FrancophonIA/ELRC3.0 huggingface dataset:
English: Respiratory, thoracic and mediastinal disorders Cough uncommon
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj občasno
English: Linagliptin added to metformin provided significant improvements in HbA1c, (-0.64% change compared to placebo), from a mean baseline HbA1c of 8%.
Slovenian: Linagliptin je kot dodatno zdravilo ob metforminu pomembno izboljšal raven HbA1c (sprememba za -0,64 % v primerjavi s placebom), in sicer pri srednji izhodiščni ravni HbA1c 8 %.
English: Bottle Keep the bottle tightly closed in order to protect from moisture.
Slovenian: Plastenka Plastenko shranjujte tesno zaprto za zagotovitev zaščite pred vlago.
English: The efficacy and safety of linagliptin 2.5 mg twice daily versus 5 mg once daily in combination with metformin in patients with insufficient glycaemic control on metformin monotherapy was evaluated in a double-blind placebo-controlled study of 12 weeks duration.
Slovenian: V dvojno slepi, s placebom nadzorovani 12-tedenski študiji so ocenili učinkovitost in varnost linagliptina, v odmerkih po 2,5 mg dvakrat na dan, v primerjavi s 5 mg enkrat na dan, v kombinaciji z metforminom, pri bolnikih z nezadostno urejeno glikemijo na monoterapiji z metforminom.
English: - if you are treated for acute heart failure or have recently had a heart attack, have severe problems with your circulation (such as shock) or have breathing difficulties.
Slovenian: Dehidracija lahko privede do težav z ledvicami, kar lahko predstavlja tveganje za nastanek laktacidoze (glejte 'Opozorila in previdnostni ukrepi') če se zdravite zaradi akutnega srčnega popuščanja ali ste pred kratkim imeli srčni infarkt, imate hude težave s krvnim obtokom (kot na primer šok) ali težave z dihanjem.
English: with a mean treatment difference of 0.20% (97.5% CI: 0.09, 0.299).
Slovenian: Ugotovili so: srednje znižanje ravni HbA1c -0,16 % pri linagliptinu (s srednjo izhodiščno ravnijo HbA1c 7,69 %) in -0,36 % pri glimepiridu (s srednjo izhodiščno ravnijo 7,69 %) s srednjo razliko zdravljenja 0,20 % (97,5-odstotni IZ: 0,09, 0,299).
English: - carbamazepine, phenobarbital or phenytoin.
Slovenian: zlasti če imate zmanjšano delovanje ledvic; - karbamazepin, fenobarbital ali fenitoin, ki so zdravila za preprečevanje napadov krčev
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 2,5 mg linagliptina in 850 mg metforminijevega klorida.
English: EU/1/12/780/001 10 x 1 film-coated tablets EU/1/12/780/002 14 x 1 film-coated tablets EU/1/12/780/003 28 x 1 film-coated tablets EU/1/12/780/004 30 x 1 film-coated tablets EU/1/12/780/005 56 x 1 film-coated tablets EU/1/12/780/006 60 x 1 film-coated tablets EU/1/12/780/007 84 x 1 film-coated tablets EU/1/12/780/008 90 x 1 film-coated tablets EU/1/12/780/009 98 x 1 film-coated tablets EU/1/12/780/010 100 x 1 film-coated tablets EU/1/12/780/011 120 x 1 film-coated tablets
Slovenian: EU/1/12/780/001 10 x 1 filmsko obloženih tablet EU/1/12/780/002 14 x 1 filmsko obloženih tablet EU/1/12/780/003 28 x 1 filmsko obloženih tablet EU/1/12/780/004 30 x 1 filmsko obloženih tablet EU/1/12/780/005 56 x 1 filmsko obloženih tablet EU/1/12/780/006 60 x 1 filmsko obloženih tablet EU/1/12/780/007 84 x 1 filmsko obloženih tablet EU/1/12/780/008 90 x 1 filmsko obloženih tablet EU/1/12/780/009 98 x 1 filmsko obloženih tablet EU/1/12/780/010 100 x 1 filmsko obloženih tablet EU/1/12/780/011 120 x 1 filmsko obloženih tablet
