MabThera

Šalis: Armėnija

kalba: anglų

Šaltinis: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Veiklioji medžiaga:

rituximab

Prieinama:

F. Hoffmann-La Roche Ltd. Wurmisweg CH-4303 Kaiseraugst-batch releaser

INN (Tarptautinis Pavadinimas):

rituximab

Dozė:

100mg/10ml

Vaisto forma:

concentrate for solution for infusion

Recepto tipas:

Prescription

Pakuotės lapelis

MABTHERA
®
Rituximab
1.
DESCRIPTION
1.1
THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG
Anti-neoplastic agent
ATC Code: L01XC02
1.2
TYPE OF DOSAGE FORM
Concentrate for solution for infusion.
1.3
ROUTE OF ADMINISTRATION
Intravenous (i.v.) infusion.
1.4
STERILE/RADIOACTIVE STATEMENT
Sterile.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: rituximab
MabThera/Rituxan is a clear, colourless liquid supplied in sterile,
preservative-free, non-pyrogenic
single-dose vials.
Single-dose vials: Vials contain 100 mg/10 ml and 500 mg/50 ml.
Excipients: Sodium citrate, polysorbate 80, sodium chloride, sodium
hydroxide, hydrochloric acid,
water for injections.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
_NON-HODGKIN’S LYMPHOMA_
MabThera/Rituxan is indicated for the treatment of:
–
patients with relapsed or chemoresistant low-grade or follicular,
CD20-positive, B-cell
non-Hodgkin’s lymphoma;
–
previously untreated patients with stage III-IV follicular lymphoma in
combination with
chemotherapy;
–
patients with follicular lymphoma as maintenance treatment, after
response to induction therapy;
–
patients with CD20-positive diffuse large B-cell non-Hodgkin’s
lymphoma in combination with
CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone)
chemotherapy.
_CHRONIC LYMPHOCYTIC LEUKAEMIA_
MabThera/Rituxan in combination with chemotherapy is indicated for the
treatment of patients with
previously untreated and relapsed/refractory chronic lymphocytic
leukaemia (CLL).
_RHEUMATOID ARTHRITIS_
MabThera/Rituxan in combination with methotrexate is indicated in
adult patients for:
-
the treatment of moderate to severe, active rheumatoid arthritis when
the response to
disease-modifying anti-rheumatic drugs including methotrexate has been
inadequate.
-
the treatment of moderate to severe, active rheumatoid arthritis in
patients with an inadequate
response or intolerance to one or more tumour necrosis factor (TNF)
inhibitor therapies.
MabThera/Rituxan has been shown to reduce the rate of progression of
joi

Prekės savybės

Summary of Product Characteristics
MabThera
1
MABTHERA
®
Rituximab
1.
DESCRIPTION
1.1
THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG
Anti-neoplastic agent
ATC Code: L01XC02
1.2
TYPE OF DOSAGE FORM
Concentrate for solution for infusion.
1.3
ROUTE OF ADMINISTRATION
Intravenous (i.v.) infusion.
1.4
STERILE/RADIOACTIVE STATEMENT
Sterile.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: rituximab
MabThera/Rituxan is a clear, colourless liquid supplied in sterile,
preservative-free, non-
pyrogenic single-dose vials.
Single-dose vials: Vials contain 100 mg/10 ml and 500 mg/50 ml.
Excipients:
Sodium
citrate,
polysorbate
80,
sodium
chloride,
sodium
hydroxide,
hydrochloric acid, water for injections.
2.
CLINICAL
PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
_NON-HODGKIN’S LYMPHOMA _
MabThera/Rituxan is indicated for the treatment of:
–
patients with relapsed or chemoresistant low-grade or follicular,
CD20-positive,
B-cell non-Hodgkin’s lymphoma;
–
previously
untreated
patients
with
stage
III-IV
follicular
lymphoma
in
combination with chemotherapy;
–
patients with follicular lymphoma as maintenance treatment, after
response to
induction therapy;
Summary of Product Characteristics
MabThera
2
–
patients with CD20-positive diffuse large B-cell non-Hodgkin’s
lymphoma in
combination
with
CHOP
(cyclophosphamide,
doxorubicin,
vincristine
and
prednisone) chemotherapy.
_CHRONIC LYMPHOCYTIC LEUKAEMIA _
MabThera/Rituxan in combination with chemotherapy is indicated for the
treatment of
patients with previously untreated and relapsed/refractory chronic
lymphocytic leukaemia
(CLL).
_RHEUMATOID ARTHRITIS _
MabThera/Rituxan in combination with methotrexate is indicated in
adult patients for:
-
the treatment of moderate to severe, active rheumatoid arthritis when
the response
to
disease-modifying
anti-rheumatic
drugs
including
methotrexate
has
been
inadequate.
-
the treatment of moderate to severe, active rheumatoid arthritis in
patients with an
inadequate response or intolerance to one or more tumour necrosis
factor (TN