SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT

Calcium Chloride Injection BP 5 millimoles in 10 ml

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Calcium Chloride, Dihydrate BP 7.35% w/v.

3    PHARMACEUTICAL FORM

Injection.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

HYPOCALCAEMIA, ELECTROLYTE IMBALANCE.

4.2    Posology and method of administration

FOR SLOW INTRAVENOUS INJECTION OR INFUSION. DILUTE BEFORE USE AT LEAST 4 TIMES WITH,SODIUM CHLORIDE INJECTION BP 0.9% W/V BP.

ADULTS AND THE ELDERLY

THE DOSAGE IS DETERMINED BY THE REQUIREMENTS OF THE PATIENT. PLASMA CALCIUM MUST BE MONITORED.

HYPOCALCAEMIA AND ELECTROLYTE IMBALANCE.AN INITIAL INJECTION OR INFUSION OF UP TO MMOLES (AT NOT MORE THAN 1 MMOLE PER MINUTE) MAY BE GIVEN. THIS MAY BE CONTINUED BY INFUSION OF UP TO 10 MMOLE PER DAY.

4.3 Contraindications

HYPERCALCAEMIA, HYPERCALCIUREA, RENAL CALCULI, CHRONIC RENAL IMPAIRMENT, DIGITALIS TOXICITY.

4.4 Special warnings and precautions for use

INJECTIONS OF CALCIUM CHLORIDE ARE EXTREMELY IRRITANT, AND SO DILUTION IS RECOMMENDED AND THEY MUST BE ADMINISTERED BY INTRAVENOUS INJECTION OR INFUSION. PATIENTS TREATED FOR HYPOCALCAEMIA SHOULD BE ADEQUATELY MONITORED, INCLUDING SERUM CALCIUM. IT SHOULD BE GIVEN CAUTIOUSLY IN PATIENTS WITH CARDIAC DISEASE OR SARCOIDOSIS.

4.5 Interaction with other medicinal products and other forms of interaction

WITH DIGITALIS OR POTASSIUM THERE IS AN INCREASED RISK OF ARRHYTHMIAS. THIAZIDE DIURETICS CAN REDUCE THE EXCRETION OF CALCIUM LEADING TO ELEVATED PLASMA LEVELS. THE EFFECTS OF PARENTERALLY ADMINISTERED MAGNESIUM MAY BE NEUTRALIZED BY CALCIUM.

CARBONATES, BICARBONATES, PHOSPHATES, SULPHATES AND TARTRATES.

4.6 Pregnancy and lactation

THERE IS NO EVIDENCE OF SAFETY OF THE DRUG IN HUMAN PREGNANCY, BUT IT HAS BEEN IN USE FOR MANY YEARS WITHOUT ILL CONSEQUENCE. IF IT IS NEEDED IN PREGNANCY, THE USE OF THIS DRUG IS ACCEPTABLE.

4.7 Effects on ability to drive and use machines

PARENTERAL CALCIUM CAN CAUSE DIZZINESS AND DROWSINESS, IF AFFECTED, PATIENTS SHOULD NOT DRIVE OR OPERATE MACHINERY.

4.8 Undesirable effects

PARENTERAL CALCIUM MAY CAUSE HYPOTENSION, DROWSINESS, FLUSHING, IRREGULAR HEARTBEA, NAUSEA, VOMITING, SWEATING AND TINGLING SENSATIONS.

4.9 Overdose

THE EARLY SIGNS OF OVERDOSAGE INCLUDE, SEVERE CONSTIPATION, DROWSINESS, CONTINUOUS HEADACHE, LOSS OF APPETITE, METALLIC TASTE, DRY MOUTH, TIREDNESS AND WEAKNESS. LATER SIGNS INCLUDE CONFUSION, HYPERTENSION, INCREASED LIGHT SENSITIVITY, THIRST, MUSCLE OR BONE PAIN, NAUSEA AND VOMITING, POLYURIA. TREATMENT: A DIURETIC SUCH AS BUMETANIDE, ETHACRYNIC ACID OR FRUSEMIDE WILL ASSIST IN THE EXCRETION OF EXCESSIVE CALCIUM, BUT IN VERY SEVERE CASES, EDTA MAY BE NECESSARY. APPROPRIATE SUPPORTIVE MEASURE SHOULD BE INSTITUTED.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

CALCIUM IS ESSENTIAL TO THE FUNCTION OF THE NERVOUS, MUSCULAR AND SKELETAL SYSTEMS. IT ALSO PLAYS A PART IN CARDIAC FUNCTION, RENAL FUNCTION, RESPIRATION,BLOOD COAGULATION ETC.

5.2 Pharmacokinetic properties

CALCIUM IS DISTRIBUTED THROUGHOUT THE BODY, BUT IS IN LARGE AMOUNTS IN THE SKELETON AS THE HYDROXYAPATITE COMPLEX. CA 2+ IS 45% PLASMA PROTEIN BOUND. ELIMINATION IS MAINLY FAECAL, WITH SMALL AMOUNTS EXCRETED IN THE URINE.

5.3 Preclinical safety data

None stated

6.1 List of excipients

Water for Injections BP. pH may be adjusted with Hydrochloric Acid BP.

6.2    Incompatibilities

Carbonates, bicarbonates, phosphates, sulphates and tartrates.

6.3    Shelf life

36 months

6.4    Special precautions for storage

None stated.

6.5    Nature and contents of container

5 or 10 ml in Type 1 colourless neutral glass ampoules. Fusion sealed.

6.6    Special precautions for disposal

None stated.

7 MARKETING AUTHORISATION HOLDER

Macarthys Laboratories t/a Martindale Pharmaceuticals

Bampton Road

Harold Hill

Romford

Essex

England. RM3 8UG

8 MARKETING AUTHORISATION NUMBER(S)

PL 01883/6124R

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION 30 January 1996

10 DATE OF REVISION OF THE TEXT