FrancophonIA/ELRC3.0 huggingface dataset:
English: Elderly
Danish: Voksne
English: You must wait at least 12 hours between each metoclopramide dose, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Danish: For at undgå overdosering skal der være mindst 12 timer mellem hver metoclopramiddosis, også hvis du kaster op eller afviser en dosis
English: 15mg strength prolonged release preparations
Danish: 15 mg formuleringer med forlænget afgift
English: - to prevent delayed nausea and vomiting that may occur after chemotherapy - to prevent nausea and vomiting caused by radiotherapy - to treat nausea and vomiting including nausea and vomiting which may occur with a migraine.
Danish: Voksne {Handelsnavn} anvendes til voksne til at: - forebygge forsinket kvalme og opkastning efter kemoterapi - forebygge kvalme og opkastning forårsaget af strålebehandling - behandle kvalme og opkastning, herunder kvalme og opkastning i forbindelse med migræne Metoclopramid kan anvendes sammen med orale smertestillende lægemidler (indtaget gennem munden) for at forbedre virkningen af de smertestillende lægemidler.
English: For the symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting and for the prevention of radiotherapy induced nausea and vomiting (RINV): the recommended single dose is 10 mg, repeated up to three times daily
Danish: Symptomatisk behandling af kvalme og opkastning, herunder kvalme og opkastning forårsaget af akut migræne, samt forebyggelse af kvalme og opkastning i forbindelse med strålebehandling (RINV):
English: Oral route
Danish: Oral administration
English: Tradename is an antiemetic.
Danish: VIRKNING OG ANVENDELSE {Handelsnavn} er et middel mod kvalme og opkastning (antiemetikum).
English: The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to three times daily by intravenous route.
Danish: Alle indikationer (pædiatriske patienter i alderen 1-18 år) Den anbefalede dosis er 0,1 til 0,15 mg/kg legemsvægt, administreret op til tre gange dagligt ved intravenøs administration.
English: The side effects were seen in the first week after use of the medicine.
Danish: Bivirkningerne blev observeret i den første uge efter lægemidlets anvendelse.
English: Arti-Cell Forte received a marketing authorisation valid throughout the EU on 29 March 2019.
Danish: Arti-Cell Forte fik en markedsføringstilladelse med gyldighed i hele EU den 29. marts 2019.
English: Further information on Arti-Cell Forte can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Yderligere information om Arti-Cell Forte findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: improvement in lameness was considered relevant and positive effects lasted over a period of one year.
Danish: Forbedringen af haltheden blev anset for at være relevant, og de positive virkninger varede i en periode på et år.
English: Stem cells can develop into other types of cells.
Danish: Stamceller kan udvikles til andre celletyper.
English: The withdrawal period for meat from horses treated with Arti-Cell Forte is ‘zero' days, which means that there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød fra heste, der behandles med Arti-Cell Forte, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: Other information about Arti-Cell Forte
Danish: Andre oplysninger om Arti-Cell Forte
English: Liquid nitrogen containers should be handled by properly trained personnel only.
Danish: Beholdere med flydende kvælstof bør kun håndteres af behørigt uddannet personale.
English: The European Medicines Agency decided that Arti-Cell Forte's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Arti-Cell Forte opvejer risiciene, og det kan godkendes til anvendelse i EU.
English: Accidental self-injection can cause pain, local inflammatory reactions and swelling at the injection site which may last for several weeks and possibly cause fever.
Danish: Utilsigtet selvinjektion kan forårsage smerte, lokale inflammatoriske reaktioner og hævelse på injektionsstedet, som kan vare i flere uger og muligvis forårsage feber.
English: All horses received intravenous ketoprofen, a medicine to relieve pain and inflammation, at the time of treatment.
Danish: Alle heste fik intravenøst ketoprofen, et lægemiddel til lindring af smerter og betændelse på behandlingstidspunktet.
English: The handling of liquid nitrogen should take place in a wellventilated area.
Danish: Håndtering af flydende kvælstof bør finde sted i et velventileret rum.
