FrancophonIA/ELRC3.0 huggingface dataset:
English: Six events were considered to be related to clofarabine of which acute cholecystitis (1 event), cholelithiasis (1 event), hepatocellular damage (1 event; patient died (see above)) and hyperbilirubinaemia (1 event; the patient discontinued therapy (see above)) were considered to be serious.
Danish: 6 tilfælde ansås for at være relateret til clofarabin, hvoraf følgende ansås for at være alvorlige: Akut cholecystitis (1 tilfælde), cholelithiasis (1 tilfælde), hepatocellulær skade (1 tilfælde, hvor patienten døde (se ovenfor)) og hyperbilirubinæmi (1 tilfælde, hvor patienterne indstillede behandlingen (se ovenfor)).
English: (66.6 to -)
Danish: (66,6 til -)
English: However, the pharmacokinetics of clofarabine in adults with relapsed or refractory AML following administration of a single dose of 40 mg/m2 clofarabine by intravenous infusion over 1 hour were comparable to those described above in patients aged between 2 to 19 years old with relapsed or refractory ALL or AML following administration of 52 mg/m2 clofarabine by intravenous infusion over 2 hours for 5 consecutive days.
Danish: Imidlertid blev clofarabins farmakokinetik hos voksne med recidiverende eller refraktær AML efter administration af en enkelt dosis clofarabin på 40 mg/ m2 givet som intravenøs infusion over 1 time sammenlignet med farmakokinetikken beskrevet ovenfor hos patienter mellem 2 og 19 år med recidiverende eller refraktær ALL eller AML efter administration af clofarabin 52 mg/m2 som intravenøs infusion over 2 timer 5 dage i træk.
English: It should be filtered through a sterile 0.2 micrometre syringe filter (the use of hydrophilic PVDF syringe filter is recommended) ) and then diluted with sodium chloride 9 mg/ml (0.9%) intravenous infusion to produce a total volume according to the examples given in the table below.
Danish: Det bør filtreres gennem et sterilt 0,2 mikrometer sprøjtefilter (brug af et hydrofilt PVDF-sprøjtefilter anbefales) og derefter fortyndes med en natriumchlorid 9 mg/ml (0,9 %) intravenøs infusion for at frembringe et samlet volumen i henhold til eksemplerne i tabellen nedenfor.
English: is expected.
Danish: forventes.
English: Should a patient experience the same severe toxicity on a second occasion, treatment should be delayed until the toxicity resolves to baseline parameters or to the point where it is no longer severe and the potential benefit of continued treatment with clofarabine outweighs the risk of such continuation.
Danish: Hvis en patient ved en senere lejlighed atter oplever den samme alvorlige forgiftning, skal behandlingen indstilles, indtil laboratorieundersøgelserne er vendt tilbage til baselineværdier, eller toksicitetsreaktionerne ikke længere er alvorlige, og fordelene ved fortsat behandling med clofarabin overstiger risikoen ved at fortsætte.
English: Severe bone marrow suppression, including neutropaenia, anaemia and thrombocytopaenia have been observed in patients treated with clofarabine.
Danish: Svær knoglemarvssuppression, herunder neutropeni, anæmi og trombocytopeni, er observeret hos patienter, der blev behandlet med clofarabin.
English: Sixty-four patients of 115 (55.7%) experienced at least one vascular disorders adverse reaction.
Danish: 64 patienter ud af 115 (55,7 %) fik mindst én vaskulær bivirkning.
English: (42.0 to -)
Danish: (42,0 til -)
English: Patients undergoing treatment with clofarabine should be evaluated and monitored for signs and symptoms of tumour lysis syndrome and cytokine release (e.g. tachypnoea, tachycardia, hypotension, pulmonary oedema) that could develop into Systemic Inflammatory Response Syndrome (SIRS), capillary leak syndrome and/or organ dysfunction (see section 4.8).
Danish: Patienter i behandling med clofarabin bør evalueres og kontrolleres for symptomer på henfald af tumorceller og frigivelse af cytokin (f.eks. takypnø, takykardi, hypotension, lungeødem), som kan udvikle sig til systemisk inflammatorisk respons-syndrom (SIRS), kapillær lækage-syndrom og/eller organdysfunktion (se pkt.
