FrancophonIA/ELRC3.0 huggingface dataset:
English: In female rats, using doses in excess of the therapeutic range, anagrelide disrupted implantation (see section 5.3).
Danish: Hos hunrotter forstyrrede anagrelid implantation ved doser over det terapeutiske interval (se pkt.
English: Each capsule contains anagrelide hydrochloride monohydrate equivalent to 1 mg anagrelide.
Danish: Hver kapsel indeholder anagrelidhydrochloridmonohydrat svarende til 1 mg anagrelid.
English: Method of administration
Danish: Ikke kendt administrationsstedet
English: Uncommon side effects: may affect up to 1 in 100 people A feeling of weakness or feeling unwell, high blood pressure, irregular heart beat, fainting, chills or fever, indigestion, loss of appetite, constipation, bruising, bleeding, swelling (oedema), weight loss, muscle aches, painful joints, back pain, decreased or loss of feeling or sensation such as numbness, especially in the skin, abnormal feeling or sensation such as tingling and ‘pins and needles',
Danish: Ikke almindelige bivirkninger: kan forekomme hos op til 1 ud af 100 personer En følelse af svaghed eller utilpashed, forhøjet blodtryk, uregelmæssigt hjerteslag, besvimelse, kuldegysninger eller feber, fordøjelsesbesvær, manglende appetit, forstoppelse, blå mærker, blødning, hævelse (ødem), vægttab, muskelsmerter, smerter i led, rygsmerter, nedsat eller manglende følesans, såsom følelsesløshed, især i huden, unormal følesans eller stikkende og prikkende fornemmelse, søvnløshed, depression, forvirring, nervøsitet, tør mund, hukommelsestab, stakåndethed, næseblod, alvorlig lungeinfektion med feber, åndenød, hoste, slim, hårtab, hudkløe eller misfarvning af huden, impotens, brystsmerter, nedsat antal blodplader, hvilket øger risikoen for blødning eller blå mærker (trombocytopeni), væskeophobning rundt om lungerne eller forhøjede leverenzymer.
English: Carton only: PC:
Danish: PC:
English: Therefore, platelets should be monitored frequently.
Danish: Antallet vil muligvis stige til værdier over baseline, hvorfor blodplader bør overvåges hyppigt.
English: Pulmonary infiltrates
Danish: Lungeinfiltrat
English: Cardiovascular
Danish: Diarré
English: Rare
Danish: Udslæt
English: Dizziness has been reported by some patients taking anagrelide.
Danish: Nogle patienter i behandling med anagrelid har rapporteret om svimmelhed.
English: The potential risks and benefits of anagrelide therapy in a patient with impairment of renal function should be assessed before treatment is commenced (see section 4.3).
Danish: De potentielle risici og fordele ved behandling med anagrelid til en patient med let nedsat leverfunktion skal vurderes, før behandling påbegyndes (se pkt.
English: Fluid retention Oedema Weight loss
Danish: Væskeretention Ødemer Vægttab
English: Manufacturer Synthon Hispania SL C/ Castelló no1
Danish: Synthon Hispania S.L.
English: The active substance is anagrelide.
Danish: - Aktivt stof: anagrelid.
English: Hepatobiliary disorders
Danish: Diplopi Synsforstyrrelser
English: Frequency of adverse reactions
Danish: Almene symptomer og reaktioner på
English: Pruritus
Danish: Gastritis
English: Name and address of the manufacturers responsible for batch release SYNTHON HISPANIA, S.L.
Danish: Navn og adresse på de fremstillere, der er ansvarlige for batchfrigivelse
English: Other medicines and Anagrelide Mylan
Danish: Hvis du har taget for meget Anagrelide Mylan
English: Hepatic impairment
Danish: Hypertension Synkope
English: Diarrhoea Vomiting Abdominal pain
Danish: Opkastning Mavesmerter Kvalme Flatulens
English: The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone.
Danish: Kombinationen af de to aktive stoffer har en additiv virkning og sænker blodtrykket mere end de enkelte lægemidler hver for sig.
English: The full EPAR for Irbesartan/Hydrochlorothiazide Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Irbesartan/Hydrochlorothiazide Teva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Doses higher than 300 mg irbesartan and 25 mg hydrochlorothiazide once a day are not recommended.
Danish: Doser på mere end 300 mg irbesartan og 25 mg hydrochlorothiazid én gang dagligt anbefales ikke.
