natgillin/translations-raw huggingface dataset:
Ammonaps was not compared with any other treatments.
Zdravila Ammonaps niso primerjali z nobenim drugim zdravilom.
The daily dose of Ammonaps is adjusted for each patient individually and depends on the patient's diet, height and weight.
Dnevni odmerek zdravila Ammonaps je prilagojen za vsakega bolnika posebej in je odvisen od bolnikove prehrane, višine in telesne mase.
Patients with urea cycle disorders cannot get rid of ammonia from the body, so it can reach high levels, leading to serious problems including disability, brain damage and death.
Bolniki z motnjami ciklusa sečnine ne morejo izločiti amoniaka iz telesa, kar pomeni, da lahko ta doseže zelo visoke ravni, ki lahko povzročijo resne težave, vključno z invalidnostjo, poškodbo možganov in smrtjo.
It must not be used in patients who are pregnant or breast-feeding.
Ne smejo ga uporabljati bolnice, ki so noseče ali dojijo.
The European Commission granted a marketing authorisation valid throughout the European Union for Ammonaps on 8 December 1999.
Evropska komisija je dovoljenje za promet z zdravilom Ammonaps, veljavno po vsej Evropski uniji, odobrila dne 8. decembra 1999.
Ammonaps was authorised under ‘Exceptional Circumstances', because, as the disease is rare, limited information was available at the time of approval.
Zdravilo Ammonaps je bilo sprva odobreno v „izjemnih okoliščinah“, saj so bile zaradi redkosti bolezni ob odobritvi dovoljenja na voljo le omejene informacije.
What benefit has Ammonaps shown during the studies?
Kakšne koristi je zdravilo Ammonaps izkazalo med študijami?
This allows the levels of nitrogen in the body to decrease, reducing the amount of ammonia produced.
Tako se ravni dušika v telesu znižajo, količina proizvedenega amoniaka pa se zmanjša.
What is the risk associated with Ammonaps?
Kakšna tveganja so povezana z zdravilom Ammonaps?
• ‘late-onset' disease in patients who show a partial lack of an enzyme after the age of one month and have had brain damage caused by high blood ammonia levels.
• pri zakasnjenem pojavu bolezni pri bolnikih, ki kažejo delno pomanjkanje encima po enem mesecu in so utrpeli poškodbo možganov zaradi visoke ravni amoniaka v krvi.
The Committee recommended that Ammonaps be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Ammonaps odobri dovoljenje za promet.
Ammonaps is used in patients who lack one or more of the following enzymes: carbamylphosphate synthetase, ornithine transcarbamylase, or argininosuccinate synthetase.
Zdravilo Ammonaps se uporablja pri bolnikih, ki jim primanjkuje enega ali več naslednjih encimov: karbamil-fosfat-sintetaze, ornitin-transkarbamilaze ali argininosukcinat-sintetaze.
Ammonaps is used as an add-on to other treatments and with a special low-protein diet to reduce the intake of nitrogen.
Zdravilo Ammonaps se uporablja kot dodatek drugim zdravljenjem ter s posebno dieto z malo beljakovinami za zmanjšanje vnosa dušika.
Other common side effects include abnormal kidney function and blood cell counts (red cells, white cells and platelets).
Drugi pogosti neželeni učinki so nenormalno delovanje ledvic in nenormalne koncentracije krvnih celic (rdečih krvničk, belih krvničk in krvnih ploščic).
Ammonaps should not be used in people who may be hypersensitive (allergic) to sodium phenylbutyrate or any of the other ingredients.
Zdravila Ammonaps ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) natrijev fenilbutirat ali katero koli drugo sestavino zdravila.
The dose of Ammonaps should be divided into equal amounts and given with each meal.
Odmerek zdravila Ammonaps je treba razdeliti na enake dele in jih vzeti skupaj z obrokom.
The full EPAR for Ammonaps is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ammonaps je na voljo tukaj .
In the body, waste nitrogen is in the form of ammonia, which is toxic, especially for the brain.
Odpadni dušik se v telesu nahaja v obliki amoniaka, ki je še zlasti strupen za možgane.