English: Jentadueto 2.5 mg/1,000 mg film-coated tablets EU/1/12/780/015 (10 x 1 film-coated tablets) EU/1/12/780/016 (14 x 1 film-coated tablets) EU/1/12/780/017 (28 x 1 film-coated tablets) EU/1/12/780/018 (30 x 1 film-coated tablets) EU/1/12/780/019 (56 x 1 film-coated tablets) EU/1/12/780/020 (60 x 1 film-coated tablets) EU/1/12/780/021 (84 x 1 film-coated tablets) EU/1/12/780/022 (90 x 1 film-coated tablets) EU/1/12/780/023 (98 x 1 film-coated tablets) EU/1/12/780/024 (100 x 1 film-coated tablets) EU/1/12/780/025 (120 x 1 film-coated tablets) EU/1/12/780/026 (14 film-coated tablets, bottle) EU/1/12/780/027 (60 film-coated tablets, bottle) EU/1/12/780/028 (180 film-coated tablets, bottle) EU/1/12/780/032 (120 (2 x 60 x 1) film-coated tablets) EU/1/12/780/033 (180 (2 x 90 x 1) film-coated tablets) EU/1/12/780/034 (200 (2 x 100 x 1) film-coated tablets)
Slovenian: Jentadueto 2,5 mg/1000 mg filmsko obložene tablete EU/1/12/780/015 (10 x 1 filmsko obložena tableta) EU/1/12/780/016 (14 x 1 filmsko obložena tableta) EU/1/12/780/017 (28 x 1 filmsko obložena tableta) EU/1/12/780/018 (30 x 1 filmsko obložena tableta) EU/1/12/780/019 (56 x 1 filmsko obložena tableta) EU/1/12/780/020 (60 x 1 filmsko obložena tableta) EU/1/12/780/021 (84 x 1 filmsko obložena tableta) EU/1/12/780/022 (90 x 1 filmsko obložena tableta) EU/1/12/780/023 (98 x 1 filmsko obložena tableta) EU/1/12/780/024 (100 x 1 filmsko obložena tableta) EU/1/12/780/025 (120 x 1 filmsko obložena tableta) EU/1/12/780/026 (14 filmsko obloženih tablet, plastenka) EU/1/12/780/027 (60 filmsko obloženih tablet, plastenka) EU/1/12/780/028 (180 filmsko obloženih tablet, plastenka) EU/1/12/780/032 (120 (2 x 60 x 1) filmsko obloženih tablet) EU/1/12/780/033 (180 (2 x 90 x 1) filmsko obloženih tablet) EU/1/12/780/034 (200 (2 x 100 x 1) filmsko obloženih tablet)
English: Bullous pemphigoid has been observed in patients taking linagliptin.
Slovenian: Pri bolnikih, ki so jemali linagliptin, so opazili bulozni pemfigoid.
English: EU/1/12/780/015 10 x 1 film-coated tablets EU/1/12/780/016 14 x 1 film-coated tablets EU/1/12/780/017 28 x 1 film-coated tablets EU/1/12/780/018 30 x 1 film-coated tablets EU/1/12/780/019 56 x 1 film-coated tablets EU/1/12/780/020 60 x 1 film-coated tablets EU/1/12/780/021 84 x 1 film-coated tablets EU/1/12/780/022 90 x 1 film-coated tablets EU/1/12/780/023 98 x 1 film-coated tablets EU/1/12/780/024 100 x 1 film-coated tablets EU/1/12/780/025 120 x 1 film-coated tablets
Slovenian: EU/1/12/780/015 10 x 1 filmsko obloženih tablet EU/1/12/780/016 14 x 1 filmsko obloženih tablet EU/1/12/780/017 28 x 1 filmsko obloženih tablet EU/1/12/780/018 30 x 1 filmsko obloženih tablet EU/1/12/780/019 56 x 1 filmsko obloženih tablet EU/1/12/780/020 60 x 1 filmsko obloženih tablet EU/1/12/780/021 84 x 1 filmsko obloženih tablet EU/1/12/780/022 90 x 1 filmsko obloženih tablet EU/1/12/780/023 98 x 1 filmsko obloženih tablet EU/1/12/780/024 100 x 1 filmsko obloženih tablet EU/1/12/780/025 120 x 1 filmsko obloženih tablet
English: feeling sick (nausea) - Uncommon: inflamed nose or throat (nasopharyngitis), cough, loss of appetite (decreased appetite), being sick (vomiting), blood enzyme increase (amylase increase), itching (pruritus) - Rare: blistering of skin (bullous pemphigoid)
Slovenian: - Občasni: vnetje nosu ali grla (nazofaringitis), kašelj, izguba teka (zmanjšan apetit) ali slabost
