natgillin/translations-raw huggingface dataset:
Before you drive a vehicle, use machinery, or carry out other activities that require concentration, you should make sure you know how you react to the effects of Riprazo.
Preden se namenite upravljati vozilo, uporabljati stroje ali opravljati druge dejavnosti, ki zahtevajo zbranost, morate dobro poznati svoj odziv na učinke zdravila Riprazo.
HOW TO TAKE RIPRAZO
KAKO JEMATI ZDRAVILO RIPRAZO
Always take Riprazo exactly as your doctor has told you.
Pri jemanju zdravila Riprazo natančno upoštevajte zdravnikova navodila.
You should take Riprazo with a light meal once a day, preferably at the same time each day.
Zdravilo Riprazo je treba jemati z lahkim obrokom enkrat na dan, najbolje vsak dan ob istem času.
If you forget to take Riprazo If you forget to take a dose of Riprazo, take it as soon as you remember and then take the next dose at
Če ste pozabili vzeti zdravilo Riprazo Če pozabite vzeti odmerek zdravila Riprazo, ga vzemite takoj, ko se spomnite nanj in nato vzemite naslednji odmerek ob običajnem času.
Like all medicines, Riprazo can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Riprazo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
HOW TO STORE RIPRAZO
SHRANJEVANJE ZDRAVILA RIPRAZO
What Riprazo contains
Kaj vsebuje zdravilo Riprazo
What Riprazo looks like and contents of the pack Riprazo 150 mg film coated tablets are light-pink, biconvex round tablets, imprinted “ IL” on one side and “ NVR” on the other side.
Izgled zdravila Riprazo in vsebina pakiranja Riprazo 150 mg filmsko obložene tablete so bikonveksne okrogle tablete svetlo roza barve, z oznako ‘ IL ’ na eni strani in ‘ NVR ’ na drugi.
45 its usual time.
45 prejšnji odmerek.
What Riprazo looks like and contents of the pack Riprazo 300 mg film coated tablets are light-red, biconvex, ovaloid tablets, imprinted “ IU” on one side and “ NVR” on the other side.
Izgled zdravila Riprazo in vsebina pakiranja Riprazo 300 mg filmsko obložene tablete so bikonveksne ovalne tablete svetlo rdeče barve, z oznako ‘ IU ’ na eni strani in ‘ NVR ’ na drugi.
Ref.
London, 18. oktober 2006 Sklic dok.
EMEA/ 410799/ 2006
EMEA/ 435970/ 2006
Riquent is a solution for injection that contains 50 mg/ ml of the active substance abetimus.
Zdravilo Riquent je raztopina za injiciranje, ki vsebuje 50 mg/ ml zdravilne učinkovine abetimus.
Riquent was expected to be used to treat lupus nephritis, an inflammation of the kidneys in patients with systemic lupus erythematosus (SLE, an auto-immune disease caused by the body’ s own defence system attacking normal tissue) who have a history of kidney disease and have been tested to check that they will benefit from the medicine.
Zdravilo Riquent bi se naj uporabljalo za zdravljenje lupusnega nefritisa, t. j. vnetja ledvic pri bolnikih s sistemskim eritematoznim lupusom (SLE, avtoimunsko boleznijo, pri kateri obrambni sistem telesa napade normalna tkiva), ki so imeli v preteklosti ledvično bolezen in so bili testirani z namenom ugotoviti, ali bi jim lahko zdravilo pomagalo.
Riquent was expected to delay and to reduce the incidence of ‘ flares’ (increased signs of kidney disease).
Zdravilo Riquent bi naj zavrlo in zmanjšalo pogostost pojava širjenja obolenja (povečanih znakov ledvične bolezni).
Because the number of patients with lupus nephritis is low, the disease is rare, and Riquent was designated an orphan medicine (a medicine used in rare diseases) on 20 November 2001.
Ker je število bolnikov z lupusnim nefritisom majhno, je ta bolezen redka, zato je bilo zdravilo Riquent 20. novembra 2001 določeno kot » zdravilo sirota « (zdravilo, ki se uporablja pri redkih boleznih).
