FrancophonIA/ELRC3.0 huggingface dataset:
English: This overview was last updated in 09-2019
Danish: Denne oversigt blev sidst ajourført i 09-2019.
English: The side effects of the medicine were typical for this class of medicines and are considered manageable.
Danish: Bivirkningerne ved lægemidlet var typiske for denne klasse af lægemidler og anses for at være håndterbare.
English: Lonquex received a marketing authorisation valid throughout the EU on 25 July 2013.
Danish: Lonquex fik en markedsføringstilladelse med gyldighed i hele EU den 25. juli 2013.
English: Lipegfilgrastim is a form of filgrastim, which has been available in the EU for a number of years.
Danish: Lipegfilgrastim er en form for filgrastim, som har været markedsført i EU i en række år.
English: Further information on Lonquex can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/lonquex
Danish: Yderligere information om Lonquex findes på agenturets websted under: www.ema.europa.eu/medicines/human/EPAR/lonquex.
English: Patients may be able to inject the medicine themselves once they have been properly trained but the first injection should be under the direct supervision of a doctor.
Danish: Patienter vil muligvis selv kunne indgive lægemidlet efter passende instruktion, men den første injektion skal ske under direkte opsyn af en læge.
English: The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in treating cancer and blood disorders.
Danish: Lægemidlet fås kun på recept, og behandlingen bør indledes og overvåges af en læge med erfaring i behandling af kræft og blodsygdomme.
English: The injections should be given under the skin in the abdomen, upper arm or thigh.
Danish: Injektionerne skal gives i huden på maven, overarmen eller låret.
English: Other information about Lonquex
Danish: Andre oplysninger om Lonquex
English: As for all medicines, data on the use of Lonquex are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Lonquex løbende overvåget.
English: This slows down the medicine's removal from the body and allows the medicine to be given less often.
Danish: Derved fjernes lægemidlet langsommere fra kroppen, hvilket gør, at lægemidlet ikke skal indgives så ofte.
English: The most common side effects with Lonquex (which may affect more than 1 in 10 patients) are nausea as well as bone and muscle pain.
Danish: De hyppigste bivirkninger ved Lonquex (som kan forekomme hos mere end 1 ud af 10 patienter) er kvalme samt knogle- og muskelsmerter.
English: What measures are being taken to ensure the safe and effective use of Lonquex?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Lonquex?
English: The Agency therefore decided that Lonquex's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet konkluderede derfor, at fordelene ved Lonquex opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Side effects reported with Lonquex are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Lonquex vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: Lonquex is a medicine that contains the active substance lipegfilgrastim.
Danish: Lonquex er et lægemiddel, der indeholder det aktive stof lipegfilgrastim.
English: An overview of Lonquex and why it is authorised in the EU
Danish: En oversigt over Lonquex, og hvorfor det er godkendt i EU
English: Why is Lonquex authorised in the EU?
Danish: Hvorfor er Lonquex godkendt i EU?
English: Another main study in 376 patients compared Lonquex with placebo (a dummy treatment).
Danish: I et andet hovedstudie, der omfattede 376 patienter, blev Lonquex sammenlignet med placebo (en uvirksom behandling).
English: The European Medicines Agency noted that the studies had shown that Lonquex is effective in reducing the duration of severe neutropenia and the number of febrile neutropenia cases.
Danish: Det Europæisk lægemiddelagentur bemærkede, at studierne havde vist, at Lonquex var effektivt til at reducere varigheden af svær neutropeni og antallet af tilfælde af febril neutropeni.
English: What is Lonquex and what is it used for?
Danish: Hvad er Lonquex, og hvad anvendes det til?
English: Lonquex is not used in patients receiving chemotherapy for chronic myeloid leukaemia (a cancer of the white blood cells) and myelodysplastic syndromes (a disease that can develop into a leukaemia).
Danish: Lonquex anvendes ikke hos patienter, der får kemoterapi for kronisk myeloid leukæmi (kræft i de hvide blodlegemer) eller myelodysplastiske syndromer (en sygdom, der kan udvikle sig til leukæmi).
English: Cytotoxic chemotherapy (medicines that kill fast growing cells) commonly causes neutropenia because in addition to cancer cells, it also kills other fast-growing cells such as neutrophils, leaving the patient at risk of infections.
