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CALCIUM GLUCONATE 10% W/V INJECTION BP

Active substance(s): CALCIUM GLUCONATE

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570/12609364/1215

PACKAGE LEAFLET: INFORMATION FOR THE USER
hameln pharmaceuticals ltd · Gloucester · UK

Calcium Gluconate 10 % w/v
Injection BP
Calcium gluconate

schwarz (20%, 45%, 100%)

Read all of this leaflet carefully before you start using
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.
• If you get any side effects talk to your doctor. This includes any
possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:
1. What Calcium Gluconate 10 % w/v Injection BP is and what it is used for
2. What you need to know before you use Calcium Gluconate
10 % w/v Injection BP
3. How to use Calcium Gluconate 10 % w/v Injection BP
4. Possible side effects
5. How to store Calcium Gluconate 10 % w/v Injection BP
6. Content of the pack and other information

1. What Calcium Gluconate 10 % w/v Injection BP is
and what it is used for
Calcium Gluconate 10 % w/v Injection BP is a solution for the
supplementation of calcium.
It is used for the supply of calcium in patients with abnormally low blood
calcium levels (hypocalcaemia) and presenting with acute symptoms
such as impaired skin sensations (numbness, itching, burning), convulsive
muscular rigidity (tetany), cramps in the hands and feet, colic, muscle
weakness, confusion, possibly culminating in convulsions and cardiac
symptoms (e.g. irregular heartbeat and even acute heart failure).

2. What you need to know before you use Calcium
Gluconate 10 % w/v Injection BP

Breast-feeding
Calcium is excreted into breast milk. Your doctor will keep this in mind
when administering calcium to you when you are breast-feeding your
infant.
This medicine has no influence on the ability to drive and use machines.

3. How to use Calcium Gluconate 10 % w/v
Injection BP
Always use this medicine exactly as your doctor has told
you. Check with your doctor if you are not sure.
The recommended dose will selected by your doctor in order to raise your
blood calcium level / your child’s blood calcium level to normal values.
Adults
The usual starting dose is 10 ml, i.e. one ampoule of Calcium Gluconate
10 % w/v Injection BP. If required, the dose may be repeated. Following
doses will be adjusted according to your actual blood calcium level.
Use in infants, toddlers, children and adolescents
The doctor will decide on the dosage and method of administration
depending on the blood calcium level and the severity of the symptoms.
In the case of mild symptoms affecting the nerves and muscles, preference
will be given to oral calcium preparations.
The following table gives usual initial dosage values for guidance:
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

Do not use Calcium Gluconate 10 % w/v Injection BP

0.2 – 0.4

• if you are allergic to calcium gluconate or any of the other ingredients of
this medicine (listed in section 6)
• if you have elevated blood calcium levels (e.g. in patients with
overactive parathyroid glands, elevated vitamin D levels in the blood,
tumour diseases with bone decomposition, impaired kidney function,
osteoporosis due to a lack of mobility, sarcoidosis and so-called milkalkali syndrome)
• in the case of excessive excretion of calcium in the urine
• in the case of poisoning with digitalis medicines (a kind of heart
medicine)
• during treatment with digitalis medicines unless you have an extremely
low blood calcium level with life-threatening symptoms, which can only
be treated by an immediate injection of calcium.
• the antibiotic ceftriaxone should not be used in premature neonates
and neonates (≤ 28 days of age) if they are receiving (or are expected to
receive) calcium-containing products which are administered into a vein.

12 years

0.1 – 0.3

> 12 years

as for adults

In the case of exceptionally low blood calcium levels in neonates and
infants with, for instance, impaired cardiac function, higher starting doses
may be required in order to quickly raise the blood calcium levels (up to
2 ml per kg body weight).
Calcium administration can be repeated, if required. The concentration
of the following doses will depend on the existing blood calcium level.
Following intravenous therapy treatment with oral calcium preparations
may be necessary, e.g. in cases of vitamin D deficiency.
Elderly patients
Certain disorders that are sometimes associated with advanced age, such
as impaired kidney function and undernourishment (malnutrition) may
affect the tolerance of calcium gluconate. Therefore, a lower dose must
be selected.

