FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacokinetics are linear in the range of 50 - 800 mg single dose and up to 600 mg once daily dosing over 10 days.
Slovenian: Farmakokinetika je linearna po zaužitju enkratnega odmerka v razponu 50 - 800 mg in med desetdnevnim jemanjem do 600 mg enkrat na dan. Koncentracija je največja pol do štiri ure po zaužitju 400 mg peroralnega odmerka in znaša 3,1 mg/l.
English: Therefore in such cases empirical moxifloxacin should be co-administered with another appropriate antibiotic (e.g. a cephalosporin) unless moxifloxacin-resistant Neisseria gonorrhoeae can be excluded.
Slovenian: V takšnih primerih je treba moksifloksacin uporabiti empirično hkrati z drugim ustreznim antibiotikom (npr. cefalosporinom), razen če je mogoče izključiti prisotnost proti moksifloksacinu odporne bakterije Neisseria gonorrhoeae.
English: Moxifloxacin is eliminated from plasma with a mean terminal half life of approximately 12 hours.
Slovenian: Povprečna končna razpolovna doba izločanja moksifloksacina iz plazme je približno 12 ur.
English: Bayer HealthCare AG 51368 Leverkusen Germany
Slovenian: Bayer HealthCare AG 51368 Leverkusen Nemčija
English: It is approved for the treatment of the following bacterial infections if they are caused by bacteria susceptible to moxifloxacin: - Acute exacerbation of chronic bronchitis - Community acquired pneumonia, except severe cases - Acute bacterial sinusitis (adequately diagnosed).
Slovenian: Zdravilo je odobreno za zdravljenje spodaj naštetih bakterijskih okužb, če jih povzročajo bakterije, občutljive na moksifloksacin: - akutnega poslabšanja kroničnega bronhitisa, - zunajbolnišnične pljučnica, razen v hudih primerih, - akutnega bakterijskega sinuzitisa (ustrezno diagnosticiranega).
English: - Taking oral medicinal charcoal at the same time as [Invented name] tablets reduces the action of [Invented name].
Slovenian: - Ker sočasno peroralno jemanje aktivnega oglja in tablet [izmišljeno ime] zmanjšuje delovanje zdravila [izmišljeno ime], sočasne uporabe ne priporočamo.
English: Concomitant administration of moxifloxacin with ranitidine or probenecid did not alter renal clearance of the parent drug.
Slovenian: Pri sočasni uporabi moksifloksacina in ranitidina ali probenecida se ledvični očistek prvotne učinkovine ni spremenil.
English: No adjustment of the dose is required in elderly patients, patients with a low bodyweight or in patients with kidney problems.
Slovenian: Starejšim bolnikom, bolnikom z majhno telesno maso in bolnikom z ledvičnimi težavami odmerka ni treba prilagajati.
English: 3 from 3 h up to 36 h post dose 4 at the end of infusion
Slovenian: 2 koncentracija nevezane učinkovine 3 3 do 36 ur po odmerku
English: In clinical practice, this would mean that moxifloxacin should be used in combination with an approved agent active against fluoroquinolone resistant N. gonorrhoeae (e.g. a cephalosporin) for empirical treatment of PID unless moxifloxacinresistant N. gonorrhoeae can be excluded.
Slovenian: V klinični praksi bi to pomenilo, da se moksifloksacin uporablja v kombinaciji z odobreno učinkovino proti N. gonorrhoeae, odporno na fluorokinolone, (npr. cefalosporinom) za empirično zdravljenje pelvičnih vnetnih bolezni, razen če je mogoče izključiti N. gonorrhoeae, odporno na moksifloksacin.
English: The magnitude of QT prolongation may increase with increasing concentrations of the drug.
Slovenian: Ker se z naraščajočimi koncentracijami zdravila dolžina podaljšanja dobe QT lahko poveča, se priporočenega odmerka ne sme prekoračiti.
English: - Moxifloxacin has been shown to prolong the QTc interval on the electrocardiogram in some patients.
Slovenian: - Elektrokardiogram nekaterih bolnikov je pokazal, da moksifloksacin podaljša interval QTc.
