Miacalcic 100 IU/ml solution for injection and infusion

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

CALCITONIN, SALMON

Dostupné s:

Essential Pharma Ltd

ATC kód:

H05BA; H05BA01

INN (Mezinárodní Name):

CALCITONIN, SALMON

Dávkování:

100 international unit(s)/millilitre

Léková forma:

Solution for injection/infusion

Druh předpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Calcitonin preparations; calcitonin (salmon synthetic)

Stav Autorizace:

Not marketed

Datum autorizace:

1987-05-07

Informace pro uživatele

Mia100IUAmpSFI-PL-IE4
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MIACALCIC 100 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 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.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet.
WHAT IS IN THIS LEAFLET
:
1.
What Miacalcic is and what it is used for
2.
What you need to know before you take Miacalcic
3.
How to take 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 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIACALCIC
DO NOT TAKE 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 your blood (hypocalemia).

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Miacalcic 100 IU/ml solution for injection and infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml
injection delivers 100 IU of
calcitonin as calcitonin (salmon,
synthetic)
where one IU corresponds to
0.167 micrograms of the drug substance.
Miacalcic is essentially sodium-free, see section 4.4.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection and infusion.
Miacalcic 100 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 in
patients with recent oseoporotic 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
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 he 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 day administered subcutaneously
or intramuscularly,
however,
a minimum
dosage regimen of 50 IU three times a