Calcium chloride Bioindustria L.I.M.: detailed information

Package leaflet: Information for the user

CALCIO CLORURO Bioindustria L.I.M. 1 g/10 ml concentrate for solution for infusion

Calcium chloride dihydrate
Read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or nurse.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4. Contents of this leaflet:
1. What CALCIO CLORURO Bioindustria L.I.M. is and what it is used for
2. What you need to know before using CALCIO CLORURO Bioindustria L.I.M.
3. How to use CALCIO CLORURO Bioindustria L.I.M.
4. Possible side effects
5. How to store CALCIO CLORURO Bioindustria L.I.M.
6. Contents of the pack and other information

1. What CALCIO CLORURO Bioindustria L.I.M. is and what it is used for

CALCIO CLORURO Bioindustria L.I.M. contains the active substance calcium chloride, which is a calcium salt.
Calcium is a very important element for bones and for many body functions.
This medicine is indicated:

for the treatment of calcium deficiency (hypocalcemia);
for the treatment of certain conditions requiring a rapid increase in calcium levels, such as kidney problems (renal failure) or parathyroid gland disorders (hypoparathyroidism), if you suffer from a muscle disorder (tetany, including neonatal tetany), if vitamin D levels are low, or if blood acidity is too low (alkalosis);
to treat elevated levels of potassium in the blood (hyperkalemia), a condition that may cause heart problems (cardiac toxicity);
to treat magnesium intoxication;
in cardiac resuscitation, used in cases of severe heart rhythm disturbances, or when the heart shows poor or inadequate contraction even after defibrillation (a medical procedure used to correct heart rate and rhythm) or after administration of adrenaline (a medicine used in cases of absent or weak cardiac activity).

2. What you should know before using CALCIO CLORURO Bioindustria L.I.M.

Do not use CALCIO CLORURO Bioindustria L.I.M.

if you are allergic to calcium chloride or to any of the other ingredients of this medicine (listed in section 6);
if calcium levels in your blood (hypercalcemia) or urine are elevated (hypercalciuria);
if you have severe kidney problems;
if you have a heart rhythm disorder (ventricular fibrillation), as calcium increases the risk of heart rhythm disturbances;
if you suffer from kidney stones;
if you have a disease called sarcoidosis, characterized by cough associated with bleeding and difficulty breathing;
if you have an increased tendency of the blood to form clots (hypercoagulability);
if you are taking medicines used to treat heart problems (cardiac glycosides);
if the patient is a newborn (≤ 28 days of age), CALCIO CLORURO Bioindustria L.I.M. (or other calcium-containing solutions) must not be administered simultaneously with ceftriaxone (an

antibiotic), even when using separate infusion lines. There is a fatal risk of particle formation
in the newborn's bloodstream.
This medicine must not be administered via intramuscular or subcutaneous routes (intramuscular or subcutaneous injection).
Warnings and precautions
Talk to your doctor or nurse before using CALCIO CLORURO Bioindustria L.I.M.
This medicine should be administered with particular caution if:

you suffer from kidney disorders (renal disease), especially if your kidneys are poorly functioning (chronic renal insufficiency);
you suffer from heart disorders; this medicine may increase the risk of heart rhythm disturbances (arrhythmias), particularly during prolonged treatment;
you have received a blood transfusion;
you suffer from lung disorders that may cause enlargement of the heart (cor pulmonale); if you have increased levels of acid in the blood (respiratory acidosis) or suffer from severe difficulty in breathing (respiratory failure); in all these cases, calcium administration may increase blood acidity;
you are predisposed to high calcium levels in the blood (hypercalcemia), severe fluid loss (dehydration), or imbalances in blood electrolyte levels (electrolyte imbalance).

During treatment with CALCIO CLORURO Bioindustria L.I.M., your doctor should monitor:

your heart activity (electrocardiogram);
fluid and electrolyte levels in your blood;
calcium levels in your blood (hypercalcemia) and urine (hypercalciuria).

