FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of bosentan (a moderate inducer of CYP3A4, CYP2C9 and possibly of CYP2C19) 125 mg twice daily with oral sildenafil 80 mg three times a day (at steady state)
Danish: Samtidig anvendelse af bosentan (en moderat induktor af CYP3A4, CYP2C9 og muligvis af CYP2C19) 125 mg 2 gange dagligt og sildenafil 80 mg 3 gange dagligt (ved steady-state) i 6 dage gav et fald i sildenafils AUC på 63% hos raske frivillige forsøgspersoner.
English: How Revatio is given
Danish: Sådan får De Revatio
English: In clinical trials with Revatio tablets side effects reported very commonly (may affect more than 1 in 10 people) were headache, facial flushing, indigestion, diarrhoea and pain in the arms or legs.
Danish: Meget almindelige bivirkninger (det sker hos flere end 1 ud af 10 patienter) set i kliniske studier med Revatio-tabletter er hovedpine, rødmen i ansigtet, mavebesvær, diarré og smerter i arme og ben.
English: Push the plunger back in to the syringe.
Danish: Peg spidsen af sprøjten mod indersiden af kinden og tryk LANGSOMT stemplet i bund.
English: burning sensation, hypoaesthesia
Danish: oppustet abdomen, mundtørhed
English: Clear, colourless solution.
Danish: Revatio er en klar, farveløs injektionsvæskep.
English: Revatio can cause a serious increase in the effects of these medicines.
Danish: Hvis De får for meget Revatio kan det øge risikoen for at få bivirkninger.
English: Co-administration of oral sildenafil and intravenous epoprostenol has been evaluated (see sections 4.8 and 5.1).
Danish: In vivo studier Samtidig anvendelse af sildenafil og intravenøs epoprostenol er undersøgt (se pkt.
English: What Revatio is and what it is used for What you need to know before you take Revatio How to take Revatio
Danish: Det skal De vide, før De begynder at tage Revatio Sådan skal De tage Revatio Bivirkninger
English: Each ml of the reconstituted suspension contains 10 mg of sildenafil (as citrate).
Danish: Efter opblanding indeholder 1 ml suspension indeholder 10 mg sildenafil (som citrat).
English: Adverse reactions which occurred in > 1 % of Revatio-treated patients and were more frequent (> 1 % difference) on Revatio in the pivotal study or in the Revatio combined data set of both the placebo-controlled studies in pulmonary arterial hypertension,, at doses of 20, 40 or 80 mg TID are listed in the table below by class and frequency grouping (very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1000 to < 1/100) and not known (cannot be estimated from the available data).
Danish: Bivirkningerne er angivet efter klasse og frekvens (meget almindelig (1/10), almindelig (1/100 til <1/10), ikke almindelig (1/1000 til <1/100), ikke kendt (kan ikke bestemmes ud fra tilgængelige data)).
English: 80 mg TID, respectively.
Danish: 50 mg.
English: Reproductive system and breast disorders Uncommon penile haemorrhage, haematospermia, gynaecomastia
Danish: Det reproduktive system og mammae Ikke almindelig blødning fra penis, hæmatospermi, gynækomasti
English: (CYPRUS BRANCH)
Danish: (“poppers”).
English: SN:
Danish: Lot:
English: Eye disorders Common retinal haemorrhage, visual impairment, vision blurred, photophobia, chromatopsia, cyanopsia, eye irritation, ocular hyperaemia
Danish: Ikke kendt retinablødning, nedsat syn, sløret syn, fotofobi, chromatopsia, cyanopsia, øjenirritation, okulær hyperæmi uskarpt syn, dobbeltsyn, usædvanlig følelse i øjet non-arteritis anterior iskæmisk opticusneuropati (NAION)*, vaskulær okklusion i retina*, synsfeltdefekt*
English: • Medicines containing St. John's Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy)
Danish: - medicin, der indeholder perikon (naturmedicin), rifampicin (mod tuberkulose), carbamazepin,
English: The European Commission issued a decision on 25 September 2017.
Danish: Europa-Kommissionen traf en afgørelse den 25. september 2017.
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/116)
Danish: Resultat af en indbringelsesprocedure i henhold til artikel 35 i direktiv 2001/82/EF (EMEA/V/A/116)
English: What is moxidectin?
Danish: Hvad er moxidectin?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom25 September 2017
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom25.
English: These included data from companies and from the published literature.
Danish: Dette omfattede data fra firmaer og litteratur udgivet om emnet.
English: Why were veterinary medicines containing moxidectin reviewed?
