FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP noted that Invanz was shown to be effective, albeit with a limited number of severe cases treated during the studies for abdominal infections, community-acquired pneumonia, gynaecological infections and diabetic foot infections.
Slovenian: CHMP je menil, da se je zdravilo Invanz izkazalo kot učinkovito, četudi le pri omejenem številu hudih primerov okužb, zdravljenih v okviru študij trebušnih okužb, zunajbolnišnične pljučnice, ginekoloških okužb in okužb stopal pri sladkornih bolnikih.
English: Invanz is also used in adults to prevent infection after colorectal surgery (surgery in the lower part of the bowel, including the rectum).
Slovenian: Zdravilo Invanz se uporablja tudi pri odraslih za preprečevanje okužb po kolorektalni operaciji (kirurškem posegu na spodnjem delu črevesa, vključno na danki).
English: For younger patients (3 months to 12 years), a dose of 15 mg per kilogram body weight is given twice a day, up to a total of 1 g per day.
Slovenian: Pri mlajših bolnikih (starih od treh mesecev do 12 let) se daje odmerek 15 mg na kilogram telesne mase dvakrat na dan, vendar skupno največ 1 g na dan. Zdravljenje z zdravilom Invanz običajno traja tri do 14 dni, odvisno od vrste in resnosti okužbe.
English: Invanz was compared with ceftriaxone (another antibiotic) for the treatment of adults with communityacquired pneumonia (866 patients) and urinary tract infections (592 patients), and with a combination of piperacillin and tazobactam for the treatment of abdominal infections (655 patients), gynaecological infections (412 patients), skin and soft tissue infections (infections of the skin and the tissues just beneath the skin, 540 patients); and foot infections in diabetes patients (576 patients).
Slovenian: Zdravilo Invanz so primerjali s ceftriaksonom (drugim antibiotikom) pri zdravljenju odraslih z zunajbolnišnično pljučnico (866 bolnikov) in okužbo sečil (592 bolnikov) ter s kombinacijo piperacilina in tazobaktama pri zdravljenju trebušnih okužb (655 bolnikov), ginekoloških okužb (412 bolnikov), okužb kože in mehkih tkiv (okužb kože in tkiv tik pod njo, 540 bolnikov) ter okužb stopal pri bolnikih s sladkorno boleznijo (576 bolnikov).
English: Invanz is available as a vial containing a powder which is dissolved before use to make up a solution for infusion (drip) into a vein.
Slovenian: Zdravilo Invanz je na voljo v obliki vial s praškom, ki se pred uporabo raztopi za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: The Committee concluded that it was also effective for treatment of infection in children and for preventing infection after colorectal surgery in adults.
Slovenian: Odbor je zaključil, da je zdravilo Invanz učinkovito tudi pri zdravljenju okužb pri otrocih in za preprečevanje okužb po kolorektalnih operacijah pri odraslih.
English: Invanz was as effective as ceftriaxone or piperacillin/tazobactam for the treatment of abdominal infections, community-acquired pneumonia, gynaecological infections and foot infections in diabetes patients: Invanz was effective for 87 to 94% of patients compared with 83 to 92% for the comparator antibiotics.
Slovenian: Zdravilo Invanz je bilo enako učinkovito kot ceftriakson ali kombinacija piperacilina/tazobaktama pri zdravljenju trebušnih okužb, zunajbolnišnične pljučnice, ginekoloških okužb in okužb stopal pri bolnikih s sladkorno boleznijo: zdravilo Invanz je bilo učinkovito pri 87 do 94 % bolnikov, medtem ko so bili primerjalni antibiotiki učinkoviti pri 83 do 92 % bolnikov.
English: In studies in children, Invanz was compared with ceftriaxone (for community-acquired pneumonia, 389 children) and with ticarcillin/clavulanate (for intra-abdominal infections, 105 children).
Slovenian: V študijah pri otrocih so zdravilo Invanz primerjali s ceftriaksonom (pri zdravljenju zunajbolnišnične pljučnice, 389 otrok) in tikarcilinom/klavulanatom (za notranje trebušne okužbe, 105 otrok).
English: Once the infection has improved, treatment can be switched to an antibiotic that can be given by mouth.
Slovenian: Če se stanje okužbe izboljša, se lahko preide na zdravljenje z antibiotikom, ki se jemlje peroralno.
