natgillin/translations-raw huggingface dataset:
Immunrelateret hepatitis medførte permanent seponering af cemiplimab hos 5 (0,8 %) af 591 patienter.
Immune-related hepatitis led to permanent discontinuation of cemiplimab in 5 (0.8%) of 591 patients.
Hypothyreoidisme forekom hos 42 (7,1 %) af de 591 patienter, der fik cemiplimab, inklusive 1 (0,2 %) patient med grad 3 hypothyreoidisme.
Hypothyroidism occurred in 42 (7.1%) of 591 patients receiving cemiplimab including 1 (0.2%) patient with Grade 3 hypothyroidism.
Immunrelateret pneumonitis medførte permanent seponering af cemiplimab hos 11 (1,9 %) ud af de 591 patienter.
Immune-related pneumonitis led to permanent discontinuation of cemiplimab in 11 (1.9%) of 591 patients.
Immunsystemet: immun trombocytopenisk purpura Vaskulære sygdomme: vasculitis Knogler, led, muskler og bindevæv: myalgi, artritis d, Sjögrens syndrom
Musculoskeletal and connective tissue disorders: Myalgia, Arthritis d, Sjogren's syndrome
Perifer neuropati c
Central nervous system inflammation Uncommon Neuropathy peripheral c
Genoptag LIBTAYO, når diabetes mellitus igen er grad 0-1 eller i øvrigt er klinisk stabil
Resume LIBTAYO when diabetes mellitus returns to Grade 0 to 1 or is otherwise clinically stable
Infusionsrelaterede reaktioner forekom hos 54 (9,1 %) af de 591 patienter, der fik cemiplimab, inklusive 1 (0,2 %) patient med grad 3 infusionsrelateret reaktion.
Infusion-related reactions occurred in 54 (9.1%) of 591 patients treated with cemiplimab including 1 (0.2%) patient with Grade 3 infusion-related reaction.
Immunrelateret diarré eller colitis medførte permanent seponering af cemiplimab hos 1 (0,2 %) af 591 patienter.
Immune-related diarrhoea or colitis led to permanent discontinuation of cemiplimab in 1 (0.2%) of 591 patients.
Type 1diabetes mellitus medførte permanent seponering af cemiplimab hos 1 (0,2 %) af 591 patienter.
Type 1 diabetes mellitus led to permanent discontinuation of cemiplimab in 1 (0.2%) of 591 patients.
• type 1-diabetes som kan omfatte øget sultfølelse eller øget tørst, hyppigere vandladning,
• type 1 diabetes that may include feeling more hungry or thirsty than usual, needing to urinate more often, weight loss, and feeling tired
Encefalitis
Encephalitis
Genoptag LIBTAYO, hvis hepatitis bedres og forbliver grad 0-1 efter nedtrapning af kortikosteroid til ≤10 mg/dag prednison eller tilsvarende eller vender tilbage til baseline ASAT- eller ALAT-niveau efter nedtrapning af kortikosteroid
Resume LIBTAYO if hepatitis improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent or returns to baseline AST or ALT after completion of corticosteroid taper
Sådan får du LIBTAYO
How to store LIBTAYO
• Nyreproblemer (nyrebetændelse og nyresvigt) som f.eks. nedsat vandladningsfrekvens, blod i urinen, hævede ankler og nedsat sultfølelse.
• Kidney problems (nephritis and kidney failure) such as passing water less often than usual, passing blood, swollen ankles and feeling less hungry than normal.
LIBTAYO 350 mg koncentrat til infusionsvæske, opløsning.
LIBTAYO 350 mg concentrate for solution for infusion.
Det skal du vide, før du begynder at få LIBTAYO Sådan får du LIBTAYO
What you need to know before you are given LIBTAYO
Genoptag LIBTAYO, når hyperthyreoidisme igen er grad 0-1 eller i øvrigt er klinisk stabil
Resume LIBTAYO when hyperthyroidism returns to Grade 0 to 1 or is otherwise clinically stable
Hyperthyreoidisme forekom hos 11 (1,9 %) af de 591 patienter, der fik cemiplimab, inklusiv 1 (0,2 %) patient med grad 3 hyperthyreoidisme.
Hyperthyroidism occurred in 11 (1.9%) of 591 patients receiving cemiplimab including 1 (0.2%) patient with Grade 3 hyperthyroidism.
