FrancophonIA/ELRC3.0 huggingface dataset:
English: Neuropsychiatric events, including seizures, delirium, hallucination and abnormal behaviour, have been reported during administration of zanamivir in patients with influenza, especially in children and adolescents.
Slovenian: Med uporabo zanamivirja pri bolnikih z gripo, zlasti pri otrocih in mladostnikih, so poročali o nevropsihiatričnih dogodkih, vključno s konvulzijami, delirijem, halucinacijami in nenormalnim vedenjem.
English: • rash.
Slovenian: • driska,
English: Influenza Positive Population, N Median TTCR, days
Slovenian: Populacija, pozitivna za gripo, N
English: Dectova contains sodium
Slovenian: Zdravilo Dectova vsebuje natrij
English: Begin maintenance dosing 12 hours after the initial dose
Slovenian: Vzdrževalno odmerjanje začnite 12 ur po začetnem odmerku
English: Adults and children (aged 6 years and over with a body weight of 50 kg or above) with creatinine clearance (CLcr) or clearance by continual renal replacement therapy (CLCRRT) < 80 mL/min should receive an initial 600 mg dose followed by twice-daily maintenance dosing according to their renal function (Table 2).
Slovenian: Odrasli in otroci (stari 6 let ali več in s telesno maso 50 kg ali več) z očistkom kreatinina (CLcr) ali očistkom ob stalnem ledvičnem nadomestnem zdravljenju (CLCRRT) < 80 ml/min morajo prejeti začetni odmerek
English: A prospective observational study to evaluate the clinical effectiveness of treatment with zanamivir 10 mg/ml solution for infusion in patients with complicated influenza infection
Slovenian: Prospektivna opazovalna študija za oceno klinične učinkovitosti zdravljenja z zanamivirjem 10 mg/ml raztopina za infundiranje pri bolnikih z zapleteno okužbo gripe.
English: What you need to know before you are given Dectova
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Dectova Ne uporabljajte zdravila Dectova:
English: The safety profile of Dectova is based primarily on data from a single Phase II and a single Phase III study, with support from Phase I studies, a compassionate use programme, and adverse drug reactions reported for inhaled zanamivir.
Slovenian: faze in ene študije III. faze, ki jih potrjujejo podatki študij I. faze, podatki programa sočutne uporabe in podatki o neželenih učinkih, o katerih so poročali med uporabo zanamivirja za inhaliranje.
English: Adults The recommended dose is 600 mg twice daily for 5 to 10 days given by intravenous infusion.
Slovenian: Priporočeni odmerek je 600 mg v intravenski infuziji dvakrat na dan od 5 do 10 dni.
English: Begin maintenance dosing 24 hours after the initial dose
Slovenian: Vzdrževalno odmerjanje začnite 24 ur po začetnem odmerku
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Intravenska uporaba
English: There was no evidence of interaction with oral oseltamivir in a clinical study.
Slovenian: V klinični študiji ni bilo dokazov o medsebojnem delovanju s peroralnim oseltamivirjem.
English: • liver damage (hepatocellular injury)
Slovenian: • okvara jeter (okvara jetrnih celic),
English: This is equivalent to 3.54% of the recommended maximum daily intake of sodium for an adult.
Slovenian: največjega priporočenega dnevnega vnosa natrija za odrasle.
English: Each mL of Dectova contains 10 mg of zanamivir (as hydrate).
Slovenian: En mililiter zdravila Dectova vsebuje 10 mg zanamivirja (v obliki hidrata).
English: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
Slovenian: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 dk-info@gsk.com
English: The potential for interactions with other medicines is low, based on the known elimination pathway of zanamivir.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Na podlagi znane poti odstranjevanja zanamivirja je možnost za medsebojno delovanje z drugimi zdravili majhna.
