FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP considered that the use of Ketoconazole HRA to treat Cushing's syndrome was well established in medical practice and documented in the scientific literature.
Danish: CHMP lagde til grund, at anvendelse af Ketoconazole HRA til behandling af Cushings syndrom var anerkendt i behandlingspraksis og dokumenteret i den videnskabelige litteratur.
English: If liver enzyme levels in the blood increase beyond three times the normal maximum (a sign of possible liver problems) or in case of symptoms such as lack of appetite, nausea, vomiting, fatigue, jaundice, abdominal pain (stomach ache) or dark urine that may suggest a liver problem, treatment must be stopped.
Danish: Behandlingen skal standses, hvis indholdet af leverenzymer i blodet er over tre gange det normale maksimum (et tegn på mulige leverproblemer), eller der er symptomer, som tyder på leverproblemer, såsom appetitløshed, kvalme, opkastning, svaghed, gulsot, mavesmerter eller mørk urin.
English: The active substance in Ketoconazole HRA, ketoconazole, is a well known substance that has been authorised for several decades for the treatment of fungal infections.
Danish: Det aktive stof i Ketoconazole HRA, ketoconazol, er velkendt og har været godkendt i flere årtier til behandling af svampeinfektioner.
English: The main measure of effectiveness in these literature studies was the level of cortisol in the urine.
Danish: I disse undersøgelser fra litteraturen blev virkningen hovedsagelig bedømt på indholdet af kortisol i urinen.
English: Ketoconazole can also block the production of other hormones produced by the adrenal gland which are often raised in Cushing's syndrome.
Danish: Ketoconazol kan desuden blokere produktionen af andre hormoner, der dannes i binyrerne, og som ofte er forhøjet ved Cushings syndrom.
English: The patient's liver function should also be checked weekly for one month when the dose is increased.
Danish: Hvis dosis sættes op, skal patientens leverfunktion desuden efterfølgende kontrolleres en gang om ugen i en måned.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Ketoconazole HRA can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Ketoconazole HRA findes på EMA's websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Ketoconazole HRA must not be used in patients with liver disease or whose blood levels of liver enzymes are above a certain level.
Danish: Ketoconazole HRA må ikke anvendes hos patienter, der har leversygdom, eller hos hvem blodets indhold af leverenzymer er over et bestemt niveau.
English: ketoconazole
Danish: ketoconazol
English: What measures are being taken to ensure the safe and effective use of Ketoconazole HRA?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ketoconazole HRA?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ketoconazole HRA, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Ketoconazole HRA, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The active substance in Ketoconazole HRA is ketoconazole.
Danish: Det aktive stof i Ketoconazole HRA er ketoconazol.
English: For more information about treatment with Ketoconazole HRA, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ketoconazole HRA, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The company that makes Ketoconazole HRA will also provide doctors who will use Ketoconazole HRA with a letter containing information regarding the risks of side effects, particularly of liver injury, and how to use the medicine properly.
Danish: Den virksomhed, der fremstiller Ketoconazole HRA, skal desuden udsende et brev til de læger, der anvender Ketoconazole HRA, med oplysninger om risiciene for bivirkninger, navnlig leverskade, og om korrekt anvendelse af lægemidlet.
English: It is not intended to provide practical advice on how to use Ketoconazole HRA.
Danish: Det er ikke en praktisk vejledning i, hvordan Ketoconazole HRA bør anvendes.
English: For the full list of all side effects and restrictions with Ketoconazole HRA, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Ketoconazole HRA fremgår af indlægssedlen.
English: Ketoconazole can still be found in topical medicines (medicines applied to the skin) to treat fungal infections.
Danish: Ketoconazol anvendes stadig i lægemidler til påføring på huden (topikale lægemidler) mod svampeinfektioner.
English: Other information about Ketoconazole HRA
Danish: Andre oplysninger om Ketoconazole HRA
English: What is Ketoconazole HRA and what is it used for?
Danish: Hvad er Ketoconazole HRA, og hvad anvendes det til?
English: What are the risks associated with Ketoconazole HRA?
Danish: Hvilke risici er der forbundet med Ketoconazole HRA?
English: For practical information about using Ketoconazole HRA, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Ketoconazole HRA, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Why is Ketoconazole HRA approved?