English: - You may develop diarrhoea whilst taking, or after taking, antibiotics including [Invented name].
Slovenian: - Med ali po jemanju antibiotikov (tudi zdravila [izmišljeno ime]) se lahko pojavi driska.
English: Medication that can reduce potassium levels should be used with caution in patients receiving moxifloxacin.
Slovenian: Pri bolnikih, ki jemljejo moksifloksacin, je treba zdravila, ki lahko zmanjšajo vrednosti kalija, uporabljati previdno.
English: - Quinolones are known to trigger seizures.
Slovenian: - Znano je, da kinoloni povzročajo epileptične napade.
English: Before you take [Invented name] …, Take special care …, Before taking [Invented name] 400 mg film-coated tablets).
Slovenian: Kaj morate vedeti ..., Bodite posebno pozorni..., Pred jemanjem zdravila [izmišljeno ime] 400 mg filmsko obložene tablete).
English: [Invented name] is used in adults for treating the following bacterial infections: - Sudden worsening of chronic bronchitis (acute exacerbation of chronic bronchitis) - Infection of the lungs (pneumonia) acquired outside the hospital, except severe cases - Acute infection of the sinuses (acute bacterial sinusitis) - Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease), including infections of the fallopian tubes and infections of the uterus mucous membrane.
Slovenian: [izmišljeno ime] se pri odraslih uporablja za zdravljenje naslednjih bakterijskih okužb: - nenadno poslabšanje kroničnega bronhitisa (akutna eksacerbacija kroničnega bronhitisa), - pljučnica (pnevmonija), pridobljena izven bolnišnice, razen hudih oblik, - akutna okužba obnosnih votlin (akutni bakterijski sinusitis), - blage do zmerne okužbe ženskih notranjih spolovil (medenična vnetna bolezen) ter okužbe jajcevodov in maternične sluznice.
English: [Invented name] 400 mg film-coated tablets are indicated for the treatment of the following bacterial infections: - Acute exacerbation of chronic bronchitis - Community acquired pneumonia, except severe cases - Acute bacterial sinusitis (adequately diagnosed) - Mild to moderate pelvic inflammatory disease (i.e. infections of female upper genital tract, including salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess.
Slovenian: Filmsko obložene tablete [izmišljeno ime] 400 mg so indicirane za zdravljenje naslednjih bakterijskih okužb: - akutne eksacerbacije kroničnega bronhitisa, - pljučnice, pridobljene v domačem okolju, razen hudih oblik, - akutnega bakterijskega vnetja obnosnih votlin (ustrezno diagnosticirano), - blaga do zmerna medenična vnetna bolezen (tj. okužbe ženskih notranjih genitalij, tudi salpingitis in endometritis), brez spremljajočega tuboovarijskega ali medeničnega abscesa.
English: For reasons of drug safety, moxifloxacin is therefore contraindicated in patients with: - Congenital or documented acquired QT prolongation - Electrolyte disturbances, particularly in uncorrected hypokalaemia - Clinically relevant bradycardia - Clinically relevant heart failure with reduced left-ventricular ejection fraction - Previous history of symptomatic arrhythmias Moxifloxacin should not be used concurrently with other drugs that prolong the QT interval (see also section 4.5).
Slovenian: Zaradi varnostnih razlogov je uporaba moksifloksacina kontraindicirana pri bolnikih s/z: - prirojenim ali dokazano pridobljenim podaljšanjem dobe QT, - motnjami elektrolitskega ravnotežja, zlasti z neizboljšano hipokaliemijo, - klinično pomembno bradikardijo, - klinično pomembnim srčnim popuščanjem in zmanjšano iztisno frakcijo levega prekata, - simptomatskimi aritmijami v anamnezi.
English: - Patients with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency are prone to haemolytic reactions when treated with quinolones.
Slovenian: - Ker so bolniki, ki imajo pomanjkanje glukoza-6-fosfat dehidrogenaze ali pa je ta motnja prisotna v družinski anamnezi, med zdravljenjem s kinoloni nagnjeni k hemolitičnim reakcijam, morajo moksifloksacin uporabljati previdno.