Warnings and precautions

Method of administration

Talk to your doctor before using Calcium Gluconate 10 % w/v Injection BP.
If you are taking digitalis preparations on a regular basis and, as an
exception, you urgently require a calcium injection (see above), your doctor
will monitor your heart function extremely carefully. The monitoring will
ensure, that any worsening of your heart function, e.g. severe arrhythmias
(irregular heartbeat), can be treated immediately.

Calcium Gluconate 10 % w/v Injection BP will be given to you as an
injection slowly into a vein or deep into a large muscle. It should be given
to you in a lying position and in particular your heart function should be
carefully monitored during the injection.

Impaired kidney function (kidney impairment) can be accompanied by
increased blood calcium levels and overactive parathyroid glands. If you
are suffering from kidney impairment, you should only receive calcium
injections if these are absolutely essential. Your calcium and phosphate
balance must, however, be monitored.
Your doctor will take special care if you are receiving the antibiotic
ceftriaxone. He will not administer it to you simultaneously with calcium
gluconate even via different infusion line or different infusion sites.
Calcium should be injected slowly in order to prevent, where possible,
widening of the blood vessels or impaired cardiac function.
Your heart rate or ECG should be monitored when this medicine is injected
into a vein (intravenous injection).
During calcium salt treatment, you will be carefully monitored to ensure
a normal calcium balance (calcium intake versus calcium excretion) and
to prevent any chalky deposits in the tissue. Blood calcium levels and the
quantities of calcium excreted in the urine will be monitored especially
when calciumis injected at high doses.
Calcium is insoluble in fatty tissue and may lead to inflammatory reactions
followed by abscess formation, hardening of the tissue and tissue
destruction (necrosis) if accidentally injected into these areas.
If the solution is inadvertently injected beside a blood vessel or not deep
enough into a muscle, this can result in local tissue irritation, possibly
followed by peeling of the skin or even necrosis (see section 4). Your doctor will ensure that no solution drains into tissue around the blood vessel
and will carefully observe the site of injection.
High doses of vitamin D should be avoided.

Children and adolescents
In children (< 18 years) Calcium Gluconate 10 % w/v Injection BP should
only be injected into veins, not into a muscle (intramuscular).

Other medicines and Calcium Gluconate 10 % w/v Injection
BP
Tell your doctor if you are taking or have recently taken any other medicines.
The effect of heart medicines like digoxin and other digitalis medicines
can be increased by calcium up to the point of digitalis poisoning.
Therefore, if you are receiving treatment with digitalis medicines, you will
only be given an intravenous calcium injection for the treatment of severe,
immediately life-threatening symptoms of a very low blood calcium level.
Administration of calcium together with adrenaline after heart surgery
weakens the effects of adrenaline on the heart and circulation.
Calcium and magnesium mutually inhibit their effects.
Calcium can reduce the effects of certain medicines used to regulate
heart function (calcium antagonists). Administration of certain
medicines increasing the urine formation and output (thiazide
diuretics) together with calcium can lead to excessively high blood
calcium levels (hypercalcaemia), as these medicinal products reduce the
excretion of calcium via the kidneys.
Administration of calcium simultaneously with ceftriaxone will lead to
agglomeration.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you maybe pregnant or are
planning to have a baby, ask your doctor for advice before using this
medicine.
Pregnancy
Calcium passes through the placenta into the circulation of the foetus and
reaches higher levels in the foetal blood than in the mother’s blood.
Pregnant women should, therefore, only receive calcium injections if
absolutely essential. The dose must then be carefully calculated and
calcium levels in the blood regularly monitored in order to avoid excessive
calcium levels in the blood, which could be harmful to the foetus.

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Driving and using machines

7.5 years

Your doctor will consider very carefully whether this medicine is suitable
for you if you suffer from:
• deposition of calcium in the kidneys (nephrocalcinosis)
• heart diseases
• sarcoidosis,
In these cases you should only be given calcium injections if these are
absolutely essential. This also applies if you receive adrenaline (see “Other
medicines and Calcium Gluconate 10 % w/v Injection BP”) or are elderly.