English: Invanz is used when the bacteria that cause the infection are likely to be killed by the antibiotic.
Slovenian: Zdravilo Invanz se uporablja, kadar obstaja verjetnost, da bo antibiotik uničil bakterije, ki povzročajo okužbo.
English: For the full list of all side effects reported with Invanz, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Invanz, glejte navodilo za uporabo.
English: Invanz was compared with cefotetan for preventing infection after colorectal surgery.
Slovenian: Zdravilo Invanz so primerjali s cefotetanom pri preprečevanju okužb po kolorektalni operaciji.
English: How is Invanz used?
Slovenian: Kako se zdravilo Invanz uporablja?
English: Invanz contains the active substance ertapenem.
Slovenian: Zdravilo Invanz vsebuje zdravilno učinkovino ertapenem.
English: However, the data were not sufficient to support the use of Invanz in the treatment of urinary tract infections and skin and soft tissue infections, except foot ulcers in diabetes patients.
Slovenian: Za podporo uporabi zdravila Invanz pri zdravljenju okužb sečil ter okužb kože in mehkih tkiv, z izjemo razjed stopal pri bolnikih s sladkorno boleznijo, podatki niso zadostovali.
English: How does Invanz work?
Slovenian: Kako zdravilo Invanz deluje?
English: • infections within the abdomen;
Slovenian: • trebušnih okužb;
English: This means that it is similar to a ‘reference medicine' already authorised in the European Union (EU), called Kaletra.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Kaletra.
English: The dose for smaller children depends on the child's body surface area and the other medicines that the child is taking.
Slovenian: Odmerek za manjše otroke je odvisen od otrokove telesne površine in drugih zdravil, ki jih jemlje.
English: This increases the levels of lopinavir in the blood, allowing a lower dose of lopinavir to be used for the same antiviral effect.
Slovenian: To poveča ravni lopinavirja v krvi, kar omogoča uporabo manjšega odmerka lopinavirja za isti protivirusni učinek.
English: This dose is also suitable for children (aged between two and 12 years) provided that they weigh more than 40 kg or have a body surface area (calculated using the child's height and weight) over 1.4 m2.
Slovenian: Ta odmerek je primeren tudi za otroke (stare od dve do 12 let), če tehtajo več kot 40 kg in imajo več kot 1,4 m2 telesne površine (izračunano na podlagi otrokove višine in telesne mase).
English: It is available as tablets (100 mg lopinavir and 25 mg ritonavir; 200 mg lopinavir and 50 mg ritonavir).
Slovenian: Na voljo je v obliki tablet (100 mg lopinavira in 25 mg ritonavira; 200 mg lopinavira in 50 mg ritonavira).
English: When the enzyme is blocked, the virus does not replicate normally, slowing down the spread of infection.
Slovenian: Ko je encim zavrt, se virus ne more več normalno razmnoževati, kar zmanjša hitrost širjenja okužbe.
English: When deciding to use once-daily dosing, the doctor should consider the fact that it might not be as effective as twice-daily dosing at keeping HIV levels low in the long term and may increase the risk of diarrhoea.
Slovenian: Pri odločanju o enojnem dnevnem odmerku mora zdravnik presoditi možnost, da bo pri dolgoročnem zadrževanju virusa HIV na nizki ravni ta odmerek morda manj učinkovit kot odmerjanje dvakrat na dan in da lahko poveča tveganje za drisko.
English: The full EPAR and risk management plan summary for Lopinavir/Ritonavir Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Lopinavir/ritonavir Mylan sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Lopinavir/Ritonavir Mylan.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Lopinavir/ritonavir Mylan.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Lopinavir/Ritonavir Mylan has been shown to have comparable quality and to be bioequivalent to Kaletra.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Lopinavir/ritonavir Mylan primerljivo raven kakovosti kot zdravilo Kaletra ter da mu je biološko enakovredno.
English: Lopinavir/Ritonavir Mylan is used in combination with other medicines to treat patients over two years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: Zdravilo Lopinavir/ritonavir Mylan se uporablja v kombinaciji z drugimi zdravili za zdravljenje bolnikov, starejših od dveh let, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: For adults (aged 18 years or over) who are infected with HIV that is likely to respond to medicines in the same class as Lopinavir/Ritonavir Mylan (protease inhibitors) the doctor may prescribe the full daily dose of four 200/50-mg tablets as a single dose.
