Calsiosol

Package leaflet: Information for the user

Calsiosol, 95.5 mg/ml, solution for injection / for infusion
Calcii gluconas ad iniectabile
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse immediately. See section 4.

Contents of the leaflet

1. What Calsiosol is and what it is used for
2. Important information before using Calsiosol
3. How to use Calsiosol
4. Possible side effects
5. How to store Calsiosol
6. Contents of the pack and other information

1. What Calsiosol is and what it is used for

This medicine is used when treatment with a high concentration of calcium ions is required,
for example, in chronic hypocalcemia and hypocalcemic tetany.
Calcium salts may also be used to prevent hypocalcemia during exchange transfusion and in long-term electrolyte replacement therapy.
During cardiopulmonary resuscitation, calcium should be administered only when there are specific indications, e.g., in pulseless electrical activity caused by hyperkalemia, hypocalcemia, or calcium channel blocker overdose.
Calsiosol is indicated for use in adults and children.

2. Important information before using Calsiosol

When not to use Calsiosol:

• if the patient is allergic to calcium gluconate or any of the other ingredients of this medicine (listed in section 6);
• if the patient has elevated calcium levels in the blood [e.g. in patients with hyperparathyroidism, elevated vitamin D levels in the blood, cancer with bone metastases, kidney disorders, immobilization-related osteoporosis, sarcoidosis, or the so-called milk-alkali syndrome (Burnett's syndrome)];
• in case of excessive urinary calcium excretion;
• in cases of cardiac glycoside poisoning (a type of heart medication);
• during treatment with cardiac glycosides, unless the patient has life-threatening, extremely low blood calcium levels with symptoms that can only be treated by immediate calcium injection;
• the antibiotic ceftriaxone must not be administered to premature infants and newborns (≤ 28 days of life) if they are receiving (or are to receive) intravenous calcium-containing medicines.

Warnings and precautions
Before starting treatment with Calsiosol, discuss it with your doctor, pharmacist, or nurse.
Inform your doctor if the patient has hyperparathyroidism, regularly takes vitamin D, has been diagnosed with cancers such as multiple myeloma, bone metastases, severe kidney disease, or calcium loss due to immobilization.
Intravenous administration of calcium-containing medicines is strictly contraindicated in patients taking digoxin. Calcium enhances the effect of digoxin on the heart and may lead to digoxin toxicity.
In patients, regardless of age, ceftriaxone must not be mixed or administered simultaneously with intravenous solutions containing calcium, even if different infusion lines are used or administration sites differ.
However, to avoid precipitation, in children older than 28 days of age, ceftriaxone and calcium-containing solutions may be administered consecutively, provided that infusion lines are inserted at different sites or are changed, or infusion lines are thoroughly flushed with physiological saline solution between infusions.
Although there is no specific evidence of a metabolic process leading to galactose formation, calcium gluconate should not be administered to patients with galactosemia.
Administration of calcium gluconate by intramuscular or subcutaneous route should be avoided, as tissue necrosis or sloughing may occur.
Aluminium oxide
Calcium gluconate may leach aluminium oxide from glass vials. Increased aluminium content may pose risks related to aluminium toxicity, such as adverse effects on bone mineralization and neurologic development (brain and nervous system), particularly in more vulnerable patients such as those with impaired kidney function and children (under 18 years of age).
Long-term use of the medicine is recommended only if the anticipated benefits outweigh the risks associated with aluminium exposure. In cases of long-term treatment, the weekly dose should not exceed 92.5 ml in adults and 1.8 ml/kg body weight weekly in children.
Patients with impaired kidney function
Due to its aluminium content, the daily dose of Calsiosol should not exceed 46 ml in patients with impaired kidney function.
Children and adolescents
Due to its aluminium content, the daily dose of Calsiosol should not exceed 0.9 ml/kg body weight in children and adolescents.
Calcium gluconate in glass vials should not be used in children requiring parenteral nutrition.
In children (<18 years of age), Calsiosol should be administered intravenously; intramuscular administration is not recommended.
Calsiosol and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
The effects of cardiac medications such as digoxin and other cardiac glycosides derived from Digitalis lanata may be enhanced by calcium, leading to cardiac glycoside toxicity. Therefore, if the patient is taking cardiac glycosides, intravenous calcium administration should only be performed to treat severe, life-threatening symptoms of very low blood calcium levels.
Concomitant administration of calcium and adrenaline after heart surgery may reduce the effects of adrenaline on the heart and circulation.
Calcium and magnesium mutually inhibit each other's actions.
Calcium may reduce the effectiveness of certain medications used to regulate heart function (calcium channel blockers). Concurrent use of certain diuretics (thiazide diuretics) that increase urine output with calcium may lead to excessively high calcium levels in the blood (hypercalcaemia), as these drugs reduce renal calcium excretion.
Simultaneous administration of calcium and ceftriaxone may result in precipitation of solid deposits in blood vessels.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Pregnancy
Calcium crosses the placenta into fetal circulation and reaches higher concentrations in fetal blood than in maternal blood.
Therefore, pregnant women should receive intravenous calcium only when absolutely necessary. The dose should be carefully adjusted and serum calcium levels should be monitored regularly to avoid hypercalcaemia, which may be harmful to the fetus.
Breastfeeding
Calcium passes into human milk. This should be taken into account by the physician when deciding to administer calcium to a breastfeeding patient.
Driving and operating machinery
Calsiosol has a moderate effect on the ability to drive and operate machinery.
Calsiosol has a clearly evident sedative effect; therefore, patients should not drive or operate machinery for several hours after intravenous calcium administration.

