natgillin/translations-raw huggingface dataset:
There is no experience regarding the administration of Sabervel in patients with a recent kidney transplantation.
Sabervel pri bolnikih po nedavni presaditvi ledvic ni nobenih izkušenj.
Exposure to AIIRA therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Znano je, da izpostavljenost antagonistom angiotenzina II v drugem in tretjem trimesečju nosečnosti lahko povzroči fetotoksične učinke pri človeku (zmanjšano delovanje ledvic, oligohidramnij, zapoznela zakostenitev lobanje) in toksične učinke pri novorojenčku (odpoved ledvic, hipotenzija, hiperkaliemija)
M anufacture r:
Izde lovale c:
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
• če imate sladkorno bolezen ali okvarjeno delovanje ledvic in se zdravite z zdravilom za znižanje
• if you get excessive vomiting or diarrhoea
• če začnete prekomerno bruhati ali dobite hudo drisko
Important information about some of the ingredients of Sabervel Sabervel contains lactose.
Pomembne informacije o nekaterih sestavinah zdravila Sabervel
The dose may later be increased to 300 mg once daily
Odmerek se lahko kasneje poveča na 300 mg enkrat na dan, odvisno od odziva krvnega tlaka.
In this leaflet: What Sabervel is and what it is used for
Navodilo vsebuje: Kaj je zdravilo Sabervel in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Sabervel
The selective antagonism of the angiotensin-II (AT1) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration.
Selektivni antagonistični učinek na receptorje angiotenzina II (AT1) povzroči povečanje plazemske ravni renina in angiotenzina
(serum creatinine ≤ 1.5 mg/dl in males and < 1.1 mg/dl in females).
300 mg/dan) in normalno ledvično funkcijo (serumski kreatinin pri moških ≤1,5 mg/dl, pri ženskah <1,1 mg/dl).
Over a subsequent two week period where patients were re-randomized to either active medicinal product or placebo, patients on placebo had increases of 2.4 and 2.0 mmHg in SeSBP and SeDBP compared to +0.1 and -0.3 mmHg changes respectively in those on all doses of irbesartan (see section 4.2).
SeSBP zvišal za 2,4 mmHg in SeDBP za 2,0 mmHg, medtem ko se je bolnikom na vseh odmerkih irbesartana SeSBP spremenil za +0,1 mmHg in SeDBP za -0,3 mmHg (glejte poglavje 4.2).
In vitro studies indicate that irbesartan is primarily oxidised by the cytochrome P450 enzyme CYP2C9; isoenzyme CYP3A4 has negligible effect.
In vitro študije kažejo, da se irbesartan primarno oksidira z citokrom P450 encimom
Renal impairment: no dosage adjustment is necessary in patients with impaired renal function.
Ledvična okvara: bolnikom s prizadeto ledvično funkcijo odmerka ni treba prilagajati.
Diabetes Mellitus (IRMA 2)” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
Preskušanje delovanja irbesartana na mikroalbuminurijo pri bolnikih z visokim krvnim tlakom z diabetesom melitusom tipa 2 (IRMA 2), je pokazalo, da pri bolnikih z mikroalbuminurijo, 300 mg irbesartana upočasni napredovanje do izražene proteinurije.
6 Dervenakion Str., 15351 Pallini, Attiki, Greece
6 Dervenakion str. 15351 Pallini Attiki, Grčija
• to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory
• za zaščito ledvic pri bolnikih z visokim krvnim tlakom, ki imajo sladkorno bolezen tipa 2 in laboratorijsko potrjeno okvaro delovanja ledvic.
blood tests may show an increased level of potassium.
Krvne preiskave lahko pokažejo zvišanje vrednosti encima, ki kaže na delovanje mišic in srca (encim kreatin-kinaza).
dizziness, orthostatic dizziness*
driska, dispepsija/zgaga
Read all of this leaflet carefully before you start taking this medicine.
Pred začetkom jemanja natančno preberete navodilo!
Renovascular hypertension: there is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Renovaskularna hipertenzija: pri bolnikih z obojestransko stenozo ledvične arterije ali s stenozo arterije ene same delujoče ledvice, je pri uporabi zdravil z vplivom na sistem renin-angiotenzin- aldosteron, povečano tveganje za hudo hipotenzijo in ledvično insuficienco.