Slovenian: Pri odraslih (starejših od 18 let), okuženih z virusom HIV, ki naj bi se po pričakovanjih odzval na zdravljenje z zdravili iz istega razreda kot Lopinavir/ritonavir Mylan (zaviralci proteaz), lahko zdravnik predpiše celoten dnevni odmerek štirih 200/50-miligramskih tablet v enkratnem odmerku.
English: The Committee recommended that Lopinavir/Ritonavir Mylan be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Lopinavir/ritonavir Mylan odobri za uporabo v EU.
English: The active substances in this medicine, lopinavir and ritonavir, are protease inhibitors: they block an enzyme called protease that is involved in the replication of HIV.
Slovenian: Zdravilni učinkovini v tem zdravilu, lopinavir in ritonavir, sta zaviralca proteaze: zavirata encim, imenovan proteaza, ki je vključen v razmnoževanje virusa HIV.
English: Because Lopinavir/Ritonavir Mylan 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.
Slovenian: Ker je zdravilo Lopinavir/ritonavir Mylan generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Therefore, the CHMP's view was that, as for Kaletra, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi enako kot pri zdravilu Kaletra odtehtajo znana tveganja.
English: For more information about treatment with Lopinavir/Ritonavir Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Lopinavir/ritonavir Mylan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Lopinavir/Ritonavir Mylan is a ‘generic medicine'.
Slovenian: Lopinavir/ritonavir Mylan je „generično zdravilo“.
English: A risk management plan has been developed to ensure that Lopinavir/Ritonavir Mylan is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Lopinavir/ritonavir Mylan je bil pripravljen načrt obvladovanja tveganj.
English: What measures are being taken to ensure the safe and effective use of Lopinavir/Ritonavir Mylan?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lopinavir/ritonavir Mylan?
English: Because Lopinavir/Ritonavir Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Kaletra.
Slovenian: Ker je zdravilo Lopinavir/ritonavir Mylan generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Kaletra.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Lopinavir/Ritonavir Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: For practical information about using Lopinavir/Ritonavir Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Lopinavir/ritonavir Mylan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: In adults and adolescents (aged 12 years and over), the recommended dose of Lopinavir/Ritonavir Mylan is two 200/50-mg tablets twice a day.
Slovenian: Priporočeni odmerek zdravila Lopinavir/ritonavir Mylan za odrasle in mladostnike (starejše od 12 let) je dve 200/50-miligramski tableti dvakrat na dan.
English: Other information about Lopinavir/Ritonavir Mylan
Slovenian: Druge informacije o zdravilu Lopinavir/ritonavir Mylan
English: What are the benefits and risks of Lopinavir/Ritonavir Mylan?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Lopinavir/ritonavir Mylan?
English: Lopinavir/Ritonavir Mylan, taken with other HIV medicines, reduces HIV in the blood and keeps the virus at a low level.
Slovenian: Če se zdravilo Lopinavir/ritonavir Mylan jemlje v kombinaciji z drugimi zdravili za zdravljenje okužbe z virusom HIV, zmanjša količino tega virusa v krvi in ga ohranja na nizki ravni.
English: Lopinavir/Ritonavir Mylan can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection.
Slovenian: Izdaja zdravila Lopinavir/ritonavir Mylan je le na recept, zdravljenje pa mora uvesti zdravnik z izkušnjami z zdravljenjem okužb z virusom HIV.
English: What is Lopinavir/Ritonavir Mylan and what is it used for?
Slovenian: Kaj je zdravilo Lopinavir/ritonavir Mylan in za kaj se uporablja?
English: It does not cure HIV infection, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.
Slovenian: Zdravilo Lopinavir/ritonavir Mylan ne ozdravi okužbe z virusom HIV, vendar lahko upočasni slabšanje imunskega sistema in prepreči razvoj okužb ter bolezni, povezanih z aidsom.
English: Lopinavir/Ritonavir Mylan lopinavir / ritonavir
Slovenian: Lopinavir/ritonavir Mylan
English: In Lopinavir/Ritonavir Mylan, lopinavir provides the activity and ritonavir is used as a ‘booster' that slows down the rate at which lopinavir is broken down by the liver.
Slovenian: Lopinavir v zdravilu Lopinavir/ritonavir Mylan zagotavlja učinkovanje, ritonavir pa služi kot „stopnjevalec“, ki upočasni razgradnjo lopinavirja v jetrih.