English: Solution for infusion 200 mg/20 mL 1 vial
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Raztopina za infundiranje 200 mg/20 ml
English: Table 4: Initial and maintenance dose regimens for infants and children (6 months to less than 6 years, with a body weight of 42.8 kg or above) with renal impairment
Slovenian: Preglednica 4: Shema začetnega in vzdrževalnih odmerkov za dojenčke in otroke (od 6. meseca do manj kot 6. leta in s telesno maso 42,8 kg ali več) z okvaro ledvic
English: Dectova 10 mg/mL solution for infusion
Slovenian: IME ZDRAVILA Dectova 10 mg/ml raztopina za infundiranje
English: Begin twice daily maintenance dosing 12 hours after the initial dose
Slovenian: Vzdrževalno odmerjanje dvakrat na dan začnite 12 ur po začetnem odmerku
English: • The volume of Dectova and total volume for infusion will depend on the patient's age, weight and renal function (see section 4.2).
Slovenian: • Količina zdravila Dectova in celotna količina za infundiranje bosta odvisni od bolnikove starosti,
English: A retrospective observational chart review study to evaluate the clinical effectiveness of treatment with zanamivir 10mg/ml solution for infusion in a cohort of intensive care unit-treated (ICU) patients with complicated influenza infection
Slovenian: Retrospektivna opazovalna študija pregleda zdravstvenih kartonov za oceno klinične učinkovitosti zdravljenja z zanamivirjem 10 mg/ml raztopina za infundiranje na kohorti bolnikov z zapleteno okužbo gripe, zdravljenih na oddelku za intenzivno nego in terapijo.
English: Adults and children aged 6 months or more can be treated with Dectova.
Slovenian: Zdravilo Dectova se lahko uporablja za zdravljenje odraslih in otrok, starih 6 mesecev ali več.
English: Each vial contains 200 mg of zanamivir (as hydrate) in 20 mL.
Slovenian: Ena viala vsebuje 200 mg zanamivirja (v obliki hidrata) v 20 ml.
English: Sodium chloride Water for injections
Slovenian: Voda za injekcije
English: Begin twice daily maintenance dosing 24 hours after the initial dose
Slovenian: Vzdrževalno odmerjanje dvakrat na dan začnite 24 ur po začetnem odmerku
English: Česká republika GlaxoSmithKline, s.r.o.
Slovenian: GlaxoSmithKline, s.r.o.
English: For patients receiving continuous renal replacement therapy, the dose should be selected using the appropriate CRRT clearance (CLCRRT in mL/min).
Slovenian: Odmerek za bolnike na stalnem ledvičnem nadomestnem zdravljenju je treba izbrati glede na ustrezni očistek
English: Each vial contains 200 mg of zanamivir (as hydrate).
Slovenian: Ena viala vsebuje 200 mg zanamivirja (v obliki hidrata).
English: Dectova contains zanamivir, which belongs to a group of medicines called antivirals.
Slovenian: Shranjevanje zdravila Dectova Vsebina pakiranja in dodatne informacije Kaj je zdravilo Dectova in za kaj ga uporabljamo Zdravilo Dectova vsebuje zanamivir, ki spada v skupino zdravil, imenovanih protivirusna zdravila.
English: Pharmacotherapeutic group: Antivirals for systemic use, neuraminidase inhibitors ATC code: J05AH01
Slovenian: Oznaka ATC: J05AH01
English: 12 mg/kg 8 mg/kg twice daily
Slovenian: 12 mg/kg 8 mg/kg dvakrat na dan
English: How to store Dectova
Slovenian: Shranjevanje zdravila Dectova
English: Each mL of solution contains 10 mg of zanamivir (as hydrate).
Slovenian: En mililiter raztopine vsebuje 10 mg zanamivirja (v obliki hidrata).
English: 600 mg 400 mg twice daily
Slovenian: 600 mg 400 mg dvakrat na dan
English: 600 mg 60 mg twice daily
Slovenian: 600 mg 60 mg dvakrat na dan
English: 600 mg 150 mg twice daily
Slovenian: 600 mg 150 mg dvakrat na dan
English: 12 mg/kg 5 mg/kg twice daily
Slovenian: 12 mg/kg 5 mg/kg dvakrat na dan
English: Cmin (g/mL)
Slovenian: (µg/ml)
English: 12 mg/kg 3 mg/kg twice daily
Slovenian: 12 mg/kg 3 mg/kg dvakrat na dan
English: Weight-based dose regimen
Slovenian: Odmerna shema na podlagi telesne mase
English: Dectova is a clear, colourless solution for infusion containing 200 mg zanamivir (as hydrate) in 20 mL.
