Package leaflet: Information for the user

Calcium gluconate 10% w/v Solution for injection calcium gluconate

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, 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Calcium gluconate 10% w/v Solution for injection. In the rest of this leaflet the name of the medicine shall be Calcium gluconate.

What is in this leaflet

1.    What Calcium gluconate is and what it is used for

2.    What you need to know before you are given Calcium gluconate

3.    How Calcium gluconate is given

4.    Possible side effects

5.    How to store Calcium gluconate

6.    Contents of the pack and other information

1.    What Calcium gluconate is and what it is used for

Calcium is found naturally in the body and is necessary for the normal function of muscles and nerves. It is needed to make the heart work properly and for blood to clot. Calcium gluconate is used:

•    to replace low levels of calcium in the body

•    in neonatal tetany (a condition affecting the muscles of newly born babies and young infants)

•    in the treatment fluoride poisoning

•    to prevent low calcium levels from blood transfusions.

2.    What you need to know before you are given Calcium gluconate

Do not use Calcium gluconate:

•    If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

•    If you have high levels of calcium in your urine or blood as a result of hyperparathyroidism (overactivity of the parathyroid gland), excessive levels of vitamin D or a tumour

•    If you have severe kidney disease

•    If you have kidney disease and require repeated or prolonged treatment

•    If you take medicines for heart problems (for example cardiac glycosides)

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given Calcium gluconate:

•    if you have kidney disease

•    if you have heart disease

•    if you have excessive levels of calcium in the urine

•    if you have sarcoidosis (Boeck's disease)

•    if you receive cardiac glycosides

•    if you receive adrenaline.

Your heart rate or ECG should be monitored when this medicine is injected into a vein (intravenous injection).

Children and adolescents

Intramuscular injections should not be performed in children. Calcium gluconate should be administered only by slow intravenous injection or intravenous infusion after dilution.

Other medicines and Calcium gluconate

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is especially important with the following medicines as they may interact with your Calcium gluconate:

•    medicines that are used for the treatment of heart conditions such as digoxin

•    medicines that are used for the reduction of blood pressure and fluid retention (thiazides)

•    medicines that are used for the treatment of bacterial infections (antibiotics) such as ceftriaxone

•    medicines that are used to regulate heart function (calcium antagonists).

Calcium and magnesium mutually inhibit their effects.

Administration of calcium together with adrenaline after heart surgery weakens the effects of adrenaline on the heart and circulation.

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 using this medicine. Calcium is excreted in breast milk. The doctor will decide if the injection is suitable for you.

Driving and using machines

Calcium gluconate has no influence on the ability to drive and use machines.

3.    How Calcium gluconate is given

Your nurse or doctor will give you the injection. Your doctor will decide the correct dosage for you and how and when the injection will be given. During treatment, your blood calcium levels will be monitored closely.

If you are given more Calcium gluconate than you should

Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. If you think you have been given too much, you feel sick, are sick, are constipated, have stomach pain, suffer muscle weakness, feel thirsty, are passing a lot of urine, feel confused or have bone pain you must tell the person giving you the injection.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

•    Feeling and being sick

•    Sweating and hot flushes

•    Low blood pressure and possible collapse

•    Damage to skin and area at the point of injection

•    Pain sensations or erythema.

If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse or pharmacist.

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 gluconate

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and ampoule after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Do not use this medicine if you notice discoloration, turbidity or visible solid particles. For single use only.

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

-    The active substance is calcium gluconate monohydrate. Each 1 mL of this solution for injection contains 95mg calcium gluconate monohydrate in a sterile solution for injection.

-    The other ingredients are calcium saccharate and water for injections.

What Calcium gluconate looks like and contents of the pack

Calcium gluconate is clear, colourless to pale yellow aqueous sterile solution.

Calcium gluconate is supplied in 10mL polypropylene ampoules, packed in cartons to contain 10 ampoules x 10mL or 20 ampoules x 10mL or 50 ampoules x 10mL.

Marketing Authorisation Holder and Manufacturer:

DEMO SA Pharmaceutical Industry, 21^st 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: Calcium gluconate 10% w/v Solution for injection

Germany:    Calciumgluconat DEMO 10% w/v

Injektionslosung

Greece:    Calcium gluconate DEMO 10% w/v

Evsoipo SiaAupa

This leaflet was last revised in 09/2016.

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: medical@athlone-laboratories.com.

The following information is intended for healthcare professionals only:

Preparation and handling

Incompatibilities

Calcium salts can form complexes with many ingredients of medicinal products, and this may result in a precipitate (See Other medicines and Calcium gluconate). Calcium salts are incompatible with oxidising agents, citrates, soluble carbonates, bicarbonates, phosphates, tartrates and sulphates. Physical incompatibility has also been reported with amphotericin, cephalothin sodium, cephazolin sodium, cephamandole nafate, ceftriaxone, novobiocin sodium, dobutamine hydrochloride, prochlorperazine, and tetracyclines.

This medicinal product must not be mixed with other medicinal products except those mentioned in section Special precautions for disposal and other handling.

Posology and method of administration

Posology

Acute hypocalcaemia Adults

The usual initial dose in adults is 10 mL of Calcium gluconate, corresponding to 2.23 mmol or 4.46 mEq of calcium. If necessary, the dose may be repeated, depending on the patient's clinical condition. Subsequent doses should be adjusted according to the actual serum calcium level.

