FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF ACTIVE SUBSTANCE(S) 50 micrograms of salmeterol (as xinafoate) and 500 micrograms of fluticasone propionate per actuation
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN v enem odmerku je 50 mikrogramov salmeterola (kot ksinafoat) in 500 mikrogramov flutikazonijevega propionata
English: 60 doses
Slovenian: 10 Diskusov s 60 odmerki
English: One inhalation of 50 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily.
Slovenian: Ena inhalacija 50 mikrogramov salmeterola in 250 mikrogramov flutikazonijevega propionata dvakrat na dan. ali
English: - Muscle cramps.
Slovenian: - Mišični krči.
English: - Hold the Diskus away from your mouth, breathe out as far as is comfortable.
Slovenian: VDIHAVANJE: Pred začetkom uporabe natančno preberite ta del. - Medtem ko Diskus držite še odmaknjen od ust, globoko izdihnite, kolikor je to mogoče, ne da bi bilo neprijetno.
English: Palpitations
Slovenian: Odmerjanje
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLICA
English: There is no incidence of additional adverse events following concurrent administration of the two compounds.
Slovenian: Ni znakov, da bi se po njuni sočasni uporabi pojavljali dodatni neželeni učinki.
English: Belgium GlaxoSmithKline s.a./n.v., Rue du Tilleul 13
Slovenian: Luksemburg GlaxoSmithKline s.a./n.v., Rue du Tilleul 13, B-1332 Genval, Belgija
English: Muscle cramps Arthralgia Myalgia
Slovenian: Salmeterolijev ksinafoat, flutikazonijev propanoat
English: The European Commission granted a marketing authorisation valid throughout the European Union for Celvapan on 4 March 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Celvapan, veljavno po vsej Evropski uniji, izdala 4. marca 2009.
English: One study involved 408 healthy adults, half of whom were over 60 years of age (202 received a full dose of Celvapan, the others a half dose) and the second involved 167 healthy children aged between six months and 17 years (101 received a full dose of Celvapan, the others a half dose).
Slovenian: V eni študiji je sodelovalo 408 zdravih odraslih, od katerih jih je bila polovica starejša od 60 let (202 oseb je prejelo celotni odmerek cepiva Celvapan, drugi samo polovičnega), v drugi pa 167 zdravih otrok v starosti od šest mesecev do 17 let (101 je prejel celotni odmerek cepiva Celvapan,
English: The virus has been inactivated (killed) so that it does not cause any disease.
Slovenian: Virus je bil inaktiviran (uničen), tako da ne povzroča bolezni.
English: A risk management plan has been developed to ensure that Celvapan is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe cepiva Celvapan je bil pripravljen načrt obvladovanja tveganj.
English: The full EPAR for Celvapan 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 Celvapan je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European Public Assessment Report (EPAR) for Celvapan.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Celvapan.
English: It contains influenza (flu) viruses that have been inactivated.
Slovenian: Vsebuje viruse gripe, ki so bili inaktivirani.
English: Celvapan must not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as formaldehyde, benzonase or sucrose.
Slovenian: Cepivo Celvapan se ne sme dajati osebam, ki so imele anafilaktično reakcijo (hudo alergijsko reakcijo) na katero koli sestavino zdravila ali na katero koli izmed snovi v sledeh (v zelo nizkih koncentracijah) v cepivu, npr. formaldehid, benzonazo ali saharozo.
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
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Celvapan, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove
English: What is the risk associated with Celvapan?
Slovenian: Kakšna tveganja so povezana z zdravilom Celvapan?
English: What benefit has Celvapan shown during the studies?
Slovenian: Kakšne koristi je zdravilo Celvapan izkazalo med študijami?
English: In both studies, the full dose of the vaccine was shown to bring about protective levels of antibodies to a satisfactory level in line with the criteria laid down by the CHMP.
Slovenian: V obeh študijah je bilo dokazano, da celotni odmerek zdravila povzroči nastanek zadovoljivih zaščitnih ravni protiteles v skladu z merili, ki jih je določil CHMP.
English: Two main studies have been carried out that looked at the ability of two doses of Celvapan H1N1 given three weeks apart to trigger an immune response.
Slovenian: Izvedeni sta bili dve glavni študiji, v katerih so proučevali, ali dva odmerka cepiva Celvapan H1N1, dana v razmiku treh tednov, lahko sprožita imunski odziv.
