natgillin/translations-raw huggingface dataset:
Autoimmune haemolytic anaemia, autoimmune aplastic anaemia, autoimmune thrombocytopenia
Bolezni krvi in limfatičnega sistema anemijaa nevtropenijaa avtoimunska hemolitična anemija, avtoimunska aplastična anemija,
After you (or your child) have been treated with Strimvelis, you or your child will not be able to donate blood, organs or tissues at any time in future.
Oseba, zdravljena z zdravilom Strimvelis, po zdravljenju nikdar več ne sme darovati krvi, organov ali tkiv,
Package leaflet: Information for the patient or carer Strimvelis 1-10 million cells/ml dispersion for infusion Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence
Navodilo za uporabo Strimvelis 1-10 milijonov celic/ml disperzija za infundiranje avtologna, s CD34+ obogatena celična frakcija s celicami CD34+, transduciranimi z retrovirusnim vektorjem,
Strimvelis is given…
Dobili boste zdravilo Strimvelis ...
Dermatitis atopic, eczema
Bolezni kože in podkožja atopijski dermatitis, ekcem
The most commonly reported adverse reaction was pyrexia.
Najpogosteje opisan neželeni učinek je bila zvišana telesna temperatura.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Total cell number:
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT Celotno število celic: x 106 celic CD34+/kg:
Name and address of the manufacturer of the biological active substance MolMed SpA
ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca biološke zdravilne učinkovine
- If you (or your child) get any side effects, talk to your doctor or nurse.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali medicinsko sestro.
Exp.: {DD MMM YY} {hh:mm} BATCH NUMBER, DONATION AND PRODUCT CODES
ŠTEVILKA SERIJE, ENOTNE OZNAKE DAROVANJA IN IZDELKOV
Respiratory, thoracic and mediastinal disorders
Bolezni jeter, žolčnika in žolčevodov avtoimunski hepatitis
LIST OF EXCIPIENTS
Št. preiskovancev
Not applicablee
POSTOPEK UPORABE
* Including data from one patient collected post intervention with PEG-ADA (>3 months treatment) or hematopoietic stem cell transplantation a Based on the entire pre-treatment period for severe infections (retrospectively collected), and the data collected at the baseline visit for T-lymphocytes.
Navedba smiselno ni potrebna * Vključno s podatki enega bolnika, zbranimi po ukrepanju s PEG-ADA (> 3 mesece zdravljenja) ali presaditvijo hematopoetskih matičnih celic.
Prior to launch of Strimvelis in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials for parents/carers and health professionals,
Pred prihodom zdravila Strimvelis na trg v posamezni državi članici mora imetnik dovoljenja za promet
- are allergic to any of the ingredients of this medicine (listed in section 6) - have or have had a type of cancer called leukaemia or myelodysplasia - have tested positive for HIV or some other infections (your doctor will advise you about this) - have already been treated with gene therapy
- imate pozitiven izvid testiranja za HIV ali kakšno drugo okužbo (zdravnik vam bo dal pojasnila v zvezi s tem).
Paediatric population
Starejši bolniki
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ZUNANJI VSEBNIK
PHARMACEUTICAL FORM AND CONTENTS
FARMACEVTSKA OBLIKA IN VSEBINA disperzija za infundiranje
Strimvelis must not be given if you (or to your child):
Zdravila Strimvelis ne smete (oz. vaš otrok, če je on bolnik) dobiti, če:
• increases in liver enzymes*
• zvišanje jetrnih encimov* • rezultati preiskav krvi (pozitivni za protijedrna protitelesa)
The recommended starting dose is 4 mg once a day, taken at the same time each day.
Priporočeni začetni odmerek je 4 mg enkrat na dan vedno ob istem času.
What measures are being taken to ensure the safe and effective use of Imnovid?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Imnovid?
Previously known as Pomalidomide Celgene.
Prej znano pod imenom Pomalidomid Celgene.
As the medicine can pass into semen, the medicine must also not be used in men who are unable to comply with the required contraceptive measures.
Ker zdravilo lahko prehaja v semenčice, se zdravilo ne sme uporabljati pri moških, ki ne morejo upoštevati zahtevanih kontracepcijskih ukrepov.
The company that makes Imnovid will set up a pregnancy-prevention programme in each Member State.
Podjetje, ki trži zdravilo Imnovid, bo v vsaki državi članici vzpostavilo program za preprečevanje nosečnosti.
