natgillin/translations-raw huggingface dataset:
Aloxi 250 mikrogram injektionsvæske, opløsning Palonosetron (som hydroklorid) Intravenøs anvendelse
Aloxi 250 micrograms solution for injection Palonosetron (as hydrochloride) IV use
19 B.
17 B.
20 INDLÆGSSEDDEL:
18 PACKAGE LEAFLET:
Læs denne indlægsseddel grundigt, inden De begynder at bruge medicinen. • Gem indlægssedlen.
You may need to read it again.
De kan få brug for at læse den igen. • Spørg lægen eller på apoteket, hvis der er mere, De vil vide.. • Lægen har ordineret Aloxi til Dem personligt.
• If you have further questions, please ask your doctor or your pharmacist.
Lad derfor være med at give det til andre.
• This medicine has been prescribed for you.
Det kan være skadeligt for andre, selvom de har de samme symptomer, som De har. • Tal med lægen, hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke er nævnt her.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Virkning og anvendelse 2.
Before you use Aloxi.
Det skal De vide, før De begynder at bruge Aloxi 3.
4.
Sådan skal De bruge Aloxi 4.
Possible side effects.
Bivirkninger 5 Opbevaring 6.
5 How to store Aloxi.
VIRKNING OG ANVENDELSE
WHAT ALOXI IS AND WHAT IT IS USED FOR
• Aloxi er en klar farveløs opløsning til injektion i en blodåre • Det aktive stof (palonosetron) hører til en gruppe lægemidler, der kaldes serotonin (5HT3) - antagonister. • Disse lægemidler kan blokere funktionen af det kemiske stof serotonin, der fremkalder kvalme og opkastning. • Aloxi anvendes til forebyggelse af kvalme og opkastning i forbindelse med kemoterapi mod kræft.
• Aloxi is a clear colourless solution for injection into a vein. • The active ingredient (palonosetron) belongs to a group of medicines known as serotonin (5HT3) antagonists. • These have the ability to block the action of the chemical, serotonin, which can cause nausea and vomiting. • Aloxi is used for the prevention of nausea and vomiting associated with cancer chemotherapy.
DET SKAL DE VIDE, FØR DE BEGYNDER AT BRUGE ALOXI
BEFORE YOU USE ALOXI
De bør ikke anvende Aloxi:
Do not take Aloxi:
Hvis De er overfølsom (allergisk) over for det aktive stof, palonosetron, eller et af de øvrige indholdsstoffer i Aloxi.
- If you are allergic to the active ingredient, palonosetron or any of the other ingredients of Aloxi.
Vær særlig forsigtig med at anvende Aloxi:
Take special care with Aloxi:
- Hvis De har akut forstoppelse eller en sygehistorie med gentagne tilfælde med forstoppelse.
- If you have acute bowel obstruction or a history of repeated constipation.
- Hvis De anvender Aloxi sammen med andre lægemidler, som kan medføre en abnorm
- If you are taking Aloxi in addition to other medicines that may induce an abnormal heart
hjerterytme.
rhythm.
- Hvis der i Deres egen eller familiens sygehistorie har været tilfælde af QT- forlængelse.
- If you have a personal or family history of QT prolongation.
Dette gælder også medicin, som ikke er købt på recept.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Graviditet Hvis De er gravid eller tror De kunne være det, vil Deres læge ikke anvende Aloxi, medmindre det er strengt nødvendigt.
Pregnancy If you are pregnant or think you might be, your doctor will not use Aloxi unless it is clearly necessary.
Det vides ikke, om Aloxi kan medføre skadelige virkninger, hvis det anvendes under graviditet.
19 It is not known whether Aloxi will cause any harmful effects when used during pregnancy.
De skal altid spørge Deres læge eller apotek til råds, før De anvender nogen form for medicin, hvis De er gravid eller tror, De kunne være det.
You should always ask your doctor or pharmacist for advice before using any medicine if you are pregnant or think you might be.
Amning Det vides ikke, om Aloxi udskilles i modermælk.
Breast-feeding It is not known if Aloxi is found in breast milk.
De bør, hvis De ammer, spørge Deres læge eller apotek til råds, før De anvender Aloxi.
You should ask your doctor or pharmacist for advice before using Aloxi if you are breast-feeding.
Aloxi kan fremkalde svimmelhed eller træthed.
Driving and using machines Aloxi may cause dizziness or tiredness.
Lad være med at arbejde med værktøj eller maskiner.
If affected, do not drive or operate machines.
SÅDAN SKAL DE BRUGE ALOXI
HOW TO USE ALOXI
30 minutter før starten af kemoterapi.
