natgillin/translations-raw huggingface dataset:
For 64Cu-mærkede lægemidler fremstillet ved mærkning med Cuprymina vil de farmakokinetiske egen-skaber afhænge af det mærkede lægemiddel.
The pharmacokinetic properties of 64Cu-labelled medicinal products prepared by radiolabelling with Cuprymina, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
For 64Cu-mærkede lægemidler, der er fremstillet ved radioaktiv mærkning med Cuprymina, vil de far- makodynamiske egenskaber afhænge af det lægemiddel, der skal mærkes radioaktivt.
The pharmacodynamic properties of 64Cu-labelled medicinal products prepared by radiolabelling with Cuprymina, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
For 64Cu-mærkede lægemidler, der fremstilles ved radioaktiv mærkning med Cuprymina inden indgift, vil de toksikologiske egenskaber afhænge af det mærkede lægemiddel.
The toxicological properties of 64Cu-labelled medicinal products prepared by radiolabelling with Cuprymina prior to administration will be dependent on the nature of the medicinal product to be radiolabelled.
For 98 % af indgrebene blev der ikke rapporteret nogen HAE-anfald inden for 72 timer efter Cinryze-dosis.
For 98% of procedures, no HAE attacks were reported within the 72 hours after the Cinryze dose.
For adjuvanter, se afsnit 2
For adjuvants, see section 2.
for afatinibrelaterede bivirkninger.
ADRs related to afatinib.
For aktiv immunisering af grise fra 2 ugers alderen mod porcint circovirus type 2 (PCV2) for at reducere dødelighed, kliniske symptomer - inklusive vægttab - og læsioner i lymfevæv som følge af PCV2 relaterede sygdomme (PCVD).
For active immunisation of pigs from the age of 2 weeks against porcine circovirus type 2 (PCV2) to reduce mortality, clinical signs - including weight loss - and lesions in lymphoid tissues associated with PCV2 related diseases (PCVD).
For aktiv immunisering af røde ræve og mårhunde for at forebygge rabiesvirus infektion.
For the active immunisation of red foxes and raccoon dogs to prevent infection by rabies virus.
For Al/Al blister og HDPE tabletbeholder
For Al/Al blisters and HDPE tablet container
For Al/Al blister og HDPE tabletbeholder:
For Al/Al blisters and HDPE tablet container:
For alle 3 doser PROCOMVAX fandtes ikke nogen væsentlige forskelle i hyppigheden af bivirkninger mellem PROCOMVAX og de monovalente vacciner Merck PRP-OMPC vaccine og Merck Hepatitis B (rekombinant) vaccine.
Across all three doses of PROCOMVAX, there were no significant differences in the frequency of adverse experiences between PROCOMVAX and the monovalent vaccines Merck PRP- OMPC Vaccine and Merck Hepatitis B (Recombinant) Vaccine.
For alle aldersgrupper:
For all age groups:
For alle analyserede undergrupper (alder, sensitivitet for tidligere hormonbehandling, antallet af involverede organer, status for læsioner i knogler alene ved baseline og tilstedeværelse af visceral metastase samt på tværs af store demografiske og prognostiske undergrupper) sås en positiv behandlingsvirkning med everolimus + exemestan med en estimeret risiko-ratio versus placebo + exemestan på mellem 0,25 og 0,60.
For all analysed subgroups (age, sensitivity to prior hormonal therapy, number of organs involved, status of bone-only lesions at baseline and presence of visceral metastasis, and across major demographic and prognostic subgroups) a positive treatment effect was seen with everolimus + exemestane with an estimated hazard ratio versus placebo + exemestane ranging from 0.25 to 0.60.
For alle endepunkterne beskrevet ovenfor blev der også påvist statistisk signifikante resultater i OSI- populationen ved uge 16.
For all of the endpoints described above, statistically significant results were also demonstrated in the OSI population.
