FrancophonIA/ELRC3.0 huggingface dataset:
English: Muscle pain, muscle weakness, bone pain, joint swelling, abnormal cartilage between bones of the spine, sudden inability to bend joint, muscle spasms, arthritis Blockage of kidney blood vessels, enlarged kidney due to blockage of urine flow out of the kidney, backflow of urine from the bladder into the kidney tubes, inability to hold urine, incomplete emptying of the bladder, urinating at night, sugar in the urine Increase in body weight, decrease in body weight Cataract, increased blood congestion in the eye, blurred vision Shaking or tremors, dizziness, fainting or passing out, ear pain, buzzing, ringing or other persistent noise in the ears
Slovenian: glivična okužba možganov, vnetje možganov, resna okužba možganov, imenovana progresivna multifokalna levkoencefalopatija (PML), otekanje možganov, zvišanje tlaka v lobanji in možganih, krči, izguba ali oslabelost mišične moči in aktivne gibljivosti polovice telesa, izguba ovojnice, ki obdaja živce, nezmožnost gibanja mišic na obrazu, kakršnakoli prizadetost možganov, ki povzroča glavobol, zvišano telesno temperaturo, halucinacije, zmedenost, motnje govora in motnje gibanja telesa, slab dotok krvi v srce, izostanek srčnih utripov, nepravilnosti aortne zaklopke, nenormalno hiter srčni utrip, nenadne težave z dihanjem, ki privedejo do poškodbe pljuč, zvišan krvni tlak v pljučih, vnetje pljuč, izkašljevanje krvi, nepravilnosti pljuč in bronhijev, nabiranje tekočine v prostoru okoli pljuč, začasno prenehanje dihanja med spanjem, nenormalen zvok med govorjenjem, genitalni herpes, vnetje kolona (debelo črevo), ki je posledica okužbe s citomegalovirusom, vnetje trebušne slinavke, razjeda želodca, tankega ali debelega črevesa, zapora tankega črevesa, črno, katranasto blato, krvavitve v danki, nenormalna barva blata, bakterijske okužbe, vnetje ali okužba notranje plasti srčne stene, tuberkuloza, okužba kosti, vnetje bezgavk, kronična razširitev dihalnih poti s pogostimi okužbami pljuč, strongiloidoza (parazitska bolezen, ki jo povzroča glista), giardioza (okužba z zajedalcem, ki povzroča drisko), bolezen ledvic, ki jo povzroča virus (s poliomavirusom povezana nefropatija), vnetje ledvic, brazgotinjenje ledvic, zmanjšanje ledvičnih cevk, vnetje sečnega mehurja s krvavitvami, nastanek krvnega strdka v ledvični arteriji,
English: An excess in mortality and graft loss was observed in the belatatacept LI + MMF group and an excess in mortality was observed in the belatacept MI + MMF group.
Slovenian: V skupini, ki je prejemala belatacept po manj intenzivnem (MI) režimu zdravljenja + mofetilmikofenolat, so poročali o večji umrljivosti in izgubi presadka, v skupini, ki je prejemala belatacept po bolj intenzivnem (BI) režimu zdravljenja + mofetilmikofenolat pa so poročali le o večji umrljivosti.
English: Abatacept administered to female rats every three days during gestation and throughout the lactation period, produced no adverse effects in offspring at doses up to 45 mg/kg, representing 3 times the exposure associated with the MRHD of 10 mg/kg based on AUC.
Slovenian: Pri mladičih podgan, ki so med gestacijo in celotno obdobje laktacije vsake tri dni prejemale abatacept v odmerkih do 45 mg/kg (na osnovi AUC 3 krat večja izpostavljenost od izpostavljenosti človeka pri največjem priporočenem odmerku 10 mg/kg) neželenih učinkov niso opazili, pri odmerku 200 mg/kg, kar je na osnovi AUC 11 krat večja izpostavljenost od izpostavljenosti človeka pri največjem priporočenem odmerku, pa so opazili spremembe imunske funkcije, in sicer 9 kratno povečanje Tceličnega protitelesnega odziva pri mladičih ženskega spola in vnetje ščitnice pri enem mladiču ženskega spola.
