natgillin/translations-raw huggingface dataset:
Hvis en dosis glemmes i mindre end 12 timer, skal du tage den anbefalede dosis.
If dose is missed by less than 12 hours, take your recommended dose.
Inkluderer patienter (N), der opnåede eller fastholdt CHR (CP-patienter) eller, OHR(AP- og BPpatienter).
Includes patients (N) who attained or maintained CHR for CP patients and OHR for AP and BP patients.
Den mediane behandlingsvarighed var 13,8 måneder (interval: 0,03-123,3 måneder).
The median duration of therapy was 13.8 months (range: 0.03 to 123.3 months).
Bosulif indeholder det aktive stof bosutinib.
Bosulif contains the active substance bosutinib.
Situationsdato: 2. oktober 2015 Bemærk: Baseline-mutationer blev identificeret før patientens første dosis studiemedicin.
Note: Baseline mutations were identified before the patient's first dose of study drug.
Kriterier for cytogenetisk respons: Major cytogenetisk respons omfattede komplet (0 % Ph+ metafaser fra knoglemarven eller < 1 % positive celler fra fluorescens-in situ-hybridisering (FISH)) eller delvist (1-35 %) cytogenetisk respons.
Cytogenetic Response criteria: Major Cytogenetic Response included Complete [0% Ph+ metaphases from bone marrow or < 1% positive cells from fluorescent in situ hybridisation (FISH)] or partial (1%-35%) cytogenetic responses.
- methadon, der anvendes til behandling af smerter.
- methadone, used to treat pain.
Tabletterne skal synkes hele sammen med vand.
Swallow the tablet(s) whole with water.
Du vil kun få ordineret Bosulif af en læge med erfaring med lægemidler til behandling af leukæmi.
Bosulif will only be prescribed to you by a doctor with experience in medicines to treat leukaemia.
I et studie af centralnervesystemet (CNS) udviste bosutinibbehandlede rotter nedsat pupilstørrelse og nedsat gang.
In a study of the central nervous system (CNS), bosutinib treated rats displayed decreased pupil size and impaired gait.
Bosutinib hæmmer den abnorme BCR-ABL-kinase, der fremmer CML.
Bosutinib inhibits the abnormal BCR-ABL kinase that promotes CML.
Mikrokrystallinsk cellulose (E460) Croscarmellosenatrium (E468) Poloxamer 188
Microcrystalline cellulose (E460) Croscarmellose sodium (E468) Poloxamer 188
Du må ikke amme under behandlingen med Bosulif, da det kan skade dit barn.
Do not breast-feed during treatment with Bosulif as it could harm your baby.
Påvirkning af hanners fertilitet kan ikke udelukkes (se pkt.
An effect on male fertility cannot be excluded (see section 4.6).
I et forsøg vedrørende udviklingstoksicitet hos kaniner ved den maternelle toksiske dosis blev der set fosterabnormiteter (sammensmeltede sternebrae, og 2 fostre havde forskellige viscerale observationer) og et let fald i den føtale legemsvægt.
In a rabbit developmental toxicity study at the maternally toxic dose, there were foetal anomalies observed (fused sternebrae, and 2 foetuses had various visceral observations), and a slight decrease in foetal body weight.
Det er påvist, at bosutinib kan absorbere lys i UV-B- og UV-A-området, og at det fordeles i huden og tractus uvealis hos pigmenterede rotter.
Bosutinib has demonstrated the ability to absorb light in the UV-B and UV-A range and is distributed into the skin and uveal tract of pigmented rats.
Tag ikke Bosulif sammen med grapefrugt eller grapefrugtjuice, da det kan øge risikoen for bivirkninger.
Bosulif with food and drink Do not take Bosulif with grapefruit or grapefruit juice, as it may increase the risk of side effects.
Mediantiden til CCyR (kun respondenter) var 23,9 uger i bosutinib-gruppen sammenlignet med 24,3 uger i imatinib-gruppen.
The median time to CCyR (responders only) was 23.9 weeks in the bosutinib group compared to the 24.3 weeks imatinib group.
Kliniske data er meget begrænsede (n = 3) for CML-patienter med moderat nyreinsufficiens, som fik en øget dosis på 600 mg bosutinib.
