Seretid - instructions for use, doses, side effects, contraindications

Name of component	Content in a single dose
Name of component	25 μg + 50 μg / dose	25 μg + 125 μg / dose	25 μg + 250 μg / dose
*Active substances*
Salmeterol xinafoate (in terms of salmeterol)^1,2	363 μg	36.3 μg	363 μg
Fluticasone propionate¹	50.0 μg	125.0 μg	250.0 μg
*Excipient*
1,1,1,2-tetrafluoroethane	up to 75.0 mg	up to 75.0 mg	up to 75.0 mg

Notes:

1. The composition includes an excess of up to 10% salmeterol xinafoate and up to 15% fluticasone nropionate to compensate for losses during production and in the dispenser inside the inhaler (in the above composition, the excess is not taken into account).

2. 36.3 μg of salmeterol xinafoate is equivalent to 25 μg of salmeterol.

Description:A nebulizer and a metal inhaler with a concave bottom sealed by a metering valve.The surface of the inhaler and the valve should not have visible defects. The contents of the inhaler are a suspension of white or almost white color.

Pharmacotherapeutic group:Bronchodilator (beta2-adrenomimetic selective + glucocorticosteroid local).

ATX: & nbsp

R.03.A.K Sympathomimetics in combination with corticosteroids or other drugs, excluding anticholinergic drugs

R.03.A.K.06 Salmeterol and fluticasone

Pharmacodynamics:

Mechanism of action

The drug Seretide® is a combined preparation that contains salmeterol and fluticasone propionate, which have different mechanisms of action. Salmeterol prevents the appearance of symptoms of bronchospasm, fluticasone propionate improves pulmonary function and prevents the exacerbation of the disease. Seretide®, because of its more convenient dosage regimen, can be an alternative for patients who simultaneously receive a beta2-adrenoreceptor agonist and an inhaled glucocorticosteroid (GCS) from different inhalers.

Salmeterol is a selective long-acting (up to 12 h) beta2-adrenergic receptor agonist, which has a long side chain that binds to the receptor's outer domain.

Pharmacological properties of salmeterol provide more effective protection against histamine-induced bronchoconstriction and longer bronchodilation (duration of at least 12 hours) than short-acting beta2-adrenoreceptor agonists.

In vitro The research showed that salmeterol is a potent inhibitor of the release from the human lungs of mast cell mediators, such as histamine, leukotrienes and prostagpandin D2, and has an extended period of action. Salmeterol oppresses the early and late phases of the response to inhaled allergens. The inhibition of the late phase of the response persists for more than 30 hours after taking a single dose, while the bronchodilator effect is no longer present. Single administration of salmeterol weakens the hyperreactivity of the bronchial tree. This indicates that salmeterol in addition to bronchodilating activity has an additional effect, not associated with the expansion of bronchi, the clinical significance of which has not been finally established. This mechanism of action is different from the anti-inflammatory effect of GCS.

Fluticasone propionate belongs to the GCS group for topical application and, when inhaled at recommended doses, it has a pronounced anti-inflammatory and anti-allergic effect in the lungs, which leads to a decrease in clinical symptoms, a decrease in the frequency of exacerbations of bronchial asthma. Fluticasone propionate does not cause undesirable phenomena, which are observed with systemic intake of corticosteroids.

With prolonged use of inhalation fluticasone propionate, the daily secretion of adrenal cortex hormones remains within normal limits in both adults and children, even when used at the maximum recommended doses. After transferring patients receiving other inhaled glucocorticosteroids to the administration of fluticasone propionate, the daily secretion of adrenal cortex hormones gradually improves, despite the previous and current recurrent use of oral steroids. This indicates the restoration of the adrenal function against the background of the inhalation application of fluticasone propionate. With prolonged use of fluticasone propionate, the reserve function of the adrenal cortex also remains within the normal range,as evidenced by a normal increase in cortisol production in response to appropriate stimulation (it must be borne in mind that the residual decrease in adrenal reserve caused by previous therapy may persist for a long time).

