FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Neupro, rotigotine, is a dopamine agonist, which means that it imitates the action of dopamine.
Slovenian: Zdravilna učinkovina zdravila Neupro, rotigotin, je agonist dopamina, kar pomeni, da posnema delovanje dopamina.
English: In the smaller studies completed later, the effectiveness of Neupro was found to be comparable with ropinirole.
Slovenian: V manjših študijah, izvedenih naknadno, je bila učinkovitost zdravila Neupro primerljiva z ropinirolom.
English: Neupro is used on its own in early-stage disease, or in combination with levodopa (another medicine used in Parkinson's disease) at any stage of the disease, including the later stages when levodopa starts becoming less effective;
Slovenian: Zdravilo Neupro se uporablja kot samostojno zdravilo v zgodnji fazi bolezni ali v kombinaciji z levodopo (drugim zdravilom za zdravljenje Parkinsonove bolezni) v kateri koli fazi bolezni, vključno v poznih fazah, ko začne učinek levodope popuščati;
English: Neupro must not be used in people who are hypersensitive (allergic) to rotigotine or any of the other ingredients.
Slovenian: Zdravila Neupro ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) rotigotin ali katero koli drugo sestavino zdravila.
English: Neupro was more effective than placebo in treating Parkinson's disease.
Slovenian: Zdravilo Neupro je bilo pri zdravljenju Parkinsonove bolezni učinkovitejše od placeba.
English: Why has Neupro been approved?
Slovenian: Zakaj je bilo zdravilo Neupro odobreno?
English: Two of these studies also compared Neupro with other dopamine agonists (ropinirole in early-stage disease and pramipexole in advanced disease).
Slovenian: V dveh od teh študij so zdravilo Neupro primerjali tudi z drugimi agonisti dopamina (ropinirolom v zgodnji fazi bolezni in pramipeksolom pri napredovali bolezni).
English: In early-stage disease, 48 to 52% of the patients using Neupro had an improvement in symptoms, compared with 19 to 30% of those using placebo.
Slovenian: V zgodnji fazi bolezni je pri 48 do 52 % bolnikov, ki so jemali zdravilo Neupro, prišlo do izboljšanja simptomov v primerjavi z 19 do 30 % tistih, ki so jemali placebo.
English: In moderate to severe restless legs syndrome, Neupro has been compared with placebo in two main studies involving a total of 963 patients.
Slovenian: Pri zmernem do hudem sindromu nemirnih nog so zdravilo Neupro primerjali s placebom v dveh glavnih študijah, ki sta vključevali skupaj 963 bolnikov.
English: In Parkinson's disease, Neupro has been compared with placebo (a dummy treatment) in four studies involving 830 patients with early-stage disease and 842 patients with advanced disease.
Slovenian: Pri zdravljenju Parkinsonove bolezni so zdravilo Neupro primerjali s placebom (zdravilom brez zdravilne učinkovine) v štirih študijah, v katere je bilo skupaj vključenih 830 bolnikov v zgodnji fazi bolezni in 842 bolnikov z napredovalo boleznijo.
English: Neupro is a range of transdermal patches (patches that deliver a medicine across the skin).
Slovenian: Zdravilo Neupro je serija transdermalnih obližev (ki dovajajo zdravilo skozi kožo).
English: The most common side effects with Neupro in patients with Parkinson's disease (seen in more than 1 patient in 10) are somnolence (sleepiness), dizziness, headache, nausea (feeling sick), vomiting, and application site reactions such as redness, itching and irritation of the skin.
Slovenian: Najpogostejši neželeni učinki zdravila Neupro pri bolnikih s Parkinsonovo boleznijo (opaženi pri več kot 1 bolniku od 10) so zaspanost, omotica, glavobol, navzeja (slabost), bruhanje in reakcije na mestu nanosa, npr. pordelost, srbečica in vzdraženost kože.
English: For the full list of all side effects reported with Neupro, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Neupro, glejte navodilo za uporabo.
English: In advanced Parkinson's disease, patients using Neupro had a greater decrease in their ‘off' time than those taking placebo (a decrease of 2.1 to 2.7 h with Neupro compared with 0.9 h with placebo).
Slovenian: Pri napredovali Parkinsonovi bolezni se je pri bolnikih, ki so uporabljali zdravilo Neupro, obdobje „izklopa“ skrajšalo bolj (zmanjšanje za 2,1 do 2,7 ure pri uporabi zdravila Neupro v primerjavi z zmanjšanjem za 0,9 ure pri uporabi placeba).
