CALCIUM 95 mg /Ml Solution

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET
2. Leaflet accompanying the packaging: patient information
3. Calcium Gluconate hameln, 95 mg/ml, solution for injection
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Calcium Gluconate hameln 95 mg/ml and what is it used for
5. Important information before using Calcium Gluconate hameln 95 mg/ml
   1. When not to use Calcium Gluconate hameln 95 mg/ml
   2. Warnings and precautions
   3. Calcium Gluconate hameln 95 mg/ml and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
6. How to use Calcium Gluconate hameln 95 mg/ml
   1. 1 month of age to 17 years.
   2. Overdose of Calcium Gluconate hameln 95 mg/ml
7. Possible side effects
   1. Serious side effects
   2. If any of the following side effects occur, the patient should immediately inform their doctor:
   3. Side effects occurring during improper use of Calcium Gluconate hameln 95 mg/ml or in special situations
   4. Reporting side effects
8. How to store Calcium Gluconate hameln 95 mg/ml
9. Contents of the packaging and other information
   1. What Calcium Gluconate hameln 95 mg/ml contains
   2. What Calcium Gluconate hameln 95 mg/ml looks like and what the pack contains
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Calcium Gluconate hameln, 95 mg/ml solution for injection
   7. Method of administration
   8. Dosage
   9. Incompatibilities
   10. Dilution

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Calcium Gluconate hameln, 95 mg/ml, solution for injection

Calcii gluconas ad iniectabile

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Calcium Gluconate hameln 95 mg/ml and what is it used for
• 2. Important information before using Calcium Gluconate hameln 95 mg/ml
• 3. How to use Calcium Gluconate hameln 95 mg/ml
• 4. Possible side effects
• 5. How to store Calcium Gluconate hameln 95 mg/ml
• 6. Contents of the packaging and other information

1. What is Calcium Gluconate hameln 95 mg/ml and what is it used for

Calcium occurs naturally in the body and is necessary for the proper functioning of muscles and nerves. It is essential for the heart to work and for blood to clot. Calcium Gluconate hameln 95 mg/ml is used to supplement low calcium levels in the body and to prevent abnormal heart rhythms (arrhythmias) caused by high potassium levels in the blood. It is indicated for the treatment of acute symptomatic hypocalcemia in adults, children, and adolescents, as well as for the treatment of severe hyperkalemia with or without changes in the electrocardiogram (ECG). It may also be used in emergency situations (cardiac arrest) to restore normal heart function if the potassium level in the blood is too high.

2. Important information before using Calcium Gluconate hameln 95 mg/ml

When not to use Calcium Gluconate hameln 95 mg/ml

• 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 high calcium levels in the blood (for example, due to hyperparathyroidism, high vitamin D levels, cancer, kidney disease, osteoporosis due to immobilization, sarcoidosis, or the so-called milk-alkali syndrome);
• if the patient has high calcium levels in the urine (hypercalciuria);
• if the patient has been treated with digitalis glycosides (heart medicines), unless administration of the medicine is necessary for the treatment of severe symptoms of hypocalcemia or acute severe hyperkalemia, despite the significant risk to the patient, in cases where safer alternative treatment methods are not available and oral calcium administration is not possible;
• in preterm infants and newborns born at term (in the first 28 days of life) who have been treated with the antibiotic ceftriaxone;
• in children (under 18 years of age) who require repeated or long-term treatment, due to the risk of exposure to aluminum, related to its leaching from the glass ampoule;
• if the patient has kidney function disorders and requires repeated or long-term treatment, due to the risk of exposure to aluminum;
• if the patient is receiving total parenteral nutrition (TPN) (bypassing the stomach, through intravenous administration), due to the risk of exposure to aluminum.

