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Seretid Multidisk 50g / 250g 60 doses for inhalation of metered powder

  • $63.30
Sku: eb6ac09d179a
The instruction for medical use

of Multidisk® Seretid® medicine

the Trade
name Seretid® Multidisk®

the International unlicensed name
Is not present

the Dosage form
Powder for inhalations of 50 mkg / 100 mkg, 60 doses
Powder for inhalations of 50 mkg / 250 mkg, 60 doses
Powder for inhalations of 50 mkg / 500 mkg, 60 doses

Composition of drug
One dose contains
active agents: salmeterol (in the form of a salmeterol of the ksinafoat) 50 mkg,
a flutikazona propionate of 100 mkg or 250 mkg or 500 mkg,
excipient - lactoses monohydrate

the Description
Powder of white color.

Pharmacotherapeutic group
Sympathomimetics in a combination with other drugs for treatment of obstructive respiratory diseases.
The code of automatic telephone exchange R03AK06

the Pharmacological

Pharmacokinetics Simultaneous Inhalation Introduction properties of a salmeterol and flutikazon of propionate does not influence pharmacokinetics of each of these substances.
Salmeterol
Salmeterol has local effect in bronchial tubes therefore its therapeutic effect does not depend on concentration in blood plasma.
Data on pharmacokinetics of a salmeterol are limited as it is technically difficult to define very low concentration of drug in plasma (200 pg/ml and less) after its inhalation introduction in therapeutic doses.
At regular use of an inhalation salmeterol of the ksinafoat in a system blood-groove hydroksinaftoyevy acid in concentration up to 100 ng/ml is defined that did not reveal negative impact on patients with obstruction at long-term use of drug (more than 12 months).
Flutikazona propionate
After inhalation introduction the absolute bioavailability of a flutikazon of propionate is 7.8% and 5.5% at use of a flutikazon in combination with salmeteroly. System absorption happens mainly in lungs. A part of the inhaled dose can be swallowed, but its systemic action is minimum owing to weak solubility of drug in water and intensive metabolism at the first passing through a liver. The bioavailability of a flutikazon of propionate at intake is less than 1%. There is a direct dependence between the size of the inhalated dose and systemic action of a flutikazon of propionate.
Flutikazona propionate has high plasma clearance (1150 ml/min.) and large volume of distribution (about 300 l). Time of semi-removal is about 8 h Flutikazon propionate possesses rather high extent of linking with proteins of blood plasma (91%).
Flutikazona propionate is quickly brought from a system blood-groove, mainly owing to biotransformation to an inactive carboxyl metabolite by means of an isoenzyme of CYP3A4 of a system of P450 cytochrome.
The renal clearance of a flutikazon of propionate is insignificant (& lt, 0.2%), in the form of a metabolite with urine less than 5% of a dose are removed. It is removed through digestive tract, mainly in the form of a hydroxylated metabolite.
A pharmacodynamics
of Seretid® Multidisk® – the combined drug which contains salmeterol and a flutikazona propionate, the actions possessing different mechanisms. Salmeterol prevents emergence of a bronchospasm, the flutikazona propionate improves function of external respiration and prevents aggravations.
Salmeterol
Salmeterol is selection is long acting (up to 12 h) the agonist of b2-adrenoceptors having a long side chain which contacts an outer domain of a b2-adrenoceptor. Salmeterol provides protection against the bronkhokonstriktion induced by a histamine and longer bronchodilatation (duration not less than 12 h), than agonists b2
adrenoceptors of short action. The beginning of effect comes within 10-20 minutes.
Salmeterol is strong and is long the operating release inhibitor from pulmonary tissue of the person of mediators of mast cells, such as histamine, leukotrienes and D2 prostaglandin.
Salmeterol oppresses early and late phases of the answer to the inhaled allergens: after introduction of one dose duration of the last phase lasts more than 30 h (time when the bronkhodilatiruyushchy effect is already absent). Single introduction of a salmeterol reduces hyperreactivity of bronchial tubes. These data demonstrate to what salmeterol, besides properties of bronchodilator, possesses additional action which clinical importance is not finalized. This mechanism of action differs from anti-inflammatory effect of glucocorticosteroids (GKS).
Flutikazona propionate
Treats the GKS group of local action and at inhalation introduction in the recommended doses has the significant anti-inflammatory and antiallergic effect in lungs that leads to reduction of expressiveness of symptoms and decrease in frequency of exacerbations of the diseases which are followed by obstruction of airways and also restores reaction of the patient to bronchodilators, allowing to reduce the frequency of their use.

