Active substanceSodium chloride solution is complex [Potassium chloride + Calcium chloride + Sodium chloride]Sodium chloride solution is complex [Potassium chloride + Calcium chloride + Sodium chloride]
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  • Dosage form: & nbspsolution for infusions
    Composition:

    Active substances: sodium chloride - 8.60 g, potassium chloride - 0.30 g, calcium chloride hexahydrate in terms of calcium chloride - 0.25 g.

    Excipients: water for injection - up to 1.0 liter.

    Ionic composition (per 1 liter): Sodium ion 147.2 mmol, Potassium ion 4.0 mmol, Calcium ion 2.25 mmol, Chloride ion 155.7 mmol.

    Theoretical osmolarity is 309 mOsm / l.

    Description:

    A clear, colorless liquid.

    Pharmacotherapeutic group:Electrolyte balance recovery agent
    ATX: & nbsp

    B.05.B.B   Solutions affecting the water-electrolyte balance

    B.05.B.B.01   Electrolytes

    Pharmacodynamics:

    Rehydrating agent, has a detoxification effect, restores water and electrolyte blood composition. When used as a means of replenishing the volume of circulating blood (BCC), because of the rapid exit from the bloodstream into the extravasal space, the effect persists only for 30-40 minutes (in connection with which the solution is only suitable for short-term replacement of the bcc).

    The main cation of extracellular fluid sodium participates in the control of water distribution, water balance, osmotic pressure of body fluids. It also binds with chlorine and bicarbonate in the regulation of the acid-base balance of the body.

    The main cation of intracellular liquid potassium takes part in the synthesis of carbohydrates and the synthesis of proteins, conduction of nerve impulses and muscle contraction.

    Calcium in ionized form is needed for the functional mechanism of blood coagulation, normal heart function, regulation of neuromuscular excitability.

    The main extracellular chlorine anion is closely associated with sodium metabolism, is involved in the regulation of the acid-base balance of the body.

    Pharmacokinetics:

    Pharmacokinetics of sodium ions (Na+) and chlorine (Cl-) is the same as for those who come with food. They are distributed in all organs, tissues and intercellular spaces and are secreted by glomerular filtration by the kidneys. In the tubules there is a significant reabsorption of ions Na+ and Cl-, especially in the Henle loop and the distal tubules.

    Ions of potassium (K+) are freely filtered in the glomeruli, but almost completely reabsorbed in the proximal tubules (excretion is about 100%). Kidneys have a limited ability to retain the concentration of K+. Therefore, when the concentration Na+ in distal tubules high, loss of K+ may be significant and hypokalemia may develop. This causes the presence of K+ in Ringer's solution.

    The homeostasis of calcium ions (Ca2+) is well controlled by hormones and rarely needs clinical intervention with intravenous solution infusion.

    The drug in the body is not metabolized, quickly excreted by the kidneys (80% within 4 hours, after 12-24 hours the drug is taken out completely).

    Indications:

    Dehydration and disturbance of electrolyte balance (thermal burns of 3rd and 4th degree), acute blood loss, correction of water-salt balance in acute diffuse peritonitis and intestinal obstruction, acute intestinal infections (severe course, inability to receive rehydrating agents for oral administration), hypovolemic shock, therapeutic plasmapheresis, intestinal fistula.

    Contraindications:

    Hypersensitivity to the drug components, hypernatremia, hyperchloremia, hypercalcemia, hyperkalemia, acidosis, chronic heart failure (CHF) (III-IV functional class for NYHA (classification of the New York Heart Association)), pulmonary edema, cerebral edema, hypercoagulation, hypervolemia, thrombophlebitis, metabolic alkalosis, severe chronic renal failure with oligo- and anuria, concomitant glucocorticosteroid therapy.

    Carefully:

    Arterial hypertension; Cardiovascular diseases (including chronic heart failure I-II functional class for NYHA), simultaneous reception of cardiac glycosides, simultaneous administration with blood products due to the risk of coagulation,liver failure; preeclampsia; peripheral edema of various genesis; hyperaldosteronism and other pathologies associated with hypernatremia or hyperkalemia (renal failure of mild to moderate severity, adrenal insufficiency, acute dehydration, extensive tissue decay); diseases and conditions predisposing to increase the concentration of the vitamin D (including sarcoidosis).

    Pregnancy and lactation:

    Investigation of the possibility of using the Rinegra solution during pregnancy and during breastfeeding was not carried out. In this regard, the drug should be used in pregnant women only after assessing the benefit / risk ratio, and when using the drug in lactating women should refrain from breastfeeding.

