natgillin/translations-raw huggingface dataset:
Ud fra PK/PD-modellering forventes eliglustat- plasmakoncentrationer, som er 11 gange så store som den forventede humane Cmax at forårsage gennemsnitlige (øvre grænse af 95 % konfidensintervallet) stigninger i PR-, QRS- og QTcF- intervallerne på henholdvis 18,8 (20,4), 6,2 (7,1) og 12,3 (14,2) msek.
Based on PK/PD modelling, eliglustat plasma concentrations 11-fold the predicted human Cmax are expected to cause mean (upper bound of the 95% confidence interval) increases in the PR, QRS, and QTcF intervals of 18.8 (20.4), 6.2 (7.1), and 12.3 (14.2) msec, respectively.
Ud fra prækliniske og kliniske mekanistiske studier anses Leydig-celletumorer, tumorer i nyretubuli og fæokromocytomer for at være specifikke for rotter.
Based on preclinical and clinical mechanistic studies, Leydig cell tumours, renal tubule tumours and pheochromocytomas are considered to be rat-specific.
Ud fra prækliniske og kliniske mekanistiske studier anses Leydig-celletumorer, tumorer i nyretubuli og fæokromocytomer for at være specifikke for rotter.
Based on preclinical and clinical mechanistic studies, Leydig cell tumours, renal tubule tumours, and pheochromocytomas are considered to be rat-specific.
Ud fra resultater fra kliniske lægemiddelinteraktionsstudier (f.eks. med escitalopram, zolpidem, ethinylestradiol) kan det ikke udelukkes, at telaprevir inducerer metaboliske enzymer.
Based on the results of drug-drug interaction clinical studies (e.g., escitalopram, zolpidem, ethinylestradiol), induction of metabolic enzymes by telaprevir cannot be excluded.
Ud fra resultaterne af en fuld række genotoksiske standardundersøgelser vurderes det, at aripiprazol ikke er genotoksisk.
Based on results of a full range of standard genotoxicity tests, aripiprazole was considered non- genotoxic.
Ud fra sager i litteraturen , kan para-aminosalicylsyre være forbundet med en øget risiko for hypothyreoidisme i HIV-smittede patienter.
Based on literature cases, para-aminosalicylic acid may be associated with an increased risk of hypothyroidism in HIV co-infected patients.
Ud fra virkningsmekanismen af ramucirumab er det sandsynligt, at ramucirumab hos dyr vil hæmme angiogenese og medføre uønskede effekter på fertilitet (ægløsning), placentaudvikling, voksende fostre og den postnatale udvikling.
Based on ramucirumab’s mechanism of action, it is likely that in animals, ramucirumab will inhibit angiogenesis and result in adverse effects on fertility (ovulation), placental development, developing foetuses and postnatal development.
Ud fra virkningsmekanismen kan anvendelse af NSAID-præparater forsinke eller forhindre ruptur af ovariefollikler, som har været forbundet med reversibel infertilitet hos nogle kvinder.
Based on the mechanism of action, the use of NSAIDs, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women.
Ud over APC'er (antigenpræsenterende celler) indeholder det færdige produkt således T- celler, B-celler, natural killer (NK)-celler og andre celler.
In addition to antigen presenting cells (APCs), the final product thus contains T cells, B cells, natural killer (NK) cells, and other cells.
Ud over at være en potent hæmmer af knogleresorption har zoledronsyre også adskillige anti-tumor egenskaber, der kan bidrage til den samlede virkning i behandling af metastaserende knoglesygdom.
In addition to being a potent inhibitor of bone resorption, zoledronic acid also possesses several anti- tumour properties that could contribute to its overall efficacy in the treatment of metastatic bone disease.
Ud over at være en potent hæmmer af knogleresorption, har zoledronsyre også adskillige anti-tumor egenskaber der kan bidrage til den samlede effekt i behandling af metastaserende knoglesygdom.
In addition to being a potent inhibitor of bone resorption, zoledronic acid also possesses several anti- tumour properties that could contribute to its overall efficacy in the treatment of metastatic bone disease.
Ud over at være en potent hæmmer af knogleresorption, har zoledronsyre også adskillige anti-tumor egenskaber, der kan bidrage til den samlede virkning i behandling af metastaserende knoglesygdom.
In addition to being a potent inhibitor of bone resorption, zoledronic acid also possesses several anti- tumour properties that could contribute to its overall efficacy in the treatment of metastatic bone disease.
