FrancophonIA/ELRC3.0 huggingface dataset:
English: Successful response in the study was defined as attainment of medical castration at day 28 and maintenance through day 364 where no single testosterone concentration was greater than 0.5 ng/ml.
Slovenian: 364. dne, če v tem obdobju nobena izmerjena koncentracija testosterona ni bila višja od 0,5 ng/ml.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR FIRMAGON 120 mg powder and solvent for solution for injection
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA FIRMAGON 120 mg prašek in vehikel za raztopino za injiciranje
English: Maintenance dose - monthly administration
Slovenian: Vzdrževalni odmerek - vsakomesečno dajanje
English: Drug-related local irritation was noted in animals when degarelix was administered subcutaneously in high doses.
Slovenian: Kadar so dajali degareliks subkutano v velikih odmerkih, so pri živalih opazili z zdravilom povezano lokalno draženje.
English: Ferring Arzneimittel GmbH Tel: +49 431 5852 0 info-service@ferring.de
Slovenian: Ferring Arzneimittel GmbH Tel: +49 431 5852 0
English: immediately after reconstitution.
Slovenian: 120 mg takoj po rekonstituciji.
English: Dizziness, headache
Slovenian: plešavost, pruritus, eritem
English: Inject 3 ml of FIRMAGON 120 mg slowly,
Slovenian: Počasi injicirajte 3 ml zdravila FIRMAGON
English: Vial adapters
Slovenian: Adapterja viale
English: Day 1 Day 3 Day 7
Slovenian: 7. dan
English: No pharmacokinetic studies in renally impaired patients have been conducted.
Slovenian: Pri bolnikih z okvaro ledvic farmakokinetičnih študij niso opravili.
English: After reconstitution, each ml solution contains 40 mg of degarelix.
Slovenian: Po rekonstituciji en ml raztopine vsebuje 40 mg degareliksa.
English: Dyspnoea
Slovenian: Levprorelin
English: After reconstitution, each ml of solution contains 20 mg of degarelix.
Slovenian: Po rekonstituciji en ml raztopine vsebuje 20 mg degareliksa.
English: 1 ml of the reconstituted solution contains 20 mg degarelix.
Slovenian: Po rekonstituciji vsebuje 1 ml rekonstituirane raztopine 20 mg degareliksa.
English: hypotension)
Slovenian: (vključno s hipotenzijo)
English: Cardiac disorders
Slovenian: Elektrokardiografske spremembe
English: FIRMAGON 120 mg powder and solvent for solution for injection
Slovenian: FIRMAGON 120 mg prašek in vehikel za raztopino za injiciranje
English: 1 ml of the reconstituted solution contains 40 mg degarelix.
Slovenian: Po rekonstituciji vsebuje 1 ml rekonstituirane raztopine 40 mg degareliksa.
English: Three months therapy with degarelix (240/80 mg dose regimen) resulted in a 37% reduction in prostate volume as measured by trans-rectal ultrasound scan (TRUS) in patients requiring hormonal therapy prior to radiotherapy and in patients who were candidates for medical castration.
Slovenian: izmerjeno s transrektalnim ultrazvokom (TRUZ), pri bolnikih, ki so pred radioterapijo potrebovali hormonsko zdravljenje, in bolnikih, ki so bili primerni za medicinsko kastracijo.
English: FIRMAGON might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or other medicines which can have an effect on heart rhythm (e.g.
Slovenian: Zdravilo FIRMAGON lahko ovira delovanje nekaterih zdravil, ki se uporabljajo za zdravljenje težav s srčnim ritmom (n.pr.
English: FIRMAGON 80 mg powder and solvent for solution for injection
Slovenian: FIRMAGON 80 mg prašek in vehikel za raztopino za injiciranje
English: The site of injection is likely to vary within the abdominal region.
Slovenian: Zdravilo se navadno injicira v različnih točkah v predelu trebuha.
English: In each case degarelix was discontinued.
Slovenian: V 4 od 8 primerov vzročne povezave med degareliksom in d ni bilo mogoče izključiti.
