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Dosage form: & nbspsolution for intravenous and intramuscular administration
Composition:

1 ml of the solution contains:

Active substance:

Calcium gluconate monohydrate

94 mg

Excipients:

Calcium saccharate

5 mg

Water for injections

up to 1 ml

Concentration of electrolytes:

Calcium

0.23 mmol / ml

Description:A clear, colorless or light brown solution.
Pharmacotherapeutic group:Calcium-phosphorus exchange regulator
ATX: & nbsp
  • Calcium gluconate
  • Pharmacodynamics:

    Calcium is the most common mineral substance in the human body (approximately 1.5% of body weight). More than 99% of calcium in the body is in bones and teeth, approximately 1% is in a dissolved state in the intracellular and extracellular fluid.

    The physiological concentration of calcium in the plasma is maintained at 2.25-2.75 mmol / l. Since about 50% calcium in the plasma is associated with albumin, the total concentration of calcium in the plasma depends on the concentration of proteins in the plasma. The concentration of ionized calcium is in the range of 1.23-1.43 mmol / l and is regulated by calcitonin and parathyroid hormone.

    Hypocalcemia (total calcium concentration below 2.25 mmol / l or unrelated calcium albumin below 1.23 mmol / L, respectively) can be caused by renal failure, a deficiency of the vitamin D, magnesium, massive blood transfusion, osteoblastic malignant tumors, hypoparathyroidism or intoxication with phosphates, oxalates, fluorides, strontium or radium.

    Hypocalcemia can be accompanied by the following symptoms: increased neuromuscular excitability up to tetany, paresthesia, carpopedic spasms, spasms of smooth muscles, for example, in the form of intestinal colic, muscle weakness, dysarthria, confusion and convulsive attacks of cerebral genesis.

    The therapeutic effect of parenteral calcium supplementation is the normalization of pathologically low calcium concentration in the serum and, thus, elimination of symptoms of hypocalcemia.

    Pharmacokinetics:

    Distribution

    After the introduction, the nature of the calcium distribution is the same as that of endogenous calcium. About 50% of calcium in the plasma is in a physiologically active ionized form, about 45%% is associated with proteins, mainly with albumin, and 5% is in complex with anions.

    Metabolism

    After the administration of calcium is added to the intravascular pool of calcium and is metabolized in the same way as endogenous calcium.

    Excretion

    Calcium excretion occurs in the urine, although most of it undergoes reabsorption in the renal tubules.

    Indications:

    Treatment of acute symptomatic hypocalcemia.

    Contraindications:

    - Hypersensitivity to calcium gluconate or other components of the drug,

    - hypercalcemia (for example, in patients with hyperparathyroidism, hypervitaminosis D, decalcifying malignant neoplasms, renal insufficiency, osteoporosis associated with immobilization, sarcoidosis, milk and alkaline syndrome),

    - hypercalciuria,

    - intoxication with cardiac glycosides,

    - therapy with cardiac glycosides.

    With the above contraindications, calcium can be administered intravenously in exceptional cases, when it is necessary to treat the expressed symptoms of hypocalcemia that threaten the patient's life and if safer treatments are not available, and calcium administration orally is impossible.

    Carefully:

    When calcium gluconate is administered intravenously in exceptional cases, patients receiving cardiac glycosides need cardiac monitoring and conditions for urgent treatment of cardiac complications such as severe arrhythmias should be provided.

    Calcium salts should be used with caution and only after careful determination of indications in patients with nephrocalcinosis, heart disease, sarcoidosis (Beck's disease), in patients receiving epinephrine, in elderly patients.

    Impaired renal function may be associated with hypercalcemia and secondary hyperparathyroidism. Therefore, in patients with impaired renal function, parenteral calcium administration should be administered only after a careful determination of the indications, while controlling the calcium-phosphate balance.

    Pregnancy and lactation:

    Calcium penetrates the placental barrier, and its concentration in fetal blood exceeds the concentration in the mother's blood.

    Calcium gluconate is prescribed by a doctor during pregnancy only in those situations where the potential benefit from using the drug in the mother exceeds the possible risk to the fetus. The administered dose should be carefully calculated, and the serum calcium level should be regularly monitored to avoid hypercalcemia, which can lead to adverse effects on the fetus.

    Calcium enters the breast milk.This must be taken into account when assigning calcium to women during breastfeeding.

    Dosing and Administration:

    Normally, the calcium concentration in the plasma is in the range of 2.25-2.75 mmol / l or 4.5-5.5 meq / l. Treatment should be aimed at restoring this level. During treatment, the concentration of calcium in the serum should be carefully monitored.

    Recommended doses

    Adults

    The initial dose for adults is usually 10 ml of calcium gluconate B. Brown, which corresponds to 2.26 mmol or 4.52 meq of calcium. Depending on the clinical condition of the patient, you can re-enter the drug. The subsequent doses are determined in accordance with the concentration of calcium in the blood serum.

