FrancophonIA/ELRC3.0 huggingface dataset:
English: - The extension and intensification of the quality control on the absence of BVD virus on different levels of manufacturing (production virus, production cells, bulk vaccine, finished product) (as described in attachment 37 (SO D-107) and in accordance with attachment 44 (FC-IBML) to the answers to the outstanding issues sent to the EMEA on 28 September 1999).
Danish: - Udvidelse og intensivering af kvalitetskontrollen vedrørende fravær af BVD-virus på forskellige trin i fremstillingsprocessen (produktionsvirus, produktionsceller, bulkvaccine, det færdige produkt) (som beskrevet i vedhæftningsbilag 37 (SO D-107) og i overensstemmelse med vedhæftningsbilag 44 (FC-IBML) til svarene på de udestående spørgsmål, der blev fremsendt til EMEA den 28. september 1999).
English: Tel no 0297-280666
Danish: Tlf. nr. 0297-280666
English: The cases were, in the first instance, suspected to relate to Bayovac IBR Marker Vivum and later also to Rhinobovin Marker Vivum.
Danish: Tilfældene formodedes i første omgang at stå i forbindelse med Bayovac IBR Marker Vivum og efterfølgende også Rhinobovin Marker Vivum.
English: 20 ml (10 doses) 100 ml (50 doses)
Danish: 20 ml (10 doser) 100 ml (50 doser)
English: No BVD-virus isolate from the last mentioned alleged field cases is available.
Danish: Der kan ikke fremskaffes noget BVD-virusisolat fra de ovennævnte konkrete tilfælde.
English: Injectable solution 10 doses + solvent 50 doses + solvent
Danish: Injicerbar opløsning 10 doser + opløsning 50 doser + opløsning
English: The use of cattle with low level of antibodies against BVD virus in the safety testing of the finished product of Bayovac IBR Marker Vivum and Rhinobovin Marker Vivum was justified.
Danish: Anvendelsen af kreaturer med et lavt niveau af antistoffer mod BVD-virus til sikkerhedsafprøvningen af det færdige produkt Bayovac IBR Marker Vivum og Rhinobovin Marker Vivum blev begrundet.
English: Tel no +49 2173 38 42 44 Fax no +49 2173 38 34 79
Danish: Tlf. nr. +49 2173 38 42 44 Fax nr. +49 2173 38 34 79
English: 5.4 Special precaution(s) for use
Danish: 5.4 Særlige forsigtighedsregler vedrørende brugen Ingen
English: B-1050 Bruxelles Tel no 32-2-535 66 47
Danish: B-1050 Bruxelles Tlf. nr. 32-2-535 66 47
English: Hoechst Roussel Vet Batch No.
Danish: Hoechst Roussel Vet Batch nr.
English: An independent expert evaluated the animal health situation in farms vaccinated with Bayovac IBR Marker Vivum and Rhinobovin Marker Vivum and comparable non-IBR-vaccinated cattle farms.
Danish: En uafhængig ekspert har vurderet dyresundhedssituationen på bedrifter, hvor besætningen var vaccineret med Bayovac IBR Marker Vivum og Rhinobovin Marker Vivum, og på sammenlignelige bedrifter, hvor kvæget ikke var IBR-vaccineret.
English: Original documentation regarding the quality control testing of Bayovac IBR Marker Vivum, batch WG4622 and vaccine bulk 77/V4392 was supplied.
Danish: Den originale dokumentation vedrørende kvalitetskontrolafprøvningen af Bayovac IBR Marker Vivum, batch WG4622 og vaccinebulk 77/V4392 blev forelagt.
English: The following batches of Bayovac IBR Marker vivum and the corresponding Rhinobovin Marker vivum were contaminated with BVD virus:
Danish: De følgende batcher af Bayovac IBR Marker vivum og de tilsvarende af Rhinobovin Marker vivum var forurenet med BVD-virus:
English: DICT50 (Min) 107 DICT50 (Max) per dose
Danish: DICT50 (Min) 107 DICT50 (Max) pr.
