FrancophonIA/ELRC3.0 huggingface dataset:
English: Sore throat, anorexia, increased appetite, depression, feeling strange, nightmare, anxiety, agitation, nervousness, decreased sexual interest, teeth grinding, numbness and tingling, shaking, muscle tense, abnormal taste, lack of attention, visual disturbance, ringing in ears, palpitations, hot flush, yawning, abdominal pain, vomiting, constipation, upset stomach, gas, rash, increased sweating, muscle pain, sexual dysfunction, erectile dysfunction, chest pain.
Danish: Almindelige bivirkninger (det forekommer hos mellem 1 og 10 ud af 100 patienter): Halsbetændelse, appetitmangel, øget appetit, depression, føle sig fremmed, mareridt, angst, rastløs uro, nervøsitet, nedsat sexlyst, skæren tænder, følelsesløshed og prikkende og stikkende fornemmelse i huden, skælven, muskelspænding, forandringer i smagen, manglende opmærksomhed, synsforstyrrelser, susen for ørerne (tinnitus), hjertebanken, hedeture, gaben, mavesmerter, opkastning, forstoppelse, fordøjelsesbesvær, luftafgang fra tarmen, udslæt, øget svedtendens, muskelsmerter, seksuelle problemer, impotens, brystsmerter.
English: Sertraline must be discontinued for at least 7 days before starting treatment with an irreversible (non-selective) MAOI (see section 4.3).
Danish: Tilsvarende bør behandling med en irreversibel (ikke-selektiv) MAOhæmmer tidligst indledes 7 dage efter seponering af sertralin (se pkt.
English: At times, a slight haze may appear in the solution after mixing; this is normal.
Danish: Fortyndingen kan nogle gange blive uklar, men det er helt normalt.
English: Use in children and adolescents:
Danish: Anvendelse til børn og unge under 18 år
English: Oesophagitis, Dysphagia, Haemorrhoids, Salivary Hypersecretion, Tongue
Danish: Øsofagitis, dysfagi, hæmorider, øget spytsekretion, sygdom i tungen, opstød
English: After one week, the dose should be increased to 50 mg once daily.
Danish: Dosis øges til 50 mg 1 gang dagligt efter en uge.
English: [See Annex I - To be completed nationally] This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest godkendt den { MM/ÅÅÅÅ } [Udfyldes nationalt]
English: Before you take Zoloft.
Danish: DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE ZOLOFT
English: Belgium PFIZER S.A. Boulevard de la Plaine, 17 1050 Brussels
Danish: Boulevard de la Plaine, 17 1050 Brussels
English: Dispose of the cap.
Danish: Smid låget ud.
English: Bone Disorder
Danish: Knogleproblemer
English: Sandwich
Danish: BRUN FLASKE
English: Glaucoma, Lacrimal Disorder, Scotoma, Diplopia,
Danish: Glaukom, tåreflåd, synsfeltdefekt, diplopi, fotofobi, hyfæma, mydriasis*
English: Sertraline must be discontinued for at least 7 days before starting treatment with an irreversible MAOI (see section 4.5).
Danish: Tilsvarende bør behandling med en irreversibel MAO-hæmmer tidligst indledes 7 dage efter seponering af sertralin (se pkt.
English: The concentrate for oral solution must always be diluted before use.
Danish: Brugsvejledning Fortynd altid koncentratet inden indtagelse.
English: Withdrawal symptoms seen on discontinuation of sertraline Abrupt discontinuation should be avoided.
Danish: Symptomer ved seponering af sertralin
English: To provide the relevant non-clinical data on juvenile animal toxicity available in the public domain, in order to justify why no further data needs to be generated in this field,
Danish: at levere relevante, offentligt tilgængelige, ikke-kliniske toksicitetsdata om dyreunger for at begrunde, hvorfor der ikke behøver at blive udarbejdet yderligere data på dette område at foretage en langsigtet undersøgelse af sikkerhed, der fokuserer på aspekter af vækst, seksuel modning samt kognitiv og følelsesmæssig udvikling som dokumentation for indikationen for OCD hos pædiatriske patienter på 6-17 år.
English: Ear Pain
Danish: Øre og labyrint
English: Following treatment with a reversible MAO-inhibitor, a shorter withdrawal period than 14 days may be used before initiation of sertraline treatment.
Danish: Sertralin kan anvendes inden for en kortere periode på 14 dage efter seponering af en reversibel MAO-hæmmer.
English: • Serotonin Syndrome.
Danish: • De lider af eller har lidt af serotonergt syndrom.
