FrancophonIA/ELRC3.0 huggingface dataset:
English: You must use effective birth control while taking Miglustat Gen.Orph.
Danish: De skal benytte effektiv prævention, mens De tager Miglustat Gen.Orph.
English: Until further information is available, it is advised that before seeking to conceive, male patients should cease Miglustat Gen.Orph and maintain reliable contraceptive methods for 3 months thereafter.
Danish: Indtil yderligere information foreligger, tilrådes det, at mandlige patienter, før konception, seponerer Miglustat Gen.Orph og anvender sikre kontraceptionsmetoder 3 måneder herefter (se pkt.
English: Don't stop taking Miglustat Gen.Orph without talking to your doctor.
Danish: Hvis De holder op med at tage Miglustat Gen.Orph Stop ikke med at tage Miglustat Gen.Orph uden at rådføre Dem med lægen.
English: NAME OF THE MEDICINAL PRODUCT Miglustat Gen.Orph 100 mg hard capsules
Danish: LÆGEMIDLETS NAVN Miglustat Gen.Orph 100 mg hårde kapsler
English: If you stop taking Miglustat Gen.Orph
Danish: Hvis De har glemt at tage Miglustat Gen.Orph
English: Delpharm Reims 10 rue Colonnel Charbonneaux 51100 Reims
Danish: 10 rue Colonnel Charbonneaux
English: What you need to know before you take Miglustat Gen.Orph 3.
Danish: Det skal De vide, før De begynder at tage Miglustat Gen.Orph
English: PHARMACEUTICAL FORM Hard capsule.
Danish: Hård kapsel.
English: NAME OF THE MEDICINAL PRODUCT Miglustat Gen.Orph 100 mg hard capsules miglustat
Danish: LÆGEMIDLETS NAVN Miglustat Gen.Orph 100 mg hårde kapsler miglustat
English: The benefit of treatment with Miglustat Gen.Orph for neurological manifestations in patients with Niemann-Pick type C disease should be evaluated on a regular basis, e.g. every 6 months; continuation of therapy should be re-appraised after at least 1 year of treatment with Miglustat Gen.Orph.
Danish: Fordelen ved behandling med Miglustat Gen.Orph ved neurologiske manifestationer hos patienter med Niemann- Picks sygdom, type C, skal evalueres regelmæssigt f.eks. hver 6. måned.
English: Male patients should maintain reliable contraceptive methods while taking Miglustat Gen.Orph.
Danish: Mandlige patienter bør anvende sikre kontraceptionsmetoder, mens de tager Miglustat Gen.Orph (se pkt.
English: Capsule contents
Danish: Kapslerne indeholder
English: How to take Miglustat Gen.Orph
Danish: Sådan skal De tage Miglustat Gen.Orph
English: What you need to know before you take Miglustat Gen.Orph Do not take Miglustat Gen.Orph - if you are allergic to miglustat or any of the other ingredients of this medicine
Danish: Tag ikke Miglustat Gen.Orph - hvis De er allergisk over for miglustat eller et af de øvrige indholdsstoffer i Miglustat Gen.Orph
English: The most common side effects are diarrhoea, flatulence (wind), abdominal (stomach) pain, weight loss and decreased appetite.
Danish: Meget almindelige bivirkninger - kan forekomme hos flere end 1 ud af 10 behandlede De almindeligste bivirkninger er diarré, flatulens (luft i maven), mavesmerter, vægttab og nedsat appetit.
English: Your doctor may reduce your dose, e.g., to one capsule (100 mg) once or twice a day, if you suffer from diarrhoea when taking Miglustat Gen.Orph (see section 4).
Danish: Hvis De lider af diarré under behandlingen med Miglustat Gen.Orph, vil Deres læge muligvis sætte Deres dosis ned, f.eks. til én kapsel (100 mg) én eller to gange dagligt (se pkt.
English: Nervous system disorders Very common
Danish: Meget almindelig Tremor Almindelig
English: Miglustat Gen.Orph 100 mg hard capsules are white opaque cap and body, hard gelatin capsules size 4 of 14.0 mm length.
