FrancophonIA/ELRC3.0 huggingface dataset:
English: Combination therapy with dexamethasone and thalidomide VELCADE 1 mg powder for solution for injection is administered via intravenous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 28 day treatment cycle.
Danish: Kombinationsbehandling med dexamethason og thalidomid VELCADE 1 mg pulver til injektionsvæske, opløsning administreres som intravenøs injektion i den anbefalede dosis på 1,3 mg/m2 legemsoverflade to gange om ugen i to uger på dag 1, 4, 8 og 11 i en 28-dages behandlingscyklus.
English: Combination therapy with dexamethasone and thalidomide VELCADE 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 28-day treatment cycle.
Danish: Kombinationsbehandling med dexamethason og thalidomid VELCADE 3,5 mg pulver til injektionsvæske, opløsning administreres som intravenøs eller subkutan injektion i den anbefalede dosis på 1,3 mg/m2 legemsoverflade to gange om ugen i to uger på dag 1, 4, 8 og 11 i en 28-dages behandlingscyklus.
English: For single use only Do not give by other routes.
Danish: Må ikke administreres via andre indgiftsveje.
English: VELCADE therapy should be withheld when the platelet count is < 25,000/l or, in the case of combination with melphalan and prednisone, when the platelet count is ≤ 30,000/l (see section 4.2).
Danish: 9/l eller, ved kombinationsbehandling med melphalan og prednison, når trombocyttallet er ≤ 30 x 10
English: Then, VELCADE may be reinitiated with one dose level reduction (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to
Danish: VELCADE kan så genoptages med et reduceret dosisniveau (fra 1,3 mg/m2 til
English: Uncommon Pulmonary embolism, Pleural effusion, Pulmonary oedema (inc acute), Pulmonary alveolar haemorrhage Bronchospasm, Chronic obstructive pulmonary disease*, Hypoxaemia*, Respiratory tract congestion*, Hypoxia, Pleurisy*, Hiccups, Rhinorrhoea, Dysphonia, Wheezing
Danish: #, bronkospasme, KOL*, hypoksæmi*, luftvejskongestion*, hypoksi, pleuritis*, hikke, rinoré, dysfoni, hvæsende vejrtrækning
English: • Stomach pain, bloating
Danish: • Mavesmerter, oppustethed
English: Very Common Nausea and vomiting symptoms*, Diarrhoea*, Constipation Common
Danish: Kvalme og opkastning*, diarré*, obstipation
English: Combination therapy with pegylated liposomal doxorubicin VELCADE 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 21-day treatment cycle.
Danish: Kombinationsbehandling med pegyleret liposomal doxorubicin VELCADE 3,5 mg pulver til injektionsvæske, opløsning administreres via intravenøs eller subkutan injektion i den anbefalede dosis på 1,3 mg/m2 legemsoverfladeareal to gange om ugen i to uger på dag 1, 4, 8 og 11 i en 21-dages behandlingscyklus.
English: Gastrointestinal haemorrhage (inc mucosal)*, Dyspepsia, Stomatitis*, Abdominal distension, Oropharyngeal pain*, Abdominal pain (inc gastrointestinal and splenic pain)*, Oral disorder*, Flatulence
Danish: fra slimhinde)*, dyspepsi, stomatitis*, abdominal distension, orofaryngeale smerter*, abdominalsmerter (inkl.
English: Combination therapy with pegylated liposomal doxorubicin VELCADE 1 mg powder for solution for injection is administered via intravenous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 21-day treatment cycle.
Danish: Kombinationsbehandling med pegyleret liposomal doxorubicin VELCADE 1 mg pulver til injektionsvæske, opløsning administreres via intravenøs injektion i den anbefalede dosis på 1,3 mg/m2 legemsoverfladeareal to gange om ugen i to uger på dag 1, 4, 8 og 11 i en 21-dages behandlingscyklus.
English: When VELCADE is given together with dexamethasone, you will receive VELCADE intravenously as a 21-day treatment cycle and dexamethasone 20 mg is given orally on days 1, 2, 4, 5, 8, 9, 11, and 12, of the VELCADE, 21-day treatment cycle.