English: Jentadueto 2.5 mg/850 mg film-coated tablets EU/1/12/780/001 (10 x 1 film-coated tablets) EU/1/12/780/002 (14 x 1 film-coated tablets) EU/1/12/780/003 (28 x 1 film-coated tablets) EU/1/12/780/004 (30 x 1 film-coated tablets) EU/1/12/780/005 (56 x 1 film-coated tablets) EU/1/12/780/006 (60 x 1 film-coated tablets) EU/1/12/780/007 (84 x 1 film-coated tablets) EU/1/12/780/008 (90 x 1 film-coated tablets) EU/1/12/780/009 (98 x 1 film-coated tablets) EU/1/12/780/010 (100 x 1 film-coated tablets) EU/1/12/780/011 (120 x 1 film-coated tablets) EU/1/12/780/012 (14 film-coated tablets, bottle) EU/1/12/780/013 (60 film-coated tablets, bottle) EU/1/12/780/014 (180 film-coated tablets, bottle) EU/1/12/780/029 (120 (2 x 60 x 1) film-coated tablets) EU/1/12/780/030 (180 (2 x 90 x 1) film-coated tablets) EU/1/12/780/031 (200 (2 x 100 x 1) film-coated tablets)
Slovenian: Jentadueto 2,5 mg/850 mg filmsko obložene tablete EU/1/12/780/001 (10 x 1 filmsko obložena tableta) EU/1/12/780/002 (14 x 1 filmsko obložena tableta) EU/1/12/780/003 (28 x 1 filmsko obložena tableta) EU/1/12/780/004 (30 x 1 filmsko obložena tableta) EU/1/12/780/005 (56 x 1 filmsko obložena tableta) EU/1/12/780/006 (60 x 1 filmsko obložena tableta) EU/1/12/780/007 (84 x 1 filmsko obložena tableta) EU/1/12/780/008 (90 x 1 filmsko obložena tableta) EU/1/12/780/009 (98 x 1 filmsko obložena tableta) EU/1/12/780/010 (100 x 1 filmsko obložena tableta) EU/1/12/780/011 (120 x 1 filmsko obložena tableta) EU/1/12/780/012 (14 filmsko obloženih tablet, plastenka) EU/1/12/780/013 (60 filmsko obloženih tablet, plastenka) EU/1/12/780/014 (180 filmsko obloženih tablet, plastenka) EU/1/12/780/029 (120 (2 x 60 x 1) filmsko obloženih tablet) EU/1/12/780/030 (180 (2 x 90 x 1) filmsko obloženih tablet) EU/1/12/780/031 (200 (2 x 100 x 1) filmsko obloženih tablet)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2.5 mg of linagliptin and 1,000 mg of metformin hydrochloride.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 2,5 mg linagliptina in 1000 mg metforminijevega klorida.
English: • Diabetic pre-coma.
Slovenian: • diabetična predkoma
English: NAME OF THE MEDICINAL PRODUCT Jentadueto 2.5 mg/850 mg film-coated tablets Linagliptin/metformin hydrochloride
Slovenian: Jentadueto 2,5 mg/850 mg filmsko obložene tablete linagliptin/metforminijev klorid
English: NAME OF THE MEDICINAL PRODUCT Jentadueto 2.5 mg/1,000 mg film-coated tablets Linagliptin/metformin hydrochloride
Slovenian: Jentadueto 2,5 mg/1000 mg filmsko obložene tablete linagliptin/metforminijev klorid
English: Dose reduction may be considered in relation to declining renal function.
Slovenian: Ob slabšanju delovanja ledvic pride v poštev zmanjšanje odmerka.
English: Metabolism and nutrition disorders Hypoglycaemia very common
Slovenian: Bolezni jeter, žolčnika in žolčevodov motnje jetrnega delovanja občasno hepatitis zelo redko
English: Skin and subcutaneous tissue disorders Angioedema rare
Slovenian: Bolezni kože in podkožja angioedem redko urtikarija redko eritem zelo redko izpuščaj občasno pruritus občasno bulozni pemfigoid redko
English: - if you drink alcohol to excess, either every day or only from time to time (see section 'Jentadueto with alcohol').
Slovenian: To lahko privede do zmanjšane oskrbe tkiv s kisikom, kar lahko predstavlja tveganje za nastanek laktacidoze (glejte poglavje 'Opozorila in previdnostni ukrepi'); - če imate težave z jetri, - če pijete prevelike količine alkohola, vsak dan ali občasno (glejte poglavje 'Zdravilo Jardiance skupaj z alkoholom').