English: FIRMAGON 120 mg powder and solvent for solution for injection degarelix
Slovenian: FIRMAGON 120 mg prašek in vehikel za raztopino za injiciranje degareliks
English: Osteoporosis/osteopenia, arthralgia muscular weakness, muscle spasms, joint swelling/stiffness
Slovenian: Bolezni mišično skeletnega sistema, vezivnega tkiva in kosti bolečine in nelagodje v mišicah in kosteh osteoporoza/osteop enija, artralgija, šibkost mišic,
English: FIRMAGON 80 mg powder and solvent for solution for injection degarelix
Slovenian: FIRMAGON 80 mg prašek in vehikel za raztopino za injiciranje degareliks
English: Nervous system disorders
Slovenian: Organski sistemi po
English: The pigs should be re-vaccinated every 6 months.
Slovenian: Cepljenje prašičev je treba ponavljati vsakih 6 mesecev.
English: If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.
Slovenian: Če bolečina traja več kot 12 ur po zdravniškem pregledu, se je treba znova zglasiti pri zdravniku.
English: Any person intending to import, sell, supply and/or use the veterinary medicinal product must be authorised by the competent authority of the Member State.
Slovenian: Vsakdo, ki želi uvažati, prodajati, dobavljati in/ali uporabljati zdravilo za uporabo v veterinarski medicini, mora dobiti dovoljenje pristojnega organa države članice.
English: The import, sale, supply and/or use of Porcilis Pesti is only allowed under the particular conditions established by European Community legislation on the control of CSF (Council Directive 80/217/EEC, as amended).
Slovenian: Uvoz, prodaja, dobava in/ali uporaba zdravila Porcilis Pesti so dovoljeni samo pod posebnimi pogoji, določenimi z zakonodajo Evropske skupnosti o nadzoru KPK (Direktiva Sveta 80/217/EGS, z vsemi spremembami).
English: This first dose is followed by a second injection 4 weeks later.
Slovenian: Prvemu odmerku sledi druga injekcija 4 tedne kasneje.
English: Maternally derived antibodies did not interfere with vaccination.
Slovenian: Maternalno pridobljena protitelesa niso vplivala na rezultate cepljenja.
English: If someone is accidentally injected with this product, they must seek immediate medical advice even if only a very small amount is injected.
Slovenian: Če pride do nehotenega injiciranja tega izdelka, mora ta oseba nemudoma poiskati zdravniško pomoč, tudi če je bila injicirana le zelo majhna količina.
English: The piglets were also tested for viraemia (presence of virus in their blood).
Slovenian: Pujski so bili testirani tudi za viremijo (prisotnost virusa v krvi).
English: It is recommended that the second vaccination is given at a different site than the first vaccination.
Slovenian: Priporočljivo je, da se drugo cepljenje ne izvede na istem mestu kot prvo.
English: When this antigen is injected, this small exposure helps the pig's immune system to recognise and attack CSF.
Slovenian: Po injiciranju tega antigena, ta majhna izpostavitev pripomore k temu, da imunski sistem prašiča prepozna in napade KPK.
English: Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger - rarely causing the loss of a finger.
Slovenian: Nenamerno injiciranje lahko povzroči hudo bolečino in otekanje, še posebej če je bilo injiciranje izvedeno v sklep ali prst, kar lahko v redkih primerih privede do izgube prsta.
English: When exposed to CSF later in life, the pig will either not become infected or have a much less serious infection.
Slovenian: Če bo prašič bolezni KPK izpostavljen pozneje v življenju, se ne bo okužil ali pa bo imel bistveno manj resno okužbo.
English: Protection from CSF starts after 2 weeks and lasts for 6 months.
Slovenian: Zaščita pred KPK začne učinkovati po 2 tednih in traja 6 mesecev.
English: The field trials confirm the results obtained in the laboratory safety experiments and show that the product is safe for the target animal (piglets from 5 weeks of age onwards) and in the most sensitive category of animals (pregnant sows).