Danish: Når VELCADE gives sammen med dexamethason, får du VELCADE intravenøst som en 21-dages behandlingscyklus, og dexamethason 20 mg gives gennem munden på dag 1, 2, 4, 5, 8, 9, 11 og 12 i den 21-dages behandlingscyklus med VELCADE.
English: rituximab 375 mg/m 2 IV on day 1; cyclophosphamide 750 mg/m 2 IV on day 1; doxorubicin 50 mg/m
Danish: på dag 1, cyclophosphamid 750 mg/m 2 i.v.
English: When VELCADE is given together with dexamethasone, you will receive VELCADE intravenously or subcutaneously as a 21-day treatment cycle and dexamethasone 20 mg is given orally on days 1, 2, 4, 5, 8, 9, 11, and 12, of the VELCADE, 21-day treatment cycle.
Danish: Når VELCADE gives sammen med dexamethason, får du VELCADE intravenøst eller subkutant som en 21-dages behandlingscyklus, og dexamethason 20 mg gives gennem munden på dag 1, 2, 4, 5, 8, 9, 11 og 12 i den 21-dages behandlingscyklus med VELCADE.
English: Musculoskeletal and connective tissue disorders
Danish: • Muskelsmerter, knoglesmerter
English: What VELCADE is and what it is used for What you need to know before you use VELCADE How to use VELCADE
Danish: Det skal du vide, før du begynder at bruge VELCADE Sådan skal du bruge VELCADE Bivirkninger
English: When VELCADE is given together with dexamethasone, you will receive VELCADE intravenously or subcutaneously as a 21-day treatment cycle and dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the VELCADE 21-day treatment cycle.
Danish: Når VELCADE gives sammen med dexamethason, får du VELCADE intravenøst eller subkutant som en 21-dages behandlingscyklus, og dexamethason 40 mg gives gennem munden på dag 1, 2, 3, 4, 8, 9, 10 og 11 i hver VELCADE 21-dages behandlingscyklus.
English: VELCADE 1 mg powder for solution for injection is administered via intravenous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 21-day treatment cycle.
Danish: VELCADE 1 mg pulver til injektionsvæske, opløsning administreres via intravenøs injektion i den anbefalede dosis på 1,3 mg/m2 legemsoverfladeareal to gange om ugen i to uger på dag 1, 4, 8 og 11 i en 21-dages behandlingscyklus.
English: OR
Danish: Alle
English: NA=not applicable, NE=not estimated TTP-Time to Progression
Danish: TTP = Tid til progression
English: • Discoloration of the veins
Danish: • Misfarvning af blodkarrene
English: VELCADE 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 21-day treatment cycle.
Danish: VELCADE 3,5 mg pulver til injektionsvæske, opløsning administreres via intravenøs eller subkutan injektion i den anbefalede dosis på 1,3 mg/m2 legemsoverfladeareal to gange om ugen i to uger på dag 1, 4, 8 og 11 i en 21-dages behandlingscyklus.
English: When VELCADE is given together with dexamethasone, you will receive VELCADE intravenously as a 21-day treatment cycle and dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the VELCADE 21-day treatment cycle.
Danish: Når VELCADE gives sammen med dexamethason, får du VELCADE intravenøst i en 21-dages behandlingscyklus, og dexamethason 40 mg gives gennem munden på dag 1, 2, 3, 4, 8, 9, 10 og 11 i hver VELCADE 21-dages behandlingscyklus.
English: severe).
Danish: døvhed)
English: Heart failure
Danish: Hjertetamponade
English: • Redness of skin
Danish: • Bleg hud
English: HR
Danish: • Brok
English: VELCADE 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 21 day treatment cycle.
Danish: VELCADE 3,5 mg pulver til injektionsvæske, opløsning administreres som intravenøs eller subkutan injektion i den anbefalede dosis på 1,3 mg/m2 legemsoverflade to gange om ugen i to uger på dag 1, 4, 8 og 11 i en 21-dages behandlingscyklus.