English: To avoid skin burns, Neupro must be removed if the patient has to have magnetic resonance imaging (MRI) or cardioversion (a process that restores the heart's normal rhythm).
Slovenian: Če je treba pri bolniku opraviti magnetnoresonančno slikanje (MRI) ali kardioverzijo (postopek za ponovno vzpostavitev normalnega srčnega ritma), je treba obliž Neupro odstraniti, da se preprečijo opekline kože.
English: What is Neupro used for?
Slovenian: Za kaj se zdravilo Neupro uporablja?
English: The decrease seen with Neupro was similar to that seen with pramipexole (2.8 h).
Slovenian: Skrajšanje tega obdobja pri uporabi zdravila Neupro je bilo podobno kot pri uporabi pramipeksola (2,8 ure).
English: How has Neupro been studied?
Slovenian: Kako je bilo zdravilo Neupro raziskano?
English: In restless legs syndrome, patients using doses of Neupro between 1 and 3 mg/24 h had a greater improvement than those using placebo in the two studies, as measured on both symptom scales.
Slovenian: Pri sindromu nemirnih nog so rezultati obeh lestvic za merjenje simptomov v obeh študijah pokazali, da je prišlo do večjega izboljšanja pri bolnikih, ki so uporabljali zdravilo Neupro v odmerku od 1 do 3 mg/24 h, kot pri tistih, ki so uporabljali placebo.
English: How is Neupro used?
Slovenian: Kako se zdravilo Neupro uporablja?
English: Neupro delivers a constant supply of rotigotine through the skin into the bloodstream.
Slovenian: Zdravilo Neupro skozi kožo v krvni obtok dovaja stalno količino rotigotina.
English: What is Neupro?
Slovenian: Kaj je zdravilo Neupro?
English: Two smaller studies comparing Neupro with ropinirole were completed after the medicine's authorisation.
Slovenian: Po odobritvi zdravila sta bili izvedeni še dve manjši študiji, v katerih so zdravilo Neupro primerjali z ropinirolom.
English: How does Neupro work?
Slovenian: Kako zdravilo Neupro deluje?
English: The full EPAR for Zoledronic acid Teva Pharma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zoledronska kislina kislina Teva Pharma je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is used in patients who are at risk of fractures (broken bones), including those who have recently broken their hip in a minor trauma such as a fall, and in patients whose osteoporosis is linked to long-term treatment with glucocorticoids (a type of steroid).
Slovenian: Uporablja se pri bolnikih, pri katerih obstaja tveganje za zlome kosti, vključno pri tistih z nedavnim zlomom kolka po lažji nezgodi, kot je padec, ter pri bolnikih, pri katerih je osteoporoza povezana z dolgotrajnim zdravljenjem z glukokortikoidi (vrsto steroidov).
English: Using paracetamol or ibuprofen (anti-inflammatory medicines) shortly after Zoledronic acid Teva Pharma can reduce symptoms such as fever, muscle pain, influenza (flu)-like symptoms, joint pain and headache in the three days following the infusion.
Slovenian: Uporaba paracetamola ali ibuprofena (zdravil proti vnetju) kmalu po zaužitju zdravila Zoledronska kislina kislina Teva Pharma lahko v treh dneh po infuziji zmanjša simptome, kot so povišana telesna temperatura, bolečine v mišicah, gripi podobni simptomi, bolečine v sklepih in glavobol.
English: This is a summary of the European public assessment report (EPAR) for Zoledronic acid Teva Pharma.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zoledronska kislina Teva Pharma.
English: For more information about treatment with Zoledronic acid Teva Pharma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Zoledronska kislina kislina Teva Pharma preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Teva Pharma has been shown to be comparable to Aclasta.
Slovenian: CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Zoledronska kislina kislina Teva Pharma primerljivo z zdravilom Aclasta.
English: For Paget's disease, only one infusion of Zoledronic acid Teva Pharma is usually given, but additional infusions can be considered if the patient's disease comes back.
Slovenian: Pri Pagetovi bolezni se običajno daje samo ena infuzija zdravila Zoledronska kislina kislina Teva Pharma, lahko pa se razmisli o dodatnih infuzijah, če se bolnikova bolezen ponovi.
English: This means that Zoledronic acid Teva Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aclasta.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Aclasta.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Teva Pharma on 16 August 2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Zoledronska kislina kislina Teva Pharma, veljavno po vsej Evropski uniji, izdala 16. avgusta 2012.
English: This leads to less bone loss in osteoporosis and less disease activity in Paget's disease.
Slovenian: Zaradi tega se pri osteoporozi zmanjša izguba kostne mase, pri Pagetovi bolezni pa se zmanjša dejavnost bolezni.
