natgillin/translations-raw huggingface dataset:
Therefore, hormone-based contraceptives alone, regardless of the route of administration (i.e., oral, injectable, transdermal or implantable forms), are not considered as reliable methods of contraception (see sections 4.4 and 4.6).
Zato kontracepcija, ki temelji samo na hormonih, ni zanesljiv način kontracepcije, ne glede na način apliciranja (npr. peroralno, parenteralno, transdermalno ali v obliki vsadka) (glejte poglavji 4.4, 4.6).
Therefore, if co- administration of delamanid with lopinavir/ritonavir is considered necessary, very frequent ECG monitoring throughout the full delamanid treatment period is recommended (see section 4.5 and refer to the delamanid SmPC).
Zato se v primeru, če se sočasno dajanje delamanida z lopinavirjem/ritonavirjem smatra za potrebno, skozi celotno obdobje zdravljenja z delamanidom priporoča zelo pogosto spremljanje EKG-ja (glejte poglavje 4.5 in povzetek glavnih značilnosti zdravila za delamanid).
Therefore, if co-administration of delamanid with lopinavir/ritonavir is considered necessary, very frequent ECG monitoring throughout the full delamanid treatment period is recommended (see section and refer to the delamanid SmPC).
Zato se v primeru, če se sočasno dajanje delamanida z lopinavirjem/ritonavirjem smatra za potrebno, skozi celotno obdobje zdravljenja z delamanidom priporoča zelo pogosto spremljanje EKG-ja (glejte poglavje 4.5 in glejte povzetek glavnih značilnosti zdravila za delamanid).
Therefore, if signs of OHSS occur such as serum oestradiol level > 5,500 pg/ml or > 20,200 pmol/l and/or ≥ 40 follicles in total, it is recommended that hCG be withheld and the patient be advised to refrain from coitus or to use barrier contraceptive methods for at least 4 days.
Zato je v primeru pojava znakov OHSS, kot so ravni estradiola v serumu > 5.500 pg/ml ali > 20.200 pmol/l in/ali skupno ≥ 40 foliklov, priporočljivo, da se opusti dajanje hCG in se bolnici svetuje, da se vzdrži spolnih odnosov ali uporablja mehanska kontracepcijska sredstva najmanj 4 dni.
Therefore, if signs of ovarian hyperstimulation occur such as serum oestradiol level > 5,500 pg/ml or > 20,200 pmol/l and/or
Zato je v primeru pojava znakov hiperstimulacije jajčnikov, kot so ravni estradiola v serumu > 5.500 pg/ml ali > 20.200 pmol/l in/ali skupno
Therefore, if SonoVue is to be used in conjunction with stress echocardiography patients must have a stable condition verified by absence of chest pain or ECG modification during the two preceding days.
Če je zdravilo SonoVue uporabljeno v povezavi z ehokardiografskim stresom, morajo biti bolniki v preteklih dveh dneh brez bolečin v prsnem košu ali brez EKG sprememb.
Therefore, if symptoms occur after discontinuing Tasmar, physicians should consider increasing the patient’s levodopa dose (see section 4.2).
Če se simptomi pojavijo po prekinitvi zdravljenja z zdravilom Tasmar, naj zdravniki razmislijo o zvečanju bolnikovega odmerka levodope (glejte poglavje 4.2).
Therefore, if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden uporabite to zdravilo.
Therefore, if you are pregnant, consult with your doctor immediately.
Zato se, če ste noseči, takoj posvetujte z zdravnikom.
Therefore, if you believe your MS is getting worse or if you or those close to you notice any new or unusual symptoms, it is very important that you speak to your doctor as soon as possible.
Če torej mislite, da se vaša multipla skleroza slabša, ali če vi ali vaši bližnji opažate kakršne koli nove ali neobičajne simptome, je zelo pomembno, da se čimprej posvetujete z zdravnikom.
Therefore, if you feel dizzy or that your vision is blurred while taking STAYVEER, do not drive or operate any tools or machines.
Če ste v času jemanja zdravila STAYVEER omotični ali imate zamegljen vid, ne vozite in ne upravljajte z nobenim orodjem ali stroji.
Therefore, if you feel dizzy or that your vision is blurred while taking Tracleer, do not drive or operate any tools or machines.
Če ste v času jemanja zdravila Tracleer omotični ali imate zamegljen vid, ne vozite in ne upravljajte z nobenim orodjem ali stroji.
Therefore, in acromegalic patients with diabetes mellitus, doses of insulin or hypoglycaemic medicinal products may need to be decreased (see section 4.5).