Warnings and precautions

Before starting treatment with Calcium Gluconate hameln 95 mg/ml, the patient should discuss it with their doctor, pharmacist, or nurse:

• if the patient has chronic kidney disease or is at risk of developing kidney stones;
• if the patient has calcium deposits in the kidneys (nephrocalcinosis);
• if the patient has heart disease;
• if the patient has sarcoidosis (swelling or inflammation of tissues, usually affecting the lungs and skin);
• if the patient has kidney function disorders. This condition may be associated with high calcium levels in the blood and hyperparathyroidism, so the doctor should carefully monitor the patient's blood chemistry, and the patient may receive this medicine only if it is absolutely necessary.

This medicine must not be mixed or administered simultaneously with ceftriaxone, even using separate intravenous access sets or at different infusion sites. This medicine must not be mixed or administered simultaneously with sodium bicarbonate (sometimes used to treat severe hyperkalemia). The medicine should be administered as a slow injection or infusion to prevent, as far as possible, vasodilation or cardiac arrhythmias. Too rapid injection or infusion may cause cardiovascular side effects due to high calcium levels. During intravenous administration of this medicine (as an injection or infusion), cardiac function should be monitored to ensure that any deterioration in cardiac function, such as severe arrhythmia (irregular heartbeat), is treated immediately. The medicinal product Calcium Gluconate hameln 95 mg/ml may cause local tissue irritation. Redness of the skin, burning sensation, and pain during injection or infusion may indicate that the medicine has been accidentally administered outside the blood vessel, which can lead to serious tissue damage (skin necrosis). The doctor will ensure that the solution does not leak into the tissues surrounding the blood vessel and will carefully observe the injection or infusion site. During treatment, calcium levels in the blood and urine should be closely monitored. Calcium gluconate may leach aluminum oxide from the glass ampoule. Increased aluminum levels can lead to the risk of aluminum toxicity, such as adverse effects on bone mineralization and neurological development (brain and nervous system), as well as blood disorders in which organs and tissues do not receive enough oxygen (microcytic anemia), especially in sensitive patients, such as those with kidney function disorders and children (under 18 years of age).

Calcium Gluconate hameln 95 mg/ml and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This is especially important in the case of the following medicines, as they may interact with Calcium Gluconate hameln 95 mg/ml:

• digoxin (heart medicines) and other digitalis glycosides, whose effects may be enhanced;
• thiazide diuretics (diuretics) may reduce the body's ability to eliminate calcium and its levels may increase;
• ceftriaxone (antibiotic), due to the risk of precipitation, must not be administered simultaneously, even in separate infusion lines;
• adrenaline (epinephrine), used after heart surgery, its effect may be reduced;
• magnesium and calcium may mutually weaken their effects;
• calcium channel blockers (heart medicines), their effects may be reduced;
• vitamin D, high doses should be avoided.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. Calcium Gluconate hameln 95 mg/ml should not be used during pregnancy, unless it is absolutely necessary. Since calcium passes into breast milk, the patient should discuss with their doctor whether to stop breastfeeding.

Driving and using machines

It is unlikely that this medicine will affect the patient's ability to drive or use machines.

3. How to use Calcium Gluconate hameln 95 mg/ml

Intravenous administration is performed by a nurse or doctor. The doctor decides on the appropriate dose for an adult or child patient and how and when it will be administered. Treatment of acute symptomatic hypocalcemia and acute severe hyperkalemia with or without changes in ECG Adults

• The recommended dose for an adult is 10 ml and can be repeated if necessary. It is not recommended to administer more than 50 ml (5 ampoules) of Calcium Gluconate hameln 95 mg/ml, solution for injection, within a 24-hour period, due to the risk of exposure to aluminum.

Newborns, children, and adolescents

• Due to the risk of exposure to aluminum, it is not recommended to use more than 1 ml/kg body weight of Calcium Gluconate hameln 95 mg/ml, solution for injection, within a 24-hour period for newborns (newly born infants), children over 1 month of age to 17 years.

1 month of age to 17 years.

In cases of mild symptoms of hypocalcemia affecting nerves and muscles, oral calcium products are preferred. After intravenous treatment of acute symptomatic hypocalcemia, oral calcium therapy should be started, for example, in cases of vitamin D deficiency. In the treatment of acute severe hyperkalemia with or without changes in ECG, calcium administration should be used only to prevent severe cardiac arrhythmias, while other treatments are started to reduce potassium levels in the blood. Cardiac arrest due to severe hyperkalemia Adults

• The recommended dose for an adult is 30 ml of Calcium Gluconate hameln 95 mg/ml, solution for injection.