Danish: Miglustat Gen.Orph 100 mg fås som hårde kapsler med en hvid uigennemsigtig overdel og underdel; kapslerne er fremstillet af hård gelatine, og de har str. 4 og en længde på 14 mm. Æske med 12 blisterpakninger hver indeholdende 7 kapsler, hvilket giver 84 kapsler i alt.
English: Growth should be monitored in paediatric and adolescent patients during treatment with Miglustat Gen.Orph; the benefit/risk balance should be re-assessed on an individual basis for continuation of therapy.
Danish: Fordel/risiko-balancen ved fortsat behandling skal revurderes på individuel basis.
English: Weight loss, decreased appetite
Danish: Metabolisme og ernæring Meget almindelig Vægttab, nedsat appetit
English: At steady state, the concentration of miglustat in cerebrospinal fluid of six type 3 Gaucher disease patients was 31.4-67.2% of that in plasma.
Danish: Dosis til børn på 200 mg 3 gange dagligt, justeret i forhold til legemsoverflade, resulterede i Cmax- og AUCτ-værdier, som var på ca. det dobbelte af det, som blev opnået efter 100 mg 3 gange dagligt hos patienter med Gauchers sygdom, type 1, hvilket er i overensstemmelse med miglustats dosis-lineære farmakokinetik.Hos seks patienter med Gauchers sygdom, type 3 var koncentrationen af miglustat i cerebrospinalvæske ved steady state 31,4-67,2% af indholdet i plasma.
English: Tremor
Danish: Amning
English: • There is insufficient data on Binocrit to know the size of any increased immunogenicity risk with sc use
Danish: • information om, at der ikke findes tilstrækkelig data om Binocrit til at kunne fastslå størrelse af den øgede risiko for immunogenicitet ved subkutan anvendelse
English: Most of these reactions occurred most likely in the first week during treatment.
Danish: De fleste af disse reaktioner sker højst sandsynligt i den første uge af behandlingen.
English: Adopted at the 5-8 March 2018 PRAC
Danish: Vedtaget på PRAC's møde den 5.-8. marts 2018
English: Frequency not known:
Danish: Hyppighed "ikke kendt":
English: The highest risk for occurrence of this serious skin reaction is within the first week of treatment.
Danish: Risikoen for forekomst af denne alvorlige hudreaktion er højest i løbet af den første uge af behandlingen.
English: Warnings and precautions - Take special care with cefalexin:
Danish: Advarsler og forsigtighedsregler - Vær særlig forsigtig med cefalexin:
English: TELL YOUR DOCTOR BEFORE TAKING CEFALEXIN:
Danish: Fortæl det til lægen, før du tager cefalexin:
English: If signs and symptoms suggestive of these reactions appear, cefalexin should be withdrawn immediately and an alternative treatment considered.
Danish: Hvis der opstår tegn og symptomer på sådanne reaktioner, bør cefalexin straks seponeres, og en alternativ behandling bør overvejes.
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/136578/2018
Danish: Ny ordlyd af produktinformation - uddrag af PRAC's anbefalinger vedrørende signaler EMA/PRAC/165788/2018
English: At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Danish: Ved ordinering bør patienterne gøres opmærksomme på tegn og symptomer og monitoreres nøje for hudreaktioner.
English: Stop using cefalexin if you develop these symptoms and contact your doctor or seek medical attention immediately.
Danish: Stop med at bruge cefalexin, hvis du udvikler disse symptomer, og kontakt straks din læge eller søg lægehjælp.
English: What do you need to know before you use cefalexin
Danish: Det skal du vide, før du begynder at bruge cefalexin
English: The most common location: mainly localized on the skin folds, trunk, and upper extremities.
Danish: Det hyppigste sted er primært i hudfolderne samt på kroppen og de øvre ekstremiteter.
English: AGEP appears at the initiation of treatment as a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever.
