Forcaltonin
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
21-11-2008
Charakterystyka produktu
(SPC)
21-11-2008
Sprawozdanie z oceny publicznego
(PAR)
21-11-2008
Składnik aktywny:
Recombinant salmon calcitonin
Dostępny od:
Unigene UK Ltd.
Kod ATC:
H05BA01
INN (International Nazwa):
recombinant salmon calcitonin
Grupa terapeutyczna:
Calcium homeostasis
Dziedzina terapeutyczna:
Hypercalcemia; Osteitis Deformans; Bone Resorption
Wskazania:
Calcitonin is indicated for:Prevention of acute bone loss due to sudden immobilisation such as in patients with recentosteoporotic fracturesPaget's diseaseHypercalcaemia of malignancy
Status autoryzacji:
Withdrawn
Data autoryzacji:
1999-01-11
Ulotka dla pacjenta
Medicinal product no longer authorised
16
B. PACKAGE LEAFLET
Medicinal product no longer authorised
17
PACKAGE LEAFLET
Read all of this leaflet carefully before you start using this
medicine.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your doctor or your
pharmacist.
-
This medicine has been prescribed for you personally and you should
not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
In this leaflet:
1.
What FORCALTONIN is and what it is used for
2.
Before you use FORCALTONIN
3.
How to use FORCALTONIN
4.
Possible side effects
5.
Storing FORCALTONIN
FORCALTONIN 100 IU Solution for Injection,
recombinant salmon calcitonin
-
The active substance is recombinant salmon calcitonin. Each ampoule
contains 100 IU
(15 micrograms in 1.0 ml) of recombinant salmon calcitonin. The salmon
calcitonin contained
in Forcaltonin is not made by a conventional, chemical method but by
genetic engineering.
However, the structure of the active substance of FORCALTONIN is the
same as that of
chemically synthesised salmon calcitonin. The effects of recombinant
salmon calcitonin on
the body have also been shown to be equivalent to those of synthetic
salmon calcitonin.
-
The other ingredients are acetic acid, glacial, sodium acetate
trihydrate, sodium chloride and
water for injections.
The Marketing Authorisation Holder for FORCALTONIN is Unigene UK
Limited, 191 Sparrows
Herne, Bushey Heath, Hertfordshire WD23 1AJ, UK.
The manufacturer is FAMAR S.A., 7 P. Marinopoulou Str., 174 56 Alimos,
Athens, Greece.
1.
WHAT FORCALTONIN IS AND WHAT IT IS USED FOR
FORCALTONIN is a solution for injection. The solution is clear,
colourless and sterile. It is contained
in a glass ampoule.
Each ampoule of FORCALTONIN contains 1 ml of solution with 100
International Units (IU) of the
active substance. This corresponds to about 15 micrograms of
recombinant salmon calcitonin. Each
pack contains 10 ampoules.
The active substance of FORCALTONIN is recombinant salmon calcit
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Charakterystyka produktu
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Forcaltonin 100 IU solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ampoule of Forcaltonin 100 IU contains 100 International Units
(IU) corresponding to
approximately 15 micrograms recombinant salmon calcitonin (produced by
recombinant DNA
technology in _Escherichia coli) _in 1 ml of an acetate buffer.
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear colourless 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
•
Paget’s disease
•
Hypercalcaemia of malignancy
4.2
Posology and method of administration
For subcutaneous, intramuscular or intravenous infusion (product
specific) use in individuals aged 18
years or more.
Salmon calcitonin may be administered at bedtime to reduce the
incidence of nausea or vomiting
which may occur, especially at the initiation of therapy.
_Prevention of acute bone loss: _
The recommended dosage is 100 I.U. daily or 50 I.U. twice daily for 2
to 4 weeks, administered
subcutaneously or intramuscularly. The dose may be reduced to 50 I.U.
daily at the start of
remobilisation. The treatment should be maintained until patients are
fully mobilized.
_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
biochemical improvement. Dosage is to be adjusted to the individual
patient’s needs. The duration of
treatment depends on the indication for treatment and the patient´s
response. The effect of calcitonin
may be monitored by measurement of suitable markers of bone
remodeling, such as serum alkaline
Medicinal product no longer authorised
3
phosphatase or urinary hydroxyproline or de
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