natgillin/translations-raw huggingface dataset:
The CHMP noted the MAH proposal for an harmonised text for this section.
Odbor CHMP je preučil predlog imetnika dovoljenja za promet z zdravilom za usklajeno besedilo tega poglavja.
Three pivotal studies supported this indication, granted in the EU since 1997.
To indikacijo, ki je v EU odobrena od leta 1997, so podprle tri ključne študije.
Therefore, the recommended dose for AECB and for cSSTIs were amended accordingly i.e. 250 mg once daily is deleted.
Zato sta bila priporočena odmerka za AEKB in zapletene okužbe kože in mehkih tkiv ustrezno prilagojena, tako da je bil odmerek 250 mg enkrat dnevno izbrisan.
The CHMP noted the MAH proposal for this section and further agreed on a number of revisions.
Odbor CHMP je proučil predlog imetnika dovoljenja za promet z zdravilom za to poglavje in se strinjal s številnimi spremembami.
This indication is approved for levofloxacin tablets in all MS identified above via nationally or mutual recognition procedure (MRP) with exception of one MS.
Ta indikacija je odobrena za tablete levofloksacina v vseh državah članicah, ki so navedene zgoraj, z nacionalnim postopkom ali postopkom z medsebojnim priznavanjem, razen v eni državi članici.
Therefore a specific warning for the pattern of resistance to fluoroquinolones resistance to E. coli is included in section 4.4 of the SmPC.
Zato je v poglavje 4.4 povzetka glavnih značilnosti zdravila vključeno posebno opozorilo na vzorec odpornosti E. coli proti fluorokinolonom.
• ABS (tablets only): 500 mg once daily for 10-14 days of treatment;
• ABS (samo tablete): 500 mg enkrat dnevno za 10-14 dni zdravljenja;
In this regard, it is noted that the 500 mg dosage given once daily by oral route allow to reach a plasmatic peak concentration (Cmax) as of 5 to 6 mg/l and a Cmax/MIC ratio of 10-12 and an AUC of approximately 50 mg.h/l corresponding to an AUC/MIC ratio as of 50-100.
5 do 6 mg/l in razmerja Cmaks./MIK 10-12 ter vrednosti AUC približno 50 mg.h/l, kar ustreza razmerju AUC/MIK 50-100.
The MAH voluntarily withdrew the marketing authorisation (MA) for the 750 mg film coated tablets and varied the terms of the MAs for the solution for infusion to remove the 150 ml presentation during this referral procedure.
Imetnik dovoljenja za promet z zdravilom je v času tega napotitvenega postopka prostovoljno umaknil dovoljenje za filmsko obložene tablete 750 mg in spremenil pogoje dovoljenja za promet z zdravilom za raztopino za infundiranje, tako da je umaknil pakiranje 150 ml.
Five additional studies since then have been performed by the MAH.
Od tedaj je imetnik dovoljenja za promet izvedel še pet dodatnih študij.
All MRP SmPCs list “Acute bacterial sinusitis” in the indication section and also specified “(adequately diagnosed according to national and/or local guidelines on the treatment of respiratory tract infections)”.
Vsi povzetki glavnih značilnosti zdravila v postopku z medsebojnim priznavanjem navajajo „akutni bakterijski sinusitis“ v poglavju z indikacijami in specifično „(ustrezno diagnosticiran v skladu z nacionalnimi in/ali lokalnimi smernicami za zdravljenje okužb dihal)“.
Acute exacerbation of chronic bronchitis (AECB)
Akutna eksacerbacija kroničnega bronhitisa (AEKB)
The evidence was provided by the MAH including a cumulative review of all fatal cases due to hepatibilary disorders.
Dokaze je predložil imetnik dovoljenja za promet z zdravilom, vključno s kumulativnim pregledom vseh smrtnih primerov zaradi bolezni jeter, žolčnika in žolčevodov.
In addition the warning section of the SmPC now refers to the co-resistance of the fluroquinolones including levofloxacin to MRSA.
Poleg tega poglavje z opozorili v povzetku glavnih značilnosti zdravila zdaj navaja soodpornost MRSA proti fluorokinolonom, vključno z levofloksacinom.