English: No other additive toxicity caused by the combination of linagliptin and metformin was observed at AUC exposure levels up to 2 and 23 times human exposure, respectively.
Slovenian: Pri izpostavljenosti ravnem AUC, ki so bile do 2-krat oziroma do 23-krat večje kot pri človeku, niso zasledili seštevanja toksičnih učinkov, ki bi bili posledica dajanja kombinacije linagliptina in metformina.
English: receptor antagonists) - medicines that may change the amount of metformin in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine,
Slovenian: kot sta ibuprofen in celekoksib), - nekatera zdravila za zdravljenje visokega krvnega tlaka (zaviralci ACE in antagonisti receptorjev angiotenzina II), - zdravila, ki lahko spremenijo količino metformina v krvi (kot so verapamil, rifampicin,
English: - Keep this leaflet.
Slovenian: PRETISNI OMOTI
English: Do not take Jentadueto if any of the above applies to you.
Slovenian: Če imate karkoli od naštetega, ne vzemite zdravila Jentadueto.
English: Number of Subjects
Slovenian: DRUGI PODATKI
English: Pancreatitis rare #
Slovenian: Bulozni pemfigoid
English: Daily
Slovenian: občasno
English: Severe infections may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Warnings and precautions').
Slovenian: Hude okužbe lahko privedejo do težav z ledvicami, kar lahko predstavlja tveganje za nastanek laktacidoze (glejte 'Opozorila in previdnostni ukrepi'); - če ste izgubili veliko vode (dehidracija), npr. zaradi dolgotrajne ali hude driske ali večkratnega zaporednega bruhanja.
English: common
Slovenian: pogosti
English: Body Mass Index (BMI)
Slovenian: Indeks telesne mase
English: No teratogenic effects were observed in rabbits at > 1,000 times human exposure.
Slovenian: Pri kuncih preko 1.000-krat večja izpostavljenost kot za človeka ni bila povezana s teratogenimi učinki.
English: Liver, kidneys, stomach, reproductive organs, thymus, spleen, and lymph nodes were target organs of toxicity in Cynomolgus monkeys at more than 450 times human exposure.
Slovenian: Pri opicah vrste Cynomolgus so se pri izpostavljenosti, ki je bila preko 450-krat večja kot pri človeku, pokazali kot tarčni organi za toksične učinke: jetra, ledvice, želodec, reproduktivni organi, timus, vranica in limfni vozli.
English: Combination requiring precautions for use
Slovenian: B. NAVODILO ZA UPORABO
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging
Slovenian: Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
English: 14 October 2016 EMA/610687/2016 EMEA/H/C/004080
Slovenian: 14. oktober 2016 EMA/610687/2016 EMEA/H/C/004080
English: The company had not yet responded to the questions at the time of the withdrawal.
Slovenian: Družba v času umika še ni odgovorila na zastavljena vprašanja.
English: The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Slovenian: Vlogo so umaknili po tem, ko je CHMP ocenil začetno dokumentacijo, ki jo je predložila družba, in oblikoval seznam vprašanj.
English: This upsets the essential functions that keep the cells alive, and kills the bacteria.
Slovenian: S tem ovira funkcije, ki so bistvenega pomena za preživetje teh celic, kar posledično uniči bakterije.
English: • gynaecological infections;
Slovenian: • ginekoloških okužb;
English: • community-acquired pneumonia (infection of the lungs caught away from hospital);
Slovenian: • zunajbolnišnične pljučnice (okužbe pljuč, s katero se bolnik okuži zunaj bolnišnice);
English: Because Ertapenem Hospira was developed as a generic medicine, the company presented the results of studies to show the quality of the medicine.
Slovenian: Ker je bilo zdravilo Ertapenem Hospira razvito kot generično zdravilo, je družba predstavila rezultate študij, ki dokazujejo kakovost zdravila.
English: It was to be available as a vial containing a powder which is dissolved before use to make up a solution for infusion (drip) into a vein.
Slovenian: Na voljo naj bi bilo v obliki vial s praškom, ki se pred uporabo raztopi za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: The CHMP had concerns about the choice of the starting materials for making the active substance, the process used to manufacture the medicine, the method for testing the purity of the medicine and the medicine's shelf life.
Slovenian: Odbor CHMP je imel zadržke glede izbire začetnega materiala za izdelavo zdravilne učinkovine, uporabljenega postopka za izdelavo zdravila, metode preskušanja čistosti zdravila in roka uporabnosti zdravila.
English: On 13 September 2016, Hospira UK Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ertapenem Hospira, for the treatment of certain infections and for the prevention of infection in colorectal surgery.
Slovenian: Družba Hospira UK Limited je dne 13. septembra 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Ertapenem Hospira, namenjenim zdravljenju določenih okužb in preprečevanju okužb pri kolorektalnih kirurških posegih.
English: Ertapenem attaches to certain proteins on the surface of the bacteria cells.
Slovenian: Ertapenem se pripoji na določene beljakovine na površini bakterijskih celic.
English: Ertapenem Hospira was expected to be used in adults and children aged over 3 months to treat the following infections, if caused by bacteria likely to be killed by ertapenem:
Slovenian: Zdravilo Ertapenem Hospira naj bi se uporabljalo pri odraslih in otrocih, starejših od treh mesecev, za zdravljenje okužb, kadar so te povzročene z bakterijami, ki naj bi jih ertapenem uničil, in sicer naslednjih:
English: • foot infections in diabetes patients.
Slovenian: • okužb stopal pri bolnikih s sladkorno boleznijo.
English: Ertapenem Hospira was also expected to be used to prevent infection at the site of colorectal surgery (surgery in the lower part of the bowel, including the rectum and anus).
Slovenian: Zdravilo Ertapenem Hospira naj bi se uporabljalo tudi za preprečevanje okužbe na mestu kolorektalnega kirurškega posega (kirurškega posega na spodnjem delu črevesja, vključno z danko in zadnjikom).
English: At the time of the withdrawal, the CHMP was of the opinion that the company had not addressed its concerns and the quality of Ertapenem Hospira had not been demonstrated.
Slovenian: Zato je v času umika menil, da družba ni obravnavala izraženih zadržkov in da kakovost zdravila Ertapenem Hospira ni bila dokazana.
English: Ertapenem can work on a range of different bacteria.
Slovenian: Ertapenem lahko učinkuje na različne bakterije.
English: This means that Ertapenem Hospira was intended to be similar to a ‘reference medicine' already authorised in the European Union called Invanz.
Slovenian: To pomeni, da naj bi bilo zdravilo Ertapenem Hospira podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Invanz.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Ertapenem Hospira could not have been approved for the treatment of infections and for the prevention of infection in colorectal surgery.
Slovenian: Na podlagi pregleda podatkov je Odbor v času umika izrazil določene zadržke in je začasno menil, da zdravila Ertapenem Hospira ni mogoče odobriti za zdravljenje okužb in za preprečevanje okužb pri kolorektalnih kirurških posegih.
English: No further studies were carried out because Ertapenem Hospira is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Invanz.
Slovenian: Niso pa bile opravljene nobene dodatne študije, saj je zdravilo Ertapenem Hospira generično zdravilo, ki se daje z infundiranjem in vsebuje enako zdravilno učinkovino kot referenčno zdravilo Invanz.
English: The active substance in Ertapenem Hospira and Invanz, ertapenem, belongs to a group of antibiotics known as ‘carbapenems'.
Slovenian: Zdravilna učinkovina v zdravilu Ertapenem Hospira, ertapenem, spada v skupino antibiotikov, imenovano „karbapenemi“.
English: Ertapenem Hospira was developed as a ‘generic medicine'.
Slovenian: Zdravilo Ertapenem Hospira je bilo razvito kot „generično zdravilo“.
English: Ertapenem Hospira is an antibiotic medicine that contains the active substance ertapenem.
Slovenian: Ertapenem Hospira je antibiotično zdravilo, ki vsebuje zdravilno učinkovino ertapenem.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal of the application is based on commercial reasons following an evaluation of the current market situation.
Slovenian: Družba je v dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da se je za umik vloge za zdravilo Ertapenem Hospira odločila zaradi poslovnih razlogov po ovrednotenju trenutnih razmer na trgu.
English: Ertapenem Hospira is expected to work in the same way as the reference medicine, Invanz.
Slovenian: Zdravilo Ertapenem Hospira naj bi delovalo na enak način kot referenčno zdravilo Invanz.
English: How does Ertapenem Hospira work?
Slovenian: Kako zdravilo Ertapenem Hospira deluje?
English: What was Ertapenem Hospira expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Ertapenem Hospira uporabljalo?
English: What is Ertapenem Hospira?
