FrancophonIA/ELRC3.0 huggingface dataset:
English: Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Danish: Olanzapins potentielle indvirken på andre lægemidler Olanzapin kan antagonisere effekten af direkte og indirekte dopamin agonister.
English: Neuroleptic malignant syndrome (see section 4.4)12
Danish: Malignt neuroleptikasyndrom (se pkt.
English: How to take Olanzapine Apotex
Danish: Sådan skal du tage Olanzapin Apotex
English: • Olanzapine Apotex 7.5 mg are white, round biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘7.5' on the other side.
Danish: • Olanzapin Apotex 7,5 mg er runde, hvide, bikonvekse filmovertrukne tabletter præget med "APO" på den ene side samt "OLA" over "7.5" på den anden side.
English: INFORMATION IN BRAILLE Olanzapine Apotex 7.5 mg film-coated tablet
Danish: INFORMATION I BRAILLESKRIFT Olanzapin Apotex 7,5 mg filmovertrukne tabletter
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 7.5 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Olanzapin Apotex 7,5 mg filmovertrukne tabletter
English: 28 orodispersible tablets 56 orodispersible tablets
Danish: 56 filmovertrukne tabletter
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2.5 mg olanzapine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 2,5 mg olanzapin
English: • Each Olanzapine Apotex 10 mg film-coated tablet contains 10 mg olanzapine.
Danish: • Hver Olanzapin Apotex 10 mg filmovertrukken tablet indeholder 10 mg olanzapin.
English: • Olanzapine Apotex 20 mg orodispersible tablets are yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘20' on the other side.
Danish: • Olanzapin Apotex 20 mg smeltetabletter er runde, gule, flade tabletter med radial kant, præget med "APO" på den ene side samt "OL" over "20" på den anden side.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/635/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/10/635/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/635/012
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/10/635/012
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg olanzapine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 20 mg olanzapin
English: Consult your doctor if your symptoms return but do not stop taking Olanzapine Apotex unless your doctor tells you to.
Danish: Din læge vil fortælle dig, hvor mange Olanzapin Apotex tabletter, du skal tage og i hvor lang tid, du skal tage dem. Dagsdosis for Olanzapin Apotex er mellem 5 mg og 20 mg. Konsulter din læge, hvis dine symptomer vender tilbage, men stop ikke med at tage Olanzapin Apotex, medmindre din læge siger det.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 7.5 mg olanzapine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 7,5 mg olanzapin.
English: Olanzapine orodispersible tablet is bioequivalent to olanzapine coated tablets, with a similar rate and extent of absorption.
Danish: Olanzepin smeltetablet er bioækvivalent med olanzepin overtrukne tabletter med lignende absorptionshastighed og -grad. Olanzapin smeltetabletter kan anvendes som et alternativ til olanzapin overtrukne tabletter.
English: • Olanzapine Apotex 10 mg are white, round biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘10' on the other side.
Danish: • Olanzapin Apotex 10 mg er runde, hvide, bikonvekse filmovertrukne tabletter præget med "APO" på den ene side samt "OLA" over "10" på den anden side.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 20 mg olanzapine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver smeltetablet indeholder 20 mg olanzapin.
English: • Each Olanzapine Apotex 15 mg orodispersible tablet contains 15 mg olanzapine.
Danish: • Hver Olanzapin Apotex 15 mg smeltetablet indeholder 15 mg olanzapin.
English: White, round, biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘2.5' on the other side.
Danish: Hvide, runde, bikonvekse filmovertrukne tabletter præget med "APO" på den ene side samt "OLA" over "2.5" på den anden side.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 2.5 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Olanzapin Apotex 2,5 mg filmovertrukne tabletter
English: • Olanzapine Apotex 2.5 mg are white, round, biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘2.5' on the other side.
Danish: • Olanzapin Apotex 2,5 mg er runde, hvide, bikonvekse filmovertrukne tabletter præget med "APO" på den ene side samt "OLA" over "2.5" på den anden side.
English: • Each Olanzapine Apotex 10 mg orodispersible tablet contains 10 mg olanzapine.
