FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients starting or stopping Lopinavir/Ritonavir Mylan while currently taking maintenance dose of lamotrigine: lamotrigine dose may need to be increased if Lopinavir/Ritonavir Mylan is added, or decreased if Lopinavir/Ritonavir Mylan is discontinued; therefore plasma lamotrigine monitoring should be conducted, particularly before and during 2 weeks after starting or stopping Lopinavir/Ritonavir Mylan, in order to see if lamotrigine dose adjustment is needed.
Danish: Der bør derfor udføres plasma-monitorering af lamotrigin, særligt før og i løbet af de første 2 uger efter initiering eller seponering af Lopinavir/Ritonavir Mylan for at se, om justering af lamotrigindosis er nødvendig.
English: The use of avanafil with Lopinavir/Ritonavir Mylan is contraindicated (see section 4.3).
Danish: Anvendelse af avanafil med Lopinavir/Ritonavir Mylan er kontraindiceret (se pkt.
English: Fluvastatin or Pravastatin Fluvastatin, Pravastatin: No clinical relevant interaction expected.
Danish: Der forventes ingen klinisk relevant interaktion.
English: Delamanid (100 mg BID)
Danish: Delamanid (100 mg 2 gange daglig)
English: Concomitant administration of Lopinavir/Ritonavir Mylan and cisapride is contraindicated as it may increase the risk of serious arrhythmias from this agent (see section 4.3).
Danish: Samtidig administration af Lopinavir/Ritonavir Mylan og cisaprid er kontraindiceret, da risikoen for alvorlige arytmier forårsaget af dette lægemiddel kan øges (se pkt.
English: Lopinavir/Ritonavir Mylan must not be administered once daily in combination with amprenavir.
Danish: Lopinavir/Ritonavir Mylan må ikke administreres en gang dagligt i kombination med amprenavir.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON OF BLISTER MULTIPACK (WITHOUT BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE INDERKARTON MED BLISTERMULTIPAKNING (UDEN BLÅ BOKS)
English: Outcomes at Week 360: Study M97-720
Danish: Resultater ved uge 360: Studie M97-720 Lopinavir/ritonavir (N = 100)
English: Dexamethasone
Danish: Kortikosteroider Dexamethason
English: Lopinavir/Ritonavir Mylan must not be administered once daily in combination with phenytoin.
Danish: Lopinavir/Ritonavir Mylan må ikke indgives en gang dagligt i kombination med phenytoin.
English: − upper respiratory tract infection.
Danish: Øvre luftvejsinfektioner
English: If a patient is already taking St John's wort, stop St John's wort and if possible check viral levels.
Danish: Påbegyndt behandling med perikon bør stoppes, og hvis det er mulig bør de virale niveauer kontrolleres.
English: Caution should be exercised in administering carbamazepine or phenobarbital with
Danish: Ved samtidig administration med carbamazepin eller phenobarbital, må en øgning af
English: Sorbitan laurate Silica, colloidal anhydrous Copovidone
Danish: - Øvrige indholdsstoffer: Sorbitanlaurat, silica, kolloid vandfri, copovidon,
English: 69800 Saint-Priest
Danish: Mylan SAS 117 Allee des Parcs 69800 Saint-Priest
English: (Lopinavir/ritonavir 400/100 mg BID, multiple dose)
Danish: (Lopinavir/ritonavir 400/100 mg 2 gange daglig fler-dosis)
English: Lopinavir/ritonavir tablets are administered orally and must be swallowed whole and not chewed, broken or crushed.
Danish: Lopinavir/ritonavir-tabletter administreres oralt og skal synkes hele.
English: Lopinavir/ritonavir is also supplied as 100 mg/25 mg film-coated tablets.
Danish: Lopinavir/ritonavir fås også som 100 mg/25 mg filmovertrukne tabletter.
English: Raltegravir
Danish: Integrase-hæmmer Raltegravir
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE MULTIPACK (LABEL)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE FLASKEMULTIPAKNING (ETIKET)
English: No dose adjustment is needed for Lopinavir/Ritonavir Mylan.
