Novopulmon E Novolayzer - instructions for use, dose, side effects, contraindications

Description:A drug: crystalline powder of white or almost white color.
Cartridge: a plastic cartridge of white color with a lid, in the opening on the lid, the figure "200" visible on a plastic tape that is a dose counter is visible.
Inhaler: a plastic inhaler with a white body, a red button-dispenser, a removable cover that closes the opening for the cartridge and a protective cap that closes the mouthpiece. Above the cap is a red indicator, the color of which changes to green after pressing the button and the hole for the dose counter on the cartridge.

Pharmacotherapeutic group:Glucocorticosteroid for topical application

ATX: & nbsp

R.03.B.A.02 Budesonide

Pharmacodynamics:Budesonide is a glucocorticorticosteroid with a pronounced local anti-inflammatory effect and a weak systemic effect. When administered as inhalations through the mouth, it has a local anti-inflammatory effect on the bronchial mucosa. Determined that budesonide inhibits the activity of many cells involved in the inflammatory reaction (mast cells, eosinophils, neutrophils, macrophages, lymphocytes),as well as the release of mediators of inflammation (histamine, eicosanoids, leukotrienes, cytokines), which leads to the restoration of respiratory function and reduced hyperreactivity of the bronchi.

Pharmacokinetics:Suction: after oral inhalation, about 25% of the administered dose of budesonide reaches the lungs, the rest of the drug lingers on the mucous membranes of the mouth, larynx and trachea, and then enters the digestive tract. Systemic bioavailability with oral administration is 10%. The maximum concentration in the blood plasma is reached approximately 30 minutes after inhalation. Distribution. Binding to plasma proteins is 85%.
Metabolism: 90% of the administered dose of budesonide undergoes metabolism on the first pass through the liver, mainly oxidation. The main metabolites (6-beta-hydroxybudesonide and 16-alpha-hydroxy-prednisolone) have insignificant glucocorticosteroid activity.
Excretion: mainly in the form of metabolites with urine and feces. The half-life in adults is approximately 2.8 hours, in children 1.5 hours.

Indications:- bronchial asthma,requiring maintenance therapy with glucocorticosteroids to control the inflammatory process;
chronic obstructive pulmonary disease.

Contraindications:Increased individual sensitivity to the components of the drug.
Rare hereditary diseases, such as galactose intolerance, lactase deficiency or glucosogalactose malabsorption.
Clinical studies in children under 6 years of age have not been conducted, therefore, the use of the drug for children under 6 years of age is not recommended.

Carefully:Active form of pulmonary tuberculosis; fungal, viral, bacterial infections of the respiratory system, pregnancy and lactation.

Pregnancy and lactation:Novopulmon E Novolayzer® should be used during pregnancy, especially in the first trimester, only if the intended benefit to the mother exceeds the potential risk to the fetus. In connection with a minor systemic effect, the drug has a lesser negative effect on the mother and fetus than glucocorticoids for oral administration.
Data on the isolation of budesonide in breast milk are absent.In connection with the extensive metabolism in the liver "at the first passage," one can expect that its concentrations in milk are low. However, when prescribing the drug during breastfeeding, it is necessary to take into account the ratio of the prospective benefit to the mother and the potential risk to the child.