Clinical data are very limited (n = 3) for CML patients with moderate renal impairment receiving an escalated dose of 600 mg bosutinib.
Genopblussen (reaktivering) af infektion med hepatitis B, når du tidligere har haft leverbetændelse af typen hepatitis B.
Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection).
- efavirenz og etravirin, der anvendes til behandling af hiv/aids.
- efavirenz and etravirine, used to treat HIV infections/AIDS.
Der er utilstrækkelige data fra anvendelse af bosutinib til gravide kvinder.
There are limited amount of data in pregnant women from the use of bosutinib.
Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med bosutinib hos en eller flere undergrupper af den pædiatriske population med CML (se pkt.
The European Medicines Agency has deferred the obligation to submit the results of studies with Bosulif in one or more subsets of the paediatric population in CML (see section 4.2 for information on paediatric use).
Bosutinib udviser pH-afhængig vandopløselighed in vitro.
Bosutinib displays pH-dependent aqueous solubility in vitro.
Seponering på grund af suboptimalt respons eller manglende terapeutisk virkning i henhold til investigators vurdering forekom for 2,0 % af patienterne i bosutinib-behandlingsgruppen sammenlignet med 6,3 % af patienterne i imatinib-behandlingsgruppen.
Discontinuations due to suboptimal response or treatment failure as assessed by the investigator occurred for 2.0% of patients in the bosutinib-treated group compared to 6.3% of patients in the imatinib-treated group.
Almindelig Forhøjet blodkreatinin, forhøjet amylase, Forhøjet serumkreatin-fosfokinase
Blood creatinine increased, Amylase increased, Blood creatine phosphokinase increased
Lægen vil eventuelt ændre dosis af disse lægemidler eller af Bosulif eller ordinere et andet lægemiddel.
Your doctor may change the dose of these medicines, change the dose of Bosulif, or switch you to a different medicine.
Modelleringsforsøg tyder på, at bosutinib binder kinasedomænet i BCR-ABL. Bosutinib hæmmer også kinaserne af Src-familien, herunder Src, Lyn og Hck.
Modeling studies indicate that bosutinib binds the kinase domain of BCR-ABL. Bosutinib is also an inhibitor of Src family kinases including Src, Lyn and Hck.
Efter 500 mg bosutinib dagligt med føde var Cmax200 (6) ng/ml og AUCss var 3.640 (12) ng•t/ml.
After 500 mg bosutinib daily with food, Cmax was 200 (6) ng/mL and AUCss was 3,640 (12) ng•h/mL.
Andre lægemidlers indvirkning på bosutinib
Effects of other medicinal products on bosutinib
Hvis du tager nogle af disse lægemidler, skal du fortælle det til lægen.
If you are taking any of them, tell your doctor.
Behandling med bosutinib er forbundet med stigning i serum-aminotransferaser (ALAT (alaninaminotransferase), ASAT (aspartataminotransferase)).
Treatment with bosutinib is associated with elevations in serum transaminases (alanine aminotransferase [ALT], aspartate aminotransferase [AST]).
Fortæl det også til lægen, hvis du oplever vægttab eller har oplevet hævelse af fødder, ankler, ben, hænder eller ansigt.
Also tell your doctor if you are losing weight or have experienced swelling of your feet, ankles, legs, hands or face.
- hvis du er allergisk over for bosutinib eller et af de øvrige indholdsstoffer i Bosulif (angivet i punkt 6).
Do not take Bosulif - if you are allergic to bosutinib or any of the other ingredients of this medicine (listed in section 6).
Efter opfølgning på mindst 12 måneder i mITT-populationen fik 77,6 % af de patienter, der blev behandlet med bosutinib (N=241) og 72,4 % af de patienter, der blev behandlet med imatinib (N=239) stadig førstevalgsbehandling.
After a minimum of 12 months of follow-up in the mITT population, 77.6% of patients treated with bosutinib (N=241) and 72.4% of patients treated with imatinib (N=239) were still receiving first-line treatment.
Spørg lægen, om den behandling, du får mod opkastninger, kan medføre en større risiko for hjerterytmeforstyrrelser.
You should ask your doctor if use of your treatment for vomiting may result in a greater risk of heart arrhythmias.
Den evaluerbare population inkluderer patienter med valid sygdomsvurdering ved baseline.
