FrancophonIA/ELRC3.0 huggingface dataset:
English: Injection site reactions (including bleeding, bruising, erythema, itching, pain, swelling)*
Slovenian: (vključno s krvavitvijo, podplutbami, eritemom, srbenjem,
English: NAME OF THE MEDICINAL PRODUCT Erelzi 50 mg injection etanercept
Slovenian: Erelzi 50 mg injekcija etanercept
English: No treatment was given for the majority of injection site reactions in the etanercept treatment groups, and the majority of patients who were given treatment received topical preparations, such as corticosteroids, or oral antihistamines.
Slovenian: V skupinah, ki so prejemale etanercept, večine reakcij na mestu injiciranja ni bilo potrebno zdraviti.
English: If symptoms of tuberculosis (such as persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy, tell your doctor immediately.
Slovenian: apatija, blaga vročina) ali kakšne druge okužbe, to nemudoma povejte zdravniku.
English: • Signs of inflammation of the blood vessels such as pain, fever, redness or warmth of the skin, or itching.
Slovenian: težave z dihanjem, motnje mišljenja, zaznavanja ali vida; • znaki vnetja krvnih žil, kot so bolečina, vročina, rdečina ali toplina kože ali srbenje.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TEXT FOR TRAY BACK - 25 MG PRE-FILLED SYRINGE
Slovenian: BESEDILO NA HRBTNI STRANI PODSTAVKA - 25 MG NAPOLNJENA INJEKCIJSKA BRIZGA
English: The needle cap should not be removed while allowing the pre-filled syringe to reach room temperature.
Slovenian: Med čakanjem, da se napolnjena injekcijska brizga segreje na sobno temperaturo, pokrovčka igle ne smete odstraniti.
English: Hypoglycaemia in patients treated for diabetes
Slovenian: Hipoglikemija pri bolnikih, ki se zdravijo zaradi sladkorne bolezni Po uvedbi etanercepta so pri bolnikih, ki so prejemali zdravila za zdravljenje sladkorne bolezni,
English: Etanercept serum values were determined by an Enzyme-Linked Immunosorbent Assay (ELISA) method, which may detect ELISA-reactive degradation products, as well as the parent compound.
Slovenian: ki zazna tako ELISA reaktivne razgradne produkte kot tudi izhodno snov.
English: red, or scaly skin patches or lesions (“psoriasis skin lesions”).
Slovenian: trdovratnega kašlja, zatrdlin ali izrastkov na koži;
English: Each pre-filled pen contains 50 mg etanercept.
Slovenian: Ena napolnjen injekcijski peresnik vsebuje 50 mg etanercepta.
English: Erelzi 50 mg solution for injection in pre-filled pen
Slovenian: Erelzi 50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: Multipack: 8 (2 packs of 4) pre-filled syringes with a needle guard.
Slovenian: Skupno pakiranje: 8 (2 pakiranji s po 4) napolnjenih injekcijskih brizg z zapiralom igle Skupno pakiranje: 12 (3 pakiranja s po 4) napolnjenih injekcijskih brizg z zapiralom igle Skupno pakiranje: 24 (6 pakiranj s po 4) napolnjenih injekcijskih brizg z zapiralom igle
English: Undesirable effects in paediatric patients with juvenile idiopathic arthritis
Slovenian: Vrste okužb, ki so jih opazili v kliničnih preskušanjih pri bolnikih z juvenilnim idiopatskim artritisom,
English: List of the names, pharmaceutical forms, strength of the medicinal product, route of administration, marketing authorisation holders in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila in imetnikov dovoljenj za promet z zdravilom v državah članicah
English: United Kingdom Genus Pharmaceuticals, Park View House, 65 London Road, Newbury, Berkshire RG14 1JN
Slovenian: Velika Britanija Genus Pharmaceuticals, Park View House, 65 London Road, Newbury, Berkshire RG14 1 JN
English: Cell Pharm GmbH Theodor-Heuss-Str. 52 61118 Bad Vilbel Germany
Slovenian: Nemčija cell pharm GmbH Theodor-Heuss-Str. 52 61118 Bad Vilbel Germany
English: Germany
Slovenian: Austria
English: Novgos 3.6mg Implant 3.6 mg
Slovenian: Novgos 3.6 mg Implant
English: Novogos 3,6 mg Implantat implant, pre-filled syringe subcutaneous use
Slovenian: Novogos 3,6 mg Implantat
English: Information for patients
Slovenian: Znanstveni zaključki
English: • In patients with a high baseline risk of fracture, carefully consider the benefit of treatment against the risks.