Danish: Cytotoksisk kemoterapi (lægemidler, der dræber hurtigvoksende celler) medfører sædvanligvis neutropeni, fordi behandlingen foruden kræftcellerne også dræber andre hurtigvoksende celler, såsom neutrofiler, så patienterne risikerer at få infektioner.
English: Patients receiving Lonquex recovered from neutropenia more quickly and fewer patients suffered severe neutropenia.
Danish: De patienter, som fik Lonquex, kom sig hurtigere efter at have haft neutropeni, og færre patienter fik svær neutropeni.
English: One 6-mg dose is given in each chemotherapy cycle around 24 hours after chemotherapy.
Danish: Ved hver behandlingsserie med kemoterapi gives der én dosis på 6 mg ca. 24 timer efter kemoterapibehandlingen.
English: For more information, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Lonquex, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: The active substance in Lonquex, lipegfilgrastim, is similar to granulocyte colony stimulating factor (G‑ CSF), a naturally occurring protein in the body that stimulates the production of white blood cells including neutrophils in the bone marrow.
Danish: Det aktive stof i Lonquex, lipegfilgrastim, svarer til granulocytkolonistimulerende faktor (G-CSF), et naturligt protein i kroppen, der fremmer knoglemarvens produktion af hvide blodlegemer, herunder neutrofiler.
English: What are the risks associated with Lonquex?
Danish: Hvilke risici er der forbundet med Lonquex?
English: In Lonquex, the filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Danish: I Lonquex er filgrastim blevet "pegyleret" (dvs. bundet til det kemiske stof polyethylenglykol).
English: Lonquex also compared well with the other medicine in the number of febrile neutropenia cases: 1 in the Lonquex-treated group versus 3 in the comparator group.
Danish: Lonquex kunne også måle sig med det andet lægemiddel, hvad angik antallet af tilfælde af febril neutropeni, hvoraf der var 1 tilfælde i Lonquex-gruppen mod 3 tilfælde i sammenligningsgruppen.
English: It is used to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in adult cancer patients receiving cytotoxic chemotherapy.
Danish: Det anvendes til at mindske varigheden af neutropeni (lavt indhold af en type hvide blodlegemer kaldet neutrofiler) og forekomsten af febril neutropeni (neutropeni med feber) hos voksne kræftpatienter i cytotoksisk kemoterapi.
English: Lonquex is available as an injection in pre-filled syringes.
Danish: Lonquex fås som injektionsvæske i fyldte sprøjter.
English: Lipegfilgrastim acts in the same way as G‑CSF, increasing the production of neutrophils and thereby helping to reduce the duration of neutropenia and the occurrence of febrile neutropenia (a sign of infection) in patients receiving chemotherapy.
Danish: Lipegfilgrastim virker på samme måde som G‑CSF og øger produktionen af neutrofiler, så varigheden af neutropeni og forekomsten af febril neutropeni (et infektionstegn) mindskes hos patienter i kemoterapi.
English: Lonquex was effective in reducing the duration of neutropenia and the number of febrile neutropenia cases among patients undergoing chemotherapy.
Danish: Lonquex var effektivt til at afkorte varigheden af neutropeni og antallet af tilfælde af febril neutropeni blandt kemoterapipatienter.
English: For the full list of side effects of Lonquex, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Lonquex fremgår af indlægssedlen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lonquex have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Lonquex.
English: How is Lonquex used?
Danish: Hvordan anvendes Lonquex?
English: In a main study in 202 breast cancer patients Lonquex compared well with another pegylated filgrastim: the average duration of severe neutropenia during chemotherapy was around 17 hours with Lonquex compared with around 19 hours with the other medicine.
Danish: Den gennemsnitlige varighed af svær neutropeni under kemoterapi var ca. 17 timer med Lonquex sammenholdt med ca. 19 timer med det andet lægemiddel.
English: What benefits of Lonquex have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Lonquex?
English: How does Lonquex work?
Danish: Hvordan virker Lonquex?
English: 1 cartridge
Danish: 3 ml (3,5 mg/ml) 1 cylinderampul
English: What is Haldol?
Danish: Hvad er Haldol?
English: The European Commission issued a decision on this opinion on 28/04/2017.