When Riquent is injected, the levels of these antibodies in the blood are lowered and this is expected to help reduce the patient’ s likelihood of experiencing a ‘ flare’.
Če se vbrizga zdravilo Riquent, se raven teh protiteles v krvi zmanjša in to bi naj prispevalo k zmanjšanju verjetnosti, da bolnik doživi pojav širjenja obolenja.
The studies measured how many patients developed ‘ flares’ and the time to the development of the flares by measuring the levels of protein in the urine and of creatinine (an enzyme that is a marker of kidney function) in the blood.
Raziskavi sta merili, pri koliko bolnikih se je razvil pojav širjenja obolenja, in čas do razvoja tega pojava z merjenjem ravni beljakovin v urinu in kreatinina (encima, ki je marker delovanja ledvic).
Following the CHMP’ s opinion, it usually takes around 2 months for the European Commission to grant a licence.
Ko podjetje pripravi odgovore na vprašanja, jih CHMP pregleda in pred izdajo mnenja lahko zaprosi podjetje še za
(44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What was the recommendation of the CHMP at that time?
Ko CHMP izda mnenje, Evropska komisija v približno 2 mesecih izda dovoljenje.
What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Riquent?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih/ programih sočutne uporabe zdravila Riquent?
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Države članice morajo zagotoviti, da so implementirani vsi pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila, ki so opisani spodaj:
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:
Imetnik dovoljenja za promet mora zagotoviti, da bo ob vpeljavi zdravila na trg vsem zdravnikom, ki bodo predpisovali/ uporabljali zdravilo RoActemra razdelil izobraževalne materiale:
• Physician Information Pack • Nurse Information Pack • Patient Information Pack
Ti vključujejo: ● paket informacij za zdravnike, ● paket informacij za medicinske sestre, ● paket informacij za bolnike.
The Physician Information Pack should contain the following key elements: • The Summary of Product Characteristics • Dose calculation, preparation of infusion and infusion rate • Risk of serious infections o The product should not be given to patients with active or suspected infection o The product may lessen signs and symptoms of acute infection delaying the diagnosis • Serious infusion reaction and their management • Serious hypersensitivity reactions and their management • Risk of gastrointestinal perforations especially in patients with history of diverticulitis or intestinal ulcerations • Reporting of serious adverse drug reactions • The Patient Information Packs (to be given to patients by healthcare professionals)
Bolniku bo ta paket dal zdravnik.
The Nurse Information Pack should contain the following key elements: • Prevention of medical errors and infusion reactions o Preparation of infusion o Infusion rate • Monitoring of the patient for infusion reactions • Reporting of serious adverse drug reactions
Paket informacij za medicinske sestre mora vključevati naslednje glavne vsebine: ● preprečevanje medicinskih napak in reakcij, povezanih z infuzijo, o priprava infuzije, o hitrost infuzije, ● nadzorovanje bolnika zaradi reakcij, povezanih z infuzijo, ● poročanje resnih neželenih učinkov.
The Patient Information Pack should contain the following key elements: • Patient Information Leaflet • Patient Alert Card
Paket informacij za bolnike mora vključevati naslednje glavne vsebine: ● navodilo za uporabo, ● opozorilna izkaznica bolnika.
What is RoActemra?
Kaj je zdravilo RoActemra?
RoActemra is a concentrate that is made up into a solution for infusion (drip into a vein).
Zdravilo RoActemra je koncentrat, ki se pripravi v raztopino za infundiranje (dajanje tekočine v veno).
It contains the active substance tocilizumab.
Zdravilo vsebuje zdravilno učinkovino tocilizumab.
What is RoActemra used for?
Za kaj se zdravilo RoActemra uporablja?
RoActemra is used to treat adults with moderate to severe active rheumatoid arthritis (an immune system disease causing inflammation of the joints).
Zdravilo RoActemra se uporablja za zdravljenje odraslih z zmernim do hudim aktivnim revmatoidnim artritisom (bolezen imunskega sistema, ki povzroča vnetje sklepov).
