Leaflet: information for the user

Suplecal Mini-Plasco injectable solution

Calcium gluconate monohydrate

Read this leaflet carefully before you start using the medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

Suplecal Mini-Plasco is an injectable solution that belongs to a group of medications called mineral calcium supplements.

Suplecal Mini-Plasco is used in the following cases:

• to treat acute calcium deficiency in the blood (acute hypocalcemia) accompanied by acute symptoms such as decreased skin sensitivity (numbness, itching, and burning), muscle stiffness (tetany), cramps in hands and feet, colic, muscle weakness, and confusion that may lead to seizures and cardiac symptoms (irregular heart rate and even acute heart failure).
• to restore electrolytes (substances with electric charge found in the blood such as: calcium, sodium, and chlorides) during intravenous nutrition (administered directly into a vein)

Do not use Suplecal Mini-Plasco:

• If you are allergic (hypersensitive) to calcium gluconate or any of the other components of Suplecal Mini-Plasco listed in section 6.

• If you have high levels of calcium in your blood (hypercalcemia) such as in patients with hyperactive parathyroid glands, high levels of vitamin D in the blood, cancer with bone decomposition, renal insufficiency, osteoporosis due to immobility, sarcoidosis (a chronic disease of unknown cause that produces inflammation characterized by the formation of granules in various organs and tissues of the body) and milk-alkali syndrome (excessive intake of calcium).
• If you have an increase in the elimination of calcium through the urine.
• In case of intoxication caused by a type of medication called digitalis glycosides (a type of medication used to treat heart irregularities such as digoxin).

• If you are being treated with digitalis glycosides, except if you have extremely low levels of calcium in your blood that put your life at risk and can only be treated by injecting calcium immediately.

Do not administer simultaneously with the antibiotic ceftrixona, nor if you expect to use this product in neonates ≤ 28 days, although it may be used through different infusion routes, precipitation may occur.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Suplecal Mini-Plasco.

If you are being treated habitually with digitalis glycosides and exceptionally need an urgent calcium injection (see "Do not use Suplecal Mini-Plasco"), your doctor will closely monitor your cardiac function. Monitoring will ensure that you can be treated immediately if your cardiac function worsens, for example with a severe arrhythmia (irregular heart rate).

Your doctor will perform regular checks of your calcium levels in the blood, especially if you:

• are being treated with high doses of vitamin D,
• are on a prolonged treatment with calcium supplements or
• have renal insufficiency (in this case, your doctor will adjust the dose depending on your calcium levels in the blood).

Your doctor will consider whether this medication is suitable for you if you have:

• calcium deposits in the kidneys (nephrocalcinosis)
• heart diseases
• sarcoidosis

In these cases, Suplecal Mini-Plasco will only be administered in situations where it is considered absolutely necessary. This also applies if you are being treated with adrenaline (see "Use of Suplecal Mini-Plasco with other medications") or are elderly.

Renal insufficiency may be accompanied by an increase in calcium levels in the blood and an increase in the activity of the parathyroid glands. If you have renal insufficiency, you should only receive calcium injections if they are absolutely necessary. Nevertheless, your calcium and phosphate levels should be monitored.

Your doctor will take special care if you are receiving the antibiotic ceftriaxona and will not administer it simultaneously with calcium gluconate, even if it is through different infusion lines or different infusion sites.

Suplecal Mini-Plasco should be injected slowly to avoid vasodilation or cardiac insufficiency.

Your heart rate or electrocardiogram should be monitored when this medication is administered intravenously.

During treatment with calcium salts, you will be closely monitored to ensure normal calcium levels (calcium intake vs. calcium excretion) and to prevent calcium deposits in tissues. Your calcium levels in the blood and the amount of calcium excreted in the urine will be monitored, especially when high doses of calcium are injected.

Calcium is insoluble in fatty tissue and can lead to inflammatory reactions followed by abscess formation, hardening, and tissue destruction (necrosis), especially if it is injected accidentally in these areas.

If the solution is accidentally injected into the side of a blood vessel or not deeply enough into a muscle, it may cause local tissue irritation, followed by skin peeling and even necrosis (see section 4). Your doctor will ensure that the solution does not drain into the tissue around the blood vessel and will closely observe the injection site.

Elevated doses of vitamin D should be avoided.

Children and adolescents

In children (<18 years)

Use of Suplecal Mini-Plasco with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to take any other medication.

The effects of heart medications such as digoxin and other digitalis glycosides may be increased by calcium to the point of causing digitalis intoxication. Therefore, if you are being treated with digitalis glycosides, only calcium injections will be administered for the treatment of severe symptoms that put your life at risk due to extremely low calcium levels in the blood.

