natgillin/translations-raw huggingface dataset:
Denne forøgelse af virkningen omfattede tab af serum HCV ( &lt; 100 kopier/ml ved PCR), forbedring i leverinflammation og normalisering af ALAT, og var opretholdt ved måling 6 måneder efter afsluttet behandling.
This enhancement in efficacy included loss of serum HCV ( &lt; 100 copies/mL by PCR), improvement in hepatic inflammation, and normalisation of ALT, and was sustained when measured 6 months after the end of treatment.
Tilgængelige langtidsdata hos børn i kombinationsbehandling med standardinterferon/ribavirin indikerer også betragtelig højdereduktion ( &gt; 15 percentilreduktion i højdepercentilen i sammenligning med baseline) hos 21 % af børnene (n=20), til trods for at børnene ikke har været behandlet i mere end 5 år.
The longer term data available in children treated with the combination therapy with standard interferon/ribavirin are also indicative of substantial growth retardation ( &gt; 15 percentile decrease in height percentile as compared to baseline) in 21 % of children (n=20) despite being off treatment for more than 5 years.
3 eller alaninaminotransferase/aspartataminotransferase (ALAT/ASAT) stiger til &gt; 5 gange den øvre normalgrænse, skal behandlingen midlertidigt afbrydes, indtil bivirkningen aftager.
3 or alanine aminotransferase/aspartate aminotransferase (ALT/AST) rises to &gt; 5 x upper limit of normal, discontinue treatment temporarily until the adverse event abates.
I alt 107 patienter fik behandling, hvoraf 52 % var kvinder, 89 % var kaukasiske, 67 % havde HCV-genotype 1, og 63 % var &lt; 12 år.
A total of 107 patients received treatment of whom 52 % were female, 89 % Caucasian, 67 % with HCV Genotype 1 and 63 % &lt; 12 years of age.
Det anbefales derfor, at behandlingen af børn og unge patienter, der får IntronA/ribavirin-kombination, afbrydes, hvis deres uge 12 HCV-RNA falder &lt; 2 log10 i forhold til før behandlingen, eller hvis de har detekterbar HCV-RNA i behandlingsuge 24.
Therefore, it is recommended that children and adolescent patients receiving IntronA/ribavirin combination be discontinued from therapy if their week 12 HCV-RNA dropped &lt; 2 log10 compared to pretreatment, or if they have detectable HCV-RNA at treatment week 24.
Sluthøjden var tilgængelig for 14 af disse børn og viste, at 12 fortsat udviste manglende højdevækst &gt; 15 percentiler, 10-12 år efter afsluttet behandling.
Final adult height was available for 14 of those children and demonstrated that 12 continued to show height deficits &gt; 15 percentiles, 10 to 12 years after the end of treatment.
Behandlingsvarigheden var 48 uger med en opfølgningsperiode på 6 måneder med undtagelse af de patienter, der var inficeret med genotype 2 og 3 og en virusbelastning &lt; 800.000 IE/ml (Amplicor), som blev behandlet i 24 uger med en opfølgningsperiode på 6 måneder.
The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load &lt; 800,000 IU/mL (Amplicor) who were treated for 24 weeks with a 6-month follow-up period.
Den givne dosis skal reduceres med 50 % i tilfælde af forekomst af hæmatologiske lidelser (hvide blodlegemer &lt; 1.500/mm 3, granulocytter &lt; 1.000/mm 3, thrombocytter &lt; 100.000/mm 3).
The administered dose should be reduced by 50 % in case of occurrence of haematological disorders (white blood cells &lt; 1,500/mm 3, granulocytes &lt; 1,000/mm 3, thrombocytes &lt; 100,000/mm 3).
Behandlingen skal seponeres i tilfælde af svær leukopeni ( &lt; 1.200/mm 3), svær neutropeni ( &lt; 750/mm 3) eller svær trombocytopeni ( &lt; 70.000/mm
Treatment should be discontinued in case of severe leukopaenia ( &lt; 1,200/mm 3), severe neutropaenia ( &lt; 750/mm or severe thrombocytopaenia ( &lt; 70,000/mm
c: Patienter med genotype 3 og lav virusbelastning ( &lt; 600.000 IE/ml) skulle have behandling i 24 uger, mens patienter med genotype 3 og høj virusbelastning (≥ 600.000 IE/ml) skulle have behandling i 48 uger.
c: Patients with genotype 3 low viral load ( &lt; 600,000 IU/mL) were to receive 24 weeks of treatment while those with genotype 3 and high viral load (≥ 600,000 IU/mL) were to receive 48 weeks of treatment.
