Universal reference book for medicines
Product name: RELVAR ELLIPTA В® (RELVAR ELLIPTA В® )

Active substance: fluticasone furoate, vilanterol

Type: Anti-inflammatory and bronchodilator drug

Manufacturer: GlaxoSmithKline Trading (Russia) manufactured by Glaxo Operations UK (UK)
Composition, form of production and packaging
Powder for inhalation dosed
22 mcg + 92 mcg / dose of white.

Strip with Vilenterol (30 cells)

1 dose *

vilantherol triphenate micronized 40 mcg,

in t.ch.
nominal amount of vilaterol 25 Ојg **
that corresponds to the delivered dose of vilaterherol 22 mcg

[PRING] magnesium stearate - 125 mg, lactose monohydrate - up to 12.5 mg.

Strip with fluticasone furoate (30 cells)

1 dose *

fluticasone furoate micronized 100 Ојg **,

which corresponds to the delivered dose of fluticasone furoate of 92 Ојg

[PRING] lactose monohydrate - up to 12.5 mg.

30 doses - plastic inhalators with a counter of doses (1) with two aluminum laminated strips (each of 30 cells) - multi-layer containers of aluminum foil (1) - packs of cardboard.

Powder for inhalation dosed with 22 Ојg + 184 Ојg / dose of white.

Strip with Vilenterol (30 cells)

1 dose *

vilantherol triphenate micronized 40 mcg,

in t.ch.
nominal amount of vilaterol 25 Ојg **
that corresponds to the delivered dose of vilaterherol 22 mcg

[PRING] magnesium stearate - 125 mg, lactose monohydrate - up to 12.5 mg.

Strip with fluticasone furoate (30 cells)

1 dose *

fluticasone furoate micronized 200 Ојg **,

which corresponds to the delivered dose of fluticasone furoate 184 Ојg

[PRING] lactose monohydrate - up to 12.5 mg.

30 doses - plastic inhalators with a counter of doses (1) with two aluminum laminated strips (each of 30 cells) - multi-layer containers of aluminum foil (1) - packs of cardboard.

* In the production of a ready-made preparation, mixtures of active ingredients and auxiliary substances can be incorporated into the final product with an excess of up to 8% to compensate for losses during filling of the cells.

** The nominal amount of active substance laid down in the production process is indicated.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2017.

PHARMACHOLOGIC EFFECT

Mechanism of action

Vilantherol and fluticasone furoate belong to two different classes of drugs: a synthetic glucocorticoid and a selective beta 2 -adrenomimetic long-acting.

Pharmacodynamic effects

Vilanterola triphenate belongs to the class of selective beta 2 -adrenomimetics long-acting (DDBA).

The pharmacological effects of beta 2 -adrenoceptor agonists, including vilaterol triphenate, are at least partially associated with stimulation of intracellular adenylate cyclase, an enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic 3 ', 5'-adenosine monophosphate (cyclic AMP).
An increase in the level of cyclic AMP results in relaxation of the smooth muscles of the bronchi and inhibition of the release of mediators of immediate-type hypersensitivity reactions from cells (primarily from mast cells).
Fluticasone furoate is a synthetic trifluoride glucocorticoid with a pronounced anti-inflammatory effect.
The exact mechanism of action, which allows to stop the symptoms of bronchial asthma and chronic obstructive pulmonary disease (COPD), is not known. Glucocorticoids have demonstrated a wide range of effects on various cell types (eg, eosinophils, macrophages, lymphocytes) and mediators (eg, cytokines and chemokines involved in inflammation).
Between glucocorticoids and DDBA molecular interactions occur, as a result of which steroid hormones activate the beta 2- adrenoreceptor gene, increasing the number of susceptible adrenoreceptors.
DDBA binds to the glucocorticoid receptor, ensuring its steroid-dependent activation and stimulating translocation into the nucleus of the cell. These synergistic interactions lead to an increase in anti-inflammatory activity, which was demonstrated in experiments in vitro and in vivo with various inflammation cells involved in the pathophysiological processes of development of bronchial asthma and COPD. The results of clinical studies using airway biopsy specimens also demonstrated the synergy of glucocorticoids and DDBA arising from the administration of these drugs to patients with COPD at therapeutic doses.
PHARMACOKINETICS

