natgillin/translations-raw huggingface dataset:
I studiet GEICAM9805 fortsatte alopeci, som forekom i løbet af behandlingsperioden, og blev fortsat observeret hos 49 patienter (9,2%) i TAC-armen og hos 35 patienter (6,7%) i FAC-armen.
In GEICAM 9805 study alopecia that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 49 patients (9.2 %) in TAC arm and 35 patients (6.7 %) in FAC arm. Alopecia related to study drug started or worsened during the follow-up period in 42 patients (7.9 %) in TAC arm and 30 patients (5.8 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), alopecia was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Dato for første markedsføringstilladelse: 12. juni 2009
Date of first authorisation:12 June 2009
Den absolutte biotilgængelighed for en tablet er omkring 77%.
The absolute bioavailability from the tablet was found to be about 77 %.
De hyppigst rapporterede bivirkninger er diaré og hovedpine, som begge forekommer hos ca. 1 % af patienterne.
The most commonly reported adverse reactions are diarrhoea and headache, both occuring in approximately 1% of patients.
Absorptionen af atazanavir er pH-afhængig.
The absorption of atazanavir is pH-dependent.
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), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
GORDdiagnosen i disse studier er baseret på endoskopisk vurdering, med undtagelse af et enkelt studie, hvor inkluderingen af patienter alene var baseret på symptomatologi.
GORD diagnosis in these studies was based on endoscopic assessment, with the exception of one study in which the inclusion of the patients was based on symptomatology alone.
Den lille stigning i AUC og Cmax hos ældre forsøgspersoner i forhold til yngre har ingen klinisk relevans.
The slight increase in AUC and Cmax in elderly volunteers compared with younger subjects was not clinically relevant.
Det forventes, at der i gennemsnit er 5 % af patienterne, som oplever bivirkninger.
Approximately 5% of patients can be expected to experience adverse reactions .
• de er under kontinuerlig symptomatisk behandling af fordøjelsesbesvær eller halsbrand i mere end 4 uger.
• They are on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks.
PANTECTA Control 20 mg enterotabletter bør ikke tygges eller knuses, men skal sluges hele med væske før et måltid.
PANTECTA Control 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal.
PANTECTA Control påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
PANTECTA Control has no or negligible influence on the ability to drive and use machines.
Patienter bør ikke tage andre protonpumpehæmmere eller H2-antagonister samtidigt .
Patients should not take another proton pump inhibitor or H2 antagonist concomitantly.
Det er ukendt, om pantoprazol udskilles i humanmælk .
It is unknown whether pantoprazole is excreted in human breast milk.
Tag ikke PANTECTA Control: - hvis du er allergisk over for pantoprazol eller et af de øvrige indholdsstoffer (angivet i afsnit 6
Do not take PANTECTA Control: - if you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6).
Specielt patienter over 55 år, som dagligt tager ikkereceptpligtige lægemidler mod fordøjelsesbesvær og halsbrand, bør informere deres apotek eller læge.
Especially, patients over 55 years taking any non-prescription indigestion or heartburn remedy on a daily basis should inform their pharmacist or doctor.
PANTECTA Control må ikke bruges af børn og unge under 18 år pga. manglende dokumentation for sikkerhed i denne aldersgruppe.
PANTECTA Control should not be used by children and adolescents under 18 years of age due to a lack of safety information in this younger age group..
PANTECTA Control bør ikke anvendes til børn og unge under 18 år på grund af utilstrækkelige data vedrørende sikkerhed og virkning.
PANTECTA Control is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
I dyrestudier (rotter) var den observerede NOAEL (intet bivirkningsniveau observeret) 5 mg/kg for embryotoksicitet.
In animal studies (rats) 5 mg/kg was the observed NOAEL (No Observed Adverse Effect Level) for embryotoxicity.
Stop med at tage PANTECTA Control, når du er symptomfri.
Stop taking PANTECTA Control when you are completely symptom-free.
- Øvrige indholdsstoffer :
- The other ingredients are:
Forhøjede leverenzymer (transaminaser, γ-GT)
Liver enzymes increased (transaminases, γ-GT)
Hvis du har taget for meget PANTECTA Control Fortæl det til lægen eller apoteket hvis du har taget mere end den anbefalede dosis.
If you take more PANTECTA Control than you should Tell your doctor or pharmacist if you have taken more than the recommended dose.
PANTECTA Control findes i aluminim/aluminium-blister med eller uden kartonforstærkning.
