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Dosage form: & nbsporal solution
Composition:

To 100 ml solution for oral administration:

Active substances:

Antibodies to bradykinin affinity purified 0.12 g *

Antibodies to histamine affinity purified 0.12 g *

Antibodies to morphine affinity purified 0.12 g *

* are administered as a mixture of three active aqueous dilutions of the substance diluted in 10012, 10030, 10050 time.

Excipients: maltitol 6.0 g, glycerol 3.0 g, potassium sorbate 0.165 g, citric acid anhydrous 0.02 g, water purified to 100 ml.

Description:

Colorless or almost colorless transparent liquid.

Pharmacotherapeutic group:Other antitussives
ATX: & nbsp
  • Other antitussives
  • Pharmacodynamics:

    It has been shown experimentally that the components of the preparation modify the activity of ligand-receptor interaction of endogenous regulators with corresponding receptors: antibodies to morphine (drug component) are modified activity of ligand-receptor interaction of endogenous regulators with opiate receptors; antibodies to histamine - with H1-histamine receptors; antibodies to bradykinin - with bradykinin receptors; while the combined use of components leads to an increase in the antitussive effect.

    In addition to the antitussive effect, the complex drug due to its components has anti-inflammatory, anti-edema, antiallergic, spasmolytic (antibodies to histamine, antibodies to bradykinin) and analgesic action (antibodies to morphine).

    Complex preparation of Rengalin due to modification of histamine-dependent activation of H1-receptors of bradykinin-dependent activation B1 and B2-receptors selectively reduces the excitability of the cough center of the medulla oblongata, inhibits the central links of the cough reflex. Inhibiting the centers of pain sensitivity in the thalamus, blocks transmission of pain impulses to the cerebral cortex. Inhibits the flow of painful impulse from the periphery due to a decrease in the release of tissue and plasma algogens (histamine, bradykinin, prostaglandins, etc.). Unlike narcotic analgesics does not cause respiratory depression, drug dependence, does not possess narcogenic and hypnotic effects.

    It alleviates the manifestations of acute pharyngitis, laryngitis and bronchitis, reducing bronchospasm. It relieves systemic and local symptoms of allergic reactions by influencing the synthesis and release of histamine and bradykinin from mast cells.

    Pharmacokinetics:

    The sensitivity of modern physicochemical methods of analysis (gas-liquid chromatography, high-performance liquid chromatography, chromatography-mass spectrometry) does not allow to estimate the content of ultra-small doses of antibodies in biological fluids, organs and tissues, which makes it technically impossible to study the pharmacokinetics of the Rengalin preparation.

    Indications:

    Acute and chronic diseases of the respiratory tract, accompanied by cough and bronchospasm.

    A productive and unproductive cough with influenza and acute respiratory viral infection, acute pharyngitis, laryngotracheitis, acute obstructive laryngitis, chronic bronchitis and other infectious-inflammatory and allergic diseases of the upper and lower respiratory tract.

    Contraindications:

    Children up to 3 years.

    Increased individual sensitivity to the components of the drug.

    Hereditary intolerance to fructose (due to the presence of maltitol).
    Carefully:Diabetes.
    Pregnancy and lactation:

    The safety of the use of Rengalin in pregnant women and during breastfeeding has not been studied.

    During pregnancy and during breastfeeding, the drug is used only in the case,if the intended use for the mother exceeds the potential risk to the fetus and the baby. The benefit / risk ratio is determined by the attending physician.

    Dosing and Administration:

    Inside. At one time - 1-2 teaspoons (5-10 ml) - out of the way of food. It is advisable to keep the solution in the mouth before swallowing for maximum effect of the drug.

    Apply 1-2 teaspoons 3 times a day. Depending on the severity of the condition in the first three days, the frequency of admission can be increased to 4-6 times a day.

    The duration of therapy depends on the severity of the disease and is determined by the attending physician.

    Side effects:

    Possible reactions of increased individual sensitivity to the components of the drug.

    If these side effects are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

    Overdose:

    In case of an accidental overdose, dyspeptic phenomena (nausea, vomiting, diarrhea) due to the excipients (maltitol, glycerol).

    Treatment is symptomatic.

    Interaction:

    In the course of clinical studies, no data were obtained on the interaction of the drug Rengalin with drugs,used as a concomitant therapy.

    Special instructions:

    Patients with diabetes mellitus it should be remembered that each teaspoon (5 ml) of the preparation contains 0.3 g of maltitol, which corresponds to 0.02 bread units (XE). For the metabolism of maltitol, insulin is needed, although due to slow hydrolysis and absorption in the gastrointestinal tract, the need for insulin is low. The energy value of maltitol is 10 kJ or 2.4 kcal / g, which is significantly lower than that of sucrose. The energy value of one teaspoon of the drug is approximately 5.7 kJ (1.37 kcal).

    Effect on the ability to drive transp. cf. and fur:

    Not studied.

    Form release / dosage:

    Solution for oral administration.

    Packaging:

    For 100 ml in bottles of glass grade OC or painted glass, sealed with lids with the control of the first opening, e dropper of polyethylene.

    Each bottle, along with instructions for medical use, is placed in a pack of cardboard.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Do not freeze.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-002790
    Date of registration:29.12.2014 / 09.11.2015
    Date of cancellation:2019-12-29
    The owner of the registration certificate:NPF Materia Medica Holding, OOO NPF Materia Medica Holding, OOO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp29.01.2016
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