English: The stem cells in the active substance (mesenchymal stem cells) are treated so that they develop into cartilage cells.
Danish: Stamceller i det aktive stof (mesenkymale stamceller) behandles, så de udvikler sig til bruskceller.
English: The medicine is available as an injection and can only be obtained with a prescription.
Danish: Lægemidlet fås som injektionsvæske og udleveres kun efter recept.
English: For more information about using Arti-Cell Forte, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Arti-Cell Forte, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: The most common side effects with Arti-Cell Forte (which may affect more than 1 in 10 horses) are mild increases in lameness, injection site reactions such as swelling and mild increases in temperature at the injection site.
Danish: De hyppigste bivirkninger ved Arti-Cell Forte (som kan forekomme hos mere end 1 ud af 10 heste) er let øget halthed, reaktioner på injektionsstedet, såsom hævelse og let stigning i temperaturen på injektionsstedet.
English: In a field study involving horses with a history of lameness lasting 2 to 6 months, 50 horses were treated with Arti-Cell Forte and 25 received a placebo (dummy injection) of saline in one fetlock joint.
Danish: I et feltstudie, der omfattede heste, som tidligere havde lidt af halthed i mellem 2-6 måneder, blev 50 heste behandlet med Arti-Cell Forte, og 25 fik en placebo-injektion (uvirksom injektion)med saltvand i et kodeled.
English: An overview of Arti-Cell Forte and why it is authorised in the EU
Danish: Oversigt over Arti-Cell Forte, og hvorfor det er godkendt i EU
English: Arti-Cell Forte is a veterinary medicine used to treat mild to moderate lameness linked to non-infective joint inflammation in horses.
Danish: Arti-Cell Forte er et veterinærlægemiddel til behandling af mild til moderat halthed i forbindelse med ikke-infektiøs ledbetændelse hos heste.
English: The vials containing equine mesenchymal stem cells and equine allogeneic plasma can be stored and transported either frozen or in liquid nitrogen containers.
Danish: Hætteglassene, som indeholder mesenkymale stamceller og equint allogent plasma, kan opbevares og transporteres enten frosne eller i beholdere med flydende kvælstof.
English: It consists of two vials which are supplied frozen: one vial contains the active substance and a second vial contains equine allogeneic plasma (EAP) which is the liquid part of blood.
Danish: Det indeholder to hætteglas, som leveres frosne: et hætteglas indeholder det aktive stof equint allogent plasma (EAP), som er den flydende del af blodet.
English: What is Arti-Cell Forte and what is it used for?
Danish: Hvad er Arti-Cell Forte, og hvad anvendes det til?
English: Before withdrawing the vials from the liquid nitrogen canister, protective equipment consisting of gloves, long sleeves and a facemask or goggles should be worn.
Danish: Ved udtagelse af hætteglassene fra beholderen med flydende nitrogen bør der anvendes personligt beskyttelsesudstyr i form af handsker, lange ærmer og ansigtsmaske eller beskyttelsesbriller.
English: This product contains chondrogenic induced equine mesenchymal stem cells and EAP.
Danish: Dette produkt indeholder kondrogent inducerede equine mesenkymale stamceller og equint allogent plasma (EAP).
English: What are the risks associated with Arti-Cell Forte?
Danish: Hvilken risiko er der forbundet med Arti-Cell Forte?
English: The addition of the EAP to the stem cells after thawing and just before injection of the medicine increases the viability (ability to live) of the stem cells.
Danish: Tilsætning af equint allogent plasma til stamcellerne efter optøning og lige før injektion af lægemidlet øger stamcellernes levedygtighed.
English: Why is Arti-Cell Forte authorised in the EU?
Danish: Hvorfor blev Arti-Cell Forte godkendt i EU?
English: It contains stem cells which are obtained from equine blood.
Danish: Det indeholder stamceller, der er fremstillet på basis af blod fra heste.
English: Six weeks after treatment 68% of the horses treated with Arti-Cell Forte had a lameness score reduction by 2 or 3 lameness grades compared to none of the horses in the control group.