The evaluable population includes patients who had a valid baseline disease assessment.
Udskillelsen af uomdannet bosutinib i urin var lav med ca. 1 % af dosis hos både raske frivillige og forsøgsdeltagere med fremskredne maligne solide tumorer.
Excretion of unchanged bosutinib in urine was low with approximately 1% of the dose in both healthy subjects and those with advanced malignant solid tumours.
Data fra dette studie tyder på, at bosutinib ikke forlænger QT-intervallet hos raske frivillige ved dosis på 500 mg dagligt sammen med føde eller under forhold, der giver anledning til supraterapeutiske plasmakoncentrationer.
The data from this study indicate that bosutinib does not prolong the QTc in healthy subjects at the dose of 500 mg daily with food, and under conditions that give rise to supratherapeutic plasma concentrations.
Hvis blodtallene forbliver lave i mere end 2 uger, reduceres dosis efter bedring med 100 mg, og behandlingen genoptages.
If blood counts remain low for > 2 weeks, upon recovery reduce dose by 100 mg and resume treatment.
Dette lægemiddel er blevet godkendt under såkaldt ”betingede omstændigheder”.
This medicinal product has been authorised under a so-called “conditional approval” scheme.
- lungebetændelse, influenza, bronkitis.
- infection of the lung (pneumonia), influenza, bronchitis.
- imatinib, der anvendes til behandling af en type leukæmi.
- imatinib, used to treat a type of leukaemia.
- bosentan, der anvendes til at sænke forhøjet blodtryk i lungerne (pulmonal arteriel hypertension).
- bosentan, used to lower high blood pressure in the lungs (pulmonary artery hypertension).
Fortæl det til lægen, hvis du har en hjerteforstyrrelse såsom et unormalt elektrisk signal, der kaldes ”forlænget QT-interval”, eller hvis du besvimer (mister bevidstheden) eller får uregelmæssig puls, mens du tager Bosulif.
Tell your doctor if you have a heart disorder, such as an abnormal electrical signal called “prolongation of the QT interval”, or if you faint (loss of consciousness) or have an irregular heart beat while taking Bosulif.
Bosutinib og N-desmethylbosutinib var de vigtigste lægemiddelrelaterede komponenter i fæces.
In faeces, bosutinib and N-desmethyl bosutinib were the major drug-related components.
Hvis der igen opstår cytopeni, reduceres dosis med yderligere 100 mg efter bedring, og behandlingen genoptages.
If cytopoenia recurs, reduce dose by an additional 100 mg upon recovery and resume treatment.
- chloroquin og halofantrin, der anvendes til behandling af malaria.
- chloroquine, halofantrine used to treat malaria.
Efter opfølgning på mindst 12 måneder i mITT-populationen var seponering på grund af sygdomsprogression til AP eller BP CML for bosutinib-behandlede patienter på 0,4 % sammenlignet med 1,7 % for imatinib-behandlede patienter.
After a minimum of 12 months of follow-up in the mITT population, discontinuations due to disease progression to AP or BP CML for bosutinib-treated patients were 0.4% compared to 1.7% for imatinib-treated patients.
Fortæl det til lægen, hvis du har en hjertesygdom, f.eks. hjerterytmeforstyrrelser eller et unormalt elektrisk signal, såkaldt ”forlængelse af QTintervallet".
Tell your doctor if you have a heart disorders, such as arrhythmias or an abnormal electrical signal called “prolongation of the QT interval”.
- livstruende allergisk reaktion (anafylaktisk shock).
- life-threatening allergic reaction (anaphylactic shock).
Hvis det er klinisk relevant, kan det overvejes at vende tilbage til dosis fra før reduktionen, som tages 1 gang dagligt (se pkt.
If clinically appropriate, re-escalation to the dose prior to the dose reduction taken once daily should be considered (see section 4.4).
Denne medicin til behandling af kvalme og opkastninger kan sammen med Bosulif øge risikoen for farlige forstyrrelser i hjerterytmen.
Treatment of nausea or vomiting with such medicines together with Bosulif may result in a greater risk of dangerous heart arrhythmias.
Det anbefales at udvise forsigtighed hos patienter med pankreatitis i anamnesen.
Caution is recommended in patients with previous history of pancreatitis.
