FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicinal product contains 3.6 mmol (or 83 mg) sodium per dose which should be taken into consideration for patients on a controlled sodium diet.
Danish: Dette medicinske produkt indeholder 3,6 mmol (eller 83 mg) natrium per dosis, hvilket bør overvejes hos patienter på kontrolleret natrium diæt.
English: Ceftriaxone can also be used to help prevent infections before, during and after surgery in patients with a certain risk of severe infections associated with surgical measures.
Danish: Ceftriaxon kan også anvendes som forebyggende behandling mod infektioner før og efter kirurgiske indgreb hos patienter som har en øget risiko for alvorlige infektioner i forbindelse med kirurgiske indgreb.
English: Patients with risk factors for biliary stasis/sludge, e.g. preceding major therapy, severe illness and total parenteral nutrition, have increased risk of pancreatitis (see section 4.8).
Danish: Patienter med risiko for galdestasis f.eks. forudgående større terapi, alvorlig sygdom og total parental ernæring har øget risiko for pankreatitis (se pkt.
English: Ceftriaxone is completely absorbed following intramuscular administration with peak plasma concentrations (about 80 mg/l) occurring between 2 and 3 hours after dosing.
Danish: Ceftriaxon er fuldstændig absorberet efter intramuskulær administration med peak plasma koncentrationer (over 80mg/l) som optræder 2 og 3 timer efter dosering.
English: For this reason, urine glucose determination during therapy with ceftriaxone should be carried out enzymatically.
Danish: På grund af dette bør bestemmelsen af urin glucose under behandling med ceftriaxon udføres enzymisk.
English: Ceftriaxone should not be mixed in the same syringe with any medicinal product other than 1% w/v lidocaine hydrochloride solution (for intramuscular injection only).
Danish: Ceftriaxon bør ikke blandes i den samme sprøjte med andre medicinske produkter end 1 % w/v lidocainhydrochlorid opløsning (kun til intramuskulær injektion).
English: Aminoglycosides:
Danish: Aminoglykosider:
English: Contrary to other cephalosporins, probenecid does not impede tubular secretion of ceftriaxone.
Danish: Modsat andre cefalosporiner forhindrer probenecid ikke tubulær udskillelse af ceftriaxon.
English: Previous immediate and/or severe hypersensitivity reaction to a penicillin or to any other beta-lactam medicinal products (see section 4.4).
Danish: Tidligere straks og/eller svær overfølsomhedsreaktion over for penicillin eller nogen anden type beta-laktam produkter (se pkt.
English: Dosage should be determined by the severity and site of infection, susceptibility of the causative micro-organism and the patient's age and condition.
Danish: Dosis bør bestemmes ud fra graden af infektionen og infektionsstedet, den årsagsgivende mikroorganismes modtagelighed og patientens alder og tilstand.
English: These newborns had been treated with intravenous ceftriaxone and calcium.
Danish: Disse nyfødte var bleven behandlet med intravenøs ceftriaxon og calcium.
English: 2 In suspected or proven Pseudomonas infection combination with an aminoglycoside is necessary.
Danish: Ved mistænkt eller påvist Pseudomonas infektion kombination med en aminoglykoside er nødvendigt.
English: The active substance is ceftriaxone disodium 3.5 H2O.
Danish: Det aktive stof er ceftriaxondinatrium 3.5 H2O.
English: Marketing Authorisation holder and manufacturer Sandoz GmbH
Danish: Indehaver af markedsføringstilladelse Sandoz GmbH
English: 3 Clinical efficacy has been demonstrated for susceptible isolates of Enterobacter cloacae and Enterobacter aerogenes in approved clinical indications.
Danish: Klinisk effekt er bleven demonstreret for modtagelige isolater af Enterobacter cloacae og Enterobacter aerogener i godkendte kliniske indikationer.
English: For infection of the meninges (meningitis) at first 100mg per kg is given once a day (but no more than 4g a day).
Danish: For infektioner i hjernehinden (meningitis), indledes med 100 mg per kg én gang daglig (men ikke mere end 4 g per dag).
