Label:Information for the User

Calcium Chloride Braun 100mg/ml

Injectable Solution

Read the entire label carefully before starting to use the medication

• Keep this label,as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this label, inform your doctor or pharmacist.

Calcium Chloride Braun injectable solution belongs to a group of medications called mineral calcium 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 adjuvant, in cardiopulmonary resuscitation, in the treatment of central nervous system depression due to hypermagnesemia (excess magnesium), in the treatment of hyperkalemia (excess potassium).

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 your blood (hypercalcemia) or calcium in your urine (hypercalciuria)
• kidney stones (calcium oxalate stones)
• chronic kidney damage
• high levels of vitamin D
• toxicity due to certain heart medications called digitalis, such as digoxin
• dehydration or electrolyte imbalance
• diarrhea or poor gastrointestinal absorption
• heart problems.

Be especially careful with Calcium Chloride Braun 100 mg/ml:

Inform your doctor of any allergy or medical condition 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 receiving any product that contains potassium.

Use of other medications

Inform your doctor or pharmacist if you are using or have used recently other medications, even those acquired without a prescription.

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

Inform your doctor or pharmacist if you are taking any of the following medications:

• medications that contain calcium and magnesium
• heart medications such as digitalis glycosides (e.g. digoxin)
• a type of diuretic called thiazides (hydrochlorothiazide) as they decrease the elimination of calcium by the urine
• magnesium sulfate administered intravenously.
• ceftriaxone (an antibiotic) administered intravenously
• a type of medication called Bifosfonates as calcium chloride decreases the absorption of these.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

There are no studies on the effects of calcium chloride on pregnant women. Your doctor will evaluate the convenience of its use.

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

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

Your doctor will inform you of the dosage 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 on the most suitable dose for you.

In the event that you are injected with more Calcium Chloride Braun than prescribed, this could cause:

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

In the event of an overdose or accidental ingestion, consult the Toxicological Information Service (phone: 91.562 04 20) or consult your doctor or pharmacist. Bring this leaflet with you.

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

Like all medications, Calcium Chloride Braun 100 mg/ml may produce adverse 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 impairments:

Nervous System Disorders:

- dizziness, somnolence

Cardiac Disorders:

- irregular heartbeats

Dermatological and Subcutaneous Tissue Disorders:

-skin redness and/or sensation of burning or heat

Gastrointestinal Disorders:

- nausea or vomiting

Vascular Disorders:

-peripheral vasodilation with mild decrease in blood pressure

General Disorders and Administration Site Conditions:

- sweating, sensation of paresthesia

- skin redness, cutaneous eruption, or pruritus at the injection site

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

No special storage conditions are required.

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

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

Composition of Calcium Chloride Braun 100 mg/ml:

The other components are: water for injections.

Appearance of the product and contents of the package

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

Holder of the marketing authorization

B|BRAUN

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Responsible for manufacturing

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.

The detailed information of this medication is available on the website ofthe Spanish Agencyof Medicines and Medical Devices.

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This information is intended solely for doctors or healthcare professionals:

Dosage

Hypocalcemia

in adults:one vial of 5 or 10 ml daily or alternately.

in children:0.2 ml/kg of body weight (maximum of1 to10 ml)

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

in adults:from2 to4 ml administered rapidly.

in children:0.2 ml/kg of body weight (maximum of1 to10 ml)

Magnesium poisoning

in adults:one vial of 5 ml daily or alternately.

Hyperkalemia

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

in children:0.2 ml/kg of body weight (maximum of1 to10 ml)

Instructions for correct administration:

It should only be administered via intracardiac, in cardiac resuscitation, or via slow intravenous injection; and by healthcare personnel.

It should be avoided to extravasate or inject intramuscularly. In case of this happening, inject, subcutaneously in the periphery of the extravasated5 to10 ml of sterile physiological solution and apply, in addition, warm compresses, with which the sclerosis will be avoided.

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

When the serum calcium concentration is greater 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. The 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 should be transparent, not contain precipitates, and the container should be intact. Do not administer otherwise.