Calcium gluconate Galenica Senese

PACKAGE LEAFLET

Calcium Gluconate Galenica Senese 500 mg/5 ml solution for infusion, 1000 mg/10 ml solution for infusion

PHARMACOTHERAPEUTIC CATEGORY
Mineral supplements
THERAPEUTIC INDICATIONS
Treatment of hypocalcemic conditions.
Adjuvant in anaphylactic treatment, 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 associated with 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 using separate infusion lines. See sections Interactions, Undesirable effects, and Dosage, method and duration of administration.

PRECAUTIONS FOR USE
Subcutaneous and intramuscular administration must be avoided, as calcium salts are irritating 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 insufficiency, 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 in patients with cardiac disease.
Calcium gluconate is physically incompatible with several substances (see Dosage, method 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: Potentiation of effects. This combination places the patient at 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 with calcium gluconate increases the risk of hypercalcemia.
Laboratory tests
Calcium gluconate may cause false negative results in laboratory tests for serum and urinary magnesium. The mechanism of this interaction is unknown.
Physical incompatibilities
See Precautions for use and Dosage, method and duration of administration.
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 section Undesirable effects).
In patients older than 28 days (including adults), ceftriaxone must not be administered concomitantly with intravenous solutions containing calcium, including Calcium gluconate Galenica Senese 500 mg/5 ml solution for infusion and Calcium gluconate Galenica Senese 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 administrations, the line must be flushed with a compatible fluid between infusions.
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 women who are breastfeeding.
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: No relevant information to report.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Normal plasma calcium concentration generally ranges between 2.25–2.75 mmol or 4.5–5.5 mEq/l. Treatment with calcium gluconate aims to restore or maintain these levels.
However, it should be noted that the absolute amount of calcium required in specific clinical situations is difficult to determine and may vary widely. During therapy, serum calcium levels must therefore be closely monitored.
Calcium gluconate must not be administered subcutaneously or intramuscularly (see Precautions for use). Calcium gluconate Galenica Senese is a hypertonic solution and must be used with caution and at a controlled infusion rate. Administration must be by slow intravenous infusion. An infusion rate exceeding 1.5 ml per minute should not be recommended.
The following dosages of calcium gluconate are suggested 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 dose 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 substances, leading to precipitate formation. Calcium salts are incompatible with oxidizing agents, citrates, soluble carbonates, bicarbonates, phosphates, tartrates and sulfates.
Furthermore, incompatibility has been reported with ceftriaxone (see Precautions for use), amphotericin, sodium cephalothin, sodium cefazolin, cefamandole nafate, sodium novobiocin, dobutamine hydrochloride, prochlorperazine, tetracyclines, methylprednisolone sodium succinate, prochlorperazine edisylate, metoclopramide hydrochloride, fluconazole, indomethacin, meropenem.
The medicine must not be mixed with intravenous nutritional emulsions.
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).
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 simultaneously 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 possible treatment option.
During overdose treatment, serum electrolyte levels must be carefully monitored.
In case of accidental ingestion/overdose of Calcium gluconate Galenica Senese, contact a doctor immediately or go to the nearest hospital.
If you have any doubts about the use of Calcium gluconate Galenica Senese, consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, calcium gluconate can cause undesirable effects, although not everyone experiences them.
The following undesirable effects of calcium gluconate are reported. There are insufficient data to establish the frequency of individual listed effects.
Many of the undesirable effects are related to a high infusion rate. This may cause vasodilation, with sweating, nausea, vomiting, hot flushes, hypotension, bradycardia, arrhythmias, as well as syncope and vasomotor collapse, even fatal.
Local extravasation of the solution may lead to soft tissue calcification, abscess formation and necrosis.
Some undesirable effects may be consequences of overdose, including nephrolithiasis due to hypercalcemia and hypercalciuria.
Precipitation of ceftriaxone-calcium salt
Serious, and in some cases fatal, adverse reactions have rarely been reported in preterm and full-term neonates (age < 28 days) who were treated with intravenous ceftriaxone and calcium. Post-mortem findings revealed ceftriaxone-calcium salt precipitation 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 treated with 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.
Ceftriaxone-calcium salt precipitation in the gallbladder has been observed, mainly in patients treated with doses exceeding 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.
Adhering to the instructions in this leaflet reduces the risk of undesirable effects.
Reporting of undesirable effects
If you experience any undesirable effect, including those not listed in this leaflet, contact your doctor or pharmacist. Undesirable effects can also be reported directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. Reporting adverse reactions contributes to providing more information on the safety of this medicine.
EXPIRY DATE AND STORAGE
Expiry date: see the date on the packaging.
The expiry date refers to the product in unopened packaging, correctly stored.
Caution: Do not use the medicine after the expiry date stated on the packaging.
Storage conditions
Store in the original packaging. Do not freeze.
After first opening of the packaging, the medicine must be used immediately for a single, uninterrupted administration.
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 the medicine out of the reach and sight of children.
COMPOSITION
Calcium gluconate Galenica Senese 500 mg/5 ml solution for infusion
1 vial contains:
Active substance: Calcium gluconate 475 mg
(mEq/l of Ca 446)
Excipients: Water for injections q.s. to 5 ml and calcium saccharate 18 mg.
pH: from 6.0 to 8.2.
Calcium gluconate Galenica Senese 1000 mg/10 ml solution for infusion
1 vial contains:
Active substance: Calcium gluconate 950 mg
(mEq/l of Ca 446)
Excipients: Water for injections q.s. to 10 ml and calcium saccharate 36 mg.
pH: from 6.0 to 8.2.
PHARMACEUTICAL FORM AND CONTENT
Solution for infusion
Calcium gluconate Galenica Senese 500 mg/5 ml solution for infusion:
5 ml glass vial
5 x 5 ml glass vials
10 x 5 ml glass vials
Calcium gluconate Galenica Senese 1000 mg/10 ml solution for infusion:
10 ml glass vial
5 x 10 ml glass vials
10 x 10 ml glass vials
MARKETING AUTHORISATION HOLDER
Industria Farmaceutica Galenica Senese S.r.l.
MANUFACTURER
Industria Farmaceutica Galenica Senese S.r.l.