Suction

The absolute bioavailability of vilantherol and fluticasone furoate in the inhalation administration of a combination of vilantherol and fluticasone furoate averaged 27.3% and 15.2%, respectively.
The oral bioavailability of vilantherol and fluticasone furoate was low, and averaged <2% and 1.26%, respectively. Taking into account the low oral bioavailability, the systemic action of vilantherol and fluticasone furoate after inhalation is primarily due to the absorption of part of the inhalation dose that has entered the lungs.
Distribution

After intravenous administration of vilantherol and fluticasone furoate are actively distributed in the body, while the average volume of distribution in the equilibrium state is 165 liters and 661 liters, respectively.

Both substances - vilantherol and fluticasone furoate - have a low ability to bind to erythrocytes.
In in vitro studies, the binding of viluterol and fluticasone furoate to human plasma proteins was high and averaged 93.9% and> 99.6%, respectively. The degree of binding to plasma proteins in vitro did not decrease in patients with impaired liver or kidney function.
Although vilaterol and fluticasone furoate are substrates of P-glycoprotein (P-gp), with the simultaneous administration of a combination of vilantherol and fluticasone furoate with P-gp inhibitors, a change in the systemic exposure of vilantherol or fluticasone furoate is unlikely.
both substances have a good absorption capacity.
Metabolism

On the basis of in vitro experiments, it can be concluded that the main ways of metabolism of vilantherol and fluticasone furoate in the human body are primarily mediated by the CYP3A4 isoenzyme of the cytochrome P450 system.

Vilantherol is predominantly metabolized by O-dealkylation to form a number of metabolites that have significantly lower beta 1 - and beta 2 -adrenomimetic activity.

Fluticasone furoate is predominantly metabolized by hydrolysis of the S-fluoromethylcarbothioate group with the formation of metabolites having significantly lower glucocorticoid activity.

A clinical study of drug interactions with a cytochrome CYP3A4 isoenzyme with the continuous administration of a combination of vilantherol and fluticasone furoate (22 Ојg + 184 Ојg / dose) and a potent inhibitor of the cytochrome cYCH3A4 isoenzyme inhibitor ketoconazole (400 mg) was performed on the example of healthy volunteers.
The combination of vilantherol and fluticasone furoate led to an increase in mean AUC (0-24) and mean C max of fluticasone furoate by 36% and 33%, respectively. An increase in the exposure of fluticasone furoate was associated with a decrease in the mean serum cortisol concentration by 27%. measured over a period of 0-24 hours.
The combination of vilantherol and fluticasone furoate and ketoconazole resulted in an increase in the mean values ​​of AUC (0-t) and C max of vilaterherol by 65% ​​and 22%, respectively.
An increase in the exposure of vilantherol did not lead to an increase in the systemic effects characteristic of beta-agonists in relation to heart rate, potassium content in the blood, or the QT interval (QTcF).
Excretion

After oral administration fluticasone furoate in the human body was metabolized, mainly with the formation of metabolites, which were mainly excreted through the gastrointestinal tract, except for a dose of radioactive material <1%, excreted in urine.
T 1/2 from plasma fluticasone furoate after inhalation of the drug was an average of 24 h.
After oral administration, vilantherol in the human body was mainly metabolized to form metabolites that were excreted in urine and feces, at a ratio of approximately 70% and 30% of the dose of the radioactive substance, respectively.
T 1/2 from the plasma of vilantherol after inhalation of the combination of vilantherol and fluticasone furoate averaged 2.5 hours.
Special patient groups

During the third phase of clinical trials, a population meta-analysis of the pharmacokinetics of vilantherol and fluticasone furoate in patients with bronchial asthma and COPD was conducted.
Within the framework of population pharmacokinetic analysis, the effect of demographic covariates (age, sex, weight, BMI, race and ethnicity) on the pharmacokinetics of vilaterol and fluticasone furoate was evaluated.
Race

