natgillin/translations-raw huggingface dataset:
krampeanfald, bevidsthedsforstyrrelser, ændringer i følesansen (f.eks.paræstesier), perifere neuropati, svimmelhed, nedsat skriveevne, forstyrrelser i nervesystemet
seizures, disturbances in consciousness, paraesthesias and dysaesthesias, peripheral neuropathies, dizziness, writing impaired, nervous system disorders uncommon:
De skal i særdeleshed oplyse lægen, hvis De tager medicin, der indeholder aktivt stof som: - svampemidler og antibiotika, især såkaldte makrolider til behandling af infektioner f.eks.
In particular, you should tell your doctor if you are taking or have recently taken medicines with active substances like: - antifungal medicines and antibiotics, particularly so-called macrolide antibiotics, used to treat infections e.g. ketoconazole, fluconazole, itraconazole, voriconazole, clotrimazole,
Patienter med nedsat leverfunktion
Paediatric patients
Infusionsvæsken kan give irritation på injektionsstedet, hvis det rekonstituerede <[(Sær)navn]> 5 mg/ml koncentrat till infusionsvæske, opløsning fejlagtigt gives intraarterielt eller perivasalt.
If administered accidentally either arterially or perivasally, the reconstituted <Invented name> 5 mg/ml Concentrate for Solution for Infusion may cause irritation at the injection site.
HVAD DE SKAL GØRE, FØR DE BEGYNDER AT TAGE <[(SÆR)NAVN]>
BEFORE YOU TAKE <INVENTED NAME>
asteni, feber, ødem, smerter og ubehag, stigning i basisk phosphatase, vægtøgning, ændret opfattelse af kropstemperatur
asthenic conditions, febrile disorders, oedema, pain and discomfort, blood alkaline phosphatase increased, weight increased, body temperature perception disturbed uncommon:
smertefuld vandladning med blod i urinen
painful urination with blood in the urine Disorders affecting the body as a whole common:
koma, blødning i centralnervesystemet og hjerneblødning, encephalopati, taleforstyrrelser ,amnesi
coma, central nervous system haemorrhages and cerebrovascular accidents, paralysis and paresis, encephalopathy, speech and language abnormalities, amnesia rare:
anuri, hæmolytisk uræmisk syndrom
anuria, haemolytic uraemic syndrome very rare:
Prograf og tilknyttede særnavne (se bilag I) 5 mg/ml koncentrat till infusionsvæske, opløsning [Se bilag I - Udfyldes nationalt]
Prograf and associated names (see Annex I) 5 mg/ml concentrate for solution for infusion [see Annex I - to be completed nationally]
Øresygdomme Almindelige:
Eye disorders common:
Grækenland Vianex S.A. Tatoiou Street
Vianex S.A.
Prograf og tilknyttede særnavne (se bilag I) 1 mg kapsler, hårde [Se bilag I - Udfyldes nationalt] Tacrolimus
Prograf and associated names (see Annex I)1 mg hard capsules [See Annex I - To be completed nationally] Tacrolimus
Blod- og lymfelidelser Almindelige:
Blood and lymph disorders common:
leversvigt, forsnævring af galdevejene
liver failure, narrowing of the bile vessel
trombose i leverarterie, venooccusive liver disease
hepatitic artery thrombosis, venoocclusive liver disease very rare:
leversvigt, galdevejsstenose Sygdomme i hud og subkutane væv Almindelige:
hepatic failure, bile duct stenosis Skin and subcutaneous disorders common:
Prograf og tilknyttede navne (se bilag I) 5 mg/ml koncentrat till infusionsvæske, opløsning [Se bilag I- bdfyldes nationalt] Tacrolimus
Prograf and associated names (see Annex I) 5 mg/ml concentrate for solution for infusion [See Annex I - to be completed nationally] Tacrolimus
HVILKE MULIGE BIVIRKNINGER <[(SÆR)NAVN]> HAR
POSSIBLE SIDE EFFECTS
Hvis De glemmer at tage <[(Sær)navn]>
If you forget to take <Invented name>
HVORDAN DE TAGER <[(SÆR)NAVN]>
HOW TO TAKE <INVENTED NAME>
Peroral <[(Sær)navn]> behandling bør starte med 0,20 - 0,30 mg/kg/dag fordelt på 2 doser (f.eks. morgen og aften).
Oral <Invented name> therapy should commence at 0.20 - 0.30 mg/kg/day administered as two divided doses (e.g. morning and evening).
Hvis den kliniske tilstand ikke tillader peroral behandling, gives en intravenøs dosis på 0,075 - 0,100 mg/kg/dag som kontinuerlig infusion over 24 timer.
