natgillin/translations-raw huggingface dataset:
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 
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.
Adults and children aged 6 months or more can be treated with Dectova. 
Zdravilo Dectova se lahko uporablja za zdravljenje odraslih in otrok, starih 6 mesecev ali več.
Each vial contains 200 mg of zanamivir (as hydrate) in 20 mL. 
Ena viala vsebuje 200 mg zanamivirja (v obliki hidrata) v 20 ml.
Sodium chloride Water for injections 
Voda za injekcije
Begin twice daily maintenance dosing 24 hours after the initial dose 
Vzdrževalno odmerjanje dvakrat na dan začnite 24 ur po začetnem odmerku
For patients receiving continuous renal replacement therapy, the dose should be selected using the appropriate CRRT clearance (CLCRRT in mL/min). 
Odmerek za bolnike na stalnem ledvičnem nadomestnem zdravljenju je treba izbrati glede na ustrezni očistek
Each vial contains 200 mg of zanamivir (as hydrate). 
Ena viala vsebuje 200 mg zanamivirja (v obliki hidrata).
Dectova contains zanamivir, which belongs to a group of medicines called antivirals. 
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.
Pharmacotherapeutic group: Antivirals for systemic use, neuraminidase inhibitors ATC code: J05AH01 
Oznaka ATC: J05AH01
12 mg/kg 8 mg/kg twice daily 
12 mg/kg 8 mg/kg dvakrat na dan
How to store Dectova 
Shranjevanje zdravila Dectova
Each mL of solution contains 10 mg of zanamivir (as hydrate). 
En mililiter raztopine vsebuje 10 mg zanamivirja (v obliki hidrata).
600 mg 400 mg twice daily 
600 mg 400 mg dvakrat na dan
600 mg 60 mg twice daily 
600 mg 60 mg dvakrat na dan
600 mg 150 mg twice daily 
600 mg 150 mg dvakrat na dan
12 mg/kg 5 mg/kg twice daily 
12 mg/kg 5 mg/kg dvakrat na dan
12 mg/kg 3 mg/kg twice daily 
12 mg/kg 3 mg/kg dvakrat na dan
Weight-based dose regimen 
Odmerna shema na podlagi telesne mase
Dectova is a clear, colourless solution for infusion containing 200 mg zanamivir (as hydrate) in 20 mL. 
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.
600 mg 250 mg twice daily 
600 mg 250 mg dvakrat na dan
Excipients 
Cmin
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 200 mg/20 ml
Uncommon side effects that may show up in your blood tests: • increase in the level of liver or bone enzymes (raised alkaline phosphatase). 
• zvišanje jetrnih ali kostnih encimov (zvišana alkalna fosfataza).
How much Dectova is given 
Kako uporabljati zdravilo Dectova Koliko zdravila Dectova se daje
What Dectova contains The active substance is zanamivir. 
Zdravilna učinkovina je zanamivir.
14 mg/kg twice daily 
14 mg/kg dvakrat na dan
• Using a sterile needle and syringe, withdraw and discard a volume of sodium chloride 9 mg/mL 
• 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.
MARKETING AUTHORISATION NUMBER(S) 
PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM V
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 
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)
• 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). 
o razširjen izpuščaj z mehurji in lupljenjem kože, zlasti okrog ust, nosu, oči in spolovil
There is no evidence that zanamivir is metabolised. 
Biotransformacija Ni dokazov, da se zanamivir presnovi.
1.4 mg/kg twice daily 
14 mg/kg 1,4 mg/kg dvakrat na dan
Contents of the pack and other information 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Dectova
How Dectova is given 
Kako in kdaj se daje zdravilo Dectova
Drug interactions 
Medsebojno delovanje zdravil
Cross-resistance between zanamivir and oseltamivir or peramivir has been observed in neuraminidase inhibition assays. 
V preizkusih zavrtja nevraminidaze so opažali navzkrižno odpornost med zanamivirjem in oseltamivirjem ali peramivirjem.
Gastrointestinal disorders diarrhoea common 
Bolezni prebavil driska pogosti
INFORMATION FOR HEALTHCARE PROFESSIONALS 
INFORMACIJE ZA ZDRAVSTVENO OSEBJE Priprava zdravila Dectova
9.3 mg/kg twice daily 
14 mg/kg 9,3 mg/kg dvakrat na dan
IV 
VB
Date of first authorisation: 16 November 2017 
Datum prve odobritve: 16. november 2017
Some infections can be serious and may lead to death. 
