natgillin/translations-raw huggingface dataset:
T - celleaktivering, induktion af immunoglobulinsekretion, induktion af hepatisk akutfaseproteinsyntese og stimulation af hæmopoiese.
IL-6 is involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, induction of hepatic acute phase protein synthesis and stimulation of haemopoiesis.
IL- 6 har været involveret i patogenesen af sygdomme, såsom inflammatoriske sygdomme, osteoporose og neoplasier.
IL-6 has been implicated in the pathogenesis of diseases including inflammatory diseases, osteoporosis and neoplasia.
I de kliniske studier med tocilizumab er der set et hurtigt fald i CRP, erytrocyt - sedimentationsreaktionen (ESR) og serumamyloid A (SAA).
In clinical studies with tocilizumab, rapid decreases in CRP, erythrocyte sedimentation rate (ESR) and serum amyloid A (SAA) were observed.
Der blev set stigninger i hæmoglobinkoncentrationen, fordi tocilizumab nedsatte den af IL- 6 medierede virkning på hepcidinproduktionen, hvorved tilgængeligheden af jern blev øget.
Increases in haemoglobin levels were observed, through tocilizumab decreasing the IL-6 driven effects on hepcidin production to increase iron availability.
Reduktionen var vedvarende under behandlingen.
In tocilizumab-treated patients, decreases in the levels of CRP to within normal ranges were seen as early as week 2, with decreases maintained while on treatment.
Klinisk virkning Tocilizumabs virkning på reduktion af symptomerne på reumatoid artrit blev undersøgt i fem randomiserede, dobbeltblindede multicenterstudier.
9 Clinical efficacy The efficacy of tocilizumab in alleviating the signs and symptoms of RA was assessed in five randomised, double-blind, multi-centre studies.
Studie I- V inkluderede patienter ≥ 18 år med aktiv reumatoid artrit, som var diagnosticerede i henhold til American College of Rheumatology (ACR) - kriterierne, og som havde mindst otte ømme led og seks hævede led ved baseline.
Studies I-V enrolled patients ≥ 18 years of age with active RA diagnosed according to the American College of Rheumatology (ACR) criteria and who had at least eight tender and six swollen joints at baseline.
Det primære endepunkt i alle fem studier var antallet af patienter, som opnåede et ACR 20- respons ved uge 24.
The primary endpoint for each of the five studies was the proportion of patients who achieved an ACR 20 response at week 24.
I studie I undersøgte man 673 patienter, som ikke havde været behandlet med MTX i seks måneder før randomiseringen, og som ikke havde stoppet tidligere MTX- behandling på grund af klinisk signifikante toksiske virkninger eller mangel på respons.
Study I evaluated 673 patients who had not been treated with MTX within six months prior to randomisation and who had not discontinued previous MTX treatment as a result of clinically important toxic effects or lack of response.
De fleste patienter (67%) havde ikke tidligere fået MTX.
The majority (67%) of patients were MTX-naïve.
Der blev givet doser på 8 mg/ kg tocilizumab hver 4. uge som monoterapi.
Doses of 8 mg/ kg of tocilizumab were given every four weeks as monotherapy.
Sammenligningsgruppen fik MTX ugentligt (dosistitrering fra 7, 5 mg til højst 20 mg ugentligt over en 8- ugers periode).
The comparator group was weekly MTX (dose titrated from 7.5 mg to a maximum of 20 mg weekly over an eight week period).
Studie II, som var et 2- års studie med planlagt analyse ved uge 24 og uge 52, undersøgte 1196 patienter, som ikke havde responderet klinisk tilstrækkeligt på MTX.
Study II, a two year study with planned analyses at week 24 and week 52, evaluated 1196 patients who had an inadequate clinical response to MTX.
Der blev givet doser på 4 eller 8 mg/ kg tocilizumab eller placebo som blindet behandling hver 4. uge i 52 uger i kombination med stabil dosis MTX (10 mg – 25 mg ugentligt).
Doses of 4 or 8 mg/ kg of tocilizumab or placebo were given every four weeks as blinded therapy for 52 weeks in combination with stable MTX (10 mg to 25 mg weekly).
Det primære endepunkt ved uge 24 var antallet af patienter, som opnåede et ACR 20- respons.
