natgillin/translations-raw huggingface dataset:
Helixate NexGen 2000 IU must not be mixed with other infusion solutions.
Zdravila Helixate NexGen 2000 i. e. ne smete mešati z drugimi raztopinami za injiciranje.
The amount of Helixate NexGen 2000 IU you should use and how often you use it depends on many factors such as your weight, the severity of your haemophilia, the site and extent of bleeding, the
Odmerek zdravila Helixate NexGen 2000 i. e., ki je primeren za vas in pogostost uporabe zdravila sta odvisna od več dejavnikov, npr. vaše telesne mase, resnosti motnje strjevanja krvi, mesta in obsega krvavitve, morebitne prisotnosti inhibitorjev faktorja VIII in njihove količine ter od želene aktivnosti faktorja VIII.
Your doctor will calculate the dose of Helixate NexGen 2000 IU and how frequently you should use it to get the necessary level of factor VIII activity in your blood.
11 82 Vaš zdravnik bo izračunal velikost in pogostost odmerka zdravila Helixate NexGen 2000 i. e., ki ga potrebujete za dosego želene aktivnosti faktorja VIII v krvi.
Your doctor should always adapt the amount of Helixate NexGen 2000 IU to be administered and the frequency of administration according to the clinical effectiveness in your individual case.
Zdravnik mora odmerek in pogostost dajanja odmerka zdravila Helixate NexGen 2000 i. e. prilagoditi glede na vaš klinični odgovor.
83 If you are using Helixate NexGen 2000 IU to prevent bleeding (prophylaxis), your doctor will calculate the dose for you.
83 Če zdravilo Helixate NexGen 2000 i. e. uporabljate za preprečevanje krvavitev (profilakso), bo velikost odmerka za vas izračunal zdravnik.
If you have the impression that the effect of Helixate NexGen 2000 IU is too strong or too weak, talk to your doctor.
Če menite, da je učinek zdravila Helixate NexGen 2000 i. e. premočan ali prešibak, se posvetujte z zdravnikom.
Helixate NexGen 2000 IU should be injected intravenously over several minutes.
Helixate NexGen 2000 i. e. je treba injicirati intravensko nekaj minut.
Your doctor will tell you, how often and at what intervals Helixate NexGen 2000 IU is to be administered.
Vaš zdravnik vam bo razložil, kako pogosto in v kakšnih presledkih morate uporabljati zdravilo Helixate NexGen 2000 i. e.
Usually, the substitution therapy with Helixate NexGen 2000 IU is a life-time treatment.
Nadomestno zdravljenje z zdravilom Helixate NexGen 2000 i. e. je ponavadi potrebno celo življenje.
If you use more Helixate NexGen 2000 IU than you should:
Če ste uporabili večji odmerek zdravila Helixate NexGen 2000 i. e. kot bi smeli:
If you have used more Helixate NexGen 2000 IU than you should, please inform your doctor.
Če ste uporabili večji odmerek zdravila Helixate NexGen 2000 i. e., kot bi smeli, prosimo o tem obvestite vašega zdravnika.
If you forget to use Helixate NexGen 2000 IU: • Proceed with the next administration immediately and continue at regular intervals as advised by your doctor. • Do not take a double dose to make up for a forgotten doses.
Če ste pozabili uporabiti zdravilo Helixate NexGen 2000 i. e.: • Takoj vzemite naslednji odmerek in zdravljenje nadaljujte, kot vam je predpisal zdravnik. • Ne uporabite dvojnega odmerka, če ste pozabili uporabiti prejšnjega.
If you stop using Helixate NexGen 2000 IU Do not stop using Helixate NexGen 2000 IU without consulting your doctor.
Ne prenehajte uporabljati zdravila Helixate NexGen 2000 i. e., ne da bi se prej posvetovali z vašim zdravnikom.
Like all medicines, Helixate NexGen 2000 IU can cause side effects, although not everybody gets them.