- nafcillin, der er et antibiotikum til behandling af bakterieinfektioner.
- nafcillin, an antibiotic used to treat bacterial infections.
Bortskaf ikke anvendt lægemiddel i henhold til lokale retningslinjer.
Dispose unused medicinal product in accordance with local requirements.
Hvis lipasestigning er ledsaget af abdominale symptomer, skal behandlingen med bosutinib afbrydes og passende diagnostiske tiltag overvejes med henblik på udelukkelse af pankreatitis (se pkt.
In case lipase elevations are accompanied by abdominal symptoms, bosutinib should be interrupted and appropriate diagnostic measures considered to exclude pancreatitis (see section 4.2).
Bosutinibbehandling reducerede størrelsen af CML-tumorer, der voksede i nøgne mus, og hæmmede væksten af murine myeloide tumorer, der udtrykte imatinib-resistente former af BCR-ABL. Bosutinib hæmmer også receptortyrosinkinase c-Fms, EphA- og B-receptorer, Trk-familie-kinaserne, Axl-familie-kinaserne, Tec-familie-kinaserne, visse medlemmer af ErbB-familien, nonreceptortyrosinkinasen Csk, serin-/treonine-kinaserne fra Ste20-familien og to calmodulin-afhængige proteinkinaser.
Bosutinib treatment reduced the size of CML tumours growing in nude mice and inhibited growth of murine myeloid tumours expressing imatinib-resistant forms of BCR-ABL. Bosutinib also inhibits receptor tyrosine kinases c-Fms, EphA and B receptors, Trk family kinases, Axl family kinases, Tec family kinases, some members of the ErbB family, the non-receptor tyrosine kinase Csk, serine/threonine kinases of the Ste20 family, and 2 calmodulin-dependent protein kinases.
Reproduktionstoksicitet og udviklingstoksicitet
Reproductive toxicity and development toxicity
F359C/I/V
Y253H E255K/V F359C/I/V
- Øvrige indholdsstoffer: Mikrokrystallinsk cellulose (E460), croscarmellosenatrium (E468), poloxamer 188, povidon (E1201) og magnesiumstearat (E470b).
- The other ingredients are: microcrystalline cellulose (E460), croscarmellose sodium (E468), poloxamer 188, povidone (E1201) and magnesium stearate (E470b).
Der skal udvises forsigtighed hos patienter med relevante hjertesygdomme (se pkt.
Caution should be exercised in patients with relevant cardiac disorders (see section 4.4).
Det antiemetiske middel domperidon kan potentielt forlænge QT-intervallet (QTc) og inducere torsades de pointes-arytmier, derfor skal samtidig administration undgås.
The antiemetic agent, domperidone, has the potential to increase QT interval (QTc) prolongation and to induce “torsade de pointes”- arrhythmias; therefore, co-administration with domperidone should be avoided.
Hvis du holder op med at tage Bosulif
If you stop taking Bosulif
Patienter, der får bosutinib, skal have testet deres leverfunktion, før behandlingen påbegyndes og månedligt i de første tre behandlingsmåneder samt efter klinisk behov.
Patients receiving bosutinib should have liver function tests prior to treatment initiation and monthly for the first 3 months of treatment, and as clinically indicated.
Du skal især tale med lægen, hvis du overvejer at bruge medicin, som indeholder domperidon mod kvalme og opkastning.
In particular, you should ask your doctor if you want to use a medicine containing domperidone for the treatment of nausea and/or vomiting.
Statistisk signifikant sammenligning på det forhåndsdefinerede signifikansniveau; baseret på CMH-test, der er stratificeret efter geografisk område og Sokal-score ved randomisering.
Statistically significant comparison at the pre-specified significance level; based on CMH test stratified by geographical region and Sokal score at randomisation.
Patienter med diarré og opkastning skal behandles med standardbehandling, inklusive antidiarrémidler eller antiemetika og/eller væskesubstitution.
Patients with diarrhoea and vomiting should be managed using standard-of-care treatment, including an antidiarrhoeal or antiemetic medicinal product and/or fluid replacement.
Lægen bør tage blodprøver for at kontrollere din leverfunktion, før du starter behandling med Bosulif, i de første tre måneder af behandlingen med Bosulif og derefter efter behov.