Danish: Seks uger efter behandlingen blev graden af halthed mindsket med 2 eller 3 grader hos 68 % af de heste, der blev behandlet med Arti-Cell Forte, mens der ingenting skete med
English: The stem cells have been prepared by being taken from blood from donor horses and grown in the laboratory to increase their numbers; they are treated so that they develop into cartilage cells which help to protect cartilage.
Danish: Stamceller fremstilles af blod fra donorheste og dyrkes i et laboratorie for at øge antallet af celler.
English: How is Arti-Cell Forte used?
Danish: Hvordan anvendes Arti-Cell Forte?
English: How does Arti-Cell Forte work?
Danish: Hvordan virker Arti-Cell Forte?
English: What benefits of Arti-Cell Forte have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Arti-Cell Forte?
English: In order to prepare the injection, the content of both vials, once thawed, are mixed and then injected only by a veterinarian directly into the affected joint.
Danish: Derefter sprøjtes det direkte ind i det berørte led af en dyrlæge.
English: Further information on Hyrimoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Hyrimoz findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: These packs will include information on the safety of the medicine.
Danish: Dette informationsmateriale skal indeholde oplysninger om lægemidlets sikkerhed.
English: This means that Hyrimoz is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Danish: Det betyder, at Hyrimoz i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), som allerede er godkendt i EU.
English: The proportion of patients who had at least a 75% reduction in symptoms after 16 weeks of treatment was 68% with Hyrimoz and 63% with Humira.
Danish: Efter 16 ugers behandling var andelen af patienter med mindst 75 % reduktion i symptomerne 68 % med Hyrimoz, og 63 % med Humira.
English: An overview of Hyrimoz and why it is authorised in the EU
Danish: En oversigt over Hyrimoz og hvorfor det er godkendt i EU
English: As for all medicines, data on the use of Hyrimoz are continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af Hyrimoz løbende overvåget.
English: In addition Hyrimoz was as effective as Humira in a study involving 465 patients with moderate or severe plaque psoriasis.
Danish: Derudover var Hyrimoz lige så effektivt som Humira i et studie med deltagelse af 465 patienter med moderat eller svær plaque-psoriasis.
English: What measures are being taken to ensure the safe and effective use of Hyrimoz?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Hyrimoz?
English: An alert card will also be given to patients.
Danish: Patienterne skal derudover have udleveret et patientkort.
English: Other information about Hyrimoz
Danish: Andre oplysninger om Hyrimoz
English: Side effects reported with Hyrimoz are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Hyrimoz vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: The reference medicine for Hyrimoz is Humira.
Danish: Referencelægemidlet for Hyrimoz er Humira.
English: By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.
Danish: Ved at bindes til TNF blokerer adalimumab dettes aktivitet og mindsker dermed betændelsen og de andre symptomer på sygdommen.
English: After training, patients or their carers may inject Hyrimoz if their doctor considers it appropriate.
Danish: Efter opøvning kan patienten eller dennes omsorgsgiver selv foretage indsprøjtningen af Hyrimoz, hvis lægen finder det hensigtsmæssigt.
English: What is Hyrimoz and what is it used for?
Danish: Hvad er Hyrimoz, og hvad anvendes det til?
English: Hyrimoz contains the active substance adalimumab and is a ‘biosimilar medicine'.
Danish: Hyrimoz indeholder det aktive stof adalimumab og er et "biosimilært" lægemiddel.
English: Because Hyrimoz is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Hyrimoz.
Danish: Da Hyrimoz er et biosimilært lægemiddel, behøver de studier af virkningen og sikkerheden af adalimumab, der er udført for Humira, ikke alle gentages for Hyrimoz.
English: Hyrimoz is a medicine that acts on the immune system and is used to treat the following conditions:
Danish: Hyrimoz er et lægemiddel, der virker på immunsystemet og anvendes til behandling af følgende sygdomme:
English: Like other medicines of its class, Hyrimoz may affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.
Danish: Ligesom andre lægemidler i samme klasse kan Hyrimoz nedsætte immunsystemets evne til at bekæmpe infektioner og kræft, og der har været tilfælde af alvorlige infektioner og blodkræft hos patienter, der får adalimumab.
English: Hyrimoz is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments.
Danish: Hyrimoz anvendes hovedsageligt hos voksne, når sygdommen er svær, moderat svær eller i forværring, eller når patienten ikke kan behandles på anden måde.
English: Hyrimoz must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).
Danish: Hyrimoz må ikke anvendes hos patienter med aktiv tuberkulose, andre svære infektioner eller moderat til svært hjertesvigt (manglende evne af hjertet til at pumpe tilstrækkeligt med blod rundt i kroppen).
English: In addition, a study in psoriasis has shown that the effects of the medicine are equivalent to those of Humira in this condition.
Danish: Derudover har et studie i forbindelse med psoriasis vist, at lægemidlets virkninger svarer til virkningerne af Humira ved denne sygdom.
English: For more information about using Hyrimoz, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Hyrimoz, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: The company that markets Hyrimoz must provide educational packs for doctors who prescribe the medicine.
Danish: Virksomheden, der markedsfører Hyrimoz, skal udlevere informationsmateriale til de læger, som ordinerer lægemidlet.
English: Why is Hyrimoz authorised in the EU?
Danish: Hvorfor blev Hyrimoz godkendt i EU?
English: All these data were considered sufficient to conclude that Hyrimoz will behave in the same way as Humira in terms of effectiveness and safety in its approved uses.
Danish: Alle disse oplysninger blev anset for tilstrækkelige til at konkludere, at Hyrimoz vil have de samme egenskaber som Humira hvad angår virkningen og sikkerheden ved de godkendte anvendelser.
English: TNF is involved in causing inflammation and is found at high levels in patients with the diseases that Hyrimoz is used to treat.
Danish: TNF er en medvirkende årsag til inflammation og findes i høj koncentration hos patienter med de sygdomme, der behandles med Hyrimoz.
English: What are the risks associated with Hyrimoz?
Danish: Hvilke risici er der forbundet med Hyrimoz?
English: Eye specialists treating uveitis should also take advice from doctors who have experience of using Hyrimoz.
Danish: Øjenlæger, der behandler uveitis, bør også søge rådgivning fra læger med erfaring i anvendelse af Hyrimoz.
English: Hyrimoz can only be obtained by prescription and treatment must be started and supervised by a doctor who has experience in the treatment of the diseases for which Hyrimoz is used.
Danish: Hyrimoz udleveres kun efter recept, og behandlingen skal iværksættes og overvåges af en læge med erfaring i behandling af de sygdomme, som Hyrimoz anvendes til.
English: Therefore, the Agency's view was that, as for Humira, the benefits of Hyrimoz outweigh the identified risks and it can be authorised.
Danish: Agenturet var derfor af den opfattelse, at fordelene ved Hyrimoz opvejer de identificerede risici som for Humira, og at det kan godkendes.
English: The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections (including in the nose, throat and sinuses), injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.
Danish: De hyppigste bivirkninger ved adalimumab (som optræder hos mere end 1 ud af 10 patienter) er infektioner (herunder i næse, hals og bihuler), reaktioner på injektionsstedet (rødme, kløe, blødning, smerter eller hævelse), hovedpine og muskel- og knoglesmerter.
English: Other rare serious side effects (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a serious skin condition).
Danish: Andre sjældne alvorlige bivirkninger (som kan forekomme hos op til 1 ud af 1 000 personer) er knoglemarvens svigtende evne af til at danne blodceller, nervesygdomme, lupus og lupuslignende sygdomme (hvor immunsystemet angriber patientens egne væv, med betændelse og organskader til følge) og den alvorlige hudsygdom Stevens-Johnsons syndrom.
English: The active substance in Hyrimoz, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF).