Danish: • Hver Olanzapin Apotex 10 mg smeltetablet indeholder 10 mg olanzapin.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 10 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Olanzapin Apotex 10 mg filmovertrukne tabletter
English: White, round biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘7.5' on the other side.
Danish: Hvide, runde, bikonvekse filmovertrukne tabletter præget med "APO" på den ene side samt "OLA" over "7.5" på den anden side.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.5 mg olanzapine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 2,5 mg olanzapin.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg olanzapine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 10 mg olanzapin.
English: Investigations Elevated plasma prolactin levels8
Danish: Forhøjede plasmaprolakti n-niveauer8
English: • Each Olanzapine Apotex 5 mg film-coated tablet contains 5 mg olanzapine.
Danish: • Hver Olanzapin Apotex 5 mg filmovertrukken tablet indeholder 5 mg olanzapin.
English: Tlf.
Danish: тел.
English: INFORMATION IN BRAILLE Olanzapine Apotex 10 mg film-coated tablet
Danish: INFORMATION I BRAILLESKRIFT Olanzapin Apotex 10 mg filmovertrukne tabletter
English: In a multinational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p= 0.001) favouring olanzapine (-6.0) versus haloperidol (-3.1).
Danish: Undersøgelsen viste en prospektiv sekundær analyse af ændring i stemningslejeniveauet fra før behandling til endt behandling en statistisk signifikant forbedring (p = 0,001) til fordel for patienter behandlet med olanzapin (-6,0) i forhold til patienter behandlet med haloperidol (-3,1).
English: Amenorrhea Breast enlargement Galactorrhea in females Gynaecomastia/breast enlargement in males
Danish: Brystforstørrelse Galaktorré hos kvinder Gynækomasti/brystforstørrelse hos mænd
English: • Olanzapine Apotex 5 mg and 10 mg orodispersible tablets are available in blisters packs of 28 , 56
Danish: • Olanzapin Apotex 5 mg og 10 mg smeltetabletter fås i blisterpakninger med 28, 56 og 98 tabletter.
English: Yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘20' on the other side.
Danish: Runde, gule, flade tabletter med radial kant præget med "APO" på den ene side samt "OL" over "20" på den anden side.
English: • Olanzapine Apotex 5 mg are white, round biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘5' on the other side.
Danish: • Olanzapin Apotex 5 mg er runde, hvide, bikonvekse filmovertrukne tabletter præget med "APO" på den ene side samt "OLA" over "5" på den anden side.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 2.5 mg film-coated tablets olanzapine
Danish: Olanzapin Apotex 2,5 mg filmovertrukne tabletter olanzapin
English: • Olanzapine Apotex 10 mg orodispersible tablets are yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘10' on the other side.
Danish: • Olanzapin Apotex 10 mg smeltetabletter er runde, gule, flade tabletter med radial kant, præget med "APO" på den ene side samt "OL" over "10" på den anden side.
English: • Olanzapine Apotex 5 mg orodispersible tablets are yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘5' on the other side.
Danish: • Olanzapin Apotex 5 mg smeltetabletter er runde, gule, flade tabletter med radial kant, præget med "APO" på den ene side samt "OL" over "5" på den anden side.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 5 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Olanzapin Apotex 5 mg filmovertrukne tabletter
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg olanzapine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 10 mg olanzapin
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg olanzapine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 15 mg olanzapin
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg olanzapine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 5 mg olanzapin.
English: INFORMATION IN BRAILLE Olanzapine Apotex 20 mg orodispersible tablet
Danish: INFORMATION I BRAILLESKRIFT Olanzapin Apotex 20 mg smeltetabletter
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg olanzapine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 5 mg olanzapin
English: 14 Observed for fasting normal levels at baseline (< 1.016 mmol/l) which increased to high
Danish: 5 Observeret for fastende normalt niveau ved baseline (< 1,69 mmol/l), der blev øget til højt niveau
English: In a multinational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p= 0.001) favouring olanzapine (-6.0) versus haloperidol
Danish: Undersøgelsen omfattede 1.481 patienter med varierende grad af hertil forbundne depressive symptomer (middelværdi før behandling lig 16,6 ved Montgomery-Asberg Depression Rating Scale).
