natgillin/translations-raw huggingface dataset:
This helps Levetiracetam Accord to stabilise electrical activity in the brain and prevent seizures.
To omogoča zdravilu Levetiracetam Accord, da stabilizira električno aktivnost v možganih in prepreči napade.
For more information about treatment with Levetiracetam Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Levetiracetam Accord preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
• partial-onset seizures with or without generalisation in patients from 1 month of age;
• parcialnih napadov z generalizacijo ali brez nje pri bolnikih, starejših od enega meseca;
Patients who cannot take tablets should be given a solution containing levetiracetam.
Bolniki, ki ne morejo jemati tablet, morajo prejemati raztopino z levetiracetamom.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Levetiracetam Accord have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Levetiracetam Accord, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
This is a summary of the European public assessment report (EPAR) for Levetiracetam Accord.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Levetiracetam Accord.
What are the benefits and risks of Levetiracetam Accord?
Kakšne so koristi in tveganja, povezani z zdravilom Levetiracetam Accord?
• myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;
• miokloničnih napadov (kratkih, krču podobnih sunkovitih gibov mišice ali skupine mišic) pri bolnikih z juvenilno mioklonično epilepsijo od 12. leta starosti dalje;
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 Levetiracetam Accord.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Levetiracetam Accord, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
• primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to be inherited).
• primarno generaliziranih tonično-kloničnih napadov (daljših napadov, vključno z izgubo zavesti) pri bolnikih od 12. leta starosti dalje z idiopatsko generalizirano epilepsijo (vrsto epilepsije, za katero se domneva, da je genetskega izvora).
Because Levetiracetam Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Levetiracetam Accord generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
Levetiracetam Accord can also be used as an add-on to other epilepsy medicines to treat:
Zdravilo Levetiracetam Accord se lahko uporablja kot dodatek drugim zdravilom proti epilepsiji za zdravljenje:
Levetiracetam Accord can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation.
Zdravilo Levetiracetam Accord se lahko uporablja kot samostojno zdravilo pri bolnikih, starejših od 16 let, ki imajo na novo diagnosticirano epilepsijo, za zdravljenje parcialnih napadov s sekundarno generalizacijo ali brez nje.
When Levetiracetam Accord is added to another epilepsy treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Kadar se zdravilo Levetiracetam Accord dodaja drugemu zdravilu proti epilepsiji, je začetni odmerek pri bolnikih, starejših od 12 let, ki tehtajo več kot 50 kg, 500 mg dvakrat dnevno.
Other information about Levetiracetam Accord
Druge informacije o zdravilu Levetiracetam Accord
Therefore, the CHMP's view was that, as for Keppra, the benefit outweighs the identified risk.
Zato je CHMP menil, da njegove koristi enako kot pri zdravilu Keppra odtehtajo znana tveganja.
Because Levetiracetam Accord is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Keppra.
Ker je zdravilo Levetiracetam Accord generično zdravilo, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Keppra.
The Committee recommended that Levetiracetam Accord be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Levetiracetam Accord izda dovoljenje za promet.
The CHMP concluded that, in accordance with EU requirements, Levetiracetam Accord has been shown to have comparable quality and to be bioequivalent to Keppra.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Levetiracetam Accord primerljivo raven kakovosti kot referenčno zdravilo Keppra ter da mu je biološko enakovredno.
Levetiracetam Accord tablets are swallowed with liquid.
Tablete Levetiracetam Accord je treba pogoltniti s tekočino.
Levetiracetam Accord is a medicine that contains the active substance levetiracetam.
Levetiracetam Accord je zdravilo, ki vsebuje zdravilno učinkovino levetiracetam.
Levetiracetam Accord is a ‘generic medicine'.
Zdravilo Levetiracetam Accord je „generično zdravilo“.
The active substance in Levetiracetam Accord, levetiracetam, is an epilepsy medicine.
Zdravilna učinkovina zdravila Levetiracetam Accord, levetiracetam, je zdravilo za zdravljenje epilepsije.
When Levetiracetam Accord is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Kadar se zdravilo Levetiracetam Accord uporablja kot samostojno zdravilo, je začetni odmerek 250 mg dvakrat na dan, ki se dva tedna pozneje poveča na 500 mg dvakrat na dan. Odmerki se lahko glede na bolnikov odziv še naprej povečujejo v dvotedenskih razmakih do največjega odmerka 1 500 mg dvakrat dnevno.
