natgillin/translations-raw huggingface dataset:
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.
Seetõttu tuleb Yttriga tahtmatu manustamise korral radiotoksilisust vähendada, manustades viivitamatult (st 1 tunni vältel) kelaatoreid (nt Ca- DTPA või Ca-EDTA) sisaldavaid preparaate, et viia radionukliid organismist välja.
Therefore, in patients receiving dasatinib, systemic administration of a potent CYP3A4 inhibitor is not recommended.
Seega patsientidele, kes kasutavad dasatiniibi, ei ole soovitatav tugevaid CYP3A4 inhibiitoreid süsteemselt manustada.
Therefore, in patients receiving Tasigna, co-administration of alternative therapeutic agents with less potential for CYP3A4 induction should be selected (see section 4.5).
Seetõttu tuleb Tasigna’t saavate patsientide puhul valida alternatiivsed ravimid, millel on väiksem CYP3A4 indutseeriv toime (vt lõik 4.5).
Therefore, in patients receiving Tasigna, co-administration of alternative therapeutic agents with less potential for CYP3A4 induction should be selected (see section 4.5).
Seetõttu tuleb Tasigna’t saavate patsientide puhul valida samaaegne manustamine alternatiivsete ravimitega, millel on väiksem CYP3A4 indutseeriv toime (vt lõik 4.5).
Therefore, in patients treated with coumarin anticoagulants (e.g. phenprocoumon or warfarin), monitoring of prothrombin time/INR is recommended after initiation, termination or during irregular use of pantoprazole.
Seetõttu soovitatakse kumariini-tüüpi antikoagulantidega (näiteks fenprokumoon või varfariin) ravitavatel patsientidel monitoorida protrombiini aega/INR’i pärast pantoprasool-ravi algust, lõppu või pantoprasooli ebaregulaarse kasutamise ajal.
Therefore, in patients treated with coumarin anticoagulants (e.g. phenprocoumon or warfarin), monitoring of prothrombin time/INR is recommended after initiation, termination or during irregular use of pantoprazole.
Seetõttu soovitatakse kumariini-tüüpi antikoagulantidega (näiteks fenprokumoon või varfariin) ravitavatel patsientidel monitoorida protrombiini aega/INR’i pärast pantoprasoolravi algust, lõppu või pantoprasooli ebaregulaarse kasutamise ajal.
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.
Seetõttu tuleb teadaoleva südamehaiguse anamneesiga patsientide ning samuti patsientide puhul, kellel on eelnevalt esinenud kardiopulmonaalseid kõrvaltoimeid, enne MabThera-ravi alustamist kaaluda infusioonireaktsioonidest tingitud kardiovaskulaarsete komplikatsioonide riski, samuti tuleb neid patsiente ravi ajal hoolikalt jälgida.
Therefore, in patients with dementia treated with rivastigmine, the ability to continue driving or operating complex machines should be routinely evaluated by the treating physician.
Seetõttu peab raviarst reeglipäraselt hindama rivastigmiinravi saavate dementsusega patsientide võimet juhtida autot või töötada masinatega.
Therefore, in patients with known hypertension and/or other cardiac disease, blood pressure monitoring is recommended, especially during the first month of treatment.
Teadaoleva hüpertensiooniga ja/või südamehaigusega patsientidel on seetõttu soovitatav jälgida vererõhku, eriti esimesel ravikuul.
Therefore, in patients with mild renal impairment Eviplera should only be used if the potential benefits of treatment outweigh the potential risks (see sections 4.4 and 5.2).
Seetõttu võib Eviplera’t kasutada kerge neerufunktsiooni kahjustusega patsientidel ainult sel juhul, kui ravi võimalik kasu on suurem sellega kaasnevatest võimalikest ohtudest (vt lõigud 4.4 ja 5.2).
Therefore, in these patients blood glucose monitoring should be considered; a dose adjustments of insulin or antidiabetics may be required, when indicated.
Seetõttu tuleb sellistel patsientidel kaalutleda vere glükoositaseme jälgimist, ning vastavate näidustuste korral võib vajalikuks osutuda insuliini või diabeedivastaste ravimite annuse kohandamine.
