Berotek n spray ing. scrapper. 100mcg / dose 10ml 200doz

$9.50

Berotek n spray ing. scrapper. 100mcg / dose 10ml 200doz

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SKU: 1741437969 Categories: , Tags: ,

Description

Composition
Active substance:
1 dose contains 100 mg of fenoterol hydrobromide (0.100 mg) ;.
Excipients:
Citric acid anhydrous 0.001 mg, 1.040 mg purified water, absolute ethanol 15.597 mg tetrafluoroethane (HFA 134a, propellant) 35.252 mg.
Description:
Transparent, colorless or pale yellow, or light brown-colored liquid, free from suspended particles.
Product form:
Aerosol for inhalation dose of 0.1 mg / dose. 10 ml (200 doses) in a metal canister with an aerosol valve and dispensing steps with the mouthpiece protective cap with the company logo. Balloon with instructions for use in a cardboard box.
Contraindications
Hypersensitivity to fenoterolu or any of the excipients of the drug, hypertrophic obstructive cardiomyopathy, tachyarrhythmia, children up to 4 years.
Carefully
Under the following conditions berotek H should be used only after careful evaluation of good / treatment risk, especially if the applied maximum recommended dose: hyperthyroidism, hypokalemia, insufficiently controlled diabetes, recent myocardial infarction (within the last 3 months), heavy organic heart disease and vessels, such as chronic heart failure, coronary heart disease, coronary artery disease, heart disease (including aortic stenosis) expressed hitting Nia cerebral and peripheral arterial disease, pheochromocytoma. Since the information on the application of the drug in children under the age of 6 years is limited, the treatment is carried out with caution, only under medical supervision.
Indications
Bronchial asthma or other condition with reversible airway obstruction, chronic bronchitis, chronic obstructive pulmonary disease. Prevention of asthma attacks due to physical stress.
Interaction with other drugs
Beta-adrenergic agents, anticholinergics, xanthine derivatives (such as theophylline), cromoglicic acid, diuretics and corticosteroids may enhance the effect and side effects of fenoterol. Hypokalemia caused by beta2 agonists may be enhanced concomitant therapy xanthine derivatives, corticosteroids and diuretics. This is especially to be taken into account in patients with severe airway obstruction patients (see. Section “Special instructions”). Perhaps a significant reduction in bronchodilation while the use of beta-blockers. Beta-adrenoceptor agonists should be used with caution in patients receiving monoamine oxidase inhibitors or tricyclic antidepressants, which are able to enhance the effect of beta-adrenoceptor agonists. Inhalation funds for general anesthesia such as halothane, trichlorethylene and enflurane, increases the likelihood of exposure to agonists of the beta-adrenergic receptors in the cardiovascular system.
Overdose
Symptoms: The symptoms of overdose are expected symptoms caused by excessive beta-adrenergic stimulation. The most prominent are tachycardia, palpitations, tremors, decreased or increased blood pressure, increased pulse pressure, angina, arrhythmias, flushing of the face. Metabolic acidosis and hypokalemia also observed when applying fenoterol at doses exceeding the recommended doses for approved indications.
Treatment: drug treatment berotek H should be discontinued. It is to monitor the acid-base balance and electrolyte balance. For the treatment used sedatives; in severe cases, intensive symptomatic therapy. As specific antidotes may be administered beta-blockers (preferably, selective beta1-adrenergic blockers); At the same time, we should consider the possibility of strengthening of bronchial obstruction and carefully titrate doses of these drugs in patients with bronchial asthma.
pharmachologic effect
Pharmacological group:
Bronchodilatory means – selective beta2-agonists.
Pharmacodynamics:
Berotek H is an effective bronchodilator for the prevention and cupping bronchoconstriction in bronchial asthma and other conditions involving reversible airway obstruction such as chronic obstructive bronchitis (with or without emphysema). Fenoterol is a selective beta2-adrenergic stimulant in the therapeutic dose range. Stimulation of the beta1-adrenergic receptor occurs at higher doses of the drug. Binding of c-beta2 adrenoceptors activates adenylate cyclase through a stimulatory GS-protein with a consequent increase in the formation of cyclic adenosine monophosphate (cAMP), which activates protein kinase A, myosin latter deprives the ability to connect to actin, which causes relaxation of smooth muscles.
Fenoterol relaxes bronchial smooth muscle and blood vessels and protects against bronchoconstrictor stimuli such as histamine, methacholine, cold air and allergens (early response). Furthermore, fenoterol inhibits the release of mast cell bronchoconstrictor and inflammatory mediators. Amplification mucociliary clearance demonstrated after applying fenoterol (at a dose of 0.6 mg).
Due to the stimulatory effect on beta1-adrenergic receptors fenoterol may have effects on the myocardium (especially in doses exceeding therapeutic), causing increased frequency and increased heart rate. Fenoterol quickly relieves bronchospasm different genesis. Bronchodilation develops within a few minutes after inhalation and lasts 3-5 hours. Fenoterol also protects against bronchoconstriction, which occurs under the influence of different stimuli, such as exercise, cold air and allergens (early response).