Danish: AGEP optræder ved påbegyndelse af behandlingen som et stort, rødt og skællende udslæt med knuder under huden og blæredannelse ledsaget af feber.
English: • If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking cefalexin or other antibacterials
Danish: • hvis du tidligere har oplevet et svært hududslæt eller hudafskalning, blæredannelse og/eller mundsår efter at have taget cefalexin eller andre antibakterielle midler
English: Norepinephrine - Stress cardiomyopathy (EPITT no
Danish: Norepinefrin - stressrelateret kardiomyopati (EPITT nr.
English: Cefalexin - Acute generalised exanthematous pustulosis (AGEP) (EPITT no 18911)
Danish: Cefalexin - Akut generaliseret eksantematøs pustulose (AGEP)(EPITT-nr. 18911)
English: Skin and subcutaneous tissue disorders (frequency: not known) Acute generalised exanthematous pustulosis (AGEP)
Danish: Hud og subkutane væv (hyppighed: ikke kendt) Akut generaliseret eksantematøs pustulose (AGEP)
English: Frequency ‘not known': Stress cardiomyopathy
Danish: Hyppighed "ikke kendt": Stressrelateret kardiomyopati
English: A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis).
Danish: Et stort, rødt og skællende udslæt med knuder under huden og blæredannelse ledsaget af feber ved påbegyndelse af behandlingen (akut generaliseret eksantamatøs pustulose).
English: Possible side effects
Danish: Oversigt over bivirkninger:
English: If you develop a serious rash or another of these skin symptoms, stop taking cefalexin and contact your doctor or seek medical attention immediately.
Danish: Hvis du udvikler et alvorligt udslæt eller får andre af disse hudsymptomer, skal du holde op med at tage cefalexin og straks kontakte din læge eller søge lægehjælp.
English: Acute generalised exanthematous pustulosis (AGEP) has been reported in association with cefalexin treatment.
Danish: Akut generaliseret eksantematøs pustulose (AGEP) er indberettet i forbindelse med behandling med cefalexin.
English: Acute generalised exanthematous pustulosis (AGEP) has been reported with the use of cefalexin.
Danish: Akut generaliseret eksantematøs pustulose (AGEP) er indberettet i forbindelse med brug af cefalexin.
English: The date for last use corresponds to the last day of the month mentioned.
Danish: Datoen for sidste anvendelse svarer til den sidste dag i den måned, der angives.
English: Do not be alarmed by this list of possible side effects.
Danish: Bliv ikke urolig over denne liste med mulige bivirkninger.
English: The following information is intended for medical or healthcare professionals only:
Danish: Følgende information er kun beregnet til medicinal- og sundhedspersonale:
English: Other tests should be performed in order to confirm HIB infection during this period.
Danish: Andre tests skal udføres for at bekræfte HIB infektionen i denne periode.
English: For this reason, the vaccinee should remain under medical supervision for at least 30 minutes.
Danish: Af denne årsag skal den vaccinerede person forblive under medicinsk tilsyn i mindst 30 minutter.
English: Most adults fully recover from the disease.
Danish: De fleste voksne bliver fuldstændig raske efter sygdommen.
English: The 3-5-12 month schedule was not evaluated.
Danish: 3 5 12 måneders programmet blev ikke evalueret.
English: You will be informed by the doctor or nurse when you should come back for subsequent injections.
Danish: Du vil blive informeret af lægen eller sygeplejersken om hvornår du skal komme tilbage for efterfølgende injektioner.
English: It occasionally causes death by suffocation.
Danish: Det medfører lejlighedsvis død ved kvælning.
English: HIV infection is not considered as a contraindication.
Danish: HIV infektion betragtes ikke som en kontraindikation.
English: Each injection is given on a separate visit.
Danish: Hver injektion gives ved separate besøg.
English: Official batch release: in accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Danish: Officiel batchfrigivelse: i overensstemmelse med artikel 114 i Rådets direktiv 2001/83/EØF vil den officielle batchfrigivelse blive foretaget af et statsligt laboratorium eller et laboratorium udpeget hertil.
