natgillin/translations-raw huggingface dataset:
Therefore, monitoring of temperature and measures to lower the fever (such as antipyretic medication as seems clinically necessary) are recommended in young children (e.g. up to approximately 6 years of age) post- vaccination.
Zato je mlajšim otrokom (npr. do približno 6. leta starosti) po cepljenju priporočljivo kontrolirati telesno temperaturo in uporabiti ukrepe za znižanje zvišane telesne temperature (npr. antipiretična zdravila, če se zdi klinično potrebno).
Therefore, monitoring of the INR during co-administration with warfarin is recommended.
Zato med sočasno uporabo varfarina priporočajo spremljanje INR.
Therefore, no adjustment is necessary for oral dosing for patients with mild to severe renal impairment (see section 5.2).
Zato pri bolnikih z blago do hudo ledvično okvaro peroralnega odmerjanja ni treba prilagajati (glejte poglavje 5.2).
Therefore, no dose adjustment and no additional monitoring are required for renally-impaired COPD patients.
Zaradi tega za bolnike s KOPB in ledvično okvaro ni potrebno prilagajanje odmerka.
Therefore, no dose adjustment for lumacaftor/ivacaftor are recommended for mild or moderate renal impairment.
Zato pri blagi ali zmerni okvari ledvic ne priporočajo nikakršnih prilagoditev odmerkov lumakaftorja/ivakaftorja.
Therefore, no dose adjustment is necessary for patients with mild hepatic impairment.
Zato pri bolnikih z blago okvaro jeter prilagajanje odmerka ni potrebno.
Therefore, no dose adjustment is needed in elderly patients except in those with creatinine clearance of 30-50 ml/min (see sections 4.2 and 4.3).
Iz tega razloga prilagoditev odmerka pri starejših bolnikih ni potrebna, razen pri tistih, ki imajo očistek kreatinina od 30-50 ml/min (glejte poglavji 4.2 in 4.3).
Therefore, no dose adjustment is recommended.
Prilagajanja odmerka ne priporočamo.
Therefore, no dose adjustment is required in patients with creatinine clearance above 30 ml/min.
Pri bolnikih s kreatininskim očistkom, večjim od 30 ml/min, odmerka ni treba prilagajati.
Therefore, no dose adjustment of alogliptin is necessary for patients with mild to moderate hepatic impairment (Child-Pugh scores of 5 to 9).
Child-Pugh-u od 5 do 9) odmerka alogliptina ni treba prilagajati.
Therefore, no dose adjustment of alogliptin is necessary for patients with mild to moderate hepatic impairment (Child-Pugh scores of to 9).
Child-Pugh-u od 5 do 9) odmerka alogliptina ni treba prilagajati.
Therefore, no dose adjustment of CYP2C8 substrates such as rosiglitazone is necessary.
Zato prilagajanje odmerkov substratov CYP2C8, na primer rosiglitazona, ni potrebno.
Therefore, no dose adjustment of CYP2D6 substrates such as desipramine is necessary.
Zato prilagajanje odmerkov substratov CYP2D6, na primer desipramina, ni potrebno.
Therefore, no increase in exposure of CYP3A4 substrates is anticipated when combining them with Jakavi.
Pri sočasni uporabi z zdravilom Jakavi se tako ne pričakuje povečane izpostavljenosti substratom za CYP3A4.
Therefore, no information is available about the penetration of anidulafungin into the cerebrospinal fluid (CSF) and/or across the blood-brain barrier.
Zato ni na voljo informacij o prodiranju anidulafungina v cerebrospinalni likvor in/ali prehajanje skozi krvno-možgansko pregrado.
Therefore, no pharmacokinetic interaction is expected with drugs known to be metabolised by these enzyme systems.
Zato ni pričakovati farmakokinetičnih medsebojnih delovanj z zdravili, ki se presnavljajo s temi encimskimi sistemi.
Therefore, no precautions are necessary when safinamide is taken with medicinal products that are BCRP substrates (e.g., pitavastatin, pravastatin, ciprofloxacin, methotrexate, topotecan, diclofenac or glyburide).
Zato previdnostni ukrepi ob jemanju safinamida z zdravili, ki so substrati BCRP (npr. pitavastatin, pravastatin, ciprofloksacin, metotreksat, topotekan, diklofenak ali gliburid), niso potrebni.
