FrancophonIA/ELRC3.0 huggingface dataset:
English: Interaction with other medicinal products and other forms of interaction: Inform your veterinary surgeon if your dog is using other medicines.
Slovenian: Obvestite svojega veterinarja, če vaš pes dobiva druga zdravila.
English: Before dosing make sure that the ringstop is locked.
Slovenian: Zaklenite zaporni obroček tako, da ga zasukate stran od sebe. Pred odmerjanjem se prepričajte, da je zaporni obroček zaklenjen.
English: NOT SWALLOWED
Slovenian: NI ZAUŽITJA
English: No measurable concentrations were found after gastro-intestinal gavage of dexmedetomidine to dogs.
Slovenian: Po dajanju deksmedetomidina psom s sondo za hranjenje niso ugotovili merljivih koncentracij zdravila.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE, ODGOVOREN ZA SPROŠČANJE SERIJE
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Slovenian: POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
English: FI-02200 Espoo FINLAND Tel.: +358 10 4261
Slovenian: FINSKA Tel.: +358 10 4261
English: The Sileo oral syringe is capable of delivering the product in 0.25 ml increments.
Slovenian: Z oralno brizgo za zdravilo Sileo se lahko zdravilo odmerja v korakih po 0,25 ml. Vsak korak označuje ena pika na batu.
English: EU/2/11/136/001 TruScient 0.66 mg Kit for implant
Slovenian: EU/2/11/136/001 TruScient 0,66 mg Komplet za implantacijo
English: 1 vial + 1 vial + 2 sterile matrices syringes needles
Slovenian: 1 viala + 1 viala + 2 sterilni matrica + 3 brizge + 3 brizge
English: Kit
Slovenian: Komplet
English: Packaging Content (Concentration)
Slovenian: Ovojnina Vsebina Velikost pakiranja
English: Withdrawal period
Slovenian: Periostalna uporaba
English: Janumet is taken twice a day.
Slovenian: Zdravilo Janumet se jemlje dvakrat na dan.
English: It is used in addition to diet and exercise in the following ways:
Slovenian: Uporablja se kot dodatek k dieti in telesni vadbi na naslednje načine:
English: Metformin has been available in the EU since the 1950s.
Slovenian: V EU je na voljo od petdesetih let prejšnjega stoletja.
English: Other information about Janumet
Slovenian: Druge informacije o zdravilu Janumet
English: The European Commission granted a marketing authorisation valid throughout the EU for Janumet on 16 July 2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Janumet, veljavno po vsej Evropski uniji, odobrila dne 16. julija 2008.
English: The full EPAR for Janumet 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 Janumet je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The maximum dose of sitagliptin is 100 mg a day.
Slovenian: Najvišji dovoljeni odmerek sitagliptina je 100 mg na dan.
English: Sitagliptin is a dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Slovenian: Sitagliptin je zaviralec dipeptidil-peptidaze-4 (DPP-4).
English: There was no difference in this effect between the patients also taking metformin and those not taking it.
Slovenian: Nobenih razlik ni bilo opaziti med bolniki, ki so jemali tudi metformin, in med tistimi, ki ga niso.
English: What benefit has Janumet shown during the studies?
Slovenian: Kakšne koristi je zdravilo Janumet izkazalo med študijami?
English: This is a summary of the European public assessment report (EPAR) for Janumet.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Janumet.
English: For more information about treatment with Janumet, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Janumet preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Janumet sitagliptin / metformin hydrochloride
Slovenian: Janumet sitagliptin/metforminijev klorid
English: It must also not be used in patients who consume excessive amounts of alcohol or are alcoholic, or in women who are breast-feeding.
Slovenian: Prav tako se ne sme uporabljati pri bolnikih, ki prekomerno uživajo alkohol ali so alkoholiki, ali pri doječih ženskah.
English: Sitagliptin has been authorised in the European Union (EU) as Januvia and Xelevia since 2007, and as Tesavel since 2008.
Slovenian: V Evropski uniji je od leta 2007 odobren pod imenoma Januvia in Xelevia, od leta 2008 pa pod imenom Tesavel.
English: The most common side effect with Janumet (seen in between 1 and 10 patients in 100) is nausea (feeling sick).
Slovenian: Najpogostejši neželeni učinek zdravila Janumet (opažen pri 1 do 10 bolnikih od 100) je navzeja (slabost).
English: The strength of tablet to use depends on the dose of the other antidiabetes medicines that the patient was taking before.