Danish: Europa-Kommissionen traf en afgørelse på grundlag af denne udtalelse den 28/04/2017.
English: In children and adolescents, for:
Danish: Hos børn og unge til:
English: Haldol is authorised in the EU via national procedures.
Danish: Haldol blev godkendt i EU via nationale procedurer.
English: Why was Haldol reviewed?
Danish: Hvorfor blev Haldol vurderet igen?
English: Haldol and associated names (such as Aloperidin and Serenase) is marketed in Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, the Netherlands, Portugal, Romania, Sweden and United Kingdom, and also in Iceland and Norway.
Danish: Haldol og relaterede navne (f.eks. Aloperidin og Serenase) markedsføres i Østrig, Belgien, Cypern, Danmark, Finland, Frankrig, Tyskland, Grækenland, Italien, Luxembourg, Malta, Holland, Portugal, Rumænien, Sverige og Storbritannien samt Island og Norge.
English: On 23 February 2017, the European Medicines Agency completed a review of Haldol.
Danish: Den 23. februar 2017 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Haldol.
English: It is also used for the treatment of vomiting.
Danish: Det kan desuden anvendes til behandling af opkastning.
English: On 18 June 2014, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Haldol and associated names in the EU.
Danish: Den 18. juni 2014 henviste Europa-Kommissionen sagen til CHMP med henblik på harmonisering af markedsføringstilladelserne for Haldol og relaterede navne i EU.
English: It is also available in the EU as generic haloperidol.
Danish: Haldol fås desuden i EU som generisk haloperidol.
English: The section was also harmonised with information on when Haldol's side effects on movement might appear, details on mortality in the elderly, and effects on the heart and the brain.
Danish: Punktet blev også harmoniseret med oplysninger om, hvornår Haldols bivirkninger på bevægelsesevnen kan forekomme, om mortaliteten hos ældre og om indvirkningen på hjertet og hjernen.
English: The CHMP harmonised the SmPC to include a warning that patients with bipolar disorders may suffer sudden depression, calling for close supervision of such patients.
Danish: CHMP harmoniserede produktresuméet, så det indeholder en advarsel om, at patienter med bipolar lidelse kan opleve en pludselig depression, hvilket nødvendiggør tæt overvågning af disse patienter.
English: • treatment of schizophrenia and schizoaffective disorder;
Danish: • behandling af skizofreni og skizoaffektiv lidelse
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Haldol in the European Union (EU).
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for harmonisering af ordineringsoplysningerne for Haldol i Den Europæiske Union (EU).
English: Haldol is an antipsychotic medicine used in adults and children for a number of mental and other brain disorders including schizophrenia, mania (feeling elated or over-excited), aggression, Tourette's syndrome and tics (repeated and uncontrollable movements) and choreatic movements (jerky and uncontrolled movements mainly of the face and hands).
Danish: Haldol er et antipsykotisk lægemiddel, der anvendes hos voksne og børn til behandling af en række mentale sygdomme og andre hjernelidelser, herunder skizofreni, mani (en følelse af opstemthed eller eksaltation), aggressivitet, Tourettes syndrom og tics (gentagne og ukontrollerede bevægelser) og choreatiske bevægelser (rykkende og ukontrollerede bevægelser, hovedsageligt af ansigtet og hænder).
English: The areas harmonised include:
Danish: De harmoniserede områder er følgende: 4.1.
English: The CHMP agreed that Haldol should no longer be used for the treatment of delirium, delusions or hallucinations which follow alcohol withdrawal because the medicine has not proven effective for treating the underlying condition and there is inadequate evidence that it is of benefit when used with a benzodiazepine.
Danish: CHMP vedtog, at Haldol ikke længere kan anvendes til behandling af delirium, vrangforestillinger eller hallucinationer, der opstår efter seponering af alkohol, fordi det ikke er påvist, at lægemidlet har en virkning den underliggende sygdom, og fordi der er utilstrækkelig evidens for dets virkning, når det bruges sammen med en benzodiazepin.
English: In particular, Haldol must not be used in patients with heart disorders such as certain heart-rhythm problems, heart failure and recent heart attack, and with central nervous depression (reduced brain activity that slows down breathing and heart rate and reduces alertness).
