FrancophonIA/ELRC3.0 huggingface dataset:
English: The doctor will give you information on how not to get pregnant.
Danish: Lægen vil give dig oplysninger om, hvordan du undgår at blive gravid.
English: • The patient complies with the conditions for pregnancy prevention as listed above, including confirmation that she has an adequate level of understanding.
Danish: - Patienten overholder betingelserne for graviditetsforebyggelse som nævnt ovenfor, herunder bekræftelse på, at hun har et tilstrækkeligt forståelsesniveau.
English: If the prescribing physician is not in a position to provide such information the patient should be referred to the relevant healthcare professional
Danish: Hvis den ordinerende læge ikke er i stand til at give sådanne oplysninger, skal patienten henvises til relevant sundhedspersonale.
English: You must agree to extra pregnancy tests if your doctor asks you.
Danish: - Du skal acceptere at få foretaget ekstra graviditetstests, hvis din læge spørger dig.
English: Particulars to appear on the outer packaging
Danish: Mærkning, der skal anføres på den ydre emballage Ydre pakning
English: Your doctor must explain the risk of harm to the unborn baby - you must understand why you must not get pregnant and what you need to do to prevent getting pregnant.
Danish: - Din læge skal forklare risikoen for skade på det ufødte barn - du skal forstå, hvorfor du ikke må blive gravid, og hvad du skal gøre for at undgå at blive gravid.
English: When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result into low systemic exposure due to minimal dermal absorption.
Danish: Når de anvendes i overensstemmelse med ordinationsforskrifterne antages det, at topikalt administrerede retinoider resulterer i lav systemisk eksponering på grund af minimal dermal absorption.
English: • She understands the need for rigorous follow-up on a monthly basis.
Danish: - Hun forstår behovet for en streng månedlig opfølgning.
English: This monthly follow-up will allow ensuring that regular pregnancy testing and monitoring is performed and that the patient is not pregnant before receiving the next cycle of medication.
Danish: Denne månedlige opfølgning vil gøre det muligt at sikre, at regelmæssig graviditetstestning og overvågning udføres, og at patienten ikke er gravid, før hun får den næste omgang medicin.
English: 4.4 Special warnings and precautions for use Teratogenic effects [TRADENAME] is a powerful human teratogen inducing a high frequency of severe and life threatening birth defects.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Teratogene virkninger [HANDELSNAVN] er et kraftigt humant teratogen, der inducerer en høj frekvens af alvorlige og livstruende fødselsdefekter.
English: If the product is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued.
Danish: Hvis produktet anvendes under graviditet, eller hvis patienten bliver gravid, mens hun tager dette lægemiddel, bør behandlingen seponeres.
English: Patients should be instructed never to give this medicinal product to another person and to return any unused capsules to their pharmacist at the end of treatment.
Danish: Patienter bør oplyses om aldrig at give dette lægemiddel til en anden person og at returnere eventuelle ubrugte kapsler til apotekspersonalet ved behandlingens afslutning.
English: This may happen even if <TRADENAME> is taken only for a short time during pregnancy.
Danish: Dette kan ske selvom <HANDELSNAVN> kun tages kortvarigt under graviditeten.
English: • She is informed and understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy or if she might be pregnant.
Danish: - Hun er informeret og forstår de mulige konsekvenser af graviditet og behovet for øjeblikkelig konsultation, hvis der er risiko for graviditet, eller hvis hun måske er gravid.
English: You must use contraception even if you do not have periods or you are not sexually active (unless your doctor decides this is not necessary).
Danish: - Du skal bruge prævention, selvom du ikke har menstruationer, eller du ikke er seksuelt aktiv (medmindre din læge beslutter, det ikke er nødvendigt).
English: Do not use <TRADENAME>:
Danish: Brug ikke <HANDELSNAVN>:
English: ‘QR code to be included' + <URL>
Danish: 'QR-kode medtages' + <hjemmeside>
English: For more information on pregnancy and contraception, see section 2 ”Pregnancy and prevention programme”.
Danish: For yderligere oplysninger om graviditet og prævention, se punkt 2 "Svangerskabsforebyggelsesprogram".
English: If pregnancy occurs after stopping treatment there remains a risk of severe and serious malformation of the fetus.
Danish: Hvis graviditet opstår efter behandlingens ophør, er der risiko for alvorlig og kritisk misdannelse af fosteret.
English: Your doctor may tell you to stop taking <TRADENAME>.
Danish: Din læge kan sige til dig, at du skal stoppe med at tage <HANDELSNAVN>.