If the clinical condition of the patient prevents oral dosing, an initial intravenous dose of 0.075 - 0.100 mg/kg/day should be administered as a continuous 24-hour infusion.
åndedrætsbesvær, lidelse i luftvejene, astma
difficulties in breathing, respiratory tract disorders, asthma rare:
insomnia
insomnia common:
Prograf og tilknyttede særnavne (se bilag I) 5 mg kapsler, hårde [Se bilag I - Udfyldes nationalt] Tacrolimus
Prograf and associated names (see Annex I) 5 mg hard capsules [See Annex I - To be completed nationally] Tacrolimus
Hvis De holder op med at tage <[(Sær)navn]>
If you stop taking <Invented name>
problemer med blodcirkulation i leveren
problems with blood flow in the liver very rare:
Udskillelse
Lactation
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN [Se bilag I - Udfyldes nationalt] MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) [Udfyldes nationalt]
MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Ciclosporin blodkoncentrationerne og patientens tilstand skal tages i betragtning før behandling med <[(Sær)navn]> indledes.
<Invented name> therapy should be initiated after considering ciclosporin blood concentrations and the clinical condition of the patient.
nedsat åndedrætsfunktion, lidelse i luftvejene, astma
respiratory failures, respiratory tract disorders, asthma rare:
ringen for ørene
ringing sound in your ears uncommon:
Karsygdomme Meget almindelige:
Vascular disorders very common:
Der er set EBV-associerede lymfoproliferative lidelser relaterede til behandling med <[(Sær)navn]>.
Patients treated with <Invented name> have been reported to develop EBV-associated lymphoproliferative disorders.
Sjældne bivirkninger forekommer hos mellem 1 og 1.000 ud af 10.000 patienter.
Rare side effects are experienced in less than one per one thousand patients but more than one per ten thousand patients.
Børn, der overgår til <[(Sær)navn]>behandling, bør initialt få perorale doser på 0,20 - 0,30 mg/kg/dag fordelt på 2 doser (f.eks. morgen og aften).
In paediatric patients converted to <Invented name>, an initial oral dose of 0.20 - 0.30 mg/kg/day should be administered in two divided doses (e.g. morning and evening).
pruritus, udslæt, alopecia, akne, svedudbrud
pruritus, rash, alopecias, acne, sweating increased uncommon:
Hvis den kliniske tilstand ikke tillader peroral behandling gives en intravenøs dosis på 0,05 mg/kg/dag som kontinuerlig infusion over 24 timer.
If the clinical condition of the patient prevents oral dosing, an initial intravenous dose of 0.05 mg/kg/day should be administered as a continuous 24-hour infusion.
Almindelige bivirkninger forekommer hos mellem 1 og 10 ud af 100 patienter.
Common side effects are experienced in less than one in ten patients but in more than one per one hundred patients.
perikardial ekssudation
hyperlipidaemia,
tørst, øget tendens til at falde, trykken for brystet, nedsat bevægelighed, sår
thirst, fall, chest tightness, mobility decreased, ulcer very rare:
Prograf og tilknyttede særnavne (se bilag I) 0,5 mg kapsler, hårde [Se bilag I - Udfyldes nationalt]
Prograf and associated names (see Annex I) 0.5 mg hard capsules [See Annex I - To be completed nationally] Tacrolimus
Usædvanlige bivirkninger forekommer hos mellem 1 og 100 ud af 1.000 patienter.
Uncommon side effects are experienced in less than one in one hundred patients but more than one per one thousand patients.
Blod dalkoncentrationer af <[(Sær)navn]> bør måles under den postoperative fase.
Blood trough levels of tacrolimus should be monitored during the post-transplantation period.
Metabolismehæmmere
Inhibitors of metabolism
Almene lidelser Almindelige:
renal impairment common:
Initialt benyttes en peroral dosering på 0,10 - 0,20 mg/kg/dag, fordelt på to doser (f.eks. morgen og aften).
Oral <Invented name> therapy should commence at 0.10 - 0.20 mg/kg/day administered as two divided doses (e.g. morning and evening).
ændringer i levertal og funktion, gulsot, ødelæggelse af levervæv og leverbetændelse
changes in liver enzymes and function, yellowing of the skin due to liver problems, liver tissue damage and inflammation of the liver rare:
iskæmiske tilstande, takykardi
subileus, pancreatic pseudocyst
Hvis den kliniske tilstand ikke tillader peroral behandling gives en intravenøs dosis på 0,01 - 0,05 mg/kg/dag som kontinuerlig infusion over 24 timer.