English: For more information about treatment with Celvapan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Celvapan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Celvapan is given by injection into the muscle of the shoulder or thigh, as two doses at least three
Slovenian: Cepivo Celvapan se injicira v ramensko ali stegensko mišico v dveh odmerkih v razmiku najmanj treh
English: The CHMP decided that Celvapan's benefits of are greater than its risks and recommended that it be
Slovenian: CHMP je zaključil, da so koristi cepiva Celvapan večje od z njim povezanih tveganj, in priporočil, da se
English: The most common side effects with Celvapan (seen in more than 1 people vaccinated in 10) are headache and fatigue (tiredness).
Slovenian: Najpogostejša neželena učinka cepiva Celvapan (opažena pri več kot 1 cepljeni osebi od 10) sta glavobol in utrujenost.
English: When a person is given the vaccine, the immune system recognises the inactivated virus as ‘foreign' and makes antibodies against it.
Slovenian: Ko oseba prejme cepivo, imunski sistem prepozna inaktivirani virus kot tujek in proti njemu razvije protitelesa.
English: Celvapan is a vaccine.
Slovenian: Zdravilo Celvapan je cepivo.
English: The viruses used in Celvapan are grown in mammal cells (‘vero cells'), as opposed to hen's eggs.
Slovenian: Virusi, uporabljeni pri cepivu Celvapan, so vzgojeni v celicah sesalcev (celicah vero) in ne v kokošjih jajcih.
English: influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated)
Slovenian: cepivo proti gripi (H1N1)v (celoten virion, razmnožen v celicah vero,
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Celvapan, including the appropriate precautions to be followed by healthcare
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti cepiva in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni
English: Celvapan was originally developed as a pandemic vaccine, to be used during the influenza A (H1N1) pandemic declared in June 2009.
Slovenian: Cepivo Celvapan je bilo prvotno pripravljeno kot pandemsko cepivo, ki naj bi se uporabljalo med pandemijo gripe A(H1N1), razglašene junija 2009.
English: How has Celvapan been studied?
Slovenian: Kako je bilo zdravilo Celvapan raziskano?
English: Celvapan is a vaccine that is given by injection.
Slovenian: Zdravilo Celvapan je cepivo za injiciranje.
English: Celvapan contains a flu strain called A/California/07/2009 (H1N1)v.
Slovenian: Cepivo Celvapan vsebuje sev gripe, imenovan A/California/07/2009 (H1N1)v.
English: Celvapan is a vaccine to protect against flu caused by the A (H1N1)v 2009 virus.
Slovenian: Zdravilo Celvapan je cepivo za zaščito pred gripo, ki jo povzroča virus A (H1N1)v 2009.
English: Celvapan contains a virus called A(H1N1)v 2009.
Slovenian: Cepivo Celvapan vsebuje virus A(H1N1) v 2009.
English: Celvapan is given
Slovenian: Cepivo se daje
English: For the full list of all side effects reported with Celvapan, see the
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila
English: The medicine can only be obtained with a prescription.
Slovenian: Zakaj je bilo zdravilo Celvapan odobreno?
English: 28830 San Fernando de Henares (Madrid) Spain
Slovenian: 28830 San Fernando de Henares (Madrid) Španija
English: 20139 Milano Italy
Slovenian: 20139 Milano Italija
English: 19002 Paiania, Greece
Slovenian: 19002 Paiania, Grčija
English: 1110 Wien Austria
Slovenian: 1110 Wien Avstrija
English: 821 02 Bratislava Slovak Republic
Slovenian: 821 02 Bratislava Slovaška Republika
English: Meda Oy Vaisalantie 4 02130 Espoo Finland
Slovenian: Meda Oy Vaisalantie 4 02130 Espoo Finska
English: Unit 34/35, Block A Dunboyne Business Park Dunboyne, Co. Meath Ireland
Slovenian: Unit 34/35, Block A Dunboyne Business Park Dunboyne, Co. Meath Irska
English: BIOPROJET PHARMA 9 Rue Rameau 75002 Paris France
Slovenian: BIOPROJET PHARMA 9 Rue Rameau 75002 Paris Francija
English: 1186 DM Amstelveen The Netherlands
Slovenian: 1186 DM Amstelveen Nizozemska
English: Pipers väg 2A, Box 906 SE-170 09, Solna Sweden
Slovenian: Pipers väg 2A, Box 906 SE-170 09, Solna Švedska
English: Meda Pharma Hungary Kft. Váci út 91.
