Actemra concentrate for solution for i/v infusion

Nchi: Armenia

Lugha: Kiingereza

Chanzo: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Viambatanisho vya kazi:

tocilizumab

Inapatikana kutoka:

F. Hoffmann-La Roche Ltd.

ATC kanuni:

L04AC07

INN (Jina la Kimataifa):

tocilizumab

Kipimo:

20mg/ml

Dawa fomu:

concentrate for solution for i/v infusion

Vitengo katika mfuko:

glass vial 10ml

Dawa ya aina:

Prescription

Idhini hali ya:

Registered

Idhini ya tarehe:

2021-11-23

Taarifa za kipeperushi

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 treatment

Tabia za bidhaa

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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 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. Actemra can be given as monotherapy (in case of