Immunrelaterede hudreaktioner forekom hos 12 (2,0 %) af de 591 patienter, der fik cemiplimab inklusive 6 (1,0 %) patienter med grad 3 immunrelaterede hudreaktioner.
Immune-related skin adverse reactions occurred in 12 (2.0%) of 591 patients receiving cemiplimab including 6 (1.0%) patients with Grade 3 immune-related skin adverse reactions.
Patienterne bør monitoreres for tegn og symptomer på diarré eller colitis og behandles med justeringer i cemiplimab-behandlingen, lægemidler mod diarré og kortikosteroid (se pkt.
Patients should be monitored for signs and symptoms of diarrhoea or colitis and managed with cemiplimab treatment modifications, anti-diarrhoeal agents, and corticosteroids (see section 4.2).
• nervebetændelse med snurrende, prikkende fornemmelse, følelsesløshed eller brændende smerte i arme eller ben
• eye pain, irritation, itchiness or redness; uncomfortable sensitivity to light • inflammation of the nerves causing tingling, numbness, weakness or burning pain of the arms or legs
Immunrelaterede bivirkninger (se pkt.
Immune-related adverse reactions (see section 4.4) Immune-related pneumonitis
Sanofi S.p.A Tel: +39 02 39394275
Tel: +39 02 39394275
Patienterne bør behandles med justeringer i cemiplimab-behandlingen og kortikosteroid (se pkt.
Patients should be managed with cemiplimab treatment modifications and corticosteroids (see section 4.2).
Immunrelateret nefritis forekom hos 3 (0,5 %) af de 591 patienter, der fik cemiplimab, inklusive 2 (0,3 %) patienter med grad 3 immunrelateret nefritis.
Immune-related nephritis occurred in 3 (0.5%) of 591 patients receiving cemiplimab including 2 (0.3%) patients with Grade 3 immune-related nephritis.
Sværhedsgrada
Severitya
Immunrelateret diarré eller colitis, defineret som behandlingskrævende med kortikosteroid og uden klar alternativ ætiologi, er observeret hos patienter, der har fået cemiplimab (se pkt.
Immune-related diarrhoea or colitis, defined as requiring use of corticosteroids with no clear alternate aetiology, has been observed in patients receiving cemiplimab (see section 4.8).
Immunrelaterede endokrinopatier, defineret som behandlingsrelaterede endokrinopatier uden anden klar ætiologi, er observeret hos patienter, der har fået cemiplimab (se pkt.
Immune-related endocrinopathies, defined as treatment-emergent endocrinopathies with no clear alternate aetiology, have been observed in patients receiving cemiplimab (see section 4.8).
Eventuelt resterende infusionsvæske må ikke gemmes til senere brug.
Do not store any unused portion of the infusion solution for re-use.
Grad 2 der varer længere end 1 uge, Grad 3 eller mistanke om StevensJohnsons syndrom (SJS) eller toksisk epidermal nekrolyse (TEN)
Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)
• infusionsrelaterede reaktioner
• Infusion-related reactions
• Infusionsrelaterede reaktioner
• infusion-related reactions
Forhøjet alkalisk fosfatase i blodet
Alanine aminotransferase increased Common Aspartate aminotransferase increased Common Blood alkaline phosphatase increased Common Blood creatinine increased
Binyrebarkinsufficiens er observeret hos patienter, der har fået cemiplimab (se pkt.
Adrenal insufficiency has been observed in patients receiving cemiplimab (see section 4.8).
Genoptag LIBTAYO, når hypothyreoidisme igen er grad 01 eller i øvrigt er klinisk stabil
Resume LIBTAYO when hypothyroidism returns to Grade 0 to 1 or is otherwise clinically stable
Immunrelateret nefritis medførte permanent seponering af cemiplimab hos 1 (0,2 %) af 591 patienter.
Immune-related nephritis led to permanent discontinuation of cemiplimab in 1 (0.2%) of 591 patients.
Hver ml koncentrat indeholder 50 mg cemiplimab.
One ml of concentrate contains 50 mg of cemiplimab.
Patienterne bør monitoreres for tegn og symptomer på hypofysitis og behandles med justeringer i cemiplimab-behandlingen og kortikosteroid (se pkt.
Patients should be monitored for signs and symptoms of hypophysitis and managed with cemiplimab treatment modifications and corticosteroids (see section 4.2).