Danish: Navnlig må Haldol ikke anvendes hos patienter med hjertesygdomme som f.eks. visse forstyrrelser af hjerterytmen, hjertesvigt og nyligt hjerteanfald og hos patienter med undertrykkelse af centralnervesystemet (nedsat hjerneaktivitet, som gør vejrtrækningen og hjerterytmen langsommere samt nedsætter bevidstheden).
English: The CHMP harmonised the starting, maintenance and maximum doses for each of the different uses of Haldol in adults, elderly patients and in children and adolescents.
Danish: CHMP harmoniserede begyndelsesdosen, vedligeholdelsesdosen og den maksimale dosis for hver af de forskellige anvendelser af Haldol hos voksne, ældre patienter og børn og unge.
English: The CHMP agreed to harmonisation of Haldol's contra-indications.
Danish: CHMP vedtog at harmonisere kontraindikationerne for Haldol.
English: It contains the active substance haloperidol and is available as tablets, oral solutions, and injection.
Danish: Haldol indeholder det aktive stof haloperidol og fås som tabletter, orale opløsninger og injektionsvæske.
English: The CHMP agreed that starting dose in the elderly should be as low as possible and harmonised advice on the starting doses of Haldol in those with liver or kidney disorders.
Danish: CHMP konkluderede, at begyndelsesdosen hos ældre skal være så lav som mulig, og harmoniserede rådgivningen vedrørende begyndelsesdosen af Haldol hos patienter med lever- eller nyresygdomme.
English: The CHMP agreed that Haldol injection can be used in adults as follows:
Danish: CHMP fastslog, at Haldol-injektionsvæske kan anvendes hos voksne som følger:
English: • for short-term treatment of delirium when non-pharmacological treatments have not worked;
Danish: • til kortvarig behandling af delirium, når ikke-farmakologisk behandling ikke har virket
English: • acute treatment of delirium when non-pharmacological treatments (treatments that do not involve medicines) have not worked;
Danish: • akut behandling af delirium, når ikke-farmakologiske behandlinger (behandlinger uden brug af lægemidler) ikke har virket
English: • persistent, severe aggression in children and adolescents aged 6 to 17 years with autism or pervasive developmental disorders, when other treatments have not worked or cause unacceptable side effects;
Danish: • vedvarende svær aggressivitet hos børn og unge i alderen 6-17 år med autisme eller pervasiv udviklingslidelse, når andre behandlinger ikke har virket eller medfører uacceptable bivirkninger
English: • tic disorders, including Tourette's syndrome, in children and adolescents aged 10 to 17 years with severe impairment after educational and psychological treatments and other medicines have not worked.
Danish: • tics, herunder Tourettes syndrom, hos børn og unge i alderen 10-17 år med svært nedsat funktionsevne, når undervisningsbehandling, psykologisk behandling og andre lægemidler ikke har virket.
English: • schizophrenia in adolescents aged 13 to 17 years when other medicines have not worked or cause unacceptable side effects;
Danish: • skizofreni hos unge i alderen 13-17 år, når andre lægemidler ikke har virket eller medfører uacceptable bivirkninger
English: • treatment of tic disorders, including Tourette's syndrome, in patients with severe impairment after educational and psychological treatments and other medicines have not worked;
Danish: • behandling af tics, herunder Tourettes syndrom, hos patienter med svært nedsat funktionsevne efter, at undervisningsbehandling, psykologisk behandling og andre lægemidler ikke har virket
English: • for rapid control of severe acute psychomotor agitation linked to psychotic disorder or manic episodes of bipolar I disorder when medicines cannot be given by mouth;
Danish: • til hurtig kontrol af svære tilfælde af akut psykomotorisk uro forbundet med psykotiske forstyrrelser eller maniske episoder af bipolar lidelse type 1, når lægemidler ikke kan gives gennem munden
English: • treatment of moderate to severe manic episodes associated with bipolar I disorder;
Danish: • behandling af moderate til svære maniske episoder associeret med bipolar lidelse type 1
English: The CHMP agreed that Haldol tablets and oral solutions can be used as follows.
Danish: Terapeutiske indikationer CHMP konkluderede, at Haldol-tabletter og orale opløsninger kan anvendes som følger: Hos voksne til:
English: • treatment of mild to moderate chorea in Huntington's disease, when other medicines do not work or have unacceptable side effects.
