natgillin/translations-raw huggingface dataset:
Each film-coated tablet contains bictegravir sodium equivalent to 50 mg of bictegravir, 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide. 
Ena tableta zdravila Biktarvy vsebuje natrijev biktegravir v količini, ki ustreza 50 mg biktegravirja, 200 mg emtricitabina in alafenamidtenofovirijev fumarat v količini, ki ustreza 25 mg alafenamidtenofovirata.
(may affect up to 1 in 10 people) 
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov)
Co-administration of itraconazole or posaconazole may increase bictegravir plasma concentrations. 
Sočasno dajanje itrakonazola ali posakonazola lahko poveča koncentracije biktegravirja v plazmi.
Missing data during window but on study drug 
V oknu podatki manjkajo, a uporablja študijsko zdravilo ABC = abakavir
Biktarvy should be administered at least 2 hours before iron supplements, or taken together with food. 
Zdravilo Biktarvy se daje vsaj 2 uri pred uporabo železovih dodatkov ali skupaj s hrano.
• feeling sick (nausea) 
• občutek tesnobe (anksioznost)
Biktarvy should not be co-administered simultaneously with magnesium/aluminium-containing antacids or iron supplements under fasted conditions. 
Sočasna uporaba drugih zdravil Zdravila Biktarvy se na tešče ne sme dajati sočasno z antacidi, ki vsebujejo magnezij ali aluminij, ali železovimi dodatki.
No dose adjustment is required upon co-administration in patients with normal renal function. 
Po sočasni uporabi pri bolnikih z normalnim delovanjem ledvic prilagoditev odmerka ni potrebna.
In GS-US-380-1878, the mean change from baseline in CD4+ cell count at Week 48 was 25 cells/mm3 in patients who switched to B/F/TAF and 0 cells/mm3 in patients who stayed on their baseline regimen. 
V študiji GS-US-380-1878 je bila povprečna sprememba števila celic CD4+ od izhodišča v 48. tednu 25 celic/mm3 pri bolnikih, ki so prešli na B/F/TAF, in
DTG + F/TAF (n = 325)e 
DTG + F/TAF
Sofosbuvir/Velpatasvir/ Voxilaprevir (400/100/100 + 100 mg3 once daily), Bictegravir/Emtricitabine/ Tenofovir alafenamide (Inhibition of P-gp/BCRP) 
Priporočilo glede sočasne uporabe z zdravilom Biktarvy sofosbuvir/velpatasvir/voksilaprevi r (400/100/100 + 100 mg3 enkrat dnevno), biktegravir/emtricitabin/ alafenamidtenofovirat
HIV-1 infected, virologically -suppressed patients 
Bolniki z virološko supresijo, okuženi z virusom HIV-1
Tenofovir alafenamide is rapidly absorbed following oral administration with peak plasma concentrations occurring at 0.5-2.0 hours after administration of B/F/TAF. 
Po peroralnem dajanju se alafenamidtenofovirat hitro absorbira in doseže največjo koncentracijo v plazmi v roku 0,5 do 2,0 uri po dajanju B/F/TAF.
Bictegravir is absorbed following oral administration with peak plasma concentrations occurring at 2.0-4.0 hours after administration of B/F/TAF. 
Biktegravir se po peroralni uporabi absorbira, z največjo koncentracijo v plazmi 2,0 do 4,0 ure po dajanju B/F/TAF .
Co-administration of ciclosporin (IV or oral use) is not recommended. 
Ne pričakuje se, da bi sočasna uporaba ciklosporina (i.v.
At the time of study entry, one treatment-naïve patient had pre-existing INSTI resistance-associated mutations Q148H + G140S and had HIV-1 RNA < 50 copies/mL at Week 4 through Week 96. 