English: Over a 0.15 to 3 g dose range, the values of elimination half-life range from 6 to 9 hours, total plasma clearance from 0.6-1.4 l/h and renal clearance from 0.3-0.7 l/h.
Danish: Over en dosis række på 0,15 til 3 g, er eliminerings halverings niveauet fra 6 til 9 timer, total plasma clearence er fra 0,6-1,4 l/t og nyre clearence fra 0,3-0,7 l/t.
English: Under no circumstances must ceftriaxone solutions be mixed with solutions containing calcium.
Danish: Ceftriaxon bør under ingen omstændigheder blandes med opløsninger der indeholder calcium.
English: Very rare including isolated reports:
Danish: Meget sjældne, herunder enkeltstående tilfælde:
English: Anaemia (including haemolytic anaemia)
Danish: Anæmi (herunder hæmolytisk anæmi).
English: The following adverse reactions, that reverse spontaneously or after treatment discontinuation, have been observed in association with ceftriaxone use.
Danish: De følgende bivirkninger som stopper spontant eller efter endt behandling er bleven observeret i sammenfald med brugen af ceftriaxon.
English: Ceftriaxone may lead to false-positive results of galactose determination in blood.
Danish: Ceftriaxon kan give falsk-positive resultater af bestemmelsen af galactose i blodet.
English: Common: Elevated liver enzymes in serum (AST, ALT, alkaline phosphatase).
Danish: Almindelige: Forhøjet leverenzymer i serum (AST, ALT, basisk phosphatase).
English: In infections caused by other bacteria in patients with neutropenic fever interventional treatment with ceftriaxone should be combined with an aminoglycoside.
Danish: Ved infektioner forårsaget af andre bakterier hos patienter med neutropenisk feber bør interventionel behandling med ceftriaxon kombineres med en aminoglycosid.
English: 20 - 80 mg/kg maximum: 80 mg/kg once daily
Danish: 20 - 80 mg/kg Maksimum: 80 mg/kg
English: Ceftriaxone is an antibiotic, a semisynthetic cephalosporin of the third generation.
Danish: Ceftriaxon er et antibiotikum, et semisyntetisk 3. generations-cephalosporin.
English: If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: Hvis en bivirkning bliver alvorlig, eller du bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør du fortælle det til din læge eller apoteket.
English: See also the information included in section 6.2.
Danish: Se også informationer i pkt.
English: Ceftriaxone cannot be removed by dialysis.
Danish: Ceftriaxon kan ikke fjernes ved dialyse.
English: This medicinal product contains 7.2 mmol (or 166 mg) sodium per dose which should be taken into consideration for patients on a controlled sodium diet.
Danish: Dette medicinske produkt indeholder 7,2 mmol (eller 166 mg) natrium per dosis, hvilket bør overvejes hos patienter på kontrolleret natrium diæt.
English: The length of treatment is usually at least 2 days beyond the normalisation of body temperature It may continue for a total of 7 to 14 days.
Danish: Behandlingsvarigheden er sædvanligvis mindst 2 dage Den kan forsætte i op til 7 -14 dage
English: Rare: Severe acute hypersensitivity reactions up to anaphylactic shock.
Danish: Sjældne: Alvorlig, akut overfølsomhedsreaktion, stigende til anafylaktisk chok.
English: (sodium content of the powder: 166 mg, equivalent to 7.2 mmol).
Danish: (Natrium indhold i pulveret: 166 mg, svarende til 7,2 mmol).
English: No tubular secretion takes place.
Danish: Ingen intubulærudskillelse finder sted.
English: Adolescents over 12 - 17 years ≥ 50 kg
Danish: Unge 12 - 17 år ≥ 50 kg
English: Blood and lymphatic system disorders Rare:
Danish: Forstyrrelser i blod- og lymfesystem Sjældne:
English: Caution should be exercised when prescribing to breast-feeding women.
Danish: Forsigtighed bør udvises ved ordination til ammende kvinder.
English: The maximum daily dose by intramuscular administration should not exceed 2 g. The summary of product characteristics of lidocaine hydrochloride solution 1% has to be taken into account.