For alle indikationer bør en enkelt mætningsdosis på 70 mg/m2 (som ikke må overstige en faktisk dosis på 70 mg) administreres på
For all indications, a single 70-mg/m2 loading dose (not to exceed an actual dose of 70 mg) should be administered on
For alle informationer om dette lægemiddel kontakt indehaveren af markedsføringstilladeolsen på følgende e-mail adresse: infoixiaro@valneva.com
For any information about this medicine, please contact the Marketing Authorization Holder by the following email-address: infoixiaro@valneva.com
For alle kontrollerede studier var seponeringsraten på grund af bivirkninger 12,2 % for patienter randomiseret til lacosamid, og 1,6 % for patienter randomiseret til placebo.
Over all controlled studies, the discontinuation rate due to adverse reactions was 12.2% for patients randomized to lacosamide and 1.6% for patients randomized to placebo.
For alle kontrollerede studier var seponeringsraten på grund af bivirkninger 12,2 % for patienter randomiseret til lacosamid, og 1,6% for patienter randomiseret til placebo.
Over all controlled studies, the discontinuation rate due to adverse reactions was 12.2% for patients randomized to lacosamide and 1.6% for patients randomized to placebo.
For alle patienter med cirrose, uanset om de har ikke-detekterbart HCV-RNA (HCV-RNA ikke påvist) i uge 4 eller 12, anbefales supplerende behandling i 36 uger med pegyleret interferon-alfa og ribavirin alene, så den samlede behandlingsvarighed bliver 48 uger (se pkt.
For all patients with cirrhosis irrespective of undetectable HCV RNA (target not detected) at weeks 4 or 12, an additional 36 weeks of peginterferon alfa and ribavirin alone for a total treatment duration of 48 weeks is recommended (see section 5.1).
For alle patienter med nedsat nyrefunktion rådes der til forsigtighed og nøje sikkerhedsovervågning (se pkt.
For all patients with renal impairment, caution and close safety monitoring is advised. (See section 5.2)
For alle patienter med tidligere forhøjede transaminaser bør der overvejes en hyppigere monitorering af leverfunktionsprøverne.
For all patients with a history of transaminase elevations, more frequent monitoring of liver function tests should be considered.
For alle patienter, der indrulleres i studie CT-AMT-011-01, skal der desuden fore- lægges en revurdering af immunresponsen med en godkendt analysemetode.
Re-evaluation of immune responses from all patients enrolled in study CT-AMT- 011-01 by using a validated assay method should also be provided.
For anbefalet dosis '0,75 mg/m2'
For recommended dose '0.75 mg/m2'
For anbefalet dosis '1,5 mg/m2'
For recommended dose '1.5 mg/m2'
For andre grad 3 eller 4 bivirkninger, der bedømmes at være relateret til pomalidomid, skal behandlingen stoppes og genstartes med 1 mg mindre end den tidligere dosis, når bivirkningen er lindret til ≤ grad 2 efter lægens bedømmelse.
For other Grade 3 or 4 adverse reactions judged to be related to pomalidomide, stop treatment and restart treatment at 1 mg less than the previous dose when an adverse reaction has resolved to ≤ Grade 2 at the physician’s discretion.
For andre grad 3 eller 4 toksiciteter, der bedømmes til at være relateret til lenalidomid, bør behandlingen stoppes og kun genstartes ved det næste lavere dosisniveau, når toksiciteten er vendt tilbage til ≤ grad 2, afhængig af lægens skøn.
For other grade 3 or 4 toxicities judged to be related to lenalidomide, treatment should be stopped and only restarted at next lower dose level when toxicity has resolved to ≤ grade 2 depending on the physician’s discretion.
For andre lægemidler er avanafils potentiale for at gribe ind i den P-gp- medierede transport ukendt.
The potential of avanafil to interfere with the transport of other medicinal products mediated by P-gp is not known.
For andre PDE5-hæmmere er der er indberettet nogle få tilfælde af hæmaturi, hæmatospermi og blødning fra penis i undersøgelser efter markedsføring og kliniske forsøg.