Slovenian: Jakost tablete, ki jo je treba uporabiti, je odvisna od odmerkov drugih zdravil za zdravljenje sladkorne bolezni, ki jih je bolnik jemal prej.
English: • in patients who are already taking a combination of sitagliptin and metformin as separate tablets;
Slovenian: • pri bolnikih, ki že jemljejo kombinacijo sitagliptina in metformina v obliki ločenih tablet;
English: The results of three further studies were used to support the use of Janumet.
Slovenian: V podporo uporabi zdravila Janumet so bili uporabljeni rezultati treh nadaljnjih študij.
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 Janumet.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Janumet, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: It is available as tablets (50 mg sitagliptin / 850 mg metformin hydrochloride; and 50 mg sitagliptin / 1,000 mg metformin hydrochloride).
Slovenian: Na voljo je v obliki tablet (50 mg sitagliptina/850 mg metforminijevega klorida in 50 mg sitaglipina/1 000 mg metforminijevega klorida).
English: The effectiveness of adding sitagliptin to metformin was similar to that of adding glipizide.
Slovenian: Učinkovitost dodajanja sitagliptina k metforminu je bila podobna kot pri dodajanju glipizida.
English: It must not be used in patients who have diabetic ketoacidosis or pre-coma (dangerous conditions that can occur in diabetes), problems with the kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack.
Slovenian: Prav tako se ne sme uporabljati pri bolnikih, ki imajo diabetično ketoacidozo, predkomo (nevarno stanje, ki se lahko pojavi pri sladkorni bolezni), težave z ledvicami in jetri, obolenja, ki lahko prizadenejo ledvice, ali obolenja, ki povzročajo zmanjšano oskrbo tkiv s kisikom, kot so srčno popuščanje, težave s pljuči ali nedavni srčni napad.
English: CHMP decided that Janumet's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Janumet večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: This study also compared the effects of adding sitagliptin or placebo.
Slovenian: V tej študiji so proučevali tudi učinek dodajanja sitagliptina ali placeba.
English: What is the risk associated with Janumet?
Slovenian: Kakšna tveganja so povezana z zdravilom Janumet?
English: In all of the studies, the main measure of effectiveness was the change in the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Slovenian: V vseh študijah je bilo glavno merilo učinkovitosti sprememba količine snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), ki kaže, kako dobro je glukoza v krvi nadzorovana.
English: Janumet must not be used in people who are hypersensitive (allergic) to sitagliptin, metformin or any of the other ingredients.
Slovenian: Zdravila Janumet ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) sitagliptin, metformin ali katero koli drugo sestavino zdravila.
English: The company carried out additional studies to show that the active substances in Janumet are absorbed by the body in the same way as the two medicines given separately.
Slovenian: Družba je opravila še nadaljnje študije, da bi dokazala, da telo zdravilni učinkovini zdravila Janumet absorbira na enak način, kot če sta vzeti v obliki ločenih zdravil.
English: Janumet is a medicine that contains two active substances, sitagliptin and metformin hydrochloride.
Slovenian: Janumet je zdravilo, ki vsebuje dve zdravilni učinkovini, sitagliptin in metforminijev klorid.
English: Janumet should be taken with food to avoid any stomach problems caused by metformin.
Slovenian: Zdravilo Janumet je treba jemati sočasno s hrano, da se preprečijo želodčne težave, ki jih povzroča metformin.
English: If Janumet is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered, to avoid hypoglycaemia (low blood sugar levels).
Slovenian: Če se zdravilo Janumet jemlje skupaj s sulfonilsečnino ali insulinom, bo morda treba odmerek sulfonilsečnine ali insulina zmanjšati, da ne bi prišlo do hipoglikemije (nizke ravni sladkorja v krvi).
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Slovenian: Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka ne tvori dovolj insulina za vzdrževanje primerne ravni glukoze v krvi ali pri kateri telo tega ne more učinkovito izrabljati.
English: Janumet is used in patients with type 2 diabetes to improve the control of blood glucose (sugar) levels.
Slovenian: Zdravilo Janumet se uporablja za zdravljenje bolnikov s sladkorno boleznijo tipa 2 za izboljšanje nadzora nad ravnmi glukoze (sladkorja) v krvi.
English: Why has Janumet been approved?
Slovenian: Zakaj je bilo zdravilo Janumet odobreno?
English: The third included 641 patients who were not satisfactorily controlled on a stable dose of insulin, three-quarters of whom were also taking metformin.
