Active substanceCalcium gluconateCalcium gluconate
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  • Dosage form: & nbspsolution for intravenous and intramuscular administration
    Composition:

    Per 1 ml:

    Active substance:

    Calcium gluconate is 100.0 mg.

    Excipients:

    Succinic acid 5.0 mg.

    0.1 M sodium hydroxide solution to pH 6.0-7.5.

    Water for injection - up to 1.0 ml.

    Description:

    A clear, colorless, odorless solution.

    Pharmacotherapeutic group:Calcium-phosphorus exchange regulator
    ATX: & nbsp

    A.12.A.A.03   Calcium gluconate

    A.12.A.A   Calcium preparations

    Pharmacodynamics:

    The preparation of calcium replenishes the deficiency of calcium ions necessary for the transmission of nerve impulses, the reduction of skeletal and smooth muscles, the activity of the myocardium, the formation of bone tissue, and the coagulation of blood.

    With intravenous administration increases the adrenal secretion of adrenaline, has a moderate diuretic effect.

    Pharmacokinetics:

    After parenteral administration, the drug with blood flow is evenly distributed in all tissues and organs. In blood plasma, about 45% of calcium ions are in complex with proteins. Passes through the placental barrier, enters the breast milk. It is excreted from the body mainly by the kidneys.

    Indications:

    Treatment of conditions due to calcium deficiency: hypocalcemic tetany, hypocalcemia due to hypoparathyroidism, rapid growth or pregnancy. Treatment of muscle spasms as an auxiliary therapy for rickets, osteomalacia, lead colic and overdose of magnesium sulfate.

    Reducing the permeability of capillaries in allergic conditions, non-morbocytopenic purpura and exudative dermatoses, for example herpetiform dermatitis and itching rash due to the use of certain medications.

    Contraindications:

    Individual intolerance to the components of the drug. Hypersensitivity, hypercalcemia (concentration of calcium ions should not exceed 12 mg% or 6 mEq / L), hypercalciuria,nefrourolitiaz (calcium), severe acute renal failure, sarcoidosis, intoxication with cardiac glycosides, simultaneous treatment with cardiac glycosides.

    Carefully:

    Dehydration, electrolyte disorders (risk of hypercalcemia), diarrhea, malabsorption syndrome, calcium nephrourolythiasis (in the anamnesis), minor hypercalciuria, moderate chronic renal failure, chronic circulatory failure, widespread atherosclerosis, hypercoagulation, childhood (for intramuscular injection, the risk of necrosis) .

    Pregnancy and lactation:

    Application of the drug during pregnancy and during breastfeeding It is possible only under strict control of serum calcium concentration. Hypercalcemia adversely affects the fetus and the baby.

    Dosing and Administration:

    Intramuscularly, intravenously slowly (for at least 3 minutes) or drip. Subcutaneous administration is not allowed.

    Adults with 5-10 ml of a solution of 100 mg / ml (10% solution) daily, every other day or two days depending on the nature of the disease and the condition of the patient.If necessary, you can enter up to 3 times a day.

    Children older than 1 year - intravenously slowly (within 2-3 minutes) or drip, depending on the age, 2-5 ml of a solution of 100 mg / ml (10% solution).

    Children under the age of 1 year do not exceed 200 mg (not more than 2 ml).

    The solution before the introduction is warmed to body temperature.

    The syringe for the administration of calcium gluconate should not contain ethanol residues (in order to avoid the precipitation of calcium gluconate). Children intramuscularly administer the drug is not recommended because of the possible development of necrosis.

    Side effects:

    With intravenous administration: nausea, vomiting, redness, sweating, lowering blood pressure, arrhythmia, collapse, cardiac arrest. Patients who use cardiac glycosides may develop arrhythmias.

    In some cases, allergic reactions (up to shock and asthmatic status).

    Redness of the skin, burning and pain with intravenous injection can be a sign of accidental introduction into surrounding tissues, which can lead to tissue necrosis.

    With extravasation, subcutaneous administration can lead to local reactions, including redness, swelling, compaction and calcification of soft tissues.Local reactions are reversible, in some cases - necrosis of soft tissues with subsequent scarring.

    Overdose:

    Symptoms

    Nausea, vomiting, diarrhea. Undesirable reactions depend on the rate of administration, causing "hot flashes", sweating, arrhythmia, lowering blood pressure and collapse.

    Treatment

    Treatment is symptomatic.

    Interaction:

    Pharmaceutically it is not compatible with ethanol, sulphates, carbonates, incl. sodium bicarbonate, salicylates due to the formation of insoluble or sparingly soluble calcium salts. Forms insoluble complexes with antibiotics of the tetracycline series and weakens their effect.

    Reduces the effect of blockers of "slow" calcium channels (intravenous calcium gluconate reduces the hypotensive effect of verapamil).

    With simultaneous application with quinidine, it is possible to slow intraventricular conduction and increase the toxicity of quinidine. Parenteral administration of calcium gluconate is not recommended during cardiac glycoside treatment because of the possible increase in the cardiotoxic effect of glycosides.

    When combined with thiazide diuretics can increase hypercalcemia.Reduces the effect of calcitonin in hypercalcemia. Reduces the bioavailability of phenytoin. It is an antagonist of preparations of magnesium salts (Mg2+).

    Special instructions:

    Too fast intravenous administration contributes to the occurrence of undesirable reactions.

    Extravasation and subcutaneous administration can lead to local reactions (see the "Side effect" section).

    With prolonged administration of high doses of calcium preparations, it is necessary to control the content of calcium ions in plasma and urine, especially in children. If the calcium content in the plasma is 2.625 mmol / l or if urinary excretion is more than 0.125 mmol / kg daily, the drug should be discontinued. It is necessary to control the heart rate.

    Patients with minor hypercalciuria, reduced glomerular filtration or with nephrourolythiasis in anamnesis should be administered under the control of calcium in the urine. If necessary, the dose is reduced or canceled treatment. Patients, prone to the formation of concrements in the urinary tract, recommended a plentiful drink.

    It is recommended to avoid the use of high doses of vitamin A D (unless specifically indicated).

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

    Information about the possible impact on the ability to manage vehicles, mechanisms are absent.

    Form release / dosage:Solution for intravenous and intramuscular injection 100 mg / ml.
    Packaging:

    5 ml into neutral glass ampoules or glass with resistance class hydrolysis HGA1 (first hydrolytic).

    5 ampoules are placed in a contiguous cell pack of a polyvinylchloride (PVC) film or a polyethylene terephthalate (PET) film.

    1 or 2 contour mesh packages together with the instruction for use and the ampoule scarifier are placed in a pack of cardboard for consumer containers. 5 or 10 ampoules together with the instruction for use and the ampoule scarifier are placed in a pack of cardboard for consumer packaging with a corrugated liner.

    When packing ampoules with a dot or a ring of fracture, the ampoule scaper is not inserted.

    Packing for hospitals

    4, 5 or 10 contour mesh packages together with instructions for use in an amount equal to the number of contour mesh packages are placed in a pack of cardboard for consumer containers.

    50 or 100 contour mesh packages, together with instructions for use in an amount equal to the number of contour mesh packages, are placed in a box of corrugated cardboard.

    Storage conditions:

    Store in a dark place at a temperature of 15 to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

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

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002350
    Date of registration:21.01.2014 / 02.10.2017
    Expiration Date:21.01.2019
    The owner of the registration certificate:ELLARA, LTD. ELLARA, LTD. Russia
    Manufacturer: & nbsp
    Information update date: & nbsp24.11.2017
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