The most common side effects with Ammonaps (seen in more than 1 patient in 10) are amenorrhoea (absence of periods) and irregular menstruation (irregular periods), but these only occur in fertile female patients.
Najpogostejša neželena učinka zdravila Ammonaps (opažena pri več kot 1 bolniku od 10) sta amenoreja (izostanek menstruacij) in neredna menstruacija, vendar se to pojavi samo pri odraslih bolnicah v rodni dobi.
For the full list of all side effects reported with Ammonaps, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ammonaps, glejte navodilo za uporabo.
The Committee for Medicinal Products for Human Use (CHMP) noted that urea cycle disorders are a serious disease with few treatments available, and that Ammonaps has been shown to prevent ammonia levels becoming too high.
Odbor za zdravila za uporabo v humani medicini (CHMP) je poudaril, da je motnja ciklusa sečnine resna bolezen, možnosti zdravljenja pa zelo malo, in da se je izkazala učinkovitost zdravila Ammonaps pri preprečevanju prevelikega porasta ravni amoniaka.
Ammonaps has been studied in 82 patients with urea cycle disorders who were treated with Ammonaps and had not received other treatments for their disease before.
Zdravilo Ammonaps so proučevali pri 82 bolnikih z motnjo ciklusa sečnine, ki so prejemali zdravilo Ammonaps in zaradi svoje bolezni še niso bili zdravljeni.
Ammonaps treatment should be supervised by a doctor who has experience in treating patients with urea cycle disorders.
Zdravljenje z zdravilom Ammonaps mora nadzorovati zdravnik z izkušnjami v obravnavi bolnikov z motnjami ciklusa sečnine.
Ammonaps is a medicine that contains the active substance sodium phenylbutyrate.
Ammonaps je zdravilo, ki vsebuje zdravilno učinkovino natrijev fenilbutirat.
Therefore, despite the limited information available, the CHMP decided that Ammonaps's benefits are greater than its risks as adjunctive therapy in the chronic management of urea cycle disorders.
Tako je odbor kljub omejenim informacijam sklenil, da so koristi zdravila Ammonaps kot dodatnega zdravljenje pri kronični obravnavi motenj ciklusa sečnine večje od z njim povezanih tveganj.
Why has Ammonaps been approved?
Zakaj je bilo zdravilo Ammonaps odobreno?
Ammonaps is a long-term treatment and needs to be taken until the patient has a successful liver transplant.
Zdravilo Ammonaps je namenjeno dolgotrajnemu zdravljenju in ga je treba jemati ves čas do uspešne presaditve jeter.
Eating protein brings nitrogen into the body, which is then transformed into ammonia.
Z uživanjem beljakovin se v telo vnese dušik, ki se nato pretvori v amoniak.
The overall survival rate was about 80% in newborn babies who received Ammonaps.
Pri novorojenčkih, ki so prejeli zdravilo Ammonaps, je bila skupna stopnja preživetja 80 %.
Ammonaps is used to treat patients who have urea cycle disorders.
Zdravilo Ammonaps se uporablja za zdravljenje bolnikov z motnjami v ciklusu sečnine.
The active substance in Ammonaps, sodium phenylbutyrate, is converted into a substance called phenylacetate in the body.
Zdravilna učinkovina zdravila Ammonaps, natrijev fenilbutirat, se v telesu pretvori v snov, imenovano fenilacetat.
How has Ammonaps been studied?
Kako je bilo zdravilo Ammonaps raziskano?
Ammonaps sodium phenylbutyrate EPAR summary for the public
Ammonaps natrijev fenilbutirat
What is Ammonaps used for?
Za kaj se zdravilo Ammonaps uporablja?
What is Ammonaps?
Kaj je zdravilo Ammonaps?
How is Ammonaps used?
Kako se zdravilo Ammonaps uporablja?
How does Ammonaps work?
Kako zdravilo Ammonaps deluje?
In children:
Otroci:
The holder of this marketing Authorisation will have to submit PSURs every 6 months.
Imetnik dovoljenja za promet z zdravilom mora predložiti PSUR-e vsakih 6 mesecev .
Antibiotics stop the growth of bacteria which cause infections.
Antibiotiki ustavijo rast bakterij, ki povzročajo okužbe.
