FrancophonIA/ELRC3.0 huggingface dataset:
English: To obtain the best possible pain relieving effect post surgery Melovem should be administered 30 minutes before surgical intervention.
Danish: For at opnå den bedst mulige post-operative smertelindrende effekt, bør Melovem administreres 30 minutter før et kirurgisk indgreb.
English: N-Methylpyrrolidone Water for injection
Danish: N-Methylpyrrolidone Vand til injektionsvæsker
English: EXP {month/year}
Danish: EXP: {MM/ÅÅÅÅ}
English: BATCH NUMBER Lot: {number}
Danish: BATCHNUMMER Lot {nummer}
English: MANUFACTURER'S BATCH NUMBER Lot: {number}
Danish: FREMSTILLERENS BATCHNUMMER Parti: {nummer}
English: EXPIRY DATE EXP {month/year} Once broached use within 28 days.
Danish: 10. UDLØBSDATO EXP {MM/ÅÅÅÅ} Efter anbrud anvendes inden 28 dage.
English: Treatment of calves with Melovem 20 minutes before dehorning reduces post-operative pain.
Danish: Behandling af kalve med Melovem 20 minutter før afhorning reducerer postoperativ smerte.
English: Treatment of piglets with Melovem before castration reduces post operative pain.
Danish: Behandling af smågrise med Melovem inden kastration reducerer post-operative smerter.
English: In the case of overdosage symptomatic treatment should be initiated.
Danish: I tilfælde af overdosering bør symptomatisk behandling initieres.
English: For the relief of post operative pain associated with minor soft tissue surgery such as castration.
Danish: Til lindring af post-operative smerter i forbindelse med mindre bløddelskirurgi såsom kastration.
English: WITHDRAWAL PERIOD Cattle:
Danish: 10. TILBAGEHOLDELSESTIDER Kvæg:
English: SPECIAL STORAGE CONDITIONS Keep the injection vial in the outer carton in order to protect from light.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Behold hætteglasset med injektionsvæske i den ydre emballage, så det beskyttes mod lys.
English: 150 mg A clear yellow solution.
Danish: 150 mg Klar gul opløsning.
English: People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Danish: Personer med kendt overfølsomhed over for nonsteroide antiinflammatoriske stoffer (NSAID-præparater) bør undgå kontakt med veterinærlægemidlet.
English: Cattle: Subcutaneous or intravenous use Pigs: Intramuscular use Horses: Intravenous use Read the package leaflet before use.
Danish: Kvæg: Subkutan eller intravenøs anvendelse Grise: Intramuskulær anvendelse Heste: Intravenøs anvendelse Læs indlægssedlen inden brug.
English: Disposal: read package leaflet.
Danish: Bortskaffelse: Læs indlægsseddel.
English: Special precautions for use in animals
Danish: Forsigtighedsregler vedrørende brug til dyr
English: Elimination Meloxicam is eliminated with a half-life of 26 hours after subcutaneous injection in young cattle.
Danish: Elimination Meloxicam elimineres med en halveringstid på 26 timer efter subkutan injektion hos ungkvæg.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, If APPLICABLE
Danish: TEKSTEN “KUN TIL DYR” SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, om nødvendigt
English: Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Danish: Må ikke anvendes i tilfælde af overfølsomhed over for det aktive stof, eller et eller flere af hjælpestofferne.
English: In pigs, after intramuscular administration, the mean plasma biological elimination half-life is approximately 2.5 hours.
Danish: Hos grise, efter intramuskulær administration, er den gennemsnitlige halveringstid ca. 2,5 time.
English: Animal species
Danish: Restmarkør Dyrearter
English: Water for injection
Danish: Vand til injektionsvæske
English: Cardboard box with 1 colourless glass injection vial of 50 ml, 100 ml or 250 ml.
Danish: Karton med enten 1 farveløse hætteglas hver indeholdende 50 ml, 100 ml eller 250 ml.
English: Overdose (symptoms, emergency procedures, antidotes): In the case of overdosage, symptomatic treatment should be initiated.
Danish: Overdosis (symptomer, nødforanstaltninger, modgift): I tilfælde af overdosering bør symptomatisk behandling initieres.
English: Hydrochloric acid/sodium hydroxide Macrogol 300
Danish: Saltsyre/natriumhydroxid Macrogol 300
English: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic effects.
