SUPLOCAL MINIPLASCO SOLUTION FOR INJECTION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Suplecal Mini-Plasco solution for injection

Calcium gluconate monohydrate

Read the entire leaflet carefully before you start using this medicine, as 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 should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Suplecal Mini-Plasco is and what it is used for

2. Before using Suplecal Mini-Plasco

3. How to use Suplecal Mini-Plasco

4. Possible side effects

5. How to store Suplecal Mini-Plasco

6. Contents of the pack and other information

1. What Suplecal Mini-Plasco is and what it is used for

Suplecal Mini-Plasco is an injectable solution belonging to a group of medicines called calcium mineral 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 reduced skin sensitivity (numbness, tingling, and burning), muscle stiffness (tetany), cramps in hands and feet, colic, muscle weakness, and confusion that may progress to seizures and cardiac symptoms (irregular heartbeat and even acute heart failure).
• to restore electrolytes (electrically charged substances found in the blood such as calcium, sodium, chlorides) during intravenous feeding (injected directly into a vein).

2. What you need to know before using Suplecal Mini-Plasco

Do not use Suplecal Mini-Plasco:

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

• If you have high levels of calcium in the blood (hypercalcemia), for example in patients with overactive parathyroid glands, high levels of vitamin D in the blood, tumour disease with bone breakdown, renal insufficiency, osteoporosis due to immobility, sarcoidosis (a chronic disease of unknown cause that produces inflammation characterized by granuloma formation in various organs and tissues of the body), or milk-alkali syndrome (excessive calcium intake).

• If you have increased excretion of calcium in the urine.

• In case of intoxication caused by medications called digitalis glycosides (a type of medication used to treat heart disorders, such as digoxin).

• If you are being treated with digitalis glycoside medications, except if you have extremely low levels of calcium in the blood that are life-threatening and can only be treated by immediate injection of calcium.

Concomitant administration with the antibiotic ceftriaxone must be avoided. Precipitates may occur even if different infusion routes are used, particularly in neonates ≤ 28 days of age.

Warnings and precautions

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

If you are regularly treated with digitalis glycosides and urgently require a calcium injection (see section “Do not use Suplecal Mini-Plasco”), your doctor will carefully monitor your cardiac function. This monitoring ensures immediate treatment in case your cardiac function worsens, for example due to severe arrhythmia (irregular heartbeat).

Your doctor will periodically check your blood calcium levels, especially if you:

• are being treated with high doses of vitamin D,
• are undergoing long-term calcium supplementation, or
• have renal insufficiency (in this case, your doctor will adjust the dose based on blood calcium levels).

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

• calcium deposits in the kidneys (nephrocalcinosis),
• heart disease,
• sarcoidosis.

In these cases, Suplecal Mini-Plasco will only be administered when absolutely necessary. This also applies if you are being treated with adrenaline (see “Use of Suplecal Mini-Plasco with other medicines”) or if you are elderly.

Renal insufficiency may be accompanied by elevated blood calcium levels and increased parathyroid gland activity. If you have renal insufficiency, calcium injections should only be given if absolutely essential. However, your calcium and phosphate levels must be monitored.

Special caution is required if you are receiving the antibiotic ceftriaxone; concomitant administration with calcium gluconate must be avoided, even when administered through different infusion lines or at different infusion sites.

Suplecal Mini-Plasco must be injected slowly to avoid vasodilation or cardiac failure.

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

During treatment with calcium salts, you will be closely monitored to ensure normal calcium balance (calcium intake versus excretion) and to prevent calcium deposits in tissues. Blood calcium levels and urinary calcium excretion will be monitored, especially when high doses of calcium are administered.

Calcium is insoluble in fatty tissue and may cause inflammatory reactions leading to abscess formation, hardening, and tissue destruction (necrosis), particularly if accidentally injected into such areas.

If the solution is inadvertently injected beside 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 leak into surrounding tissues and will carefully observe the injection site.

High doses of vitamin D should be avoided.

Children and adolescents

In children (< 18 years), Suplecal Mini-Plasco should only be administered intravenously, not intramuscularly.

Use of Suplecal Mini-Plasco with other medicines

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines.

The effects of heart medications such as digoxin and other digitalis glycosides may be enhanced by calcium to the point of causing digitalis toxicity. Therefore, if you are being treated with digitalis glycoside medications, calcium injections will only be administered to treat severe, life-threatening symptoms caused by extremely low blood calcium levels.

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

• Magnesium: calcium and magnesium mutually inhibit each other’s effects.
• Adrenaline: 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 conditions (calcium antagonists).

Administration of certain medications that increase urine production and excretion (such as thiazide diuretics) together with calcium may lead to increased blood calcium levels (hypercalcemia), because these medications reduce calcium excretion through the kidneys.

Concomitant administration of calcium with ceftriaxone may result in precipitation.

Pregnancy and breastfeeding

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

Pregnancy:

Calcium crosses the placenta and enters fetal circulation, where it reaches higher blood concentrations in the fetus than in the mother.

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

Breastfeeding:

Calcium is excreted in breast milk. Your doctor must take this into account when administering calcium if you are breastfeeding.

Driving and using machines

This medicine has no influence on the ability to drive or operate machinery.

3. How to use Suplecal Mini-Plasco

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor again.

Your doctor will decide the most appropriate dose for you in order to raise your blood calcium levels to normal values. This dose will depend on your clinical condition and the results obtained from blood tests.

This medicine will always be administered by healthcare personnel directly into a vein via a slow injection.

Adults

The usual initial dose is 10 ml, i.e., one vial of Suplecal Mini-Plasco. If necessary, the dose may be repeated. Subsequent doses will be adjusted according to your blood calcium levels.

Use in children and adolescents

The doctor will determine the dose and route of administration depending on your blood calcium levels and the severity of symptoms. In cases of mild symptoms affecting nerves and muscles, oral calcium preparations will be preferred.

Approximate initial doses are as follows:

• Infants and children under 3 years: 2 – 5 ml
• Children between 3 and 12 years: 5 – 10 ml
• Children over 12 years and adolescents: see adult recommendations.

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

Calcium administration may be repeated if necessary. 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 elderly

Sometimes, certain conditions associated with advanced age, such as renal insufficiency and malnutrition, may affect tolerance to calcium gluconate. Therefore, a lower dose should be administered.

Method of administration

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

Intramuscular administration should only be used when intravenous administration is not possible. Your doctor will ensure that the intramuscular injection is administered deeply enough, preferably into the gluteal muscle.

The rate of administration must be sufficiently slow.

Infants, children and adolescents

Intravenous administration must be slow or via slow intravenous infusion (venous drip), in both cases after dilution.

This medicine must not be injected intramuscularly or subcutaneously in children.

If you use more Suplecal Mini-Plasco than you should

It is unlikely that this will occur, as your doctor will determine the most appropriate dose for you.

Symptoms of elevated blood calcium levels (hypercalcemia) include: loss of appetite, nausea, vomiting, constipation, abdominal pain, increased urine production, increased thirst, fluid loss, muscle weakness, calcium deposition in the kidneys, drowsiness, confusion, high blood pressure (hypertension), and in severe cases, irregular heartbeat, which may lead to cardiac arrest and loss of consciousness.

If the intravenous injection is administered too quickly, symptoms of elevated blood calcium levels (hypercalcemia) may occur, such as a chalky taste, hot flushes, and a drop in blood pressure.

Treatment of overdose is aimed at reducing elevated blood calcium levels.

Your doctor will decide which treatment should be administered. This may include administration of fluids or specific medications to reduce blood calcium levels. In severe cases, dialysis may be required.

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

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

4. Possible adverse effects

Like all medicines, Suplecal Mini-Plasco may cause adverse effects, although not everyone experiences them.