• betændelse i hjertesækken
• inflammation of the liver
Hypothyreoidisme førte ikke til seponering af cemiplimab hos nogen af patienterne.
No patient discontinued cemiplimab due to hypothyroidism.
Hyperthyreoidisme førte ikke til seponering af cemiplimab hos nogen af patienterne.
No patient discontinued cemiplimab due to hyperthyroidism.
Genoptag LIBTAYO, hvis hypofysitis bedres og forbliver grad 0-1 efter nedtrapning af kortikosteroid til ≤10 mg/dag prednison eller tilsvarende eller i øvrigt er klinisk stabil
Resume LIBTAYO if hypophysitis improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent or is otherwise clinically stable
Genoptag LIBTAYO, hvis colitis eller diarré bedres og forbliver grad 0-1 efter nedtrapning af kortikosteroid til ≤10 mg/dag prednison eller tilsvarende
Resume LIBTAYO if colitis or diarrhoea improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent
Immunrelaterede hudreaktioner medførte permanent seponering af cemiplimab hos 2 (0,3 %) af 591 patienter.
Immune-related skin adverse reactions led to permanent discontinuation of cemiplimab in 2 (0.3%) of 591 patients.
Knogler, led, muskler og bindevæv Artralgi
• joint pain, swelling, polyarthritis and joint effusion
Initial dosis prednison på 12 mg/kg/dag eller tilsvarende efterfulgt af nedtrapning
Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper
Initial dosis prednison på 24 mg/kg/dag eller tilsvarende efterfulgt af nedtrapning
Initial dose of 2 to 4 mg/kg/day prednisone or equivalent followed by a taper
Spørg lægen, hvis der er noget, du er i tvivl om.
If you have any questions about your treatment, ask your doctor.
Immunrelateret hepatitis, defineret som behandlingskrævende med kortikosteroid og uden klar alternativ ætiologi, inklusive letale tilfælde, er observeret hos patienter, der har fået cemiplimab (se pkt.
Immune-related hepatitis, defined as requiring use of corticosteroids with no clear alternate aetiology, including fatal cases, has been observed in patients receiving cemiplimab (see section 4.8).
Genoptag LIBTAYO, hvis binyrebarkinsufficiens bedres og forbliver grad 0-1 efter nedtrapning af kortikosteroid til ≤10 mg/dag prednison eller tilsvarende eller i øvrigt er klinisk stabil
Resume LIBTAYO if adrenal insufficiency improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent or is otherwise clinically stable
Immunrelateret pneumonitis, defineret som behandlingskrævende med kortikosteroid og uden klar alternativ ætiologi, inklusive letale tilfælde, er observeret hos patienter, der har fået cemiplimab (se pkt.
Immune-related pneumonitis, defined as requiring use of corticosteroids with no clear alternate aetiology, including fatal cases, has been observed in patients receiving cemiplimab (see section 4.8).
Binyrebarkinsufficiens forekom hos 3 (0,5 %) af de 591 patienter, der fik cemiplimab, inklusive 1 (0,2 %) patient med grad 3 binyrebarkinsufficiens.
Adrenal insufficiency occurred in 3 (0.5%) of 591 patients receiving cemiplimab including 1 (0.2%) patient with Grade 3 adrenal insufficiency.
• Infusionsrelaterede reaktioner (kan i nogle tilfælde være alvorlige eller livstruende) som f.eks. kulderystelser, skælven eller feber, kløe eller udslæt, rødme eller hævelse af ansigtet, åndenød eller hvæsende vejrtrækning, svimmelhed eller følelse af at skulle besvime og ryg- og nakkesmerter.
shaking or fever, itching or rash, flushing or swollen face, being short of breath or wheezing, feeling dizzy or feel like passing out and back or neck pain.
Brug af anden medicin sammen med LIBTAYO Fortæl lægen, hvis du tager anden medicin eller har gjort det for nylig.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
BATCHNUMMER<, DONATIONS- OG PRODUKTKODER>
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Immunrelateret nefritis, defineret som behandlingskrævende med kortikosteroid og uden klar alternativ ætiologi, er observeret hos patienter, der har fået cemiplimab (se pkt.
Immune-related nephritis, defined as requiring use of corticosteroids with no clear alternate aetiology, has been observed in patients receiving cemiplimab (see section 4.8).