Danish: Hvorfor er Ketoconazole HRA blevet godkendt?
English: Cushing's syndrome is a disease characterised by an excess production of the hormone cortisol by the adrenal glands, two glands situated above the kidneys.
Danish: Cushings syndrom er en sygdom, der kendetegnes ved, at binyrerne producerer for meget kortisol.
English: How is Ketoconazole HRA used?
Danish: Hvordan anvendes Ketoconazole HRA ?
English: How does Ketoconazole HRA work?
Danish: Hvordan virker Ketoconazole HRA?
English: What benefits of Ketoconazole HRA have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Ketoconazole HRA?
English: This does not constitute a sign of
Danish: Dette udgør ikke et tegn på
English: Not known (cannot be estimated from the available data)
Danish: Ikke kendte (kan ikke bedømmes udfra de tilgængelige data)
English: However, the need for this dose is currently not established.
Danish: Behovet for denne dosis er dog endnu ikke fastslået.
English: The cough may last for 1-2 months or longer.
Danish: Hosten kan vare i 1-2 måneder eller længere.
English: In consequence, boostering should follow local recommendations.
Danish: Som følge heraf skal boosterdosering følge de lokale anbefalinger.
English: None of the components in the vaccine are infectious.
Danish: Ingen af komponenterne i vaccinen er smitsomme.
English: (see section 6.2.
Danish: (se afsnit 6.2)
English: If not, your child may not be fully protected against the diseases.
Danish: Hvis ikke, er dit barn måske ikke beskyttet mod disse sygdomme.
English: Vaccination is the best way to protect against these diseases.
Danish: Vaccination er den bedste måde at beskytte sig mod sygdommene på.
English: A minor infection such as a cold should not be a problem, but talk to your doctor first.
Danish: En mindre infektion såsom forkølelse bør ikke udgøre noget problem, men rådfør dig med lægen først.
English: Each injection is given on a separate visit.
Danish: Hver injektion vil blive givet ved separate besøg.
English: Tell your doctor if your child has any known allergies.
Danish: Fortæl din læge hvis dit barn har kendte allergier.
English: • fever (more than 38°C)
Danish: • Feber (mere end 38°C)
English: If additional injections are necessary, the doctor will tell you.
Danish: Hvis yderligere injektioner er nødvendige, vil din læge informere dig.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section
Danish: Dette medicinalprodukt må ikke blandes med andre medicinalprodukter undtagen de, der er nævnt i afsnit 6.6.
English: Temperature of ≥ 40.0 C within 48 hours, not due to another identifiable cause.
Danish: Temperatur på ≥ 40,0 °C indenfor 48 timer, hvilket ikke skyldes anden identificerbar årsag.
English: not less than 30 IU not less than 60 IU not less than 4 IU 10 micrograms
Danish: ikke mindre end 30 IU ikke mindre end 60 IU ikke mindre end 4 IU 10 mikrogram
English: 2-4-6 months; 3-4-5 months and 3-4½-6 months
Danish: 2-4-6-måneders; 3-4-5måneders og 3-4½-6måneders
English: • if your child has a severe infection with a high temperature (over 38°C).
Danish: • hvis dit barn har en alvorlig infektion med en høj temperatur (over 38° C).
English: Three vaccine doses must be administered at intervals of at least 4 weeks.
Danish: Tre vaccinedoser skal administreres med intervaller på mindst 4 uger.
English: For adjuvants, see section 2.
Danish: Adjuvans, se afsnit 2.
English: The vaccine should never be given into a vein.
Danish: Vaccinen må aldrig gives direkte ind i en vene.
English: Make sure your child finishes the complete vaccination course of three injections.
Danish: Vær sikker på, at dit barn afslutter det fuldstændige vaccinationsprogram på tre injektioner.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE
Danish: • BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG
English: If your child misses a scheduled injection, talk to your doctor and arrange another visit.
Danish: Hvis en planlagt injektion til dit barn aflyses, må du tale med lægen og arrangere et andet besøg.
English: Four different schedules have been studied (6-10-14 weeks, 2-4-6 months; 3-4-5 months and 3-4½-6 months) according to routine vaccination practices in different countries with three doses administered within the first
Danish: Fire forskellige programmer er blevet undersøgt (6-10-14-ugers; 2-4-6-måneders; 3-4-5-måneders og 3-4½-6-måneders) i overensstemmelse med rutine-vaccinationspraksis i forskellige lande med tre doser administreret inden for de første seks levemåneder.