English: Vaccinated cattle can be differentiated from field virus infected animals due to the marker deletion, unless the cattle were previously vaccinated with a conventional vaccine or infected with field virus.
Danish: Vaccinerede dyr kan differentieres fra naturligt inficerede dyr på grund af markør effekten, med mindre dyret tidligere har været vaccineret med en konventionel IBR vaccine eller tidligere har været naturligt inficerede med IBR virus.
English: 10 or 50 dose glass bottles + glass bottles containing 20 ml and 100 ml sterile water for injection.
Danish: 10 eller 50 dosis glasflasker + glasflasker med 20 ml og 100 ml sterilt vand til injektion.
English: 5.1 Indications for use
Danish: 5.1 Indikationer
English: Basic immunisation: Two injections of 1 dose (2 ml) each 3-5 weeks apart.
Danish: To doseringer à 2 ml ( 1 dosis ) med 3-5 ugers mellemrum.
English: 5.5 Pregnancy and lactation
Danish: 5.5 Drægtighed og diegivning
English: Tel no 0032 2 533 42 43 Fax no 0032 2 533 43 55
Danish: Tlf. nr. 0032 2 533 42 43 Fax nr. 0032 2 533 43 55
English: The CVMP concluded however on 9 November 1999, that evidence linking these ‘case 2' complaints with the subject of the original referral was equivocal and that the Opinion of the CVMP will be confined to the original referral.
Danish: CVMP konkluderede imidlertid den 9. november 1999, at beviserne for en sammenhæng mellem disse ‘case 2'-reklamationer og genstanden for den første indbringelse var usikre, og at CVMP's udtalelse udelukkende ville omhandle den oprindelige indbringelse.
English: Later Dutch field cases (‘case 2') were suspected to be related to other batches of Bayovac IBRMarker Vivum and Rhinobovin Marker Vivum, which did not originate from this bulk of vaccine.
Danish: Senere indberettedes andre sygdomstilfælde i Nederlandene (‘case 2'), som formodedes at være relateret til andre batcher af Bayovac IBR-Marker Vivum og Rhinobovin Marker Vivum, som ikke stammede fra den ovennævnte vaccinebulk.
English: Due to this gene deletion the glycoprotein gE is absent in virus particles of the IBR-Marker Vaccine MLV.
Danish: På grund af denne gen udrensning er viruspartiklerne i IBR-Marker Vaccine MLV helt fri for glykoproteinet gE.
English: Complete neutralisation complies complies complies
Danish: Komplet neutralisering
English: The vaccine induces immunity in cattle against clinical respiratory symptoms caused by the Infectious Bovine Rhinotracheitis (IBR) virus.
Danish: Vaccinen medfører udvikling af immunitet hos kvæg overfor kliniske symptomer på luftvejsinfektion forårsaget af Infektiøs Bovin Rhinotracheitis (IBR) virus.
English: The CVMP concluded on 9 November 1999, that evidence linking these ‘case 2' cases with the subject of the original referral was equivocal and that the Opinion of the CVMP will be confined to the original referral.
Danish: CVMP konkluderede den 9. november 1999, at beviserne for en sammenhæng mellem disse ‘case 2'tilfælde og genstanden for den første indbringelse var usikre, og at CVMP's udtalelse udelukkende ville omhandle den oprindelige indbringelse.
English: Company name & address
Danish: Virksomhedens navn og adresse
English: Virus titre (TCID50/dose) Moisture content
Danish: Virus titer (TCID50/dosis) Fugtighedsindhold
English: Freeze-dried live virus vaccine with diluent for reconstitution
Danish: Frysetørret levende virusvaccine med fortyndingsmiddel til rekonstituering
English: The ingredients of biological origin used in the manufacturing of Bayovac IBR Marker Vivum and Rhinobovin Marker Vivum are foetal calf serum, and trypsin.
Danish: De indholdsstoffer af biologisk oprindelse, der anvendes i fremstillingen af Bayovac IBR Marker Vivum og Rhinobovin Marker Vivum, er føtalt kalveserum og trypsin.
