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The name of your medicine is Calcium gluconate 10% w/v If you are given more Calcium gluconate than you should
Solution for injection. In the rest of this leaflet the name of the Since the injection will be given to you by a doctor or nurse, it is
medicine shall be Calcium gluconate. 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
What is in this leaflet stomach pain, suffer muscle weakness, feel thirsty, are passing a
1. What Calcium gluconate is and what it is used for lot of urine, feel confused or have bone pain you must tell the
2. What you need to know before you are given person giving you the injection.
Calcium gluconate
3. How Calcium gluconate is given 4. Possible side effects
4. Possible side effects
5. How to store Calcium gluconate Like all medicines, this medicine can cause side effects, although
6. Contents of the pack and other information not everybody gets them.
• Feeling and being sick
1. What Calcium gluconate is and what it is • Sweating and hot flushes
used for • Low blood pressure and possible collapse
• Damage to skin and area at the point of injection
Calcium is found naturally in the body and is necessary for the • Pain sensations or erythema.
normal function of muscles and nerves. It is needed to make the
heart work properly and for blood to clot. Calcium gluconate is If you think this injection is causing you any problems, or you are at
used: all worried, talk to your doctor, nurse or pharmacist.
• to replace low levels of calcium in the body
• in neonatal tetany (a condition affecting the muscles of newly Reporting of side effects
born babies and young infants) If you get any side effects, talk to your doctor, pharmacist or nurse.
• in the treatment fluoride poisoning This includes any possible side effects not listed in this leaflet. You
• to prevent low calcium levels from blood transfusions. can also report side effects directly via Yellow Card Scheme,
Website: www.mhra.gov.uk/yellowcard. By reporting side effects
2. What you need to know before you are given you can help provide more information on the safety of this
Calcium gluconate medicine.
Calcium and magnesium mutually inhibit their effects. If this leaflet is difficult to see or read please
Administration of calcium together with adrenaline after heart
contact the following address for help: Athlone
surgery weakens the effects of adrenaline on the heart and Laboratories, Ballymurray, Co. Roscommon,
circulation. Ireland, Tel: +353-9066-61109,
Email: medical@athlone-laboratories.com.
The following information is intended for healthcare In the case of significant burn due to hydrofluoric acid /fluoride
professionals only: exposure, calcium salts may be administered intravenously (for
systemic toxicity) or intra-arterially (for hand burns predominantly).
Preparation and handling - 10 mL of 10% calcium gluconate plus heparin 5000 units in a total
volume of 40 mL is administered intravenously.
Incompatibilities - 10 mL of 10% calcium gluconate in 50 mL of 0.9% sodium
Calcium salts can form complexes with many ingredients of chloride solution is intra-arterially infused over 4 h.
medicinal products, and this may result in a precipitate (See Other
medicines and Calcium gluconate). Calcium salts are incompatible Prevention of hypocalcaemia during transfusion
with oxidising agents, citrates, soluble carbonates, bicarbonates, Calcium should be administered during massive transfusion if Ca2+
phosphates, tartrates and sulphates. Physical incompatibility has concentration is low, in order to preserve normocalcaemia.
also been reported with amphotericin, cephalothin sodium, 10 mL of a 10% solution of Calcium gluconate IV diluted in 100 mL
cephazolin sodium, cephamandole nafate, ceftriaxone, novobiocin D5W (5% Glucose in water), given over 10 min or 10-20 mL for
sodium, dobutamine hydrochloride, prochlorperazine, and each 500 mL of blood infused.
tetracyclines.
This medicinal product must not be mixed with other medicinal Paediatric patients
products except those mentioned in section Special precautions for 100-200 mg/kg (or 1-2 mL/kg) IV over 5-10 min for maximum rate 5
disposal and other handling. mL/min.
Posology The patient should be in the lying position and should be closely
observed during injection. Monitoring should include heart rate or
Acute hypocalcaemia ECG.
Adults Adults
The usual initial dose in adults is 10 mL of Calcium gluconate, Slow intravenous or deep intramuscular injection.
corresponding to 2.23 mmol or 4.46 mEq of calcium. If necessary,
the dose may be repeated, depending on the patient’s clinical Because of the risk of local irritation, intramuscular injections
condition. Subsequent doses should be adjusted according to the should only be performed if intravenous injection is not
actual serum calcium level. possible. Care should be taken to administer the intramuscular
injections sufficiently deep IM, preferably into the gluteal region.