Skin and Soft Tissue Infections (SSTIs)
Okužbe kože in mehkih tkiv (OKMT)
• Benign intracranial hypertension, in line with recent labelling changes made in the US in April 2012 for levofloxacin; These cases should be kept under closely monitoring and further discussed in future PSURs.
• benigna intrakranialna hipertenzija, v skladu z nedavnimi spremembami označevanja za levofloksacin v ZDA aprila 2012.
In addition, this section of the SmpC was updated to reflect the core safety profile agreed in April 2011 as an outcome of the PSUR worksharing procedure.
Poleg tega je bilo to poglavje povzetka glavnih značilnosti zdravila posodobljeno tako, da odraža osnovni varnostni profil, ki je bil sprejet aprila 2011 kot izid projekta z deljenim delom PSUR (z zadnjimi podatki dopolnjeno redno poročilo o varnosti zdravila).
Community-acquired pneumonia in patients with additional risk factors or requiring hospitalization, or in case of known or suspected bacterial resistance to commonly used classes of anti-infectives (according to history of patients or national and /or regional resistance data), or if previous antiinfective treatment has failed.
Zunajbolnišnična pljučnica pri bolnikih z dodatnimi dejavniki tveganja ali pri bolnikih, ki potrebujejo hospitalizacijo, ali v primeru znane ali domnevne odpornosti bakterij na običajno uporabljene razrede protivnetnih zdravil (v skladu z anamnezo bolnikov ali nacionalnimi in/ali regijskimi podatki o odpornosti) ali če je bilo predhodno protivnetno zdravljenje neuspešno.
Based on the current available data, considering the current treatment guidelines and also taking into account the current SmPC wording for other fluororoquinolon products with regards this indication, the MAH proposed the following restricted wording:
Na podlagi trenutno razpoložljivih podatkov in ob upoštevanju trenutnih smernic za zdravljenje ter trenutnega besedila glavnih značilnosti zdravila za druga zdravila s fluorokinoloni v zvezi s to indikacijo je imetnik dovoljenja za promet z zdravilom predlagal naslednje omejeno besedilo:
Levofloxacin is approved in the most three common RTIs indications: acute bacterial sinusitis (ABS), acute exacerbation of chronic bronchitis (AECB) and community-acquired pneumonia (CAP).
Levofloksacin je odobren za tri najpogostejše indikacije pri okužbah dihal: akutni bakterijski sinusitis (ABS), akutno eksacerbacijo kroničnega bronhitisa (AEKB) in zunajbolnišnično pljučnico (ZBP).
• Pyelonephritis and complicated urinary tract infections (see section 4.4)
• pielonefritis in zapletene okužbe sečil (glejte poglavje 4.4)
• Uncomplicated cystitis (tablets only): 250 mg once daily for 3 days;
• nezapleteni cistitis (samo tablete): 250 mg enkrat dnevno za 3 dni;
The Core Safety Profile (CSP) approved as an outcome of the PSUR work-sharing procedure finalised on 1 April 2011 was considered.
Upoštevali so osnovni varnostni profil (CSP), ki je bil odobren 1. aprila 2011 kot izid projekta z deljenim delom PSUR (z zadnjimi podatki dopolnjeno redno poročilo o varnosti zdravila).
Acute bacterial sinusitis (adequately diagnosed according to national and/or local guidelines on the treatment of respiratory tract infections) in severe cases at risk of complications (such as frontal, sphenoidal, ethmoidal or pansinusitis), or in case of known or suspected bacterial resistance to commonly used classes of anti-infectives (according to history of patients or national and /or regional resistance data), or if previous anti-infective treatment has failed.
Akutni bakterijski sinusitis (ustrezno diagnosticiran v skladu z nacionalnimi in/ali lokalnimi smernicami za zdravljenje okužb dihal) v hudih primerih s tveganjem za zaplete (kot so čelni, sfenoidalni, etmoidni ali pansinusitis), v primeru znane ali domnevne odpornosti bakterij proti običajno uporabljenim razredom protivnetnih zdravil (v skladu z anamnezo bolnikov ali nacionalnimi in/ali regijskimi podatki o odpornosti) ali če je bilo predhodno protivnetno zdravljenje neuspešno.
This indication was only approved in one MS for both tablets (for post-exposure prophylaxis and curative treatment of anthrax) and IV solution (for the curative treatment) since 2001 in accordance with national recommendations.
