FrancophonIA/ELRC3.0 huggingface dataset:
English: MA (EU) Number Invented name Strength Pharmaceutical Form Route of Administration
Danish: MF (EU)-nummer
English: The European Commission granted a marketing authorisation valid throughout the EU for Twynsta on 7 October 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Twynsta den 7. oktober 2010.
English: The maximum dose is one tablet of the highest strength (80/10 mg) once a day.
Danish: Den maksimale dosis er én tablet med den højeste styrke (80/10 mg) én gang dagligt.
English: This is a summary of the European public assessment report (EPAR) for Twynsta.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Twynsta.
English: Both are medicines to lower the blood pressure that have been available in the European Union (EU) since the 1990s.
Danish: De er begge blodtrykssænkende lægemidler, der har været tilgængelige på markedet i Den Europæiske Union (EU) siden 1990'erne.
English: The full EPAR for Twynsta can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Twynsta findes på agenturets websted under under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: Because telmisartan and amlodipine have been used for many years, the company presented information from scientific literature as well as results from new studies that the company had carried out.
Danish: Da både telmisartan og amlodipin har været anvendt i mange år, fremlagde virksomheden oplysninger fra den videnskabelige litteratur og resultater af nye undersøgelser foretaget af virksomheden selv.
English: It is available as tablets (40 mg telmisartan/10 mg amlodipine, 40 mg telmisartan/5 mg amlodipine, 80 mg telmisartan/10 mg amlodipine and 80 mg telmisartan/5 mg amlodipine).
Danish: Det fås som tabletter (40 mg telmisartan/10 mg amlodipin, 40 mg telmisartan/5 mg amlodipin, 80 mg telmisartan/10 mg amlodipin og 80 mg telmisartan/5 mg amlodipin).
English: Other information about Twynsta:
Danish: Andre oplysninger om Twynsta:
English: It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells.
Danish: Det blokerer særlige kanaler på celleoverfladen kaldet calciumkanaler, igennem hvilke calciumionerne normalt kommer ind i cellerne.
English: Twynsta telmisartan / amlodipine
Danish: Twynsta telmisartan/amlodipin
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 Twynsta.
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 Twynsta skal anvendes.
English: When appropriate, direct switch to Twynsta may be considered.
Danish: I de tilfælde, hvor det er relevant, kan det overvejes at skifte direkte til Twynsta.
English: The Committee decided that Twynsta's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget fandt, at fordelene ved Twynsta opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The main measure of effectiveness in the three studies was the fall in diastolic blood pressure (blood pressure measured between two heartbeats) after eight weeks.
Danish: Det primære effektmål i de tre undersøgelser var faldet i det diastoliske blodtryk (blodtrykket målt mellem to hjerteslag) efter otte uger.
English: By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.
Danish: Ved at sænke blodtrykket reduceres risiciene i forbindelse med højt blodtryk, såsom slagtilfælde.
English: The CHMP noted that patients already taking the two active substances in separate tablets may be more likely to adhere to their treatment if prescribed Twynsta.
Danish: CHMP bemærkede, at patienter, som får de to aktive stoffer i separate tabletter, sandsynligvis vil følge deres behandling bedre, hvis de får Twynsta.
English: Telmisartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Danish: Telmisartan er en "angiotensin II-receptorantagonist", hvilket betyder, at det blokerer virkningen af et hormon i kroppen, der kaldes angiotensin II.
English: For more information about treatment with Twynsta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Twynsta, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The most common side effects with Twynsta (seen in up to 1 patient in 10) are dizziness and peripheral oedema (swelling, especially of the ankles and feet).
Danish: De hyppigste bivirkninger ved Twynsta (som ses hos op til 1 ud af 10 patienter) er svimmelhed og perifert ødem (hævelse, især på ankler og fødder).
English: Twynsta is taken by mouth as one tablet once a day and is used for long-term treatment.
Danish: Twynsta tages gennem munden som en tablet én gang dagligt.
English: Twynsta is used to treat essential hypertension (high blood pressure) in adults (aged 18 years or over).
Danish: Twynsta anvendes til behandling af essentiel hypertension (forhøjet blodtryk) hos voksne over 18 år.
English: They work in similar ways to reduce blood pressure by allowing the blood vessels to relax.
Danish: De virker på samme måde og sænker blodtrykket ved at få blodkarrene til at afslappes.
English: By blocking the receptors to which angiotensin II normally attaches, Telmisartan stops the hormone having an effect, allowing the blood vessels to widen.
Danish: Ved at blokere de receptorer, som angiotensin II normalt binder sig til, standser telmisartan virkningen af hormonet og gør det muligt for blodkarrene at udvide sig.
English: Twynsta must not be used in patients who have severe liver or bile problems, shock (a steep fall in blood pressure), obstruction to blood flow from the left side of their heart or in patients with heart failure after having a myocardial infarction (heart attack).
Danish: Twynsta må ikke anvendes til patienter med svær lever- eller galdeblæresygdom, chok (kraftigt blodtryksfald), obstruktion af blodgennemstrømningen fra venstre side af hjertet, eller til patienter med hjerteinsufficiens efter myokardieinfarkt (hjertetilfælde).
English: In one main study, 1,461 adults with hypertension were treated with combinations of telmisartan and amlodipine, with telmisartan or amlodipine alone, or with placebo (a dummy treatment).
Danish: I en hovedundersøgelse blev 1 461 voksne med hypertension behandlet med kombinationer af telmisartan og amlodipin, med telmisartan eller amlodipin alene eller med placebo (en virkningsløs behandling).
English: When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction.
Danish: Når der kommer calciumioner ind i muskelcellerne i blodkarrenes vægge, forårsager det en sammentrækning.
English: Studies were also carried to show that Twynsta tablets are absorbed in the same way in the body as separate tablets of amlodipine and telmisartan.
Danish: Der blev desuden gennemført undersøgelser for at vise, at Twynsta-tabletterne optages i kroppen på samme måde som de separate tabletter med amlodipin og telmisartan.
English: In addition, studies showed that the medicine was effective in patients whose blood pressure is not adequately controlled by amlodipine alone.
Danish: Desuden viste undersøgelserne, at lægemidlet var effektivt hos patienter, hvis blodtryk ikke kontrolleres tilstrækkeligt med amlodipin alene.
English: By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and this helps the blood vessels to relax.
Danish: Ved at reducere mængden af calcium til cellerne forhindrer amlodipin cellerne i at trække sig sammen, hvilket får blodkarrene til at afslappes.
English: What is the risk associated with Twynsta?
Danish: Hvilken risiko er der forbundet med Twynsta?
English: Twynsta can also be used in place of treatment with telmisartan and amlodipine in patients who are taking both medicines as separate tablets.
Danish: Twynsta kan også anvendes i stedet for behandling med telmisartan og amlodipin hos patienter, der får de to lægemidler i separate tabletter.
English: In two other main studies, 1,978 adults whose hypertension had not responded adequately to amlodipine were either given Twynsta or continued to take amlodipine at the same or a higher dose.
Danish: I to andre hovedundersøgelser blev 1 978 voksne med hypertension, hos hvem amlodipin ikke havde virket tilfredsstillende, behandlet med enten Twynsta eller fortsatte med amlodipin i samme dosis eller i en højere dosis.
English: Why has Twynsta been approved?
Danish: Hvorfor blev Twynsta godkendt?
English: In the first study, the falls in diastolic blood pressure seen in patients taking combinations of telmisartan and amlodipine were greater than those seen in patients taking only one of the active substances or placebo.
Danish: I den første undersøgelse var faldet i det diastoliske blodtryk hos patienter, der tog kombinationer af telmisartan og amlodipin, større end hos de patienter, der udelukkende tog et af de aktive stoffer eller placebo.
English: Twynsta must not be used in people who may be hypersensitive (allergic) to telmisartan, amlodipine, other medicines in the ‘dihydropyridine derivatives' class or to any of the other ingredients.