This medicine must not be administered undiluted, but only after appropriate dilution, and must be given through a large vein and not via other routes of administration (intramuscular, subcutaneous, cardiac tissues, or peri-vascular tissues), as administration via other routes may cause tissue necrosis due to the irritating nature of calcium chloride solution. This medicine should only be administered if the solution is clear, colourless, and free from particles. Slow administration is recommended (0.35–7.0 mmol/min), as too rapid administration may cause heart problems and fainting with loss of consciousness (syncope). Inform your doctor if you experience pain or redness at the injection site during administration (see section "How to use CALCIO CLORURO Bioindustria L.I.M.").
During administration of this medicine, a drop in blood pressure may occur.
Children
Data on the safety and efficacy of CALCIO CLORURO Bioindustria L.I.M. in children are limited; therefore, its use is not recommended in children except in cases of absolute necessity, such as cardiac resuscitation.
Other medicines and CALCIO CLORURO Bioindustria L.I.M.
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and consult your doctor if you are taking:

medicines used to promote fluid elimination (thiazide diuretics), as excessive increase in blood calcium levels (hypercalcemia) may occur due to reduced calcium excretion through the kidneys;
medicines used to treat heart problems (cardiac glycosides, digoxin and digitoxin; see section “Do not use CALCIO CLORURO Bioindustria L.I.M.”), as the risk of heart rhythm disturbances (arrhythmias) is higher when these medicines are taken concurrently with CALCIO CLORURO Bioindustria L.I.M.;
medicines used to treat high blood pressure (verapamil and other calcium channel blockers), as CALCIO CLORURO Bioindustria L.I.M. may reduce their antihypertensive effect;
medicines containing magnesium, as increased levels of calcium (hypercalcemia) and magnesium (hypermagnesemia) in the blood may occur, especially if you have kidney problems (renal disorders);
medicines used to reduce muscle contractions (non-depolarizing neuromuscular blockers), as CALCIO CLORURO Bioindustria L.I.M. may increase or reduce their effectiveness;
ceftriaxone (an antibiotic), due to the risk of particle formation.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before using this medicine.
This medicine should not be administered during pregnancy or breastfeeding, except in cases of absolute necessity.
Driving and using machines
The effects of this medicine on the ability to drive vehicles and operate machinery are unknown.

3. How to use CALCIO CLORURO Bioindustria L.I.M.

The medicine must be administered to you by a doctor or nurse, immediately after opening the vial and after being appropriately diluted in a compatible solution (5% glucose and 0.9% sodium chloride), through a single, uninterrupted administration. Any unused medicine must be discarded.
CALCIO CLORURO Bioindustria L.I.M. will be prepared by a doctor or nurse and will not be mixed with, nor administered simultaneously to, injections containing ceftriaxone.
The dose and rate of infusion will be determined by the doctor based on your age, body weight, and health condition. The recommended dose is reported in the information exclusively intended for doctors or healthcare professionals at the end of this leaflet.
A slow administration is recommended (not exceeding 0.35–7.0 mmol/min; see section “Warnings and precautions”), except in emergency situations.
If you experience pain or redness at the injection site during administration, treatment must be stopped immediately, as leakage of the injected solution from the vein (extravasation) may occur (see section “Possible side effects”). After administration of this medicine, remain lying down.

If you use more CALCIO CLORURO Bioindustria L.I.M. than you should
This medicine will be administered to you by a doctor or trained medical personnel; therefore, it is unlikely that you will receive an excessive dose. However, if you think you have been given too much CALCIO CLORURO Bioindustria L.I.M., inform your doctor or another healthcare professional immediately.
In case of overdose, an increase in blood calcium levels (hypercalcemia, when calcium levels exceed 2.6 mmol/l) may occur, especially if you have kidney disorders. Symptoms include:

feeling thirsty;
nausea, vomiting, constipation;
increased need to urinate (polyuria);
abdominal pain;
muscle weakness;
mental disturbances;
changes in heartbeat (arrhythmia) and coma in severe cases.
For this reason, during treatment with this medicine, your doctor must monitor your blood calcium levels (see section “Warnings and precautions”).

In case of mild overdose, treatment with this medicine and other calcium-containing medicines must be stopped immediately. In more severe cases of overdose (when calcium levels exceed 2.9 mmol/l), the doctor will take the most appropriate necessary measures.