Danish: Den maksimale daglige dosis ved intramuskulær administration bør ikke overskride 2 g. Produktresumeet for lidocainhydrochlorid, opløsning 1 % bør tages i betragtning.
English: Hypersensitivity reactions may occur in all degrees of severity up to anaphylactic shock (see section
Danish: Overfølsomhedsreaktioner kan optræde i alle grader op til anafylaktisk chok (se pkt.
English: If any of the following serious side effects happen, stop taking this medicine and tell your doctor immediately or go to your nearest hospital accident and emergency department.
Danish: Hvis nogle af følgende alvorlige bivirkninger opstår, skal du straks stoppe behandlingen og informere din læge eller koktakte det nærmeste hospital eller skadestue.
English: The injection is given as a slow injection into a vein or a deep injection into a large muscle.
Danish: injektionen kan gives som en langsom injektion i en vene eller i en stor muskel.
English: Stomatitis, glossitis, anorexia, nausea, emesis, abdominal pain, loose stool or diarrhoea.
Danish: Stomatitis, glossitis, anoreksi, kvalme, opkastning, mavesmerte, tynd afføring eller diarré.
English: The content of a 1 g vial is dissolved in 10 ml of water for injections by swirling.
Danish: Indholdet af 1 g hætteglas opløses i 10 ml vand til injektionsvæske, ved omrystning.
English: Ceftriaxone penetrates the inflamed meninges of newborn, infants and children.
Danish: Ceftriaxon trænger igennem den inflammerede hjernehinde på nyfødte, spædbørn og børn.
English: Symptomatic precipitation of ceftriaxone calcium salt in the gallbladder of children/reversible cholelithiasis in children.
Danish: Symptomatisk udfældning af ceftriaxon som calciumsalt i galdeblæren hos børn/reversibel cholelithiae hos børn.
English: Rarely severe adverse reactions have been reported in preterm and full-term newborns.
Danish: Sjældne alvorlige bivirkninger er blevet rapporteret hos for tidligt fødte og rettidigt nyfødte.
English: very common common uncommon rare very rare, including isolated reports
Danish: Meget sjældne, herunder enkeltstående tilfælde
English: Ceftriaxone kills bacteria and it can be used against various sorts of infections.
Danish: Ceftriaxon virker bakteriedræbende og kan anvendes mod forskellige typer af infektioner.
English: The respective values for anaerobes are 16 µg/ml (sensitive), 32 µg/ml (intermediate) and 64 µg/ml (resistant).
Danish: De respektive værdier for anaerobe er 16 µg/ml /følsom), 32 µg/ml (intermediat) og 64 µg/ml (resistent).
English: This can be a sign of a serious bowel inflammation (called “pseudomembranous colitis”) that can happen after taking antibiotics.
Danish: Dette kan være tegn på en alvorlig tarminfektion (pseudomembranøs colitis).
English: Ceftriaxone is indicated for perioperative prophylaxis in patients with a certain risk of severe postoperative infections (see section 4.4).
Danish: Ceftriaxon er indikeret til perioperativ profylakse hos patienter med en vis risiko for alvorlig postoperativ infektion (se pkt.
English: • infections of bones or joints
Danish: • Infektioner i knogler og led
English: Ceftriaxone distributes well in various compartments and also passes the placental barrier.
Danish: Ceftriaxon distribueres nemt ud i de forskellige kamre og passeres også placentalbarriere.
English: The Applicant/MAH was asked to discuss the benefit/risk of the different dosage recommendations for newborns, especially regarding the differentiation of newborns up to 14 days of age and from 15 up to 28 days of age and regarding the use of dose in excess of 50 mg/kg/day.
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen blev bedt om at drøfte fordele/risici ved de forskellige dosisanbefalinger til nyfødte, særligt med hensyn til differentieringen mellem nyfødte på op til 14 dage og fra 15 og op til 28 dage gamle samt med hensyn til anvendelse af doser over 50 mg/kg/dag.
English: Ceftriaxone does not undergo systemic metabolism but it is broken down in the small intestine by bacterial action.
