MIACALCIC 50 UI/ML SOLUTION FOR INJECTION AND INFUSION

Active substance: SALMON CALCITONIN

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Package Leaflet: Information for the user

Miacalcic® 50 IU/1 ml solution for
injection and infusion
Miacalcic® 100 IU/1 ml solution for
injection and infusion
Miacalcic® 400 IU/2 ml solution for
injection and infusion
Calcitonin (salmon, synthetic)
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.
–  you have any further questions, ask your doctor
If
or pharmacist.
– 
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.
–  you get any side effects talk to your doctor or
If
pharmacist. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet:
1.  hat Miacalcic is and what it is used for
W
2.  hat you need to know before you take Miacalcic
W
3.  ow to take Miacalcic
H
4.  ossible side effects
P
5.  ow to store Miacalcic
H
6.  ontents of the pack and other information
C

1. 
What Miacalcic is and what it is used for
Miacalcic contains the active substance calcitonin
(salmon, synthetic).

Calcitonin is a hormone that occurs naturally in the body
of both humans and animals. It regulates the level of
calcium in the blood. Calcitonin is used to reverse bone
loss and may also help in bone formation.
Miacalcic can be given for the following conditions:
– 
Prevention of bone loss in patients who have
suddenly become immobile. For example, patients
who are bed-bound because of a fracture.
– 
Paget’s disease of bone in patients who cannot take
other treatments for this condition, for example
patients with serious kidney problems. Paget’s
disease is a slowly progressing illness which can
cause a change in the size and shape of certain
bones.
– 
Treatment of high calcium levels in the blood
(hypercalcemia) due to cancer.

Older people
Miacalcic can be used by older people without any
specific requirements.

Do not exceed the recommended dosage. Do not take
Miacalcic if you notice that the solution is not clear and
colourless. Do not change the dose or stop treatment
without first talking to your doctor.

Other medicines and Miacalcic
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

Miacalcic is usually given by injection either into the
tissue just under the skin (subcutaneous injection) or
into a muscle (intramuscular injection). Occasionally,
the injection is given by a slow infusion into a vein
(slow intravenous infusion).

2. 
What you need to know before you take
Miacalcic

Pregnancy and breast-feeding
Miacalcic should not be used by pregnant and breastfeeding women.

Do not take Miacalcic
–  you are allergic to calcitonin (salmon, synthetic)
if
or any of the other ingredients of this medicine
(listed in section 6);
–  you have a very low calcium level in your blood
if
(hypocalcaemia).
Warning and precautions
Before treatment with Miacalcic tell your doctor if you
suspect to be allergic to calcitonin (salmon, synthetic).
Your doctor will perform a skin test before you start
taking Miacalcic.
Please tell your doctor if you have been diagnosed
with cancer. In clinical trials, patients treated with
calcitonin for osteoporosis and osteoarthritis have
shown an increase in the risk of cancer following long
term treatment. Your doctor will decide if calcitonin is
a suitable treatment for you and for how long you
can be treated.
Children and adolescent (age under 18 years)
Use of Miacalcic is not recommended in patients under
18 years of age.

It is particularly important to tell your doctor if you are
taking medicines:
– 
used to treat heart problems (e.g. digoxin) or high
blood pressure (e.g. amlodipine, diltiazem);
– containing lithium, as the dose of lithium may need
to be changed;
– containing bisphosphonate (used to treat
osteoporosis).

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
Miacalcic may cause tiredness, dizziness and disturbed
vision which could impair your reactions. If this happens
to you, do not drive or use any machines.
Miacalcic contains sodium
The solution contained in Miacalcic ampoules contains
less than 23 mg sodium per 1 ml and can therefore
be considered as sodium-free.

3. 
How to take Miacalcic
Always take this medicine exactly as your doctor
has told you. Check with your doctor, nurse or
pharmacist if you are not sure. It is advisable to
administer the medication at bedtime in order to
reduce the occurrence of nausea (feeling sick) or
vomiting (being sick) which may occur especially
at the beginning of the therapy.

Leaflet_MIACALCIC_LIAM_GB
763144_GB
Novartis
721116_GB
Order File
GB
763144_ND
763144
contract manufacturer:
297 x 148 mm
Stein
799.4.9164/06
Page 1 of 2
Sec. Edge Marks N/A
Typopharma # 105839

You should not use the injection or infusion straight from
the fridge. Let it reach room temperature naturally first.
The ampoules should be used immediately after opening.
Excess amount of Miacalcic should be discharged.
Your doctor will decide the correct dose and how long
you should receive calcitonin treatment depending on
your condition.
The usual doses are:
– 
For prevention of bone loss: 100 IU per day or 50 IU
twice daily for 2 to 4 weeks, given into the muscle or
the tissue just under the skin, normally for up to
3 months. In some cases, you doctor might decide to
extend your treatment up to 6 months.
– 
For Paget’s disease: 100 IU daily injected into a
muscle or into the tissue just under the skin, normally
for up to 3 months. In some cases, you doctor might
decide to extend your treatment up to 6 months.
– 
For the treatment of high calcium levels: 100 IU
every 6 to 8 hours, given into a muscle or into the
tissue just under the skin. In some cases, it may be
given by injection into a vein.
If you inject more Miacalcic than you should
If you accidentally inject too much Miacalcic, contact
your doctor immediately. You may require medical
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If you will be giving yourself subcutaneous injections,
make sure you understand exactly how to prepare and
give them. Your doctor or nurse will give you precise
instructions. Do not inject yourself unless you are
confident of your ability to do so.