Dosing and Administration:Powder dosed for inhalation with the Novolaser® inhaler.
Doses are selected individually. The usual recommended dose is 200 to 1600 μg budesonide per day, depending on the severity of the disease and the patient's response.
Adults and children over 12 years of age:
200 mcg Budesonide 1 - 2 times a day (that is, 1 - 2 doses per day). The maximum daily dose is 1600 μg budesonide (8 doses). If the daily dose exceeds 4 doses (800 mcg budesonide), it is divided into 3 to 4 doses.
Children 6-12 years old:
200 μg Budesonide 1 - 2 times a day (that is, 1-2 doses per day). The maximum daily dose is 800 μg budesonide (4 doses).
The drug should be administered only under the supervision of adults.
After stabilization of the patient's condition, a maintenance dose is selected (the minimum effective dose).
The drug has an anti-inflammatory effect, so it should be used consistently and regularly even after the patient's condition is improved.Usually Novopulmon E Novolayzer® is prescribed for a long-term course of treatment, as well as for preventive therapy. It should be taken regularly according to the recommended regimen, even when symptoms are absent.
Improvement of the patient's condition may occur within 24 hours, although to achieve the maximum effect, it may take another 1-2 weeks of therapy. If the patient has switched to the Novopulmon E Novolaser® application from another inhalation system, the dose should be retested individually. In this case, the type of preparation, the dosage regimen and the mode of administration should be considered.
In the period of severe bronchial asthma, if the need to reduce or stop taking glucocorticosteroids in adults (including elderly patients) at the beginning of therapy, the drug is applied 2 times a day.
For adults, including elderly patients with bronchial asthma of mild or moderate severity, the drug can be applied once a day, with the already available control of inhaled glucocorticosteroids (budesonide or beclomethasone dipropionate) taken twice daily.
If the patient passes from a reception 2 times a day for a single dose, the transition should be performed while maintaining an equivalent total daily dose (taking into account the type of drug and method of administration), in the future this dose should decrease to the minimum effective to maintain control of bronchial asthma. The regime of a single daily intake should be considered only if the symptoms of bronchial asthma are controlled.
In case of a single dose, the drug should be taken in the evening.
In case of impaired control of bronchial asthma (defined, for example, by constant respiratory symptoms, increased use of bronchodilator inhalation), the dose of inhaled glucocorticosteroids should be increased. Patients taking the drug once a day should be recommended to double the dose of an inhaled glucocorticosteroid and take 2 doses per day, each of which is equal to the previously taken dose once a day. In any case, the deterioration in the control of bronchial asthma, the patient should consult a doctor as soon as possible.
The patient should always have access to inhaled short-acting β2-adrenomimetics to relieve acute attacks of bronchial asthma.
Doses for patients not taking glucocorticosteroids:
When Novopulmon E Novolayzer® is taken in accordance with the instructions for use in patients, the improvement of the condition occurs approximately 5-7 days later. Sometimes, due to the abundant secretion of bronchi, access to the inflammation zone is difficult, in such cases it is recommended that a short course of treatment with glucocorticosteroids (GCS) for oral administration is recommended (the initial dose is equivalent to 40-60 mg of prednisone per day). Inhalation is carried out after a gradual reduction in the dose of oral glucocorticosteroids.
Doses for patients taking glucocorticosteroids for oral administration:
If the patient takes the GCS orally, the transfer for treatment with Novopulmon E Novolaser® is carried out in a stable phase of the disease. Cancellation of SCS is carried out gradually, within 7-10 days it is necessary to combine oral administration of GCS in a selected dose and inhalation Novopulmon E Novolaser ® in a high dose (up to 1600 μg / day). Then the dose of GCS is gradually reduced by 2.5 mg of prednisone every 1-2 weeks.
Exacerbation of clinical symptoms caused by acute respiratory respiratory diseases
If the symptoms worsen during acute respiratory infections of the respiratory tract, antibiotic therapy should be prescribed. You may also need a dose adjustment of Novopulmon E Novolaser® or oral GCS.
Guidelines for Novopulmon E Novolaser®
The inhaler does not contain propellant, it can be used for a long time, regularly changing the cartridge, which minimizes its negative impact on the environment.
Guidelines for Novopulmon E Novolaser®
The inhaler does not contain propellant, it can be used for a long time, regularly changing the cartridge, which minimizes its negative impact on the environment.

Replacing the cartridge
1. Take Novolayzer® in the right hand with the red button up and remove the lid by slightly pressing on the fluted surface on both sides and pulling it to the left and upwards (Figure 2).

2. Remove the protective aluminum foil from the case of the new cartridge and remove the cartridge.
3. Insert the cartridge into the Novolizer® so that the dose counter is rotated to the mouthpiece (Fig. 3).
4. Close the Novolayzer® cover, pushing it towards the red button until it clicks.
Novolayzer® is ready for use. The cartridge should be replaced after 3 months, even if the drug is not fully consumed. Cartridge Novopulmon E Novolayzer® can only be used to charge the Novolaser® inhaler.
Application
1.When using Novolayzer®, it should be in a horizontal position.
2. Remove the protective cap by pulling it in the indicated direction (Fig. 4).

3. Press the red button all the way. In this case, you should hear a click, in the control window (at the bottom) instead of red, a green color will appear. Release the red button. The green color in the control window indicates that Novolaser® is ready for use (Figure 5).

4. Take a slow, deep breath, without bringing the inhaler to your lips (Figure 6).
5. Closely grasp the mouthpiece with your lips (Fig. 7). Quickly and deeply inhale. If the inhalation is done correctly, a click will be heard, and a red color will appear in the control window. If this does not happen, repeat the inhalation.
6. As long as possible to hold your breath, if possible for 10 seconds, then make a slow exhalation (Fig.8)
7.Close the mouthpiece with a protective cap.
Dose counter displays the number of doses of unexpended (when the cartridge is full-figure 200, and with use numbers are reduced by 20, that is, 180, 160.140, 120.100, 80.60, more figures are reduced by 10, i.e. 50, 40, 30, 20, 100). If the number 0 appears in the window, replace the cartridge.
The special mechanism provided by Novolaser® does not allow the inhalation of a double dose.
Cleaning
Novolayzer® should be cleaned regularly. Cleaning is also necessary when replacing the cartridge.
1. Take Novolayzer® in the right hand with the red button up and inscription Novolizer® to yourself. Remove protective cap (pull left). Remove the mouthpiece (turn away from yourself and pull to the left) (Figure 9).

