natgillin/translations-raw huggingface dataset:
24 Hvis du ønsker yderligere oplysninger om AZOPT, skal du henvende dig til den lokale repræsentant.
25 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Slovenija Alcon d. o. o + 386 1 422 5280
Slovenija Alcon d. o. o + 386 1 422 5280
25 Italia Alcon Italia S. p. A. + 39 02 81803. 1
26 Italia Alcon Italia S. p. A. + 39 02 81803.1
Denne indlægsseddel blev senest godkendt MM/ ÅÅÅÅ
This leaflet was last approved on XXXXX
Yderligere information om produktet kan fås på lægemiddelagenturets hjemmeside (EMEA) http: // www. emea. europa. eu
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Hvis du ønsker yderligere oplysninger om baggrunden for CHMP’ s anbefalinger, kan du læse de faglige drøftelser (også en del af denne af EPAR).
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Baraclude indeholder det aktive stof entecavir.
Baraclude contains the active substance entecavir.
Det leveres som tabletter (hvide:
It is available as tablets (white:
0, 5 mg, lyserøde:
0.5 mg, pink:
1 mg) eller som oral opløsning (0, 05 mg/ ml).
1 mg) or as an oral solution (0.05 mg/ ml).
Baraclude anvendes til behandling af voksne patienter med kronisk (langvarig) hepatitis B (en leversygdom, der skyldes betændelse med hepatitis B- virus).
Baraclude is used to treat adult patients who have chronic (long term) hepatitis B (disease of the liver due to an infection by the hepatitis B virus).
Det anvendes hos patienter, som har kompenseret leversygdom (hvor leveren er beskadiget, men fungerer normalt), og som desuden udviser tegn på, at virus stadig formerer sig, samt tegn på leverbeskadigelse (forhøjede leverenzymer, tegn på beskadigelse ved mikroskopisk undersøgelse af levervævet).
It is used in patients who have compensated liver disease (when the liver is damaged but functions normally), who also show signs that the virus is still multiplying, and signs of liver damage (raised liver enzyme, signs of damage when liver tissue is examined under a microscope).
Behandlingen med Baraclude bør iværksættes af en læge med erfaring i behandling af kronisk hepatitis B.
Treatment with Baraclude should be started by a doctor with experience in the management of chronic hepatitis B.
Baraclude tages én gang dagligt.
Baraclude is taken once daily.
Dosis afhænger af, om patienten tidligere er blevet behandlet for kronisk hepatitis B med et lægemiddel i samme gruppe som Baraclude (en nukleosidanalog som f. eks. lamivudin).
The dose depends on whether or not the patient has been previously treated for chronic hepatitis B with a medicine in the same group as Baraclude (a nucleoside analogue, such as lamivudine).
Til patienter, der ikke tidligere har fået en nukleosidanalog, anvendes 0, 5 mg doseringen, mens 1 mg doseringen anvendes til patienter, der tidligere har fået lamivudin, og hos hvem dette ikke længere virker.
Patients who have not been treated before with a nucleoside analogue receive a 0.5 mg dose, while the 1 mg dose is used in patients who have received lamivudine before, but who are now ‘ refractory’ (no longer responding) to lamivudine.
Hvis man får 0, 5 mg, kan lægemidlet tages sammen med et måltid eller mellem måltiderne, men hvis man får 1 mg, skal det tages mindst to timer før eller to timer efter et måltid.
The 0.5 mg dose can be taken with or without food, but the 1 mg dose must be taken at least 2 hours before or 2 hours after a meal.
Patienter med nyresygdom får lægemidlet i en lavere dosering; hertil bruges den orale opløsning.
Doses are lower for patients who have kidney problems, for whom the oral solution can be used.
Behandlingens varighed afhænger af patientens reaktion på behandlingen.
The treatment duration is determined according to the patient’ s response.
Det aktive stof i Baraclude, entecavir, er et antiviralt middel, der tilhører gruppen af nukleosidanaloger.
The active substance in Baraclude, entecavir, is an antiviral belonging to the class of the nucleoside analogues.
