ACTEMRA tocilizumab (rch) 200 mg/10 mL injection concentrated vial

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

Tocilizumab, Quantity: 200 mg

Disponibbli minn:

Roche Products Pty Ltd

INN (Isem Internazzjonali):

Tocilizumab

Għamla farmaċewtika:

Injection, concentrated

Kompożizzjoni:

Excipient Ingredients: monobasic sodium phosphate dihydrate; water for injections; polysorbate 80; sucrose; dibasic sodium phosphate dodecahydrate

Rotta amministrattiva:

Intravenous Infusion

Unitajiet fil-pakkett:

4 vials, 1 vial

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

Rheumatoid Arthritis (IV and SC formulations),ACTEMRA is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients in combination with methotrexate (MTX) or other non-biological disease-modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs. ACTEMRA is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 Pharmacodynamic Properties, Clinical Trials) in combination with MTX in those not previously treated with MTX. In the two groups of patients above, 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 inhibit the progression of joint damage in adults, as measured by X-ray, when given in combination with methotrexate. Polyarticular Juvenile Idiopathic Arthritis (IV and SC formulations), Actemra is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (MTX). Actemra can be given alone or in combination with MTX.,Systemic Juvenile Idiopathic Arthritis (IV and SC formulations),Intravenous formulation,ACTEMRA is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. Subcutaneous formulation Actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older. Actemra IV and SC can be given alone or in combination with methotrexate (MTX).,Cytokine Release Syndrome (CRS) (IV formulation only), 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 2 years of age and older. Coronavirus disease 2019 (COVID-19) (IV formulation only),Actemra has provisional approval for the treatment of coronavirus disease 2019 (COVID-19) in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Provisional approval has been made on the basis of short-term efficacy and safety data. Continued approval depends on the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

Sommarju tal-prodott:

Visual Identification: Clear to opalescent, colourless to pale yellow liquid; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius

L-istatus ta 'awtorizzazzjoni:

Licence status A

Data ta 'l-awtorizzazzjoni:

2009-05-21

Fuljett ta 'informazzjoni

ACTEMRA
® INTRAVENOUS (IV) INFUSION
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2
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2
2
0
8
3
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING ACTEMRA?
Actemra contains the active ingredient tocilizumab. Actemra IV is used
to treat certain types of rheumatoid arthritis (RA), COVID-19
in some patients who are in hospital, patients with some types of
cytokine release syndrome (CRS), children with active systemic
juvenile idiopathic arthritis (sJIA) and active moderate to severe
polyarticular juvenile idiopathic arthritis (pJIA).
For more information, see Section 1. Why am I using Actemra? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ACTEMRA?
Do not use if you have ever had an allergic reaction to Actemra or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Actemra? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Actemra or it may interfere with
other medicines. A list of these medicines is in Section 3. What if
I am taking other medicines? in the full CMI.
4.
HOW DO I USE ACTEMRA?
•
You will receive Actemra as an infusion into a vein (intravenous
infusion), usually over one hour.
•
The dose of Actemra is dependent on your weight and the timing of your
infusions depends on what you are being treated for.
More instructions can be found in Section 4. How do I use Actemra? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ACTEMRA?
THINGS YOU SHOULD DO
•
Tell your doctor immediately or go to accident and emergency if you
develop symptoms of
an allergic reaction.
•
Tell your doctor immediately if you develop a

Karatteristiċi tal-prodott

Actemra 20220902
1
This medicinal product is subject to additional monitoring in
Australia due to
provisional approval of an extension of indications. This will allow
quick identification
of new safety information. Healthcare professionals are asked to
report any suspected
adverse events at https://www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION
ACTEMRA
® (TOCILIZUMAB)
1.
NAME OF THE MEDICINE
Tocilizumab
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Actemra 80 mg/ 4 mL concentrate solution for intravenous infusion vial
contains 80 mg
tocilizumab
Actemra 200 mg/ 10 mL concentrate solution for intravenous infusion
vial contains 200 mg
tocilizumab
Actemra 400 mg/ 20 mL concentrate solution for intravenous infusion
vial contains 400 mg
tocilizumab
Actemra 162 mg/ 0.9 mL solution for subcutaneous (SC) injection
contains 162 mg tocilizumab
Actemra SC 162 mg/ 0.9 mL solution for SC injection contains 162 mg
tocilizumab.
Excipients with known effect
Actemra concentrated solution for intravenous infusion contains
sodium.
For the full list of excipients, see section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
CONCENTRATED SOLUTION FOR INTRAVENOUS INFUSION
Actemra concentrated solution for intravenous (IV) infusion is a clear
to opalescent, colourless
to pale yellow sterile solution
SOLUTION FOR SUBCUTANEOUS INJECTION
Actemra solution for subcutaneous (SC) injection is a clear to
strongly opalescent, colourless
to slightly yellowish sterile solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
RHEUMATOID ARTHRITIS (IV AND SC FORMULATIONS)
Actemra is indicated for the treatment of moderate to severe active
rheumatoid arthritis (RA)
in adult patients in combination with methotrexate (MTX) or other
non-biological disease-
modifying anti-rheumatic drugs (DMARDs) in case of either an
inadequate response or
intolerance to previous therapy with one or more DMARDs.
▼

Actemra 20220902
2
Actemra is indicated for the treatment of moderate to severe active
rheumatoid arthritis in adult
patients with poo