A doctor or nurse will normally inject Aloxi about 30 minutes before the start of chemotherapy.
Den normale dosis af Aloxi er 250 mikrogram, givet som en hurtig injektion (bolusinjektion) i en blodåre.
The usual dose of Aloxi is 250 micrograms given as a rapid injection into a vein.
Aloxi kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Aloxi can have side effects, although not everybody gets them.
De mest almindelige bivirkninger er: hovedpine, svimmelhed, forstoppelse og diaré.
The most common side effects are: headache, dizziness, constipation and diarrhoea.
Mellem 1 og 10 ud af 100 patienter vil opleve disse bivirkninger.
Between 1 and 10 out of every 100 patients will experience these side effects.
For højt eller lavt blodtryk Anomal hjerterytme eller mangel på blodtilførsel til hjertet Misfarvning eller udvidelse af blodårerne Unormalt høje eller lave niveauer af kalium i blodet Høje niveauer af sukker i blodet eller urinen Lave niveauer af kalcium i blodet Høje niveauer af pigmentet bilirubin i blodet Høje niveauer af bestemte leverenzymer Hævet stemningsleje eller angstfølelse Søvnighed eller søvnbesvær Nedsat appetit eller tab af appetit Svaghed, træthed, feber eller influenza- lignende symptomer Følelsesløshed, brændende, prikkende eller stikkende fornemmelse på huden Kløende hududslæt Nedsat syn eller øjenirritation Transportsyge Ringen for øret Hikke, luft i maven, tør mund eller fordøjelsesbesvær
Other uncommon side effects are: high or low blood pressure abnormal heart rate or lack of blood flow to the heart discolouration or widening of the veins abnormally high or low levels of potassium in the blood high levels of sugar in the blood or sugar in the urine low levels of calcium in the blood high levels of the pigment bilirubin in the blood high levels of certain liver enzymes elevated moods or feelings of anxiousness sleepiness or trouble sleeping decrease or loss of appetite weakness, tiredness, fever or flu like symptoms numbness, burning, prickling or tingling sensations on the skin itchy skin rash impaired vision or eye irritation motion sickness ringing in the ear hiccups, flatulence, dry mouth or indigestion, abdominal (stomach) pain difficulty urinating joint pain electrocardiogram abnormalities (QT prolongation)
Mellem 1 og 10 ud af 1. 000 patienter vil opleve disse bivirkninger.
Between 1 and 10 out of every 1,000 patients will experience these side effects.
I meget få tilfælde har patienter oplevet overfølsomhedsreaktioner som følge af indgift af Aloxi eller en brændende fornemmelse eller smerte på injektionsstedet.
In some very rare cases, patients have experienced allergic reactions to Aloxi, or burning or pain at the site of injection.
Tal med lægen, hvis en bivirkning er generende eller bliver værre, eller De får bivirkninger, som ikke er nævnt her.
20 If you notice any side effects not mentioned in this leaflet, please tell your doctor..
OPBEVARING
HOW TO STORE ALOXI
Må ikke anvendes efter den udløbsdato, som er angivet på etiketten.
This medicinal product does not require any special storage conditions Do not use after the expiry date stated on the label.
Ikke anvendt opløsning skal kasseres.
Single use only, any unused solution should be disposed of..
YDERLIGERE OPLYSNINGER
6 FURTHER INFORMATION
Aloxi indeholder:
What Aloxi contains:
- Aktivt stof: palonosetron (som hydroklorid).
- The active substance is palonosetron (as hydrochloride).
En ml af opløsningen indeholder 50 mikrogram palonosetron.
One ml of solution contains 50 micrograms palonosetron.
- Øvrige indholdsstoffer: mannitol, dinatriumedetat, natriumcitrat, citronsyremonohydrat og vand til
- The other ingredients are mannitol, disodium edetate, sodium citrate, citric acid monohydrate,
injektionsvæsker, natriumhydroxidopløsning og saltsyreopløsning.
and water for injections, sodium hydroxide solution and hydrochloric acid solution.
Udseende og pakningsstørrelser Aloxi- injektionsvæske, opløsning, er en klar og farveløs opløsning, der leveres i en pakning med ét hætteglas med 5 ml af opløsningen.
What Aloxi looks like and the contents of the pack Aloxi solution for injection is a clear, colourless solution and is supplied in a pack of one glass vial, which contains 5 ml of the solution.
Indehaver af markedsføringstilladelsen og fremstiller Helsinn Birex Pharmaceuticals Ltd., Damastown, Mulhuddart, Dublin 15, Irland.
Helsinn Birex Pharmaceuticals Ltd., Damastown, Mulhuddart, Dublin 15, Ireland.
