TRUXIMA

Land: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

RITUXIMAB

Fáanlegur frá:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC númer:

L01XC02

Lyfjaform:

CONCENTRATE FOR SOLUTION FOR INFUSION

Samsetning:

RITUXIMAB 10 MG/ML

Stjórnsýsluleið:

I.V

Gerð lyfseðils:

Required

Framleitt af:

CELLTRION INC., SOUTH KOREA

Lækningarsvæði:

RITUXIMAB

Ábendingar:

Truxima is indicated in adults for the following indications: * Non-Hodgkin’s lymphoma (NHL) Truxima is indicated for the treatment of patients with relapsed or refractory low-grade or follicular, B-cell non-hodgkin’s lymphoma. Truxima is indicated for the treatment of previously untreated patients with low-grade or follicular lymphoma in combination with chemotherapy. Truxima is indicated for the treatment of patients with CD20 positive diffuse large B-cell non-Hodgkin's lymphoma in combination with CHOP chemotherapy. Truxima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.* Chronic lymphocytic leukaemia (CLL)Truxima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including rituximab or patients refractory to previous rituximab plus chemotherapy.* Granulomatosis with polyangiitis and microscopic polyangiitisTruxima, in combination with glucocorticoids, is indicated for the treatment of adult patients with granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis (WG)) and microscopic polyangiitis (MPA).*pemphigus vulgaris (PV):Truxima is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris (PV).

Leyfisdagur:

2023-01-31

Upplýsingar fylgiseðill

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS )PREPARATIONS( - 1986
This medicine can be sold with a doctor’s prescription only
TRUXIMA
Concentrate for solution for infusion
Each Truxima vial contains 100 mg or 500 mg rituximab.
Each ml of concentrate contains 10 mg rituximab.
Inactive ingredients and allergens: see section 6
"
Additional information
"
.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise information about the
medicine. If you have any further questions, ask the doctor or
pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them, even if it seems
to you that their illness is the same as yours.
FOR YOUR ATTENTION,
EACH TIME YOU RECEIVE THE MEDICINE IN THE PHARMACY, IT IS IMPORTANT
THAT YOU CONFIRM THAT YOU RECEIVE THE
SAME MEDICINE PRESCRIBED FOR YOU BY THE ATTENDING SPECIALIST DOCTOR
TREATING YOU. IF THE MEDICINE YOU RECEIVED
LOOKS DIFFERENT THAN THE ONE YOU USUALLY GET, OR IF THE INSTRUCTIONS
FOR USE HAVE CHANGED, PLEASE CONTACT THE
PHARMACIST IMMEDIATELY AND MAKE SURE YOU HAVE RECEIVED THE RIGHT
MEDICINE. ANY EXCHANGE OR CHANGE IN
DOSAGE OF A MEDICINE CONTAINING RITUXIMAB MUST BE PERFORMED BY THE
ATTENDING SPECIALIST DOCTOR ONLY.
PLEASE CHECK THAT THE BRAND NAME OF THE PRODUCT PRESCRIBED FOR YOU BY
THE SPECIALIST DOCTOR, IS IDENTICAL TO THE
NAME OF THE MEDICINE YOU RECEIVED FROM THE PHARMACIST.
1. WHAT IS THE MEDICINE INTENDED FOR?
Truxima is intended to treat adult patients in the following cases:
1. Non-Hodgkin lymphoma )NHL(: Truxima is indicated for the treatment
of patients with recurring or non-responsive,
low-grade or follicular B cell non-Hodgkin lymphoma. Truxima is
indicated for the treatment of previously untreated
patients with low-grade lymphoma or follicular lymphoma in combination
with chemotherapy.
Truxima is indicated for the treatment of patients with CD20 positive
diffuse large B cell non-Hodgkin lymphoma in
combination with CHOP chemotherapy.
Truxima

Vara einkenni

1
Truxima
Rituximab
Concentrate for solution for infusion
1.
NAME OF THE MEDICINAL PRODUCT
Truxima
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Truxima 100 mg concentrate for solution for infusion
Each mL contains 10 mg of rituximab.
Each 10 ml vial contains 100 mg of rituximab.
Truxima 500 mg concentrate for solution for infusion
Each mL contains 10 mg of rituximab.
Each 50 ml vial contains 500 mg of rituximab.
Rituximab is a genetically engineered chimeric mouse/human monoclonal
antibody representing a
glycosylated immunoglobulin with human IgG1 constant regions and
murine light-chain and
heavy-chain variable region sequences. The antibody is produced by
mammalian (Chinese hamster
ovary) cell suspension culture and purified by affinity chromatography
and ion exchange, including
specific viral inactivation and removal procedures.
Excipients with known effects:
Each 10 mL vial contains 2.3 mmol (52.6 mg) sodium.
Each 50 mL vial contains 11.5 mmol (263.2 mg) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear to opalescent, colourless to pale yellow liquid with pH of 6.3
– 6.8 and osmolality
of 329 - 387 mOsmol/kg.
Truxima is a biosimilar medicinal product that has been demonstrated
to be similar in quality, safety and
efficacy to the reference medicinal product MabThera. Please be aware
of any differences in the
indications between the biosimilar medicinal product and the reference
medicinal product. The biosimilar
is not to be switched with the reference medicinal product unless
specifically stated otherwise. More
detailed information regarding biosimilar medicinal products is
available on the website of the Ministry
of Health:
https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/Registration/Pages/Biosimilars.aspx
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Truxima is indicated in adults for the following indications:
Non-Hodgkin's lymphoma (NHL)
Truxima is indicated for the treatment of patients with relapsed or
refractory low-gra