Translation of the instruction Mose

MUKOSOL solution for infusions of 7.5 mg/ml

Instruction

On medical use of medicine

Mukosol

(mucosol)

Ingredients:

Active ingredient: Ambroxol hydrochloride (ambroxol hydrochloride);

1 ampoule contains Ambroxol of a hydrochloride 15 mg;

excipients: citric acid, monohydrate (E 330); sodium hydrophosphate, dihydrate; sodium chloride; water for injections.

Dosage form.

Solution for infusions.

Main physical and chemical properties: transparent colourless liquid.

Pharmacotherapeutic group.

Means, applied at cough and catarrhal diseases. mucolytic means.

ATX R05C B06 Code.

Pharmacological properties.

Pharmacodynamics.

Ambroxol the hydrochloride increases secretion in airways. It also strengthens discharge of pulmonary surfactant and stimulates activity of a tsiliarny epithelium. These actions lead to improvement of mucifying and its removal (mukotsiliarny clearance). Improvement of mukotsiliarny clearance was shown during clinical pharmacological trials. Activation of secretion of liquid and increase in mukotsiliarny clearance facilitate removal of slime and facilitate cough.

Research in vitro was shown that under the influence of Ambroxol of a hydrochloride the amount of cytokines and also quantity of the mononuklear circulating and connected with fabric and polimorfonuklearny cages decreases.

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during many preclinical trials also observed antioxidant effects of Ambroxol.

After use of Ambroxol of a hydrochloride the concentration of antibiotics (amoxicillin, a tsefuroksim, erythromycin) in a bronchopulmonary secret and in a phlegm increases.

Pharmacokinetics.

Ambroxol the hydrochloride contacts proteins of plasma approximately for 90% at adults and for 60–70% at newborns. Drug gets through a placental barrier and reaches fruit lungs. The high volume of distribution of 410 l indicates bigger accumulation in fabrics, than in blood plasma, concentration in tissues of lungs exceeds the corresponding indicator in plasma with coefficient 17.

Metabolism and removal.

hydrochloride is metabolized by

Ambroxol mainly in a liver by a glyukuronization and to a lesser extent — by splitting to dibromantranilovy acid (the last makes about 10% of a dose) also other insignificant metabolites are formed. The research of microsomes of a liver of the person was shown that CYP3A4 enzyme is responsible for hydrochloride Ambroxol metabolism to dibromantranilovy acid.

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In 3 days after introduction of 4.6% of a dose it is removed in not changed look whereas 35.6% of a dose are removed in the conjugated form with urine.

Elimination half-life of Ambroxol of a hydrochloride makes about 10 hours of plasma. At newborns after repeated intravenous administration the elimination half-life doubles approximately, indicating reduction of clearance.

In a serious illness of a liver the clearance of Ambroxol decreases by 20–40%. In heavy renal failures the accumulation of metabolites of Ambroxol is possible, namely — dibromantranilovy acid and glucuronides.

Ambroxol gets through hematoencephalic and placentary barriers and is excreted in breast milk.

Clinical characteristics.

Indication.

For strengthening of production of pulmonary surfactant at premature children and newborns with a syndrome of respiratory insufficiency.

Contraindication.

Known hypersensitivity to Ambroxol or to other components of medicine.

Interaction with other medicines and other types of interactions.

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it is not established clinically significant interactions with other medicines So far.

Simultaneous use of the medicine Mukosol and the means oppressing cough can lead

to excessive accumulation of slime owing to oppression of a tussive reflex; such combination is possible only after careful assessment by the doctor of a ratio of the expected advantage and possible risk owing to application.

Feature of application.

If intravenous administration is carried out by

too quickly, seldom or never there can be a headache, increased fatigue, exhaustion and heavy feeling in legs.

As Ambroxol can strengthen slime secretion, the medicine Mukosol, solution for infusions, it is necessary to apply with care at violation of bronchial motility and the strengthened slime secretion (for example, at such rare disease as primary tsiliarny dyskinesia).

Mukosol should be applied with care to patients with renal failures or a serious illness of a liver. At use of Ambroxol, as well as any other active ingredient which is metabolized in a liver, and then is removed by kidneys, the accumulation of metabolites which are formed in a liver is observed at patients with a heavy renal failure.

heavy skin reactions, such as Stephens-Johnson's syndrome or Lyell's disease (toxic epidermal necrolysis) which sometimes arose against the background of use of Ambroxol Very seldom developed. The majority of these cases is connected with a basic disease or with simultaneous use of other medicine. At emergence of any changes from skin or mucous membranes use of Ambroxol should be stopped and to see immediately a doctor.

Mukosol, solution for infusions, contains less than 1 mmol (23 mg) of sodium on an ampoule.

Use during pregnancy or feeding by a breast.

to Apply

to premature children and newborns.

Ability to influence speed of response at control of motor transport or other mechanisms.

to Apply

to premature children and newborns.

Route of administration and doses.

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It is proved that the general daily dose making 30 mg of Ambroxol of a hydrochloride on 1 kg of body weight is effective.

Dose of medicine to apply

in 4 receptions by slow intravenous infusion; it is recommended to apply each separate dose by intravenous infusion by means of the pompovy device to infusions within not less than 5 minutes.

treatment Duration — 5 days.

Maintenance of 1-6 ampoules should be parted with

in 250–500 ml of normal saline solution or Ringera solution. The solution divorced by means of normal saline solution or Ringera solution stable from the physical and chemical point of view within 24 hours at a temperature of 15-25 °C. From the microbiological point of view if opening of ampoules and cultivation are connected with risk of microbiological contamination, solution should be used right after preparation. If it did not occur, responsibility for conditions and a period of storage are born by the user. If any of these solvents is inaccessible, solution of glucose of 5% can be applied as alternative. At use of solution of glucose of 5% the contents of ampoules should be parted just before use. If solution was not used right after preparation, it needs to be utilized.

Children.

to Apply

to premature children and newborns according to indications.

Overdose.

do not have

messages about specific symptoms of overdose Yet. symptoms which are observed at accidental overdose or a medical mistake are similar to the known side reactions which are observed at application in the recommended doses, and can demand symptomatic treatment.

Side reactions.

from the immune system / from skin and hypodermic fatty tissue: erythema; anaphylactic reactions (including shock), a Quincke's disease, skin rash, a small tortoiseshell, an itch and other hypersensitivity reactions, severe damages of skin: syndrome of a stivensa-johnson, Lyell's disease.

from digestive tract: dryness in a mouth, a lock, salivation, dryness in a throat, nausea, vomiting, diarrhea, dyspepsia, an abdominal pain.

from the respiratory system, bodies of a thorax and mediastinum: rhinorrhea, short wind (as symptom of hypersensitivity reaction).

from kidneys and an urinary system: disorders of urination.

General character and the pathological phenomena in the injection site of medicine: fervescence and a fever, reactions from a mucous membrane.

Expiration date.

2 years.

Storage conditions.

to Store

out of children's reach.

to Store

in original packing at a temperature not over 25 ^about S.

Incompatibility.

Mukosol should not be mixed with any medicines, except specified in the section "route of administration and doses".

Packing.

On 2 ml in an ampoule; on 10 ampoules in a pack, or on 5 ampoules in the blister, on 2 blisters in a pack.

Category of a holiday.

According to the prescription.

Producer.

Private joint-stock company lekkhim-Kharkiv.

Location of the producer and its address of the place of implementation of activity.

Ukraine, 61115, Kharkiv Region, city of Kharkiv, street Severina Pototskogo, house 36.