Calcium gluconate-solofarm Injection 100mg / 5ml ampoules 10 mL pc

$2.41

Calcium gluconate-solofarm Injection 100mg / 5ml ampoules 10 mL pc

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Description

Composition
Active substance:
1 ml of the preparation contains:
Calcium gluconate monohydrate 94 mg.
Excipients:
Calcium saccharate 5 mg
Water for injections to 1 mL.
Description:
Transparent colorless or weakly colored liquid (brownish fluid).
Product form:
Solution for intravenous and intramuscular administration of 100 mg / ml.
5 or 10 ml vials (Politvist) low density polyethylene or polypropylene county corresponding to the requirements of the European Pharmacopoeia to polyethylene for parenteral preparations, with the twist cap for a needleless sampling preparative one or ampoule of a colorless or colored glass.
Of 10 vials of low density polyethylene or polypropylene together with instructions for use in a stack of cardboard.
5 vials made of glass in blisters of polyvinyl chloride or polyethylene terephthalate film with a polymer film or lacquered aluminum foil or a polymer film without an aluminum foil and lacquer or in the form of cardboard with cells for stacking ampoules.
2 blisters or shape of cardboard together with instructions for use and a lancet ampulnam or without a pack of cardboard.
Contraindications
Increased sensitivity to calcium gluconate and other ingredients, gi- perkaltsiemiya (including patients with hyperparathyroidism, hypervitaminosis D, dekal- tsiniruyuschimi malignancies, kidney failure, oste- oporozom associated with immobilization, sarcoidosis, milk-alkali syndrome (syn – Burnett core)), hypercalciuria, cardiac glycoside intoxication, simultaneous treatment of cardiac glycoside; for intramuscular injection – children’s age.
Carefully
Dehydration, electrolyte disorders (risk of hypercalcemia), diarrhea, malabsorption syndrome, calcium nefrourolitiaz (history), small hypercalciuria, moderate chronic renal failure, commonly atherosclerosis, hypercoagulability, elderly patients, especially in the presence of one or more of the abovementioned conditions, nephrocalcinosis pathology cardiovascular system, sarcoidosis, chronic heart failure, simultaneous treatment with epinephrine. Before using the drug should consult a doctor.
Dosage
100 mg / ml
Indications
Treatment of acute hypocalcemia. To reduce the capillary permeability in allergic conditions, netrombotsitopenicheskoy purpura and exudative dermatoses, such as dermatitis herpetiformis and itchy rash due to the use of certain medications.
Interaction with other drugs
Calcium gluconate solution fills the syringe must not contain residues of ethyl alcohol, since the latter in the presence of calcium gluconate precipitates.
Pharmaceutically compatible with carbonates, salicylates, sulfates and ceftriaxone (form insoluble or sparingly soluble calcium salt with them).
Forms insoluble complexes with the antibiotic tetracycline, reducing antibacterial effect.
Blockers reduces the effect of “slow” calcium channel (intravenous administration of calcium gluconate before or after verapamil reduces its hypotensive effect, but it has little effect on antiarrhythmic effect).
While the use of quinidine may slow intraventricular conduction and increasing quinidine toxicity.
Not recommended the use of calcium gluconate during treatment with cardiac glycosides (possibly increased cardiotoxic action of cardiac glycosides).
When combined with the thiazide diuretics may enhance hypercalcemia.
Calcitonin reduces the effect of hypercalcemia.
Reduces the bioavailability of phenytoin.
Overdose
Symptoms of hypercalcemia: anorexia, nausea, vomiting, constipation, abdominal pain, polyuria, polydipsia, dehydration, muscle weakness, bone pain, calcification of the kidneys, somnolence, hypersomnia, confusion, increased blood pressure, in severe cases – arrhythmia (up to cardiac arrest) and coma.
Treatment: aimed at reducing the increased concentration of calcium in the blood plasma.
Starting rehydration therapy includes, in severe hypercalcemia may require addition of 0.9% sodium chloride intravenous infusion to increase the amount of extracellular fluid. To reduce the calcium concentration in the serum calcitonin may be used.
Furosemide may be used to increase calcium excretion, however, should not be used “thiazide” diuretics, because they can increase the absorption of calcium in the kidneys. Hemodialysis or peritoneal dialysis is performed, if other measures are not effective or maintaining the symptoms of hypercalcemia. Treatment of overdose is performed under carefully controlled concentrations of serum electrolytes.
pharmachologic effect
Pharmacological group:
Calcium-phosphorus metabolism regulator.
ATC code: A12AA03.
Pharmacodynamics:
calcium preparation compensates deficiency of calcium ions required for nerve impulse transmission process, reduce skeletal and smooth muscles, myocardial activity, bone formation, blood coagulation.
When administered intravenously, it stimulates the sympathetic division of the autonomic nervous system, increases the adrenalin glands.
Pharmacokinetics:
Following parenteral administration of calcium gluconate with current blood uniformly distributed in all tissues and organs. The plasma calcium is bound in the form (complexed with proteins and with anions of organic and inorganic acids (hydrogen carbonate, phosphate, lactate, calcium citrate)) and a free ionized form. Crosses the placental barrier, enters the breast milk. Excreted mainly by the kidney.
Pregnancy and breast-feeding
Calcium crosses the placenta, enters the breast milk. Use of the drug during pregnancy and breastfeeding is possible only under strict control of serum calcium concentration as hypercalcemia negative effect on the fetus and child.
Conditions of supply of pharmacies
Prescription.
side effects
The incidence of side effects directly related to the rate of administration and the dose of calcium gluconate. When properly administered their frequency is 1/1000.
Cardio-vascular system: decrease in blood pressure, bradycardia, arrhythmia, vasodilatation, circulatory collapse (including fatal), “tides” of blood, usually with the rapid introduction.
From the digestive system: nausea, vomiting, diarrhea.
General disorders: feeling of warmth, sweating.
Violations at the injection site: intramuscular injection – pain or erythema (
special instructions