Slovenian: Madžarska Meda Pharma Hungary Kft. Váci út 91.
English: Denmark Meda AS Solvang 8
Slovenian: Meda AS Solvang 8
English: Adrenalin
Slovenian: Adrenaline
English: Adrenaline Ph. Eur.
Slovenian: Adrenalin Ph. Eur.
English: Belgium Meda Pharma sa-nv Chaussée de la Hulpe 166 1170 Brussels
Slovenian: Meda Pharma sa-nv Chaussée de la Hulpe 166 1170 Brussels Belgija
English: Jankovcova 1569/2c 170 00 Prague Czech Republic
Slovenian: Jankovcova 1569/2c 170 00 Prague Češka Republika
English: DK-3450 Allerød Denmark
Slovenian: DK-3450 Allerød Danska
English: Adrenaline (epinephrine) 1 in 1000 solution for injection BP auto-injector
Slovenian: Adrenalinijev tartrat Adrenaline (epinephrine) 1 in 1000 solution for injection BP auto-injector
English: Czech Republic
Slovenian: Češka Republika
English: List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the Member States
Slovenian: Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila,
English: Adrenalin (hydrochloride)
Slovenian: Adrenalin (hidroklorid)
English: Luxembourg Meda Pharma GmbH&Co.KG Benzstrasse 1
Slovenian: Luksemburg Meda Pharma GmbH&Co.KG Benzstrasse 1
English: Slovak Republic
Slovenian: Slovaška Republika
English: Salisbury SP2 0AH United Kingdom
Slovenian: Salisbury SP2 0AH Združeno Kraljestvo
English: Adrenaline (as adrenaline tartrate)
Slovenian: Adrenalin (kot adrenalinijev tartrat)
English: 1 in 1000 Solution for injection Intramuscular/subcu taneous use
Slovenian: 1 in 1000 raztopina za injiciranje intramuskularna/sub kutana uporaba
English: Epipen auto-injector 0.3mg
Slovenian: Epipen auto-injecto 0.3mg
English: Poland
Slovenian: Polska
English: 1, 61352 Bad Homburg v.d. Höhe Germany
Slovenian: 1, 61352 Bad Homburg v.d. Höhe Nemčija
English: Nepipe Junior mikrogram
Slovenian: Nepipe Junior mikrogram parenteralna uporana
English: Hersholm 2970 Denmark
Slovenian: Hersholm 2970 Danska
English: Adrenalin (tartrate) Jext
Slovenian: Adrenalin (tartrat) Jext
English: 61352 Bad Homburg Germany
Slovenian: 61352 Bad Homburg Nemčija
English: DK-2970 Hørsholm Denmark
Slovenian: DK-2970 Hørsholm Danska
English: Meda Pharma SIA Vienibas gatve 109 Riga, LV-1058 Latvia
Slovenian: Meda Pharma SIA Vienibas gatve 109 Riga, LV-1058
English: Adrenaline tartrate Emerade mikrogram
Slovenian: Adrenalinijev tartrat Emerade mikrogram parenteralna uporana
English: Meda AS Askerveien 61 Postboks 194 1371 Asker Norway
Slovenian: Norveška Meda AS Askerveien 61
English: Epinephrine hydrotartrat
Slovenian: Adrenalinijev hidrotartrat
English: Salisbury SP2 0AH Great Britain
Slovenian: Salisbury SP2 0AH
English: Jext 150 microgram, oplossing voor injectie microgram/ dosis
Slovenian: Jext 150 microgram, oplossing voor injectie microgram/ dosis ntramuskularna uporaba