The primary endpoint at week 24 was the proportion of patients who achieved an ACR 20 response.
Ved uge 52 var de co- primære endepunkter forebyggelse af ledskader og bedring af den fysiske funktion.
At week 52 the co-primary endpoints were prevention of joint damage and improvement in physical function.
Der blev givet doser på 4 eller 8 mg/ kg tocilizumab eller placebo hver 4. uge i kombination med stabil dosis MTX (10 mg – 25 mg ugentligt).
Doses of 4 or 8 mg/ kg tocilizumab or placebo were given every four weeks, in combination with stable MTX (10 mg to 25 mg weekly).
Studie IV undersøgte 1220 patienter, som havde responderet klinisk utilstrækkeligt på deres hidtidige reumatologiske behandling, herunder en eller flere DMARDs.
Study IV evaluated 1,220 patients who had an inadequate response to their existing rheumatologic therapy, including one or more DMARDs.
Der blev givet doser på 8 mg/ kg tocilizumab eller placebo hver 4. uge i kombination med stabil dosis DMARDs.
Doses of 8 mg/ kg tocilizumab or placebo were given every four weeks in combination with stable DMARDs.
Studie V undersøgte 499 patienter, som havde responderet utilstrækkeligt, eller som ikke tolererede behandling med en eller flere TNF- antagonister.
Study V evaluated 499 patients who had an inadequate clinical response or were intolerant to one or more TNF antagonist therapies.
Behandlingen med TNF- antagonister blev stoppet inden randomiseringen.
The TNF antagonist therapy was discontinued prior to randomisation.
Der blev givet doser på 4 eller 8 mg/ kg tocilizumab eller placebo hver 4. uge i kombination med behandling med stabil dosis MTX (10 mg – 25 mg ugentligt).
Doses of 4 or 8 mg/ kg tocilizumab or placebo were given every four weeks in combination with stable MTX (10 mg to 25 mg weekly).
Klinisk respons I alle studier havde de patienter, som fik behandling med tocilizumab 8 mg/ kg, statistisk signifikant højere ACR 20 -, 50 -, 70- responsrater efter 6 måneder, sammenlignet med kontrolgrupperne (tabel 2).
Clinical response In all studies, patients treated with tocilizumab 8 mg/ kg had statistically significant higher ACR 20, 50, 70 response rates at 6 months compared to control (Table 2).
I studie I var tocilizumab 8 mg/ kg bedre end den aktive komparator MTX.
In study I, superiority of tocilizumab 8 mg/ kg was demonstrated against the active comparator MTX.
Der blev set fortsat varig respons i mere end 24 måneder i de pågående, åbne ekstensionsstudier I, III, IV og V.
Continued durable responses were seen for over 24 months in the ongoing open label extension studies I, III, IV and V.
Antal ømme og hævede led, patienternes og lægernes globale vurdering, disability index score, vurdering af smerter og CRP.
In patients treated with tocilizumab 8 mg/ kg, significant improvements were noted on all individual components of the ACR response including: tender and swollen joint counts; patients and physician global assessment; disability index scores; pain assessment and CRP compared to patients receiving placebo plus MTX or other DMARDs in all studies.
10 Patienterne i studierne I – V havde en gennemsnitlig Disease Activity Score (DAS28) på 6, 5- 6, 8 ved baseline.
Patients in studies I – V had a mean Disease Activity Score (DAS28) of 6.5 – 6.8 at baseline.
Signifikant reduktion i DAS28 fra baseline (middel- forbedring) på 3, 1 – 3, 4 blev observeret hos de patienter, der blev behandlet med tocilizumab sammenlignet med kontrolpatienterne (1, 3- 2, 1).
Significant reduction in DAS28 from baseline (mean improvement) of 3.1– 3.4 were observed in tocilizumab-treated patients compared to control patients (1.3-2.1).
Efter 24 uger var der signifikant flere patienter i tocilizumab- gruppen (28- 34%), som opnåede DAS28 klinisk remission DAS28 (DAS28 < 2, 6), sammenlignet med gruppen af kontrolpatienter (1- 12%).
The proportion of patients achieving a DAS28 clinical remission (DAS28 < 2.6) was significantly higher in patients receiving
I studie II opnåede 47% af patienterne DAS28 < 2, 6 efter 52 uger, sammenlignet med 33% efter 24 uger.
