natgillin/translations-raw huggingface dataset:
Derfor kendes relevansen af denne ene positive in vitro mutagenicitetstest ikke.
Therefore, the relevance of the one positive in vitro mutagenicity test is not known.
Derfor konkluderede CHMP, at fordelene ved Flebogamma DIF opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
Therefore, the CHMP concluded that Flebogamma DIF’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Derfor konkluderede CHMP, at fordelene ved Kiovig opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
Therefore, the CHMP concluded that Kiovig’s benefits are greater than its risks and recommended that Kiovig be given marketing authorisation.
Derfor konkluderede CHMP, at fordelene ved Vibativ kun er større end risiciene, når der er tale om patienter, som er alvorligt syge af nosokomiel pneumoni, og som er under nøje observation på hospitalet, og CHMP anbefalede, at der blev udstedt markedsføringstilladelse for Vibativ.
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.
Derfor kontraindiceres anvendelsen af højdosis NSAID-præparater (se afsnit 4.3).
Therefore, the use of high-dose NSAIDs is contraindicated (see section 4.3).
Derfor kræver trombolytisk behandling omhyggelig overvågning af alle mulige blødningssteder (inkl. kateterindstikssted, arteriel og venøs injektionssted, venefremlægningssteder og injektionssteder).
Therefore, thrombolytic therapy requires careful attention to all possible bleeding sites (including catheter insertion sites, arterial and venous puncture sites, cutdown sites and needle puncture sites).
Derfor kunne mortaliteten tilskrives komplikationer i relation til primære duodenale læsioner med et muligt bidrag fra ekstra toksiciteter i umodne målorganer.
Therefore mortality may be attributed to complications related to primary duodenal lesions with possible contribution from additional toxicities in immature target organs.
Derfor mener PRAC, i betragtning af de fremlagte oplysninger i den evaluerede PSUR, at ændringerne i produktinformationen for lægemidler som indeholder umeclidinium bromid/vilanterol er berettiget.
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.
Derfor må darunavir kun anvendes i kombination med en farmakokinetisk forstærker (se pkt.
Therefore, darunavir must only be used in combination with a pharmacokinetic enhancer (see section 5.2).
Derfor må dette veterinærlægemiddel ikke anvendes til avlsdyr, drægtige eller lakterende dyr.
Therefore, do not use in breeding, pregnant or lactating animals.
Derfor må du ikke amme et barn, hvis du tager dette lægemiddel.
Therefore, you shoud not breast-feed an infant if you are taking this medicine.
Derfor må du ikke amme, mens du får dette lægemiddel.
Therefore, you should not breast- feed whilst using this medicine.
Derfor må du ikke have ubeskyttet samleje.
Therefore do not have unprotected intercourse.
Derfor må hverken gravide eller kvinder, der ikke bruger sikker prævention, behandles med MEPACT.
Therefore, MEPACT should not be used during pregnancy and in women not using effective contraception.
Derfor må Imnovid ikke anvendes til gravide kvinder.
Therefore, Imnovid must not be used in women who are pregnant.
Derfor må kvinder, der tager everolimus, ikke amme.
Therefore, women taking everolimus should not breast-feed.
Derfor må produktet ikke administreres samtidig med antibiotika med samme virkningsmekanisme, såsom andre macrolider eller lincosamider.
Therefore, the product should not be administered with antimicrobials with a similar mode of action such as other macrolides or lincosamides.
Derfor må produktet ikke bruges samtidig med antibiotika med samme virkningsmekanisme, såsom andre macrolider eller lincosamider.
Therefore, the product should not be administered with antimicrobials with a similar mode of action such as other macrolides or lincosamides.
Derfor må Revlimid ikke gives til kvinder, der er gravide.
Therefore, Revlimid must not be used in women who are pregnant.
Derfor må Senshio kun bruges til behandling af VVA, efter at behandlingen af brystcancer, herunder adjuverende behandling, er afsluttet.
Therefore Senshio should be used for the treatment of VVA only after the treatment of breast cancer, including adjuvant therapy, has been completed.
Derfor må Xiapex kun injiceres i Peyronies plaquen, og der skal udvises forsigtighed, så det undgås at injicere det i ureter, nerver, blodkar, corpora cavernosa eller andre kollagenholdige strukturer i penis.
Therefore, Xiapex must be injected only into the Peyronie’s plaque and care should be taken to avoid injecting into the urethra, nerves, blood vessels, corpora cavernosa or other collagen-containing structures of the penis.
