Calcium chloride Galenica Senese

Italy
Brand name Calcium chloride Galenica Senese
Form solution for injection for infusion concentrate
Active substance / Dosage
CALCIUM CHLORIDE
Prescription type Restricted prescription – hospital or equivalent facility use only
ATC code
B05XA07
Registration number 029830
Manufacturer INDUSTRIA FARMACEUTICA GALENICA SENESE S.R.L.

Table of Contents

PACKAGE LEAFLET

Calcium Chloride Galenica Senese 1g/10 ml

Concentrate for solution for infusion
PHARMACOTHERAPEUTIC CATEGORY
Electrolyte solutions
THERAPEUTIC INDICATIONS
Calcium chloride is indicated:

  • in hypocalcemia; in conditions requiring a rapid increase in blood calcium levels (e.g. renal failure, hypoparathyroidism, tetany, neonatal tetany, vitamin D deficiency, alkalosis);
  • in hyperkalemia with consequent cardiac toxicity;
  • in magnesium intoxication. Furthermore, calcium chloride is indicated in cardiac resuscitation, in cases of poor or inadequate cardiac contraction following defibrillation or epinephrine treatment.

CONTRAINDICATIONS
Intravenous administration of calcium chloride is contraindicated in the following cases:

  • hypersensitivity to the active substance or to any of the excipients;
  • hypercalcemia, hypercalciuria, or severe renal disease;
  • ventricular fibrillation, as calcium chloride may increase the risk of arrhythmias;
  • kidney stones, as it may exacerbate this condition;
  • sarcoidosis, as it may potentiate the typical hypercalcemia of this condition;
  • hypercoagulability;
  • patients receiving treatment with cardiac glycosides (see Interactions);
  • 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.

The injectable preparation of calcium chloride must not be administered by intramuscular or subcutaneous route.
PRECAUTIONS FOR USE
Calcium chloride must be used with great caution in patients:

  • with renal disorders;
  • with cardiac disorders;
  • who have received a blood transfusion, as ionized calcium concentrations may differ from expected values. Since calcium chloride is acidifying, caution is required when administering it in conditions such as renal disorders, pulmonary heart disease, respiratory acidosis, or respiratory failure, where acidification may worsen the clinical picture. Additionally, caution is advised in conditions where there may be an increased risk of hypercalcemia, such as chronic renal failure, dehydration, or electrolyte imbalance. Since calcium salts may increase the risk of arrhythmias, care must be taken when prolonging calcium chloride administration in patients with cardiac disorders.

Electrocardiogram monitoring and fluid and electrolyte balance monitoring are essential.
Serum calcium levels must be closely monitored during therapy to ensure they do not exceed normal values.
Urinary calcium concentrations should also be monitored to avoid hypercalciuria, as hypercalciuria may lead to hypercalcemia.
Data on the safety and efficacy of the drug in children are limited.
Do not inject the concentrated solution undiluted, but only after appropriate dilution. The solution must be clear and free from visible particles.
Administration must be slow and through a large vein at a rate not exceeding 0.35–0.7 mmol/min to avoid possible venous damage and to prevent high calcium concentrations in the heart that could cause syncope. If the patient experiences pain, administration must be stopped.
Direct administration into cardiac tissue should preferably be avoided.
Administration of calcium chloride may cause vasodilation with consequent lowering of blood pressure.
Calcium chloride solution is irritating and therefore must not be administered by intramuscular, subcutaneous, or perivascular routes, as tissue necrosis may occur.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those without a prescription.
Calcium chloride solution may interact with the following medicines:

  • thiazide diuretics, as hypercalcemia may occur due to reduced renal calcium excretion;
  • cardiac glycosides (digitalis), digoxin and digitoxin, as concomitant use may increase the risk of arrhythmias due to synergistic inotropic and toxic effects;
  • verapamil (and other calcium channel blockers), as concomitant use may reduce the antihypertensive effect of verapamil;
  • magnesium-containing medicines, as the risk of hypercalcemia or hypermagnesemia may increase, especially in patients with renal disorders; neuromuscular blockers: calcium salts may reverse the action of non-depolarizing blockers; in some cases, an increase and prolongation of the action of tubocurarine has also been observed. As with other calcium-containing solutions, concomitant treatment with ceftriaxone is contraindicated in neonates (≤ 28 days of age), even when using separate infusion lines (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 chloride Galenica Senese 1g/10 ml Concentrate for solution for infusion, through the same infusion line (e.g. via Y-connector). If the same line is used for sequential administrations, it must be flushed with a compatible fluid between infusions.

