Miacalcic 50 IU/ml solution for injection and infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Calcitonin

Available from:

Essential Pharma (M) Limited

ATC code:

H05BA; H05BA01

INN (International Name):

Calcitonin

Dosage:

50 international unit(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion

Therapeutic area:

Calcitonin preparations; calcitonin (salmon synthetic)

Authorization status:

Not marketed

Authorization date:

2016-05-26

Patient Information leaflet

Mia50IUAmpSFI-PL-IE-8a
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PACKAGE LEAFLET: INFORMATION FOR THE USER
MIACALCIC 50 IU/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.
-
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.
WHAT IS IN THIS LEAFLET
1.
What Miacalcic is and what it is used for
2.
What you need to know before you use Miacalcic
3.
How to use Miacalcic
4.
Possible side effects
5.
How to store Miacalcic
6.
Contents of the pack and other information
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 use 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MIACALCIC
DO NOT USE MIACALCIC
-
if you are allergic to calcitonin (salmon, synthetic) or any of the
other ingredients of this
medicine (listed in section 6);
-
if you have a very low calcium level in yo

Summary of Product characteristics

Health Products Regulatory Authority
18 August 2022
CRN00CW9J
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Miacalcic 50 IU/ml solution for injection and infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml solution contains 50 IU of calcitonin as calcitonin (salmon,
synthetic) where one IU corresponds to 0.167 micrograms
of the drug substance.
Excipient(s) with known effect
Each 1 ml solution contains 3.3 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection and infusion.
Miacalcic 50 IU/ml is a clear, colourless aqueous solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Calcitonin is indicated for:

Prevention of acute bone loss due to sudden immobilisation such as
patients with recent osteoporotic fractures.

For the treatment of Paget's disease, only in patients who do not
respond to alternative treatments or for whom
such treatments are not suitable, for example those with severe renal
impairment.

Treatment of hypercalcemia of malignancy
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Salmon calcitonin may be administered at bedtime to reduce the
incidence of nausea or vomiting which may occur, especially
at the initiation of therapy.
Due to evidence of an increased risk of malignancies and long term
calcitonin use (see section 4.4), the treatment duration in
all indications should be limited to the shortest period of time
possible and using the minimum effective dose.
_Prevention of acute bone loss due to sudden immobilisation such as in
patients with recent osteoporotic fractures_
The recommended dosage is 100 IU daily or 50 IU twice daily
administered subcutaneously or intramuscularly. The dose may
be reduced to 50 IU daily at the start of remobilisation. The
recommended treatment duration is 2 weeks and should not
exceed 4 weeks in any case due to the association of the increased
risk of malignancies and long term calcitonin use.
_ _
_Paget's disease_
The recommended dosage is 100 IU per da