Nekatere okužbe so lahko resne in lahko povzročijo smrt.
The clinical relevance of these findings is not known. 
Klinični pomen teh ugotovitev ni znan.
These can include: 
Ti lahko vključujejo:
Discontinue treatment. 
Ukinite zdravljenje.
This medicine has not been studied in this age group. 
Tega zdravila pri tej starostni skupini niso proučili.
All clinical studies have only been performed in adults. 
Vse klinične študije so izvedli le pri odraslih.
Overall, in almost half of the presented cases, the causality could not be excluded or was related to the study drug. 
Na splošno, v skoraj polovici predstavljenih primerov, vzročnosti ni bilo mogoče izključiti ali pa je bila ta povezana s preiskovanim zdravilom.
• Abnormal taste in mouth 
• nenormalen okus v ustih.
No dose adjustment is necessary for elderly patients (≥ 65 years). 
Prilagoditev odmerka pri starejših bolnicah ni potrebna (≥ 65 let).
Patients should be encouraged to take their dose at approximately the same time each day. 
Bolnice je treba spodbujati, da svoj odmerek vzamejo vsak dan ob približno istem času.
• if you are allergic to niraparib or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na niraparib ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
Additionally, decreased spermatogenesis was seen in both species. 
Poleg tega so pri obeh živalskih vrstah opazili zmanjšanje spermatogeneze.
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. 
PFS je bilo merjeno od časa randomizacije (ki je nastopil do 8 tednov po zaključku režima kemoterapije) do napredovanja bolezni ali smrti.
4.5 Interaction with other medicinal products and other forms of interaction 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Farmakodinamično medsebojno delovanje
This results in tumour cell death, helping to control the cancer. 
To privede do smrti tumorskih celic, kar pomaga obvladati raka.
*CTCAE=Common Terminology Criteria for Adverse Events 
*CTCAE = Terminološko poenoteni kriteriji za neželene učinke (Common Terminology Criteria for
The absolute bioavailability of niraparib is approximately 73 %, indicating minimal first pass effect. 
Absolutna biološka uporabnost nirapariba je približno 73 %, kar kaže na minimalen učinek prvega prehoda.
Tell your doctor straight away if you notice any of the following SERIOUS side effects - you may need urgent medical treatment: 
Takoj obvestite zdravnika, če opazite katerega koli od naslednjih resnih neželenih učinkov, saj boste morda potrebovali nujno zdravniško pomoč:
Treatment with Zejula should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. 
Zdravljenje z zdravilom Zejula mora začeti in nadzorovati zdravnik, ki je izkušen v uporabi zdravil proti raku.
The major primary target organ for toxicity in both species was the bone marrow, with associated changes in peripheral haematology parameters. 
Glavni primarni ciljni organ za toksičnost pri obeh živalskih vrstah je bil kostni mozeg, s čimer so bile povezane spremembe perifernih hematoloških parametrov.
Overall, the PRAC considered that the preferred term febrile neutropenia was adequate to describe the cases reviewed within this PSUSA. 
Na splošno je odbor PRAC presodil, da prednostni izraz febrilna nevtropenija zadošča za opis primerov, ki so bili pregledani v okviru tega postopka PSUSA.
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. 
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.
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). 
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).
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. 
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.
Neutrophil < 1,000/µL or Haemoglobin < 8 g/dL 
Nevtrofilci < 1.000/µl ali hemoglobin < 8 g/dl
Do not use this medicine if you notice any damage or signs of tampering to the pack. 
Ne uporabljajte tega zdravila, če opazite kakršne koli poškodbe ali znake poseganja v pakiranje.
There are no clinical data on fertility. 
Kliničnih podatkov o plodnosti ni.
The safety and efficacy of niraparib in children and adolescents below 18 years of age have not yet been established. 
Pediatrična populacija Varnost in učinkovitost nirapariba pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
Children under 18 years of age should not be given Zejula. 
Otroci, mlajši od 18 let, ne smejo prejeti zdravila Zejula.
Based on individual laboratory values, weekly monitoring for the second month may be warranted. 
Glede na posamezne laboratorijske vrednosti je lahko utemeljeno tedensko spremljanje v drugem mesecu zdravljenja.
