natgillin/translations-raw huggingface dataset:
Udseende og pakningsstørrelser - Pioglitazone Teva Pharma 15 mg abletter er hvide til grålig hvide, runde, konvekse og mærket med ‘15' på den ene side og ‘TEVA' på den anden side.
What Pioglitazone Teva Pharma looks like and contents of the pack - Pioglitazone Teva Pharma 15 mg tablets are white to off white, round, convex with the number
Hver Pioglitazone Teva Pharma 45 mg tablet indeholder 45 mg pioglitazon (som hydrochlorid).
Each Pioglitazone Teva Pharma 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).
Kontakt hurtigst muligt din læge, hvis du oplever nogle af disse bivirkninger, særligt hvis du er over 65 år..
If you experience any of these, especially if you are over the age of 65, seek medical advice straight away.
INFORMATION I BRAILLE-SKRIFT Pioglitazone Teva Pharma 15 mg
INFORMATION IN BRAILLE Pioglitazone Teva Pharma 15 mg tablets
Pioglitazone Teva Pharma 15 mg tabletter Hver tablet indeholder 15 mg pioglitazon (som hydrochlorid).
Pioglitazone Teva Pharma 15 mg tablets Each tablet contains 15 mg of pioglitazone (as hydrochloride).
Hver Pioglitazone Teva Pharma 15 mg tablet indeholder 15 mg pioglitazon (som hydrochlorid).
Each Pioglitazone Teva Pharma 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride).
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN
MARKETING AUTHORISATION NUMBER(S)
LÆGEMIDLETS NAVN Pioglitazone Teva Pharma 15 mg tabletter Pioglitazon
NAME OF THE MEDICINAL PRODUCT Pioglitazone Teva Pharma 15 mg tablets Pioglitazone
Pharma (angivet i punkt 6) - hvis du lider af hjertesvigt eller tidligere har haft hjertesvigt.
- if you have heart failure or have had heart failure in the past.
Ikke kendt
very common
Under behandlingen anbefales månedlige målinger.
During treatment, monthly measurements are recommended.
Den anbefalede startdosis er 2,5 mg én gang ugentligt i 4 uger.
The recommended starting dose is 2.5 mg once a week for 4 weeks.
Yderligere information om lægemidler til sjældne sygdomme kan findes her: ema.europa.eu/medicines/human/orphan-designations/eu309708.
Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu309708.
Lægemidlet udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af PKU.
The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in treating PKU.
De vigtigste allergiske reaktioner omfatter en akut, systemisk allergisk reaktion, angioødem (hævelse under huden i områder som ansigt, hals, arme og ben) og serumsygdom (allergisk reaktion forårsaget af animalsk protein eller serum).
The most significant allergic reactions include acute systemic allergic reaction, angioedema (swelling under the skin in areas such as the face, throat, arms and legs), and serum sickness (allergic reaction caused by animal proteins or serum).
Som for alle lægemidler er data vedrørende brug af Palynziq løbende overvåget.
As for all medicines, data on the use of Palynziq are continuously monitored.
Dosis og injektionshyppighed øges derefter gradvist (op til en maksimumsdosis på 60 mg én gang dagligt) for at opnå passende kontrol med indholdet af phenylalanin i blodet.
The dose and frequency of injection are then increased gradually (up to a maximum dose of 60 mg once a day) to achieve adequate control of phenylalanine blood levels.
Yderligere information om Palynziq findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Palynziq.
Further information on Palynziq can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Palynziq.
Sikkerheden ved Palynziq anses for acceptabel, og vigtige bivirkninger såsom allergiske reaktioner anses for at kunne håndteres med yderligere stringente foranstaltninger (se nedenfor).
The safety of Palynziq is considered acceptable, and important side effects such as allergic reactions are considered manageable with additional stringent measures (see below).
For mere information om brug af Palynziq, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
For more information about using Palynziq, see the package leaflet or contact your doctor or pharmacist.
Palynziq blev udpeget som "lægemiddel til sjældne sygdomme" den 28. januar 2010.
Palynziq was designated an ‘orphan medicine' (a medicine used in rare diseases) on 28 January 2010.