English: infestations
Danish: Krampeanfald
English: CR+nCR+ PR+MR
Danish: CR + nCR+ PR+MR Median varighed dage (måneder)
English: Eye swelling*, Vision abnormal*, Conjunctivitis* Uncommon Eye haemorrhage*, Eyelid infection*, Chalazion Blepharitis
Danish: Øjenblødning*, øjenlågsinfektion*, chalazion
English: 0.7 mg/m2).
Danish: 375 mg/m 2 i.v.
English: • Tiredness (fatigue), feeling weak
Danish: Pyreksi*, træthed, asteni
English: SUMMARY OF PRODUCT CHARACTERISTICS
Danish: Oversigt over bivirkningerne i tabelform
English: • Inflammation of the pancreas, obstruction of the bile duct
Danish: • Betændelse i bugspytkirtlen, tilstoppelse af galdegangen
English: • Tooth infection
Danish: • Urinvejsinfektion
English: • Headache
Danish: • Hikke
English: Haemorrhage*, Thrombophlebitis (inc superficial), Circulatory collapse (inc hypovolaemic shock), Phlebitis, Flushing*, Haematoma (inc perirenal)*, Poor peripheral circulation*, Vasculitis, Hyperaemia (inc ocular)*
Danish: Pancytopeni*, febril neutropeni, koagulopati*, leukocytose*, lymfadenopati, hæmolytisk anæmi# Sjælden Dissemineret intravaskulær koagulation, trombocytose*, hyperviskositetssyndrom, uspecificeret påvirkning af trombocytfunktionen, trombotisk mikroangiopati (herunder trombocytopenisk purpura)
English: • Shortness of breath with exercise
Danish: • Stakåndethed ved fysisk udfoldelse
English: In patients with advanced myeloma the severity of thrombocytopenia was related to pre-treatment platelet count: for baseline platelet counts < 75,000/l, 90% of 21 patients had a count ≤ 25,000/l during the study, including 14% < 10,000/l; in contrast, with a baseline platelet count > 75,000/l, only 14% of 309 patients had a count ≤ 25,000/l during the study.
Danish: Hos patienter med fremskreden myelom var sværhedsgraden af trombocytopeni relateret til trombocyttallet før behandlingen: for trombocyttal ved baseline < 75 x 10
English: SGOT (AST) levels
Danish: og subkutan (s.c.) anvendelse
English: Grade of hepatic impairment*
Danish: kardiogent shock)
English: SE: standard error.
Danish: SE: standardfejl
English: Long-term safety in children has not yet been established.
Danish: Sikkerhed ved langtidsbrug hos børn er ikke klarlagt.
English: It may harm them, even if their symptoms are the same as yours.
Danish: Det kan være skadeligt for andre, selv om de har de samme symptomer, som De har.
English: MOM Park "F" Ép., Hungary
Danish: MOM Park „F” Ép.,
English: The best time to do this is in the evening.
Danish: Det er bedst at dryppe øjnene om aftenen.
English: National Competent Authorities (NCAs), coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders (MAHs):
Danish: De nationale kompetente myndigheder, koordineret af referencemedlemsstaten, hvor dette er relevant, skal sikre, at følgende betingelser opfyldes af indehaverne af markedsføringstilladelsen:
English: Floridsdorfer Hauptstrasse 1
Danish: Floridsdorfer Hauptstraße 1
English: If you put too many drops into the eye, it may lead to some minor irritation in the eye and the eyes may water and turn red.
Danish: Hvis De drypper for mange dråber Xalatan i øjet, kan der opstå let irritation i øjet, og øjnene kan løbe i vand og blive røde.
English: †Adjusted estimate based on an analysis of covariance (ANCOVA) model.
Danish: Justeret estimat baseret på kovarians-analyse (ANCOVA) modellen.
English: Do not use Xalatan more than once a day, because the effectiveness of the treatment can be reduced if you administer it more often.
Danish: Brug ikke Xalatan mere end 1 gang dagligt, da hyppigere drypning kan nedsætte virkningen af behandlingen.