It is used in combination with methotrexate (another medicine used in rheumatoid arthritis) in patients who have not responded adequately to or who could not tolerate other treatments, including conventional medicines for rheumatoid arthritis (such as methotrexate) or tumour necrosis factor (TNF) blockers.
Uporablja se v kombinaciji z metotreksatom (drugim zdravilom proti revmatoidnemu artritisu) pri bolnikih, ki se niso zadostno odzvali na običajna zdravila proti revmatoidnemu artritisu (kot je metotreksat) ali zaviralce tumorje nekrotizirajočega faktorja (TNF) ali drugačnega zdravljenja niso prenašali.
RoActemra can be used on its own in patients who cannot take methotrexate.
Zdravilo RoActemra se uporablja samostojno pri bolnikih, ki ne morejo jemati metotreksata.
Treatment with RoActemra should be started by a doctor who has experience in the diagnosis and treatment of rheumatoid arthritis.
Zdravljenje z zdravilom RoActemra mora vpeljati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem revmatoidnega artritisa.
RoActemra is given once every four weeks as an infusion lasting an hour.
Zdravilo RoActemra se daje enkrat na štiri tedne kot infuzija, ki traja eno uro.
The recommended dose is 8 mg per kilogram body weight.
Priporočeni odmerek je 8 mg na kilogram telesne mase.
The minimum dose is 480 mg, and doses above 1,200 mg have not been tested.
Najmanjši odmerek je 480 mg, odmerkov nad 1 200 mg pa niso preskušali.
The dose of RoActemra or methotrexate may need to be adjusted or treatment interrupted in patients who develop liver or blood problems.
Odmerek zdravila RoActemra ali metotreksata bo morda treba prilagoditi pri bolnikih, pri katerih se pojavijo težave z jetri ali krvjo, ali pa prekiniti zdravljenje.
Doctors should monitor the kidneys carefully in patients with moderate or severe kidney problems.
Zdravniki morajo skrbno nadzorovati ledvice bolnikov z zmernimi ali hudimi ledvičnimi težavami.
Patients who receive RoActemra should be given the special alert card that summarises the safety information about the medicine.
Bolnikom, ki uporabljajo zdravilo RoActemra, je treba dati opozorilno izkaznico, ki povzema informacije o varnosti zdravila.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found in the body.
Monoklonsko protitelo je protitelo (vrsta beljakovine), oblikovano za prepoznavanje in vezanje na določeno strukturo (imenovano antigen) v telesu.
Tocilizumab has been designed to bind to the receptor for a messenger molecule (cytokine) in the body called interleukin-6.
Tocilizumab je bil oblikovan za vezanje na receptor za signalno molekulo (citokin) v telesu, ki se imenuje interlevkin- 6.
This messenger is involved in causing inflammation and is found at high levels in patients with rheumatoid arthritis.
Ta signalna molekula sodeluje pri povzročanju vnetja in jo najdemo v visokih ravneh pri bolnikih z revmatoidnim artritisom.
By preventing interleukin-6 attaching to its receptors, tocilizumab reduces the inflammation and other symptoms of rheumatoid arthritis.
Tocilizumab s preprečevanjem vezanja interlevkina- 6 na ustrezne receptorje zmanjša vnetje in druge simptome revmatoidnega artritisa.
How has RoActemra been studied?
Kako je bilo zdravilo RoActemra raziskano?
The effects of RoActemra were first tested in experimental models before being studied in humans.
Učinki zdravila RoActemra so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
RoActemra has been studied in five main studies involving a total of over 4,000 adults with moderate to severe rheumatoid arthritis.
Zdravilo RoActemra so raziskovali v petih glavnih študijah, ki so skupaj vključevale prek 4 000 odraslih z zmernim do hudim revmatoidnim artritisom.
Four of the studies compared RoActemra with placebo (a dummy treatment).
V štirih študijah so primerjali zdravilo RoActemra s placebom (zdravilom brez zdravilne učinkovine).