Patienter, der kunne indgå i disse undersøgelser, havde kronisk hepatitis C bekræftet ved en positiv HCV-RNA polymerasekædereaktions assay (PCR) ( &gt; 100 kopier/ml), en leverbiopsi i overensstemmelse med en histologisk diagnose med kronisk hepatitis uden anden årsag til den kroniske hepatitis, og abnorm serum ALAT.
Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCV-RNA polymerase chain reaction assay (PCR) ( &gt; 100 copies/mL), a liver biopsy consistent with a histologic diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum ALT.
Stor tumorbyrde er defineret som at have mindst et af følgende kriterier: Stor tumorbyrde ( &gt; 7 cm), involvering af mindst tre nodale områder (hver &gt; 3 cm), systemiske symptomer (vægttab &gt; 10 %, feber &gt; 38C i mere end 8 dage, eller natlige svedeture), splenomegali til under navlen, obstruktion af større organ eller kompressionssyndrom, orbital eller epidural involvering, serøs ekssudation eller leukæmi.
High tumour burden is defined as having at least one of the following: bulky tumour mass ( &gt; 7 cm), involvement of three or more nodal sites (each &gt; 3 cm), systemic symptoms (weight loss &gt; 10 %, pyrexia &gt; 38°C for more than 8 days, or nocturnal sweats), splenomegaly beyond the umbilicus, major organ obstruction or compression syndrome, orbital or epidural involvement, serous effusion, or leukaemia.
3 eller ALAT/ASAT stiger til &gt; 10 gange den øvre normalgrænse, skal interferon alfa-2b behandling afbrydes.
3 or ALT/AST rises to &gt; 10 x upper limit of normal, discontinue interferon alfa-2b therapy.
Følgende kategorier er anvendt: meget almindelig (≥1/10); almindelig (≥1/100 til &lt; 1/10).
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100, &lt; 1/10).
Inflammation pÃ¥ injektionsstedet, reaktion pÃ¥ injektionsstedet*, trÃ¦thed, stivhed, feber
Injection site inflammation, injection site reaction*, fatigue, rigors, pyrexia
: 800 00 673 (+357 22866700) cyprus_info@merck.com
Merck Sharp &amp; Dohme Cyprus Limited Τηλ: 80000 673 (+357 22866700) cyprus_info@merck.com
Inflammation pÃ¥ injektionsstedet, reaktion pÃ¥ injektionsstedet, trÃ¦thed, stivhed, feber Â§, influenzalignende symptomer Â§, utilpashed,
Injection site inflammation, injection site reaction, fatigue, rigors, pyrexia
Når man betragter in vitro-data for følsomheden af B. hyodysenteriae over for lincomycin, er det tydeligt, at uanset geografiske forskelle og variation som følge af manglende standardiserede testmetoder dækker den mindste hæmmende koncentration (MIC) et stort interval, og de fleste http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/LincoSpectin_100_and_associated_names/vet_referral_000097.jsp &amp; mid=WC0b01ac05805c5170
When considering lincomycin in vitro susceptibility data against B. hyodysenteriae, even if differences occur between geographical areas, and variability arises from the absence of standardised testing methodology, it appears clearly that the minimum inhibitory concentration (MIC) range is broad and http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/LincoSpectin_100_and_associated_names/vet_referral_000097.jsp &amp; mid=WC0b01ac05805c5170
Infektioner med B. hyodysenteriae hos svin kan vÃ¦re forbundet med flere forskellige enteropatogener, som er potentielle mÃ¥l for spectinomycin.
Several pig enteric pathogens can be associated with B. hyodysenteriae infections and constitute possible targets for spectinomycin.