In study II, 47% of patients achieved a DAS28 < 2.6 at 52 weeks compared to 33% of patients at week 24.
59% vs.
In a pooled analysis of studies II, III and IV, the proportion of patients achieving an ACR 20, 50 and 70 response was significantly higher (59% vs.
27%, og 18% vs.
27%, 18% vs.
11%, p < 0, 03).
11%, respectively) in the tocilizumab 8 mg/ kg plus DMARD vs. the tocilizumab 4 mg/ kg plus DMARD group (p < 0.03).
Antallet af patienter, som opnåede DAS28- remission (DAS28 < 2, 6), var også signifikant højere hos de patienter, som fik tocilizumab 8 mg/ kg plus DMARD, end hos de patienter, som fik tocilizumab 4mg/ kg plus DMARD (31% vs.
Similarly the proportion of patients achieving a DAS 28 remission (DAS28 < 2.6) was significantly higher (31% vs.
16%, p < 0, 0001).
16% respectively) in patients receiving tocilizumab 8 mg/ kg plus DMARD than in patients receiving tocilizumab 4 mg/ kg plus DMARD (p < 0.0001).
ACR respons i placebo - / MTX - / DMARD - kontrollerede studier (% patienter)
ACR responses in placebo-/ MTX-/ DMARDs-controlled studies (% patients)
MTX TCZ Place - TCZ Place - TCZ Placebo TCZ
MTX TCZ PBO TCZ PBO TCZ PBO + TCZ
TCZ MTX TCZ
TCZ MTX TCZ
Place - TCZ Place - TCZ
PBO TCZ PBO TCZ
TCZ MTX TCZ Place - TCZ Place - TCZ
TCZ MTX TCZ PBO TCZ PBO TCZ
TCZ MTX TCZ Place - TCZ Place - TCZ Placebo TCZ
TCZ MTX TCZ PBO TCZ PBO TCZ PBO + TCZ
bo + 8 mg/ kg bo
PBO +
8 mg/ kg + MTX
8 mg/ kg
+
8 +
MTX MTX
mg/ kg + MTX MTX
+ MTX + MTX
8 mg/ kg + MTX + MTX
+ DMARD
8 mg/ kg DMARD + DMARD
DMARD
8 +
+ MTX
mg/ kg MTX
N N
MTX
286
N= 286
284
N= 284
398
N= 398
205 ACR 20
N= N= N= 393 205 204 ACR 20
803
N= 803
413
N= 413
170
N= 170
158
N= 158
24
24 52
56% ***
27% 25%
50
50%***
32% ***
32%***
% ***
44%** *
29
29%** *
% *** 52
52
36% ***
36%***
22
22%** *
% *** 2%
2%
12% **
1%
TCZ - Tocilizumab MTX - Methotrexat DMARD - Sygdomsmodificerende antireumatisk middel * - p < 0, 05, tocilizumab vs. placebo + MTX / DMARD ** - p < 0, 01, tocilizumab vs. placebo + MTX / DMARD *** - p < 0, 0001, tocilizumab vs. placebo + MTX / DMARD
PBO + MTX/ DMARD
Hæmningen blev udtrykt som en ændring i modificeret Sharp score og dets komponenter, erosions- score og ledspalteforsnævrings- score.
Radiographic response In Study II, in patients with an inadequate response to MTX, inhibition of structural joint damage was assessed radiographically and expressed as change in modified Sharp score and its components, the erosion score and joint space narrowing score.
Tabel 3.
11 Table 3.
(+TCZ fra uge 24)
(+ TCZ from week 24) Total Sharp-Genant score Erosion score
N = 393
= 393 1.13 0.71
Total Sharp- Genant score
JSN score PBO MTX TCZ JSN
Erosions- score JSN- score MTX - Methotrexat TCZ - Tocilizumab JSN - Ledspalteforsnævring
0.12**
0, 71 0, 42
*
0, 17 * 0, 12 **
- p≤ 0.0001, TCZ vs.