Pharmacokinetics:
Absorption: after inhalation of 10-30% active substance released from aerosol formulation reaches the lower airways depending on inhalation devices and systems used by inhalation. The rest of the deposited in the upper respiratory tract and in the mouth and then swallowed. The absolute bioavailability after inhalation of fenoterol berotek metered aerosol H is 18.7%. Absorption of light fenoterol biphasic: 30% of the dose is absorbed rapidly (half-life time of 11 min), and 70% – slowly (half-life 120 minutes). Maximum plasma concentration after inhalation of 200 mg of fenoterol is 66.9 pg / ml (tmax of 15 min). Following oral administration of approximately 60% of absorbed dose fenoterol hydrobromide. The absorbed amount undergoes extensive first phase metabolism in the liver, resulting in an oral bioavailability of approximately 1.5%, and its contribution to the concentration of fenoterol in the plasma after inhalation of a small
Distribution: the distribution of fenoterol in the plasma after intravenous administration adequately describes the three-chamber pharmacokinetic model (half-life of talfa = 0.42 min, tbeta = 14.3 min and tgamma = 3.2 h). The distribution fenoterol at constant concentration after intravenous administration (Vss) is 1.9-2.7 l / kg, binding to plasma proteins – from 40 to 55%.
Biotransformation: fenoterol undergoes extensive metabolism in the liver by conjugation to glucuronides and sulfates. Fenoterol swallowed portion of the dose is metabolized mainly by sulfation. This metabolic inactivation of the starting material begins in the intestinal wall.
Excretion: fenoterol excreted by the kidneys and the bile as inactive sulfate conjugates. Biotransformation, including selection with bile, subjected to main part – about 85%. Isolation from urine fenoterol (0.27 l / min) corresponds to approximately 15% of the mean total clearance systemically available dose. Displacement renal clearance indicates fenoterol tubular secretion in addition to glomerular filtration. After inhalation of 2% of the dose excreted through the kidneys in unchanged form within 24 hours. Fenoterol hydrobromide in an unmodified form may penetrate through the placental barrier and fall into breast milk.
Pregnancy and breast-feeding
Pregnancy: Results of pre-clinical studies in combination with the available clinical experience of the drug showed no adverse effects during pregnancy. However, care should be taken to use the drug during pregnancy, especially during the first trimester, in the case if the potential benefit to the mother outweighs the potential risk to the fetus. It should take into account the inhibitory effect of fenoterol on uterine activity.
Breastfeeding: Preclinical studies have shown that fenoterol passes into breast milk. Safety of the drug during breast-feeding has not been studied. Caution must be exercised when using the drug during breastfeeding
Fertility: The clinical data on the effects of fenoterol on fertility are not available. Preclinical studies fenoterol showed no adverse effects on fertility.
Conditions of supply of pharmacies
Prescription.
side effects
Like all other types of inhalation treatment, the drug berotek H can cause symptoms of local irritation. The frequency of adverse reactions that can occur during treatment is shown by the following grading: very often (> 1/10); common (> 1/100,
special instructions
Paradoxical bronchospasm: like other inhalants, berotek H may cause paradoxical bronchospasm that may be life-threatening. In the event of paradoxical bronchospasm drug should be immediately repealed and replaced by an alternative therapy
Effects from cardiovascular system: effects on the part of the cardiovascular system can be observed in the application of sympathomimetic drugs, including drug berotek N. There is evidence of post-marketing studies and published in the literature about the rare cases of myocardial ischaemia associated with beta agonists. Background Patients with severe heart disease (e.g., ischemic heart disease, arrhythmia or severe heart failure), drug receiving berotek H should be warned to seek medical assistance in the event of chest pain or a worsening of heart disease. We should pay attention to the assessment of symptoms such as shortness of breath and chest pain, as they may be either respiratory or cardiac in nature.
Hypokalemia: potentially serious hypokalaemia may develop as a result of beta2-agonist therapy. Exercise caution is recommended in severe asthma as hypokalemia can potentiate concomitant therapy xanthine derivatives, corticosteroids and diuretics. Additionally, hypoxia may enhance the effect of hypokalaemia on cardiac rhythm. Hypokalemia can lead to increased susceptibility to arrhythmias in patients receiving digoxin. In such situations, it is recommended to monitor serum potassium.
Acute progressive dyspnea: The patient should be advised to seek immediate medical attention in the event of acute, rapidly increasing dyspnea.
regular use
Relief of attacks of bronchial asthma (symptomatic treatment) is preferable to regular use of the drug;