In three of these, the medicines were given as an add-on to failing treatment with methotrexate or other conventional rheumatoid arthritis medicines in a total of over 3,000 patients.
V treh od teh študij so več kot 3 000 bolnikom dajali zdravila kot dodatek k vse bolj neuspešnemu zdravljenju z metotreksatom ali z drugimi konvencionalnimi zdravili proti revmatoidnemu artritisu.
In the fourth study, the medicines were given in combination with methotrexate in 498 patients who had an inadequate response to previous treatment with TNF blockers.
V četrti študiji so 498 bolnikom, ki se niso zadostno odzvali na predhodno zdravljenje z zaviralci tumorje nekrotizirajočega faktorja, zdravila dajali v kombinaciji z metotreksatom.
The fifth study compared RoActemra given on its own with methotrexate in a total of 673 patients.
V peti študiji so zdravilo RoActemra kot samostojno zdravilo primerjali z metotreksatom pri vsega skupaj 673 bolnikih.
In all five studies, the main measure of effectiveness was the number of patients who had responded to treatment after six months.
V vseh petih študijah je bilo glavno merilo učinkovitosti število bolnikov, ki so se po šestih mesecih odzvali na zdravljenje.
A response was defined as a reduction in symptom scores of 20% or more as measured using a standard scale for rheumatoid arthritis.
Odziv so opredelili kot zmanjšanje rezultatov simptomov za najmanj 20% po meritvah na standardni lestvici za revmatoidni artritis.
A total of 2,439 patients from these studies went on to enter two studies looking at the long-term effects of RoActemra treatment.
2 439 bolnikov iz teh študij je sodelovalo še v dveh študijah, v katerih so raziskovali dolgoročne učinke zdravljenja z zdravilom RoActemra.
What benefit has RoActemra shown during the studies?
Kakšne koristi je zdravilo RoActemra izkazalo med študijami?
RoActemra was more effective than the comparator medicines at reducing the symptoms of rheumatoid arthritis.
Zdravilo RoActemra je bilo pri zmanjševanju simptomov revmatoidnega artritisa bolj učinkovito kot primerjalna zdravila.
In the three studies of patients with an inadequate response to methotrexate or other conventional rheumatoid arthritis treatments, patients adding RoActemra at the approved dose were around four times more likely to respond to treatment than those adding placebo.
V treh študijah pri bolnikih z nezadostnim odzivom na metotreksat ali druga običajna zdravila proti revmatoidnemu artritisu je bila pri bolnikih, ki so kot dodatek prejemali odobrene odmerke zdravila RoActemra, štirikrat večja verjetnost odziva na zdravljenje kot pri tistih, ki so kot dodatek prejemali placebo.
In the study of patients who had an inadequate response to TNF blockers, patients receiving RoActemra with methotrexate were around nine times more likely to respond than those receiving placebo.
V študiji bolnikov, ki so se nezadostno odzvali na zaviralce tumorje nekrotizirajočega faktorja, je bila pri bolnikih, ki so prejemali zdravilo RoActemra skupaj z metotreksatom, približno devetkrat večja verjetnost odziva kot pri tistih, ki so prejemali placebo.
The fifth study showed that patients receiving RoActemra on its own were more likely to respond than those taking methotrexate on its own.
V peti študiji so dokazali, da je bila pri bolnikih, ki so prejemali samo zdravilo RoActemra, devetkrat večja verjetnost odziva kot pri tistih, ki so jemali samo metotreksat.
The long-term studies showed that the response to RoActemra is maintained for at least a year.
V dolgoročnih študijah so dokazali, da se odziv na zdravilo RoActemra ohrani vsaj eno leto.
What is the risk associated with RoActemra?
Kakšna tveganja so povezana z zdravilom RoActemra?
For the full list of all side effects reported with RoActemra, see the Package Leaflet.
Najpogostejši neželeni učinek zdravila RoActemra (opažen pri več kot 1 bolniku od 10) so okužbe zgornjih dihal (prehladi). Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila RoActemra, glejte navodilo za uporabo.
RoActemra should not be used in people who may be hypersensitive (allergic) to tocilizumab or any of the other ingredients.