Slovenian: Poleg tega je treba pri bolnikih z velikim izhodiščnim tveganjem za zlome natančno oceniti koristnost zdravljenja za odtehtanje tveganja.
English: It is thought that Xofigo, which is taken up by the bone, accumulates at sites where the bone is already damaged, for example by osteoporosis or micro-fractures, increasing the risk of fracture.
Slovenian: Zdravilo Xofigo naj bi se kopičilo na mestih velike kostne premene, na primer na mestih degenerativne kostne bolezni (osteoporoze) ali nedavnih (mikro) zlomov, kar povečuje tveganje za zlome.
English: Monitoring should continue for at least 24 months.
Slovenian: Glede na ugotovljeno zapoznelo tveganje za zlome je treba oba vidika natančno spremljati vsaj 24 mesecev po začetku zdravljenja.
English: Therefore such preventive measures should be considered before starting or resuming treatment with Xofigo.
Slovenian: Poleg tega je treba pred začetkom ali nadaljevanjem zdravljenja z zdravilom Xofigo razmisliti o preventivnih ukrepih, na primer o uporabi bisfosfonatov ali denosumaba.
English: It is also not recommended in combination with systemic cancer therapies other than LHRH analogues.
Slovenian: Skratka, odbor PRAC je odsvetoval kombiniranje [223Ra]radija z vsemi drugimi sistemskimi zdravili proti raku razen z analogi LHRH.
English: Information for healthcare professionals
Slovenian: Podlaga za priporočilo odbora PRAC
English: • Xofigo should only be used as monotherapy or in combination with an LHRH analogue for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC), symptomatic bone metastases and no known visceral metastases, who are in progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment.
Slovenian: V splošnem je odbor PRAC presodil, da naj se zdravilo Xofigo uporablja samo kot monoterapija ali v kombinaciji z analogom luteinizirajoči hormon sproščajočega hormona (LHRH) za zdravljenje odraslih bolnikov z metastatskim proti kastraciji odpornim rakom prostate (mCRPC), simptomatičnimi kostnimi metastazami in brez znanih visceralnih metastaz, v napredovanju po vsaj dveh predhodnih vrstah sistemskega zdravljenja mCRPC (poleg analogov LHRH), ali bolnikov, za katere nobeno razpoložljivo sistemsko zdravljenje mCRPC ni primerno.
English: In another randomised, double blind, placebo controlled phase III trial (ALSYMPCA), a statistically significant overall survival benefit of treatment with Xofigo could not be demonstrated in the subgroups of patients with fewer than 6 metastases (HR for radium-223 to placebo 0.901; 95% CI [0.5531.466], p=0.674) or a baseline total alkaline phosphatase (ALP) <220 U/L (HR 0.823 95% CI 0.6331.068, p=0.142), indicating that efficacy may be diminished in patients with a low level of osteoblastic activity from their bone metastases.
Slovenian: Poleg tega v študiji ALSYMPCA pri podskupinah bolnikov z manj kot šestimi kostnimi metastazami ni bilo mogoče dokazati statistično pomembne koristi za celokupno preživetje (HR med [223Ra]radijem in placebom: 0,901; 95-odstotni IZ [0,553-1,466].
English: In addition, the combination used in this study is now contraindicated.
Slovenian: Te značilnosti se skladajo z odobreno indikacijo.
English: • In mildly symptomatic patients, the benefit of treatment should be carefully assessed against its risks, considering that high osteoblastic activity is likely to be required for treatment benefit (see below for more information).