English: Please take any unused <capsules> to your pharmacist at the end of treatment.
Danish: Tag eventuelle ubrugte <kapsler> med til apoteket ved afslutningen af behandlingen.
English: This medicine can seriously harm an unborn baby (the medicine is said to be ‘teratogenic') - it can cause serious abnormalities of the unborn baby's brain, face, ear, eye, heart and certain glands (thymus gland and parathyroid gland).
Danish: Dette lægemiddel kan forårsage alvorlig skade på et ufødt barn (lægemidlet kaldes "teratogent") - det kan forårsage alvorlige abnormaliteter i det ufødte barns hjerne, ansigt, ører, øjne, hjerte og visse lymfekirtler (thymuskirtel og biskjoldbruskkirtel).
English: A contraindication should be added as follows: Section 2
Danish: Der skal tilføjes en kontraindikation som følger: Punkt 2
English: Before you start treatment, your doctor will ask you to take a pregnancy test.
Danish: - Inden du starter behandlingen, vil din læge bede dig om at tage en graviditetstest.
English: The need for repeated medically supervised pregnancy tests every month should be determined according to local practice including consideration of the patient's sexual activity, recent menstrual history (abnormal menses, missed periods or amenorrhea) and method of contraception.
Danish: Behovet for gentagne medicinsk overvågede graviditetstests hver måned bør bestemmes i henhold til lokal praksis, herunder overvejelse af patientens seksuelle aktivitet, nylig menstruationshistorik (unormale menstruationer, udeblevne menstruationer eller amenoré) og præventionsmetode.
English: • Becoming violent or aggressive
Danish: • Voldsom eller aggressiv adfærd.
English: This is because taking <TRADENAME> may affect your mood.
Danish: Dette skyldes, at <HANDELSNAVN> kan påvirke dit humør.
English: Advice for men
Danish: Rådgivning for mænd
English: This test should ensure the patient is not pregnant when she starts treatment with [INN].
Danish: Denne test skal sikre, at patienten ikke er gravid, når hun begynder behandling med [INN].
English: Neuropsychiatric disorders
Danish: Neuropsykiatriske forstyrrelser
English: If pregnancy occurs in a woman treated with [INN], treatment must be stopped and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice.
Danish: Hvis der opstår graviditet hos en kvinde, der behandles med [INN], skal behandlingen stoppes, og patienten skal henvises til en læge, der er specialiseret i eller har erfaring med teratologi, til vurdering og rådgivning.
English: Orally administered retinoids have been associated with congenital abnormalities.
Danish: Perorale retinoider har været forbundet med medfødte abnormiteter.
English: Section 4.4 Special warnings and precautions for use Psychiatric disorders
Danish: Punkt 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Psykiske forstyrrelser
English: The prescriber must ensure that:
Danish: Ordinerende læge skal sikre at:
English: Prescribing and dispensing restrictions
Danish: Restriktioner for receptudskrivning og udlevering
English: The warning on psychiatric disorders should be revised as follows:
Danish: Advarslen om psykiske forstyrrelser bør revideres som følger:
English: According to local practice, medically supervised pregnancy tests with a minimum sensitivity of 25mUI/mL are recommended to be performed, as follows.
Danish: I henhold til lokal praksis anbefales det at foretage medicinsk overvågede graviditetstests med en sensitivitet på mindst 25 mIE/ml som følger.
English: The available data suggest that the level of maternal exposure from the semen of the patients receiving [TRADENAME], is not of a sufficient magnitude to be associated with the teratogenic effects of [TRADENAME].
Danish: De tilgængelige data tyder på, at niveauet af den kvindelige eksponering over for sæden hos patienter, der får [HANDELSNAVN], ikke er tilstrækkelig stor til at være forbundet med [HANDELSNAVN]s teratogene virkninger.
English: In order to assist prescribers, pharmacists and patients in avoiding fetal exposure to [INN] the Marketing Authorisation Holder will provide educational material to reinforce the warnings about the teratogenicity of [INN], to provide advice on contraception before therapy is started and to provide guidance on the need for pregnancy testing.
Danish: For at hjælpe de ordinerende læger, apotekspersonale og patienter med at undgå at udsætte fosteret for [INN] vil indehaveren af markedsføringstilladelsen levere undervisningsmateriale for at forstærke advarslerne om de teratogene virkninger af [INN], rådgive om prævention før behandlingen startes og give vejledning om behovet for graviditetstests.
English: Female patients must be provided with comprehensive information on pregnancy prevention and should be referred for contraceptive advice if they are not using effective contraception.
