natgillin/translations-raw huggingface dataset:
4.4 og 4.6) - Alvorlig nyrefunktionsnedsættelse (kreatininclearance < 30 ml/min) - Refraktær hypokaliæmi, hyperkalcæmi - Alvorlig leverfunktionsnedsættelse, biliær cirrose og kolestase - Samtidig brug af Ifirmacombi og lægemidler indeholdende aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m2) (se pkt.
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to other sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived substance) - Second and third trimesters of pregnancy (see sections 4.4 and 4.6) - Severe renal impairment (creatinine clearance < 30 ml/min) - Refractory hypokalaemia, hypercalcaemia - Severe hepatic impairment, biliary cirrhosis and cholestasis - The concomitant use of Ifirmacombi with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5
EU/1/11/673/009 (14 filmovertrukne tabletter) EU/1/11/673/010 (28 filmovertrukne tabletter) EU/1/11/673/011 (30 filmovertrukne tabletter) EU/1/11/673/012 (56 filmovertrukne tabletter) EU/1/11/673/013 (56 x 1 filmovertrukne tabletter) EU/1/11/673/014 (84 filmovertrukne tabletter) EU/1/11/673/015 (90 filmovertrukne tabletter) EU/1/11/673/016 (98 filmovertrukne tabletter)
EU/1/11/673/009 (14 film-coated tablets) EU/1/11/673/010 (28 film-coated tablets) EU/1/11/673/011 (30 film-coated tablets) EU/1/11/673/012 (56 film-coated tablets) EU/1/11/673/013 (56 x 1 film-coated tablets) EU/1/11/673/014 (84 film-coated tablets) EU/1/11/673/015 (90 film-coated tablets) EU/1/11/673/016 (98 film-coated tablets)
Den anbefalede dosis af Ifirmacombi 300 mg/12,5 mg er én tablet dagligt.
The recomended dose of Ifirmacombi 300 mg /12.5 mg is one tablet a day.
Ifirmacombi 300 mg/12,5 mg: mannitol, hydroxypropylcellulose, lav-substituteret hydroxypropylcellulose, natriumstivelsesglycolat, talcum, macrogol 6000, hydrogeneret ricinusolie i tabletkernen og polyvinylalcohol, titandioxid (E171), macrogol og talcum i filmovertrækket.
Ifirmacombi 300 mg/12.5 mg: mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch glycolate, talc, macrogol 6000, hydrogenated castor oil in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol, talc in the film-coating.
Lægen vil sædvanligvis ordinere behandling med Ifirmacombi 300 mg/25 mg, hvis den tidligere behandling ikke sænkede dit blodtryk tilstrækkeligt.
Ifirmacombi 300 mg/25 mg will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough.
Samtidig administration af irbesartan tenderer at ændre det kaliumtab, der er forbundet med disse diuretika, formodentligt ved at blokere renin-angiotensin-aldosteronsystemet.
Presumably through blockade of the renin-angiotensin-aldosterone system, co-administration of irbesartan tends to reverse the potassium loss associated with these diuretics.
Lægen vil sædvanligvis ordinere behandling med Ifirmacombi 150 mg/12,5 mg, hvis den tidligere behandling ikke sænkede dit blodtryk tilstrækkeligt.
Ifirmacombi 150 mg/12.5 mg will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough.
Der er dog rapporteret minimal eller ingen effekt ved den dosis på 12,5 mg, som findes i Ifirmacombi.
Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in Ifirmacombi, minimal or no effects were reported.
Ifirmacombi 150 mg/12,5 mg: mannitol, hydroxypropylcellulose, lav-substituteret hydroxypropylcellulose, natriumstivelsesglycolat, talcum, macrogol 6000, hydrogeneret ricinusolie i tabletkernen og polyvinylalcohol, titandioxid (E171), macrogol, talcum, gul jernoxid (E172) og rød jernoxid (E172) i filmovertrækket.