Paediatric patients (< 18 years)

The dose and the route of administration depend on the degree of hypocalcaemia and the nature and severity of the symptoms. In the case of mild neuromuscular symptoms oral calcium administration should be preferred.

infants, e.g. cardiac symptoms, higher initial doses (up to 2 mL per kg body weight, = 0.45 mmol calcium per kg body weight) may be necessary for a quick restoration of a normal serum calcium level.

Also, if necessary, the dose may be repeated, depending on the patient's clinical condition. Subsequent doses should be adjusted according to the actual serum calcium level.

Intravenous therapy should be followed by oral administration if indicated, e.g. in cases of calciferol deficiency.

Elderly patients

Although there is no evidence that tolerance of Calcium gluconate is directly affected by advanced age, factors that may sometimes be associated with ageing, such as impaired renal function and poor diet, may indirectly affect tolerance and may require a reduction in dosage. Renal function declines with age and prior to prescribing this product to elderly patients it should be considered that Calcium gluconate is contraindicated (See section 4.3) for repeated or prolonged administration in patients with impaired renal function.

Neonatal tetany

Intravenous administration of 10% calcium gluconate as a bolus of 100-200 mg/kg (1-2 mL/kg) over approximately 10-20 minutes, followed by a continuous infusion (0.5-1 g/kg/d) over 1-2 days.

Heart rate should be monitored during the infusion.

The IV site should also be watched closely because tissue infiltration by a calcium solution is irritating and may cause local tissue damage or necrosis.

Fluoride poisoning

Calcium gluconate regime for hypocalcaemia in fluoride poisoning: Immediate:

-    give 10 mL of 10% calcium gluconate intravenously on presentation, repeat at 1 hour, or

-    give 30 mL of 10% calcium gluconate intravenously if tetany present.

Maintenance:

-    Maintain serum calcium with intravenous 10% calcium gluconate 10 mL every 4 hours, adjusting according to frequent serum calcium concentrations.

Mild to moderate dermal toxicity due to hydrofluoric acid/fluoride exposure:

Subcutaneous calcium gluconate (10%) for dermal exposure of hydrofluoric acid >20%.

-    Infiltrate each square centimeter of the exposed area with 0.5 mL of 10% calcium gluconate.

In the case of significant burn due to hydrofluoric acid /fluoride exposure, calcium salts may be administered intravenously (for systemic toxicity) or intra-arterially (for hand burns predominantly).

-    10 mL of 10% calcium gluconate plus heparin 5000 units in a total volume of 40 mL is administered intravenously.

-    10 mL of 10% calcium gluconate in 50 mL of 0.9% sodium chloride solution is intra-arterially infused over 4 h.

Prevention of hypocalcaemia during transfusion

Calcium should be administered during massive transfusion if Ca²+

concentration is low, in order to preserve normocalcaemia.

10 mL of a 10% solution of Calcium gluconate IV diluted in 100 mL D5W (5% Glucose in water), given over 10 min or 10-20 mL for each 500 mL of blood infused.

Paediatric patients

100-200 mg/kg (or 1-2 mL/kg) IV over 5-10 min for maximum rate 5 mL/min.

Method of administration

The patient should be in the lying position and should be closely observed during injection. Monitoring should include heart rate or ECG.

Adults

Slow intravenous or deep intramuscular injection.

Because of the risk of local irritation, intramuscular injections should only be performed if intravenous injection is not possible. Care should be taken to administer the intramuscular injections sufficiently deep IM, preferably into the gluteal region.

See also sections 4.4 and 4.8. In the case of adipose patients a longer needle will have to be chosen for safe positioning of the injection into the muscle and not into adipose tissues. If repeated injections are necessary, the injection site should be changed every time.

The intravenous administration rate should not exceed 2 mL (0,45 mmol of calcium) per minute.

Paediatric patients (<18 years)

Only slow intravenous injection or intravenous infusion (both after dilution), in order to achieve sufficiently low administration rates and to avoid irritation/necrosis in case of accidental extravasation. The intravenous administration rate should not exceed 5 mL of a 1:10 dilution per minute of Calcium gluconate in children and adolescents.

Intramuscular injections should not be performed in paediatric patients.

Special precautions for disposal and other handling

Handling

The product is intended for single use only. Discard any unused solution.

The medicinal product should be visually inspected for particulate matter or discoloration. The solution should only be used if it is clear, colourless to pale yellow aqueous solution, practically free from particles.

Dilution

For intravenous infusion, Calcium Gluconate may be diluted 1:10 to a concentration of 10 mg/mL with the following two infusion fluids: sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose solution for injection. When diluted with these recommended infusion fluids, the resulting solutions are intended for immediate single use. Dilution should be performed under controlled and validated aseptic conditions. After mixing, the container should be gently agitated to ensure homogeneity.

Use as directed by a physician.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Overdose

Excessive administration of calcium salts leads to hypercalcaemia. Symptoms of hypercalcaemia may include anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, polydipsia, polyuria, mental disturbances, bone pain, nephrocalcinosis, renal calculi and if severe, cardiac arrhythmias and coma.

Severe hypercalcaemia should be treated with infusion of sodium chloride, intravenously, to expand the extracellular fluid volume.

This may be given with or followed by furosemide to increase calcium excretion. If this treatment is unsuccessful, other medicinal products which may be used include calcitonin, bisphosphonates, disodium edetate and phosphates. Haemodialysis may be considered as a last resort. During treatment of overdose, serum electrolytes should be monitored carefully.