Genoptag LIBTAYO, hvis hudreaktion eller anden immunrelateret bivirkning bedres og forbliver grad 0-1 efter nedtrapning af kortikosteroid til ≤10 mg/dag prednison eller tilsvarende
Resume LIBTAYO if skin reaction or other immune-related adverse reaction improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent
Patienterne skal monitores for tegn og symptomer på immunrelaterede bivirkninger og behandles med justeringer i cemiplimab-behandlingen og kortikosteroid (se pkt.
Patients should be monitored for signs and symptoms of immune-related adverse reactions and managed with cemiplimab treatment modifications and corticosteroids (see section 4.2).
Genoptag LIBTAYO, hvis anden immunrelateret bivirkning bedres og forbliver grad 0-1 efter nedtrapning af kortikosteroid til ≤10 mg/dag prednison eller tilsvarende
Resume LIBTAYO if other immune-related adverse reaction improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent
Genoptag LIBTAYO, hvis pneumonitis bedres og forbliver grad 0-1 efter nedtrapning af kortikosteroid til ≤10 mg/dag prednison eller tilsvarende
Resume LIBTAYO if pneumonitis improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent
Genoptag LIBTAYO, hvis nefritis bedres og forbliver grad 0-1 efter nedtrapning af kortikosteroid til ≤10 mg/dag prednison eller tilsvarende
Resume LIBTAYO if nephritis improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent
Bland den fortyndede opløsning ved forsigtigt at vende infusionsposen på hovedet.
Mix the diluted solution by gentle inversion.
Immunrelaterede hudreaktioner
Immune-related adverse reactions
Binyrebarkinsufficiens medførte ikke seponering af cemiplimab hos nogen af patienterne.
No patient discontinued cemiplimab due to adrenal insufficiency.
Genoptag LIBTAYO, hvis hudreaktion bedres og forbliver grad 0-1 efter nedtrapning af kortikosteroid til ≤10 mg/dag prednison eller tilsvarende
Resume LIBTAYO if skin reaction improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent
Patienterne bør monitoreres for tegn og symptomer på binyrebarkinsufficiens og behandles med justeringer i cemiplimab-behandlingen og kortikosteroid (se pkt.
Patients should be monitored for signs and symptoms of adrenal insufficiency during and after treatment and managed with cemiplimab treatment modifications and corticosteroids (see section 4.2).
Et hætteglas med 7 ml opløsning indeholder 350 mg cemiplimab.
Each vial contains 350 mg of cemiplimab in 7 ml.
Klargøring
LIBTAYO.
Nefritis
Nephritis
MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration Emballage
Strength Pharmaceutical form
200 mg Koncentrat til infusionsvæske, opløsning
200 mg Concentrate for solution for infusion
Hætteglas (glas) 1,33 ml (150 mg/ml)
1.33 ml (150 mg/ml)
Styrke Lægemiddelform Administration Emballage Indhold (koncentration)
Strength Pharmaceutical Form
BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), ADMINISTRATIONSVEJ(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
Storbritanien Teva United Kingdom Limted
United Kingdom Teva United Kingdom Limted
Storbritanien Ennogen Limited 78 York Street
United Kingdom Ennogen Limited 78 York Street
Storbritanien Actavis UK Limited Whiddon Valley
United Kingdom Actavis UK Limited Whiddon Valley
Ljubljana Slandrova ulica 4
Slandrova ulica 4
Storbritanien Accord Healthcare Ltd Sage House
United Kingdom Accord Healthcare Ltd Sage House
Storbritanien Amdipharm plc Regency House
United Kingdom Amdipharm plc Regency House
Storbritanien Crescent Pharma Limited Units 3 & 4
United Kingdom Crescent Pharma Limited Units 3 & 4
Effervescent granules Oral anvendelse
Effervescent granules Oral use
Storbritanien Pharmvit Limited 177 Bilton Road, Perivale Middlesex UB6 7HQ United Kingdom