Pharmacokinetics:

There is no evidence that when combined inhalation salmeterol and fluticasone propionate affect the pharmacokinetics of each other, and therefore the pharmacokinetic characteristics of each component of the Seretide® preparation can be considered separately.

A study conducted with the participation of 15 healthy volunteers who simultaneously received salmeterol (inhalation 50 μg twice a day) and inhibitor of isoenzyme CYP3A4 - ketoconazole (oral 400 mg once a day) for 7 days showed a significant increase in salmeterol concentration in blood plasma (Cmax increase 1.4 times and AUC 15-fold). There was no increase in salmeterol accumulation when taking repeated doses. In 3 patients, treatment was canceled because of prolongation of the QTc interval or rapid heart rate with sinus tachycardia.In the remaining 12 patients, simultaneous use of salmeterol and ketoconazole did not have a clinically significant effect on heart rate, potassium level in the blood, or the duration of the QTc interval (see the sections "With caution", "Special instructions and precautions for use", "Interaction with other medicinal products ").

Suction

Salmeterol acts locally in the lung tissue, so its content in the blood plasma is not an indicator of therapeutic effects. Data on its pharmacokinetics are very limited due to technical problems: when inhaled in therapeutic doses, its maximum plasma concentration is extremely low (about 200 pg / ml and below). After regular inhalation of salmeterol xinafoate, it is possible to detect hydroxynaphthoic acid in the blood, the equilibrium concentrations of which are about 100 ng / ml. These concentrations are 1000 times lower than the equilibrium concentrations observed in the toxicity studies. No adverse effects were observed with prolonged regular use (for more than 12 months) in patients with airway obstruction.

Fluticasone propionate: the absolute bioavailability of inhalation fluticasone propionate in healthy people varies depending on the inhaler used, when a combination of salmeterol and fluticasone propionate is administered using a metered aerosol for inhalations it is 5.3%. In patients with bronchial asthma and chronic obstructive pulmonary disease (COPD), lower concentrations of fluticasone propionate in blood plasma are observed. Systemic absorption occurs mainly through the lungs. At first it is faster, but then its speed slows down.

Part of the inhalation dose can be swallowed, but this part contributes minimal contribution to systemic absorption due to the low solubility of fluticasone propionate in water and due to its pre-systemic metabolism; bioavailability from the gastrointestinal tract is less than 1% - As the inhalation dose increases, a linear increase in the concentration of fluticasone propionate in the blood plasma is observed.

Distribution

There is no data on the distribution of salmeterol.

Fluticasone propionate has a large volume of distribution in the equilibrium state (about 300 liters) and has a relativelya high degree of binding to plasma proteins (91%).

Metabolism

The results of the in vitro study showed that salmeterol Extensively metabolized under the action of the CYP3A4 isoenzyme of the cytochrome P450 system to a-hydroxysalmeterol by aliphatic oxidation. In a study with repeated dosing of salmeterol and erythromycin, healthy volunteers did not have clinically significant changes in pharmacodynamic effects when taking 500 mg of erythromycin 3 times a day. However, the study of the interaction of salmeterol and ketoconazole showed a significant increase in the concentration of salmeterol in the blood plasma (see sections "Special instructions and precautions for use", "Interaction with other medicinal products").

Fluticasone propionate is rapidly eliminated from the blood, mainly as a result of metabolism under the action of the CYP3A4 isoenzyme of the cytochrome P450 system to the inactive carboxyl metabolite. Caution should be exercised while using known inhibitors of CYP3A4 and fluticasone propionate, since in such situations it is possible to increase the content of the latter in plasma. Excretion

There is no data on salmeterol excretion.

The distribution of fluticasone propionate is characterized by a rapid clearance from the plasma (1150 ml / min) and a final half-life of about 8 hours. The renal clearance of unchanged fluticasone propionate is negligible (<0.2%), a metabolite with urine displays less than 5% of the dose.