Why has Levetiracetam Accord been approved?
Zakaj je bilo zdravilo Levetiracetam Accord odobreno?
How has Levetiracetam Accord been studied?
Kako je bilo zdravilo Levetiracetam Accord raziskano?
How is Levetiracetam Accord used?
Kako se zdravilo Levetiracetam Accord uporablja?
What is Levetiracetam Accord used for?
Za kaj se zdravilo Levetiracetam Accord uporablja?
What is Levetiracetam Accord?
Kaj je zdravilo Levetiracetam Accord?
The teratological importance of these findings is unclear.
Teratološki pomen teh ugotovitev ni jasen.
Key efficacy results are presented in Table 4.
Ključni rezultati učinkovitosti so predstavljeni v preglednici 4.
Your doctor may have to adjust your dose.
Zdravnik bo odmerek pri vas mogoče moral prilagoditi.
10 to 29
10 do 29
*Absolute GFR not adjusted for body surface area
* Absolutna GFR, ki ni prilagojena na površino telesa
30 to 49
30 do 49
Chemical and physical in-use stability has been demonstrated for 72 hours at 5 ºC and 25 ºC.
Kemična in fizikalna stabilnost med uporabo je bila dokazana za 72 ur pri 5 ºC in 25 ºC.
Not known, frequency cannot be estimated from the available data
Neznana pogostnost, pogostnosti ni mogoče oceniti iz razpoložljivih podatkov
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1269/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1269/001
CI = Confidence Interval
IZ = interval zaupanja
Uncomplicated influenza in adults
Nezapletena influenca pri odraslih
Adults and adolescents (13 years and older)
Odrasli in mladostniki (13 let ali več)
This leaflet was last revised in {MM/YYYY}.
Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}>.
These medicines prevent the influenza virus from spreading inside the body.
Ta zdravila preprečujejo širjenje virusa gripe v telesu.
Treatment of an overdose should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Zdravljenje pri prevelikem odmerjanju zajema podporne ukrepe, vključno s spremljanjem vitalnih znakov in opazovanjem kliničnega stanja bolnika.
E-mail: safety@biocryst.com
E-naslov: safety@biocryst.com
%CV SD = Standard Deviation; CV = Coefficient of Variation
% CV SD = standardni odklon; CV = koeficient variacije
It must be colourless and without particulate matter.
Biti mora brezbarven in brez delcev.
Tell your doctor if you are pregnant or breast-feeding.
Povejte zdravniku, če ste noseči ali dojite.
The safety and efficacy of peramivir in children aged under 2 years has not yet been established.
Varnost in učinkovitost peramivira pri otrocih, mlajših od dveh let, še nista dokazani.
4.7 Effects on ability to drive and use machines Peramivir has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Peramivir nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Based on a population pharmacokinetic analysis, the central volume of distribution was 12.56 L.
Glede na populacijsko farmakokinetično analizo je bil centralni porazdelitveni volumen 12,56 l.
Do not use if the seal opening is broken or missing.
Ne uporabljajte, če je odprtina zamaška poškodovana ali manjka.
Available data do not support a conclusion that peramivir is effective in patients with influenza B or in patients with complicated influenza.
Razpoložljivi podatki ne podpirajo zaključka, da je peramivir učinkovit pri bolnikih z influenco B ali pri bolnikih z zapleteno influenco.
Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000).
Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
• Patients with reduced kidney function may require a reduced dose.
• Bolniki z okvaro delovanja ledvic morda potrebujejo manjši odmerek.
(3 vials with 20 mL each).
(3 viale, vsaka z 20 ml).
See section 4.8 for how to report adverse reactions.
Glejte poglavje 4.8., kako poročati o neželenih učinkih.
• low levels of a white blood cell type called neutrophils
• nizko število vrste belih krvnih celic, imenovane nevtrofilci
There is no specific antidote to treat an overdose of this medicine.
Za zdravljenje pri prevelikem odmerjanju tega zdravila ni specifičnega antidota.
The mean temperature at enrolment was 38.6 °C (axillary).
Povprečna telesna temperatura ob vključitvi je bila 38,6 °C (aksilarno).
Other side effects occur with the following frequencies:
Neželeni učinki se lahko pojavijo z naslednjo pogostnostjo:
The contribution of peramivir to these events has not been established.