2 i medfør af artikel 35 i direktiv 2001/82/EF, at indikationen "svinedysenteri forårsaget af B. hyodysenteriae" slettes fra produktinformationen for veterinærmedicinske produkter indeholdende tylosin til administration oralt i foder eller drikkevand til http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/Veterinary_medicinal_products_cont aining_tylosin_to_be_administered_orally_via_feed_or_the_drinking_water_to_pigs/vet_referral_000098.jsp &amp; mid=WC0b01 ac05805c5170
2 under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs, the CVMP recommended the indication ‘swine dysentery caused by B. hyodysenteriae' to be deleted from the http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/Veterinary_medicinal_products_cont aining_tylosin_to_be_administered_orally_via_feed_or_the_drinking_water_to_pigs/vet_referral_000098.jsp &amp; mid=WC0b01 ac05805c5170
Tyskland Bela-Pharm GmbH &amp; Co.KG Lohner Str. 19
Germany Bela-Pharm GmbH &amp; Co.KG
Bela-Pharm GmbH &amp; Co.KG Lohner Str. 19
Lithuania Bela-Pharm GmbH &amp; Co.KG
Hyppighed inddeles på følgende måde: meget almindelig (≥1/10), almindelig (≥1/100 til &lt; 1/10), ikke almindelig (≥1/1.000 til &lt; 1/100), sjælden (≥1/10.000 til &lt; 1/1.000), meget sjælden ( &lt; 1/10.000).
Frequencies are defined as: very common (≥1/10), common (≥1/100 to &lt; 1/10), uncommon (≥1/1,000 to &lt; 1/100), rare (≥1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000).
17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
UNIQUE IDENTIFIER - 2D BARCODE &lt; 2D barcode carrying the unique identifier included. &gt;
Seks patienter, der havde en estimeret glomerulær filtrationshastighed på &lt; 30 ml/min/1,73 m (beregnet ud fra MDRD-formlen [Modification of Diet in Renal Disease]), og som ikke var i dialyse på det aktuelle tidspunkt, blev sammenlignet med 6 raske forsøgspersoner med samme demografiske karakteristika ved baseline.
Six patients with an estimated glomerular filtration rate &lt; 30 mL/min/1.73m2 (calculated using the Modification of Diet in Renal Disease equation) and not currently on dialysis were compared to 6 healthy subjects with similar baseline demographics.
InfusionsoplÃ¸sningen sammenblandes forsigtigt.
The solution for infusion should be mixed gently.
Frekvenserne defineres som meget almindelige (≥1/10); almindelig ( &gt; 1/100 til &lt; 1/10); usædvanlig ( &gt; 1/1000 til &lt; 1/100); sjældne ( &gt; 1/10 000 til &lt; 1/1000); meget sjældne ( &lt; 1/10 000).
Frequencies are defined as very common (≥1/10); common ( &gt; 1/100 to &lt; 1/10); uncommon ( &gt; 1/1000 to &lt; 1/100); rare ( &gt; 1/10 000 to &lt; 1/1000); very rare ( &lt; 1/10
Metaboliseringen af doxazosin er omfattende med en ekskretion på &lt; 5 % i form af uændret produkt.
Doxazosin is extensively metabolised with &lt; 5% excreted as unchanged product.
4.8, er: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1.000 til &lt; 1/100), sjælden (≥ 1/10.000 til &lt; 1/1.000), meget sjælden ( &lt; 1/10.000).
The frequencies used in the tables throughout section 4.8 are: very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10), uncommon (≥ 1/1,000 to &lt; 1/100), rare (≥ 1/10,000 to &lt; 1/1,000), very rare
Når AIIRA'er anvendes samtidigt med non-steroide antiinflammatoriske lægemidler (NSAID'er) (dvs. selektive COX-2-hæmmere, acetylsalicylsyre ( &gt; 3 g/dag) og non-selektive NSAID'er), kan den antihypertensive effekt svækkes.
When AIIRAs are administered simultaneously with non-steroidal anti-inflammatory drugs (NSAIDs) (i.e. selective COX-2 inhibitors, acetylsalicylic acid ( &gt; 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Hos ældre ( &gt; 65 år) er Cmax og AUC for candesartan øget med ca. 50 % henholdsvis 80 % sammenlignet med yngre forsøgspersoner.