    Dosing and Administration:

    Intravenously (IV), drip, at a rate of 60-80 cap / min, with a serious condition of the patient - 70-90 cap / min, or jet. The volume of fluid administered depends on the type of dehydration, the degree of dehydration and the patient's body weight, the causes of the shock.

    The daily dose for adults is 5-20 ml / kg, if necessary, can be increased to 30-50 ml / kg.

    The daily dose for children is 5-10 ml / kg, the injection rate from 30 to 60 cap / min, with shock dehydration initially injected 20-30 ml / kg. The course of treatment is 3-5 days.

    In medical plasmapheresis, they are administered in a volume that is 2 times greater than the volume of the removed plasma (1.2-2.4 L), in the case of pronounced hypovolemia - in combination with colloidal solutions.

    For mild to moderate severity of acute intestinal infections, the drug can be used only if oral dehydration is not possible.

    With prolonged administration of large doses of the drug, control of the electrolyte composition of blood plasma and urine is necessary.

    The maximum volume of the injected solution is 3 liters / day.
    Side effects:

    Violations of electrolyte balance, hyperhydration, allergic reactions, fever (with rapid administration), local reactions at the injection site.

    Overdose:

    Symptoms: violation of water-electrolyte balance (hyperkalemia, hypernatremia, hypercalcemia, hyperchloremia, volume overload) and acid-base balance.

    Treatment: symptomatic, depending on the predominance of the form of electrolyte imbalance. In most cases, it is sufficient to interrupt the administration of the drug.In case of overload with water and sodium with a risk of edema, especially in the case of violations of excretion of sodium by the kidney, an effective method of treatment will be hemodialysis.

    Interaction:

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

    Simultaneous reception with non-steroidal anti-inflammatory drugs, androgens, anabolic hormones, estrogens, corticotropin, mineralocorticoids, vasodilators or ganglion blockers can increase sodium retention in the body.

    Simultaneous reception with potassium-sparing diuretics, angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists, tacrolimus, ciclosporin and potassium preparations increases the risk of hyperkalemia.

    Simultaneous reception with thiazide diuretics or vitamin D increases the risk of hypercalcemia.

    In combination with cardiac glycosides, the likelihood of their toxic effects increases.

    Special instructions:

    With prolonged parenteral therapy, it is necessary to determine laboratory indicators together with an assessment of the patient's condition for monitoring the water-electrolyte balance andacid-base balance every 6 hours (depending on the speed of infusion).

    In the case of rapid introduction of a large volume of solution, it is necessary to monitor the acid-base state (CBS) and the concentration of electrolytes. The change in blood pH (acidification) leads to redistribution of potassium ions (K+) (lowering the pH leads to an increase in the K content+ in the blood serum).

    The use of the drug may cause fluid overload, congestion and pulmonary edema. The risk of developing dilution is inversely proportional to the concentration of electrolytes, the risk of developing an overload volume is directly proportional.

    In connection with the content of sodium ions, the drug is used with caution in patients with clinical conditions accompanied by sodium retention and edema, as well as those receiving corticosteroids or corticotropin.

    In connection with the content of potassium ions, the drug is used with caution in patients with cardiovascular diseases, hyperkalemia, renal insufficiency, and clinical conditions accompanied by a delay in potassium.

    Due to the high content of chloride ions, prolonged use of the drug is not recommended.

    In connection with the calcium ions, the preparation is used with caution to patients taking cardiac glycosides. ECG monitoring is required. The concentration of calcium in the blood plasma does not always correlate with the concentration of calcium in the tissues.

    In case of turbidity, do not use the solution!

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

    The drug does not affect the ability to perform potentially dangerous activities requiring increased concentration of attention and speed of psychomotor reactions (vehicle management, work with moving mechanisms).

    Form release / dosage:Solution for infusion.
    Packaging:

    200 ml, 250 ml, 400 ml and 500 ml in plastic bottles with a sealed neck of low density polyethylene with a protective cap of polyethylene or polypropylene having a liner of thermoplastic elastomer and aluminum protective foil and a ring-holder on the bottom of the bottle or without it . Each bottle is packed in a pack of cardboard with instructions for use.

    From 1 to 40 bottles are placed in boxes of corrugated cardboard with an equal number of instructions for use (for hospitals).

    Storage conditions:

    Store in a dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-004120
    Date of registration:06.02.2017
    Expiration Date:06.02.2022
    The owner of the registration certificate:ALIUM PFK, LLC ALIUM PFK, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp02.03.2017
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