English: Tissue
Slovenian: Presnova
English: Liver function tests/investigations should be performed in cases where indications of liver dysfunction occur.
Slovenian: Pri bolnikih s sumom na moteno delovanje jeter je treba opraviti teste/preiskave o delovanju jeter.
English: Use should be with caution in patients with CNS disorders which may predispose to seizures or lower the seizure threshold.
Slovenian: Bolniki z motnjami centralnega živčnega sistema jih morajo uporabljati previdno, saj lahko povzročijo epileptične napade ali znižajo prag njihovega pojava.
English: Please contact your doctor before you continue the treatment if you develop signs such as rapidly feeling unwell and/or being sick associated with yellowing of the whites of the eyes, dark urine, itching of the skin, a tendency to bleed or liver induced disease of the brain (symptoms of a reduced liver function or a rapid and severe inflammation of the liver).
Slovenian: Če se razvijejo znaki, kot so nenadno slabo počutje in/ali slabotnost, porumenela beločnica, temen urin, srbenje kože, nagnjenost h krvavitvi ali zaradi jeter povzročena bolezen možganov (znaki zmanjšane jetrne funkcije ali nenadno in hudo vnetje jeter), prosimo, da se pred nadaljevanjem zdravljenja posvetujete z zdravnikom.
English: HOW TO TAKE [INVENTED NAME] 400 MG FILM-COATED TABLETS
Slovenian: KAKO JEMATI ZDRAVILO [IZMIŠLJENO IME] 400 MG FILMSKO OBLOŽENE TABLETE
English: However, studies have shown that moxifloxacin has a lower risk to induce photosensitivity.
Slovenian: - Ugotovili so, da kinoloni pri bolnikih povzročajo fotosenzitivne reakcije, vendar pa so s študijami dokazali, da je pri moksifloksacinu tveganje za nastanek fotosenzitivnosti manjše.
English: Aerobic Gram-negative micro-organisms Haemophilus influenzae*
Slovenian: Streptococcus pyogenes* (skupina A) aerobni, po Gramu negativni mikroorganizmi Haemophilus influenzae*
English: 8.2 mg/kg
Slovenian: 8,2 mg/kg nosni polipi
English: GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Slovenian: PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO
English: Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal
Slovenian: 2794-003 Carnaxide
English: - Elderly patients with renal disorders should use moxifloxacin with caution if they are unable to maintain adequate fluid intake, because dehydration may increase the risk of renal failure.
Slovenian: - Starejši bolniki z ledvičnimi motnjami, ki ne morejo skrbeti za zadosten vnos tekočine, morajo uporabljati moksifloksacin previdno.
English: - The Committee, in view of the presented data on efficacy and safety, considered that the Benefit / Risk balance for Avalox and associated names in the “ The treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis” with the restrictions concerning empirical monotherapy was favourable; - The CHMP, as a consequence, recommended the amendment of the Summary of Product Characteristics sections 4.1, 4.2, 4.3, 4.4, 5.1 and 5.2 and Package Leaflet relevant sections as set out in Annex III for Avalox and associated names (see Annex I).
Slovenian: - Odbor je ob upoštevanju predloženih podatkov o učinkovitosti in varnosti menil, da je razmerje med koristmi in tveganji za zdravilo Avalox in z njim povezana imena pri „zdravljenju blagih do zmernih pelvičnih vnetnih bolezni, tj. okužb zgornjega genitalnega trakta, vključno s salpingitisom in endometritisom“, upoštevaje omejitve glede empirične monoterapije, ugodno.
English: Renal/hepatic impairment
Slovenian: Motnje v delovanju ledvic/jeter
English: Take special care with [Invented name] 400 mg film-coated tablets
Slovenian: Bodite posebno pozorni pri jemanju zdravila [izmišljeno ime] 400 mg filmsko obložene tablete
English: The following peak concentrations (geometric mean) were observed following administration of a single oral dose of 400 mg moxifloxacin:
Slovenian: Po peroralnem zaužitju enkratnega 400 mg odmerka moksifloksacina so opazili naslednje največje koncentracije (geometrijsko povprečje):
English: 56.7 mg/kg
Slovenian: 56,7 mg/kg epitelijska tekočina
English: Moxifloxacin should be used with caution in patients with ongoing proarrhythmic conditions, such as acute myocardial ischaemia or QT prolongation as this may lead to an increased risk for ventricular arrhythmias (incl.