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 20 mg orodispersible tablets
Danish: LÆGEMIDLETS NAVN Olanzapin Apotex 20 mg smeltetabletter
English: INFORMATION IN BRAILLE Olanzapine Apotex 5 mg film-coated tablet
Danish: INFORMATION I BRAILLESKRIFT Olanzapin Apotex 5 mg filmovertrukne tabletter
English: • Each Olanzapine Apotex 5 mg orodispersible tablet contains 5 mg olanzapine.
Danish: • Hver Olanzapin Apotex 5 mg smeltetablet indeholder 5 mg olanzapin.
English: White, round biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘10' on the other side.
Danish: Hvide, runde, bikonvekse filmovertrukne tabletter præget med "APO" på den ene side samt "OLA" over "10" på den anden side.
English: Drug withdrawal syndrome neonatal (see section 4.6)
Danish: Abstinenssy ndrom hos nyfødte (se pkt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 10 mg olanzapine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver smeltetablet indeholder 10 mg olanzapin.
English: Maize starch
Danish: Mave-tarm-kanalen
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 15 mg olanzapine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver smeltetablet indeholder 15 mg olanzapin.
English: Musculoskeletal and connective tissue disorders Arthralgia
Danish: Knogler, led, muskler og bindevæv Artralgi
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 10 mg orodispersible tablets
Danish: LÆGEMIDLETS NAVN Olanzapin Apotex 10 mg smeltetabletter
English: Yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘5' on the other side.
Danish: Runde, gule, flade tabletter med radial kant præget med "APO" på den ene side samt "OL" over "5" på den anden side.
English: INFORMATION IN BRAILLE Olanzapine Apotex 15 mg orodispersible tablet
Danish: INFORMATION I BRAILLESKRIFT Olanzapin Apotex 15 mg smeltetabletter
English: • Olanzapine Apotex 15 mg orodispersible tablets are yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘15' on the other side
Danish: • Olanzapin Apotex 15 mg smeltetabletter er runde, gule, flade tabletter med radial kant, præget med "APO" på den ene side samt "OL" over "15" på den anden side.
English: INFORMATION IN BRAILLE Olanzapine Apotex 10 mg orodispersible tablet
Danish: INFORMATION I BRAILLESKRIFT Olanzapin Apotex 10 mg smeltetabletter
English: White, round biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘5' on the other side.
Danish: Hvide, runde, bikonvekse filmovertrukne tabletter præget med "APO" på den ene side samt "OLA" over "5" på den anden side.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 15 mg orodispersible tablets
Danish: LÆGEMIDLETS NAVN Olanzapin Apotex 15 mg smeltetabletter
English: Yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘10' on the other side.
Danish: Runde, gule, flade tabletter med radial kant præget med "APO" på den ene side samt "OL" over "10" på den anden side.
English: Yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘15' on the other side.
Danish: Runde, gule, flade tabletter med radial kant præget med "APO" på den ene side samt "OL" over "15" på den anden side.
English: Parkinsonism6
Danish: Akatisi6
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 5 mg orodispersible tablets
Danish: LÆGEMIDLETS NAVN Olanzapin Apotex 5 mg smeltetabletter
English: INFORMATION IN BRAILLE Olanzapine Apotex 5 mg orodispersible tablet
Danish: INFORMATION I BRAILLESKRIFT Olanzapin Apotex 5 mg smeltetabletter
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 5 mg olanzapine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver smeltetablet indeholder 5 mg olanzapin.
English: Abdominal distension
Danish: Udspilet abdomen
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 20 mg orodispersible tablets olanzapine
Danish: Olanzapin Apotex 20 mg smeltetabletter olanzapin
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/635/008-009 EU/1/10/635/017 BATCH NUMBER
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/10/635/008-009
English: EU/1/10/635/010-011 EU/1/10/635/018
Danish: EU/1/10/635/018
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 10 mg orodispersible tablets olanzapine
Danish: Olanzapin Apotex 10 mg filmovertrukne tabletter olanzapin
English: 6.5 Nature and contents of container Aluminium/aluminium blister strips in cartons of 28 orodispersible tablets per carton Not all pack sizes may be marketed.