English: Very common: Headache Common: Somnolence, peripheral neuropathy, paraesthesia, dizziness, tremor
Danish: Meget almindelig: Hovedpine Almindelig: Døsighed, perifer neuropati, paræstesi, svimmelhed, tremor
English: However, these data indicate that clofarabine may accumulate in such patients (see figure below).
Danish: Imidlertid tyder de foreliggende data på, at clofarabin akkumuleres hos disse patienter (se nedenstående figur)
English: Cases of hepatitis and hepatic failure, including fatal outcomes, have been reported with clofarabine treatment (see section 4.8).
Danish: Tilfælde af hepatitis og leversvigt, inklusive tilfælde med dødeligt udfald, er blevet rapporteret ved clofarabinbehandling (se pkt.
English: The use of disposable gloves and protective garments is recommended when handling clofarabine.
Danish: Brug af engangshandsker og beskyttelsestøj anbefales ved håndtering af clofarabin.
English: Twenty-one (18.3%) events were considered to be related to clofarabine of which catheter related infection (1 event), sepsis (2 events) and septic shock (2 events; 1 patient died (see above)) were considered to be serious.
Danish: 21 hændelser (18,3 %) ansås for at være relateret til clofarabin, og følgende ansås for alvorlige: kateterrelateret infektion (1 tilfælde), sepsis (2 tilfælde) og septisk shock (2 tilfælde, 1 patient døde (se ovenfor)).
English: Clofarabine AUC0-24 hours by baseline estimated creatinine clearance in patients aged between 2 to 19 years old with relapsed or refractory ALL or AML (n = 11 / n = 12) following administration of multiple doses of clofarabine by intravenous infusion (creatinine clearance estimated using Schwartz formula)
Danish: Clofarabins AUC0-24 timer for kreatininclearance bestemt ved baseline hos patienter mellem 2 - 19 år med recidiverende eller refraktær ALL eller AML (n = 11 / n = 12) efter administration af gentagne doser af clofarabin som intravenøs infusion (kreatininclearance bestemt i henhold til Schwartz's formel)
English: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), including fatal cases, have been reported (see section 4.8).
Danish: Stevens-Johnsons syndrom (SJS) og toksisk epidermal nekrolyse (TEN), herunder tilfælde med letalt udfald, er blevet rapporteret (se pkt.
English: Sixty-eight patients (59%) experienced at least one serious clofarabine-related adverse event.
Danish: 68 patienter (59 %) fik mindst én alvorlig bivirkning, der kunne henføres til clofarabin.
English: (3.4 to 5.1)
Danish: (3,4 til 5,1)
English: Renal failure or acute renal failure have been observed as a consequence of infections, sepsis and tumour lysis syndrome (see section 4.8).
Danish: Der er observeret nyresvigt eller akut nyresvigt som følge af infektioner, sepsis og tumorlysesyndrom (se pkt.
English: The vials contain 20 ml concentrate for solution for infusion and are packaged in a box.
Danish: Hvert af hætteglassene indeholder 20 ml koncentrat infusionsvæske, opløsning, og de er pakket i en æske.
English: Studies in animals have shown reproductive toxicity including teratogenicity (see section 5.3).
Danish: Reproduktionstoksicitet inklusive teratogenicitet er set i dyreforsøg (se pkt.
English: (58.6 to -)
Danish: (58,67 til -)
English: The use of disposable gloves and protective garments is recommended when handling Ivozall.
Danish: Under håndtering af Ivozall anbefales brug af engangshandsker og beskyttelsestøj.
English: What Ivozall contains
Danish: Ivozall indeholder:
English: The recommended dose in monotherapy is 52 mg/m2 of body surface area administered by intravenous infusion over 2 hours daily for 5 consecutive days.
Danish: Den anbefalede dosis i monoterapi er 52 mg/m legemsoverflade og administreres som intravenøs infusion over 2 timer dagligt 5 dage i træk.
English: In the post-marketing period, following treatment with clofarabine, serious hepatotoxic adverse reactions of VOD in paediatric and adult patients have been associated with a fatal outcome.
Danish: Efter markedsføring er alvorlige hepatotoksiske reaktioner på VOD hos pædiatriske og voksne patienter, der har fået behandling med clofarabin, blevet associeret med letalt udfald.