English: Uncommon bone metabolism disorder, osteitis, osteolysis, synovitis Renal and urinary disorders
Slovenian: Občasni motnje presnove kosti, osteitis, osteoliza, vnetje sinovijske membrane
English: Lung cancer, rectal cancer, breast cancer, a form of cancer in the bones, musles, or fat tissue, tumor of the skin and intestinal tract caused by a herpes virus and seen in patients with a weakened immune system, prostate cancer, cancer of the cervix, throat cancer, cancer of the lymph nodes, cancer of the bone marrow, cancer of the kidney, kidney tubes, or bladder Fungal infection of brain, inflammation of the brain, serious brain infection called PML (progressive multifocal leukoencephalopathy)
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) so: pljučni rak, rak danke, rak dojke, oblika raka v kosteh, mišicah ali maščevju, tumor kože in črevesa, ki je posledica okužbe s herpesvirusom in so ga opazili pri bolnikih z oslabljenim imunskim sistemom, rak prostate, rak materničnega vratu, rak grla, rak bezgavk, rak kostnega mozga, rak ledvice, sečevodov ali sečnega mehurja,
English: After reconstitution
Slovenian: Po redčenju
English: Total dose of belatacept in mg equals the patient weight in kg times the belatacept dose in mg/kg (5 or 10 mg/kg, see section 3) Dose modification of NULOJIX is not recommended for a change in body weight of less than
Slovenian: Skupni odmerek belatacepta (v mg) izračunate tako, da bolnikovo telesno maso (v kg) pomnožite z odmerkom belatacepta (v mg/kg) (5 ali 10 mg/kg, glejte poglavje 3).
English: Genital herpes
Slovenian: herpes zoster (pasovec).
English: It is very important to keep all appointments for NULOJIX treatment.
Slovenian: Zelo pomembno je, da vedno obiščete zdravnika ob predvidenem času za naslednji odmerek zdravila NULOJIX.
English: If any of the side effects gets serious, please tell your doctor or pharmacist.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
English: Use the silicone-free disposable syringe provided to make up the vials and to add the solution to the infusion.
Slovenian: Da bi preprečili združevanje manjših delcev v skupke, morate tako pri dodajanju vehikla v vialo kot pri dodajanju raztopine v infuzijsko tekočino uporabiti priloženo injekcijsko brizgo za enkratno uporabo, ki ne vsebuje silikona.
English: The decision to stop using NULOJIX should be discussed with your doctor and another therapy will generally be started.
Slovenian: O prekinitvi zdravljenja z zdravilom NULOJIX se morate pogovoriti z zdravnikom.
English: Musculoskeletal and connective tissue disorders Very Common arthralgia, back pain, pain in extremity Common myalgia, muscular weakness, bone pain, joint swelling, intervertebral disc disorder, joint lock, muscle spasms, osteoarthritis
Slovenian: Pogosti bolečine v mišicah, mišična oslabelost, kostna bolečina, otekanje sklepov, bolezen medvretenčne ploščice, zatikanje sklepa, mišični krči, osteoartritis
English: Belatacept was shown to cross the placenta in rats and rabbits.
Slovenian: Pri podganah in kunčicah je bilo dokazano, da belatacept prehaja preko placente.
English: Thus, 10 ml of a 25 mg/ml belatacept solution can be withdrawn from each vial.
Slovenian: Zaradi predvidenih izgub pri odvzemu raztopine iz viale vsaka viala vsebuje zadosten pribitek belatacepta, da lahko po pripravi iz ene viale izvlečete 10 ml raztopine belatacepta s koncentracijo 25 mg/ml.
English: Uncommon gastrointestinal disorder, pancreatitis, large intestinal ulcer, melaena, gastroduodenal ulcer, rectal haemorrhage, small intestinal obstruction, cheilitis, gingival hyperplasia, salivary gland pain, faeces discoloured Hepatobiliary disorders
Slovenian: Občasni prebavne motnje, pankreatitis, razjeda debelega črevesa, melena, gastroduodenalna razjeda, krvavitev iz danke, obstrukcija tankega črevesa, vnetje ustnice, hiperplazija dlesni, bolečina žleze slinavke, nenormalno obarvanje blata
English: Package leaflet: Information for the user NULOJIX 250 mg powder for concentrate for solution for infusion belatacept
Slovenian: Navodilo za uporabo NULOJIX 250 mg prašek za koncentrat za raztopino za infundiranje belatacept
English: Acne, hair loss, abnormal change to the skin, excessive sweating, night sweats Weakness/gap in abdominal muscles and out pouching of skin over healed incision, hernia on the stomach wall
Slovenian: Občasni luskavica, nenormalna rast las ali dlak, lomljenje nohtov, razjede na penisu, oteklina obraza, lomljenje las Bolezni mišično-skeletnega sistema in vezivnega tkiva Zelo pogosti bolečine v sklepih, bolečine v hrbtu, bolečine v okončinah
English: Dose of belatacept for renal transplant recipients
Slovenian: Faze belatacepta pri bolnikih z na novo presajenimi jetri.