    Children under 18 years of age

    The dose and mode of administration depend on the degree of development of hypocalcemia, the nature and severity of the symptoms. With mild neuromuscular symptoms, calcium should be given orally.

    The table shows the recommended initial dose values:

    Age

    Body weight (kg)

    ml

    Equivalent to mmol (meq) of calcium

    3 months

    5,5

    2-5

    0,45-1,13 (0,9-2,26)

    6 months

    7,5

    2-5

    0,45-1,13 (0,9-2,26)

    1 year

    10

    2-5

    0,45-1,13 (0,9-2,26)

    3 years

    14

    5-10

    1,13-2,26 (2,26-4,52)

    7,5 years

    24

    5-10

    1,13-2,26 (2,26-4,52)

    12 years

    38

    5-10

    1,13-2,26 (2,26-4,52)

    > 12 years

    >38

    as for adults

    This corresponds approximately to:

    - 0.4-1 ml / kg body weight (corresponding to 0.09-0.23 mmol [0.18-0.45 meq] of calcium per kg of body weight) for children under 3 years;

    - 0.2-0.5 ml / kg body weight (corresponding to 0.05-0.1 mmol [0.1-0.2 meq] of calcium per kg of body weight) for children from 4 to 12 years old.

    For patients over the age of 12 years applicable doses for adults.

    In cases of severe hypocalcemia, for example, symptoms of the cardiovascular system, higher initial doses (up to 2 ml / kg body weight, corresponding to 0.45 mmol [0, 9 meq] calcium / kg body weight).

    Also, depending on the clinical condition of the patient, the drug can be re-introduced. The subsequent doses are determined in accordance with the concentration of calcium in the blood serum.

    If necessary, for example, with a lack of calciferol, oral administration of calcium should be performed after intravenous administration.

    Elderly patients

    Although there is no evidence that the tolerability of calcium gluconate is directly affected by the elderly, nevertheless the age-specific features that are associated with aging,such as renal dysfunction and metabolic slowdown, can indirectly affect tolerability and may require a dose reduction.

    Method of administration

    Adults

    Slow intravenous or deep intramuscular injection.

    Children under 18 years of age

    Only slow intravenous injection or intravenous infusion after dilution, in order to achieve sufficiently low rates of administration and to exclude the possibility of local irritation or necrosis in the event of accidental ingestion of the drug into the perivascular tissue. For intravenous infusion Calcium gluconate B. Brown can be diluted 1:10 to 10 mg / ml with the following infusion solutions: 0.9% sodium chloride solution or 5% glucose solution.

    Children should not inject the drug intramuscularly.

    The rate of intravenous administration should not exceed 50 mg calcium gluconate / min. The patient should be in a prone position and under close monitoring during the injection. Monitoring should include heart rate or ECG.

    Because of the risk of local irritation, intramuscular injections should be performed only if intravenous injection is not possible.Intramuscular injections must be done deep enough in the muscle, preferably in the gluteal region.

    For patients suffering from obesity, a longer needle should be chosen for safe insertion into the muscle, rather than in fatty tissue.

    If repeated injections are required, the injection site should be changed each time.

    Side effects:

    Adverse side effects from the cardiovascular and other systems may occur as symptoms of acute hypercalcemia due to an overdose with intravenous infusion or too rapid intravenous injection. Their appearance and frequency are directly related to the rate of administration and the dose to be administered.

    With the correct introduction, it is rare (occurrence frequency <1: 1000).

    From the side of the cardiovascular system

    Arterial hypotension, bradycardia, cardiac arrhythmia, vasodilation, vasomotor collapse, high blood flow, most often after too rapid injection.

    From the digestive system

    Nausea, vomiting.

    General disorders

    Feeling of heat, sweating.

    Infringements in an injection site

    Frequent (<1:10, ≥ 1: 100): With intramuscular injection, pain or erythema may occur.

    Adverse adverse reactions that occur only if improperly administered

    If intramuscular injection is not done deep enough in the muscle, infiltration into the adipose tissue may occur, followed by the formation of an abscess, tissue tightening and necrosis.

    Calcification of soft tissues with subsequent possible damage to the skin and necrosis due to the release of calcium from the vessel into the tissue has been reported.

    Redness of the skin, burning sensation or pain during intravenous injection may be symptoms of accidental perivascular injection, which can lead to tissue necrosis.

    Overdose:

    Symptoms

    Symptoms of hypercalcemia may include: anorexia, nausea, vomiting, constipation, abdominal pain, polyuria, polydipsia, dehydration, muscle weakness, bone pain, kidney calcification, drowsiness, hypersomnia, confusion, arterial hypertension and, in severe cases, cardiac arrhythmia , up to cardiac arrest, and to whom.

