Anoro Ellipta (umeclidinium) powder for inhalation 55 mcg/22 mcg/dose 30 dose №1

$89.00

Manufacturer: GreatBritain

Umeclidinium/vilanterol is a combination of a long-acting inhaled muscarinic receptor antagonist and a long-acting beta2-adrenergic agonist. After oral inhalation, both compounds act topically on the airways, resulting in bronchial dilatation through different mechanisms of action.

Category:

Description

Ingredients

active ingredients: umeclidinium, vilanterol;

1 dose delivered contains 55 micrograms of umeclidinium (as bromide) and 22 micrograms of vilanterol (as triphenate)

this corresponds to a Pre-allocated dose of 74.2 mcg of umeclidinium bromide and 25 mcg of vilanterol (as trifenatate)

excipients : lactose monohydrate, magnesium stearate.

Dosage form

Powder for inhalation.
Basic physical and chemical properties : a plastic inhaler with a light gray body, a red spray cap and a dose counter, packed in a foil tray that contains a sachet with a desiccant. The tray is sealed from the level of the lid. The inhaler contains two strips of 30 evenly spaced blisters, each containing a white powder.

Pharmacotherapeutic group

Medicines that are used for obstructive airway diseases. Adrenergic drugs with anticholinergic drugs. Vilanterol and umeclidinium bromide.

ATC code R03A L03.

Pharmacodynamics

Mechanism of action

Umeclidinium/vilanterol is a combination of a long-acting inhaled muscarinic receptor antagonist and a long-acting beta2-adrenergic agonist. After oral inhalation, both compounds act topically on the airways, resulting in bronchial dilatation through different mechanisms of action.

Umeclidinium

Umeclidinium is a long-acting muscarinic receptor antagonist (anticholinergic agent). It is a quinuclidine derivative with activity on numerous muscarinic receptor subtypes. Umeclidinium acts as a bronchodilator by competitively inhibiting the binding of acetylcholine to muscarinic receptors in airway smooth muscle. Slow turnover to M3 subtypes of human muscarinic receptors in vitro and long-term effect in vivo when administered directly to the lungs in preclinical models have been found.

vilanterol

Vilanterol is a selective long-acting beta 2 adrenoceptor agonist (beta 2 adrenergic agonist). The pharmacological effects of beta2-adrenergic agonists, including vilanterol, are at least in part due to stimulation of intracellular adenylate cyclase, an enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3′,5′-adenosine monophosphate (cAMP). Elevated cAMP levels cause relaxation of bronchial smooth muscle and inhibit the release of immediate-type hypersensitivity mediators from cells, especially mast cells.

Indications

For maintenance bronchodilator therapy to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Contraindications

Hypersensitivity to the active substances or to any of the excipients.

Dosage and administration

Doses

adults

The recommended dose is one inhalation of Anoro Ellipta 55/22 mcg once a day.

Anoro Ellipta should be taken once a day at the same time every day to maintain bronchial dilatation. The maximum dose is one inhalation of Anoro Ellipta 55/22 mcg once a day.

Special patient groups

Elderly patients

Dose adjustment is not required for patients over 65 years of age.

Patients with impaired renal function

Dose adjustment is not required for patients with impaired renal function.

Patients with impaired liver function

Dose adjustment is not required for patients with mild to moderate hepatic impairment. Anoro Ellipta has not been studied in patients with severe hepatic insufficiency, so it should be used with caution.

Children

Anoro Ellipta was not used in children (under 18 years of age) for the treatment of COPD.

Mode of application

Anoro Ellipta is intended for inhalation only.

Instructions for use

The Ellipta inhaler contains pre-dispensed doses and is ready to use.

The inhaler is packaged in a tray containing a moisture-absorbing sachet. The desiccant sachet should be discarded and its contents must not be swallowed or inhaled. The patient should be warned that the inhaler tray should be opened when he is ready to inhale the dose.

The inhaler in the tray is in the “closed” position. After the tray is opened, it can be thrown away. The date of end use of the inhaler is 6 weeks from the date of opening the tray. The date of end use should be entered in the space provided marked “Do not use after:”. Do not use the inhaler after the date of end use.

Instructions for using the inhaler:

1. Read before use

If the cap of the inhaler is opened and closed without inhaling the drug, the dose will be lost. The lost dose is securely stored in the inhaler but is no longer available for inhalation.

It is impossible to accidentally take an excess or double dose of the drug in one inhalation.

Dose counter

It shows how many doses are left in the inhaler.

To use the first dose from the inhaler, the counter shows exactly 30 doses.

It counts down 1 dose each time the lid is opened.

When less than 10 doses remain, half of the counter turns red.

After using the last dose, half of the dose counter is colored red and the number 0 is displayed. The inhaler is now empty.

If you open the lid after that, the dose counter will turn completely red.

Lid

Each time you open, you prepare one dose of the drug

2. How to prepare a dose

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

Pull the lid down until you hear a “click”.

Now the drug is ready for inhalation. The dose counter counts down by 1, which confirms readiness.

If the dose counter has NOT counted down after you hear the “click”, then the inhaler is not working. It is necessary to contact the pharmacy with an inhaler for advice. In any case, you should not shake the inhaler.

3. How to perform inhalation of the drug

Hold the inhaler away from your mouth and exhale as deeply as is comfortable for you.

DO NOT breathe into the inhaler.

Place the mouthpiece between your lips and press them firmly around the mouthpiece.

Do not close the air valves with your fingers.

Take one long, even, deep breath, and then hold your breath for as long as possible (at least 3-4 seconds).

Take the inhaler out of your mouth.

Exhale slowly and carefully.

Even with the correct use of the inhaler, you may not feel the drug, in particular its taste.

4. Close the inhaler

If there is a need to clean the mouthpiece, use a dry cloth before closing the lid.

To cover the mouthpiece, replace the cap by sliding it up until it stops.

Best before date

2 years.

Shelf life after opening the tray – 6 weeks.

Storage conditions

Store at a temperature not exceeding 30 ° C. When stored in a refrigerator, the inhaler should be returned to room temperature less than an hour before use.

Keep out of the reach of children.

Store in original packaging to protect from moisture.

Apply within 6 weeks after opening the tray.

In a specially designated place, the patient must note the date after which the inhaler must be discarded. The date must be indicated immediately after receiving the inhaler from the tray.

Package

Powder for inhalation, metered dose, 55 mcg / 22 mcg / dose, 30 doses in powder inhaler No. 1.

The inhaler contains two blister strips of 30 evenly spaced cells, each containing 1 dose of each active ingredient, delivered simultaneously.

A plastic inhaler with a light gray body, a red spray cap and a dose counter is packaged in a foil tray containing a sachet of silica gel desiccant. The tray, sealed with a tear-off lid, is placed in a cardboard box.