CALCIUM CHLORIDE Sterile solution for slow intravenous infusion (2020)
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Περιεχόμενα
Name of the medicinal product
Calcium Chloride 10% w/v Intravenous Infusion.
Qualitative and quantitative composition
Each ml contains 100mg of Calcium Chloride dihydrate. One pre-filled syringe of 10ml contains 1g of Calcium Chloride dihydrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Sterile solution for slow intravenous infusion. Clear and Colourless, and free from visible solid particles.
Therapeutic indications
Calcium Chloride Injection is indicated for use in Cardio-pulmonary Resuscitation where there is also hyperkalaemia or hypocalcaemia or calcium channel block toxicity. It is also used for the treatment ...
Posology and method of administration
This medicinal product is not intended to deliver volumes of less than 2 mL Adults and elderly In Cardiopulmonary Resuscitation (CPR) a single dose of 10ml (10% w/v) should be considered, according to ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. In cardiac resuscitation, the use of calcium is contraindicated in the presence of ventricular fibrillation. ...
Special warnings and precautions for use
Calcium chloride must be administered slowly through the vein. Too rapid intravenous injection may lead to symptoms of hypercalcaemia. The use of calcium chloride is undesirable in patients with respiratory ...
Interaction with other medicinal products and other forms of interaction
For interaction between calcium containing products and ceftriaxone, please see sections 4.4 above. Calcium-containing products may decrease the effectiveness of calcium channel blockers. Large intravenous ...
Fertility, pregnancy and lactation
Studies on the effects of calcium chloride on pregnant women have not been carried out and problems have not been documented. Calcium crosses the placenta. The benefits of administration must outweigh ...
Effects on ability to drive and use machines
No adverse effects have been reported.
Undesirable effects
Rapid intravenous injections may cause the patient to complain of tingling sensations, a calcium taste, and a sense of oppression or “heat wave”. Injections of calcium chloride are accompanied by peripheral ...
Overdose
Symptoms An overdose of Calcium Chloride would lead to hypercalcaemia and produce the signs and symptoms described above (see Section 4.8). Treatment Initial management of hypercalcaemia should include ...
Pharmacodynamic properties
Calcium is the most abundant mineral in the body, and is an essential body electrolyte. Homeostasis is mainly regulated by the parathyroid hormone, by calcitonin, and by the activated form of vitamin D. ...
Pharmacokinetic properties
The body contains about 1200g of calcium (or 300 to 500 mmol per Kg body weight), approximately 99% of which is found in the skeleton. The normal concentration of calcium in plasma is between 2.15 to 2.60 ...
Preclinical safety data
Calcium Chloride has been used for many years and has a proven safety record. No pre-clinical safety data is supplied.
List of excipients
Water for injections Dilute Hydrochloric acid (for pH-adjustment) Calcium Hydroxide Solution (for pH-adjustment)
Incompatibilities
Calcium salts should not be mixed with carbonates, phosphates, sulfates, tartrates or tetracycline antibiotics in parenteral mixtures. Calcium containing solutions should not be mixed with Ceftriaxone ...
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Type 1 glass pre-filled syringe, containing 10ml of a 10% w/v Calcium Chloride sterile solution for slow intravenous infusion only.
Special precautions for disposal and other handling
Discard any contents after use in appropriate manner.
Marketing authorization holder
Aurum Pharmaceuticals Ltd, Bampton Road, Harold Hill, Romford, RM3 8UG, UK
Marketing authorization number(s)
PL 12064/0020
Date of first authorization / renewal of the authorization
Date of first authorisation: 9 May 1997
Date of revision of the text
22/01/2018
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