FrancophonIA/ELRC3.0 huggingface dataset:
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: BILAG II A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: A pivotal monotherapy study in a population of patients suffering from moderate to severe Alzheimer's disease (mini mental state examination (MMSE) total scores at baseline of 3 - 14) included a total of 252 outpatients.
Danish: I en pivotal monoterapiundersøgelse med en patientpopulation, der led af moderat til svær Alzheimers sygdom (med en samlet Mini mental state examination (MMSE)-score ved baseline på 3 - 14), indgik i alt 252 ambulante patienter.
English: On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day as described above.
Danish: På baggrund af de kliniske studier er den anbefalede dosis til patienter over 65 år 20 mg pr. dag (20 mg en gang dagligt), som beskrevet ovenfor.
English: Tablet core: croscarmellose sodium, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate
Danish: Tabletkerne:Mikrokrystallinsk cellulose, croscarmellosenatrium, kolloid vandfri silica og magnesiumstearat.
English: Österreich Sandoz GmbH Tel: + 43 5338 200
Danish: Sandoz GmbH Tel: + 43 5338 200
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Ved at rapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: In patients with severe renal impairment (creatinine clearance 5 - 29 mL/min) daily dose should be 10 mg per day.
Danish: Hos patienter med svært nedsat nyrefunktion (kreatinin-clearance 5-29 ml/min) er daglig dosis 10 mg pr. dag.
English: Iron oxide yellow (E 172) Iron oxide red (E 172)
Danish: Gul jernoxid (E 172) Rød jernoxid (E 172)
English: one and a half 10 mg tablets week 4 and beyond two 10 mg tablets or one 20 mg tablet once a day
Danish: 4. uge og derefter To tabletter à 10 mg eller en 20mg tabletén gang dagligt
English: A pivotal monotherapy study of memantine in the treatment of mild to moderate Alzheimer's disease (MMSE total scores at baseline of 10 to 22) included 403 patients.
Danish: I en pivotal monoterapiundersøgelse med memantin til behandling af mild til moderat Alzheimers sygdom (med en samlet MMSE-score ved baseline på 10 - 22) indgik 403 patienter.
English: Memantine LEK 20 mg film-coated tablets are presented as pale red, oval film-coated tablet scored in one side.
Danish: Memantine LEK 20mg filmovertrukne tabletter er svagt røde oval, filmovertrukket tablet med delekærv på den ene side.
English: The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician's interview based impression of change (CIBIC-plus): p=0.025; Alzheimer's disease cooperative study - activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Danish: Undersøgelsen viste en gavnlig effekt af memantinbehandlingen sammenlignet med placebo over en behandlingsperiode på 6 måneder (”observed cases analysis” for Clinician's interview based impression of change (CIBIC-plus): p=0,025; Alzheimer´s disease cooperative study - activities of daily living (ADCS-ADLsev): p=0,003; SIB: p=0,002).
English: • The active substance is memantine hydrochloride.
Danish: Aktivt stof: Memantinhydrochlorid.
English: Memantine-treated patients showed a statistically significantly better effect than placebo-treated patients on the primary endpoints: Alzheimer's disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 (last observation carried forward (LOCF)).
Danish: Hos patienterne behandlet med memantin sås en statistisk signifikant bedre effekt end hos patienterne behandlet med placebo på de primære effektmål: Alzheimer´s disease assessment scale (ADAS-cog) (p=0,003) og CIBIC-plus (p=0,004) i uge 24 (Last observation carried forward (LOCF)).
English: Film-coating: polyvinyl alcohol, titanium dioxide (E-171), talc, macrogol 3350, iron oxide yellow (E172) and iron oxide red (E-172)
Danish: Polyvinylalkohol , macrogol 3350, titandioxid (E 171), talcum, gul jernoxid (E 172, rød jernoxid (E 172)
English: In single-dose pharmacokinetic (PK) studies in young healthy subjects, no relevant active substance - active substance interaction of memantine with glyburide/metformin or donepezil was observed.
Danish: Der sås ingen relevante interaktioner mellem de aktive stoffer i memantin og glyburid/metformin henholdsvist donepezil i enkeltdosis farmakokinetiske (PK)-studier hos yngre, raske forsøgspersoner.
English: Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
Danish: Pharmathen S.A , 6, Dervenakion str., 15351 Pallini, Attiki, Greece eller Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Grækenlandeller
English: Continue to take Memantine LEK as long as it is of benefit to you.