Ob vstopu v študijo je imel en predhodno nezdravljen bolnik obstoječe mutacije Q148H + G140S, povezane z rezistenco na
HIV-1 infected, treatment-naïve patients 
Predhodno nezdravljeni bolniki, okuženi z virusom HIV-1
Blood and lymphatic system disorders Uncommon: 
Bolezni krvi in limfatičnega sistema
Bictegravir 
HBV. Biktegravir
Missing data during window but on study drug Proportion (%) of patients with HIV-1 RNA < 50 copies/mL by subgroup By baseline viral load ≤ 100,000 copies/ mL > 100,000 copies/ mL By baseline CD4+ cell count < 200 cells/mm3 ≥ 200 cells/mm3 
< 50 kopij/ml po podskupini Po izhodiščni virusni obremenitvi ≤ 100.000 kopij/ ml > 100.000 kopij/ ml
Get advice from a doctor or pharmacist if you are taking: 
Obvestite zdravnika, če jemljete:
AUC: ↔ Cmin: ↔ Cmax: ↔ 
emtricitabin: AUC: ↔ Cmin: ↔ Cmax: ↔
- adefovir dipivoxil, atazanavir, bictegravir, emtricitabine, lamivudine, tenofovir alafenamide, or tenofovir disoproxil 
- dipivoksiladefovirat, atazanavir, biktegravir, emtricitabin, lamivudin,
Co-administration is not recommended. 
ali peroralna uporaba) se ne priporoča.
Co-administration of carbamazepine may decrease bictegravir plasma concentrations. 
Sočasno dajanje karbamazepina lahko zmanjša koncentracije biktegravirja v plazmi.
Bictegravir (simultaneous administration, fasted): 
biktegravir (sočasno dajanje, na tešče):
Patients should be advised that Biktarvy or any other antiretroviral therapy does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection. 
HIV ne ozdravi in da se lahko pri njih še vedno razvijejo oportunistične okužbe ali drugi zapleti zaradi okužbe s HIV.
HIV-1 antiviral agents Atazanavir (300 mg once daily), Cobicistat (150 mg once daily), Bictegravir1 
atazanavir (300 mg enkrat dnevno), kobicistat (150 mg enkrat dnevno), biktegravir1
Co-administration of other medicinal products 
Priporočilo glede sočasne uporabe z zdravilom Biktarvy
Co-administration with St. John's wort is contraindicated, due to the effect of St. John's wort on the bictegravir component of Biktarvy. 
Sočasno dajanje s šentjanževko je kontraindicirano zaradi učinka šentjanževke na sestavino biktegravir v zdravilu Biktarvy.
Some medicinal products are not recommended for co-administration with Biktarvy: atazanavir, carbamazepine, ciclosporin (IV or oral use), oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, or sucralfate. 
Sočasno dajanje nekaterih zdravil z zdravilom Biktarvy se ne priporoča: atazanavir, karbamazepin, ciklosporin (i.v.
Talk to your doctor before taking Biktarvy: 
Pred začetkom jemanja zdravila Biktarvy se posvetujte z zdravnikom:
Co-administration of rifampicin may decrease tenofovir alafenamide plasma concentrations. 
Sočasno dajanje rifampicina lahko zmanjša koncentracije alafenamidtenofovirata v plazmi.
There were no discontinuations due to hepatic adverse events through Week 96 in Biktarvy clinical studies. 
Do konca 96. tedna v kliničnih študijah z zdravilom Biktarvy ni bilo prekinitev zdravljenja zaradi neželenih učinkov na jetra.
General disorders and administration site conditions Common: 
Splošne težave in spremembe na mestu aplikacije
Psychiatric disorders Common: 
Psihiatrične motnje
What Biktarvy is and what it is used for What you need to know before you take Biktarvy How to take Biktarvy 
Kaj morate vedeti, preden boste vzeli zdravilo Biktarvy Kako jemati zdravilo Biktarvy
Tenofovir alafenamide: 
alafenamidtenofovirat:
Following oral administration of B/F/TAF with or without food in HIV-1 infected adults, the multiple dose mean (CV%) pharmacokinetic parameters of bictegravir were Cmax = 6.15 µg/mL (22.9%), AUCtau = 102 µg•h/mL (26.9%), and Ctrough = 2.61 µg/mL (35.2%). 
Po peroralnem dajanju B/F/TAF odraslim, okuženim s HIV-1, s hrano ali brez nje, so bili povprečni farmakokinetični parametri večkratnih odmerkov (CV %) za biktegravir Cmax = 6,15 µg/ml (22,9 %),
respectively) and at the time of discontinuation had a viral value of ≥ 50 copies/mL. 
