PACKAGE LEAFLET

Calcium Gluconate S.A.L.F. 1000 mg/10 ml solution for infusion

PHARMACOTHERAPEUTIC CATEGORY
Mineral supplements.
THERAPEUTIC INDICATIONS
Treatment of hypocalcemic conditions.
Adjunctive treatment in antianaphylactic therapy, for control of increased capillary permeability in allergic conditions and in non-thrombocytopenic purpura.
CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients;
Pathological conditions or states leading to hypercalcemia (e.g. hyperparathyroidism, hypervitaminosis D, neoplastic disease with bone decalcification);
Severe hypercalciuria;
Severe renal insufficiency;
Ventricular fibrillation;
Patients receiving cardiac glycosides;
Concomitant treatment with ceftriaxone in neonates (≤28 days of age), even when separate infusion lines are used. See sections Interactions, Undesirable Effects, and Dosage, Route and Duration of Administration.

PRECAUTIONS FOR USE
Subcutaneous and intramuscular administration must be avoided, as calcium salts are irritant and may cause local abscesses and necrosis. Patients should therefore be regularly monitored at the infusion site to prevent local extravasation of the solution.
Serum calcium levels and urinary excretion should be monitored, particularly in children, in cases of chronic renal failure, or in the presence of urinary tract stones.
If plasma calcium levels exceed 2.75 mmol/L or if 24-hour urinary calcium excretion exceeds 5 mg/kg, treatment must be immediately discontinued, as cardiac arrhythmias may occur.
Calcium salts should be administered with caution in patients with impaired renal function, nephrocalcinosis, or cardiac disease.
Calcium gluconate is physically incompatible with several substances (see Dosage, Route and Duration of Administration). Avoid mixing calcium gluconate solutions with incompatible drugs in the same infusion set, or even administering them sequentially through the same line.
Serious, potentially fatal complications may occur following the simultaneous administration of physically incompatible solutions or total parenteral nutrition solutions containing calcium and phosphate, due to microcrystallization of insoluble calcium salts within the body.
Concomitant use of calcium gluconate and ceftriaxone should be avoided, as precipitation of ceftriaxone-calcium complexes may occur.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those without a prescription.
Cardiac glycosides/digitalis: enhanced effects. This combination increases the risk of digitalis toxicity.
Verapamil: concomitant systemic use of verapamil and calcium gluconate may reverse the hypotensive effect.
Thiazide diuretics: concomitant use of thiazide diuretics and calcium gluconate increases the risk of hypercalcemia.
As with other calcium-containing solutions, concomitant treatment with ceftriaxone is contraindicated in neonates (≤28 days of age), even when separate infusion lines are used (risk of fatal precipitation of ceftriaxone-calcium salt in the neonate's bloodstream; see Undesirable Effects).
In patients older than 28 days (including adults), ceftriaxone must not be administered concomitantly with intravenous solutions containing calcium, including Calcium Gluconate S.A.L.F. 1000 mg/10 ml solution for infusion, through the same infusion line (e.g. via Y-connector).
If the same line is used for sequential administration, the line must be flushed with a compatible fluid between infusions.
Laboratory Tests
Calcium gluconate may cause false negative results in laboratory tests for serum and urinary magnesium levels. The mechanism of this interaction is unknown.
Physical incompatibilities
See Precautions for Use and Dosage, Route and Duration of Administration.
SPECIAL WARNINGS
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
Calcium gluconate should be used during pregnancy only if considered essential by the physician.
Calcium is excreted in breast milk. This should be taken into account when prescribing calcium to breastfeeding women.
Effects on ability to drive and use machines
Calcium gluconate does not impair the ability to drive vehicles or operate machinery.
Important information on some excipients:
The Calcium Gluconate S.A.L.F. solution contains D-saccharate calcium as stabilizer.
DOSAGE, ROUTE AND DURATION OF ADMINISTRATION
Normal plasma calcium concentration generally ranges between 2.25–2.75 mmol/L or 4.5–5.5 mEq/L. Treatment with calcium gluconate aims to restore or maintain these levels.
However, the absolute amount of calcium required in specific clinical situations is difficult to determine and may vary widely. Therefore, serum calcium levels must be closely monitored during therapy.
Calcium gluconate must not be administered subcutaneously or intramuscularly (see Precautions for Use).
Calcium Gluconate S.A.L.F. is a hypertonic solution and must be used with caution and at a controlled infusion rate. Administration must be performed as a slow intravenous infusion. An infusion rate exceeding 1.5 mL per minute is not recommended.
The following dosage recommendations for calcium gluconate are provided as a guide:
Adults
500 mg – 2000 mg (5–20 mL of solution)
Children
200 – 500 mg (2–5 mL of solution).
Infants
No more than 200 mg (no more than 2 mL of solution).
Elderly patients
Although there is no evidence that tolerance to calcium gluconate is directly affected by advanced age, certain factors or clinical conditions—such as poor diet and impaired renal function—may negatively affect drug tolerance and therefore require dosage reduction.
Do not use if the solution is not clear; any precipitate may be redissolved by gentle warming in warm water.
Calcium gluconate for intravenous use may be diluted with 5% glucose or 0.9% sodium chloride solutions. Dilution in solutions containing bicarbonates, phosphates, or sulfates must be avoided.
