Relvar Ellipta powder 22mkg + 184mkg / dose, 30 dose

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BIDL3177684
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Expiration Date: 05/2027

Russian Pharmacy name:

Релвар Эллипта порошок 22мкг+184мкг/доза, 30 доз

Relvar Ellipta powder 22mkg + 184mkg / dose, 30 doses

bronchial asthma (Relvar ElliptaЃ is used as a maintenance therapy for bronchial asthma);

chronic obstructive pulmonary disease (Relvar ElliptaЃ is used as a maintenance therapy for airway obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and / or pulmonary emphysema). The use of Relvar ElliptaЃ can reduce the number of exacerbations of chronic obstructive pulmonary disease in patients with a history of repeated exacerbations.

Inhalation

Relvar ElliptaЃ should be used once a day at the same time, in the morning or in the evening. After inhalation, rinse your mouth with water without swallowing.

Bronchial asthma

The patient should be informed about the need for regular use of Relvar ElliptaЃ, even in the case of an asymptomatic course of the disease. If symptoms of the disease occur between doses of the drug, inhaled forms of short-acting beta2-agonists should be used as an emergency therapy. The doctor should regularly assess the patient's condition to ensure that the optimal dosage of Relvar ElliptaЃ is prescribed on time. The dosage can only be changed on the advice of a doctor.

Adults and adolescents 12 years and older. The recommended dose of Relvar ElliptaЃ: one inhalation of 22 ?g of vilanterol and 92 ?g of fluticasone furoate once a day, or one inhalation of 22 ?g of vilanterol and 184 ?g of fluticasone furoate once a day.

The initial dose of Relvar ElliptaЃ is 22 mcg of vilanterol and 92 mcg of fluticasone furoate for patients requiring low or medium doses of inhaled corticosteroids used in combination with long-acting beta2-agonists.

The drug Relvar ElliptaЃ at a dosage of 22 mcg of vilanterol and 184 mcg of fluticasone furoate should be prescribed to patients who require a higher dose of inhaled corticosteroids used in combination with long-acting beta2-agonists. If the drug Relvar ElliptaЃ at a dosage of 22 mcg of vilanterol and 92 mcg of fluticasone furoate does not provide adequate control of the disease, the issue of increasing the dose to 22 mcg of vilanterol and 184 mcg of fluticasone furoate is considered, which can improve the level of control over the course of bronchial asthma.

Children. The safety and efficacy of Relvar ElliptaЃ in children under 12 years of age has not been established.

COPD

Adults. The recommended dose of Relvar ElliptaЃ: one inhalation of 22 mcg of vilanterol and 92 mcg of fluticasone furoate once a day.

Relvar ElliptaЃ at a dosage of 22 mcg vilanterol and 184 mcg fluticasone furoate is not indicated for the treatment of patients with COPD.

Children. The drug for the indication of COPD in children is not used.

Special patient groups

Elderly patients. Patients over 65 years of age do not require individual selection of the dose of the drug (see 'Pharmacokinetics', Special patient groups).

Patients with impaired renal function. Patients with impaired renal function do not require individual selection of the dose of the drug (see 'Pharmacokinetics').

Patients with impaired liver function. According to clinical and pharmacological studies in patients with mild, moderate and severe liver dysfunction, there is a threefold increase in the degree of systemic exposure to fluticasone furoate (with an increase in indicators such as Cmax and AUC) (see Pharmacokinetics). Patients with impaired liver function should be prescribed the drug with caution, because this group of patients has a higher risk of developing systemic adverse reactions caused by taking GCS.

Recommendations for use

When using the ElliptЃ inhaler for the first time, there is no need to check its correct operation or special preparation of the inhaler for use. The recommendations for use indicated below should be followed consistently.

The ElliptaЃ inhaler is packaged in a container containing a desiccant silica gel sachet that is not intended to be eaten or inhaled. This bag should be disposed of. After removing the inhaler from the container, its lid is in the closed position. Do not open it before taking the drug.