Entecavir hæmmer et virus- enzym, dna- polymerase, som medvirker ved dannelsen af virus- dna.
Entecavir interferes with the action of a viral enzyme, DNA polymerase, which is involved in the formation of viral DNA.
Entecavir standser virusets dna- produktion og dermed dets formering og spredning.
Entecavir stops the virus making DNA, and prevents it from multiplying and spreading.
Hvordan er Baraclude blevet undersøgt?
How has Baraclude been studied?
Virkningerne af Baraclude er først testet i forsøgsmodeller, inden de er undersøgt hos mennesker.
The effects of Baraclude were first tested in experimental models before being studied in humans.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Virkningen af Baraclude ved kronisk hepatitis B er blevet sammenlignet med virkningen af lamivudin i tre kliniske hovedundersøgelser.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged The effectiveness of Baraclude in chronic hepatitis B was compared with that of lamivudine in 3 main clinical studies.
Patienterne, der hovedsagelig var mænd mellem 35 og 44 år, blev behandlet i mindst ét år med enten Baraclude eller lamivudin.
Patients were mostly male, aged between 35 and 44 years of age, and they received at least one year of treatment with either Baraclude or lamivudine.
To af undersøgelserne (1 363 patienter) blev udført hos patienter, der ikke tidligere var blevet behandlet med nukleosidanaloger.
Two studies (1,363 patients) were carried out in nucleoside-naïve patients (these are patients who have not been treated with nucleoside analogues before).
Den tredje undersøgelse (293 patienter) blev udført hos patienter, hvos hvem behandling med lamivudin ikke længere virkede.
The other study (293 patients) was carried out in patients who had become refractory to lamivudine treatment.
I undersøgelserne måltes behandlingens virkning ved registrering af, hvordan leverbeskadigelsen havde udviklet sig efter 48 ugers behandling (ved mikroskopisk undersøgelse af en leverbiopsi, dvs. en prøve af levervævet), foruden ved registrering af andre sygdomstegn som koncentrationen af et leverenzym (ALT) eller mængden af virus- dna i patientens blod.
The studies measured the effectiveness of the treatment by looking at how the liver damage had evolved after 48 weeks treatment (using a liver biopsy, when a sample of liver tissue is taken and examined under a microscope) as well as measuring other signs of the disease such as the levels of a liver enzyme (ALT) or viral DNA circulating in the blood of the patients.
Hvilken fordel viser undersøgelserne, der er ved Baraclude?
What benefit has Baraclude shown during the studies?
Leverens tilstand bedredes hos godt 70% af patienterne behandlet med Baraclude, mod godt 60% af patienterne behandlet med lamivudin.
Baraclude was more effective than lamivudine in treatment-naïve patients: an improvement in the condition of the liver was seen in just over 70% of the patients treated with Baraclude, against just over 60% of the patients treated with lamivudine.
Disse resultater sås både hos patienter, der var "HBeAg - positive" (dvs. inficeret med det almindelige hepatitis B- virus) og "HBeAg- negative" (dvs. inficeret med et virus, der har muteret og forårsager en form for kronisk hepatitis B, som er vanskeligere at Baraclude behandle). var desuden mere effektivt end lamivudin til patienter, som lamivudin ikke virkede på:
Baraclude was also more effective than lamivudine in patients refractory to lamivudine:
Leverens tilstand bedredes hos 55% af de patienter, der blev behandlet med Baraclude, mod 28% af dem, der blev behandlet med lamivudin.
55% of patients treated with Baraclude had improvements in the condition of their liver, against 28% of those treated with lamivudine.
Ved undersøgelsens slutning havde 55% af patienterne behandlet med Baraclude normal ALT- værdi og intet påviseligt virus- dna i blodet, mens samme resultater sås hos 4% af dem, dem der blev behandlet med lamivudin.
At the end of the study, 55% of the patients treated with Baraclude had both a normal ALT level and undetectable viral DNA in their blood, when 4% of those treated with lamivudine showed the same results.
