FrancophonIA/ELRC3.0 huggingface dataset:
English: Other protease inhibitors
Danish: Andre proteasehæmmere
English: ANTIDEPRESSANTS Sertraline (50 mg once daily), tenofovir alafenamide (10 mg once daily)3
Danish: ANTIDEPRESSIVA Sertralin (50 mg én gang dagligt), tenofoviralafenamid (10 mg én gang dagligt)3
English: Co-administration of rifampicin, rifabutin, and rifapentine, all of which are P-gp inducers, may decrease tenofovir alafenamide plasma concentrations, which may result in loss of therapeutic effect and development of resistance.
Danish: Samtidig administration af rifampicin, rifabutin og rifapentin, som alle er P-gp-inducere, kan reducere plasmakoncentrationerne af tenofoviralafenamid, hvilket kan forårsage svigtende terapeutisk virkning og udvikling af resistens.
English: cholesterol and glucose, or in the fasting total cholesterol to HDL cholesterol ratio in either treatment arm at Week 96.
Danish: Der var kun små ændringer i forhold til baseline i mediane fastende værdier for HDL-kolesterol og glucose eller i forholdet mellem fastende total-kolesterol og HDL-kolesterol i de to behandlingsarme ved uge 96.
English: Other HIV antiretrovirals Dolutegravir (50 mg once daily), tenofovir alafenamide (10 mg once daily)3
Danish: Andre hiv-antiretrovirale lægemidler Dolutegravir (50 mg én gang dagligt), tenofoviralafenamid (10 mg én gang dagligt)3
English: N/A 10.0 (19.6) 95.2 (46.7)
Danish: (ng/ml) Ctau (ng/ml) 102,4 (38,9)b Ikke relevant 10,0 (19,6) 95,2 (46,7) Ikke relevant 10,6 (28,5)
English: There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving emtricitabine and tenofovir alafenamide, in combination with elvitegravir and cobicistat as a fixed-dose combination tablet (see section 5.2).
Danish: Der identificeredes ingen nye sikkerhedsproblemer hos patienter med nyresygdom i slutstadiet i kronisk hæmodialyse, som fik emtricitabin og tenofoviralafenamid i kombination med elvitegravir og cobicistat som en fastdosis kombinationstablet (se pkt.
English: No virologic data at Week 48 window Discontinued study drug due to AE or deathc
Danish: Ingen virologiske data ved uge 48-vinduet Seponerede studiemedicin som følge af AE eller dødc
English: HIV-1 RNA < 50 copies/mL Treatment difference
Danish: Hiv 1-rna < 50 kopier/ml Behandlingsforskel
English: Tenofovir alafenamide: AUC: ↓ 14% Cmax: ↓ 22%
Danish: Tenofoviralafenamid: AUC: ↓ 14 %
English: • antibiotics, used to treat bacterial infections including tuberculosis, containing:
Danish: • antibiotika, der anvendes til at behandle bakterieinfektioner, herunder tuberkulose, og indeholder: rifabutin, rifampicin og rifapentin
English: Co-administration of carbamazepine, a P-gp inducer, decreases tenofovir alafenamide plasma concentrations, which may result in loss of therapeutic effect and development of resistance.
Danish: Samtidig administration af carbamazepin, en P-gp-inducer, reducerer plasmakoncentrationerne af tenofoviralafenamid, hvilket kan forårsage svigtende terapeutisk virkning og udvikling af resistens.
English: At Week 48, 92% of patients (66/72) maintained HIV-1 RNA < 50 copies/mL after switching to emtricitabine and tenofovir alafenamide, given with elvitegravir and cobicistat as a fixed-dose combination tablet.
Danish: Ved uge 48 havde 92 % af patienterne (66/72) stadig HIV-1 RNA < 50 kopier/ml efter skift til emtricitabin og tenofoviralafenamid administreret sammen med elvitegravir og cobicistat som en fastdosis kombinationstablet.