Kot vsa zdravila lahko tudi zdravilo Helixate NexGen 2000 i. e. povzroči neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
In rare cases, you may notice any of the following side effects after administration of Helixate NexGen 2000 IU: • rash/ itchy rash, local reactions at the injection site (e. g. burning sensation, temporary redness) • hypersensitivity reactions (e. g. tightness of the chest/ general feeling of being unwell, dizziness and nausea and mildly reduced blood pressure, which may make you feel faint upon standing) • unusual taste in the mouth • fever.
V redkih primerih lahko po uporabi zdravila Helixate NexGen 2000 i. e. opazite naslednje neželene učinke: • koprivnica/ srbečica, lokalne reakcije na mestu injiciranja (npr. pekoča bolečina, prehodna rdečica) • preobčutljivostne reakcije (npr. tiščanje v prsih/ splošno slabo počutje, omotičnost, slabost in blago znižanje krvnega tlaka, zaradi česar se vam lahko vrti, kadar stojite) • spremenjen okus v ustih • zvišana telesna temperatura
HOW TO STORE Helixate NexGen 2000 IU
SHRANJEVANJE ZDRAVILA Helixate NexGen 2000 i. e.
Do not use Helixate NexGen 2000 IU after the expiry date which is stated on labels and cartons.
Zdravila Helixate NexGen 2000 i. e. ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepkah in škatlah.
Do not use Helixate NexGen 2000 IU if you notice any particles or the solution is cloudy.
Ne uporabite zdravila Helixate NexGen 2000 i. e., če v raztopini opazite vidne delce ali je raztopina motna.
What Helixate NexGen 2000 IU contains
Kaj vsebuje zdravilo Helixate NexGen 2000 i. e.
What Helixate NexGen 2000 IU looks like and content of the pack
Izgled zdravila Helixate NexGen 2000 i. e. in vebina pakiranja
Helixate NexGen 2000 IU is provided as a powder and solvent for solution for injection and is a dry white to slightly yellow powder or cake.
Helixate NexGen 2000 i. e. je pakiran kot prašek in vehikel za raztopino za injiciranje in je suh, bel do rumenkast prašek ali pogača.
Medical devices for reconstitution and administration are provided with each package of Helixate NexGen 2000 IU.
Medicinski pripomočki za rekonstitucijo in aplikacijo so priloženi vsakemu pakiranju zdravila Helixate NexGen 2000 i. e.
86 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
86 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Hepsera is a medicine containing the active substance adefovir dipivoxil.
Hepsera je zdravilo, ki vsebuje zdravilno učinkovino adefovirdipivoksil.
It is available as white round tablets (10 mg).
Na voljo je v obliki belih okroglih tablet (10 mg).
Hepsera is used to treat adult patients 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 bolnikov s kroničnim (dolgotrajnim) hepatitisom B (bolezen jeter zaradi okužbe z virusom hepatitisa B).
It is used in patients with: • 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); • decompensated liver disease (when the liver is damaged and does not function normally).
Uporablja se za zdravljenje: • kompenzirane bolezni 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 znakov poškodb, ki so vidni pod mikroskopom), • dekompenzirane bolezni jeter (jetra so poškodovana in ne delujejo normalno).
Treatment with Hepsera should be initiated by a doctor who has experience in the management of chronic hepatitis B.
Zdravljenje z zdravilom Hepsera mora uvesti zdravnik, ki ima izkušnje z zdravljenjem kroničnega hepatitisa B.
The recommended dose is 10 mg once a day, taken with or without food.
Priporočeni odmerek je 10 mg enkrat na dan, s hrano ali brez nje.
The duration of treatment depends on the patient’ s condition and response to treatment.
Trajanje zdravljenja je odvisno od bolnikovega stanja in odziva na zdravljenje.
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.
Uporaba zdravila Hepsera ni priporočljiva pri bolnikih s hudim obolenjem ledvic ali tistih, ki so na dializi (tehnika čiščenja krvi); za uporabo zdravila pri teh bolnikih se je treba odločiti samo, če so bistvene koristi večje od z njim povezanih tveganj.