English: Tel no 351-21-9269883/9269711 Fax no 351-21-9202231
Danish: Tlf nr. 351-21-9269883/9269711 Fax nr. 351-21-9202231
English: Intranasal and/or intramuscolar inoculation
Danish: Intranasal og/eller intramuskulær inokulation
English: BVD virus type 1 Less than 1
Danish: BVD-virus type 1 Under 1
English: 5.3 Undesirable effects
Danish: 5.3 Bivirkninger
English: Glass bottles with 10 doses and 50 doses of freeze-dried product and glass bottles with 20 ml and 100 ml solvent, respectively
Danish: Glasflasker med 10 doser og 50 doser af frysetørret produkt og glasflasker med henholdsvis 20 ml og 100 ml solvens
English: - The use of BVD-susceptible cattle in the batch safety-test (as described in attachment 39 (SO D-123) to the answers to the outstanding issues sent to the EMEA on 28 September
Danish: - Anvendelse af BVD-modtageligt kvæg til batchsikkerhedsafprøvningen (som beskrevet i vedhæftningsbilag 39 (SO D-123) til svarene på de udestående spørgsmål, der blev fremsendt til EMEA den 28. september 1999).
English: For active immunisation of cattle against the respiratory symptoms caused by Infectious Bovine Rhinotracheitis (IBR) virus.
Danish: Aktiv immunisering af kreaturer mod luftvejsinfektioner forårsaget af Infektiøs Bovin Rhinotracheitis (IBR) virus.
English: Fax no 49-2173383479
Danish: Fax nr. 49-2173383479
English: The sequences of a BVD-virus type 2 contaminant of Bayovac IBR-Marker Vivum and a BVD virus type 2 of the first Dutch field cases were found to match fully.
Danish: Sekvenseringen i en BVD-virus type 2, der var det forurenende stof i Bayovac IBR-Marker Vivum, og sekvenseringen i en BVD-virus type 2 fra de første konkrete tilfælde i Nederlandene fandtes at matche fuldstændigt.
English: 08017 Barcelona Tel no 0034-93-306 8113 Fax no 0034-93-414 5870
Danish: 08017 Barcelona Tlf. nr. 0034-93-306 8113 Fax nr. 0034-93-414 5870
English: 6.3 Special precautions for storage
Danish: Særlige opbevaringsforhold
English: Fax no 32-2-5334355
Danish: Fax nr. 32-2-5334355
English: Intranasal Intramuscular
Danish: Intranasal Intramuskulær
English: Flow charts of the production and testing of Bayovac IBR-Marker Vivum batch WG4622 and vaccine bulk 77/V4392 were presented.
Danish: Udvalget blev forelagt flow charts vedrørende fremstillingen og afprøvningen af Bayovac IBR-Marker Vivum batch WG4622 og vaccinebulk 77/V4392.
English: Glass vials 10 doses, 50 doses
Danish: Hætteglas 10 doser, 50 doser
English: Tel no 353-1-8132222 Fax no 353-1-8132288
Danish: Tlf nr. 353-1-8132222 Fax nr. 353-1-8132288
English: 20 ml and 100 ml (respectively 10, 50 doses)
Danish: 20 ml og 100 ml (50 doser)
English: - The addition of PCR and IPLA for detecting BVD virus (as described respectively in attachment 40 (SO D-127) and attachment 35 (SO D-076) to the answers to the outstanding issues sent to the EMEA on 28 September 1999).
Danish: - Tilføjelse af PCR og IPLA med henblik på påvisning af BVD-virus (som beskrevet i henholdsvis vedhæftningsbilag 40 (SO D-127) og vedhæftningsbilag 35 (SO D-076) til svarene på de udestående spørgsmål, der blev fremsendt til EMEA den 28. september
English: 20156 Milano Tel no 0039-02-39781 Fax no 0039-02-3978 2303
Danish: 20156 Milano Tlf. nr. 0039-02-39781 Fax nr. 0039-02-3978 2303
English: The results of tests on the presence of BVD virus contaminants of all batches of vaccine of Bayovac IBR Marker Vivum and Rhinobovin Marker Vivum were supplied.