Danish: Hvorfor blev veterinærlægemidler, der indeholder moxidectin, gennemgået?
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that these medicines might have a longterm impact on the environment due to their persistent, bioaccumulative and toxic (PBT) properties.
Danish: Agenturets Udvalg for Veterinærlægemidler (CVMP) konkluderede, at lægemidlerne kan have en langsigtet indvirkning på miljøet på grund af deres vedvarende, bioakkumulerende og giftige (PBT) egenskaber.
English: The sampling will help generate further data to assess the environmental exposure of moxidectin and will be a condition for maintaining the marketing authorisations of these veterinary medicines in the EU.
Danish: Prøveudtagningen vil bidrage til at frembringe yderligere data til at vurdere den miljømæssige eksponering af moxidectin og vil være en betingelse for at opretholde markedsføringstilladelserne for disse veterinærlægemidler i EU.
English: Moxidectin is a broad-spectrum antiparasitic medicine widely used to treat and prevent parasitic infections (such as roundworms, fluke and lice) in both food-producing and companion animals.
Danish: Moxidectin er et bredspektret antiparasitisk lægemiddel, der bliver brugt i stort omfang til at behandle og forebygge parasitiske infektioner (såsom rundorm, fladorm og lus) i både dyr bestemt til levnedsmiddelproduktion og kæledyr.
English: On 22 October 2015, the German competent authority triggered a review of veterinary medicines containing moxidectin because of concerns that moxidectin may have PBT properties and could therefore pose a serious risk to the environment.
Danish: Den 22. oktober 2015 igangsatte de tyske kompetente myndigheder en gennemgang af veterinærlægemidler indeholdende moxidectin på grund af bekymringer om, at moxidectin måske har PBT-egenskaber og dermed eventuelt udgør en alvorlig risiko for miljøet.
English: The CVMP recommended obtaining samples from relevant environmental compartments after use of the 5 mg/ml pour-on solution or 100 mg/ml injectable solution in beef cattle on pasture.
Danish: CVMP anbefalede en indhentning af prøver fra relevante miljømæssige afdelinger efter indgivelse af opløsningen til indhældning på 5 mg/ml eller den injicerbare opløsning på 100 mg/ml i slagtekvæg på græs.
English: Consequently, the CVMP recommended measures to mitigate against the environmental risks, as well as warnings, to be included within the product information.
Danish: Derfor anbefalede CVMP tiltag til afbødning af miljømæssige risici såvel som advarsler, der bør inkluderes i produktinformationen.
English: The CVMP was requested to consider whether moxidectin meets the criteria to be classified as a PBT substance and, if necessary, to provide recommendations on appropriate measures to prevent environmental exposure.
Danish: CVMP blev anmodet om at vurdere, om moxidectin opfylder kriterierne for klassificering som et PBTstof, og om nødvendigt fremsætte anbefalinger om passende foranstaltninger til at forhindre miljømæssig eksponering.
English: Questions and answers on the environmental impact of moxidectin-containing veterinary medicines used in cattle, sheep and horses EMA/587529/2017
Danish: Spørgsmål og svar om miljømæssig indvirkning af veterinærlægemidler, der indeholder moxidectin og anvendes i kvæg, får og heste EMA/587529/2017
English: In order to minimise the identified environmental risks, the CVMP recommended risk mitigation measures and warnings, to be included in the product information, including a precaution that treatment should only be given when necessary and should be based on faecal counts or an evaluation risk of infestation at the animal or herd level.
Danish: For at minimere de fastslåede miljømæssige risici anbefalede CVMP tiltag om risikoreduktion og advarsler, der bør inkluderes i produktinformationen, herunder en forholdsregel om, at behandling kun bør gives, når det er nødvendigt, og bør være baseret på optælling fra fækalier eller en vurderet risiko for skadedyrsangreb for hvert enkelt dyr eller på besætningsniveau.
English: The CVMP reviewed available data on PBT properties of moxidectin.
Danish: CVMP gennemgik de tilgængelige data om moxidectins PBT-egenskaber.
English: The CVMP also noted that veterinary medicines containing moxidectin are an effective and important therapeutic option for treating internal and external parasites in cattle, sheep and horses.
Danish: CVMP bemærkede også, at veterinærlægemidler indeholdende moxidectin er en effektiv og vigtig behandlingsmulighed i bekæmpelse af indvendige og udvendige parasitter i kvæg, får og heste.
English: Based on the evaluation of the currently-available data from laboratory studies, the CVMP concluded that moxidectin fulfils the criteria to be considered a PBT substance, and that its use poses a risk to the environment.
Danish: Ud fra evalueringen af de nuværende tilgængelige data fra laboratorieundersøgelser konkluderede CVMP, at moxidectin opfylder kriterierne for at blive betragtet som et PBT-stof, og at brugen af det udgør en risiko for miljøet.
English: The CVMP also concluded that the marketing authorisation holders should investigate whether, under relevant environmental conditions of use, moxidectin is detected in the local environment.
Danish: CVMP konkluderede endvidere, at indehavere af markedsføringstilladelser skal undersøge, hvorvidt moxidectin under de relevante miljømæssige brugsbetingelser kan spores i det lokale miljø.
English: On 11 May 2017, the European Medicines Agency completed a review of oral, topical and injectable moxidectin-containing veterinary medicines used in cattle, sheep and horses.
Danish: Den 11. maj 2017 afsluttede Det Europæiske Lægemiddelagentur (agenturet) en gennemgang af orale, topiske og injicerbare veterinærlægemidler, der indeholder moxidectin og anvendes i kvæg, får og heste.
English: In addition, a condition was placed on the marketing authorisations with the purpose of obtaining field data to determine whether, under actual conditions of use and relevant environmental conditions, the hazards due to the PBT properties of these products can be prevented.
Danish: Derudover blev der vedtaget et krav til markedsføringstilladelserne med det formål at indhente feltdata til at bestemme, hvorvidt farerne grundet disse produkters PBT-egenskaber kan forhindres under de nuværende brugsbetingelser og relevante miljømæssige forhold.
English: Questions and answers on the environmental impact of moxidectin-containing veterinary medicines used in cattle, sheep and horses
Danish: Spørgsmål og svar om miljømæssig indvirkning af veterinærlægemidler, der indeholder moxidectin og anvendes i kvæg, får og heste
English: This happens usually in one of the eyes.
Danish: Dette sker sædvanligvis kun i det ene øje.
English: You may also feel confused, particularly if you are elderly.
Danish: Du kan desuden føle dig forvirret, navnlig hvis du er ældre.
English: This medicine should not be given to children (i.e. anyone below the age of 18 years).
Danish: Dette lægemiddel bør ikke gives til børn (dvs. alle under 18 år).
English: All were reported to be Grade 3 or 4.
Danish: Alle tilfældene blev indberettet som grad 3 eller 4.
English: Not known: frequency cannot be estimated from the available data
Danish: Ikke kendt: hyppigheden kan ikke vurderes ud fra de tilgængelige data
English: Date of first authorisation: 16 March 2016
Danish: Dato for første markedsføringstilladelse: 16 marts 2016
English: This is especially important if you feel depressed or might be thinking about suicide.
Danish: Dette er navnlig vigtigt, hvis du føler dig deprimeret eller tænker på selvmord.
English: If this is not the case, local or international treatment protocols and guidelines should be followed.
Danish: Er dette ikke tilfældet, bør lokale eller internationale behandlingsprotokoller og retningslinjer følges.
English: The volume of distribution is approximately 1 l/kg.
Danish: Fordelingsvolumenet er ca. 1 l/kg.
English: Other possible side effects may be:
Danish: Andre mulige bivirkninger er:
English: Before the start of treatment, any source of infection, especially tuberculosis, should be removed.
Danish: Før påbegyndelse af behandlingen bør enhver infektionskilde, navnlig tuberkulose, være fjernet.
English: Uncontrolled psychoses.
Danish: Ukontrolleret psykose.
English: During treatment with this medicine it is important to maintain a balanced diet.
Danish: Under behandlingen med dette lægemiddel er det vigtigt at få en afbalanceret kost.
English: • Periodic safety update reports
Danish: • Periodiske, opdaterede sikkerhedsberetninger
English: There is a linear relationship between administered and bioavailable doses.
Danish: Der er lineær sammenhæng mellem administreret og biotilgængelig dosis.
English: No antidote exists and treatment is symptomatic.
Danish: Der findes ingen modgift, og behandlingen er symptomatisk.
English: Your doctor will decide the dose and tell you on which days you should take it.
Danish: Lægen vil afgøre din dosis og fortælle dig, på hvilke dage du skal tage den.
English: Close clinical supervision is required to avoid life-threatening reactions.
Danish: Tæt klinisk overvågning er nødvendig for at undgå livstruende reaktioner.
English: This should be taken into consideration in the surveillance of the patient.
Danish: Dette bør man være opmærksom på ved overvågning af patienten.
English: Your doctor will arrange appropriate blood tests before and during treatment.
Danish: Lægen vil sørge for, at der bliver taget passende blodprøver før og under behandlingen.
English: In order to minimise insomnia, the tablet should preferably be taken in the morning.
Danish: For at minimere søvnløshed bør tabletten fortrinsvis tages om morgenen.
English: Vaccinations with inactivated vaccines are usually possible.
Danish: Inaktiverede vacciner kan sædvanligvis anvendes.
English: − if you have an untreated psychiatric illness.
Danish: − hvis du lider af en ubehandlet psykisk sygdom
English: Do not take a double dose to make up for a forgotten tablet.
Danish: Du må ikke tage en dobbeltdosis som erstatning for en glemt tablet.
English: Sodium intake should be reduced and blood pressure should be monitored.
Danish: Natriumindtagelsen bør reduceres og blodtrykket monitoreres.
English: Symptoms typically emerge within a few days or weeks of starting the treatment.
Danish: Symptomerne ses sædvanligvis få dage eller uger efter påbegyndelse af behandlingen.
English: The following combinations should be avoided due to safety concerns:
Danish: Følgende kombinationer bør undgås på grund af sikkerhedsproblemer:
English: If you stop taking this medicine too quickly, you may have low blood pressure.
Danish: Hvis du for hurtigt stopper med at tage dette lægemiddel, kan du få blodtryksfald.
English: If you are over 65 years old and/or frail, your doctor may prescribe a half tablet each time.
Danish: Hvis du er over 65 år og/eller skrøbelig, vil lægen muligvis ordinere en halv tablet pr. indtagelse.
English: You may experience serious side effects if you stop taking this medicine suddenly.
Danish: Du kan få alvorlige bivirkninger ved pludseligt at stoppe med at tage dette lægemiddel.
English: - if you are more than 12 hours late: do not take the tablet but take the next tablet at the usual time.
Danish: - hvis det er mere end 12 timer for sent: Tag ikke tabletten, men tag den næste tablet på det sædvanlige klokkeslæt.
English: Calcium and vitamin D levels should be monitored.
Danish: Værdierne af calcium og vitamin D bør overvåges.
English: At high doses (e.g. 40 mg), it reduces the immune response.
Danish: I høje doser (f.eks. 40 mg) mindsker det immunresponsen.
English: You doctor will observe you more closely if you have any of the listed diseases.
Danish: Lægen vil holde dig under tættere observation, hvis du har nogen af de anførte sygdomme.
English: The requirements for submission of periodic safety update reports 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: Kravene for fremsendelse af periodiske opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EC og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000 including isolated reports), not known (cannot be estimated from the available data).
Danish: Hyppighed inddeles på følgende måde: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1 000 til < 1/100), sjælden (≥ 1/10 000 til < 1/1 000), meget sjælden (< 1/10 000, herunder enkeltstående indberetninger), ikke kendt (kan ikke beregnes af forhåndenværende data).
English: Risk of infection
Danish: Infektionsrisiko
English: Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary.
Danish: De fleste reaktioner svinder efter dosisreduktion eller seponering, men specifik behandling kan være nødvendig.
English: The recommended dose is one tablet each time.
Danish: Den anbefalede dosis er én tablet pr. indtagelse.
English: Common: Vertigo.
Danish: Almindelige: Vertigo
English: Throw away half tablets that you have not taken.
Danish: Kassér halve tabletter, som du ikke har taget.
English: Inform your doctor immediately if you are pregnant or if you become pregnant during treatment.
Danish: Sig det straks til lægen, hvis du er gravid, eller hvis du bliver gravid under behandlingen.
English: No interaction study has been performed with oral contraceptives.
Danish: Der er ikke udført interaktionsundersøgelser med orale antikonceptiva.
English: You should also tell your doctor if you have recently received a vaccination or are planning to be vaccinated.
Danish: Du skal ligeledes sige det til lægen, hvis du for nylig har fået en vaccination eller påtænker at få det.
English: − Infection, inflammation of the whole body due to infection (sepsis);
Danish: − infektion, inflammation af hele kroppen på grund af infektion (sepsis)
English: Do not exceed or take less than the prescribed dose.
Danish: Du må ikke tage mere eller mindre end den ordinerede dosis.
English: Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.
Danish: Lægen vil fortælle dig herom og om fordele og mulige risici ved din behandling.
English: Genotoxicity findings have been shown to be artefactual.
Danish: De genotoksiske fund har vist sig at være artefakter.
English: You and your partner must use appropriate contraception.
Danish: Du og din partner skal bruge sikker prævention.
English: Action should be taken to try to minimize all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia).
Danish: Der bør træffes forholdsregler til minimering af alle modificerbare risikofaktorer (f.eks. rygning, hypertension og hyperlipidæmi).
English: Your doctor will monitor you more closely.
Danish: Lægen vil holde dig under tættere observation.
English: These would include depressive or manic-depressive illness and previous steroid psychoses.
Danish: Dette gælder således depressiv eller maniodepressiv sygdom og tidligere steroidinduceret psykose.
English: There is a risk of severe strongyloidiasis.
Danish: Der er risiko for svær strongyloidiasis.
English: 17, Parc des Vautes 34980 Saint Gély du Fesc France
Danish: 17, Parc des Vautes 34980 Saint Gély du Fesc Frankrig
English: The benefit from dexamethasone treatment should be carefully and continuously weighed against actual and potential risks.
Danish: Fordelen ved behandling med dexamethason bør løbende nøje afvejes mod faktiske og potentielle risici.
English: Efficacy of hormone replacement therapy may also be reduced.
Danish: Virkningen af hormonsubstitutionsterapi kan ligeledes være nedsat
English: Effective measures to avoid pregnancy must be taken (see section 4.6).
Danish: Der bør træffes effektive foranstaltninger til at undgå graviditet (se pkt.
English: They act together by killing cancerous white blood cells.
Danish: De virker sammen ved at dræbe kræftcellerne blandt de hvide blodlegemer.
English: 30 to 40% are conjugated to glucuronic acid or sulphated in the human liver and excreted in this form in the urine.
Danish: 30-40 % konjugeres til glukuronsyre eller sulfateres i human lever og udskilles i denne form i urinen.
English: Depending on the duration of treatment, calcium metabolism may be impaired.
Danish: Afhængigt af behandlingsvarigheden kan calciummetabolismen være hæmmet.
English: However, the immune response and hence the effect of the vaccination can be diminished by high glucocorticoid doses.
Danish: Immunresponsen og dermed virkningen af vaccinationen kan dog nedsættes af høje doser glukokortikoid.
English: Keep tablets in the blister packaging until you take them.
Danish: Opbevar tabletterne i blisterpakningen, indtil du tager dem.
English: The efficacy of midazolam may be reduced.
Danish: Virkningen af midazolam kan være nedsat
English: Patients should be advised to promptly report febrile episodes.
Danish: Patienten bør have besked på straks at indberette febrile episoder.
English: No chronic toxicity and carcinogenicity data are available.
Danish: Der foreligger ingen kroniske toksicitets- og karcinogenicitetsdata.
English: Water and sodium retention is common and can lead to hypertension.
Danish: Væske- og natriumretention er almindelig og kan medføre hypertension.
English: If you notice blurring or distorted vision that lasts for several days, please contact your doctor.
Danish: Hvis du bemærker sløret eller forvrænget syn, der varer i flere dage, skal du kontakte lægen.
English: In particular, pneumonia occurs commonly.
Danish: Navnlig pneumoni er almindeligt forekommende.
English: Insomnia may be minimised by administering Neofordex in the morning.
Danish: Søvnløshed kan minimeres ved, at Neofordex administreres om morgenen.
English: This risk is increased by treatment with certain antibiotics and by kidney problems.
Danish: Denne risiko øges ved behandling med visse antibiotika og ved nyreproblemer.
English: − Inability of the heart to pump enough blood round the body (heart failure);
Danish: − hjertets manglende evne til at pumpe tilstrækkeligt med blod rundt i kroppen (hjertesvigt)
English: A dose reduction of lenalidomide or pomalidomide may be required.
Danish: Dosisreduktion af lenalidomid eller pomalidomid kan være nødvendig.
English: If you need tests (in particular for infections) you should inform the person performing the tests as dexamethasone may interfere with the results.
Danish: Hvis du får brug for at få taget prøver (navnlig for infektioner), skal du sige til den, der undersøger prøverne, at dexamethason kan påvirke resultaterne.
English: At very high doses the majority of dexamethasone circulates unbound in the blood.
Danish: Ved meget høje doser cirkulerer størstedelen af dexamethason ubundet i blodet.
English: No differences were found in dexamethasone pharmacokinetics between subjects of European and Asian (Indonesian and Japanese) descent.
Danish: Der blev ikke fundet forskelle i farmakokinetikken for dexamethason mellem personer af europæisk og asiatisk (indonesisk og japansk) afstamning.
English: The following combinations require precautions due to safety concerns:
Danish: Følgende kombinationer kræver forholdsregler på grund af sikkerhedsproblemer: