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AstraZeneca

RoActemra
tocilizumab

Package Leaflet: Information for the user


RoActemra 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.



Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.


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You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.


Children with sJIA

In general, side effects in sJIA patients were of a similar type to those in adults with RA. Some side

effects were seen more often: inflamed nose and throat, diarrhoea, lower white blood cell counts and higher liver enzymes.


Children with pJIA

In general, side effects in pJIA patients were of a similar type to those in adults with RA. Some side

effects were seen more often: inflamed nose and throat, headache, feeling sick (nausea) and lower white blood cell counts.


  1. How to store RoActemra


    Keep RoActemra out of the sight and reach of children.


    Do not use this medicine after the expiry date which is stated on the carton. Store in a refrigerator (2°C - 8°C). Do not freeze.

    Keep the vial in the outer carton in order to protect from light.


  2. Contents of the pack and other information What RoActemra contains

    • The active substance is tocilizumab.

      Each 4 mL vial contains 80 mg tocilizumab (20 mg/mL). Each 10 mL vial contains 200 mg tocilizumab (20 mg/mL).

      Each 20 mL vial contains 400 mg tocilizumab (20 mg/mL).


    • The other ingredients are sucrose, polysorbate 80, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and water for injections.


What RoActemra looks like and contents of the pack

RoActemra is a concentrate for solution for infusion. The concentrate is a clear to opalescent,

colourless to pale yellow liquid.

RoActemra is supplied as vials containing 4 mL, 10 mL and 20 mL concentrate for solution for infusion. Pack size of 1 and 4 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Roche Registration GmbH Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen Germany


Manufacturer Roche Pharma AG Emil-Barell-Str. 1

D-79639 Grenzach-Wyhlen Germany


For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:


België/Belgique/Belgien

N.V. Roche S.A.

Tél/Tel: +32 (0) 2 525 82 11

Luxembourg/Luxemburg

(Voir/siehe Belgique/Belgien)


България

Рош България ЕООД Тел: +359 2 818 44 44

Magyarország

Roche (Magyarország) Kft. Tel: +36 - 1 279 4500


Česká republika

Roche s. r. o.

Tel: +420 - 2 20382111

Danmark

Roche a/s

Tlf: +45 - 36 39 99 99

Malta

(See Ireland)


Nederland

Roche Nederland B.V. Tel: +31 (0) 348 438050


Deutschland

Roche Pharma AG

Tel: +49 (0) 7624 140

oder

Chugai Pharma Europe Zweigniederlassung Deutschland

Tel: +49 (0) 69 663000 0

Norge

Roche Norge AS

Tlf: +47 - 22 78 90 00


Eesti

Roche Eesti OÜ

Tel: + 372 - 6 177 380

Österreich

Roche Austria GmbH

Tel: +43 (0) 1 27739


Ελλάδα

Roche (Hellas) A.E.

Τηλ: +30 210 61 66 100

Polska

Roche Polska Sp.z o.o.

Tel: +48 - 22 345 18 88


España

Roche Farma S.A.

Tel: +34 - 91 324 81 00

Portugal

Roche Farmacêutica Química, Lda Tel: +351 - 21 425 70 00

France

Roche

Tél: +33 (0) 1 47 61 40 00

ou

Chugai Pharma France Tél: +33 (0) 1 56 37 05 20


Hrvatska

Roche d.o.o

Tel: +385 1 47 22 333

România

Roche România S.R.L. Tel: +40 21 206 47 01


Ireland

Roche Products (Ireland) Ltd.

Tel: +353 (0) 1 469 0700

Slovenija

Roche farmacevtska družba d.o.o.

Tel: +386 - 1 360 26 00


Ísland

Roche a/s

c/o Icepharma hf Sími: +354 540 8000

Slovenská republika Roche Slovensko, s.r.o. Tel: +421 - 2 52638201


Italia

Roche S.p.A.

Tel: +39 - 039 2471

Suomi/Finland

Roche Oy

Puh/Tel: +358 (0) 10 554 500


Kύπρος

Γ.Α.Σταμάτης & Σια Λτδ. Τηλ: +357 - 22 76 62 76

Sverige

Roche AB

Tel: +46 (0) 8 726 1200


Latvija

Roche Latvija SIA

Tel: +371 - 6 7039831


Lietuva

UAB “Roche Lietuva” Tel: +370 5 2546799


This leaflet was last revised

United Kingdom (Northern Ireland)

Roche Products (Ireland) Ltd.

Tel: +44 (0) 1707 366000

or

Chugai Pharma UK Ltd. Tel: +44 (0) 208 987 5600


.

The following information is intended for healthcare professionals only:


Instructions for dilution prior to administration

Parenteral medicinal products should be inspected visually for particulate matter or discolouration prior to administration. Only solutions which are clear to opalescent, colourless to pale yellow and free

of visible particles should be diluted. Use a sterile needle and syringe to prepare RoActemra.


RA, COVID-19 and CRS adult patients (≥ 30 kg)

Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection from a 100 mL infusion bag, equal to the volume of RoActemra concentrate required for the patients

dose, under aseptic conditions. The required amount of RoActemra concentrate (0.4 mL/kg) should be withdrawn from the vial and placed in the 100 mL infusion bag. This should be a final volume of

100 mL. To mix the solution, gently invert the infusion bag to avoid foaming.

Use in the paediatric population sJIA, pJIA and CRS patients ≥ 30 kg

Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection

from a 100 mL infusion bag, equal to the volume of RoActemra concentrate required for the patients dose, under aseptic conditions. The required amount of RoActemra concentrate (0.4 mL/kg) should be withdrawn from the vial and placed in the 100 mL infusion bag. This should be a final volume of

100 mL. To mix the solution, gently invert the infusion bag to avoid foaming.


sJIA and CRS patients < 30 kg

Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection

from a 50 mL infusion bag, equal to the volume of RoActemra concentrate required for the patients dose, under aseptic conditions. The required amount of RoActemra concentrate (0.6 mL/kg) should be withdrawn from the vial and placed in the 50 mL infusion bag. This should be a final volume of

50 mL. To mix the solution, gently invert the infusion bag to avoid foaming.


pJIA patients < 30 kg

Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection

from a 50 mL infusion bag, equal to the volume of RoActemra concentrate required for the patients dose, under aseptic conditions. The required amount of RoActemra concentrate (0.5 mL/kg) should be withdrawn from the vial and placed in the 50 mL infusion bag. This should be a final volume of

50 mL. To mix the solution, gently invert the infusion bag to avoid foaming.


RoActemra is for single-use only.


Any unused product or waste material should be disposed of in accordance with local requirements.