Slovenian: Zdravilo Dectova je bistra, brezbarvna raztopina za infundiranje, ki vsebuje 200 mg zanamivirja (v obliki hidrata) v 20 ml. Na voljo je v 26-ml prozornih steklenih vialah z gumijastim zamaškom in aluminijsko prekrivno zaporo s plastično snemno zaporko.
English: 600 mg 250 mg twice daily
Slovenian: 600 mg 250 mg dvakrat na dan
English: Excipients
Slovenian: Cmin
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 200 mg/20 ml
English: Uncommon side effects that may show up in your blood tests: • increase in the level of liver or bone enzymes (raised alkaline phosphatase).
Slovenian: • zvišanje jetrnih ali kostnih encimov (zvišana alkalna fosfataza).
English: How much Dectova is given
Slovenian: Kako uporabljati zdravilo Dectova Koliko zdravila Dectova se daje
English: What Dectova contains The active substance is zanamivir.
Slovenian: Zdravilna učinkovina je zanamivir.
English: 14 mg/kg twice daily
Slovenian: 14 mg/kg dvakrat na dan
English: • Using a sterile needle and syringe, withdraw and discard a volume of sodium chloride 9 mg/mL
Slovenian: • S sterilno iglo in brizgo iz vrečke za infundiranje izvlecite količino 0,9 % (9 mg/ml) raztopine natrijevega klorida za injekcije, ki je enaka količini zdravila Dectova, in jo zavrzite.
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM V
English: Table 5: Initial and maintenance dose regimens for infants and children (6 months to less than 6 years, with a body weight less than 42.8 kg) with renal impairment
Slovenian: Preglednica 5: Shema začetnega in vzdrževalnih odmerkov za dojenčke in otroke (od 6. meseca do manj kot 6. leta in s telesno maso manj kot 42,8 kg) z okvaro ledvic CLcr ali CLCRRT (ml/min/1,73 m2)
English: • very severe skin reactions such as: o a skin rash, which may blister, and looks like small targets (erythema multiforme) o a widespread rash with blisters and peeling skin, particularly occurring around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) o extensive peeling of the skin on much of the body surface (toxic epidermal necrolysis).
Slovenian: o razširjen izpuščaj z mehurji in lupljenjem kože, zlasti okrog ust, nosu, oči in spolovil
English: There is no evidence that zanamivir is metabolised.
Slovenian: Biotransformacija Ni dokazov, da se zanamivir presnovi.
English: 1.4 mg/kg twice daily
Slovenian: 14 mg/kg 1,4 mg/kg dvakrat na dan
English: Contents of the pack and other information
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Dectova
English: How Dectova is given
Slovenian: Kako in kdaj se daje zdravilo Dectova
English: Drug interactions
Slovenian: Medsebojno delovanje zdravil
English: Cross-resistance between zanamivir and oseltamivir or peramivir has been observed in neuraminidase inhibition assays.
Slovenian: V preizkusih zavrtja nevraminidaze so opažali navzkrižno odpornost med zanamivirjem in oseltamivirjem ali peramivirjem.
English: Gastrointestinal disorders diarrhoea common
Slovenian: Bolezni prebavil driska pogosti
English: INFORMATION FOR HEALTHCARE PROFESSIONALS
Slovenian: INFORMACIJE ZA ZDRAVSTVENO OSEBJE Priprava zdravila Dectova
English: 9.3 mg/kg twice daily
Slovenian: 14 mg/kg 9,3 mg/kg dvakrat na dan
English: IV
Slovenian: VB
English: Date of first authorisation: 16 November 2017
Slovenian: Datum prve odobritve: 16. november 2017
English: Some infections can be serious and may lead to death.
Slovenian: Nekatere okužbe so lahko resne in lahko povzročijo smrt.
English: The clinical relevance of these findings is not known.
Slovenian: Klinični pomen teh ugotovitev ni znan.
English: These can include:
Slovenian: Ti lahko vključujejo:
English: Discontinue treatment.