Your doctor should do blood tests to check your liver function prior to your starting treatment with Bosulif and for the first 3 months of treatment with Bosulif, and as clinically indicated.
Bosutinibs aktivitet in vitro i hERG-analyser tyder på, at det har potentiale til at forlænge den kardiale-ventrikulære repolarisering (QT-intervallet).
Bosutinib activity in vitro in hERG assays suggested a potential for prolongation of cardiac ventricular repolarisation (QTc).
I forsøget blev 536 patienter (268 i hver behandlingsgruppe) med nydiagnosticeret Ph+ eller Ph- CP CML (intent-to-treat-population (ITT)) randomiseret, herunder 487 patienter med Ph+ CML med b2a2- og/eller b3a2-transskripter og baseline-BCR-ABL-kopier > 0 (modificeret intent-to-treat-population (mITT)).
The trial randomised 536 patients (268 in each treatment group) with Ph+ or Ph- newly-diagnosed CP CML (intent-to-treat population [ITT]) including 487 patients with Ph+ CML harbouring b2a2 and/or b3a2 transcripts and baseline BCR-ABL copies > 0 (modified intent-to-treat [mITT] population).
Trombocytter < 50 x 10 9/l
Platelets < 50 × 109/L
Bosutinib hæmmer PDGF-receptoren (platelet derived growth factor) og cKit i minimal grad.
Bosutinib minimally inhibits platelet-derived growth factor (PDGF) receptor and c-Kit.
I et fertilitetsforsøg med rotter var fertiliteten let nedsat hos handyr.
In a rat fertility study, fertility was slightly decreased in males.
Sikkerhedsprofil
Summary of safety profile
Patienter med serumkreatinin > 1,5 x ULN blev udelukket fra CML-studierne.
Patients with serum creatinine > 1.5 × ULN were excluded from the CML studies.
I analysen tillades baseline-respondenter som fastholdt respons efter baseline.
The analyses allow baseline responders who maintained response post-baseline to be responders.
Patienter med serumkreatinin > 1,5 x ULN blev udelukket fra CML-studier.
Patients with serum creatinine > 1.5×ULN were excluded from CML studies.
Blandt de 994 patienter med diarré afbrød 180 patienter (18 %) behandlingen, og 170 af disse patienter (94 %) genoptog senere bosutinib-behandlingen.
Among the 994 patients with diarrhoea, 180 patients (18%) were managed with treatment interruption and of these 170 (94%) were rechallenged with bosutinib.
Kvinder i den fertile alder skal rådes til at anvende sikker kontraception under behandlingen med bosutinib og i mindst 1 måned efter den sidste dosis for at undgå graviditet under behandlingen med bosutinib.
Women of childbearing potential should be advised to use effective contraception during treatment with bosutinib and for at least 1 month after the last dose and to avoid becoming pregnant while receiving bosutinib.
I in vitro-studier hæmmer bosutinib proliferationen og overlevelsen af etablerede CML-cellelinjer, Ph+ akut lymfoblastisk leukæmi-cellelinjer og patientderiverede primære primitive CML-celler.
In in vitro studies, bosutinib inhibits proliferation and survival of established CML cell lines, Ph+ ALL cell lines, and patient-derived primary primitive CML cells.
Tabletternes filmovertræk indeholder polyvinylalkohol, titandioxid (E171), macrogol 3350, talcum (E553b) og gul jernoxid (E172, 100 mg og 400 mg tablet) eller rød jernoxid (E172, 400 mg og 500 mg tablet).
The tablet film-coating contains polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b) and iron oxide yellow (E172, for Bosulif 100 mg and 400 mg) or iron oxide red (E172, for Bosulif 400 mg and 500 mg).
Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 patienter): - alvorlig hudsygdom pga. en allergisk reaktion, (erythema multiforme, Stevens-Johnsons syndrom, toksisk epidermal nekrolyse), udslæt med afstødning af hudens øverste lag.
Rare side effects (may affect up to 1 in 1,000 people): - severe skin disorder (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) due to an allergic reaction, exfoliative (scaly, peeling) rash.
Der blev set mindst 1 grad 3- eller 4-bivirkning hos 814 (63,9%) af patienterne.
