natgillin/translations-raw huggingface dataset:
, insulin autoimmun syndrom, som kan føre til alvorlig hypoglykæmi, især hos patienter med HLA DRA4 subtype (hyppigere i den japanske befolkning) forværring af symptomer på fødeallergi
Anaphylactic shock*, serum sickness, anaphylactoid reactions, cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4) **, insulin autoimmune syndrome, which can lead to severe hypoglycemia, particularly in patients with HLA DRA4 subtype (more frequent in the Japanese population), aggravation of allergic symptoms of food allergy*
Dyrestudier har ikke vist, at clopidogrel påvirker fertiliteten.
Clopidogrel was not shown to alter fertility in animal studies.
*, agranulocytose, alvorlig trombocytopeni, erhvervet hæmofili A, granulocytopeni, anæmi, hæmolytisk anæmi hos patienter med glucose-6-phosphatdehydrogen ase (G6PD)-mangel
Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), bone marrow failure*, aplastic anaemia, pancytopenia, bicytopenia*, agranulocytosis, severe thrombocytopenia, acquired haemophilia A, granulocytopenia, anaemia, haemolytic anaemia in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency* (see section
Muskuloskeletale, bindevævs-og knoglelidelser
Musculoskeletal and connective tissue disorders
Tabletbeholder 100 filmovertrukne tabletter
Bottles 100 film-coated tablets
Dyreforsøg har påvist reproduktionstoksitet efter administration af en prostaglandinsyntesehæmmer (se pkt.
In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in reproductive toxicity (see section 5.3).
Clopidogrel/Acetylsalicylic acid Mylan må ikke anvendes hos patienter med stærkt nedsat leverfunktion (se pkt.
Clopidogrel/Acetylsalicylic acid Mylan must not be used in patients with severe renal impairment (see section 4.3).
Gastrointestinale (GI) bivirkninger omfatter mavesmerter, halsbrand, kvalme, opkastning og gastrointestinal blødning kan forekomme.
GI undesirable effects including stomach pain, heartburn, nausea, vomiting, and GI bleeding may occur.
Trombotisk trombocytopenisk purpura (TTP) (se afsnit 4.4), knoglemarvssvigt
Hypoglycaemia*, gout* (see section 4.4)
Opbevaring af Clopidogrel/Acetylsalicylic acid Mylan Pakningsstørrelser og yderligere oplysninger
How to store Clopidogrel/Acetylsalicylic acid Mylan Contents of the pack and other information
Rapporteret i publiceret information for ASA med frekvens ”ikke kendt”.
Bleeding time prolonged, neutrophil count decreased, platelet count decreased * Information reported in published information for ASA with frequency “not known”.
Gentagne doser af 75 mg clopidogrel/dag hæmmede i væsentlig grad den ADP-inducerede trombocytaggregation fra den første dag.
Repeated doses of clopidogrel 75 mg per day produced substantial inhibition of ADP-induced platelet aggregation from the first day; this increased progressively and reached steady state between Day 3 and Day 7.
Hvis acetylsalicylsyre anvendes af en kvinde der forsøger at blive gravid, eller indtil den 24. uge med amenorré (graviditetens 5. måned), bør dosis holdes så lav som muligt, og behandlingsvarigheden så kort som muligt.
th month of pregnancy), the dose should be kept as low and duration of treatment as short as possible.
Tabletbeholderne indeholder et tørremiddel.
The bottles contain a desiccant.
Hvad Clopidogrel/Acetylsalicylic acid Mylan indeholder
What Clopidogrel/Acetylsalicylic acid Mylan contains
Syrepumpehæmmere (PPI)
Proton Pump Inhibitors (PPI)
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg filmovertrukne tabletter Clopidogrel/Acetylsalicylic acid Mylan bør gives som en enkelt daglig dosis på 75 mg/75 mg.
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Mylan should be given as a single daily 75 mg/75 mg dose.
Acetylsalicylsyre må ikke gives indtil den 24. uge med amenorré (graviditetens 5. måned), medmindre det er absolut nødvendigt.
th month of pregnancy), acetylsalicylic acid should not be given unless clearly necessary.
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 75 mg clopidogrel (som hydrogensulfat) og 75 mg acetylsalicylsyre (ASA).
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic acid (ASA).
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 75 mg clopidogrel (som hydrogensulfat) og 100 mg acetylsalicylsyre (ASA).
