FrancophonIA/ELRC3.0 huggingface dataset:
English: The study compared cows that were given Startvac with those that were given placebo (a dummy vaccine) and looked at the number of cows with mastitis, the severity of mastitis symptoms, and milk production.
Danish: I undersøgelsen sammenlignede man køer, som havde fået Startvac, med køer, som havde fået placebo (en virkningsløs behandling), og man så på antallet af køer med mastitis, sværhedsgraden af mastitis og køernes mælkeproduktion.
English: What is Startvac used for?
Danish: Hvad anvendes Startvac til?
English: How has Startvac been studied?
Danish: Hvordan blev Startvac undersøgt?
English: What benefit has Startvac shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Startvac?
English: How does Startvac work?
Danish: Hvordan virker Startvac?
English: Patients over 65 years of age and patients who reduced liver or kidney function may need a lower starting dose of 5 mg per day.
Danish: Patienter over 65 år og patienter med nedsat lever- eller nyrefunktion skal muligvis have en lavere startdosis på 5 mg om dagen.
English: It is available as orodispersible tablets (5, 7.5, 10, 15 and 20 mg).
Danish: Det fås som tabletter (5 mg, 7,5 mg, 10 mg, 15 mg og 20 mg).
English: The full EPAR for Olazax Disperzi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Olanzapin Glenmark findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Olazax Disperzi.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Olazax Disperzi.
English: The European Commission granted a marketing authorisation valid throughout the EU for Olazax Disperzi on 10 December 2009
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Olazax Disperzi den 10. december 2009.
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 Olazax Disperzi.
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 Olazax Disperzi skal anvendes.
English: For more information about treatment with Olazax Disperzi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Olazax Disperzi, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Olazax Disperzi olanzapine
Danish: Olazax Disperzi olanzapin
English: Olazax Disperzi is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Danish: Olazax Disperzi anvendes endvidere til at behandle moderate til svære maniske episoder (ekstremt højt humør) hos voksne.
English: The recommended starting dose of Olazax Disperzi depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Danish: Der anvendes 10 mg om dagen til skizofreni og forebyggelse af maniske episoder og 15 mg om dagen til behandling af maniske episoder, medmindre det anvendes sammen med andre lægemidler.
English: Olazax Disperzi is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Danish: Olazax Disperzi er også effektivt i fastholdelsen af den kliniske bedring ved fortsat behandling af patienter, der har reageret på den indledende behandling.
English: Olazax Disperzi is used to treat adults with schizophrenia.
Danish: Olazax Disperzi anvendes til behandling af voksne med skizofreni.
English: This means that Olazax Disperzi is similar to ‘reference medicines' already authorised in the European Union (EU) called Zyprexa and Zyprexa Velotab.
Danish: Det betyder, at Olazax Disperzi er identisk med »referencelægemidler«, som allerede er godkendt i Den Europæiske Union (EU), og som hedder Zyprexa og Zyprexa Velotab.
English: The active substance in Olazax Disperzi, olanzapine, is an antipsychotic medicine.
Danish: Det aktive stof i Olazax Disperzi, olanzapin, er et antipsykotisk lægemiddel.
English: The CHMP concluded that, in accordance with EU requirements, Olazax Disperzi has been shown to have comparable quality and to be bioequivalent to Zyprexa and Zyprexa Velotab.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Olazax Disperzi er af sammenlignelig kvalitet og er bioækvivalent med Zyprexa og Zyprexa Velotab.
English: Other information about Olazax Disperzi
Danish: Andre oplysninger om Olazax Disperzi
English: Olazax Disperzi is a ‘generic medicine'.
Danish: Olazax Disperzi er et »generisk lægemiddel«.
English: Because Olazax Disperzi is a generic medicine and is bioequivalent to the reference medicines, its benefit and risk are taken as being the same as the reference medicines.
Danish: Da Olazax Disperzi er et generisk lægemiddel, som er bioækvivalent med referencelægemidlerne, anses benefit/risk-forholdet for at være det samme som for referencelægemidlerne.
English: Olazax Disperzi is a medicine containing the active substance olanzapine.
