Tecentriq 1200mg20ml solution for infusion vials

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Atezolizumab

Fáanlegur frá:

Imported (United States

INN (Alþjóðlegt nafn):

Atezolizumab

Skammtar:

60mg/1ml

Lyfjaform:

Solution for infusion

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF:

Upplýsingar fylgiseðill

1
uk-ie-mt-pil-Tecentriq-clean-180404-1200mg-inf
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TECENTRIQ 1,200 MG CONCENTRATE FOR SOLUTION FOR INFUSION
atezolizumab
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 or nurse.
•
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tecentriq is and what it is used for
2.
What you need to know before you are given Tecentriq
3.
How Tecentriq is given
4.
Possible side effects
5.
How to store Tecentriq
6.
Contents of the pack and other information
1.
WHAT TECENTRIQ IS AND WHAT IT IS USED FOR
WHAT TECENTRIQ IS
Tecentriq is an anti-cancer medicine that contains the active
substance atezolizumab. It belongs to a
group of medicines called monoclonal antibodies. A monoclonal antibody
is a type of protein designed
to recognise and attach to a specific target in the body.
WHAT TECENTRIQ IS USED FOR
Tecentriq is used to treat adults with:
•
a cancer that affects the bladder and the urinary system, called
urothelial carcinoma. It is used
when this cancer has:
-
spread to other parts of the body
-
come back after previous treatment
-
or, if you cannot receive cisplatin treatment.
•
a cancer that affects the lungs, called non-small cell lung cancer. It
is used when this cancer has:
-
spread to other parts of the body
-
come back after previous treatment.
HOW TECENTRIQ WORKS
Tecentriq works by attaching to a specific protein in your body called
programmed death-ligand 1
(PD-L1). This protein suppresses the body’s immune (defense) system,
thereby protecting

Vara einkenni

OBJECT 1
TECENTRIQ 1,200 MG CONCENTRATE FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 17-Apr-2018 | Roche
Products Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Tecentriq 1,200 mg concentrate for solution for infusion.
2. Qualitative and quantitative composition
Each 20 mL vial of concentrate contains 1,200 mg atezolizumab*.
After dilution (see section 6.6)_, _one mL of solution contains
approximately 4.4 mg of atezolizumab.
*Atezolizumab is an Fc-engineered, humanised IgG1 anti-programmed
death-ligand 1 (PD-L1)
monoclonal antibody produced in Chinese hamster ovary cells by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion.
Clear, colourless to slightly yellowish liquid.
4. Clinical particulars
4.1 Therapeutic indications
Tecentriq as monotherapy is indicated for the treatment of adult
patients with locally advanced or
metastatic urothelial carcinoma (UC) after prior platinum-containing
chemotherapy or who are considered
cisplatin ineligible (see section 5.1).
Tecentriq as monotherapy is indicated for the treatment of adult
patients with locally advanced or
metastatic non-small cell lung cancer (NSCLC) after prior
chemotherapy. Patients with EGFR activating
mutations or ALK-positive tumour mutations should also have received
targeted therapy before receiving
Tecentriq (see section 5.1).
4.2 Posology and method of administration
Tecentriq must be initiated and supervised by physicians experienced
in the treatment of cancer.
Posology
The recommended dose of Tecentriq is 1,200 mg administered
intravenously every three weeks.
_Duration of treatment_
It is recommended that patients are treated with Tecentriq until loss
of clinical benefit (see section 5.1) or
unm