Slovenian: Terenske študije potrjujejo rezultate laboratorijskih preizkusov varnosti in kažejo, da je izdelek varen za ciljne živali (pujski od 5 meseca dalje) in najobčutljivejšo kategorijo živali (breje svinje).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PORCILIS PESTI EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) PORCILIS PESTI Povzetek EPAR za javnost
English: It is also used to reduce infection with CSF and excretion of CSF virus into the environment.
Slovenian: Uporablja se tudi za zmanjševanje okuženosti s KPK in izločanja virusa KPK v okolico.
English: Porcilis Pesti is an emulsion for injection.
Slovenian: Zdravilo Porcilis Pesti je emulzija za injiciranje.
English: Other information about Porcilis Pesti:
Slovenian: Druge informacije o zdravilu Porcilis Pesti:
English: The vaccine is shaken before use and an intramuscular (into a muscle) injection of one dose (2 ml) is given in the neck behind the ear.
Slovenian: Intramuskularna injekcija (injekcija v mišico) enega odmerka (2 ml) se daje v vrat v predel za ušesom.
English: Porcilis Pesti has been studied in two safety field trials, one in finishing pigs and one in sows using different vaccination doses.
Slovenian: Zdravilo Porcilis Pesti so preučevali v okviru dveh terenskih študij varnosti, eni na pitancih in eni na svinjah, pri čemer sta bila uporabljena različna odmerka cepiva.
English: Viraemia was only prevented by two injections (as recommended in the vaccination schedule for Porcilis Pesti).
Slovenian: Viremijo je bilo mogoče preprečiti z dvema injekcijama (kot je priporočeno v shemi cepljenja z zdravilom Porcilis Pesti).
English: Temporary hyperthermia (increased temperature) may occur after the second injection.
Slovenian: Po drugi injekciji lahko pride do začasne hipertermije (povišane temperature).
English: The main measure of effectiveness in a field trial with piglets was the survival of the piglets when exposed to the CSF virus later in life.
Slovenian: Glavno merilo učinkovitosti pri terenskih študijah s pujski je bilo preživetje pujskov, če so bili izpostavljeni virusu KPK pozneje v življenju.
English: Porcilis Pesti can cause a swelling at the injection site for up to 4 weeks after each injection of the vaccine.
Slovenian: Zdravilo Porcilis Pesti lahko povzroči oteklino na mestu injiciranja, ki lahko traja do 4 tedne po vsakem posameznem injiciranju cepiva.
English: All the vaccinations prevented death when the piglets were exposed to CSF virus at a later date.
Slovenian: Vsa cepljenja so preprečila smrt pujskov, ko so bili ti kasneje izpostavljeni virusu KPK.
English: What benefit has Porcilis Pesti shown during the studies?
Slovenian: Kakšne koristi je zdravilo Porcilis Pesti izkazalo med raziskavami?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis Pesti to Intervet International B.V. on 9 February 2000, which was renewed in February
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Porcilis Pesti, veljavno po vsej Evropski uniji, odobrila družbi Intervet International B.V.
English: Antibodies to the CSF antigen showed that the piglets developed immunity after 2 weeks, which was maintained for 6 months.
Slovenian: Protitelesa proti antigenu virusa KPK so pokazala, da se je imunost pri pujskih razvila po 2 tednih in je trajala 6 mesecev.
English: Porcilis Pesti contains an antigen - E2 (a substance that stimulates an immune response) to CSF.
Slovenian: Zdravilo Porcilis Pesti vsebuje antigen - E2 (snov, ki spodbuja imunski odziv) proti KPK.
English: The package leaflet should be taken to the doctor.
Slovenian: V tem primeru je treba k zdravniku odnesti tudi Navodila za uporabo.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Porcilis Pesti are greater than any risks to immunise pigs from the age of 5 weeks onwards to prevent death and to reduce clinical signs of Classical Swine Fever.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je sklenil, da so koristi zdravila Porcilis Pesti pri imunizaciji prašičev, starih 5 tednov in več, pri preprečevanju smrtnosti in zmanjšanju kliničnih znakov klasične prašičje kuge večje od morebitnih tveganj.