Indications
Basic therapy of the diseases which are followed by reversible obstruction of airways (including bronchial asthma at children and adults) when purpose of combination therapy from bronchodilators and drugs from group of inhalation GKS is reasonable:
- at the patients receiving maintenance doses of agonists of beta adrenoceptors of long action and inhalation GKS
- at patients at whom disease symptoms against the background of therapy by inhalation GKS remain
- at the patients receiving regular treatment by bronchodilators and needing inhalation GKS.
Maintenance therapy at HOBL (chronic obstructive pulmonary disease) at adults, including chronic obstructive bronchitis and emphysema of lungs.

The route of administration and doses
of Seretid® Multidisk® is intended only for inhalations.
Seretid® Multidisk® can be an alternative for patients who at the same time receive agonist of b2-adrenoceptors and inhalation GKS from different inhalers.
The doctor establishes a course of treatment and doses of drug individually.
Patsiyentov it is necessary to inform that should be applied to achievement of the maximum effect of Seretid® Multidisk® regularly, even in the absence of disease symptoms.
Patients have to be exposed regularly to medical inspection for the purpose of maintenance of an optimum dose of Seretid® Multidisk®.
Reversible obstruction of airways
the Initial dose of drug has to be selected on the basis of a dose of a flutikazon of propionate which is recommended for treatment of a disease of this severity.
The dose of drug has to be titrated before definition of the minimum effective maintenance dose. At achievement of control of symptoms of a disease by purpose of the minimum maintenance dose twice a day, perhaps further titration of Seretid® Multidisk® for the purpose of prescribing of drug of 1 times a day.
At the patients who did not reach adequate control at use of exclusively inhalation GKS the replacement them on Seretid® Multidisk® can improve control over asthma course. At the patients who reached control by use of inhalation GKS, purpose of Seretida® Multidiska® can lower their dose for maintenance of adequate control.
Adults and children at the age of 12 years are also more senior
- one inhalation of 50/100 mkg two times a day or
- one inhalation of 50/250 mkg two times a day
- one inhalation of 50/500 mkg two times a day
Adult of 18 years and
Increase in a dose twice perhaps in cases when the patients receiving continuous therapy of Seretid® Multidisk® need additional inhalation glucocorticosteroid therapy during the short term of time is more senior (up to 14 days).
Children aged from 4 years up to 12 years
- one inhalation (50 mkg of a salmeterol and 100 mkg of a flutikazon of propionate) two times a day.
The chronic obstructive pulmonary disease
For adult patients the recommended dose makes:
- one inhalation of 50/250 mkg two times a day or
- one inhalation of 50/500 mkg two times a day
Use of a dose of 50/500 mkg twice a day reduces lethality.
IInstruktsiya on use of an inhaler Multidisk'
the Unused disk is sealed in covers from a foil which protects a disk from moisture and has to be removed only if you are ready to use drug.
When you get Seretid® Multidisk® from a cardboard box and exempt it from a cover from a foil, your disk will be in the closed position.







1. Seretid® Multidisk® is closed







the Inhaler opens in this


direction 2.




The Inhaler is open for Seretid® Multidisk® has the indicator which after the carried-out inhalation shows number of the remained doses. Numbers go in the decreasing order from 60 to 0. Number from 5 to 0 have red color, warning that in an inhaler there were only a few doses. Emergence in a window of figure 0 means that the inhaler is empty and unsuitable for further use.
For performing inhalation perform four consecutive operations:
1. Open an inhaler
2. Press a lever
3. Inhale
medicine 4 dose. Close an inhaler

1. Open an inhaler

you Hold the body with one hand, having placed a thumb of other hand in special deepening. To open an inhaler, press a thumb from yourself to an emphasis, you will not hear click yet.