English: In studies GS-US-292-0104 and GS-US-292-0111, patients were randomised in a 1:1 ratio to receive either emtricitabine 200 mg and tenofovir alafenamide 10 mg (n = 866) once daily or emtricitabine
Danish: I studie GS-US-292-0104 og GS-US-292-0111 blev patienterne randomiseret i forholdet 1:1 til at få enten emtricitabin 200 mg og tenofoviralafenamid 10 mg (n = 866) én gang dagligt eller emtricitabin 200 mg +tenofovirdisoproxil (som fumarat) 245 mg (n = 867) én gang dagligt, begge givet sammen med elvitegravir 150 mg + cobicistat 150 mg som en fastdosis kombinationstablet.
English: What Descovy is and what it is used for What you need to know before you take Descovy How to take Descovy
Danish: Det skal De vide, før De begynder at tage Descovy Sådan skal De tage Descovy Bivirkninger
English: loss to follow-up, etc.
Danish: Bivirkninger, for yderligere oplysninger.
English: Sofosbuvir/velpatasvir/ voxilaprevir (400 mg/100 mg/100 mg+100 mg once daily)7/ emtricitabine (200 mg once daily)/ tenofovir alafenamide (10 mg once daily)3
Danish: Sofosbuvir/velpatasvir/ voxilaprevir (400 mg/100 mg/100 mg+100 mg én gang dagligt)7/ emtricitabin (200 mg én gang dagligt)/tenofoviralafenamid (10 mg én gang dagligt)3
English: Sofosbuvir/velpatasvir/ voxilaprevir (400 mg/100 mg/100 mg+100 mg once daily)7/ emtricitabine (200 mg once daily)/ tenofovir alafenamide (25 mg once daily)4
Danish: Sofosbuvir/velpatasvir/ voxilaprevir (400 mg/100 mg/100 mg+100 mg én gang dagligt)7/ emtricitabin (200 mg én gang dagligt)/tenofoviralafenamid (25 mg én gang dagligt)4
English: (M, N, and O), including subtypes A, B, C, D, E, F, and G (EC50 values ranged from 0.10 to 12.0 nM) and showed strain specific activity against HIV-2 (EC50 values ranged from 0.91 to 2.63 nM).
Danish: EC50-værdierne for tenofoviralafenamid var i intervallet fra 2,0 til 14,7 nM. Tenofoviralafenamid viste antiviral aktivitet i cellekultur mod alle hiv 1-grupperne (M, N og O), herunder undertype A, B, C, D, E, F og G (EC50-værdier var i intervallet fra 0,10 til 12,0 nM) og viste stammespecifik aktivitet mod hiv 2 (EC50-værdier var i intervallet fra 0,91 til 2,63 nM).
English: • If you notice within 18 hours of the time you usually take Descovy, you must take the tablet as soon as possible.
Danish: • Hvis De kommer i tanker om det inden for 18 timer efter det tidspunkt, De normalt tager
English: The safety of emtricitabine and tenofovir alafenamide was evaluated through 48 weeks in a single arm, open-label clinical study (GS-US-292-1825) in which 55 virologically suppressed HIV-1 infected patients with end stage renal disease (eGFRCG < 15 mL/min) on chronic haemodialysis received emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet.
Danish: Sikkerheden af emtricitabin og tenofoviralafenamid blev evalueret til og med 48 uger i et ublindet klinisk studie med én behandlingsarm (GS-US-292-1825), hvor 55 hiv 1-inficerede patienter, der var virologisk supprimerede med nyresygdom i slutstadiet (eGFRCG < 15 ml/min) i kronisk hæmodialyse fik emtricitabin og tenofoviralafenamid i kombination med elvitegravir og cobicistat som en fastdosis kombinationstablet.