Ved anvendelse af Palynziq skal der træffes strenge foranstaltninger for at håndtere eventuelle alvorlige allergiske reaktioner, især i de første par måneder.
Palynziq must be used with stringent measures to manage any serious allergic reactions, especially in the first few months.
Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Palynziq opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The European Medicines Agency therefore decided that Palynziq's benefits are greater than its risks and it can be authorised for use in the EU.
I den første del af studiet fik alle patienterne Palynziq i en dosis på 20 eller 40 mg i op til 13 uger.
During the first part, all patients were given Palynziq at a dose of 20 or 40 mg for up to 13 weeks.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Palynziq?
What measures are being taken to ensure the safe and effective use of Palynziq?
De hyppigste bivirkninger ved Palynziq (som kan forekomme hos mere end 7 ud af 10 personer) er reaktioner på injektionsstedet, smerter i leddene og allergiske reaktioner.
The most common side effects with Palynziq (which may affect more than 7 in 10 people) are reactions at the injection site, pain in the joints and allergic reactions.
Enzymet i pegvaliase er "pegyleret" (dvs. bundet til et kemisk stof kaldet PEG), som giver det mulighed for at blive i kroppen og virke i længere tid.
The enzyme in pegvaliase is ‘pegylated' (attached to a chemical called PEG), allowing it to remain in the body and to act for longer.
Indholdet af phenylalanin i blodet skal måles før påbegyndelse af behandlingen.
Phenylalanine blood levels must be measured before starting treatment.
I udvidelsesfasen modtog patienterne en individuelt optimeret dosis Palynziq.
In the extension phase of the study patients received an individual optimized dose of Palynziq.
Palynziq fås som fyldte sprøjter (2,5, 10 og 20 mg) til injektion under huden.
Palynziq is available as pre-filled syringes (2.5, 10 and 20 mg) for injection under the skin.
Bivirkninger rapporteret for Palynziq vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Palynziq are carefully evaluated and any necessary action taken to protect patients.
Palynziq indeholder det aktive stof pegvaliase.
Palynziq contains the active substance pegvaliase.
Virksomheden, der markedsfører Palynziq, vil udlevere informationsmateriale til læger og patienter og omsorgspersoner om risikoen for allergiske reaktioner med Palynziq, herunder om, hvordan de kan identificere dem hurtigt, og hvad der skal gøres, hvis en sådan reaktion opstår.
The company that markets Palynziq will provide information material for doctors and for patients and carers about the risk of allergic reactions with Palynziq, including how to identify them promptly and what to do in case such a reaction occurs.
Andre oplysninger om Palynziq
Other information about Palynziq
En oversigt over Palynziq, og hvorfor det er godkendt i EU
An overview of Palynziq and why it is authorised in the EU
Palynziq er et lægemiddel, der anvendes til behandling af phenylketonuria (PKU) hos voksne og unge fra 16 års-alderen.
Palynziq is a medicine that is used to treat phenylketonuria (PKU) in adults and adolescents from 16 years of age.
Hvorfor blev Palynziq godkendt i EU?
Why is Palynziq authorised in the EU?
Patienter med denne genetiske sygdom kan ikke bearbejde aminosyren phenylalanin fra kostprotein, og som følge heraf ophober aminosyren sig i blodet til unormalt høje niveauer, hvilket forårsager problemer i nervesystemet.
Patients with this genetic disease cannot process the amino acid phenylalanine from dietary protein, and as a result the amino acid builds up in the blood to abnormally high levels, causing problems in the nervous system.
Palynziq er beregnet til langtidsbehandling.
Palynziq is intended for long-term use.
Det aktive stof i Palynziq, pegvaliase, er et bakterieenzym, der kan nedbryde phenylalanin, og derved forhindre phenylalanin i at ophobe sig i kroppen og bidrage til at lindre symptomerne på phenylketonuria.
The active substance in Palynziq, pegvaliase, is a bacterial enzyme that can break down phenylalanine, thereby stopping phenylalanine from building up in the body and helping to relieve the symptoms of phenylketonuria.
Hovedstudiet af Palynziq hos patienter med PKU bestod af forskellige dele.