Your doctor will tell you how many Levviax tablets to take, at what time and for how long.
Vaš zdravnik vam bo povedal, koliko tablet zdravila Levviax jemljite, kdaj in kako dolgo.
The in vitro protein binding is approximately 60 % to 70 %.
In vitro je vezava na beljakovine približno 60 do 70 %.
Date of first renewal: 9 July 2006
Datum prvega podaljšanja dovoljenja za promet: 09.julij.2006
Patients should be cautioned about the potential effects of these events on the ability to drive or operate machinery.
Bolnike je treba opozoriti na potencialne učinke takšnih dogodkov glede zmožnosti vožnje ali upravljanja strojev.
The tablets may be taken with or without food.
Tablete se lahko vzamejo s hrano ali brez nje.
EU/1/01/192/001 10 tablets EU/1/01/192/002 14 tablets EU/1/01/192/003 20 tablets EU/1/01/192/004 100 tablets EU/1/01/192/005 5x2 tablets
EU/1/01/192/001 10 tablet EU/1/01/192/002 14 tablet EU/1/01/192/003 20 tablet EU/1/01/192/004 100 tablet EU/1/01/192/005 5 x 2 tableti
The other side effects listed below are given with an estimation of the frequency with which they may occur.
Drugi neželeni učinki, našteti spodaj, so navedeni z oceno pogostnosti, s katero se lahko pojavijo.
If you stop taking the tablets too soon, the infection may return, or your condition may get worse.
Če tablete nehate jemati prekmalu, se okužba lahko vrne ali se vam stanje poslabša.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 9 July 2001
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja za promet: 09.julij.2001
-Paediatric patients
-Pediatrični bolniki
I-67019 Scoppito (L'Aquila), Italy
I-67019 Scoppito (L'Aquila), Italija
Patients should be informed that these undesirable effects may occur as early as after the first dose of medication.
Bolnike je treba seznaniti, da seti neželeni učinkilahko pojavijo že po prvem odmerku zdravila.
Commonly susceptible species
Ponavadi občutljive vrste
MARKETING AUTHORISATION NUMBERS EU/1/01/192/001-005
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/01/192/001-005
Limited data, obtained in paediatric patients 13 to 17 years of age, showed that telithromycin concentrations in this age group were similar to the concentrations in patients 18 to 40 years of age.
Omejeni podatki za pediatrične bolnike, stare od 13 do 17 let, kažejo, da so koncentracije telitromicina v tej starostni skupini podobne koncentracijam pri bolnikih, starih od 18 do 40 let.
If you feel you are suffering from a side effect, tell a doctor immediately to get advice before taking the next dose.
Če se vam zdi, da imate kakšen neželen učinek, to takoj povejte zdravniku, da vam bo svetoval, preden vzamete naslednji odmerek.
Please tell your doctor if you are taking or have recently taken any other medecines, including medicines obtained without a prescription, as some of them could have an interaction with Levviax.
Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta, ker lahko nekatera medsebojno delujejo z zdravilom Levviax.
10 film-coated tablets 14 film-coated tablets 20 film-coated tablets 100 film-coated tablets 5 x 2 film-coated tablets
10 filmsko obloženih tablet 14 filmsko obloženih tablet 20 filmsko obloženih tablet 100 filmsko obloženih tablet 5 x 2 filmsko obloženi tableti
The above serious side effects are uncommon (1 out of 1000 to less than 1 out of 100), rare (1 out of 10,000 to less than 1 out of 1000 patients) or very rare (less than 1/10,000 patients including isolated report), but may require urgent medical attention.
Zgoraj omenjeni resni neželeni učinki so občasni (1 od 1000 do manj kot 1 od 100), redki (1 od 10.000 do manj kot 1 od 1.000 bolnikov) ali zelo redki (manj kot 1/10.000 bolnikov vključno s posameznimi primeri), vendar utegnejo zahtevati nujno medicinsko pomoč.
If pseudomembranous colitis is suspected, the treatment must be stopped immediately and patients should be treated with supportive measures and/or specific therapy.
Če obstaja sum na psevdomembranski kolitis, je treba zdravljenje takoj prekiniti, bolnika pa zdraviti s podpornimi ukrepi in/ali specifično terapijo.