The preparation is heated prior to introduction to a body temperature. The drug is administered by deep intramuscular injection or by slow intravenous injection (during 2-3 minutes), or drip, to exclude the possibility of local irritation or necrosis in the case of contact with the drug in the perivascular tissue. Intravenous injection should be carried out under close monitoring of heart rate and electrocardiogram, since at too rapid introduction of calcium gluconate may occur bradycardia with vasodilation and arrhythmia.
When administered intravenously, perhaps feeling the heat throughout the body, which passes quickly.
Because of the risk of local irritation intramuscular injections should be performed only if the intravenous injection is not possible. Intramuscular injections must be performed sufficiently deep into the muscle, preferably in the gluteal region. For obese patients, it should be chosen over a long needle for the safe introduction into the muscle, rather than fat tissue. If required repeated injections, each time necessary to change the injection site.
During treatment must be carefully controlled concentration of calcium in plasma when administered at high doses – additionally control the rate of calcium excretion.
For intravenous administration of calcium gluconate, in exceptional cases, patients receiving cardiac glycosides, requires monitoring cardiac activity and conditions must be provided for emergency treatment of cardiac events (such as arrhythmia expressed).
Calcium salts should be used with caution and only after careful determination of indications in patients with nephrocalcinosis, disorders of the cardiovascular system, sarcoidosis (Boeck’s disease), in patients receiving epinephrine, in elderly patients.
Impaired renal function may be associated with hypercalcemia and secondary hyperparathyroidism. Therefore, patients with impaired kidney function parenteral calcium administration should be initiated only after careful determination of indicators, and the need to control calcium phosphate balance.
When applied simultaneously with other drugs requires medical supervision.
The solution is to use only if it is clear and the ampoule is intact. The drug is diluted immediately after opening the ampoule. At a dilution of the drug requires strict adherence to aseptic conditions. From the point of view of the microbiological safety of diluted preparation should be used immediately. Ampoule for single use only. The exception is the breeding, prepared under controlled aseptic conditions. After cooking, the terms solution and its storage conditions prior to the introduction of the user is responsible, and should not exceed 24 hours at 2 to 8 ° C. Remaining unused amounts of the drug to be destroyed.
The effect on the ability of control of vehicles and mechanisms
In the period of treatment must be careful when performing potentially hazardous activities that require high concentration and psychomotor speed reactions (vehicle control, work with moving machinery, the work manager and operator).
Storage conditions
Store at a temperature not higher than 25 C. Keep out of reach of children.
Dosing and Administration
Normally, the total calcium concentration in the serum is 2,25-2,75 mmol / l or 4,45-5,5 Ceq / l. Calcium gluconate drug therapy aimed at restoring normal blood calcium concentration in plasma. Solutions containing calcium should be administered slowly to minimize peripheral vasodilation and inhibition of cardiac activity.
The preparation is heated prior to introduction to a body temperature. The drug is administered by deep intramuscular injection or by slow intravenous injection (during 2-3 minutes), or drip, to exclude the possibility of local irritation or necrosis in the case of contact with the drug in the perivascular tissue. Intravenous injection should be carried out under close monitoring of heart rate and electrocardiogram, since at too rapid introduction of calcium gluconate may occur bradycardia with vasodilation and arrhythmia.
When administered intravenously, perhaps feeling the heat throughout the body, which passes quickly.
Because of the risk of local irritation intramuscular injections should be performed only if the intravenous injection is not possible. Intramuscular injections must be performed sufficiently deep into the muscle, preferably in the gluteal region. For obese patients, it should be chosen over a long needle for the safe introduction into the muscle, rather than fat tissue. If required repeated injections, each time necessary to change the injection site.
During treatment must be carefully controlled concentration of calcium in plasma when administered at high doses – additionally control the rate of calcium excretion.
Adults: deep intramuscularly, intravenously slowly (within 2-3 min) or drip 5-10 ml of 100 mg / ml (10% solution) daily, every other day or 2 days later (depending on the nature of the disease and clinical condition of the patient). Subsequent doses are determined according to the concentration of calcium in blood serum.
Children under 18 years: the dose and mode of administration depend on the degree of hypocalcemia, the nature and severity of symptoms.
Babies, depending on the age, preparation concentrations of 100 mg / ml (10% solution) is administered at the following doses: 6 months – 0.1-1 ml; 7-12 months – 1-1.5 mL; 1-3 years – 1.5-2 ml; 4-6 years – 2-2.5 mL; 7-14 – 3.5 ml; over 14 years – the dose for both adults.
Children should not be administered the drug intramuscularly because of the possible development of necrosis.
Recommended only slow intravenous injection or intravenous infusion after dilution to achieve sufficiently low rates of administration, and to exclude the possibility of local irritation or necrosis at the accidental ingestion of the drug in the perivascular tissue.
For the intravenous infusion formulation is diluted in a ratio of 1: 10 to 10 mg / ml of the following solutions for infusion: 0.9% sodium chloride or 5% glucose solution. intravenous administration rate should not exceed 50 mg calcium gluconate per minute. Dilution should be carried out under aseptic conditions.
Elderly patients: data indicating unfavorable tolerance calcium gluconate elderly patients lacking, however age-related changes, such as renal dysfunction and slowing metabolism may require dose reduction.
Working with the polymer vial: 1. Take a vial and shake it, holding it by the neck. 2. Rotate and rotate movements to separate the valve. 3. Through the hole immediately connect a syringe with luer ampoule. 4. Fill the syringe contents of the vial. 5. Push the needle on the syringe.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

Grotex Ltd.

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