Zato utegne biti pri bolnikih z akromegalijo in sladkorno boleznijo potrebno zmanjšanje odmerka insulina ali peroralnih antidiabetikov (glejte poglavje 4.5).
Therefore, in addition to those laboratory tests normally required for monitoring patients with MS, complete and differential white blood cell counts, platelet counts, and blood chemistry, including liver function tests, are recommended during AVONEX therapy.
Zato je med zdravljenjem z zdravilom AVONEX za spremljanje bolnikov z MS, poleg teh laboratorijskih testov, priporočeno opazovati še celotno in diferencialno belo krvno sliko, število trombocitov in teste krvne sestave, vključno s testi delovanja jeter.
Therefore, in adult patients with renal impairment tenofovir disoproxil fumarate should only be used if the potential benefits of treatment are considered to outweigh the potential risks.
Zato se sme pri odraslih bolnikih z ledvično okvaro dizoproksiltenofovirijev fumarat uporabljati samo, če se oceni, da morebitne koristi zdravljenja odtehtajo morebitna tveganja.
Therefore, in adult patients with renal impairment tenofovir disoproxil fumarate should only be used if the potential benefits of treatment are considered to outweigh the potential risks.
Zato se sme pri vseh odraslih bolnikih z ledvično okvaro dizoproksiltenofovirijev fumarat uporabljati samo, če se oceni, da morebitne koristi zdravljenja odtehtajo morebitna tveganja.
Therefore, in both studies it was recommended that patients be maintained on their study treatments until discontinuation criteria were met as specified below for each study.
Zato se je v obeh študijah priporočalo, da bolniki ohranijo svoje študijsko zdravljenje, dokler ne dosežejo kriterijev za prekinitev, ki so določeni spodaj za vsako študijo.
Therefore, in both studies it was recommended that patients be maintained on their study treatments until discontinuation criteria were met as specified below for each study.
Zato so v obeh študijah priporočali, da bolnik prejema študijsko zdravljenje, dokler ne izpolni za vsako študijo spodaj opisanih prekinitvenih kriterijev.
Therefore, in case of an inadvertent administration of Lumark, the radiotoxicity for the patient must be reduced by immediate (i.e. within 1 hour) administration of preparations containing chelators like Ca-DTPA or Ca- EDTA in order to increase the elimination of the radionuclide from the body.
Zato je treba v primeru nenamernega dajanja radionuklidnega predhodnika Lumark radiotoksičnost za bolnika zmanjšati s takojšnjim (t.j. v roku ene ure) dajanjem pripravkov, ki vsebujejo kelatorje, kot sta Ca-DTPA ali Ca-EDTA, da se pospeši odstranjevanje radionuklidov iz telesa.
Therefore, in case of an inadvertent administration of Yttriga, the radiotoxicity for the patient must be reduced by immediate (i. e. within 1 hour) administration of preparations containing chelators like Ca- DTPA or Ca-EDTA in order to increase the elimination of the radionuclide from the body.
Zaradi tega je potrebno, v primeru nenamernega vnosa radiofarmacevtskega predhodnika Yttriga, radiotoksičnost za bolnika zmanjšati s takojšnjim (tj. v roku 1 ure) dajanjem preparatov, ki vsebujejo kelatorje, kot sta Ca-DTPA ali Ca-EDTA, da se pospeši odstranjevanje radionuklidov iz telesa.
Therefore, in order to maintain systemic exposures to alogliptin that are similar to those observed in patients with normal renal function, lower doses of alogliptin should be used in patients with moderate or severe renal impairment, or end-stage renal disease requiring dialysis (see above and section 4.2).
7 % zdravila.) Zaradi ohranjanja sistemskih izpostavljenosti alogliptinu, podobnih tistim, ki so bile opažene pri bolnikih z normalnim delovanjem ledvic, je pri bolnikih z zmerno ali s hudo okvaro ledvic ali bolnikih s končno ledvično odpovedjo, ki se zdravijo z dializo, treba uporabljati manjše odmerke alogliptina (glejte zgoraj in poglavje 4.2).
Therefore, in order to provide the most comprehensive safety information, the analysis of ADRs presented in the following has been performed on the entire study population (i.e. iNHL).
Da bi zagotovili kar najbolj celovite varnostne informacije, je bila analiza neželenih učinkov, predstavljenih v nadaljevanju, izvedena na celotni študijski populaciji (tj. iNHL).
Therefore, in patients receiving dasatinib, systemic administration of a potent CYP3A4 inhibitor is not recommended.
Pri bolnikih, ki jemljejo dasatinib, sočasne sistemske uporabe močnih zaviralcev CYP3A4 ne priporočamo.
Therefore, in patients receiving Tasigna, co-administration of alternative therapeutic agents with less potential for CYP3A4 induction should be selected (see section 4.5).
Zato je treba pri zdravljenju bolnikov, ki prejemajo zdravilo Tasigna, za sočasno uporabo izbrati druga možna zdravila z manjšim možnostjo induciranja CYP3A4 (glejte poglavje 4.5).
Therefore, in patients with a known cardiac history, and those who experienced prior cardiopulmonary adverse reactions the risk of cardiovascular complications resulting from infusion reactions should be considered before treatment with MabThera and patients closely monitored during administration.
Pred zdravljenjem z zdravilom MabThera moramo pri bolnikih, z znanimi boleznimi srca in tistih, pri katerih so v preteklosti opazili kardio-pulmonalne neželene učinke, razmisliti o možnih kardiovaskularnih zapletih, ki lahko nastanejo kot posledica reakcij, povezanih z infuzijo, bolnike pa med dajanjem zdravila skrbno nadzorovati.
Therefore, in patients with both decompensated liver disease and lamivudine-resistant HBV, combination use of entecavir plus a second antiviral agent (which does not share cross-resistance with either lamivudine or entecavir) should be considered in preference to entecavir monotherapy.
Pri bolnikih z dekompenzirano boleznijo jeter je v prisotnosti okužbe z virusom HBV, ki je odporen proti lamivudinu, tako treba dati prednost zdravljenju z entekavirjem v kombinaciji z drugim protivirusnim zdravilom (ki si navzkrižne odpornosti ne deli niti z lamivudinom niti z entekavirjem) in ne monoterapiji z entekavirjem.
Therefore, in these patients an appropriate blood glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be required when indicated.
Pri njih je treba zato presoditi o potrebi po spremljanju krvnega sladkorja.
Therefore, in these patients an approptiate blood glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be required, when indicated.
Pri njih je treba zato presoditi o potrebi po spremljanju krvnega sladkorja.
Therefore, in these patients blood glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be required, when indicated.
Pri teh bolnikih je treba zato presoditi o potrebi po spremljanju krvnega sladkorja.
Therefore, in this population, the 75 mg dose twice daily can be used. (see sections 4.2 and 4.4).
Zato se pri tej populaciji lahko uporablja odmerek 75 mg dvakrat dnevno (glejte poglavji 4.2 in 4.4).
Therefore, in UA/NSTEMI patients, where coronary angiography is performed within 48 hours after admission, the loading dose should be given at the time of PCI. (See sections 4.2, 4.4, and 4.8)
Zato je treba pri bolnikih z UA/NSTEMI, pri katerih je koronarna angiografija opravljena v 48 urah po sprejemu, polnilni odmerek dati v času perkutane koronarne intervencije (glejte poglavja 4.2, 4.4 in 4.8).
Therefore, in UA/NSTEMI patients, where coronary angiography is performed within 48 hours after admission, the loading dose should be given at the time of PCI. (see sections 4.2, 4.8 and 5.1).
Zato je treba bolnikom z UA/NSTEMI, pri katerih je koronarna angiografija opravljena v 48 urah po sprejemu, polnilni odmerek dati v času perkutane koronarne intervencije (glejte poglavja 4.2, 4.8 in 5.1).
Therefore, in view of available data regarding allergic reaction with the use of fondaparinux, the PRAC considered that changes to the product information of medicinal product containing fondaparinux were warranted.
Zato je odbor PRAC glede na razpoložljive podatke o alergijskih reakcijah pri uporabi fondaparinuksa presodil, da so spremembe informacij o izdelkih, ki vsebujejo fondaparinuks, utemeljene.
Therefore, in view of available data regarding cardiac arrhythmia and nightmares, the PRAC considered that changes to the product information were warranted.
Iz navedenih razlogov in glede na vse razpoložljive podatke o aritmijah in nočnih morah odbor PRAC meni, da so spremembe besedila v informacijah o zdravilu upravičene.
Therefore, in view of available data regarding confusional state, the PRAC considered that changes to the product information were warranted.
PRAC zato ob upoštevanju razpoložljivih podatkov, ki se nanašajo na stanje zmedenosti, smatra, da so spremembe informacij o zdravilu upravičene.
Therefore, in view of available data regarding degarelix, the PRAC considered that changes to the product information were warranted.
Odbor PRAC je zato, na podlagi razpoložljivih podatkov o degareliksu, menil, da so spremembe informacij o zdravilu upravičene.
Therefore, in view of available data regarding erythema multiforme, the PRAC considered that changes to the product information were warranted.