23 България ЦСЦ Фармасютикъл ЛТД- България ЕООД бул. “ Асен Йорданов ” 10 София 1592, България Teл.: + 359 2 975 13 95 (6)
България ЦСЦ Фармасютикъл ЛТД -България ЕООД бул. “Асен Йорданов” 10 София 1592, България Teл. :+ 359 2 975 13 95 (6)
24 Ireland Helsinn Birex Therapeutics LTD Damastown, Mulhuddart IRL- Dublin 15 Tel: + 353 1 822 54 17
Ireland Helsinn Birex Therapeutics LTD Damastown, Mulhuddart IRL-Dublin 15 Tel: + 353 1 822 54 17
London, den 28. juni 2006 Ref. dok.
Ref.
EMEA/ 462554/ 2006
EMEA/ 190896/ 2006
SPØRGSMÅL OG SVAR VEDRØRENDE ANBEFALINGEN AF AFSLAG PÅ ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for ALPHEON
QUESTIONS AND ANSWERS ON RECOMMENDATION FOR REFUSAL OF MARKETING APPLICATION for ALPHEON
Internationalt fællesnavn (INN): interferon alfa- 2a
International Non-proprietary Name (INN): interferon alfa-2a
Den 28. 06. 06 vedtog Udvalget for Humanmedicinske Lægemidler (CHMP) en negativ udtalelse, hvor det anbefalede at afslå udstedelse af markedsføringstilladelse for lægemidlet Alpheon, 6 millioner IE/ ml, injektionsvæske, til behandling af hepatitis C (leverbetændelse C).
On 28 June 2006 the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Alpheon 6 million IU/ ml solution for injection intended for the treatment of hepatitis C.
Det firma, der havde ansøgt om markedsføringstilladelsen, er BioPartners GmbH.
The company that applied for authorisation is BioPartners GmbH.
Firmaet kan anmode om, at udtalelsen tages op til fornyet overvejelse inden for 15 dage efter modtagelsen af underretningen om denne negative udtalelse.
They may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Hvad er Alpheon?
What is Alpheon?
Alpheon er en injektionsvæske, der indeholder det aktive stof interferon alfa- 2a.
Alpheon is a solution for injection that contains the active substance interferon alfa-2a.
Alpheon er udviklet som et "biosimilært lægemiddel".
Alpheon was developed as a ‘ biosimilar’ medicine.
Referencelægemidlet er i dette tilfælde Roferon- A.
This means that Alpheon was intended to be similar to a biological medicine already authorised in the EU which contains the same active substance (also known as the ‘ reference medicine’), Roferon-A.
Hvad forventedes Alpheon anvendt til?
What was Alpheon expected to be used for?
Alpheon forventedes anvendt til behandling af voksne patienter med kronisk (langvarig) hepatitis C (en leversygdom, der skyldes betændelse med et virus).
Alpheon was expected to be used to treat adult patients who have chronic (long-term) hepatitis C (a disease of the liver due to an infection by a virus).
Ved mikroskopisk undersøgelse af levervævet skal dette i nogen grad være beskadiget, og blodets indhold af et leverenzym (ALT) skal være højere end normalt.
The patients must have signs of liver damage: their liver tissues show some damage when observed with a microscope, and they have higher than normal levels of a liver enzyme (ALT) in their blood.
Desuden skal patienterne have symptomer på infektion med hepatitis C- virus.
They must also show signs of being infected by the hepatitis C virus.
Det var hensigten, at Alpheon skulle anvendes sammen med et antiviruslægemiddel, ribavirin, medmindre ribavirin ikke kunne anvendes til den pågældende patient.
Alpheon was to be used with an antiviral medicine, ribavirin, except when patients could not take ribavirin.
Hvordan forventes Alpheon at virke?
How is Alpheon expected to work?
Interferoner er naturlige stoffer, der produceres af kroppen som forsvar mod angreb f. eks. af infektioner med virus.
Interferons are natural substances produced by the body to help it fight against attacks such as infections caused by viruses.
Det produceres af en gærcelle, der har fået indsat et gen (dna), som gør den i stand til at producere stoffet.
The interferon in Alpheon, interferon alfa-2a, is made by a method known as ‘ recombinant DNA technology’: it is made by a yeast that has received a gene (DNA) that makes it able to produce it.
Hvilken dokumentation har firmaet fremlagt i forbindelse med ansøgningen til CHMP?
What documentation has been presented by the company to support the application to the CHMP?
