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Calcium Gluconate Injection B.P. 10%W/V

Patient Information Leaflet

Calcium Gluconate Injection BP 10% w/v

This leaflet will provide you with important information about your medicine. Please read it carefully before your medicine is

administered. The leaflet contains a summary but not all of the information about Calcium Gluconate Injection BP. If you require any

further information or you are unsure about anything, ask your doctor or pharmacist. WHAT’S IN YOUR MEDICINE

Each clear glass ampoule contains 10mI of clear, colourless solution. Each 10ml of sterile solution for injection contains 1,000mg of

calcium gluconate, the active ingredient (equivalent to 2.25 millimoles or 4.5mEq of calcium).

Inactive ingredients: Calcium-d-saccharate and water for injections.

Pack Size: Cartons of 10 x 10mI ampoules.

Product Licence Holder: Mercury Pharma International Ltd 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland. PL 2848/5914R.

Manufacturer: Mercury Pharma International Ltd 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland,/Hameln Pharmaceutical GmbH, Langesfeld 13, 31789 Hameln, Germany.

Type of Medicine: Calcium Gluconate Injection BP 10% w/v belongs to a group of medicines called electrolyte replacement solutions.

USES

Calcium Gluconate Injection BP 10% w/v is a concentrated solution of calcium. It may be

given by injection in situations where the action

of a high concentration of calcium is required, as for example

•    when there is a severe reduction in the normal blood levels of calcium

•    in restoring the heart beat if it has stopped (cardiac resuscitation)

•    in some cases of tetany in the newborn infant.

Injections of calcium into a vein have been used

•    in the treatment of the acute colic of lead poisoning

•    as part of the treatment of acute fluoride poisoning

•    to prevent the blood calcium level becoming too low during exchange blood transfusions.

BEFORE RECEIVING THIS MEDICINE

You should not be given Calcium gluconate Injection if :

•    You have hyperparathyroidism (overactivity of the parathyroid gland)

•    You have excessive levels of vitamin D

•    You are suffering from a tumour involving decalcification of bone

•    You have excessive levels of calcium in the urine

•    You are taking any other medicines, including digoxin or other cardiac glycosides Calcium gluconate injection should not be given with ceftriaxone in pre term and in new born upto age of 28 days.

•    you have severe kidney disease

•    you have kidney disease and require repeated or prolonged treatment

•    you are a child (less than 18 years of age) and require repeated or prolonged treatment

Take special care and please tell your doctor or nurse before being given this injection if:

•    you have a kidney disorder, or a stone in the kidney or bladder

•    you have a heart problem

•    you have not been taking a proper diet

•    you are pregnant or if you are breast-feeding

•    you are taking water tablets (diuretic such as thiazide)

Infusion site must be monitored to ensure that there is no injury during the administration of Calcium gluconate Injection.

HOW THIS MEDICINE IS ADMINISTERED

This medicine is for administration by slow injection into a vein or by deep injection into a muscle.

The normal level of calcium in the blood is between 2.25 - 2.75 millimoles (4.5 - 5.5 mEq) per litre. Treatment should be aimed at restoring or maintaining this level. During treatment, your doctor will take blood samples to check on the level of calcium in your blood.

Dosage

Severe reduction in the normal blood levels of calcium: 10 - 20mI (2.25 - 4.5 millimoles). Fluoride or lead poisoning: 0.3ml/kg body weight (0.0675 millimoles/kg).

Tetany in the newborn: 0.3ml/kg body weight (0.0675 millimoles/kg).

Cardiac resuscitation: 7 to 15ml (1.575 to 3.375 millimoles).

Injections into a vein should be administered very slowly (3 minutes for 10ml). Injections into a muscle should be given deep into a

muscle in the buttock using a long needle. Injections into a muscle are not recommended for children. If you are elderly, your doctor

may decide to reduce the dosage if you have a problem such as a kidney disorder or a poor diet.

What to do in case of a missed dose or an overdose:

If you think that you may have missed a dose, or that you have been given too much of this medicine, tell your doctor immediately.

WHILST RECEIVING THIS MEDICINE

As well as having beneficial effects, a medicine may sometimes cause unwanted effects in some patients. If calcium gluconate injection

is given too rapidly, it could have serious or even life-threatening consequences. The signs of too rapid injection include hot flushes,

nausea, vomiting, sweating and feeling weak or faint. If you notice any of these effects, make sure to tell your doctor immediately.

Co administration of calcium gluconate injection with ceftriaxone can cause the severe or fatal reactions in pre term and new born having age less than 28 days.

If a calcium solution escapes from a vein into the tissues, these tissues may become hardened by the deposit of calcium salts. Injection of calcium salts into a muscle can cause local irritation.

If you notice any of these effects, or any other unwanted effects that are not mentioned here, tell your doctor.

STORING THIS MEDICINE

Do not use after the expiry date printed on the ampoule and carton.

The ampoules should be protected from light and stored below 25°C.

If only part of an ampoule is used, the remaining solution should be discarded.

Keep out of reach of children.

Marketing authorization holder

Mercury Pharma International Ltd., 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland.

Date of last revision: March 2012