The main study investigating Palynziq in patients with PKU consisted of different parts.
Det blev påvist, at for de fleste patienter var fortsat behandling med Palynziq i 18 måneder effektivt til at holde blodets indhold af phenylalanin under kontrol (under 600 mikromol pr. liter).
It was shown that for the majority of patients continued treatment with Palynziq for 18 months was effective at keeping blood phenylalanine levels under control (below 600 micromoles per litre).
Hvad er Palynziq, og hvad anvendes det til?
What is Palynziq and what is it used for?
86 patienter, der responderede på behandlingen (dvs. hvis indhold af phenylalanin i blodet blev reduceret med mindst 20 %), fik derefter samme dosis Palynziq eller placebo (en uvirksom behandling).
Eighty-six patients who responded to treatment (i.e. whose blood phenylalanine levels were reduced by at least 20%) where then either kept on the same dose of Palynziq or were given placebo (a dummy treatment).
Palynziq må ikke anvendes til patienter, der har haft en allergisk reaktion over for pegvaliase, andre komponenter i Palynziq eller anden pegyleret medicin.
Palynziq must not be used in patients who have had an allergic reaction to pegvaliase, to any of the other components of Palynziq or to any other pegylated medicine.
Hvilke risici er der forbundet med Palynziq?
What are the risks associated with Palynziq?
Efter 8 ugers behandling var blodets indhold af phenylalanin under kontrol hos patienter, der fik Palynziq, men hos patienter, der fik placebo, blev niveauet det samme igen som før behandlingen, hvilket viste, at Palynziq var mere effektivt end placebo til at reducere indholdet af phenylalanin i blodet og holde det inden for et acceptabelt interval.
After 8 weeks of treatment, blood phenylalanine levels remained under control in patients taking Palynziq but they returned to pre-treatment levels in patients on placebo, showing that Palynziq was more effective than placebo in reducing blood phenylalanine levels and keeping them within an acceptable range.
Palynziq viste sig at være effektivt til at reducere indholdet af phenylalanin i blodet og holde det under kontrol.
Palynziq was shown to be effective at reducing levels of blood phenylalanine and keeping them under control.
Palynziq anvendes til patienter, hvis indhold af phenylalanin i blodet ikke er tilstrækkeligt kontrolleret med andre behandlinger.
Palynziq is used in patients whose blood levels of phenylalanine have not been adequately controlled with other treatments.
Patienterne skulle opretholde et konstant proteinindtag i løbet af studieforløbet for at sikre, at ændringerne i indholdet af phenylalanin i blodet kunne tilskrives behandlingen og ikke ændringer i proteinindtaget.
Throughout the study, patients were required to maintain a constant level of dietary protein intake, to ensure that changes in blood phenylalanine levels could be attributed to treatment rather than to changes in protein intake.
Den fuldstændige liste over bivirkninger ved Palynziq fremgår af indlægssedlen.
For the full list of side effects of Palynziq, see the package leaflet.
Hvordan anvendes Palynziq?
How is Palynziq used?
Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Palynziq.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Palynziq have also been included in the summary of product characteristics and the package leaflet.
Hvordan virker Palynziq?
How does Palynziq work?
Hvilke fordele viser studierne, at der er ved Palynziq?
What benefits of Palynziq have been shown in studies?
Anisolie EMA/412178/2016
Anise oil EMA/412178/2016
Lægemidler med anisolie må ikke anvendes hos børn og unge under 18 år.
Aniseed oil medicines must not be used in children and adolescents under 18 years.
De må heller ikke anvendes hos patienter, der er overfølsomme (allergiske) over for anis eller planter i skærmplantefamilien (Apiaceae /Umbelliferae) (kommen, selleri, koriander, dild, fennikel) eller anethol.
They must also not be used in patients who are allergic to aniseed or to plants of the Apiaceae family (Umbelliferae) (caraway, celery, coriander, dill, fennel) or anethole.
Lægemidler med anisolie bør kun anvendes til voksne og bør ikke tages længere end to uger.
Anise oil medicines should only be used in adults and should not be taken for longer than two weeks.
Hvad er anisolie?
What is anise oil?
Hvis symptomerne vedvarer eller forværres under brug af lægemidlet, bør der søges råd hos en læge eller på apoteket.
If symptoms last or get worse during the use of the medicine, a doctor or a qualified healthcare practitioner should be consulted.
Anisolie er fællesnavnet for den æteriske olie fra de tørrede, modne frugter af planten Pimpinella anisum L.
Anise oil is the common name for the essential oil obtained from the dry ripe fruits of the plant Pimpinella anisum L.
Anisolie
Anise oil
Andre oplysninger om lægemidler, der indeholder anisolie
Other information about anise oil medicines
Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder anisolie, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
Information on the use and licensing of anise oil medicines in EU Member States should be obtained from the relevant national authorities.
Tilberedninger af anisolie findes desuden kombineret med andre droger i visse plantelægemidler.
Anise oil preparations may also be found in combination with other herbal substances in some herbal medicines.
EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder anisolie.
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing anise oil.
Detaljerede anvisninger på, hvordan lægemidler med anisolie bør anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
Detailed instructions on how to take anise oil medicines and who can use them can be found in the package leaflet that comes with the medicine.
Dette dokument er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af anisolie.
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of anise oil.
Yderligere oplysninger om risici forbundet med disse lægemidler, der indeholder anisolie, herunder passende forholdsregler, som skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
Further information on the risks associated with these anise oil medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Ansøgninger om godkendelse af lægemidler, der indeholder , skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
Any applications for the licensing of medicines containing anise oil have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Yderligere oplysninger om HMPC's vurdering af lægemidler, der indeholder anisolie, herunder detaljerede oplysninger om udvalgets konklusioner, findes under "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
Further information on the HMPC assessment of anise oil medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Desuden kan de anvendes som slimløsnende middel (ekspektorans) ved hoste i forbindelse med forkølelse.
In addition they can be used as an expectorant (a medicine that helps bring up phlegm) for coughs associated with colds.
Ved vurderingen har HMPC gennemgået laboratoriestudier, der har vist, at anisolie virker afslappende på muskulaturen i tarmen og luftvejene.
In its assessment, the HMPC considered studies in laboratory tests which showed anise oil to have a relaxing effect on the muscle of the gut and airways.
Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder anisolie, skal anvendes.
This summary is not intended to provide practical advice on how to use medicines containing anise oil.
Plantelægemidler med anisolie i disse tilberedninger fås normalt i fast eller flydende form beregnet til anvendelse gennem munden.
Herbal medicines containing these anise oil preparations are usually available in solid or liquid forms to be taken by mouth.
Hvordan godkendes lægemidler, der indeholder anisolie, i EU?
How are anise oil medicines approved in the EU?
HMPC's konklusioner omfatter kun tilberedninger af anisolie, som fremstilles ved dampdestillation af de tørrede, modne frugter.
The HMPC conclusions only cover anise oil preparations which are obtained by steam distillation of the dry ripe fruits.
Hvilke risici er der forbundet med lægemidler, der indeholder anisolie?
What are the risks associated with anise oil medicines?
Hvilken dokumentation underbygger den medicinske anvendelse af anisolie?
What evidence supports the use of anise oil medicines?
Der kan forekomme overfølsomhedsreaktioner (allergiske reaktioner) over for anisolie fra huden eller luftvejene.
Allergic reactions to aniseed oil that affect the skin or airways may occur.
Hvis du ønsker yderligere oplysninger om behandling med lægemidler, der indeholder anisolie, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
For more information about treatment with anise oil medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
HMPC's konklusioner om anvendelsen af lægemidler med anisolie er baseret på disse lægemidlers "traditionelle anvendelse" til fordøjelsesbesvær og hoste.
The HMPC conclusions on the use of these anise oil medicines for indigestion complaints and coughs are based on their ‘traditional use' .
På baggrund af den mangeårige anvendelse har HMPC konkluderet, at anisolie kan anvendes til behandling af symptomer ved let fordøjelsesbesvær, herunder oppustethed og tarmluft.
The HMPC concluded that, on the basis of its long-standing use, these anise oil preparations can be used for treating symptoms of mild indigestion complaints including bloating and flatulence.
Hvis du ønsker praktiske oplysninger om anvendelsen af lægemidler med anisolie, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
For practical information about using anise oil medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Dato for seneste fornyelse: 11. september 2014.
Date of latest renewal: 11 September 2014.
Dato for første markedsføringstilladelse: 29. oktober 2009.
Date of first authorisation: 29 October 2009.
Opvarm ikke Eporatio på anden vis (den må for eksempel ikke varmes i mikrobølgeovn eller i varmt vand).
Do not warm Eporatio in any other way (for example, do not warm it in a microwave or in hot water).
Behandling med Eporatio inddeles i to faser: a) Afhjælpning af anæmi
Treatment with Eporatio is divided into two stages: a) Correcting the anaemia
Den skal have lov til at nå en behagelig temperatur (15 °C - 25 °C), til injektion.
It should be allowed to reach a comfortable temperature (15 °C - 25 °C) for injection.
Eporatio indeholder natrium
Eporatio contains sodium
Eporatios sikkerhed og virkning hos børn i alderen 0-17 år er endnu ikke klarlagt.
The safety and efficacy of Eporatio in children and adolescents aged up to 17 years have not yet been established.
Brug af Eporatio er ikke undersøgt hos gravide kvinder.
Eporatio has not been tested in pregnant women.
Raske mennesker må ikke bruge Eporatio.
Healthy people should not use Eporatio.
Sædvanligvis får du Eporatio indtil 1 måned efter afslutning på kemoterapien.
You will usually receive Eporatio until 1 month after the end of chemotherapy.
Tryk stemplet op til det antal (IE) på skalaen, der svarer til den dosis Eporatio, som din læge har ordineret.
Push the plunger up to the number (IU) on the syringe that matches the dose of Eporatio that your doctor prescribed.
Kontroller Eporatios udseende.
Check the appearance of Eporatio.
Kontroller det igen for at sikre dig, at sprøjten rummer den rigtige dosis Eporatio.
Check again to make sure the correct dose of Eporatio is in the syringe.
Hvis du får Eporatio som en injektion i underhuden, kan lægen foreslå, at du lærer at give dig selv indsprøjtninger.
If you are receiving Eporatio as an injection under the skin, your doctor may suggest that you learn how to inject yourself this medicine.
Normalt gives Eporatio som langtidsbehandling.
Treatment with Eporatio is normally a long-term therapy.
Hvis du ikke reagerer tilstrækkeligt på Eporatio, vil lægen kontrollere din dosis og fortælle dig, hvis din Eporatio-dosis skal ændres.
If you do not respond adequately to Eporatio, your doctor will check your dose and will inform you if you need to change doses of Eporatio.
Eporatio bruges til behandling af anæmi (blodmangel) ledsaget af symptomer (for eksempel træthed, svækkelse og åndenød).
Eporatio is used for the treatment of anaemia accompanied by symptoms (for example fatigue, weakness and shortness of breath).
Da der ikke foreligger studier af eventuelle uforligeligheder, må Eporatio ikke blandes med andre lægemidler.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
- hvis du er allergisk over for epoetin theta, andre epoetiner eller et af de øvrige indholdsstoffer i Eporatio (angivet i punkt 6).
- if you are allergic to epoetin theta, another epoetin or any of the other ingredients of this medicine (listed in section 6);
Det kan også være nødvendigt, at du får en lavere dosis Eporatio eller holder en mindre pause i behandlingen med Eporatio.
It may also be necessary to reduce your dose of Eporatio or to stop the treatment with Eporatio for a short period of time.
Din dosis Eporatio (angivet i internationale enheder, IE) afhænger af din sygdomstilstand, hvor meget du vejer, og hvordan indsprøjtningen gives (under huden [subkutan injektion] eller i en vene [intravenøs injektion]).
The dose of Eporatio (expressed in International Units or IU) depends on your disease condition, your body weight and the way the injection is given (under the skin [subcutaneous injection] or into a vein [intravenous injection]).
Stop med at bruge Eporatio, hvis du udvikler disse symptomer, og kontakt straks din læge eller søg lægehjælp.
Stop using Eporatio if you develop these symptoms and contact your doctor or seek medical attention immediately.