Danish: Meloxicam er et non-steroidt antiinflammatorisk stof (NSAID) i oxicam gruppen, som virker ved hæmning af prostaglandin syntesen, og derved udøver det en antiinflammatorisk, antiekssudativ, analgetisk og antipyretisk effekt.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) each ml contains:
Danish: ANGIVELSE AF DE AKTIVE STOFFER OG ANDRE INDHOLDSSTOFFER Hver ml indeholder:
English: Keep injection vial in the outer carton in order to protect from light.
Danish: Behold hætteglasset med injektionsvæske i den ydre emballage, så det beskyttes mod lys.
English: Overdose (symptoms, emergency procedures, antidotes) In the case of overdose, symptomatic treatment should be initiated.
Danish: Overdosis (symptomer, nødforanstaltninger, modgift) I tilfælde af overdosering bør symptomatisk behandling initieres.
English: PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Glass vial 50 ml
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Hætteglas 50 ml
English: Hydrochloric acid/sodium hydroxide Macrogol 1500
Danish: Benzylalkohol Saltsyre/natriumhydroxid Macrogol 1500
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Glass vial 100 ml and 250 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Hætteglas 100 ml og 250 ml
English: Horses: IV
Danish: Heste: i.v.
English: EXPIRY DATE EXP {month/year} Once broached use by…
Danish: UDLØBSDATO EXP {MM/ÅÅÅÅ} Efter anbrud brug af …
English: Transient swelling at the injection site was observed in clinical studies following intramuscular administration in pigs.
Danish: I kliniske undersøgelser blev der iagttaget forbigående hævelse på injektionsstedet efter intramuskulær administration hos grise.
English: Meglumine Water for injection
Danish: Natriumcitrat Vand til injektionsvæsker
English: Cardboard box with 1 colourless, type I glass injection vial of 50 ml, 100 ml and 250 ml closed with a bromobutyl rubber stopper and sealed with an aluminium cap.
Danish: Karton med 1 farveløst type I-hætteglas à 50 ml, 100 ml og 250 ml som er lukket med en bromobutyl gummiprop og forseglet med aluminiumshætte.
English: Cardboard box with 1 colourless type I glass injection vial of 100 ml, which is closed with a bromobutyl rubber stopper and sealed with an aluminium cap.
Danish: Karton med 1 farveløst type I-hætteglas à 100 ml, som er lukket med en bromobutyl gummiprop og forseglet med aluminiumshætte.
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
Danish: ORDENE “OPBEVARES UTILGÆNGELIGT FOR BØRN” Opbevares utilgængeligt for børn.
English: Meat and offal: 15 days Milk:
Danish: Kød og indmad: 15 dage Mælk:
English: Cattle: subcutaneous use Pigs: intramuscular use Read the package leaflet before use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Kvæg: Subkutan anvendelse Grise: Intramuskulær anvendelse Læs indlægssedlen inden brug.
English: Cattle: meat and offal: 15 days; milk: 5 days Pigs: meat and offal: 5 days
Danish: Kvæg: kød og indmad: 15 dage; mælk: 5 dage Grise: kød og indmad: 5 dage
English: TARGET SPECIES Cattle (calves and young cattle) and pigs
Danish: DYREARTER Kvæg (kalve og ungkvæg) og grise
English: Pregnancy and lactation Can be used during pregnancy and lactation.
Danish: Anvendelse under drægtighed og laktation Kan anvendes under drægtighed og laktation.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports)
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (mere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (mere end 1, men mindre end 10 dyr i 100 dyr) - Ualmindelige (mere end 1, men mindre end 10 dyr i 1.000 dyr) - Sjældne (mere end 1, men mindre end 10 dyr ud af 10.000 dyr) - Meget sjælden (mindre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter)
English: Interactions with other medicinal products and other forms of interaction Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.
Danish: Interaktion med andre lægemidler og andre former for interaktion Må ikke gives samtidig med glucokortikosteroider, anden non-steroid antiinflammatorisk behandling eller sammen med anti-koagulantia.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Glass vial
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Hætteglas
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (mere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (mere end 1, men mindre end 10 dyr ud af 100 dyr) - Ualmindelige (mere end 1, men mindre end 10 dyr ud af 1.000 dyr) - Sjældne (mere end 1, men mindre end 10 dyr ud af 10.000 dyr) - Meget sjælden (mindre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter).