English: Forty-one patients of 115 (35.7%) experienced at least one renal and urinary disorders adverse reaction.
Danish: 41 patienter ud af 115 (35,7 %) fik mindst én bivirkning fra nyrer eller urinveje.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN ORPHELIA Pharma
English: The safety profile of clofarabine has not been established in patients with severe renal insufficiency or patients receiving renal replacement therapy (see section 4.3).
Danish: Clofarabins sikkerhedsprofil er ikke klarlagt hos patienter med svær nyreinsufficiens eller hos patienter, som er i dialyse (se afsnit 4.3).
English: If a patient experiences one or more severe toxicities (US National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grade 3 toxicities excluding nausea and vomiting), treatment should be delayed until the toxicities resolve to baseline parameters or to the point where they are no longer severe and the potential benefit of continued treatment with clofarabine outweighs the risk of such continuation.
Danish: Hvis en patient oplever en eller flere alvorlige toksicitetsreaktioner (grad 3 toksicitet ifølge det amerikanske National Cancer Institutes Common Toxicity Criteria (NCI-CTC) eksklusive kvalme og opkastning), skal behandlingen udsættes, indtil laboratorieundersøgelser er vendt tilbage til baselineværdier, eller toksicitetsreaktionerne ikke længere er alvorlige, og de potentielle fordele ved fortsat behandling med clofarabin overstiger risikoen ved at fortsætte.
English: Twenty-three patients out of 115 experienced a vascular disorder considered to be related to clofarabine, the most frequently reported being flushing (13 events; not serious) and hypotension (5 events; all of which were considered to be serious; see section 4.4).
Danish: 23 patienter ud af 115 fik en vaskulær bivirkning, der blev anset for at være relateret til clofarabin, hvoraf den hyppigst rapporterede var flushing (13 ikke alvorlige tilfælde) og hypotension (5 tilfælde, hvoraf alle ansås for alvorlig, se pkt.
English: (9.7 to 47.9)
Danish: (9,7 til 47,9)
English: The maximum tolerated dose identified in the phase I study described above of 52 mg/m2/day clofarabine was administered by intravenous infusion for 5 consecutive days every 2 to 6 weeks.
Danish: Den maksimale tolererede dosis clofarabin identificeret i det ovenfor beskrevne fase I-studie, 52 mg/m2/dag, blev administreret som intravenøs infusion 5 dage i træk hver 2.
English: There are currently insufficient data to establish the safety and efficacy of clofarabine in patients 65 years of age or older.
Danish: Erfaringsgrundlaget er endnu utilstrækkeligt til at påvise sikkerhed og effekt af clofarabin hos patienter på 65 år og derover.
English: (15.4 to 56.1)
Danish: (15,4 til 56,1)
English: There is no experience in patients with hepatic impairment (serum bilirubin > 1.5 x ULN plus AST and ALT > 5 x ULN) and the liver is a potential target organ for toxicity.
Danish: Der er ikke erfaring med patienter med nedsat leverfunktion (serum-bilirubin > 1,5 x ULN samt ASAT og ALAT > 5 x ULN), og leveren udgør et potentielt målorgan for toksicitet.
English: It is then recommended that clofarabine be administered at a further 25% dose reduction.
Danish: I sådanne tilfælde anbefales det at reducere doseringen af clofarabin med yderligere 25 %.
English: Very common: Vomiting, nausea, diarrhoea Common: Mouth haemorrhage, gingival bleeding, haematemesis, abdominal pain, stomatitis, upper abdominal pain, proctalgia, mouth ulceration Frequency not known: Pancreatitis elevations in serum amylase and lipase, enterocolitis, neutropenic colitis, caecitis
Danish: Meget almindelig: Opkastning, kvalme, diarre Almindelig: Blødning i munden, gingivalblødning, hæmostase, abdominalsmerter, stomatitisk, øvre abdominalsmerter, proktalgi, mundsår Ikke kendt: Pancreatitis, forhøjelser i serum-amylase oglipase, enterocolitis, neutropenisk colitis, caecitis
English: (18.1 to -)
Danish: (18,1 til -)
English: (13.7 to -)
Danish: (13,7 til -)
English: It is supplied in 20 ml glass vials.