Danish: Justering af Lopinavir/Ritonavir Mylan-dosis er ikke nødvendig.
English: Uncommon Creatinine clearance decreased, nephritis, haematuria
Danish: Nedsat kreatinin-clearance, nefrit, hæmaturi
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (BOTTLE)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON (FLASKE)
English: Lopinavir/Ritonavir Mylan 100 mg/25 mg film-coated tablets are white, film coated, ovaloid, biconvex beveled edge tablets debossed with 'MLR4' on one side of the tablet and plain on the other side.
Danish: Lopinavir/Ritonavir Mylan 100 mg/25 mg filmovertrukne tabletter er hvide, ovale, bikonvekse, filmovertrukne tabletter med afskåret kant mærket med “MLR4” på den ene side og uden mærkning på den anden side.
English: Lopinavir/ritonavir is also supplied as 200 mg/50 mg film-coated tablets.
Danish: Lopinavir/ritonavir fås også som 200 mg/50 mg film-overtrukne tabletter.
English: Lopinavir/Ritonavir Mylan must not be administered once daily in combination with efavirenz.
Danish: Lopinavir/Ritonavir Mylan må ikke indgives en gang dagligt i kombination med efavirenz.
English: Severe hepatic insufficiency.
Danish: du har alvorlige leverproblemer.
English: AUC: ↑ 153% Cmax: ↑ 55%
Danish: AUC: ↑ 32% Cmax : ↔ Cmin : ↑ 51%
English: AUC: ↑ 3-fold Cmax: ↑ 1.8-fold
Danish: Cmax : ↑ 1,8-gange
English: AUC: ↑ 49-fold Due to CYP3A inhibition by lopinavir/ritonavir.
Danish: AUC: ↑ 49-gange På grund af lopinavir/ritonavirs hæmning af CYP3A.
English: Lopinavir/ritonavir (N=100)
Danish: Antiretroviral erfarne (N = 56)
English: Lopinavir/Ritonavir Mylan must not be administered once daily in combination with nevirapine.
Danish: Lopinavir/Ritonavir Mylan må ikke indgives en gang dagligt i kombination med nevirapin.
English: The use of a once daily dosing should be limited to those adult patients having only very few protease inhibitor (PI) associated mutations (i.e. less than 3 PI mutations in line with clinical trial results, see section 5.1 for the full description of the population) and should take into account the risk of a lesser sustainability of the virologic suppression (see section 5.1) and higher risk of diarrhoea (see section 4.8) compared to the recommended standard twice daily dosing.
Danish: Dosering en gang dagligt bør forbeholdes de voksne patienter, som kun har meget få proteasehæmmer associerede mutationer (PI-mutationer) (f.eks. færre end 3 PI-mutationer i tråd med resultaterne fra etklinisk studie, se pkt.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reconstitution; however, the reported time to onset is more variable and can occur many months after initiation of treatment.
Danish: Den rapporterede tid til reaktionen indtræder, er dog mere variabel, og reaktionen kan forekomme flere måneder efter påbegyndelse af behandlingen.
English: (Lopinavir/ritonavir 400/100 mg BID)
Danish: (Lopinavir/ritonavir 400/100 mg 2 gange daglig)
English: − Do not take lopinavir/ritonavir if you are currently taking avanafil or vardenafil.
Danish: Lægemidler til behandling af rejsningsproblemer (avanafil, vardenafil, sildenafil, tadalafil) Tag ikke lopinavir/ritonavir, hvis du i øjeblikket tager avanafil eller vardenafil.
English: Anaemia, leucopenia, neutropenia, lymphadenopathy
Danish: Knogler, led, muskler og bindevæv
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF BLISTER MULTIPACK (WITH BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON MED BLISTERMULTIPAKNING (MED BLÅ BOKS)
English: Oral Midazolam:
Danish: Peroral midazolam:
English: It is not recommended to coadminister Lopinavir/Ritonavir Mylan and telaprevir.
Danish: Samtidig administration af Lopinavir/Ritonavir Mylan og telaprevir anbefales ikke.