Ifirmacombi 150 mg/12.5 mg: mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch glycolate, talc, macrogol 6000, hydrogenated castor oil in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172) and red iron oxide (E172) in the film-coating.
Det er især tilfældet ved nyrefunktionsnedsættelse og/eller hjerteinsufficiens og diabetes mellitus.
Conversely, due to the irbesartan component of Ifirmacombi hyperkalaemia might occur, especially in the presence of renal impairment and/or heart failure, and diabetes mellitus.
Patienter, der planlægger at blive gravide, bør skiftes til anden antihypertensiv behandling, hvor sikkerhedsprofilen for anvendelse under graviditet er veletableret, medmindre fortsat behandling med AIIRA skønnes nødvendig.
Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Ifirmacombi 150 mg/12,5 mg, 300 mg/12,5 mg og 300 mg/25 mg filmovertrukne tabletter indeholder:
Ifirmacombi 150 mg/12.5 mg and 300 mg/25 mg film-coated tablets Film coating:
Dog skal denne faste dosis-kombination gives med forsigtighed til patienter med let til moderat nedsat nyrefunktion (kreatininclearance ≥ 30 ml/min, men < 60 ml/min).
However, in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/min but < 60 ml/min) this fixed dose combination should be administered with caution.
Lægen vil sædvanligvis ordinere behandling med Ifirmacombi 300 mg/12,5 mg, hvis den tidligere behandling ikke sænkede dit blodtryk tilstrækkeligt.
Ifirmacombi 300 mg/12.5 mg will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough.
Et randomiseret, dobbeltblindt, aktivt kontrolleret, parallelt multicenterforsøg af 8 ugers varighed har evalueret virkningen og sikkerheden af kombinationen irbesartan og hydrochlorthiazid som initial behandling ved svær hypertension (defineret som SeDBT ≥ 110 mmHg).
Efficacy and safety of the combination of irbesartan and hydrochlorothiazide as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicentre, randomized, double-blind, active-controlled, 8-week, parallel-arm study.
Ifirmacombi 300 mg/25 mg: mannitol, hydroxypropylcellulose, lav-substituteret hydroxypropylcellulose, natriumstivelsesglycolat, talcum, macrogol 6000, hydrogeneret ricinusolie i tabletkernen og polyvinylalcohol, titandioxid (E171), macrogol, talcum, gul jernoxid (E172) og rød jernoxid (E172) i filmovertrækket.Se punkt 2 ”Ifirmacombi indeholder natrium”.
Ifirmacombi 300 mg/25 mg: mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch glycolate, talc, macrogol 6000, hydrogenated castor oil in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172) and red iron oxide (E172) in the film-coating.
Ikke almindelig: rødme
Uncommon: flushing
Der er hverken observeret rebound-hypertension for irbesartan eller hydrochlorthiazid.
Although not specifically studied with the Ifirmacombi, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide.
Sådan skal du tage Ifirmacombi
How to take Ifirmacombi
150 mg med systematisk titrering (inden evaluering af responset på den lavere dosis) efter 1 uge til henholdsvis irbesartan/hydrochlorothiazid 300 mg/25 mg eller irbesartan 300 mg.
A total of 697 patients were randomized in a 2:1 ratio to either irbesartan/hydrochlorothiazide 150 mg/12.5 mg or to irbesartan 150 mg and systematically force titrated (before assessing the response to the lower dose) after one week to irbesartan/hydrochlorothiazide 300 mg/25 mg or irbesartan 300 mg, respectively.
Tilgængelige data fra epidemiologiske studier viser en kumulativ dosisafhængig forbindelse mellem hydrochlorthiazid og non-melanom hudkræft.
Based on available data from epidemiological studies, cumulative dosedependent association between HCTZ and NMSC has been observed.
