CALCIUM CHLORIDE BRAUN 100 mg/ml INJECTABLE SOLUTION

Introduction

Leaflet: information for the user

Calcium Chloride Braun 100mg/ml

Injectable solution

Read the entire leaflet carefully before starting to use the medicine

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

1. What isCalcium ChlorideBraun100 mg/mland what is it used for
2. Before usingCalcium ChlorideBraun100 mg/ml
3. How to useCalcium ChlorideBraun100 mg/ml
4. Possible side effects
5. Storage ofCalcium ChlorideBraun100 mg/ml
6. Additional information

1. What is Calcium Chloride Braun 100 mg/ml and what is it used for

Calcium Chloride Braun injectable solution belongs to a group of medicines called calcium mineral supplements.

Calcium Chloride Braun 100 mg/ml is an injectable solution used in the treatment of calcium deficiency of any cause.

Calcium Chloride Braun 100 mg/ml is an injectable solution used, as an adjunct, in cardiac resuscitation, in the treatment of central nervous system depression due to hypermagnesemia (excess magnesium), in the treatment of hyperkalemia (excess potassium).

2. Before using Calcium Chloride Braun 100 mg/ml

Do not use Calcium Chloride Braun 100 mg/ml:

• If you are allergic (hypersensitive) to calcium chloride or any of the other components of Calcium Chloride Braun.

• If you have:
• high levels of calcium in the blood (hypercalcemia) or calcium in the urine (hypercalciuria)
• kidney stones (calcium stones)
• chronic kidney damage
• if you have high levels of vitamin D
• toxicity due to heart medications called digitalis, such as digoxin
• water deficiency (dehydration) or imbalance in salt levels (electrolytes)
• diarrhea or poor gastrointestinal absorption
• heart problems.

Be careful with Calcium Chloride Braun 100 mg/ml:

Tell your doctor about any allergy or medical problem you have or have had, especially:

• in cases of kidney, heart, or liver failure
• when the body produces too much acid or the kidneys cannot eliminate enough acid from the body (metabolic acidosis)
• if you are taking any product that contains potassium.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those purchased without a prescription.

The use of Calcium Chloride Braun 100 mg/ml with other medicines may alter the effectiveness of both treatments.

Tell your doctor or pharmacist if you are taking any of the following medicines:

• medicines that contain calcium and magnesium
• heart medicines such as digitalis glycosides (e.g., digoxin)
• a type of diuretics called thiazides (hydrochlorothiazide) as they decrease calcium elimination in the urine
• magnesium sulfate by intravenous route.
• ceftriaxone (an antibiotic) by intravenous route
• a type of medicines called bisphosphonates as calcium chloride decreases their absorption.

Your doctor will check the compatibility of this medicine before using it.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

There are no studies on the effects of calcium chloride on pregnant women; your doctor will assess the convenience of its use.

Calcium is excreted in breast milk, but there are no data on its effects, if any, on the child.

3. How to use Calcium Chloride Braun 100 mg/ml

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

Your doctor will indicate the dose and duration of your treatment with Calcium Chloride Braun 100 mg/ml.

If you use more Calcium Chloride Braun 100 mg/ml than you should

It is unlikely that this will happen since your doctor will decide the most suitable dose for you.

In case you are injected with more Calcium Chloride Braun than due, this could cause:

anorexia, nausea, and continuous vomiting, constipation, water deficiency (dehydration), high blood pressure (hypertension), confusion, frequent urination (polydipsia), production of a large amount of urine (polyuria), weakness, and muscle or bone pain, depression, kidney stones, and in severe cases, cardiac arrhythmias and coma.

In case of overdose or accidental ingestion, consult the Toxicology Information Service (telephone: 91.562 04 20) or consult your doctor or pharmacist. Bring this leaflet with you.

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

4. Possible side effects

Like all medicines, Calcium Chloride Braun 100 mg/ml can cause side effects, although not everyone will experience them.

Adverse reactions may occur if the injection of the solution is too rapid, if it is used for a prolonged period, or if it is administered to patients with kidney damage:

Nervous system disorders:

• dizziness, drowsiness

Cardiac disorders:

• irregular heartbeats

Skin and subcutaneous tissue disorders:

• redness of the skin and/or sensation of burning or heat

Gastrointestinal disorders:

• nausea or vomiting

Vascular disorders:

• peripheral vasodilation (dilation of blood vessels) with slight decrease in blood pressure

General disorders and administration site conditions:

• sweating, sensation of tingling
• redness of the skin, rash, or itching at the injection site

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 not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Calcium Chloride Braun 100 mg/ml

Keep out of the reach and sight of children.

No special storage conditions are required

Do not use Calcium Chloride Braun 100 mg/ml after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Additional information

Composition of Calcium Chloride Braun 100 mg/ml:

The other components are: water for injections.

Appearance of the product and packaging content

Calcium Chloride Braun 100 mg/ml is presented in 10 ml glass ampoules in boxes of 5 and 100 units.

Marketing authorization holder

B|BRAUN

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Manufacturer

B BRAUN MEDICAL S.A.

Ronda de los Olivares, Parcela II, Poligono Industrial Los Olivares

23009 Jaén (Jaén), Spain

This leaflet was approved in June 2015.

Detailed information about this medicine is available on the website of theSpanish Agency for Medicines and Health Products.

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This information is intended only for doctors or healthcare professionals:

Dosage

Hypocalcemia

in adults: one 5 or 10 ml ampoule daily or alternately.

in children: 0.2 ml/kg body weight (maximum of 1 to 10 ml)

In cardiac resuscitation: It should be injected into the ventricular cavity. Do not inject into the myocardium.

in adults: 2 to 4 ml administered rapidly.

in children: 0.2 ml/kg body weight (maximum of 1 to 10 ml)

Magnesium poisoning

in adults: one 5 ml ampoule daily or alternately.

Hyperkalemia

in adults: Adjust the dose by monitoring the ECG during administration.

in children: 0.2 ml/kg body weight (maximum of 1 to 10 ml)

Instructions for correct administration:

It should only be administered intracardially, in cardiac resuscitation, or by slow intravenous route; and by healthcare personnel.

Extravasation or intramuscular injection should be avoided. If this happens, 5 to 10 ml of sterile physiological solution will be injected subcutaneously in the periphery of the extravasation, and warm compresses will be applied, thus avoiding any sclerosis.

When the calcium concentration in the blood is high, it may increase the possibility of calcium deposition in soft tissues if calcium salts are administered simultaneously with potassium and sodium phosphate.

When the serum calcium concentration is higher than 12 mg/100 ml, a series of immediate measures are required, such as hydration, promoting diuresis, and the use of chelating agents, calcitonin, or corticosteroids. Serum calcium levels should be determined at frequent intervals to adjust the dose.

Calcium salts usually reverse the effects of non-depolarizing neuromuscular blockers if administered simultaneously.

The solution should be visually inspected before use. The solution must be transparent, not contain precipitates, and the packaging must be intact. Do not administer otherwise.