Further information on the orphan designation can be found on ema.europa.eu/medicines/human/orphan-designations/EU309672.
Nadaljnje informacije glede določitve zdravila sirote lahko najdete tukaj: ema.europa.eu/medicines/human/orphan-designations/EU309672
Imnovid is available as capsules (1, 2, 3 and 4 mg).
Zdravilo Imnovid je na voljo v obliki kapsul (1 mg, 2 mg, 3 mg in 4 mg).
Imnovid received a marketing authorisation valid throughout the EU on 5 August 2013.
Za zdravilo Imnovid je bilo 5. avgusta 2013 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
The European Medicines Agency decided that Imnovid's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Imnovid večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
It must not be used in women who could become pregnant, unless they take all the necessary steps to ensure that they are not pregnant before treatment and that they do not become pregnant during or soon after treatment.
Prav tako ga ne smejo uporabljati ženske, ki bi utegnile zanositi, razen če ne ukrenejo vsega potrebnega za zagotovitev, da pred začetkom zdravljenja niso noseče, in da ne zanosijo med zdravljenjem ali neposredno po koncu tega.
Other information about Imnovid
Druge informacije o zdravilu Imnovid
It will also supply cards for patients to ensure that all appropriate safety measures have been taken by each patient.
Prav tako bo priskrbelo kartice za bolnike, s pomočjo katerih bo lahko vsak bolnik preveril, ali je upošteval vse ustrezne varnostne ukrepe.
As for all medicines, data on the use of Imnovid are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Imnovid stalno spremljajo.
What is Imnovid and what is it used for?
Kaj je zdravilo Imnovid in za kaj se uporablja?
What benefits of Imnovid have been shown in studies?
Kakšne koristi je zdravilo Imnovid izkazalo v študijah?
What are the risks associated with Imnovid?
Kakšna tveganja so povezana z zdravilom Imnovid?
Pomalidomide is expected to be harmful to the unborn child, causing severe and life-threatening birth defects.
Pomalidomid naj bi bil škodljiv za nerojenega otroka, zaradi česar prihaja do resnih in smrtno nevarnih prirojenih okvar.
Side effects reported with Imnovid are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Imnovid, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Why is Imnovid authorised in the EU?
Zakaj je bilo zdravilo Imnovid odobreno v EU?
An overview of Imnovid and why it is authorised in the EU
Pregled zdravila Imnovid in zakaj je odobreno v EU
For more information about using Imnovid, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Imnovid glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The company will also set up a registry of patients treated with Imnovid to monitor the side effects reported and whether the medicine is used for its approved indication and in compliance with the pregnancy-prevention programme.
Podjetje bo prav tako vzpostavilo register bolnikov, zdravljenih z zdravilom Imnovid, za spremljanje neželenih učinkov, o katerih bodo poročali, in tega, ali se zdravilo uporablja za odobreno indikacijo in v skladu s programom za preprečevanje nosečnosti.
The medicine packs containing Imnovid capsules will carry a warning on the risk of severe birth defects.
Na škatlah s kapsulami zdravila Imnovid bo opozorilo o tveganju za hude prirojene okvare.
Each Member State will also ensure that educational materials and patient cards are provided to prescribers and patients.
Poleg tega bo vsaka država članica poskrbela, da bodo zdravniki, ki bodo predpisovali zdravilo, in bolniki prejeli izobraževalno gradivo in kartice za bolnike.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imnovid have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Imnovid upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Patients treated with Imnovid, bortezomib and low-dose dexamethasone lived on average 11.2 months before their disease got worse, compared with 7.1 months for patients treated with bortezomib and low dose dexamethasone.
Bolniki, ki so se zdravili z zdravilom Imnovid, bortezomibom in nizkoodmernim deksametazonom, so v povprečju živeli 11,2 meseca, preden se je bolezen poslabšala, v primerjavi s 7,1 meseca pri bolnikih, zdravljenih z bortezomibom in visokoodmernim deksametazonom.
It will provide a letter and educational kits for healthcare workers, and brochures for patients, explaining that the medicine is expected to be harmful to the unborn child and detailing the steps needed to use the medicine safely.
Zdravstvenim delavcem bo priskrbelo dopis in izobraževalni komplet, bolnikom pa knjižico, v katerih bo razloženo, da je zdravilo lahko škodljivo za nerojene otroke, in ki bodo vsebovali podrobnosti o varni uporabi zdravila.
The Agency also noted that Imnovid's side effects were acceptable for these patients, with side effects similar to those of other medicines of this type.
