ACTEMRA 20 MGML I.V.

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

TOCILIZUMAB

Fáanlegur frá:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

ATC númer:

L04AC07

Lyfjaform:

CONCENTRATE FOR SOLUTION FOR INFUSION

Samsetning:

TOCILIZUMAB 20 MG/ML

Stjórnsýsluleið:

I.V

Gerð lyfseðils:

Required

Framleitt af:

HOFFMANN LA ROCHE LTD, SWITZERLAND

Meðferðarhópur:

TOCILIZUMAB

Lækningarsvæði:

TOCILIZUMAB

Ábendingar:

Actemra (tocilizumab), is indicated for reducing signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis who had an inadequate response to one or more DMARDs(Disease Modifying Anti-Rheumatic Drugs) or TNF antagonists or in whom DMARDs cannot be used. Actemra can be used alone or in combination with methotrexate or other DMARDs. Actemra 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. Actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. Actemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (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. Actemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Actemra in combination with methotrexate (MTX) in indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX.Actemra 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 3 years of age and older.Actemra 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.

Leyfisdagur:

2014-12-31

Upplýsingar fylgiseðill

Roche Pharmaceuticals (Israel) Ltd
Drugs regulatory affairs
6
Hacharash St.
P.O.B. 6391
Hod Hasharon 4524079
Tel. + 972-9-9737777
Fax + 972-9-9737850
רבמצד
2019
,ה/רקי ה/אפור
ר
,ה/רקי ת/חקו
לע םכעידוהל תשקבמ מ"עב )לארשי(
הקיטבצמרפ שור תרבח
אפורל ןולעב ועצובש םינוכדע רפסמ
רישכתה לש
.
צמ וז העדוהב
.הרמחה םיווהמ רשא םינוכדעו םייתוהמ
םינוכדע קר םיניו
יוותהה
תו
מושרה
תו
ל רישכת
:לארשיב
Actemra (tocilizumab) is indicated for reducing signs and symptoms in
adult patients with
moderately to severely active rheumatoid arthritis who had an
inadequate response to
one or more DMARDs (Disease Modifying Anti-Rheumatic Drugs) or TNF
antagonists or
in whom DMARDs cannot be used. Actemra can be used alone or in
combination with
methotrexate or other DMARDs.
Actemra 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.
Actemra is indicated for the treatment of active systemic juvenile
idiopathic arthritis in
patients 2 years of age and older.
Actemra in combination with methotrexate (MTX) is indicated for the
treatment of juvenile
idiopathic polyarthritis (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.
Actemra can be given as monotherapy in case of intolerance to MTX or
where continued
treatment with MTX is inappropriate.
Actemra in combination with methotrexate (MTX) in indicated for the
treatment of severe,
active and progressive rheumatoid arthritis (RA) in adults not
previously treated with MTX.
:רבסה
יתחת וק םע טסקט
.ןולעל ףסוהש טסקט ןייצמ
הצוח וק םע טסקט
.ןולעה ןמ רסוהש טסקט ןייצמ
ל ןולעב ןייעל שי ףסונ עדימל
אפור
יפכ
חלשנש
�

Vara einkenni

Ref: EMEA/H/C/000955//N/0118
Actemra IV_PI_Ver 12.0
Actemra IV_PI_Ver 12.0
Actemra 20mg/ml I.V.
®
TOCILIZUMAB
Concentrate for solution for infusion
1.
NAME OF THE MEDICINAL PRODUCT
Actemra 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
Actemra (tocilizumab) is indicated for reducing signs and symptoms in
adult patients with moderately
to severely active rheumatoid arthritis who had an inadequate response
to one or more DMARDs
(Disease Modifying Anti-Rheumatic Drugs) or TNF antagonists or in whom
DMARDs cannot be
used. Actemra can be used alone or in combination with methotrexate or
other DMARDs.
Actemra 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.
Actemra 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.
Actemra is indicated for the treatment of active systemic juvenile
idiopathic arthritis in patients 2
years of age and older.
Actemra in combination with methotrexate (MTX) is indicated for the
treatment o