Cinacalcet DOC 60 mg, filmomhulde tabletten

국가: 네덜란드

언어: 네덜란드어

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

유효 성분:

CINACALCETHYDROCHLORIDE 66,1 mg/stuk SAMENSTELLING overeenkomend met ; CINACALCET 60 mg/stuk

제공처:

DOC Generici S.r.l. Via Filippo Turati 40 20121 MILANO (ITALIË)

ATC 코드:

H05BX01

INN (국제 이름):

CINACALCETHYDROCHLORIDE 66,1 mg/stuk SAMENSTELLING overeenkomend met ; CINACALCET 60 mg/stuk

약제 형태:

Filmomhulde tablet

구성:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

관리 경로:

Oraal gebruik

치료 영역:

Cinacalcet

제품 요약:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); IJZEROXIDE GEEL (E 172); INDIGOKARMIJN ALUMINIUMLAK (E 132); MACROGOL 4000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

승인 날짜:

1900-01-01

환자 정보 전단

15.02.2018: national AIC in NL (duplicate);
21.03.2018: approval var.01/G (RVG122007-122008-122009/IA/001/G) Type
IA B.II.e.5.b. Deletion
of a pack sizes, Type IAIN B.II.b.1.a addition of secondary packager
(SCF).
11.10.2018: NL/H/l4457/001-003/MR with the national finalization of
the MRP, en-common texts
with national details were approved (DOC Generici declared that the
product was never marketed in
the Netherlands and commit that (new) Dutch product information will
be submitted for approval
before the product will be marketed in the Netherlands).
The PI have been updated, but not with substantial changes, therefore
the approval date has not been
changed.; NL/H/4457/IB/002/G 2x IB C.I.2.a + QRD
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CINACALCET DOC 30 MG, FILMOMHULDE TABLETTEN
CINACALCET DOC 60 MG, FILMOMHULDE TABLETTEN
CINACALCET DOC 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 [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 para

제품 특성 요약

15.02.2018: national AIC in NL (duplicate);
21.03.2018: approval var.01/G (RVG122007-122008-122009/IA/001/G) Type
IA B.II.e.5.b. Deletion
of a pack sizes, Type IAIN B.II.b.1.a addition of secondary packager
(SCF).
11.10.2018: NL/H/l4457/001-003/MR with the national finalization of
the MRP, en-common texts
with national details were approved (DOC Generici declared that the
product was never marketed in
the Netherlands and commit that (new) Dutch product information will
be submitted for approval
before the product will be marketed in the Netherlands).
The PI have been updated, but not with substantial changes, therefore
the approval date has not been
changed.; NL/H/4457/IB/002/G 2x IB C.I.2.a + QRD approved on
29.10.2020
1.
NAME OF THE MEDICINAL PRODUCT
CINACALCET DOC 30 MG, FILMOMHULDE TABLETTEN
CINACALCET DOC 60 MG, FILMOMHULDE TABLETTEN
CINACALCET DOC 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).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Green oval biconvex coated tablets (approximately 4.5 x 7 mm),
debossed with C9CC on one side and
30 on the other side
Green oval biconvex coated tablets (approximately 5.5 x 9 mm),
debossed with C9CC on one side and
60 on the other side
Green oval biconvex coated tablets (approximately 6.5 x 10.5 mm),
debossed with C9CC on one side
and 90 on the other side
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of secondary hyperparathyroidism (HPT) in 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).
Reduction of hypercalcaemia in patients with:
• parathyroid carcinoma.
• primary HPT for whom parathyroidectomy would be indicated on the
b