Ta indikacija je odobrena samo v eni državi članici za tablete (za profilakso po izpostavitvi in za kurativno zdravljenje vraničnega prisada) in za i.v.
Complicated urinary tract infections (cUTIs) including pyelonephritis (PN)
Zapletene okužbe sečil, vključno s pielonefritisom
The CSP was considered when harmonising the listed adverse reactions between national SmPCs of Tavanic.
Pri usklajevanju neželenih učinkov med nacionalnimi povzetki glavnih značilnosti zdravila Tavanic je bil upoštevan osnovni varnostni profil (CSP).
Following all the changes in the SPC there are several corresponding changes to the Package Leaflet.
Po spremembah povzetka glavnih značilnosti zdravila so več ustreznih sprememb vnesli še v navodilo za uporabo.
• Inhalation Anthrax: postexposure prophylaxis and curative treatment (see section 4.4).
• inhalacijski vranični prisad: profilaksa po izpostavitvi in kurativno zdravljenje (glejte poglavje 4.4)
In this harmonisation procedure the MAH claimed for RTIs indications (restricted), SSTIs, complicated and uncomplicated UTIs, chronic bacterial prostatitis and anthrax treatment.
V tem postopku usklajevanja imetnik dovoljenja za promet uveljavlja indikacije za zdravljenje okužb dihal (z omejitvami), okužb kože in mehkih tkiv, zapletenih in nezapletenih okužb sečil, kroničnega bakterijskega prostatitisa in vraničnega prisada.
Acute bacterial exacerbations of chronic bronchitis (adequately diagnosed according to national and/or local guidelines on the treatment of respiratory tract infections) in patients with severe underlying COPD and/or other risk factors, or in case of known or suspected bacterial resistance to commonly used classes of anti-infectives (according to history of patients or national and /or regional resistance data), or if previous anti-infective treatment has failed.
Akutne bakterijske eksacerbacije kroničnega bronhitisa (ustrezno diagnosticirane v skladu z nacionalnimi in/ali lokalnimi smernicami za zdravljenje okužb dihal) pri bolnikih s hudo izhodiščno KOPB in/ali drugimi dejavniki tveganja, v primeru znane ali domnevne odpornosti bakterij na običajno uporabljene razrede protivnetnih zdravil (v skladu z anamnezo bolnikov ali nacionalnimi in/ali regijskimi podatki o odpornosti) ali če je bilo predhodno protivnetno zdravljenje neuspešno.
Therefore, levofloxacin is active against a diverse range of common causative pathogens for sinusitis, acute exacerbation of chronic bronchitis (AECB), community-acquired pneumonia (CAP), urinary tract infections (UTIs) and skin and soft tissue infections (SSTIs).
Levofloksacin tako deluje proti številnim pogostim patogenom, ki povzročajo sinusitis, akutno eksacerbacijo (nenadno poslabšanje) kroničnega bronhitisa (AEKB), zunajbolnišnično pljučnico (ZBP), okužbe sečil ter okužbe kože in mehkih tkiv (OKMT).
Levofloxacin is currently indicated in adults for the treatment of respiratory tract infections (RTIs), SSTIs, complicated and uncomplicated UTIs and chronic bacterial prostatitis (CBP).
Levofloksacin je trenutno indiciran za uporabo pri odraslih za zdravljenje okužb dihal, okužb kože in mehkih tkiv, zapletenih in nezapletenih okužb sečil ter kroničnega bakterijskega prostatitisa.
A 750 mg strength in film coated tablet and as solution for infusion 750 mg/150 ml was approved in some MS.
V nekaterih državah članicah je bila odobrena jakost 750 mg za filmsko obložene tablete in 750 mg/150 ml za raztopino za infundiranje.
the CHMP has recommended the variation to the terms of the marketing authorisations for which the summary of product characteristics, labelling and package leaflets are set out in Annex III for Tavanic and associated names (see Annex I).
• Odbor je soglašal z uskladitvijo povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo, ki so jo predlagali imetniki dovoljenja za promet z zdravili, je odbor CHMP priporočil spremembo pogojev dovoljenj za promet z zdravilom Tavanic in povezanimi imeni (glejte Prilogo I), katerih povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so določeni v Prilogi III .