English: Lopinavir/Ritonavir Mylan contains the active substances lopinavir and ritonavir.
Slovenian: Zdravilo Lopinavir/ritonavir Mylan vsebuje zdravilni učinkovini lopinavir in ritonavir.
English: Why is Lopinavir/Ritonavir Mylan approved?
Slovenian: Zakaj je bilo zdravilo Lopinavir/ritonavir Mylan odobreno?
English: How has Lopinavir/Ritonavir Mylan been studied?
Slovenian: Kako je bilo zdravilo Lopinavir/ritonavir Mylan raziskano?
English: How is Lopinavir/Ritonavir Mylan used?
Slovenian: Kako se zdravilo Lopinavir/ritonavir Mylan uporablja?
English: How does Lopinavir/Ritonavir Mylan work?
Slovenian: Kako zdravilo Lopinavir/ritonavir Mylan deluje?
English: Take your capsules as soon as you remember.
Slovenian: Kapsule vzemite takoj, ko se spomnite.
English: 69800, France
Slovenian: 69800, Francija
English: The starting dose should be maintained for at least one week.
Slovenian: Začetni odmerek je treba vzdrževati vsaj en teden.
English: • > 60 years of age or
Slovenian: • starost nad 60 let ali
English: The following side effects have been reported but it is not known exactly how often they occur:
Slovenian: Poročali so o naslednjih neželenih učinkih, ni pa natančno znano, kako pogosto se pojavljajo:
English: A risk to the newborn/infant cannot be excluded.
Slovenian: Tveganja za novorojenca/dojenčka ne moremo izključiti.
English: You can take the capsules with food or after a meal or on an empty stomach.
Slovenian: Kapsule lahko zaužijete s hrano ali po obroku ali pa na prazen želodec.
English: There are also links to other websites about rare diseases and treatments.
Slovenian: kjer so na voljo tudi povezave so drugih spletnih strani o redkih boleznih in zdravljenju.
English: Do not take more capsules than your doctor has recommended.
Slovenian: Ne jemljite več kapsul, kot vam je priporočil zdravnik.
English: Currently available data are described in sections 4.4, 4.8, 5.1 and 5.2, but no recommendation on a posology can be made.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavjih 4.4, 4.8, 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
English: Take your next dose at the usual time.
Slovenian: Naslednji odmerek vzemite kot običajno.
English: Therefore, platelets should be monitored frequently.
Slovenian: Zato je treba trombocite pogosto spremljati.
English: Tell your doctor if you are taking any of the following medicines:
Slovenian: Zdravniku povejte, če jemljete katero od naslednjih zdravil:
English: Speak to your doctor if you need advice with contraception.
Slovenian: Pogovorite se z zdravnikom, če potrebujete nasvet pri kontracepciji.
English: It is best to take the capsule(s) at the same time every day.
Slovenian: Kapsulo/-e je najbolje jemati vsak dan ob istem času.
English: • If you have or think you might have a problem with your heart;
Slovenian: • če imate ali mislite, da imate težavo z delovanjem srca;
English: Mutagenic and carcinogenic potential
Slovenian: Mutageni in karcinogeni potencial
English: Carton only: PC:
Slovenian: Samo na škatli: PC:
English: 6545 CM Nijmegen NETHERLANDS
Slovenian: 6545 CM Nijmegen Nizozemska
English: Clinically relevant interactions
Slovenian: Klinično pomembne interakcije
English: After this time, your doctor may either increase or decrease the number of capsules that you take to find the dose best suited to you and which treats your condition most effectively.
Slovenian: Po tem obdobju vam utegne zdravnik povečati ali zmanjšati število kapsul, da doseže odmerek, ki vam najbolj ustreza in ki je najbolj učinkovit za vašo bolezen.
English: The safety of anagrelide has been examined in 4 open label clinical studies.
Slovenian: Varnost anagrelida so proučevali v štirih odprtih kliničnih študijah.
English: Your doctor will prescribe the best dose for you.
Slovenian: Zdravnik vam bo predpisal primeren odmerek.
English: Rare: Kidney failure (when you pass little or no urine), heart attack.
Slovenian: Redki: odpoved ledvic (ko izločate malo ali nič urina), srčni napad.
English: Very common side effects: may affect more than 1 in 10 people Headache.