English: After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 μg/ml and 2.7 μg/ml were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.
Danish: Efter en enkelt subkutan dosis på 0,5 mg meloxicam/kg opnåedes Cmax værdier på 2,1 µg/ml efter 7,7 timer og 2,7 µg/ml efter 4 timer hos henholdsvis ungkvæg og lakterende køer.
English: Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATCvet code: QM01AC06.
Danish: Farmakoterapeutisk gruppe: Antiinflammatoriske og antireumatiske lægemidler, non-steroider (oxicam).
English: Manufacturer responsible for batch release: Dopharma B.V.
Danish: Fremstiller ansvarlig for batchfrigivelse: Dopharma B.V.
English: Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.
Danish: Må ikke gives samtidig med glucokortikosteroider, andre non-steroid antiinflammatoriske lægemidler eller sammen med antikoagulantia.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: B. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN, HERUNDER BEGRÆNSNINGER FOR UDLEVERING OG BRUG
English: TARGET SPECIES Cattle, pigs and horses
Danish: DYREARTER Kvæg, grise og heste
English: Transient swelling at the injection site was commonly reported in clinical studies following subcutaneous administration in cattle.
Danish: I kliniske undersøgelser blev der hyppigt indberettet forbigående hævelse på injektionsstedet efter subkutan administration hos kvæg.
English: NO ENTRY Antiinflammatory agents/ Nonsteroidal antiinflammatory agents
Danish: Antiinflammatoriske og antireumatiske lægemidler, nonsteroider
English: Accidental self-injection may give rise to pain.
Danish: Forsigtighedsregler for personer, som indgiver lægemidlet Tilfælde af selvinjektion kan medføre smerter.
English: In cattle and pigs, subcutaneous and intramuscular administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
Danish: Subkutan og intramuskulær administration tolereres godt hos kvæg og grise; kun hos mindre end 10 % af behandlet kvæg i kliniske studier sås let og forbigående hævelse på injektionsstedet efter subkutan injektion.
English: Pigs: IM
Danish: Grise: i.m.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Dopharma Research B.V.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Dopharma Research B.V.
English: Manufacturer responsible for the batch release Dopharma B.V.
Danish: Fremstiller ansvarlig for batchfrigivelse Dopharma B.V.
English: Cattle: meat and offal: 15 days.
Danish: Kvæg: kød og indmad: 15 dage
English: Following single intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.1 to 1.5 μg/ml was reached within 1 hour in pigs.
Danish: Efter en enkelt intramuskulær dosis på 0,4 mg meloxicam/kg opnåedes efter 1 time en Cmax værdi på 1,1 til 1,5 µg/ml hos grise.
English: TARGET SPECIES Cattle and pigs
Danish: DYREARTER Kvæg og grise
English: METHOD(S) AND ROUTES OF ADMINISTRATION Cattle: SC
Danish: ANVENDELSESMÅDE(R) OG INDGIVELSESVEJE Kvæg: s.c.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Meloxicam 5 mg/ml
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Meloxicam 5 mg/ml
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 2 år Opbevaringstid efter første åbning af den indre emballage: 28 dage.
English: Cattle: meat and offal: 15 days; milk: 5 days Pigs, horses: meat and offal: 5 days
Danish: Kvæg: kød og indmad: 15 dage; mælk: 5 dage Grise, heste: kød og indmad: 5 dage Må ikke anvendes til heste, hvis mælk er bestemt til menneskeføde.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Meloxicam 30 mg/ml
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Meloxicam 30 mg/ml
English: Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3.0 ml/100 kg body weight).
Danish: Enkelt intravenøs injektion på 0,6 mg meloxicam/kg legemsvægt (d.v.s. 3,0 ml/100 kg legemsvægt).
English: After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 μg/ml were reached after 7.7 hours in young cattle.
Danish: Efter en enkelt subkutan dosis på 0,5 mg meloxicam/kg opnåedes efter 7,7 timer Cmax værdier på 2,1 µg/ml hos ungkvæg.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Meloxicam 30 mg/ml
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Meloxicam 30 mg/ml
English: MARKETING AUTHORISATION HOLDER Dopharma Research B.V.