English: AUC: ↑ 2.17-fold Cmax: ↑ 2.04-fold Ctrough: ↑ 2.36-fold (inhibition of CYP3A/efflux transporters)
Danish: AUC: ↑ 2,17 gange Cmax: ↑ 2,04 gange Ctrough: ↑ 2,36 gange
English: Lopinavir/ritonavir must not be given to these patients (see section 4.3).
Danish: Lopinavir/ritonavir må ikke gives til disse patienter.
English: Acid reducing agents
Danish: Nedsat leverfunktion
English: Lower respiratory tract infection, skin infections including cellulitis, folliculitis and furuncle
Danish: Almindelig Nedre luftvejsinfektioner, hudinfektioner herunder cellulit, follikulit og furunkler Blod og lymfesystem Almindelig Anæmi, leukopeni, neutropeni, lymfadenopati Immunsystemet
English: Fusidic acid used to treat long-term infections of the bones and joints may be taken under doctor's supervision (see Other medicines and Lopinavir/Ritonavir Mylan section);
Danish: Fusidinsyre brugt til behandling af langvarige infektioner i knogler og led kan tages med rådgivning fra lægen (se Brug af anden medicin sammen med Lopinavir/Ritonavir Mylan); colchicin (brugt til behandling af urinsyregigt), hvis du har problemer med nyre- og/eller lever (se punktet Brug af anden medicin sammen med Lopinavir/Ritonavir Mylan);
English: Serum concentrations may be increased due to CYP3A and P-gp inhibition by lopinavir/ritonavir
Danish: Serumkoncentrationen kan øges på grund af lopinavir/ritonavirs hæmning af CYP3A og P-gp.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1067/008
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/15/1067/008
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 100 mg of lopinavir co-formulated with 25 mg ritonavir as a pharmacokinetic enhancer.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 100 mg lopinavir i en formulering sammen med 25 mg ritonavir som farmakokinetisk forstærker.
English: AUC: ↑ 11-fold Due to CYP3A inhibition by lopinavir/ritonavir.
Danish: AUC: ↑ 11-gange På grund af lopinavir/ritonavirs hæmning af CYP3A.
English: Side effects where frequency is not known:
Danish: Ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelig data):
English: In adult patients, in cases where once daily dosing is considered necessary for the management of the patient, lopinavir/ritonavir tablets may be administered as
Danish: Til voksne patienter kan lopinavir/ritonavir -tabletterne, i tilfælde, hvor dosering en gang dagligt vurderes at være nødvendigt i behandlingen af patienten, administreres en gang dagligt som 800/200 mg (fire 200/50 mg tabletter) med eller uden mad.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON OF BOTTLE MULTIPACK (WITHOUT BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE INDERKARTON MED FLASKEMULTIPAKNING (UDEN BLÅ BOKS)
English: Side effects where frequency is not known
Danish: Systemorganklasse Hyppighed Bivirkning Ikke almindelig
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg ritonavir as a pharmacokinetic enhancer.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 200 mg lopinavir i en formulering sammen med 50 mg ritonavir som farmakokinetisk forstærker.
English: − eye disorder, abnormal vision;
Danish: svimmelhed (følelse af rotation); øjenforstyrrelser, unormalt syn; vægtforøgelse.
English: Caution should be exercised in administering phenytoin with Lopinavir/Ritonavir Mylan.
Danish: Der bør udvises forsigtighed ved samtidig administration af carbamazepin eller phenobarbital med Lopinavir/Ritonavir Mylan.
English: Caution is warranted and therapeutic drug monitoring of digoxin concentrations, if available, is recommended in case of coadministration of Lopinavir/Ritonavir Mylan and digoxin.
Danish: Ved samtidig administration af Lopinavir/Ritonavir Mylan og digoxin tilrådes forsigtighed og overvågning af terapeutiske digoxinlægemiddelkoncentrationer anbefales, hvis de er tilgængelige.