English: For each component of the vaccine, the following immune responses have been documented one month after completion of the primary vaccination schedule.
Danish: For hver af de fire vaccinekomponenter er følgende immunresponser blevet dokumenteret én måned efter fuldførelsen af det primære vaccinationsprogram.
English: The primary vaccination schedule consists of three doses within the first six months of life.
Danish: Det primære vaccinationsprogram består af tre doser indenfor de første seks levemåneder.
English: • if your child is suffering from an undiagnosed or progressive disease of the brain or uncontrolled epilepsy.
Danish: • hvis dit barn lider af en ikke-diagnostiseret eller en fremskridende sygdom i hjernen eller ukontrolleret epilepsi.
English: Frequencies are defined as follows:
Danish: Definition af frekvens:
English: Read all of this leaflet carefully before your child starts receiving this vaccine.
Danish: Læs denne indlægsseddel grundigt, inden dit barn modtager vaccinen.
English: Non-clinical data reveal no special hazard for humans based on general safety studies.
Danish: Prækliniske data har ikke vist humane risikofaktorer baseret på generelle sikkerhedsstudier.
English: Dispose of in accordance with local regulations
Danish: Bortskaffes I overensstemmelse med nationale regler
English: However, you should seek immediate treatment in
Danish: I alle tilfælde skal du søge øjeblikkelig lægehjælp.
English: N° of symptom checklists Local symptoms (%)
Danish: Lokale symptomer (%)
English: In these circumstances, vaccination with the combined vaccine should start at 6 weeks of age.
Danish: I disse tilfælde skal vaccination med den kombinerede vaccine indledes i 6 ugers alderen.
English: Extensive tests have demonstrated that these particles display the characteristic properties of the natural
Danish: Omfattende forsøg har vist, at disse partikler udviser de karakteristiske egenskaber for
English: As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or
Danish: Da fordelene ved vaccination er stor for denne gruppe børn, bør vaccination ikke udelades eller
English: Convulsions with or without fever, occurring within 3 days.
Danish: Kramper med eller uden feber, forekommende indenfor 3 dage.
English: Your child will remain under medical supervision for 30 minutes after each injection.
Danish: Dit barn vil forblive under lægeligt opsyn i 30 minutter efter hver injektion.
English: The expected immunological response may not be obtained after vaccination of immunosuppressed patients, e.g. patients on immunosuppressive therapy.
Danish: Det er muligt, at den forventede immunologiske reaktion ikke kan opnås efter vaccination af immunosupprimerede patienter, f.eks. patienter i immunosuppressiv terapi.
English: • Hepatitis B: Hepatitis B is caused by the hepatitis B virus.
Danish: • Hepatitis B: Hepatitis B forårsages af hepatitis B virus.
English: For this reason, the vaccinee should remain under medical supervision for 30 minutes after vaccination.
Danish: På grund af dette skal den vaccinerede altid forblive under medicinsk opsyn i 30 minutter efter vaccinationen.
English: The administration of a booster dose with trivalent DTP vaccine is recommended before the end of the second year of life.
Danish: Administration af en boosterdosis med trivalent DTP vaccine er anbefalet inden udgangen af barnets andet leveår.
English: • pain or discomfort at the injection site
Danish: • Smerte eller ubehag ved injektionsstedet
English: Such reactions may occur before leaving the doctor's surgery.
Danish: De nævnte reaktioner vil sædvanligvis optræde, inden du forlader lægens klinik.
English: In the case of children born of known HBV carrier mothers the immunoprophylactic measures for hepatitis B should not be modified.
Danish: I tilfælde af børn født af mødre, som er HBV bærere, skal de immunoprofylaktiske forholdsregler for hepatitis B ikke ændres.
English: Date of latest renewal: 19 July 2006.
Danish: Første markedsføringstilladelse: 19. juli 1996 Seneste fornyelse af markedsføringstilladelsen: 19. juli 2006
English: Persistent crying lasting ≥ 3 hours, occurring within 48 hours.
Danish: Vedvarende gråd varende ≥ 3 timer, forekommende indenfor 48 timer.