Slovenian: Pri bolnikih z napredujočimi proaritmičnimi stanji (npr. akutna miokardna ishemija ali podaljšanje dobe QT) je treba moksifloksacin uporabljati previdno, ker lahko ta stanja zvečajo tveganje za ventrikularne aritmije (vključno s torsade de pointes) in srčni zastoj (glejte tudi poglavje 4.3).
English: If you forget to take [Invented name] 400 mg film-coated tablets If you forget to take your tablet you should take it as soon as you remember on the same day.
Slovenian: Če ste pozabili vzeti tableto, jo morate vzeti isti dan takoj, ko se spomnite.
English: BE - Belgium Bayer s.a.-n.v. Avenue Louise 143
Slovenian: LU- Luksemburg Bayer s.a.-n.v.
English: Site: Plasma ratio
Slovenian: tkivo koncentracija razmerje tkivo:plazma plazma
English: Always take [Invented name] exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila [izmišljeno ime] natančno upoštevajte zdravnikova navodila.
English: Aerobic Gram-negative micro-organisms
Slovenian: Anaerobni mikroorganizmi
English: Following a 400 mg oral dose peak concentrations of 3.1 mg/l are reached within 0.5 - 4 h post administration.
Slovenian: Po dajanju 400 mg odmerka je AUC 35 mg⋅h/l.
English: Important information about some of the ingredients of [Invented name] 400 mg film-coated tablets [Invented name] tablets contain lactose.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila [izmišljeno ime] 400 mg filmsko obložene tablete
English: Maxillary sinus
Slovenian: 20,7 mg/l maksilarni sinus
English: Patients should be advised to contact their doctor prior to continuing treatment if signs and symptoms of fulminant hepatic disease develop such as rapidly developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy.
Slovenian: Če se razvijejo znaki in simptomi fulminantne jetrne bolezni (npr. hitro razvijanje astenije, zlatenica, temen urin, nagnjenost h krvavitvi ali jetrna encefalopatija), je treba bolnikom svetovati, da se pred nadaljevanjem zdravljenja posvetujejo z zdravnikom.
English: Duration of administration [Invented name] 400 mg film-coated tablets should be used for the following treatment durations: Acute exacerbation of chronic bronchitis
Slovenian: Če vam zdravnik ni predpisal drugače, je priporočeno trajanje zdravljenja z zdravilom [izmišljeno ime]: - nenadno poslabšanje kroničnega bronhitisa (akutna eksacerbacija kroničnega bronhitisa):
English: Acute sinusitis 7 days - Mild to moderate pelvic inflammatory disease 14 days
Slovenian: akutna eksacerbacija kroničnega bronhitisa: 5 - 10 dni, pljučnica, pridobljena v domačem okolju: 10 dni, akutno vnetje obnosnih votlin: 7 dni, blaga do zmerna medenilna vnetna bolezen: 14 dni.
English: BEFORE YOU TAKE [INVENTED NAME] 400 MG FILM-COATED TABLETS
Slovenian: Če ste pozabili vzeti zdravilo [izmišljeno ime] 400 mg filmsko obložene tablete
English: 3.1 mg/l
Slovenian: 3,1 mg/l slina
English: Therefore, take your [Invented name] tablet 6 hours before or after taking the other medicine.
Slovenian: Zato vzemite tablete [izmišljeno ime] šest ur pred ali po jemanju drugih zdravil.
English: Non-species related breakpoints*
Slovenian: > 1 mg/l mejne vrednosti za nespecifične vrste*
English: HU - Hungary
Slovenian: Madžarska
English: It contains the active
Slovenian: Vsebuje
English: This means that Filgrastim ratiopharm is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘reference medicine').
Slovenian: To pomeni, da je zdravilo Filgrastim ratiopharm podobno biološkemu zdravilu, ki je že odobreno v Evropski uniji (EU) in vsebujejo enako zdravilno učinkovino (t.i. „referenčno zdravilo“).
English: During the first 21-day chemotherapy cycle, patients treated with either Filgrastim ratiopharm or Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those receiving placebo.
Slovenian: Med prvim 21 dnevnim ciklom kemoterapije so imeli bolniki, zdravljeni bodisi z zdravilom Filgrastim ratiopharm ali Neupogen, hudo netropenijo v povprečju 1,1 dan, v primerjavi s 3,8 dnevi pri tistih, ki so prejemali placebo.
English: Other side effects may be seen in more than 1 patient in 10, depending on the condition that Filgrastim ratiopharm is being used for.
Slovenian: Pri več kot 1 bolniku izmed 10 se lahko pojavijo tudi drugi neželeni učinki, v odvisnosti od stanja, zaradi katerega se zdravilo Filgrastim ratiopharm uporablja.
English: The most common side effect with Filgrastim ratiopharm (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
Slovenian: Najpogostejši neželeni učinek zdravila Filgrastim ratiopharm (opažen pri več kot 1 bolniku izmed 10) je mišičnoskeletna bolečina (bolečina v mišicah in kosteh).
English: The European Commission granted a marketing authorisation valid throughout the EU for Filgrastim ratiopharm to ratiopharm GmbH on 15 September 2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Filgrastim ratiopharm, veljavno po vsej Evropski uniji, odobrila družbi ratiopharm GmbH dne 15. septembra 2008.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Filgrastim ratiopharm has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da je bilo v skladu z zahtevami Evropske unije dokazano, da ima zdravilo Filgrastim ratiopharm podoben profil kakovosti, varnosti in učinkovitosti kot zdravilo Neupogen.
English: The active substance in Filgrastim ratiopharm, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Slovenian: Učinkovina v zdravilu Filgrastim ratiopharm, filgrastim, je zelo podobna človeški beljakovini, imenovani granulocitne kolonije stimulirajoči faktor (granulocyte colony stimulating factor - G-CSF).
English: To study the safety of Filgrastim ratiopharm, two further studies were carried out in patients with lung cancer and with non-Hodgkin's lymphoma.
Slovenian: Za preučitev varnosti zdravila Filgrastim ratiopharm sta bili izvedeni še dve študiji z bolniki s pljučnim rakom in z neHodgkinovim limfomom.
English: Filgrastim ratiopharm can also be used in patients who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow.
Slovenian: Zdravilo Filgrastim ratiopharm se lahko uporablja tudi pri bolnikih, ki bi naj darovali matične celice za presaditev, za sproščanje teh celic iz kostnega mozga.
English: Treatment with Filgrastim ratiopharm and Neupogen brought about similar reductions in duration of severe neutropenia.
Slovenian: Zdravljenje z zdraviloma Filgrastim ratiopharm in Neupogen je privedlo do podobnega skrajšanja trajanja hude nevtropenije.
English: Filgrastim ratiopharm was compared to Neupogen and to placebo (a dummy treatment) in one main study involving 348 patients with breast cancer.
Slovenian: Zdravilo Filgrastim ratiopharm so primerjali z zdravilom Neupogen in placebom v eni glavni študiji, ki je vključevala 348 bolnikov z rakom dojke.
English: • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy (cancer treatment) that is cytotoxic (cell-killing);
Slovenian: • za skrajšanje trajanja nevtropenije (nizke ravni nevtrofilcev, vrste belih krvničk) in zmanjšanje pojava febrilne nevtropenije (nevtropenije s povišano telesno temperaturo) pri bolnikih, ki prejemajo kemoterapijo (zdravljenje proti raku), ki je citotoksična (ubija celice);
English: Filgrastim ratiopharm is used to stimulate the production of white blood cells in the following
Slovenian: Zdravilo Filgrastim ratiopharm se uporablja za spodbujanje tvorbe belih krvničk v naslednjih
English: Other information about Filgrastim ratiopharm:
Slovenian: Druge informacije o zdravilu Filgrastim ratiopharm:
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) FILGRASTIM RATIOPHARM
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) FILGRASTIM RATIOPHARM Povzetek EPAR za javnost
English: For more information on biosimilar medicines, see the question-and-answer
Slovenian: Za več informacij o podobnih bioloških zdravilih si oglejte dokument z vprašanji in odgovori, ki je na voljo tukaj.