Haematuria, haematospermia and penile haemorrhage has been reported in a small number of post- marketing and clinical trial cases with other PDE5 inhibitors.
For andre PDE5-hæmmere er der indberettet et lille antal tilfælde af ikke-arteritisk anterior iskæmisk opticusneuropati (NAION) og pludseligt høretab i undersøgelser efter markedsføring og kliniske forsøg.
Non-arteritic anterior ischaemic optic neuropathy (NAION) and sudden loss of hearing have been reported in a small number of postmarketing and clinical trial cases with other PDE5 inhibitors.
For andre PDE5-hæmmere er der indberettet nogle få tilfælde af priapisme i forsøg efter markedsføring og kliniske undersøgelser.
Priapism has been reported in a small number of post-marketing and clinical trial cases with other PDE5 inhibitors.
For andre substrater af BCRP (f.eks. methotrexat, topotecan, sulfasalazin, daunorubicin, doxorubicin) og OATP-familien, især HMG-CoA reduktasehæmmere (f.eks. simvastatin, atorvastatin, pravastatin, methotrexat, nateglinid, repaglinid, rifampicin), bør samtidig administration også ske med forsigtighed.
For othersubstrates of BCRP (e.g. methotrexate, topotecan, sulfasalazine, daunorubicin, doxorubicin) and the OATP family especially HMG-CoA reductase inhibitors (e.g. simvastatin, atorvastatin, pravastatin, methotrexate, nateglinide, repaglinide, rifampicin) concomitant administration should also be undertaken with caution.
For anti- cardiolipin IgA-antistoffer sås en reduktion på 37 % ved uge 52 (p=0,0003), for anti-cardiolipin IgG- antistoffer sås en reduktion på 26 % ved uge 52 (p=0,0324) og for anti-cardiolipin IgM-antistoffer sås en reduktion på 25 % (p=NS, 0,46).
For anti-cardiolipin IgA antibody a 37% reduction at Week 52 was seen (p=0.0003), for anti-cardiolipin IgG antibody a 26% reduction at Week 52 was seen (p=0.0324) and for anti-cardiolipin IgM a 25% reduction was seen (p=NS, 0.46).
For antipsykotiske lægemidler er der rapporteret om forekomst af malignt neuroleptikasyndrom, som er karakteriseret ved hypertermi, muskelrigiditet, autonom ustabilitet, ændret bevidsthedsniveau og forhøjet serumkreatinfosfokinase inklusive lurasidon.
Neuroleptic Malignant Syndrome, characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels, has been reported to occur with antipsychotics including lurasidone.
For anvendelse af EQUIOXX i en dosis på 0,1 mg firocoxib/kg skal sprøjtens stempel sættes på den vægtinddeling, der passer til hestens vægt.
To administer EQUIOXX at the dose of 0.1 mg firocoxib/kg, set the syringe plunger to the appropriate dose division for the horse’s weight.
For at adressere tilbageblevne sikkerhedsspørgsmål hvad angår den nye type produkt, og usikkerheden om mulige interaktioner af samtidigt anvendte produkter under operationen og i den post-operative periode, skal indehaveren af markedsføringstilladelsen arrangere indsamling og vurdering af detaljerede data om den kliniske sikkerhed af produktet fra en repræsentativ prøvestørrelse af hunde.
To address the safety concerns remaining in relation to the novel type of product, and the uncertainty about possible interactions of concomitantly used products during the operation and in the post- operative period, the marketing authorisation holder should arrange for collation and assessment of detailed data on the clinical safety of the product in a representative sample of dogs.
For at afmåle dosis så præcist som muligt, skal det øverste del af stemplet være lige ud for mærket på den dosis der skal anvendes. (Figur 8).
To measure the dose accurately, the top edge of the plunger should be lined up with the appropriate graduated mark on the oral dosing syringe (figure 8).