Det skal du vide, før du begynder at tage Ifirmacombi Sådan skal du tage Ifirmacombi Bivirkninger
What Ifirmacombi is and what it is used for What you need to know before you take Ifirmacombi How to take Ifirmacombi
Dosis af Ifirmacombi 300 mg/25 mg:
Dosage of Ifirmacombi 300 mg/25 mg
Ifirmacombi 300 mg/12,5 mg Hvide, bikonvekse, kapselformede, filmovertrukne tabletter (tabletter).
Ifirmacombi 300 mg/12.5 mg White, biconvex, capsule shaped, film-coated tablets (tablets).
Ifirmacombi 150 mg/12,5 mg filmovertrukne tabletter Svagt lyserøde, bikonvekse, ovale, filmovertrukne tabletter.
Ifirmacombi 150 mg/12.5 mg film-coated tablets Pale pink, biconvex, oval, film-coated tablets.
Ifirmacombi 150 mg/12,5 mg filmovertrukne tabletter Ifirmacombi 300 mg/12,5 mg filmovertrukne tabletter Ifirmacombi 300 mg/25 mg filmovertrukne tabletter
Ifirmacombi 150 mg/12.5 mg film-coated tablets Ifirmacombi 300 mg/12.5 mg film-coated tablets Ifirmacombi 300 mg/25 mg film-coated tablets
Forholdet mellem den laveste og den maksimale effekt af Ifirmacombi 150 mg/12,5 mg var 100%, når blodtrykket blev monitoreret ambulant.
When measured by ambulatory blood pressure monitoring, the trough to peak effects of Ifirmacombi 150 mg/12.5 mg were 100%.
Irbesartans farmakokinetiske parametre ændres ikke væsentligt hos patienter med let/moderat cirrose.
In patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Ifirmacombi 300 mg/12,5 mg filmovertrukne tabletter Hvide, bikonvekse, kapselformede, filmovertrukne tabletter.
Ifirmacombi 300 mg/12.5 mg film-coated tablets White, biconvex, capsule shaped, film-coated tablets.
Ifirmacombi 300 mg/25 mg filmovertrukne tabletter Svagt lyserøde, bikonvekse, kapselformede, filmovertrukne tabletter.
Ifirmacombi 300 mg/25 mg film-coated tablets Pale pink, biconvex, capsule shaped, film-coated tablets.
Ifirmacombi 300 mg/12,5 mg kan gives til patienter, der er utilstrækkeligt regulerede med irbesartan 300 mg eller med Ifirmacombi 150 mg/12,5 mg.
- Ifirmacombi 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; - Ifirmacombi 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Ifirmacombi 150 mg/12.5 mg. - Ifirmacombi 300 mg/25 mg may be administered in patients insufficiently controlled by Ifirmacombi 300 mg/12.5 mg.
Ifirmacombi 150 mg/12,5 mg filmovertrukne tabletter Ifirmacombi 300 mg/12,5 mg filmovertrukne tabletter Ifirmacombi 300 mg/25 mg filmovertrukne tabletter Irbesartan/hydrochlorthiazid
Ifirmacombi 150 mg/12.5 mg film-coated tablets Ifirmacombi 300 mg/12.5 mg film-coated tablets Ifirmacombi 300 mg/25 mg film-coated tablets Irbesartan/Hydrochlorothiazide
Hver filmovertrukket tablet indeholder 300 mg irbesartan (som irbesartanhydrochlorid) og 25 mg hydrochlorthiazid.
Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg hydrochlorothiazide.
Dosisjustering er ikke nødvendig til patienter med nedsat nyrefunktion, hvis den renale kreatininclearance er ≥ 30 ml/min (se pkt.
No dosage adjustment is necessary in patients with renal impairment whose renal creatinine clearance is ≥ 30 ml/min (see sections 4.3 and 4.4).
Om nødvendigt kan Ifirmacombi kombineres med andre antihypertensiva (se pkt.
When necessary, Ifirmacombi may be administered with another antihypertensive medicinal product (see section 4.3, 4.4, 4.5 and 5.1).