If you forget to use CALCIO CLORURO Bioindustria L.I.M.
Since this medicine will be administered under close medical supervision, it is unlikely that a dose will be missed. However, inform your doctor if you think a dose has been missed.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur, particularly in case of improper administration (administration route other than intravenous) or too rapid administration (see section “Warnings and precautions”):
Frequency not known (frequency cannot be estimated from the available data)

dilation of veins and arteries (vasodilation),
decrease in blood pressure (hypotension);
slowing of heart rate (bradycardia) or irregular heart rhythm (arrhythmias, ventricular fibrillation);
fainting associated with loss of consciousness (syncope);
cessation of heart activity (cardiac arrest);
sudden sensation of warmth (hot flashes);
increase in blood pressure (hypertension);
damage to the vein where the medicine is administered (extravasation);
fever, skin redness, skin irritations (rash), pain and infection at the infusion site, calcium deposits in tissues (cutaneous calcification), inflammation due to pus accumulation (abscesses), formation of blood clots in veins (venous thrombosis), inflammation of veins (venous phlebitis) also in areas near the infusion site, leakage of the injected solution from the vein (extravasation), tissue damage and death (tissue necrosis);
increased levels of calcium in the blood and/or decreased blood acidity (hypercalcemia, Burnett syndrome);
irritation of the stomach and intestine, nausea, vomiting, constipation, altered taste (metallic or chalky taste);
abdominal pain, accumulation of air in the abdomen (pneumoperitoneum);
increased need to urinate (polyuria);
mental disturbances;
muscle weakness;
kidney problems caused by calcium-ceftriaxone deposits. Pain during urination or reduced urine output may occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CALCIO CLORURO Bioindustria L.I.M.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”. The expiry date refers to the last day of that month.
Store this medicine in its original packaging, protected from light. No special temperature requirements for storage. Do not freeze.
This medicine must not be administered to you if the solution is not clear and colourless or if it contains particles.
Each vial is intended for single and uninterrupted administration; any remaining medicine should be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What CALCIO CLORURO Bioindustria L.I.M. contains
CALCIO CLORURO Bioindustria L.I.M. 1 g/10 ml

The active substance is calcium chloride dihydrate. Each 10 ml vial contains 1 g of calcium chloride dihydrate, equivalent to 1,360 mEq/ml of Ca and 0,680 mmol/ml of Ca.
The other component is water for injections.

Description of the appearance of CALCIO CLORURO Bioindustria L.I.M. and contents of the pack
Calcium chloride Bioindustria L.I.M. 1 g/10 ml concentrate for solution for infusion. Sterile,
apyrogenic, clear and colourless solution.
Pack containing 10 vials of 10 ml.
Marketing Authorisation Holder and Manufacturer
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A. - Via De Ambrosiis, 2 - 15067 Novi Ligure (AL)

The following information is intended exclusively for physicians or healthcare professionals:
Dosage
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, administered slowly. Repeat
administration only if the clinical condition does not improve.
Cardiac resuscitation
Adults:
a) intravenous administration: the recommended dose of calcium is 0.054–0.109 mmol (0.109–
0.218 mEq) per kg 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 dose of calcium is 0.136 mmol (0.272 mEq) per kg body weight (calcium chloride has better calcium bioavailability compared to calcium gluconate). Slow administration via a central vein is preferred; however, intraosseous administration is also considered acceptable.
In children, the efficacy and safety of calcium chloride have not been established.
Patients with renal impairment
In patients with severe renal impairment with creatinine clearance below 25 ml/min, dosage adjustments may be necessary based on serum calcium levels.
Overdose
In case of mild overdose, discontinue immediately the treatment with 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 by administration of 0.9% sodium chloride solution;
use of non-thiazide diuretics to enhance 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.

Incompatibilities
Calcium chloride solution is incompatible with:

magnesium sulfate: formation of a precipitate;
medications containing phosphate: formation of calcium phosphate precipitate;
medications containing carbonate: formation of calcium carbonate precipitate;
medications containing tartrate: formation of calcium tartrate precipitate.

Incompatibilities of calcium chloride solution have been reported with:

aminophylline: due to precipitate formation;
amphotericin B: due to development of turbidity;
cefamandole: due to presence of sodium carbonate in cefamandole formulation;
ceftriaxone sodium: due to precipitate formation; therefore, calcium solution must not be administered within 48 hours following ceftriaxone administration;
cephalothin: due to physical incompatibility;
cefradine: due to presence of sodium carbonate in cefradine formulation;
chlorpheniramine: due to physical incompatibility;
dobutamine: due to development of turbidity;
fat emulsion: due to presence of flocculation;
sodium heparin;
indomethacin: due to precipitate formation;
sodium nitrofurantoin;
promethazine: due to precipitate formation;
propofol: due to precipitate formation;
streptomycin: since calcium may inhibit streptomycin activity;
tetracyclines: calcium salts may form complexes with tetracyclines.

Calcium salts may form complexes with many drugs, potentially leading to precipitate formation. Physical incompatibility has been reported with ceftriaxone.
For further information, please refer to the Summary of Product Characteristics.