Marketing Authorisation Holder: Pharmathen S.A,
Imetnik dovoljenja za promet: Pharmathen S.A.
Each tablet of Sabervel 75 mg contains 75 mg irbesartan.
Ena tableta zdravila Sabervel 75 mg vsebuje 75 mg
Sabervel 300mg film-coated tablets are supplied in blister packs of 28, 56, 90 or 98 film- coated tablets.
Sabervel 300 mg filmsko obložene tablete so na voljo v pretisnih omotih s 28, 56, 90 ali 98 filmsko obloženimi tabletami.
Sabervel 75 mg film-coated tablets irbesartan
Sabervel 75 mg filmsko obložene tablete irbesartan
Sabervel 75mg film-coated tablets are supplied in blister packs of 28, 56, 90 or 98 film- coated tablets.
Sabervel 75 mg filmsko obložene tablete so na voljo v pretisnih omotih s 28, 56, 90 ali 98 filmsko obloženimi tabletami.
Sabervel 150mg film-coated tablets are supplied in blister packs of 28, 56, 90 or 98 film- coated tablets.
Sabervel 150 mg filmsko obložene tablete so na voljo v pretisnih omotih s 28, 56, 90 ali 98 filmsko obloženimi tabletami.
Each tablet of Sabervel 150 mg contains 150 mg irbesartan.
Ena tableta zdravila Sabervel 150 mg vsebuje 150 mg
What Sabervel looks like and contents of the pack Sabervel 75 mg film-coated tablets are white, concave, round, film-coated tablets with 7 mm diameter.
Izgled zdravila Sabervel in vsebina pakiranja Sabervel 75 mg filmsko obložene tablete so bele, konkavne, okrogle, s premerom 7 mm.
Renal impairment: in patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Ledvična okvara: farmakokinetični parametri irbesartana pri bolnikih z ledvično okvaro ali tistih na hemodializi, niso pomembno spremenjeni.
Each tablet contains 150 mg irbesartan
Ena tableta vsebuje 150 mg irbesartana,
Each tablet of Sabervel 300 mg contains 300 mg irbesartan.
Ena tableta zdravila Sabervel 300 mg vsebuje 300 mg
diuretics, beta blockers, alpha blockers) to reach a predefined blood pressure goal of ≤ 135/85 mmHg or a 10 mmHg reduction in systolic pressure if baseline was > 160 mmHg.
V vseh zdravljenih skupinah so bolniki običajno prejemali 2 do 4 antihipertenzive (diuretike, antagoniste adrenergičnih receptorjev beta, antagoniste adrenergičnih receptorjev alfa), da so dosegli ciljni krvni tlak, ki je bil ≤135/85 mmHg, ali znižanje krvnega tlaka za najmanj 10 mmHg, če je bil začetni krvni tlak >160 mmHg.
What Sabervel looks like and contents of the pack Sabervel 300 mg film-coated tablets are white, concave, round, film-coated tablets with 11 mm diameter.
Izgled zdravila Sabervel in vsebina pakiranja Sabervel 300 mg filmsko obložene tablete so bele, konkavne, okrogle, s 11 premerom mm.
In a randomised trial of 318 hypertensive children and adolescents aged 6 to 16 years, the following adverse reactions occurred in the 3-week double-blind phase: headache (7.9%), hypotension (2.2%), dizziness (1.9%), cough (0.9%).
so se med 3-tedensko dvojno slepo fazo pojavili naslednji neželeni učinki: glavobol (7,9%), hipotenzija
White, concave, round, film-coated tablet with 11 mm diameter.
filmsko obložene tablete Bela, konkavna, okrogla, filmsko obložena tableta s 11 premerom mm.
NAME OF THE MEDICINAL PRODUCT Sabervel 75 mg film-coated tablets
IME ZDRAVILA Sabervel 75 mg filmsko obložene tablete.
What Sabervel looks like and contents of the pack Sabervel 150 mg film-coated tablets are white, concave, round, film-coated tablets with 9 mm diameter.
Izgled zdravila Sabervel in vsebina pakiranja Sabervel 150 mg filmsko obložene tablete so bele, konkavne, okrogle, s premerom 9 mm.
Sabervel 300 mg film-coated tablets irbesartan
Sabervel 300 mg filmsko obložene tablete irbesartan
Because no information is available regarding the use of Sabervel during breast-feeding, Sabervel is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.