Danish: Kvindelige patienter skal have omfattende information om graviditetsforebyggelse og bør henvises til præventionsrådgivning, hvis de ikke bruger effektiv prævention.
English: Mental problems
Danish: Psykiske problemer
English: − If you are planning a pregnancy
Danish: − Hvis du planlægger en graviditet.
English: Your doctor may send you to a specialist for advice.
Danish: Lægen kan sende dig til en specialist for rådgivning.
English: Very rare (may affect up to 1 in 10,000 people):
Danish: Meget sjældne (kan påvirke op til 1 ud af 10.000 personer):
English: Ideally, pregnancy testing, issuing a prescription and dispensing of [TRADENAME] should occur on the same day.
Danish: Idéelt set bør graviditetstest, udstedelse af recept og udlevering af [HANDELSNAVN] ske samme dag.
English: [for acitretin: ‘every 1 to 3 months for 3 years after stopping <TRADENAME>']
Danish: [for acitretin: 'hver 1 til 3 måneder i 3 år efter behandlingsstop med <HANDELSNAVN>']
English: Pregnancy prevention programme
Danish: Svangerskabsforebyggelsesprogram
English: This is because your mood may be affected while taking <TRADENAME>.
Danish: Dette skyldes, at dit humør kan påvirkes, når du tager <HANDELSNAVN>.
English: If you get pregnant while taking <TRADENAME>, stop taking the medicine straight away, and contact your doctor.
Danish: Hvis du bliver gravid, mens du tager <HANDELSNAVN>, skal du straks stoppe med at tage lægemidlet og kontakte din læge.
English: The doctor may send you to a specialist for contraception advice.
Danish: Lægen kan sende dig til en specialist for rådgivning om prævention.
English: You may not notice some changes in your mood and behaviour and so it is very important that you tell your friends and family that this medicine could affect your mood and behaviour.
Danish: Du bemærker måske ikke selv nogle ændringer i dit humør og din adfærd, og det er derfor meget vigtigt, at du fortæller dine venner og familie, at dette lægemiddel kan påvirke dit humør og din adfærd.
English: This risk persists until the product has been completely eliminated, which is within one month following the end of treatment [3 years for acitretin].
Danish: Denne risiko fortsætter, indtil produktet er fuldstændigt elimineret, hvilket er inden for en måned efter afslutningen af behandlingen [3 år for acitretin].
English: 1 month after stopping treatment, women should undergo a final pregnancy test.
Danish: 1 måned efter endt behandling skal kvinder få foretaget en endelig graviditetstest.
English: Women who are pregnant must not take <TRADENAME>
Danish: Kvinder, der er gravide, må ikke tage <HANDELSNAVN>
English: You may not notice some changes in your mood and behaviour and so it is very important that you tell your friends and family that you are taking this medicine.
Danish: Du bemærker måske ikke selv nogle ændringer i dit humør og din adfærd, og det er derfor meget vigtigt, at du fortæller dine venner og familie, at du tager dette lægemiddel.
English: Patients should be monitored for signs of depression and referred for appropriate treatment if necessary.
Danish: Patienter skal overvåges for tegn på depression og om nødvendigt henvises til passende behandling.
English: • If there is any chance you could become pregnant, you must follow the precautions under ”Pregnancy and prevention programme”, see section on ”Warnings and precautions”.
Danish: hvis der er nogen risiko for, at du kan blive gravid, skal du følge forholdsreglerne under "Svangerskabsforebyggelsesprogram", se punktet "Advarsler og forsigtighedsregler".
English: For women of childbearing potential, the prescription duration of [TRADENAME] should ideally be limited to 30 days in order to support regular follow up, including pregnancy testing and monitoring.
Danish: Fertile kvinder bør idéelt set kun få ordineret [HANDELSNAVN] til 30 dage for at understøtte regelmæssig opfølgning, herunder graviditetstest og overvågning.
English: Particular care should be taken in patients with a history of depression.
Danish: Der skal udvises særlig forsigtighed hos patienter med tidligere depression.
English: Where indicated, follow-up pregnancy tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the prescriber.
Danish: Hvis indikeret, bør opfølgende graviditetstests foretages på dagen, hvor lægemidlet ordineres eller i de 3 dage forud for besøget hos ordinerende læge.
English: You must agree to have regular pregnancy tests, ideally every month during treatment and, because some medicine may still be left in your body, 1 month after stopping <TRADENAME> (unless your doctor decides this is not necessary in your case).
