Cinacalcet Devatis 90 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

CINACALCETHYDROCHLORIDE 99,2 mg/stuk SAMENSTELLING overeenkomend met ; CINACALCET 90 mg/stuk

Beschikbaar vanaf:

Devatis GmbH Spitalstrasse 22 795 39 LORRACH (DUITSLAND)

ATC-code:

H05BX01

INN (Algemene Internationale Benaming):

CINACALCETHYDROCHLORIDE 99,2 mg/stuk SAMENSTELLING overeenkomend met ; CINACALCET 90 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Cinacalcet

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); INDIGOKARMIJN ALUMINIUMLAK (E 132); LACTOSE 1-WATER; MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Autorisatie datum:

2015-11-19

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CINACALCET DEVATIS 30 MG FILMOMHULDE TABLETTEN
CINACALCET DEVATIS 60 MG FILMOMHULDE TABLETTEN
CINACALCET DEVATIS 90 MG FILMOMHULDE TABLETTEN
Cinacalcet
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Cinacalcet Devatis is and what it is used for
2.
What you need to know before you take Cinacalcet Devatis
3.
How to take Cinacalcet Devatis
4.
Possible side effects
5.
How to store Cinacalcet Devatis
6.
Contents of the pack and other information
1.
WHAT CINACALCET DEVATIS IS AND WHAT IT IS USED FOR
Cinacalcet Devatis works by controlling the levels of parathyroid
hormone (PTH), calcium and phosphorous
in your body. It is used to treat problems with organs called
parathyroid glands. The parathyroids are four
small glands in the neck, near the thyroid gland, that produce
parathyroid hormone (PTH).
Cinacalcet Devatis is used in adults:
-
to treat secondary hyperparathyroidism in adults with serious kidney
disease who need dialysis to clear
their blood of waste products.
-
to reduce high levels of calcium in the blood (hypercalcaemia) in
adult patients with parathyroid cancer.
-
to reduce high levels of calcium in the blood (hypercalcaemia) in
adult patients with primary
hyperparathyroidism when removal of the gland is not possible.
Cinacalcet Devatis is used in children aged 3 years to less than 18
years of age:
-
to treat secondary hyperparathyroidism in patients with serious kidney
disease who need dialysis to
clear their blood of waste pro

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cinacalcet Devatis 30 mg filmomhulde tabletten
Cinacalcet Devatis 60 mg filmomhulde tabletten
Cinacalcet Devatis 90 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg cinacalcet (as hydrochloride)
Each tablet contains 60 mg cinacalcet (as hydrochloride)
Each tablet contains 90 mg cinacalcet (as hydrochloride)
Excipient with known effect:
Each 30 mg tablet contains 0.285 mg of lactose
Each 60 mg tablet contains 0.57 mg of lactose
Each 90 mg tablet contains 0.855 mg of lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
30 mg tablets:
Light green, oval film-coated tablets, marked with “30” on one
side and the dimensions 7.1 mm x 4.6 mm.
60 mg tablets:
Light green, oval film-coated tablets, marked with “60” on one
side and the dimensions 8.8 mm x 5.6 mm.
90 mg tablets
Light green, oval film-coated tablets, marked with “90” on one
side and the dimensions 10.1 mm x 6.6 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Secondary hyperparathyroidism
_Adults _
Treatment of secondary hyperparathyroidism (HPT) in adult patients
with end-stage renal disease (ESRD) on
maintenance dialysis therapy.
_Paediatric population _
Treatment of secondary hyperparathyroidism (HPT) in children aged 3
years and older with end-stage renal
disease (ESRD) on maintenance dialysis therapy in whom secondary HPT
is not adequately controlled with
standard of care therapy (see section 4.4).
Cinacalcet may be used as part of a therapeutic regimen including
phosphate binders and/or Vitamin D
sterols, as appropriate (see section 5.1).
Parathyroid carcinoma and primary hyperparathyroidism in adults
2
Reduction of hypercalcaemia in adult patients with:
•
parathyroid carcinoma.
•
primary HPT for whom parathyroidectomy would be indicated on the basis
of serum calcium levels (as
defined by relevant treatment guidelines), but in whom
parathyroidectomy is not clinically appr