Danish: Resultaterne af afprøvningen af forekomsten af BVD-virus i alle vaccinebatcher af Bayovac IBR Marker Vivum og Rhinobovin Marker Vivum blev forelagt.
English: lot No: P2233
Danish: Parti nr. V3852 Parti nr. P2233
English: 20149 Milano Tel no 0039-02-345 4981 Fax no 0039-02-345 49826
Danish: 20149 Milano Tlf. nr. 0039-02-345 4981 Fax nr. 0039-02-345 49826
English: - In addition the screening of foetal calf serum on BVD virus and antibodies before gammairradiation to be used in the manufacturing (as described in attachment 47 (SP-017) and attachment 33 (SO D-020) to the answers to the outstanding issues sent to the EMEA on 28 September 1999).
Danish: - Supplerende screening af det føtale kalveserum, der skal anvendes ved fremstillingen, for BVD-virus og antistoffer før gammabestråling (som beskrevet i vedhæftningsbilag 47 (SP017) og vedhæftningsbilag 33 (SO D-020) til svarene på de udestående spørgsmål, der blev fremsendt til EMEA den 28. september 1999).
English: Tel no 089-31 00 60
Danish: Tlf. nr. 089-31 00 60
English: Tel no 32-2-5334243
Danish: Tlf nr. 32-2-5334243
English: Powder for injection (lyophilized) + suspension intra-muscular or Intra-nasal
Danish: Pulver til injektion (frysetørret) + suspension
English: Vials with 10 and 50 dose
Danish: Hætteglas med 10 og 50 doser
English: Tel no 49-2173384244
Danish: Tlf. nr. 49-2173384244
English: Tel no 0034-93-495 6500 Fax no 0034-93-322 5413
Danish: Tlf nr. 0034-93-495 6500 Fax nr. 0034-93-322 5413
English: 6.5 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from such veterinary medicinal products Not recorded.
Danish: Særlige forsigtighedsregler vedrørende bortskaffelse af rester eller evt. affald Ikke optegnet.
English: Booster vaccinations: 1 dose (2 ml) 6 months apart.
Danish: 1 dosis ( 2 ml ) med 6 måneders mellemrum.
English: Administration route Pack size/ nature of container
Danish: Pakningsstørrelse/ Emballage
English: last positive at dilution 10-3 last positive at 10-3 last positive at 10-3
Danish: Sidst positiv ved fortynding 10 -1
English: mycoplasma no mycoplasma detectable no mycoplasma detectable no mycoplasma detectable growth promotion must comply complies complies
Danish: Ingen mycoplasma påviselig Ingen mycoplasma påviselig
English: Following intranasal inoculation slight transient, serous nasal discharge may occur in rare chases.
Danish: Efter intranasal vaccination kan der i sjældne tilfælde ses svag kortvarig, serøst næseflåd.
English: DATE OF REVISION OF THE TEXT
Danish: REVISION AF PRODUKTRESUMÉ
English: Data on investigation of batches of foetal calf serum were presented.
Danish: Udvalget havde fået forelagt data vedrørende undersøgelsen af batcher af føtalt kalveserum.
English: Virus titre (TCID50/vial) for potency*
Danish: Virus titer (TCID50/hætteglas) styrke
English: 6.2.1 Unopened product:
Danish: Uåbnet produkt: 30 måneder.
English: no cpe detectable no cpe detectable no cpe detectable hemadsorption (ha)
Danish: Ingen cpe påviselig Ingen cpe påviselig
English: Last positive at dilution 10
Danish: Sidst positiv ved 10
English: No cpe detectable No haemadsorption No live BVD virus detectable complies complies No live BVD virus detectable complies complies No live BVD virus detectable complies complies No live BVD virus detectable
Danish: Ingen cpe påviselig Ingen haemadsorption Ingen levende BVD-virus påviselig
English: Hoechst Roussel Vet N.V. Benelux Contact Germany:
Danish: Benelux Contact Germany:
English: negative negative negative
Danish: Negativ
English: Dextran 60
Danish: Hjælpestoffer Stabilisator: Dextran 60 mg
English: *10 dose vial *50 dose vial
Danish: *50 dosis hætteglas
English: * virus only isolated from concentrated samples.