Danish: - Du skal acceptere at få foretaget regelmæssige graviditetstest, helst hver måned under behandlingen, og, fordi nogle lægemidler stadig kan være i din krop, 1 måned efter behandlingsstop med <HANDELSNAVN> (medmindre din læge beslutter at det ikke er nødvendigt i dit tilfælde).
English: Depression, depression aggravated, anxiety, and mood alterations have been reported in patients treated with systemic retinoids, including <INN>.
Danish: Der er rapporteret om depression, forværring af depression, angst og humørændringer hos patienter, der er behandlet med systemiske retinoider, herunder <INN>.
English: • The patient understands that she must consistently and correctly use one highly effective method of contraception (i.e. a user-independent form) or two complementary user-dependent forms of contraception, for at least 1 month prior to starting treatment and is continuing to use effective contraception throughout the treatment period and for at least 1 month [3 years for acitretin] after cessation of treatment.
Danish: - Patienten forstår, at hun konsekvent og korrekt skal anvende en yderst effektiv præventionsmetode (dvs. en brugeruafhængig form) eller to komplementære brugerafhængige former for prævention, i mindst 1 måned før behandlingen påbegyndes og fortsætte med at anvende effektiv prævention i hele behandlingsperioden og i mindst 1 måned [3 år for acitretin] efter ophør af behandlingen.
English: Section 4.6 Fertility, pregnancy and breastfeeding:
Danish: Punkt 4.6 Fertilitet, graviditet og amning
English: The test must show that you are not pregnant when starting treatment with <TRADENAME>
Danish: Prøven skal vise, at du ikke er gravid, når du begynder behandling med <HANDELSNAVN>.
English: Women who could get pregnant are prescribed <TRADENAME> under strict rules.
Danish: Kvinder, der kan blive gravide, kan kun få udskrevet recept på <HANDELSNAVN> under strenge regler.
English: They may notice these changes and help you quickly identify any problems that you need to talk to your doctor about.
Danish: De lægger måske mærke til disse ændringer og kan hurtigt hjælpe dig med at identificere eventuelle problemer, som du skal tale med din læge om.
English: Women must use effective contraception before, during and after taking <TRADENAME>
Danish: Kvinder skal anvende effektiv prævention inden, under og efter de tager <HANDELSNAVN>.
English: They may notice these changes and help you identify any problems that you need to talk to your doctor about.
Danish: De lægger måske mærke til disse ændringer og kan hjælpe dig med at identificere eventuelle problemer, som du skal tale med din læge om.
English: Patients should not donate blood during therapy and for 1 month [3 years for acitretin] following discontinuation of [INN] because of the potential risk to the foetus of a pregnant transfusion recipient.
Danish: Patienter bør ikke donere blod under behandlingen og i 1 måned [3 år for acitretin] efter seponering af [INN] på grund af den potentielle risiko for fosteret hos en gravid transfusionsmodtager.
English: Particular care needs to be taken in patients with a history of depression and all patients should be monitored for signs of depression and referred for appropriate treatment if necessary.
Danish: Der skal udvises særlig forsigtighed hos patienter med tidligere depression, og alle patienter skal overvåges for tegn på depression og om nødvendigt henvises til passende behandling.
English: • [approved indications] (see section 4.1 „Therapeutic indications“).
Danish: 4.1 "Terapeutiske indikationer").
English: You should not donate blood during treatment with this medicine and for 1 month [3 years for acitretin] after stopping <TRADENAME> because an unborn baby could be harmed if a pregnant patient receives your blood.
Danish: Du må ikke give blod under behandling med dette lægemiddel og i 1 måned [3 år for acitretin] efter behandlingsstop med <HANDELSNAVN>, fordi et ufødt barn kan blive skadet, hvis en gravid patient modtager dit blod.
English: Contraception should be used for at least 1 month prior to starting treatment, throughout treatment and continue for at least 1 month [3 years for acitretin] after stopping treatment with [INN], even in patients with amenorrhea.
Danish: Der skal anvendes prævention i mindst 1 måned før behandlingen påbegyndes, under hele behandlingen, og der fortsættes i mindst 1 måned [3 år for acitretin] efter behandling med [INN] er ophørt, selv hos patienter med amenoré.
English: See section 4.8 for how to report adverse reactions.
Danish: Se punkt 4.8 om indberetning af bivirkninger.
English: Pregnancy, breastfeeding and fertility:
Danish: Graviditet, amning og fertilitet:
English: Women must agree to pregnancy testing before, during and after taking <TRADENAME>
Danish: Kvinder skal acceptere at få foretaget graviditetstests før, under og efter de tager <HANDELSNAVN>.