English: Very common Diarrhoea, nausea Common
Danish: Diarre, kvalme
English: Hepatitis including AST, ALT and GGT increases Uncommon Hepatic steatosis, hepatomegaly, cholangitis, hyperbilirubinemia
Danish: Leversteatosis, hepatomegali, kolangit, hyperbilirubinæmi
English: Bosentan
Danish: Amning
English: NAME OF THE MEDICINAL PRODUCT Lopinavir/Ritonavir Mylan 200 mg/50 mg film-coated tablets lopinavir/ritonavir
Danish: Lopinavir/Ritonavir Mylan 200 mg/50 mg filmovertrukne tabletter lopinavir/ritonavir
English: Serum concentrations may be increased due to CYP3A inhibition by lopinavir/ritonavir.
Danish: Serumkoncentrationerne kan være øget på grund af lopinavir/ritonavirs hæmning af CYP3A.
English: NAME OF THE MEDICINAL PRODUCT Lopinavir/Ritonavir Mylan 100 mg/25 mg film-coated tablets lopinavir/ritonavir
Danish: Lopinavir/Ritonavir Mylan 100 mg/25 mg filmovertrukne tabletter lopinavir/ritonavir
English: Patients should be informed that nausea has been reported during treatment with lopinavir/ritonavir (see section 4.8).
Danish: Patienterne bør informeres om, at der er rapporteret om kvalme ved behandling med lopinavir/ritonavir, som der skal tages hensyn til, når man kører bil eller anvender maskiner (se pkt.
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: Spørg lægen eller apotekspersonalet.
English: Due to CYP3A inhibition by lopinavir/ritonavir.
Danish: På grund lopinavir/ritonavirs hæmning af CYP3A.
English: Cmax: ↔
Danish: AUC: ↔
English: C are at increased risk of severe and potentially fatal liver side effects.
Danish: 4.3), da der kan være forhøjet risiko for arytmier eller andre alvorlige bivirkninger.
English: − medicines used to correct heart rhythm (e.g. bepridil, systemic lidocaine, quinidine);
Danish: lægemidler, der anvendes mod uregelmæssig hjerterytme (f.eks. bepridil, systemisk lidocain, quinidin); hiv-CCR5-antagonister (f.eks. maraviroc); hiv-1-integrase-hæmmer (f.eks. raltegravir);
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1067/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1067/001
English: − anticancer medicines (e.g. afatinib, ceritinib, ibrutinib, venetoclax, most tyrosine kinases inhibitors such as dasatinib and nilotinib, also vincristine and vinblastine);
Danish: antibiotika (f.eks. rifabutin, rifampicin, clarithromycin); medicin mod kræft (f.eks. afatinib, ceritinib, ibrutinib, venetoclax, de fleste tyrosinkinasehæmmere sådan som dasatinib og nilotinib, også vincristin og vinblastin); blodfortyndende lægemidler (f.eks. warfarin, rivaroxaban, vorapaxar); lægemidler mod depression (f.eks. trazodon, bupropion); lægemidler mod epilepsi (f.eks. carbamazepin, phenytoin, phenobarbital, lamotrigin og valproat); lægemidler mod svamp (f.eks. ketoconazol, itraconazol, voriconazol); lægemidler mod urinsyregigt (f.eks. colchicin).
English: AUC: ↑ 295% Cmax: ↑ 97%
Danish: AUC: ↑ 295%
English: Hypertension Uncommon Deep vein thrombosis
Danish: Dyb venetrombose
English: If you or your child take more Lopinavir/Ritonavir Mylan than you should
Danish: Hvis du eller dit barn har taget for meget Lopinavir/Ritonavir Mylan
English: Due to the risk of bedaquiline related adverse events, the combination of bedaquiline and Lopinavir/Ritonavir Mylan should be avoided.
Danish: Kombination af bedaquilin og Lopinavir/Ritonavir Mylan bør undgås på grund af risikoen for bedaquilinrelaterede bivirkninger.Hvis fordelen opvejer risikoen, skal samtidig administration af bedaquilin og Lopinavir/Ritonavir Mylan foretages med forsigtighed.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1067/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1067/004
English: AUC and Cmax ↓ ~50% This effect may be due to induction of bupropion metabolism.
Danish: Denne virkning kan skyldes induktion af bupropion-metabolisme.