Danish: Ceftriaxon undergår ikke systemisk metabolisme men bliver nedbrudt i tyndtarmen ved hjælp af bakterier.
English: In severe infections the daily dose of 50 mg per kg bodyweight must not be exceeded.
Danish: Ved alvorlige infektioner må den daglige dosis på 50 mg pr. kg. kropsvægt ikke overskrides.
English: Children with a bodyweight of 50 kg or more receive the usual adult dosage once daily (see above).
Danish: Børn med en kropsvægt på 50 kg eller mere får den normale voksne dosis en gang dagligt (se ovenfor).
English: Special caution is required to determine any other type of previous hypersensitivity reactions to penicillin or to other beta-lactam-medicinal products because patients hypersensitive to these medicines may be hypersensitive to ceftriaxone as well (cross-allergy).
Danish: Speciel forsigtighed er påkrævet for at fastslå andre typer af tidligere overfølsomhedsreaktioner overfor penicillin eller overfor andre betalaktamprodukter da patienter som er overfølsomme for disse kan være overfølsomme overfor ceftriaxon også (krydsallergi).
English: Pack sizes: 1, 5, 10 vials.
Danish: Pakningsstørrelser: 1, 5, 10 hætteglas.
English: Do not use Ceftriaxone after the expiry date which is stated on the pack.
Danish: Anvend ikke Ceftriaxon Tyrol pharma efter den udløbsdato, der er anført på pakningen.
English: Subsequent to an intramuscular injection of 1 g of ceftriaxone the serum concentration amounted to 79.2 µg/ml after 1.5 hours, and afterwards 58.2, 35.5 and 7.8 µg/ml at the respective time-points 4, 12 and 24 hours after injection.
Danish: Efterfølgende en intramuskulær injektion af 1 g af ceftriaxon nåede serum koncentrationerne op på 79,2 µg/ml efter 1.5 timer og efterfølgende 58,2, 35,5 og 7,8 µg/ml på de respektive time-points 4, 12 og 24 timer efter injektion.
English: It is bactericidal against a wide range of Gram-positive and Gram-negative bacteria by inhibiting the mucopeptide synthesis in the bacterial cell wall.
Danish: Det har bakteriedræbende effekt mod en lang række grampositive og gramnegative bakterier ved at hæmme mucopeptidsyntesen i bakteriernes cellevæg.
English: Precipitates of ceftriaxone in the kidneys in paediatric patients, mostly in children older than 3 years treated either with high daily doses (e.g. 80 mg/kg BW per day and more) or with total doses above 10 g ceftriaxone and who presented several risk factors (e.g. restricted fluid supply).
Danish: Udfældning af cefriaxon i nyrerne hos pædiatriske patienter oftest hos børn over 3 år behandlet med enten høje daglige doser f.eks. 80 mg/kg kropsvægt per dag og mere) eller med totale doser over 10 g ceftriaxon og som har flere risiko faktorer (f.eks. begrænset væsketilførsel).
English: After high doses of ceftriaxone diarrhoea, formation of biliary caliculi in the gallbladder and nephropathy were observed in monkeys and dogs.
Danish: Efter høje doser af ceftriaxon er diarré, formation af galdecaliculi i galdeblæren og nefropati observeret hos aber og hunde.
English: This can happen in patients of any age, but is more likely in infants and small children who are usually given a larger dose of ceftriaxone on a body weight basis.
Danish: Dette kan forekomme hos patienter i alle aldre, men er mere sandsynligt hos nyfødte og små børn, som normalt gives en højere dosis ceftriaxon set ud fra kropsvægt.
English: Excessive serum concentration of ceftriaxone cannot be reduced by haemodialysis or peritoneal dialysis.
Danish: For høje serum koncentrationer af ceftriaxon kan reduceres ved hæmodialyse eller peritonal dialyse.
English: Ceftriaxone is indicated for the treatment of the following infections when caused by micro-organisms that are susceptible to ceftriaxone and if parenteral treatment is necessary (see section 5.1):
Danish: Ceftriaxon er indiceret til brug mod følgende infektioner, som skyldes mikroorganismer, der er følsomme over for ceftriaxon og som kræver parenteral behandling (se pkt.
