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:

2023-05-18

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACTEMRA 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 Actemra.
WHAT IS IN THIS LEAFLET
:
1.
What Actemra is and what it is used for
2.
What you need to know before you are given Actemra
3.
How Actemra is given
4.
Possible side effects
5.
How to store Actemra
6.
Contents of the pack and other information
1.
WHAT ACTEMRA IS AND WHAT IT IS USED FOR
Actemra 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. Actemra helps to reduce symptoms such as
pain and swelling in your
joints and can also improve your performance of daily tasks. Actemra
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.
•
ACTEMRA IS USED TO TREAT ADULTS
with moderate to severe active rheumatoid arthritis (RA), an
autoimmune disease, if previous therapies did not work well enough.
Actemra is usually given
in combination with methotrexate. However, Actemra can be given alone
if your doctor
determines that methotrexate is inappropriate.
•
Actemra can also be used to treat adults who have not had previous
methotrexate treatme

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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, 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, Actemra can be given as monotherapy in case of
intolerance to MTX or where
continued treatment with MTX is inappropriate.
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 ar