Det firma, der fremstiller Alpheon, har fremlagt dokumentation for, at Alpheon er blevet sammenlignet med Roferon- A (hvad angår strukturen af det aktive stof, lægemidlets sammensætning og renhed samt dets virkningsmekanisme, sikkerhed og effekt ved hepatitis C).
The company that makes Alpheon presented information showing that Alpheon had been compared to Roferon-A (structure of the active substance, composition and purity of the medicine, the way it works, safety and effectiveness in hepatitis C).
I undersøgelsen vedrørende hepatitis C blev virkningen af Alpheon sammenholdt med virkningen af referencelægemidlet hos 455 patienter.
The study in patients with hepatitis C compared the efficacy of Alpheon with that of the reference medicine in 455 patients.
I undersøgelsen registreredes, hvor mange patienter, der reagerede positivt på lægemidlet (ingen tegn på virus i blodet) efter 12 af 48 ugers behandling og 6 måneder efter behandlingens ophør.
The study measured how many patients responded (no sign of virus in their blood) after 12 out of the 48 weeks of treatment and 6 months after stopping treatment.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hvori bestod de vigtigste betænkeligheder, som førte til, at CHMP anbefalede afslag på ansøgningen om markedsføringstilladelse?
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What were the major concerns which led the CHMP to recommend the refusal of the marketing authorisation?
I CHMP var der væsentlig betænkelighed vedrørende overensstemmelsen mellem Alpheon og Roferon- A på grund af de fundne forskelle mellem de to lægemidler (således urenheder).
The CHMP had major concerns regarding the comparability of Alpheon and Roferon-A, because of differences identified between the two medicines (such as impurities).
Udvalget fandt det ligeledes betænkeligt, at der ikke forelå tilstrækkelige oplysninger om stabiliteten af det aktive stof og af det lægemiddel, der skulle markedsføres.
They also had concerns that there was not enough data on the stability of the active substance and of the medicine that was going to be marketed.
Desuden var fremstillingsprocessen for det færdige lægemiddel ikke tilstrækkelig valideret.
Also, the process used for making the finished medicine had not been adequately validated.
Det antal patienter med hepatitis C, som behandlingen virkede på, var omtrent det samme for Alpheon og Roferon- A i den kliniske undersøgelse.
The number of patients with hepatitis C responding to treatment with Alpheon and Roferon-A was similar in the clinical study.
Der var flere patienter i Alpheon- gruppen end i sammenligningsgruppen, som fik tilbagefald af sygdommen efter behandlingens ophør, og Alpheon gav flere bivirkninger.
However, some differences were seen between the two medicines: more patients experienced a return of the disease after treatment with Alpheon was stopped than with the reference medicine, and there were more side effects with Alpheon.
Desuden savnedes tilstrækkelig validering af den test, der i undersøgelsen blev anvendt til at fastslå, om lægemidlet eventuelt kan udløse en immunologisk reaktion (dvs. en reaktion, hvor kroppen danner nogle særlige proteiner, der kaldes antistoffer, mod lægemidlet).
In addition, the test used in the study to investigate the potential for the medicine to trigger an immunological response (when the body makes special proteins, called antibodies, against the medicine) had not been sufficiently validated.
På dette tidspunkt var det CHMPs opfattelse, at Alpheon ikke kunne anses for at være et biosimilært lægemiddel til referencelægemidlet Roferon- A.
At this point in time, the CHMP was of the opinion that Alpheon could not be considered as a biosimilar medicine of Roferon-A, the reference medicinal product.
CHMP anbefalede derfor afslag på ansøgningen om markedsføringstilladelse for Alpheon.
Hence, the CHMP recommended that Alpheon be refused marketing authorisation.
Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser med Alpheon eller i programmer for anvendelse med særlig udleveringstilladelse?
What are the consequences of the refusal for patients undergoing clinical trials/ compassionate use programmes with Alpheon?
Der er ingen igangværende kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for Alpheon i EU.
There are no ongoing clinical trials or compassionate use programmes with Alpheon in the European Union.
Det anvendes til korttidsbehandling af overfladiske hudinfektio - ner.
It is used for short-term treatment of superficial skin infections.
Altargo bør ikke anvendes til behandling af infektioner, der skyldes methicillin- resistente Staphylococcus aureus (MRSA), da det ikke nødvendigvis virker mod infektioner af denne art.
Altargo should not be used to treat infections known or thought likely to be due to methicillin-resistant Staphylococcus aureus (MRSA), as it may not work against this type of infection.
Når læ - gen ordinerer medicinen, bør officielle retningslinjer for hensigtsmæssig brug af antibiotika følges.
Prescribers should consider official guidance on the use of antibacterial agents.