Paediatric patients (< 18 years) See also sections 4.4 and 4.8. In the case of adipose patients a
The dose and the route of administration depend on the degree of longer needle will have to be chosen for safe positioning of the
hypocalcaemia and the nature and severity of the symptoms. In the injection into the muscle and not into adipose tissues. If repeated
case of mild neuromuscular symptoms oral calcium administration injections are necessary, the injection site should be changed every
should be preferred. time.
Age mL/kg The intravenous administration rate should not exceed 2 mL (0,45
3 months 0.4-0.9 mmol of calcium) per minute.
6 months 0.3-0.7
1 year 0.2-0.5 Paediatric patients (<18 years)
3 years 0.4-0.7 Only slow intravenous injection or intravenous infusion (both after
7.5 years 0.2-0.4 dilution), in order to achieve sufficiently low administration rates and
12 years 0.1-0.3 to avoid irritation/necrosis in case of accidental extravasation. The
intravenous administration rate should not exceed 5 mL of a 1:10
> 12 years As for adults
dilution per minute of Calcium gluconate in children and
In cases of severe symptoms of hypocalcaemia in neonates or
adolescents.
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
Intramuscular injections should not be performed in paediatric
necessary for a quick restoration of a normal serum calcium level.
patients.
Also, if necessary, the dose may be repeated, depending on the
Special precautions for disposal and other handling
patient’s clinical condition. Subsequent doses should be adjusted
according to the actual serum calcium level.
Handling
The product is intended for single use only. Discard any unused
Intravenous therapy should be followed by oral administration if
solution.
indicated, e.g. in cases of calciferol deficiency.
The medicinal product should be visually inspected for particulate
matter or discoloration. The solution should only be used if it is
Elderly patients
clear, colourless to pale yellow aqueous solution, practically free
Although there is no evidence that tolerance of Calcium gluconate
from particles.
is directly affected by advanced age, factors that may sometimes be
associated with ageing, such as impaired renal function and poor
Dilution
diet, may indirectly affect tolerance and may require a reduction in
For intravenous infusion, Calcium Gluconate may be diluted 1:10 to
dosage. Renal function declines with age and prior to prescribing
a concentration of 10 mg/mL with the following two infusion fluids:
this product to elderly patients it should be considered that Calcium
sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL
gluconate is contraindicated (See section 4.3) for repeated or
(5%) glucose solution for injection. When diluted with these
prolonged administration in patients with impaired renal function.
recommended infusion fluids, the resulting solutions are intended
for immediate single use. Dilution should be performed under
Neonatal tetany
controlled and validated aseptic conditions. After mixing, the
Intravenous administration of 10% calcium gluconate as a bolus of
container should be gently agitated to ensure homogeneity.
100-200 mg/kg (1-2 mL/kg) over approximately 10-20 minutes,
Use as directed by a physician.
followed by a continuous infusion (0.5-1 g/kg/d) over 1-2 days.
Any unused medicinal product or waste material should be
Heart rate should be monitored during the infusion.
disposed of in accordance with local requirements.
The IV site should also be watched closely because tissue
infiltration by a calcium solution is irritating and may cause local
Overdose
tissue damage or necrosis.
Excessive administration of calcium salts leads to hypercalcaemia.
Fluoride poisoning
Symptoms of hypercalcaemia may include anorexia, nausea,
Calcium gluconate regime for hypocalcaemia in fluoride poisoning:
vomiting, constipation, abdominal pain, muscle weakness,
polydipsia, polyuria, mental disturbances, bone pain,
Immediate:
nephrocalcinosis, renal calculi and if severe, cardiac arrhythmias
- give 10 mL of 10% calcium gluconate intravenously on
and coma.
presentation, repeat at 1 hour, or
Severe hypercalcaemia should be treated with infusion of sodium
- give 30 mL of 10% calcium gluconate intravenously if tetany
chloride, intravenously, to expand the extracellular fluid volume.
present.
This may be given with or followed by furosemide to increase
calcium excretion. If this treatment is unsuccessful, other medicinal
Maintenance:
products which may be used include calcitonin, bisphosphonates,
- Maintain serum calcium with intravenous 10% calcium gluconate
disodium edetate and phosphates. Haemodialysis may be
10 mL every 4 hours, adjusting according to frequent serum calcium
considered as a last resort. During treatment of overdose, serum
concentrations.
electrolytes should be monitored carefully.
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.