Patients whose disease is caused by a virus that is resistant (does not respond) to lamivudine (another antiviral medicine) should not take Hepsera on its own, but should take it in combination with lamivudine.
Bolniki, katerih bolezen povzroča virus, ki je odporen (se ne odziva) na lamivudin (drugo protivirusno zdravilo), zdravila Hepsera ne smejo jemati samostojno, ampak v kombinaciji z lamivudinom.
This may reduce the risk of resistance to Hepsera developing.
S tem se zmanjša tveganje za razvoj odpornosti na zdravilo Hepsera.
A change to treatment should also be considered if levels of the virus remain high after a year of treatment with Hepsera on its own.
O spremembi zdravljenja je treba razmisliti tudi, če ravni virusa ostanejo visoke tudi po letu zdravljenja z zdravilom Hepsera, jemanega samostojno.
For more information, see the Summary of Product Characteristics (also part of the EPAR).
Za več informacij glejte povzetek glavnih značilnosti zdravila (ki je tudi del EPAR).
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Adefovir moti 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
The active substance in Hepsera, adefovir dipivoxil, is a ‘ prodrug ’ that is converted into adefovir in the body.
Reproduction is authorised provided the source is acknowledged. delovanje virusnega encima DNA- polimeraza, ki sodeluje pri tvorjenju virusne DNA.
Adefovir stops the virus making DNA and prevents it from multiplying and spreading.
Adefovir zaustavi tvorjenje virusne DNA in virusu prepreči razmnoževanje in razširjanje.
Hepsera has been studied in two main studies, in which it was compared with placebo (a dummy treatment).
Zdravilo Hepsera so preučevali v dveh glavnih študijah, v katerih so ga primerjali s placebom (zdravilom brez zdravilne učinkovine).
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 študija pa je vključevala 184 bolnikov, ki so bili „ HBeAg negativni “ (okuženi z virusom, ki je mutiral [se spremenil], kar je povzročilo pojav kronične oblike hepatitisa B, ki jo je težje zdraviti).
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 ocenjevali z opazovanjem napredovanja poškodb jeter po 48 tednih zdravljenja z uporabo biopsije jeter (odvzeti vzorec jeter se pregleda pod mikroskopom).
Studies have also examined the effectiveness of Hepsera in patients whose disease was resistant to lamivudine.
V študijah so raziskali tudi učinkovitost zdravila Hepsera pri bolnikih, katerih bolezen je bila odporna na lamivudin.
Among those who took Hepsera, 53% of the HBeAg positive and 64% of the HBeAg negative patients had an improvement in liver damage 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 po biopsiji opazili izboljšanje stanja poškodb jeter v primerjavi s 25% HBeAg pozitivnimi in 33% HBeAg negativnimi bolniki, ki so prejemali placebo.
In the studies with lamivudine-resistant patients, treatment with Hepsera led to a decrease in the levels of viral DNA circulating in the blood.
V študiji pri bolnikih, ki so bili odporni na lamivudin, je zdravljenje z zdravilom Hepsera pripeljalo do znižanja ravni virusne DNA, ki je krožila v krvi.
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).
Najpogostejša neželena učinka zdravila Hepsera (opažena pri več kot 1 bolniku od 10) sta zvišana raven kreatinina (označevalec težav z jetri) in astenija (šibkost).
For the full list of all side effects reported with Hepsera, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Hepsera, glejte navodilo za uporabo.
Hepsera should not be used in people who may be hypersensitive (allergic) to adefovir dipivoxil or any of the other ingredients.
Zdravila Hepsera ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) adefovirdipivoksil ali katero koli drugo sestavino zdravila.