4 v 48. oz. 96. tednu), in so imeli v času prekinitve virološko vrednost ≥ 50 kopij/ml.
In Study GS-US-380-1878, the efficacy and safety of switching from either abacavir/lamivudine or emtricitabine/tenofovir disoproxil fumarate (200/300 mg) plus atazanavir or darunavir (boosted by either cobicistat or ritonavir) to B/F/TAF were evaluated in a randomised, open-label study of virologically-suppressed HIV-1 infected adults (n = 577). 
V študiji GS-US-380-1878 so učinkovitost in varnost prehoda z abakavirja/lamivudina ali emtricitabina/dizoproksiltenofovirijevega fumarata (200/300 mg) plus atazanavir ali darunavir
Co-administration may decrease bictegravir plasma concentrations. 
Sočasno dajanje lahko zmanjša koncentracije biktegravirja v plazmi.
Voriconazole (300 mg twice daily), Bictegravir1 
Antimikotiki vorikonazol (300 mg dvakrat dnevno), biktegravir1
angioedema3,4, rash, pruritus, urticaria4 Musculoskeletal and connective tissue disorders Uncommon: 
angioedem3,4, izpuščaj, pruritus, urtikarija4
AUC: ↑ 61% Cmax: ↔ 
biktegravir: AUC: ↑ 61 % Cmax: ↔
Co-administration of rifapentine may decrease bictegravir and tenofovir alafenamide plasma concentrations. 
Sočasno dajanje rifapentina lahko zmanjša koncentracije biktegravirja in alafenamidtenofovirata v plazmi.
The prevalence of different HIV-1 subtypes was comparable between treatment groups, with subtype B predominant in both groups; 5% were non-B subtypes. 
Prevalenca različnih podtipov HIV-1 je bila primerljiva v vseh skupinah zdravljenja, pri čemer je v obeh skupinah prevladoval podtip B; 5 % jih ni bilo podtipov B. Povprečno število celic CD4+ ob izhodišču je bilo 723 celic/mm3 (razpon 124-2.444).
Co-administration of oxcarbazepine, phenobarbital, or phenytoin may decrease bictegravir and tenofovir alafenamide plasma concentrations. 
fenobarbitala ali fenitoina lahko zmanjša koncentracije biktegravija in alafenamidtenofovirata v plazmi.
Co-administration may decrease bictegravir and tenofovir alafenamide plasma concentrations. 
Sočasno dajanje lahko zmanjša koncentracije biktegravirja in alafenamidtenofovirata v plazmi.
Following a single dose oral administration of [14C]-bictegravir, ~60% of the dose from faeces included unchanged parent, desfluoro-hydroxy-BIC-cysteine-conjugate, and other minor oxidative metabolites. 
-biktegravirja je ~ 60 % odmerka iz blata vključevalo nespremenjeno izhodno spojino,
In GS-US-380-1844, the mean change from baseline in CD4+ cell count at Week 48 was -31 cells/mm3 in patients who switched to B/F/TAF and 4 cells/mm3 in patients who stayed on abacavir/dolutegravir/lamivudine. 
-31 celic/mm3 pri bolnikih, ki so prešli na B/F/TAF, in 4 celice/mm3 pri bolnikih, ki so ostali na abakavirju/dolutegravirju/lamivudinu.
HIV-1 RNA < 50 copies/mL Treatment difference (95% CI) 
< 50 kopij/ml Razlika zdravljenja (95 %
The prevalence of different subtypes was comparable across all three treatment groups, with subtype B predominant in both groups; 11% were non-B subtypes. 
Prevalenca različnih podtipov je bila primerljiva v vseh treh skupinah zdravljenja, pri čemer je v obeh skupinah prevladoval podtip B; 11 % jih ni bilo podtipov B. Povprečna izhodiščna vrednost HIV-1 RNA v plazmi je bila 4,4 log10 kopij/ml (razpon 1,3-6,6).
In Study GS-US-380-1490, patients were randomised in a 1:1 ratio to receive either B/F/TAF (n = 320) or dolutegravir + emtricitabine/tenofovir alafenamide (50+200/25 mg) (n = 325) once daily. 