Danish: Olazax Disperzi er et lægemiddel, som indeholder det aktive stof olanzapin.
English: What are the benefits and risks of Olazax Disperzi shown during the studies?
Danish: Hvilken fordel og risiko viser undersøgelserne, at der er ved Olazax Disperzi?
English: The Committee recommended that Olazax Disperzi be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Olazax Disperzi.
English: Because Olazax Disperzi is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicines, Zyprexa and Zyprexa Velotab.
Danish: Da Olazax Disperzi er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlerne Zyprexa og Zyprexa Velotab.
English: Why has Olazax Disperzi been approved?
Danish: Hvorfor blev Olazax Disperzi godkendt?
English: What is Olazax Disperzi?
Danish: Hvad er Olazax Disperzi?
English: How has Olazax Disperzi been studied?
Danish: Hvordan blev Olazax Disperzi undersøgt?
English: What is Olazax Disperzi used for?
Danish: Hvad anvendes Olazax Disperzi til?
English: How is Olazax Disperzi used?
Danish: Hvordan anvendes Olazax Disperzi?
English: How does Olazax Disperzi work?
Danish: Hvordan virker Olazax Disperzi?
English: The effect of vaccine on reproductive performance has not been investigated.
Danish: Effekten af vaccinen på reproduktionseffektivitet er ikke blevet undersøgt.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/16/197/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/16/197/001
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27/06/2017
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 27/06/2017
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Danish: Det aktive stof som er af biologisk oprindelse, og som har til hensigt at producere aktiv immunitet, er ikke omfattet af regulativ (EC) nr. 470/2009.
English: Injection equipment should be calibrated and inspected regularly to ensure appropriate dosing of the fish.
Danish: Injektionsudstyret skal kalibreres og kontrolleres regelmæssigt for at garantere korrekt dosering af fisken.
English: Transient changes in swimming behaviour, pigmentation and inappetence are very common and can be observed for up to 2, 7 and 9 days, respectively.
Danish: Kortvarige ændringer i svømmeadfærd, pigmentering og appetitløshed er meget almindeligt og kan ses i op til henholdsvis 2, 7 og 9 dage.
English: ATCvet code: QI10AX.
Danish: ATCvet-kode: QI10AX
English: Shake product gently before use.
Danish: Ryst produktet forsigtigt før brug.
English: Only healthy fish should be vaccinated.
Danish: Kun raske fisk bør vaccineres.
English: A minimum body weight of 25 g is recommended at vaccination.
Danish: En minimum legemsvægt på 25 g anbefales ved vaccination.
English: Do not mix with any other veterinary medicinal products prior to or during administration.
Danish: Må ikke blandes med andre veterinærlægemidler før eller under administration.
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Danish: En beslutning om at bruge vaccinen før eller efter andre veterinærlægemidler skal derfor foretages baseret på det enkelte tilfælde.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne anført under punkt 6.1 i SPC'et er tilladte hjælpestoffer som i henhold til Tabel 1 i bilaget til Kommissionens forordning (EU) nr. 37/2010 ikke behøver MRL-værdier eller betragtes som ikke omfattet af regulativ (EC) nr. 470/2009 ved brug som i dette veterinærlægemiddel.
English: BATCH NUMBER Batch {number}
Danish: Batch {nummer}
English: Needle injuries at the site of injection are common following administration of the vaccine which can persist in up to 5% of fish for at least 90 days, and can be seen both macroscopically and microscopically.
Danish: Det er almindeligt at se kanyleskader på injektionsstedet efter vaccinationen, hvilket hos op til 5 % af fiskene kan ses i mindst 90 dage både makroskopisk og mikroskopisk.
English: Do not use in broodstock.
Danish: Må ikke bruges til gydebestand.
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: I tilfælde af utilsigtet selvinjektion, skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with any other veterinary medicinal products.
Danish: Da der ikke foreligger studier til sammenligning må dette veterinære lægemiddel ikke blandes med andre veterinære lægemidler.