Patients with bronchial asthma and COPD of East Asian, Japanese and Southeast Asian origin (12-14% of patients) had on average higher AUC (0-24) values ​​(no more than 53% higher) compared to Caucasoid patients.
Nevertheless, in these populations, no signs of a higher systemic exposure were associated with a more pronounced effect on the excretion of cortisol in the urine over a 24-hour period. In patients with COPD, the influence of race on the pharmacokinetic parameters of vilantherol has not been revealed.
On the average, according to the assessment, C max of vilaterol was 220-287% higher, and AUC (0-24) was comparable in patients of Asian descent compared to those of other racial groups.
However, a higher C max of vilaterherol had no clinically significant effect on heart rate.
Children

For adolescents (12 years or older) there is no recommendation for a change in the dosing regimen.

The pharmacokinetics of the combination of vilantherol and fluticasone furoate in patients under 12 years of age have not been studied.
The safety and effectiveness of the combination of vilantherol and fluticasone furoate in children younger than 12 years has not yet been established.
Elderly patients

The effect of age on the pharmacokinetics of vilantherol and fluticasone furoate was studied in the third phase of clinical trials involving patients with COPD and bronchial asthma.

In patients with bronchial asthma, there was no evidence of age (12-84 years) influence on the pharmacokinetic profile of fluticasone furoate and vilaterherol.

Despite the increase in (37%) AUC (0-24) of vilaterherol in patients with COPD throughout the observed age range from 41 to 84 years, no signs of age-related effects on the pharmacokinetic profile of fluticasone furoate have been identified.
In an elderly patient (age 84 years) with a low body weight (35 kg), AUC (0-24) vilaterherol is expected to be 35% higher than the result calculated for the population (on average, a patient with COPD aged 60 and weighing 70 kg ), while C max of vilaterherol remains unchanged. It is unlikely that these differences are clinically relevant.
Patients with impaired renal function

According to the clinical pharmacological study for vilantherol and fluticasone furoate, severe renal dysfunction (CK <30 mL / min) does not significantly increase the systemic exposure of vilantherol or fluticasone furoate or to the development of more pronounced systemic effects of glucocorticosteroids or beta 2 -agonists in comparison with healthy volunteers.
Dose adjustments for patients with impaired renal function are not required.
The effect of hemodialysis is not studied.

Patients with impaired hepatic function

After continuous administration of a combination of vilaterol and fluticasone furoate for 7 days in patients with impaired hepatic function (according to the Child-Pugh cirrhosis classification: cirrhosis stage A, B or C), an increase in systemic exposure to fluticasone furoate (measured AUC (0-24 ) up to three times) in comparison with healthy volunteers.
An increase in the systemic exposure of fluticasone furoate (in the appointment of a combination of vilaterol and fluticasone furoate at a dosage of 22 Ојg + 184 Ојg / dose) in patients with impaired liver function of the middle degree (stage B in the Child-Pugh classification) was associated with a decrease in serum cortisol 34% in comparison with healthy volunteers. In patients with severe hepatic dysfunction (Child-Pugh Stage C) who received a lower dose of 11 Ојg + 92 Ојg, there was no decrease in serum cortisol concentration. For patients with impaired liver function of moderate and severe degree, the maximum dose is 22 Ојg + 92 Ојg (see section "Dosage regimen").
After continuous administration of a combination of vilaterol and fluticasone furoate for 7 days in patients with a mild, moderate or severe liver failure (stage A, B and C according to the Child-Pugh classification), there was no significant increase in systemic exposure to vilantherol (C max and AUC ).

In comparison with healthy volunteers, patients with a mild or moderate liver function disorder (taking vilantherol at a dose of 22 mcg) or severe (who took vilaterol at a dose of 11 mcg) showed no clinically significant beta-adrenergic systemic effects (change in heart rate or serum potassium concentration) , caused by taking a combination of vilantherol and fluticasone furoate.

