natgillin/translations-raw huggingface dataset:
Trazimera and anthracyclines should not be given concurrently in combination in the adjuvant treatment setting. 
Pri zdravljenju metastatskega raka dojk kombinacije zdravila Trazimera in antraciklinov ne smemo dajati sočasno.
Trazimera 150 mg powder for concentrate for solution for infusion 
Trazimera 150 mg prašek za koncentrat za raztopino za infundiranje
Do not use Trazimera if you notice any particulate matter or discoloration prior to administration. 
Če pred dajanjem opazite kakršnekoli delce ali obarvanje, ne uporabite zdravila Trazimera.
Not known 
nezanesljivo
Hazard Ratio vs AC→D (95% CI) p-value 
Razmerje ogroženosti v primerjavi z AC → D (95 % IZ) p-vrednost
Ear and labyrinth disorders Deafness 
Ušesne bolezni, vključno z motnjami labirinta oglušelost občasni
which was followed by • CMF on day 1 and 8 every 4 weeks for 3 cycles which was followed after surgery by • additional cycles of adjuvant trastuzumab (to complete 1 year of treatment) 
po operaciji so sledili - dodatni cikli trastuzumaba, adjuvantno (do zaključka prvega leta zdravljenja).
Trazimera 150 mg powder for concentrate for solution for infusion trastuzumab 
Trazimera 150 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
The recommended maintenance dose at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose. 
Priporočeni vzdrževalni odmerek je 6 mg/kg telesne mase po 3 tednih od prejema polnilnega odmerka in nato v 3-tedenskih razmakih.
Hazard Ratio vs AC→D (95% CI) 
Razmerje ogroženosti v primerjavi z AC → D (95 % IZ)
Table 5 Efficacy Results from the Non-Comparative Monotherapy and Combination Therapy Studies 
Rezultati učinkovitosti monoterapije in kombiniranega zdravljenja iz študij brez primerjalne skupine
Your doctor may prescribe Trazimera for the treatment of breast and gastric cancer when: • You have early breast cancer, with high levels of a protein called HER2. 
Vaš zdravnik vam lahko zdravilo Trazimera predpiše za zdravljenje raka dojk in raka želodca, če:
In addition, terms reported in the post marketing setting are included in Table 1. 
Poleg tega so v preglednici 1 navedeni tudi neželeni učinki o katerih so poročali v obdobju trženja zdravila.
Disease-free survival No. patients with event p<0.0001 
Preživetje brez ponovitve bolezni: število bolnikov z dogodkom p < 0,0001
Death (OS event): No. patients with event p=0.014 
Smrt (dogodek celokupnega preživetja): število bolnikov z dogodkom p = 0,014**
• muscle weakness 
• mišična šibkost • zlatenica
• altered taste 
• sprememba okušanja
• throat infections 
• suhe oči okužbe grla
Mucosal inflammation 
Bolezni živčevja
STATEMENT OF ACTIVE SUBSTANCE(S) 
Analiza dolgoročnega spremljanja učinkovitosti**
Distant disease-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation 
Preživetje brez pojava oddaljenih metastaz - št. bolnikov z dogodkom - št. bolnikov brez dogodka
• neck pain 
• tesnoba vnetje dojk
Urinary tract infection 
Shranjevanje zdravila Trazimera
Response rate (95% CI) Median duration of response (months) (range) Median TTP (months) (95% CI) 
Mediana časa odgovora (meseci) (95 % IZ)
Hepatocellular injury 
• bolečina v kosteh hemoroidi
Most patients who developed CHF or asymptomatic cardiac dysfunction in pivotal trials improved with standard CHF treatment consisting of an angiotensinconverting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and a beta-blocker. 
To vključuje zaviralec angiotenzinske konvertaze ali zaviralec angiotenzinskih receptorjev in antagonist receptorjev beta.
Refer to the SmPC for paclitaxel, docetaxel or aromatase inhibitor for information on dose reduction or delays. 
Za zmanjšanje odmerka ali odložitev zdravljenja s paklitakselom, docetakselom ali zaviralcem aromataze glejte njihove Povzetke glavnih značilnosti zdravila.