PANTECTA Control is available in Alu/Alu blisters with or without cardboard reinforcement.
Tag ikke PANTECTA Control samtidigt med anden medicin, som begrænser mængden af syre i din mave, så som andre syrepumpehæmmere (omeprazol, lansoprazol eller rabeprazol) eller en H2antagonist (f.eks. ranitidin, famotidin).
Do not take PANTECTA Control with other medicines which limit the amount of acid produced in your stomach, such as another proton pump inhibitor (omeprazole, lansoprazole or rabeprazole) or an H2 antagonist (e.g. ranitidine, famotidine).
Efter 14 og 28 dage oplevede henholdsvis 62,9 % til 88,6 % og 68,1 % til 92,3 % af patienterne fuldstændig lindring af halsbranden.
After 14 and 28 days, complete heartburn relief was experienced in 62.9% to 88.6% and 68.1% to 92.3% of the patients, respectively.
Det er vist, at samtidig anvendelse af atazanavir 300 mg/ ritonavir 100 mg og omeprazol (40 mg én gang daglig) eller atazanavir 400 mg og lanzoprazol (60 mg givet som enkeltdosis) hos raske forsøgspersoner har medført en betydelig reduktion i atazanavirs biotilgængelighed.
It has been shown that co-administration of atazanavir 300 mg/ritonavir 100 mg with omeprazole (40 mg once daily) or atazanavir 400 mg with lansoprazole (60 mg single dose) to healthy volunteers resulted in a substantial reduction in the bioavailability of atazanavir.
PANTECTA Control indeholder det aktive stof pantoprazol, som blokerer den ”pumpe”, der producerer mavesyre.
PANTECTA Control contains the active substance pantoprazole, which blocks the ‘pump' that produces stomach acid.
Du må ikke tage PANTECTA Control, hvis du tager atazanavir.
You must not use PANTECTA Control if you are taking atazanavir.
I disse studier var procentdelen af de patienter, som opnåede fuldstændig lindring af halsbranden efter 7 dage, mellem 54,0% og 80,6 % i gruppen som blev behandlet med pantoprazol.
In these studies, the percentage of patients experiencing complete relief from heartburn after 7 days was between 54.0% and 80.6% in the pantoprazole group.
Se 'tag ikke PANTECTA Control'.
See ‘Do not take PANTECTA Control'.
- Methotrexat (bruges til behandling af reumatoid artrit, psoriasis og cancer) - hvis du tager methotrexat, kan din læge midlertidigt stoppe din behandling med PANTECTA Control, da PANTECTA Control kan forøge niveauet af methotrexat i blodet.
You may need further blood tests - methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate your doctor may temporarily stop your PANTECTA Control treatment because pantoprazole can increase levels of methotrexate in the blood.
Derfor bør pantoprazol ikke gives sammen med atazanavir (se pkt.
Therefore, pantoprazole must not be co-administered with atazanavir (see section 4.3).
PANTECTA Control kan reducere absorptionen af aktive stoffer, hvis biotilgængelighed er pHafhængig (fx. ketoconazol).
PANTECTA Control may reduce the absorption of active substances whose bioavailability is dependent on the gastric pH (e.g. ketoconazole).
Dyrestudier har vist, at pantoprazol udskilles i brystmælk.
Animal studies have shown excretion of pantoprazole in breast milk.
Farmakoterapeutisk klassifikation: Protonpumpehæmmere, ATC-kode: A02BC02
Pharmacotherapeutic group: : Drugs for acid related disorders,Proton pump inhibitors, ATC code: A02BC02
Hyponatræmi, hypomagnesæmi
Hyponatraemia, Hypomagnesaemia
Derfor bør patienter, der er i behandling med kumarinantikoagulantia (f.eks. phenprocoumon eller warfarin), have foretaget ekstra analyser af prothrombintid/INR ved behandlingsstart og -ophør samt ved uregelmæssig brug af pantoprazol.
Therefore, in patients treated with coumarin anticoagulants (e.g. phenprocoumon or warfarin), monitoring of prothrombin time/INR is recommended after initiation, termination or during irregular use of pantoprazole.
Du kan opleve lindring af dine symptomer på sure opstød og halsbrand efter kun en dags behandling med PANTECTA Control, men denne medicin har ikke til hensigt at give øjeblikkelig lindring.
You may experience relief from your acid reflux and heartburn symptoms after just one day of treatment with PANTECTA Control, but this medicine is not meant to bring immediate relief.