I de kliniske undersøgelser var de almindeligste bivirkninger hovedpine (optrådte hos 9% af patienterne), træthed (6%), svimmelhed (4%) og kvalme (3%).
In clinical studies, the most common side effects were headache (seen in 9% of patients), fatigue (tiredness, 6%), dizziness (4%) and nausea (feeling sick, 3%).
Den fuldstændige liste over de indberettede bivirkninger for Baraclude fremgår af indlægssedlen.
For the full list of side effects reported with Baraclude, see the Package Leaflet.
Baraclude bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for entecavir eller andre af indholdsstofferne.
Baraclude should not be used in people who may be hypersensitive (allergic) to entecavir or any of the other ingredients.
Ved mælkesyreacidose er koncentrationen af mælkesyre i blodet unormalt høj, hvilket medfører kvalme, opkastning og mavesmerter.
Patients and doctors need to be aware that Baraclude belongs to a group of medicines, the nucleoside analogues, which have been known to cause ‘ lactic acidosis’: when the level of the chemical lactic acid becomes abnormally high in the blood, causing nausea, vomiting and stomach pain.
Som patient bør man desuden vide, at leversygdommen kan forværres.
Patients also need to know that they may also suffer a worsening of their liver disease.
Dette kan ske under behandlingen eller efter ophør af behandlingen.
This can happen during the treatment, or after it has been stopped.
Resistens over for entecavir (dvs. at virus ikke længere er følsomt for det antivirale middel) er forekommet hos patienter, som lamivudin ikke længere virker på.
Resistance to entecavir (when a virus becomes insensitive to the antiviral) has been seen in lamivudine-refractory patients.
Da resistens kan forringe lægemidlets virkning, vil dette blive overvåget nøje under langtidsopfølgningen.
As resistance may have an impact on effectiveness, this will be closely monitored during long-term follow-up.
Hvorfor er Baraclude blevet godkendt?
Why has Baraclude been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) har konkluderet, at Baraclude er påvist at være mere effektivt end den nuværende behandling af infektioner med hepatitis B- virus.
The Committee for Medicinal Products for Human Use (CHMP) concluded that Baraclude had shown that it was as or more effective than the current treatment for hepatitis B virus infections.
Udvalget har fundet, at fordelene ved Baraclude opvejer risiciene til behandling af patienter med kronisk hepatitis B med kompenseret leversygdom.
They decided that Baraclude’ s benefits are greater than its risks for the treatment of patients with chronic hepatitis B with compensated liver disease.
Udvalget har anbefalet udstedelse af markedsføringstilladelse for Baraclude.
They recommended that Baraclude be given marketing authorisation.
Andre oplysninger om Baraclude:
Other information about Baraclude:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Baraclude til BRISTOL- MYERS SQUIBB PHARMA EEIG den 26. juni 2006.
The European Commission granted a marketing authorisation valid throughout the European Union for Baraclude to BRISTOL-MYERS SQUIBB PHARMA EEIG on 26 June 2006.
Den Europæiske Offentlige Vurderingsrapport (EPAR) for Baraclude kan ses i sin helhed her.
The full EPAR for Baraclude can be found here.
Dette sammendrag blev sidst opdateret i 05- 2006.
This summary was last updated in 05-2006.