Zdravila RoActemra ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) tocilizumab ali katero koli drugo sestavino zdravila.
It must not be used in patients who have an active, severe infection.
Zdravila ne smejo uporabljati bolniki z aktivno, hudo okužbo.
Doctors should monitor patients carefully for signs of infection during treatment, and should prescribe RoActemra with caution in patients who have had recurring or long-term infections, or diseases that could increase the risk of infections, such as diverticulitis (a disease affecting the gut) or diabetes.
Zdravniki morajo bolnike med zdravljenjem pozorno spremljati zaradi znakov okužb in morajo zdravilo RoActemra predpisovati previdno pri bolnikih s ponavljajočimi ali dolgotrajnimi okužbami ali z boleznimi, ki bi lahko povečale tveganje okužb, kakršni sta divertikulitis (bolezen, ki prizadene črevesje) ali sladkorna bolezen.
Why has RoActemra been approved?
Zakaj je bilo zdravilo RoActemra odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that RoActemra’ s benefits are greater than its risks, in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis 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 or TNF antagonists, or as monotherapy in case of intolerance to methotrexate or where continued treatment with methotrexate is inappropriate.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila RoActemra večje od z njim povezanih tveganj pri uporabi v kombinaciji z metotreksatom za zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa pri odraslih bolnikih, ki se na predhodno zdravljenje z enim imunomodulirajočim antirevmatičnim zdravilom ali več imunomodulirajočimi antirevmatičnimi zdravili niso zadostno odzvali ali takega zdravljenja niso prenašali, ali pri uporabi kot samostojno zdravilo v primeru neprenašanja metotreksata ali če nadaljevanje zdravljenja z metotreksatom ni primerno.
The Committee recommended that RoActemra be given marketing authorisation.
Odbor je priporočil, da se za zdravilo RoActemra odobri dovoljenje za promet.
Which measures are being taken to ensure the safe use of RoActemra?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila RoActemra?
The company that makes RoActemra will supply packs containing information for doctors, nurses and patients prior to the medicine ’ s launch in each Member State.
Družba, ki proizvaja zdravilo RoActemra bo priskrbela pakete z informacijami za zdravnike, sestre in bolnike pred izdajo zdravila na trg v vsaki državi članici.
These packs will include information on RoActemra’ s safety and on how it should be given to patients.
Ti paketi vključujejo informacije o varnosti in načinu dajanja zdravila RoActemra bolnikom.
Other information about RoActemra:
2/ 3 Druge informacije o zdravilu RoActemra:
The European Commission granted a marketing authorisation valid throughout the European Union for RoActemra to Roche Registration Limited on 16 January 2009.
Evropska komisija je dovoljenje za promet z zdravilom RoActemra, veljavno po vsej Evropski uniji, odobrila družbi Roche Registration Limited dne 16. januarja 2009.
2/ 3 The full EPAR for RoActemra can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo RoActemra je na voljo tukaj.
Pharmaceutical Form
Intravenska uporaba
Route of Administration
Intravenska uporaba
EU/ 1/ 08/ 492/ 001 EU/ 1/ 08/ 492/ 002 EU/ 1/ 08/ 492/ 003 EU/ 1/ 08/ 492/ 004 EU/ 1/ 08/ 492/ 005 EU/ 1/ 08/ 492/ 006
EU/ 1/ 08/ 492/ 004
Intravenous use Intravenous use Intravenous use Intravenous use Intravenous use Intravenous use
Koncentrat za raztopino za infundiranje
Vial (glass) Vial (glass) Vial (glass) Vial (glass) Vial (glass) Vial (glass)
Viala (steklo)
1 vial 4 vials 1 vial 4 vials 1 vial 4 vials
Koncentrat za raztopino za infundiranje
RoActemra 20 mg/ ml concentrate for solution for infusion.
RoActemra 20 mg/ ml koncentrat za raztopino za infundiranje
Each ml concentrate contains 20 mg tocilizumab*.
En ml koncentrata vsebuje 20 mg tocilizumaba *.