B/F/TAF (n = 320) ali dolutegravir + emtricitabin/alafenamidtenofovirat (50 + 200/25 mg) (n = 325) enkrat dnevno.
Therefore, caution is recommended when bictegravir is combined with medicinal products known to inhibit P-gp and/or BCRP (e.g. macrolides, ciclosporin, verapamil, dronedarone, glecaprevir/pibrentasvir) (see also table below). 
makrolidi, ciklosporin, verapamil, dronedaron, glekaprevir/pibrentasvir) (glejte tudi spodnjo preglednico), priporoča previdnost.
Each film-coated tablet contains bictegravir sodium equivalent to 50 mg of bictegravir, 200 mg of emtricitabine, and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide. 
200 mg emtricitabina in alafenamidtenofovirijev fumarat v količini, ki ustreza 25 mg alafenamidtenofovirata.
 Do not stop taking Biktarvy if you have hepatitis B. Talk to your doctor first. 
 Če imate hepatitis B, ne prenehajte jemati zdravila Biktarvy.
ANTI-INFECTIVES Antimycobacterials Rifampicin (600 mg once daily), Bictegravir1 (Induction of CYP3A, UGT1A1, and P-gp) 
Zdravila za zdravljenje okužb z mikobakterijami rifampicin (600 mg enkrat dnevno), biktegravir1
SPECIAL STORAGE CONDITIONS 
PRIPRAVKI RASTLINSKEGA IZVORA
hyperbilirubinaemia Skin and subcutaneous tissue disorders Uncommon: 
desfluoro-hidroksi-BIC-cistein-konjugat, in druge manj pomembne oksidativne presnovke.
Gastrointestinal disorders Common: 
Znaki osteonekroze so:
Co-administration of ciclosporin (IV or oral use) is expected to increase plasma concentrations of both bictegravir and tenofovir alafenamide. 
ali peroralna uporaba) povečala koncentracije biktegravirja in alafenamidtenofovirata v plazmi.
• anticonvulsants used to treat epilepsy, containing: - carbamazepine, oxcarbazepine, phenobarbital or phenytoin 
- karbamazepin, okskarbazepin, fenobarbital ali fenitoin
• tiredness (fatigue) 
• koprivnica (urtikarija)
Hepatitis C virus antiviral agents Ledipasvir/Sofosbuvir (90 mg/400 mg once daily), Bictegravir/Emtricitabine/ Tenofovir alafenamide2 
(90 mg/400 mg enkrat dnevno), biktegravir/emtricitabin/ alafenamidtenofovirat2
Baseline ATVor DRV-based regimen (n = 287) 
Izhodiščni režim na podlagi ATV ali DRV
AUC: ↓ 54% Cmax: ↓ 57% 
alafenamidtenofovirat: AUC: ↓ 54 % Cmax: ↓ 57 %
Antifungals 
rifapentin
The European Commission granted a marketing authorisation valid throughout the European Union for Karvea on 27 August 1997. 
Evropska komisija je dovoljenje za promet z zdravilom Karvea, veljavno po vsej Evropski uniji, odobrila 27. avgusta 1997.
Other information about Karvea 
Druge informacije o zdravilu Karvea
The full EPAR for Karvea can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Karvea je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What benefit has Karvea shown during the studies? 
Kakšne koristi je zdravilo Karvea izkazalo med študijami?
This is a summary of the European public assessment report (EPAR) for Karvea. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Karvea.
Karvea was used for two years or more. 
Bolniki so zdravilo Karvea jemali dve leti ali več.
The usual recommended dose of Karvea is 150 mg once a day. 
Običajni priporočeni odmerek zdravila Karvea znaša 150 mg enkrat dnevno.
What is the risk associated with Karvea? 
Kakšna tveganja so povezana z zdravilom Karvea?
For more information about treatment with Karvea, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Karvea preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
For the treatment of kidney disease, Karvea was studied in two large studies involving a total of 2,326 patients with type 2 diabetes. 
Zdravilo Karvea so glede zdravljenja ledvičnega obolenja preučevali v okviru dveh velikih študij, ki sta vključevali skupno 2 326 bolnikov s sladkorno boleznijo tipa 2.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Karvea. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Karvea, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The CHMP decided that Karvea's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Karvea večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
In this study, Karvea was compared with placebo and with amlodipine. 
