FrancophonIA/ELRC3.0 huggingface dataset:
English: Because diclofenac epolamine (50 mg tablets) is a generic medicine, a study has been carried out to show that it is bioequivalent to the reference medicine, Flector, which is available as diclofenac
Danish: Da diclofenacepolamin (50 mg, tabletter) er et generisk lægemiddel, er der udført en undersøgelse, der skal vise, at det er bioækvivalent med referencelægemidlet, Flector, der fås som et granulat af diclofenacepolamin til fremstilling af en oral opløsning.
English: Why is diclofenac epolamine (50 mg tablets) reviewed?
Danish: Hvorfor er diclofenacepolamin (50 mg, tabletter) blevet gennemgået på ny?
English: What is diclofenac epolamine (50 mg tablets)?
Danish: Hvad er diclofenacepolamin (50 mg, tabletter)?
English: Since some prostaglandins are involved in causing pain and inflammation at sites of injury or damage in the body, reduced prostaglandin production reduces pain and inflammation.
Danish: Prostaglandiner medvirker til smerter og inflammation de steder i kroppen, hvor der sker skade.
English: ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BILAG BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT MEDLEMSLANDENE MED HENSYN TIL SIKKER OG EFFEKTIV BRUG AF LÆGEMIDLET
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE ADDRESSED BY THE MEMBER STATES The Member States should ensure that the MAH provides an educational programme for Remicade to ensure that physicians who intend to prescribe Remicade to paediatric Crohn's disease patients are aware of:
Danish: BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT MEDLEMSLANDENE MED HENSYN TIL SIKKER OG EFFEKTIV BRUG AF LÆGEMIDLET Medlemslandene skal sikre, at indehaveren af markedsføringstilladelsen udvikler et undervisningsprogram for Remicade, som sikrer, at læger, der har til hensigt at udskrive Remicade til pædiatriske Crohns patienter, er opmærksomme på:
English: • The risk of lymphoma and other malignancies.
Danish: • Risikoen for lymfom og andre maligniteter.
English: • That children may be at increased risk of developing infections and the need for immunisations to be up to date.
Danish: • At børn kan have en øget risiko for at udvikle infektioner og behovet for at holde immuniseringer opdateret.
English: • The risk of acute infusion related reactions and delayed hypersensitivity reactions.
Danish: • Risikoen for akute infusionsrelaterede reaktioner og forsinkede overfølsomhedsreaktioner.
English: • The risk of opportunistic infections and tuberculosis (TB) in patients treated with Remicade.
Danish: • Risikoen for opportunistiske infektioner og tuberkulose (TB) hos patienter behandlet med Remicade.
English: • The need to assess the risk of TB in patients prior to treating with Remicade.
Danish: • Behovet for at vurdere risikoen for TB hos patienter før behandling med Remicade.
English: • The patient alert card, which is to be given to patients using Remicade.
Danish: • Patientkortet, som skal udleveres til Remicadepatienter.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 March 2012
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første tilladelse: 26 marts 2012
English: Date of latest renewal: 17 February 2017
Danish: Dato for seneste fornyelse: 17 februar 2017
English: Magyarország Teva Gyógyszergyár Zrt.
Danish: Teva Gyógyszergyár Zrt.
English: Investigations weight increased6
Danish: Undersøgelser øget vægt6
English: Pioglitazone Teva Pharma helps control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces.
Danish: Pioglitazone Teva Pharma hjælper med at kontrollere sukkerniveauet i dit blod, hvis du har type 2-diabetes, ved at hjælpe din krop til bedre at udnytte den insulin, kroppen producerer.
English: When Pioglitazone Teva Pharma is taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.
Danish: Når Pioglitazone Teva Pharma tages sammen med andre lægemidler, der anvendes til behandling af sukkersyge (f.eks. insulin, chlorpropamid, glibenclamid, gliclazid, tolbutamid), vil din læge give dig besked på, om du skal tage en mindre dosis af lægemidlerne.
English: Pioglitazone Teva Pharma has no or negligible influence on the ability to drive and use machines.
Danish: Pioglitazone Teva Pharma påvirker ikke eller i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: It is an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus in adults, when metformin is not suitable or has failed to work adequately.
Danish: Det er en antidiabetisk medicin, der anvendes til behandling af type 2-diabetes mellitus (ikke-insulinkrævende sukkersyge) hos voksne, når metformin ikke er egnet eller ikke har haft tilstrækkelig virkning.
English: There may be an increased possibility of becoming pregnant because you may ovulate again when you take Pioglitazone Teva Pharma.
