natgillin/translations-raw huggingface dataset:
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.
Ifirmacombi 300 mg/12,5 mg: manitol, hidroksipropilceluloza, nizko substituirana hidroksipropilceluloza, natrijev karboksimetilškrob, smukec, makrogol 6000 in hidrogenirano ricinusovo olje v jedru tablete ter polivinilalkohol, titanov dioksid (E171), makrogol in smukec v filmski oblogi.
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.
Ifirmacombi 150 mg/12,5 mg: manitol, hidroksipropilceluloza, nizko substituirana hidroksipropilceluloza, natrijev karboksimetilškrob, smukec, makrogol 6000 in hidrogenirano ricinusovo olje v jedru tablete ter polivinilalkohol, titanov dioksid (E171), makrogol, smukec, rumeni železov oksid (E172) in rdeči železov oksid (E172) v filmski oblogi.
Hydroxypropylcellulose Hydroxypropylcellulose, low-substituted Sodium starch glycolate Talc
Jedro tablete: manitol hidroksipropilceluloza nizko substituirana hidroksipropilceluloza natrijev karboksimetilškrob smukec makrogol 6000 hidrogenirano ricinusovo olje
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.
Pri bolnikih, ki so jemali po 12,5 mg hidroklorotiazida, kolikor ga vsebuje zdravilo Ifirmacombi, je bil ta učinek zelo majhen ali pa ga sploh ni bilo.
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
Ifirmacombi 150 mg/12,5 mg filmsko obložene tablete Ifirmacombi 300 mg/12,5 mg filmsko obložene tablete Ifirmacombi 300 mg/25 mg filmsko obložene tablete irbesartan/hidroklorotiazid
Periodic monitoring of serum potassium is recommended when Ifirmacombi is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics).
Zdravila, na katera vplivajo motnje serumske koncentracije kalija Med sočasnim zdravljenjem z zdravilom Ifirmacombi in drugimi zdravili, katerih delovanje vpliva na motnje serumske koncentracije kalija (npr. z digitalisovimi glikozidi, antiaritmiki), je priporočeno redno preverjanje kalija v serumu.
The recommended dose of Ifirmacombi 300 mg/25 mg is one tablet a day.
Odmerjanje zdravila Ifirmacombi 300 mg/25 mg Priporočeni odmerek zdravila Ifirmacombi 300 mg/25 mg je ena tableta na dan. Tega odmerka se ne sme povečati.
Not known: pancreatitis, anorexia, diarrhoea, constipation, gastric irritation, sialadenitis, loss of appetite
Neznana pogostnost: vnetje trebušne slinavke, anoreksija, driska, obstipacija, draženje želodca, vnetje žleze slinavke, izguba apetita
As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Stenoza aortne in mitralne zaklopke, obstruktivna hipertrofična kardiomiopatija Tako kot pri zdravljenju z drugimi vazodilatatorji je tudi pri bolnikih z aortno ali mitralno stenozo ali obstruktivno hipertrofično kardiomiopatijo potrebna posebna previdnost.
Non-steroidal anti-inflammatory drugs: the administration of a non-steroidal anti-inflammatory drug may reduce the diuretic, natriuretic and antihypertensive effects of thiazide diuretics in some patients;
Pri nekaterih bolnikih se lahko med hkratnim jemanjem nesteroidnih protivnetnih zdravil zmanjša diuretični, natriuretični in antihipertenzijski učinek tiazidnih diuretikov.
Not known: weakness, muscle spasm
Neznana pogostnost: oslabelost, mišični krč
Once daily dosing with 150 mg irbesartan and 12.5 mg hydrochlorothiazide gave systolic/diastolic mean placebo-adjusted blood pressure reductions at trough (24 hours post-dosing) of 12.9/6.9 mmHg in patients with mild-to-moderate hypertension.
Pri bolnikih z blago do zmerno hipertenzijo, ki so enkrat na dan dobili po 150 mg irbesartana in 12,5 mg hidroklorotizida, se je sistolični krvni tlak 24 ur po zaužitju odmerka znižal za 12,9 mm Hg bolj kot po placebu, diastolični pa za 6,9 mm Hg.
The recomended dose of Ifirmacombi 300 mg /12.5 mg is one tablet a day.