Therefore, no specific frequency can be presented.
Natancne pogostnosti ni mogoce navesti.
Therefore, no tenofovir disoproxil fumarate dose adjustment is required in patients with hepatic impairment.
Zato prilagajanje odmerka dizoproksiltenofovirijevega fumarata pri bolnikih z jetrno okvaro ni potrebno.
Therefore, no valid figures on the incidence of clinically relevant specific inhibitors are currently available.
Zato trenutno veljavnih podatkov o pojavnosti klinično pomembnih specifičnih inhibitorjev ni na voljo.
Therefore, Orkambi should not be used in children under the age of 12 years.
Zato zdravila Orkambi pri otrocih, mlajših od 12 let, ne smete uporabljati.
Therefore, ospemifene may increase concentrations of medicinal products which are substrates of OCT1 (e.g. metformin, acyclovir, ganciclovir and oxaliplatin).
Zato lahko ospemifen poveča koncentracije zdravil, ki so substrati OCT1 (npr. metformin, aciklovir, ganciklovir and oksaliplatin).
Therefore, other intravenous substances, additives or other medicinal products mixed in sodium chloride solution should not be added to oritavancin single- use vials or infused simultaneously through the same intravenous line or through a common intravenous port.
Zato se vialam oritavancina za enkratno uporabo ne sme dodajati drugih intravenskih učinkovin, aditivov ali drugih učinkovin, primešanih raztopini natrijevega klorida, ali jih hkrati infundirati skozi isto intravensko linijo ali skozi skupni intravenski vhod.
Therefore, pantoprazole must not be co-administered with atazanavir (see section 4.3).
Zaradi tega se pantoprazola ne sme uporabljati sočasno z atazanavirjem (glejte poglavje 4.3).
Therefore, parecoxib is not recommended in these patients.
Parekoksib se torej pri tej skupini bolnikov ne priporoča.
Therefore, particular caution is required if Eurartesim is administered to patients taking potent CYP3A4 inhibitors (e.g. some protease inhibitors amprenavir, atazanavir, indinavir, nelfinavir, ritonavir], nefazodone or verapamil), and ECG monitoring should be considered due to the risk of higher plasma concentrations of piperaquine (see section 4.4).
Zato je potrebna posebna pozornost, ko se zdravilo Eurartesim daje pri bolnikih, ki že jemljejo močne zaviralce CYP3A4 (npr. nekateri zaviralci proteaze [amprenavir, atazanavir, indinavir, nelfinavir, ritonavir], nefazodon ali verpamil), pomisliti pa je treba na spremljanje EKG zaradi tveganja višjih koncentracij piperakina v plazmi (glejte poglavje 4.4).
Therefore, patient leukapheresis material and Provenge may carry the risk of transmitting infectious viruses (HIV 1 and 2, hepatitis B and C) to healthcare professionals handling the product.
Zato lahko za zdravstveno osebje, ki ravna z zdravilom, bolnikov levkaferezni material in zdravilo Provenge predstavljata tveganje za prenos kužnih virusov (HIV 1 in 2, hepatitisa B in C).
Therefore, patients hoping to achieve conception should either avoid using Fortacin, or, if this medicine is essential to achieve penetration, should wash the penis as thoroughly as possible five minutes after Fortacin has been applied, but prior to intercourse.
Zato naj se bolniki, ki želijo spočeti otroka, izogibajo uporabi zdravila Fortacin, če je uporaba tega zdravila nujna za dosego penetracije, pa naj si pet minut po nanosu zdravila Fortacin, vendar pred spolnim odnosom, čim temeljiteje sperejo glavico penisa.
Therefore, patients may need reduction in, or discontinuation of, intravenous iron and/or ESAs.
Bolniki bodo torej morda potrebovali zmanjšanje ali prekinitev vnosa intravenskega železa in/ali ESA.
Therefore, patients must wait at least 30 minutes after taking alendronate before taking any other oral medicinal product (see sections 4.2 and 5.2).
Zato morajo bolniki po zaužitju alendronata vsaj 30 minut počakati, preden peroralno vzamejo katerokoli drugo zdravilo (glejte poglavji 4.2 in 5.2).