A: doxorubicin; C: cyclophosphamide; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab CI = confidence interval 
A = doksorubicin; C = ciklofosfamid; P = paklitaksel; H = trastuzumab; IZ = interval zaupanja
The risk of neutropenia may be slightly increased when trastuzumab is administered with docetaxel following anthracycline therapy. 
Če trastuzumab dajemo z docetakselom po zdravljenju z antraciklini, je lahko tveganje za nevtropenijo rahlo povečano.
• inflammation of the liver 
• depresija vnetje jeter
After a median follow-up of 12 months, the hazard ratio (HR) for disease free survival (DFS) was 0.54 (95% CI 0.44, 0.67) which translates into an absolute benefit, in terms of a 2-year disease-free survival rate, of 7.6 percentage points (85.8% versus 78.2%) in favour of the trastuzumab arm. 
Posodobljeni rezultati analize preživetja brez ponovitve bolezni (stratificirano razmerje ogroženosti 0,61; 95 % IZ [0,54; 0,69]) so pokazali podobno korist glede preživetja brez ponovitve bolezni v primerjavi s končno primarno analizo preživetja brez ponovitve bolezni, ne glede na to, da je 24,8 % bolnikov v skupini AC→P prešlo na zdravljenje s trastuzumabom.
Content Concentration 
Stična ovojnina Vsebina (koncentracija)
4 single-dose kits (1 vial + 1 prefilled syringe + 1 vial connector + 2 needles) 
4 enoodmerni seti (1 viala + 1 napolnjena injekcijska brizga + 1 povezovalec viale + 2 igli)
12 (3 x 4) singledose kits (1 vial + 1 pre-filled syringe + 1 vial connector + 2 needles) (multipack) 
12 (3 x 4) enoodmernih setov (1 viala + 1 napolnjena injekcijska brizga + 1 povezovalec viale + 2 igli) (skupno pakiranje)
4 pre-filled pens + 1 needle 
4 napolnjeni injekcijski peresniki + 1 igla
12 (3 x 4) prefilled pens + 3 needles (multipack) 
12 (3 x 4) napolnjenih injekcijskih peresnikov + 3 igle (skupno pakiranje)
12 (3 x 4) prefilled pens (multipack) 
12 (3 x 4) napolnjenih injekcijskih peresnikov (skupno pakiranje)
The withdrawal letter can be found here. 
Dopis o umiku je na voljo tukaj.
No new studies were submitted to support this application. 
V podporo tej vlogi niso bile predložene nobene nove študije.
The application was withdrawn after ‘day 90'. 
Družba je vlogo umaknila po 90. dnevu.
The full European Public Assessment Report for Qutenza can found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila Qutenza je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The company presented further detailed analysis of the results of some of the studies that had been submitted at time the medicine was first approved. 
Družba je predložila dodatno podrobno analizo izsledkov nekaterih študij, ki so bile predložene takrat, ko je bilo zdravilo prvič odobreno.
This means that the CHMP had evaluated the documentation provided by the company and formulated lists of questions. 
To pomeni, da je CHMP ocenil dokumentacijo, ki jo je predložila družba, in pripravil sezname vprašanj.
What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes? 
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe?
This means that it stimulates the TRPV1 receptor, which is found in the nociceptors (pain receptors) in the skin. 
To pomeni, da stimulira receptor TRPV1, ki ga najdemo v nociceptorjih (receptorjih za bolečino) v koži.
The analysis included data on 2,073 diabetic and non-diabetic patients from six studies. 
V analizo so bili vključeni podatki iz šestih študij z 2 073 bolniki s sladkorno boleznijo ali brez nje.
It contains the active substance capsaicin (8%). 
Vsebuje zdravilno učinkovino kapsaicin (8
In patients with diabetes, Qutenza is expected to work in the same way as it does in its existing indication. 
Pri bolnikih s sladkorno boleznijo naj bi zdravilo Qutenza delovalo enako kot pri obstoječi indikaciji.
After the CHMP had assessed the company's responses to the questions, there were still some unresolved issues. 
Potem ko je ocenil odgovore družbe na seznam vprašanj, so nekatera izmed njih še vedno ostala nerešena.