The Committee for Medicinal Products for Human Use (CHMP) decided that Hepsera’ s benefits are greater than its risks for the treatment of chronic hepatitis B in adults with compensated liver disease with evidence of active viral replication, persistently elevated serum ALT levels and histological evidence of active liver inflammation and fibrosis, and in adults with decompensated liver disease.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Hepsera pri zdravljenju kronične oblike hepatitisa B pri odraslih s kompenzirano boleznijo jeter, pri katerih obstajajo dokazi aktivnega razmnoževanja virusov, stalno povišanih ravni alanin- aminotransferaze (ALT) v serumu in s histološkimi dokazi aktivnega vnetja jeter in fibroze, kakor tudi pri zdravljenju dekompenzirane bolezni jeter večje od z njim povezanih tveganj.
The Committee recommended that Hepsera be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Hepsera odobri dovoljenje za promet.
Other information about Hepsera:
Druge informacije o zdravilu Hepsera:
The European Commission granted a marketing authorisation valid throughout the European Union for Hepsera to Gilead Sciences International Limited on 6 March 2003.
Evropska komisija je dovoljenje za promet z zdravilom Hepsera, veljavno po vsej Evropski uniji, odobrila družbi Gilead Sciences International Limited dne 6. marca 2003.
The marketing authorisation was renewed on 6 March 2008.
Dovoljenje za promet je bilo podaljšano dne 6. marca 2008.
The full EPAR for Hepsera is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Hepsera je na voljo tukaj.
EU number EU/ 1/ 03/ 251/ 001 EU/ 1/ 03/ 251/ 002
Številka EU EU/ 1/ 03/ 251/ 001
Invented name Hepsera Hepsera
Izmišljeno ime Hepsera
Strength 10 mg 10 mg
jakost 10 mg
Pharmaceutical form Tablet Tablet
pot uporabe Peroralna uporaba
Route of administration Oral use Oral use
ovojnina Steklenička (HDPE)
Packaging Bottle (HDPE) Bottle (HDPE)
Steklenička (HDPE)
Package size 30 tablets 3 x 30 tablets
3 x 30 tablet
Each tablet contains 10 mg adefovir dipivoxil.
Ena tableta vsebuje 10 mg adefovirdipivoksila.
White to off-white, round, flat-faced, bevelled-edge tablets, debossed with “ GILEAD” and “ 10” on one side and a stylised shape of a liver on the other side.
Bele do skoraj bele, okrogle, ploščate tablete z zabrušenim robom z vtisnjenima znakoma “ GILEAD ” in “ 10 ” na eni strani ter stilizirano obliko jeter na drugi strani.
Hepsera is indicated for the treatment of chronic hepatitis B in adults with:
Hepsera je indicirana za zdravljenje kroničnega hepatitisa B pri odraslih s:
• compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and fibrosis
• kompenzirano boleznijo jeter z dokazom aktivne virusne replikacije, z vztrajno povišano vrednostjo serumske alanin- aminotransferaze (ALT) in histološkim dokazom aktivnega vnetja jeter in fibroze
• decompensated liver disease.
• dekompenzirano boleznijo jeter.
Therapy should be initiated by a physician experienced in the management of chronic hepatitis B.
Terapijo mora izvajati zdravnik, ki že ima izkušnje z zdravljenjem kroničnega hepatitisa B.
The recommended dose of Hepsera is 10 mg (one tablet) once daily taken orally with or without food.
Priporočeni odmerek Hepsere je 10 mg (ena tableta) enkrat na dan, peroralno z ali brez hrane.
In HBeAg positive patients, treatment should be administered at least until HBeAg seroconversion (HBeAg and HBV DNA loss with HBeAb detection on 2 consecutive serum samples at least 3 months apart) or until HBsAg seroconversion or in case of evidence of loss of efficacy (see section 4.4).
Bolniki s pozitivnim HBeAg naj bi se zdravili vsaj do HBeAg serokonverzije (do izginotja HBeAg in HBV DNA in odkritja anti- HBe v dveh zaporednih serumskih vzorcih, ki sta najmanj tri mesece narazen) ali do HBsAg serokonverzije ali v primeru dokaza izgube učinkovitosti (glejte poglavje 4. 4).