English: Name and address of the manufacturer of the biological active substance Elanco Canada Ltd
Danish: Navn og adresse på fremstilleren (fremstillerne) af de(t) biologisk aktive stof(fer) Elanco Canada Ltd
English: For the active immunisation of Atlantic salmon to reduce impaired daily weight gain, and reduce mortality, and cardiac, pancreatic and skeletal muscle lesions caused by pancreas disease following infection with salmonid alphavirus subtype 3 (SAV3).
Danish: Til aktiv immunisering af atlantisk laks for at begrænse forringet daglig tilvækst og reducere dødelighed, og læsioner i hjerte, pankreas og skeletmuskulatur forårsaget af pankreassygdom efter infektion med Salmonid alfavirus subtype 3 (SAV3).
English: PACKAGE SIZE 250 ml
Danish: 250 ml
English: Connect the other end of the transfer tubing set to the vaccine injection equipment (gun).
Danish: Den anden ende af overføringssættet forbindes med vaccineinjektionsudstyret (pistol).
English: Potassium chloride
Danish: Kaliumklorid
English: EXPIRY DATE EXP {month/year}
Danish: ANVENDES INDEN EXP {måned/år}
English: MANUFACTURER'S BATCH NUMBER Batch {number}
Danish: FREMSTILLERENS BATCHNUMMER
English: Do not use in clinically diseased groups of fish.
Danish: Må ikke bruges til grupper af klinisk syge fisk.
English: Potassium dihydrogen phosphate Disodium hydrogen phosphate heptahydrate Sodium chloride
Danish: Kaliumdihydrogenfosfat Natriumhydrogenfosfatheptahydrat Natriumklorid
English: WITHDRAWAL PERIOD Zero degree days.
Danish: 10. TILBAGEHOLDELSESTID Nul graddage.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Danish: Der foreligger ingen oplysninger om sikkerhed og virkning ved brug af vaccinen sammen med andre veterinære lægemiddelprodukter.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelige (flere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1 men færre end 10 dyr i 100 dyr) - Ualmindelige (flere end 1 men færre end 10 dyr i 1.000 dyr) - Sjældne (flere end 1 men færre end 10 ud af 10.000 dyr) - Meget sjælden (færre end 1 ud af 10.000 dyr, herunder isolerede rapporter).
English: CLYNAV stimulates active immunity against salmonid alphavirus subtype 3 (SAV3).
Danish: CLYNAV stimulerer aktiv immunitet imod Salmonid alfavirus subtype 3 (SAV3).
English: Based on a 25 g fish weight a standard 0.5 mm diameter 3mm depth needle is recommended to be used routinely.
Danish: Baseret på en fisk, som vejer 25 g, anbefales rutinemæssig brug af en kanyle med en standard diameter på 0,5 mm og en dybde på 3 mm. Fiskens vægt skal overvejes inden endeligt valg.
English: Atlantic salmon (Salmo salar).
Danish: Atlantisk laks (Salmo salar)
English: CLYNAV contains a supercoiled DNA plasmid which expresses proteins of salmon alphavirus which induces a protective immune response in vaccinated Atlantic salmon.
Danish: CLYNAV indeholder en supercoiled DNA-plasmid, som eksprimerer proteiner af salmonid alfavirus, hvilket inducerer et beskyttende immunrespons hos vaccinerede atlantiske laks.
English: Pharmacotherapeutic group: Immunologicals for Atlantic salmon.
Danish: Farmakoterapeutisk gruppe: Immunologiske midler til atlantisk laks.
English: Position the needle at 90° in the epaxial muscle, central to the dorsal fin and above the mid-line.
Danish: Anbring nålen vinkelret (90°) på den epaxiale muskel midt i rygfinnen og over midtlinjen.
English: A clear, colourless, particulate-free solution.
Danish: LÆGEMIDDELFORM Injektionsvæske, opløsning En klar, farveløs, partikelfri opløsning
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.05 ml dose contains:
Danish: Hver 0,05 ml dosis indeholder:
English: Onset of immunity occurs within 399 degree days (mean water temperature in °C multiplied by number of holding days) following vaccination.
Danish: Den beskyttende immunitet udvikles inden for 399 graddage (middel vandtemperatur i °C gange med antal dage) efter vaccination.
English: Duration of immunity is approximately 3 months after vaccination (demonstrated under laboratory conditions at a water temperature of 12 ±2 °C).