Danish: 6.5 Emballagetype og pakningsstørrelser Aluminium/aluminium blisterkort i kartoner á 28 smeltetabletter pr. karton.
English: Elevated cholesterol levels
Danish: Forhøjede kolesterolniveauer2,3
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 5 mg orodispersible tablets olanzapine
Danish: Olanzapin Apotex 5 mg filmovertrukne tabletter olanzapin
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 15 mg orodispersible tablets olanzapine
Danish: Olanzapin Apotex 15 mg smeltetabletter olanzapin
English: Both antibiotics were given for up to two weeks.
Danish: Begge antibiotika blev givet i op til to uger.
English: What is Tygacil?
Danish: Hvad er Tygacil?
English: International non-proprietary name (INN): tigecycline
Danish: Internationalt fællesnavn (INN): tigecyclin
English: What was Tygacil expected to be used for?
Danish: Hvad forventedes Tygacil anvendt til?
English: By blocking the production of new proteins, the bacteria cannot multiply and they eventually die.
Danish: Når produktionen af nye proteiner blokeres, kan bakterierne ikke formere sig og vil til sidst dø.
English: The effects of Tygacil were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Tygacil blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: It contains the active substance tigecycline.
Danish: Det indeholder det aktive stof tigecyclin.
English: The application was at day 150 when the company withdrew.
Danish: Ansøgningsproceduren var ved dag 150, da virksomheden trak sin ansøgning tilbage.
English: The CHMP also had concerns over the measures that the company intended to put in place to minimise the risks associated with the medicine.
Danish: CHMP havde også betænkeligheder med hensyn til de foranstaltninger, virksomheden havde til hensigt at træffe for at reducere de risici, der var forbundet med lægemidlet.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE APPLICATION FOR A CHANGE TO THE MARKETING AUTHORISATION for TYGACIL
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNINGEN AF ANSØGNINGEN OM ÆNDRING AF MARKEDSFØRINGSTILLADELSEN for TYGACIL
English: Following the CHMP's opinion, it usually takes around six weeks for the European Commission to update the licence.
Danish: Efter at CHMP har afgivet sin udtalelse, er Europa-Kommissionen sædvanligvis ca. seks uger om at ajourføre tilladelsen.
English: Both studies compared Tygacil with levofloxacin (another antibiotic).
Danish: Begge undersøgelser sammenlignede Tygacil med levofloxacin (et andet antibiotikum).
English: On 22 April 2008, Wyeth Europa Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Tygacil, in the treatment of community-acquired pneumonia.
Danish: Den 22. april 2008 meddelte Wyeth Europa Limited officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at firmaet ønsker at tilbagetrække sin ansøgning om en ny indikation for Tygacil til behandling af ikke-hospitalserhvervet lungebetændelse.
English: There are no consequences on the use of Tygacil in the authorised indications, for which the balance of benefits and risks remains unchanged.
Danish: Det får ingen konsekvenser at anvende Tygacil til den godkendte indikation, for hvilken benefit/riskforholdet forbliver uændret.
English: The main measure of effectiveness was the number of patients who were cured of their pneumonia within the three weeks after their last dose of antibiotic.
Danish: Den vigtigste målestok for virkningen var antallet af patienter, der blev helbredt for lungebetændelse inden for tre uger efter den sidste dosis antibiotika.
English: The CHMP normally takes up to 90 days to adopt an opinion after it has received an application for a change to a marketing authorisation.
Danish: Det tager normalt CHMP op til 90 dage at vedtage en udtalelse, efter at udvalget har modtaget en ansøgning om ændring af en markedsføringstilladelse.
English: What were the major concerns that led the CHMP to recommend the refusal of the change to the marketing authorisation?
Danish: Hvori bestod de vigtigste betænkeligheder, som førte til, at CHMP anbefalede at give afslag på ansøgningen om ændring af markedsføringstilladelsen?