3. How to use Calsiosol

This medicinal product should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
Calcium dosage depends on the individual patient's requirements.
10 to 20 ml of Calsiosol 95.5 mg/ml solution for injection/infusion (corresponding to 2.2 to
4.4 mmol of calcium) may be administered undiluted as a slow intravenous injection
over 10 minutes, with monitoring of plasma calcium levels and ECG.
10 to 20 ml of Calsiosol 95.5 mg/ml solution for injection/infusion (corresponding to 2.2 to
4.4 mmol of calcium) may be diluted in 50 to 100 ml of 5% glucose solution or 0.9% sodium chloride
and administered as a slow intravenous infusion over 10 minutes, with monitoring of plasma calcium
levels and ECG.
If necessary, the dose may be repeated depending on the patient's clinical condition. Subsequent doses
should be adjusted according to current plasma calcium concentrations.
Administration of more than 46 ml (10.12 mmol calcium) of Calsiosol 95.5 mg/ml solution for
injection/infusion within a 24-hour period is not recommended.
If needed, doses may be repeated every 1 to 3 days.
Cardiopulmonary resuscitation
Typically, 7 to 15 ml (1.54 to 3.3 mmol) is administered. Note that the exact amount of
calcium required for this indication is difficult to determine and may vary significantly.
Table of calcium ion equivalents in Calsiosol

Use in children and adolescents
The initial dose used in children and infants is generally 0.3 ml/kg body weight to 0.6 ml/kg body weight (0.066 mmol/kg body weight – 0.132 mmol/kg body weight).
Administration of more than 0.9 ml/kg body weight (0.198 mmol) of Calsiosol, 95.5 mg/ml, solution for injection / for infusion, is not recommended within 24 hours.
The medicinal product is administered intravenously (into a vein) as a slow injection or slow infusion (drip), after dilution.
Subcutaneous and intramuscular injection is contraindicated in children.

Method of administration
Calcium gluconate is administered intravenously as a solution, either by slow direct intravenous injection or by continuous or intermittent intravenous infusion. The injection should be given with the patient lying down, and cardiac function must be closely monitored during administration.
Various maximum rates of administration have been used for direct intravenous injection, including 2 ml/min, 1.5 to 3 ml/min, and 5 ml/min. For intermittent infusion, a maximum infusion rate of 2 ml/min is recommended. Serum calcium levels must be closely monitored during intravenous administration of calcium salts. The rate of intravenous infusion or injection should be appropriately slow. After intravenous injection, the patient should remain lying down for 15 minutes.
Rapid intravenous injection of calcium salts may cause vasodilation, hypotension, bradycardia (slow heart rate), cardiac arrhythmias, syncope, and cardiac arrest. Administration should be temporarily interrupted if abnormal electrocardiogram (ECG) readings occur or if the patient reports discomfort; administration may be resumed once normal readings return or discomfort resolves.
Intramuscular and subcutaneous administration of calcium gluconate is not recommended due to the risk of tissue necrosis, skin sloughing, and abscess formation. For this reason, extravascular administration should also be avoided.