Slovenian: V tretjo študijo je bilo vključenih 641 bolnikov, pri katerih s stalnim odmerkom insulina niso mogli vzpostaviti zadovoljivega nadzora, od katerih jih je tri četrtine prejemalo tudi metformin.
English: As a result of the action of both active substances, blood glucose levels are reduced and this helps to control type 2 diabetes.
Slovenian: Kot posledica delovanja obeh zdravilnih učinkovin se raven glukoze v krvi zniža, kar prispeva k uravnavanju sladkorne bolezni tipa 2.
English: These hormones are released after a meal and stimulate the pancreas to produce insulin.
Slovenian: Ti hormoni se sproščajo po obroku in spodbujajo trebušno slinavko k tvorjenju insulina.
English: The first included 1,091 patients who were not satisfactorily controlled on diet and exercise alone and compared the effect of Janumet with that of metformin or sitagliptin alone.
Slovenian: V prvo je bilo vključenih 1 091 bolnikov, pri katerih zadosten nadzor ni bil dosežen zgolj z dieto in telesno vadbo, v njej pa so primerjali učinke zdravila Janumet z učinki metformina ali sitagliptina, uporabljenih kot samostojni zdravili.
English: The second included 278 patients who were not satisfactorily controlled on the combination of metformin and rosiglitazone (a PPAR-gamma agonist) and compared the effects of adding sitagliptin or placebo.
Slovenian: V drugo študijo je bilo vključenih 278 bolnikov, pri katerih s kombinacijo metformina in rosiglitazona (agonista PPAR gama) niso mogli vzpostaviti zadostnega nadzora, v njej pa so primerjali učinke dodajanja sitagliptina ali placeba.
English: Two of the studies looked at sitagliptin as an add-on to metformin: the first compared it with placebo (a dummy treatment) in 701 patients, and the second compared it with glipizide (a sulphonylurea) in 1,172 patients.
Slovenian: V dveh od teh študij so proučevali sitagliptin kot dodatek k metforminu: v prvi so ga pri 701 bolniku primerjali s placebom (zdravilom brez zdravilne učinkovine), v drugi pa z glipizidom (sulfonilsečnino) pri 1 172 bolnikih.
English: In the first of the three further studies, Janumet was more effective than metformin or sitagliptin alone.
Slovenian: V prvi od treh dodatnih študij je bilo zdravilo Janumet učinkovitejše od metformina ali sitagliptina, uporabljenih kot samostojni zdravili.
English: The active substances in Janumet, sitagliptin and metformin hydrochloride, each have a different mode of action.
Slovenian: Zdravilni učinkovini v zdravilu Janumet, sitagliptin in metforminijev klorid, imata različna načina delovanja.
English: By increasing the levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Slovenian: Sitagliptin s povečanjem ravni inkretinskih hormonov v krvi spodbudi trebušno slinavko k tvorjenju večjih količin insulina, kadar so ravni krvnega sladkorja previsoke.
English: • in patients who are not satisfactorily controlled on metformin (an antidiabetes medicine) used on its own;
Slovenian: • pri bolnikih, pri katerih sladkorna bolezen ni zadostno nadzorovana zgolj z metforminom (zdravilom proti sladkorni bolezni);
English: For the full list of all side effects reported with Janumet, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Janumet, glejte navodilo za uporabo.
English: Sitagliptin on its own as Januvia/Xelevia/Tesavel can be used with metformin, and with both metformin and a sulphonylurea, in type 2 diabetes patients.
Slovenian: Sitagliptin kot samostojno zdravilo, ki je na voljo pod imeni Januvia, Xelevia in Tesavel, se lahko pri bolnikih s sladkorno boleznijo tipa 2 uporablja skupaj z metforminom ter hkrati z metforminom in sulfonilsečnino.
English: Janumet was more effective than metformin alone.
Slovenian: Zdravilo Janumet je bilo učinkovitejše od metformina, uporabljenega kot samostojno zdravilo.
English: What is Janumet used for?
Slovenian: Za kaj se zdravilo Janumet uporablja?
English: The third study compared sitagliptin with placebo, when used as an add-on to glimepiride (another sulphonylurea), with or without metformin, in 441 patients.
Slovenian: V tretji študiji so pri 441 bolnikih sitagliptin primerjali s placebom, ki so ga uporabili kot dodatek h glimepiridu (drugi vrsti sulfonilsečnine) z metforminom ali brez njega.
English: The company presented the results of three studies of Januvia/Xelevia to support the use of Janumet in patients who were not satisfactorily controlled on their existing metformin treatment.