Prav tako je ugotovila, da so neželeni učinki zdravila Imnovid za te bolnike sprejemljivi, pri čemer so neželeni učinki podobni učinkom drugih tovrstnih zdravil.
Treatment with Imnovid must be started and supervised by a doctor experienced in treating multiple myeloma.
Zdravljenje z zdravilom Imnovid mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem diseminiranega plazmacitoma.
Pomalidomide works in a number of ways in multiple myeloma, similarly to other immunomodulating medicines such as lenalidomide and thalidomide: it blocks the development of tumour cells, prevents the growth of blood vessels within tumours and also stimulates some specialised cells of the immune system to attack the tumour cells.
Pomalidomid deluje pri diseminiranem plazmacitomu na različne načine, podobno kot drugi imunomodulatorji, kot sta lenalidomid in talidomid: preprečuje razvoj tumorskih celic, preprečuje rast krvnih žil v tumorjih in spodbuja nekatere posebne celice imunskega sistema k napadanju tumorskih celic.
A further study included 559 patients with multiple myeloma who had received at least one treatment including lenalidomide, and whose disease got worse during or after their last treatment.
V nadaljnjo študijo je bilo vključenih 559 bolnikov z diseminiranim plazmacitomom, ki so prejeli vsaj eno zdravljenje, vključno z lenalidomidom, in pri katerih se je bolezen poslabšala med zadnjim zdravljenjem ali po njem.
The Agency concluded that Imnovid is effective at delaying the progression of multiple myeloma in patients whose disease has not got better or has come back after previous treatment, who have very limited treatment options.
Ugotovila je, da je zdravilo Imnovid učinkovito pri podaljševanju obdobja do napredovanja diseminiranega plazmacitoma pri bolnikih, katerih bolezen se ni izboljšala ali se je po predhodnem zdravljenju ponovila ter ki imajo zelo omejene možnosti zdravljenja.
The disease worsened after 16 weeks on average in patients taking Imnovid plus low-dose dexamethasone, compared with 8 weeks in those taking high-dose dexamethasone.
Bolezen se je v povprečju poslabšala po 16 tednih pri bolnikih, ki so jemali zdravilo Imnovid in nizkoodmerni deksametazon, v primerjavi z osmimi tedni pri bolnikih, ki so jemali visokoodmerni deksametazon.
The active substance in Imnovid, pomalidomide, is an immunomodulating agent.
Učinkovina zdravila Imnovid, pomalidomid, je imunomodulator.
It is taken in the first 2 weeks of 3-week treatment cycles, when given in combination with bortezomib and dexamethasone, and in the first 3 weeks of 4-week treatment cycles when given in combination with dexamethasone only.
V vsakem tritedenskem ciklu zdravljenja se zdravilo jemlje prva dva tedna, kadar se daje v kombinaciji z bortezomibom in deksametazonom, ter prve tri tedne v vsakem štiritedenskem ciklu, kadar se daje v kombinaciji samo z deksametazonom.
It is used in combination with bortezomib (another cancer medicine) and dexamethasone (an anti-inflammatory medicine) in adults who have received at least one treatment including lenalidomide (another cancer medicine).
Uporablja se v kombinaciji z bortezomibom (drugim zdravilom za zdravljenje raka) in deksametazonom (protivnetnim zdravilom) pri odraslih, ki so prejeli vsaj eno zdravljenje, vključno z lenalidomidom (drugim zdravilom za zdravljenje raka).
Imnovid has been studied in one main study involving 455 adults with multiple myeloma whose disease did not get better or came back after previous treatments.
Zdravilo Imnovid so proučevali v glavni študiji, ki je vključevala 455 odraslih z diseminiranim plazmacitomom, katerih bolezen se ni izboljšala ali se je po predhodnih zdravljenjih ponovila.
The most common side effects with Imnovid (which affect more than 1 in 10 patients), some of which can be serious, include anaemia (low red blood cell counts), neutropenia (low white blood cell count), tiredness, thrombocytopenia (low platelet counts), fever, peripheral oedema (swelling of the limbs due to fluid retention), peripheral neuropathy (nerve damage causing tingling, pain and numbness in the hands and feet) and infections including pneumonia (infection of the lungs).