Ud over at være en potent hæmmer af knogleresorption, har zolendronsyre også adskillige anti-tumor egenskaber der kan bidrage til den samlede effekt i behandling af metastaserende knoglesygdom.
In addition to being a potent inhibitor of bone resorption, zoledronic acid also possesses several anti- tumour properties that could contribute to its overall efficacy in the treatment of metastatic bone disease.
Ud over behovet for en revaccination ved 12 måneder i det komprimerede 0, 1, 2-måneders program er behovet for en boosterdosis af HBVAXPRO endnu ikke defineret .
The need for a booster dose of HBVAXPRO is not yet defined beyond the 12 month booster dose required for the 0, 1, 2 compressed schedule.
Ud over behovet for en revaccination ved 12 måneder i det komprimerede 0, 1, 2-måneders program er behovet for en boosterdosis af HBVAXPRO er endnu ikke defineret
The need for a booster dose of HBVAXPRO is not yet defined beyond the 12 month booster dose required for the 0, 1, 2 compressed schedule.
Ud over behovet for en revaccination ved 12 måneder i det komprimerede 0, 1, 2-måneders program er behovet for en boosterdosis af HBVAXPRO er endnu ikke defineret.
The need for a booster dose of HBVAXPRO is not yet defined beyond the 12 month booster dose required for the 0, 1, 2 compressed schedule.
Ud over bivirkninger nævnt herunder for Epivir kan du få andre sygdomme, når du får kombinationsbehandling mod hiv.
As well as the side effects listed below for Epivir, other conditions can develop during combination therapy for HIV.
Ud over bivirkninger ved Epivir nævnt nedenfor kan du få andre sygdomme, når du får kombinationsbehandling mod hiv.
As well as the side effects listed below for Epivir, other conditions can develop during combination therapy for HIV.
Ud over bivirkninger ved Lamivudin Teva Pharma B.V. nævnt nedenfor, kan du få andre sygdomme, når du får kombinationsbehandling mod hiv.
As well as the side effects listed below for Lamivudine Teva Pharma B.V., other conditions can develop during combination therapy for HIV.
Ud over de alvorlige bivirkninger, der er nævnt ovenfor, kan personer, der tager Tafinlar, også få andre bivirkninger.
Besides the serious side effects mentioned above, people taking Tafinlar may also get other side effects.
Ud over de antimikrobielle egenskaber udviser tulathromycin immunmodulerende og antiinflammatoriske virkninger i eksperimentelle studier.
In addition to its antimicrobial properties, tulathromycin demonstrates immune-modulating and anti- inflammatory actions in experimental studies.
Ud over de bivirkninger ved Lamivudin Teva, der er nævnt nedenfor, kan andre tilstande udvikle sig under behandling mod hepatitis B.
As well as the side effects listed below for Lamivudine Teva, other conditions can develop during therapy for hepatitis B.
Ud over de bivirkninger, som blev observeret i studiet, angives også bivirkninger baseret på erfaringer med lægemidlet efter markedsføringen jf. tabel 3.
In addition to the adverse reactions noted in the pivotal study, adverse reactions based on post-marketing experience with the medicinal product are provided after Table 3.
Ud over de laboratorietests, som normalt er nødvendige til monitorering af patienter med dissemineret sklerose, anbefales fuldstændig blodtælling og differentialtælling af hvide blodceller og blodpladetal samt blodkemi, herunder leverfunktionstests (f.eks.
In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential white blood cell counts, platelet counts, and blood chemistries, including liver function tests (e.g.
Ud over de laboratorietests, som normalt er nødvendige til monitorering af patienter med dissemineret sklerose, anbefales fuldstændig blodtælling og differentialtælling af hvide blodceller og blodpladetal samt blodkemi, herunder leverfunktionstests (f.eks. aspartat aminotransferase serum glutamin- oksalsyre transaminase (SGOT), alanin aminotransferase serum glutamat pyruvat transaminase (SGPT) og gamma-glutamyltransferase) før behandlingen indledes med regelmæssige intervaller efter Extavia-behandlingen og med mellemrum derefter, hvis der ikke foreligger nogen kliniske symptomer.
In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential white blood cell counts, platelet counts, and blood chemistries, including liver function tests (e.g. aspartate aminotransferase serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase serum glutamate pyruvate transaminase (SGPT) and gamma glutamyltransferase), are recommended prior to initiation and at regular intervals following introduction of Extavia therapy, and then periodically thereafter in the absence of clinical symptoms.
Ud over de opportunistiske infektioner kan autoimmune lidelser (hvor immunsystemet angriber rask kropsvæv) også opstå, efter du er begyndt at tage medicin til behandling af din hiv- infektion.