English: The MIC breakpoints according to the Clinical and Laboratory Standards Institute (formerly National Committee for Clinical Laboratory Standards are 8 µg/ml (sensitive), 16-32 µg/ml (intermediate) and 64 µg/ml (resistant) for Enterobacteriaceae and Staphylococcus spp..
Danish: MIC break-point er i følge Clinical and Laboratory Standards Institute (før National Committee for Clinical Laboratory Standards) er 8 µg/ml (følsom), 16-32 µg/ml (intermediate) og 64 µg/ml (resistent) overfor Entrobakterier og Staphylococcuss spp.
English: Like all medicines Ceftriaxone can cause side effects, although not everybody gets them.
Danish: Ceftriaxon Tyrol Pharma kan, som al anden medicin, give bivirkninger, selvom ikke alle får dem.
English: 1 Some strains produce inducible or stably derepressed chromosomally-encoded cephalosporinases and ESBLs (extended spectrum beta-lactamases) and thus are clinically resistant to cephalosporins.
Danish: Nogle strenge producere inducerbare eller stabile, undertrykte, kromosom indkodet cefalosporinaser og ESBL'er (udvidet spektrum beta-laktamaser) og er derfor klinisk resistente overfor cefalosporiner.
English: Symptomatic precipitation of ceftriaxone calcium salt in the gallbladder of adults, which disappeared after discontinuation or cessation of therapy with ceftriaxone.
Danish: Symptomatisk udfældning af ceftriaxon som calciumsalt i galdeblæren hos voksne som forsvinder ved afbrydelse eller ophør af behandlingen med ceftriaxon.
English: Following an the intravenous infusion of 1 g of ceftriaxone for 30 minutes, serum levels immediately after cessation of the infusion process were at 123.2 µg/ml, and at 94.81, 57.8, 20.2 and 4.6 µg/ml, respectively, 1.5, 4, 12 and 24 hours after the onset of infusion.
Danish: Efter den intravenøse infusion af 1 g ceftriaxon i 30 minutter, var serum niveauer straks efter ophør af infusion var på respektive 123,2 µg/ml og på 94,81, 57,8, 20,2 og 4,6 µg/ml, 1,5, 4, 12 og 24 timer efter begyndelse af infusion.
English: Ceftriaxone Tyrol Pharma 2g must never be mixed with any of the following solutions: - solutions containing calcium such as Hartmann's and Ringer's solutions.
Danish: Ceftriaxon Tyrol Pharma 2 g bør aldrig blandes med nogen af de følgende opløsninger: - opløsninger der indeholder calcium så som Hartmann's og Ringer's opløsninger.
English: Kidney stones in children
Danish: Nyresten hos børn
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8oC, otherwise any unused portion must be discarded.
Danish: Hvis det ikke bruges med det samme, er i brug, opbevaringstid og opbevaringsbetingelser før brug, brugerens ansvar og bør normalt ikke være længere end 24 timer ved 2°C til 8°C.
English: In vitro studies have shown that ceftriaxone can displace bilirubin from its binding to serum albumin and bilirubin encephalopathy can possibly develop in these patients.
Danish: In vitro studier har vist, at ceftriaxon kan hæmme bindingen af bilirubin til serum albumin og bilirubin encefalopati kan muligvis udvikles hos disse patienter.
English: Ceftriaxone is a cephalosporin for parenteral administration.
Danish: Ceftiaxon er en cefalosporin til parental administration.
English: Pain at the site of infusion.
Danish: Smerte ved infusionsstedet.
English: Pain at the site of injection.
Danish: Smerte ved injektionsstedet.
English: The Coombs test may be false-positive in rare cases during treatment with ceftriaxone (see section
Danish: Coomb testen kan i sjældne tilfælde give falsk-positive resultater under behandling med ceftriaxon (se pkt.
English: In severe renal impairment accompanied by hepatic insufficiency, dosage reduction is required as outlined in section 4.2.