Derfor og på grund af lav oral absorption er der meget lille sandsynlighed for, at nyfødte, der bliver ammet, udsættes for aztreonam, hvis moderen bliver behandlet med Cayston.
Therefore, and because of low oral absorption, aztreonam exposure in breast-fed infants due to mothers receiving Cayston is likely to be extremely low.
Derfor reducerer hæmmere af disse isoenzymer vardenafil- clearance.
Therefore, inhibitors of these isoenzymes reduce vardenafil clearance.
Derfor rådes der til forsigtighed, når netupitant kombineres med digoxin eller med andre P-gp- substrater, såsom dabigatran eller colchicin.
Therefore, caution is recommended when netupitant is combined with digoxin or with other P-gp substrates such as dabigatran, or colchicine.
Derfor skal anbefalingerne i sektion 4.5 tages i betragtning, før behandling med Advocate.
Therefore prior to treatment with Advocate, the advice provided in section 4.5 should be considered.
Derfor skal Benlysta administreres et sted, hvor der altid er ressourcer til rådighed til behandling af sådanne reaktioner.
Therefore, Benlysta should be administered in an environment where resources for managing such reactions are immediately available.
Derfor skal beslutning om at vaccinere avlsorner og smågrise med maternelle antistoffer baseres på det aktuelle udbrud og associerede kontrolzoner.
Therefore the decision to vaccinate breeding boars and piglets with maternally derived antibodies should be taken based on the actual outbreak case and associated control zones.
Derfor skal bivirkningen ”Akut nyreskade” tilføjes under MedDRA-systemorganklassen ”Nyrer og urinveje (hyppighed ‘sjælden’)”, samt anføres som en advarsel i produktinformationen for alle lægemidler, som indeholder levetiracetam.
Therefore the undesirable effect “Acute kidney injury” should be added under the MedDRA System Organ Class (SOC) Renal and urinary disorders (frequency ‘rare’) as well as a warning in the Product Information of all levetiracetam-containing products.
Derfor skal børn på 6 år og derover med legemsvægt under 20 kg behandles med forsigtighed.
Therefore children aged 6 years and above and with a body weight less than 20 kg should be treated with caution.
Derfor skal de givne råd i afsnittet ”SÆRLIGE ADVARSLER” tages i betragtning før behandling med Advocate.
Therefore before treatment with Advocate, the advice provided in the section “SPECIAL WARNING(S)” should be considered.
Derfor skal De klargøre pumpen (fylde den op) ved at trykke doseringspumpen helt ned fem gange i træk (fig.
Therefore, the pump must be prepared (primed) by pushing the dosing pump head down completely five times in succession (fig.
Derfor skal De straks fortælle lægen, hvis De mærker hjertebanken eller uregelmæssige hjerteslag Gentagen anvendelse
Therefore tell the medical staff immediately if you feel palpitations or an irregular heart beat Repeated use
Derfor skal der anvendes et in-line filter som en forebyggende foranstaltning, og dette medfølger i pakken.
Thus, an in-line filter must be used as a precautionary measure and is provided in the package.
Derfor skal der udvises forsigtighed ved anvendelse af Renvela til disse patienter.
Therefore caution should be exercised when Renvela is used in these patients.
Derfor skal der udvises forsigtighed ved anvendelse af Sevelamer carbonate Zentiva til disse patienter.
Therefore caution should be exercised when Sevelamer carbonate Zentiva is used in these patients.
Derfor skal der udvises forsigtighed ved samtidig administration af cabozantinib og potente CYP3A4-hæmmere (f.eks. ritonavir, itraconazol, erythromycin, clarithromycin, grapefrugtjuice).
Therefore co-administration of strong CYP3A4 inhibitors (e.g., ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) with cabozantinib should be approached with caution.
Derfor skal det overvejes omhyggeligt, før opicapon anvendes sammen med lægemidler, der transporteres af OATP1B1, og der skal udvises passende forsigtighed, når de anvendes sammen.
Thus, particular consideration should be given to medicinal products transported by OATP1B1 and their concomitant use should be considered with appropriate caution.
Derfor skal dette lægemiddel seponeres før eller på testtidspunktet og må ikke genoptages før 48 timer derefter, og kun efter nyrefunktionen er blevet revurderet og fundet normal (se pkt.
Therefore, this medicinal product must be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5).
Derfor skal diabetikere i medicinsk behandling konsultere en læge inden behandlingen med alli for at få undersøgt, om de skal have justeret doseringen af antidiabetika.