Danish: INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Dopharma Research B.V.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Meloxicam 20 mg/ml
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Meloxicam 20 mg/ml
English: ROUTE(S) OF ADMINISTRATION Cattle: SC
Danish: INDGIVELSESVEJ(E) Kvæg: s.c.
English: Cattle: SC or IV
Danish: Kvæg: s.c. eller i.v Grise: i.m.
English: Meat and offal: 5 days
Danish: Kød og indmad: 5 dage
English: PACKAGE LEAFLET FOR: Melovem 5 mg/ml solution for injection for cattle and pigs
Danish: INDLÆGSSEDDEL TIL: Melovem 5 mg/ml injektionsvæske, opløsning til kvæg og grise
English: Cattle: meat and offal: 15 days; milk: 5 days.
Danish: Kød og indmad: 15 dage Mælk: 5 dage
English: Pigs: Meat and offal: 5 days
Danish: Grise: kød og indmad: 5 dage
English: Meat and offal: 15 days.
Danish: Kød og indmad: 15 dage
English: Pigs: Intramuscular use
Danish: Grise: intramuskulær injektion.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 20 mg/ml solution for injection for cattle, pigs and horses Meloxicam
Danish: VETERINÆRLÆGEMIDLETS NAVN Melovem 20 mg/ml injektionsvæske, opløsning til kvæg, grise og heste Meloxicam
English: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/100 kg body weight) in combination with antibiotic therapy, as appropriate.
Danish: Enkelt intramuskulær injektion på 0,4 mg meloxicam/kg legemsvægt (d.v.s. 2,0 ml/100 kg legemsvægt) i kombination med passende antibiotika-behandling.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 5 mg/ml solution for injection for cattle and pigs
Danish: VETERINÆRLÆGEMIDLETS NAVN Melovem 5 mg/ml injektionsvæske, opløsning til kvæg og grise
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/006 (100 ml)
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/09/098/006 (100 ml)
English: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/150 kg body weight) in combination with antibiotic therapy, as appropriate.
Danish: Enkelt intramuskulær injektion på 0,4 mg meloxicam/kg legemsvægt (d.v.s. 2,0 ml/150 kg legemsvægt) i kombination med passende antibiotika-behandling.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 20 mg/ml solution for injection for cattle, pigs and horses
Danish: VETERINÆRLÆGEMIDLETS NAVN Melovem 20 mg/ml injektionsvæske, opløsning til kvæg, grise og heste
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/005 (50 ml)
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/09/098/005 (50 ml)
English: PACKAGE LEAFLET FOR Melovem 20 mg/ml solution for injection for cattle, pigs and horses
Danish: INDLÆGSSEDDEL Melovem 20 mg/ml injektionsvæske, opløsning til kvæg, grise og heste
English: METHOD AND ROUTE(S) OF ADMINISTRATION Cattle: Subcutaneous use
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Kvæg: subkutan injektion.
English: 4941 VX Raamsdonksveer THE NETHERLANDS
Danish: 4941 VX Raamsdonksveer Nederlandene
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/003 (100 ml)
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/09/098/003 (100 ml)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 30 mg/ml solution for injection for cattle and pigs.
Danish: VETERINÆRLÆGEMIDLETS NAVN Melovem 30 mg/ml injektionsvæske, opløsning til kvæg og grise.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 5 mg/ml solution for injection for cattle and pigs Meloxicam
Danish: VETERINÆRLÆGEMIDLETS NAVN Melovem 5 mg/ml injektionsvæske, opløsning til kvæg og grise Meloxicam
English: PACKAGE LEAFLET FOR Melovem 30 mg/ml solution for injection for cattle and pigs
Danish: INDLÆGSSEDDEL Melovem 30 mg/ml injektionsvæske, opløsning til kvæg og grise
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 30 mg/ml solution for injection for cattle and pigs Meloxicam
Danish: VETERINÆRLÆGEMIDLETS NAVN Melovem 30 mg/ml injektionsvæske, opløsning til kvæg og grise Meloxicam
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 30 mg/ml solution for injection for cattle and pigs
Danish: VETERINÆRLÆGEMIDLETS NAVN Melovem 30 mg/ml injektionsvæske, opløsning til kvæg og grise
English: METHOD AND ROUTE(S) OF ADMINISTRATION Cattle: SC
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Kvæg: s.c.