English: 4.5 Interaction with other medicinal products and other forms of interaction Paediatric population
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: The next updated version of the Risk Management Plan (RMP) will have to include all relevant annexed documents and amendments to reflect the following:
Danish: Den næste opdaterede udgave af risikostyringsplanen skal omfatte alle relevante vedlagte dokumenter og ændringer med henblik på at afspejle følgende:
English: The primary efficacy endpoint was the mean reduction in intraocular pressure (IOP) from baseline at Week 12 of the study.
Danish: Det primære effektendepunkt var den gennemsnitlige reduktion i det intraokulære tryk (IOP) fra baseline ved uge 12 af undersøgelsen.
English: p-value vs. timolol
Danish: p-værdi vs. timolol
English: The effect on IOP was seen after the first week of treatment and was maintained throughout the 12 week period of study, as in adults.
Danish: Der blev set effekt på IOP efter den første uge af behandlingen (se graf), og effekten blev opretholdt gennem hele den 12 uger lange forsøgsperiode, som hos voksne.
English: Interaction studies have only been performed in adults.
Danish: Pædiatrisk population Interaktionsforsøg er kun udført hos voksne.
English: - make clear/provide reassurance that Adverse Drug Reactions are transmitted to NCAs within the legal timelines; - include information with regard to the absolute frequency or maximum time interval between audits for the Pharmacovigilance system for Drug Safety and Surveillance.
Danish: - gøre det klart/give sikkerhed for, at information om bivirkninger fremsendes til de nationale kompetente myndigheder inden for de forskriftsmæssige tidsfrister, - medtage information om den absolutte hyppighed eller det maksimale tidsinterval mellem revisionerne, hvad angår lægemiddelovervågningssystemet for lægemiddelsikkerhed og -tilsyn.
English: Table: IOP reduction (mmHg) at week 12 by active treatment group and baseline diagnosis Latanoprost N=53
Danish: Tabel: Reduktion i IOP (mmHg) ved uge 12 samt behandlings undergrupper og baseline-diagnose Latanoprost N=53
English: Rivium Westlaan 142 2909 LD Capelle a/d IJssel
Danish: 2909 LD Capelle a/d IJssel
English: Submission of a 6-monthly Period Safety Updated Report (PSUR) during the first 2 years following the European Commission decision and then after yearly;
Danish: Fremsendelse af en halvårlig periodisk, opdateret sikkerhedsindberetning (PSUR) i løbet af de to første år efter Europa-Kommissionens afgørelse og herefter årligt;
English: ANNEX III CONDITIONS OF THE MARKETING AUTHORISATION(S)
Danish: BILAG III BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN/-ERNE
English: You can still use{Invented name}, but follow the instruction for contact lens wearers in Section 3
Danish: De kan stadig bruge Xalatan, men De skal følge vejledningen for kontaktlinsebrugere i afsnit 3
English: Pfizer Oy, Tietokuja 4, 00330 Helsinki, Finland
Danish: Pfizer Oy, Tietokuja 4, 00330 Helsinki,
English: The usual dosage for adults (including the elderly) and children is one drop once a day in the affected eye(s).
Danish: Den sædvanlige dosis til voksne (herunder ældre) og børn er 1 dråbe dagligt i det/de angrebne øje/øjne.
English: 9 Riverwalk National Digital Park Citywest Business Campus
Danish: Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24 Ireland
English: In children from 0 to < 3 years old) that mainly suffers from PCG (Primary Congenital Glaucoma), surgery (e.g. trabeculotomy/goniotomy) remains the first line treatment.
Danish: Hos børn i alderen 0 til < 3 år, som primært lider af primær kongenit glukom (PCG), er operation (f.eks. trabekulotomi/goniotomi) stadig førstevalgsbehandling.
English: Median time to reach peak plasma concentration was 5 minutes post-dose across all age groups.
Danish: Median tid til at nå maksimal plasmakoncentration var 5 minutter efter indgivelse af dosis for alle aldersgrupper.
English: - Risk of drug interactions in paediatric patients as important missing information; - Cystoid macular oedema assessment using the study Adverse Event (AE) report page in the case report form (CRF).
Danish: - risikoen for lægemiddelinteraktioner hos pædiatriske patienter som vigtig manglende information, - en vurdering af cystoidt maculaødem ved hjælp af indberetningsformularens (CRF's) side om utilsigtede hændelser (AE'er) i undersøgelsen.
