FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with Ecalta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ecalta, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It works by interfering with the production of a component of the fungal cell wall called 1,3 β D glucan, which is necessary for the fungus to continue living and growing.
Danish: Det virker ved at påvirke produktionen af en komponent i svampens cellevæg, som kaldes 1,3-β-D-glucan.
English: The active substance in Ecalta, anidulafungin, is an antifungal medicine, which belongs to the group ‘echinocandins'.
Danish: Det aktive stof i Ecalta, anidulafungin, er et svampemiddel, der tilhører echinocandingruppen.
English: Ecalta is given as an initial dose of 200 mg on day one, followed by 100 mg each day from day two.
Danish: Ecalta indgives med en startdosis på 200 mg på dag et, efterfulgt af 100 mg dagligt fra dag to. Ecalta må kun indgives ved infusion med en maksimal hastighed på 1,1 mg pr. minut for at undgå
English: Why has Ecalta been approved?
Danish: Hvorfor blev Ecalta godkendt?
English: The list of fungi against which Ecalta is active can be found in the summary of product characteristics (also part of the EPAR).
Danish: Listen over svampe, som Ecalta virker mod, fremgår af produktresuméet (også en del af denne EPAR).
English: For the full list of all side effects reported with Ecalta, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Ecalta fremgår af indlægssedlen.
English: For practical information about using Ecalta, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Ecalta, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What is Ecalta?
Danish: Hvad er Ecalta?
English: Ecalta should only be given by infusion, at a maximum rate of 1.1 mg per minute to avoid side effects: this corresponds to about three hours for the initial infusion, and one and a half hours for the subsequent infusions.
Danish: Dette svarer til ca. 3 timer for den første infusion og 1,5 time for de efterfølgende infusioner.
English: Ecalta is a powder that is made up into a solution for infusion (drip) into a vein.
Danish: Ecalta leveres som et pulver, som blandes til en infusionsvæske, opløsning, til drop i en vene.
English: What benefit has Ecalta shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Ecalta?
English: How has Ecalta been studied?
Danish: Hvordan blev Ecalta undersøgt?
English: What is Ecalta used for?
Danish: Hvad anvendes Ecalta til?
English: How is Ecalta used?
Danish: Hvordan anvendes Ecalta?
English: How does Ecalta work?
Danish: Hvordan virker Ecalta?
English: On a regular basis
Danish: På regelmæssig basis
English: ATCvet code: QI02AA.
Danish: ATCvet-kode: QI02AA.
English: Off-white or pink liquid.
Danish: Off-white eller lyserød væske.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/02/2015
Danish: 9 DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 06/02/2015
English: Continue to develop a test to quantify saponin in the finished product and provide regular updates on results
Danish: Fortsætte med at udvikle en test til kvantificering af saponin i det færdige produkt og indsende regelmæssige opdateringer af resultaterne
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Danish: Den aktive substans som principielt er af biologisk oprindelse hvis formål er at producere aktiv immunitet falder ikke indenfor anvendelsesområdet af Forordning (EF) Nr. 470/2009.
English: Store and transport refrigerated (2 °C - 8 °C).
Danish: Opbevares og transporteres nedkølet (2 °C - 8 ºC).
English: Provide batch records for a second batch of finished product manufactured according to the dossier
Danish: Indsende batchfortegnelser for en ny batch af det færdige produkt, der er fremstillet i henhold til dossieret
English: Can be used from 2 months of pregnancy and onwards.
Danish: Kan anvendes fra 2. drægtighedsmåned og fremefter.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after “EXP”.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på den ydre emballage og etiketten efter EXP.
English: Provide stability results for batch 19512 at the end of shelf life
Danish: Indsende resultater fra stabilitetsundersøgelser for batch 19512 efter udløbsdatoen
English: Inactivated Schmallenberg virus, strain BH80/11-4
Danish: Inaktiveret Schmallenberg-virus, stamme BH80/11-4
English: At next commercial batch manufacture
Danish: Ved fremstilling af den næste salgsbatch
English: MARKETING AUTHORISATION NUMBER(S) EU/2/14/178/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/2/14/178/001
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne (inklusive adjuvanter) anført under punkt 6.1 i SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet, eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: Subcutaneous use (in the axillar region behind the elbow).