At least 1 Grade 3 or Grade 4 adverse reaction was reported for 814 (63.9%) patients.
Skema 6 - Respons efter baseline-BCR-ABL-mutationsstatus hos den CP CML-evaluerbare population: tidligere behandling med imatinib og dasatinib og/eller nilotinib (tredje linie)
Table 6 - Response by baseline BCR-ABL mutation status in CP CML evaluable population: prior imatinib and dasatinib and/or nilotinib (third-line)
- diarré, opkastning, mavesmerter, kvalme.
- diarrhoea, vomiting, stomach pain, nausea.
Opløseligheden af bosutinib er pH-afhængig, og absorptionen reduceres i takt med stigende pH (se pkt.
The solubility of bosutinib is pH-dependent and absorption is reduced when gastric pH is increased (see section 4.5).
Ph+ CP CML tidligere behandlet med imatinib og dasatinib eller nilotinib
Ph+ CP CML with prior treatment with imatinib and dasatinib or nilotinib
Toksicitet efter gentagne doser
Repeated-dose toxicity
Nedenstående bivirkninger er set hos patienter i kliniske studie med bosutinib (skema 2).
The following adverse reactions were reported in patients in bosutinib clinical studies (Table 2).
In vitro- og in vivo-studier tyder på, at bosutinib (moderstoffet) fortrinsvis metaboliseres i leveren hos mennesker.
In vitro and in vivo studies indicated that bosutinib (parent compound) undergoes predominantly hepatic metabolism in humans.
In vitro-studier tyder på, at bosutinib har lavt potentiale for at hæmme brystcancer-resistensprotein (BCRP, systemisk), organisk anion-transporterende polypeptid (OATP)1B1, OATP1B3, organisk anion-transportør (OAT)1, OAT3, organisk kation-transportør (OCT)2 i klinisk relevante koncentrationer, men har muligvis potentiale for at hæmme BCRP i mave-tarmkanalen og OCT1.
In vitro studies indicate that bosutinib has a low potential to inhibit breast cancer resistance protein (BCRP, systemically), organic anion transporting polypeptide (OATP)1B1, OATP1B3, organic anion transporter (OAT)1, OAT3, organic cation transporter (OCT)2 at clinically relevant concentrations, but may have the potential to inhibit BCRP in the gastrointestinal tract and OCT1.
- phenytoin og carbamazepin, der anvendes til behandling af epilepsi.
- phenytoin and carbamazepine, used to treat epilepsy.
Det bør overvejes at anvende korttidsvirkende antacida i stedet for PPI'er, og bosutinib og antacida skal om muligt administreres på separate tidspunkter (f.eks. kan bosutinib tages om morgenen og antacida om aftenen).
Short-acting antacids should be considered as an alternative to PPIs and administration times of bosutinib and antacids should be separated (i.e. take bosutinib in the morning and antacids in the evening) whenever possible.
Af disse patienter deltog 268 (startdosis på 400 mg) og 248 (startdosis på 500 mg) i de 2 fase 3-studier hos tidligere ikke-behandlede CML-patienter, og 570 henholdsvis 63 deltog i de 2 fase 1/2-studier hos tidligere behandlede patienter med Ph+-leukæmi, og 123 patienter deltog i et fase 4-studie hos tidligere behandlede CML-patienter.
Of these patients, 268 (400 mg starting dose) and 248 (500 mg starting dose) are from the 2 Phase 3 studies in previously untreated CML patients, 570 and 63 are from 2 Phase 1/2 studies in previously treated Ph+ leukaemias, and 123 patients from a Phase 4 study in previously treated CML.
Diarré og opkastning
Diarrhoea and vomiting
Der blev set mindst 1 bivirkning af alle grader hos 1.240 (97,5%) af patienterne.
At least 1 adverse reaction of any toxicity grade was reported for 1,240 (97.5%) patients.
Der blev set histopatologisk luminal dilation, slimcellehyperplasi, hæmoragi, erosion og ødem i tarmkanalen og sinus-erytrocytose og hæmoragi i de mesenteriale lymfeknuder.
Histopathologically, luminal dilation, goblet cell hyperplasia, haemorrhage, erosion, and oedema of the intestinal tract, and sinus erythrocytosis and haemorrhage in the mesenteric lymph nodes, were observed.