English: Uncommon retinitis, conjunctivitis, eye inflammation, keratitis, photophobia, eyelid oedema Ear and labyrinth disorders
Slovenian: Občasni retinitis, konjunktivitis, vnetje očesa, keratitis, fotofobija, edem očesnih vek Ušesne bolezni, vključno z motnjami labirinta Pogosti vrtoglavica, bolečina v ušesu, tinitus
English: The European Commission granted a marketing authorisation valid throughout the European Union for Exviera on 15 January 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Exviera, veljavno po vsej Evropski uniji, izdala 15. januarja 2015.
English: What measures are being taken to ensure the safe and effective use of Exviera?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Exviera?
English: It must also not be used together with medicines that affect the activity of certain enzymes that can raise or lower the level of the active substance in the blood.
Slovenian: Prav tako se ne sme uporabljati skupaj z zdravili, ki vplivajo na delovanje določenih encimov, ki lahko zvišajo ali znižajo raven zdravilne učinkovine v krvi.
English: Exviera is available as 250 mg tablets, and the recommended dose is two tablets a day, one in the morning and one in the evening for 8, 12 or 24 weeks.
Slovenian: Zdravilo Exviera je na voljo v obliki 250-miligramskih tablet, priporočeni odmerek pa sta dve tableti na dan, ena zjutraj in ena zvečer, ki ju je treba jemati osem, 12 ali 24 tednov.
English: This is a summary of the European public assessment report (EPAR) for Exviera.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Exviera.
English: The full EPAR and risk management plan summary for Exviera 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 Exviera sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Exviera
Slovenian: Druge informacije o zdravilu Exviera
English: The Agency therefore concluded that the benefits of Exviera outweigh its risks and recommended that it be approved for use in the EU.
Slovenian: Agencija je tako zaključila, da so koristi zdravila Exviera večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: This stops the hepatitis C virus from multiplying and infecting new cells.
Slovenian: S tem prepreči, da bi se virus hepatitisa C razmnoževal in okužil nove celice.
English: Almost all the patients in the studies had the virus cleared from their blood after 12 or 24 weeks.
Slovenian: Pri skoraj vseh bolnikih v študijah je bil po 12 ali 24 tednih virus odstranjen iz krvi.
English: The clearance rate was particularly high in patients infected with genotype 1b.
Slovenian: Odstranjevanje je bilo še zlasti uspešno pri bolnikih, okuženih z genotipom 1b.
English: What are the risks associated with Exviera?
Slovenian: Kakšna tveganja so povezana z zdravilom Exviera?
English: What benefits of Exviera have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Exviera izkazalo v študijah?
English: What is Exviera and what is it used for?
Slovenian: Kaj je zdravilo Exviera in za kaj se uporablja?
English: Why is Exviera approved?
Slovenian: Zakaj je bilo zdravilo Exviera odobreno?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Exviera have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Exviera upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: For more information about treatment with Exviera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Exviera preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The combination of medicines used and the duration of treatment will depend on which genotype of hepatitis C virus the patient is infected with, the nature of the liver problems they have (for example, if they have liver cirrhosis (scarring) or their liver is not working properly) and whether they have received previous treatment.
Slovenian: Uporabljena kombinacija zdravil in trajanje zdravljenja sta odvisna od genotipa virusa hepatitisa C, s katerim je bolnik okužen, in vrste njegovih težav z jetri (ali gre na primer za cirozo (brazgotinjenje) jeter ali njihovo nepravilno delovanje), oziroma od tega, ali se je predhodno že zdravil.
English: It is not intended to provide practical advice on how to use Exviera.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Several varieties (genotypes) of hepatitis C virus exist and Exviera is recommended for use in patients with virus of genotypes 1a and 1b.
Slovenian: Obstaja več vrst (genotipov) virusa hepatitisa C, zdravilo Exviera pa je priporočeno za bolnike z virusom genotipa 1a in 1b.
English: It contains the active substance dasabuvir.
Slovenian: Zdravilo vsebuje zdravilno učinkovino dasabuvir.
English: Exviera is an antiviral medicine used in combination with other medicines to treat adults with chronic (long-term) hepatitis C, an infectious disease of the liver caused by the hepatitis C virus.