In the event of an overdose, physicians should follow general supportive measures and should treat symptomatically. 
V primeru prevelikega odmerjanja morajo zdravniki uporabljati splošne podporne ukrepe in bolnico zdraviti simptomatično.
It is recommended that treatment should be continued until disease progression. 
Z zdravljenjem je priporočljivo nadaljevati do napredovanja bolezni.
Each hard capsule contains 254.5 mg of lactose monohydrate (see section 4.4). 
Ena trda kapsula vsebuje 254,5 mg laktoze monohidrata (glejte poglavje 4.4).
Patients who experience these symptoms should observe caution when driving or using machines. 
Bolnice, ki imajo te simptome, morajo biti pri vožnji ali upravljanju strojev previdne.
It is used after the cancer has responded to previous treatment with standard platinum-based chemotherapy. 
Uporablja se potem, ko se je rak odzval na predhodno zdravljenje s standardno kemoterapijo na osnovi platine.
However, due to its high permeability and bioavailability, the risk of clinically relevant interactions with medicinal products that inhibit these transporters is unlikely. 
Zaradi njegove velike permeabilnosti in biološke uporabnosti pa je tveganje za klinično pomembna medsebojna delovanja z zdravili, ki zavirajo te prenašalce, malo verjetno.
See section 4.8 for how to report adverse reactions. 
Glejte poglavje 4.8, kako poročati o neželenih učinkih..
All patients had received multiple platinum-containing chemotherapy regimens and many had also received other DNA damaging agents and radiotherapy. 
Vse bolnice so prejele več režimov kemoterapije na osnovi platine in mnoge so prejele tudi druga zdravila, ki poškodujejo DNA, in radioterapijo.
• Fever or infection - low white blood cell count (neutropenia) can increase your risk for infection. 
• Vročina ali okužba - nizko število belih krvničk (nevtropenija) lahko poveča vaše tveganje za okužbo.
Pharmacotherapeutic group: other antineoplastic agents, ATC code: L01XX54. 
Farmakoterapevtska skupina: druga antineoplastična zdravila, oznaka ATC: L01XX54.
• Feeling tired 
• občutek utrujenosti,
The duration of Zejula treatment in patients prior to developing MDS/AML varied from 1 month to > 2 years. 
Zdravljenje z zdravilom Zejula, preden so bolnice razvile MDS/AML, je trajalo od 1 meseca do > 2 leti.
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. 
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.
Signs and symptoms you need to look out for include fever or infection, and abnormal bruising or bleeding (see section 4 for more information). 
Znaki in simptomi, na katere morate biti pozorni, vključujejo vročino ali okužbo ter nenormalne modrice ali krvavitev (za več informacij glejte poglavje 4).
Table 5: Secondary endpoints* 
Preglednica 5: Sekundarni opazovani dogodki*
PARP helps cells repair damaged DNA so blocking it means that the DNA of cancer cells cannot be repaired. 
Ker PARP pomaga celicam popraviti poškodovano DNA, z njegovim blokiranjem dosežemo, da se DNA rakavih celic ne more popraviti.
Niraparib was moderately protein bound in human plasma (83.0 %), mainly with serum albumin. 
Niraparib se je v človeški plazmi zmerno vezal na beljakovine (83,0 %), v glavnem na serumski albumin.
Very common (may affect more than 1 in 10 people) 
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnic):
• Low potassium levels in the blood 
• nizka raven kalija v krvi,
Your doctor may want to test your bone marrow to check for these problems. 
Zdravnik bo morda opravil preiskave vašega kostnega mozga, da preveri, ali so pri vas prisotne te težave.
Decreased appetite 
Občasni zmanjšan apetit
Overall, MDS/AML has been reported in 7 out of 751 (0.9 %) patients treated with Zejula in clinical studies. 
Skupno so o MDS/AML poročali pri 7 bolnicah od 751 (0,9 %) bolnic, ki so bile zdravljene z zdravilom Zejula v kliničnih študijah.
The most commonly used dose in niraparib-treated patients in the NOVA study was 200 mg. 
Najpogosteje uporabljen odmerek pri bolnicah, zdravljenih z niraparibom v študiji NOVA, je bil 200 mg.
Hypertension, including hypertensive crisis 
Hipertenzija, vključno s hipertenzivno krizo
Increased plasma concentrations of co-administered medicinal products that are substrates of these transporters (e.g. metformin) cannot be excluded. 