Na podlagi razpoložljivih podatkov o multiformnem eritemu PRAC meni, da je informacije o zdravilu treba spremeniti.
Therefore, in view of available data regarding Fuzeon, the PRAC considered that changes to the product information were warranted.
Zato je glede na razpoložljive podatke o zdravilu Fuzeon PRAC menil, da so bile spremembe informacij o zdravilu utemeljene.
Therefore, in view of available data regarding gastrointestinal haemorrhages with the use of apremilast, the PRAC considered that changes to the product information were warranted.
Zato je spričo razpoložljivih podatkov glede gastrointestinalnih krvavitev pri uporabi apremilasta PRAC menil, da so upravičene spremembe informacij o zdravilu.
Therefore, in view of available data regarding hyponatremia, the PRAC considered that changes to the product information were warranted.
Skladno z razpoložljivimi podatki glede hiponatriemije odbor PRAC zato meni, da je potrebna posodobitev informacij o zdravilu.
Therefore, in view of available data regarding nephrotic syndrome adverse reactions and skin lesions reported in children, the PRAC considered that changes to the product information were warranted.”
Torej lahko, glede na razpoložljive podatke o škodljivih učinkih, ki povzročajo nefrotični sindrom in kožne lezije pri otrocih, PRAC sklepa, da so bile spremembe informacij o izdelku zajamčene.”
Therefore, in view of available data regarding orlistat, the PRAC considered that changes to the product information were warranted.
V luči razpoložljivih podatkov za orlistat je PRAC smatral, da so spremembe v informacijah o zdravilu utemeljene.
Therefore, in view of available data regarding orlistat, the PRAC considered that changes to the product information were warranted.
Zato PRAC v skladu z dostopnimi podatki o orlistatu meni, da so spremembe informacij o zdravilu utemeljene.
Therefore, in view of available data regarding overdose the PRAC considered that changes to the product information were warranted.
Glede na razpoložljive podatke o prevelikem odmerjanju je bil Odbor za oceno tveganja na področju farmakovigilance zato mnenja, da so bile spremembe informacij o zdravilu utemeljene.
Therefore, in view of available data regarding pallor and over-whitening, the PRAC considered that changes to the product information are warranted.
Odbor PRAC je zato na podlagi razpoložljivih podatkov o bledici in čezmernem obeljenju menil, da so potrebne spremembe informacij o zdravilu.
Therefore, in view of available data regarding rash and cases of incorrect route of administration, the PRAC considered that changes to the product information were warranted.
Zato glede na razpoložljive podatke o izpuščaju in primerih nepravilne poti uporabe odbor PRAC meni, da so spremembe informacij o zdravilu upravičene.
Therefore, in view of available data regarding regadenoson, the PRAC considered that changes to the product information were warranted.
Torej odbor PRAC glede na razpoložljive podatke o regadenozonu meni, da so spremembe informacij o zdravilu utemeljene.
Therefore, in view of available data regarding temozolomide, the PRAC considered that changes to the product information were warranted.
Glede na razpoložljive podatke o temozolomidu tako odbor PRAC meni, da so spremembe v informacijah o zdravilu utemeljene.
Therefore, in view of available data regarding teriflunomide, the PRAC considered that changes to the product information were warranted.
Odbor PRAC zato glede na dostopne podatke glede teriflunomida meni, da so spremembe v informacijah o zdravilu utemeljene.
Therefore, in view of available data regarding vildagliptin and vildagliptin/metformin, the PRAC considered that changes to the product information were warranted.
Iz navedenih razlogov in glede na vse razpoložljive podatke o vildagliptinu in sočasni uporabi vildagliptina in metformina odbor PRAC meni, da so spremembe besedila v informacijah o zdravilu upravičene.
Therefore, in view of available data regarding, the PRAC considered that changes to the product information were warranted.
Glede na razpoložljive podatke je odbor PRAC torej menil, da je treba ustrezno spremeniti informacije o zdravilu.
Therefore, in view of available data the PRAC considered that changes to the conditions of the marketing authorisation were warranted.
Odbor PRAC na podlagi razpoložljivih podatkov priporoča spremembo pogojev dovoljenja za promet z zdravilom.
Therefore, in view of the data presented in the reviewed PSUR(s), the PRAC considered that changes to the product information of medicinal product(s) containing sofosbuvir were warranted.
Zato je na podlagi podatkov, predstavljenih v revidirani(-h) PSUR, PRAC ocenil, da so spremembe v informacijah o zdravilu(-ih), ki vsebuje(-jo) sofosbuvir, utemeljene.
Therefore, in view of the data presented in the reviewed PSUR(s), the PRAC considered that changes to the product information of medicinal products containing bimatoprost were warranted.