English: Function, Increased Serum
Danish: Aborme kliniske undersøgelsesresultater, påvirket trombocytfunktion, forhøjet serumkolesterol
English: When co-administering sertraline with lithium, patients should be appropriately monitored.
Danish: Glykæmisk kontrol bør monitoreres omhyggeligt hos patienter, der anvender sertralin.
English: Frequency not Known pyschomotor restlessness (see section 4.4).
Danish: Akatisi og psykomotorisk rastløshed (se pkt.
English: Use in elderly Elderly should be dosed carefully, as elderly may be more at risk for hyponatraemia (see section 4.4).
Danish: Da ældre patienter har en større risiko for udvikling af hyponatriæmi, skal deres dosis overvejes omhyggeligt (se pkt.
English: 50 mg 100 mg film-coated tablets
Danish: Filmovertrukne tabletterOral anvendelse 50 mg
English: Children and adolescents with obsessive compulsive disorder Age 13-17 years: Initially 50 mg once daily.
Danish: 13-17 år: Initialt gives 50 mg 1 gang dagligt.
English: The mixture should be taken immediately after mixing.
Danish: Den fremstillede opløsning skal drikkes med det samme og ikke forberedes i forvejen.
English: BEFORE YOU TAKE ZOLOFT
Danish: Hvis De har taget for meget Zoloft
English: Sertraline tablet can be administered with or without food Sertraline capsule should be administered with food.
Danish: Sertralin tabletter kan tages med eller uden føde.
English: Upper
Danish: Kramper
English: The local reactions disappear completely within approximately 5 weeks after vaccination.
Danish: De lokale reaktioner forsvinder helt inden for ca. 5 uger efter vaccination.
English: The animals return to normal within 1-2 days after the peak temperature is observed.
Danish: Dyrene vender tilbage til normaltilstand inden for 1-2 dage efter, temperaturen har toppet.
English: Moreover, a transient increase in body temperature on the day of vaccination of about 0.2 °C is common.
Danish: Desuden er en forbigående stigning i kropstemperaturen på vaccinationsdagen på ca. 0,2 °C almindeligt forekommende.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse:
English: Homogenous, white to nearly white emulsion after shaking.
Danish: Homogen hvid til næsten hvid emulsion efter omrystning.
English: For intradermal use.
Danish: Til intradermal anvendelse.
English: In individual pigs this temperature may increase up to 2 °C.
Danish: Hos enkelte grise kan temperaturen stige med op til 2 °C.
English: Transient local reactions mostly consisting of hard non-painful swellings of a diameter of up to 2 cm are very common.
Danish: Forbigående lokale reaktioner, som oftest består af hårde, ikke smertefulde hævelser med en diameter på op til 2 cm, er meget almindelige.
English: A biphasic pattern of the local reactions, consisting of an increase and decrease followed by another increase and decrease of the size, is commonly observed.
Danish: Lokale reaktioner, der udviser et bifasisk mønster, idet de består af en stigning og et fald efterfulgt af endnu en stigning og et fald i størrelse, er almindelige.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/015/187/001-004
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/015/187/001-004
English: The excipients (including adjuvants) 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 are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne (inklusiv adjuvanter) som er anført i punkt 6.1 af SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer at MRL-værdier ikke er påkrævet eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: Duration of immunity: 23 weeks after vaccination.
Danish: Immunitetens varighed: 23 uger efter vaccination.
English: Vaccination scheme: Vaccinate once from an age of 3 weeks onwards.
Danish: Vaccinationsprogram: Vaccinér én gang fra en alder på 3 uger og opefter.
English: Sodium chloride Potassium chloride Disodium phosphate dehydrate Potassium dihydrogen phosphate dl-α-tocopheryl acetate Light liquid paraffin Water for injections
Danish: Natriumchlorid Kaliumchlorid Dinatriumphosphatdihydrat Kaliumdihydrogenphosphat DL-alpha-tocopherylacetat Tynd paraffinolie Vand til injektionsvæsker
English: 8.3 mg Antigenic units as determined in the in vitro potency test (antigenic mass assay).
Danish: 8,3 mg Antigen-enheder målt ved in vitro potency test (antigenic mass assay).
English: In addition, to reduce loss of daily weight gain and mortality associated with PCV2 infection.
Danish: Desuden for at reducere fald i daglig tilvækst og dødelighed i forbindelse med PCV2-infektion.
English: Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: Safety and efficacy of Porcilis PCV ID have been demonstrated using the device IDAL.