Slovenian: Zdravilo Exviera je protivirusno zdravilo, ki se uporablja v kombinaciji z drugimi zdravili za zdravljenje odraslih s kroničnim (dolgotrajnim) hepatitisom C, tj. nalezljivo boleznijo jeter, ki jo povzroča virus hepatitisa C.
English: The most common side effects with Exviera when used with Viekirax and ribavirin (which may affect more than 1 in 10 people) are insomnia (difficulty sleeping), nausea, pruritus (itching), asthenia (weakness) and fatigue (tiredness).
Slovenian: Najpogostejši neželeni učinki zdravila Exviera, kadar se uporablja skupaj z zdravilom Viekirax in ribavirinom (ki lahko prizadenejo več kot 1 osebo od 10), so insomnija (nespečnost), navzeja (slabost), pruritus (srbenje), astenija (šibkost) in utrujenost.
English: In 6 initial main studies involving around 2,300 patients infected with hepatitis C virus genotypes 1a or 1b, Exviera in combination with Viekirax was effective in clearing the virus from the blood.
Slovenian: V šestih začetnih glavnih študijah, v katere je bilo vključenih približno 2 300 bolnikov, okuženih z genotipoma 1a ali 1b virusa hepatitisa C, je bilo zdravilo Exviera v kombinaciji z zdravilom Viekirax učinkovito pri odstranjevanju virusa iz krvi.
English: The active substance in Exviera, dasabuvir, works by blocking the action of an enzyme in the hepatitis C virus called ‘NS5B RNA-dependent polymerase', which the virus needs to multiply.
Slovenian: Zdravilna učinkovina zdravila Exviera, dasabuvir, deluje tako, da zavira delovanje encima v virusu hepatitisa C, imenovanega „polimeraza NS5B, odvisna od RNK“, ki ga virus potrebuje za svoje razmnoževanje.
English: For practical information about using Exviera, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Exviera naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Exviera can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in managing patients with chronic hepatitis C.
Slovenian: Predpisovanje in izdaja zdravila Exviera je le na recept, zdravljenje pa mora uvesti in spremljati zdravnik, ki ima izkušnje z zdravljenjem bolnikov s kroničnim hepatitisom C.
English: Regarding its safety, although there were some cases of raised liver enzymes in patients treated with Exviera in combination with Viekirax and ribavirin, side effects seen with this combination were generally well tolerated.
Slovenian: Kar zadeva varnost, so bolniki kljub zabeleženim nekaj primerom povišanih jetrnih encimov pri bolnikih, zdravljenih z zdravilom Exviera v kombinaciji z zdravilom Viekirax in ribavirinom, neželene učinke pri tej kombinaciji na splošno dobro prenašali.
English: Exviera must not be used in women taking ethinylestradiol, an oestrogen found in hormonal contraceptives.
Slovenian: Zdravilo Exviera se ne sme predpisovati ženskam, ki jemljejo etinilestradiol, tj. vrsto estrogena, ki ga vsebujejo hormonska kontracepcijska sredstva.
English: Exviera is always used in combination with another medicine, Viekirax, which contains the active substances ombitasvir, paritaprevir and ritonavir.
Slovenian: Zdravilo Exviera se vedno uporablja v kombinaciji z zdravilom Viekirax, ki vsebuje zdravilne učinkovine ombitasvir, paritaprevir in ritonavir.
English: The European Medicines Agency noted that Exviera used in combination with Viekirax is effective in clearing the hepatitis C virus genotypes 1a and 1b from the blood with and without ribavirin.
Slovenian: Evropska agencija za zdravila je ugotovila, da zdravilo Exviera v kombinaciji z zdravilom Viekirax učinkovito odstranjuje virus hepatitisa C genotipov 1a in 1b iz krvi, in sicer v kombinaciji z ribavirinom in brez njega.
English: In a seventh study, patients with liver scarring but stable liver function (compensated cirrhosis) who had genotype 1b infection were treated with Exviera and Viekirax without ribavirin and 100% of patients (60 out of 60 patients) had their blood cleared of the virus.
Slovenian: V sedmi študiji so bolnike s cirozo jeter in stabilnim delovanjem jeter (kompenzirano cirozo), okužene z genotipom 1b, zdravili z zdraviloma Exviera in Viekirax brez ribavirina in pri 100 % (60 od 60) bolnikov je bil virus odstranjen iz krvi.
English: In patients with liver scarring, Exviera treatment in combination with Viekirax and ribavirin resulted in a clearance rate of between 93% and 100% after 24 weeks of treatment.