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid (ASA).
• Skal du fortælle lægen, at du er i behandling med Clopidogrel/Acetylsalicylic acid Mylan: - Hvis du skal have foretaget en planlagt operation (også hos tandlægen).
• You should tell your doctor if a surgery (including dental) is planned.
*, unormal leverfunktionstest, kronisk hepatitis
• Severe hepatic impairment.
• hvis du lider af urinsur gigt.
• if you have gout.
Når du tager Clopidogrel/Acetylsalicylic acid Mylan
While you are taking Clopidogrel/Acetylsalicylic acid Mylan
PRODUKTRESUME
Manufacturers
Valproinsyre
Valproic acid
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg filmovertrukne tabletter Pink, ovalformede, bikonvekse, filmovertrukne tabletter, ca. 14,8 mm × 7,8 mm, præget med et ”CA3” på den ene side af tabletten og et ”M” præget på den anden side.
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets Pink, oval shaped, biconvex, film-coated tablets, approximately 14.8 mm x 7.8 mm debossed with “CA3” on one side of the tablet and “M” on the other side.
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg filmovertrukne tabletter Gule, ovalformede, bikonvekse, filmovertrukne tabletter, ca. 14,5 mm × 7,4 mm, præget med et ”CA2” på den ene side af tabletten og et ”M” præget på den anden side.
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets Yellow, oval shaped, biconvex, film-coated tablets, approximately 14.5 mm x 7.4 mm debossed with “CA2” on one side of the tablet and “M” on the other side.
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg filmovertrukne tabletter Clopidogrel/Acetylsalicylic acid Mylan bør gives som en enkelt daglig dosis på 75 mg/100 mg.
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Mylan should be given as a single daily 75 mg/100 mg dose
(NSAID'er), der sædvanligvis anvendes til behandling af smertefulde og/eller betændelseslignende tilstande i muskler eller led (gigt).
• if you are allergic to other products called non-steroidal anti-inflammatory products usually used to treat painful and/or inflammatory conditions of muscles or joints.
SSRI'er
SSRIs
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg filmovertrukne tabletter EU/1/19/1395/001 - Kartoner med 28 filmovertrukne tabletter i aluminium-blisterpakninger EU/1/19/1395/002 - Kartoner med 30 filmovertrukne tabletter i aluminium-blisterpakninger EU/1/19/1395/003 - Kartoner med 28 × 1 (enhedsdosis) filmovertrukne tabletter i aluminiumblisterpakninger
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets EU/1/19/1395/001 - Cartons of 28 film coated tablets in aluminium blister packs EU/1/19/1395/002 - Cartons of 30 film coated tablets in aluminium blister packs EU/1/19/1395/003 - Cartons of 28 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/004 - Cartons of 30 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/005 - Cartons of 100 film coated tablets in HDPE bottle packs
EU/1/19/1395/001 - 28 filmovertrukne tabletter i aluminium-blisterpakninger EU/1/19/1395/002 - 30 filmovertrukne tabletter i aluminium-blisterpakninger EU/1/19/1395/003 - 28 × 1 (enhedsdosis) filmovertrukne tabletter i aluminium-blisterpakninger EU/1/19/1395/004 - 30 × 1 (enhedsdosis) filmovertrukne tabletter i aluminium-blisterpakninger EU/1/19/1395/005 - 100 filmovertrukne tabletter i HDPE-flaskepakninger
EU/1/19/1395/001 - 28 film coated tablets in aluminium blister packs EU/1/19/1395/002 - 30 film coated tablets in aluminium blister packs EU/1/19/1395/003 - 28 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/004 - 30 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/005 - 100 film coated tablets in HDPE bottle packs
ETIKET TIL TABLETBEHOLDER
BOTTLE LABEL
Det skal du vide, før du begynder at tage Clopidogrel/Acetylsalicylic acid Mylan
What you need to know before you take Clopidogrel/Acetylsalicylic acid Mylan Do not take Clopidogrel/Acetylsalicylic acid Mylan
Opbevaring af Clopidogrel/Acetylsalicylic acid Mylan
How to store Clopidogrel/Acetylsalicylic acid Mylan
Overtræk
Haematuria
EU/1/19/1395/006 - 28 filmovertrukne tabletter i aluminium-blisterpakninger EU/1/19/1395/007 - 30 filmovertrukne tabletter i aluminium-blisterpakninger EU/1/19/1395/008 - 28 × 1 (enhedsdosis) filmovertrukne tabletter i aluminium-blisterpakninger EU/1/19/1395/009 - 30 × 1 (enhedsdosis) filmovertrukne tabletter i aluminium-blisterpakninger EU/1/19/1395/010 - 100 filmovertrukne tabletter i HDPE-flaskepakninger
EU/1/19/1395/006 - 28 film coated tablets in aluminium blister packs EU/1/19/1395/007 - 30 film coated tablets in aluminium blister packs EU/1/19/1395/008 - 28 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/009 - 30 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/010 - 100 film coated tablets in HDPE bottle packs
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg filmovertrukket tablet Aktive stoffer: clopidogrel og acetylsalicylsyre.