English: This does not constitute a sign of deterioration.
Danish: Dette er ikke et tegn på nedbrydning.
English: Do not use after the expiry date stated on the pack.
Danish: Må ikke anvendes efter den udløbsdato, som er angivet på pakningen.
English: If not, your child may not be fully protected against the diseases.
Danish: Hvis ikke, er dit barn måske ikke fuldstændig beskyttet mod sygdommene.
English: In these cases, the vaccination will be postponed until your child has recovered.
Danish: I disse tilfælde, vil vaccinationen blive udskudt, indtil dit barn er blevet rask.
English: But some people, particularly children, who may not have shown signs of the disease can remain infected.
Danish: Nogle mennesker, særligt børn, som måske ikke har haft symptomer på sygdommen kan forblive smittede.
English: However the stability has been demonstrated for 8 hours at 25°C after reconstitution.
Danish: Stabiliteten er dog demonstreret for 8 timer ved + 25oC efter rekonstitution.
English: If your child misses the visit scheduled for the second or third injection, talk to your doctor and arrange another visit as soon as possible.
Danish: Hvis dit barn går glip af anden eller tredje injektion, skal du tale med lægen og arrangere et nyt besøg hurtigst muligt.
English: HIB infection also causes inflammation of the throat.
Danish: HIB infektion medfører også inflammation af halsen.
English: As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Danish: Da fordelene ved vaccination er stor for denne gruppe børn, bør vaccination ikke udelades eller forsinkes
English: Such reactions may occur before leaving the doctor's surgery.
Danish: Sådanne reaktioner vil opstå før lægens praksis forlades.
English: Freezing destroys the vaccine.
Danish: Frost ødelægger vaccinen.
English: - If you have further questions, please ask your doctor or your pharmacist.
Danish: - Hvis du har yderligere spørgsmål, bedes du kontakte din læge eller apoteket.
English: MANUFACTURER'S BATCH NUMBER LOT:
Danish: FREMSTILLERENS BATCHNUMMER LOT:
English: A minor infection such as a cold should not be a problem, but talk to your doctor first.
Danish: En mindre infektion såsom en forkølelse bør ikke være et problem, men rådfør dig med lægen først.
English: There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.
Danish: Der kan være omstændigheder, såsom en høj hyppighed af kighoste, hvor de potentielle fordele vejer tungere end de mulige risici.
English: See section 6.5 for the number of doses per vial.
Danish: Se afsnit 6.5 for antal doser pr. hætteglas.
English: Antipyretic treatment should be initiated according to local treatment guidelines.
Danish: Antipyretisk behandling skal initieres i overensstemmelse med lokale behandlingsguidelines.
English: As with all injectable vaccines, there is an extremely small risk of allergic reactions.
Danish: Som med alle injicerbare vacciner, er der en ekstremt lille risiko for allergiske reaktioner.
English: The vaccine works by causing the body to produce its own protection (antibodies) against these infectious diseases.
Danish: Vaccinen virker ved at hjælpe kroppen til selv at producere beskyttelse (antistoffer) mod disse infektionssygdomme.
English: Your child will receive a total of three injections with an interval of at least one month between each one.
Danish: Dit barn vil modtage i alt 3 injektioner med et interval på mindst én måned mellem hver injektion.
English: Tell you doctor if your child has any known allergies.
Danish: Fortæl lægen hvis dit barn har nogle kendte allergier.
English: Hepatitis B surface antigen (rDNA) 2, 3
Danish: Hepatitis B overflade antigen (rDNA) 2, 3
English: • Collapse (floppiness) or periods of unconsciousness or lack of awareness
Danish: • Kollaps (slaphed) eller perioder med bevidstløshed eller mangel på tilstedeværelse
English: Not all pack sizes may be marketed.
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsførte.
English: Any unused vaccine or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt vaccine eller affald heraf bør bortskaffes i overensstemmelse med lokale krav.
