Imatinib Sandoz 100 mg, filmomhulde tabletten

国家: 荷兰

语言: 荷兰文

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

有效成分:

IMATINIBMESILAAT 119,5 mg/stuk SAMENSTELLING overeenkomend met ; IMATINIB 100 mg/stuk

可用日期:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC代码:

L01XE01

INN（国际名称）:

IMATINIBMESILAAT 119,5 mg/stuk SAMENSTELLING overeenkomend met ; IMATINIB 100 mg/stuk

药物剂型:

Filmomhulde tablet

组成:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B),

给药途径:

Oraal gebruik

治疗领域:

Imatinib

產品總結:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 4000; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TALK (E 553 B);

授权日期:

2015-12-02

资料单张

Sandoz B.V.
Page 1/10
Imatinib Sandoz
®
100/400 mg, filmomhulde tabletten
RVG 116276- 116277
1313-V13
1.3.1.3 Bijsluiter
September 2022
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
IMATINIB SANDOZ
® 100 MG, FILMOMHULDE TABLETTEN
IMATINIB SANDOZ
® 400 MG, FILMOMHULDE TABLETTEN
imatinib
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 [Nationally completed name] is and what it is used for
2. What you need to know before you take [Nationally completed name]
3. How to take [Nationally completed name]
4. Possible side effects
5. How to store [Nationally completed name]
6. Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] is a medicine containing an active
substance called imatinib. This
medicine works by inhibiting the growth of abnormal cells in the
diseases listed below. These include
some types of cancer.
[NATIONALLY COMPLETED NAME] IS A TREATMENT FOR ADULTS AND CHILDREN
FOR:
•
CHRONIC MYELOID LEUKAEMIA (CML).
Leukaemia is a cancer of white blood cells. These
white cells usually help the body to fight infection. Chronic myeloid
leukaemia is a form of
leukaemia in which certain abnormal white cells (named myeloid cells)
start growing out of
control.
•
PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKAEMIA
(PH-POSITIVE ALL)
.
Leukaemia is a cancer of white blood cells. These white cells usually
help the body to fight
infection. Acute lymphoblastic leukaemia is a form of leukaemia in
which certa

产品特点

Sandoz B.V.
Page 1/38
Imatinib Sandoz 100/400 mg, filmomhulde tabletten
RVG 116276, 116277
1311-V14
1.3.1.1 Samenvatting van de Productkenmerken
November 2022
1.
NAME OF THE MEDICINAL PRODUCT
Imatinib Sandoz 100 mg, filmomhulde tabletten
Imatinib Sandoz 400 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg of imatinib (as mesilate).
Each film-coated tablet contains 400 mg of imatinib (as mesilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Very dark yellow to brownish orange, round, biconvex with bevelled
edges, debossed with “NVR” on
one side and “SA” and score between the letters on the other side.
Approximate diameter 9.2 mm.
Very dark yellow to brownish orange, ovaloid, biconvex with bevelled
edges, debossed with “400” on
one side and score on the other side and SL on each side of the score.
Approximate length 19.2 mm
and width 7.7 mm.
The film-coated tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] is indicated for the treatment of
•
adult and paediatric patients with newly diagnosed Philadelphia
chromosome (bcr-abl) positive
(Ph+)
chronic
myeloid
leukaemia
(CML)
for
whom
bone
marrow
transplantation is
not
considered as the first line of treatment.
•
adult and paediatric patients with Ph+ CML in chronic phase after
failure of interferon-alpha
therapy, or in accelerated phase or blast crisis.
•
adult and paediatric patients with newly diagnosed Philadelphia
chromosome positive acute
lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
•
adult patients with relapsed or refractory Ph+ ALL as monotherapy.
•
adult patients with myelodysplastic/myeloproliferative diseases
(MDS/MPD) associated with
platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
•
adult patients with advanced hypereosinophilic syndrome (HES) and/or
chronic eosinophilic
leukaemia (CEL) with FIP1L1-PDGFRα rearrange