Slovenian: Ukinite zdravljenje.
English: This medicine has not been studied in this age group.
Slovenian: Tega zdravila pri tej starostni skupini niso proučili.
English: All clinical studies have only been performed in adults.
Slovenian: Vse klinične študije so izvedli le pri odraslih.
English: Overall, in almost half of the presented cases, the causality could not be excluded or was related to the study drug.
Slovenian: Na splošno, v skoraj polovici predstavljenih primerov, vzročnosti ni bilo mogoče izključiti ali pa je bila ta povezana s preiskovanim zdravilom.
English: • Abnormal taste in mouth
Slovenian: • nenormalen okus v ustih.
English: No dose adjustment is necessary for elderly patients (≥ 65 years).
Slovenian: Prilagoditev odmerka pri starejših bolnicah ni potrebna (≥ 65 let).
English: Patients should be encouraged to take their dose at approximately the same time each day.
Slovenian: Bolnice je treba spodbujati, da svoj odmerek vzamejo vsak dan ob približno istem času.
English: • if you are allergic to niraparib or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na niraparib ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: Additionally, decreased spermatogenesis was seen in both species.
Slovenian: Poleg tega so pri obeh živalskih vrstah opazili zmanjšanje spermatogeneze.
English: 1114 AB Amsterdam-Duivendrecht
Slovenian: 1114 AB Amsterdam-Duivendrecht Nizozemska
English: PFS was measured from the time of randomisation (which occurred up to 8 weeks after completion of the chemotherapy regimen) to disease progression or death.
Slovenian: PFS je bilo merjeno od časa randomizacije (ki je nastopil do 8 tednov po zaključku režima kemoterapije) do napredovanja bolezni ali smrti.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Farmakodinamično medsebojno delovanje
English: This results in tumour cell death, helping to control the cancer.
Slovenian: To privede do smrti tumorskih celic, kar pomaga obvladati raka.
English: *CTCAE=Common Terminology Criteria for Adverse Events
Slovenian: *CTCAE = Terminološko poenoteni kriteriji za neželene učinke (Common Terminology Criteria for
English: The absolute bioavailability of niraparib is approximately 73 %, indicating minimal first pass effect.
Slovenian: Absolutna biološka uporabnost nirapariba je približno 73 %, kar kaže na minimalen učinek prvega prehoda.
English: Tell your doctor straight away if you notice any of the following SERIOUS side effects - you may need urgent medical treatment:
Slovenian: Takoj obvestite zdravnika, če opazite katerega koli od naslednjih resnih neželenih učinkov, saj boste morda potrebovali nujno zdravniško pomoč:
English: Treatment with Zejula should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Slovenian: Zdravljenje z zdravilom Zejula mora začeti in nadzorovati zdravnik, ki je izkušen v uporabi zdravil proti raku.
English: The major primary target organ for toxicity in both species was the bone marrow, with associated changes in peripheral haematology parameters.
Slovenian: Glavni primarni ciljni organ za toksičnost pri obeh živalskih vrstah je bil kostni mozeg, s čimer so bile povezane spremembe perifernih hematoloških parametrov.
English: Overall, the PRAC considered that the preferred term febrile neutropenia was adequate to describe the cases reviewed within this PSUSA.
Slovenian: Na splošno je odbor PRAC presodil, da prednostni izraz febrilna nevtropenija zadošča za opis primerov, ki so bili pregledani v okviru tega postopka PSUSA.
English: In general, it is recommended to first interrupt the treatment (but no longer than 28 consecutive days) to allow the patient to recover from the adverse reaction and then restart at the same dose.
Slovenian: Na splošno je priporočljivo, da se najprej prekine zdravljenje (vendar ne za več kot 28 dni), da lahko bolnica okreva po neželenem učinku, nato pa se zdravljenje ponovno začne z enakim odmerkom.
English: Frequencies of occurrence of undesirable effects 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); very rare (< 1/10,000).
Slovenian: Pogostnost pojavljanja neželenih učinkov je opredeljena 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); zelo redki (<1/10.000).
English: Your doctor will check you on a regular basis, and you will normally continue to take Zejula as long as you experience benefit, and do not suffer unacceptable side effects.