Zvišanih plazemskih koncentracij sočasno danih zdravil, ki so substrati teh prenašalcev (npr. metformin), ni mogoče izključiti.
This medicine contains lactose and tartrazine - see section 2 for more information. 
To zdravilo vsebuje laktozo in tartrazin - za več informacij glejte poglavje 2.
This clastogenicity is consistent with genomic instability resulting from the primary pharmacology of niraparib and indicates potential for genotoxicity in humans. 
Ta klastogenost je konsistentna z genomsko nestabilnostjo, ki izhaja iz primarne farmakologije nirapariba in kaže na potencial za genotoksičnost pri ljudeh.
The hard capsules are packed in blister packs of 
Trde kapsule so pakirane v pretisne omote po
Ask your doctor for advice before taking this medicine. 
Posvetujte se z zdravnikom, preden vzamete to zdravilo.
Women of childbearing potential should not become pregnant while on treatment and should not be pregnant at the beginning of treatment. 
Ženske v rodni dobi med zdravljenjem ne smejo zanositi in ob začetku zdravljenja ne smejo biti noseče.
This medicinal product contains tartrazine (E 102), which may cause allergic reactions. 
To zdravilo vsebuje tartrazin (E 102), ki lahko povzroči alergijske reakcije.
Following a signal regarding sepsis with niraparib, a number of relevant cases were identified. 
Tekom obravnave varnostnega signala v zvezi s sepso za niraparib je bilo ugotovljenih več relevantnih primerov.
The capsules should not be chewed or crushed. 
Kapsul se ne sme žvečiti ali zdrobiti.
Observe caution when driving or using machines. 
Pri vožnji ali upravljanju strojev bodite previdni.
Hypertension of any grade occurred in 19.3 % of patients treated with Zejula. 
Hipertenzija katere koli stopnje se je pojavila pri 19,3 % bolnic, zdravljenih z zdravilom Zejula.
Niraparib is not a substrate of MATE 1 or 2, while M1 is a substrate of both. 
Niraparib ni substrat MATE 1 ali 2, medtem ko je M1 substrat obeh.
• Palpitations (feeling like your heart is skipping beats or beating harder than usual) 
• okužba sečil, • palpitacije (občutek, da srce preskakuje utripe ali da bije močneje kot ponavadi),
Swallow the capsules whole, with some water. 
Kapsule pogoltnite cele, z nekaj vode.
Progression-free survival was determined per RECIST (Response Evaluation Criteria in Solid Tumors, version 1.1) or clinical signs and symptoms and increased CA-125. 
Preživetje brez napredovanja bolezni (PFS - progression-free survival) je bilo ugotovljeno po merilih RECIST (Response Evaluation Criteria in Solid Tumors, različica 1.1) ali na osnovi kliničnih znakov in simptomov in zvišanega CA125.
Niraparib can cause haematological toxicity that includes febrile neutropenia. 
Niraparib lahko povzroči hematološko toksičnost, ki vključuje febrilno nevtropenijo.
The recommended dose modifications for adverse reactions are listed in Tables 1 and 2. 
Priporočene prilagoditve odmerka za posamezne neželene učinke so navedene v preglednicah 1 in 2.
The capsules should be swallowed whole with water. 
Kapsule je treba pogoltniti cele z vodo.
Zejula should not be taken during pregnancy as it could harm your baby. 
Zdravila Zejula ne smete jemati med nosečnostjo, saj bi lahko škodilo vašemu otroku.
There is no specific treatment in the event of Zejula overdose, and symptoms of overdose are not established. 
Specifičnega zdravljenja v primeru prevelikega odmerjanja zdravila Zejula ni, simptomi prevelikega odmerjanja pa še niso ugotovljeni.
Frequency of CTCAE grade 3 or 4 
Pogostnost stopenj 3 ali 4 po
Induction of CYPs (CYP1A2 and CYP3A4) 
Spodbujanje CYP (CYP1A2 in CYP3A4)
Patients with ECOG performance status 2 to 4 Clinical data are not available in patients with ECOG performance status 2 to 4. 
Bolnice z oceno zmogljivosti 2 do 4 po ECOG Kliničnih podatkov za bolnice z oceno zmogljivosti 2 do 4 po ECOG ni na voljo.