Suplecal Mini-Plasco should be used with caution with the following medications, as concurrent use may alter the effectiveness of both treatments:

• Magnesium: calcium and magnesium inhibit each other's effects.
• Adrenaline: the administration of calcium together with adrenaline after heart surgery reduces the effects of adrenaline on the heart and circulation.

Calcium may reduce the effects of certain medications used to treat heart diseases (calcium antagonists).

The administration of certain medications that increase the creation and elimination of urine (such as thiazide diuretics) together with calcium may produce an increase in calcium levels in the blood (hypercalcemia), due to the fact that these medications reduce calcium excretion through the kidneys.

The administration of calcium simultaneously with ceftriaxona will result in precipitation.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

Calcium crosses the placenta and reaches the fetal circulation, where it reaches higher levels in the fetal blood than in the maternal blood.

Therefore, pregnant women should only receive calcium injections if they are absolutely necessary. The dose should be carefully calculated, and calcium levels in the blood should be monitored frequently to avoid excessively high calcium levels in the blood, which could harm the fetus.

Lactation:

Calcium is excreted in breast milk. Your doctor should take this into account when administering calcium to you while you are breastfeeding.

Driving and operating machinery

This medication has no influence on the ability to drive and operate machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Your doctor will decide on the most suitable dose for you in order to elevate your blood calcium levels to normal values. This dose will depend on your clinical condition and the blood test results.

This medication will always be administered by healthcare personnel, directly into a vein, and through a slow injection.

Adults

The usual initial dose is 10 ml, that is, one Suplecal Mini-Plasco ampoule. If necessary, the dose can be repeated. Subsequent doses will be adjusted according to your blood calcium levels.

Use in children and adolescents

Your doctor will decide on the dose and method of administration based on your blood calcium levels and the severity of symptoms. In cases of mild symptoms affecting the nerves and muscles, oral calcium preparations will be preferred.

Approximate initial doses are as follows:

• Newborns and children under 3 years: 2 - 5ml
• Children between 3 and 12 years: 5 – 10 ml
• Children over 12 years and adolescents: see recommendations for adults.

In cases of extremely low blood calcium levels in newborns or infants, for example, with heart failure, higher initial doses may be necessary to quickly elevate blood calcium levels (up to 2 ml per kg of body weight).

If necessary, calcium administration can be repeated. The concentration of subsequent doses will depend on existing blood calcium levels. After intravenous therapy, it may be necessary to continue treatment with oral calcium preparations, for example, in cases of vitamin D deficiency.

Use in the elderly

In some age-related disorders, such as renal insufficiency and malnutrition, the tolerance of calcium gluconate may be affected. Therefore, a lower dose should be administered.

Administration method

Suplecal Mini-Plasco will be administered through a slow intravenous injection or through a deep injection into a large muscle. It should be administered while lying down, especially if cardiac function needs to be closely monitored during the injection.

Only intramuscular use should be used in cases where intravenous use is not possible. Your doctor will ensure that the intramuscular injection is administered deeply enough, preferably in the gluteus maximus muscle.

The administration rate should be slow enough.

Newborns, children, and adolescents

Intravenous administration should be slow or through a slow intravenous infusion (venous drip), in both cases after dilution.

This medication should not be injected intramuscularly or subcutaneously in children.

If you use more Suplecal Mini-Plasco than you should

This is unlikely to happen since your doctor will decide on the most suitable dose for you.

Symptoms of elevated blood calcium levels (hypercalcemia) include: loss of appetite, nausea, vomiting, constipation, abdominal pain, increased urine formation, increased sensation of thirst, fluid loss, muscle weakness, calcium precipitation in the kidneys, drowsiness, confusion, high blood pressure, and in severe cases, irregular heart rate, which can lead to cardiac arrest and loss of consciousness.

In case the intravenous injection is administered too quickly, symptoms of elevated blood calcium levels (hypercalcemia) may occur, including a metallic taste, hot flashes, and a drop in blood pressure.

Treatment for excessive administration of this medication is aimed at reducing elevated blood calcium levels.

Your doctor will decide on the treatment you should receive. This may include the administration of fluids or specific medications to reduce blood calcium levels. In severe cases, dialysis may be necessary.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service (phone: 91.562 04 20) indicating the medication and the amount ingested. Bring this leaflet with you.

Like all medicines, Suplecal Mini-Plasco can cause side effects, although not everyone will experience them.

The frequency of side effects is expressed in the following way:

Very common(≥1/10)

Common(≥1/100 to <1)

Uncommon(≥ 1/1,000 to <1)

Rare(≥1/10,000 to <1)

Very rare(<1)

Frequency not known(cannot be estimated from available data)

Side effects in the heart, circulation, or other bodily functions may appear as symptoms of excessively high calcium levels in the blood after an overdose or a too rapid intravenous injection. The appearance and frequency of these symptoms depend directly on the injection speed and the administered dose.