11
+ MTX
* - p ≤ 0, 0001, tocilizumab vs. placebo + MTX ** - p < 0, 005, tocilizumab vs. placebo + MTX
PBO + MTX
Effekten på sundhed og livskvalitet De patienter, som blev behandlet med tocilizumab, berettede om forbedring i alle patientrapporterede resultater (Health Assessment Questionnaire Disability Index – HAQ- DI, den korte version af SF- 36 og Functional Assessment of Chronic Illness Therapy Questionnaires).
Health-related and quality of life outcomes Tocilizumab-treated patients reported an improvement in all patient-reported outcomes (Health Assessment Questionnaire Disability Index - HAQ-DI), Short Form-36 and Functional Assessment of Chronic Illness Therapy questionnaires.
Sammenlignet med de patienter, som fik DMARDs, blev der set statistisk signifikante forbedringer i HAQ- DI- scoren hos de patienter, som fik behandling med RoActemra.
Statistically significant improvements in HAQ-DI scores were observed in patients treated with RoActemra compared with patients treated with DMARDs.
Hæmoglobinkoncentrationer I uge 24 blev der set statistisk signifikante forbedringer i hæmoglobinkoncentrationerne efter behandling med tocilizumab, sammenlignet med behandling med DMARDs (p < 0, 0001).
Haemoglobin levels Statistically significant improvements in haemoglobin levels were observed with tocilizumab compared with DMARDs (p < 0.0001) at week 24.
Middelkoncentrationerne af hæmoglobin blev øget efter uge 2 og forblev indenfor normalområdet frem til uge 24.
Mean haemoglobin levels increased by week 2 and remained within normal range through to week 24.
Tocilizumabs farmakokinetik blev bestemt ved en populationsfarmakokinetisk analyse af en database, som omfattede 1793 patienter med reumatoid artrit, som blev behandlet med en infusion af en times varighed af 4 og 8 mg/ kg tocilizumab hver 4. uge i 24 uger.
The pharmacokinetics of tocilizumab were determined using a population pharmacokinetic analysis on a database composed of 1,793 RA patients treated with a one-hour infusion of 4 and 8 mg/ kg tocilizumab every 4 weeks for 24 weeks.
1, 22 og 1, 06.
The following parameters (predicted mean ± SD) were estimated for a dose of 8 mg/ kg tocilizumab given every 4 weeks: steady-state area under curve (AUC) = 35000 ± 15500 h µg/ ml, trough concentration (Cmin) = 9.74 ± 10.5 μ g/ ml and maximum concentration (Cmax) = 183 ± 85.6 µg/ ml, and. the accumulation ratios for AUC and Cmax were small, 1.22 and 1.06, respectively.
Akkumulationsratio var højere for Cmin (2, 35), hvilket var forventet på grund af bidraget fra den non- lineære clearance ved lavere koncentrationer.
The accumulation ratio was higher for Cmin (2.35), which was expected based on the non-linear clearance contribution at lower concentrations.
8 og 20 uger.
Steady-state was reached following the first administration for Cmax and after 8 and 20 weeks for AUC and Cmin, respectively.
Det resulterede i et fordelingsvolumen i steady- state på 6, 4 l.
Distribution In RA patients the central volume of distribution was 3.5 l, the peripheral volume of distribution was 2.9 l resulting in a volume of distribution at steady state of 6.4 l.
Elimination Efter intravenøs indgift undergår tocilizumab en bifasisk elimination fra cirkulationen.
Elimination Following intravenous administration, tocilizumab undergoes biphasic elimination from the circulation.
Den totale clearance for tocilizumab var koncentrationsafhængig og er summen af den lineære og den non - lineære clearance.
The total clearance of tocilizumab was concentration-dependent and is the sum of the linear and non-linear clearance.
Den lineære clearance blev estimeret som en parameter i den populationsfarmakokinetiske analyse og var 12, 5 ml/ time.
The linear clearance was estimated as a parameter in the population pharmacokinetic analysis and was 12.5 ml/ h.
Den koncentrationsafhængige non- lineære clearance spiller en væsentlig rolle ved lave koncentrationer af tocilizumab.
The concentration-dependent non-linear clearance plays a major role at low tocilizumab concentrations.
Når den non- lineære clearance pathway først er mættet, ved højere koncentrationer af tocilizumab, bestemmes clearance hovedsageligt af den lineære clearance.
Once the non-linear clearance pathway is saturated, at higher tocilizumab concentrations, clearance is mainly determined by the linear clearance.