2. Press a lever

you Hold an inhaler a mouthpiece to the person. The inhaler can be held with the right or left hand. Press a lever in the direction from yourself against the stop, yet you will not hear click. Now the inhaler is ready to work.
When you press a lever, the next cell with powder for inhalation is opened, at the same time the number of the remained doses decreases that is specified in an indicator window. Press a lever only before performing inhalation, otherwise it leads to medicine waste.

3. Inhale a dose of medicine
you Hold an inhaler at some distance from a mouth and make a deep exhalation without effort.
Remember – it is never impossible to do an exhalation in an inhaler!
- Densely clasp a mouthpiece with lips. Make a slow and deep breath through a mouth (not through a nose).
- Take out an inhaler from a mouth.
- Hold the breath approximately for 10 seconds or longer as far as you will be able.
- Make a slow exhalation.

4. Close an inhaler
to close an inhaler, place a thumb in special deepening and press in the direction to yourself against the stop, yet you will not hear click. The lever automatically returns to a starting position.
5. Cleaning of an inhaler
After use of an inhaler the mouthpiece is wiped with dry fabric.

Side effects
- candidiasis of an oral cavity and throat
- skin allergic reactions, rash, anaphylactic reactions, a Quincke's disease, abdominal pain, nausea, vomiting, a dysphonia and/or a bronchospasm, a paradoxical bronchospasm, change of flavoring feelings
- at prolonged use of drug in the doses considerably exceeding recommended the oppression of function of adrenal glands, Cushing's syndrome, a growth inhibition at children and teenagers is possible, decrease in a mineralization of bones, a cataract, glaucoma, a hyperglycemia
- a headache, a tremor
- heartbeat, tachycardia, arrhythmias (including an atrial fibrillation, supraventricular tachycardia and premature ventricular contraction)
- muscular spasms, an arthralgia,

Contraindication myalgia
- hypersensitivity to drug components
- children's age up to 4 years

Medicinal interactions
Derivative xanthine, GKS and diuretics increase risk of development of a hypopotassemia.
Inhibitors of a monoamonooksidaza and tricyclic antidepressants increase risk of development of side effects from a cardiovascular system.
It is necessary to avoid use of non-selective and selection beta-blockers for patients unless they are extremely necessary.
At simultaneous use of inhibitor of an isoenzyme of CYP3A4 can considerably concentration of a flutikazon of propionate in blood plasma will increase therefore concentration of cortisol in serum considerably decreases. Therefore it is necessary to avoid simultaneous use of a flutikazon of propionate and a ritonavir if only, the expected advantage for the patient exceeds possible side effect of a system corticosteroid.
Other inhibitors of an isoenzyme CYP3A4 (erythromycin, ketokonazol) cause increase in system influence of a flutikazon propionate without noticeable decrease in concentration of cortisol in serum. Ketokanazol can cause increase in system influence of a salmeterol in blood plasma and lead to lengthening of an interval of QT.
Use of a system ketokanazol together with drugs which part is salmeterol (Serevent) can bring to lengthening of an interval of QT. It is necessary to be careful, at in common appointment with CYP3A4 inhibitors.

