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

    1000 ml of solution contains:

    Active substance:

    Sodium chloride

    9.00 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:Pa clear, colorless solution.
    Pharmacotherapeutic group:Rehydrating agent
    ATX: & nbsp

    B.05.C.B.01   Sodium chloride

    B.05.X.A.03   Sodium chloride

    Pharmacodynamics:

    Mechanism of action

    Sodium is the main cation of the intercellular space and, together with various anions, regulates the dimensions of this space. Along with potassium, sodium is the main ion in bioelectric processes in the body.

    Therapeutic action

    The sodium content and the water balance in the body are closely related. Any deviation of the concentration of sodium in the plasma from the physiological value causes changes in the body's water balance.

    An increase in the sodium content in the body leads to a decrease in the volume of free fluid, regardless of the osmolality of the blood serum.

    A 0.9% solution of sodium chloride has the same osmolarity as human plasma. The introduction of a solution of sodium chloride leads to the replenishment of the interstitial space, which is about 2/3 of the entire extracellular space. Only 1/3 of the administered volume remains in the intravascular space. Therefore, the duration of the hemodynamic effect of 0.9% solution of sodium chloride is low.

    Pharmacokinetics:

    Distribution

    The total sodium content in the body is about 80 mmol / kg body weight, of which about 97% are outside, and 3% - inside cells. The daily requirement is 100-180 mmol (corresponding to 1.5-2.5 mmol / kg body weight).

    Metabolism

    Kidneys are the main regulator of sodium and water balance. Together with the mechanism of hormonal control (renin-angiotensin-aldosterone system, antidiuretic hormone) and natriuretic peptide, they maintain a constant volume of extracellular space and regulate fluid balance.

    Chloride is replaced by bicarbonate in the tubular system and is thus included in the regulation of acid-base balance.

    Excretion

    Quickly excreted by the kidneys unchanged, but a large amount of sodium is reabsorbed (renal reabsorption). A small amount of sodium is lost with feces and with sweating.

    Indications:

    - Disorders of water and electrolyte balance in hypochloraemic alkalosis;

    - hypochloremia;

    - short-term volumetric substitution therapy;

    - hypotonic dehydration or isotonic dehydration;

    - as a carrier of compatible concentrated solutions of electrolytes and drugs;

    - external application: for washing and treatment of wound surfaces and wetting of dressings.

    Contraindications:

    The drug should not be used for hyperhydration.

    Carefully:

    The drug should be used with caution in the following cases:

    - hypokalemia,

    - hypernatremia,

    - hyperchloremia,

    - states in which the restriction of sodium administration is shown: heart failure; generalized edema, pulmonary edema, increased blood pressure, eclampsia, severe renal failure.

    Pregnancy and lactation:

    A 0.9% solution of sodium chloride can be used according to indications during pregnancy and during breastfeeding.

    The drug should be used with caution in eclampsia.

    Dosing and Administration:

    Method of administration

    For intravenous administration.

    Doses

    The dose is selected individually according to the patient's needs in the liquid and electrolytes.

    The maximum daily dose

    40 ml / kg body weight, corresponding to 6 mmol sodium / kg body weight.

    The rate of administration

    Up to 5 ml / kg body weight / hour.

    In hypovolemia, which threatens the development of hypovolemic shock, hypovolemic shock may be administered increased doses, for example, by infusion under pressure.

    The amount of solution used for washing and treating the surfaces of wounds or wetting of dressings depends on actual requirements.

    Side effects:

    The introduction of increased doses of the drug may result in the following adverse side effects:

    Disorders from the metabolism and nutrition

    Hypernatremia and hyperchloremia.

    Overdose:

    Symptoms

    Overdose of the drug with intravenous administration may lead to such phenomena as hypernatremia, hyperchloremia, hyperhydration, hyperosmolarity of blood serum and metabolic acidosis.

    Treatment

    Immediately stop the infusion, prescribe diuretics with constant monitoring of the concentration of electrolytes of blood plasma, carry out correction of acidosis, electrolyte balance.

    Interaction:

    Unknown.

    Special instructions:

    When the drug is administered, clinical observations should be conducted, including regular monitoring of water balance, ionogram of blood serum and acid-base balance.

    In hypertensive dehydration, a high rate of administration should be avoided,this can lead to an increase in osmolarity and sodium concentration in the plasma.

    When infusion under pressure, which may be necessary with emergency care, all air must be removed from the container and from the infusion system.

    The bottle is for single use only. Remaining unused quantities of the drug are subject to destruction.

    The solution is to be used only if it is transparent, does not contain visible mechanical inclusions, the bottle and the cap are not damaged.

    After mixing with other drugs from a microbiological point of view, the drug should be used immediately. It is possible to store for no longer than 24 hours at a temperature of 2 to 8 ° C, provided that the preparation of drug solutions was carried out in accordance with the rules of aseptic.

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

    The drug does not affect the ability to drive vehicles, mechanisms, as well as engage in potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:Solution for infusions, 0,9%.
    Packaging:

    100 ml, 250 ml, 500 ml and 1000 ml into bottles of polyethylene without additives meeting the requirements of the European Pharmacopoeia for parenteral preparations. The bottle has a self-falling body and a suspension ring. The bottle is welded with a polyethylene cap with two separate sterile ports at the top, under which there is a rubber disc; each of the ports is individually sealed with foil. The bottle cap is compatible with a two-sided cannula for mixing "Ecoflac Mix" solutions.

    For 20 bottles of 100 ml or 10 bottles of 250 ml, 500 ml or 1000 ml with the appropriate number of instructions for use in a cardboard box (for hospitals). 1 bottle of 100 ml, 250 ml, 500 ml or 1000 ml together with instructions for use in a cardboard pack.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-001564
    Date of registration:17.10.2011 / 01.06.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:B. Brown Mehlungen AGB. Brown Mehlungen AG Germany
    Manufacturer: & nbsp
    Representation: & nbspB. Brown Medikal, Open CompanyB. Brown Medikal, Open Company
    Information update date: & nbsp16.06.2018
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