- Levviax tablets are not recommended for use in children and adolescents less than 12 years old.
- Uporaba tablet Levviax ni priporočljiva pri otrocih in mladostnikih pod 12 let.
This information provides only an approximate guidance on probabilities as to whether microorganisms will be susceptible to telithromycin.
Te informacije so le približno vodilo o verjetnosti za občutljivost mikroorganizmov za telitromicin.
Effect on oral and faecal flora
Učinek na oralno in fekalno floro
If you are pregnant do not take Levviax tablets as the safety of Levviax in pregnancy is insufficiently established.
Če ste noseči, ne jemljite tablet Levviax, ker varnost zdravila Levviax med nosečnostjo ni zadostno dokazana.
If you stop taking the tablets too soon you may also create a bacterial resistance to the medicine.
Če tablete nehate jemati prekmalu, lahko poleg tega povzročite razvoj odpornosti bakterij proti zdravilu.
Refer also to sections “Do not take Levviax”, “Taking other medicines” and “Driving and using machines”.
Glejte tudi poglavja "Ne jemljite zdravila Levviax", "Jemanje drugih zdravil" in "Vpliv na sposobnost upravljanja vozil in strojev".
Available as pack of 5 x 2 tablets.
Na voljo je pakiranje 5 x 2 tableti.
Levviax should not be used during pregnancy unless clearly necessary.
Zdravila Levviax ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
Intravenous dosage of midazolam should be adjusted as necessary and monitoring of the patient be undertaken.
Intravenski odmerek midazolama je treba prilagoditi, če je potrebno, bolnika pa nadzirati.
These symptoms may appear as early as after the first dose of Levviax.
Takšni simptomi se lahko pojavijo že po prvem odmerku zdravila Levviax.
Cerivastatin should be used with caution and patients should be carefully monitored for signs and symptoms of myopathy.
Cerivastatin je treba uporabljati previdno in bolnike skrbno nadzorovati, da bi odkrili znake in simptome miopatije.
Due to the potential for the prolongation of the QT interval and increased risk of arrhythmia, ECG monitoring must take place
Zaradi možnega podaljšanja intervala QT in večjega tveganja za aritmije je potreben nadzor z EKG.
Approximately one-third of telithromycin was eliminated unchanged; 20 % in faeces and 12 % in urine.
Približno ena tretjina telitromicina se je izločila nespremenjenega; 20% z blatom in 12% z urinom.
There are no adequate data from the use of Levviax in pregnant women.
Ni zadostnih podatkov o uporabi zdravila Levviax pri nosečnicah.
These hepatic reactions were observed during or immediately after treatment, and in most cases were reversible after discontinuation of telithromycin.
Te jetrne reakcije so opazili med ali takoj po zdravljenju in so bile večinoma reverzibilne po ukinitvi telitromicina.
Pharmacotherapeutic group: macrolides, lincosamides and streptogramins, ATC Code: J01FA15.
Farmakoterapevtska skupina: makrolidi, linkozamidi in streptogramini, oznaka ATC: J01FA15.
Development of in vitro resistance to telithromycin due to spontaneous mutation is rare.
Razvoj odpornosti proti telitromicinu in vitro zaradi spontane mutacije je redek.
Benzodiazepins
Benzodiazepini
- Signs and symptoms of hepatitis (liver disease) such as yellowing of skin and eyes, dark urine,
- Znaki in simptomi hepatitisa (bolezen jeter) kot so porumenelost kože in oči, temen urin,
Visual disturbances (<1%) associated with the use of Levviax, including blurred vision, difficulty focusing and diplopia, were mostly mild to moderate.
Motnje vida (< 1%), povezane z uporabo zdravila Levviax, vključno z nejasnim vidom, težavami pri fokusiranju in diplopijo, so bile večinoma blage do zmerne.
The pharmacokinetics of telithromycin in paediatric population less than 12 years old have not yet been studied.
Farmakokinetika telitromicina v skupini pediatričnih bolnikov do 12. leta starosti še ni raziskana.
In 2461 patients treated by Levviax in phase III clinical trials, the following undesirable effects possibly or probably related to telithromycin have been reported.