Danish: Bliv ved med at tage Memantine LEK, så længe De har gavn af det. Deres læge bør regelmæssigt vurdere Deres behandling.
English: 10 mg: Film-coating: polyvinyl alcohol, titanium dioxide (E-171), talc, macrogol 3350 and iron oxide yellow (E
Danish: Polyvinylalkohol , macrogol 3350, titandioxid (E 171), talcum, gul jernoxid (E 172)
English: Yellow, oval film-coated tablet scored in one side.
Danish: Gul, oval, filmovertrukket tablet med delekærv på den ene side.
English: Common Uncommon
Danish: Unormal gang
English: The patient should take one 20 mg film-coated tablet (20 mg) per day for 7 days.
Danish: Patienten bør indtage en filmovertrukken 20 mg-tablet dagligt i 7 dage.
English: Administration of Memantine LEK is not recommended in patients with severe hepatic impairment.
Danish: Administration af Memantine LEK til patienter med svært nedsat leverfunktion kan ikke anbefales.
English: • Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity
Danish: • Hovedpine, stærk søvnighed, forstoppelse, forhøjede værdier ved leverfunktionsprøver, svimmelhed, balanceforstyrrelser, kortåndethed, forhøjet blodtryk og overfølsomhed over for medicinen Ikke almindelige (kan påvirke op til 1 ud af 100 personer):
English: How to take Memantine LEK
Danish: Sådan skal De tage Memantine LEK
English: Marketing Authorisation Holder Pharmathen S.A., 6, Dervenakion str., 15351 Pallini, Attiki, Greece
Danish: Indehaveren af markedsføringstilladelsen Pharmathen S.A., 6, Dervenakion str., 15351 Pallini, Attiki, Grækenland
English: • Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism)
Danish: • Træthed, svampeinfektioner, forvirring, hallucinationer, opkastning, unormal gang, hjertesvigt og blodprop i en blodåre (vene) Meget sjældne (kan påvirke op til 1 ud af 10 000 personer):
English: • if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).
Danish: Kontakt lægen eller apotekspersonalet, før De tager Memantine LEK - hvis De tidligere har haft epileptiske anfald - hvis De for nylig har haft en blodprop i hjertet (myokardieinfarkt), eller hvis De lider af dårligt hjerte eller ukontrolleret forhøjet blodtryk (hypertension).
English: The use of memantine in pregnant women is not recommended.
Danish: Memantine LEK bør normalt ikke bruges til gravide kvinder.
English: Each 10 mg tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Danish: Hver 10mg tablet indeholder 10 mg memantinhydrochlorid (svarende til 8,31 mg memantin).
English: What Memantine LEK is and what it is used for What you need to know before you take Memantine LEK How to take Memantine LEK Possible side effects
Danish: Det skal De vide, før De begynder at tage Memantine LEK Sådan skal De tage Memantine LEK Bivirkninger
English: Iron oxide yellow (E 172)
Danish: Gul jernoxid (E 172)
English: Each 20 mg tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Danish: Hver 20mg tablet indeholder 20 mg memantinhydrochlorid (svarende til 16,62 mg memantin).
English: Tel.: +30 210 66 65 067 Email: info@pharmathen.com
Danish: Email: info@pharmathen.com
English: Pale red, oval film-coated tablet scored in one side.
Danish: Svagt røde oval, filmovertrukket tablet med delekærv på den ene side.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 20 mg memantinhydrochlorid svarende til 16,62 mg memantin.
English: What Memantine LEK looks like and contents of the pack Memantine LEK 10 mg film-coated tablets are presented as yellow, oval film-coated tablet scored in one side.
Danish: Memantine LEK 10mg filmovertrukne tabletter er gul, oval, filmovertrukket tablet med delekærv på den ene side.
English: half 10 mg tablet week 2
Danish: En halv tablet à 10 mg
English: EU/1/13/826 /007 28 film-coated tablets EU/1/13/826 /008 30 film-coated tablets EU/1/13/826 /009 42 film-coated tablets EU/1/13/826 /010 56 film-coated tablets EU/1/13/826 /011 98 film-coated tablets EU/1/13/826 /015 100 film-coated tablets
Danish: EU/1/13/826 /007 28 filmovertrukne tabletter EU/1/13/826 /008 30 filmovertrukne tabletter EU/1/13/826 /009 42 filmovertrukne tabletter EU/1/13/826 /010 56 filmovertrukne tabletter EU/1/13/826 /011 98 filmovertrukne tabletter EU/1/13/826 /015 100 filmovertrukne tabletter
English: NAME OF THE MEDICINAL PRODUCT Memantine LEK 10 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Memantine LEK 10 mg filmovertrukne tabletter.