English: In these circumstances the vaccination course should be continued with DT and HBV vaccines.
Danish: Under disse omstændigheder bør vaccinations-programmet fortsætte med DT og HBV vacciner.
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 ialt tre injektioner med et interval på mindst én måned mellem hver injektion.
English: Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of adverse reactions) and a clinical examination.
Danish: Vaccination skal forudgåes af en gennemgang af anamnesen (især med hensyn til tidligere vaccination og mulig forekomst af bivirkninger) samt en klinisk undersøgelse.
English: • Diphtheria: Diphtheria mainly affects the airways and sometimes the skin.
Danish: • Difteri: Difteri angriber hovedsagelig luftvejene og nogle gange huden.
English: As with all injectable vaccines, appropriate medical treatment should always be readily available in case of anaphylactic reactions following the administration of the vaccine.
Danish: Som ved alle injicérbare vacciner skal passende medicinsk behandling altid være lettilgængelig i tilfælde af anafylaktiske reaktioner som følge af administration af vaccinen.
English: In these studies the immune response to the oral polio vaccine has not been investigated, however, previous experience with simultaneous administration of DTP, OPV and HBV vaccines has not shown any interference.
Danish: I disse studier er immunresponset af den orale polio vaccine dog ikke blevet undersøgt; tidligere erfaringer med samtidig administration af DTP, OPV og HBV vacciner har dog ikke vist nogen interferens.
English: Upon storage, a white deposit and clear supernatant can be observed.
Danish: Efter opbevaring kan et hvidt bundfald og en klar supernatant observeres.
English: Wounds that are especially prone to infection are burns, fractures, deep wounds or wounds contaminated with soil, dust, horse manure/dung or wood splinters.
Danish: Sår særligt udsat for infektion er brandsår, brud, dybe sår eller sår forurenet med jord, støv, hestemøg/gødning eller træflis.
English: Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000)
Danish: Almindelig (≥ 1/100 og < 1/10) Ikke almindelig (≥ 1/1000 og < 1/100) Sjælden (≥ 1/10.000 og < 1/1000) Meget sjælden (<1/10.000)
English: When Tritanrix HepB is given according to the 6-10-14 weeks schedule, it is recommended to administer a dose of HBV vaccine at birth to improve protection.
Danish: Når Tritanrix HepB gives som et 6-10-14-ugers program, anbefales det at administrere en dosis HBVvaccine ved fødslen for at forbedre beskyttelsen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/014/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/96/014/002
English: The following undesirable events have occurred very rarely following the administration of hepatitis
Danish: De følgende uønskede reaktioner er observeret meget sjældent efter administration af
English: The Pw component is obtained by heat inactivation of phase I culture of Bordetella pertussis bacteria.
Danish: Pw komponenten fremstilles ved varmeinaktivering af fase I kultur af Bordetella pertussis bakterier.
English: The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Danish: Den potentielle risiko for apnø og behov for respiratorisk overvågning i 48-72 timer bør overvejes ved primære immuniseringprogrammer til meget tidligt fødte børn (fødsel ≤ uge 28 af svangerskabet) og specielt for tidligere respiratorisk immature børn.
English: Novartis Vaccines and Diagnostics GmbH & Co. KG
Danish: Norvartis Vaccines and Diagnostics GmbH & Co.KG
English: Where there is a high endemicity of HBV, the practice to administer HBV vaccine at birth should be continued.
Danish: Hvor der er en høj endemisk forekomst af HBV, skal praksis med at administrere HBV vaccinen ved fødsel fortsættes.
English: As Tritanrix HepB is not intended for use in adults, information on the safety of the vaccine when used during pregnancy or lactation is not available.
Danish: Da Tritanrix HepB ikke er beregnet til brug hos voksne, er information angående vaccinens sikkerhed anvendt under graviditet og amning ikke tilgængeligt.
English: The D and T toxoids are prepared from the toxins of cultures of Corynebacterium diphtheriae and Clostridium tetani by formalin inactivation using established technology.
Danish: D og T toxoiderne er fremstillet ud fra toxiner fra kulturer af Corynebacterium diphtheriae og Clostridium tetani ved formalininaktivering ved hjælp af etableret teknologi.