English: Because Zoledronic acid Teva Pharma is a generic, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Zoledronska kislina kislina Teva Pharma generično zdravilo, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic acid Teva Pharma, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: 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 Zoledronic acid Teva Pharma.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: In the treatment of Paget's disease of the bone, Zoledronic acid Teva Pharma must only be used by a doctor who has experience in the treatment of the disease.
Slovenian: Pri zdravljenju Pagetove bolezni kosti sme zdravilo Zoledronska kislina kislina Teva Pharma uporabljati samo zdravnik, ki ima izkušnje z zdravljenjem te bolezni.
English: What measures are being taken to ensure the safe and effective use of Zoledronic acid Teva Pharma?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovine uporabe zdravila Zoledronska kislina Teva Pharma?
English: Zoledronic acid Teva Pharma is given as an infusion lasting at least 15 minutes.
Slovenian: Zdravilo Zoledronska kislina kislina Teva Pharma se daje z infuzijo, ki traja najmanj 15 minut.
English: Zoledronic acid Teva Pharma is a solution for infusion (drip) into a vein that contains the active substance zoledronic acid (5 mg).
Slovenian: Zdravilo Zoledronska kislina kislina Teva Pharma je raztopina za infundiranje (kapalno infuzijo) v veno, ki vsebuje zdravilno učinkovino zoledronska kislina (5 mg).
English: Zoledronic acid Teva Pharma is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men.
Slovenian: Zdravilo Zoledronska kislina kislina Teva Pharma se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah v obdobju po menopavzi in pri moških.
English: Patients who have broken their hip should not receive Zoledronic acid Teva Pharma any earlier than two weeks after the operation to repair the fracture.
Slovenian: Bolniki z zlomljenim kolkom lahko zdravilo Zoledronska kislina Teva Pharma prejmejo šele dva tedna po operaciji, da se zlom zaceli.
English: Therefore, the CHMP's view was that, as for Aclasta, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi, tako kot pri zdravilu Aclasta, odtehtajo znana tveganja.
English: What are the benefits and risks of Zoledronic acid Teva Pharma?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Zoledronska kislina kislina Teva Pharma?
English: Other information about Zoledronic acid Teva Pharma
Slovenian: Druge informacije o zdravilu Zoledronska kislina Teva Pharma
English: The Committee recommended that Zoledronic acid Teva Pharma be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Zoledronska kislina kislina Teva Pharma izda dovoljenje za promet.
English: A risk management plan has been developed to ensure that Zoledronic acid Teva Pharma is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Zoledronska kislina Teva Pharma je bil pripravljen načrt obvladovanja tveganj.
English: Zoledronic acid Teva Pharma zoledronic acid
Slovenian: Zoledronska kislina Teva Pharma zoledronska kislina
English: Zoledronic acid Teva Pharma is a ‘generic medicine'.
Slovenian: Zdravilo Zoledronska kislina kislina Teva Pharma je „generično zdravilo“.
English: The active substance in Zoledronic acid Teva Pharma, zoledronic acid, is a bisphosphonate.
Slovenian: Zdravilna učinkovina zdravila Zoledronska kislina kislina Teva Pharma, zoledronska kislina, je difosfonat.
English: No additional studies were needed as Zoledronic acid Teva Pharma is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Aclasta.
Slovenian: Ker je zdravilo Zoledronska kislina kislina Teva Pharma generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Aclasta, niso bile potrebne nobene dodatne študije.
English: Why has Zoledronic acid Teva Pharma been approved?
Slovenian: Zakaj je bilo zdravilo Zoledronska kislina kislina Teva Pharma odobreno?
English: Zoledronic acid Teva Pharma is also used to treat Paget's disease of the bone in adults.
Slovenian: Zdravilo Zoledronska kislina kislina Teva Pharma se uporablja tudi za zdravljenje Pagetove bolezni kosti pri odraslih, tj. bolezni, pri kateri je normalen postopek rasti kosti spremenjen.
English: Zoledronic acid Teva Pharma should not be used in patients with severe kidney problems.
Slovenian: Bolniki s hudimi ledvičnimi težavami zdravila Zoledronska kislina kislina Teva Pharma ne smejo uporabljati.
English: What is Zoledronic acid Teva Pharma?
Slovenian: Kaj je zdravilo Zoledronska kislina Teva Pharma?
English: How does Zoledronic acid Teva Pharma work?
Slovenian: Kako zdravilo Zoledronska kislina kislina Teva Pharma deluje?
English: What is Zoledronic acid Teva Pharma used for?
Slovenian: Za kaj se zdravilo Zoledronska kislina kislina Teva Pharma uporablja?
English: How is Zoledronic acid Teva Pharma used?
Slovenian: Kako se zdravilo Zoledronska kislina kislina Teva Pharma uporablja?
English: How has Zoledronic acid Teva Pharma been studied?
Slovenian: Kako je bilo zdravilo Zoledronska kislina kislina Teva Pharma raziskano?
English: This is to be expected and you should not be concerned
Slovenian: To je pričakovano in naj vas ne skrbi.
English: Your doctor will tell you if this applies to you.
Slovenian: Zdravnik vam bo povedal, ali to velja za vas.
English: Some may be serious and need medical attention.
Slovenian: Nekateri so lahko resni in zahtevajo zdravniško pomoč.
English: Date of first authorisation: 22 March 2017
Slovenian: Datum prve odobritve: 22. marec 2017
English: Maximum effects were generally observed within 6 weeks.
Slovenian: Na splošno so največje učinke opazili v 6 tednih.
English: However, this difference is not considered to be clinically relevant.
Slovenian: Kljub temu ta razlika ni klinično pomembna.
English: Efficacy may be decreased
Slovenian: Lahko zmanjša učinkovitost.
English: These responses were similar to those observed in healthy volunteers aged 50 years and older.
Slovenian: Ti odzivi so bili podobni tistim, ki so jih opazili pri zdravih prostovoljcih, starih 50 let in več.
English: • Japanese or Korean patients.
Slovenian: • japonskih ali korejskih bolnikih,
English: These changes generally resolved within 2-6 weeks after discontinuation of treatment.
Slovenian: Te spremembe so na splošno izzvenele 2-6 tednov po prekinitvi zdravljenja.
English: Antimalarials were allowed.
Slovenian: Antimalariki so bili dovoljeni.
English: This treatment difference was consistent between the 2 subgroups (Table 16).
Slovenian: Ta razlika med zdravljenjema je bila konsistentna med obema podskupinama (preglednica 16).
English: Active control (ADA)
Slovenian: kontrolna učinkovina (ADA)
English: Talk to your doctor if you smoke.
Slovenian: Posvetujte se z zdravnikom, če kadite.
English: • If your treatment is interrupted, your doctor may decide to restart your treatment.
Slovenian: • Če je vaše zdravljenje prekinjeno, se zdravnik lahko odloči, da ga ponovno začne.
English: Dose should be maintained.
Slovenian: Odmerek je treba vzdrževati.
English: Formal studies of the potential effect on human fertility have not been conducted.
Slovenian: Formalnih študij o morebitnih učinkih na plodnost pri človeku niso izvedli.
English: • who have been exposed to TB,
Slovenian: • ki so bili izpostavljeni TB,
English: Tell your doctor immediately if you feel unwell.
Slovenian: Nemudoma obvestite zdravnika, če se ne počutite dobro.
English: OPAL BEYOND had a duration of 6 months.
Slovenian: Preskušanje OPAL BEYOND je trajalo 6 mesecev.
English: • swelling of the lips, tongue or throat
Slovenian: • otekanje ustnic, jezika ali žrela,
English: Women were estimated to have 7% lower AUC compared to men.
Slovenian: Ocenjujejo, da je vrednost AUC pri ženskah za 7 % manjša kot pri moških.
English: Treatment groups (randomisation ratio)
Slovenian: Skupine zdravljenja (razmerje randomizacije)
English: Your doctor will decide whether you need to have herpes zoster vaccination.
Slovenian: Zdravnik se bo odločil, ali potrebujete cepljenje proti herpesu zostru.
English: If lab value confirmed by repeat testing within 7 days, dosing should be discontinued.
Slovenian: Če je laboratorijska vrednost potrjena s ponovnim testiranjem v 7 dneh, je treba zdravljenje prekiniti.
English: Try to take your tablet at the same time every day (one tablet in the morning and one tablet in the evening).
Slovenian: Tableto poskusite vzeti vsak dan ob isti uri (eno tableto zjutraj in eno tableto zvečer).
English: 3 Parallel arms:
Slovenian: 3 vzporedne skupine:
English: N=number of patients in the analysis set.
Slovenian: n = število bolnikov v analizirani skupini.
English: • with recurrent infections,
Slovenian: • s ponavljajočimi se okužbami,
English: Additional monitoring tests
Slovenian: Dodatni testi za spremljanje
English: Tell your doctor as soon as you notice any signs or symptoms of infections.