SPECIAL WARNINGS
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
Pregnancy
Calcium chloride must not be used during pregnancy unless absolutely necessary.
In assessing the risk/benefit ratio, it should be considered that calcium chloride is also used as a life-saving agent in cardiac emergencies.
Breastfeeding
Although calcium is a normal component of breast milk, it is not known whether calcium chloride is excreted in breast milk. Therefore, calcium chloride must not be used during breastfeeding unless absolutely necessary.
Effects on ability to drive and use machines
Not applicable.
Important information about certain excipients: no relevant information to report.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Calcium chloride Galenica Senese concentrate for solution for infusion is a hypertonic solution and must be diluted before administration; the solution is compatible with 5% glucose and 0.9% sodium chloride. Once the vial is opened, the solution must be used immediately.
After dilution, use for a single uninterrupted administration; any remaining solution must be discarded.
Calcium chloride is administered, after appropriate dilution, by slow intravenous infusion, except in emergency situations.
Do not exceed an administration rate of 0.35–0.7 mmol (0.7–1.4 mEq)/minute to avoid venous damage and to prevent high calcium concentrations in the heart that could cause syncope (see section 4.4).
Administration must be stopped if the patient experiences pain or redness at the injection site, as this may indicate extravasation of the drug.
It is advisable for the patient to remain lying down for a short period after administration.
Dosage and infusion rate depend on the patient's age, weight, and clinical condition.
Plasma calcium concentrations must be frequently monitored.
In children, the efficacy and safety of calcium chloride have not been established.
Acute hypocalcemia
Adults: the recommended initial dose is 3.5–7 mmol (7–14 mEq) of calcium. If necessary, repeat administration at intervals of 1–3 days.
Hypocalcemic tetany
Adults: the recommended initial dose is 2.25–8 mmol (4.5–16 mEq) of calcium. Repeat administration until response is achieved.
Hyperkalemia
Adults: the recommended initial dose is 1.12–7 mmol (2.25–14 mEq) of calcium. If necessary, the dose may be repeated after 1–2 minutes. ECG monitoring is required during administration.
Magnesium intoxication
Adults: the recommended dose is 3.5 mmol (7 mEq) of calcium. Repeat administration only if the clinical condition does not improve.
Cardiac resuscitation
Adults:
a) intravenous administration: the recommended calcium dose is 0.054–0.109 mmol (0.109–0.218 mEq) per kg of body weight or 3.5–7 mmol (7–14 mEq) of calcium. If necessary, repeat administration at 10-minute intervals;
b) intraventricular administration: the recommended dose is 1.35–2.7 mmol (2.7–5.4 mEq) of calcium.
Children: the recommended calcium dose is 0.136 mmol (0.272 mEq) per kg of body weight (calcium chloride has better calcium bioavailability compared to calcium gluconate). Slow administration via a central vein is preferred, although intraosseous administration is also considered acceptable.
Patients with renal failure
In patients with severe renal failure with creatinine clearance below 25 ml/min, dosage adjustments may be necessary based on serum calcium levels.
Calcium chloride solution is incompatible with:

  • magnesium sulfate: precipitation occurs;
  • medicines containing phosphate: calcium phosphate precipitate forms;
  • medicines containing carbonate: calcium carbonate precipitate forms;
  • medicines containing tartrate: calcium tartrate precipitate forms. Incompatibilities of calcium chloride solution have been reported with:
  • aminophylline: due to precipitate formation;
  • amphotericin B: due to development of cloudiness;
  • cefamandole: due to presence of sodium carbonate in cefamandole preparation;
  • ceftriaxone sodium: due to precipitate formation; therefore, calcium solution administration must not occur within 48 hours after ceftriaxone administration;
  • cephalothin: due to physical incompatibility;
  • cefradine: due to presence of sodium carbonate in cefradine preparation;
  • chlorpheniramine: due to physical incompatibility;
  • dobutamine: due to development of cloudiness;
  • fat emulsion: due to flocculation;
  • sodium heparin;
  • indomethacin: due to precipitate formation;
  • sodium nitrofurantoin;
  • promethazine: due to precipitate formation;
  • propofol: due to precipitate formation;
  • streptomycin: as calcium may inhibit streptomycin activity;
  • tetracyclines: calcium salts may complex with tetracyclines.

