Calsiosol

Leaflet attached to the packaging: information for the user

Calsiosol, 95.5 mg/ml, solution for injection/infusion

Calcii gluconas ad iniectabile

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Calsiosol and what is it 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 is Calsiosol and what is it used for

This medicine is used when treatment with high concentrations of calcium ions is necessary, for example in chronic hypocalcemia and hypocalcemic tetany. Calcium salts can also be used to prevent hypocalcemia during exchange transfusion and long-term electrolyte replacement therapy. During cardiopulmonary resuscitation, calcium should only be administered when there are specific indications, such as electrical activity without pulse caused by hyperkalemia, hypocalcemia, or overdose of calcium antagonists. Calsiosol is indicated for 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 blood calcium levels [e.g. in patients with hyperparathyroidism, elevated vitamin D levels, cancer with bone metastases, renal dysfunction, osteoporosis related to lack of physical activity, sarcoidosis, and so-called milk-alkali syndrome (Burnett's syndrome)];
• in case of excessive calcium excretion in the urine;
• in case of digitalis glycoside poisoning (a type of heart medication);
• during treatment with digitalis glycosides, unless the patient has extremely low blood calcium levels with life-threatening symptoms that can only be treated by immediate calcium injection;
• the antibiotic ceftriaxone should not be used in premature infants and newborns (≤ 28 days of life) if they are receiving (or will receive) calcium-containing products intravenously.

Warnings and precautions

Before starting treatment with Calsiosol, discuss it with your doctor, pharmacist, or nurse. You should tell your doctor if you have hyperparathyroidism, regularly take vitamin D, or have been diagnosed with tumors such as multiple myeloma, bone metastases, severe kidney disease, and calcium loss due to immobilization. Intravenous administration of calcium-containing products is strictly contraindicated in patients taking digoxin. Calcium enhances the effect of digoxin on the heart and can lead to digoxin toxicity. In patients of any age, ceftriaxone must not be mixed or administered simultaneously with intravenous calcium-containing solutions, even if different infusion lines or injection sites are used. However, to avoid precipitation, in children over 28 days of age, ceftriaxone and calcium-containing solutions can be administered sequentially, one after the other, if the infusion lines are inserted at different sites or are changed, or if the infusions are carefully flushed with physiological saline between administrations. Although there is no specific evidence of a metabolic process leading to galactosemia, it is recommended that calcium gluconate not be administered to patients with galactosemia. Calcium gluconate should be avoided for intramuscular or subcutaneous administration, as tissue necrosis or sloughing may occur.

Aluminum oxide

Calcium gluconate may leach aluminum from glass ampoules. Increased aluminum content can lead to the risk of aluminum toxicity, such as adverse effects on bone mineralization and neurological development (brain and nervous system), especially in more sensitive patients such as those with renal impairment and children (under 18 years of age). Long-term use of the medicine is only indicated if the expected benefits outweigh the risk associated with aluminum exposure. In the case of long-term use of the medicine, it is not recommended to exceed a dose of 92.5 ml per week in adults and 1.8 ml/kg body weight per week in children.

Patients with renal impairment

Due to the aluminum content, in patients with renal impairment, the dose of Calsiosol should not exceed 46 ml per day.

Children and adolescents

Due to the aluminum content, in children and adolescents, the dose of Calsiosol should not exceed 0.9 ml/kg body weight per day. Calcium gluconate in glass ampoules should not be used in children requiring parenteral nutrition. In children (<18 years), calsiosol should be administered intravenously, and intramuscular administration is not recommended.< p>

Calsiosol and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. The effect of heart medications such as digoxin and other digitalis glycosides may be enhanced by calcium and lead to digitalis glycoside toxicity. Therefore, if you are taking digitalis glycosides, intravenous calcium administration should only be performed to treat severe, life-threatening symptoms of very low blood calcium levels. Administration of calcium with adrenaline after heart surgery weakens the effect of adrenaline on the heart and circulation. Calcium and magnesium mutually inhibit their effects. Calcium may weaken the effect of certain medications used to regulate heart function (calcium antagonists). Administration of certain diuretics (thiazide diuretics) with calcium may lead to excessively high blood calcium levels (hypercalcemia), as these medications reduce calcium excretion by the kidneys. Administration of calcium with ceftriaxone may lead to the formation of solid precipitates in blood vessels.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor before using this medicine. PregnancyCalcium crosses the placenta into the fetal circulation and reaches higher concentrations in fetal blood than in maternal blood. Pregnant women should therefore receive calcium intravenously only when absolutely necessary. The dose should be carefully selected, and blood calcium levels should be regularly monitored to avoid excessive blood calcium levels, which can be harmful to the fetus. BreastfeedingCalcium passes into breast milk. Your doctor should consider this when deciding whether to administer calcium to a breastfeeding patient.

Driving and using machines

Calsiosol has a moderate effect on the ability to drive and use machines. Calsiosol has a pronounced sedative effect, so the patient should not drive or operate machines for several hours after intravenous administration of calcium.