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablet The active substances are clopidogrel and acetylsalicylic acid.
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg tabletter
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg tablets
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg filmovertrukne tabletter Hypromellose
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets Hypromellose
• omeprazol eller esomeprazol til behandling af for meget mavesyre,
• omeprazole or esomeprazole, medicines to treat upset stomach,
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg filmovertrukne tabletter er pink, ovalformede, bikonvekse, filmovertrukne tabletter præget med et ”CA3” på den ene side af tabletten og et ”M” præget på den anden side.
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets are pink, oval-shaped biconvex, tablets imprinted with CA3 on one side of the tablet and M on the other side.
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg filmovertrukne tabletter Hypromellose
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets Hypromellose
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg filmovertrukket tablet Aktive stoffer: clopidogrel og acetylsalicylsyre.
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablet The active substances are clopidogrel and acetylsalicylic acid.
Hver tablet indeholder 75 mg clopidogrel (som hydrogensulfat) og 100 mg acetylsalicylsyre.
Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid.
Trombolytika
Tenofovir
Hver tablet indeholder 75 mg clopidogrel (som hydrogensulfat) og 75 mg acetylsalicylsyre.
Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic acid.
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg filmovertrukne tabletter clopidogrel/acetylsalicylsyre
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg filmovertrukne tabletter Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg filmovertrukne tabletter
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg tabletter
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg tablets
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg filmovertrukne tabletter EU/1/19/1395/006 - Kartoner med 28 filmovertrukne tabletter i aluminium-blisterpakninger EU/1/19/1395/007 - Kartoner med 30 filmovertrukne tabletter i aluminium-blisterpakninger EU/1/19/1395/008 - Kartoner med 28 × 1 (enhedsdosis) filmovertrukne tabletter i aluminiumblisterpakninger
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets EU/1/19/1395/006 - Cartons of 28 film coated tablets in aluminium blister packs EU/1/19/1395/007 - Cartons of 30 film coated tablets in aluminium blister packs EU/1/19/1395/008 - Cartons of 28 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/009 - Cartons of 30 x 1 (unit dose) film coated tablets in aluminium blister packs EU/1/19/1395/010 - Cartons of 100 film coated tablets in HDPE bottle packs
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg filmovertrukne tabletter Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg filmovertrukne tabletter clopidogrel/acetylsalicylsyre
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Clopidogrel/Acetylsalicylic acid Mylan tages af voksne for at forebygge dannelse af blodpropper i blodårer, som er blevet stive.
Clopidogrel/Acetylsalicylic acid Mylan is taken by adults to prevent blood clots forming in hardened arteries which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Blødning ved injektionssted et
Bleeding at the puncture site
Sådan skal du tage Clopidogrel/Acetylsalicylic acid Mylan
How to take Clopidogrel/Acetylsalicylic acid Mylan
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg filmovertrukne tabletter clopidogrel/acetylsalicylsyre
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets clopidogrel/acetylsalicylic acid
Hver filmovertrukket tablet indeholder 75 mg clopidogrel (som hydrogensulfat) og 75 mg acetylsalicylsyre (ASA).
Each film-coated tablet contains 75 mg clopidogrel (as hydrogen sulphate) and 75 mg acetylsalicylic acid.
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg filmovertrukne tabletter er gule, ovalformede, bikonvekse, filmovertrukne tabletter præget med et ”CA2” på den ene side af tabletten og et ”M” præget på den anden side.