Sex, body weight, BMI

According to the results of the population pharmacokinetic analysis of the data of the third phase of clinical trials, including 1213 patients with bronchial asthma (712 women) and 1225 patients with COPD (392 women), no signs of influence of sex, body weight or BMI on the pharmacokinetic profile of fluticasone furoate were found.

According to the population analysis of pharmacokinetics, 856 patients with bronchial asthma (500 women) and 1091 patients with COPD (340 women) showed no signs of influence of sex, body weight or BMI on the pharmacokinetic profile of vilaterherol.

No dosage adjustment is required based on data on gender, body weight or BMI.

INDICATIONS

- bronchial asthma: the drug Rellar Ellipta В® is used as a maintenance therapy for bronchial asthma;

- COPD (chronic obstructive pulmonary disease): The Relavar Ellipta В® preparation is used as a maintenance therapy for airway obstruction in patients with COPD, including chronic bronchitis and / or pulmonary emphysema.
The use of the RELVAR ELLIPT В® product allows to reduce the number of exacerbations of COPD in patients with repeated exacerbations in the anamnesis.
DOSING MODE

The preparation of RELVAR Ellipta В® is intended only for inhalation use.

The drug RELVAR ElliptВ® should be applied 1 time / day at the same time, in the morning or in the evening.

After inhalation, rinse mouth with water without swallowing.

Bronchial asthma

The patient should be informed of the need for regular use of the RELVAR ElliptВ® even in the case of asymptomatic disease.

If symptoms of the disease occur between the intake of the drug as an emergency therapy, inhalation forms of beta 2 -agonists of short action should be used.

The physician should regularly assess the patient's condition in order to ensure the timely administration of the optimal dosage of the RELVAR ElliptВ® drug.
Dosage can be changed only on the advice of a doctor.
Adults and adolescents 12 years and older

The recommended dose of the drug Relar Ellipta В® :

one inhalation 22 mcg + 92 mcg 1 time / day

or one inhalation of 22 Ојg + 184 Ојg 1 time / day.

The initial dose of RELVAR ELLIPT В® 22 Ојg + 92 Ојg is administered to patients who require low or moderate doses of inhaled glucocorticoids used in combination with long-acting beta 2 -agonists.

The RELVAR ELLIPT В® preparation at a dosage of 22 Ојg + 184 Ојg should be administered to patients who require a higher dose of inhaled glucocorticosteroids used in combination with long-acting beta 2 -agonists.

If the drug Rellar Ellipta at a dosage of 22 Ојg + 92 Ојg does not provide adequate control of the disease, the question of increasing the dose to 22 Ојg + 184 Ојg is considered, which can improve the level of control over the course of bronchial asthma.

Children

The safety and effectiveness of the use of the RELVAR Ellipta В® in children under the age of 12 years is not established.

COPD

Adults

The recommended dose of the drug Relar Ellipta В® :

one inhalation 22 mcg + 92 mcg 1 time / day.

The RELVAR ELLIPT В® preparation at a dosage of 22 Ојg + 184 Ојg is not indicated for the treatment of patients with COPD.

Children

The drug according to COPD in children is not used.

Special patient groups

Elderly patients

Patients over 65 years of age do not need a dose adjustment (see the section "Pharmacokinetics", subsection "Special patient groups").

Patients with impaired renal function

Patients with impaired renal function do not need a dose adjustment (see the section "Pharmacokinetics").

Patients with impaired hepatic function

According to the clinical and pharmacological study, a threefold increase in the degree of systemic exposure of fluticasone furoate (AUC) is observed in patients with impaired liver function of mild, moderate and severe degree (see section "Pharmacokinetics").