Slovenian: Odbor PRAC je presodil, da je treba pri odraslih s CRPC in blago simptomatičnimi kostnimi metastazami natančno oceniti, ali koristnost zdravljenja odtehta tveganja, ob upoštevanju, da bo za koristnost zdravljenja verjetno potrebna visoka osteoblastna aktivnost.
English: • Before starting and during treatment with Xofigo, an assessment of patients' bone status (e.g. by scintigraphy, bone mineral density measurement) and risk of fractures (e.g. osteoporosis, fewer than 6 bone metastases, medication increasing fracture risk, low body mass index) should be performed.
Slovenian: Na podlagi omenjenih ugotovitev je odbor PRAC presodil, da je treba pred začetkom zdravljenja z [223Ra]radijem na podlagi znanih dejavnikov tveganja in dejavnikov, ugotovljenih v tem postopku (npr. osteoporoze, manj kot šestih kostnih metastaz, zdravil, ki povečujejo tveganje za zlome in nizkega indeksa telesne mase), oceniti kostni status, na primer z uporabo scintigrafije in meritve kostne mineralne gostote, ter izhodiščno tveganje za zlome pri bolnikih.
English: The above recommendations are based on the assessment of data from a randomised, double blind, placebo controlled phase III trial (ERA-223), which showed that there was an increased incidence of fractures (28.6% vs 11.4%), a possible reduction in median overall survival (30.7 months vs 33.3 months, HR 1.195, 95% confidence interval (CI) 0.950 - 1.505, p=0.13) and an increased risk of radiological non-bone progression (HR 1.376 [95% CIs 0.972, 1.948], p=0.07) among patients receiving Xofigo in combination with abiraterone acetate plus prednisone/prednisolone (n=401) compared to patients receiving placebo in combination with abiraterone acetate plus prednisone/prednisolone (n=405).
Slovenian: V celotni populaciji je bilo ugotovljeno večje tveganje za radiološko nekostno napredovanje v skupini, ki je prejemala [223Ra]radij, v primerjavi s skupino, ki je prejemala placebo (HR 1,376; 95odstotni IZ (0,972; 1,948), p = 0,07), kar vzbuja skrb, da [223Ra]radij spodbuja visceralne in nodalne metastaze.
English: More about the procedure
Slovenian: Splošni zaključek
English: In the study, patients given the combination with Xofigo died on average 2.6 months earlier than those given the combination with placebo.
Slovenian: V študiji ALSYMPCA je bila incidenca zlomov pri bolnikih z manj kot šestimi kostnimi metastazami približno dvakrat tolikšna kot v skupini, ki je prejemala placebo.
English: The review of Xofigo was initiated on 1 December 2017 at the request of the European Commission, Article 20 of Regulation (EC) No 726/2004.
Slovenian: Dne 30. novembra 2017 je Evropska komisija v skladu s členom 20 Uredbe (ES) št. 726/2004 agencijo zaprosila za mnenje o tem, ali je treba ohraniti, spremeniti, začasno odvzeti ali preklicati dovoljenje za promet z zdravilom Xofigo ([223Ra]radijev diklorid).
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines.
Slovenian: Skladno z rezultati zasedanja onkološke znanstvene svetovalne skupine (SAG) je odbor PRAC torej presodil, da so te ugotovitve relevantne za odobreno indikacijo.
English: An increased fracture risk was found particularly in patients with a medical history of osteoporosis and in patients with fewer than 6 bone metastases.
Slovenian: V multivariatnih analizah se je v veji, ki je prejemala [223Ra]radij, večje tveganje za zlome kazalo pri bolnikih z manj kot šestimi kostnimi metastazami kot pri bolnikih s šestimi ali več kostnimi metastazami.
English: The PRAC's recommendations were endorsed by EMA's Committee for Medicinal Products for Human Use (CHMP).
Slovenian: Odbor PRAC je proučil tudi stališča znanstvene svetovalne skupine za onkologijo.
English: • Xofigo is contraindicated in combination with abiraterone acetate and prednisone/prednisolone.