English: It is available as tablets (150 mg or 300 mg irbesartan and 12.5 mg hydrochlorothiazide; and 300 mg irbesartan and 25 mg hydrochlorothiazide).
Danish: Det fås som tabletter (150 mg eller 300 mg irbesartan og 12,5 mg hydrochlorothiazid, og 300 mg irbesartan og 25 mg hydrochlorothiazid).
English: Irbesartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Danish: Irbesartan er en "angiotensin II-receptorantagonist", hvilket betyder, at den blokerer virkningen af et hormon i kroppen, der kaldes angiotensin II.
English: 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 Irbesartan/Hydrochlorothiazide Teva.
Danish: 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 Irbesartan/Hydrochlorothiazide Teva skal anvendes.
English: The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan/Hydrochlorothiazide Teva on 26 November 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Irbesartan/Hydrochlorothiazide Teva den 26. november 2009.
English: Therefore, the CHMP's view was that, as for CoAprovel, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for CoAprovel.
English: For more information about treatment with Irbesartan/Hydrochlorothiazide Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Irbesartan/Hydrochlorothiazide Teva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The CHMP concluded that, in accordance with EU requirements, Irbesartan/Hydrochlorothiazide Teva has been shown to have comparable quality and to be bioequivalent to CoAprovel.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Irbesartan/Hydrochlorothiazide Teva er af sammenlignelig kvalitet og er bioækvivalent med CoAprovel.
English: This means that Irbesartan/Hydrochlorothiazide Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called CoAprovel.
Danish: Det betyder, at Irbesartan/Hydrochlorothiazide Teva er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder CoAprovel.
English: This is a summary of the European public assessment report (EPAR) for Irbesartan/Hydrochlorothiazide Teva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Irbesartan/Hydrochlorothiazide Teva.
English: Irbesartan/Hydrochlorothiazide Teva is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone.
Danish: Irbesartan/Hydrochlorothiazide Teva anvendes til voksne med essentiel hypertension (forhøjet blodtryk), hvis blodtryk ikke kan kontrolleres tilfredsstillende ved hjælp af irbesartan eller hydrochlorothiazid alene.
English: Irbesartan/Hydrochlorothiazide Teva is a ‘generic medicine'.
Danish: Irbesartan/Hydrochlorothiazide Teva er et "generisk lægemiddel".
English: Because Irbesartan/Hydrochlorothiazide Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Irbesartan/Hydrochlorothiazide Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Because Irbesartan/Hydrochlorothiazide Teva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, CoAprovel.
Danish: Da Irbesartan/Hydrochlorothiazide Teva er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet CoAprovel.
English: Other information about Irbesartan/Hydrochlorothiazide Teva
Danish: Andre oplysninger om Irbesartan/Hydrochlorothiazide Teva
English: Irbesartan/Hydrochlorothiazide Teva may be added to other treatments for hypertension.
Danish: Irbesartan/Hydrochlorothiazide Teva kan bruges som tillægsbehandling til andre behandlinger mod hypertension.
English: The dose of Irbesartan/Hydrochlorothiazide Teva to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking
Danish: Dosen af Irbesartan/Hydrochlorothiazide Teva afhænger af den dosis af irbesartan eller hydrochlorothiazid, som patienten fik tidligere.
English: Irbesartan/Hydrochlorothiazide Teva irbesartan and hydrochlorothiazide
Danish: Irbesartan/Hydrochlorothiazide Teva irbesartan og hydrochlorothiazid
English: Irbesartan/Hydrochlorothiazide Teva contains two active substances, irbesartan and hydrochlorothiazide.
Danish: Irbesartan/Hydrochlorothiazide Teva indeholder to aktive stoffer, irbesartan og hydrochlorothiazid.
English: Irbesartan/Hydrochlorothiazide Teva is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
Danish: Irbesartan/Hydrochlorothiazide Teva er et lægemiddel, der indeholder de to aktive stoffer irbesartan og hydrochlorothiazid.
English: What are the benefits and risks of Irbesartan/Hydrochlorothiazide Teva?
Danish: Hvilken fordel og risiko er der forbundet med Irbesartan/Hydrochlorothiazide Teva?
English: The Committee recommended that Irbesartan/Hydrochlorothiazide Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Irbesartan/Hydrochlorothiazide Teva.