The drug should be administered with caution to patients with impaired hepatic function, in whom the risk of developing systemic adverse reactions caused by SCS is higher.
For patients with impaired liver function of moderate and severe degree, the maximum dose is 22 Ојg + 92 Ојg (see section "Pharmacokinetics").
Recommendations for use

The first time you use the Ellipse В® inhaler, you do not need to check the correctness of its operation or the special preparation of the inhaler for use.
Just consistently follow the recommendations but apply.
Inhaler elliptic В® packaged in a container containing a desiccant sachet of silica gel, which is not intended for food or inhalation. This bag should be disposed of.
When you remove the inhaler from the container, the lid is in the closed position. Do not open it until then, until you are ready to receive the drug.
Below are the steps you use an inhaler elliptic В® :
I. The Read the following information before you use
when opening or closing the cover of the inhaler elliptic В®without receiving the drug is lost per dose. This dose remains enclosed within the inhaler, but it is not available for reception. It is impossible to accidentally get a large dose or double dose of one inhalation.
A single dose of the drug is ready for inhalation after each opening the lid.
Dose counter displays how many doses of medicament left in the inhaler.
Before using the inhaler the dose counter displays the number 30.
Each opening the lid the number of doses reduced by 1 .
When there is less than 10 doses, counter half turns red.
After the last dose of the drug consumed , counter half highlighted in red, the counter displays the digit 0.This means that the inhaler is empty.
If you open the lid after this, the dose counter will be completely red.
II.
Preparing a dose
Do not open until you are ready to receive the drug. Do not shake the inhaler.
1. Lower the cover down until it clicks.
2. The dose is ready for inhalation and confirmation of the dose counter decreases the number of doses per unit.
3. If the dose counter has not reduced the number of doses after you hear a click, the inhaler is not ready to supply the dose of the drug. In this case, please contact by phone or address listed under "For more information contact".
4. Do not shake the inhaler.
III.
Inhalation drug
1. Hold the inhaler at a certain distance from the mouth. exhale maximum depth. Do not breathe out into the inhaler.
2. Place the mouthpiece between the lips and tightly wrapped around his lips. Do not cover the vent with your fingers.
3. Take a deep, long, steady breath through the mouth. Hold the breath as possible (at least 3-4 seconds).
4. Remove the inhaler from the mouth.
5. Slowly and quietly exhale.
You can not taste or feel the flow of the drug even when used properly inhaler.
IV.
Closing the inhaler and rinsing the mouth
if you want to clean the mouthpiece, use a dry cloth before closing the lid.
1. Lift the lid until it stops, achieving a complete closing of the mouthpiece.
2. After inhalation should rinse your mouth with water. This will reduce the chance of developing side effects such as sore throat and mouth.
When stored in a refrigerator inhaler should be kept at room temperature for at least an hour before use.
SIDE EFFECT

To determine the frequency of adverse reactions associated with drug intake Relvar elliptic В® , used data from large clinical trials in patients with COPD and bronchial asthma. Clinical drug development program for the treatment of asthma included 7034 patients who had carried out a comprehensive assessment of adverse reactions. The program of clinical development of the drug for the treatment of COPD, 6237 patients participated who conducted a comprehensive assessment of adverse reactions.
Excluding pneumonia and fractures, the safety profile of the drug in patients with COPD and asthma were similar. According to clinical studies pneumonia and fractures more frequently observed in patients with COPD.
Adverse reactions shown below are listed in accordance with a lesion of organs and organ systems, and frequency of occurrence. The frequency of occurrence, according to the WHO classification is defined as follows: very common (1/10?). often (? 1/100 and <1/10). infrequently (? 1/1000 and <1/100), rarely (? 1/10 000 and <1/1000), very rare (<1/10 000 including isolated cases).
The frequency of adverse reactions
Infectious and parasitic diseases: often - pneumonia, upper respiratory tract infections, bronchitis, influenza, candidiasis of the oral cavity and pharynx.
From the nervous system: very often - headache.
Of the heart: rarely - extrasystole.
The respiratory system, organs, thoracic and mediastinal disorders:very often - nasopharyngitis; often - oropharyngeal pain, sinusitis, pharyngitis, rhinitis, cough, dysphonia.
On the part of the digestive tract: often - pain in the abdomen.
On the part of the musculoskeletal system and connective tissue disorders: often - arthralgia. back pain, fractures.
General disorders and the site of injection: often - fever.
These post-marketing surveillance
Violations of the immune system: rarely - hypersensitivity reactions, including anaphylaxis, angioedema, rash, urticaria.
Mental disorders: rare - anxiety.
From the nervous system: rarely - a tremor.
Of the heart: rarely - palpitations, tachycardia.
On the part of the musculoskeletal system and connective tissue disorders: often - muscle spasm.
CONTRAINDICATIONS