English: They recommended that Porcilis Pesti should be given a marketing authorisation.
Slovenian: Zato je priporočil, da se za zdravilo Porcilis Pesti odobri dovoljenje za promet.
English: What is the risk associated with Porcilis Pesti?
Slovenian: Kakšna tveganja so povezana z zdravilom Porcilis Pesti?
English: Porcilis Pesti contains Classical Swine Fever Virus -E2 subunit antigen.
Slovenian: Zdravilo Porcilis Pesti vsebuje virus klasične prašičje kuge - antigenska podenota E2.
English: The start and length of immunity was measured by antibodies produced by the piglets to the CSF antigen (E2).
Slovenian: Začetek in trajanje imunosti so merili na podlagi protiteles proti antigenu (E2) virusa KPK, ki so jih tvorili pujski.
English: Why has Porcilis Pesti been approved?
Slovenian: Zakaj je bilo zdravilo Porcilis Pesti odobreno?
English: Abscesses may be seen at the injection site.
Slovenian: Na mestu injiciranja so možni abscesi.
English: What is Porcilis Pesti used for?
Slovenian: Za kaj se zdravilo Porcilis Pesti uporablja?
English: What is Porcilis Pesti?
Slovenian: Kaj je zdravilo Porcilis Pesti?
English: How does Porcilis Pesti work?
Slovenian: Kako zdravilo Porcilis Pesti deluje?
English: How has Porcilis Pesti been studied?
Slovenian: Kako je bilo zdravilo Porcilis Pesti raziskano?
English: Porcilis Pesti contains mineral oil.
Slovenian: Zdravilo Porcilis Pesti vsebuje tekoči parafin.
English: Porcilis Pesti is used to immunise healthy pigs from the age of 5 weeks onwards to prevent death and to reduce clinical signs of Classical Swine Fever (CSF).
Slovenian: S tem se preprečuje smrtnost in zmanjšujejo klinični znaki klasične prašičje kuge (KPK).
English: This summary was last updated on 05/09/2006.
Slovenian: Ta povzetek je bil nazadnje posodobljen 05/09/2006.
English: The vaccine was assessed in the context of an emergency situation which means that further studies with Nobilis H5N2 are still ongoing and will be assessed.
Slovenian: Cepivo je bilo ocenjeno v izrednih razmerah, kar pomeni, da nadaljnje raziskave z zdravilom Nobilis Influenza H5N2 še vedno potekajo in bodo ovrednotene v prihodnosti.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Nobilis Influenza H5N2 to Intervet International BV on 01/09/2006.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Nobilis Influenza H5N2, veljavno po vsej Evropski uniji, odobrila družbi Intervet International BV dne 01/09/2006.
English: The virus used for the vaccine carries the H5 (haemagglutinin 5) and N2 (neuramidase 2) antigens.
Slovenian: Virus, uporabljen za cepivo, vsebuje antigena H5 (hemaglutinin 5) in N2 (nevraminidaza 2).
English: The company carried out laboratory safety studies using a vaccine very similar to Nobilis Influenza H5N2.
Slovenian: Podjetje je izvedlo laboratorijske raziskave o varnosti v katerih je uporabilo cepivo, ki je zelo podobno zdravilu Nobilis Influenza H5N2.
English: Vaccinated birds can be differentiated from infected birds by a diagnostic test for antibodies against the N2 component.
Slovenian: Cepljene ptice je mogoče razlikovati od okuženih ptic z diagnostičnim testom za protitelesa proti sestavini N2.
English: Nobilis Influenza H5N2 is a vaccine containing an inactivated avian influenza virus H5N2 (inactivated means that the virus has been killed so that it cannot cause the disease any more).
Slovenian: Zdravilo Nobilis Influenza H5N2 je cepivo, ki vsebuje inaktivirani virus aviarne influence H5N2 (inaktiviran pomeni, da je bil virus ubit, zaradi česar ne more več povzročiti bolezni).
English: Nobilis Influenza H5N2 has been authorised under “Exceptional Circumstances”.