Du må gerne tage PANTECTA Control samtidig med syreneutraliserende medicin (f.eks. magaldrat, alginsyre, natriumbicarbonat, aluminiumhydroxid, magnesiumcarbonat eller kombinationer heraf), hvis det er nødvendigt.
However, you may take PANTECTA Control with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed.
PANTECTA Control bør ikke anvendes under graviditet.
Pantoprazole should not be used during pregnancy.
- hvis du tager medicin, som indeholder atazanavir (til behandling af HIV-infektion).
- if you are taking a medicine containing atazanavir (for the treatment of HIV-infection) See
Tag ikke PANTECTA Control-tabletter i mere end 4 uger uden at kontakte lægen.
Do not take PANTECTA Control tablets for more than 4 weeks without consulting your doctor.
Hallucinationer, forvirring (specielt hos patienter som i forvejen har haft disse symptomer); nedsat natrium;og magnesium i blodet.
- Frequency not known: hallucination, confusion (especially in patients with a history of these symptoms); decreased level of sodium in blood; decreased level of magnesium in blood.
Du kan finde yderligere information om PANTECTA Control på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Fortæl det straks til lægen før eller efter du har taget medicinen, hvis du oplever nogle af følgende symptomer, som kan være et tegn på en anden, mere alvorlig, sygdom: - uventet vægttab (som ikke er relateret til diæt eller et motionsprogram) - opkastning, især ved gentagelse - blodigt opkast, dette kan ses som mørkt kaffegrums i dit opkast - du opdager blodig afføring, som kan være sort eller tjærefarvet - synkebesvær eller smerte i forbindelse med synkning - du ser bleg ud eller føler dig sløj (blodmangel) - brystsmerter - mavesmerter - kraftig og/eller vedvarende diaré, da dette lægemiddel er forbundet med en let øget risiko for infektiøs diaré
Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease: - an unintentional loss of weight (not related to a diet or an exercise programme) - vomiting, particularly if repeated - vomiting blood; this may appear as dark coffee grounds in your vomit - you notice blood in your stools; which may be black or tarry in appearance - difficulty in swallowing or pain when swallowing - you look pale and feel weak (anaemia) - chest pain - stomach pain - severe and/or persistent diarrhoea, because this medicine has been associated with a small increase in infectious diarrhoea.
Overtræk: hypromellose, povidon K25, titandioxid (E 171), gul jernoxid (E 172), propylenglycol, methacrylsyre-ethylacrylat copolymer (1:1), natriumlaurilsulfat, polysorbat 80, triethylcitrat.
Coating: hypromellose, povidone, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, methacrylic acid-ethyl acrylate copolymer, sodium lauril sulfate, polysorbate 80, triethyl citrate.
Det skal du vide, før du begynder at tage PANTECTA Control
What you need to know before you take PANTECTA Control
Blæk til prægning: Shellac; rød, sort og gul jernoxid (E 172); koncentreret ammoniakopløsning.
Printing ink: shellac, red, black and yellow iron oxide (E172) and ammonia solution, concentrated.
Povidon K25
Hypromellose Povidone K25
Hvis du har glemt at tage PANTECTA Control Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
Do not take a double dose to make up for the forgotten dose.
ketoconazol (bruges ved svampeinfektion) - warfarin og phenprocoumon (medicin som virker blodfortyndende og forebygger blodpropper).
- warfarin and phenprocoumon (used to thin blood and prevent clots).
- Meget sjældne bivirkninger (kan påvirke færre end 1 ud af 10.000 patienter): Desorientering; nedsat antal blodplader i blodet, hvilket kan medføre at du lettere bløder eller får blå mærker; nedsat antal hvide blodlegemer, hvilket kan øge tendensen til betændelse; unormal reduktion af antallet af hvide og røde blodlegemer samt blodplader (i blodprøver).
- Very rare side effects (may affect up to 1 in 10,000 people): disorientation; reduction in the number of blood platelets, which may cause you to bleed or bruise more than normal; reduction in the number of white blood cells, which may lead to more frequent infections; coexisting abnormal reduction in the number of red and white blood cells, as well as platelets (seen in blood tests).
Blod og lymfesystem
Blood and lymphatic system disorders Immune system disorders
Kerne: Natriumcarbonat, vandfrit; mannitol (E 421), crospovidon, povidon K90, calciumstearat.
Core: sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, calcium stearate.
- atazanavir (bruges til behandling af HIV-infektion).
- ketoconazole (used for fungal infections).
