SALCO 100 IU

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

CALCITONIN SALMON; CALCITONIN SALMON

Verfügbar ab:

GENMEDIX , ISRAEL

ATC-Code:

H05BA01

Darreichungsform:

SOLUTION FOR INJECTION

Zusammensetzung:

CALCITONIN SALMON 100 IU/ML; CALCITONIN SALMON 100 IU/ML

Verabreichungsweg:

I.M, I.V, S.C, I.M, I.V, S.C

Verschreibungstyp:

Required

Hergestellt von:

LABORATORIO ITALIANO BIOCHIMICO FARMACEUTICO LISAPHARMA S.P.A, ITALY

Therapiegruppe:

CALCITONIN (SALMON SYNTHETIC)

Therapiebereich:

CALCITONIN (SALMON SYNTHETIC)

Anwendungsgebiete:

Calcitonin is indicated for:• Prevention of acute bone loss due to sudden immobilisation such as in 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. Calcitonin is indicated for:• Prevention of acute bone loss due to sudden immobilisation such as in 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.

Berechtigungsdatum:

2011-11-30

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
SALCO 100 IU
, solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SALCO 100 IU/ml solution for injection – 1 ampoule contains:
_Active principle:_
Salmon calcitonin
100 IU/ML
SALCO is essentially sodium-free, see section 4.4.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for intramuscular, intravenous and subcutaneous injection.
Salco 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 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
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 day administered subcutaneously
or
intramuscularly, however, a minimum dosage regimen of 50 IU three
times a
week has achieved clinical and