Danish: Der kan være større sandsynlighed for at blive gravid, fordi du kan få ægløsning igen, når du tager Pioglitazone Teva Pharma.
English: as monotherapy - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance
Danish: som monoterapi: - hos voksne patienter (specielt overvægtige patienter), der er utilstrækkeligt reguleret via diæt og motion, og for hvem metformin ikke er velegnet på grund af kontraindikationer eller intolerans
English: 50 x 1 tablets in Aluminium/aluminium perforated unit dose blisters.
Danish: 50 x 1 tabletter i perforerede aluminium/aluminium-enkeltdosisblisterpakninger.
English: Pioglitazone Teva Pharma may also be used in patients who are unable to take metformin, and where treatment with diet and exercise has failed to control blood sugar or may be added to insulin therapy when it fails to provide sufficient control of blood sugar.
Danish: Pioglitazone Teva Pharma kan anvendes til patienter, som ikke er i stand til at tage metformin, og hos hvem diæt og motion ikke har været i stand til at kontrollere blodsukkeret, eller det kan anvendes som supplement til andre insulinbehandlinger, hvis disse ikke har været i stand til at kontrollere blodsukkeret tilstrækkeligt.
English: If you take Pioglitazone Teva Pharma with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia).
Danish: Hvis du tager Pioglitazone Teva Pharma sammen med anden diabetesmedicin, er der en større risiko for, at dit blodsukker falder til under det normale niveau (hypoglykæmi).
English: Before you start taking Pioglitazone Teva Pharma you will have a blood sample taken to check your liver function.
Danish: Før du begynder at tage Pioglitazone Teva Pharma, vil du få taget en blodprøve til kontrol af leverfunktionen.
English: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Danish: Brampton Road, Hampden Park, Eastbourne East Sussex, BN22 9AG Storbritannien
English: Your doctor will ask you to have blood tests periodically during treatment with Pioglitazone Teva Pharma.
Danish: Din læge vil bede dig om at få taget blodprøver periodevis, mens du er i behandling med Pioglitazone Teva Pharma.
English: General disorders and administration site conditions oedema5
Danish: Almene symptomer og reaktioner på administrationsstedet ødem5
English: If you stop using Pioglitazone Teva Pharma, your blood sugar may go up.
Danish: Hvis du holder op med at tage Pioglitazone Teva Pharma, kan dit blodsukker stige.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) bladder cancer uncommon uncommon uncommon uncommon uncommon
Danish: Benigne, maligne og uspecificerede tumorer (inklusive cyster og polypper) blærecancer ikke almindelig ikke almindelig ikke almindelig ikke almindelig ikke almindelig
English: In patients on insulin with no pioglitazone the incidence of heart failure was 8.2% in those >65 years compared to 4.0% in patients less than 65 years.
Danish: Hos de patienter, der fik insulin uden pioglitazon, var incidensen af hjertesvigt 8,2 % hos patienter ≥ 65 år og 4,0 % hos patienter under 65 år.
English: In this study in patients receiving pioglitazone and insulin, a higher percentage of patients with heart failure was observed in patients aged >65 years compared with those less than 65 years (9.7% compared to 4.0%).
Danish: Hos de patienter, der fik pioglitazon og insulin i dette studie, var procentdelen af patienter med hjertesvigt højere hos patienterne ≥ 65 år end hos patienterne under 65 år (9,7 % sammenlignet med
English: If you are following a special diet for diabetes, you should continue with this while you are taking Pioglitazone Teva Pharma.
Danish: Hvis du følger en særlig diæt på grund af din diabetes, skal du fortsætte med denne diæt, mens du tager Pioglitazone Teva Pharma.
English: Do not take Pioglitazone Teva Pharma - if you are allergic to pioglitazone or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Pioglitazone Teva Pharma - hvis du er allergisk over for pioglitazon, eller et af de øvrige indholdsstoffer i Pioglitazone Teva
English: Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o.
Danish: TEVA Pharmaceuticals Slovakia s.r.o.
English: Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4).
Danish: Pioglitazon er også indiceret til kombinationsbehandling med insulin hos voksne patienter med type 2diabetes mellitus, der har utilstrækkelig glykæmisk kontrol med insulin, og for hvem metformin er uhensigtsmæssig på grund af kontraindikationer eller intolerans (se pkt.