Danish: BVD-virus type 1 10 1,6 * kun i form af isoleret virus fra koncentrerede prøver.
English: Extraneous agents
Danish: Fremmedstoffer
English: Following reconstitution the vaccine remains potent for max. 8 hours when the product is withdrawn aseptically and the vaccine is refrigerated.
Danish: Anbrudt beholder: Hvis produktet er trukket aseptisk fra det anbrudte hætteglas og hvis vaccinen holdes afkølet kan den bruges indenfor max. 8 timer.
English: 4.1 Properties of active ingredient
Danish: 4.1 Farmakologiske egenskaber
English: 5.0 Target species
Danish: 5.0 Dyrearter, som lægemidlet er beregnet til
English: last positive at last positive at last positive at virus titre (lg TCID50/ml)
Danish: Virus titer (lg TCID50/ml) ≥ 7,0
English: Pharmacotherapeutic group: {group}, ATCvet code: {code}
Danish: Terapeutisk klassifikation:
English: Glass bottles with 10 doses and 50 doses of freeze-dried product and glass bottles with 20 ml and 100 ml solvent, respectively.
Danish: Hætteglas med 10/50 doser frysetørret produkt og hætteglas med 20/100 ml solvens.
English: 105 DICT50 (Min) 107 DICT50 (Max) per dose
Danish: Pulver og solvens til injektionsvæske, suspension 105 DICT50 (Min) 107 DICT50 (Max) pr.
English: Intra-nasal or/and intra-muscular
Danish: Intranasal eller/og intramuskulær
English: Per 0.1 ml dose * propagated in fertilised hens' eggs from healthy chicken flocks ** haemagglutinin l t o r
Danish: per 0,1 ml-dosis * opformeret i befrugtede hønseæg fra raske kyllingebesætninger ** hæmagglutinin
English: 15 micrograms HA** B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type) ............................................ 15 micrograms HA**
Danish: B/Brisbane/60/2008 - lignende stamme (B/Brisbane/60/2008, vild type) ..............................................
English: A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A) ....... 15 micrograms HA** A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B) .
Danish: A/Hong Kong/4801/2014 (H3N2) - lignende stamme (A/Hong Kong/4801/2014, NYMC X-263B) ...
English: The full EPAR for PritorPlus can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for PritorPlus findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for PritorPlus on 22 April 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for PritorPlus den 22. april 2002.
English: This is a summary of the European public assessment report (EPAR) for PritorPlus.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for PritorPlus.
English: PritorPlus is taken by mouth once a day with liquid, with or without food.
Danish: PritorPlus indtages gennem munden en gang dagligt med væske enten med eller uden føde.
English: Other information about PritorPlus
Danish: Andre oplysninger om PritorPlus
English: A risk management plan has been developed to ensure that PritorPlus is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at PritorPlus anvendes så sikkert som muligt.
English: PritorPlus has been studied in five main studies involving a total of 2,985 patients with mild to moderate hypertension.
Danish: PritorPlus blev undersøgt i fem hovedundersøgelser med deltagelse af i alt 2 985 patienter med mild til moderat hypertension.
English: The most common side effect with PritorPlus (seen in between 1 and 10 patients in 100) is dizziness.
Danish: Den mest almindelige bivirkning ved PritorPlus (som ses hos mellem 1 og 10 patienter ud af 100) er svimmelhed.
English: PritorPlus must not be used in women who are more than three months pregnant.
Danish: Det må ikke anvendes til gravide, som er længere end tre måneder henne i graviditeten.
English: What measures are being taken to ensure the safe and effective use of PritorPlus?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af PritorPlus?