Dosis af Ifirmacombi 300 mg/12,5 mg:
Dosage of Ifirmacombi 300 mg/12.5 mg
Ifirmacombi 300 mg/25 mg tabletter Irbesartan/hydrochlorthiazid
Ifirmacombi 300 mg/25 mg tablets Irbesartan/Hydrochlorothiazide
Bivirkninger indberettet efter markedsføring af kombinationen af irbesartan og hydrochlorthiazid
Side effects reported since the launch of the combination of Irbesartan and Hydrochlorothiazide Some undesirable effects have been reported since marketing of Ifirmacombi.
Tabel 2: Bivirkninger rapporteret ved anvendelse af irbesartan alene
Table 2: Adverse reactions reported with the use of irbesartan alone Blood and lymphatic system disorders
- Lægen har ordineret Ifirmacombi til dig personligt.
- This medicine has been prescribed for you only.
Hver filmovertrukket tablet indeholder 150 mg irbesartan (som irbesartanhydrochlorid) og 12,5 mg hydrochlorthiazid.
Each film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Ifirmacombi 300 mg/25 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 300 mg irbesartan (som irbesartanhydrochlorid) og 25 mg hydrochlorthiazid.
Ifirmacombi 300 mg/25 mg film-coated tablets Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg hydrochlorothiazide.
Ifirmacombi 150 mg/12,5 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 150 mg irbesartan (som irbesartanhydrochlorid) og 12,5 mg hydrochlorthiazid.
Ifirmacombi 150 mg/12.5 mg film-coated tablets Each film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Ifirmacombi 300 mg/25 mg Svagt lyserøde, hvælvede, kapselformede, filmovertrukne tabletter (tabletter).
Ifirmacombi 300 mg/25 mg Pale pink, biconvex, capsule shaped, film-coated tablets (tablets).
Ifirmacombi 150 mg/12,5 mg tabletter Irbesartan/hydrochlorthiazid
Ifirmacombi 150 mg/12.5 mg tablets Irbesartan/Hydrochlorothiazide
Hver Ifirmacombi 150 mg/12,5 mg filmovertrukket tablet indeholder 150 mg irbesartan (som irbesartanhydrochlorid) og 12,5 mg hydrochlorthiazid.
Each Ifirmacombi 150 mg/12.5 mg film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Hver Ifirmacombi 300 mg/25 mg filmovertrukket tablet indeholder 300 mg irbesartan (som irbesartanhydrochlorid) og 25 mg hydrochlorthiazid.
Each Ifirmacombi 300 mg/25 mg film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg hydrochlorothiazide.
Hver filmovertrukket tablet indeholder 300 mg irbesartan (som irbesartanhydrochlorid) og 12,5 mg hydrochlorthiazid.
Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Dosis af Ifirmacombi 150 mg/12,5 mg:
Dosage of Ifirmacombi 150 mg/12.5 mg
Hver Ifirmacombi 300 mg/12,5 mg filmovertrukket tablet indeholder 300 mg irbesartan (som irbesartanhydrochlorid) og 12,5 mg hydrochlorthiazid.
Each Ifirmacombi 300 mg/12.5 mg film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Begrænsede kliniske data (7 patienter ud af 22) tyder på, at patienter, som ikke er tilstrækkelig regulerede med 300 mg/12,5 mg-kombinationen, kan respondere ved dosisøgning til 300 mg/25 mg. Der er hos disse patienter observeret en øget blodtryksreduktionen for såvel systolisk blodtryk (SBP) som diastolisk blodtryk (DBP) (henholdsvis 13,3 mmHg og 8,3 mmHg).
Limited clinical data (7 out of 22 patients) suggest that patients not controlled with the 300 mg/12.5 mg combination may respond when uptitrated to 300 mg/25 mg.
Ifirmacombi 300 mg/12,5 mg tabletter Irbesartan/hydrochlorthiazid
Ifirmacombi 300 mg/12.5 mg tablets Irbesartan/Hydrochlorothiazide
Ifirmacombi 300 mg/12,5 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 300 mg irbesartan (som irbesartanhydrochlorid) og 12,5 mg hydrochlorthiazid.