Patients taking levothyroxine should consult a doctor before starting treatment with alli, as orlistat and levothyroxine may need to be taken at different times and the dose of levothyroxine may need to be adjusted.
Derfor skal din hjertefunktion kontrolleres før, under (hver tredje måned) og efter (op til to til fem år) behandlingen med Herceptin.
Therefore, your heart function will be checked before, during (every three months) and after (up to two to five years) treatment with Herceptin.
Derfor skal dit blod kontrolleres regelmæssigt for at være sikker på, at hiv- infektionen ikke forværres.
Therefore, your blood will be checked regularly to be sure that the HIV infection is not getting worse.
Derfor skal du benytte sikre præventionsmetoder, hvis du er kvinde og kan blive gravid (se ”Prævention” nedenfor).
Therefore you must use effective methods of contraception if you are a woman of childbearing potential (see “Contraception” below).
Derfor skal du fortælle det til lægen eller sygeplejersken, hvis du tidligere er besvimet i forbindelse med en injektion.
Therefore tell the doctor or nurse if you fainted with a previous injection.
Derfor skal du kontrollere dit blodsukkerniveau oftere end normalt.
You should therefore monitor your blood sugar level more often than usual.
Derfor skal du og din partner tage særlige forholdsregler i forbindelse med seksuel aktivitet, for at undgå graviditet:
Therefore, you and your partner must take special precautions in sexual activity if there is any chance for pregnancy to occur:
Derfor skal du også have injektionssprøjter og nåle til rådighed.
Therefore, keep injection syringes and needles as well.
Derfor skal indehaveren af markedsføringstilladelsen tilføje bivirkningen ”Rabdomyolyse” under MedDRA- sy stemorganklassen ”Knogler, led, muskler og bindevæv (hyppighed ‘sjælden’)” i p roduktinformationen for alle lægemidler, som indeholder levetiracetam.
Therefore, the MAHs should add the undesirable effect “Rhabdomyolysis” under the SOC Musculoskeletal and connective tissue disorders (frequency ‘rare’) in the Product Information of all levetiracetam-containing products.
Derfor skal interaktion med andre lægemidler overvåges tæt vedrørende hunde, der også behandles med andre veterinærlægemidler.
Therefore, for dogs receiving treatments in addition to the veterinary medicinal product, drug interactions should be monitored closely.
Derfor skal ivacaftor administreres sammen med fedtholdig mad.
Therefore, ivacaftor should be administered with fat-containing food.
Derfor skal kontakt med hud og øjne undgås.
Therefore, contact with skin or eyes should be avoided.
Derfor skal kvinder, der tager Odomzo, anvende effektiv prævention under behandlingen og i 20 måneder efter behandlingens afslutning.
Therefore, women taking Odomzo must take effective measures to prevent pregnancy during treatment and for 20 months after stopping it.
Derfor skal lægemidler, der metaboliseres af CYP1A2 (som f.eks. duloxetin, alosetron, theophyllin og tizanidin), anvendes med forsigtighed under behandling med teriflunomid, da det kan medføre nedsat virkning af disse lægemidler.
Therefore, medicinal products metabolised by CYP1A2 (such as duloxetin, alosetron, theophylline and tizanidine) should be used with caution during treatment with teriflunomide, as it could lead to the reduction of the efficacy of these products.
Derfor skal man fortsætte med at tage passende forholdsregler mod seksuelt overførte sygdomme.
Therefore appropriate precautions against sexually transmitted disease should continue to be used.
Derfor skal patienten informeres om, at klargøringen skal foretages på et sted med god udluftning, og at næsesprayen skal pege væk fra patienten og andre personer samt flader og genstande, som kan komme i kontakt med andre personer, især børn
Therefore, the patient must be instructed that the priming should be conducted in a well ventilated area, pointing away from the patient and other people, and away from surfaces and objects that could come into contact with other people, particularly children.
Derfor skal patienter i risikogruppen, især små børn og patienter i intensiv immunsuppression kontrolleres med f.eks. ekkokardiografi eller ekg før og efter transplantation (f.eks. efter 3 måneder i begyndelsen af behandlingen og igen efter 9-12 måneder).
Accordingly, high-risk patients, particularly young children and those receiving substantial immunosuppression should be monitored, using such procedures as echocardiography or ECG pre- and post-transplant (e.g. initially at 3 months and then at 9-12 months).
Derfor skal patienter med en kendt overfølsomhed over for jordnødder eller soja overvåges nøje for tegn på en allergisk reaktion.
Therefore, patients with known hypersensitivity to peanut or soya should be monitored closely for signs of an allergic reaction.