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Tygacil had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Danish: På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ved Tygacil ikke var blevet tilstrækkeligt påvist, og at de eventuelle fordele ikke opvejede de påviste risici.
English: How is Tygacil expected to work?
Danish: Hvordan forventes Tygacil at virke?
English: Tigecycline works by blocking the bacteria's ribosomes, the parts of the bacterial cells where new proteins are made.
Danish: Tigecyclin virker ved at blokere bakteriernes ribosomer, dvs. de dele af bakteriecellen, hvor der produceres nye proteiner.
English: The CHMP was concerned that the patients included in the main studies may not have needed hospital treatment using medicines given intravenously (into a vein), so they did not match the types of patients for whom the medicine was intended.
Danish: CHMP var betænkelig ved, at de patienter, der var omfattet af hovedundersøgelsen, måske ikke havde behøvet hospitalsbehandling med anvendelse af medicin beregnet til intravenøs indgivelse (i en vene), så de modsvarede ikke de patienter, lægemidlet var beregnet til.
English: The active substance in Tygacil, tigecycline, belongs to the group of antibiotics called ‘glycylcyclines', which are similar to tetracycline.
Danish: Det aktive stof i Tygacil er tigecyclin, som tilhører en gruppe antibiotika, der kaldes glycylcycliner og som ligner tetracyclin.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Tygacil could not have been approved for the treatment of community-acquired pneumonia.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål havde CHMP på tidspunktet for tilbagetrækningen af ansøgningen visse betænkeligheder og var af den foreløbige opfattelse, at Tygacil ikke kunne være blevet godkendt til behandling af ikkehospitalserhvervet lungebetændelse.
English: What are the consequences of the refusal for patients in clinical trials using Tygacil?
Danish: Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser med Tygacil?
English: The Committee was also concerned over the number of deaths in patients receiving Tygacil with more serious infections, especially in the study of patients who had caught pneumonia in hospital.
Danish: Udvalget var også bekymret over antallet af dødsfald hos patienter, der fik Tygacil, og som havde alvorligere infektioner, navnlig de undersøgte patienter, som havde fået lungebetændelse på hospitalet.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Tygacil.
Danish: Firmaet har til CHMP oplyst, at afslaget ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Tygacil.
English: What is happening for Tygacil for treatment of complicated skin and soft tissue infections and complicated infections in the abdomen?
Danish: Hvad sker der med Tygacil til behandling af komplicerede hud og bløddelsinfektioner og komplicerede infektioner i maveregionen (abdomen)?
English: Tygacil is a powder that is made up into a solution for infusion (drip into a vein).
Danish: Tygacil er et pulver, der blandes til en opløsning til infusion (dråbetilførsel i en vene).
English: Community-acquired pneumonia is usually caused by infection with bacteria.
Danish: Ikke-hospitalserhvervet lungebetændelse skyldes normalt infektion med bakterier.
English: The effectiveness of Tygacil was tested in two main studies involving a total of 846 adults who needed treatment in hospital for community-acquired pneumonia.
Danish: Virkningen af Tygacil blev undersøgt i to hovedundersøgelser af i alt 846 voksne med ikkehospitalserhvervet lungebetændelse, som krævede hospitalsbehandling.
English: Tygacil is an antibiotic that is already used to treat adults with complicated infections of the skin or soft tissue (the tissue below the skin) and complicated infections in the abdomen.
Danish: Tygacil er et antibiotikum, som allerede anvendes til behandling af voksne med komplicerede infektioner i hud eller bløddele (vævet under huden) og i maveregionen (abdomen).
English: This raised doubts over whether Tygacil would be sufficiently effective in the treatment of patients with severe community-acquired pneumonia.
Danish: Dette gav anledning til alvorlige betænkeligheder med hensyn til, om Tygacil ville være tilstrækkelig effektivt til behandling af patienter med alvorlig ikke-hospitalserhvervet lungebetændelse.
English: This is a serious type of lung infection that is caught outside of hospital.
Danish: Dette er en alvorlig form for lungebetændelse, som ikke er erhvervet i forbindelse med hospitalsindlæggelse.