Podatkov o uporabi zdravila Sabervel med dojenjem ni na voljo, zato uporaba zdravila Sabervel med dojenjem ni priporočljiva.
ACE inhibitors, angiotensin II receptor antagonists and dihydropyridine calcium blockers) were added as needed to help achieve the blood pressure goal.
Po potrebi, so za doseganje načrtovanega krvnega tlaka uporabljali dodatne antihipertenzive (brez zaviralcev ACE, antagonistov receptorjev za angiotenzin II in dihidropiridinskih zaviralcev kalcija).
Hepatic impairment: no dosage adjustment is necessary in patients with mild to moderate hepatic impairment.
Jetrna okvara: bolnikom z lažjo do srednje težko jetrno okvaro odmerka ni treba prilagajati.
Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group.
hipotenzija in disfunkcija ledvic) so bili v skupini, ki je prejemala aliskiren, pogostejši kot v skupini, ki je prejemala placebo.
Sabervel 150 mg film-coated tablets irbesartan
Sabervel 150 mg filmsko obložene tablete irbesartan
In 1,715
153 51 Pallini
vertigo, headache Ear and labyrinth disorder: Not known:
Ušesne bolezni, vključno z motnjami labirinta:
White, concave, round, film-coated tablet with 7 mm diameter.
filmsko obložene tablete Bela, konkavna, okrogla, filmsko obložena tableta s premerom 7 mm.
Each tablet contains 300 mg irbesartan
Ena tableta vsebuje 300 mg irbesartana.
This leaflet was last approved in
Rezultati so pokazali, da so bili
• Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Priporočeni vzdrževalni odmerek za zdravljenje bolezni ledvic, povezane z visokim krvnim tlakom in sladkorno boleznijo tipa 2, je 300 mg enkrat na dan.
White, concave, round, film-coated tablet with 9 mm diameter.
filmsko obložene tablete Bela, konkavna, okrogla, filmsko obložena tableta s premerom 9 mm.
NAME OF THE MEDICINAL PRODUCT Sabervel 150 mg film-coated tablets
IME ZDRAVILA Sabervel 150 mg filmsko obložene tablete.
NAME OF THE MEDICINAL PRODUCT Sabervel 300 mg film-coated tablets
IME ZDRAVILA Sabervel 300 mg filmsko obložene tablete.
hepatitis, abnormal liver function
hepatitis, motnje v delovanju jeter Bolezni kože in podkožja:
Rebound hypertension has not been observed.
nidacijo ali preživetje zarodkov niso opazili.
Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
(RAAS) s hkratno uporabo zaviralcev ACE, blokatorjev receptorjev angiotenzina II ali aliskirena povezana z večjo pogostnostjo neželenih učinkov, npr. hipotenzije, hiperkaliemije in zmanjšanega delovanja ledvic (vključno z akutno odpovedjo ledvic) kot uporaba enega samega zdravila, ki deluje na
40 mg of lactose monohydrate per film-coated tablet For the full list of excipients, see section 6.1.
40 mg laktoze monohidrata na filmsko obloženo tableto.
6, Dervenakion str., 153 51 Pallini Attiki, Greece
6, Dervenakion str., 153 51 Pallini
5.5 mEq/L) occurred in 29.4% of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group.
Pri diabetičnih bolnikih z visokim krvnim tlakom z mikroalbuminurijo in normalno ledvično funkcijo, se je hiperkaliemija (≥ 5,5 mEq/l) pojavila pri 29,4% bolnikov, ki so prejemali 300 mg irbesartana in pri 22% bolnikov v skupini s placebom.
• Patients with high blood pressure The usual dose is 150 mg once a day.
Običajen odmerek je 150 mg enkrat na dan .
20 mg of lactose monohydrate per film-coated tablet For the full list of excipients, see section 6.1.
20 mg laktoze monohidrata na filmsko obloženo tableto.
80 mg of lactose monohydrate per film-coated tablet For the full list of excipients, see section 6.1.
80 mg laktoze monohidrata na filmsko obloženo tableto.
NAME OF THE MEDICINAL PRODUCT Sabervel 75 mg film-coated tablets irbesartan
NAVODILO ZA UPORABO Sabervel 75 mg filmsko obložene tablete irbesartan
Respiratory, thoracic and mediastinal disorders: Uncommon:
Bolezni dihal, prsnega koša in mediastinalnega prostora:
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 75 mg irbesartan
Ena filmsko obložena tableta vsebuje 75 mg irbesartana.