Calcium salts may form complexes with many drugs, leading to precipitate formation.
Physical incompatibility has been reported with ceftriaxone (see sections Contraindications, Interactions and Undesirable effects).
OVERDOSE
Administration of high doses of calcium chloride may result in hypercalcemia, especially in patients with renal disorders. Typical symptoms of hypercalcemia include thirst, nausea, vomiting, constipation, polyuria, abdominal pain, muscle weakness, mental disturbances, and in severe cases, cardiac arrhythmia and coma. Hypercalcemia is defined as plasma calcium concentrations exceeding 2.6 mmol/l; therefore, such concentrations must be constantly monitored.
In case of mild overdose, treatment includes immediate discontinuation of calcium chloride and any other calcium-containing medication.
In case of severe overdose (plasma concentrations > 2.9 mmol/l), the following measures should be taken:

  • rehydration via administration of 0.9% sodium chloride solution;
  • use of non-thiazide diuretics to promote calcium excretion;
  • monitoring of plasma potassium and magnesium levels with immediate correction to normal values;
  • monitoring of cardiac function, use of beta-blockers to reduce the risk of cardiac arrhythmia;
  • hemodialysis if necessary.

In case of accidental ingestion/overdose of Calcium chloride Galenica Senese, contact your doctor immediately or go to the nearest hospital.
IF YOU HAVE ANY DOUBTS ABOUT THE USE OF CALCIO CLORURO GALENICA SENESE, CONSULT YOUR DOCTOR OR PHARMACIST.
UNDESIRABLE EFFECTS
Like all medicines, Calcium chloride Galenica Senese may cause undesirable effects, although not everyone experiences them.
Below are the undesirable effects of calcium chloride. There are insufficient data to determine the frequency of individual listed effects.
Some of the undesirable effects listed below occurred due to inadequate administration of the drug, e.g. too rapid administration or administration by a route other than intravenous.
Cardiac and vascular disorders
Vasodilation, hypotension, bradycardia, arrhythmias, syncope, cardiac arrest, flushing, hypertension, ventricular fibrillation.
Systemic disorders and administration site conditions
Extravasation, tissue necrosis, abscess formation, cutaneous calcification, injection site infection, venous thrombosis, phlebitis, redness, rash, pain, fever.
Metabolism and nutrition disorders
Hypercalcemia, Burnett syndrome (milk-alkali syndrome).
Gastrointestinal disorders
Gastrointestinal irritation, constipation, metallic taste, chalky taste, nausea, vomiting.
Renal and urinary disorders
Polyuria.
Respiratory, thoracic and mediastinal disorders
Abdominal pain, pneumothorax.
Nervous system disorders
Mental disturbances.
Musculoskeletal and connective tissue disorders
Muscle weakness.
Precipitation of calcium-ceftriaxone salt
Serious, and in some cases fatal, adverse reactions have rarely been reported in preterm and full-term neonates (age < 28 days) treated with ceftriaxone and calcium by intravenous route. 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, mainly 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.
Precipitation of calcium-ceftriaxone salt has been observed in the gallbladder, mainly in patients treated with doses above the recommended standard dose. In children, prospective studies 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, precipitations have been accompanied by clinical symptoms such as pain, nausea, and vomiting. In such cases, symptomatic treatment is recommended. Precipitation is generally reversible upon discontinuation of administration.
Following 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, consult your doctor or pharmacist. Undesirable effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting undesirable effects contributes to providing more information on the safety of this medicine.
EXPIRY DATE AND STORAGE
Expiry date: see date on the packaging.
The expiry date refers to the product in intact packaging, correctly stored.
WARNING: do not use the medicine after the expiry date stated on the packaging.
Storage conditions
Store in the original packaging to protect from light.
Do not use the medicine if the solution is not clear and colourless or contains particles.
Do not freeze.
Period of validity after dilution:
After dilution, use for a single uninterrupted administration; any remaining 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 REACH AND SIGHT OF CHILDREN.
COMPOSITION
One 10 ml vial contains
Active substance: calcium chloride 1 g
(mEq/ml Ca 1,360)
(mmol/ml Ca 0.680)
(3.7 g calcium chloride = 1 g calcium = 25 mmol = 50 mEq)
Excipients: water for injections q.s. to 10 ml
PHARMACEUTICAL FORM AND CONTENT
Concentrate for solution for infusion
Sterile, pyrogen-free, clear and colourless solution.
Glass vials of 10 ml.
MARKETING AUTHORISATION HOLDER
Industria Farmaceutica Galenica Senese S.r.l.
MANUFACTURER
Industria Farmaceutica Galenica Senese S.r.l.