    If intravenous injection is performed at too high a rate, the symptoms of hypercalcemia may also include chalk flavor in the mouth, flushing and arterial hypotension.

    Emergency therapy, antidotes

    Treatment should be aimed at reducing the elevated calcium concentration in the plasma.

    Initial therapy should include rehydration and, with severe hypercalcemia, it may be necessary to administer a 0.9% sodium chloride solution by intravenous infusion to increase the amount of extracellular fluid.

    To reduce the increased concentration of calcium in the blood serum can be prescribed calcitonin.

    Furosemide may be prescribed to increase calcium excretion, but thiazide diuretics should not be prescribed because they can increase the absorption of calcium in the kidneys.

    Hemodialysis or peritoneal dialysis may be performed if other interventions do not work, and if the patient persists with acute symptoms of hypercalcemia.

    During the treatment of overdose, it is necessary to carefully monitor the level of electrolytes in the blood serum.

    Interaction:

    The drug should not be confused with other drugs, unless their compatibility is shown.

    Salts of calcium can form complexes with many drugs, which can lead to precipitation.

    Calcium salts are incompatible with oxidants, citrates, soluble carbonates, bicarbonates, oxalates, phosphates, tartrates and sulfates.

    There are data on physical incompatibility with amphotericin, cephalothin sodium, cefazolin sodium, cefamandol naphate, novobiocin sodium, dobutamine hydrochloride, prochlorperazine and tetracyclines.

    The pharmacological action of digoxin and other cardiac glycosides can be enhanced in the presence of calcium, which can lead to severe intoxication. Therefore, intravenous administration of calcium preparations to patients receiving cardiac glycosides is contraindicated. Calcium can be administered intravenously in exceptional cases when it is necessary to treat the severe symptoms of hypocalcemia that threaten the patient's life and if safer treatments are not available and oral calcium is not possible.

    Simultaneous administration of calcium and epinephrine can lead to cardiac arrhythmia. Calcium and magnesium are mutual antagonists.

    Calcium can interfere with the action of calcium antagonists (calcium channel blockers).

    The appointment together with thiazide diuretics can cause hypercalcemia, because they reduce the excretion of calcium by the kidneys.

    When diluted to 10 mg / ml, as indicated by 0.9% sodium chloride solution or 5% glucose solution, physical stability during use is indicated for 48 hours when stored at room temperature. From a microbiological point of view, dilute the drug should be used immediately. If the drug is not used immediately, the responsibility for the duration and storage conditions before use lies with the person who uses the drug and they should not normally exceed 24 hours at 2-8 ° C if the dilution is not carried out under aseptic conditions.

    Special instructions:

    The drug is intended for single use only. Unused volumes of the drug should be discarded immediately after the first use.

    Before use, the preparation should be checked for mechanical inclusions, discoloration and integrity of the container.

    Use the solution only if it is transparent and the container is not damaged.

    For intravenous infusion Calcium gluconate B. Brown can be diluted in a ratio of 1:10 to a concentration of 10 mg / ml with the following solutions for infusion: 0.9% solution of sodium chloride or 5% glucose solution.After dilution, the solution is intended for immediate single use. The rate of intravenous infusion should not exceed 50 mg calcium gluconate / min. Dilution should be carried out under aseptic conditions. After mixing, the container should be gently shaken to ensure uniformity.

    Solutions containing calcium should be administered slowly in order to minimize peripheral vasodilation and inhibition of cardiac activity.

    Intravenous injections should be administered under the control of heart rate or ECG, because with too rapid administration of calcium, bradycardia with vasodilation or arrhythmia can occur.

    Children Calcium gluconate B. Brown can not be administered intramuscularly, but only intravenously slowly.

    Patients who receive calcium salts should be under close monitoring to ensure that the correct balance of calcium is maintained without deposition in the tissues.

    When parenteral administration in high doses, the concentration of calcium in the plasma and the rate of excretion in the urine should be monitored.

    Calcium is insoluble in adipose tissue and therefore can cause infiltration and subsequent abscess formation, tissue tightening and necrosis.

    After a perivascular or shallow intramuscular injection, local irritation may occur, possibly followed by destruction of the skin or tissue necrosis. Avoid leaving the vessel in the tissue; The injection site must be carefully monitored.

    You should avoid taking a vitamin D in high doses.
    Effect on the ability to drive transp. cf. and fur:

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

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

    10 ml per ampoule of polyethylene, which meets the requirements of the European Pharmacopoeia for materials for preparations for parenteral administration.

    For 20 ampoules together with instructions for use in a cardboard bundle.

    Storage conditions:

    Store at a temperature of 2 to 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:LP-000962
    Date of registration:18.10.2011 / 19.10.2016
    Expiration Date:Unlimited
    Date of cancellation:2016-10-18
    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: & nbsp23.11.2017
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