natgillin/translations-raw huggingface dataset:
Hæmninger er dosisafhængig og reversibel, og virkningen gælder både basal og stimuleret sekretion af mavesyre. 
The inhibition is dose dependent and reversible, and the effect applies to both basal and stimulated secretion of gastric acid.
Da lansoprazol bliver metaboliseret via et lægemiddelmetaboliserende enzymsystem forbundet med cytochrom P450 (CYP2C19 og CYP3A4), er interaktioner med aktive substanser, der metaboliseres via det samme enzymsystem, mulige. 
As lansoprazole is metabolised via a drug metabolising enzyme system associated with cytochrome P450 (CYP2C19 and CYP3A4), interactions with active substances metabolised via the same enzyme system are possible.
Hos patienter med skrumpelever er AUC for lansoprazol signifikant øget, og eliminationshalveringstiden er forlænget, men der er ikke fundet nogen tegn på akkumulering af lansoprazol. 
In patients with cirrhosis the AUC of lansoprazole is significantly increased and the elimination half-life is prolonged, but no signs of accumulation of lansoprazole have been detected.
NAME OF THE MARKETING AUTHORISATION HOLDER ratiopharm GmbH [udfyldes nationalt] 
NAME OF THE MARKETING AUTHORISATION HOLDER ratiopharm GmbH [to be completed nationally]
Indtagelsen af føde nedsætter biotilgængeligheden af lansoprazol: det anbefales at tage lansoprazol inden måltidet. 
The intake of food reduces the bioavailability of lansoprazole: it is recommended to take lansoprazole before the meal.
De følgende data over hyppighed anvendes til evalueringen af bivirkninger: Meget almindelig mere end 1 ud af 10 behandlede personer Almindelig mindre end 1 ud af 10, men mere end 1 ud af 100 behandlede patienter 
The following frequency data are used in the evaluation of side effects: Very common more than 1 in 10 persons treated Common less than 1 in 10, but more than 1 in 100 treated patients
Behandling af Zollinger-Ellison syndrome 
Treatment of Zollinger-Ellison syndrome
7 gastro-resistente hårde kapsler 14 gastro-resistente hårde kapsler 28 gastro-resistente hårde kapsler 56 gastro-resistente hårde kapsler 98 gastro-resistente hårde kapsler 
7 Gastro-resistant hard capsules 14 Gastro-resistant hard capsules 28 Gastro-resistant hard capsules 56 Gastro-resistant hard capsules 98 Gastro-resistant hard capsules
Lansoprazols metabolisme katalyseres hovedsagelig af enzymet CYP2C19. 
The metabolism of lansoprazole is mainly catalysed by the enzyme CYP2C19.
4.8 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner 
4.7 Effects on ability to drive and use machines
Øger biotilgængeligheden og halveringstiden for lansoprazol med hver 30 %; øgede plasmaniveauer af en clarithromycin metabolit med 30 % 
Increase bioaivalability and half-life of lansoprazole by 30 % each; increased plasma levels of a clarithromycin metabolite by 30 %
[se Bilag I - udfyldes nationalt] 
[see Annex I - to be completed nationally]
BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMEER, ETIKETTERING OG INDLÆGSSEDLER FREMLAGT AF EMEA 
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Endokrine forstyrrelse 
Endocrine disorders
Efter gentagen daglig administration i syv dage, opnås omkring 90% hæmning af mavesyresekretion. 
After repeated daily administration for seven days, about 90% inhibition of gastric acid secretion is achieved.
− at behandle sår i duodenum og mavesækken (diagnosticeret gennem gastroskopi eller røntgen). 
− to treat ulcers in the duodenum and stomach (diagnosed through gastroscopy or X-ray)
De foreliggende data understøtter anvendelse af lansoprazol-amoxicillin-clarithromycin som førstevalgsbehandling. 
Available data support the use of lansoprazole-amoxicillin-clarithromycin as a first-line treatment.
Pancreatitis, candidiasis i øsofagus og glossitis. 
Pancreatitis, candidiasis of oesophagus and glossitis.
Det kan ikke udelukkes, at lansoprazol kan påvirke transport via dette protein og give anledning til øgede plasmakoncentrationer af P-gp substrater såsom digoxin. 