English: This may require separate vaccination with HBV and DTPw vaccines and also include the administration of HBIg at birth.
Danish: Dette kan indebære separat vaccination med HBV og DTPw vacciner og kan også omfatte indgift af HBIg ved fødsel.
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 ved en høj incidens af pertussis, hvor den potentielle fordel vejer tungere end de mulige risici.
English: • Tetanus (Lockjaw): Tetanus bacteria enter the body through cuts, scratches or wounds in the skin.
Danish: • Stivkrampe (tetanus): Stivkrampebakterier kommer ind i kroppen via snitsår, rifter eller sår i huden.
English: Do not use Tritanrix HepB after the expiry date which is stated on the carton.
Danish: Brug ikke Tritanrix HepB efter den udløbsdato, der står på pakningen.
English: Official batch release: in accordance with Article 114 of Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Danish: Officiel batchfrigivelse: Den officielle batchfrigivelse vil blive foretaget af et statsligt laboratorium eller et laboratorium udpeget hertil i henhold til artikel 114 i Rådets direktiv 2001/83/EØF, med
English: In a prospective comparative study, which compared the administration of the combined DTPw-HBV vaccine with the simultaneous separate administration of DTPw and HBV vaccine, higher incidences of pain, redness, swelling and fever were reported in the group receiving the combined vaccine.
Danish: I et prospektivt sammenlignende studie, som sammenholdt administration af kombineret DTPw-HBV med samtidig og separat administration af DTPw og HBV, fandtes højere incidens af smerte, rødme, hævelse og feber i den gruppe, der modtog den kombinerede vaccine.
English: When using a multidose vial, each dose should be taken with a sterile needle and syringe.
Danish: Når et hætteglas til flergangsdosering anvendes, skal hver dosis tages op med en steril nål og sprøjte.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Bivirkningerne er inden for hver hyppighedsgruppe opstillet efter faldende alvorlighed.
English: Pharmaco-therapeutic group: Bacterial and viral vaccines combined, ATC code J07CA05.
Danish: Farmakoterapeutisk klassifikation: En bakteriel-viral kombinationsvaccine, ATC kode: J07CA05.
English: The disease affects the airways causing severe spells of coughing that may interfere with normal breathing.
Danish: Sygdommen angriber luftvejene og fører til alvorlige hosteanfald, som kan forstyrre den normale vejrtrækning.
English: A booster dose with Tritanrix HepB will give rise to increased reactogenicity as would be expected for a booster during the second year of life.
Danish: En boosterdosis af Tritanrix HepB vil medføre en øget reaktogenicitet som forventet for en booster givet i 2. leveår.
English: The coughing is often accompanied by a “whooping” sound, hence the common name “whooping cough”.
Danish: Hosteanfaldene følges ofte af en pibende lyd (”kigen”), heraf navnet ”kighoste”.
English: These may be local or widespread rashes that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness.
Danish: Disse kan være lokalt eller udbredt rødme, kløende udslæt, blærer, opsvulmning af øjne og ansigt, synke- og vejrtræknings besvær, pludselig fald i blodtryk og besvimmelse.
English: PSUR: The Marketing Authorisation Holder will continue to submit Periodic Safety Update Reports on a 2
Danish: PSUR: Indehaveren af markedsføringstilladelsen vil forsætte med at indgive PSUR hvert andet år.
English: Name and address of the manufacturers of the biological active substances
Danish: Navn og adresse på fremstiller(e) af det biologisk aktive stof
English: Where HBV vaccine is not given at birth, the combined vaccine can be administered beginning as early as 8 weeks of age.
Danish: Hvor HBV vaccine ikke gives ved fødslen, kan den kombinerede vaccine gives allerede i 8 ugers alderen.
English: It is current practice in paediatric vaccination to co-administer different vaccines during the same session with injectable vaccines being administered at separate injection sites.
Danish: Det er vanlig praksis ved pædiatriske vaccinationer at administrere forskellige vacciner samtidigt ved den samme lejlighed, idet forskellige vacciner administeres på forskellige injektionssteder.
English: For long-term protection against HBV, a booster dose of HBV vaccine could also be administered after the first year of life.
Danish: For at give langtidsbeskyttelse mod HBV kan en boosterdosis af HBV vaccine også administreres efter barnets første leveår.