If the dose cannot be administered orally as a result of the clinical condition of the patient, intravenous therapy of 0.01 - 0.05 mg/kg/day should be initiated as a continuous 24-hour infusion.
6.6 Særlige forholdsregler ved bortskaffelse [Udfyldes nationalt]
PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally] 6.2 Incompatibilities [To be completed nationally] 6.3 Shelf life [To be completed nationally] 6.4 Special precautions for storage [To be completed nationally] 6.5 Nature and contents of container [To be completed nationally] 6.6 Special precautions for disposal
<[(Sær)navn]> udskilles i modermælken og De bør derfor ikke amme mens De behandles med <[(Sær)navn]>.
Therefore you should not breast-feed whilst receiving <Invented name>.
Hvis den kliniske tilstand ikke tillader peroral behandling gives en intravenøs dosis på 0,01-0,02 mg/kg/dag som kontinuerlig infusion over 24 timer.
If the dose cannot be administered orally as a result of the clinical condition of the patient, intravenous therapy of 0.01 to 0.02 mg/kg/day should be initiated as a continuous 24-hour infusion.
INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER [Udfyldes nationalt]
EXPIRY DATE EXP: {MM/YYYY} BATCH NUMBER Batch: {number} CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT [To be completed nationally]
Hvis den kliniske tilstand ikke tillader peroral behandling, gives en intravenøs dosis på 0,05 - 0,10 mg/kg/dag som kontinuerlig infusion over 24 timer.
If the dose cannot be administered orally as a result of the clinical condition of the patient, intravenous therapy of 0.05 - 0.10 mg/kg/day should be initiated as a continuous 24-hour infusion.
- Så længe De er i behandling med <[(Sær)navn]> vil lægen med mellemrum foretage en række undersøgelser (inkl.
Whilst you are receiving <Invented name> your doctor may want to carry out a number of tests (including blood, urine, heart function, visual and neurological tests) from time to time.
tørst,svækkelse, trykken for brystet, nedsat bevægelighed, mavesår
thirst, fall, feeling of tightness in your chest, decreased mobility, ulcer very rare:
Dette sammendrag blev sidst ajourført i 09-2016.
This summary was last updated in 09-2016.
Infusionen bør strække sig over tre timer.
The infusion should last three hours.
Disse målinger blev foretaget ved undersøgelsens start og efter et års behandling.
These measurements were taken at the start of the study and after a year of treatment.
Elaprase er godkendt under "særlige omstændigheder".
Elaprase has been authorised under ‘exceptional circumstances'.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Elaprase den 8. januar 2007.
The European Commission granted a marketing authorisation valid throughout the European Union for Elaprase on 8 January 2007.
Ved undersøgelsens start kunne patienterne gå gennemsnitligt ca. 395 m på seks minutter.
At the start of the study, the patients could walk an average of around 395 metres in six minutes.
Uden behandling forværres disse symptomer med tiden.
Without treatment, these symptoms become more severe over time.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Elaprase.
This is a summary of the European public assessment report (EPAR) for Elaprase.
Elaprase gives hver uge som en infusion i en vene i en dosis på 0,5 mg pr. kg legemsvægt.
Elaprase is given every week, as an infusion into a vein, at a dose of 0.5 mg per kilogram body weight.
Hovedundersøgelsen af Elaprase omfattede 96 mandlige patienter i alderen 5-31 år, og heri sammenlignedes det med placebo (en uvirksom behandling).
The main study of Elaprase involved 96 male patients aged between 5 and 31 years, and compared it with placebo (a dummy treatment).
Andre oplysninger om Elaprase
Other information about Elaprase
Dette giver anledning til en lang række symptomer, især vejrtrækningsbesvær og gangbesvær.
This causes a wide range of symptoms, particularly difficulty breathing and difficulty walking.
Lægemidlet er beregnet til langtidsbehandling.
It is designed for long-term use.
CHMP konkluderede, at de ved undersøgelsen konstaterede forbedringer, også selv om de var begrænsede, havde klinisk virkning ved behandling af Hunters syndrom.
The CHMP concluded that the improvements shown in the study, even if limited, represent a clinical benefit in the treatment of Hunter syndrome.
Hunters syndrom, der også er kendt som mukopolysakkaridose II, er en sjælden, arvelig sygdom, som primært forekommer hos mandlige patienter.
Hunter syndrome, which is also known as mucopolysaccharidosis II, is a rare, inherited disease that primarily affects male patients.
Hvis du ønsker yderligere oplysninger om behandling med Elaprase, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Elaprase, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Da patienter med Hunters syndrom ikke kan nedbryde disse stoffer, ophober glykosaminglykanerne sig gradvist i de fleste af kroppens organer og beskadiger dem.