Indications:

The drug Seretide® is intended for regular treatment of bronchial asthma if combined therapy with long-acting beta2-adrenomimetic and inhaled glucocorticosteroid is indicated:

- patients with insufficient control of the disease against the background of continuous monotherapy with inhaled glucocorticosteroids in the periodical use of short-acting beta2-adrenomimetics,

- patients with adequate control of the disease on the background of therapy with inhaled glucocorticosteroid and long-acting beta2-adrenomimetic,

- as a starting maintenance therapy in patients with persistent bronchial asthma in the presence of indications for the appointment of glucocorticosteroids to achieve control of the disease.

The drug Seretide® is intended for maintenance therapy in patients with COPD with the value of forced expiratory flow (FEV1) <60% of the proper values (before inhalation bronchodilator) and repeated exacerbations in the history, in which the expressed symptoms of the disease persist despite regular therapy with bronchodilators.

Contraindications:

- Hypersensitivity to the components of the drug;

- children's age up to 4 years.

Carefully:

Like all other inhaled preparations containing GCS, Seretide® should be used with caution in patients with acute or latent pulmonary tuberculosis. Seretide® should be given with caution in thyrotoxicosis. Seretide ® should be used with caution in fungal, viral or bacterial infections of the respiratory system.

When taking any drugs group of sympathomimetics, especially when the therapeutic dose is exceeded, it is possible to develop cardiovascular events such as an increase in systolic blood pressure and heart rate. For this reason, Seretide® should be administered with caution to patients,suffering from cardiovascular diseases, including with arrhythmias, such as supraventricular tachycardia and extrasystole, ventricular extrasystole, atrial fibrillation.

All simpatomimeticheskie drugs in dosages exceeding the therapeutic, can cause a transient decrease in the level of potassium in the serum. Therefore, Seretide® should be used with caution in patients with hypokalemia. Any inhaled GCS can cause systemic effects, especially with prolonged use in high doses. Therefore, the drug should be used with caution in glaucoma, cataracts, osteoporosis (see section "Special instructions and precautions for use").

There are very rare reports of an increase in blood glucose, so patients with diabetes should use the drug Seretide ® with caution (see section "Side effects").

Pregnancy and lactation:

Pregnant women and women should be prescribed lactation only if the expected benefit to the mother exceeds any possible risk to the fetus or child.

There is insufficient data on the use of salmeterol and fluticasone propionate in pregnancy and lactation.

Pregnancy

Reproductive toxicity of the drug and its components was studied during preclinical studies. Excessive systemic concentration of active beta2-adrenomimetic and GCS affects the fetus.

Extensive experience in the clinical use of drugs of this class indicates that with the use of therapeutic doses, the described effects are not clinically significant. Salmeterol and fluticasone propionate do not possess genotoxicity.

Lactation

The concentration of salmeterol and fluticasone propionate in blood plasma after inhaling the drug in therapeutic doses is extremely low, so their concentration in breast milk should be the same low. This is confirmed by studies in animals in the milk of which low concentrations of salmeterol and fluticasone propionate were measured. There is no data on the concentration of salmeterol and fluticasone propionate in breast milk of women during lactation.

Dosing and Administration:

The drug Seretide® is for inhalations only.

The patient should be informed that to obtain the optimal effect the drug should be used regularly, even in the absence of clinical symptoms of bronchial asthma and COPD.

The physician should regularly evaluate the effectiveness of the patient's treatment

Determining the duration of the course of therapy and changing the dose of the drug is possible only on the advice of a doctor.

Bronchial asthma

The dose of Seretide® should be reduced to the lowest dose, which provides effective control of symptoms.

If taking Seretide® 2 times a day provides control over the symptoms, within the dose reduction to minimally effective it is possible to reduce the frequency of taking the drug up to 1 time per day.

The patient should be prescribed a form of Seretide®, which contains a dose of fluticasone propionate, corresponding to the severity of his disease. If therapy with inhaled glucocorticosteroids does not provide adequate control over the disease, then replacing them with Seretide® at a dose therapeutically equivalent to the dose of glucocorticosteroids administered can improve asthma control. In patients who can monitor the course of asthma exclusively with the help of inhaled GCS,their replacement with Seretide® can help reduce the dose of GCS necessary to control the course of asthma.