Calcium salts may form complexes with many drugs, potentially leading to precipitate formation. Physical incompatibility has been reported with ceftriaxone (see sections Contraindications, Interactions, and Undesirable Effects).
Calcium salts are incompatible with oxidizing agents, citrates, soluble carbonates, bicarbonate, phosphates, tartrates, and sulfates.
In addition, the following are incompatible: amphotericin, sodium cephalothin, sodium cefazolin, cefamandole nafate, sodium novobiocin, hydrochloride dobutamine, prochlorperazine, tetracyclines, methylprednisolone sodium succinate, prochlorperazine edisylate, hydrochloride metoclopramide, fluconazole, indomethacin, meropenem.
The medicinal product must not be mixed with intravenous nutritional emulsions.
OVERDOSE
Excessive administration of calcium salts leads to hypercalcemia. Symptoms of hypercalcemia may include: anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, polydipsia, polyuria, mental disturbances, bone pain, nephrocalcinosis, kidney stones, and, in severe cases, cardiac arrhythmias and coma.
Treatment of overdose
Severe hypercalcemia is treated by infusion of a sodium chloride solution to increase extracellular fluid volume. Furosemide may then be used, either concurrently or subsequently, to further enhance calcium excretion. If treatment proves ineffective, other drugs such as calcitonin, bisphosphonates, disodium edetate, and phosphates may be used.
Hemodialysis may be considered as a last resort.
During treatment of overdose, serum electrolyte levels must be closely monitored.
In case of accidental ingestion/overdose of Calcium Gluconate S.A.L.F., contact a doctor immediately or go to the nearest hospital.
If you have any doubts about the use of Calcium Gluconate S.A.L.F., consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, calcium gluconate can cause adverse effects, although not everyone experiences them.
The following are adverse effects associated with calcium gluconate. There are insufficient data to determine the frequency of the individual effects listed.
Many of the adverse effects are due to excessively rapid infusion. This may cause vasodilation, with sweating, nausea, vomiting, hot flushes, hypotension, bradycardia, arrhythmias, and even syncope and vasomotor collapse, which may be fatal.
Local extravasation of the solution may lead to soft tissue calcification, abscess formation, and necrosis.
Some adverse effects may be consequences of overdose, including nephrolithiasis due to hypercalcemia and hypercalciuria.
Precipitation of calcium-ceftriaxone salt
Rarely, serious and sometimes fatal adverse reactions have been reported in preterm and full-term neonates (aged <28 days) treated with intravenous ceftriaxone and calcium. Post-mortem findings revealed precipitation of calcium-ceftriaxone salt in the lungs and kidneys. The high risk of precipitation in neonates is due to their low blood volume and longer ceftriaxone half-life compared to adults (see sections Contraindications and Interactions).
Cases of renal precipitation have been reported, primarily in children over 3 years of age receiving high daily doses (e.g. ≥80 mg/kg/day) or total doses exceeding 10 grams, and who had other risk factors (e.g. fluid restriction, bedridden patients). The risk of precipitate formation increases in immobilized or dehydrated patients. This event may be symptomatic or asymptomatic, may cause renal failure and anuria, and is reversible upon discontinuation of administration.
Calcium-ceftriaxone salt precipitation in the gallbladder has been observed, primarily in patients treated with doses above the recommended standard dose. Prospective studies in children have shown variable incidence of precipitation with intravenous administration; in some studies, incidence exceeded 30%. This incidence appears lower when infusions are administered slowly (20–30 minutes). This effect is generally asymptomatic, but in rare cases precipitation has been associated with clinical symptoms such as pain, nausea, and vomiting. Symptomatic treatment is recommended in such cases. Precipitation is generally reversible upon discontinuation of administration.
Following the instructions provided in this leaflet reduces the risk of adverse effects.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, contact your doctor or pharmacist. Adverse effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting adverse effects contributes to providing more information on the safety of this medicinal product.
EXPIRY DATE AND STORAGE
Expiry date: see the date on the packaging.
The expiry date refers to the product stored unopened and under recommended conditions.
WARNING: do not use the medicinal product after the expiry date stated on the packaging.
Storage conditions
Store in the original packaging.
No special storage conditions regarding temperature are required. Do not freeze.
The solution should be clear, colorless, and free from visible particles.
Do not use if the solution is not clear; any precipitate may be redissolved by gentle warming in warm water.
The medicinal product must be used immediately after opening; any unused solution must be discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Keep this medicine out of the reach and sight of children.
COMPOSITION
1 vial contains:
Active substance: Calcium gluconate monohydrate 950 mg
Excipients: Tetrahydrate D-saccharate calcium, Water for injections.
(mEq/L Ca 446)
PHARMACEUTICAL FORM AND CONTENT
Solution for infusion
5 vials of 10 mL
MARKETING AUTHORIZATION HOLDER
S.A.L.F. S.p.A. Laboratorio Farmacologico via Marconi, 2 - 24069 Cenate Sotto (BG) - Tel. 035 - 940097
MANUFACTURER
S.A.L.F. S.p.A. Laboratorio Farmacologico via Marconi, 2 - 24069 Cenate Sotto (BG) - Tel. 035 - 940097