Ifirmacombi 300 mg/12.5 mg film-coated tablets Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Ifirmacombi 300 mg/25 mg filmovertrukne tabletter Irbesartan/hydrochlorthiazid
Ifirmacombi 300 mg/25 mg film-coated tablets Irbesartan/Hydrochlorothiazide
Valsartan
Posology
Irbesartan forebygger at angiotensin II binder sig til disse receptorer.
Irbesartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Ifirmacombi 300 mg/12,5 mg filmovertrukne tabletter
Ifirmacombi 300 mg/12.5 mg film-coated tablets Film coating:
Psykiske forstyrrelser
Psychiatric disorders:
Ifirmacombi 300 mg/12,5 mg filmovertrukne tabletter Irbesartan/hydrochlorthiazid
Ifirmacombi 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide
Ifirmacombi 150 mg/12,5 mg filmovertrukne tabletter Irbesartan/hydrochlorthiazid
Ifirmacombi 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide
Aktive stoffer: irbesartan og hydrochlorthiazid
What Ifirmacombi contains - The active substances are irbesartan and hydrochlorothiazide.
Ikke kendt: hjertearytmier
Not known: cardiac arrhythmias
Oversigt over indlægssedlen:
Anti-doping test:
Ifirmacombi skal tages gennem munden.
Ifirmacombi is for oral use.
Behandlingens varighed afhænger af patientens tilstand samt respons på behandlingen.
The duration of treatment depends on the patient's condition and response to treatment.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Hepsera den 6. marts 2003.
The European Commission granted a marketing authorisation valid throughout the European Union for Hepsera on 6 March 2003.
Hepsera adefovirdipivoxil
Hepsera adefovir dipivoxil
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Hepsera.
This is a summary of the European public assessment report (EPAR) for Hepsera.
Den fuldstændige EPAR for Hepsera findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Hepsera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
• dekompenseret leversygdom (hvor leveren er beskadiget og ikke fungerer normalt).
• decompensated liver disease (when the liver is damaged and does not function normally.
Patienter med nyreproblemer bør tage Hepsera mindre hyppigt.
Patients who have problems with their kidneys should take Hepsera less frequently.
Adefovir bremser virusset i at lave DNA og forhindrer, at den formerer sig og spredes.
Adefovir stops the virus making DNA and prevents it from multiplying and spreading.
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 Hepsera.
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 Hepsera.
Hepsera er blevet undersøgt i to hovedundersøgelser, hvor det blev sammenlignet med placebo (en uvirksom behandling).
Hepsera has been studied in two main studies, in which it was compared with placebo (a dummy treatment).
Andre oplysninger om Hepsera:
Other information about Hepsera
Blandt de patienter, der fik Hepsera, oplevede 53 % af de HBeAg-positive og 64 % af de HBeAg-negative patienter en bedring af leverbeskadigelsen, vurderet ved hjælp af en biopsi, sammenlignet med henholdsvis 25 % og 33 % af de patienter, der fik placebo.
Among those who took Hepsera, 53% of the HBeAg-positive and 64% of the HBeAg-negative patients had an improvement in liver damage as assessed in a biopsy, compared with 25% and 33%, respectively, in the patients who took placebo.
Hvis du ønsker yderligere oplysninger om behandling med Hepsera, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Hepsera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Den første undersøgelse omfattede 511 patienter, som var ‘HBeAg positive' (smittede med den almindelige type hepatitis B-virus), og den anden undersøgelse omfattede 184 patienter, der var ‘HBeAg negative' (smittede med et virus, der var muteret [ændret], hvilket medfører en form for kronisk hepatitis B, som er vanskeligere at behandle).
The first study included 511 patients who were ‘HBeAg positive' (infected with the common type of the hepatitis B virus) and the second included 184 patients who were ‘HBeAg negative' (infected with a virus that has mutated [changed], leading to a form of chronic hepatitis B that is more difficult to treat).