Danish: Sikkerhed og virkning af Porcilis PCV ID er blevet påvist ved anvendelse af det nålefri apparat IDAL®.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIALS OF 10 AND 20 ML
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Hætteglas med 10 og 20 ml
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD BOX
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE
English: Cardboard box with 1 or 10 glass vials.
Danish: Æske med 1 eller 10 hætteglas af glas.
English: Intradermal administration of 0.2 ml per animal, preferably at the sides of the neck, along the muscles of the back or in the hind leg using a multi-dose needle-free injection device for intradermal application of liquids suitable to deliver a “jet-stream” volume of vaccine (0.2ml ± 10%) through the epidermal layers of the skin.
Danish: Intradermal administration af 0,2 ml pr. dyr helst på siden af halsen, langs musklerne i ryggen eller i bagbenet ved brug af et egnet nålefrit apparat til intradermal flerdosisinjektion beregnet til at levere en ”jet-strøm” volumen af vaccine (0,2 ml+ 10%) igennem det epidermale lag i huden.
English: Porcine circovirus type 2 ORF2 subunit antigen
Danish: Porcint circovirus type 2 ORF2 subunit-antigen
English: The product literature of Porcilis M Hyo ID ONCE should be consulted.
Danish: Specifik information om Porcilis M Hyo ID ONCE bør søges i produktresumeet.
English: Onset of immunity: 2 weeks after vaccination.
Danish: Immunitetens indtræden: 2 uger efter vaccination.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 0.2 ml contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Én dosis på 0,2 ml indeholder:
English: WITHDRAWAL PERIOD(S) Withdrawal period: zero days
Danish: TILBAGEHOLDELSESTID(ER) Tilbageholdelsestid: 0 døgn
English: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Danish: - meget almindelige (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - almindelige (flere end 1, men færre end 10 dyr ud af 100 behandlede dyr) - ikke almindelige (flere end 1, men færre end 10 dyr ud af 1.000 behandlede dyr) - sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - meget sjældne (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: The product stimulates the development of active immunity against porcine circovirus type 2 in pigs.
Danish: Produktet stimulerer udviklingen af aktiv immunitet mod porcint circovirus type 2 hos svin.
English: Even if small amounts have been administered, accidental administration with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit.
Danish: Selv hvis der er tale om små injicerede mængder, kan uforsætlig injektion af produktet medføre kraftige hævelser, der eksempelvis kan resultere i iskæmisk nekrose og endog tab af en finger.
English: In individual pigs the size may increase to 4 cm and redness may be observed.
Danish: Hos enkelte svin kan størrelsen blive op til 4 cm og rødme kan observeres.
English: Pharmacotherapeutic group: immunologicals for Suidae, inactivated viral vaccines for pigs.
Danish: Farmakoterapeutisk gruppe: Immunologika til Suidae, inaktiverede virale vacciner til svin.
English: Cardboard box with 1 or 10 PET vials.
Danish: Æske med 1 eller 10 PET-hætteglas.
English: Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the administration area, especially where there is involvement of finger pulp or tendon.
Danish: Der kræves ØJEBLIKKELIG kirurgisk behandling, og der kan opstå behov for tidlig incision og irrigation af det injicerede område, navnlig når det drejer sig om fingerbløddele eller -sener.
English: STATEMENT OF ACTIVE SUBSTANCES One dose (0.2 ml) contains:
Danish: ANGIVELSE AF AKTIVE STOFFER En dosis (0,2 ml) indeholder:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis PCV ID
Danish: VETERINÆRLÆGEMIDLETS NAVN Porcilis PCV ID
English: Shelf-life after first opening the vial: 8 hours.
Danish: Opbevaringstid efter første anbrud af hætteglasset: 8 timer.
English: Incompatibilities Do not mix with any other veterinary medicinal product.
Danish: Væsentlige uforligeligheder Må ikke blandes med andre lægemidler til dyr.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) PCV2 ORF2 subunit antigen
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) PCV2 ORF2 subunit-antigen
English: Once broached use within 8 hours.
Danish: Anvendes inden 8 timer efter anbrud.
English: In the event that the crust is rubbed off, some small skin damage may be commonly observed.
Danish: I det tilfælde at skorpen gnubbes af, er det almindeligt, at der sker mindre beskadigelser af huden.
English: Interaction with other medicinal products and other forms of interaction Safety and efficacy data are available which demonstrate that this vaccine can be given with Porcilis M Hyo ID ONCE on the same day from 3 weeks of age, either at different sites (e.g. alternate sides of the neck), or at the same site providing that intradermal administration of each vaccine is separated by at least 3 cm.