Slovenian: Odbor PRAC je poleg tega presodil, da mora biti [223Ra]radij kontraindiciran v kombinaciji z abirateron acetatom in prednizonom/prednizolonom.
English: On 26 July 2018, the European Medicines Agency concluded its review of the cancer medicine Xofigo (radium-223 dichloride), and recommended restricting its use to patients who have had two previous treatments for metastatic prostate cancer (prostate cancer that has spread to the bone) or who cannot receive other treatments.
Slovenian: Splošni povzetek znanstvenega vrednotenja odbora PRAC Zdravilo Xofigo ([223Ra]radijev diklorid) je centralno odobreno zdravilo, indicirano za zdravljenje odraslih z na kastracijo odpornim rakom prostate, s simptomatičnimi kostnimi metastazami in brez znanih visceralnih metastaz.
English: A possible increased risk of death was also observed in a clinical trial investigating Xofigo in combination with abiraterone acetate and prednisone/prednisolone in patients with asymptomatic or mildly symptomatic castration-resistant prostate cancer.
Slovenian: Podobno ni mogoče izključiti nadaljnjega povečanja tveganja zaradi znanega škodljivega vpliva kemoterapije, ki je odobrena za zdravljenje mCRPC v kombinaciji s prednizonom/prednizolonom, na kosti.
English: The medicine should also not be used in patients who have no symptoms, in line with the current indication; in addition, the use of Xofigo is not recommended in patients with a low number of bone metastases called osteoblastic bone metastases.
Slovenian: Populacija v študijo ALSYMPCA vključenih bolnikov, ki še niso bili zdravljeni s kemoterapijo, posledično ni bila dobro opredeljena, značilnosti drugačnih subpopulacij pa niso znane.
English: The review of Xofigo was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC) after data from a clinical study suggested that patients given Xofigo in combination with Zytiga and prednisone/prednisolone could be at risk of dying earlier and had more fractures than patients given placebo (a dummy treatment) with Zytiga and prednisone/prednisolone.
Slovenian: Z analizami neprečiščenih predhodnih podatkov iz kliničnega preskušanja, v katerem so ocenjevali zdravilo Xofigo ([223Ra]radijev diklorid) v populaciji bolnikov brez simptomov ali z blagimi simptomi raka prostate (študija ERA-223 [1]), je bilo ugotovljeno, da je incidenca zlomov in smrtnosti, ki jih je povzročilo zdravljenje, povečana pri veji zdravljenja (z [223Ra]radijevim dikloridom v kombinaciji z abirateron acetatom in prednizonom/prednizolonom) v primerjavi s kontrolno vejo (placebo v kombinaciji z abirateron acetatom in prednizonom/prednizolonom).
English: In March 2018, the PRAC recommended contraindicating the use of Xofigo with Zytiga and prednisone/prednisolone, as an interim measure, while the review was ongoing.
Slovenian: V celoti gledano je odbor PRAC presodil, da je treba kontraindikacijo, uvedeno v času začasnih ukrepov za uporabo [223Ra]radija v kombinaciji z abirateronom in prednizonom/prednizolonom, ohraniti.
English: More information on Xofigo is available on the EMA website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports
Slovenian: Preostaja, da so v študiji ERA-223 o vseh zlomih poročali dlje kot v študiji ALSYMPCA in da so v fazi zdravljenja opravili kostno/računalniško tomografsko (CT) preiskavo.
English: The study included patients with no or only mild symptoms, whereas Xofigo is only authorised in patients with symptoms.
Slovenian: Nekateri strokovnjaki skupine SAG so menili, da bi bil [223Ra]radij lahko uporabna možnost kot monoterapija samo pri bolnikih z zelo simptomatičnimi kostnimi metastazami.
English: However, the reasons for a possible earlier death seen in this study are not fully understood.
Slovenian: Poleg tega se rezultati dveh končanih randomiziranih kontroliranih preskušanj ne ujemajo glede celokupnega preživetja.
English: In addition Xofigo, used on its own or with medicines called ‘luteinising hormone releasing hormone (LHRH) analogues', will be reserved for patients who have had at least two previous treatments for prostate cancer that has spread to the bone, or who cannot receive other treatments.