Danish: Subkutan anvendelse (i aksilregionen bag albuen).
English: Intramuscular use (in the neck).
Danish: Intramuskulæranvendelse (i nakken).
English: Sheep: subcutaneous use.
Danish: Får: subkutan anvendelse.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Inactivated Schmallenberg virus (RP ≥ 1/dose)
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Inaktiveret Schmallenberg-virus (RP ≥ 1/dosis)
English: To stimulate active immunity against Schmallenberg virus in cattle and sheep.
Danish: Til stimulation af aktiv immunitet mod Schmallenberg-virus hos kvæg og får.
English: Sheep: Safety data are available to demonstrate the safety of the vaccine when administered to pregnant sheep.
Danish: Får: Sikkerhedsdata er tilgængelige til at demonstrere vaccinens sikkerhed, når den administreres til drægtige får.
English: Aluminium hydroxide Saponin
Danish: Aluminiumhydroxid Saponin
English: Shelf life of the veterinary medicinal product as packaged for sale: 1 year.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 1 år.
English: Pharmacotherapeutic group: immunologicals for bovidae, inactivated viral vaccines for cattle.
Danish: Farmakoterapeutisk gruppe: Immunologiske midler til bovidae, inaktiverede virale vacciner til kvæg.
English: Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dihydrate Sodium chloride Water for injections
Danish: Kaliumchlorid Kaliumdihydrogenphosphat Dinatriumphosphatdihydrat Natriumchlorid Vand til injektionsvæsker
English: Provide data to support the effectiveness of the antimicrobial preservative at the end of shelf life
Danish: Indsende data til understøttelse af virkningen af det antimikrobielle konserveringsmiddel efter udløbsdatoen
English: ADVICE ON CORRECT ADMINISTRATION Shake the vial before use.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Ryst hætteglasset før brug.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial (50 ml)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Hætteglas (50 ml)
English: * Below the level of detection by the validated RT-PCR method at 3.6 log10 RNA copies/ml of plasma for cattle and at 3.4 log10 RNA copies/ml of plasma for sheep.
Danish: * Under detektionsgrænsen bestemt med den validerede RT-PCR-metode på 3,6 log10 RNA kopier/ml plasma hos kvæg og på 3,4 log10 RNA kopier/ml plasma hos får.
English: Amount per 2 ml dose (cattle)
Danish: Mængde pr. 2 ml dosis (kvæg)
English: No information is available on the use of the vaccine in seropositive animals including those with maternally-derived antibodies.
Danish: Der foreligger ingen oplysninger om brugen af vaccinen til seropositive dyr herunder dyr med maternelle antistoffer.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Cattle: intramuscular use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Kvæg: intramuskulær anvendelse.
English: SC (sheep)
Danish: (kvæg) s.c. (får)
English: 4.5 Special precautions for use
Danish: 4.5 Særlige forholdsregler vedrørende brugen
English: Amount per 1 ml dose (sheep)
Danish: Mængde pr. 1 ml dosis (får)
English: Manufacturer responsible for batch release: Zoetis Manufacturing & Research Spain, S.L.
Danish: Fremstiller ansvarlig for batchfrigivelse: Zoetis Manufacturing & Research Spanien, SL Ctra.
English: Shake the vial before use.
Danish: Ryst hætteglasset før brug.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Active substance:
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Aktivt stof:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton
English: 0.1 mg * Relative potency (mice potency test) compared to a reference vaccine that was shown efficacious in the target animal species
Danish: 0,1 mg *Relativ styrke (styrketest i mus) som blev sammenlignet med en referencevaccine, der blev påvist at være effektiv hos dyrearterne
English: 0.1 mg * Relative potency (mice potency test) compared to a reference vaccine that was shown efficacious in the target animal species.
Danish: 0,1 mg * Relativ styrke (styrketest i mus) som blev sammenlignet med en referencevaccine, der blev påvist at være effektiv hos dyrearterne.
English: Special precautions for use in animals: Vaccinate only healthy animals.
Danish: Special forholdsregler til brug hos dyr: Kun raske dyr må vaccineres.
English: ZULVAC SBV is available in a cardboard box with 1 high density polyethylene (HDPE) vial with chlorobutyl stopper and aluminium seal, containing 50 ml of vaccine.
