Calcium Chloride 10% W/V Solution For Infusion
Package leaflet: Information for the user
Calcium chloride 10%w/v Solution for Infusion
Calcium chloride dihydrate
Read all of this leaflet carefully before you are given 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, or nurse.
- 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Calcium chloride is and what it is used for
2. What you need to know before you are given Calcium chloride
3. How Calcium chloride is given
4. Possible side effects
5. How to store Calcium chloride
6. Contents of the pack and other information
1. What Calcium chloride is and what it is used for
Calcium Chloride is a mineral salt, which is administered to increase the blood levels of Calcium in the body and to get the heart working where potassium levels are too high.
Calcium Chloride is used:
• as part of the resuscitation procedure following a cardiac arrest
• for the treatment of low calcium levels.
2. What you need to know before you are given Calcium chloride
DO NOT use Calcium chloride:
• if you are allergic (hypersensitive) to calcium salts or any of the ingredients of Calcium chloride (see section 6)
• if you are taking medicines for heart problems (e.g. digitalis)
• if you have low calcium levels due to kidney problems
• if you have an excess of calcium present in either your blood or your urine
• if you have breathing problems.
Take special care with Calcium chloride if:
• you have kidney problems
• you have heart problems
• you suffer from an inflammatory disorder known as sarcoidosis.
If any of the above applies to you, please consult your doctor.
Other medicines and Calcium chloride
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Medicines that may interact with Calcium chloride include:
• medicines used in the treatment of some bone disorders (e.g. Paget's disease) (bisphosphonates) such as etidronate or alendronate.
• medicines used to treat bacterial infections (antibiotics) e.g. tetracycline
• medicines used to reduce blood pressure and fluid retention (thiazides) e.g. indapamide
• medicines used to treat heart problems e.g. digitoxin.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Calcium chloride should only be used during pregnancy if clearly needed.
Calcium chloride can be used during breastfeeding.
Driving and using machines
There is no known effect of Calcium chloride on driving or using machines.
3. How Calcium chloride is given
Your doctor or nurse will administer the injection slowly through a vein (intravenous).
Adults (including the elderly)
• in cases where your heart has stopped a single dose of 10ml will be given
• if you have recently developed low calcium levels about 3 - 7ml will be given. This may be repeated as required.
Use in children
• not recommended.
If you are given more Calcium chloride than you should
As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too little or too much, however, tell your doctor or pharmacist if you have any concerns.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects include:
• a chalky taste in the mouth
• hot flushes
• lowered blood pressure
• loss of appetite
• feeling sick (nausea)
• being sick (vomiting)
• constipation
• stomach pain
• feeling weak
• mental disturbances
• extreme thirst
• passing a large amount of urine
• bone pain
• calcium deposits in the kidney
• kidney stones
• irregular heart beat
• coma
If any of these side effects get serious, or if you notice any side effects not listed in this leaflet please tell your doctor as soon as possible as this may be a sign of overly high calcium blood levels (hypercalcaemia).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: (www.mhra.gov.uk/yellowcard).
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Calcium chloride
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
For single use only. The product should be used immediately after opening. Any unused solution should be discarded.
Do not use this medicine if you notice turbidity, precipitation or discoloration.
Do not use after expiry date has passed. The doctor or nurse will check that the expiry date on the label has not passed before you are given Calcium chloride.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Calcium chloride contains
- The active substance is Calcium chloride dihydrate .
- The other excipient is Water for injections.
What Calcium chloride looks like and contents of the pack
Calcium chloride is a pale brown-yellow, clear solution in polypropylene ampoules of 10 ml. One outer carton contains 10 or 50 ampoules.
Marketing Authorisation Holder and Manufacturer: DEMO SA, Pharmaceutical Industry, 21st km National Road Athens - Lamia, 14568 Krioneri, Attiki, Greece,
Tel: +30 210 8161802, Fax: +30 210 8161587.
This medicinal product is authorised in the Member States of the EEA under the following names:
United
Kingdom:
Greece:
Poland:
Calcium chloride 10% Solution for infusion Calcium chloride DEMO 10% AidAupa Yia SYXUop Calcium chloride DEMO
This leaflet was last revised in 01/2016.
The following information is intended for healthcare professionals only:
Preparation and handling
Incompatibilities
Calcium salts have been reported to be incompatible with a wide range of drugs (see section 4.5 - Interaction with other medicinal products and other forms of interaction). Complexes may form resulting in the formation of a precipitate.
Posology and method of administration
For slow intravenous infusion only. Not for intramuscular use, or subcutaneous use.
Cardiopulmonary Resuscitation (CPR)
Adults
In Cardiopulmonary Resuscitation (CPR) a single dose of 10ml (10% w/v) should be considered, according to the algorithm recommended by the European Resuscitation Council.
Acute hypocalcaemia
Adults
Adults in acute hypocalcaemia, a typical dose is 2.25 to 4.5 mmol (approximately 3-7 ml of a 10% w/v solution) of calcium given by slow intravenous infusion and repeated as required.
Use in children
Not recommended.
Patients with impaired renal function
Calcium salts should be given cautiously to patients with impaired renal function.
Disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Overdose
Signs
An overdose of Calcium chloride would lead to hypercalcaemia and produce the signs and symptoms described above (see undesirable effects).
Management
Initial management of hypercalcaemia should include rehydration by either the oral or intravenous route. In severe hypercalcaemia, administration of sodium chloride by intravenous infusion to expand the extracellular fluid may be necessary.
Intravenous rehydration may be given with, or followed by, furosemide or other loop diuretics to increase calcium excretion.
Thiazide diuretics should be avoided as they may increase the renal absorption of calcium.
Other drugs which may be used if this treatment proves unsuccessful include calcitonins, the bisphosphonates and plicamycin.
Phosphates may be useful, but should be given by mouth and only to patients with low serum phosphate concentrations and normal renal function.
Haemodialysis may be considered as a last resort.
If this leaflet is difficult to see or read please contact the following address for help: Athlone Laboratories, Ballymurray, Co. Roscommon, Ireland.
Tel: +353-9066-61109. Email