Active substanceSodium chlorideSodium chloride
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  • Dosage form: & nbspsolution for infusions
    Composition:

    1000 ml of solution contains:

    Active substance: Sodium chloride -9.0 g

    Excipient: Water for injections - up to 1000 ml

    Concentration of electrolytes:

    Sodium - 154 mmol / l

    Chloride - 154 mmol / l

    Physico-chemical characteristics:

    Theoretical osmolality 308 mOsm / l

    pH 4,5 - 7,0

    Description:clear, colorless liquid.
    Pharmacotherapeutic group:rehydrating agent.
    ATX: & nbsp

    B.05.C.B.01   Sodium chloride

    B.05.X.A.03   Sodium chloride

    Pharmacodynamics:

    Plasma-substituting agent. Has a detoxifying and rehydrating effect. Replenishes the deficiency of sodium ions in various pathological conditions.

    0.9% solution of sodium chloride is isotonic with human plasma, and therefore it is rapidly excreted from the vascular bed, only temporarily increasing the volume of circulating blood (effectiveness with blood loss and shock is insufficient).

    Pharmacokinetics:

    The concentration of sodium ions is 142 mmol / l (plasma) and 145 mmol / l (interstitial fluid), the chloride concentration is 101 mmol / l (interstitial fluid). It is excreted by the kidneys.

    Indications:

    Large losses of extracellular fluid or insufficient intake (toxic dyspepsia, cholera, diarrhea, "indomitable" vomiting, extensive burns with severe exudation and other conditions), hypochloraemia and hyponatremia with dehydration, intestinal obstruction, intoxication.

    Contraindications:

    Hypernatremia, acidosis, hyperchloremia, hypokalemia, extracellular hyperhydration; circulatory disorders, threatening edema of the brain and lungs, cerebral edema, pulmonary edema, acute left ventricular failure, concomitant administration of glucocorticosteroids in large doses.

    Carefully:

    decompensated chronic cardiac insufficiency, chronic renal failure (oligoanuria).

    Pregnancy and lactation:

    Isotonic sodium chloride solution can be used for indications during pregnancy and during lactation.

    Dosing and Administration:

    Intravenously drip.

    Before administration, the solution is heated to 36-38 ° C. The dose is determined depending on the loss of body fluids, sodium and chloride ions and an average of I l / day. With large losses of fluid and severe intoxication, administration up to 3 l / day is possible. The rate of administration is 540 ml / h, if necessary, the rate of administration is increased.

    Children are injected with 20-30 ml / kg with a marked decrease in blood pressure against a background of dehydration without determining laboratory parameters.

    In the future, the dosage regimen is adjusted depending on the laboratory parameters.

    With long-term administration of large doses of isotonic sodium chloride solution, it is necessary to monitor the acid-base state and electrolytes in blood plasma and urine.

    Side effects:

    Acidosis, hyperhydration, hypokalemia.

    Overdose:

    Symptoms: nausea, vomiting, diarrhea, abdominal cramps, thirst, reduced saliva and tear, increased sweating, fever, tachycardia, increased blood pressure, renal failure, peripheral edema, pulmonary edema, respiratory arrest, headache, dizziness, restlessness , irritability, weakness, muscle cramps and rehydration, generalized convulsions, coma and death. Excessive administration of an isotonic solution of sodium chloride can cause hypernatremia. Excessive intake of chloride into the body can lead to hyperchloroemic acidosis. If isotonic sodium chloride solution is used as a base solution for the dilution and transport of other drugs, symptoms and complaints with excessive administration are most often associated with the properties of the drugs added to the solution. In case of unintended excess solution administration, treatment should be discontinued and the patient's condition assessed.

    Treatment: symptomatic.

    Interaction:

    Compatible with colloid hemodynamic blood substitutes (mutual enhancement of the effect).

    When mixed with other drugs, it is necessary to visually control the pharmaceutical compatibility.

    Special instructions:

    With caution apply large amounts of sodium chloride in patients with impaired renal excretion, with hypokalemia.

    Freezing during transportation is allowed.

    Effect on the ability to drive transp. cf. and fur:not described
    Form release / dosage:

    Solution for infusion 0.9%.

    250 ml and 500 ml in polyethylene bottles that meet the requirements of the European Pharmacopoeia for polyethylene for parenteral preparations. Vials are of two types. Type A is a flask with a self-falling body and with a volume scale on the side surface. Type B is a vial with a self-falling body and without a volume scale. On the bottles are welded polyethylene caps of one of two types. Type I - polyethylene cap with two separate ports in the upper part, under which there is a rubber disc; each of the ports is individually sealed with foil. Type II is a polyethylene cap with one port in the upper part, under which there is a rubber disc, and with a control ring of the first opening.

    15, 12 or 10 bottles of 250 ml, 12 or

    10 bottles of 500 ml with an equal number of instructions for medical use in a cardboard box (for hospitals).

    1 bottle of 250 ml or 500 ml with instructions for medical use in a cardboard pack.

    15, 12 or 10 bottles of 250 ml or 12 or 10 bottles of 500 ml with an equal number of bilateral cannula for mixing the solutions of "Ecoflac Mix" or plugs for infusion bottles "Ecopine", each in a sterile package for single use, in a cardboard box. The box contains instructions on the medical use of the drug and instructions on how to use the cannula for mixing EcoFlac Mix solutions or plugs for Ecopin infusion bottles in an amount corresponding to the number of bottles (for hospitals).

    15, 12 or 10 bottles of 250 ml or 12 or 10 bottles of 500 ml with an equal number of systems for infusion of "Intrafix Safe Safe" in a length of 180 cm or 220 cm, each in a sterile package for single use, in a cardboard box. The box contains instructions on the medical use of the drug and instructions for the use of Intrafix SafeSet infusion systems in an amount corresponding to the number of bottles (for hospitals).

    Packaging:polyethylene bottles (1), cardboard
    polyethylene bottles (10) / complete with plugs for infusion bottles-10 pcs ./- carton boxes
    polyethylene bottles (10) / complete with cannula double-sided-10 pcs ./- carton boxes
    polyethylene bottles (10) / complete with infusion systems-10 pcs. / cartons
    polyethylene bottles (10) - cardboard boxes
    polyethylene bottles (12) / complete with plugs for infusion bottles-12 pcs ./- carton boxes
    polyethylene bottles (12) / complete with cannula double-sided-12 pcs ./- carton boxes
    polyethylene bottles (12) / complete with infusion systems-12 pcs / cartons
    polyethylene bottles (12) - cardboard boxes
    polyethylene bottles (15) / complete with plugs for infusion bottles-15 pcs ./- carton boxes
    polyethylene bottles (15) / complete with cannula double-sided-15 pcs ./- carton boxes
    polyethylene bottles (15) / complete with infusion systems-15 pcs / cartons
    polyethylene bottles (15), cardboard boxes
    Storage conditions:

    Store at temperatures between 2 ° C and 30 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years. Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:For hospitals
    Registration number:P N003832 / 01
    Date of registration:29.10.2009
    The owner of the registration certificate:GEMATEK, LLC GEMATEK, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp24.06.2013
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