Derfor skal patienter som er blevet behandlet med cladribine, kontrolleres regelmæssigt.
Therefore, patients treated with cladribine should be regularly monitored.
Derfor skal patienter, der udvikler tegn eller symptomer på angioødem efter administration af Esbriet, ophøre med behandlingen omgående.
Therefore, patients who develop signs or symptoms of angioedema following administration of Esbriet should immediately discontinue treatment.
Derfor skal patienterne rådes til ikke at køre bil eller betjene maskiner, før de ved, hvor følsomme de er for dette lægemiddel.
Therefore, patients should be advised not to drive or operate machines until their individual susceptibility to this medicinal product is known.
Derfor skal patienterne undersøges for symptomer på hereditær fructoseintolerans, før de får Flebogamma DIF.
Therefore, patients should be examined for the symptoms of Hereditary Fructose Intolerance prior to receiving
Derfor skal post partum- patienter monitoreres nøje for bivirkninger.
Therefore, postpartum patients should be closely monitored for adverse reactions.
Derfor skal pumpen klargøres (fyldes op) ved at trykke doseringspumpen helt ned fem gange i træk (fig.
Therefore, the pump must be prepared (primed) by pushing the dosing pump head down completely five times in succession (fig.
Derfor skal relevant beskyttelse mod seksuelt overførte sygdomme fortsat anvendes.
Therefore appropriate precautions against sexually transmitted disease should continue to be used.
Derfor skal samtidig administration af tolvaptan og stærke CYP3A-inducere (f.eks. rifampicin, rifabutin, rifapentin, phenytoin, carbamazepin og prikbladet perikum) undgås.
Therefore, concomitant administration of tolvaptan with potent CYP3A inducers (e.g., rifampicin, rifabutin, rifapentin, phenytoin, carbamazepine, and St. John’s Wort) is to be avoided.
Derfor skal samtidig brug af IMBRUVICA og potente eller moderate CYP3A4-hæmmere/induktorer undgås, når det er muligt, og co-administration bør udelukkende overvejes, når de potentielle fordele tydeligt opvejer de potentielle risici.
Therefore, concomitant use of IMBRUVICA with strong or moderate CYP3A4 inhibitors/inducers should be avoided whenever possible and co-administration should only be considered when the potential benefits clearly outweigh the potential risks.
Derfor skal sundhedspersonalet overveje benefit/risk-forholdet inden administration af denne vaccine til personer med trombocytopeni eller andre blødningslidelser, som kontraindicerer intramuskulær injektion, medmindre den potentielle fordel opvejer risikoen for blødninger.
Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings
Derfor skal Xarelto anvendes med forsigtighed hos disse patienter.
Therefore, Xarelto is to be used with caution in these patients.
Derfor standses hepatitis C-virussets formering, og det kan ikke inficere nye celler.
This stops the hepatitis C virus from multiplying and infecting new cells.
Derfor tilrådes det, at kvinder benytter en pålidelig barriereprævention indtil næste menstruation, efter at de har taget ellaOne.
Therefore, after using emergency contraception, women should be advised to use a reliable barrier method until her next menstrual period.
Derfor tilrådes en nøje overvågning af blodsukkeret samt dyrlægetilsyn.
Therefore, close glucose monitoring and veterinary supervision is advised.
Derfor tilrådes indgivelse af nukleoside analoger samtidig med cladribine ikke.
Therefore, simultaneous administration of nucleoside analogues with cladribine is not advisable.
Derfor tilrådes nøje klinisk overvågning af disse patienter (se pkt.
Therefore, careful clinical monitoring is advised in these patients (see section 5.2).
Derfor tilrådes tæt monitorering hos patienter, hvor der sker synsændringer, eller hvor der tidligere er set øget intraokulært tryk, glaukom og/eller katarakt.
Therefore close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma and/or cataracts.
Derfor var CVMP af den opfattelse, at ligesom det er tilfældet med Metacam, er fordelene ved Melosus større end risiciene, når det gælder lindring af betændelse og smerter ved lidelser i bevægeapparatet, og CVMP anbefalede, at der blev udstedt markedsføringstilladelse for Melosus.
Therefore the CVMP’s view was that, as for Metacam, Melosus’s benefits are greater than its risks to alleviate inflammation and pain in musculo-skeletal disorders and they recommended that Melosus should be given a marketing authorisation.
