FrancophonIA/ELRC3.0 huggingface dataset:
English: Prontax 5 mg/ml pour-on solution for cattle (and associated names) contains doramectin.
Danish: Prontax, pour-on opløsning, 5 mg/ml, til kvæg (og relaterede navne) indeholder doramectin.
English: Based on evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Prontax 5 mg/ml pour-on solution for cattle and associated names is deemed to be positive provided that the recommended risk mitigation measures are added to the product information regarding risk to aquatic organisms and dung fauna.
Danish: På grundlag af de foreliggende data anså CVMP benefit/risk-forholdet for at være positivt for Prontax, pour-on opløsning, 5 mg/ml, forudsat at der i produktoplysningerne tilføjes de anbefalede foranstalt
English: referral for Prontax 5 mg/ml pour-on solution for cattle and associated names
Danish: 1, for Prontax, pour-on opløsning til kvæg, 5 mg/ml, og relaterede navne
English: Opinion following an Article 33(4)F F referral for Prontax 5 mg/ml pour-on solution for cattle and associated names
Danish: Udtalelse efter en indbringelse i henhold til artikel 33, stk. 4F F, for Prontax, pour-on opløsning til kvæg, 5 mg/ml, og relaterede navne EMA/421633/2012
English: recommending the granting of a Marketing Authorisation for Prontax 5 mg/ml pour-on solution for cattle and associated names.
Danish: Den 8. februar 2012 vedtog CVMP derfor en positiv udtalelse og anbefalede udstedelse af markedsføringstilladelse for Prontax, pour-on opløsning, 5 mg/ml, til kvæg, og relaterede navne.
English: The active substance in Pioglitazone Teva Generics, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Danish: Det aktive stof i Pioglitazone Teva Generics, pioglitazon, gør cellerne (fedt, muskel og lever) mere følsomme over for insulin, hvilket betyder, at kroppen bedre udnytter den insulin, den selv danner.
English: This means that Pioglitazone Teva Generics is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Danish: Det betyder, at Pioglitazone Teva Generics er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU), kaldet Actos.
English: The CHMP concluded that, in accordance with EU requirements, Pioglitazone Teva Generics had been shown to have comparable quality and to be bioequivalent to Actos.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Pioglitazone ratio er af sammenlignelig kvalitet og er bioækvivalent med Actos.
English: Pioglitazone Teva Generics was to be used to treat type 2 diabetes in adults, particularly those who are overweight.
Danish: Pioglitazone Teva Generics skulle have været anvendt til behandling af type 2-diabetes hos voksne, især overvægtige.
English: Pioglitazone Teva Generics was developed as a ‘generic medicine'.
Danish: Pioglitazone Teva Generics blev udviklet som et ‘generisk lægemiddel'.
English: Therefore, at the time of the withdrawal, the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Pioglitazone Teva Generics for the treatment of type 2 diabetes.
Danish: På tidspunktet for tilbagetrækningen havde CHMP derfor afgivet en positiv udtalelse, hvori der anbefaledes udstedelse af markedsføringstilladelse for Pioglitazone Teva Generics til behandling af type 2-diabetes.
English: Pioglitazone Teva Generics is a medicine that contains the active substance pioglitazone.
Danish: Pioglitazone Teva Generics er et lægemiddel, der indeholder det aktive stof pioglitazon.
English: Because Pioglitazone Teva Generics is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Danish: Da Pioglitazone Teva Generics er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Actos.
English: What is Pioglitazone Teva Generics?
Danish: Hvad er Pioglitazone Teva Generics?
English: Pioglitazone Teva Generics was also to be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Danish: Pioglitazone Teva Generics skulle også have været anvendt sammen med insulin til patienter, som ikke er tilfredsstillende reguleret med insulin alene, og som ikke kan tage metformin.
English: On 26 January 2012, TEVA Generics B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pioglitazone Teva Generics, for the treatment of type 2 diabetes.
Danish: officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse for Pioglitazone Teva Generics til behandling af type 2-diabetes tilbage.
English: Pioglitazone Teva Generics was to used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Danish: Pioglitazone Teva Generics skulle have været anvendt alene til patienter, hos hvem metformin (et andet lægemiddel mod diabetes) ikke er egnet.
English: Pioglitazone Teva Generics was also to be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone.
Danish: Pioglitazone Teva Generics skulle også have været anvendt i kombination med metformin til patienter, som ikke er tilfredsstillende reguleret med metformin alene (‘tostofsbehandling').