Slovenian: • Odbor PRAC je zato priporočil, da se indikacija za uporabo [223Ra]radija omeji na samostojno uporabo ali uporabo v kombinaciji z analogom luteinizirajoči hormon sproščajočega hormona (LHRH) za zdravljenje odraslih bolnikov z metastatskim proti kastraciji odpornim rakom prostate (mCRPC), simptomatičnimi kostnimi metastazami in brez znanih visceralnih metastaz, pri napredovanju po vsaj dveh predhodnih vrstah sistemskega zdravljenja mCRPC (poleg analogov LHRH), ali bolnikov, ki jih ni mogoče zdraviti z nobenim razpoložljivim sistemskim zdravljenjem mCRPC.
English: EMA restricts use of prostate cancer medicine Xofigo
Slovenian: Odbor zato priporoča spremembo pogojev dovoljenja za promet z zdravilom Xofigo ([223Ra]radijev diklorid).
English: Subsequent systemic cancer treatment should not be initiated for at least 30 days after the last administration of Xofigo.
Slovenian: Ker niso bili na voljo klinični podatki, je odbor PRAC presodil, da je treba zdravstvenim delavcem na podlagi razpolovnega časa izločanja priporočiti uvajanje razmika vsaj petih dni po zdravljenju z abirateronom in pred začetkom zdravljenja z [223Ra]radijem ter razmika vsaj 30 dni po zadnjem odmerku [223Ra]radija, preden se začne nadaljnje sistemsko zdravljenje raka.
English: Strength Pharmaceutical Form Route of Administration Packaging
Slovenian: ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja o č
English: Only results from Part 1 are described henceforth.
Slovenian: V nadaljevanju so opisani samo rezultati prvega dela.
English: Date of first authorisation: 20 May 2016 Date of latest renewal: 24 April 2017
Slovenian: Datum prve odobritve: 20. maj 2016 Datum zadnjega podaljšanja: 24. april 2017
English: These may include:
Slovenian: Ta zdravila lahko vključujejo:
English: Ringaskiddy, Co. Cork Ireland
Slovenian: Ringaskiddy, Co. Cork Irska
English: Therefore, the incidence of antibody development might not have been reliably determined.
Slovenian: Zato je mogoče, da pojavnost razvoja protiteles ni bila zanesljivo določena.
English: This includes medicines you can get without a prescription, and herbal medicines.
Slovenian: To vključuje tudi zdravila, ki jih lahko dobite brez zdravniškega recepta, in zdravila rastlinskega izvora.
English: If you need a blood transfusion, you will have a blood test first to match your blood type.
Slovenian: Če potrebujete transfuzijo krvi, vam bodo najprej opravili test za določanje krvne skupine.
English: Unopened vials 24 months
Slovenian: Zaprte viale 24 mesecev
English: Consider supportive care with transfusions or growth factors.
Slovenian: Razmisliti velja o podpornem zdravljenju s transfuzijami ali rastnimi faktorji.
English: These reactions are most likely to happen with the first infusion.
Slovenian: Te reakcije se najpogosteje pojavijo med prvo infuzijo.
English: Dilute under appropriate aseptic conditions.
Slovenian: Razredčevanje izvajajte v ustreznih aseptičnih pogojih.
English: People with breathing problems
Slovenian: Ljudje, ki imajo težave z dihanjem
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Slovenian: Pred začetkom prejemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke.
English: Monoclonal antibodies are proteins that have been designed to recognise and attach to specific targets in the body.
Slovenian: Monoklonska protitelesa so beljakovine, ki so namenjene prepoznavanju in vezavi na točno določene tarče v telesu.
English: 7.4 (5.5, NE)
Slovenian: 7,4 (5,5, NMO)
English: This is because the medicine may pass into the mother's milk and it is not known how it will affect the baby.
Slovenian: Zdravilo namreč lahko prehaja v materino mleko in ni znano, kako lahko vpliva na dojenega otroka.
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali boste morda začeli jemati katero koli drugo zdravilo.