Qutenza contains high doses of capsaicin that are released quickly and overstimulate the TRPV1 receptors. 
Zdravilo Qutenza vsebuje visoke odmerke kapsaicina, ki se hitro sproščajo in prekomerno stimulirajo receptorje TRPV1.
Overstimulating the receptors makes them become ‘desensitised' and no longer able to respond to the stimuli that normally cause pain in patients with peripheral neuropathic pain. 
Receptorji s prekomernim stimuliranjem postanejo „desenzitirani“ in se ne morejo več odzivati na dražljaje, ki običajno povzročajo bolečino pri bolnikih s periferno nevropatsko bolečino.
Patients with diabetes, but especially those with diabetic neuropathic pain, could be put at risk as Qutenza may increase their chances of developing ulcers in the foot, which could lead to serious complications. 
Bolniki s sladkorno boleznijo, zlasti tisti z nevropatskimi bolečinami zaradi sladkorne bolezni, so lahko ogroženi, saj lahko zdravilo Qutenza poveča možnost, da se pri njih pojavijo razjede na stopalih, kar bi lahko pripeljalo do hudih zapletov.
What is Qutenza? 
Kaj je zdravilo Qutenza?
There are no consequences on the use of Qutenza in its authorised indication. 
Umik nima posledic za uporabo zdravila Qutenza pri odobreni indikaciji.
Qutenza has been authorised in the EU since May 2009 and is already used to treat peripheral neuropathic pain (pain that is caused by damage to the nerves in the extremities) in adults who do not have diabetes. 
Zdravilo Qutenza je v EU odobreno od maja 2009 in se že uporablja za zdravljenje periferne nevropatske bolečine (bolečine, ki jo povzroča poškodba živcev v okončinah) pri odraslih, ki nimajo sladkorne bolezni.
In its official letter, the company stated that its decision to withdraw the application was based on the CHMP's view that the data provided do not allow the Committee to conclude on a positive benefit-risk balance. 
Družba je v uradnem dopisu navedla, da je podlaga za odločitev o umiku vloge mnenje odbora CHMP, da predloženi podatki ne omogočajo, da bi Odbor lahko sprejel pozitivno mnenje o razmerju med koristmi in tveganji.
It is used either alone or together with other painkillers. 
Uporablja se lahko kot samostojno zdravilo ali v kombinaciji z drugimi zdravili za lajšanje bolečin.
The active substance in Qutenza, capsaicin, is a substance normally found in chilli peppers that is a ‘selective agonist' of the ‘transient receptor potential vanilloid 1' (TRPV1) receptor. 
Zdravilna učinkovina v zdravilu Qutenza, kapsaicin, je snov, ki jo običajno najdemo v papriki čili in je selektivni agonist vaniloidnega receptorja 1 (TRPV1).
At the time of the initial approval, the evidence supporting the medicine's use in patients with diabetic neuropathic pain was considered insufficient and the CHMP excluded its use in all patients with diabetes. 
Ob prvi odobritvi se je štelo, da so dokazi, ki podpirajo uporabo zdravila pri bolnikih z nevropatsko bolečino, ki je posledica sladkorne bolezni, nezadostni, zato je CHMP izključil njegovo uporabo pri bolnikih s sladkorno boleznijo.
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Qutenza could not have been approved to treat diabetic patients with non-diabetic peripheral neuropathic pain. 
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP, je Odbor v času umika izrazil določene zadržke in je začasno menil, da zdravila Qutenza ni mogoče odobriti za zdravljenje sladkornih bolnikov s periferno nevropatsko bolečino, ki ni posledica sladkorne bolezni.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Qutenza in diabetic patients did not outweigh its risks. 
Zato je CHMP v času umika vloge menil, da koristi zdravila Qutenza pri sladkornih bolnikih ne odtehtajo z njim povezanih tveganj.
What was Qutenza expected to be used for? 
Za kaj naj bi se zdravilo Qutenza uporabljalo?