Recommended doses

Adults and children 12 years and older

Two inhalations (25 μg salmeterol and 50 μg fluticasone propionate) 2 times a day,

two inhalations (25 μg salmeterol and 125 μg fluticasone propionate) 2 times a day,

two inhalations (25 μg salmeterol and 250 μg fluticasone propionate) 2 times a day. Children 4 years and over

Two inhalations (25 mcg salmeterol and 50 mcg fluticasone propionate) 2 times a day. Currently, there is no data on the use of Seretide® in children under 4 years of age.

Chronic obstructive pulmonary disease (COPD)

For adult patients, the maximum recommended dose is 2 inhalations (25 μg salmeterol and 250 μg fluticasone propionate) 2 times a day.

Special patient groups

There is no need to reduce the dose of Seretide ® in elderly patients, as well as in patients with impaired renal or hepatic function.

INSTRUCTION FOR USE OF THE INHIBITOR

Checking the inhaler

Before the first use of the inhaler, or in the event that the inhaler has not been used for a week or more, remove the cap from the mouthpiece,slightly squeezing the cap from the sides, hold the inhaler between the thumb and the other fingers of one hand, so that the thumb is placed on the base under the mouthpiece, shake the inhaler well and discharge two jets into the air to make sure that the inhaler is working. Use of an inhaler

1. Remove the cap from the mouthpiece, slightly squeezing the cap from the sides.

2. Inspect the inhaler from the outside and inside, including the mouthpiece, for the detection of foreign objects.

3. Shake the inhaler well to ensure that any foreign objects are removed and that the contents of the inhaler are evenly mixed.

4. Take the inhaler between the thumb and the other fingers of one hand vertically upside down, with the thumb on the base under the mouthpiece.

5. Exhale as deeply as possible, then put the mouthpiece in the mouth between your teeth, closing your lips around it, but not biting the mouthpiece.

6. Immediately after inhalation through the mouth, press the top of the inhaler to spray the Seretide®, while continuing to inhale deeply and slowly.

7.Holding the breath, remove the inhaler from the mouth and remove the finger from the top of the inhaler. Continue to hold your breath as long as possible.

8. For the second spray, hold the inhaler vertically and repeat steps 3-7 approximately after 30 seconds.

9. After using the inhaler, rinse the mouth with water and then spit it out.

10. Immediately close the mouthpiece cap by pressing and snapping in the desired position. If no snapping occurs, rotate the mouthpiece cap and try to close the mouthpiece again. Do not force the cap. The drug can also be administered via

spacer.

Attention!

Performing stages 5, 6 and 7, you can not hurry. Start inhaling as slowly as possible, just before pressing the inhaler valve. The first few times it is recommended to practice before the mirror. If you see a "fog" coming from the top of the inhaler or from the corners of the mouth, then you should start all over again, beginning from step 2. If the doctor gave you other instructions for using the inhaler, then strictly observe them. Contact your doctor if you have difficulty using the inhaler.

Children

To small children may require assistance with the use of an inhaler, and adults should help them. Wait for the child to breathe out and bring the inhaler into operation at the time of inspiration. Practice using the inhaler along with the baby. Children are more old age and adults with weak hands should keep the inhaler with both hands. Thus both index fingers should settle down on the top part of an inhaler, and both greater fingers - on the basis below a mouthpiece.

Cleaning the inhaler

The inhaler should be cleaned at least once a week.

1. Remove the protective cap from the mouthpiece.

2. Do not remove the metal can from the plastic casing.

3. A dry fabric or wipe with a cotton swab and a plastic mouthpiece cover inside and outside.

4. Close the mouthpiece with a protective cap.

Do not immerse the metal can into the water.

Side effects:

All the undesirable reactions presented below are characteristic for the active substances - salmeterol and fluticasone propionate alone. The profile of undesirable reactions of the drug Seretide® does not differ from the profile of undesirable reactions of its active substances.