English: ALK-Abelló AS Bøge Alle 6-8
Slovenian: Norveška ALK-Abelló AS Bøge Alle 6-8
English: ALK ABELLÓ, S/A Bloque Alle, 6-8 DK-2970 Horsholm Denmark
Slovenian: ALK ABELLÓ, S/A Bloque Alle, 6-8 DK-2970 Horsholm Danska
English: Sweden Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton Salisbury SP20AH
Slovenian: Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton Salisbury SP20AH
English: EpiPen jr mikrogram
Slovenian: EpiPen jr mikrogram parenteralna uporana
English: ALK-Abello A/S Bøge Alle 6-8 B.O.BOX 408 2970 Horsholm Denmark
Slovenian: ALK-Abello A/S Bøge Alle 6-8 B.O.BOX 408 2970 Horsholm Danska
English: 2970 Horsholm Denmark
Slovenian: 2970 Horsholm Danska
English: Adrenaline tartrate Jext mikrogram
Slovenian: Adrenalinijev tartrat Jext mikrogram parenteralna uporana
English: Alk Abello A-S Boge Alle 6-8 Hersholm 2970 Denmark
Slovenian: Alk Abello A-S Boge Alle 6-8 Hersholm 2970 Danska
English: Germany Lincoln Medical Ltd. Unit 8 Wilton Buisiness Centre
Slovenian: Lincoln Medical Ltd. Unit 8 Wilton Buisiness Centre
English: EpiPen mikrogram
Slovenian: EpiPen mikrogram parenteralna uporana
English: DK-2970 Horshlom Denmark
Slovenian: DK-2970 Horshlom Danska
English: Nepipe mikrogram
Slovenian: Nepipe mikrogram parenteralna uporana
English: Adrenaline tartrate Jext 300 microgramos solución inyectable en pluma precargada
Slovenian: Adrenalinijev tartrat Jext 300 microgramos solución inyectable en pluma precargada
English: Luxembourg Lincoln Medical Ltd. Unit 8, Wilton Business Centre, Wilton
Slovenian: Luksemburg Lincoln Medical Ltd. Unit 8, Wilton Business Centre, Wilton
English: Luxembourg Alk Abello A/S Boge Alle 6-8
Slovenian: Luksemburg Alk Abello A/S Boge Alle 6-8
English: Adrenaline tartrate Jext
Slovenian: Adrenalinijev tartrat Jext
English: DK-2970 Horsholm Denmark
Slovenian: DK-2970 Horsholm Danska
English: 165 mcg Solution for injection in a prefilled injector
Slovenian: 165 mcg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Sweden ALK-Abelló A/S Boge Allé 6-8 DK-2970 Horsholm
Slovenian: ALK-Abelló A/S Boge Allé 6-8 DK-2970 Horsholm
English: Alk Abello A/S Boge Alle 6-8 2970 Horsholm Denmark
Slovenian: Alk Abello A/S Boge Alle 6-8 2970 Horsholm Danska
English: Meda Pharma GmbH & Co. KG
Slovenian: MEDA Pharma GmbH & Co.
English: MEDA Pharma GmbH & Co. KG
Slovenian: Meda Pharma GmbH & Co.
English: Adrenaline tartrate Jext 300 micrograms solution for injection in pre-filled pen micrograms
Slovenian: Adrenalinijev tartrat Jext 300 micrograms solution for injection in pre-filled pen micrograms
English: 0,3 mg/dose Solution for injection Intramuscular use
Slovenian: 0,3 mg/dose raztopina za injiciranje
English: Germany MEDA Pharma GmbH & Co. KG
Slovenian: Romunija MEDA Pharma GmbH & Co.