Therefore, patients should be advised not to drive or operate machines until their individual susceptibility to this medicinal product is known.
Zato je treba bolnikom odsvetovati vožnjo oziroma upravljanje s stroji, dokler ni znana njihova lastna dovzetnost za to zdravilo.
Therefore, patients should be advised not to open the capsules and taking the pellets alone (e.g. sprinkled over food or into beverages) (see section 4.2).
Zato je treba bolnike poučiti, da kapsul ne smejo odpirati in jemati pelet (npr. jih stresti na hrano ali v pijačo) (glejte poglavje 4.2).
Therefore, patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir).
Zato je treba bolnike, ki prejemajo bortezomib v kombinaciji z močnimi inhibitorji encima CYP3A4 (npr. ketokonazolom, ritonavirjem), skrbno spremljati.
Therefore, patients should be monitored for opiate withdrawal syndrome.
Bolnike je treba med hkratnim
Therefore, patients should be monitored for opiate withdrawal syndrome.
Bolnike je treba spremljati zaradi sindroma odvzema opiatov.
Therefore, patients should fast overnight (at least 6 hours) before taking Bondenza and continue fasting for 1 hour following intake of Bondenza (see section 4.2).
Zato morajo bolniki jemati zdravilo Bondenza zjutraj na prazen želodec (vsaj 6 ur brez obroka), po zaužitju zdravila Bondenza pa morajo biti še 1 uro tešči (glejte poglavje 4.2).
Therefore, patients should have access to water and be able to drink sufficient amounts of water.
Zato morajo imeti bolniki dostop do vode in biti sposobni spiti zadostne količine vode.
Therefore, patients switching from immediate-release nicotinic acid to Pelzont should be initiated at the 1,000 mg/20 mg dose.
Zato morate pri bolnikih, ki na zdravilo Pelzont preidejo z nikotinske kisline s takojšnjim sproščanjem, na začetku uporabiti odmerek 1.000 mg/20 mg.
Therefore, patients switching from immediate-release nicotinic acid to Tredaptive should be initiated at the 1,000 mg/20 mg dose.
Zato morate pri bolnikih, ki na zdravilo Tredaptive preidejo z nikotinske kisline s takojšnjim sproščanjem, na začetku uporabiti odmerek 1.000 mg/20 mg.
Therefore, patients switching from immediate-release nicotinic acid to Trevaclyn should be initiated at the 1,000 mg/20 mg dose.
Zato morate pri bolnikih, ki na zdravilo Trevaclyn preidejo z nikotinske kisline s takojšnjim sproščanjem, na začetku uporabiti odmerek 1.000 mg/20 mg.
Therefore, patients treated with glucocorticoids should have their growth monitored carefully to assess the potential impact of glucocorticoid treatment on growth.
Zato je treba pri bolnikih, ki se zdravijo z glukokortikoidi, skrbno nadzirati rast, da se oceni možne vplive zdravljenja z glukokortikoidi na rast.
Therefore, patients who develop signs or symptoms of angioedema following administration of Esbriet should immediately discontinue treatment.
Zato je treba pri bolnikih, pri katerih se po uporabi zdravila Esbriet pojavijo znaki ali simptomi angioedema, zdravljenje takoj prekiniti.
Therefore, patients with known hypersensitivity to peanut or soya should be monitored closely for signs of an allergic reaction.
Zaradi tega je treba bolnike z znano preobčutljivostjo na arašide ali sojo skrbno spremljati glede znakov alergijske reakcije.
Therefore, physicians should use caution when prescribing Neulasta in patients with sickle cell trait or sickle cell disease, should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of this medicine with splenic enlargement and vaso-occlusive crisis.
Zato morajo biti zdravniki previdni, kadar predpisujejo zdravilo Neulasta bolnikom s srpastocelično dispozicijo ali s srpastocelično anemijo, spremljati morajo ustrezne klinične parametre in laboratorijski status in biti pozorni na morebitno povezavo tega zdravila z zvečanjem vranice in vazookluzivno krizo.
Therefore, pioglitazone should not be administered to breast- feeding women.
Zato se pioglitazona doječim ženskam ne sme dajati.