English: HIV-1 RNA ≥ 50 copies/mLb
Danish: Hiv 1-rna ≥ 50 kopier/mlb
English: Sofosbuvir (400 mg once daily)/ velpatasvir (100 mg once daily), emtricitabine (200 mg once daily)/ tenofovir alafenamide (10 mg once daily)3
Danish: Sofosbuvir (400 mg én gang dagligt)/ velpatasvir (100 mg én gang dagligt), emtricitabin (200 mg én gang dagligt)/ tenofoviralafenamid (10 mg én gang dagligt)3
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable, and these events can occur many months after initiation of treatment.
Danish: Autoimmunsygdomme (som Graves sygdom og autoimmum hepatitis) er også rapporteret i tilfælde af immunreaktivering.
English: Race Black Non-black
Danish: Etnicitet Sort
English: HIV-1 RNA ≥ 50 copies/mLc
Danish: Hiv 1-rna ≥ 50 kopier/mlc
English: Anti-hepatitis C virus medicinal products Ledipasvir (90 mg once daily)/ sofosbuvir (400 mg once daily), emtricitabine (200 mg once daily)/ tenofovir alafenamide (10 mg once daily) 3
Danish: Lægemidler mod hepatitis C-virus Ledipasvir (90 mg én gang dagligt)/sofosbuvir (400 mg én gang dagligt), emtricitabin (200 mg én gang dagligt)/tenofoviralafenamid (10 mg én gang dagligt)3
English: In open-label Study GS-US-292-1249, the efficacy and safety of emtricitabine and tenofovir alafenamide, given with elvitegravir and cobicistat as a fixed-dose combination tablet (E/C/F/TAF), were evaluated in adult patients co-infected with HIV-1 and chronic hepatitis B. Sixty-nine of the 72 patients were on prior TDF-containing antiretroviral therapy.
Danish: Sikkerheden og virkningen af emtricitabin og tenofoviralafenamid i kombination med elvitegravir og cobicistat som en fastdosis kombinationstablet (E/C/F/TAF) blev evalueret i det ublindede studie GS-US-292-1249 hos voksne patienter med samtidig infektion med hiv-1 og kronisk hepatitis B. 69 ud af de 72 patienter havde tidligere fået TDF-baseret antiretroviral behandling.
English: Rifampicin Rifapentine
Danish: Rifapentin
English: Lopinavir/ritonavir (800/200 mg once daily), tenofovir alafenamide (10 mg once daily)
Danish: Lopinavir/ritonavir (800/200 mg én gang dagligt), tenofoviralafenamid (10 mg én gang dagligt)
English: Darunavir/ritonavir (800/100 mg once daily), tenofovir alafenamide (10 mg once daily)
Danish: Darunavir/ritonavir (800/100 mg én gang dagligt), tenofoviralafenamid (10 mg én gang dagligt)
English: Ledipasvir (90 mg once daily)/ sofosbuvir (400 mg once daily), emtricitabine (200 mg once daily)/ tenofovir alafenamide (25 mg once daily) 4
Danish: Ledipasvir (90 mg én gang dagligt)/sofosbuvir (400 mg én gang dagligt), emtricitabin (200 mg én gang dagligt)/tenofoviralafenamid (25 mg én gang dagligt)4
English: No dose adjustment of Descovy is required in adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis; however, Descovy should generally be avoided but may be used in these patients if the potential benefits are considered to outweigh the potential risks (see sections 4.4 and 5.2).
Danish: Descovy bør generelt undgås, men kan dog anvendes hos disse patienter, hvis de potentielle fordele anses for at opveje de potentielle risici (se pkt.
English: Each tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
Danish: Hver tablet indeholder 200 mg emtricitabin og tenofoviralafenamidfumarat svarende til 25 mg tenofoviralafenamid.
English: Co-administration of St. John's wort, a P-gp inducer, may decrease tenofovir alafenamide plasma concentrations, which may result in loss of therapeutic effect and development of resistance.
Danish: Samtidig administration af prikbladet perikum, en P-gp-inducer, kan reducere plasmakoncentrationerne af tenofoviralafenamid, hvilket kan forårsage svigtende terapeutisk virkning og udvikling af resistens.
English: Each tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide.
