Actemra concentrate for solution for i/v infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

tocilizumab

Available from:

F. Hoffmann-La Roche Ltd.

ATC code:

L04AC07

INN (International Name):

tocilizumab

Dosage:

20mg/ml

Pharmaceutical form:

concentrate for solution for i/v infusion

Units in package:

(1) glass vial 4ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-12-03

Patient Information leaflet

Artwork
Creator
Date
Version
Signature
Proofreader
Date
Signature
Perigord / MAH
12 Mar 2020
1
Genisys-No.
10223673
make-up code:
FE
Type size:
8 pt
Printing colour:
Pantone Black
Format:
450x500 mm folded: 47x60 mm
Drawing Norm:
NP9357 17.08.10 10.114
ACTEMRA
®
Tocilizumab
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6)
receptor monoclonal antibody of the immunoglobulin (Ig) IgG
1
subclass.
ATC Code: L04AC07.
1.2
TYPE OF DOSAGE FORM
Concentrate solution for infusion.
1.3
ROUTE OF ADMINISTRATION
Intravenous (IV) infusion.
1.4
STERILE / RADIOACTIVE STATEMENT
Sterile.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: tocilizumab.
Tocilizumab is a clear to opalescent, colorless to pale yellow liquid,
supplied in preservative-free, nonpyrogenic single-use vials.
Tocilizumab is supplied in 10 ml and 20 ml vials containing 4 ml, 10
ml
or 20 ml of tocilizumab (20 mg/ml).
Excipients: polysorbate 80, sucrose, disodium phosphate dodecahydrate,
sodium dihydrogen phosphate dihydrate and water for injections.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
RHEUMATOID ARTHRITIS (RA)
Tocilizumab is indicated for the treatment of moderate to severe
active
rheumatoid arthritis (RA) in adult patients. Tocilizumab can be used
alone
or in combination with methotrexate (MTX) and/or other disease-
modifying anti-rheumatic drugs (DMARDs). Tocilizumab has been
shown to inhibit progression of joint damage as measured by X-ray and
to
improve physical function.
POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (PJIA)
Tocilizumab is indicated for the treatment of active polyarticular
juvenile
idiopathic arthritis in patients 2 years of age and older. Tocilizumab
can
be given alone or in combination with MTX.
SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA)
Tocilizumab is indicated for the treatment of active systemic juvenile
idiopathic arthritis in patients 2 years of age and older. Tocilizumab
can
be given alone or in combination with MTX.
2.2

Summary of Product characteristics

March 2019
Product Information FE/English
Ro-4877533
Actemra
March 2019
Product Information FE/English
1
ACTEMRA
®
Tocilizumab
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Tocilizumab
is
a
recombinant
humanized
anti-human
interleukin-6
(IL-6)
receptor
monoclonal antibody of the immunoglobulin (Ig) IgG
1
subclass.
ATC Code: L04AC07.
1.2
TYPE OF DOSAGE FORM
Concentrate solution for infusion.
1.3
ROUTE OF ADMINISTRATION
Intravenous (IV) infusion.
1.4
STERILE / RADIOACTIVE STATEMENT
Sterile.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: tocilizumab.
Tocilizumab
is
a
clear
to
opalescent,
colorless
to
pale
yellow
liquid,
supplied
in
preservative-free, nonpyrogenic single-use vials.
Tocilizumab is supplied in 10 ml and 20 ml vials containing 4 ml, 10
ml or 20 ml of
tocilizumab (20 mg/ml).
Excipients:
polysorbate
80,
sucrose,
disodium
phosphate
dodecahydrate,
sodium
dihydrogen phosphate dihydrate and water for injections.
2.
CLINICAL
PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
RHEUMATOID ARTHRITIS (RA)
Tocilizumab is indicated for the treatment of moderate to severe
active rheumatoid
arthritis (RA) in adult patients. Tocilizumab can be used alone or in
combination with
methotrexate (MTX) and/or other disease-modifying anti-rheumatic drugs
(DMARDs).
Tocilizumab has been shown to inhibit progression of joint damage as
measured by X-ray
and to improve physical function.
POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (PJIA)
March 2019
Product Information FE/English
Ro-4877533
Actemra
March 2019
Product Information FE/English
2
Tocilizumab is indicated for the treatment of active polyarticular
juvenile idiopathic
arthritis in patients 2 years of age and older. Tocilizumab can be
given alone or in
combination with MTX.
SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA)
Tocilizumab is indicated for the treatment of active systemic juvenile
idiopathic arthritis
in patients 2 years of age and older. Tocilizumab can be given alone
or in combination
with MTX.
2.2
DOSAGE AND ADMINISTRATION
_General _
Tociliz