Najpogostejši neželeni učinki zdravila Imnovid (ki se lahko pojavijo pri več kot 1 bolniku od 10), med katerimi so lahko nekateri resni, so anemija (nizko število rdečih krvnih celic), nevtropenija (nizko število belih krvnih celic), utrujenost, trombocitopenija (nizko število trombocitov), zvišana telesna temperatura, periferni edem (otekanje okončin zaradi zadrževanja tekočine), periferna nevropatija (poškodba živca, ki povzroča mravljinčenje, bolečino in odrevenelost v rokah in stopalih) ter okužbe, vključno s pljučnico (okužbo pljuč).
The company will also provide final results from a study with Imnovid in combination with bortezomib and dexamethasone in patients with multiple myeloma who had received at least one treatment including lenalidomide, to confirm the medicine's effect on overall survival.
Podjetje bo objavilo tudi končne rezultate študije z zdravilom Imnovid v kombinaciji z bortezomibom in deksametazonom pri bolnikih z diseminiranim plazmacitomom, ki so prejeli vsaj eno zdravljenje z lenalidomidom, da bi potrdili učinek zdravila na celokupno preživetje.
It is also used in combination with dexamethasone in adults who have received at least two prior therapies, including both lenalidomide and bortezomib, and whose disease has worsened.
V kombinaciji z deksametazonom se uporablja tudi pri odraslih, ki so predhodno prejeli vsaj dve zdravljenji, vključno z lenalidomidom in bortezomibom, ter pri katerih se je bolezen poslabšala.
For the full list of side effects and restrictions with Imnovid, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Imnovid glejte navodilo za uporabo.
Multiple myeloma is rare, and Imnovid was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 October 2009.
Diseminirani plazmacitom je redka bolezen, zato je bilo zdravilo Imnovid 8. oktobra 2009 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Further information on Imnovid can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/imnovid-previously-pomalidomide-celgene
Nadaljnje informacije o zdravilu Imnovid so na voljo na spletni strani agencije: ema.europa.eu/en/medicines/human/EPAR/imnovid-previously-pomalidomide-celgene Povzetek je bil nazadnje posodobljen 04-2019.
Serious side effects, which affect up to 1 in 10 patients, include blood disorders (such as neutropenia, anaemia and thrombocytopenia), lower respiratory tract infection (such as bronchitis or pneumonia), pulmonary embolism (clot in a blood vessel in the lungs), flu, and acute kidney injury.
Resni neželeni učinki (ki se lahko pojavijo pri največ 1 bolniku od 10) vključujejo krvne motnje (kot so nevtropenija, anemija in trombocitopenija), okužbe spodnjih dihal (kot je bronhitis ali pljučnica), pljučno embolijo (strdek v krvni žili pljuč), gripo in akutne poškodbe ledvic.
Imnovid plus low-dose dexamethasone was more effective than high-dose dexamethasone alone at delaying the worsening of multiple myeloma.
Zdravilo Imnovid je bilo v kombinaciji z nizkoodmernim deksametazonom učinkovitejše od samostojnega jemanja visokoodmernega deksametazona pri podaljšanju obdobja do poslabšanja diseminiranega plazmocitoma.
How is Imnovid used?
Kako se zdravilo Imnovid uporablja?
Imnovid is a cancer medicine used to treat multiple myeloma (a cancer of the bone marrow).
Imnovid je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje diseminiranega plazmacitomoa (raka kostnega mozga).
Imnovid contains the active substance pomalidomide.
Zdravilo Imnovid vsebuje učinkovino pomalidomid.
Treatment with Imnovid may need to be interrupted or stopped, or the dose reduced, if the disease gets worse or certain side effects occur.
Če se bolezen poslabša ali se pri bolniku pojavijo nekateri neželeni učinki, bo morda treba začasno ali trajno prekiniti zdravljenje z zdravilom Imnovid ali zmanjšati odmerek.
Therefore, Imnovid must not be used in women who are pregnant.
Nosečnice zato zdravila Imnovid ne smejo jemati.
How does Imnovid work?
Kako zdravilo Imnovid deluje?
Date of first authorisation: 15 October 2015.
Datum prve odobritve: 15. oktober 2015
Do not pass it on to others.
in ga ne smete dajati drugim.
Take the capsules as soon as you remember.
Kapsule vzemite takoj, ko se spomnite.
Capsules length: 24.2 mm.
Dolžina kapsul: 24,2 mm.
There are also links to other websites about rare diseases and treatments.
Na voljo so tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
Median treatment duration was 45 days.
Mediana trajanja zdravljenja je bila 45 dni.
If this happens, do not drive or use machines.