Slovenian: Zelo pogosti neželeni učinki: (pojavijo se lahko pri več kot 1 od 10 bolnikov glavobol.
English: Any abnormalities should be evaluated promptly and appropriate measures taken, which may also include dose reduction, interruption or discontinuation.
Slovenian: Vse nenormalnosti je treba nemudoma ovrednotiti in izvesti ustrezne ukrepe, ki lahko vključujejo tudi zmanjšanje odmerka, prekinitev ali ukinitev zdravljenja.
English: See the instructions in the patient leaflet of the contraceptive pill you are taking.
Slovenian: Glejte navodila za uporabo kontracepcijskih tablet, ki jih jemljete.
English: Within the system organ classes they are listed under the following headings: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: Navedeni so po organskih sistemih z naslednjimi opisi pogostnosti: 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); zelo redki (< 1/10.000), neznana pogostost (ni mogoče oceniti iz razpoložljivih podatkov).
English: During clinical development doses of 10 mg/day have been used.
Slovenian: Med kliničnim razvojem so bili uporabljeni odmerki 10 mg dnevno.
English: Although the rate of such progression is not known, children have a longer disease course and may, therefore, be at increased risk for malignant transformation, relative to adults.
Slovenian: Čeprav hitrost tega napredovanja ni znana, imajo otroci daljši potek bolezni in je zato lahko pri njih tveganje maligne transformacije večje kot pri odraslih.
English: However, safety data are limited and do not allow a meaningful comparison between adult and paediatric patients to be made (see section 4.4).
Slovenian: Vendar je podatkov o varnosti malo in ne omogočajo pomembne primerjave med odraslimi in pediatričnimi bolniki (glejte poglavje 4.4).
English: Discontinuation of treatment should be considered in paediatric patients who do not have a satisfactory treatment response after approximately 3 months.
Slovenian: O prekinitvi zdravljenja je potrebno razmisliti pri pediatričnih bolnikih, ki se po približno 3 mesecih ne odzovejo zadovoljivo na zdravljenje.
English: Gradual dose titration may help diminish these effects (see section 4.2).
Slovenian: Postopna titracija odmerka utegne pomagati pri zmanjšanju teh učinkov (glejte poglavje 4.2).
English: Your capsules should be swallowed whole with a glass of water.
Slovenian: Kapsule morate zaužiti cele s kozarcem vode.
English: This means that due to the rarity of this disease it has not been possible to obtain complete information on this medicinal product.
Slovenian: To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh podatkov o zdravilu.
English: The average daily dose tended to be higher in adolescents.
Slovenian: Povprečni dnevni odmerek je bil pri mladostnikih nekoliko večji.
English: An at risk patient
Slovenian: Bolnik s tveganjem
English: • The effects of food on bioavailability are not considered clinically relevant to the use of anagrelide.
Slovenian: • Učinki hrane na biološko uporabnost niso klinično pomembni za uporabo anagrelida.
English: In studies 700-012, 700-014, 700-999 and study 13970-301 the time to complete response ranged from 4 to 12 weeks.
Slovenian: V študijah 700-012, 700-014, 700-999 in študiji 13970-301 so za dosego popolnega odziva potrebovali od 4 do 12 tednov.
English: Close monitoring for an effect on the QTc interval is advisable.
Slovenian: Priporočljivo je natančno spremljanje morebitnega učinka na interval QTc.
English: • If you are allergic to anagrelide or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na anagrelid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Food also decreased the Cmax of the active metabolite, 3-hydroxy-anagrelide, by 29%, although it had no effect on the AUC.
Slovenian: Hrana je tudi zmanjšala Cmax aktivnega presnovka, 3-hidroksi-anagrelida, za 29 %, vendar ni imela vpliva na AUC.
English: Do not drive or use machines if you feel dizzy.
Slovenian: Ne vozite avtomobila ali ne uporabljajte strojev, če ste omotični.
English: Clinical benefit in terms of thrombohaemorrhagic events has not been convincingly demonstrated.
Slovenian: Klinične koristi v smislu trombohemoragičnih dogodkov niso bile dovolj prepričljive.
English: Your doctor will ask you to have blood tests at regular intervals to check that your medicine is working effectively and that your liver and kidneys are working well.
Slovenian: Zdravnik vas bo v rednih intervalih napotil na krvne preiskave, da bo preveril, ali zdravilo učinkuje in ali vaša jetra in ledvice delujejo dobro.