PACKAGE LEAFLET

Calcium Chloride Galenica Senese 5 mEq/10 ml concentrate for solution for infusion

PHARMACOTHERAPEUTIC CATEGORY
Electrolyte solutions

THERAPEUTIC INDICATIONS
Calcium chloride is indicated:

  • in hypocalcemia; in conditions requiring a rapid increase in blood calcium levels (e.g. renal failure, hypoparathyroidism, tetany, neonatal tetany, vitamin D deficiency, alkalosis);
  • in hyperkalemia with associated cardiac toxicity;
  • in magnesium intoxication.
    Additionally, calcium chloride is indicated in cardiac resuscitation, in cases of poor or inadequate myocardial contraction following defibrillation or epinephrine treatment.

CONTRAINDICATIONS
Intravenous administration of calcium chloride is contraindicated in:

  • hypersensitivity to the active substance or to any of the excipients;
  • hypercalcemia, hypercalciuria, or severe renal disease;
  • ventricular fibrillation, as calcium chloride may increase the risk of arrhythmias;
  • kidney stones, as it may exacerbate this condition;
  • sarcoidosis, as it may potentiate the typical hypercalcemia of this condition;
  • hypercoagulability;
  • patients receiving treatment with cardiac glycosides (see Interactions);
  • 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.

Injectable calcium chloride preparation must not be administered by intramuscular or subcutaneous route.

PRECAUTIONS FOR USE
Calcium chloride must be used with great caution in patients:

  • with renal disorders;
  • with cardiac disorders;
  • who have received blood transfusions, as calcium ion concentrations may differ from expected values.
    Since calcium chloride is an acidifying agent, caution is required when administering it in conditions such as renal disease, cor pulmonale, respiratory acidosis, or respiratory insufficiency, where acidification may worsen the clinical picture.
    Additionally, caution is advised in conditions where an increased risk of hypercalcemia may occur, such as chronic renal failure, dehydration, or electrolyte imbalance.
    Since calcium salts may increase the risk of arrhythmias, care must be taken when prolonging calcium chloride administration in patients with cardiac disorders.

Continuous electrocardiogram (ECG) monitoring and fluid and electrolyte balance monitoring are essential.
Serum calcium levels must be closely monitored during therapy to ensure they do not exceed normal limits.
Urinary calcium concentrations should also be monitored to prevent hypercalciuria, as hypercalciuria may progress to hypercalcemia.
Data on the safety and efficacy of the drug in children are limited.
Do not inject the concentrated solution undiluted; it must be diluted before administration. The solution must be clear and free from visible particles.
Administration must be slow and through a large vein at a rate not exceeding 0.35–0.7 mmol/min to avoid venous damage and prevent high calcium concentrations in the heart, which may cause syncope. If the patient experiences pain, administration must be stopped.
Direct administration into cardiac tissue should be avoided.
Calcium chloride administration may cause vasodilation with consequent lowering of blood pressure.
Calcium chloride solution is irritating and must not be administered intramuscularly, subcutaneously, or into peri-vascular tissue, as tissue necrosis may occur.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those without a prescription.
Calcium chloride solution may interact with the following medicines:

  • thiazide diuretics, as hypercalcemia may occur due to reduced renal calcium excretion;
  • cardiac glycosides (digitalis), digoxin and digitoxin, as concomitant use may increase the risk of arrhythmias due to synergistic inotropic and toxic effects;
  • verapamil (and other calcium channel blockers), as concomitant use may reduce the antihypertensive effect of verapamil;
  • magnesium-containing medicines, as the risk of hypercalcemia or hypermagnesemia may increase, especially in patients with renal impairment;
  • neuromuscular blocking agents: calcium salts may antagonize the effects of non-depolarizing blockers; in some cases, an increased and prolonged effect of tubocurarine has also been observed.