NAME OF THE MEDICINAL PRODUCT Sabervel 150 mg film-coated tablets irbesartan
NAVODILO ZA UPORABO Sabervel 150 mg filmsko obložene tablete irbesartan
NAME OF THE MEDICINAL PRODUCT Sabervel 300 mg film-coated tablets irbesartan
NAVODILO ZA UPORABO Sabervel 300 mg filmsko obložene tablete irbesartan
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
impaired renal function including cases of renal failure in patients at risk (see section 4.4)
motnje v delovanju ledvic, vključno s primeri odpovedi ledvic pri ogroženih bolnikih
Hrvatska
tahikardija
The main measure in these studies was the neutrophil count over the first 10 days of treatment.
Glavno merilo učinkovitosti pri teh študijah je bilo število nevtrofilcev v prvih 10 dneh zdravljenja.
The full EPAR for Filgrastim Hexal 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 Filgrastim Hexal je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It contains the active substance filgrastim (30 or 48 million units).
Vsebuje zdravilno učinkovino filgrastim (30 ali 40 milijonov enot).
This means that Filgrastim Hexal is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘reference medicine').
To pomeni, da je podobno biološkemu zdravilu, ki je že odobreno v Evropski uniji (EU) in vsebuje enako zdravilno učinkovino (imenovano tudi „referenčno zdravilo“).
The European Commission granted a marketing authorisation valid throughout the EU for Filgrastim Hexal on 06 February 2009.
Evropska komisija je dovoljenje za promet z zdravilom Filgrastim Hexal , veljavno po vsej Evropski uniji, izdala 6. februarja 2009.
The most common side effect with Filgrastim Hexal (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
Najpogostejši neželeni učinki zdravila Filgrastim Hexal (opaženi pri več kot 1 bolniku od 10) so mišično-skeletne bolečine (bolečine v mišicah in kosteh).
The studies looked at the effects of single and repeated administration of various doses of the medicines, either injected under the skin or infused into a vein.
S študijami so raziskovali učinke enkratnega ali ponavljajočega se prejemanja različnih odmerkov zdravil, injiciranih v podkožje ali infundiranih v veno.
This is a summary of the European public assessment report (EPAR) for Filgrastim Hexal.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Filgrastim Hexal.
What measures are being taken to ensure the safe and effective use of Filgrastim Hexal?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Filgrastim Hexal?
Four studies looked at the levels of neutrophils in the blood in a total of 146 healthy volunteers who received Filgrastim Hexal or Neupogen.
S štirimi študijami so raziskovali ravni nevtrofilcev v krvi pri skupaj 146 zdravih prostovoljcih, ki so prejeli zdravili Filgrastim Hexal ali Neupogen.
For more information about treatment with Filgrastim Hexal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Filgrastim Hexal preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The active substance in Filgrastim Hexal, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G CSF).
Zdravilna učinkovina v zdravilu Filgrastim Hexal, filgrastim, je zelo podobna človeški beljakovini, imenovani granulocitne kolonije spodbujajoči faktor (G CSF).
Filgrastim Hexal is used to stimulate the production of white blood cells in the following situations:
Zdravilo Filgrastim Hexal se uporablja za stimulacijo tvorbe belih krvničk v naslednjih primerih:
Filgrastim Hexal is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately.
Zdravilo Filgrastim Hexal se ponavadi daje v specializiranih centrih za zdravljenje, čeprav si lahko bolniki, ki prejemajo injekcijo v podkožje in so bili ustrezno usposobljeni, cepivo vbrizgajo sami.
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 Filgrastim Hexal.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Filgrastim Hexal can also be used in people who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow.
Zdravilo Filgrastim Hexal lahko uporabljajo tudi darovalci krvnih matičnih celic, namenjenih za presaditev, da se olajša sproščanje teh celic iz kostnega mozga.
A risk management plan has been developed to ensure that Filgrastim Hexal is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Filgrastim Hexal je bil pripravljen načrt obvladovanja tveganj.
Other side effects may be seen in more than 1 patient in 10, depending on the condition that Filgrastim Hexal is being used for.
Drugi neželeni učinki se lahko pojavijo pri več kot 1 bolniku od 10, odvisno od bolezni, ki se zdravi z zdravilom Filgrastim Hexal.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Filgrastim Hexal, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Filgrastim Hexal and Neupogen brought about similar increases in blood neutrophil counts in healthy volunteers over the course of the studies.