Indhold EU- nummer
EU Number
(Koncentration)
Content
EU/ 1/ 06/ 343/ 001
EU/ 1/ 06/ 343/ 001 EU/ 1/ 06/ 343/ 002 EU/ 1/ 06/ 343/ 003 EU/ 1/ 06/ 343/ 004
0, 5 mg
0.5 mg 1 mg 0.5 mg 1 mg
Filmovertrukket tablet
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Beholder (HDPE)
bottle (HDPE) bottle (HDPE) blister (alu/ alu) blister (alu/ alu)
30 tabletter
30 tablets 30 tablets 30 x 1 tablets 30 x 1 tablets
EU/ 1/ 06/ 343/ 003 EU/ 1/ 06/ 343/ 002
EU/ 1/ 06/ 343/ 005
Baraclude Baraclude
Baraclude
0, 5 mg 1 mg
0.05 mg/ ml
Filmovertrukket tablet Filmovertrukket tablet
Oral solution
Blister (alu/ alu) Beholder (HDPE)
bottle (HDPE)
30 x 1 tabletter 30 tabletter
1 bottle + 1 measuring spoon
EU/ 1/ 06/ 343/ 004 EU/ 1/ 06/ 343/ 005 EU/ 1/ 06/ 343/ 006 EU/ 1/ 06/ 343/ 007
EU/ 1/ 06/ 343/ 006 EU/ 1/ 06/ 343/ 007
Baraclude Baraclude Baraclude Baraclude
Baraclude Baraclude
1 mg 0, 05 mg/ ml 0, 5 mg 1 mg
0.5 mg 1 mg
Filmovertrukket tablet Oral opløsning Filmovertrukket tablet Filmovertrukket tablet
Film-coated tablet Film-coated tablet
Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Oral use Oral use
Blister (alu/ alu) Flaske (HDPE) 210 ml Blister (alu/ alu) Blister (alu/ alu)
blister (alu/ alu) blister (alu/ alu)
30 x 1 tabletter 1 flaske + måleske 90 x 1 tabletter 90 x 1 tabletter
90 x 1 tablets 90 x 1 tablets
Baraclude 0, 5 mg filmovertrukne tabletter
Baraclude 0.5 mg film-coated tablets
Hver tablet indeholder 0, 5 mg entecavir (som monohydrat).
Each tablet contains 0.5 mg entecavir (as monohydrate).
Hjælpestoffer: hver tablet indeholder 120, 5 mg lactose.
Excipients: each tablet contains 120.5 mg lactose.
Hvid til grålighvid, trekantet tablet med “ BMS ” mærket på den ene side og “ 1611 ” på den anden.
White to off-white and triangular-shaped tablet with “ BMS ” debossed on one side and “ 1611” on the other.
Baraclude er indiceret til behandling af kronisk hepatitis- B virus (HBV) infektion hos voksne med kompenseret leversygdom og tegn på aktiv virusreplikation, vedvarende forhøjet serum - alaninaminotransferase (ALAT) og histologisk påvist aktiv inflammation og/ eller fibrose.
Baraclude is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/ or fibrosis.
Denne indikation er baseret på data fra kliniske forsøg hos patienter med HBeAg- positiv og HBeAg- negativ HBV- infektion, der ikke tidligere er behandlet med nukleosid.
This indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection.
4. 4 og 5. 1.
With respect to patients with lamivudine-refractory hepatitis B, see sections 4.4 and 5.1.
Behandlingen skal initieres af en læge med erfaring i behandling af kronisk hepatitis- B infektion.
Therapy should be initiated by a physician experienced in the management of chronic hepatitis B infection.
Baraclude skal tages oralt, én gang dagligt.
Baraclude should be taken orally, once-daily.
Den anbefalede dosis er 0, 5 mg, én gang dagligt, med eller uden mad.
Nucleoside naïve patients: the recommended dose is 0.5 mg once daily, with or without food.
5. 2).
Lamivudine-refractory patients (i. e. with evidence of viraemia while on lamivudine or the presence of lamivudine resistance [LVDr] mutations) (see sections 4.4 and 5.1): the recommended dose is 1 mg once daily, which must be taken on an empty stomach (more than 2 hours before or more than 2 hours after a meal) (see section 5.2).
Varighed af behandling: den optimale behandlingsvarighed kendes ikke.
Duration of therapy: the optimal duration of treatment is unknown.
HBeAg- positive patienter skal behandles mindst indtil HBe- serokonvertering (HBeAg- tab og HBV DNA- tab med påvisning af anti- HBe ved 2 på hinanden følgende serumprøver med mindst 3 - 6 måneders mellemrum) eller indtil HBs- serokonvertering, eller indtil behandlingen ikke virker (se pkt.
In HBeAg positive patients, treatment should be administered at least until HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection on two consecutive serum samples at least 3-6 months apart) or until HBs seroconversion or there is loss of efficacy (see section 4.4).