Odmerjanje zdravila Ifirmacombi 300 mg/12,5 mg Priporočeni odmerek zdravila Ifirmacombi 300 mg/12,5 mg je ena tableta na dan.
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Med sočasnim jemanjem litija in zaviralcev angiotenzinske konvertaze so opazili reverzibilno povečanje serumske koncentracije litija in toksičnost.
Not known: cardiac arrhythmias
Neznana pogostnost: aritmija
Thiazides should be used with caution in patients with impaired hepatic function.
Pri bolnikih z okvarjenom jetrnim delovanjem je treba tiazidne diuretike uporabljati zelo previdno.
Not known: postural hypotension
Neznana pogostnost: ortostatska hipotenzija
No teratogenic effects were seen in rats given irbesartan and hydrochlorothiazide in combination at doses that produced maternal toxicity.
Pri podganjih samicah se teratogeni učinki kljub toksičnim odmerkom kombinacije irbesartana in hidroklorotiazida niso pojavili.
How to store Ifirmacombi
Shranjevanje zdravila Ifirmacombi
Uncommon: Not known:
Občasni: Neznana pogostnost:
Ifirmacombi 300 mg/25 mg film-coated tablets Pale pink, biconvex, capsule shaped, film-coated tablets.
Ifirmacombi 300 mg/25 mg filmsko obložene tablete Bledo roza, izbočene, filmsko obložene tablete v obliki kapsule.
No significant pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was coadministered with warfarin, a medicinal product metabolised by CYP2C9.
Pri sočasnem jemanju irbesartana in varfarina, zdravila, ki se presnavlja prek CYP2C9, niso opazili nobenih pomembnih farmakokinetičnih in farmakodinamičnih interakcij.
Psychiatric disorders:
Psihiatrične motnje
Ifirmacombi 300 mg/25 mg will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough.
Zdravnik vam je zdravilo Ifirmacombi 300 mg/25 mg predpisal zato, ker se vaš krvni tlak med dosedanjim zdravljenjem ni dovolj znižal.
The mean baseline blood pressure was approximately 172/113 mmHg in each treatment group and decreases of SeSBP/SeDBP at five weeks were 30.8/24.0 mmHg and 21.1/19.3 mmHg for irbesartan/hydrochlorothiazide and irbesartan, respectively (p < 0.0001).
Po petih zdravljenja se je v skupini, ki je prejemala kombinacijo irbesartana in hidroklorotiazida, zmanjšala za 30,8/24,0 mm Hg (sistolični in diastolični krvni tlak v sedečem položaju), v skupini, ki je prejemala irbesartan, pa za 21,1/19,3 mm Hg (p < 0,0001).
Although not specifically studied with the Ifirmacombi, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide.
Posebnih študij z zdravilom Ifirmacombi ni, kljub temu pa povratnega zvišanja krvnega tlaka pri bolnikih, ki so jemali bodisi irbesartan bodisi hidroklorotiazid, po prenehanju jemanja zdravila niso opazili.
Ifirmacombi 300 mg/12.5 mg will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough.
Zdravnik vam je zdravilo Ifirmacombi 300 mg/12,5 mg predpisal zato, ker se vaš krvni tlak med dosedanjim zdravljenjem ni dovolj znižal.
Hepatobiliary disorders:
Digitalisovi glikozidi:
Ifirmacombi 300 mg/12.5 mg film-coated tablets White, biconvex, capsule shaped, film-coated tablets.
Ifirmacombi 300 mg/12,5 mg filmsko obložene tablete Bele, izbočene, filmsko obložene tablete v obliki kapsule.
The addition of 12.5 mg hydrochlorothiazide to 300 mg irbesartan once daily in patients not adequately controlled on 300 mg irbesartan alone resulted in further placebo-corrected diastolic blood pressure reductions at trough (24 hours post-dosing) of 6.1 mmHg.
Diastolični krvni tlak se je pri bolnikih, pri katerih zdravljenje s 300 mg irbesartana ni bilo dovolj učinkovito in so začeli jemati tudi po 12,5 mg hidroklorotiazida enkrat na dan, 24 ur po zaužitju odmerka znižal za povprečno 6,1 mm Hg bolj kot po uporabi placeba.