Slovenian: Pri bolnikih s cirozo jeter, ki so prejemali zdravilo Exviera v kombinaciji z zdravilom Viekirax in ribavirinom, je bil po 24 tednih zdravljenja virus odstranjen pri 93-100 % bolnikov.
English: Some patients taking Exviera are also treated with another antiviral medicine, ribavirin, in addition to Viekirax.
Slovenian: Nekateri bolniki, ki jemljejo zdravilo Exviera, poleg zdravila Viekirax prejemajo tudi ribavirin, še eno protivirusno zdravilo.
English: Between 96% and 100% of patients without liver scarring had their blood cleared of the virus after 12 weeks of treatment (with or without ribavirin).
Slovenian: Pri 96-100 % bolnikov brez ciroze jeter po 12 tednih zdravljenja (brez ribavirina ali v kombinaciji z njim) ni bilo zaznati virusa v krvi.
English: The company that markets Exviera will carry out a study in patients who previously have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as
Slovenian: Družba, ki trži zdravilo Exviera, bo za oceno tveganja ponovitve raka jeter po zdravljenju z neposredno delujočimi protivirusnimi zdravili, kot je zdravilo Exviera, izvedla študijo pri bolnikih, ki so preboleli raka jeter.
English: How is Exviera used?
Slovenian: Kako se zdravilo Exviera uporablja?
English: How does Exviera work?
Slovenian: Kako zdravilo Exviera deluje?
English: It is generally given once a day, except in life-threatening situations.
Slovenian: Načeloma se daje enkrat dnevno, razen v življenjsko nevarnih situacijah.
English: Nonafact can be used in adults and children over the age of 6.
Slovenian: Nonafact se lahko uporablja pri odraslih in otrocih, starih več kot 6 let.
English: Patients may sometimes be able to give the medicine themselves after suitable training.
Slovenian: Bolniki si lahko dajo zdravilo sami, potem ko so bili za to ustrezno usposobljeni.
English: The full EPAR for Nonafact 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) za zdravilo Nonafact je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Nonafact on 3 July 2001.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Nonafact, veljavno po vsej Evropski uniji, izdala 3. julija 2001.
English: This is a summary of the European public assessment report (EPAR) for Nonafact.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Nonafact.
English: Most patients had severe haemophilia B. The studies assessed the number of major or life-threatening bleeding episodes that occurred during treatment, or during and after surgery.
Slovenian: Večina bolnikov je imela hudo hemofilijo B. V študijah so ocenjevali število večjih ali življenjsko nevarnih epizod krvavitev, do katerih je prišlo med zdravljenjem ali med kirurškim posegom in po njem.
English: If this happens Nonafact may not work effectively.
Slovenian: Če do tega pride, zdravilo Nonafact morda ne bo več učinkovito delovalo.
English: What measures are being taken to ensure the safe and effective use of Nonafact?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Nonafact?
English: Treatment should be started under the supervision of a doctor with experience in treating haemophilia.
Slovenian: Zdravljenje se lahko uvede le pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem hemofilije.
English: Nonafact is intended for either short-term or long-term use.
Slovenian: Namenjen je za kratkotrajno ali dolgotrajno uporabo.
English: Nonafact human coagulation factor IX
Slovenian: Nonafact humani koagulacijski faktor IX
English: For more information about treatment with Nonafact, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Nonafact preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: 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 Nonafact.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: In the body, factor IX is one of the substances (factors) needed for blood coagulation (clotting).
Slovenian: Faktor IX je ena izmed snovi (faktorjev) v telesu, potrebnih za koagulacijo (strjevanje) krvi.
English: Nonafact has been studied in two clinical studies, including 26 patients who received Nonafact as a prevention treatment (for example before extensive exercise), and 8 patients who received Nonafact during 11 surgical interventions.
Slovenian: Zdravilo Nonafact so proučevali v dveh kliničnih študijah, ki sta zajeli 26 bolnikov, ki so prejemali Nonafact kot preventivno terapijo (npr. pred obsežno telesno vadbo), in nadaljnjih 8 bolnikov, ki so zdravilo Nonafact prejeli med 11 kirurškimi posegi.
English: The full detail on how to calculate the doses is included in the package leaflet.
Slovenian: Podrobni podatki o tem, kako izračunati ustrezni odmerek, so na voljo v navodilu za uporabo.
English: A risk management plan has been developed to ensure that Nonafact is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Nonafact je bil pripravljen načrt obvladovanja tveganj.