V tej študiji so zdravilo Karvea primerjali s placebom in amlodipinom.
The active substance in Karvea, irbesartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II. 
Zdravilna učinkovina v zdravilu Karvea, irbesartan, je „antagonist receptorjev angiotenzina II“, kar pomeni, da v telesu preprečuje delovanje hormona, imenovanega angiotenzin II.
Karvea is a medicine that contains the active substance irbesartan. 
Karvea je zdravilo, ki vsebuje zdravilno učinkovino irbesartan.
Karvea is used in adults who have essential hypertension (high blood pressure). 
Zdravilo Karvea se uporablja pri odraslih, ki imajo esencialno hipertenzijo (visok krvni tlak).
Karvea must not be used in people who are hypersensitive (allergic) to irbesartan or any of the other ingredients. 
Zdravila Karvea ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) irbesartan ali katero koli drugo sestavino zdravila.
The most common side effect with Karvea (seen in more than 1 patient in 10) is hyperkalaemia (high blood potassium levels). 
Najpogostejši neželeni učinek zdravila Karvea (opažen pri več kot 1 bolniku od 10) je hiperkaliemija (visoka raven kalija v krvi).
Karvea was compared with placebo (a dummy treatment) in 712 patients and with other medicines for hypertension (atenolol, enalapril or amlodipine) in 823 patients. 
Zdravilo Karvea so pri 712 bolnikih primerjali s placebom (zdravilom brez zdravilne učinkovine), pri 823 bolnikih pa z drugimi zdravili za zdravljenje visokega krvnega tlaka (atenololom, enalaprilom ali amlodipinom).
Why has Karvea been approved? 
Zakaj je bilo zdravilo Karvea odobreno?
Karvea in combination with aliskirencontaining medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment. 
Zdravilo Karvea se v kombinaciji z zdravili, ki vsebujejo aliskiren (ki se uporablja za zdravljenje esencialne hipertenzije), ne sme uporabljati pri bolnikih s sladkorno boleznijo ali zmerno do hudo ledvično okvaro.
For the full list of all side effects reported with Karvea, see the Package Leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Karvea, glejte navodilo za uporabo.
In patients with hypertension and type 2 diabetes, Karvea is added to some other treatments for hypertension. 
Pri bolnikih z visokim krvnim tlakom in sladkorno boleznijo tipa 2 se zdravilo Karvea dodaja nekaterim drugim zdravilom za zdravljenje visokega krvnega tlaka.
In the blood pressure studies, Karvea was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension. 
V študijah krvnega tlaka je bilo zdravilo Karvea pri zniževanju diastoličnega krvnega tlaka učinkovitejše od placeba in je imelo podobne učinke kot druga zdravila za zdravljenje visokega krvnega tlaka.
In the first kidney disease study, Karvea was more effective than placebo at reducing the risk of developing kidney damage as measured by protein excretion. 
V prvi študiji ledvičnega obolenja je bilo zdravilo Karvea učinkovitejše od placeba pri zmanjševanju tveganja za razvoj poškodbe ledvic, merjene na podlagi izločanja beljakovin.
The second study looked at whether Karvea increased the time taken until the patients' blood creatinine levels had doubled (a marker of kidney disease), until they needed a kidney transplant or dialysis, or until they died. 
V drugi študiji so preučevali, ali zdravilo Karvea podaljša čas, v katerem se raven kreatinina (označevalca ledvičnega obolenja) v krvi bolnikov podvoji, čas do pojava potrebe po presaditvi ledvic ali dializi oziroma čas do nastopa smrti.
Karvea is also used to treat kidney disease in adults with hypertension and type 2 diabetes (non-insulin-dependent diabetes). 
Zdravilo Karvea se uporablja tudi za zdravljenje ledvičnega obolenja pri odraslih z visokim krvnim tlakom in sladkorno boleznijo tipa 2 (sladkorno boleznijo, ki je neodvisna od insulina).
Karvea was originally studied in 11 trials for its effects on blood pressure. 
Učinke zdravila Karvea na krvni tlak so prvotno preučevali v 11 preskušanjih.