Pri 2461 bolnikih, zdravljenih z zdravilom Levviax v kliničnih preskušanjih III. faze, so bili opisani naslednji neželeni učinki, ki so morda ali verjetno povezani s telitromicinom in so navedeni spodaj.
This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics.
Morda gre za znak vnetja črevesa (psevdomembranski kolitis), ki se lahko pojavi po zdravljenju z antibiotiki.
Legionella pneumophila Moraxella catarrhalis* Other
Legionella pneumophila Moraxella catarrhalis*
Its principal circulating metabolite represents approximately 13 % of telithromycin AUC, and has little antimicrobial activity compared with the parent medicinal product.
Njegov glavni presnovek v obtoku predstavlja približno 13% AUC telitromicina in ima v primerjavi z matičnim zdravilom majhno protimikrobno delovanje.
- Acute sinusitis
- akutnega sinuzitisa.
Taking Levviax with food and drink Levviax may be taken with or without food.
Jemanje zdravila Levviax skupaj s hrano in pijačo Levviax lahko jemljete s hrano ali brez nje.
Levviax is used in adults and adolescents of 12 years and older to treat infections due to bacteria against which the medicine is active.
Levviax se uporablja pri odraslih in mladostnikih od 12. leta dalje za zdravljenje okužb z bakterijami, proti katerim to zdravilo deluje.
During post-marketing experience, liver failure has been reported (frequency unknown).
Med postmarketinškim obdobjem so poročali o odpovedi jeter (pogostnost ni znana).
WHAT LEVVIAX IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO LEVVIAX IN ZA KAJ GA UPORABLJAMO
-Gender The pharmacokinetics of telithromycin are similar between males and females.
-Spol Farmakokinetika telitromicina je podobna pri moških in ženskah.
$ natural intermediate susceptibility +Among MRSA the rate of MLSBc resistant strains is more than 80%, telithromycin is not active against MLSBc.
$ naravna intermediarna občutljivost+ Med MRSA je delež MLSBc odpornih sevov več kot 80 %, telitromicin ni aktiven proti MLSBc.
The majority of MRSA are resistant to erythromycin A by a constitutive MLSB mechanism.
Večina MRSA je odpornih proti eritromicinu A zaradi konstitutivnega mehanizma MLSB.
- if you or someone in your family are known to have an abnormality of electrocardiogram (ECG) called “long QT syndrome”.
- če imate vi ali kdo v vaši družini na elektrokardiogramu (EKG) nepravilnost, imenovano "sindrom podaljšanega intervala QT".
The same precautions should also apply to the other benzodiazepins which are metabolized by CYP3A4, (especially triazolam but also to a lesser extent alprazolam).
Ista opozorila je treba upoštevati pri drugih benzodiazepinih, ki se presnavljajo s CYP3A4 (zlasti pri triazolamu, v manjši meri pa tudi pri alprazolamu).
In similarity to some macrolides, telithromycin caused a prolongation of Qtc interval in dogs and on action potential duration in rabbit Purkinje fibers in vitro.
Podobno kot nekateri makrolidi je telitromicin povzročil podaljšanje QTc intervala pri psih ter trajanje akcijskega potenciala v kunčjih Purkinjevih vlaknih in vitro.
Hypokalaemia and quinidine had additive/supra-additive effects in vitro while potentiation was evident with sotalol.
Hipokaliemija in kinidin sta imela in vitro aditivne/supraaditivne učinke, pri sotalolu pa je bila opazna potenciacija.
In a comparative study in healthy human volunteers, telithromycin 800 mg daily and clarithromycin 500 mg twice daily for 10 days showed a similar and reversible reduction of oral and faecal flora.
V primerjalni raziskavi pri zdravih prostovoljcih sta telitromicin 800 mg na dan in klaritromicin 500 mg dvakrat na dan 10 dni povzročila podobno in reverzibilno zmanjšanje oralne in fekalne flore.
These events have not been associated with signs of ocular abnormality (see sections 4.4 and 4.7).
Ti dogodki niso bili povezni z znaki abnormalnosti na očeh (glejte poglavji 4.4 in 4.7).
Telithromycin interferes with the ribosome translation at the 23S ribosomal RNA level, where it interacts with domain V and II.