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2 Seiten

Due to the risk of local tissue irritation, injections into a muscle
(intramuscular injection) should only be made if intravenous injection is
not feasible. Your doctor will carefully ensure that the intramuscular injections are administered sufficiently deep, preferably into the large buttock
muscle.
The rate of intravenous infusion or injection should be sufficiently slow.
Infants, toddlers, children and adolescents
For intravenous (into a vein) administration as a slow injection or slow
intravenous infusion (venous drip), both after dilution. In children, this
medicine should not be injected into a muscle or under the skin.

If you receive more Calcium Gluconate 10 % w/v Injection
BP than you should
Symptoms of a high blood calcium level (hypercalcaemia) include: loss of
appetite, feeling sick, being sick (vomiting), constipation, belly ache, passing
large quantities of urine, increased thirst, fluid loss, muscle weakness, deposition of calcium in the kidneys, drowsiness, confusion, high blood pressure
(hypertension) and, in severe cases, irregular heartbeat, up to the point of
cardiac arrest and loss of consciousness.
Symptoms of high blood calcium level (hypercalcaemia) and chalky taste,
hot flushes and a drop in blood pressure can occur if the intravenous injection is made too rapidly.
Treatment is aimed at lowering the elevated high blood calcium levels. Your
doctor will decide on the treatment to be given. It may include administration of fluids or specific medication to lower the blood calcium level. In severe
cases dialysis may become necessary.
If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
The frequency of side effects is expressed as follows:
Very common: affects more than 1 user in 10
Common:
affects 1 to 10 users in 100
Uncommon:
affects 1 to 10 users in 1,000
Rare:
affects 1 to 10 users in 10,000
Very rare:
affects less than 1 user in 10,000
Not known:
frequency cannot be estimated based on the available
data.
Side effects on the heart, circulation or other body functions may appear
as symptoms of an excessively high blood calcium level after overdosing
or too rapid injection into a vein.
The presence and frequency of such symptoms depend directly on the
speed of injection and the dose administered.

The following side effects may be serious. If any of the following side effects occur tell your doctor immediately, he will
stop giving you this medicine:
Not known (Frequency cannot be estimated from the available data):
• slow or irregular heartbeat
• drop in blood pressure (hypotension)
• circulatory collapse (possibly fatal)
Rarely (affects 1 to 10 users in 10, 000):
Severe, and in some cases, fatal, adverse reactions have been reported in
pre-term and full-term neonates (aged <28 days) who had been treated
with intravenous ceftriaxone and calcium. Precipitations of ceftriaxonecalcium salt have been observed in lung and kidneys post-mortem.

Other side effects include:
Not known (Frequency cannot be estimated from the available data):
• widening of blood vessels,
• hot flushes, mainly after the injection has been administered too rapidly.
• feeling sick or being sick (vomiting)
• sensation of heat
• sweating
• injections into muscles may be accompanied by pain and redness

Side effects when the medicinal product is used incorrectly
• If the injection is not given deep enough into a muscle, the solution may
penetrate the fatty tissue, possibly resulting in inflammation, hardening
and destruction (necrosis) of the tissue.

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• It is been reported that following leaking of the solution from a vein into
the surrounding tissue calcium deposition in the soft tissue may occur. It
may be followed by peeling and destruction of the skin .
• Redness of the skin and a feeling of burn or pain during intravenous
injection may indicate an inadvertent injection beside the blood vessel,
which could result in the destruction of the tissue.
Reporting of side effects
If you get any side effects talk to your doctor or pharmacist. This includes
any side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: 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 10 % w/v Injection
BP
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
container and carton.
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
The solution must be used immediately once the ampoule has been
opened.
After diluting the ready-to-use solution must be administered as
soon as possible but should not be stored for longer than 24 hours at
2 – 8° C.
Do not use this medicine if you notice the following changes:
• damage to the ampoule, discolouration or cloudiness (turbidity) of the
solution, visible particles in the solution.
Do not throw away any medicines via household waste. Ask your
pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.