English: Adrenaline tartrate Jext 150 micrograms solution for injection in pre-filled pen micrograms
Slovenian: Adrenalinijev tartrat Jext 150 micrograms solution for injection in pre-filled pen micrograms
English: 150 mcg Solution for infusion Intramuscular use
Slovenian: 150 mcg raztopina za injiciranje
English: 300 mcg Solution for infusion Intramuscular use
Slovenian: 300 mcg raztopina za injiciranje
English: Slovenia
Slovenian: Litva
English: 300 microg Solution for injection Intramuscular use
Slovenian: 300 microg raztopina za injiciranje
English: Adrenalinum bítartrat (Epinephrinum bítartrat)
Slovenian: Adrenalinijev bítartrat
English: Denmark ALK-Abello A/S Bøge Alle 6-8
Slovenian: ALK-Abello A/S Bøge Alle 6-8
English: 0,15 mg/3ml Solution for injection Intramuscular use
Slovenian: 0,15 mg/3ml raztopina za injiciranje
English: Adrenaline tartrate Emerade 500 micrograms solution for injection in pre-filled pen micrograms
Slovenian: Adrenalinijev tartrat Emerade 500 micrograms solution for injection in pre-filled pen micrograms
English: Sweden ALK-Abelló A/S Boge Allé 6-8
Slovenian: Nizozemska ALK-Abelló A/S Boge Allé 6-8
English: 330 mcg Solution for injection in a prefilled injector
Slovenian: 330 mcg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: MEDA PHARMA S.P.A. Viale Brenta 18
Slovenian: Viale Brenta 18
English: Lithuania Lincoln Medical Ltd Unit 8, Wilton Business Centre
Slovenian: Madžarska Lincoln Medical Ltd Unit 8, Wilton Business Centre
English: 150 microg Solution for injection Intramuscular use
Slovenian: 150 microg raztopina za injiciranje
English: 0,5 mg/ 1 ml Solution for injection Intramuscular use
Slovenian: 0,5 mg/ 1 ml raztopina za injiciranje
English: Adrenaline tartrate Emerade 300 micrograms solution for injection in pre-filled pen micrograms
Slovenian: Adrenalinijev tartrat Emerade 300 micrograms solution for injection in pre-filled pen micrograms
English: Adrenaline tartrate Emerade 150 micrograms solution for injection in pre-filled pen micrograms
Slovenian: Adrenalinijev tartrat Emerade 150 micrograms solution for injection in pre-filled pen micrograms
English: 0,15 mg Solution for injection Intramuscular use
Slovenian: 0,15 mg raztopina za injiciranje
English: Jext 150 mikrogramov 150 µg/dose Solution for injection in pre-filled pen
Slovenian: Jext 150 mikrogramov 150 µg/dose raztopina za injiciranje v napolnjenem peresniku
English: Anapen 300 micrograms in 0.3ml solution for injection in a pre-filled syringe micrograms in 0.3ml solution
Slovenian: Anapen 300 micrograms in 0.3ml solution for injection in a pre-filled syringe micrograms in 0.3ml solution raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Lincoln Medical limited Unit 8 Wilton Business Centre Wilton
Slovenian: Norveška Lincoln Medical limited Unit 8 Wilton Business Centre Wilton
English: Denmark Lincoln Medical Ltd Unit 8 Wilton Business Centre
Slovenian: Slovenija Lincoln Medical Ltd Unit 8 Wilton Business Centre
English: Anapen 150 micrograms/0,3 ml solution for injection in pre-filled syringe micrograms/ 0,3 ml
Slovenian: Anapen 150 micrograms/0,3 ml solution for injection in pre-filled syringe micrograms/ 0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
English: ANAPEN 300 mikrogramm/0,3 ml oldatos injekció előretöltött fecskendőben microgramm /0,3 ml
Slovenian: ANAPEN 300 mikrogramm/0,3 ml oldatos injekció előretöltött fecskendőben microgramm /0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Jext 300 mikrogramov 300 µg/dose Solution for injection in pre-filled pen
Slovenian: Jext 300 mikrogramov 300 µg/dose raztopina za injiciranje v napolnjenem peresniku
English: Anapen 300 micrograms/0,3 ml solution for injection in pre-filled syringe micrograms/ 0,3 ml
Slovenian: Anapen 300 micrograms/0,3 ml solution for injection in pre-filled syringe micrograms/ 0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
English: 0.15 mg Solution for injection Intramuscular use
Slovenian: 0.15 mg raztopina za injiciranje
English: Adrenaline tartrate Jext 150 microgramos solución inyectable en pluma precargada
Slovenian: Jext 150 microgramos solución inyectable en pluma precargada
English: ANAPEN JUNIOR 150 mikrogramm/0,3 ml oldatos injekció előretöltött fecskendőben microgramm /0,3 ml
Slovenian: ANAPEN JUNIOR 150 mikrogramm/0,3 ml oldatos injekció előretöltött fecskendőben microgramm /0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Epinephrine Bitartrate
Slovenian: Adrenalinijev Bitartrat
English: 150 mcg Solution for injection, prefilled pen
Slovenian: 150 mcg raztopina za injiciranje, napolnjen peresnik
English: Adults, including the elderly
Slovenian: Odrasli, vključno s starejšimi
English: These include:
Slovenian: Med takšnimi so:
English: Not known (frequency cannot be estimated from the available data).