Each vial contains 80 mg of tocilizumab* in 4 ml (20 mg/ ml).
Ena viala vsebuje 80 mg tocilizumaba * v 4 ml (20 mg/ ml).
Each vial contains 200 mg of tocilizumab* in 10 ml (20 mg/ ml).
Ena viala vsebuje 200 mg tocilizumaba * v 10 ml (20 mg/ ml).
Each vial contains 400 mg of tocilizumab* in 20 ml (20 mg/ ml).
Ena viala vsebuje 400 mg tocilizumaba * v 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.
* humanizirano monoklonsko protitelo IgG1 proti človeškemu receptorju za interlevkin- 6 (IL- 6), pridobljeno s tehnologijo rekombinantne DNA v celicah jajčnikov kitajskega hrčka.
Each 80 mg vial contains 0.10 mmol (2.21 mg) sodium.
Ena 80- mg viala vsebuje 0, 10 mmol (2, 21 mg) natrija.
Each 200 mg vial contains 0.20 mmol (4.43 mg) sodium.
Ena 200- mg viala vsebuje 0, 20 mmol (4, 43 mg) natrija.
Each 400 mg vial contains 0.39 mmol (8.85 mg) sodium.
Ena 400- mg viala vsebuje 0, 39 mmol (8, 85 mg) natrija.
Clear to opalescent, colourless to pale yellow solution.
Bistra do opalescentna, brezbarvna do bledorumena raztopina.
RoActemra, in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe active rheumatoid arthritis (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.
Zdravilo RoActemra je indicirano za zdravljenje zmerno do hudo aktivnega revmatoidnega artritisa v kombinaciji z metotreksatom pri odraslih bolnikih, ki se niso zadostno odzvali na predhodno zdravljenje z enim ali več imunomodulirajočimi antirevmatičnimi zdravili ali zaviralci tumorje nekrotizirajočega faktorja (TNF) ali takšnega zdravljenja niso prenašali.
Patients treated with RoActemra should be given the Patient Alert Card.
Bolniki, ki se zdravijo z zdravilom RoActemra, morajo dobiti opozorilno izkaznico.
Posology The recommended posology is 8 mg/ kg body weight, but no lower than 480 mg, given once every four weeks.
Odmerjanje Priporočeno odmerjanje je 8 mg/ kg telesne mase, vendar ne manj kot 480 mg, enkrat na 4 tedne.
Doses above 1.2 g have not been evaluated in clinical studies (see section 5.1).
V kliničnih študijah niso ocenili odmerkov, večjih od 1, 2 g (glejte poglavje 5. 1).
2 Dose adjustments due to laboratory abnormalities (see section 4.4).
2 Prilagoditev odmerka zaradi nenormalnih laboratorijskih vrednosti (glejte poglavje 4. 4).
> 1 to 3 x Upper Dose modify concomitant MTX if appropriate Limit of Normal For persistent increases in this range, reduce RoActemra dose to 4 mg/ kg or (ULN) interrupt RoActemra until alanine aminotransferase (ALT) or aspartate aminotransferase (AST) have normalised Restart with 4 mg/ kg or 8 mg/ kg, as clinically appropriate
V primeru dolgotrajnih zvišanj v tem razponu zmanjšajte odmerek zdravila RoActemra na 4 mg/ kg ali prekinite njegovo uporabo, dokler se alanin - aminotransferaza (ALT) ali aspartat- aminotransferaza (AST) ne normalizirata.
> 3 to 5 x ULN
> 3 - do 5- kratna ZMN (potrjeno s ponovnim testiranjem, glejte
Interrupt RoActemra dosing until < 3 x ULN
Prekinite uporabo zdravila RoActemra, dokler ni dosežena < 3- kratna ZMN.
by When values reach < 3 x ULN, resume RoActemra at 4 mg/ kg or 8 mg/ kg dose
Ko vrednosti dosežejo < 3- kratno ZMN, znova uvedite zdravilo RoActemra v odmerku 4 mg/ kg ali 8 mg/ kg.