English: How does Memantine LEK work
Danish: Hvordan virker Memantine LEK?
English: NAME OF THE MEDICINAL PRODUCT Memantine LEK 20 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Memantine LEK 20 mg filmovertrukne tabletter.
English: Tablet core
Danish: Tabletovertræk:.
English: NAME OF THE MEDICINAL PRODUCT Memantine LEK 20 mg film-coated tablets memantine hydrochloride
Danish: LÆGEMIDLETS NAVN Memantine LEK 20 mg filmovertrukne tabletter memantinhydrochlorid
English: NAME OF THE MEDICINAL PRODUCT Memantine LEK 10 mg film-coated tablets memantine hydrochloride
Danish: LÆGEMIDLETS NAVN Memantine LEK 10 mg filmovertrukne tabletter memantinhydrochlorid
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 10 mg memantinhydrochlorid (svarende til 8,31 mg memantin).
English: Common Common Uncommon Very rare
Danish: Meget sjælden
English: Aluminium-PVC/PVDC blisters placed into cardboard boxes containing 28, 30, 42, 50, 56, 60, 98, 100 and 112 film-coated tablets.
Danish: Aluminium/PVC/PVDC-blisterkort i æsker, som indeholder 28, 30, 42, 50, 56, 60, 98, 100 og 112 filmovertrukne tabletter.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Memantine LEK Fortæl altid lægen eller på apoteketspersonalet, hvis De tager anden medicin eller har gjort det for nylig.
English: Do not take Memantine LEK
Danish: Lad derfor være med at give Memantine LEK til andre.
English: Aluminium-PVC/PVDC blisters placed into cardboard boxes containing 28, 30, 42, 56, 98 and 100 filmcoated tablets.
Danish: Aluminium/PVC/PVDC-blisterkort i æsker, som indeholder 28, 30, 42, 56, 98 og 100 filmovertrukne tabletter.
English: In a clinical study in young healthy subjects, no relevant effect of memantine on the pharmacokinetics of galantamine was observed.
Danish: Der sås ingen relevant virkning af memantin på galantamins farmakokinetik i en klinisk undersøgelse med yngre, raske frivillige forsøgspersoner.
English: Memantine LEK 20 mg film-coated tablets are available in PVC/PVDC-Aluminium blister packs of 28, 30, 42, 56, 98 and 100 tablets.
Danish: Memantine LEK 20mg filmovertrukne tabletter fås i aluminium/PVC/PVDC-blisterkort i æsker, som indeholder 28, 30, 42, 56, 98 og 100 filmovertrukne tabletter.
English: Memantine LEK 10 mg film-coated tablets are available in PVC/PVDC-Aluminium blister packs of 28, 30, 42, 50, 56, 60, 98, 100 and 112 tablets.
Danish: Memantine LEK 10mg filmovertrukne tabletter fås i aluminium/PVC/PVDC-blisterkort i æsker, som indeholder 28, 30, 42, 50, 56, 60, 98, 100 og 112 filmovertrukne tabletter.
English: 28 film-coated tablets 30 film-coated tablets 42 film-coated tablets 56 film-coated tablets 98 film-coated tablets 100 film-coated tablets
Danish: 98 filmovertrukne tabletter 100 filmovertrukne tabletter.
English: Package leaflet: Information for the user Memantine LEK 10 mg film-coated tablets Memantine LEK 20 mg film-coated tablets memantine hydrochloride
Danish: Memantine LEK 10 mg filmovertrukne tabletter Memantine LEK 20 mg filmovertrukne tabletter memantinhydrochlorid
English: Not known (frequency cannot be estimated from the available data): • Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions
Danish: • Krampeanfald Ikke kendte (hyppighed kan ikke estimeres ud fra forhåndenværende data):
English: PC:
Danish: Dosistilpasning:
English: Pharmathen S.A. 6 Dervenakion str. 15351 Pallini, Attiki Greece
Danish: 6, Dervenakion str. 15351 Pallini, Attiki Grækenland
English: Maintenance dose
Danish: Nedsat leverfunktion
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis De vil have yderligere oplysninger om Memantine LEK, skal De henvende Dem til den lokale repræsentant:
English: Check with your doctor or pharmacist if you are not sure.