Danish: • behandling af mild til moderat chorea ved Huntingtons sygdom, når andre lægemidler ikke har virket eller har uacceptable bivirkninger.
English: • for treatment of mild to moderate chorea in Huntington's disease, when other medicines are ineffective or have unacceptable side effects and when medicines cannot be given by mouth;
Danish: • til behandling af mild til moderat chorea ved Huntingtons sygdom, når andre lægemidler ikke har virket eller medfører uacceptable bivirkninger, og når andre lægemidler ikke kan gives gennem munden
English: • treatment of acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder;
Danish: • behandling af akut psykomotorisk uro associeret med psykotiske forstyrrelser eller maniske episoder relateret til bipolar lidelse type 1
English: • alone or with other medicines, for prevention of nausea and vomiting after surgery in those who are at moderate to high risk, when other medicines do not work or have unacceptable side effects;
Danish: • alene eller i tillæg til andre lægemidler til forebyggelse af kvalme og opkastning efter kirurgi hos patienter med moderat til høj risiko, når andre lægemidler ikke har virket eller medfører uacceptable bivirkninger
English: Haldol was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Danish: Koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMDh) fandt, at der er behov for harmonisering for Haldol.
English: Alzheimer's dementia and vascular dementia when non-pharmacological treatments have not worked and when there is a risk of harm to the patient or to others;
Danish: • behandling af vedvarende aggression og psykotiske symptomer hos patienter med moderat til svær Alzheimer-demens og vaskulær demens, når ikke-farmakologiske behandlinger ikke har virket, og når der er en risiko for skade på patienten eller andre personer
English: • with other medicines, for treatment of nausea and vomiting after surgery when other medicines do not work or have unacceptable side effects.
Danish: • i tillæg til andre lægemidler til behandling af kvalme og opkastning efter kirurgi, når andre lægemidler ikke har virket eller medfører uacceptable bivirkninger.
English: The CHMP harmonised other sections of the SmPC including interactions between Haldol and other medicines (section 4.5), information on pregnancy, lactation and fertility (section 4.6) and added angioedema as a side effect (section 4.8).
Danish: 4.5) samt oplysninger om graviditet, amning og fertilitet (pkt.
English: --1 Porcine circovirus type 2 orf-2 protein 2.3-12.4 RP* * Relative potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine
Danish: --1 Porcint circovirus type 2 ORF2-protein 2,3-12,4 RP* *Relativ styrke påvist vha. ELISA antigentest (in vitro styrketest) ved sammenligning med referencevaccine.
English: It may take longer than a month for the patient to feel an improvement.
Danish: Det kan vare over end en måned, inden patienten oplever en forbedring.
English: Livensa testosterone
Danish: Livensa testosteron
English: The company will also provide an educational plan for doctors and patients.
Danish: Det skal fremlægge en uddannelsesplan for både læger og patienter.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Livensa on 28 July 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Livensa den 28. juli 2006.
English: The marketing authorisation holder is Warner Chilcott Deutschland GmbH.
Danish: Indehaveren af markedsføringstilladelsen er Warner Chilcott Deutschland GmbH.
English: Women should contact their doctor if they notice any of these effects.
Danish: Kvinder bør kontakte deres læge, hvis de bemærker en eller flere af disse bivirkninger.
English: This document is a summary of the European public assessment report (EPAR) for Livensa.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Livensa.
English: Livensa was more effective than placebo.
Danish: Livensa var mere effektivt end placebo.
English: If a patient does not feel any improvement after three to six months of treatment, she should contact her doctor and have her treatment reviewed.
Danish: En patient, der efter tre eller seks måneders behandling ikke oplever nogen forbedring, bør kontakte sin læge og få sin behandling revurderet.
English: Other information about Livensa:
Danish: Andre oplysninger om Livensa:
English: Because testosterone is a well-known substance that is already used in other medicines, the company used data from the published literature as well as carrying out studies itself.
Danish: Da testosteron er et velkendt aktivt stof, der allerede anvendes i andre lægemidler, anvendte firmaet data fra den publicerede faglitteratur og gennemførte desuden undersøgelser selv.
English: Livensa is used as a continuous treatment, as one patch twice a week.
Danish: Livensa anvendes som kontinuerlig behandling i form af ét plaster to gange om ugen.