Detailed instructions for using the ElliptЃ inhaler

When opening and closing the lid of the ElliptЃ inhaler without taking the drug, one dose is lost. This dose remains closed inside the inhaler, but it will not be available to receive. It is impossible to accidentally receive a large dose or a double dose in one inhalation.

One dose of medication is ready for inhalation after each opening of the lid.

The dose counter shows how many doses of the drug are left in the inhaler. Before using the inhaler, the dose counter shows the number 30. Each time you open the lid, the number of doses decreases by 1. When there are less than 10 doses remaining, half of the counter turns red. After the last dose of the drug has been consumed, half of the counter is highlighted in red, the counter shows the number 0. This means that the inhaler is empty. When you open the lid after that, the dose counter will turn completely red.

Dose preparation

Do not open the lid until you are ready to take the drug. Do not shake the inhaler.

1. Push the cover down until it clicks.

2. The dose of the drug is ready for inhalation, and in confirmation of this, the counter decreases the number of doses by one.

3. If the counter has not decreased the number of doses after clicking, then the inhaler is not ready to deliver a dose of the drug. In this case, you should contact by phone or the address specified in the subsection 'For additional information, contact'.

4. Do not shake the inhaler.

Inhalation of the drug

1. Holding the inhaler at some distance from the mouth, exhale as deep as possible. Do not breathe out into the inhaler.

2. Place the mouthpiece between your lips and wrap your lips tightly around it. Do not cover the ventilation hole with your fingers.

The lips should closely follow the shape of the inhaler mouthpiece.

3. Take one deep, long, even breath. Hold your breath as much as possible (at least 3-4 s).

4. Remove the inhaler from your mouth.

5. Exhale slowly and calmly.

If the inhaler is used correctly, the patient may not taste or feel the drug coming in.

Closing the inhaler and rinsing the mouth

If necessary, clean the mouthpiece, use a dry paper towel before closing the lid.

1. Raise the lid until it stops, achieving complete closure of the mouthpiece.

2. After inhalation, rinse your mouth with water. This will reduce the likelihood of side effects such as sore throat and mouth pain.

Dosed powder for inhalation, 22 + 92 mcg / dose1 dose / cell *
Vilanterol strip
active substance:
vilanterol triphenatate micronized40 mcg
(equivalent to 25 mcg ** vilanterol)
excipients: magnesium stearate - 125 mcg; lactose monohydrate - up to 12.5 mg
Fluticasone furoat strip
active substance:
fluticasone furoate micronized100 mcg **
excipient: lactose monohydrate - up to 12.5 mg

Dosed powder for inhalation, 22 + 184 mcg / dose1 dose / cell *
Vilanterol strip
active substance:
vilanterol triphenatate micronized40 mcg
(equivalent to 25 mcg ** vilanterol)
excipients: magnesium stearate - 125 mcg; lactose monohydrate - up to 12.5 mg
Fluticasone furoat strip
active substance:
fluticasone furoate micronized200 ?g **
excipient: lactose monohydrate - up to 12.5 mg
* In the production of the finished product, mixtures of active and auxiliary substances can be added to the final product with an excess of up to 8% to compensate for losses during filling the cells.
** Indicated is the nominal amount of the active ingredient, which is included in the production process; the delivered amount is 22 ?g of vilanterol, 92 and 184 ?g of fluticasone furoate, which corresponds to the indicated dosages.

severe allergic reactions to milk protein or hypersensitivity to active substances or any other component that is part of the drug in history;

children under 12 years of age (for the treatment of bronchial asthma);

the drug Relvar ElliptaЃ at a dose of 22 + 184 ?g / dose is not indicated for the treatment of chronic obstructive pulmonary disease.

With caution: when taking sympathomimetics, including the drug Relvar ElliptaЃ, undesirable effects such as arrhythmias (for example, supraventricular tachycardia and extrasystole) can be observed from the CVS. In this regard, for patients suffering from severe forms of cardiovascular diseases, the drug Relvar ElliptaЃ should be prescribed with caution. Like other drugs that include corticosteroids, Relvar ElliptaЃ should be prescribed with caution to patients with pulmonary tuberculosis, as well as to patients with chronic or untreated infections.

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