Behandling med Hepsera bør startes af en læge med erfaring i behandling af kronisk hepatitis B. Den anbefalede dosis er 10 mg én gang daglig.
Treatment with Hepsera should be started by a doctor who has experience in the management of chronic hepatitis B. The recommended dose is 10 mg once a day.
Hepsera var mere effektivt end placebo til at hæmme udviklingen af leversygdom.
Hepsera was more effective than placebo in slowing down the progression of liver disease.
• kompenseret leversygdom (hvor leveren er beskadiget men fungerer normalt), og hvor der endvidere er tegn på, at virusset stadig formerer sig, og hvor der er tegn på leverbeskadigelse (forhøjede niveauer af leverenzymet ‘alanin-amino-transferase' [ALT] samt tegn på beskadigelse, når levervævet undersøges under mikroskop).
• compensated liver disease (when the liver is damaged but functions normally), who also show signs that the virus is still multiplying, and have signs of liver damage (raised levels of the liver enzyme ‘alanine aminotransferase' [ALT] and signs of damage when liver tissue is examined under a microscope).
Det anbefales ikke at anvende Hepsera til patienter med svær nyresygdom, eller som er i dialyse (en blodrensningsteknik) - det bør kun overvejes at anvende det til disse patienter, hvis de potentielle fordele er større end de potentielle risici herved.
Hepsera is not recommended for use in patients with severe kidney disease or who are on dialysis (a blood clearing technique) - its use should only be considered in these patients if its potential benefits are greater than its potential risks.
Hvilken risiko er der forbundet med Hepsera?
What is the risk associated with Hepsera?
Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Hepsera er større end risiciene og anbefalede udstedelse af markedsføringstilladelse for Hepsera.
The Committee for Medicinal Products for Human Use (CHMP) decided that Hepsera's benefits are greater than its risks and recommended that it be given marketing authorisation.
Det aktive stof i Hepsera, adefovirdipivoxil, er et ‘prodrug', der omdannes til adefovir i kroppen.
The active substance in Hepsera, adefovir dipivoxil, is a ‘prodrug' that is converted into adefovir in the body.
Hepsera anvendes til behandling af voksne med kronisk (langvarig) hepatitis B (en leversygdom, der skyldes en infektion med hepatitis B-virus).
Hepsera is used to treat adults with chronic (long-term) hepatitis B (a disease of the liver due to infection with the hepatitis B virus).
For at mindske risikoen for resistens skal Hepsera anvendes i kombination med et andet anti-hepatitis Bmiddel, som ikke medfører resistens på same måde som Hepsera.
To reduce the risk of resistance, Hepsera must be used in combination with another anti-hepatitis B medicine that does not cause resistance in the same way as Hepsera.
Adefovir påvirker virkningsmekanismen for et viralt enzym kaldet DNA polymerase, som medvirker ved dannelsen af viral DNA.
Adefovir interferes with the action of a viral enzyme called DNA polymerase, which is involved in the formation of viral DNA.
Da hepatitis B-virusset kan blive resistent over for Hepsera, bør lægen kun ordinere Hepsera, hvis der ikke kan anvendes andre behandlinger, som giver mindre risiko for udvikling af resistens,
Because the hepatitis B virus can become resistant to Hepsera, the doctor should only consider prescribing Hepsera if other treatments that are less likely to lead to resistance cannot be used;
De hyppigste bivirkninger ved Hepsera (som optræder hos flere end 1 ud af 10 patienter) er forhøjede kreatininniveauer (et tegn på nyreproblemer) samt asteni (svaghed).
The most common side effects with Hepsera (seen in more than 1 patient in 10) are raised creatinine (a marker of kidney problems) and asthenia (weakness).
Hvad er Hepsera?
What is Hepsera?
Hepsera er et lægemiddel, der indeholder det aktive stof adefovirdipivoxil.
Hepsera is a medicine that contains the active substance adefovir dipivoxil.