Altargo kan an - vendes til patienter fra ni måneders alderen, men til patienter under 18 år må det behandlede område højst udgøre 2% af legemsoverfladen.
Altargo can be used in patients from the age of nine months, but in patients under 18 years of age, the area to be treated should not be more than 2% of the body’ s surface.
Er behandlingen ikke begyndt at virke efter to- tre dage, bør lægen revurdere patienten og overveje andre behandlingsmuligheder.
If there is no response to treatment after two to three days, doctors should re-evaluate the patient and consider alternative treatments.
Det aktive stof i Altargo, retapamulin, er et antibiotikum tilhørende gruppen af "pleuromutiliner".
The active substance in Altargo, retapamulin, is an antibiotic belonging to the ‘ pleuromutilin’ class.
Derved hæmmes bakteriernes vækst.
It works by blocking the bacteria’ s ribosomes (the parts of the cells where proteins are produced), inhibiting the growth of the bacteria.
Altargo har været genstand for fem hovedundersøgelser med over 3 000 patienter i alderen fra 9 må - neder og opefter.
Altargo has been studied in five main studies involving over 3,000 patients aged from 9 months upwards.
I den anden blev Altargo sammenlignet med fusidinsyre (en anden antibiotisk salve) hos 519 patienter.
The first compared the effects of five days’ treatment with Altargo to those of placebo (a dummy treatment) in 213 patients, and the second compared Altargo to fusidic acid (another antibiotic ointment) in 519 patients.
Der blev ud - 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
The other three studies 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged ført to undersøgelser hos i alt 1 918 patienter med inficerede hudsår, og den sidste undersøgelse blev udført hos 545 patienter med inficeret dermatitis (hudbetændelse).
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged compared the effects of five days’ treatment with Altargo to those of cefalexin (an oral antibiotic medicine): two studies were carried out in a total of 1,918 patients with infected skin wounds, and the final study was carried out in 545 patients with infected dermatitis (skin inflammation).
I alle fem undersøgelser blev be - handlingens virkning hovedsagelig bedømt på den andel af patienterne, hvor infektionen var svundet ved afslutningen af behandlingen.
In all five studies, the main measure of effectiveness was the proportion of patients whose infections had cleared up after the end of treatment.
Til børnesår var Altargo mere effektivt end placebo, idet behandlingen virkede hos 119 (85, 6%) af de 139 patienter, der fik Altargo, og hos 37 (52, 1%) af de 71 patienter, der fik placebo.
In patients with impetigo, Altargo was more effective than placebo, with 119 (85.6%) of the 139 patients using Altargo and 37 (52.1%) of the 71 using placebo responding to treatment.
Altargo var mindst lige så effektivt som fusidinsyre, idet behandlingen virkede hos henholdsvis 314 (99, 1%) ud af 317 og 141 (94, 0%) ud af 150 patienter.
Altargo was at least as effective as fusidic acid, with 314 (99.1%) of 317 and 141 (94.0%) of 150 patients, respectively, responding to treatment.
Når resultaterne af de to undersøgelser vedrørende hudsår blev lagt sammen, virkede behandlingen hos omkring 90% af patienterne i de to grupper.
For the treatment of infected skin wounds, Altargo and cefalexin had similar response rates: when the results of both skin wound studies were taken together, around 90% of both groups of patients responded to treatment.
I disse to undersøgelser blev Altargo imidlertid ikke fundet tilstrækkelig effektivt til behandling af bylder eller infektioner, der vi - des eller formodes at skyldes MRSA.
However, these two studies found that Altargo was not sufficiently effective in the treatment of abscesses (cavities containing pus) or of infections known or likely to be caused by MRSA.
De forelagte oplysninger var utilstrækkelige som dokumentation for anvendelsen af Altargo til be - handling af inficeret dermatitis.
The data presented were insufficient to support the use of Altargo in the treatment of infected dermatitis.
Den fuldstændige liste over de indberettede bivirkninger for Altargo fremgår af ind - lægssedlen.
For the full list of all side effects reported with Altargo, see the Package Leaflet.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Altargo er større end risiciene ved korttidsbehandling af følgende overfladiske hudinfektioner: • børnesår, • inficerede smårifter, hudafskrabninger og sår, der er blevet syet.
The Committee for Medicinal Products for Human Use (CHMP) decided that Altargo’ s benefits are greater than its risks for the short term treatment of the following superficial skin infections: • impetigo, • infected small lacerations, abrasions or sutured wounds.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Altargo til Glaxo Group Ltd den 24. maj 2007.
The European Commission granted a marketing authorisation valid throughout the European Union for Altargo to Glaxo Group Ltd on 24 May 2007.