Newborns, children, and adolescents

• The recommended dose is 0.6 ml/kg body weight of Calcium Gluconate hameln 95 mg/ml, solution for injection, and can be repeated if necessary. Due to the risk of exposure to aluminum, it is not recommended to use more than 1 ml/kg body weight of Calcium Gluconate hameln 95 mg/ml, solution for injection, within a 24-hour period for newborns (newly born infants), children over 1 month of age to 17 years.

Considering the aluminum content in one ampoule (measured at the end of the shelf life) and taking into account current knowledge, it cannot be excluded that exposure to aluminum (when administering more ampoules than recommended) may contribute to future total exposure to aluminum (from the environment, drinking water, and food) and potential toxicity in patients. Due to the risk associated with aluminum, repeated or long-term treatment is not recommended in children (under 18 years of age). The patient should remain in a lying position during administration. Calcium levels in the blood and urine should be closely monitored during treatment.

Overdose of Calcium Gluconate hameln 95 mg/ml

Since this medicine is administered by a doctor or nurse, it is unlikely that the patient will receive too much of the medicine. If the patient thinks they have been given too much of the medicine, has nausea, vomiting, constipation, abdominal pain, muscle weakness, feeling of thirst, excessive urination, feeling of confusion, or bone pain, they should immediately inform the medical staff administering the medicine.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

If any of the following side effects occur, the patient should immediately inform their doctor:

Rare (may affect up to 1 in 1000 people):

• Severe, and in some cases fatal, side effects have been reported in preterm infants and newborns born at term (under 28 days of age) who were treated intravenously with ceftriaxone and calcium. Precipitation of calcium ceftriaxone salts was observed post-mortem in the lungs and kidneys.

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

• slow or irregular heartbeat
• decreased blood pressure (hypotension)
• circulatory collapse, which can be fatal
• vasodilation
• hot flashes, mainly after too rapid administration
• nausea or vomiting
• feeling of warmth
• sweating

Side effects occurring during improper use of Calcium Gluconate hameln 95 mg/ml or in special situations

• Too rapid injection or infusion may cause cardiovascular side effects due to high calcium levels. The occurrence and frequency of such side effects depend directly on the speed of injection or infusion and the dose.
• It has been reported that after the solution leaks from the vein into the surrounding tissue (extravasation), soft tissue calcification may occur. This may be preceded by desquamation and skin necrosis.
• If Calcium Gluconate hameln 95 mg/ml is administered as repeated or long-term treatment to children under 18 years of age or patients with kidney disease, there is a risk of aluminum accumulation, which may lead to side effects such as brain development disorders and bone growth disorders, as well as blood disorders in which organs and tissues do not receive enough oxygen (microcytic anemia).

In case of any doubts about the administration of the medicine, the patient should consult their doctor, pharmacist, or nurse.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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, PL-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, more information can be collected on the safety of the medicine.

5. How to store Calcium Gluconate hameln 95 mg/ml

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the label and carton after: EXP. The expiry date refers to the last day of the month. There are no special precautions for storage. The medicine should be used immediately after opening the container. Preparation of the solution for infusion:The product shows chemical and physical stability in a 5% glucose solution and 0.9% sodium chloride solution for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, the user is responsible for the storage conditions before use. Do not use this medicine if the color changes, sediment forms, or other visible solid particles appear.

6. Contents of the packaging and other information

What Calcium Gluconate hameln 95 mg/ml contains

The active substance of the medicine is calcium gluconate for injection. 1 ml of the solution contains 95 mg of calcium gluconate for injection, which corresponds to 0.21 mmol of calcium. 10 ml of the solution contains 950 mg of calcium gluconate for injection, which corresponds to 2.12 mmol of calcium. The medicinal product contains the excipient calcium saccharate, which corresponds to 0.01 mmol of calcium/ml (0.11 mmol of calcium/10 ml). Total calcium content: 0.22 mmol/ml (2.23 mmol/10 ml). The other ingredient is water for injection.