The undesirable reactions presented below,are listed in accordance with the damage to organs and organ systems and frequency of occurrence. Frequency of occurrence is defined as follows: very often (> 1/10), often (>1/100 and <1/10), infrequently (> 1/1 000 and <1/100), rarely (> 1/10 000 and <1/1 000), very rarely (<1/10 000, including individual cases). Frequency categories were formed on the basis of clinical

drug research and post-registration surveillance.

Clinical Trials Data

Frequency of occurrence of undesirable reactions

Infectious and parasitic diseases

Often: candidiasis of the oral cavity and pharynx, pneumonia (in patients with COPD).

Rarely: Candidiasis of the esophagus.

Immune system disorders

Hypersensitivity reactions

Infrequent: skin reactions of hypersensitivity, dyspnea.

Rarely: anaphylactic reactions.

Disorders from the endocrine system

Possible systemic effects include (see the sections "With caution" and "Special instructions"):

Infrequently: cataract.

Rarely: glaucoma.

Disorders from the metabolism and nutrition

Infrequently: hyperglycemia.

Very rarely: hypokalemia.

Disorders of the psyche

Infrequently: anxiety, sleep disturbances.

Rarely: changes in behavior, including increased activity and irritability (especially in children).

Disturbances from the nervous system

Often: headache (see section "Special instructions").

Infrequently: tremor (see section "Special instructions").

Heart Disease

Infrequently: heart palpitations (see "With caution" and "Special instructions"), tachycardia, atrial fibrillation.

Rarely: arrhythmia, including ventricular extrasystole, supraventricular tachycardia and extrasystole.

Violations from the respiratory system, chest organs and the mediastinum

Often: hoarseness of voice and / or dysphonia.

Infrequently: irritation of pharynx.

Disturbances from the skin and subcutaneous tissues

Infrequent: bruising.

Disturbances from musculoskeletal and connective tissue

Often: muscle spasms, arthralgia.

Post-registration data

Frequency of occurrence of undesirable reactions

Immune system disorders

Hypersensitivity reactions

Rarely: angioedema (mainly, edema of the face and oropharynx), bronchospasm.

Disorders from the endocrine system

Possible systemic effects include (see the sections "With caution" and "Special instructions"):

Rarely: Cushing's syndrome, cushingoid symptoms, suppression of adrenal function, growth retardation in children and adolescents, reduction of bone mineral density.

Disturbances from the respiratory system, chest and mediastinal organs

Rarely: paradoxical bronchospasm (see section "Special instructions").

Overdose:

It is not recommended to administer the drug at doses exceeding those specified in the section "Method of administration and dose". It is very important to regularly review the patient's dosage regimen and reduce the dose to the lowest recommended dose, which provides effective control

over the disease ("Mode of administration and dose").

Symptoms

The expected symptoms and signs of an overdose of salmeterol are typical for excessive beta2-adrenergic stimulation, and include tremor, headache, tachycardia, increased systolic blood pressure, and hypokalemia. Acute overdose of fluticasone

propionate with inhalation can provoke a temporary suppression of the hypothalamic-pituitary-adrenal system. Usually this does not require the adoption of any emergency measures, since the normal function of the adrenal glands is restored within a few days.

When taking the drug in doses above the recommended for a long period of time, a significant suppression of the function of the adrenal cortex is possible. Rare cases of acute adrenal crisis, which occurred mainly in children who received doses of the drug above recommended for a long time (several months or years), are described. Acute adrenal crisis is manifested by hypoglycaemia, accompanied by confusion and / or convulsions. Situations that can serve as triggers for an acute adrenal crisis include trauma, surgery, infection, or any rapid reduction in the dose of inhaled fluticasone propionate, which is part of the Seretide® preparation.

Treatment

There is no specific treatment for an overdose of salmeterol and fluticasone propionate. In case of an overdose, supportive therapy should be followed and the patient's condition monitored. In chronic overdose, it is recommended to monitor the reserve function of the adrenal cortex.