English: 28108 Alcobendas, (Madrid)
Danish: Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid)
English: The Netherlands microgram/ml
Danish: The Netherlands mikrogram/ml
English: The short term safety profiles in the different paediatric subsets were also similar (see Section 5.1).
Danish: Desuden var korttids-sikkerhedsprofilerne ens i de pædiatriske undergrupper (se pkt.
English: Latanoprost acid systemic exposure was approximately 2-fold higher in 3 to <12 year olds and 6fold higher in children <3 years old compared with adults, but a wide safety margin for systemic adverse effects was maintained (see section 4.9).
Danish: Systemisk eksposition for latanoprost-syre var ca. 2 gange højere hos børn i alderen 3 - < 12 år og 6 gange højere hos børn < 3 år sammenlignet med voksne, men en bred sikkerhedsmargin mht. systemiske bivirkninger blev opretholdt (se pkt.
English: The median plasma elimination half-life was short (<20 minutes), similar for paediatric and adult patients, and resulted in no accumulation of latanoprost acid in the systemic circulation under steady-state conditions.
Danish: Median plasmahalveringstid var kort (< 20 minutter), var den samme for pædiatriske og voksne patienter og resulterede ikke i akkumulering af systemisk latanoprost ved steady-state.
English: BEFORE YOU USE {INVENTED NAME} {Invented name} can be used in adult men and women (including the elderly) and in children from birth to 18 years of age.
Danish: Xalatan kan anvendes hos voksne mænd og kvinder (herunder ældre) og børn fra fødslen til 18 år.
English: If you or your child wear contact lenses, they should be removed before using Xalatan.
Danish: Hvis De eller Deres barn bruger kontaktlinser, skal disse tages ud, inden De drypper øjnene med Xalatan.
English: Vetenskapsvagen 10, SE 191 90 Sollentuna Sweden
Danish: Pfizer AB Vetenskabsvägen 10, SE-191 90 Sollentuna Sweden
English: The final version of the CRF will be annexed to the study A6111143 protocol; - The MAH discussion whether the OCT (optical coherence tomography) technique can be recommended in the protocol's Appendix 1 “recommended assessment methods”; - The PASS (Post-Authorisation Safety) studies will include a comparison between macular oedema reported in aphakin and non-aphakin patients;
Danish: Den endelige udgave af CRF'en skal vedlægges protokollen for undersøgelse A6111143, - en redegørelse fra indehaveren af markedsføringstilladelsen om, hvorvidt OCT-teknikken (optisk kohærenstomografi) kan anbefales, i protokollens bilag I om "anbefalede vurderingsmetoder", - PASS-undersøgelserne (sikkerhedsundersøgelserne efter godkendelsen) skal omfatte en sammenligning mellem maculaødem, som er indberettet hos patienter uden øjelinse og hos patienter med øjelinse,
English: Reduction of elevated intraocular pressure in paediatric patients with elevated intraocular pressure and paediatric glaucoma.
Danish: Reduktion af forhøjet intraokulært tryk hos børn med forhøjet intraokulært tryk og pædiatrisk glaukom.
English: The PSURs will include a separate review on drug interaction in the paediatric population and on the current and lost to follow up numbers in PASSs;
Danish: De periodiske, opdaterede sikkerhedsindberetninger skal omfatte en separat gennemgang af lægemiddelinteraktionerne hos den pædiatriske population samt af de aktuelle tal og tallene for personer, der er tabt for follow-up, i PASS-undersøgelserne.
English: Pfizer Holding France Xalatan
Danish: Pfizer Holding France
English: After using Xalatan you should wait 15 minutes before putting the contact lenses back into the eyes.
Danish: Efter drypning med Xalatan skal De vente 15 minutter, inden De sætter kontaktlinserne i igen.
English: Neonates were required to be at least 36 weeks gestational age.
Danish: For nyfødte skulle gestationsalderen være mindst 36 uger.
English: Efficacy and safety data in the age group < 1 year (4 patients) are very limited (see Section 5.1).