What Calcium Gluconate hameln 95 mg/ml looks like and what the pack contains

Calcium Gluconate hameln 95 mg/ml is a clear, colorless solution, without visible solid particles, available in colorless glass ampoules of 10 ml capacity. Each pack contains 5 or 10 ampoules. Not all pack sizes may be marketed.

Marketing authorization holder

hameln pharma gmbh, Inselstraße 1, 31787 Hameln, Germany

Manufacturer

Siegfried Hameln GmbH, Langes Feld 13, 31789 Hameln, Germany, HBM Pharma s.r.o., Sklabinská 30, 036 80 Martin, Slovakia, hameln rds s.r.o., Horná 36, 900 01 Modra, Slovakia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:01.10.2021
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Information intended for healthcare professionals only:

Calcium Gluconate hameln, 95 mg/ml solution for injection

• Colorless, clear without visible solid particles
• pH 6.0-7.0
• Osmolality: 270-310 mOsmol/kg
• Intravenous administration

To obtain full information about the medicine, please refer to the Summary of Product Characteristics

Method of administration

Slow intravenous injection and (or) infusion. The patient should remain in a lying position and be closely monitored during administration. Monitoring should include calcium levels in the blood and ECG. Ensure adequate venous access, as extravasation can cause severe skin damage, including tissue necrosis. The rate of intravenous administration should not exceed 0.45 mmol of calcium per minute in adults and 0.22 mmol of calcium per minute as a bolus in children. In the case of continuous infusion, the rate of administration should be adjusted according to the calcium level in the blood and the severity of hypocalcemia symptoms. In the case of acute severe hyperkalemia, the dose and rate of administration should be adjusted according to the ECG recording.

Dosage

Acute symptomatic hypocalcemia The normal calcium level in the blood is between 2.25-2.75 mmol or 4.5-5.5 mEq per liter in adults. Treatment should aim to restore or maintain this level. Severe hyperkalemia with or without changes in ECG Calcium administration in severe hyperkalemia aims to prevent the development of severe cardiac arrhythmias, thereby normalizing the ECG, while other medicines are administered to reduce potassium levels in the blood. Calcium administration in adults should be started when the potassium level in the blood exceeds 6.5 mmol/l and/or when changes appear in the ECG. In children and adolescents, the decision to start calcium administration should be made based on the potassium level in the serum with or without changes in the ECG. However, local guidelines applicable in emergency situations regarding potassium levels requiring calcium administration should be followed. Calcium should not be routinely used during cardiac arrest in adults, children, and adolescents, but only during cardiopulmonary resuscitation due to hyperkalemia. During treatment, calcium levels in the blood should be closely monitored.

Incompatibilities

Calcium salts can form complexes with many medicines, which may lead to precipitation. Calcium salts are incompatible with oxidizing agents, citrates, soluble carbonates, bicarbonates, oxalates, phosphates, tartrates, and sulfates. Physical incompatibilities have also been reported with amphotericin, sodium cefalotin, sodium cefazolin, sodium cefamandole, ceftriaxone, sodium novobiocin, dobutamine hydrochloride, prochlorperazine, and tetracyclines.

Dilution

For continuous intravenous infusion, Calcium Gluconate hameln 95 mg/ml can be diluted with a 5% glucose solution or 0.9% sodium chloride solution. The product shows chemical and physical stability in a 5% glucose solution and 0.9% sodium chloride solution for 24 hours at 25°C. Dilutions should be performed under aseptic conditions. Before administration, the solution should be visually inspected for the presence of solid particles and color changes. The solution can only be used if it is clear and free of solid particles. From a microbiological point of view, the product should be used immediately. If not used immediately, the user is responsible for the storage conditions before use. Avoid diluting with solutions containing bicarbonates, phosphates, or sulfates. Storage: There are no special precautions for storing the medicinal product. For single use only. No special requirements for disposal.