Elderly patients
Some conditions occasionally observed in elderly patients, such as impaired renal function and malnutrition, may affect tolerance to calcium gluconate. Therefore, a lower dose should be used in these patients.

Overdose of Calsiosol
Symptoms of elevated blood calcium levels (hypercalcemia) include: loss of appetite, nausea, vomiting, constipation, abdominal pain, excessive urination, increased thirst, fluid loss, muscle weakness, calcium deposition in the kidneys, drowsiness, confusion, high blood pressure (hypertension), and in severe cases, irregular heartbeat, up to cardiac arrest and loss of consciousness.
If intravenous injection is administered too rapidly, symptoms of hypercalcemia may occur, along with a chalky taste in the mouth, hot flushes, and a drop in blood pressure.
Treatment aims to reduce excessively high blood calcium levels. The physician will determine the appropriate treatment approach. Treatment may include fluid administration or specific medications used to lower blood calcium levels. In severe cases, dialysis may be necessary.
If you have any further questions regarding the use of this medicinal product, consult your doctor.

Missed dose of Calsiosol
If a recommended dose is missed, administer the missed dose as soon as possible. However, if the time for the next dose is approaching, skip the missed dose. Do not administer a double dose to make up for a missed dose.

Discontinuation of Calsiosol
Do not discontinue treatment with Calsiosol without consulting your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions affecting the heart, circulation or other body functions may occur as symptoms of excessively high calcium levels in the blood following overdose or too rapid intravenous injection.
The occurrence and frequency of adverse reactions depend directly on the rate of injection and the dose administered.
The adverse reactions described below may be serious. If any of the following adverse reactions occur,
a doctor must be informed immediately and administration of the medicine must be discontinued:
Frequency unknown (frequency cannot be estimated from available data):

• slowed or irregular heartbeat,
• drop in blood pressure (hypotension),
• circulatory collapse (which may lead to death).

Rare (occurs in 1 to 10 out of 10,000 patients):
Severe, and in several cases fatal, adverse reactions have been observed in preterm and full-term newborns (age < 28 days) receiving intravenous ceftriaxone and calcium. Post-mortem examinations revealed deposits of calcium-ceftriaxone salts in the lungs and kidneys.
Other adverse reactions include:
Frequency unknown (frequency cannot be estimated from available data):

• vasodilation,
• hot flushes, mainly after too rapid injection,
• nausea or vomiting,
• sensation of warmth,
• sweating,
• pain and redness may occur at the site of intramuscular injection.

If any adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform a doctor or nurse.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Calsiosol

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Expiry
(EXP) and on the ampoule after: EXP. The expiry date refers to the last day of the stated month.
No special storage instructions are required for this medicine. Do not freeze.
The solution should be used immediately after opening the ampoule.
Do not use this medicine if you notice: damage to the ampoule, change in colour or cloudiness
of the solution, or presence of particles in the solution.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures help protect
the environment.

6. Contents of the packaging and other information

What the medicinal product Calsiosol contains

• The active substance is calcium gluconate for injection.
• 1 ml of solution contains 95.5 mg of calcium gluconate for injection.

One 5 ml ampoule contains 477.5 mg of calcium gluconate for injection.
One 10 ml ampoule contains 955 mg of calcium gluconate for injection.

• Other ingredients (excipients) are:
• calcium sulfate,
• water for injections.

Total calcium content: 0.22 mmol/ml (1.1 mmol/5 ml, 2.2 mmol/10 ml).
What Calsiosol looks like and contents of the packaging
Injection solution. A clear, colourless solution free from visible particles.
Ampoules of 5 ml or 10 ml capacity made of colourless type I glass with a break ring or
score mark. Packaging size: 5 ampoules containing 5 ml or 10 ml of solution,
placed in a PVC blister. 1 or 2 blisters are packed in a cardboard box.
Marketing Authorisation Holder and Importer
Marketing Authorisation Holder
Neupharm Sp. z o.o.
ul. Ługowa 85
96-320 Mszczonów
Poland
Importer
SciencePharma Sp. z o.o.
ul. Chełmska 30/34
00-725 Warsaw
Poland