In the second kidney disease study, Karvea reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant, or death during the study by 20% in comparison with placebo. 
V drugi študiji ledvičnega obolenja je zdravilo Karvea v primerjavi s placebom za 20 % zmanjšalo relativno tveganje za podvojitev ravni kreatinina v krvi, za pojav potrebe po presaditvi ledvic ali za nastop smrti med študijo.
What is Karvea used for? 
Za kaj se zdravilo Karvea uporablja?
How has Karvea been studied? 
Kako je bilo zdravilo Karvea raziskano?
What is Karvea? 
Kaj je zdravilo Karvea?
How is Karvea used? 
Kako se zdravilo Karvea uporablja?
How does Karvea work? 
Kako zdravilo Karvea deluje?
If you suddenly notice: 
Če nenadoma opazite:
Study protocol within 2 months after Commission Decision 
Protokol študije v 2 mesecih po sklepu Komisije
Date of first authorisation: 08/01/2013 
Datum prve odobritve: 08/01/2013
The applicant should submit yearly interim reports. 
Predlagatelj mora predložiti letna vmesna poročila.
Availability of resuscitation equipment must be ensured. 
Treba je zagotoviti, da je na razpolago oprema za oživljanje.
95% Confidence Interval1 
95-odstotni interval zaupanja
There are no data from the use in pregnant women. 
Podatkov o uporabi pri nosečnicah ni.
Others resolved with supportive treatment with i.v. 
Druge so izginile po podpornem zdravljenju z i.v.
No overall differences in safety or efficacy were observed between older and younger patients, but greater sensitivity of some older individuals cannot be ruled out. 
Med starejšimi in mlajšimi bolniki niso opazili splošnih razlik glede varnosti ali učinkovitosti, vendar ni mogoče izključiti večje občutljivosti pri nekaterih starejših posameznikih.
This should be considered when the decision is made for a therapy longer than 6 months. 
To je treba upoštevati, kadar se odločate o zdravljenju, daljšem od 6 mesecev.
Special attention is recommended for patients with pre-existing cardiopulmonary disease. 
Posebna pozornost se priporoča pri bolnikih z obstoječo kardiopulmonalno boleznijo.
Tell your doctor if you are taking, have recently taken or might take any other medicines. 
Obvestite svojega zdravnika, če jemljete, ste pred kratkim jemali ali boste začeli jemati katero koli drugo zdravilo.
The potential clinical relevance of these findings is currently unknown; however no adverse effects were associated with the presence of vacuoles. 
Morebitni klinični pomen teh ugotovitev trenutno ni znan, vendar so bili neželeni učinki povezani s prisotnostjo vakuol.
This medicine will be stored in a healthcare facility where it is administered. 
To zdravilo se shranjuje v zdravstveni ustanovi, kjer se uporablja.
Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co. Dublin Ireland 
Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co. Dublin Irska
The CHMP agrees with the scientific conclusions made by the PRAC. 
Skupina CMDh se strinja z znanstvenimi zaključki odbora PRAC.
Although the 4-week regimen also demonstrated efficacy for the primary endpoint, this regimen was associated with increased frequency of infusion reactions. 
Čeprav so pri 4-tedenskem režimu pokazali učinkovitost za primarni opazovani dogodek, je bil ta režim povezan s povečano pogostnostjo reakcij na infundiranje.
People with gout have too much uric acid in their body. 
Osebe s protinom imajo preveč sečne kisline v telesu.
The results of the on-going reproductive toxicity studies are not available (see section 5.3). 
Rezultati potekajočih študij reproduktivne toksičnosti niso na voljo (glejte poglavje 5.3).
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte s svojim zdravnikom, preden vzamete to zdravilo.
Haemolysis and/or Methemoglobinemia 
Hemoliza in/ali methemoglobinemija
Instructions for preparation: 
Navodila za pripravo:
The potency of this product should not be compared to the one of another pegylated or non-pegylated protein of the same therapeutic class. 
Jakost tega zdravila se ne sme primerjati z jakostjo drugega pegiliranega ali nepegiliranega proteina iz istega terapevtskega razreda.
• Appropriate aseptic technique should be used when preparing the infusion. 
• Pri pripravi infuzije je treba uporabiti aseptično tehniko.