Danish: Ivozall udleveres i 20 ml hætteglas.
English: Ivozall 1 mg/ml concentrate for solution for infusion must be diluted prior to administration.
Danish: Ivozall 1 mg/ml koncentrat til infusion, opløsning, skal fortyndes før administration.
English: (13.7 to 56.1)
Danish: (13,7 til 56,1)
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release
Danish: På lægemidlets trykte indlægsseddel skal der anføres navn og adresse på den fremstiller, som er ansvarlig for frigivelsen af den pågældende batch.
English: Common: Haematuria*, renal failure, acute renal failure
Danish: Almindelig: Hæmaturi*, nyresvigt, akut nyresvigt
English: Thus, the concomitant use of medicinal products that have been associated with hepatic toxicity should be avoided wherever possible (see sections 4.4 and
Danish: Samtidig anvendelse af lægemidler, der er sat i forbindelse med levertoksicitet, bør derfor så vidt muligt undgås (se pkt.
English: (5.0 to -)
Danish: (5,0 til -)
English: However, for patients with a body surface area > 0.38 m2, the contents of between 1 to 7 vials will be required to produce the recommended daily dosage of clofarabine.
Danish: Til en patient med legemsoverflade > 0,38 m2 vil der imidlertid være behov for at anvende indholdet fra 1-7 hætteglas til at fremstille den anbefalede daglige dosis clofarabin.
English: Therefore, the potential benefit and risks associated with continued therapy in patients who do not show haematological and/or clinical improvement after 2 treatment cycles should be assessed by the treating physician.
Danish: Derfor bør den behandlende læge vurdere de potentielle fordele og risici forbundet med at fortsætte behandlingen hos patienter, som ikke udviser hæmatologisk og/eller klinisk forbedring efter 2 behandlingscykler.
English: 28.8 l/h/m2
Danish: 28,8 l/time/m2
English: breathlessness, cough; - vomiting blood, stomach ache, pain in the bottom; - bleeding inside the head, stomach, intestine or lungs, mouth or gums, mouth ulcers, inflamed mouth lining; - yellowing of the skin and eyes (also called jaundice), or other liver disorders; - bruising, hair loss, changes to skin colour, increased sweating, dry skin, or other skin problems; - pain in the chest wall or bones, neck or back pain, pain in limbs, muscles, or joints; - blood in urine; - failure of organs, pain, increased muscle tension, water retention and swelling in parts of the body, including the arms and legs, changes in mental state, feeling hot, cold or abnormal; - clofarabine may affect the levels of certain substances in the blood.
Danish: - opkastning af blod, mavesmerter, smerter i endetarmen; - blødning i hjerne, mave, tarme eller lunger, mund eller tandkød, mundsår, betændelse i mundhulen; - gullig hud og øjne (gulsot) eller andre leversygdomme; - blå mærker, hårtab, forandringer i hudfarve, øget svedtendens, tør hud eller andre hudproblemer; - smerter i brystkasse eller knogler, hals- eller rygsmerter, smerter i arme og ben, muskler eller led; - blod i urinen; - organsvigt, smerter, øget muskelspænding, væskeophobning og hævelser i forskellige legemsdele inklusive arme og ben, forandringer i sindstilstand, varmefølelse, kulderystelser eller ubehag; - clofarabin kan påvirke koncentrationen af visse stoffer i blodet.
English: if you have suffered a severe reaction after previously using this medicine; if you have kidney disease, or used to have it; if you have liver disease, or used to have it; if you have heart disease, or used to have it.
Danish: I så fald er Ivozall måske ikke det rette middel til dig: - hvis du har haft en alvorlig reaktion efter tidligere behandling med lægemidlet; - hvis du har en nyresygdom eller har haft; - hvis du har en leversygdom eller har haft; - hvis du har en hjertesygdom eller har haft.
English: During the post-marketing period prolonged cytopaenias (thrombocytopaenia, anaemia, neutropaenia and leukopaenia) and bone marrow failure have been reported.
Danish: Længerevarende cytopenier (trombocytopeni, anæmi, neutropeni og leukopeni) og knoglemarvssvigt er blevet indberettet i tiden efter markedsføring.