In HBeAg negative (pre-core mutant) patients, treatment should be administered at least until HBsAg seroconversion or in case of evidence of loss of efficacy (see section 4.4).
Bolniki z negativnim HBeAg (pre- core mutanti) naj bi se zdravili vsaj do HBsAg serokonverzije ali v primeru dokaza izgube učinkovitosti (glejte poglavje 4. 4).
2 In patients with decompensated liver disease or cirrhosis, treatment cessation is not recommended (see section 4.4).
2 Pri bolnikih z dekompenziranim obolenjem jeter ali cirozo prenehanje zdravljenja ni priporočljivo (glejte poglavje 4. 4).
Hepsera is not recommended for use in children below the age of 18 years due to insufficient data on safety and efficacy (see section 5.1).
Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba Hepsere pri otrocih pod 18 let ni priporočljiva (glejte poglavje 5. 1).
No data are available to support a dose recommendation for patients over the age of 65 years (see section 4.4).
Podatkov, na osnovi katerih bi lahko priporočili odmerke za bolnike starejše od 65 let, ni na voljo (glejte poglavje 4. 4).
Adefovir is eliminated by renal excretion and adjustments of the dosing interval are required in patients with a creatinine clearance < 50 ml/ min or on dialysis.
Potrebno je prilagajanje intervalov med odmerki pri bolnikih z očistkom kreatinina < 50 ml/ min ali bolnikih na dializi.
The recommended dosing frequency according to renal function must not be exceeded (see sections 4.4 and 5.2).
Priporočena pogostnost odmerjanja glede na ledvično funkcijo se ne sme prekoračiti (glejte poglavji 4. 4 in 5. 2).
Patients with creatinine clearance between 30 and 49 ml/ min:
Bolniki z očistkom kreatinina od 30 do 49 ml/ min:
It is recommended to administer adefovir dipivoxil (one 10 mg tablet) every 48 hours in these patients.
Tem bolnikom je priporočeno dajati adefovirdipivoksil (eno 10- miligramsko tableto) vsakih 48 ur.
Therefore, clinical response to treatment and renal function should be closely monitored in these patients (see section 4.4).
Zato je potrebno pri teh bolnikih skrbno nadzorovati klinični odziv na zdravljenje in ledvično funkcijo (glejte poglavje 4. 4).
Patients with creatinine clearance < 30 ml/ min and dialysis patients:
Bolniki z očistkom kreatinina < 30 ml/ min in bolniki na dializi:
There are no safety and efficacy data to support the use of adefovir dipivoxil in patients with a creatinine clearance < 30 ml/ min or on dialysis.
Podatkov o varnosti in učinkovitosti, ki podpirajo uporabo adefovirdipivoksila pri bolnikih z očistkom kreatinina < 30 ml/ min ali bolnikih na dializi, ni.
Therefore, use of adefovir dipivoxil is not recommended in these patients and should only be considered if the potential benefits outweigh the potential risks.
Uporaba adefovirdipivoksila pri teh bolnikih zato ni priporočena, možnost uporabe se lahko pretehta samo, če morebitne koristi odtehtajo morebitna tveganja.
In that case, the limited data available suggest that for patients with creatinine clearance between 10 and 29 ml/ min, adefovir dipivoxil (one 10 mg tablet) may be administered every 72 hours; for haemodialysis patients, adefovir dipivoxil (one 10 mg tablet) may be administered every 7 days following 12 hours continuous dialysis (or 3 dialysis sessions, each of 4 hours duration).
V tem primeru omejeni podatki, ki so na voljo, kažejo, da se lahko pri bolnikih z očistkom kreatinina od 10 do 29 ml/ min, adefovirdipivoksil (ena 10- miligramska tableta) uporabi vsakih 72 ur; pri bolnikih na hemodializi se lahko adefovirdipivoksil (ena 10- miligramska tableta) uporabi vsakih 7 dni po 12- urni neprekinjeni dializi (ali po treh dializah po 4 ure).