Not known: fever
Neznana pogostnost: zvišana telesna temperatura
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.
Skupaj je bilo randomiziranih 697 bolnikov v razmerju 2: 1, bodisi na kombinacijo 150 mg irbesartana in 12,5 mg hidroklorotiazida bodisi na 150 mg irbesartana.
Ifirmacombi has been rarely associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension.
Simptomatska hipotenzija je pri bolnikih z zvišanim krvnim tlakom, ki jemljejo zdravilo Ifirmacombi, nimajo pa drugih dejavnikov tveganja za hipotenzijo, redka.
Given their similar pharmacodynamic properties, these results are also relevant for other ACE-inhibitors and angiotensin II receptor blockers.
Ti izsledki so pomembni tudi za druge zaviralce ACE in antagoniste receptorjev angiotenzina II, ker so njihove farmakodinamične lastnosti podobne.
Additional information on individual components: in addition to the adverse reactions listed above for the combination product, other adverse reactions previously reported with one of the individual components may be potential adverse reactions with Ifirmacombi.
Poleg naštetih neželenih učinkov, ki se lahko pojavijo med uporabo kombiniranega zdravila, se med jemanjem zdravila Ifirmacombi utegnejo pojaviti tudi neželeni učinki, o katerih so poročali pri jemanju posamezne učinkovine.
While this is not documented with Ifirmacombi, a similar effect should be anticipated.
Podoben učinek bi lahko pričakovali pri zdravljenju z zdravilom Ifirmacombi, vendar to ni bilo dokazano.
The combination of 300 mg irbesartan and 12.5 mg hydrochlorothiazide resulted in an overall placebo-subtracted systolic/diastolic reductions of up to 13.6/11.5 mmHg.
Med kombiniranim zdravljenjem s 300 mg irbesartana in 12,5 mg hidroklorotiazida se je sistolični krvni tlak znižal za 13,6 mm Hg, diastolični pa za 11,5 mm Hg bolj kot po uporabi placeba.
The two active ingredients in Ifirmacombi work together to lower blood pressure further than if either was given alone.
Učinkovini v zdravilu Ifirmacombi znižujeta krvni tlak, in to še bolj, kot če bi jemali vsako učinkovino posebej.
Side effects associated with irbesartan alone
Po peroralni ali intravenski uporabi irbesartana
Do not take Ifirmacombi - if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to hydrochlorothiazide or any other sulfonamide-derived medicines - if you are more than 3 months pregnant.
Ne jemljite zdravila Ifirmacombi - če ste alergični na irbesartan ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če ste alergični na hidroklorotiazid ali druga zdravila, ki vsebujejo sulfonamidne derivate; - če ste noseči dlje kot tri mesece (jemanju zdravila Ifirmacombi se je bolje izogniti tudi med zgodnjo nosečnostjo - glejte poglavje o nosečnosti); - če imate hudo jetrno ali ledvično okvaro; - če imate težave z odvajanjem seča; - če je zdravnik ugotovil, da imate stalno povečano koncentracijo kalcija ali zmanjšano koncentracijo kalija v krvi; - če imate sladkorno bolezen ali okvarjeno delovanje ledvic in se zdravite z zdravilom za znižanje krvnega tlaka, ki vsebuje aliskiren.
Calcium salts: thiazide diuretics may increase serum calcium levels due to decreased excretion.
Tiazidni diuretiki lahko zmanjšajo izločanje kalcija in tako povečajo njegovo serumsko koncentracijo.
Uncommon: flushing
Občasni: zardevanje
Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg hydrochlorothiazide.
Ena filmsko obložena tableta vsebuje 300 mg irbesartana (v obliki irbesartanijevega klorida) in 25 mg hidroklorotiazida.
Ifirmacombi 300 mg/25 mg Pale pink, biconvex, capsule shaped, film-coated tablets (tablets).
Ifirmacombi 300 mg/25 mg Bledo roza, izbočene, filmsko obložene tablete (tablete) v obliki kapsule.
Ifirmacombi 300 mg/12.5 mg White, biconvex, capsule shaped, film-coated tablets (tablets).
Ifirmacombi 300 mg/12,5 mg Bele, izbočene, filmsko obložene tablete (tablete) v obliki kapsule.