English: • to treat persistent neutropenia in patients with advanced human immunodeficiency virus (HIV) infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Slovenian: • za zdravljenje netropenije pri bolnikih z napredovalo okužbo z virusom humane imunske pomanjkljivosti (HIV), z namenom zmanjšanja tveganja za bakterijske okužbe, ko druge oblike
English: What benefit has Filgrastim ratiopharm shown during the studies?
Slovenian: Kakšne koristi je zdravilo Filgrastim ratiopharm izkazalo med študijami?
English: Filgrastim ratiopharm is given by injection under the skin or infusion into a vein.
Slovenian: Zdravilo Cepivo Filgrastim ratiopharm se daje z injekcijo pod kožo ali infuzijo v veno.
English: For the full list of all side effects reported with Filgrastim ratiopharm, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Filgrastim ratiopharm, glejte navodilo za uporabo.
English: The Committee recommended that Filgrastim ratiopharm be given marketing
Slovenian: Odbor je priporočil, da se za zdravilo Filgrastim ratiopharm odobri dovoljenje za promet.
English: Filgrastim ratiopharm should not be used in people who may be hypersensitive (allergic) to filgrastim
Slovenian: Zdravila Rebetol se ne sme uporabljati pri ljudeh, ki utegnejo biti preobčutljivi za (alergični na) filgrastim ali katero koli drugo sestavino zdravila.
English: Filgrastim ratiopharm is a solution for injection or for infusion (drip into a vein).
Slovenian: Zdravilo Filgrastim ratiopharm je raztopina za injiciranje ali infundiranje (dajanje v veno).
English: Therefore, the CHMP's view was that, as for Neupogen, the benefit outweighs the identified risk.
Slovenian: Zaradi tega je CHMP menil, da so koristi zdravila Filgrastim ratiopharm, tako kot pri zdravilu Neupogen, večje od znanih tveganj.
English: What is the risk associated with Filgrastim ratiopharm?
Slovenian: Kakšna tveganja so povezana z zdravilom Filgrastim ratiopharm?
English: Filgrastim ratiopharm was studied to show that it is comparable to the reference medicine, Neupogen.
Slovenian: Zdravilo Filgrastim ratiopharm so preučevali, da bi dokazali, da je podobno referenčnemu zdravilu
English: Why has Filgrastim ratiopharm been approved?
Slovenian: Zakaj je bilo zdravilo Filgrastim ratiopharm odobreno?
English: Filgrastim ratiopharm is a ‘biosimilar' medicine.
Slovenian: Zdravilo Filgrastim ratiopharm je podobno biološko zdravilo.
English: The full EPAR for Filgrastim ratiopharm can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Filgrastim ratiopharm je na voljo tukaj.
English: The reference medicine for Filgrastim ratiopharm is Neupogen.
Slovenian: Referenčno zdravilo za zdravilo Filgrastim ratiopharm je zdravilo Neupogen.
English: How has Filgrastim ratiopharm been studied?
Slovenian: Kako je bilo zdravilo Filgrastim ratiopharm raziskano?
English: Filgrastim ratiopharm is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately.
Slovenian: vendar pa si ga lahko bolniki, ki ga prejemajo s podkožno injekcijo, dajejo tudi sami, pod pogojem, da so bili ustrezno usposobljeni.
English: What is Filgrastim ratiopharm used for?
Slovenian: Za kaj se zdravilo Filgrastim ratiopharm uporablja?
English: Therefore, the effectiveness of Filgrastim ratiopharm was shown to be
Slovenian: Tako je bilo dokazano, da je učinkovitost zdravila Filgrastim ratiopharm ekvivalentna učinkovitosti zdravila Neupogen.
English: How does Filgrastim ratiopharm work?
Slovenian: Kako zdravilo Filgrastim ratiopharm deluje?