Derfor var CVMP af den opfattelse, at ligesom det er tilfældet med Metacam, er fordelene ved Meloxoral større end risiciene, når det gælder lindring af betændelse og smerter ved lidelser i bevægeapparatet, og CVMP anbefalede, at der blev udstedt markedsføringstilladelse for Meloxoral.
Therefore the CVMP’s view was that, as for Metacam, Meloxoral’s benefits are greater than its risks to alleviate inflammation and pain in musculo-skeletal disorders and they recommended that Meloxoral should be given a marketing authorisation.
Derfor var den maternale NOAEL
Therefore, the maternal NOAEL was
Derfor var en patient som opretholdt respons, i en tilstand af vedvarende klinisk respons ved hver evaluering til og med uge 54.
Therefore, a patient who maintained response was in a state of continuous clinical response at each evaluation through week 54.
Derfor var NOAEL for disse observerede virkninger <25 mg/kg/dag (AUC 24h var 39.960 ng•t/ml (nanogram•time/ml) ved denne lavest testede dosis, og eksponeringsratio var 99 gange i forhold til en klinisk dosis på 4 mg).
Therefore, the NOAEL for these observed effects was <25 mg/kg/day (AUC 24h was 39960 ng•h/mL (nanogram•hour/millilitres) at this lowest dose tested, and the exposure ratio was 99-fold relative to a 4 mg clinical dose).
Derfor vil 6-måneders eller årlige PSUR’er, som falder inden for den pandemiske periode, blive erstattet af månedlige ’simplificerede PSUR’er’ (S-PSUR) ledsaget af en oversigt over vaccinedistributionen.
Therefore, 6-monthly or annual PSURs falling within the pandemic period will be replaced by monthly “simplified PSURs” (S-PSUR) accompanied by a summary of vaccine distribution.
Derfor vil administration af siltuximab sammen med substrater for CYP450, der har et snævert terapeutisk indeks, potentielt kunne ændre terapeutiske virkninger og toksicitet af disse lægemidler på grund af ændringen af
Therefore, administering siltuximab with CYP450 substrates that have a narrow therapeutic index has the potential to change therapeutic effects and toxicity of these medicinal products due to alteration in the CYP450 pathways.
Derfor vil co-administration sandsynligvis resultere i ændrede plasmakoncentrationer af Viramune og cobicistat.
Therefore coadministration would likely result
Derfor vil der i lyset af tilgængelige data vedrørende hjertearytmi og mareridt, PRAC overvejet, at ændringer i produktinformationen blev berettiget.
Therefore, in view of available data regarding cardiac arrhythmia and nightmares, the PRAC considered that changes to the product information were warranted.
Derfor vil Deres læge omhyggeligt overvåge brugen af dette lægemiddel, når det gives sammen med medicin, der modvirker dannelse af blodpropper.
Therefore your doctor will carefully monitor the use of this medicine when administered together with these anti-clotting medicines.
Derfor vil din hjertefunktion blive undersøgt før, i løbet af (hver tredje måned) og efter (op til to-fem år) behandling med Herceptin.
Therefore, your heart function will be checked before, during (every three months) and after (up to two to five years) treatment with Herceptin.
Derfor vil din læge tjekke din nyrefunktion, mens du tager Afinitor. forårsage åndenød, hoste og feber.
Therefore, your doctor will monitor your kidney function while you are taking Afinitor. cause shortness of breath, cough and fever.
Derfor vil din læge tjekke din nyrefunktion, mens du tager Votubia. forårsage åndenød, hoste og feber (se afsnit 4 ”Bivirkninger”).
Therefore, your doctor will monitor your kidney function while you are taking Votubia. cause shortness of breath, cough and fever (see section 4 ‘Possible side effects’).
Derfor vil samtidig administration af CYP3A4-inducere (f.eks. rifampicin, phenytoin, carbamazepin, phenobarbital, perikon) sandsynligvis resultere i subterapeutiske koncentrationer af telithromycin og tab af effekt.
Therefore, concomitant administration of CYP3A4 inducers (such as rifampicin, phenytoin, carbamazepine, phenobarbital, St John’s wort) is likely to result in subtherapeutic levels of telithromycin and loss of effect.
Derfor vurderer PRAC, i lyset af tilgængelig data angående erythema multiforme, at ændringerne til produktinformationen er berettiget.
Therefore, in view of available data regarding erythema multiforme, the PRAC considered that changes to the product information were warranted.
Derfor, i betragtning af de foreliggende data for degarelix, mener PRAC at ændringer i produktinformationen var berettiget.
Therefore, in view of available data regarding degarelix, the PRAC considered that changes to the product information were warranted.