Prispevek peramivira k tem dogodkom ni dokazan.
Renal clearance of unchanged peramivir accounts for approximately 90 % of total clearance.
Ledvični očistek nespremenjenega peramivira predstavlja približno 90 % vsega očistka.
Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza.
Resne bakterijske okužbe se lahko začnejo z influenci podobnimi simptomi ali pa soobstajajo ali se pojavijo kot zapleti pri poteku influence.
Check the seal of each vial.
Preverite zamašek vsake viale.
Children and Adolescents from 2 years Side effects were similar to adults but also included the following: Common, may affect up to 1 in 10 people
Otroci in mladostniki, starejši od dveh let Neželeni učinki so bili podobni kot pri odraslih, vendar so vključevali tudi naslednje: Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov
In general, nephrotoxicity was observed in rabbits, no unexpected toxicity was observed, and no other target organ toxicity was identified in juvenile animals.
V splošnem je bila pri kuncih opažena nefrotoksičnost, opažena ni bila nobena nepričakovana toksičnost, pri mladih živalih pa ni bila ugotovljena druga toksičnost za ciljne organe.
Table 4: Key efficacy results from study 0722T0621 (ITTI Population) Peramivir 600 mg n=97
Preglednica 4: Ključni rezultati učinkovitosti iz študije 0722T0621 (populacija ITTI) Peramivir, 600 mg n = 97
• if you are allergic to peramivir or any of the other ingredients of this medicine (listed in section
• če ste alergični na peramivir ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
• Check the seal of each vial.
• Preverite zamašek vsake viale.
Haemodialysis initiated at 2 hours after dosing reduced systemic exposure of peramivir by 73 to 81 %.
Hemodializa, začeta po dveh urah po odmerjanju, je sistemsko izpostavljenost peramiviru zmanjšala za 73 do 81 %.
Symptoms may include confusion, difficulty thinking or hallucinations.
Simptomi lahko vključujejo zmedenost, težave z mišljenjem ali halucinacije.
Each carton contains 3 vials.
Ena škatla vsebuje 3 viale.
It allows continued monitoring of the benefit/risk balance of the medicinal product.
Omogoča namreč stalno spremljanje razmerja med tveganjem in koristjo zdravila.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from peramivir therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja s peramivirom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
There is no evidence for efficacy of peramivir in any illness caused by agents other than influenza viruses.
Ni dokazov o učinkovitosti peramivira pri kateri koli bolezni, ki jo povzročajo drugi povzročitelji kot virusi influence.
Pharmacokinetic sampling in this study was limited to approximately 3 hours after administration of peramivir.
Farmakokinetično vzorčenje v tej študiji je bilo omejeno na približno tri ure po dajanju peramivira.
This is equivalent to 10.6 % of the recommended maximum daily dietary intake of sodium for an adult.
To je enako 10,6 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
Serum creatinine measurements were used to calculate creatinine clearance (Cockcroft-Gault equation).
Očistek kreatinina je bil izračunan na podlagi meritev serumskega kreatinina (Cockcroft-Gaultova enačba).
Adverse Reaction According to Frequency*
Neželeni učinek po pogostnosti*
In-vitro activity
Aktivnost in vitro
Resistance to peramivir
Odpornost proti peramiviru
N Cmax (ng/mL)
N Cmaks (ng/ml)
Patients with influenza and already existing diseases should be closely monitored for renal function.
Pri bolnikih z influenco in že obstoječimi boleznimi je treba natančno spremljati delovanje ledvic.
The ITTI population included 84 subjects with influenza confirmed by PCR.
Populacija ITTI je vključevala 84 preiskovancev z influenco, potrjeno s PCR.
As a precautionary measure, it is preferable to avoid the use of peramivir during pregnancy.
Iz previdnostnih razlogov se je med nosečnostjo uporabi peramivira bolje izogibati.
What Alpivab is and what it is used for 2.
Kaj je zdravilo Alpivab in za kaj ga uporabljamo 2.
The European Medicines Agency has deferred the obligation to submit the results of studies with Alpivab in one or more subsets of the paediatric population for the treatment of influenza (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Alpivab za eno ali več podskupin pediatrične populacije pri zdravljenju influence (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The recommended 600 mg single intravenous dose resulted in shortening of the median time to alleviation of symptoms by 21 hours (see section 5.1).
Priporočeni enkratni intravenski odmerek 600 mg je skrajšal srednji čas do ublažitve simptomov za 21 ur (glejte poglavje 5.1).
• The active substance is peramivir.
• Učinkovina je peramivir.
The efficacy of peramivir as a single dose treatment for uncomplicated influenza was demonstrated in a single placebo-controlled study conducted in 300 adult patients in Japan during the 2007/2008 influenza season.
Učinkovitost peramivira kot zdravila z enkratnim odmerkom pri nezapleteni influenci je bila dokazana v eni s placebom nadzorovani študiji, izvedeni na 300 odraslih bolnikih na Japonskem v sezoni influence 2007/2008.
Crossresistance between peramivir and each of oseltamivir and zanamivir may also occur.
Pojavi se lahko tudi navzkrižna odpornost med peramivirom in oseltamivirom ali zanamivirom.
If any hypersensitivity reaction occurs during infusion of peramivir, the infusion must be stopped immediately and appropriate management should be instituted.
Če se med infundiranjem peramivira pojavi katera koli preobčutljivostna reakcija, je treba infundiranje takoj prekiniti in uvesti ustrezno zdravljenje.
• abnormal behaviour, delirium
• nenormalno vedenje, delirij
Alpivab is used to treat adults and children aged from 2 years with influenza that is not severe enough to require hospitalisation.
Zdravilo Alpivab se uporablja za zdravljenje odraslih in otrok, starejših od dveh let, z gripo, ki ni tako huda, da bi bilo potrebno bolnišnično zdravljenje.
Peramivir is an inhibitor of influenza virus neuraminidase, an enzyme that releases viral particles from the plasma membrane of infected cells and is also important for viral entry into uninfected cells, which causes further spread of infectious virus in the body.
Peramivir je zaviralec nevraminidaze virusov influence, encima, ki s celične membrane okuženih celic sprošča virusne delce in je pomemben tudi za vstop virusov v neokužene celice, kar povzroči nadaljnje širjenje kužnega virusa v telesu.
Table 5: Pharmacokinetic parameters in paediatric subjects
Preglednica 5: Farmakokinetični parametri pri pediatričnih preiskovancih
Efficacy (time to resolution of fever; time to resolution of influenza symptoms, viral shedding, virus susceptibility) was a secondary endpoint.
Učinkovitost (čas do prenehanja vročine, čas do prenehanja simptomov influence, izločanje virusa, občutljivost virusa) je bil sekundarni cilj študije.
The recommended single intravenous dose of peramivir depends on age and body weight as shown in Table 1.
Priporočeni enkratni intravenski odmerek peramivira je odvisen od starosti in telesne mase, kot je prikazano v preglednici 1.
• prolonged time of the heart ventricle activity, measured in the ECG
• podaljšan čas dejavnosti srčnih prekatov, izmerjen z EKG
What you need to know before you are given Alpivab 3.
Kaj morate vedeti, preden boste prejeli zdravilo Alpivab 3.
Patients with influenza should be closely monitored for signs of abnormal behaviour.
Bolnike z influenco je treba natančno spremljati zaradi pojava znakov nenormalnega vedenja.
Subjects participating in the trial were required to self-assess their influenza symptoms as “none', ‘mild', ‘moderate' or ‘severe' twice daily.
Od preiskovancev, ki so sodelovali v preskušanju, se je zahtevalo, da dvakrat na dan sami ocenijo svoje simptome influence kot „brez“, „blagi“, „zmerni“ ali „hudi“.
From a microbiological point of view, the product, once diluted, should be used immediately.
Z mikrobiološkega vidika je treba zdravilo po redčenju uporabiti takoj.
The major route of elimination of peramivir is via the kidney.
Glavna pot izločanja peramivira je skozi ledvice.
• increased level of urine ketone body
• zvišana raven ketonskih teles v urinu
Serious hypersensitivity reactions
Resne preobčutljivostne reakcije
Two-week oral toxicity studies were conducted in juvenile rats and rabbits, and a four-week IV toxicity study was conducted in juvenile rats.
Opravljene so bile dvotedenske študije peroralne toksičnosti na mladih podganah in kuncih ter štiritedenska študija intravenske toksičnosti na mladih podganah.
There are no or limited amount of data (less than 300 pregnancies outcomes) from the use of peramivir in pregnant women.
Podatkov o uporabi peramivira pri nosečnicah ni ali pa so omejeni (manj kot 300 izidov nosečnosti).
The H275Y substitution is associated with reduced susceptibility to peramivir and oseltamivir.
Substitucija H275Y je povezana z zmanjšano občutljivostjo na peramivir in oseltamivir.
Your doctor will advise on whether you can be given Alpivab during pregnancy, or whether you are to stop breast-feeding for a short period after getting Alpivab.
Zdravnik vam bo svetoval, ali lahko v nosečnosti prejmete zdravilo Alpivab oziroma ali morate po prejemu zdravila Alpivab za kratek čas prenehati dojiti.
Table 1: Peramivir dose based on age and body weight Age and body weight
Preglednica 1: Odmerek peramivira glede na starost in telesno maso Starost in telesna masa
Other medicines and Alpivab
Druga zdravila in zdravilo Alpivab
AUClast (ng•h/mL)
AUCzadnji (ng•h/ml)
Carcinogenicity studies by intravenous injection of peramivir were not performed.
Študije kancerogenosti intravensko injiciranega peramivira niso bile opravljene.
Time to recovery of normal temperature median (hours) (95 % CI)
Čas do vrnitve normalne temperature mediana (v urah) (95-odstotni IZ)
Recommended single dose
Priporočeni enkratni odmerek
In-vitro binding of peramivir to human plasma proteins is less than 30 %.
In vitro je na humane plazemske beljakovine vezanega manj kot 30 odstotkov peramivira.
Table 3: Adverse reactions in studies investigating peramivir for treatment of uncomplicated influenza in adults
Preglednica 3: Neželeni učinki v študijah, v katerih so proučevali peramivir za zdravljenje nezapletene influence pri odraslih
In paediatric subjects (age 2 to 17 years) with uncomplicated influenza enrolled in a clinical trial, the safety profile of peramivir was similar to that reported in adults.
Pri pediatričnih preiskovancih (starih od 2 do 17 let) z nezapleteno influenco, ki so bili vključeni v klinično preskušanje, je bil varnostni profil peramivira podoben kot tisti, o katerem so poročali pri odraslih.
Pharmacotherapeutic group: Antivirals for systemic use, neuraminidase inhibitors ATC code: J05AH03
Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, zaviralci nevraminidaze, oznaka ATC: J05AH03
There is no preservative or antibacterial agent in the solution.
V raztopini ni konzervansa ali protibakterijskega sredstva.
Peramivir has not been shown to prevent such complications.
Ni dokazov, da bi peramivir preprečeval tovrstne zaplete.
The intent to treat influenza population (ITTI) included 296 subjects with influenza confirmed by polymerase chain reaction (PCR).
Populacija z influenco z namenom zdravljenja (ITTI-intent to treat influenza population) je vključevala 296 oseb z influenco, potrjeno z verižno reakcijo s polimerazo (PCR).
The pharmacokinetic parameters following intravenous (IV) administration of peramivir (0.17 to 2 times the recommended dose) showed a linear relationship between dose and exposure parameters (maximum serum concentration [Cmax] and area under the curve [AUC]).
Farmakokinetični parametri po intravenskem dajanju peramivira (0,17- do 2-kratnik priporočenega odmerka) so pokazali linearno razmerje med odmerkom in parametri izpostavljenosti (največja serumska koncentracija [Cmaks] in površina pod krivuljo [AUC]).
• severe allergic reactions, including severe allergic shock reaction with features such as itchy rash, swelling of the throat and tongue, breathing difficulty, lightheadedness and vomiting
• hude alergijske reakcije, vključno s hudo alergijsko šokovno reakcijo s simptomi, kot so srbeč izpuščaj, otekanje žrela in jezika, oteženo dihanje, omotica in bruhanje
Most of the cases occurred in elderly patients with comorbidities and multiple concomitant medicinal products.
Ti primeri so se večinoma pojavili pri starejših bolnikih s sočasnimi boleznimi in več sočasnimi zdravili.
Rare, may affect up to 1 in 1,000 people • severe skin rash with or without blisters and fever
Redki, pojavijo se lahko pri največ 1 od 1.000 bolnikov • hud kožni izpuščaj z mehurji in vročino ali brez njih