It may not be excluded that lansoprazole may affect transport via this protein giving rise to increased plasma concentrations of P-gp substrates such as digoxin.
Til dato er der ikke påvist klinisk relevante interaktioner mellem lansoprazol og diazepam. 
To date, no clinically relevant interactions have been demonstrated between lansoprazole and diazepam.
Opbevares i originalemballagen for at beskytte mod fugt. 
Store in the original package in order to protect from moisture.
Virkningen kan også være tilstede,hvis lansoprazol kombineres med andre aktive substanser med pH-afhængig absorption. 
The effect may also be present if lansoprazole is combined with other active substances with pH dependent absorption.
Hvis nogen af bivirkningerne bliver alvorlige, eller hvis du bemærker nogen bivirkninger, der ikke er angivet i denne indlægsseddel, så fortæl det til din læge eller apotek. 
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Monitorering af serumniveauerne for andre lægemidler taget unde den 1 uge lange udryddelsesbehandling anbefales derfor. 
Monitoring of the serum levels of other medicinal products taken during the 1-week eradication therapy is therefore recommended.
Ved doseringer på mere end 120 mg daglig, bør dosis gives som 2 opdelte doser (hver 12. time). 
At dosages of more than 120 mg daily, the dose should be given in 2 divided doses (every 12 hours).
Øgede plasmaniveauer af en clarithromycin metabolit med 16 %; øget biotilgænglighed for lansoprazol med 19 % op til 32 % 
Increased plasma levels of a clarithromycin metabolite by 16 %; increased bioaivalability of lansoprazole by 19 % up to 32 %
Lansoprazol er koncentreret i parietalcellerne og bliver aktiv i deres syrlige miljø, hvorefter det reagerer med sulfydrylgruppen i H+/K+ATPase, hvilket medfører hæmning af enzymaktiviteten. 
Lansoprazole is concentrated in the parietal cells and becomes active in their acidic environment, whereupon it reacts with the sulphydryl group of H+/K+ATPase causing inhibition of the enzyme activity.
[udfyldes nationalt] 
[to be completed nationally]
DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN [udfyldes nationalt] 
DATE OF FIRST AUTHRORISATION/RENEWAL OF AUTHORISATION [to be completed nationally]
Det er blevet set, at lansoprazol hæmmer transportproteinet P-glycoprotein (P-gp) in vitro. 
Lansoprazole has been observed to inhibit the transport protein, P-glycoprotein (P-gp) in vitro.
− behandling af Zollinger-Ellison syndrom (ulcusdannelse i mavesækken og duodenum på grund af øget produktion af et hormon, der udskiller mavesyre, hvilket skyldes en bestemt type tumor). 
− in the treatment of Zollinger-Ellison syndrome (ulcer formation in the stomach and duodenum, due to increased production of a hormone which secrets stomach acid, caused by a certain type of tumour).
Patienter med kraftig nedsat leverfunktion bør ikke tage Lansoprazol-CT, og de bør heller ikke få kombinationsbehandling med clarithromycin. 
Patients with severely impaired liver function should not take Lansoprazol-CT, nor should they be given combination therapy with clarithromycin.
Det vides ikke, om lansoprazol udskilles i human brystmælk. 
It is not known whether lansoprazole is excreted in human breast milk.
En enkelt dosis lansoprazol har en hæmmende virkning på mavesyresekretionen, der varer mere end 24 timer. 
A single dose of lansoprazole has an inhibitory effect on gastric acid secretion lasting more than 24 hours.
Lansoprazol har samme virkningsmekanisme som omeprazol og begge øger gastrisk pH, gælder følgende udtalelse analogt med omeprazol. 
Lansoprazole has similar mechanism of action to omeprazole and both increase gastric pH, the following statement is made by analogy to omeprazole.
Muligheden for malign gastrisk tumor bør udelukkes, inden der indledes behandling af gastrisk ulcus med lansoprazol, da lansoprazol kan maskere symptomerne og forsinke diagnosen. 
The possibility of malignant gastric tumour should be excluded before initiating treatment of gastric ulcer with lansoprazole because lansoprazole can mask the symptoms and delay the diagnosis.