Danish: Zulvac SBV fås i æsker med 1 High Density Polyethylene (HDPE) hætteglas med chlorobutylprop forseglet med aluminiumshætte, indeholdende 50 ml vaccine.
English: WITHDRAWAL PERIOD Withdrawal period: Zero days.
Danish: TILBAGEHOLDELSESTID Tilbageholdelsestid: 0 dage.
English: PACKAGE SIZE
Danish: PAKNINGSTØRRELSE
English: D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Danish: ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: EXPIRY DATE EXP {month/year} Once broached, use immediately.
Danish: UDLØBSDATO EXP {måneder/år} Anvendes straks efter anbrud.
English: Incompatibilities: Do not mix with any other veterinary medicinal product.
Danish: Uforligeligheder Må ikke blandes med andre lægemidler til dyr.
English: Local reactions may very commonly appear in the vaccinated animals in the form of diffuse swellings or subcutaneous granulomas of up to a maximum diameter of 8 cm.
Danish: Lokale reaktioner kan forekomme meget almindeligt hos vaccinerede dyr i form af diffuse hævelser eller subkutane granulomer med op til en maksimal diameter på 8 cm.
English: Onset of immunity: 21 days after vaccination.
Danish: Indtræden af immunitet: 21 dage efter vaccination.
English: Special precautions for use in animals Vaccinate only healthy animals.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr Kun raske dyr må vaccineres.
English: Name and address of the manufacturer of the biological active substance and the manufacturer responsible for batch release:
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof og fremstiller ansvarlig for batchfrigivelse:
English: Cardboard box with 1 high density polyethylene (HDPE) vial with chlorobutyl stopper and aluminium seal, containing 50 ml of vaccine.
Danish: Æske med 1 High Density Polyethylene (HDPE) hætteglas med chlorobutylprop forseglet med aluminiumshætte, indeholdende 50 ml vaccine.
English: Excipient: Thiomersal
Danish: Hjælpestof: Thiomersal
English: • OBLIGATION TO CONDUCT POST-AUTHORISATION MEASURES The MAH shall complete, within the stated timeframe, the following measures: Description
Danish: UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE Indehaveren af markedsføringstilladelse skal inden for den fastsatte tidsramme afslutte følgende foranstaltninger/tiltag:
English: For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Danish: Du bedes kontakte den lokale repræsentant for indehaveren af markedsføringstilladelsen, hvis du ønsker yderligere oplysninger om dette lægemiddel.
English: Duration of immunity: 6 months after vaccination.
Danish: Immunitetens varighed: 6 måneder efter vaccination.
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made by the veterinary surgeon on a case by case basis.
Danish: En eventuel beslutning om at anvende vaccinen umiddelbart før eller efter brug af et andet lægemiddel til dyr skal derfor tages af dyrlægen med udgangspunkt i det enkelte tilfælde.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZULVAC SBV suspension for injection for cattle and sheep
Danish: VETERINÆRLÆGEMIDLETS NAVN ZULVAC SBV injektionsvæske, suspension til kvæg og får
English: Shelf life after first opening the immediate packaging: use immediately.
Danish: Opbevaringstid efter første åbning af den indre emballage: anvendes straks.
English: ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: BILAG II A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Cattle:
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: Shelf life after first opening the container: use immediately.
Danish: Opbevaringstid efter første åbning af beholderen: anvendes straks
English: The reactions may last for at least 47 days in the form of diffuse swelling of less than 2 cm diameter.
Danish: Reaktionerne kan vare mindst 47 dage i form af diffus hævelse på mindre end 2 cm i diameter.
English: In case of accidental self-injection seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: Særlige forsigtighedsregler for personer, der indgiver lægemidlet til dyr I tilfælde af selvinjektion ved hændeligt uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: TARGET SPECIES Cattle and sheep
Danish: DYREARTER Kvæg og får
English: Booster vaccination: - For non-breeding sheep: administer one dose of 1 ml, every 6 months.
Danish: Booster-vaccination: - Får der ikke anvendes til avl: administrer 1 dosis på 1 ml, hver 6. måned.
English: Vaccination of breeding sheep before pregnancy according to the recommended schedule described in section 8 results in reduction of viraemia* and transplacental infection associated with infection by Schmallenberg virus during the first trimester of pregnancy.