On 14 March 2012, Astellas Pharma Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Qutenza, which would have extended its use to patients with diabetes who have peripheral neuropathic pain not caused by their diabetes. 
je 14. marca 2012 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za spremembo dovoljenja za promet z zdravilom Qutenza, s katerim je želela njegovo uporabo razširiti na bolnike s sladkorno boleznijo, pri katerih se pojavi periferna nevropatska bolečina, ki ni posledica sladkorne bolezni.
The Committee was concerned that it would not be possible in clinical practice to distinguish patients with non-diabetic neuropathic pain from those with diabetic neuropathic pain. 
Odbor je bil zaskrbljen, da v klinični praksi morda ne bi bilo mogoče razlikovati med bolniki z nevropatsko bolečino, ki ni posledica sladkorne bolezni, in tistimi z nevropatsko bolečino, ki je posledica sladkorne bolezni.
The company's analysis was intended to show that diabetic patients with peripheral neuropathic pain not caused by diabetes have as good outcomes with Qutenza as non-diabetic patients. 
Namen analize, ki jo je opravila družba, je bil dokazati, da imajo sladkorni bolniki s periferno nevropatsko boleznijo, ki ni posledica sladkorne bolezni, enako dobre rezultate z zdravilom Qutenza kot bolniki brez sladkorne bolezni.
What is happening with Qutenza for the treatment of neuropathic pain in patients who do not have diabetes? 
Kakšne so posledice za zdravilo Qutenza, indicirano za zdravljenje nevropatske bolečine pri bolnikih, ki nimajo sladkorne bolezni?
How is Qutenza expected to work? 
Kako naj bi zdravilo Qutenza delovalo?
Qutenza was also expected to be used in patients with diabetes who have peripheral neuropathic pain not caused by their diabetes. 
Zdravilo Qutenza naj bi se uporabljalo tudi za zdravljenje bolnikov s sladkorno boleznijo, pri katerih se pojavi periferna nevropatska bolečina, ki ni posledica sladkorne bolezni.
Qutenza is a cutaneous patch (a patch that delivers a medicine to the skin). 
Qutenza je dermalni obliž (obliž, ki dovaja zdravilo na kožo).
The frequency of these events is unknown. 
Pogostnost teh dogodkov je neznana.
• Anaemia (low number of red blood cells). 
• anemija (majhno število rdečih krvnih celic).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 January 2015 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 15.01.2015
Main demographics in TURQUOISE-III Characteristics 
Glavne demografske značilnosti v TURQUOISE-III
Component of a multipack, can't be sold separately. 
Komponenta večkratnega pakiranja, ni za ločeno prodajo.
(administered 12 hours apart) 
(uporabljena v razmaku 12 ur)
MARKETING AUTHORISATION NUMBER(S) EU/1/14/982/001 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/982/001
Table 15 shows SVR rates for these subjects. 
Preglednica 15 prikazuje deleže SVR za te preiskovance.
Limited data in patients with endstage renal disease indicate no clinically significant changes in exposure also in this patient group. 
Omejeni podatki pri bolnikih z ledvično odpovedjo ne kažejo nobenih klinično pomembnih sprememb pri izpostavitvi tudi pri tej skupini bolnikov.
PHARMACEUTICAL FORM AND CONTENTS 14 film-coated tablets 
FARMACEVTSKA OBLIKA IN VSEBINA 14 filmsko obloženih tablet
• Feeling weak or lack of energy (asthenia). 
• občutek šibkosti ali pomanjkanja energije (astenija).
Arm B 24 Weeks N = 32 
Skupina B 24 tednov N = 32
Treatment-emergent variants and their prevalence in these virologic failure populations are shown in Table 5. 
Med zdravljenjem nastale variante in njihova prevalenca v teh populacijah z virološkim neuspehom so prikazane v preglednici 5.
See section 5.1 for additional information. 
Za dodatne informacije glejte poglavje 5.1.
If you accidentally take more than the recommended dose, you should contact your doctor or go to the nearest hospital straight away. 
Če ste pomotoma vzeli večji odmerek od priporočenega, takoj obvestite svojega zdravnika ali pojdite v najbližjo bolnišnico.
Genotype 1a N=67 
Genotip 1a N = 67
• Monitor for clinical signs and symptoms of hepatic decompensation (such as ascites, hepatic encephalopathy, variceal haemorrhage). 