Since patients with Hunter syndrome cannot break these substances down, the GAGs gradually build up in most of the organs in the body and damage them.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Elaprase?
What measures are being taken to ensure the safe and effective use of Elaprase?
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Elaprase skal anvendes.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Elaprase.
Elaprase er et lægemiddel, der indeholder det aktive stof idursulfase.
Elaprase is a medicine that contains the active substance idursulfase.
Da antallet af patienter med Hunters syndrom er lavt, betragtes sygdommen som "sjælden", og Elaprase blev udpeget som "lægemiddel til sjældne sygdomme" den 11. december 2001.
Because the number of patients with Hunter syndrome is low, the disease is considered ‘rare', and Elaprase was designated an ‘orphan medicine' (a medicine used in rare diseases) on 11 December
Det erstatter det enzym, der mangler eller er utilstrækkeligt hos patienter med Hunters syndrom.
It replaces the enzyme that is missing or defective in patients with Hunter syndrome.
Patienter med Hunters syndrom producerer ikke et enzym kaldet iduronate-2-sulfatase.
Patients with Hunter syndrome do not produce an enzyme called iduronate-2-sulfatase.
Den fuldstændige EPAR for Elaprase findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Elaprase can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Elaprase anvendes til behandling af patienter med Hunters syndrom.
Elaprase is used to treat patients with Hunter syndrome.
Det primære effektmål var lungefunktionen ("forceret vitalkapacitet", som er den maksimale mængde luft, patienten kunne udånde) og den distance, patienterne kunne gå på seks minutter, hvilket måler sygdommens kombinerede indvirkning på hjerte, lunger, led og andre organer.
The main measures of effectiveness were lung function (‘forced vital capacity', the maximum amount of air the patient could breathe out), and the distance the patients could walk in six minutes, which measures the combined effects of the illness on the heart, lungs, joints and other organs.
Virksomheden, som fremstiller Elaprase, skal undersøge lægemidlets virkning på lang sigt, særlig på lungerne, hjertet og blodkarrene, og hvorvidt det stimulerer kroppen til at danne antistoffer, som kan have indflydelse på lægemidlets sikkerhed og effekt.
The company that markets Elaprase will investigate the long-term effects of the medicine, particularly on the lungs, the heart and the blood vessels, and whether the body produces antibodies that could affect the medicine's safety and effectiveness.
Der er forekommet svære allergiske reaktioner hos nogle patienter, som fik Elaprase.
Severe allergic reactions have occurred in some patients taking Elaprase.
Udvalget besluttede, at fordelene ved Elaprase opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Elaprase.
The Committee decided that Elaprase's benefits are greater than its risks and recommended that it be given marketing authorisation.
Elaprase må ikke anvendes til personer, der har haft en svær eller livstruende allergisk reaktion (anafylaktisk reaktion) over for idursulfase eller andre af indholdsstofferne, hvis deres allergi ikke kan kontrolleres.
Elaprase must not be used in people who have had a severe or life-threatening allergic (anaphylactic) reaction to idursulfase or any of the other ingredients if their allergy is not controllable.
Så længe patienten ikke får infusionsreaktioner (udslæt, kløe, feber, hovedpine, forhøjet blodtryk eller rødme), kan infusionstiden dog gradvis nedsættes til en time.
However, as long as the patient does not develop infusion reactions (rash, itching, fever, headache, high blood pressure or flushing), the duration of the infusion can be gradually reduced to one hour.
Dette enzym er nødvendigt for at nedbryde de stoffer i kroppen, som kaldes glykosaminglykaner (GAG).
This enzyme is needed to break down substances in the body called glycosaminoglycans (GAGs).
Det aktive stof i Elaprase, idursulfase, er en kopi af det humane enzym iduronat-2-sulfatase.
The active substance in Elaprase, idursulfase, is a copy of the human enzyme iduronate-2-sulfatase.
Hvilke oplysninger afventes der stadig for Elaprase?
What information is still awaited for Elaprase?
Hvis Elaprase gives til patienter, der tidligere har haft svære allergiske reaktioner, skal det gives med forsigtighed, og uddannet personale og udstyr til akut genoplivning skal være tilgængelig under infusionen.
If given to patients who have had severe allergic reactions in the past, Elaprase should be used with caution, and trained staff and equipment for emergency resuscitation should be available during infusion.
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Elaprase findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of the opinion of the Committee for Orphan Medicinal Products for Elaprase can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Elaprase forbedrede lungefunktionen og den afstand, patienterne kunne gå.