Interaction:

Because of the risk of developing bronchospasm, selective and nonselective beta-blockers should be avoided, unless they are extremely necessary for the patient.

In usual situations, inhalations of fluticasone propionate are accompanied by low plasma concentrations due to intensive metabolism in the "first" passage and high systemic clearance under the influence of the CYP3A4 isoenzyme of the cytochrome P450 system in the intestine and liver. Due to this, clinically significant interactions involving fluticasone propionate are unlikely.

The study of drug interactions in healthy volunteers showed that ritonavir - a highly active inhibitor of the isoenzyme CYP3A4 - can cause a sharp increase in the concentration of fluticasone propionate in the plasma, resulting in a significant decrease in serum cortisol concentrations. During post-registration observations, clinically significant drug interactions were reported in patients who simultaneously received fluticasone propionate (intranasally or by inhalation) and ritonavir. These interactions caused systemic side effects peculiar to SCS, such as Cushing's syndrome and suppression of adrenal function. Given this, simultaneous use of fluticasone propionate and ritonavir should be avoided, unless the potential benefit to the patient exceeds the risk of systemic side effects of GCS.

Studies have shown that other inhibitors of the CYP3A4 isoenzyme cause negligible (erythromycin) and insignificant (ketoconazole) an increase in the content of fluticasone propionate in plasma, in which the concentrations of serum cortisol are practically not reduced. Nevertheless, caution should be exercised when using fluticasone propionate and strong inhibitors of CYP3A4 (eg, ketoconazole), since such combinations do not exclude the possibility of an increase in the concentration of fluticasone propionate in the plasma, which can potentially increase the systemic effects of fluticasone propionate.

When studying the interaction of drugs, it was found that the use of ketoconazole as a concomitant systemic therapy significantly increases the concentration of salmeterolin blood plasma (an increase of Cmax by 1.4 times and AUC by 15 times). This can lead to an elongation of the QTc interval. Caution should be exercised when co-administration of strong inhibitors of CYP3A4 (eg, ketoconazole) and salmeterol.

The derivatives of xanthine, GCS and diuretics increase the risk of hypokalemia (especially in patients with exacerbation of bronchial asthma, hypoxia). Monoamine oxidase inhibitors and tricyclic antidepressants increase the risk of developing side effects from the cardiovascular system. The drug Seretide® is compatible with cromoglycic acid.

Special instructions:

The drug Seretide® is not intended to alleviate acute symptoms, since in such cases a rapid and short-acting inhalation bronchodilator (eg, salbutamol). Patients should be informed that they always have at hand a drug to stop acute symptoms. The combination of salmeterol with fluticasone propionate can be used for initial maintenance therapy in patients with persistent asthma (daily occurrence of symptoms or daily use of remediesseizures) in the presence of indications for the appointment of glucocorticosteroids and when determining their approximate dosage. The more frequent use of short-acting bronchodilators to relieve symptoms indicates a worsening of control over the disease, and in such situations the patient should consult a doctor.

The sudden and increasing deterioration in the control of bronchial asthma poses a potential threat to life, and in such situations, the patient should also consult a doctor. The doctor should consider the possibility of prescribing a higher dose of GCS. If the used dose of Seretide® does not provide adequate control over the disease, the patient should also consult a doctor. Patients with asthma should not abruptly stop treatment with Seretide® because of the risk of developing an exacerbation, the dose of the drug should be reduced gradually under the supervision of a doctor. In patients with COPD, the withdrawal of the drug may be accompanied by symptoms of decompensation and requires the supervision of a physician.

In clinical studies, data have been obtained on the increase in the incidence of pneumonia in patients with COPD receiving Seretide® (see "Side effect").Doctors should be aware of the possibility of developing pneumonia in COPD, as the clinical picture of pneumonia and exacerbations of COPD are often similar.