Danish: Den beskyttende immunitet varer cirka 3 måneder efter vaccination (påvist på laboratorie ved en vandtemperatur på 12 °C+ 2 °C).
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Danish: BILAG II A. FREMSTILLER(E) AF DET BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG C. ANGIVELSE AF MRL-VÆRDIER
English: Special warnings for the target species Do not use in clinically diseased groups of fish.
Danish: Særlige advarsler for hver dyreart: Må ikke bruges til grupper af klinisk syge fisk.
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2 °C - 8 °C).
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares og transporteres nedkølet (2 °C-8 °C).
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten efter EXP. Opbevaringstiden for det veterinære lægemiddelprodukt i salgspakning: 2 år.
English: Anaesthetise the fish to immobilise them, and administer 0.05 ml of the vaccine by intramuscular injection in the area immediately anterior and lateral to the dorsal fin in the epaxial muscle.
Danish: Immobiliser fisken med bedøvelse og injicer 0,05 ml af vaccinen intramuskulært i området lige cranialt og lateralt for rygfinnen i den epaxiale muskel.
English: Personal protective equipment, for example, appropriate protective gloves, should be worn when handling the veterinary product.
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: Personligt værnemiddel f.eks. i form af passende beskyttelseshandsker bør anvendes ved håndtering af veterinærlægemidlet.
English: Store and transport refrigerated (2 °C - 8 °C).
Danish: Opbevares og transporteres nedkølet (2-8 °C).
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER(E) AF DET BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE
English: Manufacturer responsible for batch release: Lohmann Animal Health GmbH Heinz-Lohmann-Straβe 4, 27472 Cuxhaven
Danish: Fremstiller ansvarlig for batchfrigivelse: Lohmann Animal Health GmbH Heinz-Lohmann-Straβe 4, 27472 Cuxhaven
English: 250 ml sterile, flexible, ethyl vinyl acetate (EVA) bags with a locking snap down port. A sterile and individually packaged transfer tube set is included in the final product packaging.
Danish: 250 ml steril, fleksibel, ethylvinylacetat (EVA)- pose med en låsbar tilsætningsport.
English: TARGET SPECIES Atlantic salmon (Salmo salar).
Danish: DYREARTER Atlantisk laks (Salmo salar)
English: Transfer tubing kit instructions: using the spiked end, screw the transfer tubing set onto the fill port of the ethyl vinyl acetate (EVA) bag with a ¼ turn in order to secure the line in place.
Danish: Instruktioner til overføringssættet: Skru den tilspidsede ende af overføringssættet på ethylvinylacetat (EVA)-posens tilsætningsport med en kvart omdrejning for at sikre at slangen sidder korrekt.
English: No effects other than those described in section 4.6 have been observed following the administration of an overdose.
Danish: 4.6, er observeret efter indgivelse af en overdosis.
English: EXPIRY DATE EXP {month/year} Once opened use within 10 hours.
Danish: Skal bruges inden for 10 timer efter åbning.
English: No effects other than those described in section 6 have been observed following the administration of an overdose.
Danish: 6, er observeret efter indgivelse af en overdosis.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Intramuskulær injektion Læs indlægssedlen inden brug.
English: SPECIAL WARNING(S), IF NECESSARY
Danish: TILBAGEHOLDELSESTID Tilbageholdelsestid: Nul graddage SÆRLIG(E) ADVARSEL/ADVARSLER, OM NØDVENDIGT
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Each 0.05 ml dose contains: pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins: 5.1 - 9.4 μg.
Danish: Hver 0,05 ml dosis indeholder: pUK-SPDV-poly2#1 DNA-plasmid kodende for virusproteiner ved pankreassygdom hos laks: 5,1-9,4 μg
English: NAME OF THE VETERINARY MEDICINAL PRODUCT CLYNAV solution for injection for Atlantic salmon
Danish: VETERINÆRLÆGEMIDLETS NAVN CLYNAV, injektionsvæske, opløsning, til atlantisk laks
English: Active substance: pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins: 5.1 - 9.4 μg.