Therefore, in this patient group, EBV-VCA serology should be ascertained before starting treatment with Advagraf.
Seetõttu tuleb antud patsientide grupis enne ravi alustamist Advagraf’iga kindlaks teha EBV- VCA seroloogia.
Therefore, in this patient group, EBV-VCA serology should be ascertained before starting treatment with Envarsus.
Seetõttu tuleb selles patsientide rühmas Epstein-Barri viiruse kapsiidi antigeeni seroloogia enne ravi alustamist Envarsusega kindlaks määrata.
Therefore, in this patient group, EBV-VCA serology should be ascertained before starting treatment with Modigraf.
Seetõttu tuleb antud patsientide grupis enne ravi alustamist Modigraf’iga kindlaks teha EBV-VCA seroloogia.
Therefore, in this population, the 75 mg dose twice daily can be used. (see sections 4.2 and 4.4).
Seetõttu võib sellel rühmal kasutada annust 75 mg kaks korda ööpäevas (vt lõigud 4.2 ja 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)
Seetõttu UA/NSTEMI patsientidel, kellel koronaarangiograafia tehakse 48 tunni jooksul pärast hospitaliseerimist, tuleb manustada löökannus PCI ajal (vt lõigud 4.2, 4.4 ja 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).
Seetõttu tuleb ST-segmendi elevatsioonita kulgeva müokardiinfarktiga (UA/NSTEMIMI) patsientidele, kellel koronaarangiograafia viiakse läbi 48 tunni jooksul pärast hospitaliseerimist, manustada löökannus PCI ajal (vt lõigud 4.2, 4.8 ja 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.
Seega, arvestades olemasolevaid andmeid fondapariinuksi kasutamisel esineva allergilise reaktsiooni kohta, on ravimiohutuse riskihindamise komitee hinnangul fondapariinuksi sisaldava ravimi ravimiteabe muudatused õigustatud.
Therefore, in view of available data regarding cardiac arrhythmia and nightmares, the PRAC considered that changes to the product information were warranted.
Seega, võttes arvesse olemasolevaid andmeid arütmia ja luupainajate esinemise kohta, peab PRAC vajalikuks ravimiteabe muutmist.
Therefore, in view of available data regarding confusional state, the PRAC considered that changes to the product information were warranted.
Seega, võttes arvesse olemasolevaid andmeid segasusseisundi kohta, on ravimiohutuse riskihindamise komitee (PRAC) arvamusel, et ravimiteabes tuleb teha muudatus.
Therefore, in view of available data regarding degarelix, the PRAC considered that changes to the product information were warranted.
Toetudes olemasolevatele andmetele degarelixi kohta, leidis ravimiohutuse riskihindamise komitee, et muutused ravimi omaduste kokkuvõttes on põhjendatud.
Therefore, in view of available data regarding erythema multiforme, the PRAC considered that changes to the product information were warranted.
Seetõttu on ravimiohutuse riskihindamise komitee multiformse erüteemi kohta olemasolevate andmete valguses arvamusel, et muudatused ravimiteabes olid vajalikud.
Therefore, in view of available data regarding Fuzeon, the PRAC considered that changes to the product information were warranted.
Seega, pidades silmas olemasolevaid andmeid Fuzeon’i kohta, leidis ravimiohutuse riskihindamise komitee, et ravimiteavet tuleb uuendada.
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.
Olemasolevate andmete põhjal seedetrakti verejooksude kohta apremilasti kasutamise korral peab ravimiohutuse riskihindamise komitee ravimiteabe muudatusi põhjendatuks.
Therefore, in view of available data regarding hyponatremia, the PRAC considered that changes to the product information were warranted.
Võttes arvesse hüponatreemia kohta teadaolevaid andmeid, peab ravimiohutuse riskihindamise komitee ravimiinfo muudatusi põhjendatuks.
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.”