English: What was Pioglitazone Teva Generics expected to be used for?
Danish: Hvad forventedes Pioglitazone Teva Generics anvendt til?
English: How is Pioglitazone Teva Generics expected to work?
Danish: Hvordan forventedes Pioglitazone Teva Generics at virke?
English: BEFORE YOU START
Danish: FØR DU STARTER
English: An observer is someone who:
Danish: En observatør er en person, der:
English: It is normal to see an air bubble.
Danish: Det er normalt at se en luftboble.
English: Relatively low titres of IgE has also been observed.
Danish: Der er også observeret relativt lave titre af IgE.
English: Most people respond within 18 months, but it can sometimes take up to 30 months.
Danish: De fleste mennesker reagerer inden for 18 måneder, men det kan sommetider tage op til 30 måneder.
English: o Your doctor will tell you if you need an observer for longer than 6 months.
Danish: o Lægen vil fortælle dig, om du har brug for en observatør i mere end 6 måneder.
English: Symptoms of inattention and mood were also evaluated during this period.
Danish: Symptomer på uopmærksomhed og humør blev også evalueret i denne periode.
English: Linearity/nonlinearity
Danish: Linearitet/non-linearitet
English: Serious side effects include:
Danish: Alvorlige bivirkninger omfatter:
English: The time to reach a response ranged from 0.5 to 30 months.
Danish: Den tid, det tog at opnå respons, lå mellem 0,5 og 30 måneder.
English: The absolute bioavailability in humans is unknown.
Danish: Den absolutte biotilgængelighed hos mennesker er ukendt.
English: Duration prior to next dose increase
Danish: Varighed indtil næste øgning af dosis
English: Overall treatment experience from Study 301 and Study 302
Danish: Generel behandlingserfaring fra studie 301 og studie 302
English: Some of these allergic reactions can be more serious, as described below, and will require immediate attention.
Danish: Nogle af disse allergiske reaktioner kan være mere alvorlige, som beskrevet nedenfor, og vil kræve øjeblikkelig behandling.
English: Immune response affects clearance and time to reach steady state.
Danish: Immunrespons påvirker clearance og tid til opnåelse af steady state.
English: Study 302: Efficacy assessment
Danish: Studie 302: Effektvurdering
English: The recommended injection sites are:
Danish: De anbefalede injektionssteder er:
English: The immune response stabilises over 6 to 9 months of total treatment.
Danish: Immunresponset stabiliserer sig over 6 til 9 måneders samlet behandling.
English: Your doctor will tell you how long to stay at each dose.
Danish: Lægen fortæller dig, hvor længe du skal fortsætte med hver dosis.
English: Tell your doctor that you had a severe allergic reaction.
Danish: Fortæl din læge, at du har haft en svær allergisk reaktion.
English: No vacuolation was observed in the brain.
Danish: Der blev ikke observeret vakuolation i hjernen.
English: Do not use a microwave and do not place in hot water.
Danish: Brug ikke en mikroovn, og anbring ikke produktet i varmt vand.
English: The clinical significance of these findings and functional consequences are unknown.
Danish: Den kliniske betydning af disse resultater og de funktionsmæssige konsekvenser er ukendte.
English: It can be on the same part of the body or a different part of the body (see Figures E and F).
Danish: Det kan være samme del af kroppen eller en anden del af kroppen (se figur E og F).
English: These medicines help to reduce the symptoms of an allergic reaction.
Danish: Disse lægemidler er med til at reducere symptomerne på en allergisk reaktion.
English: Long-term extension period
Danish: Langsigtet forlængelsesperiode
English: Refer to the adrenaline product information for complete information.
Danish: Se produktinformationen for adrenalin for at få fuldstændige oplysninger.
English: After 6 months of Palynziq treatment, the need for an observer may be reconsidered.
Danish: Efter 6 måneders behandling med Palynziq kan behovet for en observatør genovervejes.
English: These patients received the same induction/titration/maintenance regimen as patients aged 18 years and older in this study.
Danish: Disse patienter fik det samme induktions-/titrerings-/vedligeholdelsesregime som patienter i alderen 18 år og derover i dette studie.
English: If your phenylalanine levels are too high or too low during pregnancy, this may harm you or your baby.
Danish: Hvis dit fenylalaninniveau er for højt eller for lavt under graviditet, kan det skade dig eller barnet.
English: Also, talk to your healthcare provider about your medical condition or your treatment.
Danish: Tal desuden med sundhedspersonalet om din medicinske tilstand eller din behandling.
English: Dose titration and time to achieve response
Danish: Dosistitrering og tid til at opnå respons
English: 4 Change from baseline was based on subjects with available measurements at both time points.
Danish: 4 Ændring fra baseline var baseret på forsøgspersoner med tilgængelige målinger på begge tidspunkter.
English: The majority of patients (66%) reached a response by 18 months of total treatment.
Danish: Størstedelen af patienterne (66 %) opnåede respons efter 18 måneders samlet behandling.
English: Table 1: Recommended dosing regimen
Danish: Tabel 1: Anbefalet doseringsregime
English: • train the patient and assess patient competency on proper self-administration of this medicinal product.
Danish: • uddanne patienten og vurdere patientens kompetence til korrekt selvadministration af dette lægemiddel
English: • Do not change your protein intake unless your doctor tells you to.
Danish: • Du må ikke ændre dit proteinindtag, medmindre lægen beder dig om det.
English: Individual values for half-life range from 14 to 132 hours.
Danish: Individuelle værdier for halveringstid ligger i intervallet 14 til 132 timer.
English: As a consequence, these patients were more likely to develop hypophenylalaninaemia.
Danish: Derfor havde disse patienter større sandsynlighed for at udvikle hypofenylalaninæmi.
English: Maximum recommended dose
Danish: Anbefalet maksimal dosis
English: • would be present with the patient during and after Palynziq administration,
Danish: • er til stede sammen med patienten under og efter administration af Palynziq
English: See section 4 for details on what to do based on your symptoms.
Danish: Se punkt 4 for at få oplysninger om, hvad du skal gøre på basis af dine symptomer.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Danish: Hyppigheder defineres som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Check the expiry date on the carton.
Danish: Kontrollér udløbsdatoen på pakningen.
English: Step 15: Treat injection site (if needed).
Danish: Trin 15: Behandl injektionsstedet (hvis det er nødvendigt).
English: People who have PKU have high levels of phenylalanine and this can lead to serious health problems.
Danish: Mennesker, der har PKU, har et højt niveau af fenylalanin, og det kan føre til alvorlige helbredsproblemer.
English: The average molecular mass is approximately 1,000 kDa of which the protein moiety constitutes approximately 248 kDa.
Danish: Den gennemsnitlige molekylmasse er ca. 1.000 kDa, hvoraf proteinmolekyledelen udgør ca. 248 kDa.
English: The potency of this medicinal product should not be compared to any other PEGylated or non-PEGylated protein of the same therapeutic class.
Danish: Dette lægemiddels styrke bør ikke sammenlignes med noget andet PEGyleret eller ikke-PEGyleret protein fra samme terapeutiske klasse.
English: There are no or limited amount of data from the use of Palynziq in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af Palynziq til gravide kvinder.
English: Gather your supplies for the injection and place them on a clean flat surface.
Danish: Saml tingene til injektionen, og læg dem på en ren, jævn overflade.
English: No data are available in paediatric patients less than 16 years of age.
Danish: Der foreligger ingen data for pædiatriske patienter under 16 år.
English: Abdominal pain2,4
Danish: Abdominalsmerter2,4
English: Slowly increasing your dose over time allows your body to adjust to this medicine.
Danish: Når din dosis bliver øget langsomt over tid, kan kroppen tilpasse sig lægemidlet.
English: • Front middle of the thighs.
Danish: • Midt foran på lårene.
English: Step 7: Wash your hands well with soap and water (see Figure G).
Danish: Trin 7: Vask hænderne godt med sæbe og vand (se figur G).
English: In maintenance phase of the treatment, steady state is expected 4 to 24 weeks after maintenance dose started.
Danish: I behandlingens vedligeholdelsesfase forventes steady state 4 til 24 uger efter start med vedligeholdelsesdosis.
English: The duration of titration varied among patients and was based on patient tolerability (up to 30 weeks).
Danish: Titreringens varighed var forskellig fra patient til patient og var baseret på den enkelte patients tolerabilitet (op til 30 uger).
English: Due to lack of human data, Palynziq should only be administered to breast-feeding women if the potential benefit is considered to outweigh the potential risk to the infant.
Danish: På grund af manglende humane data bør Palynziq kun administreres til ammende kvinder, hvis den potentielle fordel anses for at opveje den potentielle risiko for spædbarnet.
English: Colourless to pale yellow, clear to slightly opalescent solution with pH 6.6 - 7.4.
Danish: Farveløs til svagt gul, klar til let opaliserende opløsning med pH 6,6-7,4.
English: Patients should be instructed to pre-medicate with an H1-receptor antagonist, H2-receptor antagonist, and antipyretic.
Danish: Patienterne skal instrueres i at præmedicinere med en H1-receptorantagonist, H2-receptorantagonist og et antipyretikum.
English: Osmolality: 260 - 290 mOsm/kg
Danish: Osmolalitet: 260-290 mOsm/kg
English: The effects in offspring were associated with maternal toxicity.
Danish: Effekterne hos afkommet var forbundet med maternel toksicitet.
English: An additional 7% of patients responded to Palynziq after 18 months of treatment.
Danish: Yderligere 7 % af patienterne responderede på Palynziq efter 18 måneders behandling.
English: No human data are available.
Danish: Der foreligger ingen humane data.
English: Let the skin air dry for at least 10 seconds before injecting (see Figure H).
Danish: Lad huden lufttørre i mindst 10 sekunder, før du injicerer (se figur H).
English: You may cover the injection site with an adhesive bandage if needed.
Danish: Du kan dække injektionsstedet med et hæfteplaster, hvis det er nødvendigt.
English: Study 302 RDT Week 8
Danish: Studie 302 RDT uge 8
English: Prescribing physician should continue or consider resuming use of premedication.
Danish: Den ordinerende læge bør fortsætte eller overveje at genoptage brugen af præmedicin.
English: Seven out of the 16 patients discontinued treatment.
Danish: Syv ud af de 16 patienter seponerede behandlingen.
English: 4 Abdominal pain reflects the following terms: abdominal pain, abdominal pain upper and abdominal discomfort.
Danish: 4 Abdominalsmerter dækker over følgende termer: abdominalsmerter, smerter i øvre abdomen og abdominalt ubehag.
English: Posology is the same in these patients as in adults.
Danish: Doseringen er den samme hos disse patienter som hos voksne.
English: Prior to launch of Palynziq in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Før markedsføringen af Palynziq i hver enkelt medlemsstat skal indehaveren af markedsføringstilladelsen aftale indholdet og formatet af uddannelsesprogrammet, herunder kommunikationsmidler, distributionsmetoder og andre eventuelle aspekter af programmet, med den nationale kompetente myndighed.
English: Thus, mean dose levels also stabilized with long-term treatment with sustained therapeutic effect.
Danish: Således stabiliseredes middeldosisniveauet også ved langtidsbehandling med vedvarende terapeutisk effekt.
English: Animal studies suggest that women may have difficulty becoming pregnant if their phenylalanine levels are abnormally low.
Danish: Dyreforsøg tyder på, at kvinder kan have svært ved at blive gravide, hvis deres fenylalaninniveau er unormalt lavt.
English: Step 8: Clean the chosen site with an alcohol pad.
Danish: Trin 8: Rens det valgte sted med en spritserviet.
English: It is unknown whether pegvaliase is excreted in human milk.
Danish: Det er ukendt, om pegvaliase udskilles i human mælk.
English: Step 1: Collect supplies:
Danish: Trin 1: Saml tingene:
English: Step 5: Check syringe strength and check for particles:
Danish: Trin 5: Kontrollér injektionssprøjtens styrke, og se efter partikler:
English: Use your other hand to pinch up the skin around the injection site.
Danish: Brug den anden hånd til at trykke huden op omkring injektionsstedet.
English: In clinical trials, doses of pegvaliase were explored up to 150 mg/day and no specific signs or symptoms were identified following these higher doses.
Danish: I kliniske forsøg blev der undersøgt pegvaliasedoser på op til 150 mg/dag, og der blev ikke påvist nogen specifikke tegn eller symptomer efter disse højere doser.
English: • You will start Palynziq at the lowest dose.
Danish: • Du starter med Palynziq i den laveste dosis.
English: Date removed from refrigeration: _____/_____/______
Danish: Dato for fjernelse fra køl: _____/_____/______
English: - Place each sealed tray on a clean, flat surface out of reach of children and pets.
Danish: - Anbring hver forseglet bakke på en ren, jævn overflade utilgængeligt for børn og kæledyr.
English: • Note: Do not inject multiple injections in the same spot.
Danish: • Bemærk: Udfør ikke flere injektioner på det samme sted.
English: • Never pull back on the plunger.
Danish: • Træk aldrig stemplet tilbage.
English: If you miss a dose, take your next dose at the regular time.
Danish: Hvis du glemmer en dosis, skal du tage den næste dosis på det planlagte tidspunkt.
English: Do not divide your daily dose throughout the day.
Danish: Du må ikke fordele den daglige dosis over dagen.
English: • Your doctor will then slowly increase your dose and/or how often you inject Palynziq.
Danish: • Lægen øger derefter langsomt din dosis og/eller hvor ofte du injicerer Palynziq.
English: Figure A below shows what the pre-filled syringe looks like before use.
Danish: Figur A nedenfor viser, hvordan den fyldte injektionssprøjte ser ud før brug.
English: Keep it with you at all times.
Danish: Sørg for altid at medbringe den.
English: Arteritis was attributed to the immune-mediated response associated with chronic administration of foreign protein to the animals.
Danish: Arteritis blev tilskrevet det immunmedierede respons i forbindelse med kronisk administration af fremmed protein til dyrene.
English: 5 Complement factor C3/C4 decrease is defined changing from normal or high baseline complement value to low post-baseline complement value.
Danish: 5 Fald i komplementfaktor C3/C4 er defineret som ændring fra normal eller høj komplementværdi ved baseline til lav komplementværdi efter baseline.
English: Necrobiosis lipoidica diabeticorum was treated with steroid injections and complicated by Pseudomonas infection.
Danish: Necrobiosis lipoidica diabeticorum blev behandlet med steroidinjektioner og blev kompliceret af Pseudomonas-infektion.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For single use only.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Udelukkende til engangsbrug.
English: • Do not flick or try to push the bubble out.
Danish: • Prøv ikke at trykke eller skubbe boblen ud.
English: The bioavailability is not affected by the different injection sites on the body (see section 4.2).
Danish: Biotilgængeligheden påvirkes ikke af de forskellige injektionssteder på kroppen (se pkt.
English: Presence of antibody titres were not predictive of hypersensitivity reactions.
Danish: Tilstedeværelse af antistoftitre var ikke prædiktiv for overfølsomhedsreaktioner.
English: The vacuolation observed in these studies was not associated with any organ related toxicities as determined by clinical chemistry/urinalysis and histopathological analysis.
Danish: Den vakuolation, der blev observeret i disse studier, var ikke forbundet med nogen organrelaterede toksiciteter som bestemt ved klinisk kemi/urinanalyse og histopatologisk analyse.
English: • Each day, change (rotate) your injection sites.
Danish: • Skift (rotér) injektionssted hver dag.
English: Additional risk to the unborn child due to hypophenylalaninaemia is not established.
Danish: Yderligere risiko for det ufødte barn som følge af hypofenylalaninæmi er ikke fastslået.
English: Choose an injection site that is at least 5 centimetres away from the injection site(s) you used the day before.
Danish: Vælg et injektionssted, der er 5 centimeter fra det/de injektionssted(er), du brugte dagen før.
English: Vacuoles in all tissues, with the exception of the kidney, resolved or were diminished by the end of the recovery period, suggesting partial reversibility.
Danish: Vakuoler i alle væv med undtagelse af nyrerne var forsvundet eller formindsket ved afslutningen på den dosisfrie periode, hvilket tyder på delvis reversibilitet.
English: The mean (SD) time from first dose of pegvaliase to onset was 372 (384) days.
Danish: Middeltiden (SD) fra første dosis pegvaliase til frembrud var 372 (384) dage.
English: Look at the liquid through the viewing window (see Figure D).
Danish: Se på væsken gennem vinduet (se figur D).
English: PEGylated proteins have the potential to elicit an immune response.
Danish: PEGylerede proteiner har potentialet til at fremkalde immunrespons.
English: The vascular inflammation observed in these studies was reversible upon cessation of treatment.
Danish: Den vaskulære inflammation, der blev observeret i disse studier, var reversibel ved behandlingsophør.
English: If more than one syringe is needed:
Danish: Hvis der kræves mere end én injektionssprøjte:
English: Phenylalanine levels over time
Danish: Fenylalaninniveauer over tid
English: Angioedema can also present as one of the symptoms of an acute systemic hypersensitivity reaction.
Danish: Angioødem kan også være til stede som et af symptomerne på en akut systemisk overfølsomhedsreaktion.
English: • Do not touch the cleaned injection site.
Danish: • Rør ikke ved det rensede injektionssted.