Enterotabletterne er gule, ovale, bikonvekse filmovertrukne tabletter præget med ”P20” på den ene side.
What PANTECTA Control looks like and contents of the pack The gastro-resistant tablets are yellow, oval, biconvex film-coated tablets imprinted with “P20” on one side.
PANTECTA Control bruges til korttidsbehandling af reflukssymptomer (f.eks. halsbrand og sure opstød) hos voksne.
PANTECTA Control is used for the short-term treatment of reflux symptoms (for example heartburn, acid regurgitation) in adults.
Sådan skal du tage PANTECTA Control
How to take PANTECTA Control
- Ikke almindelige bivirkninger ( kan påvirke mellem 1 og 100 personer): Hovedpine; svimmelhed; diaré; kvalme, opkastning; oppustethed og luftafgang fra tarmen; forstoppelse; mundtørhed; smerter og ubehag i maven; hududslæt og eksem; kløe; svaghedsfornemmelse, udmattet eller generelt utilpas; søvnforstyrrelser; forøgede leverenzymtal ved blodprøve.
- Uncommon side effects(may affect up to 1 in 100 people): headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind); constipation; dry mouth; bellyache and discomfort; skin rash or hives; itching; feeling weak, exhausted or generally unwell; sleep disorders; increase in liver enzymes in a blood test.
Chokolade, pebermynte, spearmint, fed og friturestegt mad, syreholdig mad, krydret mad,
spearmint, fatty and fried food, acidic food, spicy food, citrus fruits and fruit juices, tomatoes.
PANTECTA Control er indiceret til korttidsbehandling af reflukssymptomer (fx halsbrand, syreregurgitation) hos voksne.
PANTECTA Control is indicated for short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
- hvis du tidligere har haft et mavesår eller har fået foretaget en maveoperation - hvis du har leverproblemer eller gulsot (gulfarvning af huden og øjnene) - hvis du regelmæssigt tager til læge på grund af alvorlige sygdomme eller lidelser - hvis du skal have fortaget en endoskopi eller en udåndingstest kaldet C-urea.
- if you have been treated for heartburn or indigestion continuously for 4 or more weeks - if you are over 55 years old and taking non-prescription indigestion treatment on a daily basis - if you are over 55 years old with any new or recently changed reflux symptoms - if you have previously had a gastric ulcer or stomach surgery - if you have liver problems or jaundice (yellowing of skin or eyes) - if you regularly see your doctor for serious complaints or conditions - if you are due to have an endoscopy or a breath test called a C-urea test.
Det skal du vide, før du begynder at tage PANTECTA Control Sådan skal du tage PANTECTA Control Bivirkninger
What PANTECTA Control is and what it is used for What you need to know before you take PANTECTA Control How to take PANTECTA Control Possible side effects
Se brug af andet medicin sammen med PANTECTA Control.
Other medicines and PANTECTA Control
PANTECTA Control 20 mg enterotabletter Pantoprazol
PANTECTA Control 20 mg gastro-resistant tablets Pantoprazole
Overtræk
Pruritus
- Aktivt stof: Pantoprazol.
What PANTECTA Control contains - The active substance is pantoprazole.
Samtidig behandling med atazanavir (se pkt.
Co-administration with atazanavir (see section 4.5).
PANTECTA Control 20 mg enterotabletter
PANTECTA Control 20 mg gastro-resistant tablets
Søvnforstyrrelser Depression (og
Sleep disorders
”PANTECTA Control indeholder”).
‘Other medicines and PANTECTA Control'.
Brug af anden medicin sammen med PANTECTA Control Fortæl det til lægen eller apoteket, hvis du tager, har taget eller overvejer at tage andet medicin.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines PANTECTA Control may stop certain other medicines from working properly.
PANTECTA Control bør ikke anvendes under amning.
Pantoprazole should not be used during breast-feeding.
Hypromellose
Fertility
PANTECTA Control indeholder:
What PANTECTA Control is and what it is used for
Telefon:
A.
Det fremgik ikke klart af de oplysninger, som udvalget havde fået fremlagt, om dette skyldtes måden, undersøgelsen var udformet på, måden resultaterne blev analyseret på eller selve lægemidlet.
Based on the information presented to the Committee, it was not clear whether this was due to the way the study was designed, the way the results were analysed, or to the medicine itself.
Relapsing-remitterende betyder, at patienten får attakker (tilbagefald) efterfulgt af perioder med mildere symptomer (remission).