Danish: Vaccination af avlsfår før drægtighed i henhold til den anbefalede tidsplan beskrevet i afsnit 8 resulterer i reduktion af viræmi * og transplacental infektion i forbindelse med infektion, som er forårsaget af Schmallenberg-virus i drægtighedens første trimester.
English: PACKAGE LEAFLET FOR: ZULVAC SBV suspension for injection for cattle and sheep
Danish: INDLÆGSSEDDEL TIL: ZULVAC SBV injektionsvæske, suspension til kvæg og får
English: Booster vaccination: administer two doses of 2 ml three weeks apart, every twelve months.
Danish: Booster-vaccination: Administrer 2 doser på 2 ml med tre ugers mellemrum hver 12. måned.
English: In pregnant ewes, a transient increase in rectal temperature, not exceeding 0.8 ºC, may very commonly occur during the first 4 hours after vaccination.
Danish: Hos drægtige moderfår kan en forbigående stigning i rektaltemperaturen, der ikke overstiger 0,8 °C, meget almindeligt forekomme i løbet af de første 4 timer efter vaccination.
English: The reactions may persist for at least 97 days in the form of small granules of less than 0.5 cm of diameter.
Danish: Reaktionerne kan vare mindst 97 dage i form af små granula på mindre end 0,5 cm i diameter.
English: In cattle, a transient increase in rectal temperature, not exceeding 1.5 °C, may very commonly occur during the 48 hours following vaccination.
Danish: Hos kvæg kan en forbigående stigning i rektaltemperaturen, der ikke overstiger 1,5 °C, forekomme meget almindeligt i løbet af de første 48 timer efter vaccination.
English: Vaccination of breeding sheep before pregnancy according to the recommended schedule described in section 4.9 results in reduction of viraemia* and transplacental infection associated with infection by Schmallenberg virus during the first trimester of pregnancy.
Danish: Vaccination af avlsfår før drægtighed i henhold til den anbefalede tidsplan beskrevet i afsnit 4.9 resulterer i reduktion af viræmi* og transplacental infektion i forbindelse med infektion, som er forårsaget af Schmallenberg-virus i drægtighedens første trimester.
English: 4.4 Special warnings for each target species
Danish: 4.4 Særlige advarsler for hver enkel dyreart, som lægemidlet er beregnet til
English: In sheep, a transient increase in rectal temperature, not exceeding 1.5 ºC, may very commonly occur during the first 24 hours after vaccination.
Danish: Hos får kan en forbigående stigning i rektaltemperaturen, der ikke overstiger 1,5 °C, forekomme meget almindeligt i løbet af de første 24 timer efter vaccination.
English: For active immunisation of cattle from 3.5 months of age to reduce viraemia* associated with infection by Schmallenberg virus.
Danish: Til aktiv immunisering af kvæg fra 3,5 måneders alderen for at reducere viræmi* i forbindelse med infektion, som er forårsaget af Schmallenberg-virus.
English: For active immunisation of sheep from 3.5 months of age to reduce viraemia* associated with infection by Schmallenberg virus.
Danish: Til aktiv immunisering af får fra 3,5 måneders alderen for at reducere viræmi* i forbindelse med infektion, som er forårsaget af Schmallenberg-virus.
English: WITHDRAWAL PERIOD Zero days.
Danish: 10. TILBAGEHOLDELSESTID 0 dage.
English: Primary vaccination: - For cattle from 3.5 months of age: administer two doses of 2 ml three weeks apart.
Danish: Basisvaccination - Kvæg fra 3,5 måneders alderen: Administrer 2doser på 2 ml med 3 ugers mellemrum.
English: MARKETING AUTHORISATION HOLDER
Danish: 7 INDEHAVER AF MARKEDSFØRINGSTILLADELSEN
English: Duration of immunity: 12 months after completion of the primary vaccination course.
Danish: Immunitetens varighed: 12 måneder efter afslutning af basisvaccinationsprogrammet.
English: Primary vaccination: - For sheep from 3.5 months of age: administer one dose of 1 ml.
Danish: Basisvaccination - Får fra 3,5 måneders alderen: Administrer 1 dosis på 1 ml.