Zdravili Filgrastim Hexal in Neupogen sta med študijami povzročili približno enako povečanje števila nevtrofilcev v krvi pri zdravih prostovoljcih.
The Committee recommended that Filgrastim Hexal be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Filgrastim Hexal izda dovoljenje za promet.
This was considered sufficient to demonstrate that the benefits of Filgrastim Hexal are comparable to those of the reference medicine.
To je štelo kot zadosten dokaz, da so koristi zdravila Filgrastim Hexal primerljivi s tistimi pri referenčnem zdravilu.
The replacement acts in the same way as naturally produced G CSF by encouraging the bone marrow to produce more white blood cells.
Nadomestek deluje enako kot naravno tvorjeni granulocitne kolonije stimulirajoči faktor, tako da spodbuja kostni mozeg k tvorjenju več belih krvničk.
What benefit has Filgrastim Hexal shown during the studies?
Kakšne koristi je zdravilo Filgrastim Hexal izkazalo med študijami?
Filgrastim Hexal was studied to show that it is comparable to the reference medicine, Neupogen.
Zdravilo Filgrastim Hexal so proučevali, da bi dokazali, da je primerljivo z referenčnim zdravilom Neupogen.
The CHMP decided that, in accordance with EU requirements, Filgrastim Hexal has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Filgrastim Hexal po kakovosti, varnosti in učinkovitosti primerljivo z zdravilom
Filgrastim Hexal is a solution for injection or infusion (drip into a vein) in a pre-filled syringe.
Zdravilo Filgrastim Hexal je raztopina za injiciranje ali infundiranje (dajanje v veno) v napolnjeni injekcijski brizgi.
Other information about Filgrastim Hexal
Druge informacije o zdravilu Filgrastim Hexal
Filgrastim Hexal is a ‘biosimilar' medicine.
Filgrastim Hexal je podobno biološko zdravilo.
What is the risk associated with Filgrastim Hexal?
Kakšna tveganja so povezana z zdravilom Filgrastim Hexal?
Why has Filgrastim Hexal been approved?
Zakaj je bilo zdravilo Filgrastim Hexal odobreno?
Filgrastim Hexal is given by injection under the skin or infusion into a vein.
Zdravilo Filgrastim Hexal se injicira v podkožje ali infundira v veno.
The reference medicine for Filgrastim Hexal is Neupogen.
Referenčno zdravilo za Filgrastim Hexal je zdravilo Neupogen.
How has Filgrastim Hexal been studied?
Kako je bilo zdravilo Filgrastim Hexal raziskano?
How is Filgrastim Hexal used?
Kako se zdravilo Filgrastim Hexal uporablja?
What is Filgrastim Hexal used for?
Za kaj se zdravilo Filgrastim Hexal uporablja?
What is Filgrastim Hexal?
Kaj je zdravilo Filgrastim Hexal?
How does Filgrastim Hexal work?
Kako zdravilo Filgrastim Hexal deluje?
Intravenous use vial (glass)
Intravenska uporaba viala (iz stekla)
ONIVYDE pegylated liposomal
ONIVYDE pegilirani liposomski
Package size
Stična ovojnina Velikost pakiranja
usually starts to have an effect after four to six weeks.
Zdravilo navadno začne učinkovati po štirih do šestih tednih.
The recommended maintenance dose is 10 to 20 mg once a day.
Priporočeni vzdrževalni odmerek je 10 do 20 mg enkrat na
It is available as tablets (white and round: 10 mg; dark beige and triangular: 20 mg).
Na voljo je v obliki tablet (belih in okroglih: 10mg; temno bež in trikotnih: 20 mg).
The medicine
dan.
The full EPAR for Leflunomide Teva 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 Leflunomide Teva je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Dve zdravili sta biološko enakovredni, ko dosegata enake ravni zdravilne učinkovine v telesu .
Leflunomide Teva treatment starts with a ‘loading dose' of 100 mg once a day for three days, followed by a maintenance dose.
Zdravljenje z zdravilom Leflunomide Teva se začne z začetnim odmerkom 100 mg enkrat na dan prve tri dni, čemur sledi vzdrževalni odmerek.
This means that Leflunomide Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Arava.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Arava.