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 calcium-ceftriaxone 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 calcium-containing solutions, including Calcium Chloride Galenica Senese 5 mEq/10 ml concentrate for solution for infusion, via 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.

SPECIAL WARNINGS
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
Pregnancy
Calcium chloride must not be used during pregnancy unless absolutely necessary.
In assessing the risk/benefit ratio, it should be considered that calcium chloride is also used as a life-saving agent in cardiac emergencies.
Breastfeeding
Although calcium is a normal component of breast milk, it is not known whether calcium chloride is excreted in breast milk. Therefore, calcium chloride must not be used during breastfeeding unless absolutely necessary.

Effects on ability to drive and use machines
Not applicable.

Important information about excipients: No relevant information.

DOSAGE, ROUTE AND DURATION OF ADMINISTRATION
Calcium Chloride Galenica Senese concentrate for solution for infusion is a hypertonic solution and must be diluted before administration; the solution is compatible with 5% glucose and 0.9% sodium chloride. Once the vial is opened, the solution must be used immediately.
After dilution, use for a single, uninterrupted administration; any unused portion must be discarded.
Calcium chloride is administered, after appropriate dilution, by slow intravenous infusion, except in emergency situations.
Do not exceed an administration rate of 0.35–0.7 mmol (0.7–1.4 mEq)/minute to avoid venous damage and prevent high calcium concentrations in the heart, which may cause syncope (see section 4.4).
Administration must be stopped if the patient experiences pain or redness at the injection site, as this may indicate extravasation.
It is recommended that the patient remain lying down for a short period after administration.
Dosage and rate of administration depend on the patient's age, weight, and clinical condition.
Plasma calcium concentrations must be frequently monitored.
In children, the efficacy and safety of calcium chloride have not been established.

Acute hypocalcemia
Adults: The recommended initial dose is 3.5–7 mmol (7–14 mEq) of calcium. If necessary, repeat administration at intervals of 1–3 days.

Tetany due to hypocalcemia
Adults: The recommended initial dose is 2.25–8 mmol (4.5–16 mEq) of calcium. Repeat administration until response is achieved.

Hyperkalemia
Adults: The recommended initial dose is 1.12–7 mmol (2.25–14 mEq) of calcium. If necessary, the dose may be repeated after 1–2 minutes. ECG monitoring is required during administration.

Magnesium intoxication
Adults: The recommended dose is 3.5 mmol (7 mEq) of calcium, administered slowly. Repeat administration only if the clinical condition does not improve.

Cardiac resuscitation
Adults:
a) intravenous administration: the recommended calcium dose is 0.054–0.109 mmol (0.109–0.218 mEq) per kg of body weight or 3.5–7 mmol (7–14 mEq) of calcium. If necessary, repeat administration at 10-minute intervals;
b) intraventricular administration: the recommended dose is 1.35–2.7 mmol (2.7–5.4 mEq) of calcium.
Children: The recommended calcium dose is 0.136 mmol (0.272 mEq) per kg of body weight (calcium chloride has better calcium bioavailability compared to calcium gluconate). Slow administration into a central vein is preferred, although intraosseous administration is also acceptable.

Patients with renal failure
In patients with severe renal failure and creatinine clearance below 25 ml/min, dosage adjustments may be necessary based on serum calcium levels.

Calcium chloride solution is incompatible with:

  • magnesium sulfate: formation of a precipitate;
  • phosphate-containing medicines: formation of calcium phosphate precipitate;
  • carbonate-containing medicines: formation of calcium carbonate precipitate;
  • tartrate-containing medicines: formation of calcium tartrate precipitate.

Incompatibilities have been reported with:

  • aminophylline: precipitate formation;
  • amphotericin B: development of cloudiness;
  • cefamandole: due to presence of sodium carbonate in cefamandole preparation;
  • ceftriaxone sodium: precipitate formation; therefore, calcium solution administration must not occur within 48 hours after ceftriaxone administration;
  • cephalothin: physical incompatibility;
  • cefradine: due to presence of sodium carbonate in cefradine preparation;
  • chlorpheniramine: physical incompatibility;
  • dobutamine: development of cloudiness;
  • fat emulsion: presence of flocculation;
  • sodium heparin;
  • indomethacin: precipitate formation;
  • sodium nitrofurantoin;
  • promethazine: precipitate formation;
  • propofol: precipitate formation;
  • streptomycin: calcium may inhibit streptomycin activity;
  • tetracyclines: calcium salts may complex with tetracyclines.