Slovenian: Zdravnik bo redno preverjal vaše stanje in običajno boste lahko jemali zdravilo Zejula, dokler vam koristi in se pri vas ne pojavijo nesprejemljivi neželeni učinki.
English: Neutrophil < 1,000/µL or Haemoglobin < 8 g/dL
Slovenian: Nevtrofilci < 1.000/µl ali hemoglobin < 8 g/dl
English: Do not use this medicine if you notice any damage or signs of tampering to the pack.
Slovenian: Ne uporabljajte tega zdravila, če opazite kakršne koli poškodbe ali znake poseganja v pakiranje.
English: There are no clinical data on fertility.
Slovenian: Kliničnih podatkov o plodnosti ni.
English: The safety and efficacy of niraparib in children and adolescents below 18 years of age have not yet been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost nirapariba pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
English: Children under 18 years of age should not be given Zejula.
Slovenian: Otroci, mlajši od 18 let, ne smejo prejeti zdravila Zejula.
English: Based on individual laboratory values, weekly monitoring for the second month may be warranted.
Slovenian: Glede na posamezne laboratorijske vrednosti je lahko utemeljeno tedensko spremljanje v drugem mesecu zdravljenja.
English: In the event of an overdose, physicians should follow general supportive measures and should treat symptomatically.
Slovenian: V primeru prevelikega odmerjanja morajo zdravniki uporabljati splošne podporne ukrepe in bolnico zdraviti simptomatično.
English: It is recommended that treatment should be continued until disease progression.
Slovenian: Z zdravljenjem je priporočljivo nadaljevati do napredovanja bolezni.
English: Each hard capsule contains 254.5 mg of lactose monohydrate (see section 4.4).
Slovenian: Ena trda kapsula vsebuje 254,5 mg laktoze monohidrata (glejte poglavje 4.4).
English: Patients who experience these symptoms should observe caution when driving or using machines.
Slovenian: Bolnice, ki imajo te simptome, morajo biti pri vožnji ali upravljanju strojev previdne.
English: It is used after the cancer has responded to previous treatment with standard platinum-based chemotherapy.
Slovenian: Uporablja se potem, ko se je rak odzval na predhodno zdravljenje s standardno kemoterapijo na osnovi platine.
English: However, due to its high permeability and bioavailability, the risk of clinically relevant interactions with medicinal products that inhibit these transporters is unlikely.
Slovenian: Zaradi njegove velike permeabilnosti in biološke uporabnosti pa je tveganje za klinično pomembna medsebojna delovanja z zdravili, ki zavirajo te prenašalce, malo verjetno.
English: See section 4.8 for how to report adverse reactions.
Slovenian: Glejte poglavje 4.8, kako poročati o neželenih učinkih..
English: All patients had received multiple platinum-containing chemotherapy regimens and many had also received other DNA damaging agents and radiotherapy.
Slovenian: Vse bolnice so prejele več režimov kemoterapije na osnovi platine in mnoge so prejele tudi druga zdravila, ki poškodujejo DNA, in radioterapijo.
English: • Fever or infection - low white blood cell count (neutropenia) can increase your risk for infection.
Slovenian: • Vročina ali okužba - nizko število belih krvničk (nevtropenija) lahko poveča vaše tveganje za okužbo.
English: Pharmacotherapeutic group: other antineoplastic agents, ATC code: L01XX54.
Slovenian: Farmakoterapevtska skupina: druga antineoplastična zdravila, oznaka ATC: L01XX54.
English: • Feeling tired
Slovenian: • občutek utrujenosti,
English: The duration of Zejula treatment in patients prior to developing MDS/AML varied from 1 month to > 2 years.
Slovenian: Zdravljenje z zdravilom Zejula, preden so bolnice razvile MDS/AML, je trajalo od 1 meseca do > 2 leti.
English: The CA-125 levels should be normal (or a > 90 % decrease in CA-125 from baseline) following their last platinum treatment, and be stable for at least 7 days.
Slovenian: Ravni CA-125 so morale biti normalne (oziroma je morala biti raven CA-125 za > 90 % znižana glede na izhodišče) po zadnjem zdravljenju na osnovi platine in morale so biti stabilne vsaj 7 dni.
English: Signs and symptoms you need to look out for include fever or infection, and abnormal bruising or bleeding (see section 4 for more information).
Slovenian: Znaki in simptomi, na katere morate biti pozorni, vključujejo vročino ali okužbo ter nenormalne modrice ali krvavitev (za več informacij glejte poglavje 4).
English: Table 5: Secondary endpoints*
Slovenian: Preglednica 5: Sekundarni opazovani dogodki*
English: PARP helps cells repair damaged DNA so blocking it means that the DNA of cancer cells cannot be repaired.
Slovenian: Ker PARP pomaga celicam popraviti poškodovano DNA, z njegovim blokiranjem dosežemo, da se DNA rakavih celic ne more popraviti.
English: Niraparib was moderately protein bound in human plasma (83.0 %), mainly with serum albumin.
Slovenian: Niraparib se je v človeški plazmi zmerno vezal na beljakovine (83,0 %), v glavnem na serumski albumin.
English: Very common (may affect more than 1 in 10 people)
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnic):
English: • Low potassium levels in the blood
Slovenian: • nizka raven kalija v krvi,
English: Your doctor may want to test your bone marrow to check for these problems.
Slovenian: Zdravnik bo morda opravil preiskave vašega kostnega mozga, da preveri, ali so pri vas prisotne te težave.
English: Decreased appetite
Slovenian: Občasni zmanjšan apetit
English: Overall, MDS/AML has been reported in 7 out of 751 (0.9 %) patients treated with Zejula in clinical studies.
Slovenian: Skupno so o MDS/AML poročali pri 7 bolnicah od 751 (0,9 %) bolnic, ki so bile zdravljene z zdravilom Zejula v kliničnih študijah.
English: The most commonly used dose in niraparib-treated patients in the NOVA study was 200 mg.
Slovenian: Najpogosteje uporabljen odmerek pri bolnicah, zdravljenih z niraparibom v študiji NOVA, je bil 200 mg.
English: Hypertension, including hypertensive crisis
Slovenian: Hipertenzija, vključno s hipertenzivno krizo
English: Increased plasma concentrations of co-administered medicinal products that are substrates of these transporters (e.g. metformin) cannot be excluded.
Slovenian: Zvišanih plazemskih koncentracij sočasno danih zdravil, ki so substrati teh prenašalcev (npr. metformin), ni mogoče izključiti.
English: This medicine contains lactose and tartrazine - see section 2 for more information.
Slovenian: To zdravilo vsebuje laktozo in tartrazin - za več informacij glejte poglavje 2.
English: This clastogenicity is consistent with genomic instability resulting from the primary pharmacology of niraparib and indicates potential for genotoxicity in humans.
Slovenian: Ta klastogenost je konsistentna z genomsko nestabilnostjo, ki izhaja iz primarne farmakologije nirapariba in kaže na potencial za genotoksičnost pri ljudeh.
English: The hard capsules are packed in blister packs of
Slovenian: Trde kapsule so pakirane v pretisne omote po
English: Ask your doctor for advice before taking this medicine.
Slovenian: Posvetujte se z zdravnikom, preden vzamete to zdravilo.
English: Women of childbearing potential should not become pregnant while on treatment and should not be pregnant at the beginning of treatment.
Slovenian: Ženske v rodni dobi med zdravljenjem ne smejo zanositi in ob začetku zdravljenja ne smejo biti noseče.
English: This medicinal product contains tartrazine (E 102), which may cause allergic reactions.
Slovenian: To zdravilo vsebuje tartrazin (E 102), ki lahko povzroči alergijske reakcije.
English: Following a signal regarding sepsis with niraparib, a number of relevant cases were identified.
Slovenian: Tekom obravnave varnostnega signala v zvezi s sepso za niraparib je bilo ugotovljenih več relevantnih primerov.
English: The capsules should not be chewed or crushed.
Slovenian: Kapsul se ne sme žvečiti ali zdrobiti.
English: Observe caution when driving or using machines.
Slovenian: Pri vožnji ali upravljanju strojev bodite previdni.