- patients who have a history of severe allergic reactions to milk protein or an increased sensitivity to the active compounds, or any other component, part of the drug;
- Children up to 12 years for the treatment of bronchial asthma;
- preparation Relvar elliptic В® in a dose of 22 .mu.g + 184 mg / dose is not indicated for the treatment of COPD.
Precautions: when receiving sympathomimetics, including drug Relvar elliptic В® , with the cardiovascular system can occur undesirable phenomena such as an arrhythmia (e.g., tachycardia and supraventricular extrasystoles). In this regard, patients with severe cardiovascular disease, a drug Relvar elliptic В®should be used with caution.
Like other drugs, which include corticosteroids, drug Relvar elliptic В® should be used with caution in patients with pulmonary tuberculosis, as well as patients with chronic infections or unbaked.
PREGNANCY AND LACTATION

Fertility

Data on the effect on human fertility are not available. In preclinical studies, exposure vilanterola and fluticasone furoate on fertility were found.
Pregnancy

Data on the use of the drug during pregnancy is limited.
Use of the drug Relvar elliptic В® in pregnant women is permissible only if the potential benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding period
Data on excretion vilanterola or fluticasone furoate or their metabolites in human breast milk is not enough. However, other corticosteroids and beta 2 agonists defined in breast milk. The risk of penetration of the drug with milk in the body of the newborn or a child can not be excluded.
Taking into account the ratio of the benefit of therapy for the mother and breast-feeding for the child, it is necessary to solve the problem or the abolition of the drug, or the termination of breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER

Patients with impaired renal function is not the individual selection of doses required.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

According to clinical and pharmacological studies in patients with mild hepatic dysfunction, moderate and severe seen a threefold increase in the degree of systemic exposure of fluticasone furoate (AUC) (see. "Pharmacokinetics" section).
The drug should be used with caution in patients with impaired liver function, in which the risk of systemic adverse reactions induced by administration of glucocorticoids, higher. For patients with moderate and severe liver function maximum dose is 22 mg + 92 mg (cm. "Pharmacokinetics" section).
APPLICATION FOR CHILDREN

Use of the drug to children under 12 years of age is contraindicated.
APPLICATION IN ELDERLY PATIENTS

Patients older than 65 years is not the individual selection of doses required.
SPECIAL INSTRUCTIONS