Danish: - Spørg lægen eller på apoteket, hvis der er mere, De vil vide.
English: Cardiac failure
Danish: Krampeanfald
English: Week 2 (day 8-14): The patient should take 10 mg per day for 7 days.
Danish: 2. uge (dag 8-14): Patienten bør indtage en filmovertrukken 10 mg-tablet dagligt i 7 dage.
English: PHARMACEUTICAL FORM Film-coated tablet.
Danish: 56 filmovertrukne tabletter.
English: Week 3 (day 15-21): The patient should take 15 mg per day for 7 days.
Danish: 3. uge (dag 15-21): Patienten bør indtage en filmovertrukken 15 mg-tablet dagligt i 7 dage.
English: Week 1 (day 1-7): The patient should take 5 mg per day for 7 days.
Danish: 1. uge (dag 1-7): Patienten bør indtage en filmovertrukken 5 mg-tablet dagligt i 7 dage.
English: Hepatobiliary disorders
Danish: Filmovertrukne tabletter
English: Tablet coat
Danish: BLISTER TIL TABLETTER
English: p=0.025; Alzheimer's disease cooperative study - activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Danish: Undersøgelsen viste gavnlig effekt af memantinbehandlingen sammenlignet med placebo over en behandlingsperiode på 6 måneder (”observed cases analysis” for Clinician's interview based impression of change (CIBIC-plus): p=0,025; Alzheimer´s disease cooperative study - activities of daily living (ADCS-ADLsev): p=0,003; SIB: p=0,002).
English: 08 October 2012
Danish: Den 8. oktober 2012
English: The European Commission issued a decision on 08 October 2012.
Danish: Europa-Kommissionen traf en afgørelse den 8. oktober 2012.
English: In addition, there were concerns over the methodology used to analyse these in vitro results.
Danish: Derudover var der betænkeligheder ved den anvendte metode til analyse af disse in vitro-resultater.
English: However, the Member States were not able to reach an agreement, and the Spanish medicines regulatory agency referred the matter to the CHMP for arbitration on 23 February 2012.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den spanske lægemiddelstyrelse indbragte sagen for CHMP med henblik på voldgift den 23. februar 2012.
English: On 19 July 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Mometasone Furoate Sandoz.
Danish: Den 19. juli 2012 gennemførte Det Europæiske Lægemiddelagentur en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) vedrørende godkendelsen af lægemidlet Mometasonfuroat Sandoz.
English: This means that it is similar to a ‘reference medicine' already authorised in the EU that contains the same active substance, but which is given using a different type of nasal spray device.
Danish: Det vil sige, at det svarer til et “referencelægemiddel”, som allerede er godkendt i EU og indeholder samme aktive stof, men som gives med en anden type næsespraybeholder.
English: The Spanish agency therefore considered that the results from the in vitro studies could not be used to predict how well the medicine would work in patients.
Danish: Den spanske lægemiddelstyrelse fandt derfor, at resultaterne af in vitro undersøgelserne ikke kunne anvendes til at forudsige, hvor godt lægemidlet ville virke hos patienterne.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Mometasone Furoate Sandoz outweigh its risks, and that the marketing authorisation can be granted in the Netherlands and in the following Member States of the EU: Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Luxembourg, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom, as well as Norway.
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) konkluderede, at fordelene ved Mometasonfuroat Sandoz er større end risiciene, og at der kan udstedes markedsføringstilladelse i Nederlandene og i følgende EU-medlemsstater: Belgien, Tjekkiet, Danmark, Estland, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Italien, Luxembourg, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Spanien, Sverige og Det Forenede Kongerige samt Norge.
English: The CHMP therefore concluded that the benefits of Mometasone Furoate Sandoz outweigh its risks and recommended that the marketing authorisation be granted in the concerned Member States.
Danish: CHMP konkluderede derfor, at fordelene ved Mometasonfuroat Sandoz overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse i de berørte medlemsstater.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the Netherlands) assesses a medicine with a view to 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 Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Luxembourg, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom, as well as Norway).
Danish: Dette sker med henblik på udstedelse af en markedsføringstilladelse, der ud over denne stat er gyldig i andre medlemsstater (de “berørte medlemsstater”, her Belgien, Tjekkiet, Danmark, Estland, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Italien, Luxembourg, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Spanien, Sverige og Det Forenede Kongerige samt Norge).