• kontrola glede kliničnih znakov in simptomov dekompenzacije jeter (kot so ascites, jetrna encefalopatija, krvavitev iz varic),
The combined action of the three active substances stops the hepatitis C virus from multiplying and infecting new cells, thus clearing the virus from your blood over a period of time. 
Kombinirano delovanje treh zdravilnih učinkovin ustavi razmnoževanje virusa hepatitisa C in okužbo novih celic ter v določenem časovnem obdobju odstrani virus iz krvi.
A 10 kg change in body weight from 76 kg (median weight in the Phase 3 studies) would results in <10% change in ombitasvir exposures, and no change in paritaprevir exposures. 
Sprememba telesne mase za10 kg od 76 kg (mediana telesna masa v študijah 3. faze) bi imela za posledico < 10 % spremembo izpostavljenosti ombitasvirju in nobene spremembe izpostavljenosti paritaprevirju.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. 
Podrobne informacije o zdravilu so objavljenje na spletni strain Evropske agencije za zdravila: http://www.ema.europa.eu.
• If you have severe liver problems other than hepatitis C. 
• Če imate hudo bolezen jeter, ki ni hepatitis C.
Effect of baseline HCV substitutions/polymorphisms on treatment outcome 
Vpliv izhodiščnih substitucij/polimorfizmov HCV na izid zdravljenja
Pharmacotherapeutic group: Antivirals for systemic use; direct-acting antivirals, ATC code: J05AX67 
Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje virusnih infekcij, zdravila z direktnim delovanjem na viruse, oznaka ATC: J05AX67
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 
Preobčutljivost na zdravilne učinkovine ali katero koli pomožno snov, navedeno v poglavju 6.1.
• Discontinue treatment in patients who develop evidence of hepatic decompensation. 
• prekiniti zdravljenje pri bolnikih, pri katerih so se pojavili znaki dekompenzacije jeter.
25 mg once daily administered in the morning, with food 
25 mg enkrat na dan, zjutraj s hrano
AbbVie Ltd Maidenhead SL6 4UB United Kingdom 
AbbVie Ltd Maidenhead SL6 4UB Velika Britanija
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Viekirax. 
Če kar koli od zgoraj navedenega velja za vas (ali če ste negotovi), se posvetujte z zdravnikom ali farmacevtom, preden vzamete zdraviloViekirax.
Contraceptive medicines that contain ethinyl estradiol cannot be used in combination with Viekirax. 
Zdravila za kontracepcijo, ki vsebujejo etinilestradiol, se ne smejo uporabljati v kombinaciji z zdravilom Viekirax.
If you take more Viekirax than you should 
Če ste vzeli večji odmerek zdravila Viekirax, kot bi smeli
Coadministration of Viekirax with other antivirals has not been studied and therefore cannot be recommended. 
Sočasna uporaba zdravila Viekirax z drugimi protivirusnimi zdravili ni bila raziskana in je zato ni mogoče priporočati.
Purpose of the medicine 
Namen uporabe zdravila
HIV-1 Co-infection 
Sočasna okužba s HIV-1
If you forget to take Viekirax 
Če ste pozabili vzeti zdravilo Viekirax
Follow the dosing recommendations in Table 1. 
Upoštevajte navodila za odmerjanje v preglednici 1.
NA Clinical monitoring of patients is recommended. 
NA Bolnike je priporočljivo klinično nadzirati.
The assay had a lower limit of quantification (LLOQ) of 25 IU per mL. 
Preizkus je imel spodnjo mejo kvantifikacije (LLOQ) 25 i.e. na ml.
Viekirax is an antiviral medicine used to treat adults with chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus). 
Zdravilo Viekirax je protivirusno zdravilo, ki se uporablja za zdravljenje odraslih s kroničnim (dolgotrajnim) hepatitisom C (nalezljiva bolezen, ki prizadane jetra in jo povzroča virus hepatitisa C).
How much to take The recommended dose is two tablets taken together in the morning. 
Priporočeni odmerek je dve tableti, ki ju vzamete zjutraj.
If an HIV protease inhibitor is added (atazanavir, darunavir), rilpivirine exposure may increase even further and is therefore not recommended. 