Therefore, please discard unused reconstituted concentrate immediately.
Zato neporabljen koncentrat takoj zavrzite.
Therefore, please tell your doctor about all medicines you are receiving or have recently received, including medicines obtained without a prescription.
Zato obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Therefore, PREZISTA must only be used in combination with low dose ritonavir as a pharmacokinetic enhancer (see sections 4.4 and 5.2).
Darunavir smete torej uporabljati samo v kombinaciji s farmakokinetičnim ojačevalcem (glejte poglavje 5.2).
Therefore, Provenge may carry the risk of transmitting infectious viruses (HIV 1 and 2, hepatitis B and C) to health care professionals handling the product.
Zato lahko bolnikov levkaferezni material za zdravstveno osebje, ki ravna z zdravilom, predstavlja tveganje za prenos kužnih virusov (HIV 1 in 2, hepatitisa B in C).
Therefore, PVC bags and medical devices must not be used for the preparation, storage and administration of Torisel solutions for infusions.
Zato se vrečke in medicinski pripomočki iz PVC ne smejo uporabljati za pripravo, shranjevanje in dajanje raztopin za infundiranje, ki vsebujejo Torisel.
Therefore, Rapiscan would be expected to have no or negligible influence on the ability to drive or use machines once treatment has been completed and these reactions have resolved..
Zato se pričakuje, da zdravilo Rapiscan nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje ali upravljanja s stroji po zaključku zdravljenja ali izzvenetju teh učinkov.
Therefore, reproductive toxicology studies have been performed with a homologous reagent recognising rat TNF.
Zato so reproduktivne toksikološke raziskave izvedli s homolognim reagentom, ki prepozna podganji TNF.
Therefore, Respreeza may have a minor influence on the ability to drive and use machines.
Zato ima lahko zdravilo Respreeza blag vpliv na sposobnost vožnje in upravljanja s stroji.
Therefore, Revlimid must not be used in women who are pregnant.
Nosečnice zato zdravila Revlimid ne smejo jemati.
Therefore, REYATAZ with ritonavir is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index: astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, orally administered midazolam, and ergot alkaloids, particularly ergotamine and dihydroergotamine (see section 4.3).
Zato je kontraindicirana uporaba kombinacije zdravila REYATAZ in ritonavirja z zdravili, ki so substrati za CYP3A4 in imajo ozek terapevtski indeks, npr. astemizol, terfenadin, cisaprid, pimozid, kinidin, bepridil, triazolam, peroralne oblike midazolama in alkaloidi ergot, zlasti ergotamin in dihidroergotamin (glejte poglavje 4.3).
Therefore, Soliris should be given to a pregnant woman only if clearly needed.
Zaradi tega se zdravilo Soliris nosečnici daje le v primeru nedvomne potrebe.
Therefore, special care should be taken when TMZ is administered in elderly patients.
Zato je potrebna posebna previdnost, kadar se temozolomid daje starejšim bolnikom.
Therefore, starting or ending treatment with St John’s wort should be done with caution.
Zato je treba previdno izvesti začetek ali konec zdravljenja s šentjanževko.
Therefore, taking into account the contra indication of pravastatin during lactation, Pravafenix is contraindicated during breastfeeding (see section 4.3).
Ob upoštevanju kontraindikacije za pravastatin med dojenjem je tudi zdravilo Pravafenix med dojenjem kontraindicirano (glejte poglavje 4.3).
Therefore, tasimelteon should be taken without food; if patients eat a high-fat meal, it is recommended to wait at least 2 hours before taking tasimelteon.
Tasimelteon je zato treba jemati brez hrane – če bolniki zaužijejo obrok z visoko vsebnostjo maščob, je priporočljivo, da počakajo vsaj dve uri, preden vzamejo tasimelteon.
Therefore, tenofovir disoproxil fumarate should only be used if the potential benefits of treatment are considered to outweigh the potential risks.
Zato se sme dizoproksiltenofovirijev fumarat uporabljati samo, če se oceni, da morebitne koristi zdravljenja odtehtajo morebitna tveganja.