English: Local reactions may very commonly appear in the vaccinated animals in the form of small intramuscular granulomas up to 0.7 cm of diameter, which resolve in a maximum of 10 days.
Danish: Lokale reaktioner kan forekomme meget almindeligt hos vaccinerede dyr i form af små intramuskulære granulomer med en maksimal diameter på op til 0,7 cm.
English: 4.1 Target species
Danish: 4.1 Dyrearter, som lægemidler er beregnet til
English: Onset of immunity: 14 days after completion of the primary vaccination course.
Danish: Indtræden af immunitet: 14 dage efter afslutning af basisvaccinationsprogrammet.
English: AUTHORISATION
Danish: Beskrivelse
English: - For female breeding sheep: administer one dose of 1 ml at least 14 days prior to every breeding.
Danish: - Hos hunavlsfår: administrer 1 dosis på 1 ml senest 14 dage før hver parring.
English: Lactation: The safety and the efficacy of the vaccine have not been established in lactating animals.
Danish: Laktation: Vaccinens sikkerhed og virkning er ikke blevet fastlagt hos diegivende dyr.
English: Fertility: The safety and the efficacy of the vaccine have not been established in breeding males.
Danish: Fertilitet: Vaccinens sikkerhed og virkning er endnu ikke fastlagt hos avlshanner.
English: Cattle: The safety and efficacy of the vaccine has not been established in pregnant cattle.
Danish: Kvæg: Vaccinens sikkerhed og virkning er endnu ikke fastlagt hos drægtigt kvæg.
English: Lactation: The safety and the efficacy of the vaccine have not been established during lactation.
Danish: Laktation: Vaccinens sikkerhed og virkning under laktation er ikke fastlagt.
English: Cattle: The safety and efficacy of the vaccine have not been established during pregnancy.
Danish: Kvæg: Vaccinens sikkerhed og virkning er endnu ikke fastlagt under drægtighed.
English: - For female sheep at breeding age: administer one dose of 1 ml at least 14 days prior to breeding.
Danish: - Hunfår i avlsalderen: Administrer 1 dosis på 1 ml senest 14 dage før parring.
English: Further information on Ambrisentan Mylan can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ambrisentan-mylan.
Danish: Yderligere information om Ambrisentan Mylan findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/ambrisentan-mylan.
English: The ‘class' reflects the severity of the disease: ‘class II' involves slight limitation of physical activity and ‘class III' involves marked limitation of physical activity.
Danish: "Funktionsklassen" afspejler sygdommens sværhedsgrad: "Funktionsklasse II" omfatter lettere begrænsning af fysisk aktivitet, og "funktionsklasse III" omfatter markant begrænsning af fysisk aktivitet.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Danish: To lægemidler er bioækvivalente, når de giver de samme niveauer af det aktive stof i kroppen, og de derfor forventes at have samme effekt.
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Danish: Virksomheden har også foretaget et studie, der har vist, at det er "bioækvivalent" med referencelægemidlet.
English: As for every medicine, the company provided studies on the quality of Ambrisentan Mylan.
Danish: Som for alle lægemidler har virksomheden leveret studier vedrørende kvaliteten af Ambrisentan Mylan.
English: Ambrisentan Mylan is available as tablets (5 and 10 mg).
Danish: Ambrisentan Mylan fås som tabletter (5 og 10 mg).
English: Because Ambrisentan Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Ambrisentan Mylan er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som for referencelægemidlet.
English: The company that markets Ambrisentan Mylan will provide a patient card containing important information on the medicine's side effects and the need to avoid pregnancy during treatment.
Danish: Virksomheden, der markedsfører Ambrisentan Mylan, vil udlevere et patientkort med vigtige oplysninger om lægemidlets bivirkninger og nødvendigheden af at undgå graviditet under behandlingen.
English: As for all medicines, data on the use of Ambrisentan Mylan are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Ambrisentan Mylan løbende overvåget.
English: Ambrisentan Mylan is a medicine that is used alone or combined with other medicines to treat adults with pulmonary arterial hypertension (PAH).
Danish: Ambrisentan Mylan er et lægemiddel, der anvendes alene eller i kombination med andre lægemidler til behandling af voksne med pulmonal arteriel hypertension (PAH).