Če je dodan zaviralec proteaze HIV (atazanavir, darunavir), se lahko izpostavljenost rilpivirinu še dodatno poveča, zato takšna uporaba ni priporočljiva.
Obligation to conduct post-authorisation measures 
• Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet
These ALT elevations were significantly more frequent in the subgroup of subjects who were using ethinylestradiol-containing medicinal products such as combined oral contraceptives or contraceptive vaginal rings (6 of 25 subjects); (see section 4.3). 
Ta zvišanja ALT so bila bistveno pogostejša v podskupini preiskovank, ki so uporabljale zdravila z etinilestradiolom, na primer kombinirane peroralne kontraceptive ali kontracepcijske vaginalne obročke (6 od 25 oseb); (glejte poglavje 4.3).
It is important not to miss a dose of this medicine. 
Pomembno je, da ne pozabite vzeti tega zdravila.
The dose of ribavirin was left to the discretion of the investigator, with most patients receiving 600 to 800 mg per day as a starting dose, and most patients also receiving 600 to 800 mg per day at the end of treatment. 
Odmerek ribavirina je bil prepuščen raziskovalčevi presoji; večina bolnikov je kot začetni odmerek prejemala od 600 do 800 mg na dan in večina bolnikov je tudi na koncu zdravljenja prejemala od 600 do
Yes (for all three parameters listed above) No (for any parameter listed above) *AFP= serum alpha fetoprotein 
Ne (za kateri koli zgoraj našteti parameter) *AFP= alfa fetoprotein v serumu
Subjects were on a stable HIV-1 antiretroviral therapy (ART) regimen that included ritonavir-boosted atazanavir or raltegravir, coadministered with a backbone of tenofovir plus emtricitabine or lamivudine. 
Preiskovanci so prejemali stabilno shemo antiretrovirusne terapije (ART) za HIV-1, ki je vključevala z ritonavirjem okrepljen atazanavir ali raltegravir, uporabljen z osnovno shemo tenofovirja ter emtricitabina ali lamivudina.
SVR12, n/N (%) [95% CI] Outcome for subjects without SVR12 On-treatment virologic failure Post-treatment relapse 
SVR12, n/N (%) [95 % IZ] Izid pri preiskovancih brez SVR12 Virološki neuspeh med zdravljenjem Recidiv po zdravljenju a
In contrast, the rate of ALT elevations in subjects using other types of estrogens as typically used in hormonal replacement therapy (i.e., oral and topical estradiol and conjugated estrogens) was similar to the rate observed in subjects who were not using estrogencontaining products (approximately 1% in each group). 
V nasprotju s tem so bila zvišanja ALT pri tistih, ki so uporabljale druge vrste estrogenov, kakršni se običajno uporabljajo pri hormonskem nadomestnem zdravljenju (tj. peroralni in lokalni estradiol in konjugirani estrogeni), podobna deležu, opaženem med neuporabnicami zdravil z estrogenom (približno 1 % v vsaki skupini).
The interactions between pitavastatin and fluvastatin and Viekirax have not been investigated. 
Medsebojna delovanja med pitavastatinom in fluvastatinom ter zdravilom Viekirax niso raziskana.
Three interrupted Viekirax and dasabuvir for one to seven days, including one on ethinylestradiol. 
Tri osebe so jemanje zdravila Viekirax in dasabuvirja prekinile za obdobje od enega do sedmih dni; ena od njih je dobivala etinilestradiol.
(see sections 4.2, 4.4, and 
(glejte poglavje 4.4).
INFORMATION IN BRAILLE viekirax 
PODATKI V BRAILLOVI PISAVI viekirax
Concerning genotypespecific virological and clinical activity, see section 5.1. 
Za virološko in klinično aktivnost, specifično za genotip, glejte poglavje 5.1.
Number of Responders at the End of Treatment AFP* < 20 ng/mL, platelets ≥ 90 x 109/L, AND albumin ≥ 35 g/L prior to treatment 
AFP* < 20 ng/ml, trombociti ≥ 90 x 109/l, IN albumin ≥ 35 g/l pred zdravljenjem