Each film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Ena filmsko obložena tableta vsebuje 150 mg irbesartana (v obliki irbesartanijevega klorida) in 12,5 mg hidroklorotiazida.
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 150 mg/12,5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 150 mg irbesartana (v obliki irbesartanijevega klorida) in 12,5 mg hidroklorotiazida.
Ifirmacombi 300 mg/25 mg film-coated tablets Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg hydrochlorothiazide.
Ifirmacombi 300 mg/25 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 300 mg irbesartana (v obliki irbesartanijevega klorida) in 25 mg hidroklorotiazida.
In diabetic patients dosage adjustments of insulin or oral hypoglycemic agents may be required.
Bolnikom s sladkorno boleznijo je treba po potrebi prilagoditi odmerek inzulina ali peroralnih antidiabetičnih zdravil.
Each Ifirmacombi 150 mg/12.5 mg film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Ena Ifirmacombi 150 mg/12,5 mg filmsko obložena tableta vsebuje 150 mg irbesartana (v obliki irbesartanijevega klorida) in 12,5 mg hidroklorotiazida.
Each Ifirmacombi 300 mg/25 mg film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg hydrochlorothiazide.
Ena Ifirmacombi 300 mg/25 mg filmsko obložena tableta vsebuje 300 mg irbesartana (v obliki irbesartanijevega klorida) in 25 mg hidroklorotiazida.
Hepatic impairment:
Ledvična okvara:
Ifirmacombi 300 mg/25 mg film-coated tablets Irbesartan/Hydrochlorothiazide
Ifirmacombi 300 mg/25 mg filmsko obložene tablete irbesartan/hidroklorotiazid
Anti-doping test:
Zdravila za zdravljenje protina:
Following oral or intravenous administration of
NAVEDBA ENE ALI VEČ UČINKOVIN
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/12,5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 300 mg irbesartana (v obliki irbesartanijevega klorida) in 12,5 mg hidroklorotiazida.
Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Ena filmsko obložena tableta vsebuje 300 mg irbesartana (v obliki irbesartanijevega klorida) in 12,5 mg hidroklorotiazida.
Each Ifirmacombi 300 mg/12.5 mg film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Ena Ifirmacombi 300 mg/12,5 mg filmsko obložena tableta vsebuje 300 mg irbesartana (v obliki irbesartanijevega klorida) in 12,5 mg hidroklorotiazida.
Ifirmacombi 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide
Ifirmacombi 150 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
Ifirmacombi 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide
Ifirmacombi 300 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
Lithium:
EXP:
Renal artery stenosis - Renovascular hypertension:
Holestiramin in holestipol:
- 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.
- Zdravilo Ifirmacombi 300 mg/12,5 mg je namenjeno bolnikom, pri katerih se krvni tlak med zdravljenjem s 300 mg irbesartana ali z zdravilom Ifirmacombi 150 mg/12,5 mg ni dovolj znižal.
No dosage adjustment of Ifirmacombi is necessary in older people.
Starostniki Pri starostnikih odmerka zdravila Ifirmacombi ni treba prilagajati.
Colestyramine and Colestipol resins: absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.
Absorpcija hidroklorotiazida je zaradi anionskih izmenjevalnih smol motena.
Pregnancy:
Jetrna okvara:
Thiazide diuretic-associated azotaemia may occur in patients with impaired renal function.
Pri bolnikih z okvarjenim ledvičnim delovanjem se lahko zaradi jemanja tiazidnih diuretikov pojavi azotemija.
What Ifirmacombi looks like and contents of the pack
Shranjevanje zdravila Ifirmacombi Vsebina pakiranja in dodatne informacije
Antigout medicinal products: dosage adjustments of antigout medicinal products may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Hidroklorotiazid lahko poveča serumsko koncentracijo sečne kisline, zato je treba v takem primeru odmerek zdravil za zdravljenje protina prilagoditi.
Titanium dioxide (E171) Macrogol
Ifirmacombi 300 mg/12,5 mg Filmska obloga: polivinilalkohol titanov dioksid (E171) makrogol smukec
These lesions were not observed in macaques; - decreases in serum potassium due to hydrochlorothiazide and partly prevented when hydrochlorothiazide was given in combination with irbesartan.