Slovenian: Družba je v podporo uporabi zdravila Janumet pri bolnikih, pri katerih obstoječe zdravljenje z metforminom bolezni ni zadostno za nadzor bolezni, predstavila rezultate treh študij z zdraviloma Januvia in Xelevia.
English: Adding 100 mg sitagliptin to metformin reduced HbA1c levels by 0.67% (from around 8.0%) after 24 weeks, compared with a fall of 0.02% in the patients adding placebo.
Slovenian: Z dodajanjem 100 mg sitagliptina k metforminu so se ravni HbA1c po 24 tednih znižale za 0,67 % (z okoli 8,0 %) v primerjavi z 0,02-odstotnim znižanjem pri bolnikih, ki so kot dodatek prejemali placebo.
English: In the study in which sitagliptin was added to glimepiride and metformin, the levels of HbA1c were reduced by 0.59% after 24 weeks, compared with an increase of 0.30% in the patients adding placebo.
Slovenian: V študiji, pri kateri so sitagliptin dodajali glimepiridu in metforminu, so se ravni HbA1c po 24 tednih znižale za 0,59 % v primerjavi z 0,30-odstotnim povečanjem pri bolnikih, ki so kot dodatek prejemali placebo.
English: How has Janumet been studied?
Slovenian: Kako je bilo zdravilo Janumet raziskano?
English: In the second, HbA1c levels were reduced by 1.03% after 18 weeks in patients adding sitagliptin to metformin and rosiglitazone, compared with a fall of 0.31% in those adding placebo.
Slovenian: V drugi študiji so se po 18 tednih ravni HbA1c znižale za 1,03 % pri bolnikih, ki so sitagliptin dodajali metforminu in rosiglitazonu, v primerjavi z 0,31-odstotnim znižanjem pri tistih, ki so kot dodatek prejemali placebo.
English: How is Janumet used?
Slovenian: Kako se zdravilo Janumet uporablja?
English: What is Janumet?
Slovenian: Kaj je zdravilo Janumet?
English: How does Janumet work?
Slovenian: Kako zdravilo Janumet deluje?
English: Finally, they were reduced by 0.59% after 24 weeks in patients adding sitagliptin to insulin, compared with a fall of 0.03% in those adding placebo.
Slovenian: V zadnji študiji pa so se ravni HbA1c po 24 tednih znižale za 0,59 % pri bolnikih, ki so insulinu dodajali sitagliptin, v primerjavi z 0,03-odstotnim znižanjem pri bolnikih, ki so kot dodatek prejemali placebo.
English: • in combination with a sulphonylurea, a PPAR-gamma agonist such as a thiazolidinedione, or insulin
Slovenian: • v kombinaciji s sulfonilsečnino, agonistom PPAR gama, kot je tiazolidinedion, ali insulinom (tj. drugimi vrstami zdravil proti sladkorni bolezni) pri bolnikih, pri katerih bolezen ni zadostno nadzorovana s kombinacijo enega od teh zdravil in metformina.
English: Article 34 of Directive 2001/82/EC, as amended.
Slovenian: Člen 34 Direktive 2001/82/ES, kakor je bila spremenjena.
English: London, 15 October 2009 EMEA/608931/2009
Slovenian: London, 15. oktobra 2009 EMEA/608931/2009
English: The Committee appointed Dr C. Rubio Montejano as rapporteur and Dr L. Jodkonis as co-rapporteur.
Slovenian: Odbor je imenoval dr. C. Rubio Montejano za poročevalko, dr. L. Jodkonisa pa za soporočevalca.
English: The referral procedure started on 16 July 2008.
Slovenian: Napotitveni postopek se je začel 16. julija 2008.
English: The final opinion was converted into a Decision by the European Commission on 15 October 2009.
Slovenian: Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 15. oktobra 2009.
English: A revised Opinion, necessitated by purely administrative changes, was adopted in July 2009.
Slovenian: Revidirano mnenje, potrebno zaradi administrativnih sprememb, je bilo sprejeto julija 2009.
English: Written explanations were provided by the Marketing Authorisation Holders on 15 January 2009 and supplementary information was submitted on 16 March 2009.
Slovenian: Imetniki dovoljenja za promet z zdravilom so pisna pojasnila predložili 15. januarja 2009, dodatne informacije pa 16. marca 2009.
English: Marketing Authorisations for three different strengths (40g, 100g and 200g per kg) were granted in 19 Member States of the European Union via different authorisation procedures (mutual recognition procedures or national procedures).