English: Any patient who experiences a severe toxicity on a third occasion, a severe toxicity that does not recover within 14 days (see above for exclusions), or a life-threatening or disabling toxicity (US NCI CTC Grade 4 toxicity) should be withdrawn from treatment with clofarabine (see section 4.4).
Danish: Enhver patient, som for tredje gang oplever en alvorlig forgiftning, som ikke fortager sig i løbet af 14 dage (se undtagelserne ovenfor), eller en livstruende eller invaliderende forgiftning (grad 4toksicitet ifølge NCI-CTC), skal stoppe behandling med clofarabin (se pkt.
English: Dose-limiting toxicities in this study were hyperbilirubinaemia, elevated transaminase levels and maculo-papular rash experienced at 70 mg/m2/day (2 ALL patients; see section 4.9).
Danish: I dette studie var de dosisbegrænsende toksiciteter hyperbilirubinæmi, forhøjede aminotransferaser og makulopapulært udslæt ved 70 mg/m2/dag (2 ALL-patienter, se pkt.
English: (7.6 to 47.9)
Danish: (7,6 til 47,9)
English: Suggested dilution schedule based on the recommended dosage of 52 mg/m2/day clofarabine Body surface area (m2)
Danish: Foreslået fortyndingsforhold baseret på den anbefalede dosering på 52 mg/m2/dag clofarabin Legemsoverflade (m2)
English: It should be filtered through a sterile 0.2 micrometre syringe filter (the use of hydrophilic PVDF syringe filter is recommended) and then diluted in sodium chloride 9 mg/ml (0.9%) intravenous transparent PVC or polyolefine (polypropylene) infusion bags to produce a total volume according to the examples given in the table below.
Danish: Opløsningen filtreres gennem et sterilt 0,2 µm sprøjtefilter (brug af et hydrofilt PVDF-sprøjtefilter anbefales) og fortyndes så i gennemsigtige PVC- eller polyolefin (polypropylen)-infusionsposer med 9 mg/ml (0,9 %) natriumchlorid til fortynding af infusionskoncentrat, så der opnås et samlet volumen som angivet i eksemplerne i tabellen nedenfor.
English: • The use of prophylactic steroids (e.g., 100 mg/m2 hydrocortisone on Days 1 through 3) may be of benefit in preventing signs or symptoms of SIRS or capillary leak.
Danish: • Anvendelse af profylaktiske steroider (f.eks. 100 mg hydrocortison/m2 på dag 1 til og med dag 3)
English: Very common: Flushing* Common: Hypotension*, capillary leak syndrome, haematoma
Danish: Almindelig: Hypotension*, kapillær lækage-syndrom, hæmatom
English: - If you have any further questions, ask your doctor.
Danish: Spørg din læge, hvis du har yderligere spørgsmål om behandling med lægemidlet.
English: Any patient who experiences a severe non-hematologic toxicity (US NCI CTC Grade 3 toxicity) on a third occasion, a severe toxicity that does not recover within 14 days (excluding nausea/vomiting) or a life-threatening or disabling non-infectious non-hematologic toxicity (US NCI CTC Grade 4 toxicity) should be withdrawn from treatment with clofarabine (see section 4.2).
Danish: Patienter, som for tredje gang får en svær ikke-hæmatologisk toksicitetsreaktion (NCI-CTC grad 3toksicitet), en svær toksicitetsreaktion, der ikke aftager i løbet af 14 dage bortset fra kvalme/opkastning), eller en livstruende eller invaliderende ikke-infektiøs, ikke-hæmatologisk toksicitetsreaktion (grad 4-toksicitet i henhold til NCI CTC), bør afslutte behandlingen med clofarabin (se pkt.
English: It is then recommended that clofarabine be administered at a 25% dose reduction.
Danish: I sådanne tilfælde anbefales det at reducere doseringen af clofarabin med 25 %.
English: The active substance is clofarabine.
Danish: Aktivt stof: Clofarabin.
English: Therefore, the potential benefit and risks associated with continued therapy in patients who do not show haematological and/or clinical improvement after 2 treatment cycles should be assessed by the treating physician (see section 4.4).
