Zelbeen Tablet 150

Nchi: Tanzania

Lugha: Kiingereza

Chanzo: Tanzania Medicinces & Medical Devices Authority

Viambatanisho vya kazi:

Capecitabine

Inapatikana kutoka:

Eurolab (Pty) Ltd, SOUTH AFRICA

ATC kanuni:

Antimetabolites

INN (Jina la Kimataifa):

Capecitabine

Kipimo:

150

Dawa fomu:

Tablet

Viwandani na:

REMEDICA LIMITED, CYPRUS

Bidhaa muhtasari:

Physical description: Light-Peach, oval, film-coated tablets embossed with ''150'' on one side. Of approximate dimensions 11.4mm X 5.9mm; Local technical representative: BB PHARMA CONSULTANCY LTD (3955)

Idhini hali ya:

Registered/Compliant

Idhini ya tarehe:

2021-11-26

Tabia za bidhaa

1
SUMMARY OF PRODUCT CHARACTERISTICS (SMPC)
1.
NAME OF THE MEDICINAL PRODUCT
Zelbeen 150 mg film-coated tablets
Zelbeen 500 mg film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zelbeen 150 mg film-coated tablets
Each film-coated tablet contains 150 mg Capecitabine.
Zelbeen 500 mg film-coated tablets
Each film-coated tablet contains 500 mg Capecitabine
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Zelbeen 150 mg film-coated tablets
The film-coated tablets are Light-peach oval film-coated tablets
embossed with “150” on one side.
Of approximate dimensions 11.4 mm x 5.9 mm
Zelbeen 500 mg film-caoted tablets
The film-coated tablets are Peach, oblong capsule-shaped, film-coated
tablets embossed with
“500” on one side. Of approximate dimensions 17.1 mm x 8.1 mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zelbeen is indicated for the treatment of:
-for the adjuvant treatment of patients following surgery of stage III
(Dukes’ stage C) colon
cancer (see section 5.1).
-
metastatic colorectal cancer (see section 5.1).
-
first-line treatment of advanced gastric cancer in combination with a
platinum-based
regimen (see section 5.1).
-
in combination with docetaxel (see section 5.1) for the treatment of
patients with locally
advanced or metastatic breast cancer after failure of cytotoxic
chemotherapy. Previous
therapy should have included an anthracycline.
2
-
as monotherapy for the treatment of patients with locally advanced or
metastatic breast
cancer after failure of taxanes and an anthracycline-containing
chemotherapy regimen or
for whom further anthracycline therapy is not indicated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Zelbeen should only be prescribed by a qualified physician experienced
in the utilisation of
anti- neoplastic medicinal products. Careful monitoring during the
first cycle of treatment is
recommended for all patients.
Treatment should be discontinued if progressive disease or intolerable
toxicity is observed.
Standard and redu