Danish: Effekt- og sikkerhedsdata i aldersgruppen < 1 år (4 patienter) er meget begrænsede (se pkt.
English: In two short term clinical trials ( 12 weeks) involving 93 (25 and 68) paediatric patients the safety profile was similar to that in adults and no new adverse events were identified.
Danish: I to korttids-kliniske forsøg (≤ 12 uger) med 93 pædiatriske patienter (henholdsvis 25 og 68) svarede sikkerhedsprofilen til den, der blev set for voksne, og der blev ikke se nogen nye bivirkninger.
English: Use Xalatan as instructed by your doctor, or the doctor treating your child until they tell you to stop.
Danish: Brug Xalatan, som Deres læge eller Deres barns læge har anvist, indtil De får besked på at ophøre med behandlingen.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E)OG INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: In all age groups studied (0 to <3 years, 3 to <12 years and 12 to 18 years of age) the mean IOP reduction at Week 12 in the latanoprost group was similar to that in the timolol group.
Danish: Den gennemsnitlige reduktion i IOP i latanoprost- og timolol-grupperne var ens. I alle de undersøgte aldersgrupper (0 - <3 år, 3 - <12 år og 12 - 18 år) var den gennemsnitlige reduktion i IOP ved uge 12 i latanoprost-gruppen den samme som i timolol-gruppen.
English: The non-PCG (e.g. juvenile open angle glaucoma, aphakic glaucoma) subgroup showed similar results as the PCG subgroup.
Danish: Ikke-PCG-undergruppen (f.eks. juvenil åbenvinklet glaukom og afakisk glaukom) viste lignende resultater som PCG-undergruppen.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR XALATAN AND ASSOCIATED NAMES (as per Annex I)
Danish: ÆNDRINGER TIL DE RELEVANTE AFSNIT I PRODUKTRESUMEET FOR XALATAN OG ASSOCIEREDE NAVNE (se Annex I)
English: Patients received either latanoprost 0.005% once daily or timolol 0.5% (or optionally 0.25% for subjects younger than 3 years old) twice daily.
Danish: Patienterne fik enten latanoprost 50 mikrogram/ml 1 gang dagligt eller timolol 5 mg/ml (eller valgfrit 2,5 mg/ml for patienter yngre end 3 år) to gange dagligt.
English: The efficacy of latanoprost in paediatric patients ≤18 years of age was demonstrated in a 12-week, doublemasked clinical study of latanoprost compared with timolol in 107 patients diagnosed with ocular hypertension and paediatric glaucoma.
Danish: Effekten af latanoprost hos pædiatriske patienter ≤ 18 år blev vist i et 12-ugers, dobbeltblindet klinisk forsøg, hvor latanoprost blev sammenlignet med timolol hos 107 patienter diagnosticeret med okulær hypertension og pædiatrisk glaukom.
English: United Kingdom Pfizer Limited Ramsgate Road
Danish: Storbritannien Pfizer Limited, Ramsgate Road,
English: Kennedy, L-1855 Luxembourg, G. D. of Luxembourg
Danish: Kennedy, L-1855 Luxembourg, G. D. of Luxembourg mikrogram/ml
English: {Invented name} is also used to treat increased eye pressure and glaucoma in all ages of children and babies.
Danish: Xalatan kan også anvendes til behandling af forhøjet tryk i øjet eller glaukom hos børn og spædbørn i alle aldre.
English: Nevertheless, efficacy data in the age group 0 - < 3 year old were based on only 13 patients for latanoprost and no relevant efficacy was shown from the 4 patients representing the age group 0 -< 1 year old in the clinical paediatric study.
Danish: Imdilertid var effektdata for aldersgruppen 0<3 år kun baseret på 13 patienter for latanoprost og ingen relvant effekt blev set hos de 4 patienter, som udgjorde aldersgruppen 0- <1 år.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET FOR XALATAN AND ASSOCIATED NAMES (as per Annex I)
Danish: ÆNDRINGER TIL DE RELEVANTE DELE AF INDLÆGSSEDLEN TIL XALATAN OG ASSOCIEREDE NAVNE (se Annex 1)