English: It is also used to prevent moderate to severe symptoms of seasonal allergic rhinitis before the pollen seasons starts.
Danish: Det anvendes desuden til forebyggelse af moderate til svære symptomer på sæsonbetinget allergisk rhinitis inden pollensæsonen begynder.
English: The active substance, mometasone furoate, belongs to the group ‘glucocorticoids'.
Danish: Det aktive stof, mometasonfuroat, tilhører glukokortikoid-gruppen.
English: Mometasone Furoate Sandoz is used in adults and children from six years of age to treat the symptoms of seasonal allergic or perennial rhinitis (inflammation of the nasal passages caused by an allergy such as hay fever, or which occurs throughout the year).
Danish: Mometasonfuroat Sandoz anvendes hos voksne og børn over seks år til behandling af symptomer på sæsonbetinget allergisk eller tilbagevendende rhinitis (inflammation af næseslimhinden, som er forårsaget af en allergi såsom høfeber, eller som optræder hele året).
English: The grounds for the referral were concerns over the type of in vitro (experimental) studies carried out to demonstrate that Mometasone Furoate Sandoz is comparable to Nasonex (that it produces the same levels of the active substance in the nose as Nasonex).
Danish: Begrundelsen for indbringelsen var betænkeligheder ved den type in vitro-undersøgelser (eksperimentelle undersøgelser), der er udført for at påvise, at Mometasonfuroat Sandoz er sammenligneligt med Nasonex (dvs. at det frembringer samme mængde aktivt stof i næsen som Nasonex).
English: In addition, it is used in adults to treat the symptoms of nasal polyps (growths in the lining of the nose).
Danish: Derudover anvendes det hos voksne til behandling af symptomer på polypper i næsen (udvækster af næseslimhinden).
English: Why was Mometasone Furoate Sandoz reviewed?
Danish: Hvorfor blev Mometasonfuroat Sandoz vurderet igen?
English: Mometasone Furoate Sandoz is a medicine that contains the active substance mometasone furoate.
Danish: Mometasonfuroat Sandoz er et lægemiddel, der indeholder det aktive stof mometasonfuroat.
English: What is Mometasone Furoate Sandoz?
Danish: Hvad er Mometasonfuroat Sandoz?
English: Mometasone Furoate Sandoz is a ‘hybrid medicine'.
Danish: Mometasonfuroat Sandoz er et “hybridt lægemiddel”.
English: It is available as a nasal spray.
Danish: Det leveres som næsespray.
English: The ‘reference medicine' for Mometasone Furoate Sandoz is called Nasonex.
Danish: Referencelægemidlet for Mometasonfuroat Sandoz er Nasonex.
English: Also, data from a clinical study provided additional evidence that Mometasone Furoate Sandoz nasal spray works as well as Nasonex nasal spray in patients.
Danish: Desuden giver en klinisk undersøgelse yderligere dokumentation for, at Mometasonfuroat Sandoz næsespray virker lige så godt som Nasonex næsespray hos patienterne.
English: It works by attaching to receptors in various types of immune cells, leading to a reduction in the release of substances that are involved in the inflammation process, and thereby reducing the symptoms of allergy.
Danish: Derved mindskes frigivelsen af de stoffer, der medvirker ved inflammationsprocessen, så allergisymptomerne mindskes.
English: Sandoz B.V. submitted an application for Mometasone Furoate Sandoz to the Dutch medicines regulatory agency for a decentralised procedure.
Danish: søgte Mometasonfuroat Sandoz godkendt hos den nederlandske lægemiddelstyrelse ved en decentral procedure.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP recognised some of the concerns of the Spanish agency, but concluded that overall it was sufficiently demonstrated that possible differences between Mometasone Furoate Sandoz and the reference medicine would not affect the benefit-risk balance of the product, taking into account all the in vitro data.
Danish: Udvalget konkluderede imidlertid, at det overordnet var tilstrækkelig bevist, at eventuelle forskelle mellem Mometasonfuroat Sandoz og referencelægemidlet ikke ville have betydning for benefit/risk-forholdet af produktet, når man tager hensyn til alle in vitro-dataene.
English: It can be used in the following situations:
Danish: Det kan anvendes i følgende tilfælde:
English: Generally one kit is sufficient.
Danish: Det er normalt tilstrækkeligt med ét sæt.