Danish: Det aktive stof i Hyrimoz, adalimumab, er et protein af typen monoklonalt antistof, der er fremstillet således, at det genkender og bindes til et stof i kroppen, der kaldes tumornekrosefaktor (TNF).
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Hyrimoz has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Hyrimoz's og Humiras struktur, renhed og biologiske aktivitet svarer nøje til hinanden, og at de fordeles i kroppen på samme måde.
English: Laboratory studies comparing Hyrimoz with Humira have shown that the active substance in Hyrimoz is highly similar to that in Humira in terms of structure, purity and biological activity.
Danish: Laboratoriestudier, hvor Hyrimoz sammenlignes med Humira, har vist, at det aktive stof i Hyrimoz i meget høj grad svarer til Humira hvad angår struktur, renhed og biologisk aktivitet.
English: • polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis (both rare diseases causing inflammation in the joints);
Danish: • polyartikulær juvenil idiopatisk artritis og aktiv enthesitis-relateret artritis (begge er sjældne sygdomme, der medfører inflammation af leddene)
English: For the full list of side effects and restrictions with Hyrimoz, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Hyrimoz fremgår af indlægssedlen.
English: Studies have also shown that giving Hyrimoz produces similar levels of the active substance in the body to giving Humira.
Danish: Studier har desuden vist, at behandling med Hyrimoz frembringer samme mængde aktivt stof i kroppen som behandling med Humira.
English: How is Hyrimoz used?
Danish: Hvordan anvendes Hyrimoz?
English: • axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when X-ray does not show disease but there are clear signs of inflammation;
Danish: • aksial spondyloarthritis (betændelse i rygsøjlen, der medfører rygsmerter), herunder Bekhterevs sygdom (ankyloserende spondylitis) og sygdom uden røntgenforandringer, men med tydelige tegn på inflammation
English: • hidradenitis suppurativa (acne inversa), a long-term skin disease that causes lumps, abscesses
Danish: • svedkirtelbetændelse (hidradenitis suppurativa) (acne inversa), en varig hudsygdom, der forårsager knuder, pusansamlinger (abscesser) og ar i huden
English: • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
Danish: • ulcerøs colitis (en sygdom, der medfører inflammation og sår i tarmslimhinden)
English: The dose and frequency of injection depends on the condition to be treated and the dose for a child is usually calculated according to the child's weight; because Hyrimoz is only available in doses of 40 mg, it is not suitable for children who need less than a 40-mg dose.
Danish: Da Hyrimoz kun fås i doser på 40 mg, egner det sig ikke til børn, når de behøver en dosis under 40 mg.
English: How does Hyrimoz work?
Danish: Hvordan virker Hyrimoz?
English: What benefits of Hyrimoz have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Hyrimoz?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hyrimoz have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Hyrimoz.
English: Hyrimoz is available as a solution for injection under the skin in a pre-filled syringe or pen and is usually given every 2 weeks.
Danish: Hyrimoz fås som en injektionsvæske, opløsning, enten i fyldte injektionssprøjter eller i penne, til indsprøjtning under huden.
English: For more information on the use of Hyrimoz in all conditions, including when it can be used in children, see the package leaflet or contact your doctor or pharmacist.
Danish: Nærmere oplysninger om anvendelsen af Hyrimoz til de forskellige sygdomme, herunder hvornår det kan anvendes til børn, fremgår af produktresuméet.
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints);
Danish: • psoriasisgigt (en sygdom, der giver røde, skællende hudområder og betændelsesreaktion
English: (collections of pus) and scarring on the skin;
Danish: (inflammation) i leddene)
English: Date of last renewal: 23/03/2010
Danish: Dato for seneste fornyelse: 23/03/2010
English: ADVICE ON CORRECT ADMINISTRATION See above.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Se ovenfor.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09/03/2000
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første tilladelse: 09/03/2000
English: MARKETING AUTHORISATION NUMBER(S) EU/2/99/017/001-006
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/99/017/001-006
English: Store and transport refrigerated (2°C- 8°C).
Danish: Opbevares og transporteres koldt (2°C - 8°C).