Slovenian: Zdravilo Nobilis Influenza H5N2 je bilo odobreno v »izjemnih okoliščinah«.
English: Nobilis Influenza H5N2 is a vaccine used in chickens to protect against avian influenza.
Slovenian: Zdravilo Nobilis Influenza H5N2 je cepivo, ki se uporablja pri piščancih za zaščito pred aviarno influenco.
English: • If the circulating avian influenza field virus has a different N component to the N2 included in the vaccine, it may be possible to differentiate between vaccinated from infected birds by using a diagnostic test to detect Neuraminidase antibodies.
Slovenian: • Če ima krožeči divji virus aviarne influence sestavino N, ki se razlikuje od sestavine N2 v cepivu, lahko cepljene ptice razlikujemo od okuženih z diagnostičnim testom za odkrivanje protiteles proti nevraminidazi.
English: They also tested the safety of three standard production batches of Nobilis Influenza H5N2.
Slovenian: Preizkušena je bila tudi varnost treh standardnih proizvodnih serij zdravila Nobilis Influenza H5N2.
English: Nobilis Influenza H5N2 is a vaccine.
Slovenian: Zdravilo Nobilis Influenza H5N2 je cepivo.
English: Other information about Nobilis Influenza H5N2:
Slovenian: Druge informacije o zdravilu Nobilis Influenza H5N2:
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NOBILIS INFLUENZA H5N2
Slovenian: EMEA/V/C/118 EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) NOBILIS INFLUENZA H5N2 Povzetek EPAR za javnost
English: What benefit has Nobilis Influenza H5N2 shown during the studies?
Slovenian: Kakšne koristi je zdravilo Nobilis Influenza H5N2 izkazalo med raziskavami?
English: What is the risk associated with Nobilis Influenza H5N2?
Slovenian: Kakšna tveganja so povezana z zdravilom Nobilis Influenza H5N2?
English: Why has Nobilis Influenza H5N2 been approved?
Slovenian: Zakaj je bilo zdravilo Nobilis Influenza H5N2 odobreno?
English: How has Nobilis Influenza H5N2 been studied?
Slovenian: Kako je bilo zdravilo Nobilis Influenza H5N2 raziskano?
English: What is Nobilis Influenza H5N2?
Slovenian: Kaj je zdravilo Nobilis Influenza H5N2?
English: What is Nobilis Influenza H5N2 used for?
Slovenian: Za kaj se zdravilo Nobilis Influenza H5N2 uporablja?
English: How does Nobilis Influenza H5N2 work?
Slovenian: Kako zdravilo Nobilis Influenza H5N2 deluje?
English: Annual reports: as part of the annual re-assessment dossier
Slovenian: Letna poročila: kot del letnega poročila o ponovni oceni
English: The more points = worse symptoms.
Slovenian: Več točk = slabši simptomi.
English: The clinical relevance of these results is unknown.
Slovenian: Klinični pomen teh rezultatov ni znan.
English: • Cold hands and feet
Slovenian: • hladne dlani in stopala
English: Your doctor will also monitor your heart at the start of your treatment and also every year thereafter.
Slovenian: Zdravnik bo spremljal tudi vaše srce na začetku zdravljenja in nato vsako leto.
English: (1=terrible to 7=delighted).
Slovenian: (1 = izjemno slabo do 7 = odlično).
English: The following side effects have also been reported (frequencies cannot be estimated from the available data):
Slovenian: Ugotovili so tudi naslednje neželene učinke (njihove pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
English: Baseline assessments were obtained on day 0.
Slovenian: Izhodiščne ocene so bile pridobljene na dan 0.
English: Monitoring is advised when possible.
Slovenian: Če je možno, je priporočljivo spremljanje.
English: They can present in many locations, therefore the clinical presentation can be varied.
Slovenian: Nastanejo lahko na številnih mestih, zato so klinične slike lahko različne.
English: Frequencies are defined as: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000) and Unknown (cannot be estimated from available data).