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Ud over de opportunistiske infektioner kan autoimmune sygdomme (skyldes, at immunsystemet angriber kroppens raske celler) også forekomme, efter du er begyndt at tage medicin mod din hiv- infektion.
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Ud over de opportunistiske infektioner, kan autoimmune lidelser (en tilstand, der opstår, når immunsystemet angriber sundt kropsvæv) også opstå, efter dit barn er begyndt at tage medicin til behandling af hiv infektionen.
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after your child starts taking medicines for the treatment of your child’s HIV infection.
Ud over de ovenfor nævnte bivirkninger er der rapporteret om overfølsomhedsreaktioner hos brugere af IOA (hyppighed ikke kendt).
In addition to the above mentioned adverse reactions, hypersensitivity reactions have been reported in IOA users (frequency unknown).
Ud over den ambulante procedure til remodellering af penis skal patienten have udleveret instruktioner i den passende teknik til hjemme dagligt at udføre remodellering af penis i en 6-ugers periode efter lægebesøget med remodellering af penis i hver behandlingscyklus, i henhold til de detaljerede anvisninger, der gives i indlægssedlen.
In addition to the in-office penile modeling procedure, patients should be provided instructions on the appropriate technique to self-perform penile modeling activities at home each day for the 6-week period following the physician penile plaque modeling visit of each treatment cycle, according to the detailed instructions provided in the package leaflet.
Ud over dette kan capecitabin, når det anvendes alene, have følgende meget almindelige bivirkninger, som kan påvirke flere end 1 person ud af 10:
In addition to the above, when capecitabine is used alone, the very common side effects which may affect more than 1 in 10 people are:
Ud over dette kan Capecitabine Teva når det anvendes alene have følgende meget almindelige bivirkninger, som kan påvirke flere end 1 ud af 10 personer:
In addition to the above, when capecitabine is used alone, very common side effects which may affect more than 1 in 10 people are:
Ud over et let fald i antallet af levedygtige implantationer indikerede studier hos dyr med liraglutid ikke nogen skadelig effekt, hvad angår fertilitet.
Apart from a slight decrease in the number of live implants, animal studies with liraglutide did not indicate harmful effects with respect to fertility.
Ud over et let fald i antallet af levedygtige implantationer, indikerede studier hos dyr ikke nogen skadelig effekt hvad angår fertilitet.
Apart from a slight decrease in the number of live implants, animal studies did not indicate harmful effects with respect to fertility.
Ud over fase III EINSTEIN-programmet er der gennemført et åbent, prospektivt, ikke-interventions- kohortestudie (XALIA) med central evaluering af resultaterne, herunder recidiverende VTE, alvorlige blødninger og død.
In addition to the phase III EINSTEIN program, a prospective, non-interventional, open-label cohort study (XALIA) with central outcome adjudication including recurrent VTE, major bleeding and death has been conducted.
Ud over fase III-studiet ROCKET AF er der efter godkendelse gennemført et åbent, prospektivt, ikke- interventions kohortestudie med en enkelt arm (XANTUS) med central evaluering af resultaterne, herunder tromboemboliske hændelser og alvorlige blødninger.
In addition to the phase III ROCKET AF study, a prospective, single-arm, post-authorization, non- interventional, open-label cohort study (XANTUS) with central outcome adjudication including thromboembolic events and major bleeding has been conducted.
Ud over fase III-studiet ROCKET AF er der efter godkendelse gennemført et åbent, prospektivt, ikke- interventions-kohortestudie med en enkelt arm (XANTUS) med central evaluering af resultaterne, herunder tromboemboliske hændelser og alvorlige blødninger.
In addition to the phase III ROCKET AF study, a prospective, single-arm, post-authorization, non- interventional, open-label cohort study (XANTUS) with central outcome adjudication including thromboembolic events and major bleeding has been conducted.
Ud over hydrolyse elimineres topotecan overvejende renalt som en mindre komponent, der metaboliseres til N-desmetylmetabolit (SB-209780) og er fundet i plasma, urin og fæces.
Other than hydrolysis, topotecan is cleared predominantly renally, with a minor component metabolized to the N-desmethyl metabolite (SB-209780) identified in plasma, urine and faeces.
Ud over ovennævnte bivirkninger er der ved brug af risperidon-præparater observeret følgende bivirkninger, som også kan forventes at forekomme med Xeplion.
In addition to the above adverse reactions, the following adverse reactions have been noted with the use of risperdone products and can be expected to occur with Xeplion.
Ud over ovenstående oplysninger om specifik lægemiddelinteraktion er der ikke udført interaktions- forsøg med clopidogrel og visse lægemidler, som almindeligvis gives til patienter med aterotrombotiske sygdomme.
Apart from the specific medicinal product interaction information described above, interaction studies with clopidogrel and some medicinal products commonly administered in patients with atherothrombotic disease have not been performed.
Ud over ovenstående oplysninger om specifik lægemiddelinteraktion er der ikke udført interaktions- studier med clopidogrel og visse lægemidler, som almindeligvis gives til patienter med aterotrombotiske sygdomme.
Apart from the specific medicinal product interaction information described above, interaction studies with clopidogrel and some medicinal products commonly administered in patients with atherothrombotic disease have not been performed.
Ud over patientens sædvanlige hjemmekontrol af glucose i blod og/eller urin skal patientens blodglucose også kontrolleres regelmæssigt af lægen for at fastsætte mindste effektive dosis for patienten.
In addition to the usual self-monitoring by the patient of blood and/or urinary glucose, the patient’s blood glucose must be monitored periodically by the physician to determine the minimum effective dose for the patient.
Ud over smerterne kan du føle dig svedig, stakåndet, døsig og svag og have kvalme eller du kan besvime.
You may feel sweaty, breathless, fatigued, nauseous and faint in addition to the pain
Ud over studie 1 foreligger der også effektdata for patienter med CD fra et fase 1-studie med en enkelt arm (studie 2).
In addition to Study 1, efficacy data are available in patients with CD from a single arm Phase 1 study (Study 2).
Ud over thalidomid findes der hydrolyseprodukter, N-(o-karboxybenzoyl)-glutarimid og ftaloylisoglutamin dannet via non- enzymatiske processer, i plasma og specielthovedsageligt i urinen.
In addition to thalidomide, hydrolytic products N-(o- carboxybenzoyl) glutarimide and phthaloyl isoglutamine formed via non-enzymatic processes are also present in plasma and in majority in urine.
Ud over udvikling af antistoffer (inhibitorer) hos børn, der ikke var behandlet tidligere, og komplikationer i forbindelse med katetre, blev der ikke set alderspecikke forskelle i bivirkningerne i de kliniske forsøg.
Other than the development of inhibitors in previously untreated paediatric patients (PUPs), and catheter-related complications, no age-specific differences in side effects were noted in the clinical studies.
Ud over udvikling af inhibitorer hos tidligere ubehandlede pædiatriske patienter og kateterrelaterede komplikationer blev der ikke bemærket nogle aldersspecifikke bivirkninger i de kliniske studier.
Other than the development of inhibitors in previously untreated paediatric patients (PUPs), and catheter-related complications, no age-specific differences in ADRs were noted in the clinical studies.
Ud tag den mængde af lægemidlet, der svarer til den beregnede daglige vedligeholdelsesdosis (Trin 1), fra hætteglasset.
Remove the volume of medicinal product equal to the calculated daily maintenance dose (Step 1) from the vial.
Ud tag det volumen af lægemidlet, der svarer til den beregnede daglige vedligeholdelsesdosis (Trin 1), fra hætteglasset.
Remove the volume of medicine equal to the calculated daily maintenance dose (Step 1) from the vial.
Ud tag det volumen af lægemidlet, der svarer til den beregnedemætningsdosis (Trin 1), fra hætteglasset.
Remove the volume of medicine equal to the calculated loading dose (Step 1) from the vial.
Ud tag detvolumen af lægemidlet, der svarer til den beregnede mætnings dosis (Trin 1), fra hætteglasset.
Remove the volume of medicinal product equal to the calculated loading dose (Step 1) from the vial.
Udadgående bule i navleområdet (navlebrok)
Outward bulge in the navel area (Umbilical hernia)
Udbredelsen og graden af fordeling til forskellige compartments i kroppen er ikke blevet fuldstændigt undersøgt.
The extent and degree of distribution to various body compartments have not been fully studied.
