Calcium hloride Demo

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

Calcium chloride DEMO 10%w/v, solution for infusion

Dihydrate calcium chloride

Read the leaflet carefully before receiving the medicine, because

it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Calcium chloride DEMO and what is it used for
• 2. Important information before receiving Calcium chloride DEMO
• 3. How is Calcium chloride DEMO administered
• 4. Possible side effects
• 5. How to store Calcium chloride DEMO
• 6. Package contents and other information

1. What is Calcium chloride DEMO and what is it used for

Calcium chloride is a mineral salt administered to increase the concentration of calcium in the blood and stimulate the heart in cases of excessive potassium levels. Calcium chloride is used:

• in the resuscitation process after cardiac arrest
• to treat low calcium levels

2. Important information before receiving Calcium chloride DEMO

When NOT to use Calcium chloride DEMO:

• if the patient is allergic to calcium salts or any other component of the medicine (listed in section 6)
• if the patient is taking heart medication (e.g., digitalis preparations)
• if the patient has low calcium levels due to kidney disease.
• if the patient has an excess of calcium in the blood or urine
• if the patient has breathing problems

Special caution is required when using Calcium chloride DEMO:

• if the patient has kidney problems
• if the patient has heart disease
• if the patient has sarcoidosis, an inflammatory disease

If any of the above situations apply to the patient, they should consult a doctor.

Calcium chloride DEMO and other medicines

Tell the doctor or pharmacist about all other medicines the patient is currently taking or has recently taken, including those available without a prescription. Medicines that may interact with Calcium chloride DEMO include:

• medicines used to treat certain bone diseases (e.g., Paget's disease) (bisphosphonates), such as etidronate or alendronate.
• antibiotics used to treat bacterial infections, e.g., tetracycline
• thiazide diuretics used to lower blood pressure and reduce fluid retention, e.g., indapamide
• medicines used to treat heart conditions, e.g., digoxin

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine. Calcium chloride DEMO may be used during pregnancy only if absolutely necessary. Calcium chloride DEMO can be used during breastfeeding.

Driving and operating machinery

No effects of Calcium chloride DEMO on the ability to drive or operate machinery have been observed.

3. How is Calcium chloride DEMO administered

The doctor or nurse will administer the medicine by slow intravenous injection.

Adults (including the elderly)

• in case of cardiac arrest, a single dose of 10 ml will be administered
• in case of recent decreased calcium levels, a dose of approximately 3-7ml will be administered. This dose may be repeated if necessary.

Use in children

• Not recommended

Administration of a higher dose of Calcium chloride DEMO than recommended

Since this medicine will be administered to the patient during their hospital stay, it is unlikely that they will receive too little or too much of the dose. If the patient has any concerns, they should inform their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Possible side effects include:

• chalky taste in the mouth
• hot flashes
• decreased blood pressure
• loss of appetite
• nausea
• vomiting
• constipation
• stomach pain
• weakness
• mental disorders
• increased thirst
• excessive urination
• bone pain
• calcium deposits in the kidneys
• kidney stones
• irregular heartbeat
• coma

If any side effects occur, including any not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse as soon as possible, as they may be symptoms of high calcium levels in the blood (hypercalcemia).

Reporting side effects

If any side effects occur, including any not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected]. Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Calcium chloride DEMO

Store the medicine out of sight and reach of children. No special storage instructions for the medicinal product. For single use only. Use the product immediately after opening the container. Any unused solution should be discarded. Do not use the medicinal product if it shows any visible signs of precipitation, sedimentation, or color change. Do not use this medicine after the expiry date. Before administering Calcium chloride DEMO, the doctor or nurse will check the expiry date on the label. The expiry date is the last day of the specified month. Medicines should not be disposed of via wastewater or household waste containers. Ask a pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Calcium chloride DEMO contains

• The active substance is dihydrate calcium chloride.
• The other ingredient is water for injections.

What Calcium chloride DEMO looks like and what the pack contains

Calcium chloride DEMO is a clear, light brown-yellow solution in polypropylene ampoules of 10 ml. One carton contains 10 or 50 ampoules.

Marketing authorization holder and manufacturer:

DEMO S.A., 21st km National Road Athens-Lamia, 14568 Krioneri, Athens, Greece.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

United Kingdom: Calcium chloride 10% Solution for infusion Greece: Calcium chloride DEMO 10% Διάλυμα για έγχυση Poland: Calcium chloride DEMO

Date of last revision of the leaflet 01/2016.

Information intended for healthcare professionals only:

Preparation of the medicine and handling

Incompatibilities

It has been reported that calcium salts are incompatible with numerous other medicines (see section 4.5 – Interactions with other medicinal products and other forms of interaction). Complexes may form, leading to precipitation.

Dosage and administration

Administered exclusively by slow intravenous infusion. Do not administer intramuscularly or subcutaneously. Cardiopulmonary resuscitation (CPR)AdultsIn cardiopulmonary resuscitation (CPR), consider administering a single dose of 10 ml (10% w/v), according to the algorithm recommended by the European Resuscitation Council (ERC). Acute hypocalcemiaAdultsIn adults with acute hypocalcemia, the typical dose is 2.25 to 4.5 mmol (approximately 3–7 ml of a 10% w/v solution) of calcium administered by slow intravenous infusion. Repeat as necessary. Use in childrenNot recommended Patient with renal impairmentCalcium salts should be administered with caution to patients with renal impairment. DisposalAny unused medicinal product or waste should be disposed of in accordance with local regulations. OverdoseSymptomsOverdose of Calcium chloride DEMO leads to hypercalcemia and causes the above-mentioned subjective and objective symptoms (see "Side effects"). TreatmentInitial treatment for hypercalcemia should include oral or intravenous hydration of the patient. In patients with severe hypercalcemia, it may be necessary to administer sodium chloride intravenously to increase the volume of extracellular fluids. Concurrently with or after the administration of intravenous hydrating fluids, furosemide or other loop diuretics may be administered to increase calcium excretion. Thiazide diuretics should be avoided, as they may increase calcium absorption by the kidneys. Other medicines that may be used in case of ineffective treatment include calcitonins, bisphosphonates, and plicamycin. Phosphates may be useful, but they should be administered orally and only to patients with decreased serum phosphate levels and normal kidney function. Hemodialysis may be considered as a last resort.