Inhalation Anthrax
Inhalacijski vranični prisad
Due to the combination of the MRP and National granted MAs some divergent information has been identified in the product information (PI) for Tavanic.
Zaradi kombinacije postopka z medsebojnim priznavanjem in nacionalno odobrenih dovoljenj za promet z zdravilom je bilo v informacijah o zdravilu Tavanic ugotovljenih nekaj razhajanj.
Tavanic, film-coated tablets, 250 mg and 500mg
Usklajene terapevtske indikacije za zdravilo Tavanic, filmsko obložene tablete 250 mg in 500 mg ter za i.v.
Tablets - Inhalation Anthrax: post-exposure prophylaxis and curative treatment IV solution - Inhalation Anthrax: curative treatment
tablete - inhalacijski vranični prisad: profilaksa po izpostavitvi in kurativno zdravljenje; i.v.
• AECB (tablets only): 250 - 500 mg once daily for 7 - 10 days;
• AEKB (samo tablete): 250-500 mg enkrat dnevno za 7-10 dni;
Package Leaflet (PL)
Priloga II
For the above-mentioned infections Tavanic should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections.
Za zgoraj navedene okužbe se zdravilo Tavanic uporablja le, kadar se uporaba splošno priporočenih protibakterijskih sredstev za začetno zdravljenje teh okužb šteje za neustrezno.
• Community-acquired pneumonia
• zunajbolnišnična pljučnica
Based on the review of all the data currently available, the MAH proposed to harmonise the wording for levofloxacin tablets and IV solution to be recommended in PN and complicated urinary tract infections with consideration being given to official guidance on the appropriate use of antibacterial agents.
raztopino levofloksacina, tako da bo priporočeno zdravljenje pielonefritisa in zapletenih okužb sečil z upoštevanjem uradnih smernic za ustrezno uporabo protibakterijskih sredstev.
Tavanic film coated tablets is indicated for the treatment of AECB in adults only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections.
Filmsko obložene tablete Tavanic so indicirane za zdravljenje AEKB pri odraslih osebah samo, kadar se uporaba splošno priporočenih protibakterijskih sredstev za začetno zdravljenje teh okužb šteje za neustrezno.
This indication has been approved for levofloxacin tablets in all MS identified above via nationally or MRP.
Ta indikacija je bila odobrena za tablete levofloksacina v vseh naštetih državah članicah z nacionalnim postopkom ali postopkom z medsebojnim priznavanjem.
The most important pathogens in these indications are S. pneumoniae, H. influenzae with the addition of intracellular/atypical bacteria for CAP. Hospital-acquired pneumonia (HAP) is also a RTI for which levofloxacin was approved for in two MS and for which the MAH is not pursuing its maintenance as summarised below.
Najpomembnejši patogeni pri teh indikacijah so S. pneumoniae, H. influenzae z dodanimi znotrajceličnimi/atipičnimi bakterijami za ZBP.
This indication has been approved in all MS for both tablets and IV formulation, except in one MS.
Ta indikacija ni bila odobrena v vseh državah članicah za obe vrsti tablet in za i.v.
• cSSTIs (tablets): 250mg once daily or 500 mg once or twice daily for 7 to 14 days;
• zapletene okužbe kože in mehkih tkiv (tablete): 250 mg enkrat dnevno ali 500 mg enkrat ali dvakrat dnevno za 7 do 14 dni;
Levofloxacin is also indicated in a few atypical indications like urosepsis, digestive and hepatobiliary infections, Anthrax curative treatment, and hospital-acquired pneumonia (HAP).
Uporablja se tudi za nekatere atipične indikacije, kot so urosepsa, okužbe prebavil, jeter, žolčnika in žolčevodov, za zdravljenje vraničnega prisada in bolnišnične pljučnice.
The MAH agreed that Tavanic film coated tablets is indicated for the treatment of ABS in adults only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections.
Imetnik dovoljenja za promet z zdravilom je soglašal, da so filmsko obložene tablete Tavanic indicirane za zdravljenje ABS pri odraslih samo, kadar se uporaba splošno priporočenih protibakterijskih sredstev za začetno zdravljenje teh okužb šteje za neustrezno.
The CAP indication is approved for both tablets and IV formulation of levofloxacin.