Undersøgelser har vist, at dosis af fenytoin (et CYP2C19 og CYP2C9 substrat) måske må nedsættes, når det gives samtidig med lansoprazol. 
Studies have shown that the dose of phenytoin (a CYP2C19 and CYP2C9 substrate) may have to be reduced when administered concomitantly with lansoprazole.
Indenfor hver hyppighedsgruppering vises bivirkningerne i faldende avorlighed. 
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Agranulocytose. 
Agranulocytosis.
Duodenal ulcus: 
Duodenal ulcer:
Dyreundersøgelser har vist udskillelse af lansoprazol i mælk. 
Animal studies have shown excretion of lansoprazole in milk.
Aktive substanser forbundet med cytochrom P450 
Active substances associated with cytochrome P450
Indtagelse af Lansoprazol-CT kan maskere symptomerne på en tumor og forsinke diagnosen af denne tilstand. 
Intake of Lansoprazol-CT may mask the symptoms of a tumour and delay diagnosis of this condition
Om nødvendigt anbefales maveudpumpning, aktivt kul og symptomatisk behandling. 
If necessary, gastric emptying, charcoal and symptomatic therapy is recommended.
Udryddelse af Helicobacter pylori bakterien 
Eradication of the Helicobacter pylori bacterium
Du bør undgå at amme, mens du tager Lansoprazol-CT, da der er utilstrækkelig erfaring med dets brug under amning. 
You should avoid breastfeeding while taking Lansoprazol-CT, as there has been insufficient experience with its use during lactation.
Det anbefales, at du tager Lansoprazol-CT inden måltiderne, da samtidig fødeindtaelse nedsætter tilgængeligheden af lansoprazol til kroppen. 
It is recommended that you take Lansoprazol-CT before meals, as simultaneous food intake reduces the availability of lansoprazole to the body.
En enkelt oral dosis på 30 mg hæmmer pentagastrin-stimuleret mavesyresekretion med omkring 80%. 
A single oral dose of 30 mg inhibits pentagastrin-stimulated gastric acid secretion by about 80%.
Gastro-resistent hård kapsel (gastro-resistent kapsel) Hårde gelatinekapsler med ugennemsigtig gul hætte og krop, indeholdende pellets med enterisk belægning. 
Gastro-resistant hard capsule (Gastro-resistant capsule) Hard gelatine capsules, with opaque yellow cap and body, containing pellets with enteric coating.
Ugennemsigtig hvid hætte og krop. 
Opaque white cap and body.
Daglige doser på op til 180 mg lansoprazol er imidlertid blevet givet under afprøvninger uden signifikante bivirkninger. 
However, daily doses of up to 180 mg of lansoprazole have been administered in trials without significant undesirable effects.
Samtidigt administrerede lægemidler 
Co-administered medicinal products
Hvis lansoprazol, i kombination md antibiotika, anvendes til udryddelsesbehandling af H. pylori, bør brugsanvisningen for disse antibiotika også følges. 
If lansoprazole, in combination with antibiotics, is used for eradication therapy of H. pylori, then also instructions for the use of these antibiotics should be followed.
Læs indlægssedlen inden anvendelsen. 
Read the package leaflet before use.
Mens der afventes en bekræftelse af resultaterne af rapporten Maastricht 3-2005 Consensus, anbefales der dog en dosis på 500 mg to gange dagligt. 
However, awaiting confirmation as well as the results of the Maastricht 3-2005 Consensus Report, it is recommended that the dose should be 500 mg clarithromycin twice daily.
Der tilrådes forsigtighed, når man kombinerer lansoprazol med aktive substanser, der metaboliseres af dette enzym. 
Caution is advised when combining lansoprazole with active substances, which are metabolised by this enzyme.
Dosis kan øge op til 30 mg daglig efter behov. 
The dose may be increased up to 30 mg daily as necessary.
LISTE OVER HJÆLPESTOFFER Indeholder også sukrose (sukker). 
LIST OF EXCIPIENTS Also contains sucrose (sugar).
− længerevarende behandling for at forhindre en gentagelse af inflammation i spiserøret på grund af refluks af mavesyre. 