Danish: Twynsta må ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for telmisartan, amlodipin eller andre lægemidler i gruppen af "dihydropyridinderivater" eller over for andre af indholdsstofferne.
English: Twynsta must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Danish: Twynsta i kombination med lægemidler, der indeholder aliskiren (som desuden anvendes til behandling af essentiel hypertension), må heller ikke anvendes til patienter med type 2-diabetes eller moderat eller alvorlig nyresygdom.
English: For the full list of all side effects reported with Twynsta, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Twynsta fremgår af indlægssedlen.
English: Twynsta is a medicine that contains two active substances, telmisartan and amlodipine.
Danish: Twynsta er et lægemiddel, som indeholder de to aktive stoffer telmisartan og amlodipin.
English: What is Twynsta?
Danish: Hvad er Twynsta?
English: Twynsta is used in patients whose blood pressure is not adequately controlled by amlodipine alone.
Danish: Twynsta anvendes til patienter, hvis blodtryk ikke kan reguleres tilfredsstillende ved hjælp af amlodipin alene.
English: For a patient who has been taking telmisartan and amlodipine as separate tablets, the dose of Twynsta to be taken depends on the doses of telmisartan and amlodipine that he or she was taking before.
Danish: For patienter, der har fået telmisartan og amlodipin i separate tabletter, afhænger dosen af Twynsta af de doser telmisartan og amlodipin, patienterne fik tidligere.
English: Twynsta contains two active substances, telmisartan and amlodipine.
Danish: Twynsta indeholder de to aktive stoffer telmisartan og amlodipin.
English: What is Twynsta used for?
Danish: Hvad anvendes Twynsta til?
English: For a patient whose blood pressure is not adequately controlled by amlodipine, separate tablets of amlodipine and telmisartan should be used to adjust the doses before switching to Twynsta.
Danish: Der bør anvendes separate tabletter med amlodipin og telmisartan til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin, for at justere dosis inden der skiftes til Twynsta.
English: How has Twynsta been studied?
Danish: Hvordan blev Twynsta undersøgt?
English: In the two other studies, Twynsta was more effective at reducing diastolic blood pressure than continued treatment with amlodipine alone: depending on the strengths of Twynsta and amlodipine, the fall in diastolic blood pressure was greater in patients taking Twynsta by between 1.4 mmHg and 4.9 mmHg.
Danish: Afhængigt af styrkerne af Twynsta og amlodipin var faldet i det diastoliske blodtryk mellem 1,4 mmHg og 4,9 mmHg større hos patienter, som fik Twynsta.
English: How is Twynsta used?
Danish: Hvordan anvendes Twynsta?
English: What benefit has Twynsta shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Twynsta?
English: How does Twynsta work?
Danish: Hvordan virker Twynsta?
English: Date of first authorisation: 23/02/2005 Date of last renewal: 25/01/2010
Danish: Dato for første markedsføringstilladelse: 23/02/2005 Dato for seneste fornyelse af markedsføringstilladelsen: 25/01/2010
English: ATCvet code: QI06AH09.
Danish: ATCvet-kode: QI06AH09
English: Laboratoire Porte des Alpes Rue de l'aviation
Danish: Laboratoires Porte des Alpes Rue de l'Aviation
English: SC.
Danish: s.c.
English: Manufacturer responsible for the batch release: MERIAL
Danish: Fremstiller ansvarlig for batchfrigivelse: MERIAL
English: Water for injection ....................................................................................................................... q.s.
Danish: Vand til injektion ......................................................................................................................... q.s.
English: No effects other than those already mentioned in section 4.6 “Adverse reactions” have been observed, except hyperthermia that may exceptionally last 5 days.
Danish: Der er ikke iagttaget andre symptomer end de, der er nævnt under punkt 4.6 ”Bivirkninger”, bortset fra hypertermi, der i sjældne tilfælde kan vare op til 5 dage.
English: EU/2/04/052/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/052/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
Danish: EU/2/04/052/001 Lyofilisat (10 flasker à 1 dosis) + solvens (10 flasker à 1 ml) EU/2/04/052/002 Lyofilisat (50 flasker à 1 dosis) + solvens (50 flasker à 1 ml)
English: Inject by subcutaneous route one dose (1 ml) of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination schedule:
Danish: Injicer subkutant en dosis (1 ml) af vaccinen efter opløsning af den frysetørrede pille i solvens, i henhold til følgende vaccinationsprogram:
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administrated with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Danish: Der foreligger oplysninger om sikkerhed og virkning der viser, at denne vaccine kan blandes og gives med Merials vaccine uden adjuvans mod felin leukæmi og/eller anvendes den samme dag men ikke blandes med Merials vaccine med adjuvans mod rabies.
English: Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs, - against feline panleucopenia to prevent mortality and clinical signs.
Danish: Aktiv immunisering af katte, der er 8 uger eller ældre: - mod felin viral rhinotracheitis for at reducere kliniske tegn, - mod calicivirus infektion for at reducere kliniske tegn, - mod felin panleukopeni til forebyggelse af dødsfald og kliniske tegn.
English: 1 ml 1 cell culture infective dose 50%.
Danish: 1 ml 1 cellekultur infektiøs dosis 50%.
English: Where high levels of maternal antibodies against rhinotracheitis, calicivirosis or panleucopenia components are expected to be present (e.g. in kittens of 9-12 weeks of age born from queens which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
Danish: Ved mistanke om tilstedeværelse af høje værdier af maternelle antistoffer over for rhinotracheitis, calicivirus eller panleukopeni komponenterne (fx hos 9-12 uger gamle killinger født af hunkatte, der var vaccineret før drægtighed, og/eller ved kendskab til eller mistanke om, at moderdyret har været udsat for de pågældende patogener), bør basisvaccination udsættes, til killingerne er 12 uger gamle.
English: Revaccination: - the first revaccination must be carried out one year after the primary vaccination course, - subsequent revaccinations must be carried out at intervals of up to three years for the rhinotracheitis, calicivirosis and panleucopenia components.
Danish: Revaccination: - den første revaccination skal foretages et år efter basisvaccinationen, - efterfølgende revaccinationer skal foretages med intervaller på op til tre år for rhinotracheitis,
English: The duration of immunity after the last re-vaccination is 3 years for rhinotracheitis, calicivirosis and panleucopenia components.
Danish: Varigheden af immunitet efter sidste revaccination er 3 år for rhinotracheitis, calicivirus og panleukopeni komponenterne.
English: Purevax RCP solvent
Danish: Purevax RCP solvens.
English: EXP (mm/yyyy) Once reconstituted use immediately.
Danish: EXP {MM/ÅÅÅÅ} Anvendes straks efter rekonstituering .
English: Vaccine against feline viral rhinotracheitis, feline calicivirosis and feline panleucopenia.
Danish: Vaccine mod felin viral rhinotracheitis, felin calicivirus og felin panleukopeni.
English: Stimulates active immunity against feline rhinotracheitis virus, feline calicivirus, and feline panleucopenia virus.
Danish: Stimulerer aktivt immuniteten over for felin rhinotracheitis virus, felin calicivirus og felin panleukopeni virus.
English: No effect other than those already mentioned in section on “Adverse reactions” have been observed after the administration of several doses, except hyperthermia that may exceptionally last 5 days.
Danish: Efter administration af flere doser er der ikke iagttaget andre symptomer end de, der er nævnt under ”Bivirkninger”, bortset fra forhøjet temperatur, der i sjældne tilfælde kan vare op til 5 dage.
English: Gentamicin, at most ....................................................................................................................... 16.5 µg Solvent:
Danish: Gentamycin max............................................................................................................................... 16,5 µg Solvens:
English: Onsets of immunity have been demonstrated 1 week after primary vaccination course for the rhinotracheitis, calicivirus and panleucopenia components.
Danish: Det er vist, at immuniteten indtræder 1 uge efter basisvaccination for rhinotracheitis, calicivirus og panleukopeni.
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and G1 strains) antigens ................................... ≥ 2.0 ELISA U. Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
Danish: Svækket felin rhinotracheitis herpesvirus (FHV F2 stamme) .......................................... ≥ 104,9 CCID501 Dræbte feline calicivirusantigener (FCV 431 og G1 stammer) ..................................... ≥ 2,0 ELISA U. Svækket felin panleukopeni virus (PLI IV) ...................................................................... ≥ 103,5 CCID501
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and FCV G1 strains) antigens .......................... ≥ 2.0 ELISA U. Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
Danish: Svækket felin rhinotracheitis herpesvirus (FHV F2 stamme) .......................................... ≥ 104,9 CCID501 Dræbte feline calicivirusantigener (FCV 431 og G1 stammer) ...................................... ≥ 2,0 ELISA U. Svækket felin panleukopeni virus (PLI IV) ...................................................................... ≥ 103,5 CCID501
English: FHV (F2 strain) ................................................................................................................. ≥ 104.9 CCID50 FCV (431 and G1 strains) ............................................................................................... ≥ 2.0 ELISA U. FPV (PLI IV) .................................................................................................................... ≥ 103.5 CCID50.
Danish: FCV (431 og G1 stammer) ............................................................................................ ≥ 2,0 ELISA U. FPV (PLI IV) .................................................................................................................... ≥ 103,5 CCID50
English: Laboratory of Lyon Porte des Alpes Rue de l'aviation
Danish: Laboratory of Lyon Porte des Alpes Rue de l'Aviation 69800 Saint-Priest FRANKRIG
English: Purevax RCP lyophilisate and solvent for suspension for injection.
Danish: Purevax RCP lyofilisat og solvens til injektionsvæske, suspension.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Pack of 10 bottles of lyophilisate and 10 bottles of solvent Pack of 50 bottles of lyophilisate and 50 bottles of solvent
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske med 10 flasker lyofilisat og 10 flasker solvens
English: Purevax RCP lyophilisate and solvent for suspension for injection
Danish: Purevax RCP, lyofilisat og solvens til injektionsvæske, suspension.
English: Nyxoid can be used in adults and adolescents from 14 years of age.
Danish: Nyxoid kan anvendes til voksne og unge fra 14 år.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but is given in a different way.
Danish: Det vil sige, at det svarer til et "referencelægemiddel", der indeholder samme aktive stof, men indgives på en anden måde.
English: This is a summary of the European public assessment report (EPAR) for Nyxoid.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Nyxoid.
English: The full EPAR for Nyxoid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Nyxoid findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Nyxoid is a ‘hybrid medicine'.
Danish: Nyxoid er et "hybridt lægemiddel".
English: The most common side effect with Nyxoid (which may affect more than 1 in 10 people) is nausea (feeling sick).
Danish: Den hyppigste bivirkning ved Nyxoid (som kan forekomme hos mere end 1 ud af 10 personer) er kvalme.
English: Nyxoid naloxone
Danish: Nyxoid naloxon
English: What is Nyxoid and what is it used for?
Danish: Hvad er Nyxoid, og hvad anvendes det til?
English: Other information about Nyxoid
Danish: Andre oplysninger om Nyxoid
English: Opioids work by attaching to and activating opioid receptors (targets) in the body.
Danish: Opioider virker ved at binde til og aktivere opioidreceptorer (mål) i kroppen.
English: What measures are being taken to ensure the safe and effective use of Nyxoid?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Nyxoid?
English: Naloxone rapidly blocks these receptors, ending the opioid's effects such as slow breathing.
Danish: Naloxon blokerer hurtigt disse receptorer og standser dermed opioidernes virkning som f.eks. langsom vejrtrækning.
English: If the first dose works well but the patient later worsens a second dose should be given immediately in the other nostril.
Danish: Hvis den første dosis virker, men patienten efterfølgende får det dårligt, bør en ny dosis gives øjeblikkeligt i det andet næsebor.