Udbredt betændelse i lungerne, hvilket kan medføre ardannelse
Widespread inflammation of the lungs which may lead to scarring
udbredt hududslæt
widespread skin rash
Udbredt hævelse, udbredte smerter, muskelskeletale brystsmerter, ledstivhed, betændelse i hæle.
general swelling, general pain, musculoskeletal chest pain, stiffness of joint, inflammation of the heel
Udbredt kløe og en følelse af varme – der især berører hovedbunden, munden, halsen, håndfladerne og fodsålerne
General itching and feeling of heat – especially affecting the scalp, mouth, throat, palms or soles of your feet
Udbredt sygdom
Bulky disease:
Udbredt udslæt med blærer og skællende hud, især omkring munden, næsen, øjnene og kønsdelene (Stevens-Johnsons syndrom), og en mere alvorlig form, der forårsager hudafskalning på mere end 30 % af kropsoverfladen (toksisk epidermal nekrolyse)
A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens–Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
udbredte
generalized
Udbredte blodpropper og blødning
widespread blood clotting and bleeding
Udbredte hudreaktioner, fx kløe, nældefeber eller udslæt
Generalised skin reactions such as itching, hives or rash
Udbrud af en influenzapandemi forekommer, når der opstår en ny type (stamme) af et influenzavirus, der let smitter fra menneske til menneske, fordi mennesker er uden immunitet (beskyttelse) mod den.
A flu pandemic occurs when a new type (strain) of flu virus emerges that can spread easily from person to person because people have no immunity (protection) against it.
Udbrud af en influenzapandemi forekommer, når der opstår en ny type (stamme) af et influenzavirus, der let smitter fra person til person, fordi mennesker ikke er immune over for den.
A flu pandemic occurs when a new type (strain) of flu virus emerges that can spread easily from person to person because people have no immunity (protection) against it.
Udbruddene tog til efter den 8 ugers profylaktiske periode, hvorefter de aftog gradvist med tiden (henholdsvis 64 % og 70 % af deltagerne blev behandlet for udbrud af arthritis urica i perioden uge 8- 52).
After the 8-week prophylaxis period, the incidences of flares increased and gradually decreased over time (64% and 70% of subjects received treatment for gout flares from Week 8-52).
Uddannelsen af patienten og/eller plejepersonalet skal omfatte følgende områder:
The training to be provided to the patient and /or caregiver should address the following elements:
Uddannelseskort for patienter
Educational card for patients
Uddannelsesmateriale (herunder tjekliste for ordinerende person) for sundhedspersonale
Educational material (including prescriber checklist) for the healthcare professionals
Uddannelsesmateriale for læger
Physician educational material
Uddannelsesmateriale for sundhedspersonale
Educational material for Healthcare Professionals
Uddannelsesmateriale for sundhedspersoner
Educational material for Healthcare professionals
Uddannelsesmateriale for sundhedspersoner
Physician educational material
Uddannelsesmateriale omkring ABC-overfølsomhedsreaktion til sundhedsprofessionelle
ABC HSR educational material for health care professionals
Uddannelsesmateriale til al apotekspersonale skal indeholde følgende:
Educational material for the pharmacists should highlight the following:
Uddannelsesmateriale til lægen
The Physician Educational Materials (PEM)
Uddannelsesmateriale til læger
Healthcare professional educational material
Uddannelsesmateriale til læger
Physician educational material
Uddannelsesmateriale til læger og sundhedspersonale
Healthcare professionals educational material
Uddannelsesmateriale til læger og sundhedspersonale
Physician educational material
Uddannelsesmateriale til medarbejdere i sundhedssektoren
Educational material for health care providers
Uddannelsesmateriale til patienter
Patient educational material
Uddannelsesmateriale til patienter og plejepersonale
Educational material for patients and caregivers
Uddannelsesmateriale til sundhedspersonale
Educational material for Healthcare Professionals
Uddannelsesmateriale til sundhedspersonale skal indeholde oplysninger om de følgende hovedpunkter:
The educational material for Healthcare Professionals should include information on the following key elements:
uddannelsesmateriale til sundhedspersoner patientadvarselskort
Educational material for Healthcare Professionals (HCPs)
Uddannelsesmaterialet bør inkludere NEURACEQ PET-scanningscases med korrekt fortolkning af PET-scanningen foretaget af en erfaren aflæser af NEURACEQ-PET-scanninger til selvevaluering og en selvkvalificerende procedure, der skal tilbydes hver person i oplæring.
The training material should include NEURACEQ PET demonstration cases with correct PET scan interpretation by an experienced reader NEURACEQ-PET scans for self-assessment and a self-qualification procedure to be offered to each trainee.
Uddannelsesmaterialet for personer, der ikke er sundhedspersonale, skal indeholde information om de følgende nøgleelementer:
The educational material for non healthcare professionals should include information on the following key elements:
Uddannelsesmaterialet for sundhedspersoner skal indeholde:
The health professional educational material should contain: