FrancophonIA/ELRC3.0 huggingface dataset:
English: This is not an approved indication for SGLT2 inhibitors containing products, nevertheless the PRAC considered that healthcare professionals should be warned of this risk and reminded that patients with T1DM should not be treated with SGLT2 inhibitors.
Danish: Type 1-diabetes er ikke en godkendt indikation for lægemidler, der indeholder SGLT2hæmmere, men ikke desto mindre finder PRAC, at sundhedspersoner skal advares om denne risiko, og at de skal mindes om, at type 1-diabetikere ikke bør behandles med SGLT2hæmmere.
English: In a study that reported population-based rates of DKA, the incidence rate of DKA in T2DM patients, requiring hospital admission, was reported to be 0.5 per 1,000 patient-years.
Danish: I en undersøgelse, hvor der blev foretaget populationsbaseret registrering af frekvensen af diabetisk ketoacidose, var incidensen af indlæggelseskrævende diabetisk ketoacidose hos type 2-diabetikere 0,5 tilfælde pr. 1 000 patientår.
English: The PRAC considered that these should be included in the product information and physicians advised to consider the patient's history before initiating treatment with SGLT2 inhibitors.
Danish: PRAC mener, at disse faktorer bør inkluderes i produktinformationen, således at lægerne bliver rådet til at tage højde for patientens journal før iværksættelse af behandling med SGLT2-hæmmere.
English: Moreover, risk factors reported in the cases are consistent with those previously reported in the literature and the risks factors inherent to the patient population (e.g. patients with low beta-cell function reserve, restricted food intake or severe dehydration, sudden reduction in insulin dose and increased insulin requirements due to acute medical illness, surgery or alcohol abuse).
Danish: som kendetegner patientpopulationen (f.eks. patienter med en lav betacellefunktion, begrænset fødeindtag eller svær dehydrering, pludselig nedsættelse af insulindosen og øget insulinbehov på grund af akut sygdom, kirurgi eller alkoholmisbrug).
English: Non-clinical mechanistic studies are already planned or on-going for dapagliflozin- and empagliflozin-containing products; such study is also required to be undertaken by the MAH of canagliflozin-containing products.
Danish: Prækliniske mekanistiske undersøgelser er allerede planlagt eller i gang for lægemidler, der indeholder dapagliflozin og empagliflozin; indehaveren af markedsføringstilladelsen for lægemidler, der indeholder canagliflozin, er også blevet pålagt at gennemføre en sådan undersøgelse.
English: Several postauthorisation safety studies are planned or ongoing in order to compare the incidence of DKA in SGLT2 inhibitors and other anti-hyperglycaemic agents.
Danish: Adskillige sikkerhedsmæssige studier efter markedsføringen er enten planlagt eller i gang med henblik på at sammenligne incidensen af diabetisk ketoacidose ved behandling med SGLT2-hæmmere og andre antihyperglykæmiske midler.
English: The PRAC, as a consequence, recommended the variation to the terms of the marketing authorisations for SGLT2 inhibitors-containing products.
Danish: PRAC anbefaler derfor en ændring af betingelserne for markedsføringstilladelserne for lægemidler, der indeholder SGLT2-hæmmere.
English: Limited data from clinical trials suggest that DKA occurs with common frequency in T1DM patients.
Danish: Begrænsede data fra kliniske forsøg tyder på, at diabetisk ketoacidose er en almindelig bivirkning hos type 1-diabetikere.
English: Further, restarting SGLT2 inhibitor medication in patients with previous DKA while on treatment is not recommended unless another clear precipitating factor is identified and resolved.
Danish: Genopstart af SGLT2-hæmmer-behandling hos patienter, der har fået diabetisk ketoacidose under behandlingen, anbefales ikke, medmindre en anden medvirkende faktor tydeligt identificeres og fortager sig.
English: In addition, the MAHs are required to clarify the mechanism behind SGLT2 inhibitors-induced DKA.
Danish: Derudover er indehaverne af markedsføringstilladelserne blevet pålagt at klarlægge mekanismen bag SGLT2-hæmmer-induceret diabetisk ketoacidose.
English: DKA typically occurs in T1DM patients with high blood glucose concentrations.
Danish: Diabetisk ketoacidose opstår typisk hos type 1-diabetikere med høje blodsukkerkoncentrationer.
English: Importantly, DKA with atypical presentation may occur in association with SGLT2 inhibitors.
Danish: Det er vigtigt at understrege, at diabetisk ketoacidose med atypisk præsentation kan forekomme i forbindelse med SGLT2-hæmmere.
English: • The PRAC reviewed the totality of the data submitted by the marketing authorisation holders in relation to the risk of DKA in association with SGLT2 inhibitors-containing products and in support of the efficacy of SGLT2 inhibitors-containing products.
Danish: • PRAC har gennemgået samtlige data fra indehaverne af markedsføringstilladelserne vedrørende risikoen for diabetisk ketoacidose ved behandling med lægemidler, der indeholder SGLT2-hæmmere og vedrørende virkningen af disse.
English: • The PRAC further concluded that a risk of DKA, including with atypical presentation, is also associated with the use of SGLT2 inhibitors in patients with T1DM.
Danish: • PRAC konkluderer også, at der er en risiko for diabetisk ketoacidose, herunder med atypisk præsentation, forbundet med brugen af SGLT2-hæmmere hos type 1-diabetikere.
English: One hundred and two serious and sometimes life-threatening cases of DKA suggestive of a causal association were identified in T2DM patients for the three active substances, raising thus a safety signal.
Danish: Hos type 2-diabetikere blev der for de tre aktive stoffer fundet 102 alvorlige tilfælde af diabetisk ketoacidose, hvoraf nogle var livstruende, hvilket kan tyde på en årsagssammenhæng, og det rejser en sikkerhedsmæssig bekymring.
English: The PRAC considered that this information should be included in the PI and, considering that the safety and efficacy of SGLT2 inhibitors have not been established in patients with T1DM, healthcare professionals should be reminded that these should not be used in this indication.
Danish: PRAC er af den opfattelse, at disse oplysninger bør fremgå af produktinformationen, og at sundhedspersoner skal mindes om, at SGLT2-hæmmere ikke må anvendes til type 1-diabetikere, da disse stoffers sikkerhed og virkning ikke er klarlagt hos denne population.
English: • The PRAC concluded that a small excess risk of DKA associated with SGLT2 inhibitors treatment in patients with T2DM could not be excluded.
Danish: • PRAC's konklusion er, at det ikke kan udelukkes, at type 2-diabetikere i behandling med SGLT2-hæmmere har en lille forhøjet risiko for diabetisk ketoacidose.
English: The PRAC further concluded that a risk of DKA, including with atypical presentation, is also associated with SGLT2 inhibitors treatment in patients with T1DM.
Danish: PRAC konkluderer endvidere, at der også er risiko for diabetisk ketoacidose, herunder med atypisk præsentation, ved SGLT2-hæmmer-behandling af type 1-diabetikere.
English: No subset of the population at increased risk could be identified from the analysis of cases reported in clinical studies.
Danish: I analysen af de tilfælde, der er rapporteret i kliniske undersøgelser, er der ikke identificeret nogen undergruppe af populationen med forhøjet risiko.
English: In addition, a DUS, ideally based on secondary observational data via existing databases, is also required to be undertaken by the MAH of canagliflozin-containing products.
Danish: Desuden er indehaveren af markedsføringstilladelserne blevet pålagt at gennemføre en undersøgelse af anvendelse af lægemidler, der indeholder canagliflozin, ideelt set baseret på sekundære observationsdata via eksisterende databaser.
English: However, cases reported with SLGT2 inhibitors occurred in patients with T2DM as well as T1DM.
Danish: Der er imidlertid rapporteret om diabetisk ketoacidose ved SGLT2hæmmer-behandling af såvel type 2-diabetikere som type 1-diabetikere.
English: therefore the populations may not share the same baseline risk of DKA and careful consideration should be given to any direct incidence comparison.
Danish: Desuden blev der anvendt forskellige inklusions- og eksklusionskriterier i de kliniske udviklingsprogrammer for produkterne, og derfor deler populationerne ikke nødvendigvis den samme baseline-risiko for diabetisk ketoacidose; der skal følgelig udvises forsigtighed ved direkte sammenligning af incidensen.
English: Some of these effects were severe.
Danish: Nogle af disse bivirkninger var alvorlige.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Jevtana on 17 March 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Jevtana den 17. marts 2011.
English: The full EPAR for Jevtana can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Jevtana 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 Jevtana.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Jevtana.
English: With their skeleton still in place, the cells cannot divide and they eventually die.
Danish: Når skelettet stadig er der, kan cellerne ikke dele sig, og de dør efterhånden.
English: It is given once every three weeks as an infusion lasting one hour, at a dose of 25 mg per square metre body surface area (calculated using the patient's weight and height).
Danish: Det gives én gang hver tredje uge som en infusion, der varer en time, med en dosis på 25 mg pr. kvadratmeter kropsoverflade (beregnet ved hjælp af patientens vægt og højde).
English: Other information about Jevtana
Danish: Andre oplysninger om Jevtana
English: The doses should also be reduced in patients with mildly or moderately reduced liver function.
Danish: Dosen bør også nedsættes for patienter med let eller moderat nedsat leverfunktion.
English: What measures are being taken to ensure the safe and effective use of Jevtana?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Jevtana?
English: Both medicines were given in combination with prednisone or prednisolone.
Danish: Begge lægemidler blev givet i kombination med prednison eller prednisolon.
English: It must not be given to patients whose blood neutrophil count is below 1,500/mm3, who have severely reduced liver function or who recently received or are about to receive a yellow fever vaccine.
Danish: Det må ikke gives til patienter med et neutrofiltal på under 1 500/mm3, som har svært nedsat leverfunktion eller som lige er blevet eller snart vil blive vaccineret mod gul feber.
English: The average overall survival for patients treated with Jevtana was 15.1 months compared with 12.7 months for patients given mitoxantrone.
Danish: Den gennemsnitlige samlede overlevelse for patienter behandlet med Jevtana var 15,1 måneder sammenlignet med 12,7 måneder for patienter, der fik mitoxantron.
English: It is given in combination with prednisone or prednisolone, taken daily throughout treatment.
Danish: Det gives i kombination med prednison eller prednisolon, som tages dagligt i løbet af hele behandlingen.
English: Cabazitaxel works by blocking the ability of cancer cells to break down their internal ‘skeleton' that allows them to divide and multiply.
Danish: Cabazitaxel virker ved at hæmme kræftcellernes evne til at nedbryde deres interne "skelet", som gør det muligt for dem at dele sig og formere sig.
English: Why has Jevtana been approved?
Danish: Hvorfor blev Jevtana godkendt?
English: What is Jevtana and what is it used for?
Danish: Hvad er Jevtana, og hvad anvendes det til?
English: The most common side effects with Jevtana (seen in more than 1 patient in 10) include anaemia (low red blood cell counts), leucopenia (low white blood cell counts), neutropenia (low counts of neutrophils, a type of white blood cell), thrombocytopenia (low blood platelet counts) and diarrhoea.
Danish: De hyppigste bivirkninger ved Jevtana (som optræder hos flere end 1 ud af 10 patienter) er anæmi (lavt antal røde blodlegemer), leukopeni (lavt antal hvide blodlegemer), neutropeni (lavt antal neutrofiler, som er en type hvide blodlegemer), trombocytopeni (lavt antal blodplader) og diarré.
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 Jevtana.
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 Jevtana skal anvendes.
English: For more information about treatment with Jevtana, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Jevtana, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What are the risks associated with Jevtana?
Danish: Hvilke risici er der forbundet med Jevtana?
English: Jevtana also affects non-cancer cells, such as blood and nerve cells, which can cause side effects.
Danish: Jevtana påvirker også andre celler end kræftceller, f.eks. blod- og nerveceller, hvilket kan medføre bivirkninger.
English: It decided that Jevtana's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Jevtana er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Jevtana.
English: Jevtana contains the active substance cabazitaxel.
Danish: Jevtana indeholder det aktive stof cabazitaxel.
English: The active substance in Jevtana, cabazitaxel, belongs to the group of cancer medicines known as ‘taxanes'.
Danish: Det aktive stof i Jevtana, cabazitaxel, tilhører en gruppe lægemidler mod kræft, der er kendt som "taxaner".
English: Jevtana must not be used in people who are hypersensitive (allergic) to cabazitaxel, to any other taxane, or to any of the other ingredients.
Danish: Jevtana må ikke anvendes hos personer, som er overfølsomme (allergiske) over for cabazitaxel, andre taxaner eller andre af indholdsstofferne.
English: Jevtana is used when the cancer has spread to other parts of the body (metastatic) despite treatments to prevent the production of testosterone or after surgical removal of the testes (castration).
Danish: Jevtana anvendes, når kræften har bredt sig til andre dele af kroppen (metastatisk kræft) trods behandlinger til forebyggelse af produktion af testosteron eller efter kirurgisk fjernelse af testiklerne (kastrering).
English: Before receiving Jevtana infusions, patients should first be given medicines to prevent allergic reactions and medicines to prevent vomiting.
Danish: Inden der gives infusioner af Jevtana, skal patienterne have lægemidler, der mindsker risikoen for allergiske reaktioner og forhindrer opkastning.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the ability of Jevtana to prolong overall survival in castration-resistant metastatic prostate cancer patients was clinically important.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) anså Jevtanas evne til at forlænge den samlede overlevelse hos patienter med kastrationsresistent metastatisk prostatakræft for klinisk betydningsfuld.
English: Jevtana is used in combination with prednisone or prednisolone (anti-inflammatory medicines) in patients who have previously been treated with docetaxel (another cancer medicine).
Danish: Jevtana anvendes i kombination med prednison eller prednisolon (antiinflammatoriske lægemidler) hos patienter, der tidligere er blevet behandlet med docetaxel (et andet lægemiddel mod kræft).
English: Jevtana prolonged overall survival (the average length of time the patients lived) in one main study involving 755 men with metastatic castration-resistant prostate cancer who had previously been treated with docetaxel.
Danish: Jevtana forlængede den samlede overlevelse (hvor længe patienterne levede i gennemsnit) i en hovedundersøgelse med 755 mænd med kastrationsresistent metastatisk prostatakræft, som tidligere var blevet behandlet med docetaxel.
English: Jevtana is available as a concentrate and a solvent to be made up into a solution for infusion (drip) into a vein.
Danish: Jevtana fås som et koncentrat og en solvens, der anvendes til at fremstille en væske til infusion (drop) i en vene.
English: The effects of Jevtana were compared with another cancer medicine, mitoxantrone.
Danish: Virkningen af Jevtana blev sammenlignet med virkningen af et andet lægemiddel mod kræft, mitoxantron.
English: Jevtana can only be obtained with a prescription and should only be used in units specialising in chemotherapy (medicines to treat cancer) under the supervision of a doctor experienced in the use of chemotherapy.
Danish: Jevtana udleveres kun efter recept og bør udelukkende anvendes på afdelinger, der er specialiseret i kemoterapi (lægemidler til behandling af kræft), under opsyn af en læge, som har erfaring med brugen af kemoterapi.
English: For the full list of all side effects reported with Jevtana, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Jevtana fremgår af indlægssedlen.
English: This is cancer that affects the prostate gland in men that produces the liquid in semen.
Danish: Det er en kræfttype, der berører prostatakirtlen, som er den kirtel, som producerer sædvæske.
English: Jevtana is a cancer medicine used to treat men with metastatic castration-resistant prostate cancer.
Danish: Jevtana er et kræftlægemiddel til behandling af mænd med kastrationsresistent metastatisk prostatakræft.
English: How is Jevtana used?
Danish: Hvordan anvendes Jevtana?
English: What benefits of Jevtana have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Jevtana?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jevtana have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Jevtana.
English: The dose of Jevtana should be reduced or treatment stopped if the patient has certain side effects.
Danish: Hvis patienten oplever visse bivirkninger, bør behandlingen afbrydes eller dosis nedsættes.
English: How does Jevtana work?
Danish: Hvordan virker Jevtana?
English: O1 Manisa, O Taiwan 3/97 and A Turkey
Danish: O1 Manisa and O Taiwan 3/97 and
English: A22 Iraq and SAT2 Saudi Arabia ≥ 6 PD50*
Danish: A22 Iraq & SAT2 Saudi Arabia ≥ 6 PD50*
English: A22 Iraq, Asai1 Shamir and SAT2 Saudi Arabia ≥ 6 PD50*
Danish: A22 Iraq, Asai1 Shamir & SAT2 Saudi Arabia ≥ 6 PD50*
English: O Taiwan 3/97, A Turkey 14/98 and Asia1 Shamir ≥ 6 PD50*
Danish: O Taiwan 3/97 and A Turkey 14/98 and Asia1 Shamir ≥ 6 PD50*
English: A24 Cruzeiro, A Turkey 14/98 and Asia1 Shamir ≥ 6 PD50*
Danish: A24 Cruzeiro and A Turkey 14/98 and Asia1 Shamir ≥ 6 PD50*
English: A24 Cruzeiro, Asia 1 Shamir and SAT2 Saudi Arabia ≥ 6 PD50*
Danish: A24 Cruzeiro, Asia 1 Shamir & SAT2 Saudi Arabia ≥ 6 PD50*
English: A Turkey 14/98, Asia1 Shamir and SAT2 Saudi Arabia ≥ 6 PD50*
Danish: A Turkey 14/98, Asia1 Shamir & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 Manisa, O1 BFS and A 24 Cruzeiro ≥ 6 PD50*
Danish: O1 Manisa and O1 BFS and A 24 Cruzeiro ≥ 6 PD50*
English: A24 Cruzeiro, A Turkey 14/98 and SAT2 Saudi Arabia ≥ 6 PD50*
Danish: A24 Cruzeiro, A Turkey 14/98 & SAT2 Saudi Arabia ≥ 6 PD50*
English: Asia1 Shamir and SAT2 Saudi Arabia ≥ 6 PD50*
Danish: Asia1 Shamir & SAT2 Saudi Arabia ≥ 6 PD50*
English: A Turkey 14/98 and SAT2 Saudi Arabia ≥ 6 PD50*
Danish: A Turkey 14/98 & SAT2 Saudi Arabia ≥ 6 PD50*
English: O Taiwan 3/97, A Turkey 14/98 and SAT2 Saudi Arabia ≥ 6 PD50*
Danish: O Taiwan 3/97, A Turkey 14/98 & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 Manisa, O1 BFS and O Taiwan 3/97 ≥ 6 PD50*
Danish: O1 Manisa and O1 BFS and O Taiwan 3/97 ≥ 6 PD50*
English: SAT2 Saudi Arabia ≥ 6 PD50*
Danish: Saudi Arabia ≥ 6 PD50*
English: A22 Iraq, A24 Cruzeiro and SAT2 Saudi Arabia ≥ 6 PD50*
Danish: A22 Iraq, A24 Cruzeiro & SAT2 Saudi Arabia ≥ 6 PD50*
English: A24 Cruzeiro and SAT2 Saudi Arabia ≥ 6 PD50*
Danish: A24 Cruzeiro & SAT2 Saudi Arabia ≥ 6 PD50*
English: O Taiwan 3/97, Asia1 Shamir and SAT2 Saudi Arabia ≥ 6 PD50*
Danish: O Taiwan 3/97, Asia1 Shamir & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 Manisa, O1 BFS and A Turkey 14/98 ≥ 6 PD50*
Danish: O1 Manisa and O1 BFS and A Turkey 14/98 ≥ 6 PD50*
English: O1 Manisa, A24 Cruzeiro and SAT2 Saudi Arabia ≥ 6 PD50*
Danish: O1 Manisa, A24 Cruzeiro & SAT2 Saudi Arabia ≥ 6 PD50*
English: O Taiwan 3/97, A24 Cruzeiro and SAT2 Saudi Arabia ≥ 6 PD50*
Danish: O Taiwan 3/97, A24 Cruzeiro & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 BFS, A22 Iraq and SAT2 Saudi Arabia ≥ 6 PD50*
Danish: O1 BFS, A22 Iraq & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 BFS, Asia1 Shamir and SAT2 Saudi Arabia ≥ 6 PD50*
Danish: O1 BFS, Asia1 Shamir & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 Manisa, A22 Iraq and Asia 1 Shamir ≥ 6 PD50*
Danish: O1 Manisa and A22 Iraq and Asia 1 Shamir ≥ 6 PD50*