Even though inhibition of CYP3A4 in the liver is not expected, the potential to inhibit CYP3A4 at the intestinal level has not been established at relevant niraparib concentrations. 
Čeprav zaviranje CYP3A4 v jetrih ni pričakovano, potencial za zaviranje CYP3A4 na črevesni ravni pri relevantnih koncentracijah nirapariba še ni bil ugotovljen.
Approximately 47 % of patients restarted at a reduced dose in Cycle 2. 
Približno 47 % bolnic je v 2. ciklu ponovno začelo zdravljenje z zmanjšanim odmerkom.
In the clinical programme, blood pressure measurements were obtained on Day 1 of each 28-day cycle while the patient remained on Zejula. 
V kliničnem programu so meritve krvnega tlaka izvajali 1. dan vsakega 28-dnevnega cikla, dokler je bila bolnica zdravljena z zdravilom Zejula.
The most common serious adverse reactions > 1 % (treatment-emergent frequencies) were thrombocytopenia and anaemia. 
Najpogostejša resna neželena učinka > 1 % (pogostnosti pojavljanja med zdravljenjem) sta bila trombocitopenija in anemija.
Eligible patients were assigned to one of two cohorts based on the results of a germline BRCA mutation test. 
Primerne bolnice so bile razporejene v eno od dveh kohort na osnovi rezultatov testa zarodne mutacije BRCA (germline BRCA mutation).
In vitro studies have shown that niraparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, apoptosis and cell death. 
Študije in vitro so pokazale, da citotoksičnost, ki jo spodbuja niraparib, morda vključuje zaviranje encimske aktivnosti PARP in povečano tvorbo kompleksov PARP-DNA, ki privedejo do poškodb DNA, apoptoze in celične smrti.
Effect of other medicinal products on niraparib 
Učinki drugih zdravil na niraparib
Febrile neutropenia was reported in 2 out of 367 patients in the NOVA trial leading to the frequency uncommon. 
O febrilni nevtropeniji so poročali pri 2 bolnikih od 367 bolnikov v preskušanju NOVA, zaradi česar je njena pogostnost označena kot občasna.
In the NOVA study, 48 % of patients had a dose interruption in Cycle 1. 
V študiji NOVA je pri 48 % bolnic prišlo do prekinitve odmerjanja v 1. ciklu.
Other medicines and Zejula 
Druga zdravila in zdravilo Zejula
Most patients were age 18 to 64 years (78 %), Caucasian (86 %) and had an ECOG performance status of 0 (68 %). 
Večina bolnic je bila starih od 18 do 64 let (78 %), belk (86 %) in je imela oceno zmogljivosti 0 po ECOG
If MDS and/or AML are confirmed while on treatment with Zejula, treatment should be discontinued and the patient treated appropriately. 
Če sta med zdravljenjem z zdravilom Zejula potrjena MDS in/ali AML, je treba zdravljenje ukiniti in bolnico ustrezno zdraviti.
He or she may also give you medicine to treat high blood pressure and adjust your Zejula dose, if necessary. 
Morda vam bo tudi dal zdravilo za zdravljenje visokega krvnega tlaka in po potrebi prilagodil vaš odmerek zdravila Zejula.
In the pivotal Phase 3 international trial (ENGOT-OV16), the incidence of MDS/AML in patients who received niraparib (1.4 %) was similar to that in patients who received placebo (1.1 %). 
V osrednjem mednarodnem preskušanju 3. faze (ENGOT-OV16) je bila pojavnost MDS/AML pri bolnicah, ki so prejele niraparib (1,4 %), podobna kot pri bolnicah, ki so prejele placebo (1,1 %).
Take Zejula at approximately the same time each day. 
Zdravilo Zejula vedno vzemite ob približno istem času dneva.
On the basis of the scientific conclusions for niraparib, the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing niraparib is unchanged subject to the proposed changes to the product information. 
Na podlagi znanstvenih zaključkov za niraparib odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) niraparib nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
• Feeling of weakness 
• občutek slabotnosti,
Signs may include fever, chills, feeling weak or confused, cough, pain or burning feeling when passing urine. 
Znaki lahko vključujejo vročino, mrzlico, občutek slabotnosti ali zmedenosti, kašelj, bolečino ali pekoč občutek pri uriniranju.
• Feeling of worry, nervousness, or unease 
• občutek zaskrbljenosti, živčnosti ali nelagodja,