Cinacalcet Aristo 30 mg, filmomhulde tabletten

Pajjiż: Olanda

Lingwa: Olandiż

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

Ingredjent attiv:

CINACALCETHYDROCHLORIDE 33 mg/stuk SAMENSTELLING overeenkomend met ; CINACALCET 30 mg/stuk

Disponibbli minn:

Aristo Pharma GmbH Wallenroder Strasse 8-10 13435 BERLIJN (DUITSLAND)

Kodiċi ATC:

H05BX01

INN (Isem Internazzjonali):

CINACALCETHYDROCHLORIDE 33 mg/stuk SAMENSTELLING overeenkomend met ; CINACALCET 30 mg/stuk

Għamla farmaċewtika:

Filmomhulde tablet

Kompożizzjoni:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 6000 ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMSTEARYLFUMARAAT ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 6000 ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMSTEARYLFUMARAAT ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171)

Rotta amministrattiva:

Oraal gebruik

Żona terapewtika:

Cinacalcet

Data ta 'l-awtorizzazzjoni:

1900-01-01

Fuljett ta 'informazzjoni

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CINACALCET ARISTO 30 MG, FILMOMHULDE TABLETTEN
CINACALCET ARISTO 60 MG, FILMOMHULDE TABLETTEN
CINACALCET ARISTO 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 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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [product name] is and what it is used for
2.
What you need to know before you take [product name]
3.
How to take [product name]
4.
Possible side effects
5.
How to store [product name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[Product name] 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).
[Product name] 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.
In primary and secondary hyperparathyroidism too much PTH is produced
by the parathyroid glands.
“Primary” means that the hyperparathyroidism is not caused by any
other condition and “secondary”
means that the hyperparathyroidism is caused by anoth

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cinacalcet Aristo 30 mg, filmomhulde tabletten
Cinacalcet Aristo 60 mg, filmomhulde tabletten
Cinacalcet Aristo 90 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains cinacalcet hydrochloride equivalent
to 30 mg, 60 mg or 90 mg
cinacalcet.
Excipient with known effect
_[product name] 30 mg film-coated tablets _
Each 30 mg tablet contains approximately 2mg of lactose.
Each 30 mg tablet contains approximately 0.05mg of sodium.
_[product name] 60 mg film-coated tablets _
Each 60 mg tablet contains approximately 5 mg of lactose.
Each 60 mg tablet contains approximately 0.1mg of sodium.
_[product name] 90 mg film-coated tablets _
Each 90 mg tablet contains approximately 7 mg of lactose.
Each 90 mg tablet contains approximately 0.2mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
_[product name] 30 mg film-coated tablets _
White to off-white, oval shaped film-coated tablets debossed with
‘30’ on one side, with a length of
approximately 10.0 mm and a width of approximately 6.3 mm.
_[product name] 60 mg film-coated tablets _
White to off-white, oval shaped film-coated tablets debossed with
‘60’ on one side, with a length of
approximately. 12.5 mm and a width of approximately 7.9 mm.
_[product name] 90 mg film-coated tablets _
White to off-white, oval shaped film-coated tablets debossed with
‘90’ on one side, with a length of
approximately. 14.3 mm and a width of approximately 9.0 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
_Secondary hyperparathyroidism in adults _
Adults
Treatment of secondary hyperparathyroidism (HPT) in adult patients
with end-stage renal disease
(ESRD) on maintenance dialysis therapy.
[product name] 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 adult