For at afmåle dosis så præcist som muligt, skal det øverste del af stemplet være lige ud for mærket på den dosis, der skal anvendes. (figur 8).
To measure the dose accurately, the top edge of the plunger should be lined up with the appropriate graduated mark on the oral dosing syringe (figure 8).
For at aktivere menuen “opstart/titrering” skal du først vælge
Too activate the “initiation/titration” menu you need to first select
For at anvende denne doseringstabel er det nødvendigt at beregne p atientens kreatininclearance (CLcr) i ml/min.
To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed.
For at anvende en EXUBERA blister skal De først dele blisterne fra bagsiden ved at rive langs linjen (perforeringen).
To use an EXUBERA blister, first separate the blister from the spine by tearing along the tear line (perforation).
For at at gøre det muligt at starte behandlingen med en lav dosis, kan der anvendes en alternativ formulering (oral opløsning) som mere egnet end Aripiprazole Sandoz tabletter.
To allow the start of the treatment at a low dose you can use an alternative formulation (oral solution - liquid) more suitable than Aripiprazole Sandoz tablets.
For at begrænse den mængde produkt, som dyret kan slikke i sig, er det vigtigt, at produktet påføres huden som beskrevet.
It is important to apply the dose as indicated to minimise the quantity that the animal can lick off.
For at begrænse fremtidig resistensudvikling bør brugen af produktet derfor være baseret på en vurdering af det enkelte tilfælde samt lokal epidemiologisk viden om den aktuelle følsomhed hos målarten.
Therefore, the use of this product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.
For at behandle blødninger hos børn var en højere gennemsnitsdosis (43,9 IE/kg) af Nuwiq nødvendig end hos voksne (33,0 IE/kg), og det var nødvendigt med en højere gennemsnitsdosis til behandling af moderate til større blødninger end til mindre blødninger (78,2 IE/kg vs.
A higher median dose of Nuwiq was required to treat bleedings in children (43.9 IU/kg) than in adults (33.0 IU/kg), and a higher median dose was required to treat moderate to major than minor bleedings (78.2 IU/kg vs.
For at bekræfte diagnosen anbefales scanning af hjernen.
To confirm the diagnosis, brain imaging is recommended.
For at bekræfte validiteten af ansøgerens påstand af ændringer i antistoftitre med tiden, skal ansøgeren levere statusrapporter for ekstra batches af serumanalyser fra fremtidige kliniske studier
In order to confirm the validity of the applicant’s claims regarding changes in antibody titres over time, the applicant should provide status reports on additional batched serum analysis of future clinical studies
For at bekræfte, at der kommer en stråle af insulin ud gennem nålen, når du trykker doseringsknappen ind.
Confirms that a stream of insulin comes out of the tip of the needle when you push the Dose Knob in.
For at beregne BSA anbefales det at bruge Mosteller´s ligning:
To calculate BSA, it is recommended to use Mosteller’s equation:
For at beregne den nødvendige dosis (i ml) skal kroppens overflade ganges med 3,1 for doser på 250 mg/ m2, med 3,8 for doser på 300 mg/ m2, og med 4,4 for 350 mg/ m2.
To calculate the volume to be administered (in ml) the body surface area should be multiplied by a factor of: 3.1 for a dose of 250 mg/m²; 3.8 for one of 300 mg/m²; and by 4.4 for 350 mg/m².
For at beregne den nødvendige dosis (i ml) skal kroppens overflade ganges med: 25 for doser på 250 mg/ m2, med 30 for doser på 300 mg/ m2, og med 35 for 350 mg/ m2.
To calculate the volume to be administered (in mL) for intermediate body surface areas not included in the above table, the body surface area should be multiplied by a factor of: 25 for a dose of 250 mg/m²; 30 for 300 mg/m²; and 35 for 350 mg/m².
For at beskytte andre personer mod at blive smittet med hepatitis B:
To protect other people from becoming infected with hepatitis B:
For at beskytte Dem selv og andre mod nålestik er det meget vigtigt at kassere alle sprøjter med den påsatte kanyle og placere dem i den brudsikre beholder straks efter brug.
To protect yourself and others from possible needle sticks, it is very important to throw away every syringe, with the needle attached, in the puncture-resistant container right after use.
For at bevare egenskaberne ved den modificerede udløsning må tabletterne ikke deles, brydes, knuses eller tygges, før de sluges.
To preserve the modified-release properties, the tablets must not be split, broken, crushed, or chewed before
For at bevare egenskaberne ved den modificerede udløsning, må tabletterne ikke deles, brydes, knuses eller tygges, før de sluges.
To preserve the modified-release properties, the tablets must not be split, broken, crushed, or chewed before
For at bevare en forbindelse mellem patienten og den pågældende batch af lægemidlet anbefales det stærkt, at produktets navn og batchnummer registreres, hver gang Nuwiq administreres til en patient.
It is strongly recommended that every time that Nuwiq is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
For at blive inkluderet i begge studier skulle behandlingsnaive patienter have genotypisk sensitivitet over for REYATAZ og to NRTI’er, og behandlingserfarne patienter skulle have dokumenteret genotypisk og fænotypisk sensitivitet ved screening over for REYATAZ og mindst 2 NRTI’er.
For inclusion in both trials, treatment-naive patients had to have genotypic sensitivity to REYATAZ and two NRTIs, and treatment-experienced patients had to have documented genotypic and phenotypic sensitivity at screening to REYATAZ and at least 2 NRTIs.
For at blive inkluderet i studiet skulle patienterne have total bilirubin på ≤ 1,5 mg/dl og AST og ALT ≤ 3 gange ULN, eller ≤ 5 gange ULN ved tilstedeværelse af levermetastaser.
To be included in the study, patients were required to have total bilirubin of ≤1.5 mg/dl and AST and ALT ≤3 times ULN, or ≤5 times ULN if liver metastases were present.
For at blive kvalificeret som havende utilstrækkeligt respons på laksantia skulle patienterne i de to uger inden det første studiebesøg have rapporteret om symptomer på opioidinduceret obstipation af mindst moderat sværhedsgrad, selvom de tog mindst en klasse af laksantia i mindst fire dage inden studieperioden.
To qualify as LIR, in the two weeks prior to first study visit patients had to have reported concurrent OIC symptoms of at least moderate severity while taking at least one laxative class for a minimum of four days during the pre-study period.
For at bruge dette lægemiddel skal De have et BMI over 17 (efter drænage af ascites-væsken) og et Karnofsky Index over 60.
You are required to have a BMI above 17 (after drainage of the ascites fluid) and a Karnofsky Index above 60 to use this medicine.
For at bruge din Genuair-inhalator er der 2 trin, du skal udføre, efter at have taget hætten af:
To use your Genuair inhaler there are 2 steps you need to perform after removing the cap:
For at bruge din Genuair-inhalator skal du gøre to ting, efter du har taget hætten af:
To use your Genuair inhaler there are 2 steps you need to perform after removing the cap:
For at bryde forseglingen bøjes den længste ende ned og op, indtil den brækker (se billede 13).
To break the seal, bend the larger end down and then up until broken (see Diagram 13).
For at CYSTAGON skal virke korrekt, er følgende vigtigt:
In order for CYSTAGON to work correctly, you must do the following:
For at dette lægemiddel skal virke, skal det tages dagligt som foreskrevet.
In order for this medicine to work, it should be taken daily as prescribed.
For at dit barn får den bedste beskyttelse , er det nødvendigt at følge lægens råd om, hvornår dit barn skal have yderligere doser Synagis.
For your child’s best protection, it is necessary to take the doctor’s advice about when to return for additional doses of Synagis.
For at dit barn får den bedste beskyttelse, er det nødvendigt at følge lægens råd om, hvornår dit barn skal have yderligere doser Synagis.
For your child’s best protection, it is necessary to take the doctor’s advice about when to return for additional doses of Synagis.
For at du får hele din dosis, skal medicinen blandes godt.
To get your full dose the medicine must be mixed well.
For at en blødning i et kritisk område eller kritisk organ kan klassificeres som MBE, skal den kunne tilknyttes en symptomatisk klinisk tilstand
In order for bleeding in a critical area or organ to be classified as a MBE it had to be associated with a symptomatic clinical presentation
For at en blødning i et kritisk område eller kritisk organ kan klassificeres som MBE, skal den kunne tilknyttes en symptomatisk klinisk tilstand.
In order for bleeding in a critical area or organ to be classified as a MBE it had to be associated with a symptomatic clinical presentation
For at fastholde et vægttab er det ikke nok at ændre kosten i en kortere periode og så genoptage de gamle vaner.
Successful weight loss is not just about eating differently for a short period of time before reverting to your old habits.
For at finde frem til, hvornår det er bedst at høste stamcellerne, skal De til blodprøvekontrol hos lægen.
Your doctor will monitor your blood to determine the best time to collect the stem cells.
For at fjerne blokeringen:
To clear the jam:
For at fjerne luft peges sprøjten med kanylen opad.
To remove air, point the syringe needle upwards.
For at fjerne luft, der kan være i nålen, eller der kan have samlet sig i insulinampullen ved normal brug.
Removes air that may collect in the needle or insulin cartridge during normal use.
For at fjerne luftbobler fra den fyldte injektionssprøjte skal du holde injektionssprøjten med kanylen pegende opad.
To remove air bubbles from the pre- filled syringe, hold the syringe with the needle pointing up.
For at fjerne skruelåget fra flasken skal det drejes mod uret og skrues helt af (fig.
For removing the screw cap from the bottle the cap must be turned anticlockwise and unscrewed completely (fig.1).
For at forbedre absorptionen af posaconazol bør det så vidt muligt tages med eller umiddelbart efter et måltid eller et ernæringstilskud (se punkt 3 ”Sådan skal du tage Noxafil”).
To improve absorption of posaconazole, whenever possible it should be taken during or immediately after food or a nutritional drink (see section 3 “How to take Noxafil”).
For at forbedre den gastrointestinale tolerance er startdosis 0,6 mg liraglutid dagligt.
To improve gastro­intestinal tolerability, the starting dose is 0.6 mg liraglutide daily.
For at forbedre ensartetheden af vaccinationen holdes kyllingerne inde i transportkassen i mindst 1 time, så de får indtaget alle vaccinedråberne.
To improve the uniformity of the vaccination maintain the chicks inside the transportation box for at least 1 hour in order to let them ingest all the vaccine droplets.
For at forbedre sporbarheden af biologiske lægemidler bør handelsnavnet af det administrerede præparat tydeligt registreres (eller angives) i patientjournalen.
In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
For at forbedre sporbarheden af biologiske lægemidler, skal det administrerede produkts handelsnavn tydeligt registreres (eller angives) i patientjournalen.
In order to improve the traceability of biological medicinal products, the tradename of the administered product should be clearly recorded (or stated) in the patient file.
For at forbedre sporbarheden af biologiske præparater skal handelsnavnet og batchnummeret for det administrerede præparat registreres tydeligt.
In order to improve traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.
For at forbedre sporbarheden af erythropoietin stimulerende stoffer (ESA’er) bør navnet på det ordinerede ESA angives i patientens journal.
In order to improve the traceability of erythropoiesis-stimulating agents (ESAs), the name of the prescribed ESA should be clearly recorded (or: stated) in the patient file.
For at forbedre sporbarheden af erythropoietin-stimulerende stoffer (ESA’er) bør navnet på det ordinerede ESA angives i patientens journal.
In order to improve the traceability of erythropoiesis-stimulating agents (ESAs), the name of the prescribed ESA should be clearly recorded (or: stated) in the patient file.