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 PritorPlus.
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 PritorPlus skal anvendes.
English: For more information about treatment with PritorPlus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med PritorPlus, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: PritorPlus telmisartan / hydrochlorothiazide
Danish: Telmisartan/hydrochlorothiazid
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for PritorPlus, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for PritorPlus, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: In patients with type 2 diabetes or in patients with moderate or severe kidney impairment, PritorPlus must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension).
Danish: Hos patienter med type 2-diabetes eller moderat eller alvorlig nyresygdom må PritorPlus desuden ikke anvendes i kombination med lægemidler, der indeholder aliskiren (som også anvendes til behandling af essentiel hypertension).
English: It is available as tablets (40 or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide).
Danish: Det fås som tabletter (40 eller 80 mg telmisartan og 12,5 mg hydrochlorothiazid; 80 mg telmisartan og 25 mg hydrochlorothiazid).
English: The Committee recommended that PritorPlus be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for PritorPlus.
English: The CHMP decided that PritorPlus's benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone.
Danish: CHMP vurderede, at fordelene ved PritorPlus er større end risiciene til behandling af essentiel hypertension hos patienter, hvis blodtryk ikke er tilstrækkeligt under kontrol med telmisartan alene.
English: In four of these studies, PritorPlus was compared with placebo (a dummy treatment) and with telmisartan taken alone in a total of 2,272 patients.
Danish: I fire af disse undersøgelser (2 272 patienter) blev PritorPlus sammenlignet med placebo (en uvirksom behandling) og med telmisartan taget alene.
English: What is the risk associated with PritorPlus?
Danish: Hvilken risiko er der forbundet med PritorPlus?
English: The dose of PritorPlus to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/12.5 mg tablets.
Danish: Den dosis af PritorPlus, som skal anvendes, afhænger af den dosis af telmisartan, som patienten tog tidligere: Patienter, som fik 40 mg telmisartan, skal tage 40/12,5 mg-tabletterne, og patienter, der fik 80 mg telmisartan, skal tage 80/12,5 mg-tabletterne.
English: PritorPlus must also not be used in people who have severe liver, kidney or bile problems, blood potassium levels that are too low, or blood calcium levels that are too high.
Danish: PritorPlus må heller ikke anvendes hos personer, der har alvorlige lever-, nyre- eller galdesygdomme, eller som har for lavt indhold af kalium i blodet eller for højt indhold af kalcium i blodet.
English: Care must be taken when using PritorPlus with other medicines that have an effect on blood potassium levels.
Danish: Der skal udvises forsigtighed, når PritorPlus anvendes sammen med andre lægemidler, som kan påvirke indholdet af kalium i blodet.
English: PritorPlus is a medicine that contains two active substances, telmisartan and hydrochlorothiazide.
Danish: PritorPlus er et lægemiddel, som indeholder to aktive stoffer, telmisartan og hydrochlorothiazid.
English: The 80/25 mg tablets are used in patients whose blood pressure is not controlled using the 80/12.5 mg tablets or who have been stabilised using the two active substances taken separately before switching to PritorPlus.
Danish: Tabletterne med 80/25 mg anvendes til patienter, hvis blodtryk ikke kan kontrolleres med 80/12,5 mg-tabletterne, eller som er blevet stabiliseret ved hjælp af de to aktive stoffer indtaget separat, inden de skiftede til PritorPlus.
English: PritorPlus is used in adult patients who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone.
Danish: PritorPlus anvendes til patienter med essentiel hypertension (højt blodtryk), som ikke kan kontrolleres tilfredsstillende ved hjælp af telmisartan alene.
English: Why has PritorPlus been approved?
Danish: Hvorfor blev PritorPlus godkendt?
English: PritorPlus contains two active substances, telmisartan and hydrochlorothiazide.
Danish: PritorPlus indeholder to aktive stoffer, telmisartan og hydrochlorothiazid.
English: For the full list of all side effects reported with PritorPlus, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved PritorPlus fremgår af indlægssedlen.