Indikacija ZBP je odobrena za tablete in i.v.
Respiratory Tract Infections (RTIs)
Zunajbolnišnična pljučnica (ZBP)
This indication is approved for both tablets and IV formulation of levofloxacin.
Ta indikacija je odobrena za tablete in i.v.
Therefore, it was agreed to reflect in the SmPCs for both tablets and IV that Tavanic is indicated for the treatment of CAP in adults only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections.
obliko odražati, da je zdravilo Tavanic indicirano za zdravljenje ZBP pri odraslih samo, kadar se uporaba splošno priporočenih protibakterijskih sredstev za začetno zdravljenje teh okužb šteje za neustrezno.
• cSSTIs (IV solution): 500 mg twice daily;
raztopina): 500 mg dvakrat dnevno.
56 (4x14) tablets (multipack)
56 (4x14) tablet (večkratno pakiranje)
Film-coated tablet Oral use blister (PVC/PE/PCTFE/Alu)
12,5 mg/75 mg/50 mg filmsko obložena tableta peroralna uporaba pretisni omot (PVC/PE/PCTFE/Alu)
- 5.0 µg in 0.5 ml.
v 0,5 ml.
Invented name Strength Pharmaceutical Form Route of Administration Packaging
Številka EU Izmišljeno ime Jakost Farmacevtska oblika Pot uporabe
EU/1/99/104/001 Procomvax
EU/1/99/104/001 Procomvax suspenzija za injiciranje intramuskularna uporaba viala (steklena)
Polyribosylribitol phosphate (PRP) from Haemophilus influenzae type b as PRP-OMPC -7.5 µg Neisseria meningitidis OMPC (outer membrane protein complex of the B11 strain of Neisseria meningitidis subgroup B) - 125 µg Adsorbed hepatitis B surface antigen produced in recombinant yeast cells(Saccharomyces cerevisiae)
OMPC (outer membrane protein complex - beljakovinski kompleks zunanje membrane) Neisserie meningitidis (seva B11 Neisserie meningitidis podskupine B)
These measures will help protect the environment.
S temi ukrepi pomagate varovati okolje.
7 days (1 week)
7 dni (1 teden)
• Both you and your partner must use effective contraception.
• Oba s partnerjem morata uporabljati učinkovito kontracepcijo.
This schedule is repeated in cycles of 4 weeks.
Ta razpored ponavljate v 4-tedenskih ciklih.
There was no effect of food on the overall exposure (AUC).
Hrana ni imela učinka na celotno izpostavljenost (AUC).
Each pack contains 1 bottle.
Vsako pakiranje vsebuje 1 plastenko.
P-value (Log rank test)
P-vrednost (Log rank test)
• Taste changes or loss of taste.
• Sprememba okusa ali izguba okusa.
It was reported as serious in one patient.
Poročali so o resnem primeru pri enem bolniku.
This includes herbal medicines and other medicines you have bought without a prescription.
To vključuje zdravila rastlinskega izvora in druga zdravila, ki ste jih kupili brez recepta.
Tell your doctor immediately if you think you have high blood pressure.
Zdravniku takoj povejte, če menite, da imate visok krvni tlak.
This treatment schedule should be continued until disease progression or unacceptable toxicity.
Ta razpored zdravljenja je treba nadaljevati, dokler bolezen ne napreduje ali do nesprejemljive toksičnosti.
• Increased amount of protein in the urine.
• Povečana količina beljakovin v urinu.
• Increase in number of red blood cells.
• Povečano število rdečih krvnih celic.
Decreased appetite
Zmanjšan apetit
The following terms have been combined:
Naslednji izrazi so bili združeni v skupine:
It is unknown whether tivozanib is excreted in human milk, but the potential exists.
Ni znano, ali se tivozanib izloča v človeško mleko, vendar obstaja verjetnost.
• Tiredness and lack of energy.
• Utrujenost in pomanjkanje energije.
In the ITT population there was a small numerical difference between the two arms in terms of overall survival.
V populaciji ITT je bila manjša razlika v številkah med dvema krakoma z vidika celokupnega preživetja.
Other medicines and Fotivda
Druga zdravila in Fotivda
What Fotivda is and what it is used for
Kaj je zdravilo Fotivda in za kaj ga uporabljamo
• Blocked ears.
• Zamašena ušesa.
Taking with food and drink
Zdravilo skupaj s hrano in pijačo
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Pred začetkom jemanja tega zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
This medicine has not been studied in children and adolescents.
To zdravilo ni bilo raziskano pri otrocih in mladostnikih.
Avoid driving or using machines if you feel weak, tired, or dizzy.
Ne vozite ali upravljate strojev, če se počutite šibko, utrujeno ali omotično.
Study AV-951-09-301
Študija AV-951-09-301
In approximately one-third of the patients, hypertension developed within the first 2 months of treatment.
Pri približno tretjini bolnikov je hipertenzija nastopila v prvih 2 mesecih zdravljenja.
High blood pressure is the most serious and a very common side effect (see also in section 2 “Warnings and Precautions”).
Visok krvni tlak je najresnejši in zelo pogost neželeni učinek (glejte tudi poglavje 2 „Opozorila in previdnostni ukrepi“).
Do not chew, dissolve or open the capsule before swallowing.
Ne žvečite, raztapljajte ali odpirajte kapsule, preden jo pogoltnete.
Tell your doctor if you are taking any of the following medicines; they may decide to change your medication:
Povejte zdravniku, če jemljete katero koli od naslednjih zdravil; morda se bo zdravnik odločil zamenjati zdravilo:
Do not take Fotivda:
Zdravila Fotivda ne vzemite:
The capsules must be swallowed whole with a glass of water and must not be opened.
Kapsule je treba pogoltniti z vodo in se jih ne sme odpirati.
It allows continued monitoring of the benefit/risk balance of the medicinal product.
Omogoča stalno nadzorovanje razmerja med koristijo in tveganjem zdravila.
• nafcillin, rifampicin, rifabutin, rifapentin (antibiotics);
• nafcillin, rifampicin, rifabutin, rifapentin (antibiotiki);
CYP and UGT in vitro studies
CYP in UGT v študijah in vitro
Hypothyroidism should be treated according to standard medical practice.
Hipotiroidizem je treba zdraviti po standardni medicinski praksi.
Do not give Fotivda to children and adolescents under 18 years of age.
Ne dajte zdravila Fotivda otrokom in mladostnikom, mlajšim od 18 let.
Swallow the capsule whole.
Pogoltnite celo kapsulo.
The most important serious adverse reaction is hypertension.
Najpomembnejši resen neželeni učinek je hipertenzija.
Average Cmax and AUC0-24hr were not significantly affected (8% increase and 6% decrease respectively).
Na povprečno Cmax in AUC0-24hr ni bilo pomembnega vpliva (8 % povečanje oziroma 6 % zmanjšanje).
• Abnormal electrocardiogram (ECG), rapid and/or irregular heart beat.
• Nenormalen elektrokardiogram (EKG), hiter in/ali nepravilen srčni utrip.
• Sight problems including blurred vision.
• Težave z vidom, vključno z zamegljenim vidom.
• Memory loss.
• Izguba spomina.
If you or your partner are taking hormonal contraceptives (the pill, an implant or patch) you must use an additional barrier method throughout treatment and for another month after completing treatment.
Če vi ali vaš partner jemljeta hormonsko kontracepcijo (tableta, vsadek ali obliž) morate uporabiti dodatno pregradno metodo ves čas zdravljenja in še en mesec po zaključenem zdravljenju.
• Difficulty speaking
• Težave pri govoru.
What you need to know before you take Fotivda
Kaj morate vedeti, preden vzamete zdravilo Fotivda
These are all symptoms of high blood pressure.
To so vse simptomi visokega krvnega tlaka.
Contraindication of concomitant use
Kontraindikacija za sočasno uporabo
See also Section 4 “Possible side effects”.
Glejte poglavje 4 „Možni neželeni učinki“.
One patient experienced Grade 4 PRES and hypertension in Study AV-951-09-901.
PRES 4. stopnje in hipertenzijo v študiji AV-951-09-901.
• Temporary reduced blood flow to the brain.
• Začasno zmanjšan dotok krvi v možgane.
• rosuvastatin (a medicine used to help lower cholesterol levels in your blood);
• rosuvastatin (zdravilo, ki pomaga znižati ravni holesterola v krvi);