− as long-term treatment to prevent a recurrence of inflammation of the gullet due to reflux of stomach acid
Klinisk signifikante interaktioner af lansoprazol med diazepam er ikke blevet påvist. 
Clinically significant interactions of lansoprazole with diazepam have not been demonstrated.
Behandling af Helicobacter pylori infektion er beregnet til at blive kombineret med samtidig administration af lansoprazol med to antibiotika. 
Therapy of Helicobacter pylori infection is intended to be combined with concurrent administration of lansoprazole with two antibiotics.
Brug af Lansoprazol-CT anbefales ikke under graviditet. 
Use of Lansoprazol-CT is not recommended during pregnancy.
Doseringer på op til 180 mg er blevet givet. 
Dosages up to 180 mg have been administered.
Intestinal metaplasi blev også observeret, ligesom Leydig cellehyperplasi og benigne Leydig celletumorer. 
Intestinal metaplasia was also observed, as were Leydig cell hyperplasia and bening Leydig cell tumours.
Eksponeringen af lansoprazol er adskillige gange højere hos PM'er end hos ekstensive metabolisatorer (EM'er). 
The exposure of lansoprazole is several-fold higher in PMs than in extensive metabolisers (EMs).
Lansoprazol bør anvendes med forsigtighed hos patienter med hepatisk dysfunktion. 
Lansoprazole should be used with caution in patients with hepatic dysfunction.
Forstyrrelser i blod og lymfesystem 
Blood and lymphatic system disorders
I tilfælde af resistens over for clarithromycin eller fejlslagen behandling kan der anvendes en kombination af lansoprazol-amoxicillin-metronidazol, og i tilfælde af allergi over for beta-lactam er det tilrådeligt at anvende en kombination af lansoprazol-clarithromycin-metronidazol. 
In case of clarithromycin resistance, or treatment failure, the combination of lansoprazole-amoxicillin metronidazole may be used, and in case of beta-lactam allergy the combination of lansoprazoleclarithromycin-metronidazole is advisable.
Anafylaktisk shock, impotens og almen utilpashed 
Anaphylactic shock, impotence and general malaise
Lansoprazol-CT er en medicin, der nedsætter mængden af syre, der laves af maven (selektiv protonpumphæmmer). 
Lansoprazol-CT is a medicine which reduces the amount of acid made by the stomach (selective proton pump inhibitor).
Gastrisk ulcus: 
Gastric ulcer:
Det hæmmer slutstadiet af dannelsen af mavesyre ved at hæmme aktiviteten af H+/K+ ATPase i mavens parietalceller. 
It inhibits the final stage of gastric acid formation by inhibiting the activity of H+/K+ ATPase of the parietal cells in the stomach.
Baseret på resultaterne fra dreundersøgelser menes det, at lansoprazol krydser over i brystmælken. 
Based on the results of animal studies, it is thought that lansoprazole crosses into the breast milk.
Af denne grund bør plasmaniveauerne hos patienter, der bliver behandlet med digoxin, overvåges og en dosisjustering af digoxin foretages om nødvendigt. 
For this reason, the plasma levels of patients being treated with digoxin should be monitored and a dose adjustment of digoxin made if necessary.
Lansoprazol kan anledning til øgede plasmakoncentrationer af aktive substanser, der metaboliseres af CYP3A4. 
Lansoprazole may give rise to increased plasma concentrations of active substances metabolised by CYP3A4.
i ”Wiener Klinische Wochenschrift 2004”, anføres det, at 250 mg to gange dagligt kan være lige så virksomt som 500 mg to gange dagligt til udryddelse af H. pylori hos patienter med dyspepsi, selv om eradikationsraterne var noget lavere. 
The paper newly published by Bago et al in Wiener Klinische Wochenschrift 2004, indicates that 250 mg twice daily may be as effective as 500 mg twice daily in eradicating H. pylori in patients with dyspepsia, even if numerically, eradication rates were somewhat lower.
Forstrelser i nervesystemet 
Nervous system disorders
Kombinationsbehandling med clarithromycin bør ikke anvendes til patienter med nedsat leverfunktion. 
Combination treatment with clarithromycine should not be used in patients with impaired hepatic function.