HBeAg- negative patienter skal behandles mindst indtil HBs- serokonvertering, eller indtil behandlingen ikke virker.
In HBeAg negative patients, treatment should be administered at least until HBs seroconversion or there is evidence of loss of efficacy.
2 Børn og unge:
2 Children and adolescents:
Baraclude bør ikke anvendes til børn under 18 år pga. manglende dokumentation for sikkerhed og virkning.
Baraclude is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Dosisjustering er ikke nødvendig på baggrund af alder.
Elderly: no dosage adjustment based on age is required.
5. 2).
The dose should be adjusted according to the patient ’ s renal function (see dosage recommendations in renal impairment and section 5.2).
Dosisjustering er ikke nødvendig på baggrund af køn eller race.
Gender and race: no dosage adjustment based on gender or race is required.
5. 2).
Renal impairment: the clearance of entecavir decreases with decreasing creatinine clearance (see section 5.2).
Dosisjustering anbefales hos patienter med creatinin- clearance < 50 ml/ min, inklusive patienter i hæmodialyse eller i vedvarende ambulant peritoneal dialyse (CAPD).
Dose adjustment is recommended for patients with creatinine clearance < 50 ml/ min, including those on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
Baraclude dosis‫٭ ‬
Baraclude dosage*
Creatinin- clearance (ml/ min)
Creatinine clearance (ml/ min)
Nukleosid naive patienter
Nucleoside naïve patients
0, 5 mg én gang dagligt
Lamivudine-refractory
30 – 49
≥ 50 30 - 49
0, 25 mg én gang dagligt * ELLER 0, 5 mg hver 48. time
0.5 mg once daily 0.25 mg once daily* OR 0.5 mg every 48 hours
0, 5 mg én gang dagligt
1 mg once daily 0.5 mg once daily
10 – 29
10 - 29
0, 15 mg én gang dagligt * ELLER 0, 5 mg hver 72. time
0.15 mg once daily* OR 0.5 mg every 72 hours
0, 3 mg én gang dagligt * ELLER 0, 5 mg hver 48. time
0.3 mg once daily* OR 0.5 mg every 48 hours
0, 05 mg én gang dagligt *
< 10 Haemodialysis or CAPD**
0, 1 mg én gang dagligt *
0.05 mg once daily* OR 0.5 mg every 5-7 days
0, 5 mg hver 72. time
0.1 mg once daily* OR 0.5 mg every 72 hours
* ved doser < 0, 5 mg Baraclude anbefales oral opløsning. ** på hæmodialysedage administreres entecavir efter hæmodialysen.
* for doses < 0.5 mg Baraclude oral solution is recommended. ** on haemodialysis days, administer entecavir after haemodialysis.
4. 2).
Renal impairment: dosage adjustment is recommended for patients with renal impairment (see section 4.2).
Spontane exacerbationer ved kronisk hepatitis B er relativt hyppige og karakteriseres ved forbigående stigninger i serum- ALAT.
Exacerbations of hepatitis: spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum ALT.
4. 8).
After initiating antiviral therapy, serum ALT may increase in some patients as serum HBV DNA levels decline (see section 4.8).
Blandt entecavir- behandlede patienter gik der i gennemsnit 4 - 5 uger inden exacerbationerne indtrådte.
Among entecavir-treated patients on-treatment exacerbations had a median time of onset of 4-5 weeks.
Hos patienter med kompenseret leversygdom ledsages disse stigninger i serum- ALAT generelt ikke af stigninger i serum- bilirubin eller hepatisk inkompensation.
In patients with compensated liver disease, these increases in serum ALT are generally not accompanied by an increase in serum bilirubin concentrations or hepatic decompensation.
Patienter med cirrhose kan have højere risiko for hepatisk inkompensation efter hepatitis- exacerbation og bør derfor monitoreres tæt under behandling.
Patients with cirrhosis may be at a higher risk for hepatic decompensation following hepatitis exacerbation, and therefore should be monitored closely during therapy.