Danish: Interaktion med andre lægemidler og andre former for interaktion Der foreligger oplysninger om sikkerhed og virkning, som viser, at denne vaccine fra 3-ugers-alderen kan gives samme dag som Porcilis M Hyo ID ONCE enten på forskellige injektionssteder (fx på forskellige sider af halsen), eller på samme sted såfremt den intradermale administration af hver vaccine sker med mindst 3 cm mellemrum.
English: Safety and efficacy data are available which demonstrate that this vaccine can be given with Porcilis M Hyo ID ONCE on the same day from 3 weeks of age, either at different sites (e.g. alternate sides of the neck), or at the same site providing that intradermal administration of each vaccine is separated by at least 3 cm.
Danish: Der foreligger oplysninger om sikkerhed og virkning, som viser, at denne vaccine fra 3-ugers-alderen kan gives samme dag som Porcilis M Hyo ID ONCE enten på forskellige injektionssteder (fx på forskellige sider af halsen), eller på samme sted såfremt den intradermale administration af hver vaccine sker med mindst 3 cm mellemrum.
English: Pigs (for fattening).
Danish: Dyrearter Svin (til opfedning).
English: PET (polyethylene terephthalate) vial of 20 ml closed with a nitryl-based rubber stopper and sealed with an aluminium cap.
Danish: PET (polyethylenterephthalat) hætteglas med 20 ml lukket med prop af nitrilgummi og forseglet med aluminiumshætte.
English: ROUTE(S) OF ADMINISTRATION Intradermal use
Danish: INDGIVELSESVEJ(E) Intradermal anvendelse
English: 4.2 Indications for use, specifying the target species For the active immunisation of fattening pigs to reduce viraemia, virus load in lungs and lymphoid tissues and virus shedding caused by PCV2 infection.
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Til aktiv immunisering af grise til opfedning for at reducere viræmi, virusmængden i lunger og lymfevæv samt virusudskillelse forårsaget af PCV2-infektion.
English: In the case both vaccines are used on the same day the size of the local reactions may increase up to 6 cm in individual pigs and may last 7 weeks and are very commonly accompanied by redness and crusts.
Danish: Hvis begge vacciner gives samme dag, kan størrelsen af lokale reaktioner blive op til 6 cm hos enkelte grise og vare ved i 7 uger, og det er meget almindeligt, at de er efterfulgt af rødme og skorpedannelse.
English: Glass vial (type I) of 10 ml closed with a nitryl-based rubber stopper and sealed with an aluminium cap.
Danish: Hætteglas af glas (type I) med 10 ml lukket med prop af nitrilgummi og forseglet med aluminiumshætte.
English: For the active immunisation of pigs to reduce viraemia, virus load in lungs and lymphoid tissues and virus shedding caused by PCV2 infection.
Danish: Til aktiv immunisering af svin for at reducere tilstedeværelse af virus i blodet (viræmi), virusmængden i lunger og lymfevæv samt virusudskillelse forårsaget af PCV2-infektion.
English: OTHER INFORMATION The vaccine stimulates active immunity against porcine circovirus type 2
Danish: Vaccinen stimulerer udviklingen af aktiv immunitet mod porcint circovirus type 2.
English: Adjuvants: dl-α-tocopheryl acetate
Danish: Adjuvanser: DL-alpha-tocopherylacetat
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Each dose of 0.2 ml contains:
Danish: ANGIVELSE AF DET AKTIVE STOF OG ANDRE INDHOLDSSTOFFER Én dosis på 0,2 ml indeholder:
English: ADVICE ON CORRECT ADMINISTRATION Before use allow the vaccine to reach room temperature.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Vaccinen skal have opnået stuetemperatur, før den anvendes.
English: dl-α-tocopheryl acetate
Danish: DL-alpha-tocopherylacetat
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intradermal use
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Til intradermal anvendelse
English: Special precautions for use in animals
Danish: Særlige forholdsregler vedrørende brug til dyr Ikke relevant
English: SPECIAL WARNING(S) Special precautions for use in animals Not applicable.
Danish: 4.5 Særlige forsigtighedsregler vedrørende brugen Særlige forsigtighedsregler vedrørende brug til dyr Ikke relevant.
English: Shelf-life of the veterinary medical product as packaged for sale: 2 years.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 2 år Opbevaringstid efter første anbrud af hætteglasset: 8 timer
English: PHARMACEUTICAL FORM Emulsion for injection.
Danish: Injektionsvæske, emulsion.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis PCV ID emulsion for injection for pigs
Danish: VETERINÆRLÆGEMIDLETS NAVN Porcilis PCV ID injektionsvæske, emulsion, til svin
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V.5831 AN Boxmeer
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Intervet International B.V.
English: Before use allow the vaccine to reach room temperature.
Danish: Vaccinen skal have opnået stuetemperatur, før den anvendes.
English: Light liquid paraffin
Danish: Tynd paraffinolie
English: PACKAGE LEAFLET: Porcilis PCV ID emulsion for injection for pigs
Danish: INDLÆGSSEDDEL Porcilis PCV ID injektionsvæske, emulsion, til svin
English: WITHDRAWAL PERIOD(S) Zero days.
Danish: 10. TILBAGEHOLDELSESTID 0 døgn.
English: TARGET SPECIES Pigs (for fattening).
Danish: DYREARTER Grise til opfedning.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED DD/MM/YYYY
Danish: DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN
English: Special warnings for each target species:
Danish: Særlige advarsler for hver dyreart: Kun raske dyr må vaccineres.
English: EXPIRY DATE EXP
Danish: Intervet International B.V.
English: International non-proprietary name (INN): repaglinide
Danish: Internationalt fællesnavn (INN): repaglinid
English: It is used together with diet and exercise.
Danish: Det anvendes sammen diæt og motion.
English: It is available as tablets containing 0.5 mg, 1 mg and 2 mg of the active substance repaglinide.
Danish: Det fås som tabletter, der indeholder 0,5 mg, 1 mg og 2 mg af det aktive stof repaglinid.
English: The company presented information on 2 clinical studies, involving 498 patients with type 2 diabetes.
Danish: Virksomheden fremsendte oplysninger om 2 kliniske undersøgelser, der omfattede 498 patienter med type 2-diabetes.
English: The CHMP may take 90 days or more to adopt an opinion after it has received an application for a change to a marketing authorisation.
Danish: Det tager CHMP 90 dage eller længere at vedtage en udtalelse, efter at det har modtaget en ansøgning om ændring af en markedsføringstilladelse.
English: Following the CHMP's opinion, it usually takes around 6 weeks for the European Commission to update the licence.
Danish: Efter at CHMP har afgivet sin udtalelse, er EuropaKommissionen sædvanligvis ca. seks uger om at ajourføre tilladelsen.
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Danish: Skrivelsen fra virksomheden, hvori EMEA underrettes om tilbagetrækning af ansøgningen, kan ses her.
English: Ref. EMEA/405238/2006
Danish: London, den 18. oktober 2006 Ref. EMEA/405238/2006
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Danish: Da CHMP havde vurderet virksomhedens svar på en liste med spørgsmål, var der stadig nogle uafklarende spørgsmål.
English: HbA1c gives an indication of how well the blood glucose is controlled.
Danish: HbA1c giver en indikation af, hvor godt blodglykosen reguleres.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE APPLICATION FOR A CHANGE TO THE MARKETING AUTHORISATION for NOVONORM/PRANDIN
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNINGEN AF ANSØGNINGEN OM ÆNDRING AF MARKEDSFØRINGSTILLADELSEN for NOVONORM/PRANDIN
English: There are no consequences for NovoNorm/Prandin's use in the indications for which it is already authorised, where the known benefit and risk remain unchanged.©EMEA 2006
Danish: Tilbagetrækningen har ingen konsekvenser for anvendelsen af NovoNorm/Prandin til de indikationer, det allerede er godkendt til, og hvor de kendte fordele og risici forbliver uændrede.©EMEA 2006
English: NovoNorm/Prandin is an antidiabetic medicine.
Danish: NovoNorm/Prandin er et antidiabetisk lægemiddel.
English: What were the concerns of the CHMP at the time of the withdrawal?
Danish: Hvilke betænkeligheder havde CHMP på tidspunktet for tilbagetrækningen?
English: The studies measured the level of a substance in the blood (glycosylated haemoglobin, HbA1c) after 24 weeks of treatment.
Danish: I undersøgelserne var det niveauet for et stof i blodet (glykosyleret hæmoglobin, HbA1c), der blev målt efter 24 ugers behandling.
English: Consequently, they could not be regarded as having failed treatment with thiazolidinediones.
Danish: De kunne følgelig ikke betragtes som patienter, der ikke havde haft effekt af behandling med thiazolidindioner.
English: Both studies included patients whose blood sugar levels were not controlled satisfactorily with a sulphonylurea or metformin (other antidiabetic medicines).
Danish: Begge undersøgelser omfattede patienter, hvis blodsukkerniveauer ikke var under tilfredsstillende kontrol med et sulfonylurinstof eller med metformin (andre antidiabetiske lægemidler).