Relapsing-remitting means that the patient has attacks (relapses) followed by periods with milder symptoms (remission).
Hver patient fik enten Biferonex eller placebo i to år.
Each patient received either Biferonex or placebo for two years.
Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse for Biferonex interferon beta-1a
Questions and answers on the withdrawal of the marketing authorisation application for Biferonex interferon beta-1a
Virksomheden havde anmodet om, at den negative udtalelse blev taget op til fornyet overvejelse, men denne var endnu ikke afsluttet, da virksomheden trak ansøgningen tilbage.
The company had requested a re-examination of the negative opinion, but this re-examination had not yet finished when the company withdrew.
Biferonex indeholder det samme aktive stof som andre lægemidler, kaldet Avonex og Rebif, som har været godkendt i EU siden henholdsvis 1997 og 1998.
Biferonex contains the same active substance as other medicines called Avonex and Rebif, which have been authorised in the European Union since 1997 and 1998, respectively.
Virkningerne af Biferonex blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Biferonex were first tested in experimental models before being studied in humans.
I modsætning til disse lægemidler er Biferonex fremstillet på en måde, så det ikke indeholder blodproteinet humant albumin.
In contrast to these medicines, Biferonex is made in such a way that it does not contain the human blood protein, albumin.
Hvad er Biferonex?
What is Biferonex?
Biferonex var beregnet til patienter, der havde haft to eller flere attakker inden for de sidste to år.
Biferonex was intended for patients who had experienced two or more attacks in the previous two years.
Biferonex forventes at virke ved at modulere aktiviteten i immunsystemet (kroppens naturlige forsvar) og forebygge tilbagefald af dissemineret sklerose.
Biferonex is expected to work by modulating the activity of the immune system (the body's natural defences) and preventing relapses of multiple sclerosis.
Behandlingens virkning blev hovedsagelig bedømt på reduktionen i antallet af attakker.
The main measure of effectiveness was the reduction in the number of attacks.
Virksomheden fremlagde resultaterne af en hovedundersøgelse, hvori Biferonex blev sammenlignet med placebo (en virkningsløs behandling) hos 339 voksne med relapsing-remitterende dissemineret sklerose.
The company presented the results of one main study, in which Biferonex was compared with placebo (a dummy treatment) in 339 adults with relapsing-remitting multiple sclerosis.
Virksomheden anvendte også oplysninger om Avonex og oplysninger fra den offentliggjorte faglitteratur om andre lægemidler indeholdende interferon beta.
The company also used information relating to Avonex, and information from the published literature on other medicines containing interferon beta.
Interferon beta-1a produceres ved en metode, der er kendt som "rekombinant DNA-teknologi": Det fremstilles af en celle, som har modtaget et gen (DNA), der sætter den i stand til at producere interferon beta-1a.
Interferon beta-1a is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce interferon beta-1a.
CHMP var også af den opfattelse, at resultaterne af den eneste hovedundersøgelse, der var foretaget af Biferonex, ikke udgjorde tilstrækkeligt bevis for, at lægemidlet var effektivt.
The CHMP was also of the opinion that the results of the single pivotal study of Biferonex did not show enough evidence that the medicine was effective.
Den 28. maj 2009 meddelte BioPartners GmbH officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Biferonex til behandling af relapsing-remitterende dissemineret sklerose.
On 28 May 2009, BioPartners GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Biferonex, for the treatment of relapsing-remitting multiple sclerosis.
Det skulle have været leveret i fyldte injektionssprøjter.
It was to be available in prefilled syringes.
Hvad forventedes Biferonex anvendt til?
What was Biferonex expected to be used for?
Det konkluderede derfor, at det ikke var berettiget at anvende de offentliggjorte undersøgelser af disse lægemidler indeholdende interferon beta til støtte for anvendelsen af Biferonex, og at der krævedes undersøgelser af selve lægemidlet Biferonex.
It therefore concluded that using the published studies on these interferon beta-containing medicines to support the use of Biferonex was not justified, and that studies on Biferonex itself were required.
Biferonex forventedes anvendt til behandling af voksne med relapsing-remitterende dissemineret sklerose.
Biferonex was expected to be used to treat adults with relapsing-remitting multiple sclerosis.
Dissemineret sklerose er en nervesygdom, der ødelægger den beskyttende skede omkring nerverne som følge af en betændelseslignende tilstand.
Multiple sclerosis is a disease of the nerves, in which inflammation destroys the protective sheath around the nerves.