In elderly subjects (over 65 years), Cmax and AUC of candesartan are increased by approximately 50% and 80%, respectively in comparison to young subjects.
Atacand Plus er kontraindiceret hos patienter med stærkt nedsat nyrefunktion (kreatinclearance &lt; 30 ml/min/1,73 m2 legemsoverfladeareal) (se pkt.
Atacand Plus is contraindicated in patients with severe renal impairment (creatinine clearance &lt; 30 ml/min/1.73 m2 BSA) (see section 4.3).
Stærkt nedsat nyrefunktion (kreatininclearance &lt; 30 ml/min/1,73 m
Second and third trimesters of pregnancy (see sections 4.4 and 4.6) Severe renal impairment (creatinine clearance &lt; 30 ml/min/1.73 m2 BSA).
Inden for systemorganklasserne er bivirkningerne anført under overskrifter for hyppighed ved brug af følgende kategorier: meget almindelig (≥1/10); almindelig (≥1/100 til &lt; 1/10); ikke almindelig (≥1/1.000 til &lt; 1/100); sjælden (≥1/10.000 til &lt; 1/1.000); meget sjælden ( &lt; 1/10.000); ikke kendt.
Tabulated list of adverse reactions Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100 to &lt; 1/10); uncommon (≥1/1,000 to &lt; 1/100); rare (≥ 1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000); not known.
Posaconazol absorberes langsomt og elimineres langsomt med et stort tilsyneladende fordelingsvolumen (1.774 liter), og proteinbindingen, hovedsagelig til serum albumin, er høj ( &gt; 98 %).
Posaconazole is slowly absorbed and slowly eliminated with a large apparent volume of distribution (1,774 litres) and is highly protein bound ( &gt; 98 %), predominantly to serum albumin.
Hos patienter med svært nedsat nyrefunktion (n=6, Clcr &lt; 20 ml/min/1,73 m2) var AUC for posaconazol meget variabel [ &gt; 96 % CV (varianskoefficient)] sammenlignet med andre grupper med nyrelidelse [ &lt; 40 % CV].
In subjects with severe renal impairment (n=6, Cl cr &lt; 20 mL/min/1.73 m2), the AUC of posaconazole was highly variable [ &gt; 96 % CV (coefficient of variance)] compared to other renal groups [ &lt; 40 % CV].
EUCAST-MIC-grænseværdier for posaconazol [følsomme (S); resistente (R)]: - Candida albicans: S ≤0,06 mg/l, R &gt; 0,06 mg/l - Candida tropicalis: S ≤0,06 mg/l, R &gt; 0,06 mg/l - Candida parapsilosis: S ≤0,06 mg/l, R &gt; 0,06 mg/l Der er for tiden utilstrækkelige data til at fastsætte kliniske grænseværdier for andre Candida-arter.
- Candida albicans: S ≤0.06 mg/L, R &gt; 0.06 mg/L - Candida tropicalis: S ≤0.06 mg/L, R &gt; 0.06 mg/L - Candida parapsilosis: S ≤0.06 mg/L, R &gt; 0.06 mg/L
Alvorlig humoral eller cellulær (primær eller erhvervet) immundefekt, f.eks. alvorlig kombineret immundefekt, agammaglobulinæmi, aids, symptomgivende hiv-infektion eller en aldersspecifik CD4+ T-lymfocytprocent hos børn under 12 måneder: CD4+ &lt; 25 %; hos børn i alderen 12-35 måneder: CD4+ &lt; 20 %; hos børn i alderen 36-59 måneder: CD4+ &lt; 15 % (se pkt.
Severe humoral or cellular (primary or acquired) immunodeficiency, e.g. severe combined immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection or an age-specific CD4+ T-lymphocyte percentage in children below 12 months: CD4+ &lt; 25%; children between 12-35 months: CD4+ &lt; 20%; children between 36-59 months: CD4+ &lt; 15% (see section 4.4).
Information om graviditet skal skrives pÃ¥ fÃ¸lgende mÃ¥de: â[PRODUKT NAVN] mÃ¥ ikke gives til gravide kvinder.
The wording regarding pregnancy should read as follows: “[PRODUCT NAME] should not be administrated to pregnant women.