Slovenian: Dovoljenja za promet z zdravilom za tri različne jakosti (40 g, 100 g in 200 g na kg) so bila odobrena v 19 državah članicah Evropske unije z različnimi postopki izdaje dovoljenja (postopki z medsebojnim priznavanjem ali nacionalnimi postopki).
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended Summary of Product Characteristics and labelling in the Annex III
Slovenian: Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II, skupaj s spremenjenim povzetkom glavnih značilnosti zdravila in označevanjem v Dodatku III.
English: Due to divergences (i.e. indications for use, amount to be administered and withdrawal period) amongst the nationally authorised Summary of Product Characteristics for Pulmotil 40 VET Premix, Pulmotil 100 VET Premix and Pulmotil 200 VET Premix, Belgium referred the matter to the EMEA on 3 July 2008, under Article 34 of Directive 2001/82/EC.
Slovenian: Zaradi razlik (tj. v indikacijah za uporabo, količinah, ki jo je treba vzeti, in karencah) med nacionalno odobrenimi povzetki glavnih značilnosti zdravil Pulmotil 40 VET Premix, Pulmotil 100 VET Premix in Pulmotil 200 VET Premix je Belgija 3. julija 2008 zadevo napotila na agencijo EMEA v skladu s členom 34 Direktive 2001/82/ES.
English: Based on evaluation of currently available data and the rapporteur's assessment report, the CVMP considered that the benefit/risk profile of Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated names is positive subject to the recommended changes of the Summary of the Product Characteristics and product information and therefore adopted an Opinion in May 2009 recommending amendments of the Marketing Authorisations.
Slovenian: Na podlagi ocene trenutno dostopnih podatkov in poročevalčevega poročila o oceni je Odbor za zdravila za uporabo v veterinarski medicini (CVMP) menil, da je razmerje med koristmi in tveganji zdravil Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix in z njimi povezanih imen pozitivno, ob upoštevanju priporočenih sprememb povzetka glavnih značilnosti zdravila in informacij o zdravilu, zato je maja 2009 sprejel mnenje, s katerim je priporočil spremembo dovoljenj za promet.
English: Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated names are premixes for medicated feeding stuff whose active ingredient is tilmicosin which is a chemically modified macrolide antibiotic with properties broadly similar to other macrolides.
Slovenian: Zdravila Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix in z njimi povezana imena so predmešanica za izdelavo medicirane krme, katere zdravilna učinkovina je tilmikozin, ki je kemijsko prilagojen makrolidni antibiotik z lastnostmi, ki so precej podobne drugim makrolidom.
English: REFERRAL Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated names
Slovenian: MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 341 za zdravila Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix in z njimi povezana imena
English: Oral explanations were given by the Marketing Authorisation Holders 15 April 2009.
Slovenian: Ustna pojasnila so podali 15. aprila 2009.
English: Strength Pharmaceutical Form Route of Administration Packaging
Slovenian: Številka EU ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja o ā
English: Austria, Belgium, Bulgaria, Czech Republic, Estonia, Finland, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden and United Kingdom: Kytril Germany: Kevatril
Slovenian: Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni: Avstrija, Belgija, Bolgarija, Češka republika, Estonija, Finska, Francija, Grčija, Madžarska, Irska, Italija, Latvija, Litva, Luksemburg, Malta, Nizozemska, Portugalska, Romunija, Slovaška republika, Slovenija, Španija, Švedska, Velika Britanija: Kytril
English: Frequency categories are as follows:
Slovenian: Razvrstitve pogostnosti so naslednje:
English: Your doctor will monitor your condition.
Slovenian: Zdravnik bo vaše stanje spremljal.
English: If you notice the following problem you must see a doctor straight away:
Slovenian: Če opazite naslednje težave, morate takoj obiskati zdravnika:
English: Plasma protein binding is approximately 65%.
Slovenian: Vezava na beljakovine v plazmi znaša približno 65 %.
English: ATC code: A04AA02
Slovenian: Oznaka ATC: A04AA02
English: Do not take a double dose to make up for a forgotten tablet.
Slovenian: Ne vzemite dvojnega odmerka, da bi nadoknadili pozabljeni odmerek.
English: Currently available data are described in section 5.1, but no recommendation on a posology can be made.
Slovenian: Trenutno dostopni podatki so opisani v poglavju 5.1, vendar pa priporočil o odmerjanju ni mogoče dati.
English: Children will be given a maximum of 2 doses a day, at least 10 minutes apart.
Slovenian: Otroci bodo prejeli največ 2 odmerka na dan v vsaj 10 minutnem presledku.