Virkningerne af andre aktive substanser på lansoprazol 
The effects of other active substances on lansoprazole
Tre metabolitter er blevet identificeret i plasma: Sulfonen, 5-hydroxy lansoprazol og sulfiden. 
Three metabolites have been identified in the plasma: the sulphone, 5-hydroxy lansoprazole and the sulphide.
Dette kan lede til en øgning af antallet af naturlige bakterier, der er tilstede i mave-tarmkanalen. 
This can lead to an increase in the number of natural bacteria present in the gastrointestinal tract.
Hepatobiliære forstyrrelser 
Hepatobiliary disorders
Lansoprazol eksponering øgede middeleksponeringen for tacrolimus med op til 81%. 
Lansoprazole exposure increased the mean exposure of tacrolimus by up to 81%.
Palpitation og brystsmerter. 
Palpitation and chest pain.
Samtidig administration af lansoprazol øger plasmakoncentrationerne af tacrolimus (et CYP3A og Pgp substrat). 
Co-administration of lansoprazole increases the plasma concentrations of tacrolimus (a CYP3A and Pgp substrate).
Overvågning af plasmaniveauerne for andre lægemidler, der gives samtidig med behandling med lansoprazol og antibiotika, anbefales derfor. 
Monitoring of the plasma levels of other medicines administered during simultaneous treatment with lansoprazole and antibiotics is therefore recommended.
4.7 Anvendelsen af lansoprazol under graviditet anbefales ikke. 
The use of lansoprazole during pregnancy is not recommended.
Udryddelse af Helicobacter pylori: 
Helicobacter pylori eradication:
Theofyllin (astmamedicin) 
Theophylline (asthma medicine)
Hos patienter, der får digoxin, bør plasmaniveauerne derfor monitoreres, og digoxindosis justeres om nødvendigt. 
In patients receiving digoxin, the plasma levels should therefore be monitored and the dose of digoxin adjusted if necessary.
Øjenforstyrrelser og ændringer i smagssansen Ualmindelig: Smagsforstyrrelser Sjælden: 
Eye disorders and changes in the sensation of taste Uncommon: disturbances in taste Rare:
Tre metabolitter er blevet identificeret i urinen: 5-hydroxysulfon, 5-hydroxysulfid og 5-hydroxylansoprazol. 
Three metabolites have been identified in the urine: 5hydroxy sulphone, 5-hydroxy sulphide and 5-hydroxy lansoprazole.
DATO FOR ÆNDRING AF TEKSTEN [udfyldes nationalt] 
DATE OF REVISION OF THE TEXT [to be completed nationally]
Brug af andre lægemidler 
Using other medicines
Flere på hinanden svigtende resultater håndteres fra tilfælde til tilfælde. 
Subsequent failures should be handled on caseby-case basis.
Andetvalgsbehandlingen med firedobbelt behandling med en protonpumpe-hæmmer kombineret med vismutsubcitrat (subsalicylat) og metronidazol, og tertacyclin i mindst 7 dage er blevet anbefalet. 
Second-line therapy with quadruple therapy using proton pump inhibitor combined with bismuth subcitrate (subsalicylate) and metronidazole, and tertacycline for a minimum of 7 days has been recommended.
Der tilrådes forsigtighed uder samtidig behandling med carbamazepin (et CYP3A substrat) og lansoprazol. 
Caution is advised during co-treatment with carbamazepine (a CYP3A substrate) and lansoprazole.
Lansoprazol-CT må ikke anvendes til børn, da dets sikkerhed og virkning ikke er blevet fastslået hos denne patientgruppe. 
Lansoprazol-CT may not be used in children, as its safety and efficacy have not been established in this patient group.
Der manes til forsigtighed, hvis lansoprazol kombineres med nogen potente lægemidler, da påvirkningen af lansoprazol på andre aktive substanser endnu ikke er blevet endeligt undersøgt. 
Caution is urged if lansoprazole is combined with some potent medicines, as the influence of lansoprazole on other active substances has not yet been conclusively investigated.
Doseringer på op til 180 mg daglig er mulige. 
Dosages up to 180 mg daily are possible.
Lansoprazol metaboliseres hovedsagelig i leveren. 
Lansoprazole is mainly metabolised in the liver.