Informationen om graviditet og immunkompromitterede patienter skal skrives pÃ¥ fÃ¸lgende mÃ¥de: Informationen i dette afsnit skal skrives pÃ¥ fÃ¸lgende mÃ¥de:
The wording regarding pregnancy and immunocompromised patients should read as follows: The text of this section should be read as follows:
Informationen om graviditet og immunkompromitterede patienter skal skrives pÃ¥ fÃ¸lgende mÃ¥de:
The wording regarding pregnancy and immunocompromised patients should read as follows:
Bivirkninger fra kliniske undersøgelser og spontane indberetninger, som forekommer hos &gt; 1% af patienterne, er angivet i tabellen nedenfor efter systemorganklasse og frekvens (meget almindelig: ≥1/10, almindelig ≥1/100 til &lt; 1/10, ikke almindelig: ≥1/1.000 til &lt; 1/100, sjælden: ≥1/10.000 til &lt; 1/1.000, meget sjælden: &lt; 1/10.000).
Tabulated list of adverse reactions Adverse reactions from clinical trials and spontaneous reporting, occurring in &gt; 1% of patients, are listed in the table below by system organ class and frequency (very common: ≥ 1/10, common: ≥ 1/100 &lt; 1/10, uncommon: ≥1/1,000 to &lt; 1/100, rare: ≥1/10,000 to &lt; 1/1,000, very rare: &lt; 1/10,000).
Anvendelse af Miglustat Dipharma til patienter med svær nyreinsufficiens (kreatinin-clearance &lt; 30 ml/min/1.73 m2) kan ikke anbefales.
Use of Miglustat Dipharma in patients with severe renal impairment (creatinine clearance &lt; 30 ml/min/1.73 m2) is not recommended.
Der foreligger ingen tilgængelige farmakokinetiske data for patienter med leverinsufficiens, børn og unge med Gauchers sygdom, type 1, eller ældre ( &gt; 70 år).
There are no pharmacokinetic data available in patients with liver impairment or in the elderly ( &gt; 70 years).
Hos patienter med en justeret kreatinin-clearance på 30-50 ml/min/1.73 m2 bør indgivelsen starte med en dosis på 100 mg én gang dagligt hos patienter med Gauchers sygdom, type 1 og en dosis på 100 mg to gange dagligt (justeret efter legemsoverflade hos patienter under 12 år) hos patienter med NiemannPicks sygdom, type C. Anvendelse til patienter med svær nyreinsufficiens (kreatinin-clearance &lt; 30 ml/min/1.73 m2) kan ikke anbefales (se pkt.
In patients with an adjusted creatinine clearance of 30-50 ml/min/1.73 m2, administration should commence at a dose of 100 mg once daily in patients with type 1 Gaucher disease and at a dose of 100 mg twice daily (adjusted for body surface area in patients below the age of 12) in patients with Niemann-Pick type C disease.
DATO FOR ÆNDRING AF TEKSTEN &lt; {MM/ÅÅÅÅ} &gt;
10 DATE OF REVISION OF THE TEXT &lt; {MM/YYYY} &gt;
Meget almindelig (≥ 1/10) Almindelig (≥ 1/100 til &lt; 1/10) Ikke almindelig (≥ 1/1.000 til &lt; 1 /100) Sjælden ((≥1/10.000 til &lt; 1/1.000) Meget sjælden ( &lt; 1/10.000)
Very common (≥1/10) Common (≥1/100 to &lt; 1/10) Uncommon (≥1/1,000 to &lt; 1/100) Rare (≥1/10,000 to &lt; 1/1,000) Very rare ( &lt; 1/10,000)
En firdobbelt stigning i serum-neutraliserende antistof mod A/Indonesia/05/2005 blev opnået hos &gt; 90 personer efter to doser uafhængigt af vaccinationsprogram.
A 4-fold increase in serum neutralising antibody against A/Indonesia/5/2005 was achieved in &gt; 90% of subjects after two doses regardless of the schedule.
På dag 180 var seroprotektionsraten hos personer &gt; 60 år 52,9 % efter administration af to enkeltdoser og 69,5 % for de personer, som fik to dobbeltdoser på dag 0 og dag 21.