Slovenian: Pogostnosti so opredeljene 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) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: It is especially important to talk to your doctor if you are taking one of the following medicines or plan to start taking the following medicines:
Slovenian: Zlasti je pomembno, da se pogovorite z zdravnikom, če jemljete katero izmed naslednjih zdravil ali nameravate začeti jemati katero izmed naslednjih zdravil:
English: • Increase sweating, cold sweat
Slovenian: • povečano znojenje, hladen znoj
English: Tablets are to be taken with food.
Slovenian: Tablete je treba vzeti s hrano.
English: Amifampridine 20 mg
Slovenian: Amifampridin 20 mg
English: The dose you should take is established by your doctor based on the intensity of your symptoms and certain genetic factors.
Slovenian: Odmerek, ki ga boste jemali, določi zdravnik na podlagi jakosti vaših simptomov in nekaterih genskih dejavnikov.
English: Date of latest renewal: 1 December 2014
Slovenian: Datum prve odobritve: 23. december 2009 Datum zadnjega podaljšanja: 1. december 2014
English: Patients had a median age of 55.5 years (range: 31 to 75 years) and 62% were female and 38% were male.
Slovenian: Mediana starost bolnikov je bila 55,5 let (razpon: 31 do 75 let), 62 % je bilo žensk in 38 % je bilo moških.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/601/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/601/001
English: The safety and efficacy of FIRDAPSE in children aged 0 to 17 years has not been established.
Slovenian: Varnost in učinkovitost zdravila FIRDAPSE pri otrocih, starih od 0 do 17 let, še nista bili dokazani.
English: Combinations to be taken into consideration
Slovenian: Kombinacije, ki jih je treba upoštevati
English: No safety margins to human exposure were achieved in the animal studies due to the sensitivity of the animal models used.
Slovenian: Varnostne meje za izpostavljenost pri človeku v študijah na živalih niso bile določene zaradi občutljivosti živalskih modelov.
English: The following medicines must not be combined with FIRDAPSE:
Slovenian: Naslednjih zdravil ne smete kombinirati z zdravilom FIRDAPSE:
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve za predložitev občasno posodobljenih poročil o varnosti zdravila za to zdravilo so navedene na seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in morebitnih nadaljnjih posodobitev, objavljenih na evropskem spletnem portalu o zdravilih.
English: Treatment should be initiated under supervision of a physician experienced in the treatment of the disease.
Slovenian: Zdravljenje je treba začeti pod nadzorom zdravnika z izkušnjami pri zdravljenju te bolezni.
English: The tablets can be divided into equal halves.
Slovenian: Tableta se lahko deli na enaki polovici.
English: PHARMACEUTICAL FORM AND CONTENTS 100 tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 100 tablet
English: Tell your doctor if you have
Slovenian: Obvestite svojega zdravnika, če imate:
English: e p-value based on the Wilcoxon Rank Sum Test for treatment differences.
Slovenian: e p-vrednost na podlagi Wilcoxonovega testa vsote rangov za razlike v zdravljenju.
English: • Together with medicines with a therapeutic dose close to the maximum safe dose
Slovenian: • sočasno z zdravili, katerih terapevtski odmerek je blizu največjemu varnemu odmerku,
English: If you discover that you are pregnant during the treatment, inform your doctor immediately.
Slovenian: Če med zdravljenjem ugotovite, da ste noseči, nemudoma obvestite svojega zdravnika.
English: Clinical and electrocardiogram (ECG) monitoring are indicated at the initiation of the treatment and yearly thereafter.
Slovenian: Klinično in elektrokardiogramsko (EKG) spremljanje je indicirano ob uvedbi zdravljenja in nato vsako leto.
English: b SGI is a 7-point scale which rates the global impression of the effects of study treatment
Slovenian: b SGI je 7-točkovna lestvica, ki ocenjuje globalno oceno učinkov študijskega zdravljenja
English: See section 4.8 for how to report adverse reactions.
Slovenian: Glejte poglavje 4.8, kako poročati o neželenih učinkih.>
English: The dose of the concomitantly given medicinal product should be adjusted if necessary.
Slovenian: Odmerek sočasno uporabljenega zdravila je treba po potrebi prilagoditi.