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Novartis Pharma Stein AG
Fontsize
7,5 pt / 8 pt / 100 %
technical
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additional

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TVT compatible
yes
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If you forget to inject Miacalcic
If you forget to inject yourself a dose, give it as soon
as you remember it unless it is less than 4 hours until
your next dose is due. In that case, wait and inject your
next dose at the usual time. Do not inject a double
dose to make up for a forgotten one.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. 
Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them. The most frequently
observed side effects are nausea, vomiting and redness
of the face/neck.
Some side effects could be serious:
– 
Increased heartbeat, nettle rash (hives), difficulty
breathing, swelling of the tongue and throat,
tightness in your chest, a sudden fall in blood
pressure or shock. These may be signs of a severe
allergic reaction (anaphylaxis) and are very rare.
– 
Swelling of your face, limbs or entire body
(uncommon).
If you experience any of these, contact a doctor
immediately.
Other side effects:
Very common side effects (may affect more than 1 in
10 people):
– 
Feeling sick with or without being sick. These are
less frequent when the injection is done in the
evening and after meals.
– 
Sudden waves of redness of the face and/or neck,
usually observed 10 to 20 minutes after injection.
Common side effects (may affect up to 1 in
10 people):
– 
diarrhoea, stomach pain,
– tiredness,
– 
pain in bone, joints or muscles
– dizziness,

– headache,
– 
changes in the way things taste,
– 
cancer (following long term treatment)

Once the vial has been opened it can be kept at room
temperature (not above 25°C) for up to one month.
If there is anything left afterwards throw it away.

Miacalcic 50 IU/ml and 100IU/ml solution for injection
and infusion are available in packs of 5, 10, 50 and
100 ampoules.

Uncommon side effects (may affect up to 1 in
100 people):
– 
high blood pressure (hypertension),
– flu-like symptoms,
– 
redness and swelling at the injection site, skin rash,
itching
– 
pain in muscles
– disturbed vision
– 
frequent need to pass water,
– allergic reactions

For infusion, use Miacalcic immediately after dilution in
0.9% w/v sodium chloride in soft PVC bags.

Not all strengths and pack sizes may be available in
your country.

Do not take this medicine if you notice that the solution
is not clear and colorless.

Miacalcic vials are made of clear glass and contain
2 ml of clear, colourless solution for injection and
infusion.

Rare side effects (may affect up to 1 in 1,000 people):

What Miacalcic ampoules contains
– 
The active substance is calcitonin (salmon,
synthetic). Each 1 ml of Miacalcic solution for
injection and infusion contains 50 IU or 100IU/ml.
One IU (International Unit) corresponds to
0.167 micrograms calcitonin (salmon, synthetic).
– 
The other ingredients are acetic acid, sodium acetate
trihydrate, sodium chloride and water for injection.
– 
These are for single use only.

Calcium levels in your blood can fall 4 to 6 hours after
dose administration, it is unlikely that you notice any
symptoms because of this.
Not known (frequency cannot be estimated from the
available data):
Trembling
In rare cases, the effectiveness of Miacalcic may be
reduced.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet.

5. 
How to store Miacalcic
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 after “exp”. The expiry date refers to
the last day of that month.
The unopened ampoules and vials should be stored in
a refrigerator (2-8°C). Do not freeze.
The ampoules should be used immediately after
opening. If you do not use the whole of the ampoule,
DO NOT keep the remainder.

Do not throw away any medicine via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help to protect the environment.

6. 
Contents of the pack and other information

What Miacalcic vials contains
– 
The active substance is calcitonin (salmon,
synthetic). Each 2 ml of Miacalcic solution for
injection and infusion contains 400 IU. One IU
(International Unit) corresponds to 0.167 micro­
grams calcitonin (salmon, synthetic).
– 
The other ingredients are acetic acid, sodium acetate
trihydrate, sodium chloride, water for injection and
the preservative, phenol.

Leaflet_MIACALCIC_LIAM_GB
763144_GB
Novartis
721116_GB
Order File
GB
763144_ND
763144
contract manufacturer:
297 x 148 mm
Stein
799.4.9164/06
Page 2 of 2
Sec. Edge Marks N/A
Typopharma # 105839

Marketing Authorisation Holder
Novartis Pharmaceuticals UK Ltd, Trading as Sandoz
Pharmaceuticals, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, England.
Manufacturer
Novartis Pharmaceuticals UK Ltd, Wimblehurst Road,
Horsham, West Sussex, RH12 5AB
United Kingdom and Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, England, United
Kingdom
This leaflet was last revised in April 2013.
If you would like any more information, or would
like the leaflet in a different format, please contact
Medical Information at Novartis Pharmaceuticals UK
Ltd, tel. 01276 698370.
MIACALCIC is a registered Trade Mark
Copyright Novartis Pharmaceuticals UK Ltd

What Miacalcic looks like and contents of the pack
Miacalcic 50 IU/ml and 100 IU/ml is a solution for
injection and infusion.
Miacalcic ampoules are made of uncoloured glass that
contain 1 ml of clear, colourless solution for injection
and infusion.

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Product
Material No.
Replaced No.
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Code No.
Dimension
Drawing No.

Each Miacalcic pack contains one vial.

763144  GB

06.05.13 15:34:35

Stein_297x148
Novartis Pharma Stein AG
Fontsize
7,5 pt / 8 pt / 100 %
technical
6 pt
Used Font NewsGothicMT Pro
Colours
Black

additional

Cutting

1. proof
2. proof
3. proof
4. proof
5. proof
6. proof

06.05.2013 kh

TVT compatible
yes
no

X

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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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