Slovenian: Ni znano (pogostnosti ni mogoče oceniti na podlagi podatkov, ki so na voljo).
English: Date of first authorisation: 22 March 2018
Slovenian: Datum prve odobritve: 22. marec 2018
English: Treatment was discontinued on study exit (Day 365).
Slovenian: Zdravljenje se je prenehalo ob izhodu iz študije (365. dan).
English: Do not give this medicine to children and adolescents under 18 years of age.
Slovenian: Tega zdravila ne dajajte otrokom in mladostnikom, mlajšim od 18 let.
English: Hypokalaemia may be observed (see section 4.8).
Slovenian: Lahko se pojavi hipokaliemija (glejte poglavje 4.8).
English: In addition, clinical studies have shown it not to be systemically absorbed.
Slovenian: Poleg tega so klinične študije pokazale, da se ne absorbira sistemsko.
English: • Try to take Lokelma at the same time each day.
Slovenian: • Zdravilo Lokelma poskusite vzeti vsak dan ob istem času.
English: To open, cut across top.
Slovenian: Za odprtje prerežite na vrhu.
English: The white powder will settle in the glass quickly.
Slovenian: Beli prašek se v kozarcu hitro sesede.
English: Do not use this medicine during pregnancy because there is no information on its use in pregnancy.
Slovenian: Ne uporabljajte tega zdravila med nosečnostjo, ker o njegovi uporabi med nosečnostjo ni informacij.
English: • Then take the next dose as usual at your normal time.
Slovenian: • Naslednji običajni odmerek vzemite kot po navadi.
English: • Do not take this starting dose for more than three days.
Slovenian: • Tega začetnega odmerka ne jemljite več kot tri dni.
English: • diuretics (medicines that increase urine production)
Slovenian: • diuretiki (zdravila, ki povečajo nastajanje urina)
English: • This is to make sure you are getting the correct dose.
Slovenian: • Tako se bosta prepričala, da prejemate ustrezen odmerek.
English: • You can take this medicine with or without meal.
Slovenian: • To zdravilo lahko vzamete s hrano ali brez nje.
English: It should be ensured that all of the content is taken.
Slovenian: Zagotoviti je treba, da bolnik zaužije celotno vsebino.
English: NS: not significant
Slovenian: NZ: neznačilno
English: No dietary restrictions were imposed; patients were instructed to continue their usual diet without any specified alterations.
Slovenian: Prehranskih omejitev ni bilo; bolnikom je bilo naročeno, naj nadaljujejo svojo običajno prehrano brez specifičnih sprememb.
English: If this happens, stir the liquid again and drink it all up.
Slovenian: Če se to zgodi, tekočino spet premešajte in jo vso popijte.
English: No consistent effect on systolic and diastolic blood pressure has been observed.
Slovenian: Doslednega učinka na sistolični ali diastolični krvni tlak niso opazili.
English: • The medicine takes one to two days to work.
Slovenian: • Da zdravilo začne delovati, sta potrebna dan ali dva.
English: Do not reduce the dose of this medicine or stop taking it without talking to the doctor who prescribed it.
Slovenian: Ne zmanjšajte odmerka tega zdravila in ne prenehajte ga jemati, ne da bi se posvetovali z zdravnikom, ki vam ga je predpisal.
English: In addition, two open-label maintenance studies tested long-term safety of Lokelma.
Slovenian: Poleg tega sta dve odprti vzdrževalni študiji preverjali dolgoročno varnost zdravila Lokelma.
English: The safety and efficacy of Lokelma in children and adolescents (< 18 years) have not been established.
Slovenian: Varnost in učinkovitost zdravila Lokelma pri otrocih in mladostnikih (< 18 let) nista bili dokazani.
English: Due to these factors and its insolubility, no in vivo or in vitro studies have been performed to examine its effect on cytochrome P450 (CYP450) enzymes or transporter activity.
Slovenian: Zaradi teh dejavnikov in njegove netopnosti niso izvedli in vivo ali in vitro študij za proučitev njegovega vpliva na encime citokroma P450 (CYP450) ali aktivnost prenašalcev.
English: The powder will not dissolve.
Slovenian: Prašek se ne raztopi.