The special
instructions Seretid® Multidisk® it is intended for long-term treatment of a disease, but not for elimination of attacks. For this purpose use of bronchodilators of short action (for example, salbutamol) which patients are always recommended to have at themselves is required.
At insufficient efficiency of Seretid® Multidisk® it is necessary to revise the treatment plan and, in case of need, in addition to appoint GKS and antibiotics at development of an infection. Treatment cannot be stopped sharply.
Seretid® Multidisk® should appoint with care to patients with an active and inactive form of a pulmonary tuberculosis, with a hyperthyroidism.
At use of sympathomimetic means, especially in doses above than it is recommended, increase in systolic pressure and a takhkhikardiya is possible. Therefore it is necessary to appoint with care Seretid® Multidisk® to patients with cardiovascular diseases.
At prolonged use of inhalation GKS in high doses system effects can be noted, but the probability of their development is much lower, than when using oral GKS. Possible system effects include Cushing's syndrome, oppression of adrenal glands, a growth inhibition at children and teenagers, decrease in a mineralization of bones a cataract and glaucoma. Therefore it is important to pick up the minimum dose of Seretid which controls a course of the disease. It is regularly recommended to control growth of the children receiving long-term treatment by inhalation corticosteroids.
Individuals can be more sensitive to influence of inhalation corticosteroids, than most of patients.
Considering a possibility of dysfunction of adrenal glands, to patients, when translating from treatment by oral GKS on inhalation therapy of a flutikazon propionate, it is necessary to control indicators of function of bark of adrenal glands regularly. Patients need to recommend to have at themselves the special card indicating the possible need of additional reception of GKS at various stressful situations.
Were reported about exceptional cases of increase in level of glucose in blood therefore it is necessary to appoint with care Seretid® Multidisk® to patients with diabetes.
At emergence or for prevention of development of hoarseness of a voice and candidiasis of a mouth and throat it is recommended to rinse after inhalation a mouth and a throat water.
Symptomatic candidiasis it is possible to treat local antifungal drugs, without stopping use of Seretid® Multidisk®.
The paradoxical bronchospasm which needs to be stopped immediately by means of high-speed inhalation bronchodilator can develop. Seretid® Multidisk® should be cancelled immediately and if necessary to appoint therapy other drugs.
Seretid® Multidisk® should appoint with care to patients with predisposition to decrease in level of potassium in serum.
At patients with exacerbation of bronchial asthma, in a hypoxia it is necessary to control potassium concentration in blood plasma.
Special groups of patients
Are not present need to reduce a dose of Seretid® Multidisk® at elderly patients and also at patients with renal failures or a liver. At the moment there are no data on use of Seretid® Multidisk® for children under 4 years.
Pregnancy and the period of a lactation
Drug is appointed only when the expected advantage for mother exceeds possible risk for a fruit or the child.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
does not influence.

The overdose
Is not present information on overdose by the drug Seretid® Multidisk®.
Data on overdose of separate drugs of a salmeterol and flutikazon of propionate are provided.
Symptoms: the overdose of a salmeterol is shown by a tremor, a headache, tachycardia, decrease in systolic pressure and a hyperpotassemia.
Inhalations of a flutikazon of propionate in the doses exceeding recommended can lead to temporary oppression gipotalamo - a hypophysial and adrenal system. This phenomenon does not demand immediate intervention as function of adrenal glands is restored within several days.
If exceeding the recommended doses happens during the long period, there can come suppression of function of adrenal glands. It is recommended to carry out monitoring of reserve function of bark of adrenal glands.
Treatment: optimum antidotes are cardioselective beta1-adrenoblockers, but they should be applied with care at patients with a bronchospasm in the anamnesis. If Seretid it is necessary to cancel because of overdose of a salmeterol, the patient needs to appoint the corresponding replacement steroid therapy. At overdose of a flutikazon of propionate it is possible to continue treatment by Seretid in the doses sufficient for maintenance of therapeutic effect.

A form of release and packing
Powder for inhalations of 50 mkg / 100 mkg, 50 mkg / 250 mkg and 50 mkg / 500 mkg, 60 doses.
A round plastic inhaler Multidisk of lilac color of two tones with the indicator of doses. Inside the blister from a foil with 60 evenly located cells, contains in each of which one dose of drug. The inhaler together with the instruction for use in the state and Russian languages is placed in a cardboard box.


To Store storage conditions in the dry place at a temperature not above 30 °C
to Store out of children's reach!

A period of storage
1.5 years
not to use drug after the expiry date specified on packing.

Prescription status
According to the prescription

the Producer
Glakso Wellk Opereyshens, Great Britain,
Priory Street, Ware, Hertfordshire, SG12 0 DJs, UK.


Seretid and Multidisk are registered trade marks of GlaxoSmithKline group of companies.

The address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of Predstavitelstvo GlaksoSmitKlyayn Export Ltd in
Kazakhstan 050059, Almaty, Furmanov St., 273
Phone number: +7 727 258 28 92, +7 727 259 09 96
Fax number: + 7 727 258 28 90
E-mail address:

To Develop kaz.med@gsk.com
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