English: This includes depression, aggressive tendencies or mood changes.
Danish: Dette omfatter depression, aggressive tendenser eller humørsvingninger.
English: Follow-up visits should be arranged at regular intervals, ideally monthly.
Danish: Der skal aftales opfølgende besøg med jævne mellemrum, helst månedligt.
English: What you need to know before you take <TRADENAME>
Danish: Det skal du vide, før du begynder at tage <HANDELSNAVN>
English: Individual circumstances should be evaluated in each case, when choosing the contraception method involving the patient in the discussion, to guarantee her engagement and compliance with the chosen measures.
Danish: Individuelle forhold bør vurderes i hvert tilfælde, når der vælges præventionsmetode, ved at involvere patienten i diskussionen, for at sikre hendes engagement og overholdelse af de valgte foranstaltninger.
English: You must agree to regular follow-up visits, ideally every month.
Danish: - Du skal acceptere regelmæssige opfølgende besøg, helst hver måned.
English: A boxed warning should be added to the outer packaging for the oral retinoids acitretin, alitretinoin and isotretinoin as follows:
Danish: Den ydre emballage skal tilføjes en advarselsboks for de orale retinoider acitretin, alitretinoin og isotretinoin som følger:
English: <Detailed and updated information on this product is available by scanning the QR code included in the PL with a smartphone.
Danish: Følgende sætning skal indgå i slutningen af indlægssedlen (sidste sætning): <Detaljerede og opdaterede oplysninger om dette product kan fås ved at scanne QR-koden på indlægssedlen med en smartphone.
English: [for acitretin this last paragraph should be]
Danish: [for acitretin skal sidste afsnit være]
English: Suicide, suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour Package leaflet
Danish: Selvmord, selvmordsforsøg, selvmordstanker, psykotisk lidelse, unormal adfærd.
English: • She understands and accepts the need for effective contraception, without interruption, 1 month before starting treatment, throughout the entire duration of treatment and for 1 month [3 years for acitretin] after the end of treatment.
Danish: - Hun forstår og accepterer behovet for effektiv prævention, uden afbrydelse, 1 måned før behandlingen påbegyndes, igennem hele behandlingsforløbet og i 1 måned [3 år efter acitretin] efter behandlingens afslutning.
English: • Individual circumstances should be evaluated in each case, when choosing the contraception method, involving the patient in the discussion, to guarantee her engagement and compliance with the chosen measures.
Danish: - Individuelle forhold bør vurderes i hvert tilfælde, når der vælges præventionsmetode ved at involvere patienten i diskussionen, for at sikre hendes engagement og overholdelse af de valgte foranstaltninger.
English: You must use contraception for a month before taking <TRADENAME>, during treatment and for a month afterwards [for acitretin should be during 3 years]
Danish: - Du skal bruge prævention i en måned, før du tager <HANDELSNAVN>, under behandling og i en måned efter behandling [for acitretin skal det være i 3 år]
English: Depression, depression aggravated, aggressive tendencies, anxiety, mood alterations.
Danish: Depression, forværring af depression, aggressive tendenser, angst, humørsvingninger.
English: Signs of this include sad or altered mood, anxiety, feelings of emotional discomfort
Danish: Tegn på dette omfatter trist eller ændret humør, angst,
English: You must agree to use at least one very reliable method of contraception (for example an intra uterine device or contraceptive implant) or, two effective methods that work in different ways (for example a hormonal contraceptive pill and a condom).
Danish: - Du skal acceptere at bruge mindst en meget pålidelig præventionsmetode (f.eks. en spiral eller et antikonceptionsimplantat) eller to effektive metoder, der virker på forskellige måder (for eksempel p-piller og kondom).
English: Depression, depression aggravated, anxiety, aggressive tendencies, mood alterations, psychotic symptoms, and very rarely, suicidal ideation, suicide attempts and suicide have been reported in patients treated with <INN> (see section 4.8).
Danish: Der er rapporteret depression, forværring af depression, angst, aggressive tendenser, humørsvingninger, psykotiske symptomer, og meget sjældent selvmordstanker, selvmordsforsøg og selvmord hos patienter behandlet med <INN> (se pkt.
English: Section 4 Possible side effects
Danish: Punkt 4 Bivirkninger
English: Boxed warning
Danish: Advarselsboks
English: At least one highly effective method of contraception (i.e. a user-independent form) or two complementary user-dependent forms of contraception should be used.
Danish: Der bør anvendes mindst en meget effektiv præventionsmetode (dvs. en brugeruafhængig form) eller to komplementære brugerafhængige former for prævention.