English: O1 Manisa, Asia1 Shamir and SAT2 Saudi Arabia ≥ 6 PD50*
Danish: O1 Manisa, Asia1 Shamir & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 Manisa and SAT2 Saudi Arabia ≥ 6 PD50*
Danish: O1 Manisa & SAT2 Saudi Arabia ≥ 6 PD50*
English: A24 Cruzeiro and A Turkey 14/98 ≥ 6 PD50*
Danish: Cruzeiro and A Turkey 14/98 ≥ 6 PD50*
English: O1 BFS, O Taiwan 3/97 and A22 Iraq ≥ 6 PD50*
Danish: O1 BFS and O Taiwan 3/97 and A22 Iraq ≥ 6 PD50*
English: O1 BFS, A Turkey 14/98 and SAT2 Saudi Arabia ≥ 6 PD50*
Danish: O1 BFS, A Turkey 14/98 & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 Manisa, O Taiwan 3/97 and A22 Iraq ≥ 6 PD50*
Danish: O1 Manisa and O Taiwan 3/97 and A22 Iraq ≥ 6 PD50*
English: O1 Manisa, A Turkey 14/98 and SAT2 Saudi Arabia ≥ 6 PD50*
Danish: O1 Manisa, A Turkey 14/98 & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 BFS, O Taiwan 3/97 and SAT2 Saudi Arabia ≥ 6 PD50*
Danish: O1 BFS, O Taiwan 3/97 & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 Manisa, O Taiwan 3/97 and SAT2 Saudi Arabia ≥ 6 PD50*
Danish: O1 Manisa, O Taiwan 3/97 & SAT2 Saudi Arabia ≥ 6 PD50*
English: O Taiwan 3/97 and SAT2 Saudi Arabia ≥ 6 PD50*
Danish: O Taiwan 3/97 & SAT2 Saudi Arabia ≥ 6 PD50*
English: O Taiwan 3/97, A22 Iraq and SAT2 Saudi Arabia ≥ 6 PD50*
Danish: O Taiwan 3/97, A22 Iraq & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 BFS and SAT2 Saudi Arabia ≥ 6 PD50*
Danish: O1 BFS & SAT2 Saudi Arabia ≥ 6 PD50*
English: O1 Manisa, O1 BFS and A22 Iraq ≥ 6 PD50*
Danish: O1 Manisa and O1 BFS and A22 Iraq ≥ 6 PD50*
English: O1 BFS, A22 Iraq and Asia1 Shamir ≥ 6 PD50*
Danish: O1 BFS and A22 Iraq and Asia1 Shamir ≥ 6 PD50*
English: O1 Manisa, A22 Iraq and A24 Cruzeiro ≥ 6 PD50*
Danish: O1 Manisa and A22 Iraq and A24 Cruzeiro ≥ 6 PD50*
English: O Taiwan 3/97, A24 Cruzeiro and A Turkey
Danish: A24 Cruzeiro and A Turkey
English: O1 BFS, A22 Iraq and A24 Cruzeiro ≥ 6 PD50*
Danish: O1 BFS and A22 Iraq and A24 Cruzeiro ≥ 6 PD50*
English: O1 Manisa, O1 BFS and Asia1 Shamir ≥ 6 PD50*
Danish: O1 Manisa and O1 BFS and Asia1 Shamir ≥ 6 PD50*
English: A24 Cruzeiro and Asia 1 Shamir ≥ 6 PD50*
Danish: Cruzeiro and Asia1 Shamir ≥ 6 PD50*
English: Date of latest renewal: 18 May 2011
Danish: Dato for seneste fornyelse: 18. maj 2011
English: From 6 weeks to 32 weeks
Danish: Fra 6 uger til 32 uger
English: - has not been gaining weight and growing as expected.
Danish: ikke har taget på og ikke er vokset som forventet.
English: Effectiveness % [95%CI]
Danish: Effektivitet % [95%CI]
English: The results of these analyses are presented in the following tables.
Danish: Resultaterne af disse analyser er præsenteret i nedenstående skema.
English: Statistically significant
Danish: Statistisk signifikant
English: Frequencies are reported as:
Danish: Hyppigheden angives som: