SUPLECAL MINIPLASCO INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Suplecal Mini-Plasco Injectable Solution

Calcium Gluconate Monohydrate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Suplecal Mini-Plasco is and what it is used for
2. Before you use Suplecal Mini-Plasco
3. How to use Suplecal Mini-Plasco
4. Possible side effects
5. Storage of Suplecal Mini-Plasco

1. Contents of the pack and further information

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

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

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

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 the blood (hypercalcemia), such as in patients with overactive parathyroid glands, high levels of vitamin D in the blood, bone tumor disease, kidney failure, osteoporosis due to lack of mobility, sarcoidosis (a chronic disease of unknown cause that produces inflammation characterized by the formation of granules in different organs and tissues of the body), and the milk-alkali syndrome (excessive intake of calcium).
• If you have an increased elimination of calcium in the urine.
• In case of poisoning caused by certain 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 injecting calcium immediately.

It should not be administered simultaneously with the antibiotic ceftriaxone, nor if it is expected to be used in neonates ≤ 28 days, even if it is used through different infusion lines or different infusion sites, precipitates may occur.

Warnings and precautions

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

If you are being treated regularly with digitalis glycosides and exceptionally need an urgent calcium injection (see section "Do not use Suplecal Mini-Plasco"), your doctor will monitor your heart function extremely carefully. The monitoring will ensure that you can be treated immediately if your heart function worsens, for example, with a severe arrhythmia (irregular heartbeat).

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

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

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

• formation of calcium deposits in the kidneys (nephrocalcinosis)
• heart disease
• sarcoidosis

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

Kidney failure may be accompanied by an increase in calcium levels in the blood and an increase in parathyroid gland activity. If you have kidney failure, you should only receive calcium injections if they are absolutely essential. In any case, your calcium and phosphate levels should be monitored.

Your doctor will be extremely careful if you are receiving the antibiotic ceftriaxone 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 heart failure.

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

During treatment with calcium salts, you will be monitored extremely carefully to ensure normal calcium levels (calcium intake versus calcium excretion) and to prevent calcium deposits in tissues. 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 incorrectly into these areas.

If the solution is injected involuntarily next to a blood vessel or not deeply enough into a muscle, it can 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 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 injected intravenously, not intramuscularly.< p>

Using Suplecal Mini-Plasco with other medications

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medications.

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

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

• Magnesium: calcium and magnesium mutually inhibit their effects.
• Adrenaline: the administration of calcium together with adrenaline after heart surgery reduces the effects of adrenaline on the heart and circulation.

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

The administration of certain medications that increase urine production (such as thiazide diuretics) together with calcium can lead to an increase in calcium levels in the blood (hypercalcemia), as these medications reduce calcium excretion through the kidneys.

The administration of calcium simultaneously with ceftriaxone can lead to 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 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 it is absolutely essential. The dose should be calculated carefully, and calcium levels in the blood should be monitored frequently to avoid excessively high calcium levels in the blood, which could harm the fetus.

Breastfeeding:

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

Driving and using machines

This medication does not affect your ability to drive or use machines.

3. How to use Suplecal Mini-Plasco

Follow the instructions for administration of this medication exactly as indicated by your doctor. If you are unsure, consult your doctor again.

Your doctor will decide what dose is most suitable for you to raise your calcium levels in the blood to normal values. This dose will depend on your clinical situation and the values obtained in blood tests.

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, i.e., one ampoule of Suplecal Mini-Plasco. If necessary, the dose can be repeated. Subsequent doses will be adjusted based on your calcium levels in the blood.

Use in children and adolescents

The doctor will decide the dose and method of administration based on calcium levels in the blood and the severity of symptoms. In case of mild symptoms affecting the nerves and muscles, preference will be given to oral calcium preparations.

The approximate initial doses are as follows:

• Infants 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 the case of extremely low calcium levels in the blood in newborns or infants with, for example, heart failure, higher initial doses may be necessary to rapidly raise calcium levels in the blood (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 calcium levels in the blood. After treatment with intravenous therapy, it may be necessary to continue with oral calcium preparations, for example, in cases of vitamin D deficiency.

Use in the elderly

Occasionally, certain disorders associated with advanced age, such as kidney failure and malnutrition, can affect the tolerance of calcium gluconate. Therefore, a lower dose should be administered.

Method of administration

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

The intramuscular route should only be used in cases where the intravenous route is not possible. Your doctor will ensure that the intramuscular injection is administered deeply enough, preferably into the gluteal muscle.

The rate of administration should be slow enough.

Infants, children, and adolescents

Intravenous administration should be slow or through a slow intravenous infusion (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 the most suitable dose for you.

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

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

Treatment of overdose of this medication is aimed at reducing high calcium levels in the blood.

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

If you have any further questions 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 Toxicology Information Service (telephone: 91.562 04 20) indicating the medication and the amount ingested. Bring this leaflet with you.

4. Possible side effects

Like all medicines, Suplecal Mini-Plasco can cause side effects, although not everybody gets them.

The frequency of side effects is expressed as follows:

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 the available data)

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

The following side effects can be serious. If you experience any of the following side effects, tell your doctor immediately, as they will stop administering this medication to you.

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

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

Rare (affect 1 to 10 in every 10,000)

Severe and sometimes fatal adverse reactions have been detected in premature and newborn infants (<28 days old) treated with ceftriaxone and calcium intravenously. precipitates of ceftriaxone-calcium have been observed in the lungs kidneys post-mortem.< p>

Other side effects include:

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

• vasodilation
• flushing, especially after too rapid administration
• nausea or vomiting
• feeling of heat
• sweating
• intramuscular injection can be accompanied by pain and redness

Side effects when the medication is used incorrectly

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Suplecal Mini-Plasco

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

Do not store above 25°C.

Do not use this medication after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

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

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

After dilution of the solution, it should be administered as soon as possible and should not be stored for more than 24 hours between 2 – 8 ºC.

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

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

6. Container Content and Additional Information

Composition of Suplecal Mini-Plasco:

• The active ingredient 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-calcium saccharate tetrahydrate equivalent to 0.02 mmol calcium per ml (or 0.15 mmol 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 Container Content

Suplecal Mini-Plasco is a clear, colorless to slightly brownish injectable solution (a solution administered via 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:

• 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 Last Review of this Leaflet:January 2019.

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

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This information is intended solely for doctors or healthcare professionals:

Posology and Method of Administration

Posology

Pediatric population (< 18 years)

The following table shows the usual initialdose:

Method of administration

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

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

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

Pediatric population (< 18 years)

In order to achieve slow administration rates and avoid irritation/necrosis in case of accidental extravasation, it should only be administered through slow intravenous injections or intravenous perfusion (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.

Special Warnings and 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, sodium cefalotin, ceftriaxone, sodium novobiocin, prochlorperazine, and tetracyclines.

Incompatibilities

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

Dilution

Before using this product with other solutions with a Y connector or a bypass set, the compatibility of these fluids should 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 an isotonic sodium chloride solution through intravenous perfusion to expand the extracellular fluid. Calcitonin can be administered to decrease the elevated serum calcium concentration. Furosemide can be administered to increase calcium excretion, but thiazide diuretics should be avoided, as they can increase renal absorption of calcium.

Serum electrolytes should be carefully monitored throughout the treatment of the overdose.

B|BRAUN