Ob upoštevanju predstavljenih rezultatov v pregledanih poročilih PSUR se je odbor PRAC odločil, da so spremembe informacij o zdravilih, ki vsebujejo bimatoprost, upravičene.
Therefore, in view of the data presented in the reviewed PSUR(s), the PRAC considered that changes to the product information of medicinal products containing irbesartan are warranted.
Odbor PRAC zato glede na podatke, predstavljene v pregledanem PSUR/pregledanih PSUR, meni, da so utemeljene spremembe informacij o zdravilih, ki vsebujejo irbesartan.
Therefore, in view of the data presented in the reviewed PSUR(s), the PRAC considered that changes to the product information of medicinal products containing paclitaxel albumin were warranted.
Odbor PRAC je zato na podlagi podatkov iz pregledanih poročil PSUR menil, da so potrebne spremembe informacij o zdravilu za zdravila, ki vsebujejo paklitaksel albumin.
Therefore, in view of the data presented in the reviewed PSUR(s), the PRAC considered that changes to the product information of medicinal products containing zoledronic acid (indicated for cancer and fractures) were warranted.
V skladu s podatki, predstavljenimi v pregledanem PSUR, odbor PRAC meni, da so spremembe informacij o zdravilu za zdravila, ki vsebujejo zoledronsko kislino (indicirano pri rakavih obolenjih in zlomih) utemeljene.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the PI of medicinal products containing ibandronic acid were warranted.
Zaradi navedenih podatkov po oceni PSUR je odbor PRAC mnenja, da so spremembe besedila v informacijah o zdravilih, ki vsebujejo ibandronsko kislino, upravičene.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information and conditions of the marketing authorisation of medicinal products containing vismodegib were warranted.
Zato je, glede na podatke, navedene v obravnavanem PSUR-u, PRAC menil, da so bile spremembe informacij o zdravilu in pogojev za izdajo dovoljenja za promet z zdravili, ki vsebujejo vismodegib, utemeljene.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal product containing eribulin were warranted.
Zato je glede na podatke, predstavljene v pregledanem PSUR, odbor PRAC menil, da so spremembe informacij o zdravilu za zdravila, ki vsebujejo eribulin, upravičene.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing aclidinium bromide were warranted.
PRAC zato v smislu predstavljenih podatkov v pregledanem PSUR smatra, da so spremembe v informacijah o zdravilih, ki vsebujejo aklidinijev bromid utemeljene.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing aclidinium bromide/formoterol fumarate dihydrate were warranted.
Odbor PRAC zato glede na podatke, predstavljene v pregledanem PSUR, meni, da so spremembe v informacijah o zdravilih, ki vsebujejo aklidinijev bromid/formoterolijev fumarat dihidrat, utemeljene.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing aflibercept were warranted.
Zato, glede na podatke predstavljene v ocenjenem PSUR, odbor PRAC meni da so spremembe v informacijah o zdravilih, ki vsebujejo aflibercept utemeljene.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing alemtuzumab were warranted.
Odbor PRAC zato glede na podatke v pregledanem PSUR meni, da so spremembe v informacijah o zdravilih, ki vsebujejo alemtuzumab, utemeljene.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing bimatoprost/timolol were warranted.
Odbor PRAC je zato glede na podatke, predstavljene v pregledanih poročilih PSUR, menil, da so bile spremembe informacij o zdravilih, ki vsebujejo bimatoprost/timolol, upravičene.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing clofarabine were warranted.
Glede na podatke, predstavljene v pregledanih PSUR, odbor PRAC zato meni, da so utemeljene spremembe informacij o zdravilih, ki vsebujejo klofarabin.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing deferasirox were warranted.
Zaradi tega in podatkov, ki so navedeni v pregledanem poročilu PSUR, je odbor PRAC mnenja, da so spremembe besedila v informacijah o zdravilih, ki vsebujejo deferasiroks, upravičene.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing florbetaben were warranted.
Na podlagi podatkov, predloženih v pregledanih PSUR , je odbor PRAC ocenil, da so spremembe informacij o zdravilu za zdravila, ki vsebujejo florbetaben, utemeljene.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing influenza vaccine (surface antigen, inactivated, prepared in cell cultures) were warranted.
Odbor PRAC je menil, da so bile z vidika podatkov, ki so predstavljeni v rednih posodobljenih poročilih o varnosti zdravila (PSUR), spremembe informacij o zdravilu, ki vsebuje cepivo proti gripi (površinski antigen, neaktiviran, pripravljen v celičnih kulturah), potrebne.