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CALCIUM GLUCONATE 10% W/V SOLUTION FOR INJECTION

Active substance(s): CALCIUM GLUCONATE MONOHYDRATE / CALCIUM GLUCONATE MONOHYDRATE / CALCIUM GLUCONATE MONOHYDRATE

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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, 21st 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
Injektionslösung
Greece:
Calcium gluconate DEMO 10% w/v
Ενέσιμο διάλυμα
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.

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.

Posology and method of administration

Method of administration

Posology

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

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.
Age
mL/kg
3 months
0.4-0.9
6 months
0.3-0.7
1 year
0.2-0.5
3 years
0.4-0.7
7.5 years
0.2-0.4
12 years
0.1-0.3
> 12 years
As for adults
In cases of severe symptoms of hypocalcaemia in neonates or
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.

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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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