Elaprase improved lung function and the walking ability of the patients.
Behandling med Elaprase bør overvåges af en læge eller en anden sundhedsuddannet person, som har erfaring i behandling af patienter med Hunters syndrom eller andre arvelige sygdomme, der påvirker stofskiftet.
Elaprase treatment should be supervised by a doctor or other healthcare professional who has experience in the management of patients with Hunter syndrome or other inherited diseases affecting the metabolism.
Hvilken risiko er der forbundet med Elaprase?
What is the risk associated with Elaprase?
Patienter, som tåler infusionerne godt i en periode på flere måneder på en klinik, kan eventuelt begynde at få dem hjemme.
Patients who tolerate the infusions well for several months in a clinic may be able to start having them at home. Home infusions should be supervised by a doctor or nurse.
Efter et år kunne de patienter, der fik Elaprase, gå yderligere 43 m i gennemsnit, og de patienter, der fik placebo, kunne gå yderligere 8 m. Lægemidlet forbedrede også lungefunktionen, mens de patienter, der fik placebo, oplevede en let forværring.
After a year, the patients receiving Elaprase could walk a further 43 metres on average, and the patients receiving placebo could walk a further 8 metres.
Hvorfor blev Elaprase godkendt?
Why has Elaprase been approved?
De hyppigste bivirkninger ved Elaprase er forbundet med infusionen, herunder hudreaktioner (udslæt eller kløe), feber, hovedpine, forhøjet blodtryk og rødme.
The most common side effects with Elaprase are related to the infusion, including skin reactions (rash or itching), fever, headache, high blood pressure and flushing.
Andre bivirkninger, som optræder hos flere end 1 ud af 10 patienter, er hiven efter vejret, dyspnø (vejrtrækningsbesvær), mavesmerter, kvalme, dyspepsi (halsbrand), diarré, opkastning, hævelse på infusionsstedet og brystsmerter.
Other side effects seen in more than 1 patient in 10 are wheezing, dyspnoea (difficulty breathing), abdominal pain (stomach ache), nausea (feeling sick), dyspepsia (heartburn), diarrhoea, vomiting, swelling at the site of infusion and chest pain.
Det leveres som et koncentrat, der blandes til en infusionsvæske, opløsning (drop i en vene).
It is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Den fuldstændige liste over indberettede bivirkninger ved Elaprase fremgår af indlægssedlen.
For the full list of all side effects reported with Elaprase, see the package leaflet.
Det betyder, at det ikke har været muligt at indhente fyldestgørende oplysninger om Elaprase, fordi Hunters syndrom er sjældent.
This means that because Hunter syndrome is rare, it has not been possible to obtain complete information about Elaprase.
Tilføjelsen af enzymet forbedrer nedbrydningen af glykosaminglykanerne og forhindrer, at de hober sig op i kropsvæv.
Supplying the enzyme will help to break down GAGs and stop them building up in body tissue, thereby helping to improve the symptoms of the disease.
Hvordan blev Elaprase undersøgt?
How has Elaprase been studied?
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Elaprase.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Elaprase have been included in the summary of product characteristics and the package leaflet.
Hvad er Elaprase?
What is Elaprase?
Hvilken fordel viser undersøgelserne, at der er ved Elaprase?
What benefit has Elaprase shown during the studies?
Hvordan anvendes Elaprase?
How is Elaprase used?
Hvad anvendes Elaprase til?
What is Elaprase used for?
Hvordan virker Elaprase?
How does Elaprase work?
Natriumchloridopløsning (0.9 %)
Sodium chloride solution (0.9 %)
Aktiv substans som principielt er af biologisk oprindelse hvis formål er at producere aktiv immunitet falder ikke indenfor anvendelsesområdet af Forordning (EF) nr. 470/2009.
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten og den ydre emballage efter EXP.
Do not use this veterinary medicinal product after the expiry date which is stated on the label and carton after EXP.
Hætteglasset opbevares i den ydre karton for at beskytte mod lys.
Keep the vial in the outer carton in order to protect from light.
Opbevares i køleskab (2°C - 8°C).
Store in a refrigerator (2 ºC − 8 ºC).
1 dosis på 2 ml indeholder:
Each dose of 2 ml contains:
4.10 Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt
Overdose (symptoms, emergency procedures, antidotes), if necessary
Dato for første markedsføringstilladelse: 14/01/2010 Dato for seneste fornyelse af markedsføringstilladelse: DD/MM/YYYY
Date of first authorisation: 14/01/2010 Date of last renewal : DD/MM/YYYY
ANDRE OPLYSNINGER>
OTHER INFORMATION