English: These reactions can happen during the infusion or in the 3 days after the infusion.
Slovenian: Te reakcije se lahko pojavijo med infundiranjem ali v 3 dneh po infuziji.
English: Otherwise, continue to use instructions indicated in the table for the Week 2 infusion rate.
Slovenian: V nasprotnem primeru še naprej upoštevajte navodila, ki so v preglednici navedena za hitrost infundiranja v 2. tednu.
English: Component of an initiation pack, cannot be sold separately.
Slovenian: Posamezni deli se ne smejo prodajati ločeno.
English: It belongs to a group of medicines called “monoclonal antibodies”.
Slovenian: Sodi v skupino zdravil, imenovanih “monoklonska protitelesa”.
English: Continuous monitoring for this safety signal will be performed in clinical studies and post-marketing safety data.
Slovenian: Morebiten pojav tega varnostnega signala bodo redno spremljali v podatkih o varnosti iz kliničnih študij in obdobja trženja zdravila.
English: Recommended concomitant medications
Slovenian: Priporočena sočasna zdravila
English: • unusual feeling in the skin (such as a tingling or crawling feeling).
Slovenian: • neobičajen občutek v koži (kot sta mravljinčenje ali gomazenje)
English: The efficacy results in this subgroup were consistent with the overall population.
Slovenian: Rezultati učinkovitosti v tej podskupini so bili podobni kot v celotni populaciji.
English: No chronic toxicity testing has been conducted.
Slovenian: Preizkusov kronične toksičnosti niso izvajali.
English: Clearance also decreased with multiple doses, which may be related to tumour burden decreases.
Slovenian: Očistek se je zmanjšal tudi po večkratnem odmerjanju, kar je lahko povezano z zmanjšanjem tumorskega bremena.
English: The Patient Alert Card, shall contain the following key elements:
Slovenian: Opozorilna kartica za bolnika mora vsebovati naslednje ključne elemente:
English: • then once every 4 weeks after that as long as your condition does not worsen.
Slovenian: • nato ga boste prejemali enkrat na 4 tedne do poslabšanja vaše bolezni.
English: There is a theoretical risk of haemolysis.
Slovenian: Obstaja teoretična možnost za pojav hemolize.
English: Therefore daratumumab should not be used during pregnancy unless the benefit of treatment to the woman is considered to outweigh the potential risks to the fetus.
Slovenian: Zato se daratumumaba med nosečnostjo ne sme uporabljati, razen kadar koristi zdravljenja za žensko presegajo možna tveganja za plod.
English: Very good partial response (VGPR)
Slovenian: zelo dober delni odziv (VGPR)
English: This medicinal product is for single-use only.
Slovenian: Zdravilo je samo za enkratno uporabo.
English: Your healthcare professional will throw away any medicines that are no longer being used.
Slovenian: Zdravstveni delavci bodo ustrezno zavrgli zdravilo, ki ga ne rabijo več.
English: The safety and efficacy of DARZALEX in children aged below 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila DARZALEX pri otrocih, starih manj kot 18 let, nista bili dokazani.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000).
Slovenian: Pogostnosti neželenih učinkov so opredeljene kot zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
English: Women of child-bearing potential/Contraception
Slovenian: Ženske v rodni dobi/kontracepcija
English: Median Time to Response [months (range)]
Slovenian: mediani čas do odziva [meseci (okvirne vrednosti ranga)]
English: 6/kg; VTd 8.9 x 10
Slovenian: 6/kg; v skupini VTd 8,9 x 10
English: See below “Recommended concomitant medications”, “Management of infusion-related reactions” and section 4.4.
Slovenian: Glejte spodnja odstavka “Priporočena sočasna zdravila” in “Obvladovanje infuzijskih reakcij” ter poglavje 4.4.
English: You must not be given DARZALEX - if you are allergic to daratumumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Zdravila DARZALEX ne smete prejeti - če ste alergični na daratumumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Hepatitis B virus (HBV) Reactivation
Slovenian: Reaktivacija virusa hepatitisa B (HBV)