The frequency of side effects is expressed as follows:

Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Frequency not known (cannot be estimated from available data)

Adverse effects on the heart, circulation, or other body functions may appear as symptoms of excessively high blood calcium levels following an overdose or too rapid intravenous injection. The onset and frequency of such symptoms depend directly on the rate of injection and the dose administered.

The following adverse effects may be serious. If you experience any of the following, inform your doctor immediately, as treatment with this medicine will be discontinued.

Frequency not known (cannot be estimated from available data)

• slow or irregular heartbeat
• decrease in blood pressure (hypotension)
• circulatory collapse (potentially fatal)

Rare (affects between 1 and 10 in 10,000)
Severe and in some cases fatal adverse reactions have been reported in premature infants and newborns (<28 days of age) treated with intravenous ceftriaxone and calcium. Post-mortem findings have shown precipitation of ceftriaxone-calcium salts in the lungs and kidneys.

Other adverse effects include:

Frequency not known (cannot be estimated from available data)

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

Adverse effects when the medicine is used incorrectly

• If the intramuscular injection is not deep enough, the solution may enter fatty tissue and cause inflammation, hardening, and destruction (necrosis) of the skin.
• It has been reported that leakage of the solution from the vein into surrounding tissue may lead to calcium deposition in soft tissues, which may be accompanied by skin peeling and tissue destruction.
• Skin redness and a burning or painful sensation during intravenous injection may indicate accidental injection beside a blood vessel, which could result in tissue destruction.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Suplecal Mini-Plasco

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

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

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

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

After dilution, the solution should be administered as soon as possible and must not be stored for longer than 24 hours at 2–8°C.

Do not use this medicine if you observe any of the following changes:

Damage to the ampoule, discoloration, cloudiness in the solution, or presence of visible particles in the solution.

6. Contents of the pack and other information

Composition of Suplecal Mini-Plasco:

• The active substance 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: calcium D-saccharate tetrahydrate, equivalent to 0.02 mmol calcium per ml (or 0.15 mmol calcium per 10 ml).
• The other components are: water for injections.

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 pack

Suplecal Mini-Plasco is an injectable solution (a solution administered with a syringe), clear, colourless to slightly light brown.

It is available in:

Low-density polyethylene ampoules (MiniPlasco®) of 10 ml

packaged in boxes of 20 x 10 ml

Marketing Authorization Holder:

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Tel. 93 586 62 00

Manufacturer:

B. Braun Melsungen AG

Mistelweg 2

D-12357 (Berlin)

Germany

Date of the most recent review of this leaflet: January 2019

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

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This information is intended for healthcare professionals only:

Posology and method of administration

Posology

Paediatric population (< 18 years)

The following table shows the usual initial dose:

Method of administration

In obese patients, a longer needle should be used to ensure intramuscular injection and avoid injection into adipose tissue.

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

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

Paediatric population (< 18 years)

To achieve slow administration rates and avoid irritation/necrosis in case of accidental extravasation, administration should only be performed via slow intravenous injection or intravenous infusion (both after dilution).

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

Warnings and special precautions for use

This product must not be mixed or administered simultaneously with intravenous solutions containing calcium, even through separate infusion lines or different infusion sites. Calcium salts may 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, compatibility with any added medicinal product must be verified before addition. In the absence of compatibility studies, this medicine must not be mixed with others.

Dilution

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

Emergency treatment in case of overdose

Initial treatment should include rehydration and, in cases of severe hypercalcemia, administration of an isotonic sodium chloride solution by intravenous infusion may be necessary to expand the extracellular fluid volume. Calcitonin may be administered to reduce elevated serum calcium levels. Furosemide may be given to increase calcium excretion, but thiazide diuretics should be avoided, as they may enhance renal calcium reabsorption.

Serum electrolytes must be closely monitored throughout the treatment of overdose.

B|BRAUN