Danish: Aktivt stof: pUK-SPDV-poly2#1 DNA-plasmid kodende for virusproteiner ved pankreassygdom hos laks:
English: PACKAGE LEAFLET FOR: CLYNAV solution for injection for Atlantic salmon
Danish: INDLÆGSSEDDEL TIL: CLYNAV, injektionsvæske, opløsning, til atlantisk laks
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr Personligt værnemiddel i form af beskyttelseshandsker bør bæres ved håndtering af veterinærlægemidlet.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER)
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 0.05 ml dose contains: pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins: 5.1 - 9.4 μg.
Danish: VETERINÆRLÆGEMIDLETS NAVN CLYNAV, injektionsvæske, opløsning, til atlantisk laks ANGIVELSE AF ANDRE STOFFER OG ANDRE STOFFER Hver 0,05 ml dosis indeholder: pUK-SPDV-poly2#1 DNA-plasmid kodende for virusproteiner ved pankreassygdom hos laks: 5,1-9,4 μg LÆGEMIDDELFORM Injektionsvæske, opløsning PAKNINGSSTØRRELSE 250 ml DYREARTER Atlantisk laks (Salmo salar) INDIKATION(ER)
English: 4.11 Withdrawal period(s) Zero degree days.
Danish: 4.11 Tilbageholdelsestid(er)
English: Disposal: read package leaflet.
Danish: UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE Bortskaffelse: Læs indlægssedlen.
English: Open both bottles.
Danish: Åbn begge flasker.
English: The product comes in 2 bottles.
Danish: Produktet leveres i 2 flasker.
English: PK/PD relationship:
Danish: PK/PD-forholdet:
English: Frequency not known (cannot be estimated from available data)
Danish: Ukendt hyppihed (kan ikke beregnes fra de foreliggende data)
English: The absolute bioavailability is approximately 70-80%.
Danish: Den absolutte biotilgængelighed er ca. 70-80%.
English: If taken on an empty stomach, the active substance is absorbed more rapidly.
Danish: Hvis de tages på tom mave, absorberes det aktive stof hurtigere.
English: A statement in section 5.1 referring to this indication was also recommended as follows:
Danish: Den følgende vending i afsnit 5.1, der henviser til denne indikation, blev også anbefalet:
English: Tell your doctor if you are planning to get pregnant.
Danish: Fortæl det til din læge, hvis du har planer om at blive gravid.
English: However, these proposals were not in line with the bioequivalence data.
Danish: Disse forslag var dog ikke i overensstemmelse med bioækvivalensdataene.
English: It is important to inform your doctor about your medicine.
Danish: Det er vigtigt, at du oplyser lægen om din medicin.
English: Food and Dairy Products
Danish: Levnedsmidler og mejeriprodukter
English: Only after reconstitution.
Danish: Kun efter rekonstitution.
English: These reactions are more frequent if the infusion time is 30 minutes or less.
Danish: Reaktionerne forekommer hyppigere, hvis infusionstiden er 30 minutter eller mindre.
English: B - 1050 Bruxelles-Brussel Belgium
Danish: B - 1050 Bruxelles-Brussel Belgien
English: This will depend on the type of infection you have and how bad it is.
Danish: Det afhænger af hvilken infektion, du har, og hvor svær den er.
English: The following sections of the Product Information were addressed during this harmonisation procedure.
Danish: Følgende afsnit i produktresuméet blev behandlet i denne harmoniseringsprocedure.
English: 28 days up to 3 months
Danish: 28 dage op til 3 måneder
English: ¾ It is important that you finish the course of treatment even if you begin to feel better after a few days.
Danish: ¾ Det er vigtigt, at du gennemfører hele behandlingsforløbet, også selv om du begynder at føle dig bedre efter nogle dage.
English: This should be taken into account in patients with diabetes mellitus.
Danish: Det skal tages i betragtning hos patienter med diabetes mellitus.
English: These values are within the range reported for adults at therapeutic doses.
Danish: Disse værdier ligger inden for det rapporterede område hos voksne ved terapeutiske doser.
English: In daylight conditions complete efficacy is guaranteed for a period of three days.
Danish: I dagslys er der garanteret fuld effekt i tre dage.