchospasm, laryngitis, sinusitis:

Gastrointestinal disorders

незначительна¤ сухость во рту, запор, кандидоз полости рта, дисфаги¤, гастроэзофагеальный рефлюкс. гингивит, глоссит, стоматит: кишечна¤ непроходимость, включа¤ паралитическую кишечную непроходимость:

Ќарушени¤ со стороны кожных покровов кожные инфекции и ¤звы на коже, сухость кожи

јллергические реакции

сыпь, зуд, ангноневротическнп отек, крапивница, гиперчувствительность включа¤ реакции немедленного типа:

 остно-мышечна¤ система и св¤занные с ней заболевани¤ соединительной ткани артралги¤, припухлость в области суставов, боль в спине*

Hapyшени¤ со стороны почек и мочевыделительной системы:

дизури¤, задержка мочи (чаше у мужчин с наличием предрасполагающих факторов), инфекци¤ мочены вод¤щих путей.

* нежелательный эффект, относ¤щейс¤ к препарату —ѕ»ќЋ“ќ –?—ѕ»ћј“, а не к его компонентам

ћногие из перечисленных нежелательных эффектов относ¤тс¤ к антихолинергичеекпм свойствам гиотрони¤ бромида или к –-адреномиметпческим свойствам олодатсрола. ѕоэтому следует принимать во внимание возможность возникновени¤ нежелательных эффектов, характерных дл¤ всего класса (3-адрепомиметпков. таких как: аритми¤, ишеми¤ миокарда, стенокарди¤, гипотепзи¤. тремор, головна¤ боль, нервозность, тошнота, мышечные спазмы, усталость, недомогание, гипокалиеми¤. гпиергликемп¤ и метаболический ацидоз.

ѕередозировка

—имптомы

ѕередозировка олодатерола может привести к выраженным эффектам, типичным дл¤ бета2-адреномиметиков, например, к ишемии миокарда, повышению или снижению артериального давлени¤, тахикардии, аритми¤м, ощущению сердцебиени¤, головокружению, нервозности, бессоннице, беспокойству, головной боли, тремору, сухости во рту, спазму мышц, тошноте, усталости, недомоганию, гпиокалиемии. гипергликемии и метаболическому ацидозу.

ѕри фименении высоких доз пютропи¤ бромида возможны про¤влени¤ м-холиноблокирующего спс ви¤. ѕосле 14-дневного ингал¤ционного применени¤ пютропи¤ бромида в дозах, достигавших 40 мкг. у здоровых лиц не наблюдалось значимых неблагопри¤тных ¤влении, кроме чувства сухости слизистых оболочек носа и ротоглотки, частота которых зависела от величины дозы (10-40 мкг в день). »сключение составл¤ло отчетливое снижение саливации, начина¤ с 7 дн¤ применени¤ препарата.

Ћечение

ѕрием препарата —ѕ»ќЋ“ќ –?—ѕ»ћј“ј должен быть прекращен. ѕоказано поддерживающее и симптоматическое лечение. ¬ т¤желых случа¤х необходима госпитализаци¤. ћожет рекомендоватьс¤ применение бета1-адреноблокаторов. но только при соблюдении особой осторожности, так как использование этих препаратов может вызвать бронхосиазм.

¬заимодействие с другими лекарственными средствами

’от¤ специальных исследовании лекарственных взаимодействий не проводилось, тиотропи¤ бромид примен¤лс¤ совместно с другими препаратами, дл¤ лечени¤ ’ќЅЋ, включа¤ метилксантины, стероиды дл¤ приема внутрь и ингал¤ционного применени¤, при этом клиш ческих признаков лекарственных взаимодействий не отмечалось.

?лительное совместное применение тиотропи¤ бромида с другими м-холиноблокирующими препаратами не изучалось. ѕоэтому долгосрочное совместное применение препарата —ѕ»ќЋ“ќ –?—ѕ»ћј“ с другими м-холиноблокирующими препаратами не рекомендуетс¤.

ќдновременное применение других адренергичееких препаратов может усиливать нежелательные эффекты препарата —ѕ»ќЋ“ќ –?—ѕ»ћј“.

ќдновременное применение ксантиновых производных, стероидов или диуретиков (не относ¤щихс¤ к группе калийсберегающих) может усиливать гипокалиемичеекий эффект адреиомиметиков.

Ѕета-адреноблокаторы могут ослабл¤ть эффект олодатерола или противодействовать этому эффекту. ¬ этом случае предпочтительно применение бета1-адрепоблокаторов, хот¤ и они должны примен¤тьс¤ с осторожностью.

»нгибиторы моноаминооксидазы, трициклическне антидепрессанты или другие препараты, способные удлин¤ть интервал QTc, могут усиливать действие —ѕ»ќЋ“ќ P?—ѕ»ћј“ј на сердечно-сосудистую систему.

—овместное применение олодатерола с кетоконазолом приводило к увеличению системного воздействи¤ олодатерола в 1.7 раза. ќднако это не вли¤ло на безопасность. »зменени¤ дозы не требуетс¤.

ќсобые указани¤

ѕрепарат —ѕ»ќЋ“ќ –?—ѕ»ћј“ не должен использоватьс¤ при бронхиальной астме. Ёффективность и безопасность препарата —ѕ»ќЋ“ќ –?—ѕ»ћј“ при бронхиальной астме не изучались

ќстрый бронхоспазм

ѕрепарат —ѕ»ќЋ“ќ PECѕ»ћј“ не показан дл¤ лечени¤ острых эпизодов бронхоспазма, то есть в качестве средства скорой помощи.

vиперчувствительность

ѕосле применени¤ препарата —ѕ»ќЋ“ќ –?—ѕ»ћј“ возможно развитие реакций гиперчувствительности немедленного типа.

ѕарадоксальный бропхоспазм

ѕрименение препарата —ѕ»ќЋ“ќ PE—ѕ»ћј“, как и других ингал¤ционных лекарственных средств, может привести к парадоксальному бронхоспазму. иногда угрожающему жизни. ¬ случае развити¤ парадоксального ороихоспазма применение препарата —ѕ»ќЋ“ќ –?—ѕ»ћј“ должно быть немедленно прекращено и назначена альтернативна¤ терапи¤.

ѕациенты с нарушени¤ми функции почек

“ак как тиотропи¤ бромид выводитс¤ преимущественно ночками, пациенты с почечной недостаточностью средней и т¤желой степени т¤жести (клиренс креатинина < 50 мл/мин) примен¤ющие препарат —ѕ»ќЋ“ќ –?—ѕ»ћј“, должны находитьс¤ под тщательным наблюдением врача.

Ќарушени¤ со стороны органа зрени¤

ѕациенты должны быть ознакомлены о правильном применении препарата —ѕ»ќЋ“ќ –?—ѕ»ћј“. Ќе следует допускать попадани¤ раствора или аэрозол¤ в глаза. Ѕоль или дискомфорт в глазах, нечеткое зрение, зрительные ореолы вокруг источников света в сочетании с покраснением глаз, вызванным отеком конъюнктивы и роговицы могут быть симптомами острой закрытоугольной глаукомы. ѕри развитии любой комбинации этих симптомов следует немедленно обратитьс¤ к специалисту. vлазные капли, обладающие миотическим действием, не считаютс¤ эффективным лечением.

—ердечно-сосудистые эффекты

ќлодатерол, как и другие бета2-адреномиметики, может оказывать клинически существенное вли¤ние на сердечно-сосудистую систему у некоторых пациентов (учащение пульса, повышение артериального давлени¤ и/или по¤вление соответствующих симптомов). ¬ случае возникновени¤ таких симптомов может потребоватьс¤ прекращение лечени¤.  роме того, сообщалось, что бета2- адреномиметики приводили к таким изменени¤м электрокардиограммы (Ё v), как уплощение зубца “ и депресси¤ сегмента ST. хот¤ клиническое значение этих изменений неизвестно.

vипокалиеми¤

Ѕета2-адреномиметики у некоторых пациентов могут приводить к развитию гипокалиемии, создающей предпосылки дл¤ возникновени¤ нежелательных вли¤нии на сердечно-сосудистую систему. —нижение концентрации кали¤ в сыворотке крови обычно кратковременно и не требует его восполнени¤. ” пациентов с т¤желой ’ќЅЋ ппюкалиемн¤ может усиливатьс¤ из-за гипоксии и сопутствующего лечени¤ и увеличивать риск развити¤ аритмии.

vипергликеми¤

»нгал¤ционное применение больших доз бета2-адреномиметиков может привести к увеличению концентрации глюкозы в плазме крови. ѕрепарат —ѕ»ќЋ“ќ –?—ѕ»ћј“ не следует примен¤ть в комбинации с каким-либо другим лекарственным препаратом, содержащим бета2-адреномиметики длительного действи¤.

ѕациентов. часто примен¤ющих ингал¤ционные бета2-адреномиметики короткого действи¤т (например, четыре раза в день), необходимо проинструктировать о том, что эти препараты используютс¤ только дл¤ облегчени¤ острых симптомов бронхоспазма.

ѕрепарат—ѕ»ќЋ“ќ –?—ѕ»ћј“ предназначен дл¤ поддерживающего лечени¤ больных ’ќЅЋ. ¬ св¤зи с тем обсто¤тельством, что в общей попул¤ции ’ќЅЋ существенно преобладают больные в возрасте старше 40 лет. при назначении препарата пациентам моложе 40 лет требуетс¤ спирометрическое подтверждение диагноза ’ќЅЋ

¬ли¤ние препарата на способность управл¤ть транспортными средствами и механизмами

Studies to study the effect on the ability to drive vehicles and mechanisms have not been conducted. Care should be taken when performing these types of activities; yyusti. since dizziness or blurred vision may develop.

Release form

Solution for inhalation dosed 2.5 mcg + 2.5 mcg / dose

RespimatЃ inhaler complete with a 4.5 ml cartridge. housed in an aluminum cylinder. Inhaler and cylinder with cartridge with instructions for use in a cardboard box.

Storage conditions

At a temperature not higher than 25 ? C. Keep out of the reach of children!

Term of one

3 years

Use within 3 months after the first inhalation.

Do not use after the expiration date printed on the package.

Conditions of dispensing from pharmacies

Prescribed by a doctor.