Slovenian: Kaj je zdravilo Ertapenem Hospira?
English: • infections in the abdomen;
Slovenian: • trebušnih okužb;
English: Frequency not known (cannot be estimated from the available data)
Slovenian: Pogostnost neznana (ni mogoče oceniti iz razpoložljivih podatkov)
English: The safety database from these studies comprises 923 patients.
Slovenian: Podatkovna baza o varnosti iz teh študij zajema 923 bolnikov.
English: - if you have active cancer.
Slovenian: - če imate aktivnega raka.
English: • Information on pregnancy prevention.
Slovenian: • podatke o preprečevanju nosečnosti.
English: Treatment consists of careful observation and initiation of appropriate supportive measures.
Slovenian: Zdravljenje je sestavljeno iz skrbnega opazovanja in uvedbe ustreznih podpornih ukrepov.
English: Avoid touching your nose, eyes, and other parts of the body.
Slovenian: Ne dotikajte se nosu, oči in drugih delov telesa.
English: Your doctor may need to supervise you more closely.
Slovenian: Morda vas bo moral zdravnik bolj skrbno spremljati.
English: (1) Open the flap on the left end.
Slovenian: (1) Odprite zavihek na levem koncu.
English: You can take them with meals or between meals.
Slovenian: Lahko jih jemljete med obrokom ali med dvema obrokoma.
English: It is important to talk to your doctor if you think you have an infection.
Slovenian: Pomembno je, da se posvetujte z zdravnikom, če menite, da imate okužbo.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 August 2017
Slovenian: Datum prve odobritve: 22. avgust 2017
English: Your doctor will give you guidance on appropriate methods of contraception.
Slovenian: Zdravnik vam bo dal navodila za ustrezne metode kontracepcije.
English: Efficacy in patients with high disease activity
Slovenian: Učinkovitost pri bolnikih z veliko aktivnostjo bolezni
English: Your doctor will tell you what to do if you have to take these medicines.
Slovenian: Zdravnik vam bo povedal, kaj morate storiti, če jemljete ta zdravila.
English: If this is not the case, your treatment will be delayed.
Slovenian: Če niso, bo zdravljenje preloženo.
English: For details, see Tables 1 and 2 below.
Slovenian: Za podrobnosti glejte spodnji preglednici 1 in 2.
English: The primary objective of this study was safety, while efficacy endpoints were exploratory.
Slovenian: Primarni cilj te študije je bila varnost, medtem ko so bili opazovani dogodki glede učinkovitosti eksplorativni.
English: - if you are HIV positive, meaning you are infected with the human immunodeficiency virus (HIV).
Slovenian: - če ste HIV pozitivni, to pomeni, da ste okuženi z virusom humane imunske pomanjkljivosti (HIV).
English: Your doctor will decide if you need to stop treatment or not.
Slovenian: Zdravnik bo odločil, ali morate zdravljenje ustaviti ali ne.
English: Criteria for initiating and continuing therapy
Slovenian: Kriteriji za uvedbo in nadaljevanje terapije
English: Example: if you start your treatment mid April, you take your tablets as shown.
Slovenian: Primer: če zdravljenje začnete sredi aprila, tablete jemljete, kot je prikazano.
English: Table 3 Clinical outcomes in the CLARITY study (96 weeks)
Slovenian: Preglednica 3 Klinični izidi študije CLARITY (96 tednov)
English: The tablets can be taken independent of food intake.
Slovenian: Tablete se lahko jemlje neodvisno od vnosa hrane.
English: There can be overlaps in the effect on your immune system.
Slovenian: Lahko pride do prekrivanj v učinku na vaš imunski sistem.
English: Your doctor will decide the best treatment options for you.
Slovenian: Zdravnik bo odločil o najboljših možnostih zdravljenja za vas.
English: R-Pharm Germany GmbH Heinrich-Mack-Strasse 35 89257 Illertissen Germany
Slovenian: R-Pharm Germany GmbH Heinrich-Mack-Strasse 35 89257 Illertissen Nemčija
English: PML is a serious condition that may lead to severe disability or death.
Slovenian: PML je resno stanje, ki lahko povzroči hudo prizadetost ali smrt.
English: This however does not result in any drug accumulation after once daily dosing as this half-life only accounts for a small portion of the AUC.
Slovenian: Vendar pa to ne povzroči kopičenja zdravila po odmerjanju enkrat na dan, saj predstavlja ta razpolovna doba le majhen delež AUC.