Any inhaled GCS can cause systemic reactions, especially with prolonged use in high doses; but the likelihood of such symptoms is much lower than when treated with oral GCS (see the section "Overdose"). Possible systemic reactions include Cushing's syndrome, cushingoid features, suppression of adrenal function, growth retardation in children and adolescents, reduction of bone mineral density, cataract and glaucoma. Therefore, in the treatment of asthma, it is important to reduce the dose to the lowest dose, which provides effective control over the disease.

In emergency and planned situations that can cause stress, it is always necessary to remember the possibility of suppressing the function of the adrenal gland and be ready for use by the GCS (see section "Overdose").

When carrying out resuscitation measures or surgical interventions, it is required to determine the degree of adrenal insufficiency. It is recommended to regularly measure the growth of children who receive prolonged therapy with inhaled glucocorticosteroids.Because of the possibility of adrenal suppression, patients transferred from oral corticosteroids to inhalation of fluticasone propionate therapy should be treated with extreme caution and regular monitoring of their function of the adrenal cortex.

After initiation of treatment with inhaled fluticasone propionate, systemic GCS should be discontinued gradually, and such patients should carry a special patient card containing an indication of the possible need for additional administration of SCS in stressful situations. In patients with exacerbation of bronchial asthma, hypoxia, it is necessary to monitor the concentration of K + ions in the plasma.

There are very rare reports of an increase in blood glucose levels, and this should be borne in mind when appointing a combination of salmeterol with fluticasone propionate in patients with diabetes mellitus (see section "Side effect").

During the post-registration period, reports of a clinically significant drug interaction between fluticasone propionate and ritonavir resulted in systemic effects of GCS, including Cushing's syndrome and suppression of adrenal function.Therefore, the simultaneous use of fluticasone propionate and ritonavir should be avoided, unless the potential benefit to the patient exceeds the risk associated with systemic effects of GCS (see "Interactions with Other Drugs").

A clinical study of the safety of salmeterol added to ongoing asthma therapy compared with placebo showed that the incidence of deaths due to bronchial asthma was significantly higher in the salmeterol group. When taking salmeterol compared with placebo, the risk of serious adverse reactions from the respiratory system or death in patients with African American origin, presumably, higher than in other patients. The importance of pharmacogenetic factors or other causes is unknown. The effect of the concomitant use of inhaled glucocorticosteroids on the risk of fatal outcomes in patients with asthma has not been studied in this study. Like other inhaled drugs, the drug Seretide® can cause a paradoxical bronchospasm, manifested by the increase of dyspnea immediately after use.In this case, a quick-and short-acting inhaled bronchodilator should be immediately applied, the Seretide® drug should be revoked, the patient should be examined and, if necessary, an alternative therapy should be started (see "Side effect" section).

There are reports of adverse reactions associated with the pharmacological action of beta2-antagonists, such as tremor, subjective palpitation and headache. However, these reactions are of a short-term nature, and their severity decreases with regular therapy (see section "Side effect").

Effect on the ability to drive transp. cf. and fur:In clinical trials, no evidence of the effect of the drug on the ability to drive vehicles and other mechanisms has been obtained, but side effects that the drug may cause should be considered.

Form release / dosage:

The aerosol for inhalation is dosed, 25 μg + 50 μg / dose, 25 μg + 125 μg / dose, 25 μg + 250 μg / dose.

Packaging:

For 120 doses in an aluminum inhaler equipped with a plastic nebulizer with a protective cap. The inhaler and nebulizer, when assembled, together with the instructions for medical use, are placed in a cardboard box.

Storage conditions:

Store at temperatures not exceeding 30 ° C, do not freeze, do not expose to direct sunlight.

Keep out of the reach of children.

Shelf life:

2 years.

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

Terms of leave from pharmacies:On prescription

Registration number:П N015937 / 01

Date of registration:10.09.2009

The owner of the registration certificate:GlaxoSmithKline Trading, ZAO GlaxoSmithKline Trading, ZAO Russia

Manufacturer: & nbsp

GlaxoSmithKline Pharmaceuticals, S.A. Poland

GLAXO WELLCOME PRODUCTION France

Information update date: & nbsp17.08.2015

Illustrated instructions

Instructions

Seretide® (Seretide® )