English: common (may affect up to 1 in 10 people) - headache - dizziness - joint pain - impotence - back pain - shortness of breath - small reduction in red blood cell count - flatulence uncommon (may affect up to 1 in 100 people) - sugar in urine, proteins in urine - increase in enzymes - spinning sensation (vertigo) sweating tiredness increased appetite
Danish: almindelige (forekommer hos op til 1 ud af 10 patienter) - hovedpine - svimmelhed - ledsmerter - impotens - rygsmerter - kortåndethed - mindre fald i de røde blodlegemer (blodmangel) - luftafgang fra tarmen ikke almindelige (forekommer hos op til 1 ud af 100 patienter) - sukker i urinen, protein i urinen - forhøjede enzymtal - svimmelhed, hvor verden drejer rundt (vertigo) - svedudbrud - træthed
English: This leaflet was last revised in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest godkendt {MM/YYYY}.
English: Pioglitazone Teva Pharma with food and drink You may take your tablets with or without food.
Danish: Brug af Pioglitazone Teva Pharma sammen med mad og drikke Du kan tage dine tabletter i forbindelse med et måltid, men det er ikke nødvendigt.
English: Other medicines and Pioglitazone Teva Pharma Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Pioglitazone Teva Pharma Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har brugt det for nylig.
English: You can usually continue to take other medicines whilst you are being treated with Pioglitazone Teva Pharma.
Danish: Du kan normalt blive ved med at tage anden medicin, mens du får Pioglitazone Teva Pharma.
English: What Pioglitazone Teva Pharma contains - The active substance is pioglitazone.
Danish: Pioglitazone Teva Pharma indeholder - Aktivt stof: pioglitazon.
English: Pioglitazone Teva Pharma 15 mg tablets Pioglitazone Teva Pharma 30 mg tablets Pioglitazone Teva Pharma 45 mg tablets
Danish: Pioglitazone Teva Pharma 15 mg tabletter Pioglitazone Teva Pharma 30 mg tabletter Pioglitazone Teva Pharma 45 mg tabletter
English: not known not known not known not known not known
Danish: Øjne Synsforstyrrelser2 almindelig almindelig ikke almindelig makulaødem ikke kendt ikke kendt ikke kendt ikke kendt ikke kendt
English: Your blood sugar will be checked, and your dose of Pioglitazone Teva Pharma may need to be changed.
Danish: Du vil få kontrolleret blodsukkeret for at se, om du skal have ændret dosis af Pioglitazone Teva Pharma.
English: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Pioglitazone Teva Pharma and insulin experienced the development of heart failure.
Danish: Nogle patienter, som har haft type 2-diabetes i mange år og samtidig har hjertesygdom, eller som har haft et slagtilfælde, har udviklet hjertesvigt, når de blev behandlet med Pioglitazone Teva Pharma og insulin samtidig.
English: Pioglitazone Teva Pharma contains pioglitazone.
Danish: Pioglitazone Teva Pharma indeholder pioglitazon.
English: 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 84 tablets 90 tablets 98 tablets 112 tablets 196 tablets 50 x 1 tablets
Danish: 14 tabletter 28 tabletter 30 tabletter 50 tabletter 56 tabletter 84 tabletter 90 tabletter 98 tabletter 112 tabletter 196 tabletter 50 x 1 tablet
English: - The tablets are supplied in Aluminium/aluminium blisters in packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 or 196 tablets or 50 x 1 tablets in Aluminium/aluminium perforated unit dose blisters.
Danish: - Tabletterne leveres i aluminium/aluminium-blister a 14, 28, 30, 50, 56, 84, 90, 98, 112 eller 196 tabletter eller 50 x 1 tabletter i perforerede aluminium/aluminiumenkeltdosisblisterpakninger.
English: prior myocardial infarction or symptomatic coronary artery disease or the elderly), physicians should start with the lowest available dose and increase the dose gradually.
Danish: Ved behandling af patienter, der har mindst én risikofaktor for udvikling af hjerteinsufficiens (f.eks. tidligere hjerteinfarkt eller symptomgivende koronar arteriel sygdom eller hos ældre), bør lægen starte med den lavest tilgængelige dosis, som derefter øges gradvist.
English: common common common common common blood creatine phospho-kinase increased common increased lactic dehydro-genase uncommon alanine aminotransferase increased7
Danish: almindelig almindelig almindelig almindelig almindelig forhøjet kreatinkinase almindelig forhøjet laktatdehydrogenase ikke almindelig aminotransferase7 ikke kendt ikke kendt ikke kendt ikke kendt ikke kendt
English: If you take more Pioglitazone Teva Pharma than you should If you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately.