Tocilizumabs halveringstid (t1/ 2) var koncentrationsafhængig.
The t1/ 2 of tocilizumab was concentration-dependent.
I steady- state efter en dosis på 8 mg/ kg hver 4. uge aftog den effektive t1/ 2 med faldende koncentrationer inden for et dosisinterval fra 14 dage til 8 dage.
At steady-state following a dose of 8 mg/ kg every 4 weeks, the effective t1/ 2 decreased with decreasing concentrations within a dosing interval from 14 days to 8 days.
Linearitet Tocilizumabs farmakokinetiske parametre ændrede sig ikke med tiden.
Linearity Pharmacokinetic parameters of tocilizumab did not change with time.
Der blev set en mere end dosisproportional stigning i AUC og Cmax efter doser på 4 og 8 mg/ kg hver 4. uge.
A more than dose-proportional increase in the AUC and Cmin was observed for doses of 4 and 8 mg/ kg every 4 weeks.
Cmax øgedes dosisproportionalt.
Cmax increased
I steady- state var de ventede værdier for AUC og Cmin hhv.
12 dose-proportionally.
2, 7 og 6, 5 gange højere efter 8 mg/ kg, sammenlignet med 4 mg/ kg.
At steady-state, predicted AUC and Cmin were 2.7 and 6.5 fold higher at 8 mg/ kg as compared to 4 mg/ kg, respectively.
Specielle populationer
Special populations Renal impairment:
Der er ikke gennemført kliniske studier om virkningen af nedsat nyrefunktion på tocilizumabs farmakokinetik.
No formal study of the effect of renal impairment on the pharmacokinetics of tocilizumab has been conducted.
Cockcroft- Gault) påvirkede ikke tocilizumabs farmakokinetik.
Mild renal impairment (creatinine clearance based on Cockcroft-Gault < 80 ml/ min and ≥ 50 ml/ min) did not impact the pharmacokinetics of tocilizumab.
12 Nedsat leverfunktion:
Hepatic impairment:
Der er ikke gennemført formelle studier om virkningen af nedsat leverfunktion på tocilizumabs farmakokinetik.
No formal study of the effect of hepatic impairment on the pharmacokinetics of tocilizumab has been conducted.
Alder, køn og etnicitet:
Age, gender and ethnicity:
Populationsfarmakokinetiske analyser af voksne patienter med reumatoid artrit viste, at alder, køn og race ikke påvirkede tocilizumabs farmakokinetik.
Population pharmacokinetic analyses in adult RA patients, showed that age, gender and ethnic origin did not affect the pharmacokinetics of tocilizumab.
På grund af mangel på passende modeller for et antistof uden reaktivitet på IL- 6- receptorer hos gnavere, er der ikke udført studier om carcinogenicitet og fertilitet med tocilizumab.
Carcinogenicity and fertility studies were not performed with tocilizumab due to the lack of appropriate models for an antibody with no reactivity to rodent IL-6 receptors.
De foreliggende non- kliniske data viste virkningen af IL- 6 på malign progression og forskellige cancertypers resistens overfor apoptose.
Available non-clinical data demonstrated the effect of IL-6 on malignant progression and apoptosis resistance to various cancer types.
Der blev desuden ikke observeret prolifererende læsioner i et 6- måneders kronisk toksicitetsstudie hos cynomolgusaber eller hos IL- 6 - deficiente mus.
Additionally, proliferative lesions were not observed in a 6-month chronic toxicity study in cynomolgus monkeys or in IL-6 deficient mice.
De foreliggende non- kliniske data tyder ikke på en virkning på fertiliteten under behandling med tocilizumab.
Available non-clinical data do not suggest an effect on fertility under tocilizumab treatment.
I et kronisk toksicitetsstudie hos cynomolgusaber blev der ikke set virkninger på endokrint aktive organer og organer i det reproduktive system, og reproduktionsevnen var ikke påvirket hos IL- 6- deficiente mus.
Effects on endocrine active and reproductive system organs were not observed in a chronic cynomolgus monkey toxicity study and reproductive performance was not affected in IL-6 deficient mice.
Der blev ikke set direkte eller indirekte skadelig virkning på graviditet eller embryonal- føtal udvikling efter indgift af tocilizumab til cynomolgusaber i den tidlige graviditet.