Patients should be examined to identify the need for assigning or increased antiinflammatory therapy (e.g., inhaled corticosteroids) to control airway inflammation and prevention of delayed lung injury.
In the event the bronchial obstruction is unacceptable and can be risky increase multiplicity receiving beta2-adrenergic agonists such as Berotec formulation H in excess of the recommended doses and for a long time. The use of high doses of beta 2-agonists such as Berotec H drug on a regular basis to control symptoms of bronchial obstruction may indicate a worsening of disease control. In such a situation it is necessary to revise the treatment plan and, in particular, the adequacy of anti-inflammatory therapy to prevent potentially life-threatening deterioration of disease control.
Sharing with anticholinergic bronchodilators and sympathomimetic: other sympathomimetic bronchodilators should be used together with the drug berotek H only under medical supervision. Anticholinergic bronchodilators can be inhaled simultaneously with the preparation berotek H
Effect on laboratory results: the use of the drug berotek H can lead to positive results of tests for the presence of fenoterol in abusing drugs for non-medical research, for example, due to increased physical capacity in athletes (doping). It will be appreciated that the preparation contains a small amount of ethanol (15.597 mg per dose).
Effect on ability to drive and use machines: study the effects of the drug on the ability to road management and use has not been mechanisms. However, in the course of the clinical studies were observed symptoms such as dizziness. Therefore, we recommend caution in the road time management or the use of mechanisms.
Storage conditions
At a temperature of not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Dose for adults and children over 6 years
Bronchial asthma, and other conditions, accompanied by reversible airway obstruction
In most cases, for the relief of bronchospasm, only one inhalation dose. If within 5 minutes of relief of breathing does not come, you can repeat the inhalation.
If there is no effect after two doses of inhaled, and requires additional inhalation should immediately seek medical help. The maximum permissible dose for the day – 8 inhaled doses.
Prevention of asthma attacks due to physical exertion 1-2 inhaled doses up exercise, inhaled up to 8 doses per day.
In children aged 6 to 12 years berotek H medication should be used only after consulting a doctor and under adult supervision.
Doses for children from 4 to 6 years
Bronchial asthma, and other conditions, accompanied by reversible airway obstruction
For the relief of bronchospasm, only one inhalation dose.
If there is no effect, you should immediately seek medical help.
Prevention of asthma attacks due to physical exertion one inhalation dose before exercise, inhaled to 4 doses per day.
For children aged 4 to 6 years berotek H medication should be used only after consulting a doctor and under adult supervision
To prepare a new inhaler for use, remove the cap, turn the inhaler Donets up and make two injection into the air (double-click on the bottom of the cartridge).
Each time you use the inhaler, follow these instructions: 1. Remove the protective cap. 2. Make full exhalation. 3. Hold the canister firmly clasp the mouth mouthpiece. The bottom of the inhaler drawn up. 4. Making the most deep breath at the same time strongly pressed to the bottom of the cartridge to release the inhalation dose. For a few seconds to hold his breath, and then remove the mouthpiece mouth and exhale slowly.
If you need to re-inhalation, repeat the same procedure (steps 2-4). 5. Wear protective cap. 6. If the inhaler has not been used for more than three days, which should be pressed once to the bottom of the cartridge.
Since the container is opaque, it is impossible to determine visually whether the tank is empty. The balloon is designed for 200 inhalations. After use, this amount small amount of solution may remain in the dose container. However, the inhaler should be replaced, since otherwise you may not get the required therapeutic dose.
The amount of drug in the cartridge can be determined as follows: removing the protective cap, the cartridge is immersed in a container filled with water. The amount of drug is determined depending on the position of the cartridge in the water (see. Instructions for use)
The inhaler should be cleaned at least once a week.
It is important to keep the mouthpiece of your inhaler clean to medication is not accumulated and does not block spray.
For cleaning, remove the cap and remove the canister from the inhaler. Wash the inhaler body with warm water to remove the accumulated drug or visible contamination.
After cleaning, shake the inhaler and let it dry in the air without the use of heating devices. When the mouthpiece is dry, return to the place of the can and cap.
WARNING: a plastic mouthpiece is specifically designed for drug
Berotek N and serves for precise dosing of the drug. The mouthpiece should not be used with other metered aerosol. Also, use of the drug can not be
H berotek with any other adapters except mouthpiece provided with the drug.
The cylinder is pressurized. The container must not be opened and exposed to heat above 50 ° C.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

Behringer

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