Biotilgængeligheden for lansoprazol er ikke signifikant ændret ved nyreinsufficiens. 
The bioavailability of lansoprazole is not significantly changed in renal insufficiency.
Da lansoprazol aktiveres i parietalcellerne, er dets plamakoncentration ikke relateret til hæmning af mavesyre. 
Since lansoprazole is activated in the parietal cells, its plasma concentration is not related to gastric acid inhibition.
Fluvoxamin (et lægemiddel til behandling af depression), ketoconazol og itraconazole (lægemidler til behandling af svampeinfektioner), proteasehæmmere (aktive substanser anvendt til behandling af AIDS virus) og makrolider (visse typer antibiotika) kan mærkbart øge koncentrationen af lansoprazol i blodet og dermed øge virkningen af Lansoprazol-CT. 
Fluvoxamine (a medicine for the treatment of depression), ketoconazole and itraconazole (medicines for the treatment of fungal infections), protease inhibitors (active substances used in the treatment of the AIDS virus) and macrolides (certain types of antibiotics) may markedly raise the concentration of lansoprazole in the blood and thus increase the effect of Lansoprazol-CT.
Daglige doseringer større end 120 mg bør gives som opdelte doser. 
Daily dosages of greater than 120 mg should be administered in divided doses.
Udryddelse af H. pyolori og heling af peptisk ulcus Med det formål at harmonisere behandlingerne til udryddelse af Helicobacter pylori blev der offentliggjort retningslinjer for behandling af Helicobacter pylori- infektion af European Helicobacter pylori Study Group. 
Eradication of H. pylori and peptic ulcer healing In order to standardise the treatment regimens for H. pylori eradication guidelines on the management of Helicobacter pylori infection were published by the European Helicobacter pylori Study Group.
Lansoprazol CT-Arzneimittel 15 mg, 30 mg udviser et gunstigt benefit/risk-forhold, forudsat at der indføjes passende oplysninger vedrørende eradikationsbehandlingen for H. pylori i produktresuméet. 
The risk/benefit ratio of Lansoprazol CT-Arzneimittel 15 mg, 30 mg is considered to be favourable provided that appropriate information regarding H. pylori eradication therapy are included in the SPC.
Almindelig: Kvalme, opkastning, diaré, mavepine, forstoppelse, flatulense (nogle gange ledsaget af abdominalsmerter), smerter i øvre abdomen. 
nausea, vomiting, diarrhoea, stomach-ache, constipation, flatulence (sometimes accompanied by abdominal pain), upper abdominal pain.
Meget sjælden (<1/10000) inklusive isolerede rapporter 
Very rare including isolated reports
Der bør udvises forsigtighed, når man kombinerer lansoprazol med aktive substanser, der har et snævert terapeutisk indeks, da virkningen af lansoprazol på andre aktive substansers metabolisme ikke er blevet undersøgt i omfattende grad. 
Caution should be exercised when combining lansoprazole with active substances which have a narrow therapeutic index, as the effect of lansoprazole on the metabolism of other active substances has not been extensively investigated.
Lansoprazol giver en 14% reduktion i plasmakoncentrationerne af teofyllin. 
Lansoprazole gives a 14% reduction in the plasma concentrations of theophyllin.
Thrombocytopeni, eosinofili, pancytopeni, anæmi og leukopeni. 
Thrombocytopenia, eosinophilia, pancytopenia, anemia and leucopenia.
I to carcinogenicitetsundersøgelser på rotter frembragte lansoprazol dosis-relateret gastrisk ECL cellehyperplasi og ECL cellecarcinoider forbundet med hypergastrinæmi grundet hæmning af syresekretion. 
In two rat carcinogenicity studies, lansoprazole produced dose-related gastric ECL cell hyperplasia and ECL cell carcinoids associated with hypergastrinaemia due to inhibition of acid secretion.
Hudblødning (punktformig kapillærblødning og inflammeret, hovedsagelig symmetrisk hudblødning), håtab, overdreven sveden, inflammation af lodkar med hudændringer (erythema multiforme). 
skin bleeding (punctiform capillary bleeding and inflamed, mainly symmetrical skin bleeding), hair loss, excessive sweating, blood vessel inflammation with skin changes (erythema multiforme).