United Kingdom Pharmvit Limited 177 Bilton Road, Perivale Middlesex UB6 7HQ United Kingdom
ARENA GROUP S.A Str. Stefan Mihaileanu, nr.31 sector 2; Bucuresti 024022 Romania
ARENA GROUP S.A Str. Stefan Mihaileanu, nr.31 sector 2; Bucuresti 024022 România
Culliganlaan 1 C 1831 Diegem
Culliganlaan 1 C 1831 Diegem Belgium
Storbritanien Generics (United Kingdom Limited
United Kingdom Generics (United Kingdom) Limited
Storbritanien Mercury Pharma International Limited 4045 Kingswood Raod City West Business Park County Dublin
United Kingdom Mercury Pharma International Limited 4045 Kingswood Raod City West Business Park County Dublin
KG Wasastrasse 50
Wasastrasse 50
Sirton Medicare spa Piazza XX Settembre, 2 22079 Villa Guardia - COMO Italy
Sirton Medicare spa Piazza XX Settembre, 2 22079 Villa GuardiaCOMO
Oral opløsning
Oral solution
Kapsel, blød
Capsule, soft
Quidhampton Business Units Polhampton Lane, Overton Hampshire RG25 3ED
Polhampton Lane, Overton Hampshire RG25 3ED
Oral opløsning betapharm Arzneimittel GmbH
Oral solution betapharm Arzneimittel GmbH
Sanofi-aventis Denmark A/S Slotsmarken 13
Sanofi-aventis Denmark A/S
Koncentrat til infusion, opløsning
Concentrate for solution for infusion
Storbritanien Rosemont Pharmaceuticals Limited
United Kingdom Rosemont Pharmaceuticals Limited
Storbritanien Metwest Pharmaceuticals Limited
United Kingdom Metwest Pharmaceuticals Limited
Kapsler med modificeret udløsning, hård
Modified-release capsules, hard
Storbritanien Hameln Pharmaceuticals Limited
United Kingdom Hameln Pharmaceuticals Limited
Kapsel med modificeret udløsning, blød
Modified-release capsule, soft
Orale dråber
Oral drops
Medochemie Limited 1-10 Constantinoupleos Str 3011 Limassol Cyprus
Medochemie Limited 1-10 Constantinoupleos Str
Rua Manuel Ribeiro de Pavia 1 - 1 - Venda Nova 2700-547 Amadora Portugal
1 - 1 - Venda Nova 2700-547 Amadora Portugal
AWD.pharma GmbH&Co.KG Wasastrasse 50
AWD.pharma GmbH&Co.KG Wasastrasse 50 Radebeul
Rektal anvendelse
Rectal use
Metoclopramide Hydrochloride 5mg/5ml Oral opløsning
Metoclopramide Hydrochloride 5mg/5ml Oral Solution
Næsespray, opløsning Nasal anvendelse
Nasal spray, solution Nasal use
Suppositorium
Suppository
Nexus, Gloucester Business Park
Nexus, Gloucester
Orale dråber, opløsning Oral anvendelse
Oral drops, solution
Metoclopramidemonohydrochl oride Accord 10 mg Tabletten
Metoclopramidemonohydrochlor ide Accord 10 mg Tabletten
Intramuskulær anvendelse
Solution for injection Intravenous use
Elitan Injection, 10mg/2ml, Injektionsvæske, opløsning
Elitan Injection, 10mg/2ml, Solution for Injection
Paspertin 50mg/10ml Ampullen
Paspertin 50mg/10ml Ampullen 50mg/10ml
Storbritanien Chelonia Healthcare Limited Boumpoulinas 11, 3rd Floor Nicosia, CY-1060
Boumpoulinas 11, 3rd Floor
METOCLOPRAMID 10 mg 10mg
METOCLOPRAMID 10 mg
Oral opløsning ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Oral solution ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Rektal anvendelse ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Rectal use ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
MCP-CT 4mg/1ml Tropfen 5.2mg/ml
MCP-CT 4mg/1ml Tropfen
Depotkapsel ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Prolonged-release capsule ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
METOCLOPRAMID LAROPHARM
METOCLOPRAMID LAROPHARM 10mg
Depotkapsel, hård
Prolonged-release capsule, hard
MCP Heumann 10mg Tabletten
MCP Heumann 10mg Tabletten 10.53mg
Maxolon Paediatric Liquid 5mg/5ml
Maxolon Paediatric Liquid
Sector 3, Bucureşti 032266 Romania
Sector 3, Bucureşti
Langvarig eksponering (mindst 48 uger)
Long-term exposure (at least 48 weeks)
Du og din læge bør jævnligt kontrollere din vægt.