English: If these events continue or become severe, tell your doctor.
Danish: Hvis disse gener fortsætter eller bliver alvorlige, skal du kontakte din læge.
English: If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Danish: Hvis du bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør du oplyse din læge eller apotek herom.
English: Any vaccine can have some side effects.
Danish: Enhver vaccine kan give bivirkninger.
English: In the absence of compatibility studies, the reconstituted Quintanrix vaccine must not be mixed with other medicinal products.
Danish: I fravær af forligelighedsstudier, må den rekonstituerede Quintanrix vaccine ikke blandes med andre lægemidler.
English: In the following cases, your doctor can determine the right time and scheme of vaccination for your child. Tell your doctor:
Danish: I følgende tilfælde vil din læge fastlægge det rette tidspunkt og vaccinationsprogram for dit barn.
English: Your doctor will be able to tell you what to do if Quintanrix is to be given with another vaccine or medicine.
Danish: Din læge vil fortælle dig hvad der skal gøres hvis Quintanrix skal gives med andre vacciner eller anden medicin.
English: The doctor or nurse will give Quintanrix as an injection into the muscle.
Danish: Lægen eller sygeplejersken vil give Quintanrix som en injektion i musklen.
English: This is a multidose container.
Danish: Dette er en flerdosis beholder.
English: - This medicine has been prescribed for your child and should not be passed on to others.
Danish: - Denne vaccine er ordineret til dit barn og må ikke gives videre til andre.
English: This may require separate administration of hepatitis B vaccine and should follow official recommendations.
Danish: Dette kræver muligvis separat administration af hepatitis B vaccine og bør følge officielle anbefalinger.
English: For adjuvants, see section 2.
Danish: Vedrørende adjuvans, se afsnit 2.
English: Signs of the disease may not be seen for 6 weeks to 6 months after infection.
Danish: Symptomer på sygdommen ses ikke nødvendigvis før 6 uger til 6 måneder efter infektion.
English: At this time, the percentage of infants with anti-PRP titres ≥ 0.15 µg/ml was > 99% and the percentage with anti-HBs titres ≥ 10 mIU/ml was 97.3%.
Danish: På dette tidspunkt, var procentdelen af spædbørn med anti-PRP titre ≥ 0.15 µg/ml,> 99 % og procentdelen med anti-HB titre ≥ 10 mIU/ml var 97,3 %.
English: Your doctor will advise on the possible need for extra doses.
Danish: Din læge vil afgøre om der er behov for ekstra doser.
English: Pharmaco-therapeutic group: Bacterial and viral vaccines combined, ATC code JO7CA10
Danish: Farmakoterapeutisk gruppe: Bakterielle og virale vacciner, kombinerede, ATC kode JO7CA10
English: The presence of a minor infection, such as a cold, is not a contraindication for vaccination.
Danish: Tilstedeværelsen af en mindre infektion, som forkølelse, er ikke en kontraindikation for vaccination.
English: • Temperature of ≥ 40.0 °C within 48 hours, not due to another identifiable cause.
Danish: • Temperatur på ≥ 40.0 °C inden for 48 timer, som ikke skyldes en anden infektion.
English: The primary vaccination schedule consists of three doses of 0.5 ml to be administered at intervals of at least 4 weeks within the first six months of life in accordance with local official recommendations.
Danish: Det primære vaccinationsprogram består af tre doser af 0,5 ml som skal administreres med intervaller på mindst 4 uger, inden for de første 6 levemåneder i overensstemmelse med lokale officielle anbefalinger.
English: • if your child has a severe infection with a high temperature (over 38°C).
Danish: • hvis dit barn har en alvorlig infektion med høj feber (over 38o C).
English: Since the capsular polysaccharide antigen is excreted in the urine a positive urine antigen test can be observed within 1-2 weeks following vaccination.
Danish: Da kapsel polysakkarid antigenet udskilles i urinen kan der observeres en positiv urin antigen test inden for 1-2 uger efter vaccination.
English: Quintanrix was administered as a booster to 435 infants in the second year of life.