Danish: Hvis du har taget for meget Pioglitazone Teva Pharma Kontakt lægen, skadestuen eller apoteket, hvis du ved en fejltagelse har taget for mange tabletter, eller hvis en anden eller et barn tager din medicin.
English: Pioglitazone Teva Pharma 45 mg tablets EU/1/12/758/021-030
Danish: Pioglitazone Teva Pharma 45 mg tabletter EU/1/12/758/021-030
English: Pioglitazone Teva Pharma 30 mg tablets EU/1/12/758/011-020
Danish: Pioglitazone Teva Pharma 30 mg tabletter EU/1/12/758/011-020
English: Take Pioglitazone Teva Pharma daily as prescribed.
Danish: Hvis du har glemt at tage Pioglitazone Teva Pharma Tag Pioglitazone Teva Pharma dagligt som foreskrevet.
English: Aluminium/aluminium blisters, packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 and 196 tablets.
Danish: Aluminium/aluminium-blisterpakninger, pakninger a 14, 28, 30, 50, 56, 84, 90, 98, 112 og 196 tabletter.
English: Hungary
Danish: Magyarország
English: - Pioglitazone Teva Pharma 30 mg tablets are white to off white, round, convex with the number ‘30' on one side and ‘TEVA' on the other side.
Danish: - Pioglitazone Teva Pharma 30 mg tabletter er hvide til grålig hvide, runde, konvekse og mærket med ‘30' på den ene side og ‘TEVA' på den anden side.
English: - Pioglitazone Teva Pharma 45 mg tablets are white to off white, round, convex with the number ‘45' on one side and ‘TEVA' on the other side.
Danish: - Pioglitazone Teva Pharma 45 mg tabletter er hvide til grålig hvide, runde, konvekse og mærket med ‘45' på den ene side og ‘TEVA' på den anden side.
English: Your doctor will check whether Pioglitazone Teva Pharma is working 3 to 6 months after you start taking it.
Danish: Når du har taget Pioglitazone Teva Pharma i 3-6 måneder, vil din læge undersøge, om medicinen virker.
English: - The tablets are supplied in Aluminium/aluminium blisters in packs of 14, 28, 30, 50, 56, 84, 90,
Danish: - Tabletterne leveres i aluminium/aluminium-blister a 14, 28, 30, 50, 56, 84, 90, 98, 112 eller
English: 98, 112 or 196 tablets.
Danish: 196 tabletter.
English: What you need to know before you take Pioglitazone Teva Pharma
Danish: Det skal du vide, før du begynder at tage Pioglitazone Teva Pharma
English: Pioglitazone is contraindicated in patients with: - hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - cardiac failure or history of cardiac failure (NYHA stages I to IV) - hepatic impairment - diabetic ketoacidosis - current bladder cancer or a history of bladder cancer - uninvestigated macroscopic haematuria
Danish: 6.1 - hjerteinsufficiens eller hjerteinsufficiens i anamnesen (NYHA-klasse I til IV) - nedsat leverfunktion - diabetisk ketoacidose - aktuel blærecancer eller blærecancer i anamnesen - ikke udredt makroskopisk hæmaturi.
English: Pioglitazone Teva Pharma 30 mg tablets
Danish: Pioglitazone Teva Pharma 30 mg tabletter
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/758/001-010
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/12/758/001-010
English: Pioglitazone Teva Pharma 15 mg tablets
Danish: Pioglitazone Teva Pharma 15 mg tabletter
English: Pioglitazone Teva Pharma 45 mg tablets
Danish: Pioglitazone Teva Pharma 45 mg tabletter
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/758/021-030
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/12/758/021-030
English: How to take Pioglitazone Teva Pharma
Danish: Sådan skal du tage Pioglitazone Teva Pharma
English: prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).
Danish: I lyset af de potentielle risici ved længerevarende behandling bør den ordinerende læge ved efterfølgende rutinemæssige kontroller bekræfte den kliniske fordel ved pioglitazon (se pkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/758/011-020
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/12/758/011-020
English: If you have the impression that the effect of Pioglitazone Teva Pharma is too weak, talk to your doctor.
Danish: Tal med lægen, hvis du har indtryk af, at effekten af Pioglitazone Teva Pharma er for svag.
English: - if you retain water (fluid retention) or have heart failure problems, in particular if you are over 75 years old.
Danish: Kontakt lægen eller apotektspersonalet, før du tager Pioglitazone Teva Pharma (se også punkt 4) - hvis du har vand i kroppen (ødemer) eller har problemer med hjertesvigt, specielt hvis du er over 75 år.