Preparation Relvar elliptic В® is not intended for relief of acute symptoms of asthma or COPD exacerbation, in such cases, a short-acting bronchodilators assignment. Increasing the frequency of reception of bronchodilators of short-acting for the purpose of relief of symptoms indicates deterioration of control of the disease and the need to consult a doctor.
Patients with bronchial asthma or COPD should not terminate treatment with Relvar elliptic В® without observing physician because abolition of therapy can lead to a resumption of symptoms.
Against the background of treatment with Relvar elliptic В®may develop adverse events associated with bronchial asthma or exacerbation of the disease. Patients should be advised to continue the treatment. In the absence of control of the disease or deterioration after the start of therapy with Relvar elliptic В® should consult a doctor.
As with other types of inhalation therapy, paradoxical bronchospasm may occur, accompanied by a rapid increase in wheezing after dosing. In this case shows the urgent appointment of inhaled short-acting bronchodilator and an immediate withdrawal of the drug Relvar elliptic В® . The patient should be examined by a doctor, and he, if necessary, alternative therapy may be assigned.
Patients with impaired liver function moderate and severe be administered a dose of 22 mg + 92 mg, such patients should be under the supervision of a physician to control systemic adverse reactions associated with the use of corticosteroids (see. The sections "Pharmacokinetics", "dosage regimen").
In the application of inhaled glucocorticosteroids (especially after prolonged administration of high doses) may develop systemic side reaction. Such side reactions occur much less frequently than with oral corticosteroids. By the manifestation of possible adverse systemic effects include suppression of the hypothalamic-pituitary-adrenal axis, decreased bone mineral density, slowing the rate of growth in children and adolescents, cataract and glaucoma.
In patients with COPD,receiving the drug Relvar ellipticВ® , there was an increased frequency of pneumonia, as well as the incidence of severe pneumonia requiring hospitalization. In some cases, clinical episodes of pneumonia were fatal. Physicians should be aware of the possibility of pneumonia in patients with COPD, without forgetting that the clinical signs of the infection are masked symptoms of COPD exacerbation. A higher risk of pneumonia in patients receiving the drug Relvar elliptic В® has the following groups of patients with COPD: smoking patients, patients previously undergone pneumonia, patients with a BMI <25 kg / m 2 and patients with forced expiratory volume (FEV 1 ) <50% by proper greatness. In appointing the drug therapy Relvar elliptic В®should take into account the above factors, the treatment should be reviewed in case of pneumonia.
In patients with bronchial asthma cases of pneumonia were observed infrequently. Patients with asthma who received drug Relvar elliptic В® at a dosage of 22 .mu.g + 184 ug / dose, may have a higher risk of pneumonia versus those treated with a lower dose Relvar elliptic В® (22 .mu.g + 92 pg / dose) or with placebo. The risk factors have not been established.
During clinical trials in patients suffering from COPD. low incidence of bone fracture in all treatment groups, but in all groups receiving combination vilanterola and fluticasone furoate, it was slightly higher (2%) than in the group receiving monotherapy vilanterolom 22 mg (<1%) was detected.
Impact on the ability to drive vehicles and manage mechanisms

Studies on the influence of drug Relvar elliptic В® on the ability to drive and operating mechanisms are not performed. Based on data from pharmacology vilanterola or fluticasone furoate, an adverse effect of the drug on these activities is not expected.
OVERDOSE

Symptoms
In clinical studies there was no evidence of a combination of overdose vilanterola and fluticasone furoate.
Drug overdose Relvar elliptic В® can cause the development of symptoms and signs caused by the action of the individual components of the drug overdose and characteristic of the beta 2 -agonists and inhaled glucocorticosteroids (see. The "Special instructions").
Treatment

Specific treatment of overdosage combination vilanterola and fluticasone furoate is absent. In the case of overdose assigned symptomatic therapy, and, provided appropriate monitoring of patients if necessary.
The use of cardioselective beta-blockers should be considered only in cases of strongly pronounced effects vilanterolom overdose, which clinically manifested immunity to maintenance therapy. Cardioselective beta-blockers should be used with caution in patients who have had episodes of bronchospasm in history.
DRUG INTERACTION

By administering the drug at therapeutic doses, clinically significant drug interactions vilanterola fire fluticasone furoate considered unlikely due to the low plasma concentrations at the last inhalation administration.
Beta-blockers may weaken or antagonize the effect of beta 2 -adrenomimetikov. Avoid the simultaneous reception of non-selective and selective beta-blockers, except in cases where their purpose is strictly necessary.
Vilanterol and fluticasone furoate undergo rapid primary metabolism in the liver by isoenzyme cytochrome CYP3A4.
When concomitant administration of drug with potent inhibitors isoenzyme cytochrome CYP3A4 (e.g., ketoconazole, ritonavir) caution, since it is possible increase the systemic exposure vilanterola and fluticasone furoate, which in turn may lead to increased risk of adverse reactions (refer. To "Pharmacokinetics" ).
Vilanterol and fluticasone furoate are substrates of P-gp. According to the results of clinical and pharmacological studies in healthy volunteers who were administered simultaneously vilanterol and a potent inhibitor of P-gp and a mild inhibitor of cytochrome CYP3A4 isoenzyme verapamil, a significant effect on the pharmacokinetics vilanterola not revealed. Clinico-pharmacological study P-gp joint destination specific inhibitor and fluticasone furoate not conducted.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

RU / FFT / 0044/16 23.12.2016
TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 В° C.
Shelf life - not open aluminum container - 2 years. Opened aluminum container - 6 weeks.
Do not use after the expiration date stated on the package.

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