natgillin/translations-raw huggingface dataset:
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.
Študije kancerogenosti in plodnosti s tocilizumabom niso bile izvedene, ker ni ustreznega modela za protitelo, ki ne reagira z glodalskimi receptorji IL- 6.
Available non-clinical data demonstrated the effect of IL-6 on malignant progression and apoptosis resistance to various cancer types.
Razpoložljivi neklinični podatki so pri več različnih vrstah raka pokazali učinek IL- 6 na napredovanje malignoma in odpornosti proti apoptozi.
Additionally, proliferative lesions were not observed in a 6-month chronic toxicity study in cynomolgus monkeys or in IL-6 deficient mice.
Poleg tega v 6 - mesečni študiji kronične toksičnosti pri opicah cynomolgus in pri miših s pomanjkanjem IL- 6 niso opazili proliferativnih lezij.
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.
V študiji kroničnih toksičnih učinkov pri opicah cynomolgus niso opazili učinkov na endokrino aktivnih in reproduktivnih organih in reproduktivna sposobnost miši s pomanjkanjem IL- 6 ni bila prizadeta.
Tocilizumab administered to cynomolgus monkeys during early gestation, was observed to have no direct or indirect harmful effect on pregnancy or embryonal-foetal development.
Uporaba tocilizumaba pri opicah cynomolgus med zgodnjo gestacijo ni niti neposredno niti posredno škodljivo vplivala na nosečnost ali embrio- fetalni razvoj.
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.
Vendar pa so pri veliki sistemski izpostavljenosti (> 100- kratna izpostavljenost kot pri človeku) v visokoodmerni skupini 50 mg/ kg/ dan opažali rahel porast splavov oz. embrio- fetalnih smrti v primerjavi s skupino, ki je prejemala placebo in drugimi nizkoodmernimi skupinami.
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.
Čeprav ne kaže, da bi bil citokin IL- 6 ključen za rast ploda ali imunološki nadzor stika mati- plod, povezanosti tega izsledka s tocilizumabom ni mogoče izključiti.
Sucrose Polysorbate 80 Disodium phosphate dodecahydrate Sodium dihydrogen phosphate dihydrate Water for injections
Saharoza Polisorbat 80 Natrijev hidrogenfosfat dodekahidrat Natrijev dihidrogenfosfat dihidrat Voda za injekcije
13 6.3 Shelf life
13 6. 3 Rok uporabnosti
Diluted product:
Razredčeno zdravilo:
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.
Pripravljena raztopina za infundiranje je po razredčenju v raztopini natrijevega klorida 9 mg/ ml (0, 9%) za injiciranje, pri 30 °C fizikalno in kemično stabilna 24 ur.
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.
Če ni uporabljena takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika; čas običajno ne sme presegati 24 ur pri temperaturi od 2 do 8 °C, razen če je bilo razredčenje opravljeno v nadzorovanih in validiranih aseptičnih pogojih.
RoActemra is supplied as a sterile concentrate that does not contain preservatives.
Zdravilo RoActemra je na voljo kot sterilen koncentrat, ki ne vsebuje konzervansov.
Store vials in a refrigerator (2°C– 8°C).
Viale shranjujte v hladilniku (2 °C – 8 °C).
For storage conditions of the diluted medicinal product see section 6.3.
Za pogoje shranjevanja razredčenega zdravila glejte poglavje 6. 3.
RoActemra is supplied in a vial (type I glass) with a stopper (butyl rubber) containing 4 ml, 10 ml or 20 ml concentrate.
Viale vsebujejo 4, 10 ali 20 ml koncentrata.
Instructions for dilution prior to administration Parenteral medicinal products should be inspected visually for particulate matter or discoloration prior to administration.
Navodila za redčenje pred uporabo Parenteralna zdravila je treba pred uporabo pregledati in se prepričati, da ne vsebujejo delcev in niso obarvana.
Only solutions which are clear to opalescent, colourless to pale yellow and free of visible particles should be diluted
Razredčiti smete le raztopine, ki so bistre do opalescentne, brezbarvne do bledorumene in ne vsebujejo vidnih delcev.
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.
V aseptičnih pogojih iz 100- ml vrečke za infundiranje izvlecite toliko sterilne, apirogene 0, 9 -% (9 mg/ ml) raztopine natrijevega klorida za injiciranje, kot je potrebni volumen koncentrata zdravila RoActemra za bolnikov odmerek.
The required amount of RoActemra concentrate (0.4 ml/ kg) should be withdrawn from the vial and placed in the 100 ml infusion bag.
Potrebno količino koncentrata zdravila RoActemra (0, 4 ml/ kg) morate izvleči iz viale in dati v 100- ml vrečko za infundiranje.
This should be a final volume of 100 ml.
To mora biti končni volumen (100 ml).
16-3 Kiyohara Kogyodanchi Utsunomiya City Tochigi, 321-3231 Japan
16- 3 Kiyohara Kogyodanchi Utsunomiya City Tochigi, 321- 3231 Japonska
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
Paket informacij za medicinske sestre mora vključevati naslednje glavne vsebine: • preprečevanje medicinskih napak in reakcij, povezanih z infuzijo, o priprava infuzije, o hitrost infuzije,
17 • Monitoring of the patient for infusion reactions • Reporting of serious adverse drug reactions
17 • 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.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 3.3 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, ki je opisan v različici 3. 3 v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
Risk Management plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt za obvladovanje tveganja Imetnik dovoljenja za promet se zavezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, ki so podrobno opisane v načrtu farmakovigilance, ki je bil sprejet v različici 3 načrta za obvladovanje tveganja (RMP, Risk Management Plan), predstavljenem v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnih posodobitvah RMP, s katerimi soglaša odbor CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
ob prejemu nove informacije, ki lahko vpliva na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja;
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
v 60 dneh po dosegu pomembnega mejnika (pri farmakovigilanci ali zmanjševanju tveganja);
RoActemra 20 mg/ml concentrate for solution for infusion Tocilizumab
RoActemra 20 mg/ ml koncentrat za raztopino za infundiranje tocilizumab
Concentrate for solution for infusion 80 mg/4 ml 1 vial of 4 ml 4 vials of 4 ml
Koncentrat za raztopino za infundiranje 80 mg/ 4 ml 1 viala s 4 ml 4 viale s 4 ml
For intravenous infusion after dilution The diluted product should be used immediately Read the package leaflet before use
Za intravensko infundiranje po razredčenju Razredčeno zdravilo je treba uporabiti takoj Pred uporabo preberite priloženo navodilo
Store in a refrigerator Do not freeze Keep the vial in the outer carton in order to protect from light
Shranjujte v hladilniku Ne zamrzujte Viale shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo
Concentrate for solution for infusion 200 mg/10 ml 1 vial of 10 ml 4 vials of 10 ml
Koncentrat za raztopino za infundiranje 200 mg/ 10 ml 1 viala z 10 ml 4 viale z 10 ml
Store in a refrigerator Do not freeze Keep the vial in the outer carton, in order to protect from light
Shranjujte v hladilniku Ne zamrzujte Viale shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo
Concentrate for solution for infusion 400 mg/20 ml 1 vial of 20 ml 4 vials of 20 ml
Koncentrat za raztopino za infundiranje 400 mg/ 20 ml 1 viala z 20 ml 4 viale z 20 ml
RoActemra 20 mg/ml sterile concentrate Tocilizumab IV
RoActemra 20 mg/ ml sterilni koncentrat tocilizumab i. v.
IV infusion
i. v. infundiranje
RoActemra Patient Alert Card
RoActemra – opozorilna izkaznica bolnika
Complications of Diverticulitis
Zapleti divertikulitisa
This patient alert card contains important safety Patients using RoActemra may develop information that you need to be aware of before complications of diverticulitis which can and
Ta opozorilna izkaznica vsebuje pomembne informacije o varnosti, ki jih morate poznati, preden dobite zdravilo RoActemra, pa tudi med zdravljenjem z njim.
during treatment with RoActemra.
Pri bolnikih, ki uporabljajo zdravilo RoActemra, se lahko pojavijo zapleti divertikulitisa.
serious if not treated.
Ti zapleti lahko postanejo resni, če niso zdravljeni.