Danish: Quintanrix blev administreret som en booster til 435 spædbørn i det andet leveår.
English: • Diphtheria: Diphtheria mainly affects the airways and sometimes the skin.
Danish: • Difteri: Difteri påvirker hovedsageligt luftvejene og nogen gange huden.
English: Quintanrix may be used to boost responses to DTP, HBV and HIB antigens if its composition is in accordance with official recommendations for boosting.
Danish: Quintanrix kan bruges til at booste responset overfor DTP, HBV og HIB antigener, hvis dens komposition er i overensstemmelse med officielle anbefalinger for boosting.
English: This leaflet was last approved on:
Danish: Denne indlægsseddel blev senest godkendt den:
English: No preclinical safety testing with the vaccine has been conducted.
Danish: Der er ikke udført præklinisk sikkerhedstestning med vaccinen.
English: • if your child is taking any other medicine or has recently received any other vaccine.
Danish: • hvis dit barn tager anden medicin eller for nylig har fået andre vacciner.
English: Hepatitis B carriers can infect others throughout their lives.
Danish: Hepatitis B virusbærere kan smitte andre gennem hele livet.
English: WHAT QUINTANRIX IS AND WHAT IT IS USED FOR
Danish: HVAD QUINTANRIX ER OG HVAD DET ANVENDES TIL
English: The active substances and other ingredients in Quintanrix are listed at the beginning of the leaflet.
Danish: De aktive substanser samt øvrige indholdsstoffer i Quintanrix er nævnt i indledningen af denne indlægsseddel.
English: They are called hepatitis B virus carriers.
Danish: De kaldes hepatitis B virusbærere.
English: Water for injections.
Danish: Vand til injektionsvæske.
English: The following schedules have been studied in clinical trials: 2-4-6 months, 3-4-5 months and 6-10-14 weeks.
Danish: Følgende programmer er blevet undersøgt i kliniske studier: 2 4 6 måneder, 3 4 5 måneder og 6 10 14 uger.
English: • Convulsions with or without fever, occurring within 3 days.
Danish: • Kramper med eller uden feber, der opstår inden for 3 dage.
English: They may be extremely tired, and have dark urine, pale faces, yellowish skin and/or eyes (jaundice), and other signs of the disease possibly requiring hospitalisation.
Danish: De kan blive ekstremt trætte, have mørkfarvet urin, blege ansigter, gullig hud og/eller øjne (gulsot), samt andre symptomer på sygdommen, som muligvis vil kræve hospitalsindlæggelse.
English: Store in the original package in order to protect from light.
Danish: Opbevares i den originale emballage for beskyttelse mod lys.
English: Quintanrix should under no circumstances be administered intravascularly.
Danish: Quintanrix bør under ingen omstændigheder administreres intravaskulært.
English: The booster dose should preferably be given at least 6 months after the last primary dose.
Danish: Boosterdosis skal helst gives mindst 6 måneder efter den sidste primære vaccination.
English: In paediatric vaccination it is often practice to co-administer different injectable vaccines at separate injection sites, during the same session.
Danish: I pædiatri vaccination er det normal praksis, at co-administrere forskellige injicerbare vacciner på separate injektionssteder, under samme konsultation.
English: After the addition of the DTPw-HBV component to the HIB powder, the mixture should be well shaken until the powder is completely dissolved.
Danish: Efter tilsætningen af DTPw HBV komponenten til HIB pulveret, skal sammenblandingen rystes godt, indtil pulveret er fuldstændig opløst.
English: The vaccine should never be given into a vein.
Danish: Vaccinen må aldrig indgives venøst.
English: As with other vaccines, the administration of Quintanrix should be postponed in subjects suffering from acute severe febrile illness.
Danish: Som med andre vacciner, skal administration af Quintanrix udsættes hos individer med akut alvorlig febril sygdom.
English: The first dose can be administered at 6 weeks of age.
Danish: Den første dosis kan administreres ved en alder på 6 uger.