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CALCIUM GLUCONATE INJECTION B.P. 10%

Active substance(s): CALCIUM GLUCONATE

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Patient Information Leaflet

hameln

Calcium Gluconate Injection 10%
Important information about your medicine
Your doctor or nurse will give you the injection
► If this injection causes you any problems talk to your doctor, nurse or pharmacist
► Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to
any of the ingredients of this medicine
► Please tell your doctor or pharmacist, if you are taking any other medicines


• 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, pharmacist or nurse.
• 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.

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

1. What Calcium Gluconate Injection 10% 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
Injection 10% is used:
• to replace low levels of calcium in the body
• in the treatment of heart attacks
• in neonatal tetany (a condition affecting the
muscles of newly born babies and young infants)
• in the treatment of lead and fluoride poisoning
• to prevent low calcium levels from blood
transfusions

2. What you need to know before you use
Calcium Gluconate Injection 10%
Do NOT use Calcium Gluconate Injection
10%:
• if you are allergic to Calcium Gluconate
Injection 10% or any of the other ingredients in
this injection (listed in section 6)
• if you have high levels of calcium in your urine
• if you have high levels of calcium in your blood
(for example as a result of hyperparathyroidism
(overactivity of the parathyroid gland),
excessive levels of vitamin D, a tumour,
impaired kidney function, osteoporosis due
to a lack of mobility, sarcoidosis or so-called
milk-alkali syndrome)
• if you have severe kidney disease
• if you have kidney disease and require repeated
or prolonged treatment
• if you are receiving 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
• 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 using Calcium Gluconate Injection
10%:
• if you suffer from deposition of calcium in the
kidneys (nephrocalcinosis)
• if you have sarcoidosis

• if you have kidney disease
• if you have heart disease
• if you have excessive levels of calcium in the
urine
• if you are receiving adrenaline (epinephrine)
• if you are elderly

Children and Adolescents:
Children and adolescents (under the age of 18)
should not be routinely administered Calcium
Gluconate Injection 10%.

Other medicines and Calcium Gluconate
Injection 10%:
Tell your doctor or nurse if you are taking,
have recently taken or might take any other
medicines, including medicines obtained without
a prescription. This is especially important with
the following medicines as they may interact with
your Calcium Gluconate Injection 10%:
• digoxin (a heart medicine)
• diuretics (water tablets)
• ceftriaxone (an antibiotic)
• adrenaline (epinephrine)
• magnesium
• calcium channel blockers

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
taking this medicine.

Driving and using machines:
You should not drive or use machinery if you
are affected by the administration of Calcium
Gluconate Injection 10%.

3. How to use Calcium Gluconate Injection
10%
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 use more Calcium Gluconate
Injection 10% 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 immediately.

Your injection will be stored at less than 25°C and
protected from light.

4. Possible side effects

The active substance is calcium gluconate. Each
1 ml of solution contains 95 mg calcium gluconate
in a sterile solution for injection.
The other ingredients are Calcium D Saccharate
USP and Sterile Water for Injections EP.

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

6. Contents of the pack and other information
What Calcium Gluconate Injection 10%
contains

What Calcium Gluconate Injection 10%
looks like and contents of the pack
Calcium Gluconate Injection 10% is supplied in
10 ml clear glass ampoules. 10 ampoules
supplied in each carton.
The marketing authorisation number of this
medicine is: PL 01502/0038.

The following side effects may be serious
If any of the following side effects occur
tell your doctor immediately:

Marketing Authorisation Holder

Rare: may affect up to 1 in 1,000 people
• 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 ceftriaxone-calcium
salt have been observed in lung and kidneys
post-mortem.

Manufacturer

Not known: frequency cannot be estimated from
the available data
• slow or irregular heartbeat
• drop in blood pressure (hypotension)
• circulatory collapse (possibly fatal)

Other side effects

hameln pharmaceuticals ltd
Gloucester
United Kingdom
hameln pharmaceuticals gmbh
Langes Feld 13
31789 Hameln
Germany
hameln rds a.s.
Horná 36
900 01 Modra
Slovak Republic
HBM Pharma s.r.o.
Sklabinská 30
03680 Martin
Slovak Republic

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

For
any
information
about
this
medicine, please contact the Marketing
Authorisation Holder.

Side effects when Calcium Gluconate
Injection 10% is used incorrectly

43888/06/16

• It has been reported that following leaking of the
solution from a vein into the surrounding tissue
(extravasation), calcium deposition in the soft
tissue may occur. It may be followed by peeling
and destruction of the skin.
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 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 Injection
10%
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 label and carton after “Exp.
date”. The expiry date refers to the last day of that
month.

This leaflet was last revised in February 2016.

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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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