English: Why has Irbesartan/Hydrochlorothiazide Teva been approved?
Danish: Hvorfor blev Irbesartan/Hydrochlorothiazide Teva godkendt?
English: What is Irbesartan/Hydrochlorothiazide Teva?
Danish: Hvad er Irbesartan/Hydrochlorothiazide Teva?
English: How has Irbesartan/Hydrochlorothiazide Teva been studied?
Danish: Hvordan blev Irbesartan/Hydrochlorothiazide Teva undersøgt?
English: Irbesartan/Hydrochlorothiazide Teva is taken by mouth.
Danish: Irbesartan/Hydrochlorothiazide Teva indtages oralt.
English: How is Irbesartan/Hydrochlorothiazide Teva used?
Danish: Hvordan anvendes Irbesartan/Hydrochlorothiazide Teva?
English: What is Irbesartan/Hydrochlorothiazide Teva used for?
Danish: Hvad anvendes Irbesartan/Hydrochlorothiazide Teva til?
English: Your treatment will then continue at the normal times.
Danish: Din behandling vil derefter fortsætte på de sædvanlige tidspunkter.
English: Add the rest of the water.
Danish: Tilsæt resten af vandet
English: Children (aged 2 to 18 years)
Danish: Børn (i alderen 2 til 18 år)
English: Your doctor will do regular blood tests to check for any changes in:
Danish: Lægen vil tage blodprøver regelmæssigt for at tjekke for ændringer i:
English: Cellcept is usually given by a doctor or nurse in hospital.
Danish: CellCept gives sædvanligvis af en læge eller sygeplejerske på et hospital.
English: Capsules, hard.
Danish: Kapsler, hårde.
English: You will have the medicine for at least 4 days.
Danish: • Du vil få medicinen i mindst 4 dage.
English: Your baby may be affected by one or more of these.
Danish: Barnet kan have en eller flere af disse misdannelser.
English: If you are planning to have a child, talk to your doctor about the potential risks and alternative therapies.
Danish: Hvis du planlægger at få et barn, skal du tale med din læge om potentielle risici og alternative behandlinger.
English: Your doctor or nurse will make up the medicine and give it to you.
Danish: Lægen eller sygeplejersken vil blande medicinen og give den til dig.
English: Allow it to dry in the air before using it again.
Danish: Lad den lufttørre, før den skal bruges igen.
English: The proportion of patients with CMV viraemia/syndrome was 13.5%.
Danish: Andelen af patienter med CMV-viræmi/syndrom var 13,5 %.
English: Try not to inhale the dry powder.
Danish: Undgå at inhalere det tørre pulver.
English: In addition, there have been isolated reports of the following malformations:
Danish: Derudover har der været enkelte rapporter om følgende misdannelser:
English: If you need to do it yourself, follow the steps below:
Danish: Hvis du skal gøre det selv, skal du følge nedenstående vejledning:
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Danish: Patienter med sjælden hereditær fructoseintolerans bør ikke anvende dette lægemiddel.
English: CellCept reduces your body's defences.
Danish: CellCept nedsætter kroppens forsvar.
English: This will be given as 1 g in the morning and then 1 g in the evening.
Danish: • Den vil blive givet som 1 g om morgenen og 1 g om aftenen.
English: Keep pulling it out until the desired amount of medicine is in the dispenser.
Danish: • Fortsæt med at trække tilbage, indtil den ønskede medicinmængde er i dispenseren.
English: Turn the whole thing upside down (bottle and dispenser - see picture below).
Danish: 5 Vend det hele med bunden i vejret (flaske og dispenser - se nedenstående billede).
English: The educational materials shall contain the following key elements:
Danish: Uddannelsesmaterialet skal indeholde følgende hovedemner:
English: The medicine comes as a powder.
Danish: Medicinen findes som pulver.
English: (body surface area - measured as square metres or “m2”).
Danish: (legemsoverfladeareal - målt som kvadratmeter eller ”m2”).
English: Swallow your tablets whole with a glass of water.
Danish: • Synk tabletterne hele med et glas vand.
English: They will follow the instructions under Section 7 “Making up the medicine”.
Danish: De vil følge instruktionerne under punkt 7 ”Opblanding af medicinen”.
English: Turn the whole thing back round the right way.
Danish: Vend det hele opad igen.
English: The bottle adapter should stay in the bottle.
Danish: Flaskeadaptoren skal blive i flasken.
English: It is given as a slow drip (infusion) into a vein.
Danish: Det gives som et langsomt drop (infusion) i en blodåre.
English: There have also been reports of bronchiectasis in children and adults.
Danish: Der er også rapporteret bronkiektasi hos børn og voksne.
English: This effect tended to diminish with continued antibiotic use and to cease within a few days of antibiotic discontinuation.
Danish: Denne effekt havde tendens til at blive mindre ved fortsat brug af antibiotika og ophøre inden for få dage efter seponering af antibiotika.
English: Preparation of Infusion Solution (6 mg/mL)
Danish: Fremstilling af infusionsopløsning (6 mg/ml)
English: Do not use the suspension past this expiry date.
Danish: Anvend ikke suspensionen efter denne udløbsdato.
English: Your pharmacist will normally make up the medicine for you.
Danish: Apotekspersonalet vil sædvanligvis blande medicinen for dig.
English: • rifampicin - an antibiotic used to prevent and treat infections such as tuberculosis (TB)
Danish: • rifampicin - et antibiotikum, som bruges til forebyggelse og behandling af infektioner såsom tuberkulose (TB)
English: • azathioprine or other medicines which suppress your immune system - given after a transplant operation
Danish: • azathioprin eller anden medicin, som undertrykker immunsystemet - gives efter en transplantation
English: However, at high MPAG plasma concentrations (> 100µg/mL), small amounts of MPAG are removed.
Danish: Ved høje MPAG-plasmakoncentrationer (> 100 µg/ml) fjernes dog mindre mængder MPAG.
English: Shake the closed bottle well for about 5 seconds before each use.
Danish: Ryst den lukkede flaske godt i ca. 5 sek. før hver brug.
English: It is not known whether this substance is excreted in human milk.
Danish: Det vides ikke om dette lægemiddel udskilles i human mælk.
English: Urinary problems such as: blood in the urine.
Danish: Urinvejslidelser såsom: • blod i urinen.
English: Like all medicines, CellCept can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: In this leaflet the shorter name CellCept is used.
Danish: • I denne indlægsseddel er det kortere navn CellCept anvendt.
English: It is recommended that CellCept should not be administered concomitantly with azathioprine because such concomitant administration has not been studied.
Danish: CellCept bør ikke administreres sammen med azathioprin, da en sådan samtidig administration ikke er blevet undersøgt.
English: If a dose of CellCept is missed, this will be given to you as soon as possible.
Danish: Hvis en dosis CellCept bliver glemt, skal du have den så hurtigt som muligt.
English: This medicinal product contains sorbitol.
Danish: Dette lægemiddel indeholder sorbitol.
English: CellCept is used to prevent your body rejecting a transplanted organ.
Danish: CellCept anvendes til at forhindre din krop i at afstøde et transplanteret organ.
English: the number of your blood cells or signs of infections.
Danish: • antallet af blodceller eller tegn på infektion.
English: Add about half of the total amount of purified water to the bottle.
Danish: Tilsæt ca. halvdelen af den totale mængde renset vand til flasken.
English: If this happens, wash the area thoroughly with soap and water.
Danish: • Hvis dette sker, skal du vaske området grundigt med vand og sæbe.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsinberetninger (PSURs) Kravene for fremsendelse af PSURs for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: If you are planning to become pregnant or if you get pregnant while you or your partner are taking CellCept.
Danish: • hvis du planlægger at blive gravid, eller hvis du bliver gravid, mens du eller din partner tager CellCept.
English: It is recommended, however, to administer CellCept at least one hour before or three hours after sevelamer intake to minimise the impact on the absorption of MPA.
Danish: CellCept bør imidlertid administreres mindst én time før eller tre timer efter indtagelsen af sevelamer for at minimere dets indvirkning på MPA-absorptionen.
English: Important information about some of the ingredients of CellCept
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i CellCept
English: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000)
Danish: (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til
English: Pharmacotherapeutic group: immunosuppressive agents ATC code L04AA06
Danish: Farmakoterapeutisk klassifikation: immunsuppressive midler, ATC kode L04AA06
English: For 6 weeks after you stop taking CellCept.
Danish: • I 6 uger efter du er stoppet med at tage CellCept.
English: PHARMACEUTICAL FORM Powder for oral suspension.
Danish: LÆGEMIDDELFORM Pulver til oral suspension.
English: and very rare (<1/10,000).
Danish: <1/1.000) og meget sjælden (<1/10.000).
English: Caution is therefore recommended when administering these drugs concomitantly with CellCept.
Danish: Forsigtighed anbefales derfor, når disse lægemidler administreres samtidigt med CellCept.
English: If you need to do it yourself, see Section 7 “Making up the medicine”
Danish: Hvis du skal gøre det selv, skal du se under punkt 7 ”Opblanding af medicinen”.
English: In those overdose cases in which adverse events were reported, the events fall within the known safety profile of the medicinal product.
Danish: I de tilfælde af overdosis, hvor der var bivirkninger, fandtes disse at være inden for den kendte sikkerhedsprofil for lægemidlet.
English: CellCept should be used together with other medicines: Ciclosporin and corticosteroids.
Danish: CellCept skal bruges sammen med anden medicin: • Ciclosporin og kortikosteroider.
English: This is because CellCept can affect the way some other medicines work.
Danish: Dette skyldes, at CellCept kan påvirke den måde, anden medicin virker på.
English: When you are able to swallow, you will be given this medicine by mouth.
Danish: • Når du kan synke, vil du få lægemidlet igennem munden.
English: Serum levels of LH, FSH and progesterone were not significantly affected.
Danish: Serumnivauet af LH, FSH og progesteron blev ikke signifikant påvirket.
English: There is also evidence of a higher frequency of certain types of infections (see section
Danish: Der er også tegn på større hyppighed af visse typer infektioner (se pkt.
English: As a result of enterohepatic recirculation, secondary increases in plasma MPA concentration are usually observed at approximately 6 - 12 hours post-dose.
Danish: Som et resultat af det enterohepatiske kredsløb observeres sekundære stigninger i plasmakoncentrationen af MPA sædvanligvis omkring 6-12 timer efter indgift.
English: Put the end of the dispenser directly into your mouth and swallow the medicine.
Danish: Sæt spidsen af dispenseren direkte ind i din mund og synk medicinen.
English: CAUTION: CELLCEPT I.V.
Danish: FORSIGTIGHEDSREGEL: CELLCEPT I.V.
English: CellCept contains aspartame.
Danish: • CellCept indeholder aspartam.
English: Safety and efficacy of CellCept for infusion in paediatric patients have not been established.
Danish: Sikkerhed og virkning af CellCept til infusion hos pædiatriske patienter er ikke fastslået.
English: Counselling of patients: This section will emphasise the importance of a thorough, informative and ongoing dialogue between patient and healthcare professional about the pregnancy risks associated with mycophenolate mofetil and the relevant minimisation strategies including alternative treatment choices, if applicable.
Danish: • Vejledning til patienter: Dette afsnit skal understrege vigtigheden af en grundig, informativ og løbende dialog mellem patient og sundhedspersoner omkring de graviditetsrisici, der er forbundet med mycophenolatmofetil, og de relevante minimeringsstrategier, herunder alternative behandlingsmuligheder, hvis det er relevant.
English: A detailed description of the preparation is given below:
Danish: En detaljeret beskrivelse af fremstillingen er anført nedenfor.
English: Infections and infestations Bacterial infections
Danish: Infektioner og parasitære sygdomme Bakterielle infektioner
English: Do not take CellCept:
Danish: Tag ikke CellCept:
English: Medicinal products that interfere with enterohepatic recirculation (e.g. cholestyramine, ciclosporin A, antibiotics)
Danish: Lægemidler som interfererer med den enterohepatiske recirkulation (f.eks. colestyramin, ciclosporin A, antibiotika)
English: Also other medicines can affect the way CellCept works.
Danish: Anden medicin kan også påvirke den måde, CellCept virker på.
English: If you have a rare problem with your metabolism called “phenylketonuria”, talk to your doctor before you start taking this medicine.
Danish: Hvis du har et sjældent problem med din metabolisme kaldet ”phenylketonuri”, skal du tale med din læge, før du begynder at tage denne medicin.
English: Wearing disposable gloves is recommended during reconstitution and when wiping the outer surface of the bottle/cap and the table after reconstitution.
Danish: Det anbefales at bruge engangshandsker under rekonstitution, samt ved aftørring af ydersiden af flasken/hætten og bordet efter rekonstitution.