You and your doctor should check your weight regularly.
Forsøg at tage tabletterne på samme tidspunkt hver dag.
Try to take your tablets at the same time each day.
Der foreligger ikke tilstrækkelige og velkontrollerede studier af gravide kvinder.
There are no adequate and well-controlled studies in pregnant women.
Patienterne bør følges nøje i denne periode.
Patients should be closely monitored during this period.
Øget appetit
Increased appetite
Information om sikkerheden ved langvarig brug er primært begrænset til open-label, ikke kontrollerede data.
Information on long term safety is primarily limited to open-label, uncontrolled data.
Det vil sædvanligvis gå over af sig selv, men hvis det ikke gør, så fortæl det til lægen.
This will usually pass on its own but if it does not, tell your doctor.
Vækstparametre mindskedes ved høje doser.
Growth parameters were decreased at high doses.
Det anbefales at måle blodtrykket periodisk på patienter over 65 år.
It is recommended that blood pressure is measured periodically in patients over 65 years.
Der udvikledes tolerance over for CNS depressionen.
Tolerance developed to the CNS depression.
Derfor bør nyfødte omhyggeligt monitoreres.
Consequently, newborns should be monitored carefully.
Omhyggelig medicinsk kontrol og overvågning bør fortsætte indtil patienten kommer sig.
Close medical supervision and monitoring should continue until the patient recovers.
Disse symptomer kan temporært forværres eller endog opstå efter afslutning af behandling.
These symptoms can temporally deteriorate or even arise after discontinuation of treatment.
Der er set nogle dødsfald i denne gruppe af patienter.
Some fatal cases have been reported in this particular group of patients.
Fortæl det til din læge.
Tell your doctor.
En lavere startdosis (5 mg) bør overvejes til sådanne patienter.
A lower starting dose (5 mg) should be considered for such patients.
Taleforstyrrelser blev ligeledes rapporteret almindeligt.
Speech disorder was also reported commonly.
Tegn og symptomer
Signs and symptoms
Mennesker med denne lidelse kan også føle sig deprimerede, angste eller anspændte.
People with this disease may also feel depressed, anxious or tense.
Sådanne faktorer medvirker muligvis til den højere gennemsnitlige eksponering, som blev set hos unge.
Such factors possibly contribute to the higher average exposure observed in adolescents.
I nogle tilfælde er en forudgående vægtøgning rapporteret, hvilket kan være en disponerende faktor.
In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
I et studie af kaukasiske, japanske og kinesiske individer fandtes ingen forskel i farmakokinetiske parametre i de tre populationsgrupper.
In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
Demografiske forskelle mellem unge og voksne omfatter en lavere gennemsnitlig legemsvægt og færre unge var rygere.
Demographic differences between the adolescents and adults include a lower average body weight and fewer adolescents were smokers.
Hvis du lider af en af de følgende sygdomme, skal du fortælle det til din læge hurtigst muligt:
If you suffer from any of the following illnesses tell your doctor as soon as possible:
Forhøjet totalbilirubin
Increased total bilirubin
• Denne type medicin kan forårsage usædvanlige bevægelser af især ansigt eller tunge.
• Medicines of this type may cause unusual movements mainly of the face or tongue.
Den gennemsnitlige øgning af olanzapin AUC var henholdsvis 52 % og 108 %.
The mean increase in olanzapine AUC was 52 % and 108 % respectively.
Det er nødvendigt at overvåge det kardiovaskulære system for at afsløre mulige arytmier.
Cardiovascular monitoring is necessary to detect possible arrhythmias.
Fuldstændig peroral biotilgængelighed relativ til intravenøs administration er ikke bestemt.
Absolute oral bioavailability relative to intravenous administration has not been determined.
Din læge vil måske foreslå dig, at du nedsætter din dosis gradvist, før du helt stopper.
Your doctor may suggest you to reduce the dose gradually before stopping treatment.
Hyperglykæmi og diabetes
Hyperglycaemia and diabetes
NMS er en potentielt livstruende tilstand, som er forbundet med antipsykotika.
NMS is a potentially life-threatening condition associated with antipsychotic medicinal products.
Den overvejende cirkulerende metabolit er 10-N-glucuronid, som ikke passerer blod-hjerne barrieren.
The major circulating metabolite is the 10-N-glucuronide, which does not pass the blood brain barrier.