MABTHERA SOLUTION FOR SUBCUTANEOUS INJECTION 1400MG

Ülke: Singapur

Dil: İngilizce

Kaynak: HSA (Health Sciences Authority)

Aktif bileşen:

Rituximab

Mevcut itibaren:

ROCHE SINGAPORE PTE. LTD.

ATC kodu:

L01XC02

Farmasötik formu:

INJECTION, SOLUTION

Kompozisyon:

Rituximab 1400mg

Uygulama yolu:

SUBCUTANEOUS

Reçete türü:

Prescription Only

Tarafından üretildi:

F. Hoffmann-La Roche Ltd

Yetkilendirme durumu:

ACTIVE

Yetkilendirme tarihi:

2016-06-01

Ürün özellikleri

1
Please visit www.roche.com.sg/pharma/mabthera for a printable version
of this leaflet.
INF/INJ-MAB-2022 08-0
MabThera
®
Rituximab
1.
DESCRIPTION
1.1
THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG
Antineoplastic agent.
ATC Code: L01FA01
1.2
TYPE OF DOSAGE FORM
Intravenous (IV) formulation: concentrate for solution for infusion
Subcutaneous (SC) formulation: solution for subcutaneous injection
1.3
ROUTE OF ADMINISTRATION
Intravenous formulation: intravenous infusion
Subcutaneous formulation: subcutaneous injection
1.4
STERILE/RADIOACTIVE STATEMENT
Sterile product.
The content of the vial is a clear to opalescent liquid, colorless to
pale yellow.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient:
rituximab.
_INTRAVENOUS FORMULATION _
MabThera IV is a clear, colourless liquid supplied in sterile,
preservative-free, non-pyrogenic single-dose vials.
Excipients: Sodium citrate, Polysorbate 80, Sodium chloride, Water for
injection
Single-dose vials contain 100 mg/10 ml and 500 mg/50 ml.
_SUBCUTANEOUS FORMULATION _
MabThera SC is a clear to opalescent, colourless to yellowish liquid
supplied in sterile, preservative-free, non-pyrogenic, single use
vials.
MabThera SC contains recombinant human hyaluronidase (rHuPH20), an
enzyme used to increase the dispersion and absorption of
co-administered
substances when administered subcutaneously
_._
Excipients:
Recombinant human hyaluronidase (rHuPH20), L-histidine, L-histidine
hydrochloride monohydrate,

,

-trehalose dihydrate, L-methionine,
Polysorbate 80, Water for injection
_Subcutaneous formulation for non-Hodgkin’s lymphoma: _
Single dose vials contain 1400 mg/11.7 mL rituximab.
2.
CLINICAL
PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
_MABTHERA IV AND MABTHERA SC _
NON-HODGKIN’S LYMPHOMA:
MabThera IV and MabThera SC are indicated for the treatment of:

patients with CD20 positive diffuse large B-cell non-Hodgkin’s
lymphoma (DLCL) in combination with CHOP (cyclophosphamide,
doxorubicin, vincristine and prednisone) chemotherapy.

previously untreated pat