Clopidogrel/Acetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets are yellow, oval shaped biconvex tablets imprinted with CA2 on one side of the tablet and M on the other side.
Hver filmovertrukket tablet indeholder 75 mg clopidogrel (som hydrogensulfat) og 100 mg acetylsalicylsyre (ASA).
Each film-coated tablet contains 75 mg clopidogrel (as hydrogen sulphate) and 100 mg acetylsalicylic acid
4.5 over CYP2C19-hæmmere for en liste se også pkt.
As a precaution, concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see section 4.5 for a list of CYP2C19 inhibitors, see also section 5.2).
Retroperitone al blødning
Retroperitoneal haemorrhage
Lidelser i nyrer og urinveje
Renal and urinary disorders
Fremstiller:
PC:
Dette sammendrag blev sidst ajourført i 04-2012.
This summary was last updated in 04-2012.
EMA/CVMP/156189/2012 EMEA/H/C/000713
EMA/CHMP/156189/2012 EMEA/H/C/000713
Hvis dette ikke er muligt, bør de tage tabletterne mindre hyppigt.
If this is not possible, they should take the tablets less often.
Patienterne var hovedsagelig af asiatisk oprindelse og deres gennemsnitsalder 36 år.
The patients were mainly of Asian origin and had an average age of 36 years.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Sebivo den 24. april 2007.
The European Commission granted a marketing authorisation valid throughout the European Union for Sebivo on 24 April 2007.
Ingen af patienterne var tidligere blevet behandlet med nukleosidanaloger.
None of the patients had been treated with nucleoside analogues before.
Den fuldstændige EPAR for Sebivo findes på agenturets websted på ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Sebivo can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
EPAR sammendrag for offentligheden telbivudin
EPAR summary for the public telbivudine
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Sebivo.
This is a summary of the European public assessment report (EPAR) for Sebivo.
Det fås som kapsler (600 mg) og som oral opløsning (20 mg/ml).
It is available as tablets (600 mg) and as an oral solution (20 mg/ml).
Patienter med nyreproblemer bør overvåges nøje.
Patients with kidney problems should be closely monitored.
Andre oplysninger om Sebivo
Other information about Sebivo
Ved at standse virussets dna-dannelse forhindrer telbivudin det i at formere og sprede sig.
By stopping the virus making DNA, telbivudine prevents it from multiplying and spreading.
Den orale opløsning kan overvejes til patienter, som har vanskeligt ved at synke tabletter.
The oral solution can be considered for patients who have difficulty swallowing tablets.
Der bør overvejes en ændring i behandlingen, hvis der påvises viralt dna.
A change of treatment should be considered if viral DNA is found.
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Sebivo.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Sebivo.
Virksomheden fremlagde også resultaterne fra en undersøgelse, hvor den orale opløsning frembragte samme mængder af det aktive stof i blodet som tabletterne.
The company also presented the results of a study showing that the oral solution produced the same levels of the active substance in the blood as the tablets.
Patientens blod skal kontrolleres hver sjette måned for forekomst af dna fra hepatitis B-virus.
The patient's blood should be monitored every six months for the presence of DNA from the hepatitis B virus.
Da kreatin-fosfokinase er et enzym, som forhøjes ved muskelskader, skal lægen nøje overvåge alle muskelrelaterede bivirkninger.
Because creatine phosphokinase is an enzyme that is raised when muscles are damaged, doctors need to monitor all muscle-related side effects closely.
Virkningen blev hovedsagelig bedømt på antallet af patienter, der havde responderet på behandlingen efter et år.
The main measure of effectiveness was the number of patients who had responded to treatment after a year.
Det bør kun overvejes at indlede behandling med Sebivo, når det ikke er muligt eller hensigtsmæssigt at anvende et alternativt lægemiddel, som der er mindre sandsynlighed for, at hepatitis B virus vil udvikle resistens over for.
Starting treatment with Sebivo should only be considered when it is not possible or appropriate to use an alternative medicine which the hepatitis B virus is less likely to develop resistance to.
Hvis du ønsker yderligere oplysninger om behandling med Sebivo, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Sebivo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
CHMP konkluderede, at fordelene ved Sebivo opvejer risiciene og anbefalede udstedelse af markedsføringstilladelse.
The CHMP decided that Sebivo's benefits are greater than its risks and recommended that it be given marketing authorisation.