Therefore, the Agency’s Committee for Medicinal Products for Human Use (CHMP) considered that there are no clinically meaningful differences between Inhixa and Clexane in terms of effectiveness and safety and took the view that, as for Clexane, the benefit outweighs the identified risk.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zato zaključil, da med zdraviloma Inhixa in Clexane ni klinično pomembnih razlik v učinkovitosti ali varnosti, in menil, da enako kot pri zdravilu Clexane koristi odtehtajo znana tveganja.
Therefore, the Agency’s Committee for Medicinal Products for Human Use (CHMP) considered that there are no clinically meaningful differences between Thorinane and Clexane in terms of effectiveness and safety and took the view that, as for Clexane, the benefit outweighs the identified risk.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zato zaključil, da med zdraviloma Thorinane in Clexane ni klinično pomembnih razlik v učinkovitosti ali varnosti, in menil, da enako kot pri zdravilu Clexane koristi odtehtajo znana tveganja.
Therefore, the Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Respreeza’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zato zaključil, da so koristi zdravila Respreeza večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Therefore, the CHMP concluded that Flebogamma DIF’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zato zaključil, da so koristi zdravila Flebogamma DIF večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Therefore, the CHMP concluded that Kiovig’s benefits are greater than its risks and recommended that Kiovig be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Kiovig večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Therefore, the CHMP concluded that the benefits of Zytiga were greater than its risks, and recommended it be granted marketing authorisation.
CHMP je zato zaključil, da so koristi zdravila Zytiga večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Therefore, the CHMP decided that Adcetris’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je sklenil, da so koristi zdravila Adcetris večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Therefore, the CHMP decided that Bexsero’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi cepiva Bexsero večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Therefore, the CHMP decided that Bretaris Genuair’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Bretaris Genuair večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Therefore, the CHMP decided that Cuprymina’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Cuprymina večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Therefore, the CHMP decided that Cyanokit’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je odbor CHMP zaključil, da so koristi zdravila Cyanokit večje od z njim povezanih tveganj in priporočil, da se zanj izda dovoljenje za promet.
Therefore, the CHMP decided that Eklira Genuair’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Eklira Genuair večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Therefore, the CHMP decided that Enurev Breezhaler’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Enurev Breezhaler večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Therefore, the CHMP decided that Eylea’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zaključil je, da so koristi zdravila Eylea večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Therefore, the CHMP decided that Firmagon’s benefits are greater than its risks for the treatment of adult male patients with advanced hormone-dependent prostate cancer.
Zaradi tega je CHMP zaključil, da so koristi zdravila Firmagon pri zdravljenju odraslih moških bolnikov z napredovalim rakom prostate, ki je odvisen od hormonov, večje od z njim povezanih tveganj.
Therefore, the CHMP decided that Fycompa’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Fycompa večje od z njim povezanih tveganj in priporočil, da se zanj izda dovoljenje za promet.
Therefore, the CHMP decided that Orfadin’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je odbor za zdravila za uporabo v humani medicini (CHMP), zaključil, da so koristi zdravila Orfadin večje od z njim povezanih tveganj in priporočil, da se zanj izda dovoljenje za promet.
Therefore, the CHMP decided that Revestive’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Revestive večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Therefore, the CHMP decided that Sancuso’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zato zaključil, da so koristi zdravila Sancuso večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Therefore, the CHMP decided that Seebri Breezhaler’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Seebri Breezhaler večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Therefore, the CHMP decided that the benefits of Nimenrix are greater than its risks and recommended that it be granted marketing authorisation.
Zato je zaključil, da so koristi cepiva Nimenrix večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Therefore, the CHMP decided that Thymanax’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Thymanax večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Therefore, the CHMP decided that Tovanor Breezhaler’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Tovanor Breezhaler večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Therefore, the CHMP decided that Valdoxan’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Valdoxan večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Therefore, the CHMP decided that Vibativ’s benefits are only greater than its risks for patients who are severely ill with nosocomial pneumonia and are under close observation in hospital, and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Vibativ večje od z njim povezanih tveganj le pri hudo bolnih bolnikih z bolnišnično pljučnico, ki jih skrbno spremljajo v bolnišnici, in priporočil, da se zanj izda dovoljenje za promet.
Therefore, the CHMP’s view was that, as for Abilify, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi enako kot pri zdravilu Abilify odtehtajo znana tveganja.