English: What Lopinavir/Ritonavir Mylan looks like and contents of the pack Lopinavir/Ritonavir Mylan 200 mg/50 mg film-coated tablets are white, film coated, ovaloid, biconvex beveled edge tablets debossed with 'MLR3' on one side of the tablet and plain on the other side.
Danish: Lopinavir/Ritonavir Mylan 200 mg/50 mg filmovertrukne tabletter er hvide, ovale, bikonvekse, filmovertrukne tabletter med afskåret kant mærket med “MLR3” på den ene side og uden mærkning på den anden side.
English: Uncommon Rhabdomyolysis, osteonecrosis
Danish: Rabdomyolyse, osteonekrose
English: Therefore, concomitant administration of Lopinavir/Ritonavir Mylan with salmeterol is not recommended (see section 4.4).
Danish: Samtidig administration af riociguat og Lopinavir/Ritonavir Mylan anbefales ikke (se pkt.
English: Fusidic Acid
Danish: Fusidinsyre
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1067/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1067/003
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF BOTTLE MULTIPACK (WITH BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON MED FLASKEMULTIPAKNING (MED BLÅ BOKS)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1067/007
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1067/007
English: Increased plasma concentrations of lovastatin and simvastatin; thereby, increasing the risk of myopathy including rhabdomyolysis (see section 4.5).
Danish: Derved øges risikoen for myopati, inklusive rabdomyolyse (se pkt.
English: Vasodilating agents
Danish: Vasodilaterende midler Bosentan
English: Carbamazepine and phenobarbital levels should be monitored when coadministering with
Danish: Carbamazepin- og phenobarbitalniveauerne bør overvåges ved samtidig administration med Lopinavir/Ritonavir Mylan.
English: What Lopinavir/Ritonavir Mylan is and what it is used for What you need to know before you or your child takes Lopinavir/Ritonavir Mylan How to take Lopinavir/Ritonavir Mylan
Danish: Det skal du vide, før du eller dit barn begynder at tage Lopinavir/Ritonavir Mylan Sådan skal du tage Lopinavir/Ritonavir Mylan Bivirkninger
English: − antiviral medicine used to treat chronic hepatitis C virus (HCV) in adults (e.g. boceprevir, simeprevir and telaprevir);
Danish: lægemiddel mod tuberkulose (bedaquilin, delamanid); antivirale midler, som bruges til at behandle kronisk hepatitis C-virusinfektion hos voksne (f.eks. boceprevir, simeprevir og telaprevir); lægemidler til behandling af rejsningsproblemer (f.eks. sildenafil og tadalafil); fusidinsyre brugt til behandling af langvarige infektioner i knogler og led (f.eks. osteomyelitis); hjertemedicin, herunder:
English: Antipsychotics/ Neuroleptics
Danish: Antipsykotika Lurasidon
English: • At the request of the EMEA
Danish: • efter anmodning fra EMEA.
English: Alisade has virtually no taste or smell.
Danish: Alisade har stort set ingen smag og ingen lugt.
English: • Do not use in children under 6 years old.
Danish: • Må ikke anvendes til børn under 6 år.
English: Never pass it on to others.
Danish: Lad derfor være med at give det til andre.
English: Risk Management plan
Danish: Risikostyringsplan
English: In addition, an updated RMP should be submitted
Danish: Yderligere skal der indsendes en opdateret RMP:
English: Allergic reactions: get a doctor's help straight away
Danish: Allergiske reaktioner: Søg straks lægehjælp
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Danish: • når der modtages ny information, der kan have indflydelse på nuværende sikkerhedsspecifikation, lægemiddelovervågningsplan eller på risikominimeringsaktiviteter
English: Six important things you need to know about using the nasal spray
Danish: Seks vigtige ting, du har brug for at vide om brug af næsesprayen
English: It is especially important to tell your doctor if you are taking, or have recently taken any of the following medicines:
Danish: Det er særligt vigtigt at fortælle lægen det, hvis du tager eller lige har taget et af følgende lægemidler:
English: • Alisade comes in a brown bottle.