English: Pregnancy and lactation
Danish: Anvendelse under drægtighed og laktation:
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/002 (50 ml)
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/09/098/002 (50 ml)
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER(NUMRE) EU/2/09/098/001
English: Single subcutaneous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/150 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Danish: Enkelt subkutan injektion på 0,5 mg meloxicam/kg legemsvægt (d.v.s. 2,5 ml/150 kg legemsvægt), om nødvendigt i kombination med antibiotika-behandling eller med oral tilførsel af passende mængder vand.
English: ROUTE(S) OF ADMINISTRATION Cattle: SC or IV
Danish: INDGIVELSESVEJ(E) Kvæg: s.c. eller i.v Grise: i.m.
English: Single subcutaneous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 10.0 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Danish: Enkelt subkutan injektion på 0,5 mg meloxicam/kg legemsvægt (d.v.s. 10,0 ml/100 kg legemsvægt), om nødvendigt i kombination med antibiotika-behandling eller med oral tilførsel af passende mængder vand.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/005
Danish: MARKEDSFØRINGSTILLADELSENS NUMRE EU/2/09/098/005
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/002
Danish: MARKEDSFØRINGSTILLADELSENS NUMRE EU/2/09/098/002
English: Assessment was undertaken by a blinded observer.
Danish: Evaluering blev foretaget af en blindet observatør.
English: Date of first authorisation: 3 March 2017
Danish: Dato for første markedsføringstilladelse: 3. marts 2017
English: Do not apply Ledaga more than once per day.
Danish: Påfør ikke Ledaga mere end én gang om dagen.
English: The response criteria were the same as for CAILS.
Danish: Responskriterierne var de samme som for CAILS.
English: Response rates (%)
Danish: Responsrater (%)
English: Cutaneous hypersensitivity reactions were reported in 2.3% of the treated patients.
Danish: Kutane overfølsomhedsreaktioner blev rapporteret hos 2,3 % af de behandlede patienter.
English: • The opening of the tube is covered with a foil safety seal.
Danish: • Tubens åbning er dækket med en folie-sikkerhedforsegling.
English: Study medicinal product was to be applied topically once daily for 12 months.
Danish: Studielægemidlet skulle appliceres én gang dagligt i 12 måneder.
English: Topical use.
Danish: Topikal anvendelse.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel.
English: CAILS = Composite Assessment of Index Lesion Severity; CI = confidence interval; CR = Complete Response; PR = Partial Response; SWAT = Severity Weighted Assessment Tool.
Danish: CAILS = Composite Assessment of Index Lesion Severity; CI = konfidensinterval; CR = Komplet respons; PR = Delvist respons; SWAT = Severity Weighted Assessment Tool.
English: Do not stop using your medicine until your doctor advises you to do so.
Danish: Stop ikke med at bruge medicinen, før din læge råder dig dertil.
English: Treatment with Ledaga should be initiated by an appropriately experienced physician.
Danish: Behandling med Ledaga skal initieres af en læge med tilstrækkelig erfaring.
English: Blindness and severe irreversible anterior eye injury may occur.
Danish: Blindhed og alvorlig irreversibel anterior øjenskade kan forekomme.
English: Patients were not required to be refractory to or intolerant of prior therapies.
Danish: Det blev ikke krævet, at patienterne skulle være refraktære eller intolerante over for tidligere behandlinger.
English: • Fire, flame, and smoking must be avoided until Ledaga has dried.
Danish: • Ild, flammer og rygning skal undgås, indtil Ledaga er tørret.
English: A small number of subjects (6.3%, 8/128) treated with Ledaga utilised topical corticosteroids.
Danish: En lille antal forsøgspersoner (6,3 %, 8/128) behandlet med Ledaga brugte topikale kortikosteroider.
English: Frequencies were defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Danish: Hyppighederne er defineret som: 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); meget sjælden (< 1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Comparator N=95
Danish: Komparator N = 95
English: It attaches to the DNA of dividing cells, like cancer cells, which stops them from multiplying and growing.
Danish: Den binder sig til dna'et i celler, der deler sig, som f.eks. kræftceller, hvilket får dem til at holde op med at dele sig og vokse.
English: Cytotoxic: Handle with caution Flammable: Avoid fire, flame, and smoking
Danish: Cytotoksisk: Håndteres med forsigtighed Brandfarlig: Undgå ild, flammer og rygning