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

Frequency not known(cannot be estimated from available data)

• slow or irregular heart rate
• decreased blood pressure (hypotension)
• circulatory collapse (potentially fatal)

Rare(affects between 1 and 10 in 10,000)

Severe and sometimes fatal adverse reactions have been detected in premature and newborn infants (<28)

Other side effects include:

Frequency not known(cannot be estimated from available data)

• vasodilation
• headaches, especially after a too rapid administration
• nausea or vomiting
• sensation of heat
• sweating
• intramuscular injection may be accompanied by pain and redness

Side effects when the medicine is used incorrectly

• If the intramuscular injection is not deep enough, the solution may penetrate into fatty tissue and cause inflammation, hardening, and destruction (necrosis) of the skin.
• It has been reported that after the solution leaks from the vein into surrounding tissue, calcium may deposit in soft tissues and be accompanied by peeling and destruction of the skin.
• Redness of the skin and a sensation of burning or pain during intravenous injection may indicate an unintended injection into a blood vessel, which could cause tissue destruction.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not store at a temperature above 25°C.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the solution is not clear, if you observe particles at the bottom, or if the packaging shows visible signs of deterioration.

Once the ampule is opened, the solution must be used immediately.

After diluting the solution, it must be administered as soon as possible and should not be stored for more than 24 hours between 2 – 8°C.

Do not use this medication if you observe the following changes:

Damage to the ampule, discoloration, turbidity in the solution, or visible particles in the solution.

Composition of Suplecal Mini-Plasco:

• The active principle is calcium gluconate monohydrate for injection.
• 1 ml of injection solution contains 94 mg of calcium gluconate for injection, equivalent to 0.21 mmol of calcium.
• 10 ml contain 940 mg of calcium gluconate for injection, equivalent to 2.10 mmol of calcium.
• The other excipients are: D-saccharate calcium tetrahydrate equivalent to 0.02 mmol of calcium per ml (or 0.15 mmol of calcium per 10 ml).
• The other components are: water for injectable preparations.

The total calcium content is 0.23 mmol per ml (equivalent to 9.22 mg of calcium per ml) and 2.25 mmol per 10 ml (equivalent to 92.2 mg of calcium per 10 ml).

Appearance of the product and contents of the package:

Suplecal Mini-Plasco is a clear, colorless to light brownish clear injectable solution (a solution administered through a syringe).

It is presented in:

Low-density polyethylene ampoules (MiniPlasco) of 10 ml

Available in boxes of 20 x 10 ml

Marketing Authorization Holder:

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Tel. 93 586 62 00

Responsible for manufacturing:

B.Braun Melsungen AG

Mistelweg 2

D-12357 (Berlin)

Germany

Last review date of this leaflet:January 2019.

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

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This information is intended solely for doctors or healthcare professionals:

Dosage and administration form:

Dosage:

Pediatric population (<18)

The following table shows the usual initial dose:

Administration method:

In the case of obese patients, a longer needle should be chosen to ensure the injection in the muscle and not in the adipose tissue.

If more than one injection is required, the injection site must be changed.

The intravenous administration rate should not exceed 2 ml (0.45 mmol of calcium) per minute.

Pediatric population (<18)

To obtain slow administration rates and avoid irritation/necrosis in case of accidental extravasation, it should only be administered through slow intravenous injections or intravenous infusion (both after dilution).

The intravenous administration rate in children and adolescents should not exceed 5 ml per minute of a 1:10 dilution of Suplecal Mini-Plasco.

Warnings and special precautions for use:

It should not be mixed or administered simultaneously with intravenous solutions containing calcium, even through different infusion lines or different infusion sites. Calcium salts can form complexes with certain substances and precipitate.

Calcium salts are incompatible with oxidizing agents, citrates, soluble carbonates, bicarbonates, phosphates, oxalates, tartrates, and sulfates.

Physical incompatibility has also been demonstrated with amphotericin, cephalothin sodium, ceftriaxone, sodium novobiocin, prochlorperazine, and tetracyclines.

Incompatibilities:

As with all parenteral solutions, before adding medications, the compatibility of the same with the solution must be checked. In the absence of compatibility studies, this medication should not be mixed with others.

Dilution:

Before using this product with other solutions using a Y-connector or a bypass set, the compatibility of these fluids must be checked.

Emergency treatment in case of overdose:

The initial treatment should include rehydration, and in cases of severe hypercalcemia, it may be necessary to administer a normal saline solution through intravenous infusion to expand the extracellular fluid. Calcitonin may be administered to reduce elevated serum calcium levels. Furosemide may be administered to increase calcium excretion, but diuretics should be avoided, as they can increase renal calcium absorption.

Electrolytes should be closely monitored during the entire treatment of the overdose.

B|BRAUN