The day 180 seroprotection rates in subjects aged &gt; 60 years were 52.9% for those who received two single doses and 69.5% of subjects for those who had received two double doses at day 0 and day 21.
6.6 Regler for destruktion &lt; og anden håndtering &gt;
6.6 Special precautions for disposal and other handling
Meget begrænsede data for seronegative personer &gt; 80 år (N = 5) viste, at ingen personer opnåede serobeskyttelse efter administration af to enkeltdoser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1).
Very limited data in seronegative subjects &gt; 80 years of age (N=5) showed that no subject achieved seroprotection following two administrations of a single dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1).
Baseret på meget få data kan ældre over 80 år have behov for dobbelt dosis Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline 3,75 μg på en bestemt dag og igen efter mindst 3 uger for at opnå et immunrespons (se pkt.
Based on very limited data, adults aged &gt; 80 years may require a double dose of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg on an elected date and again after an interval of at least three weeks in order to achieve an immune response (see section 5.1).
Smith Kline &amp; French Portuguesa, Produtos Farmacêuticos, Lda.
GlaxoSmithKline, Produtos Farmacêuticos, Lda.
Uanset om der var blevet givet en eller to primære vaccinedoser 6 måneder tidligere, var seroprotektionsraterne &gt; 80 % mod A/Indonesia efter en dosis AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 og seroprotektionsraterne &gt; 90 % mod A/Vietnam efter en dosis af AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Indonesia/05/2005.
Regardless of whether one or two doses of priming vaccine had been given 6 months earlier, the seroprotection rates against A/Indonesia were &gt; 80% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 and the seroprotection rates against A/Vietnam were &gt; 90% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005.
Hos 152 personer i alderen over 60 år var anti-HA-antistof-serobeskyttelsen og serokonverteringsraten 23 % mod A/Indonesia/05/2005 på dag 42 efter to doser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 og serokonverteringsfaktoren var 2,7.
In 152 subjects aged &gt; 60 years the anti-HA antibody seroprotection and seroconversion rates against A/Indonesia/5/2005 at day 42 after two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 were 23% and the seroconversion factor was 2.7.
I et andet klinisk forsøg fik 152 personer over 60 år (stratificeret i grupper fra 61-70 år, 71-80 år og &gt; 80 år) enten en enkelt- eller en dobbeltdosis AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1) på dag 0 og 21.
In another clinical study, 152 subjects aged &gt; 60 years (stratified in ranges from 61 to 70, 71 to 80 and &gt; 80 years of age) received either a single or a double dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days.
KG Zirkustraße 40, D-01069 Dresden Tyskland
GlaxoSmithKline Biologicals Branch of SmithKline Beecham Pharma GmbH &amp; Co. KG Zirkustraße 40, D-01069 Dresden Germany
Meget almindelig (≥1/10), almindelig (≥1/100 til &lt; 1/10), ikke almindelig (≥1/1.000 til &lt; 1/100), sjælden (≥1/10.000 til &lt; 1/1.000), meget sjælden (≥1/100.000 til 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Very common (≥1/10); common (≥1/100 to &lt; 1/10); uncommon (≥1/1,000 to &lt; 1/100); rare (≥1/10,000 to &lt; 1/1,000); very rare (≥1/100,000 to &lt; 1/10,000); not known (cannot be estimated from the available data).
Bronchitol er ikke undersøgt hos patienter med signifikante episoder af hæmoptyse ( &gt; 60 ml) i de foregående tre måneder.
Bronchitol has not been studied in patients with a history of significant episodes of haemoptysis ( &gt; 60 ml) in the previous three months.
I ITT-populationen i en ublindet dosisrespons studie, DPM-CF-202, var middelværdien (SD) for den procentvise ændring i FEV1 for dosen på 400 mg 8,75 (SD: 12,4) og -1,569 (SD: 9,0) for dosen på 40 mg (p &lt; 0,0001).
In the ITT population of an open label dose response study, DPM-CF-202, the mean (SD) percent change in FEV1 for the 400 mg dose was 8.75 (SD: 12.4) and -1.569 (SD: 9.0) for 40 mg dose (p &lt;