English: Nervous system disorders hypo-aesthesia common common common common common headache common uncommon
Danish: Nervesystemet hypæstesi almindelig almindelig almindelig almindelig almindelig hovedpine almindelig ikke almindelig svimmelhed almindelig insomni ikke almindelig ikke almindelig ikke almindelig ikke almindelig ikke almindelig
English: INFORMATION IN BRAILLE Pioglitazone Teva Pharma 30 mg tablets
Danish: INFORMATION I BRAILLE-SKRIFT Pioglitazone Teva Pharma 30 mg
English: What Pioglitazone Teva Pharma is and what it is used for What you need to know before you take Pioglitazone Teva Pharma How to take Pioglitazone Teva Pharma Possible side effects
Danish: Det skal du vide, før du begynder at tage Pioglitazone Teva Pharma Sådan skal du tage Pioglitazone Teva Pharma Bivirkninger
English: NAME OF THE MEDICINAL PRODUCT Pioglitazone Teva Pharma 30 mg tablets Pioglitazone
Danish: LÆGEMIDLETS NAVN Pioglitazone Teva Pharma 30 mg tabletter Pioglitazon
English: Pioglitazone Teva Pharma 30 mg tablets Each tablet contains 30 mg of pioglitazone (as hydrochloride).
Danish: Pioglitazone Teva Pharma 30 mg tabletter Hver tablet indeholder 30 mg pioglitazon (som hydrochlorid).
English: NAME OF THE MEDICINAL PRODUCT Pioglitazone Teva Pharma 45 mg tablets Pioglitazone
Danish: LÆGEMIDLETS NAVN Pioglitazone Teva Pharma 45 mg tabletter Pioglitazon
English: INFORMATION IN BRAILLE Pioglitazone Teva Pharma 45 mg tablets
Danish: INFORMATION I BRAILLE-SKRIFT Pioglitazone Teva Pharma 45 mg
English: Each Pioglitazone Teva Pharma 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride).
Danish: Hver Pioglitazone Teva Pharma 30 mg tablet indeholder 30 mg pioglitazon (som hydrochlorid).
English: Pioglitazone Teva Pharma 45 mg tablets Each tablet contains 45 mg of pioglitazone (as hydrochloride).
Danish: Pioglitazone Teva Pharma 45 mg tabletter Hver tablet indeholder 45 mg pioglitazon (som hydrochlorid).
English: 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
Danish: 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.
English: Each Pioglitazone Teva Pharma 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).
Danish: Hver Pioglitazone Teva Pharma 45 mg tablet indeholder 45 mg pioglitazon (som hydrochlorid).
English: If you experience any of these, especially if you are over the age of 65, seek medical advice straight away.
Danish: Kontakt hurtigst muligt din læge, hvis du oplever nogle af disse bivirkninger, særligt hvis du er over 65 år..
English: INFORMATION IN BRAILLE Pioglitazone Teva Pharma 15 mg tablets
Danish: INFORMATION I BRAILLE-SKRIFT Pioglitazone Teva Pharma 15 mg
English: Pioglitazone Teva Pharma 15 mg tablets Each tablet contains 15 mg of pioglitazone (as hydrochloride).
Danish: Pioglitazone Teva Pharma 15 mg tabletter Hver tablet indeholder 15 mg pioglitazon (som hydrochlorid).
English: Each Pioglitazone Teva Pharma 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride).
Danish: Hver Pioglitazone Teva Pharma 15 mg tablet indeholder 15 mg pioglitazon (som hydrochlorid).
English: MARKETING AUTHORISATION NUMBER(S)
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN
English: NAME OF THE MEDICINAL PRODUCT Pioglitazone Teva Pharma 15 mg tablets Pioglitazone
Danish: LÆGEMIDLETS NAVN Pioglitazone Teva Pharma 15 mg tabletter Pioglitazon
English: - if you have heart failure or have had heart failure in the past.
Danish: Pharma (angivet i punkt 6) - hvis du lider af hjertesvigt eller tidligere har haft hjertesvigt.
English: very common
Danish: Ikke kendt
English: During treatment, monthly measurements are recommended.
Danish: Under behandlingen anbefales månedlige målinger.
English: The recommended starting dose is 2.5 mg once a week for 4 weeks.
Danish: Den anbefalede startdosis er 2,5 mg én gang ugentligt i 4 uger.
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu309708.
Danish: Yderligere information om lægemidler til sjældne sygdomme kan findes her: ema.europa.eu/medicines/human/orphan-designations/eu309708.
English: 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.
Danish: Lægemidlet udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af PKU.
English: 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).
Danish: 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).