Danish: Hver tablet indeholder 200 mg emtricitabin og tenofoviralafenamidfumarat svarende til 10 mg tenofoviralafenamid.
English: Mean percent change in AUC,
Danish: Gennemsnitlig procentvis ændring i AUC, Cmax, Cmin2
English: Each Descovy film-coated tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
Danish: Hver Descovy filmovertrukken tablet indeholder 200 mg emtricitabin og tenofoviralafenamidfumarat svarende til 25 mg tenofoviralafenamid.
English: Each Descovy film-coated tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide.
Danish: Hver Descovy filmovertrukken tablet indeholder 200 mg emtricitabin og tenofoviralafenamidfumarat svarende til 10 mg tenofoviralafenamid.
English: Each film-coated tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide.
Danish: Hver filmovertrukken tablet indeholder 200 mg emtricitabin og tenofoviralafenamidfumarat, svarende til 10 mg tenofoviralafenamid.
English: Each film-coated tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
Danish: Hver filmovertrukket tablet indeholder 200 mg emtricitabin og tenofoviralafenamidfumarat, svarende til 25 mg tenofoviralafenamid.
English: Breast-feeding
Danish: Rifampicin
English: Protection lasts for one year.
Danish: Beskyttelsen varer i et år.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 15 March 2016.
Danish: Da virksomheden havde fremlagt de yderligere oplysninger, den var blevet anmodet om, blev de "særlige omstændigheder" ophævet den 15. marts 2016.
English: For booster vaccination a single injection is given every year.
Danish: Ved boostervaccination gives en enkelt injektion én gang om året.
English: In all studies the vaccinated sheep and cattle were compared with unvaccinated animals (controls).
Danish: I alle undersøgelserne blev de vaccinerede får og kvæg sammenlignet med ikkevaccinerede dyr (kontrolemner).
English: The most common side effect with Bluevac BTV8 (which may affect up to 1 in 10 animals) is an increase in body temperature between 0.5 and 1.0˚C that lasts no longer than one to two days.
Danish: De hyppigste bivirkninger ved Bluevac BTV8 (som kan optræde hos op til 1 ud af 10 dyr) er øget kropstemperatur med mellem 0,5 og 1,0 ˚C, som varer i højest 1-2 dage.
English: The European Commission granted a marketing authorisation valid throughout the EU, for Bluevac BTV8 on 14 April 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Bluevac BTV8 den 14. april 2011.
English: The full EPAR for Bluevac BTV8 can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Bluevac BTV8 findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Protection starts 31 days after the second injection in cattle and 20 days after the second injection in sheep.
Danish: Beskyttelsen begynder 31 dage efter den anden injektion hos kvæg og 20 dage efter den anden injektion hos får.
English: The effectiveness of the vaccine was investigated in a number of laboratory trials in sheep and cattle of the minimum recommended age.
Danish: Vaccinens virkning blev undersøgt i forbindelse med en række laboratorieundersøgelser hos får og kvæg i den anbefalede minimumsalder.
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to stimulate a better reaction by the immune system.
Danish: Vaccinen indeholder også "adjuvanser" (aluminiumhydroxid og saponin), som forstærker immunsystemets respons.
English: The first injection is given from two and a half months of age and a second injection is given three weeks later.
Danish: Den første injektion gives, fra dyret er 2,5 måned gammelt, og den anden injektion gives tre uger senere.
English: The vaccine is given to cattle and sheep as two injections under the skin.
Danish: Vaccinen gives til kvæg og får som to injektioner under huden.
English: The withdrawal period for meat and milk from cattle and sheep treated with Bluevac BTV8 is ‘zero' days, which means that there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød fra kvæg og får, der behandles med Bluevac BTV8, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Bluevac BTV8's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Bluevac BTV8 opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: In the future, if the animals are exposed to the same type of bluetongue virus, the immune system will be able to produce antibodies more quickly.
Danish: Hvis dyrene efterfølgende udsættes for den samme type bluetonguevirus, vil immunsystemet hurtigere kunne danne antistoffer mod den.
English: Bluevac BTV8 was originally authorised under ‘exceptional circumstances' because, as bluetongue disease falls under national disease control programmes, limited information was available at the time of approval.
Danish: Bluevac BTV8 blev oprindelig godkendt under "særlige omstændigheder", fordi bluetonguesygdommen er omfattet af nationale sygdomskontrolprogrammer, og der kun forelå begrænsede oplysninger på godkendelsestidspunktet.
English: When it is given to cattle and sheep, the animals' immune system recognises the virus as ‘foreign' and produces antibodies against it.
Danish: Når kvæg og får vaccineres, opfatter immunsystemet virussen som "fremmed" og producerer antistoffer mod den.
English: The vaccine is available as a suspension for injection and can only be obtained with a prescription.
Danish: Vaccinen fås som injektionsvæske, suspension, og udleveres kun efter recept.
English: Clinical signs of the disease include fever, skin ulceration, as well as swelling and occasionally blueish discolouration of the tongue mainly seen in sheep.
Danish: De kliniske tegn på sygdommen omfatter feber, hudsår og hævelser samt indimellem blåfarvning af tungen, hovedsageligt hos får.
English: Bluevac BTV8 is a vaccine.
Danish: Bluevac BTV8 er en vaccine.
English: Bluevac BTV8 is a vaccine used in cattle and sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus, which is transmitted by midges.
Danish: Bluevac BTV8 anvendes til får og kvæg for at beskytte dem mod sygdommen bluetongue, som er en infektion, der forårsages af bluetonguevirus, som overføres gennem mitter.
English: The studies showed that the vaccine prevents viraemia in sheep and cattle and reduces clinical signs in sheep when infected with bluetongue virus serotype 8.
Danish: Undersøgelserne viste, at vaccinen forebyggede viræmi hos får og kvæg og reducerede de kliniske tegn hos får, der var smittet med bluetonguevirus serotype 8.
English: The main measures of the effectiveness of the vaccine were viraemia (levels of BTV8 in the blood) and clinical signs of bluetongue virus infection.
Danish: Virkningen af vaccinen blev hovedsagelig målt på viræmi (niveauet af BTV8 i blodet) og kliniske tegn på bluetonguevirusinfektion.
English: For the full list of restrictions and all side effects reported with Bluevac BTV8, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger og indberettede bivirkninger ved Bluevac BTV8 fremgår af indlægssedlen.
English: The vaccine is used to prevent viraemia (the presence of viruses in the blood) and to reduce clinical signs caused by bluetongue virus in sheep and to prevent viraemia in cattle.
Danish: Vaccinen anvendes til at forebygge viræmi (tilstedeværelse af virus i blodet), reducere kliniske symptomer forårsaget af bluetonguevirus hos får og til at forebygge viræmi hos kvæg.
English: For more information about treatment with Bluevac BTV8, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Bluevac BTV8, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Bluevac BTV8 contains a bluetongue virus that has been inactivated so that it cannot cause the disease.
Danish: Bluevac BTV8 indeholder bluetonguevirus, der er blevet inaktiveret, så den ikke er sygdomsfremkaldende.
English: bluetongue virus vaccine serotype 8 (inactivated)
Danish: Vaccine mod bluetonguevirus, serotype 8 (inaktiveret)
English: What is Bluevac BTV8 and what is it used for?
Danish: Hvad er Bluevac BTV8, og hvad anvendes det til?
English: Bluevac BTV8 contains bluetongue viruses of one type (‘serotype 8').
Danish: Bluevac BTV8 indeholder bluetonguevirus af typen serotype 8.
English: The vaccine contains inactivated (killed) bluetongue virus serotype 8.
Danish: Vaccinen indeholder inaktiveret (dræbt) bluetonguevirus, serotype 8.
English: Why is Bluevac BTV8 approved?
Danish: Hvorfor blev Bluevac BTV8 godkendt?
English: What are the risks associated with Bluevac BTV8?
Danish: Hvilke risici er der forbundet med Bluevac BTV8?
English: Other information about Bluevac BTV8:
Danish: Andre oplysninger om Bluevac BTV8
English: How does Bluevac BTV8 work?
Danish: Hvordan virker Bluevac BTV8?
English: How is Bluevac BTV8 used?
Danish: Hvordan anvendes Bluevac BTV8?
English: What benefits have Bluevac BTV8 shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Bluevac BTV8?
English: Ref. EMEA/CHMP/194790/2009 EMEA/H/A-29/991
Danish: EMEA/CHMP/194661/2009 EMEA/H/A-29/991
English: This is a procedure when one Member State (the ‘reference Member State', in this instance Sweden) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other member states (the ‘concerned Member States', in this instance Austria, Germany, Ireland and Spain).
Danish: Det er en procedure, hvor en medlemsstat ("referencemedlemsstaten", i dette tilfælde Sverige) vurderer et lægemiddel med henblik på at udstede en markedsføringstilladelse, som gælder i dette land og i andre medlemsstater (de "berørte medlemsstater", i dette tilfælde Østrig, Tyskland, Irland og Spanien).
English: What is Sanohex?
Danish: Hvad er Sanohex?
English: It can also be used to prevent asthma symptoms caused by exercise or other triggering factors, such as house dust, pollen, cats, dogs and cigarette smoke.
Danish: Sanohex kan også anvendes til at forebygge astmasymptomer udløst af anstrengelse eller andre udløsende faktorer som husstøv, pollen, katte, hunde og cigaretrøg.
English: Why was Sanohex reviewed?
Danish: Hvorfor blev Sanohex vurderet igen?
English: This means that Sanohex is similar to a ‘reference medicine' already authorised in the European Union (EU) called Sultanol inhaler.
Danish: Det betyder, at Sanohex ligner et referencelægemiddel, som allerede er godkendt i EU, kaldet Sultanol Inhaler.
English: Questions and answers on the referral for Sanohex salbutamol, metered dose aerosol inhaler, 100 μg/dose
Danish: Spørgsmål og svar vedrørende indbringelsen af sagen om Sanohex salbutamol, inhalationsspray med afmålte doser, 100 μg/dosis
English: The grounds for the referral were concerns regarding that there was not enough data showing that Sanohex is equivalent to the reference medicine.
Danish: Årsagerne til indbringelsen var betænkeligheder ved, at der ikke forelå tilstrækkelige data, som viste, at Sanohex svarer til referencelægemidlet.
English: The European Medicines Agency (EMEA) has completed a referral procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Sanohex.
Danish: Det Europæiske Lægemiddelagentur (EMEA) har afsluttet en procedure for indbragte sager efter en uoverensstemmelse mellem visse medlemsstater i Den Europæiske Union angående udstedelse af markedsføringstilladelse for lægemidlet Sanohex.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Sanohex outweigh its risks, and that therefore the marketing authorisation for Sanohex should be granted in all concerned member states.
Danish: På grundlag af en vurdering af de tilgængelige data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at den gavnlige virkning af Sanohex er større end risiciene, og at markedsføringstilladelsen for Sanohex derfor bør fornyes i alle de berørte medlemsstater.
English: Hexal AG submitted Sanohex to the Swedish medicines regulatory agency for a decentralised procedure on 5 December 2006.
Danish: Hexal AG indgav den 5. december 2006 ansøgningen for Sanohex gennem en decentraliseret procedure til den svenske regulerende myndighed for lægemidler.
English: Sanohex is used to relieve symptoms, and its use should not delay the use of inhaled steroids.
Danish: Sanohex anvendes til symptomlindring og bør ikke udsætte anvendelsen af inhalerede steroider.
English: Sanohex is used to treat the breathing difficulties caused by asthma and chronic obstructive pulmonary disease (COPD).
Danish: Sanohex anvendes til behandling af vejrtrækningsbesvær forårsaget af astma og kronisk obstruktiv lungesygdom (KOL).