•
• To kartico pokažite vsakemu zdravniku, ki sodeluje pri vaši zdravstveni oskrbi. • Za več informacij preberite navodilo za uporabo zdravila RoActemra.
Show this card to any doctor involved in your care.
- Takoj poiščite zdravniško pomoč, če se vam pojavijo bolečine v trebuhu, krči v trebuhu (kolike), ali če opazite kri v blatu.
- Seek medical attention immediately if you develop stomach pain, colic, or
Okužbe Zdravilo RoActemra poveča tveganje za okužbe, ki lahko postanejo resne, če niso Začetek:
•
zdravilom
Read the RoActemra package leaflet for more information.
zdravljene.
notice blood in your stools.
______________________
Infections Start:
Z zdravilom RoActemra se ne smete zdraviti, če imate hudo okužbo.
RoActemra increases the risk of getting infections which can become serious if not
Pred zdravljenjem z zdravilom RoActemra morate opraviti presejalni
______________________
Zadnji odmerek, ki ste ga prejeli: ______________________
treated. - -You should not be treated with RoActemra if you have a severe infection.
• Poskrbite, da boste na vsak pregled pri
Most recent: ______________________
-
- You should have been screened for tuberculosis prior to treatment with RoActemra - Talk to your doctor about any
Z zdravnikom se posvetujte o cepljenjih, ki jih morda potrebujete pred začetkom zdravljenja z zdravilom RoActemra.
• Please make sure you also have a list of all your other medicines with you at any visit to a healthcare professional.
zdravniku prinesli spisek vseh drugih zdravil, ki jih uporabljate.
vaccinations you may need before you start treatment with RoActemra - If you have an infection of any kind (even a head cold) at the time of your next treatment, the infusion should be
Če imate tedaj, ko je čas za naslednji odmerek zdravila, kakršnokoli okužbo (tudi če je samo prehlad), je treba infuzijo odložiti, dokler se ne počutite bolje.
Patient’s Name: __________________ Doctor’s Name: __________________ Doctor’s Phone: __________________
Bolnikovo ime: __________________ Zdravnikovo ime: __________________ Zdravnikov telefon: __________________
delayed until you are feeling better - Seek medical attention immediately if you develop symptoms such as fever, persistent cough, weight loss, throat pain or soreness, wheezing, red or swollen skin blisters, tears, wounds, severe weakness or tiredness.
Takoj poiščite zdravniško pomoč, če se vam pojavijo simptomi, kot so zvišana telesna temperatura, trdovraten kašelj, hujšanje, boleče ali vneto žrelo, piskajoče dihanje, rdeči ali otekli kožni mehurji, solzenje, rane, huda šibkost ali utrujenost.
Keep this card with you for 3 months after the last RoActemra dose, since side effects could occur for some time after your last dose of RoActemra.
To izkaznico imejte pri sebi še 3 mesece po zadnjem odmerku zdravila RoActemra, kajti neželeni učinki se lahko pojavijo še nekaj časa po zadnjem odmerku zdravila RoActemra.
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 RoActemra.
Na njej so pomembne informacije o varnosti, ki jih morate poznati pred zdravljenjem z zdravilom RoActemra in med zdravljenjem z njim.
What RoActemra is and what it is used for 2.
Kaj je zdravilo RoActemra in za kaj ga uporabljamo 2.
Before you use RoActemra 3.
Kaj morate vedeti, preden boste uporabili zdravilo RoActemra 3.
How to use RoActemra 4.
Kako uporabljati zdravilo RoActemra 4.
How to store RoActemra 6.
Shranjevanje zdravila RoActemra 6.
WHAT ROACTEMRA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ROACTEMRA IN ZA KAJ GA UPORABLJAMO
RoActemra contains the active substance tocilizumab, a monoclonal antibody that blocks the action of a specific protein (cytokine) called interleukin-6.
Zdravilo RoActemra vsebuje zdravilno učinkovino tocilizumab, monoklonsko protitelo, ki blokira delovanje posebne beljakovine (citokina), imenovane interlevkin- 6.
BEFORE YOU USE ROACTEMRA
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO ROACTEMRA
Do not use RoActemra
Ne uporabljajte zdravila RoActemra
- if you are allergic (hypersensitive) to tocilizumab or any of the other ingredients of RoActemra
- če ste alergični (preobčutljivi) na tocilizumab ali katerokoli sestavino zdravila RoActemra
(listed in section 6, ‘What RoActemra contains’).
(naštete so v poglavju 6, "Kaj vsebuje zdravilo RoActemra").
- if you have an active, severe infection.
- če imate aktivno, hudo okužbo.
Take special care with RoActemra
Bodite posebno pozorni pri uporabi zdravila RoActemra
headedness, swelling of the lips or skin rash during or after the infusion, then tell your doctor immediately.
- Če se vam med infundiranjem ali po njem pojavi alergijska reakcija, npr. tiščanje v prsih,
Tell your
piskajoče dihanje, huda omotica ali vrtoglavost, otekanje ustnic ali izpuščaj na koži, morate to nemudoma povedati zdravniku.
- If you have had tuberculosis, tell your doctor.
- Če imate kakršnokoli okužbo, naj bo kratkotrajna ali dolgotrajna, ali če se vam pogosto
Your doctor will check for signs and symptoms
Če se ne počutite dobro, morate to nemudoma povedati zdravniku.
of tuberculosis before starting RoActemra.
znakov in simptomov tuberkuloze, preden vas bo začel zdraviti z zdravilom RoActemra.
- If you have had intestinal ulcers or diverticulitis, tell your doctor.
- Če ste kdaj imeli razjede na črevesu ali divertikulitis, morate to povedati zdravniku.
Symptoms would include
Med
abdominal pain and unexplained changes in bowel habits with a fever.
simptomi so lahko bolečine v trebuhu, nepojasnjene spremembe v razporedu iztrebljanja z zvišano telesno temperaturo.
- If you have liver disease, tell your doctor.
- Če imate kakršnokoli bolezen jeter, morate to povedati zdravniku.
Before you use RoActemra, your doctor may examine
Zdravnik lahko opravi
your liver function.
preiskave delovanja jeter, preden boste dobili zdravilo RoActemra.
Certain types of
- Če ste pred kratkim opravili kakšno cepljenje ali se nameravate cepiti, morate to povedati
vaccines should not be given while receiving RoActemra.
Med zdravljenjem z zdravilom RoActemra se ne sme uporabljati nekaterih vrst cepiv.
- If you have cancer, tell your doctor.
- Če imate raka, morate to povedati svojemu zdravniku.
Your doctor will have to decide if you can still be given
Zdravnik bo presodil, ali lahko dobite
RoActemra.
zdravilo RoActemra.
- If you have cardiovascular risk factors such as raised blood pressure and raised cholesterol
- Če imate srčno- žilne dejavnike tveganja, npr. zvišan krvni tlak ali zvišano koncentracijo
levels, tell your doctor.
holesterola, morate to povedati svojemu zdravniku.
- If you have moderate to severe kidney function problems, your doctor will monitor you.
- Če imate zmerne do hude težave z delovanjem ledvic, vas bo zdravnik nadzoroval.
Your doctor will perform a blood test before you receive RoActemra, to determine if you have a low white blood cell count, low platelet count or high liver enzymes.
Preden boste dobili zdravilo RoActemra, bo zdravnik opravil preiskavo krvi, da bo ugotovil, ali imate majhno število belih krvnih celic, majhno število trombocitov ali zvišane jetrne encime.
RoActemra is not recommended for use in children or adolescents under 18 years of age.
Zdravila RoActemra ni priporočljivo uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
Using other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Uporaba drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
You should tell your doctor if you are using medicines containing any of the following active substances: • atorvastatin, used to reduce cholesterol levels • calcium channel blockers (e.g. amlodipine), used to treat raised blood pressure • theophylline, used to treat asthma • warfarin, used as a blood thinning agent • phenytoin, used to treat convulsions • ciclosporin, used to suppress your immune system during organ transplants • benzodiazepines (e.g. temazepam), used to relieve anxiety
Zdravniku morate povedati, če uporabljate zdravila, ki vsebujejo katero od naslednjih učinkovin: • atorvastatin, ki se uporablja za zniževanje koncentracije holesterola, • zaviralce kalcijevih kanalčkov (npr. amlodipin), ki se uporabljajo za zdravljenje zvišanega krvnega tlaka, • teofilin, ki se uporablja za zdravljenje astme, • varfarin, ki se uporablja za redčenje krvi, • fenitoin, ki se uporablja za zdravljenje epileptičnih napadov (konvulzij), • ciklosporin, ki se uporablja za zaviranje imunskega sistema v primeru presaditve organa, • benzodiazepine (npr. temazepam), ki se uporabljajo za odpravljanje tesnobnosti.