Danish: • Alisade er i en brun flaske.
English: However, it is usually effective within 8 to 24 hours of use.
Danish: Men normalt begynder det at virke i løbet af 8-24 timer.
English: • Use at the same time each day.
Danish: • På samme tidspunkt hver dag
English: • Irritation or discomfort in the inside of the nose - you may also get streaks of blood when you blow your nose.
Danish: • Irritation og ubehag i næsen - måske også spor af blod, når du pudser næse.
English: It may harm them, even if their symptoms seem the same as yours.
Danish: Det kan være skadeligt for andre, selvom de har samme symptomer, som du har.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Danish: • inden for 60 dage efter en vigtig milepæl er nået (lægemiddelovervågning eller risikominimering)
English: Allergic reactions to Alisade are rare and affect less than 1 person in 1,000.
Danish: Allergiske reaktioner over for Alisade er sjældne og forekommer hos færre end 1 ud af 1000 personer.
English: See a doctor as soon as possible.
Danish: Søg lægehjælp hurtigst muligt.
English: In some patients this can cause irritation in the inside of the nose.
Danish: Hos nogle patienter kan det forårsage irritation i næsen.
English: PHARMACEUTICAL FORM Nasal spray, suspension.
Danish: LÆGEMIDDELFORM Næsespray, suspension.
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http://www.emea.europa.eu/
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs (EMEAs) hjemmeside http://www.emea.europa.eu/.
English: The expiry date refers to the last day of the month.
Danish: Udløbsdatoen (Exp) er den sidste dag i den nævnte måned.
English: The following convention has been used for the classification of frequencies: Very common >1/10; Common >1/100 to <1/10; Uncommon >1/1000 to <1/100; Rare >1/10,000 to <1/1000; Very rare
Danish: Hyppigheden defineres således: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000) og meget sjælden (<1/10.000).
English: Like all medicines, Alisade can cause side effects, although not everybody gets them.
Danish: Alisade kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Tell your doctor if you had these conditions in the past, or if you notice any change in your vision while you are taking Alisade
Danish: Du skal fortælle din læge, hvis du tidligere har haft sådanne ændringer i øjet, eller hvis du bemærker, at dit syn ændres, mens du er i behandling med Alisade.
English: Distribution: The plasma protein binding of fluticasone furoate is greater than 99 %.
Danish: Fordeling: Proteinbindingen af fluticasonfuroat i plasma er over 99 %.
English: Clinical experience:
Danish: Klinisk erfaring:
English: This is important as Alisade is a thick suspension that becomes liquid when you shake it well - see picture b. It will only spray when it becomes liquid.
Danish: Dette er vigtigt, fordi Alisade er en tyk suspension, som bliver flydende, når du ryster den grundigt - se billede b. Den kan kun afgive et pust, når den er flydende.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Danish: Som angivet i CHMP's "Guideline on Risk Management Systems for Medicinal Products for Human Use" skal den opdaterede RMP indsendes samtidig med den næste periodiske sikkerhedsopdatering (Periodic Safety Update Report, PSUR).
English: INFORMATION IN BRAILLE alisade
Danish: INFORMATION I BRAILLE-SKRIFT Alisade
English: Further, there were no treatment-related increases in the incidence of tumours in two year inhalation studies in rats and mice.
Danish: Der var heller ingen behandlingsrelaterede stigninger i forekomst af tumorer ved to års inhalationsforsøg hos rotter og mus.
English: Your doctor will assess whether you should take Alisade with these medicines.
Danish: Lægen vurderer, om du kan tage Alisade sammen med disse lægemidler.
English: • If you have difficulty pressing the button with your thumb, you can use two hands - see picture d
Danish: • Hvis du har problemer med at trykke på dosisknappen med tommelfingeren, kan du bruge begge hænder - se billede d.
English: The exposure of fluticasone furoate is likely to be further increased in such patients.
Danish: Påvirkningen af fluticasonfuroat øges sandsynligvis yderligere hos disse patienter.
English: Always use Alisade exactly as your doctor has told you.
Danish: Brug altid Alisade nøjagtigt efter lægens anvisning.