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CALCIUM CHLORIDE INTRAVENOUS INFUSION 10% W/V

Active substance(s): CALCIUM CHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Calcium Chloride Intravenous Infusion, 10% w/v

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcium Chloride Ph Eur 10% w/v
Water for Injections Ph Eur to 100%

3.

PHARMACEUTICAL FORM
Sterile solution for slow intravenous infusion

4.

CLINICAL PARTICULARS

4.1.

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 of hypocalcaemia and of calcium deficiency
states (a decrease in plasma-calcium concentration below the normal range of
2.15-2.60 mmol/L) as a result of impaired or reduced absorption from the
gastrointestinal tract, increased deposition in bone, or to excessive losses, for
instance during lactation. Additionally, hypocalcaemia may develop during
transfusions utilising citrated blood or during longterm parenteral nutrition
unless prophylactic calcium supplementation is employed. Other causes of
hypocalcaemia include decreased parathyroid hormone activity, vitamin D
deficiency and hypomagnesaemia.

4.2.

Posology and Method of Administration
For slow intravenous infusion only. Not for intramuscular use, or
subcutaneous use.

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 & the Resuscitation Council (UK).
Adults in acute hypocalcaemia, a typical dose is 2.25 to 4.5 mmol
(approximately 3-7ml of a 10% w/v solution) of calcium given by slow
intravenous infusion and repeated as required.
For children - Not recommended

4.3.

Contra-Indications
Parenteral calcium therapy is contra-indicated in patients receiving cardiac
glycosides, because calcium enhances the effects of digitalis glycosides on the
heart and may precipitate digitalis intoxication.
Calcium salts should be given cautiously to patients with impaired renal
function, cardiac disease, or sarcoidosis.
Calcium chloride, because of its acidifying nature, is unsuitable for the
treatment of hypocalcaemia caused by renal insufficiency or in patients with
respiratory acidosis or failure. It should not be administered to patients with
hypercalcaemia or hypercalciuria.

4.4.

Special Warnings and Special Precautions for Use
Excessive amounts of calcium salts may cause hypercalcaemia. Careful
monitoring of serum-electrolyte concentrations is essential throughout therapy.
Parenteral administration may cause local reactions at the injection site and
soft tissue calcification. Calcium Chloride is generally considered to be the
most irritant of the commonly used calcium salts. Care should be taken to
prevent extravasation during intravenous injection.
Calcium chloride, must be administered slowly through the vein. Too rapid
intravenous injection may lead to symptoms of hypercalcaemia.

4.5

Interaction with other medicinal products and other forms of interaction
Calcium salts have been reported to be incompatible with a wide range of
drugs. Complexes may form resulting in the formation of a precipitate.

Calcium salts reduce the absorption of bisphosphonates (in the treatment of
Paget’s disease or hypercalcaemia of malignancy) and must be given at least
12 hours apart.
Calcium salts reduce the absorption of tetracyclines.
Diuretics, such as thiazides increase the risk of hypercalcaemia.
Large intravenous doses of calcium can precipitate arrhythmias by interacting
with cardiac glycosides (e.g. digitoxin and digoxin).

4.6.

Pregnancy and Lactation
Calcium crosses the placenta and is also excreted in breast milk. It is
recommended in the UK for an increase in calcium intake during lactation.
Furthermore, the absorption of calcium is increased during pregnancy and
lactation.

4.7.

Effects on Ability to Drive and Use Machines
No adverse effects have been reported.

4.8.

Undesirable Effects
Injection of calcium salts can produce irritation. Solutions of calcium chloride
are extremely irritant and should not be injected intramuscularly or
subcutaneously.
Soft tissue calcification has also been reported following parenteral
administration of calcium salts.
Excessive amounts of calcium salts may lead to hypercalcaemia. Symptoms
of hypercalcaemia may include anorexia, nausea, vomiting, constipation,
abdominal pain, muscle weakness, mental disturbances, polydipsia, polyuria,
bone pain, nephrocalcinosis, renal calculi, and, in severe cases, cardiac
arrhythmias and coma.
Too rapid intravenous injection of calcium salts may also lead to many of the
symptoms of hypercalcaemia as well as a chalky taste, hot flushes and
peripheral vasodilation.

4.9.

Overdose

An overdose of Calcium Chloride would lead to hypercalcaemia and produce
the signs and symptoms described above (see undesirable effects).
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, frusemide 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.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

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.
Parathyroid hormone is released when the calcium blood level is low. It
stimulates osteoclasts to release calcium into the blood, and increases the
absorption of calcium from the gastrointestinal tract.
Calcitonin, from the thyroid gland, decreases the blood level of calcium by
stimulating osteoblasts and inhibiting osteoclasts. In the presence of
calcitonin, osteoblasts remove calcium from the blood and deposit it in the
bone.
Calcium is a structural component of bones and teeth. It is also required for
blood clotting, neurotransmitter release, muscle contraction and normal
heartbeat.

5.2.

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 mmol per litre.
Calcium is absorbed from the small intestine. The amount of calcium
absorbed varies depending on several factors including the requirements of the
body, but is normally only about 30% of the dietary intake.
The absorption of calcium is increased during periods of high physiological
requirement such as during pregnancy and lactation.
The amount of dietary calcium required by an adult is about 700 to 800 mg
(17.5 - 20 mmol) per day.
After absorption calcium is eventually incorporated into bones and teeth with
99% of the body’s calcium content being present in such skeletal tissue. The
remaining calcium is present in both the intra- and extracellular fluids.
About 50% of the total blood-calcium content is in the physiologically active
ionised form with 5% being complexed to citrate, phosphate or other anions
and 45% being bound to proteins.
Excretion of calcium occurs in the urine although a large proportion is
reabsorbed in the renal tubules. Excretion also occurs in the faeces, this
consisting of unabsorbed calcium as well as that secreted in the bile and
pancreatic juice. Minor amounts are lost in the sweat. Calcium crosses the
placenta and is also excreted in breast milk.

5.3.

Pre-clinical Safety Data
Calcium Chloride has been used for many years and has a proven safety
record. No pre-clinical safety data is supplied.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Water for injections Ph Eur.

6.2.

Incompatibilities

Calcium salts have been reported to be incompatible with a wide range of
drugs (see section 4.5). Complexes may form resulting in the formation of a
precipitate.

6.3.

Shelf Life
3 years.

6.4.

Special precautions for storage
Do not store above 25°C.

6.5.

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.

6.6.

Instructions for Use, Handling and Disposal
Discard any contents after use in appropriate manner.

7.

MARKETING AUTHORISATION HOLDER
Aurum Pharmaceuticals Ltd
Bampton Road
Harold Hill
Romford
Essex
RM3 8UG

8.

MARKETING AUTHORISATION NUMBER
PL 12064/0020

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
9 May 1997

10

DATE OF REVISION OF THE TEXT
09/02/2010

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Source: Medicines and Healthcare Products Regulatory Agency

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