Sebivo er et lægemiddel, der indeholder det aktive stof telbivudin.
Sebivo is a medicine that contains the active substance telbivudine.
De hyppigste bivirkninger af Sebivo (som optræder hos mellem 1 og 10 patienter ud af 100) er svimmelhed, hovedpine, hoste, højere niveauer af visse enzymer i blodet (amylase, lipase, kreatinfosfokinase og alanin-aminotransferase), diarré, kvalme, mavesmerter, hududslæt og træthed.
The most common side effects with Sebivo (seen in between 1 and 10 patients in 100) are dizziness, headache, cough, increased levels of some enzymes in the blood (amylase, lipase, creatine phosphokinase and alanine aminotransferase), diarrhoea, nausea (feeling sick), abdominal pain (stomach ache), skin rash and fatigue (tiredness).
Sebivo-tabletterne blev sammenlignet med lamivudin (et andet lægemiddel, som anvendes ved kronisk hepatitis B) i en toårig undersøgelse, der omfattede 1 367 patienter.
Sebivo tablets were compared with lamivudine (another medicine used in chronic hepatitis B) in a twoyear study involving 1,367 patients.
Sebivo var som helhed mindst lige så effektivt som lamivudin, idet ca. tre fjerdedele af patienterne responderede på behandlingen efter et år.
Overall, Sebivo was at least as effective as lamivudine, with about three-quarters of the patients responding to treatment after a year.
Behandling af Sebivo skal indledes af en læge med erfaring i behandling af kronisk hepatitis B. Den anbefalede dosis Sebivo er 600 mg (en tablet) dagligt.
Treatment with Sebivo should be started by a doctor who has experience in the management of chronic hepatitis B. The recommended dose of Sebivo is 600 mg (one tablet) once a day.
Hvilken risiko er der forbundet med Sebivo?
What is the risk associated with Sebivo?
Til patienter, som har nyreproblemer, kan det være nødvendigt at anvende en lavere dosis af den orale opløsning.
Patients who have problems with their kidneys may need to take a lower daily dose using the oral solution.
Den fuldstændige liste over alle de indberettede bivirkninger ved Sebivo fremgår af indlægssedlen.
For the full list of all side effects reported with Sebivo, see the package leaflet.
Hvad er Sebivo?
What is Sebivo?
I gruppen af HBeAg-negative patienter var Sebivo lige så effektivt som lamivudin (henholdsvis 75 % og 77 % responderede på behandlingen).
In the HBeAg-negative patients, Sebivo was as effective as lamivudine (75% and 77% responding, respectively).
Sebivo må ikke anvendes til personer, som er overfølsomme (allergiske) over for telbivudin eller andre af indholdsstofferne.
Sebivo must not be used in people who are hypersensitive (allergic) to telbivudine or to any of the other ingredients.
Det aktive stof i Sebivo, telbivudin, er et antiviralt lægemiddel, der tilhører gruppen af ‘nukleosidanaloger'.
The active substance in Sebivo, telbivudine, is an antiviral medicine that belongs to the class ‘nucleoside analogues'.
Det anvendes til patienter, som har kompenseret leversygdom (hvor leveren er beskadiget, men stadig fungerer normalt), og som desuden udviser tegn på, at virus stadig formerer sig, og tegn på leverbeskadigelse (forhøjet mængde af leverenzymer i blodet eller tegn på beskadigelse ved mikroskopisk undersøgelse af levervævet).
It is used in patients who have compensated liver disease (when the liver is damaged but is still able to work normally), who also show signs that the virus is still multiplying, and have signs of liver damage (raised liver enzymes in the blood or signs of damage when liver tissue is examined under a microscope).
Sebivo må ikke anvendes i kombination med pegyleret eller standardinterferon alfa (andre lægemidler til behandling af hepatitis).
Sebivo must not be used in combination with pegylated or standard interferon alfa (other medicines used in the treatment of hepatitis).
Respons blev defineret som et lavt indhold af viralt dna i blodet sammen med enten en tilbagevenden til normale mængder af leverenzymet alaninaminotransferase [ALT], eller at markøren for hepatitis B-virus forsvinder fra blodet.
A response was defined as low levels of viral DNA in the blood, together with either the levels of a liver enzyme called alanine aminotransferase (ALT) returning to normal or the marker for the hepatitis B virus disappearing from the blood.