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
Administration of high doses of calcium chloride may result in hypercalcemia, especially in patients with renal disorders. Typical symptoms of hypercalcemia include thirst, nausea, vomiting, constipation, polyuria, abdominal pain, muscle weakness, mental disturbances, and, in severe cases, cardiac arrhythmia and coma. Hypercalcemia is defined as plasma calcium concentrations exceeding 2.6 mmol/l; therefore, these concentrations must be continuously monitored.
In case of mild overdose, treatment includes immediate discontinuation of calcium chloride and any other calcium-containing medication.
In case of severe overdose (plasma concentrations > 2.9 mmol/l), the following measures should be taken:

  • rehydration with 0.9% sodium chloride solution;
  • use of non-thiazide diuretics to promote calcium excretion;
  • monitoring of plasma potassium and magnesium levels, with immediate correction to normal values;
  • cardiac function monitoring, and use of beta-blockers to reduce the risk of cardiac arrhythmia;
  • hemodialysis if necessary.

In case of accidental ingestion/overdose of Calcium Chloride Galenica Senese, contact a doctor immediately or go to the nearest hospital.

IF YOU HAVE ANY DOUBTS ABOUT THE USE OF CALCIUM CHLORIDE GALENICA SENESE, CONSULT YOUR DOCTOR OR PHARMACIST.

UNDESIRABLE EFFECTS
Like all medicines, Calcium Chloride Galenica Senese can cause adverse effects, although not everyone experiences them.
The following are adverse effects associated with calcium chloride. There are insufficient data to determine the frequency of individual effects listed below.
Some of the adverse effects listed below occurred due to inadequate administration, such as too rapid administration or non-intravenous routes.

Cardiac and vascular disorders
Vasodilation, hypotension, bradycardia, arrhythmias, syncope, cardiac arrest, flushing, hypertension, ventricular fibrillation.

Systemic disorders and administration site conditions
Extravasation, tissue necrosis, abscess formation, cutaneous calcification, injection site infection, venous thrombosis, phlebitis, redness, rash, pain, fever.

Metabolism and nutrition disorders
Hypercalcemia, Burnett syndrome (milk-alkali syndrome).

Gastrointestinal disorders
Gastrointestinal irritation, constipation, metallic taste, chalky taste, nausea, vomiting.

Renal and urinary disorders
Polyuria.

Respiratory, thoracic and mediastinal disorders
Abdominal pain, pneumothorax.

Nervous system disorders
Mental disturbances.

Musculoskeletal and connective tissue disorders
Muscle weakness.

Calcium-ceftriaxone salt precipitation
Rarely, serious and sometimes fatal adverse reactions have been reported in preterm and full-term neonates (age < 28 days) treated with intravenous ceftriaxone and calcium. Post-mortem findings revealed calcium-ceftriaxone 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, mainly 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.
Calcium-ceftriaxone salt precipitation in the gallbladder has been observed, mainly in patients treated with doses exceeding the standard recommended dose. In children, prospective studies 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, precipitations have been accompanied by 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 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 helps provide 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 stored unopened and correctly stored.

WARNING: Do not use the medicine after the expiry date stated on the packaging.

Storage conditions
Store in the original packaging to protect from light.
Do not use the medicine if the solution is not clear and colorless or contains particles.
Do not freeze.

Period of validity after dilution:
After dilution, use for a single, uninterrupted administration; any unused portion 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 helps protect the environment.

Keep this medicine out of the reach and sight of children.

COMPOSITION
One 10 ml vial contains
Active substance: calcium chloride 0.37 g
(mEq/ml Ca 0.5)
(mmol/ml Ca 1.0)
(3.7 g calcium chloride = 1 g calcium = 25 mmol = 50 mEq)
Excipients: water for injections q.s. to 10 ml

PHARMACEUTICAL FORM AND CONTENT
Concentrate for solution for infusion
Sterile, pyrogen-free, clear and colorless solution.
Glass vials of 10 ml.

MARKETING AUTHORIZATION HOLDER
Industria Farmaceutica Galenica Senese S.r.l.

MANUFACTURER
Industria Farmaceutica Galenica Senese S.r.l.