These patients should be closely monitored for possible adverse reactions and to ensure efficacy is maintained (see sections 4.4 and 4.8).
Te bolnike je treba skrbno nadzorovati zaradi možnega pojava neželenih učinkov in zato da se zagotovi ohranitev učinkovitosti (glejte poglavji 4. 4 in 4. 8).
No dosing interval recommendations are available for other dialysis patients (e. g. ambulatory peritoneal dialysis patients) or non-haemodialysed patients with creatinine clearance less than 10 ml/ min.
Priporočil za intervale med odmerki za druge bolnike na dializi (npr. bolnike na ambulantni peritonealni dializi) ali bolnike, ki niso na hemodializi, imajo pa očistek kreatinina manjši od 10 ml/ min, ni.
Hepatic impairment:
Motnje v delovanju jeter:
No dose adjustment is required in patients with hepatic impairment (see section 5.2).
Za bolnike z motnjami v delovanju jeter prilagajanje odmerkov ni potrebno (glejte poglavje 5. 2).
Clinical resistance:
Klinična odpornost:
Lamivudine-refractory patients and patients harbouring HBV with evidence of resistance to lamivudine (mutations at rtL180M, rtA181T and/ or rtM204I/ V) should not be treated with adefovir dipivoxil monotherapy in order to reduce the risk of resistance to adefovir.
Bolnikov, ki se ne odzivajo na zdravljenje z lamivudinom in bolnikov, ki so nosilci HBV z dokazano odpornostjo na lamivudin (mutacija na rtL180M, rtA181T in/ ali rtM204I/ V), se ne sme zdraviti z monoterapijo adefovirdipivoksila, zato da bi zmanjšali tveganje za odpornost na adefovir.
Adefovir may be used in combination with lamivudine in lamivudine-refractory patients and in patients harbouring HBV with mutations at rtL180M and/ or rtM204I/ V.
Adefovir se lahko uporablja v kombinaciji z lamivudinom pri bolnikih, ki se ne odzivajo na zdravljenje z lamivudinom in pri bolnikih, ki so nosilci HBV z mutacijami na rtL180M in/ ali rtM204I/ V.
However, for patients harbouring HBV that contains the rtA181T mutation, consideration should be given to alternative treatment regimens due to the risk of reduced susceptibility to adefovir (see section 5.1).
Vendar je treba pomisliti na alternativni režim zdravljenja bolnikov, ki so nosilci HBV z mutacijo rtA181T zaradi tveganja za zmanjšano občutljivost za adefovir (glejte poglavje 5. 1).
In order to reduce the risk of resistance in patients receiving adefovir dipivoxil monotherapy, a modification of treatment should be considered if serum HBV DNA remains above 1,000 copies/ ml at or beyond 1 year of treatment.
Da bi zmanjšali tveganje odpornosti pri bolnikih na monoterapiji z adefovirdipivoksilom, je treba razmisliti o spremembi zdravljenja, če vrednost serumske HBV DNA po enem letu ostane večja od 1. 000 kopij/ ml.
While the
Zdravljenje z adefovirdipivoksilom lahko privede do motenj v delovanju ledvic.
3 overall risk of renal impairment in patients with adequate renal function is low, this is of special importance in patients at risk of, or having underlying renal dysfunction and in patients receiving medicinal products that may affect renal function.
Pri bolnikih s tveganjem za ledvično disfunkcijo oziroma bolnikih, ki jo že imajo in pri bolnikih, ki prejemajo zdravila, ki lahko vplivajo na ledvično funkcijo, je potrebno biti posebej pozoren na možnost tega tveganja.
It is recommended that creatinine clearance is calculated in all patients prior to initiating therapy with adefovir dipivoxil.
Pred začetkom zdravljenja z adefovirdipivoksilom se priporoča določiti očistek kreatinina pri vseh bolnikih.