Tocilizumab administered to cynomolgus monkeys during early gestation, was observed to have no direct or indirect harmful effect on pregnancy or embryonal-foetal development.
Der blev dog set en mindre stigning i antallet af aborter/ embryonal- føtal død efter høj systemisk eksponering i højdosisgruppen (> 100 gange human eksponering), som fik 50 mg/ kg/ dag, sammenlignet med placebo og andre lavdosisgrupper.
However, a slight increase in abortion/ embryonal-foetal death was observed with high systemic exposure (> 100 x human exposure) in the 50 mg/ kg/ day high-dose group compared to placebo and other low-dose groups.
Selvom IL- 6 ikke synes at være et kritisk cytokin over for føtal vækst eller immunologisk kontrol af den maternelle/ føtale interface, kan en forbindelse mellem disse fund og tocilizumab ikke udelukkes.
Although IL-6 does not seem to be a critical cytokine for foetal growth or the immunological control of the maternal/ foetal interface, a relation of this finding to tocilizumab cannot be excluded.
Saccharose Polysorbat 80 Dinatriumphosphatdodecahydrat Natriumdihydrogenphosphat Vand til injektionsvæsker
Sucrose Polysorbate 80 Disodium phosphate dodecahydrate Sodium dihydrogen phosphate dihydrate Water for injections
Fortyndet produkt:
Diluted product:
Efter fortynding er den tilberedte infusionvæske, opløsning fysisk og kemisk stabil i natriumchlorid 9 mg/ ml (0, 9%) injektionsvæske, opløsning i 24 timer ved 30 ºC.
After dilution, the prepared solution for infusion is physically and chemically stable in sodium chloride 9 mg/ ml (0.9%) solution for injection at 30ºC for 24 hours.
Det bør normalt ikke være længere end 24 timer ved 2 – 8 °C, medmindre fortyndingen fandt sted under kontrollerede og validerede aseptiske betingelser.
If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C– 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
13 RoActemra leveres som et sterilt koncentrat, der ikke indeholder konserveringsmidler.
RoActemra is supplied as a sterile concentrate that does not contain preservatives.
Opbevar hætteglas i køleskab (2 – 8 °C).
Store vials in a refrigerator (2°C– 8°C).
6. 3.
For storage conditions of the diluted medicinal product see section 6.3.
Instrukser for fortynding før indgivelse Parenterale lægemidler bør inspiceres visuelt for partikler og misfarvning før anvendelse.
Instructions for dilution prior to administration Parenteral medicinal products should be inspected visually for particulate matter or discoloration prior to administration.
Kun opløsninger, som er klare til opaliserende, farveløse til lysegule og fri for synlige partikler, må fortyndes.
Only solutions which are clear to opalescent, colourless to pale yellow and free of visible particles should be diluted
Under anvendelse af aseptiske procedurer tages der en mængde steril, pyrogenfri natriumchlorid 9 mg/ ml (0, 9%) injektionsvæske, opløsning fra en 100 ml infusionspose svarende til den påkrævede mængde RoActemra- koncentrat.
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.
Den påkrævede mængde RoActemra- koncentrat (0, 4 ml/ kg) trækkes op af hætteglasset og anbringes i infusionsposen på 100 ml.
The required amount of RoActemra concentrate (0.4 ml/ kg) should be withdrawn from the vial and placed in the 100 ml infusion bag.
Det samlede volumen skal være 100 ml.
This should be a final volume of 100 ml.
16- 3 Kiyohara Kogyodanchi Utsunomiya City Tochigi, 321- 3231 Japan
16-3 Kiyohara Kogyodanchi Utsunomiya City Tochigi, 321-3231 Japan
Indehaveren af markedsføringstilladelsen (MAH) skal inden lanceringen af produktet sikre, at al sundhedspersonale, som forventes at skulle udskrive/ anvende RoActemra, får udleveret undervisningsmateriale, der indeholder følgende:
The Marketing Authorisation Holder (MAH) shall ensure that, at launch, all healthcare professionals who are expected to prescribe/ use RoActemra are provided with educational materials containing the following:
Informationsmateriale til lægen Informationsmateriale til sygeplejersken Informationsmateriale til patienten
Physician Information Pack Nurse Information Pack Patient Information Pack