Telitromicin ovira ribosomsko translacijo na ravni 23S ribosomske RNA, kjer interagira z območjema V in II.
Hence, Levviax should be used with caution (see also section 4.4 and 5.2).
Zato je treba zdravilo Levviax uporabljati previdno (glejte tudi poglavje 4.4 in 5.2).
itching, loss of appetite or abdominal pain.
srbenje, izguba apetita ali bolečine v trebuhu.
The recommended MIC breakpoints for telithromycin, separating susceptible organisms from intermediately susceptible organisms and intermediately susceptible organisms from resistant organisms, are: susceptible ≤0.5 mg/l, resistant >2mg/l.
Priporočeni mejni vrednosti MIK za telitromicin, ki ločita občutljive organizme od srednje občutljivih ter srednje občutljive od odpornih, sta: občutljivi ≤ 0,5 mg/l, odporni > 2 mg/l.
When prescribing Levviax, consideration should be given to official guidance on the appropriate use of antibacterial agents and the local prevalence of resistance (see also sections 4.4 and 5.1).
Pri predpisovanju zdravila Levviax je treba upoštevati uradne smernice za ustrezno uporabo protibakterijskih zdravil in podatke o lokalni prevalenci odpornosti (glejte tudi poglavji 4.4 in 5.1).
Ranitidine (taken 1 hour before Levviax) and antacid containing aluminium and magnesium hydroxide has no clinically relevant influence on telithromycin pharmacokinetics.
Ranitidin (zaužit 1 uro pred zdravilom Levviax) ali antacid z aluminijevim in magnezijevim hidroksidom nima klinično pomembnega vpliva na farmakokinetiko telitromicina.
Furthermore, telithromycin is able to block the formation of the 50S and 30S ribosomal subunits.
Poleg tega lahko telitromicin zavira nastajanje ribosomskih podenot 50S in 30S.
Levviax belongs to one of a group of medicines called ketolides, a new class of antibiotics related to macrolides.
Levviax spada v skupino zdravil, imenovanih ketolidi, nov razred antibiotikov, sorodnih makrolidom.
For Streptococcus pneumoniae, there is no cross- or co-resistance between telithromycin and other antibacterial classes including erythromycin A and/or penicillin resistance.
Pri Streptococcus pneumoniae ni navzkrižne odpornosti ali soodpornosti med telitromicinom in drugimi skupinami protibakterijskih zdravil, vključno z eritromicinsko A in/ali penicilinsko rezistenco.
- Severe, persistent or bloody diarrhoea associated with abdominal pain or fever, which can be a sign of serious bowel inflammation which may occur very rarely following treatment with antibiotics.
- Huda, trdovratna ali krvava driska, ki jo spremljajo bolečine v trebuhu ali zvišana telesna temperatura; lahko gre za znak resnega vnetja črevesa, ki se zelo redko pojavi po zdravljenju z antibiotiki.
The absolute bioavailability is about 57 % after a single dose of 800 mg.
Absolutna biološka uporabnost po enem 800 mg odmerku je približno 57%.
Telithromycin inhibits protein synthesis by acting at the ribosome level.
Telitromicin zavira sintezo beljakovin z delovanjem na ribosomski ravni.
- if you are allergic (hypersensitive) to telithromycin, to any of the macrolide antibiotics or to any of the other ingredients of Levviax.
- če ste alergični na (preobčutljivi za) telitromicin, katerikoli makrolidni antibiotik ali katerokoli drugo sestavino zdravila Levviax.
Although Levviax has no clinically relevant pharmacokinetic or pharmacodynamic interaction with warfarin after single dose administration, more frequent monitoring of prothrombin time/INR (International Normalised Ratio) values should be considered during concomitant treatment.
Čeprav po uporabi enega odmerka Levviax nima klinično pomembnih farmakokinetičnih ali farmakodinamičnih interakcij z varfarinom, je potrebno razmisliti o pogostejšem nadziranju protrombinskega časa/INR (»International Normalised Ratio«) med sočasnim zdravljenjem.
Refer also to section “Do not take Levviax”.
Glejte tudi poglavje "Ne jemljite zdravila Levviax".