Calcium chloride demo

Package leaflet: Information for the user

Calcium chloride DEMO 10% w/v, solution for infusion
Calcium chloride dihydrate
Please read all of this leaflet carefully before receiving the medicine, because
it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Calcium chloride DEMO is and what it is used for
2. Important information before receiving Calcium chloride DEMO
3. How Calcium chloride DEMO is given
4. Possible side effects
5. How to store Calcium chloride DEMO
6. Contents of the pack and other information

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

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

• during resuscitation after cardiac arrest
• in the treatment of 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 of the other components of this medicine (listed in section 6)
• if the patient is taking medicines for heart disease (e.g. digitalis preparations)
• if the patient has low calcium levels due to kidney disease
• if the patient has excess calcium in the blood or urine
• if the patient has breathing problems

Special caution must be taken when using Calcium chloride DEMO:

• if the patient has kidney problems
• if the patient has heart disease
• if the patient suffers from an inflammatory condition called sarcoidosis

If any of the above situations apply to the patient, he/she 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 obtained 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
• medicines used to treat bacterial infections (antibiotics), e.g. tetracycline
• medicines used to lower blood pressure and reduce fluid retention (thiazides), e.g. indapamide
• medicines used to treat heart conditions, e.g. digitoxin

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Calcium chloride DEMO may be used during pregnancy only if absolutely necessary.
Calcium chloride DEMO may 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 Calcium chloride DEMO is given

Calcium chloride DEMO will be administered by a doctor or nurse as a slow intravenous injection.

Adults (including elderly patients)

• In case of cardiac arrest, a single dose of 10 ml will be given.
• In case of recent hypocalcemia, a dose of approximately 3–7 ml will be given. This dose may be repeated if necessary.

Use in children

• Not recommended

Administration of a higher than recommended dose of Calcium chloride DEMO
Since this medicine will be given to the patient during a hospital stay, it is unlikely that the patient will receive too low or too high a dose. However, if the patient has any concerns, they should inform their doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not
everyone will experience them.
Possible adverse reactions include:

• Chalky taste in the mouth
• Hot flushes
• Decreased blood pressure
• Loss of appetite
• Nausea
• Vomiting
• Constipation
• Stomach pains
• Weakness
• Mental disturbances
• Excessive thirst
• Passing large amounts of urine
• Bone pain
• Calcium deposition in the kidneys
• Kidney stones
• Irregular heartbeat
• Coma

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, you should inform your doctor as soon as possible, as these may be symptoms of excessively high calcium levels in the blood (hypercalcaemia).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, you should inform your doctor, pharmacist, or nurse.
Adverse reactions can also be reported directly to the
Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C,
PL-02 222 Warszawa,
Tel.: + 48 22 49 21 301,
Fax: + 48 22 49 21 309,
e-mail: [email protected] .
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Calcium chloride DEMO

Keep the medicinal product out of the sight and reach of children.
No special storage instructions apply to this medicinal product.
Single-use product. The product should be used immediately after opening the container.
Any unused solution remaining after use must be discarded.
Do not use the medicinal product if cloudiness, precipitation, or change in colour is observed.
Do not use this medicine after the expiry date. Prior to administration of Calcium chloride DEMO, the doctor or nurse will check the expiry date shown on the label.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste.
Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Calcium chloride DEMO contains

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

What Calcium chloride DEMO looks like and contents of the pack
Calcium chloride DEMO is a light brown-yellow, clear solution in polypropylene ampoules of 10 ml. One cardboard box contains 10 or 50 ampoules.
Marketing Authorisation Holder and Manufacturer:
DEMO S.A., 21st km National Road Athens-Lamia, 14568 Krioneri, Athens, Greece.
This medicinal product is authorised for sale 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

Information intended for healthcare professionals only:
Preparation and handling of the medicinal product
Pharmaceutical incompatibilities
Calcium salts have been reported to be pharmaceutically incompatible with many other drugs (see section 4.5 – Interactions with other medicinal products and other forms of interactions). Complexes may form, leading to precipitation.

Dosage and method of administration
For slow intravenous infusion only. Do not administer intramuscularly or subcutaneously.

Cardiopulmonary resuscitation (CPR)
Adults
In cardiopulmonary resuscitation (CPR), consider administration of a single dose of 10 ml (10% w/v), according to the algorithm recommended by the European Resuscitation Council (ERC).

Acute hypocalcemia
Adults
In adults with acute hypocalcemia, the usual 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. This may be repeated as required.

Use in children
Not recommended

Patients with renal impairment
Calcium salts should be administered with caution to patients with renal impairment.

Disposal of unused medicinal product or waste
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

Overdose
Symptoms
Overdose of Calcium chloride DEMO leads to hypercalcemia and causes the subjective and objective symptoms described above (see "Undesirable effects").

Treatment
Initial management of hypercalcemia should include hydration orally or intravenously. In patients with severe hypercalcemia, administration of sodium chloride in intravenous infusion may be necessary to increase extracellular fluid volume.

Concurrently with or after administration of intravenous hydration fluids, furosemide or other loop diuretics may also be given to enhance calcium excretion.

Thiazide diuretics should be avoided, as they may increase renal calcium reabsorption.

Other drugs that may be used if the above treatment is ineffective include calcitonins, bisphosphonates, and plicamycin.

Phosphates may be helpful, but should be administered orally and only to patients with low serum phosphate levels and normal renal function.

As a last resort, hemodialysis may be considered.