RoActemra
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
20-03-2024
Valmisteyhteenveto
(SPC)
20-03-2024
Julkisesta arviointikertomuksesta
(PAR)
10-12-2021
Aktiivinen ainesosa:
tocilizumab
Saatavilla:
Roche Registration GmbH
ATC-koodi:
L04AC07
INN (Kansainvälinen yleisnimi):
tocilizumab
Terapeuttinen ryhmä:
Immunosuppressants
Terapeuttinen alue:
Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Cytokine Release Syndrome; Giant Cell Arteritis; COVID-19 virus infection
Käyttöaiheet:
RoActemra, in combination with methotrexate (MTX), is indicated forthe treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX.the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.RoActemra is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients.RoActemra, in combination with methotrexate (MTX), is indicated for:the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX.the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.RoActemra is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.RoActemra is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.RoActemra, in combination with methotrexate (MTX), is indicated for:the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX.the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.RoActemra is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.RoActemra is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.
Tuoteyhteenveto:
Revision: 41
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2009-01-15
Pakkausseloste
133
B. PACKAGE LEAFLET
134
PACKAGE LEAFLET: INFORMATION FOR THE USER
ROACTEMRA 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
tocilizumab
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.
This medicine has been prescribed for you only.
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.
In addition to this leaflet, you will be given a
PATIENT ALERT CARD
, which contains important safety
information that you need to be aware of before and during treatment
with RoActemra.
WHAT IS IN THIS LEAFLET
:
1.
What RoActemra is and what it is used for
2.
What you need to know before you are given RoActemra
3.
How RoActemra is given
4.
Possible side effects
5.
How to store RoActemra
6.
Contents of the pack and other information
1.
WHAT ROACTEMRA IS AND WHAT IT IS USED FOR
RoActemra contains the active substance tocilizumab, which is a
protein made from specific immune
cells (monoclonal antibody), that blocks the action of a specific
protein (cytokine) called interleukin-6.
This protein is involved in inflammatory processes of the body, and
blocking it can reduce the
inflammation in your body. RoActemra helps to reduce symptoms such as
pain and swelling in your
joints and can also improve your performance of daily tasks. RoActemra
has been shown to slow the
damage to the cartilage and bone of the joints caused by the disease
and to improve your ability to do
normal daily activities.
ROACTEMRA IS USED TO TREAT ADULTS
with moderate to severe active rheumatoid arthritis (RA),
an autoimmune disease, if previous therapies did not work well enough.
RoActemra is usually
given in combination with methotrexate. However, RoActemra can be
given alone if your
doctor determines that methotrexate is inappropriate.
RoActemra can also be used to treat adults who have not had
Lue koko asiakirja
Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME
OF
THE
MEDICINAL
PRODUCT
RoActemra 20 mg/mL concentrate for solution for infusion.
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
Each mL concentrate contains 20 mg tocilizumab*.
Each vial contains 80 mg of tocilizumab* in 4 mL (20 mg/mL).
Each vial contains 200 mg of tocilizumab* in 10 mL (20 mg/mL).
Each vial contains 400 mg of tocilizumab* in 20 mL (20 mg/mL).
*humanised IgG1 monoclonal antibody against the human interleukin-6
(IL-6) receptor produced in
Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Excipients with known effects
Each 80 mg vial contains 0.10 mmol (2.21 mg) sodium.
Each 200 mg vial contains 0.20 mmol (4.43 mg) sodium.
Each 400 mg vial contains 0.39 mmol (8.85 mg) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Concentrate for solution for infusion (sterile concentrate).
Clear to opalescent, colourless to pale yellow solution.
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
RoActemra, in combination with methotrexate (MTX), is indicated for:
the treatment of severe, active and progressive rheumatoid arthritis
(RA) in adults not
previously treated with MTX.
the treatment of moderate to severe active RA in adult patients who
have either responded
inadequately to, or who were intolerant to, previous therapy with one
or more disease-
modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor
(TNF) antagonists.
In these patients, RoActemra can be given as monotherapy in case of
intolerance to MTX or where
continued treatment with MTX is inappropriate.
RoActemra has been shown to reduce the rate of progression of joint
damage as measured by X-ray
and to improve physical function when given in combination with
methotrexate.
RoActemra is indicated for the treatment of coronavirus disease 2019
(COVID-19) in adults who are
receiving systemic corticosteroids and require supplemental oxygen or
mechanical ventilation.
RoActemra is indicated for the treatment of active systemic juvenile
idiopathi
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