3 Akut hepatitis- exacerbation er ligeledes indberettet hos patienter, som har seponeret hepatitis B - behandling.
3 Acute exacerbation of hepatitis has also been reported in patients who have discontinued hepatitis B therapy.
Exacerbationer efter behandling er sædvanligvis forbundet med stigning i HBV DNA, og størstedelen synes at være selvbegrænsende.
Post-treatment exacerbations are usually associated with rising HBV DNA, and the majority appears to be self-limited.
Der er dog indberettet svære exacerbationer, inklusive dødsfald.
However, severe exacerbations, including fatalities, have been reported.
4. 8).
Among entecavir-treated nucleoside naive patients, post-treatment exacerbations had a median time to onset of 23-24 weeks, and most were reported in HBeAg negative patients (see section 4.8).
Leverfunktionen skal løbende monitoreres med faste intervaller med såvel klinisk som laboratoriemæssig opfølgning igennem mindst 6 måneder efter seponering af hepatitis B- behandling.
Hepatic function should be monitored at repeated intervals with both clinical and laboratory follow-up for at least 6 months after discontinuation of hepatitis B therapy.
Hvis det er relevant, kan genoptagelse af hepatitis B- behandling være berettiget.
If appropriate, resumption of hepatitis B therapy may be warranted.
Der er set en højere forekomst af alvorlige leverbivirkninger hos patienter med inkompenseret cirrhose sammenlignet med patienter med kompenseret leverfunktion.
Patients with decompensated cirrhosis: a higher rate of serious hepatic adverse events has been observed in patients with decompensated cirrhosis compared with rates in patients with compensated liver function.
Denne observation er baseret på begrænset erfaring med 45 patienter med Child- Pugh score ≥ 7 ved påbegyndelse af behandling med entecavir.
This observation is based on limited experience in 45 patients with Child-Pugh score ≥ 7 at the start of entecavir treatment.
Disse patienter skal monitoreres jævnligt for kliniske, virologiske og serologiske parametre forbundet med hepatitis B, lever - og nyrefunktion samt antiviralt respons under behandling og, hvis behandlingen seponeres, i mindst 6 måneder herefter.
These patients should be regularly monitored for clinical, virological and serological parameters associated with hepatitis B, liver and renal function and antiviral response during treatment, and if treatment is discontinued, for at least 6 months thereafter.
Patienter, der oplever tegn på leverinsufficiens under eller efter behandling, skal – alt efter behov - monitoreres hyppigere.
Patients experiencing signs of hepatic insufficiency during or post-treatment should be monitored more frequently as appropriate.
Der er indberettet forekomst af lactacidose (uden hypoxæmi), i nogle tilfælde fatal, sædvanligvis forbundet med svær hepatomegali og leversteatosis, ved brug af nukleosidanaloger.
Lactic acidosis and severe hepatomegaly with steatosis: occurrences of lactic acidosis (in the absence of hypoxaemia), sometimes fatal, usually associated with severe hepatomegaly and hepatic steatosis, have been reported with the use of nucleoside analogues.
Behandling med nukleosidanaloger skal seponeres i tilfælde af hurtigt stigende aminotransferaseniveauer, progressiv hepatomegali eller metabolisk acidose/ lactacidose af ukendt ætiologi.
Treatment with nucleoside analogues should be discontinued when rapidly elevating aminotransferase levels, progressive hepatomegaly or metabolic/ lactic acidosis of unknown aetiology occur.
Benigne fordøjelsessymptomer, fx kvalme, opkastning og mavesmerter, kan være tegn på udvikling af lactacidose.
Benign digestive symptoms, such as nausea, vomiting and abdominal pain, might be indicative of lactic acidosis development.
Svære tilfælde, i visse tilfælde med dødelig udgang, har været forbundet med pankreatitis, leversvigt/ leversteatosis, nyresvigt og forhøjede niveauer af serum- lactat.
Severe cases, sometimes with fatal outcome, were associated with pancreatitis, liver failure/ hepatic steatosis, renal failure and higher levels of serum lactate.