3. How to use Calsiosol

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist. The dosage of calcium depends on the individual patient's needs. 10 to 20 ml of Calsiosol, 95.5 mg/ml, solution for injection/infusion (corresponding to 2.2 to 4.4 mmol of calcium), can be administered as an undiluted solution by slow intravenous injection over 10 minutes, monitoring serum calcium levels and ECG results. 10 to 20 ml of Calsiosol, 95.5 mg/ml, solution for injection/infusion (corresponding to 2.2 to 4.4 mmol of calcium), can be diluted in 50 to 100 ml of 5% glucose solution or 0.9% sodium chloride solution and administered as a slow intravenous infusion over 10 minutes, monitoring serum calcium levels and ECG results. If necessary, the dose can be repeated depending on the patient's clinical condition. Subsequent doses should be adjusted according to the current serum calcium level. It is not recommended to administer more than 46 ml (10.12 mmol of calcium) of Calsiosol, 95.5 mg/ml, solution for injection/infusion, within 24 hours. If necessary, doses can be repeated every 1-3 days. Cardiopulmonary resuscitation Usually, 7 to 15 ml (1.54 to 3.3 mmol) is administered. Note that the absolute amount of calcium required for this indication is difficult to determine and may vary significantly. Table of calcium ion equivalence in Calsiosol

Use in children and adolescents

The initial dose used in children and infants is usually 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). It is not recommended to administer more than 0.9 ml/kg body weight (0.198 mmol) of Calsiosol, 95.5 mg/ml, solution for injection/infusion, within 24 hours. The medicine is administered intravenously (into a vein) as a slow injection or slow infusion (drip), after dilution. Intramuscular and subcutaneous injections are contraindicated in children. Method of administration Calcium gluconate is administered intravenously as a solution, by slow direct intravenous injection or by continuous or intermittent intravenous infusion. The injection should be performed in a lying position, with close monitoring of heart function during the injection. With direct intravenous injection, various maximum administration rates have been used, including 2 ml/min, 1.5 to 3 ml/min, and 5 ml/min. With intermittent infusion, a maximum administration rate of 2 ml/min is suggested. During intravenous administration of calcium salts, serum calcium levels should be closely monitored. The rate of intravenous infusion or injection should be slow. After intravenous injection, the patient should remain in a lying position for 15 minutes. Rapid intravenous injection of calcium salts can cause vasodilation, hypotension, bradycardia (slow heart rate), cardiac arrhythmias, fainting, and cardiac arrest. Administration should be temporarily discontinued if abnormal ECG readings or patient discomfort occur; administration can be resumed when the ECG reading returns to normal or the patient's 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

Certain disorders that occur in elderly patients, such as renal impairment and malnutrition, may affect the tolerance of calcium gluconate. Therefore, a lower dose should be used in these patients.

Use of a higher than recommended dose of Calsiosol

Symptoms of high blood calcium levels (hypercalcemia) include loss of appetite, nausea, vomiting, constipation, abdominal pain, excessive urine production, increased thirst, fluid loss, muscle weakness, calcium deposition in the kidneys, drowsiness, confusion, and high blood pressure (hypertension), and in severe cases, irregular heartbeat, up to cardiac arrest and loss of consciousness. If intravenous injection is performed too quickly, symptoms of hypercalcemia may occur, as well as a chalky taste in the mouth, hot flashes, and a drop in blood pressure. Treatment aims to reduce high blood calcium levels. Your doctor will decide on the treatment method. Treatment may include administration of fluids or special medications used to reduce blood calcium levels. In severe cases, dialysis may be necessary. If you have any further questions about the use of this medicine, ask your doctor.

Missing a dose of Calsiosol

If you miss a scheduled dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a missed dose.

Stopping treatment with Calsiosol

Do not stop treatment with Calsiosol without consulting your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects related to the heart, circulation, or other body functions may occur as symptoms of excessively high blood calcium levels after overdose or too rapid intravenous injection. The occurrence and frequency of side effects depend directly on the rate of injection and the administered dose.

The following side effects may be serious. If you experience any of the following side effects, inform your doctor immediately, who will stop administering the medicine:

Frequency not known (frequency cannot be estimated from the available data):

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

Rare (occurs in 1 to 10 per 10,000 patients): Severe, and in some cases fatal, side effects have been observed in premature infants and newborns (≤ 28 days of age) receiving ceftriaxone and calcium intravenously. In post-mortem examination, calcium ceftriaxone precipitates were observed in the lungs and kidneys. Other side effects include: Frequency not known (frequency cannot be estimated from the available data):

• vasodilation,
• hot flashes, mainly after injection at too rapid a rate,
• nausea or vomiting,
• feeling of warmth,
• sweating,
• injections into the muscle may be accompanied by pain and redness.

If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Calsiosol

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton after EXP and on the ampoule after EXP. The expiry date refers to the last day of the month. There are no special storage precautions 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 color, or turbidity of the solution, solid 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. This will help protect the environment.

6. Contents of the pack and other information

What Calsiosol contains

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

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

• The 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 pack

Solution for injection. Clear, colorless solution, free from visible particles. Ampoules of 5 ml or 10 ml, made of colorless glass type I with a ring or break point. Pack size: 5 ampoules containing 5 ml or 10 ml of solution, placed in a PVC blister pack. 1 or 2 blister packs are packaged in a cardboard box.

Marketing authorization holder and importer

Marketing authorization 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 Date of last revision of the leaflet:July 2024