Če se to zgodi, ne vozite in ne uporabljajte strojev.
Usual dose after the first two days
Običajni odmerek po prvih dveh dneh
A risk to newborns and infants cannot be excluded.
Tveganja za novorojenčke in dojenčke ni mogoče izključiti.
Susceptibility data were available in only a small subset of cases.
Podatki o občutljivosti so na voljo le pri majhnem številu primerov podskupin.
Your doctor may carry out blood tests while you are taking this medicine.
Zdravnik bo morda opravil krvne preiskave, medtem ko jemljete to zdravilo.
The clinical experience in other species is very limited (Lichtheimia spp.
Klinične izkušnje pri drugih vrstah so zelo omejene (Lichtheimia spp.
No carcinogenicity studies have been performed.
Študij kancerogenosti niso izvedli.
Effect of food on absorption
Vpliv hrane na absorpcijo
(Mechanism unknown)
(Mehanizem je neznan)
The infusion should be stopped if these reactions occur.
Infundiranje je treba prekiniti, če pride do te reakcije.
This is started 12 to 24 hours after your last starting dose.
S tem začnete 12 do 24 ur po zadnjem začetnem odmerku.
A stable response was observed in an additional 10/35 patients (28.6%).
Stabilen odziv je bil opažen pri dodatnih 10/35 bolnikov (28,6 %).
This is because it is not known if it may affect or harm your unborn baby.
To je zato, ker ni znano, ali lahko zdravilo vpliva na nerojenega otroka ali mu škoduje.
Other statins were not studied.
Drugi statini niso bili preučevani.
The pharmacokinetics in paediatric patients (< 18 years) have not yet been evaluated.
Farmakokinetika pri pediatričnih bolnikih (<18 let) še ni bila ocenjena.
^ Indicates that grouping of appropriate preferred terms into a single medical concept occurred.
^ Označuje združevanje ustreznih prednostnih izrazov v en sam medicinski koncept.
The protocol-defined maximum treatment duration was 84 days.
Najdaljše trajanje zdravljenja, opredeljeno v protokolu, je bilo 84 dni.
Take the medicine pack with you so the doctor knows what you have taken.
Vzemite zdravilo s sabo, da bo zdravnik vedel, kaj ste vzeli.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, navedenimi v poglavju 6.6.
The safety and efficacy of CRESEMBA in children aged below 18 years has not yet been established.
Varnost in učinkovitost zdravila CRESEMBA pri otrocih, mlajših od 18 let, še ni bila dokazana.
Cresemba should not be used in children or adolescents younger than 18 years because there is no information on use in this age group.
Zdravila Cresemba se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let, ker ni podatkov o uporabi v tej starostni skupini.
As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed.
Ker boste to zdravilo pod strogim zdravniškim nadzorom, je malo verjetno, da bi izpustili odmerek.
Delirium includes reactions of confusional state.
Delirij vključuje reakcije stanja zmedenosti.
However, tell your doctor or nurse if you think that a dose has been forgotten.
Kljub temu obvestite zdravnika ali medicinsko sestro, če menite, da je bil odmerek pozabljen.
Not studied.
Ni bilo preučevano.
Environmental risk assessment has shown that Cresemba may pose a risk for the aquatic environment.
Ocena tveganja za okolje je pokazala, da lahko zdravilo Cresemba predstavlja tveganje za vodno okolje.
It can also make you pass out.
Zaradi njega lahko tudi omedlite.
Do not chew, crush, dissolve or open the capsules.
Ne žvečite, drobite, raztopite ali odprite kapsul.
These patients should be carefully monitored for potential drug toxicity.
Te bolnike je treba skrbno spremljati zaradi morebitnih toksičnih učinkov zdravila.
• At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• na zahtevo Evropske agencije za zdravila; • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
However, if it is nearly time for the next dose, skip the missed dose.
Če pa je že skoraj čas za naslednji odmerek, pozabljeni odmerek izpustite.
The duration of treatment with Cresemba may be longer than 6 months if your doctor considers this necessary.
Zdravljenje z zdravilom Cresemba sme biti daljše od 6 mesecev, če zdravnik meni, da je potrebno.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotoviti več informacij o varnosti tega zdravila.
Isavuconazole has no discernible mutagenic or genotoxic potential.
Izavukonazol nima opaznega mutagenega ali genotoksičnega potenciala.
Elevated liver transaminases or hepatitis
Povišane vrednosti jetrnih transaminaz ali hepatitis