10 mg/kg/dan), so opazili spremembo barve želodca, razjede in fokalno nekrozo želodčne sluznice; teh lezij pri opicah ni bilo; - znižanje kalija v serumu med uporabo hidroklorotiazida, ki je bilo med kombiniranim dajanjem z irbesartanom manj izrazito.
These should be monitored every six months.
Bolnike je treba opazovati vsakih šest mesecev.
It is used in patients with:
Uporablja se pri bolnikih s:
The European Commission granted a marketing authorisation valid throughout the European Union for Hepsera on 6 March 2003.
Evropska komisija je dovoljenje za promet z zdravilom Hepsera, veljavno po vsej Evropski uniji, odobrila dne 6. marca 2003.
The full EPAR for Hepsera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Hepsera je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
• decompensated liver disease (when the liver is damaged and does not function normally.
• dekompenzirano boleznijo jeter (jetra so poškodovana in ne delujejo normalno).
This is a summary of the European public assessment report (EPAR) for Hepsera.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Hepsera.
Other information about Hepsera
Druge informacije o zdravilu Hepsera
Hepsera adefovir dipivoxil
Hepsera dipivoksiladefovirat
Adefovir stops the virus making DNA and prevents it from multiplying and spreading.
Adefovir zaustavi tvorbo DNK v virusu in tako prepreči njegovo razmnoževanje in širjenje.
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).
Prva študija je vključevala 511 bolnikov, ki so bili „HBeAg pozitivni“ (okuženi z običajno vrsto virusa hepatitisa B), druga pa 184 bolnikov, ki so bili „HBeAg negativni“ (okuženi z virusom, ki je mutiral [se spremenil], kar je privedlo do kroničnega hepatitisa B, ki ga je težje zdraviti).
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.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Hepsera večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Patients who have problems with their kidneys should take Hepsera less frequently.
Bolniki, ki imajo težave z ledvicami, morajo zdravilo Hepsera jemati manj pogosto.
What benefit has Hepsera shown during the studies?
Kakšne koristi je zdravilo Hepsera izkazalo med študijami?
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.
Med bolniki, ki so jemali zdravilo Hepsera, so pri 53 % HBeAg pozitivnih in 64 % HBeAg negativnih bolnikih pri biopsiji opazili izboljšanje stanja poškodb jeter, v primerjavi s 25 % HBeAg pozitivnimi in 33 % HBeAg negativnimi bolniki, ki so prejemali placebo.
• 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).
• kompenzirano boleznijo jeter (jetra so poškodovana, a delujejo normalno) pri bolnikih, ki kažejo tudi znake še vedno potekajočega razmnoževanja virusa in znake poškodb jeter (povišane ravni jetrnega encima „alanin-aminotransferaze“ [ALT] in znake poškodb, ki so vidni pod mikroskopom).
For more information about treatment with Hepsera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Hepsera preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Hepsera has been studied in two main studies, in which it was compared with placebo (a dummy treatment).
Zdravilo Hepsera so proučevali v dveh glavnih študijah, v katerih so ga primerjali s placebom (zdravilom brez zdravilne učinkovine).
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;
Ker lahko virus hepatitisa B postane odporen na zdravilo Hepsera, naj ga zdravnik predpiše le, če drugih zdravil, pri katerih je razvoj odpornosti manj verjeten, ni mogoče uporabiti;
In both studies, the effectiveness was measured by looking at how the liver damage had evolved after 48 weeks of treatment using a liver biopsy (when a sample of liver tissue is taken and examined under a microscope).
V obeh študijah so učinkovitost zdravila ocenjevali z opazovanjem napredovanja poškodb jeter po 48 tednih zdravljenja, kar so dosegli s pomočjo biopsije jeter (odvzeti vzorec jeter se pregleda pod mikroskopom).
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).
Zdravilo Hepsera se uporablja za zdravljenje odraslih s kroničnim (dolgotrajnim) hepatitisom B (boleznijo jeter zaradi okužbe z virusom hepatitisa B).
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.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Hepsera, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Adefovir is an antiviral belonging to the class ‘nucleoside analogues'.
Adefovir je protivirusno sredstvo, ki spada v razred „analogov nuklezoidov“.
What is the risk associated with Hepsera?
Kakšna tveganja so povezana z zdravilom Hepsera?