Seetõttu, arvestades olemasolevaid andmeid lastel esinevate nefrootilise sündroomi kahjulike reaktsioonide ja nahakahjustuste kohta, leidis PRAC, et muudatused tooteinformatsioonis olid põhjendatud.”
Therefore, in view of available data regarding orlistat, the PRAC considered that changes to the product information were warranted.
Seega, võttes arvesse olemasolevaid andmeteid orlistaadi kohta, leidis PRAC, et ravimi omaduste kokkuvõtte muutmine oli õigustatud.
Therefore, in view of available data regarding orlistat, the PRAC considered that changes to the product information were warranted.
Seepärast, võttes arvesse olemasolevaid andmeid orlistati kohta, leidis ravimiohutuse riskihindamise komitee, et on vaja uuendada ravimiteavet.
Therefore, in view of available data regarding overdose the PRAC considered that changes to the product information were warranted.
Seega leidis ravimiohutuse riskihindamise komitee, arvestades kättesaadavaid andmeid üleannustamise kohta, et ravimiteabes muudatuste tegemine on põhjendatud.
Therefore, in view of available data regarding pallor and over-whitening, the PRAC considered that changes to the product information are warranted.
Seetõttu on ravimiohutuse riskihindamise komitee naha kahvatuse ja ülevalgenemise kohta olemasolevaid andmeid arvesse võttes seisukohal, et muudatused ravimiteabes on õigustatud.
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.
Seetõttu leiab ravimiohutuse riskihindamise komitee, et arvestades olemasolevaid andmeid lööbe ning ebaõige manustamisviisi kohta, on vajalik ravimiteabe muutmine.
Therefore, in view of available data regarding regadenoson, the PRAC considered that changes to the product information were warranted.
Seega peab ravimiohutuse riskihindamise komitee kättesaadavate andmete põhjal regadenosooni kohta vajalikuks teha ravimiteabes muudatused.
Therefore, in view of available data regarding temozolomide, the PRAC considered that changes to the product information were warranted.
Seega leidis ravimiohutuse riskihindamise komitee temosolomiidi kohta kättesaadavate andmete põhjal, et ravimiteabes on vaja teha muudatusi.
Therefore, in view of available data regarding teriflunomide, the PRAC considered that changes to the product information were warranted.
Olemasolevate andmete põhjal teriflunomiidi kohta on ravimiteabe muutused ravimiohutuse riskihindamise komitee arvates põhjendatud.
Therefore, in view of available data regarding vildagliptin and vildagliptin/metformin, the PRAC considered that changes to the product information were warranted.
Seega, võttes arvesse olemasolevaid andmeid vildagliptiini ja vildagliptiini/metformiini kohta, peab PRAC vajalikuks ravimiteabe muutmist.
Therefore, in view of available data regarding, the PRAC considered that changes to the product information were warranted.
Arvestades olemasolevat vastavat teavet, peab ravimiohutuse riskihindamise komitee tooteinformatsiooni muutusi õigustatuks.
Therefore, in view of available data the PRAC considered that changes to the conditions of the marketing authorisation were warranted.
Sellest tulenevalt leiab ravimiohutuse riskihindamise komitee kättesaadavate andmete põhjal, et müügiloa tingimustes on vaja teha muudatusi.
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.
Seetõttu oli ravimiohutuse riskihindamise komitee läbi vaadatud perioodilises ohutusaruandes (perioodilistes ohutusaruannetes) esitatud teabe põhjal seisukohal, et sofosbuviiri sisaldava(te) ravimi(te) ravimiteabe muudatused on põhjendatud.
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.
Seega, pidades silmas perioodilis(t)es ohutusaruandes (ohutusaruannetes) esitatud andmeid, leidis PRAC, et muudatused bimatoprosti sisaldavate ravimite teabes on õigustatud.
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.
Hinnatud perioodilises ohutusaruandes esitatud andmete alusel on ravimiohutuse riskihindamise komitee arvamusel, et muudatused irbesartaani sisaldavate ravimite ravimiteabes on põhjendatud.
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.