Danish: Derfor bør den behandlende læge vurdere de potentielle fordele og risici forbundet med at fortsætte behandlingen hos patienter, som ikke udviser hæmatologisk og/eller klinisk forbedring efter 2 behandlingscykler (se pkt.
English: Common: Tumour lysis syndrome*
Danish: Almindelig: Tumorlysesyndrom*
English: There are currently insufficient data to establish the safety and efficacy of clofarabine in adult patients.
Danish: Erfaringsgrundlaget er endnu utilstrækkeligt til at påvise sikkerhed og effekt af clofarabin til voksne patienter.
English: The vials contain 20 mg of clofarabine and are packaged in a box.
Danish: Hvert af hætteglassene indeholder 20 mg clofarabin, og de er pakket i en æske.
English: Haemorrhage, including cerebral, gastrointestinal and pulmonary haemorrhage, has been reported and may be associated with a fatal outcome (see section 4.4).
Danish: Blødninger, herunder cerebrale, gastrointestinale og pulmonale blødninger er rapporteret og kan være forbundet med letalt udfald (se pkt.
English: There is no experience in patients with hepatic impairment (serum bilirubin > 1.5 x ULN plus AST and ALT > 5 x ULN) and the liver is a potential target organ for toxicity (see sections 4.3 and 4.4).
Danish: Der er ikke erfaring med patienter med nedsat leverfunktion (serum-bilirubin > 1,5 x ULN samt ASAT og ALAT > 5 x ULN), og leveren udgør et potentielt målorgan for toksicitet (se pkt.
English: Pharmacokinetics in patients aged between 2 to 19 years old with relapsed or refractory ALL or AML following administration of multiple doses of clofarabine by intravenous infusion
Danish: Farmakokinetikken hos patienter mellem 2 og 19 år med recidiverende eller refraktær ALL eller AML efter administration af gentagne doser clofarabin som intravenøs infusion Parameter
English: To date, there are limited data on the pharmacokinetics of clofarabine in paediatric patients with decreased creatinine clearance.
Danish: Der er begrænsede farmakokinetiske data fra pædiatriske patienter med nyreinsufficiens.
English: Common: Maculo-papular rash, petechiae, erythema, pruritic rash, skin exfoliation, generalised rash, alopecia, skin hyperpigmentation, generalised erythema, erythematous rash, dry skin, hyperhidrosis Frequency not known: Stevens Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN)
Danish: Almindelig: Makulo-papulært udslæt, petekkier, erytem, kløende udslæt (pruritic rash), hudeksfoliation, generaliseret udslæt, alopeci, hyperpigmentering af hud, generaliseret erytem, erytematøst udslæt, tør hud, hyperhidrose
English: (7.0 to -)
Danish: (7,0 til -)
English: Capillary leak syndrome cases reported during the post-marketing period have been associated with a fatal outcome (See section 4.4).
Danish: Tilfælde af kapillær lækage-syndrom indberettet efter markedsføring og har været forbundet med letalt udfald (se pkt.
English: Each 20 ml vial contains 20 mg of clofarabine.
Danish: Hvert 20 ml hætteglas indeholder 20 mg clofarabin.
English: Very common: Fatigue, pyrexia, mucosal inflammation Common: Multi-organ failure, systemic inflammatory response syndrome*, pain, chills, irritability, oedema, peripheral oedema, feeling hot, feeling abnormal
Danish: Almindelig: Multiorgansvigt, systemisk inflammatorisk responssyndrom*, smerter, kulderystelser, irritabilitet, ødem, perifert ødem, varmefølelse, unormal følelse
English: LIST OF EXCIPIENTS Excipients: Sodium chloride and water for injections.
Danish: Hjælpestoffer: Natriumchlorid og vand til injektionsvæsker.
English: Therefore, for patients with a body surface area ≤ 0.38 m2, the partial contents of a single vial will be required to produce the recommended daily dosage of clofarabine.
Danish: Til en patient med legemsoverflade ≤ 0,38 m2 skal der derfor kun anvendes en del af indholdet i et enkelt hætteglas til at fremstille den anbefalede daglige dosis clofarabin.
English: During the post-marketing period, bacterial, fungal and viral infections have been reported and may be fatal.
Danish: Svampe-, virus- og bakterieinfektioner, som kan være dødelige, er blevet indberettet efter markedsføring.