6. Content of the pack and other information
What Calcium Gluconate 10 % w/v Injection BP contains
• The active substance is calcium gluconate.
• 1 ml of solution contains 94 mg of calcium gluconate, equivalent to
0.21 mmol calcium
10 ml contains 940 mg of calcium gluconate, equivalent to 2.10 mmol
calcium
• Excipients: The product also contains an amount of the excipient calcium
D-saccharate tetrahydrate equivalent to 0.02 mmol calcium per ml (or
0.15 mmol calcium per 10ml).

The following information is intended for healthcare professionals only:
Method of administration
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 the adipose
tissues.
If repeated injections are necessary, the injection site should be changed
every time.
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 10% w/v Injection BP in children and adolescents.

Special warnings and precautions for use
In patients of any age ceftriaxone must not be mixed or administered simultaneously with any calcium-containing intravenous solutions even via
different infusion lines or different infusion sites.
Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and
kidneys in premature and full-term newborns aged less than 1 month have
been described.
However, in patients older than 28 days of age ceftriaxone and calciumcontaining solutions may be administered sequentially one after another if
infusion lines at different sites are used or if the infusion lines are replaced
or thoroughly flushed between infusions with physiological salt-solution
to avoid precipitation. Sequential infusions of ceftriaxone and calciumcontaining products must be avoided in case of hypovolaemia.

• The other ingredient is water for injections.
Total calcium content: 0.23 mmol per ml (2.25 mmol per 10ml).

What Calcium Gluconate 10 % w/v Injection BP looks like and
contents of the pack
Calcium Gluconate 10 % w/v Injection BP is a solution for injection (a
solution that is administered in a syringe). It is a clear, colourless to light
brown aqueous solution.
It comes in:
Polyethylene ampoules, content: 10 ml
available in packs of 20 x 10 ml

Marketing Authorisation Holder and Manufacturer:
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen
Germany
Postal address:
34209 Melsungen
Germany
Phone: +49-5661-71-0
Fax: +49-5661-71-4567

Distributor
hameln pharmaceuticals ltd
Gloucester
UK

This medicinal product is authorised in the Member States of
the EEA under the following names:
Belgium

: Calcium Gluconate 10 % B. Braun oplossing voor
injectie
Denmark
: Calciumgluconat B. Braun 100 mg/ml
Finland
: Calciumgluconat B. Braun 100 mg/ml
France
: Gluconate de Calcium 10 % B.Braun, solution pour
perfusion
Italy
: Calcio gluconato 10% B.Braun soluzione iniettabile
Netherlands
: Calcium Gluconaat 10 % B.Braun, oplossing voor
injectie 10 %
Austria
: Calciumgluconat 10% B.BRAUN Injektionslösung
Portugal
: Gluconato de cálcio 10 % B.Braun
Slovak Republic : Calcium Gluconicum 10% B.Braun
Czech Republic : Calcium Gluconicum 10 % B.Braun
United Kingdom : Calcium Gluconate 10 % w/v Injection BP

This leaflet was last revised in 10/2015

Incompatibilities
Calcium salts can form complexes with many drugs and this may result in
a precipitate.
Calcium salts are incompatible with oxidising agents, citrates, soluble carbonates, bicarbonates, oxalates, phosphates, tartrates and sulphates.
Physical incompatibility has also been reported with amphotericin, cephalothin sodium, ceftriaxone (see “Warnings and precautions”), cephazolin
sodium, cephamandole nafate, novobiocin sodium, dobutamine hydrochloride, prochlorperazine and tetracyclines.
This medicinal product must not be mixed with other medicinal products
except those mentioned in section “Dilution” or unless compatibility has
been satisfactorily demonstrated.

Dilution
For intravenous infusion, Calcium Gluconate 10% w/v Injection BP 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
glucose 50 mg/ml (5%) 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.

Treatment of overdose
Initial management should include rehydration and, in severe hypercalcaemia, it may be necessary to administer isotonic sodium chloride solution
by intravenous infusion to expand the extracellular fluid. Calcitonin may
be given to lower the elevated serum calcium concentration. Furosemide
may be administered to increase calcium excretion but thiazide diuretics should be avoided as they may increase renal absorption of calcium.
Serum electrolytes should be carefully monitored throughout treatment
of overdose.

hameln pharmaceuticals ltd
Gloucester
UK

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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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