Seepärast, lähtudes läbivaadatud perioodilises ohutusaruandes esitatud andmetest, leiab ravimiohutuse riskihindamise komitee, et paklitakseelalbumiini sisaldavate ravimpreparaatide ravimiteabe muutmine on õigustatud.
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.
Seega, võttes arvesse olemasolevaid andmeid, peab ravimiohutuse riskihindamise komitee vajalikuks zoledroonhapet (näidustatud vähi ja luumurdude korral) sisaldavate ravimite ravimiteabe muutmist.
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.
Seepärast, pidades silmas läbi vaadatud perioodilises ohutusaruandes esitatud andmeid, leidis ravimiohutuse riskihindamise komitee, et on vaja muuta ibandroonhapet sisaldavate ravimpreparaatide ravimiteavet.
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.
Seepärast, pidades silmas läbivaadatud perioodilises ohutusaruandes toodud andmeid, leidis ravimiohutuse riskihindamise komitee, et on vaja muuta ravimiteavet ja vismodegiibi sisaldavate ravimpreparaatide müügiloa tingimusi.
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.
Seega pidas ravimiohutuse riskihindamise komitee läbivaadatud perioodilises ohutusaruandes esitatud andmete põhjal vajalikuks teha eribuliini sisaldavate ravimite ravimiteabes muudatused.
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.
Ravimiohutuse riskihindamise komitee otsustas hinnatud perioodilises ohutusaruandes esitatud andmete alusel, et aklidiinbromiidi sisaldavate ravimite ravimiteabesse tehtavad muudatused on põhjendatud.
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.
Seetõttu otsustas ravimiohutuse riskihindamise komitee, et arvestades läbivaadatud perioodilises ohutusaruandes toodud andmeid on muudatused aklidiiniumbromiidi / formoteroolfumaraatdihüdraati sisaldavate ravimite ravimi omaduste kokkuvõtetes põhjendatud.
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.
Perioodilises ohutusaruandes toodud andmete põhjal on ravimiohutuse risk- ihindamise komitee seisukohal, et muutused aflibertsepti sisaldavate ravimite ravimiteabes on õigus- tatud.
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.
Hinnatud perioodilises ohutusaruandes esitatud andmete alusel on ravimiohutuse riskihindamise komitee arvamusel, et muudatused alemtuzumabi sisaldavate ravimite ravimiteabes on põhjendatud.
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.
Seega, pidades silmas perioodilises ohutusaruandes esitatud andmeid, leidis ravimiohutuse riskihindamise komitee, et muudatused bimatoprosti/timololi sisaldavate ravimite tooteteabes on õigustatud.
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.
Seega peab ravimiohutuse riskihindamise komitee kõnealuses perioodilises ohutusaruandes esitatud andmete põhjal vajalikuks teha klofarabiini sisaldavate ravimite ravimiteabes muudatused.
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.
Seega, võttes arvesse andmeid kõnealusest perioodilisest ohutusaruandest, peab ravimiohutuse riskihindamise komitee vajalikuks deferasiroksi sisaldavate ravimite ravimiteabe muutmist.
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.
Seega, arvestades läbivaadatud perioodilises ohutusaruandes esitatud andmeid, on ravimisohutuse riskihindamise komitee arvamusel, et florbetabeeni sisaldavate ravimpreparaatide ravimiteabesse tuleb teha vastavad muudatused.
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.
Seetõttu otsustas ravimiohutuse riskihindamise komitee, et hinnatud perioodilises ohutusaruandes esitatud andmete alusel on gripivaktsiini (pinnaantigeen, inaktiveeritud, valmistatud rakukultuuril) sisaldavate ravimpreparaatide ravimiteabe muutmine põhjendatud.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing ingenol mebutate were warranted.
Seetõttu, arvestades perioodilistes ohutusaruannetes esitatud andmeid, leiab ravimiohutuse riskihindamise komitee, et muudatused ingenoolmebutaati sisaldavate ravimite ravimiteabes on õigustatud.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing liraglutide were warranted
Seetõttu, arvestades perioodilises ohutusaruandes esitatud andmeid, leidis ravimiohutuse riskihindamise komitee, et liraglutiidi sisaldavate ravimite ravimi omaduste kokkuvõttesse tehtud muudatused olid õigustatud.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing mirabegron were warranted.
Seega arvestades olemasolevaid andmeid mirabegrooni kohta leidis ravimiohutuse riskihindamise komitee, et muutused ravimiteabes on õigustatud.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing omalizumab were warranted.
Seega, võttes arvesse olemasolevaid andmeid omalizumabi perioodilisest ohutusaruandest, peab ravimiohutuse riskihindamise komitee vajalikuks omalizumabi sisaldavate ravimite ravimiteabe muutmist.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing para-aminosalicylic acid were warranted.
Seetõttu otsustas ravimiohutuse riskihindamise komitee (PRAC) kõnealuses PSURis esitatud andmeid silmas pidades, et paraaminosalitsüülhapet sisaldavate ravimite ravimiteabe muudatused on õigustatud.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing tegafur, gimeracil and oteracil (as monopotassium) were warranted.
Seega, pidades silmas perioodilises ohutusaruandes esitatud andmeid, leidis ravimiohutuse riskihindamise komitee, et muudatused tegafuuri, gimeratsiili ja oteratsiili (kui monokaalium) sisaldavate ravimite ravimiteabes on õigustatud.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing thalidomide were warranted.
Seega peab ravimiohutuse riskihindamise komitee läbivaadatud perioodilises ohutusaruandes esitatud andmete põhjal vajalikuks teha talidomiidi sisaldavate ravimite ravimiteabes muudatused.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing trametinib were warranted.
Seega, võttes arvesse olemasolevaid andmeid trametiniibi perioodilisest ohutusaruandest, peab ravimiohutuse riskihindamise komitee vajalikuks trametiniibi sisaldavate ravimite ravimiteabe muutmist.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considers that changes to the product information of medicinal products containing umeclidinium bromide /vilanterol are warranted.
Arvestades kõnealuses perioodilises ohutusaruandes esitatud andmeid, on ravimiohutuse riskihindamise komitee hinnangul umeklidiinbromiidi/vilanterooli sisaldavate ravimite ravimiteabe muutmine õigustatud.
Therefore, in view of the data presented in the reviewed PSURs, the PRAC considered that changes to the product information of medicinal products containing aripiprazole were warranted.
Seega, võttes arvesse kõnealuseid perioodilisi ohutusaruandeid, on ravimiohutuse riskihindamise komitee (PRAC) hinnangul aripiprasooli sisaldavate ravimite ravimiteabe muutmine õigustatud.
Therefore, in view of the data presented in the reviewed PSURs, the PRAC considered that changes to the product information of medicinal products containing pregabalin were warranted.
Tuginedes läbivaadatud perioodilises ohutusaruandes esitatud andmetele, otsustas ravimiohutuse riskihindamise komitee, et muutused ravimiteabes on õigustatud.
Therefore, in view of the data presented in the reviewed PSURs, the PRAC considered that changes to the product information of medicinal products containing sevelamer hydrochloride and carbonate were warranted.
Seetõttu, arvestades läbivaadatud perioodilises ohutusaruandes esitatud andmeid, peab ravimiohutuse riskihindamise komitee põhjendatuks muudatusi sevelameervesinikkloriidi ja –karbonaati sisaldavate ravimite ravimteabes.
Therefore, INCIVO is not recommended in these patients (see sections 4.2 and 5.2).
Seetõttu ei ole soovitatav kasutada INCIVO’t nendel patsientidel (vt lõigud 4.2 ja 5.2).
Therefore, INCIVO must not be co-administered with rifampicin.
Seetõttu ei tohi INCIVO’t manustada koos rifampitsiiniga.
Therefore, induction leading to reduced efficacy of medicinal products, including hormonal contraceptives, is not expected if lenalidomide is administered alone.
Seega ei esine lenalidomiidi manustamisel ainsa ravimina eeldatavalt indutseerimist, mis ravimite, sealhulgas hormonaalsete rasestumisvastaste vahendite efektiivsust vähendaks.