Danish: Ved alvorlig nedsat nyrefunktion ledsaget af nedsat hepatisk funktion er dosisreduktion er påkrævet som specificeret i pkt.
English: Hospital packs: 10, 25, 50 100 vials.
Danish: Hospitals pakning: 10, 25, 50 og 100 hætteglas.
English: When reconstituted for intramuscular or intravenous injection, the white to yellowish crystalline powder gives a pale yellow to amber solution.
Danish: Når opløsningen til intramuskulær eller intravenøs injektion er rekonstitueret, giver den hvide til gullige krystalliske pulver en svag gul til ravgul opløsning.
English: Agranulocytosis (<500/mm3), mostly after 10-day treatment and a total dose of 20 g ceftriaxone and more; Coagulation disorders, Thrombocytopenia.
Danish: Agranulocytose (< 500/mm3) de fleste af dem forekommer efter 10 dages behandling eller efter en total dosis på 20 g ceftriaxon og mere; koagulationssygdomme; thrombocytopeni.
English: Infections: Having a course of ceftriaxone can temporarily increase the chance that you can get infections caused by other pathogens.
Danish: Infektioner: En ceftriaxon behandling, kan midlertidigt øge risikoen for en infektion, som er forårsaget af andre sygdoms fremkaldene bakterier, som f.eks. svamp.
English: There is no clear evidence of gallstones or of acute cholecystitis developing in children or infants treated with ceftriaxone, and conservative management of Ceftriaxone precipitate in the gallbladder is recommended.
Danish: Der er ingen klare beviser for dannelse af galdesten eller på akut galdeblærebetændelse hos børn eller nyfødte behandlet med ceftriaxon og konservativ ledelse af ceftriaxon til galdeblæren anbefales.
English: METHOD AND ROUTE(S) OF ADMINISTRATION The reconstituted solutions should be used immediately.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Den blandede opløsning bør anvendes med det samme.
English: For intravenous use.
Danish: Til intraveneøs brug.
English: Like all antibiotics, ceftriaxone is only effective against some types of bacteria.
Danish: Som andre antibiotika, er Ceftriaxon kun effektiv mod visse typer af bakterier og er derfor kun egnet til behandling af visse typer af infektioner.
English: The pharmacokinetics of ceftriaxone are non-linear with respect to the dose.
Danish: Ceftriaxons farmakokinetiske egenskaber er ikke-linieret med hensyn til dosis.
English: Miscibility
Danish: Blandbarhed
English: Diarrhoea and fungal infection of the mucous membrane could occur in the breast-fed infant, so that nursing might have to be discontinued.
Danish: Diarre og svampe infektioner af slimhinden kan forekomme hos det ammende barn, hvorfor amning muligvis skal stoppes.
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMEET, ETIKETTERINGEN OG INDLÆGSSEDLEN
English: For other routes of administration other strengths of ceftriaxone are available.
Danish: Til andre administrationsveje er andre styrker af ceftriaxon tilgængelig.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Cardboard carton
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton, pap.
English: Biochemiestrasse 10 6250 Kundl, Austria
Danish: Sandoz GmbH Biochemiestrasse 10 6250 Kundl, Østrig
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN (Se Bilag 1 for national færdiggørelse)
English: Patients with an impaired renal function, as well as an impaired liver function, may have an increased ceftriaxone plasma elimination half-life.
Danish: Patienter med en nedsat nyrefunktion så vel som en nedsat leverfunktion kan have en øget plasma eliminerings halveringstid af ceftriaxon.
English: Precipitations of ceftriaxone - calcium salt have been observed in lungs and kidneys of these dead preterm newborns.
Danish: Udfældninger af ceftriaxon - der er observeret calciumsalt i lunger og nyrer hos disse døde præmature nyfødte.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN (Se Bilag 1 for national færdiggørelse)
English: * Clinical efficacy has been demonstrated for susceptible isolates in approved clinical indications $ Species with natural intermediate susceptibility
Danish: *Klinisk effekt er blevet vist for følsomme isolater i godkendte kliniske indikationer.