Slovenian: Zdravnika obvestite takoj, ko opazite kakršnekoli znake ali simptome okužb.
English: He / she will also evaluate whether your body weight, age, or problems being mobile will affect your risk to develop blood clots.
Slovenian: Ocenil bo, ali vaša telesna masa, starost ali težave z gibanjem vplivajo na vaše tveganje za nastanek krvnih strdkov.
English: - if you have or had hepatitis B or hepatitis C (viruses that affect the liver).
Slovenian: - če imate ali ste imeli hepatitis B ali hepatitis C (virusa, ki prizadeneta jetra).
English: There are no adequate and well-controlled studies on the use of tofacitinib in pregnant women.
Slovenian: Ustreznih in dobro nadzorovanih študij uporabe tofacitiniba pri nosečnicah niso izvedli.
English: The median PsA disease duration was 7.5 years.
Slovenian: Mediano trajanje PsA je bilo 7,5 leta.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Slovenian: Znotraj razvrstitve pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: Physical function response and health-related outcomes
Slovenian: Odziv telesne funkcije in izidi, povezani z zdravjem
English: The median PsA disease duration was 3.8 years.
Slovenian: Mediano trajanje PsA je bilo 3,8 leta.
English: Pharmacokinetic data up to and including a single dose of 100 mg in healthy volunteers indicate that more than 95% of the administered dose is expected to be eliminated within 24 hours.
Slovenian: Farmakokinetični podatki do vključno enkratnega odmerka 100 mg pri zdravih prostovoljcih kažejo, da se več kot 95 % uporabljenega odmerka predvidoma izloči v 24 urah.
English: • antibiotics such as rifampicin, used to treat bacterial infections
Slovenian: • antibiotiki, kot je rifampicin, ki se uporablja za zdravljenje bakterijskih okužb,
English: • Active tuberculosis (TB), serious infections such as sepsis, or opportunistic infections (see section 4.4).
Slovenian: • Aktivna tuberkuloza (TB), resne okužbe, kot je sepsa, ali oportunistične okužbe (glejte poglavje 4.4).
English: The efficacy results for important endpoints assessed are shown in Table 12.
Slovenian: Rezultati učinkovitosti za pomembne opazovane dogodke, ki so jih ocenjevali, so prikazani v preglednici 12.
English: Severe (including patients undergoing haemodialysis)
Slovenian: huda (vključno z bolniki, ki prejemajo hemodializo)
English: - if you have heart problems, high blood pressure, or high cholesterol
Slovenian: - če imate težave s srcem, visok krvni tlak ali zvišano raven holesterola v krvi.
English: Serious infections in the elderly
Slovenian: Resne okužbe pri starejših
English: In contrast, tofacitinib has a high degree of selectivity against other kinases in the human genome.
Slovenian: Za razliko od tega ima tofacitinib veliko stopnjo selektivnosti proti drugim kinazam v človeškem genomu.
English: You should tell your doctor if you are using medicines (taken by mouth) that contain any of the following active substances:
Slovenian: Zdravniku povejte, če uporabljate zdravila (jih jemljete tako, da jih pogoltnete), ki vsebujejo katerokoli izmed naslednjih učinkovin:
English: No data are available on the secondary transmission of infection by live vaccines to patients receiving tofacitinib.
Slovenian: Ni podatkov o sekundarnem prenosu okužbe z živimi cepivi na bolnike, ki prejemajo tofacitinib.
English: • Use of combined hormonal contraceptives or hormone replacement therapy
Slovenian: • uporaba kombiniranih hormonskih kontraceptivov ali nadomestne hormonske terapije,
English: 4.1 Therapeutic indication
Slovenian: 4.1 Terapevtske indikacije
English: In addition, safety and efficacy of tofacitinib were assessed in an open-label long-term extension study (OCTAVE Open).
Slovenian: Poleg tega so varnost in učinkovitost tofacitiniba ocenili tudi v odprtem, dolgoročnem podaljšanem preskušanju (OCTAVE Open).
English: Greater than 2 g/dL decrease or less than 8.0 g/dL (confirmed by repeat testing)
Slovenian: zmanjšanje za več kot 2 g/dl ali vrednost, manjša od 8,0 g/dl (potrjeno s ponovnim testiranjem)
English: Take your next tablet at the usual time and continue as before.
Slovenian: Naslednjo tableto vzemite ob običajnem času in nadaljujte z jemanjem kot običajno.
English: The treatment interruption period in clinical studies extended up to 1 year.
Slovenian: Obdobje prekinitve zdravljenja je v kliničnih preskušanjih trajalo največ 1 leto.