2.Rotate Novolayzer® (red button down) and remove the dispenser by pulling it to the left and upwards (Figure 10).
3. Carefully pour out the remaining powder from Novolayzer. Wipe the components of Novolaser dry, clean and soft cloth. Do not wash the inhaler with water or use it for cleaning with any chemical means.
4. Again, put the dispenser on, pushing it towards the red button and down.
5. Attach the mouthpiece, moving it towards the red button and slightly turning down. Put the protective cap on.

Side effects:The incidence of side effects is defined as follows:
Very often:> 1/10;
Often: <1/10> 1/100;
Infrequently: <1/100> 1/1000;
Rarely: <1/1000> 1/10000;
Very rarely: <1/10000.
From the gastrointestinal tract: often - irritation of the oral mucosa, difficulty in swallowing, candidiasis of the esophagus.
From the respiratory system: often hoarseness, cough; rarely - a bronchial spasm is paradoxical.
From the immune system: rarely - hypersensitivity, angioedema.
From the skin and subcutaneous tissues: rare skin reactions, urticaria, rash, dermatitis, itching, erythema, bruising.
From the side of the musculoskeletal system, connective and bone tissue: rarely growth retardation; very rarely - decreased bone density.
From the endocrine system: very rarely - oppression of the adrenal cortex.
From the nervous system: very rarely - psychomotor hyperactivity, anxiety, increased excitability, depression and behavioral disorders.
On the part of the organs of vision: very rarely - cataract, glaucoma.

Overdose:Acute overdose is almost impossible due to the presence of a special mechanism in the dosing system, which prevents the intake of an excessive dose of medication in the body.There are no special clinical manifestations of acute overdose, no special treatment is required.
With prolonged use of the drug in doses much higher than recommended, a systemic glucocorticosteroid effect may develop in the form of hypercorticism and suppression of the function of the adrenal cortex. In such cases, a gradual dose reduction to the recommended dose is necessary.

Interaction:Preliminary inhalation of p2-adrenomimetics expands bronchi, improves the flow of budesonide into the respiratory tract and enhances its therapeutic effect. Due to the fact that with inhalation dosing plasma concentrations are very low, clinically significant drug interactions are usually very rare.
However, potent inhibitors of the CYP3A4 isoenzyme (for example, ritonavir, itraconazole, ketoconazole, nelfinavir) can significantly increase the levels of budesonide in plasma. Due to the fact that there is insufficient data for dosing recommendations, the interval between taking inhibitors and budesonide should be as large as possible and the possibility of reducing the dose of budesonide should be considered.

Special instructions:Novopulmon E Novolayzer® is not intended for use in acute bronchoconstriction. With pulmonary tuberculosis Novopulmon E Novolayzer® is prescribed only in combination with anti-tuberculosis drugs.
If the patient has infectious diseases of the respiratory tract (including fungal), the drug Novopulmon E Novolayzer® must be combined with the use of appropriate specific therapy.
If the patient develops a paradoxical bronchospasm following the inhalation of Novopulmon E Novolaser®, inhalation of β2-adrenomimetics should be prescribed before every Novopulmon E Novolaser® application. With a serious violation of liver function, the rate of excretion of GCS (including Novopulmon E Novolayer®) is reduced from the body, so the risk of systemic side effects increases. The concentration of cortisol should be monitored regularly.
The cancellation of therapy with Novopulmon E Novolaser® should be gradual. In children and adolescents receiving treatment with GCS (regardless of the method of delivery) for a long period, it is recommended that growth rates be regularly monitored.

Effect on the ability to drive transp. cf. and fur:Novopulmon E Novolayzer® usually does not affect the ability to drive a vehicle or work with complex machinery. However, with increased motor activity and excitability, in a state of anxiety, with depression and behavioral disorders, which are very rare, one should abandon the management of vehicles or from working with complex mechanisms.

Form release / dosage:Powder for inhalation dosed with 200 μg / dose.

Packaging:200 doses per cartridge. One cartridge in a case made of polypropylene, covered with aluminum foil.
One case together with instructions for use in a cardboard box or one case complete with an inhaler together with instructions for use in a cardboard box.

Storage conditions:In a dry place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.

Shelf life:Cartridge - 3 years.
Shelf life of the cartridge after the first use is 3 months.
The expiration date of the inhaler after the first use is -1 year.
Do not use Novopulmon E Novolayzer® after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LS-002405

Date of registration:23.12.2011

The owner of the registration certificate:MEDA Pharmaceuticals Switzerland GmbHMEDA Pharmaceuticals Switzerland GmbH Switzerland

Manufacturer: & nbsp

MEDA Manufacturing, GmbH Germany

Representation: & nbspMEDA Pharmaceuticals Switzerland GmbH MEDA Pharmaceuticals Switzerland GmbH Switzerland

Information update date: & nbsp2015-11-26

Illustrated instructions

Instructions

Novopulmon E Novolayzer® (Novopulmon E Novolizer®)