Due to lack of clinical experience, RoActemra is not recommended for use with other biological medicines for the treatment of RA.
Zaradi nezadostnih kliničnih izkušenj zdravila RoActemra ni priporočljivo uporabljati z drugimi biološkimi zdravili za zdravljenje revmatoidnega artritisa.
Pregnancy and breast-feeding Talk to your doctor if you are pregnant, may be pregnant, intend to become pregnant or if you are breast-feeding.
Nosečnost in dojenje Če ste noseči, če bi lahko bili noseči, če načrtujete nosečnost, ali če dojite, se posvetujte z zdravnikom.
Women of childbearing potential must use effective contraception during and up to 6 months after treatment.
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in 6 mesecev po njem.
It is not known whether RoActemra is excreted in breast milk.
33 Ni znano, ali se zdravilo RoActemra izloča v materino mleko.
If you are a nursing mother, you should stop breast-feeding if you are to be given RoActemra.
Če dojite, morate nehati dojiti, če dobite zdravilo RoActemra.
Before starting breast-feeding, your last treatment with RoActemra should be at least 3 months ago.
Preden začnete dojiti, mora od vaše zadnje uporabe zdravila RoActemra miniti vsaj 3 mesece.
Driving and using machines There are no studies on the effects of RoActemra on the ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Študij o vplivu zdravila RoActemra na sposobnost upravljanja vozil in strojev ni.
However, if you experience dizziness, a common side effect, then you should not drive or use machines.
Če opazite omotico, ki je pogost neželeni učinek, ne smete voziti ali upravljati s stroji.
33 Important information about some of the ingredients of RoActemra This medicinal product contains 26.55 mg sodium per maximum dose of 1200 mg (8.85 mg sodium per 400 mg vial).
Pomembne informacije o nekaterih sestavinah zdravila RoActemra To zdravilo vsebuje 26, 55 mg natrija na največji odmerek 1200 mg (8, 85 mg natrija na 400- mg vialo).
To be taken into consideration by patients on a controlled sodium diet.
To je treba upoštevati pri bolnikih, ki potrebujejo prehrano z nadzorovano količino natrija.
Doses below 1025 mg of this medicinal product contain less than 1 mmol sodium (23 mg), i.e. essentially ‘sodium free’.
Odmerki tega zdravila, manjši od 1025 mg, vsebujejo manj kot 1 mmol natrija (23 mg) in so torej praktično "brez natrija".
HOW TO USE ROACTEMRA
KAKO UPORABLJATI ZDRAVILO ROACTEMRA
Depending on your response, your doctor may decrease your dose to 4 mg/kg then increase back to 8 mg/kg when appropriate.
Odvisno od vašega odziva vam lahko zdravnik zmanjša odmerek na 4 mg/ kg in ga nato spet poveča na 8 mg/ kg, ko je primerno.
You will receive RoActemra once every 4 weeks through a drip in your vein (intravenous infusion) over one hour.
Zdravilo RoActemra boste dobili enkrat na 4 tedne v intravenski infuziji (kapalni infuziji v veno), ki bo trajala eno uro.
After dilution, RoActemra will be given to you by a doctor or nurse, who will also monitor you during and after administration.
Po pripravi (razredčenju) vam bo zdravilo RoActemra dal zdravnik ali medicinska sestra, ki vas bo tudi nadziral med dajanjem zdravila in po njem.
If you use more RoActemra than you should Since RoActemra is given by a doctor or nurse, it is unlikely that you will be given too much.
Če ste dobili večji odmerek zdravila RoActemra, kot bi smeli Ker vam bo zdravilo RoActemra dal zdravnik ali medicinska sestra, ni verjetno, da bi ga dobili preveč.