FrancophonIA/ELRC3.0 huggingface dataset:
English: Butylated hydroxytoluene (E321)
Slovenian: Zdravilo Altargo vsebuje butilhidroksitoluen (E321)
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
English: In 14-day (50, 150 or 450 mg/kg) oral toxicity studies in rats there was evidence of adaptive hepatic and thyroid changes.
Slovenian: Pri podganah so pri 14-dnevnih študijah toksičnosti pri peroralni uporabi (50, 150 ali 450 mg/kg) opazili adaptivne spremembe v jetrih in ščitnici.
English: In a study conducted in healthy adult subjects, 10 mg/g retapamulin ointment was applied daily to intact and to abraded skin under occlusion for up to 7 days.
Slovenian: V študiji, opravljeni pri zdravih odraslih preiskovancih, so osebe dnevno nanašale retapamulin 10 mg/g mazila na zdravo in poškodovano kožo pod obvezo.
English: If you get any side effects, talk to your doctor, nurse or pharmacist.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Sampling occurred pre-dose for adult subjects on days 3 or 4, and between 0-12 hours after the last application for paediatric subjects on days 3 or 4.
Slovenian: Vzorci so bili pri odraslih odvzeti 3. ali 4. dan zdravljenja pred nanosom odmerka, pri otrocih pa 3. ali 4. dan zdravljenja od 0 do 12 ur po zadnjem nanosu.
English: Maternal toxicity was demonstrated at dosages of ≥ 7.2 mg/kg/day corresponding to ≥ 8 times the estimated human exposure (see above).
Slovenian: Pri odmerkih ≥ 7,2 mg/kg/dan, kar ustreza ≥ 8-kratni pričakovani izpostavljenosti človeka (glejte zgoraj), so ugotovili toksičnost za mater.
English: However, see section 4.4 and below regarding clinical efficacy against MRSA.
Slovenian: O klinični učinkovitosti proti MRSA glejte poglavje 4.4 in podatke v nadaljevanju.
English: The excretion of retapamulin in milk has not been studied in animals.
Slovenian: Pri živalih izločanja retapamulina z mlekom niso raziskovali.
English: Retapamulin elimination in humans has not been investigated.
Slovenian: Izločanje Izločanja retapamulina pri človeku niso raziskovali.
English: In monkeys dosed orally (50, 150 or 450 mg/kg) for 14 days there was dose-related emesis.
Slovenian: Pri opicah so pri 14-dnevnem peroralnem dajanju (50, 150 ali 450 mg/kg) opazili od odmerka odvisen
English: However, since plasma concentrations of retapamulin during topical application have been low (see section 5.2), it is not expected that concurrent systemic administration of CYP3A4 substrates will result in clinically important inhibition of their metabolism by retapamulin.
Slovenian: Vendar je bila koncentracija retapamulina v plazmi med lokalno uporabo majhna (glejte poglavje 5.2), zato ni pričakovati, da bi retapamulin pomembno zavrl presnovo sočasno sistemsko uporabljenih substratov
English: Each gram contains 10 mg retapamulin (1% w/w)
Slovenian: En gram vsebuje 10 mg retapamulina (1 % m/m).
English: Contact dermatitis
Slovenian: Kontaktni dermatitis Reakcije na mestu uporabe
English: Check with your doctor or pharmacist if
Slovenian: Posvetujte se s svojim zdravnikom ali s farmacevtom.
English: Uncommon side effects (may affect up to 1 in 100 people): - pain, itching, redness or rash (contact dermatitis) Other side effects (frequency not known, cannot be estimated from the available data):
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 oseb): - bolečina, srbenje, rdečina ali izpuščaj (kontaktni dermatitis).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 0.5 g SACHET
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA 0,5 g VREČICO
English: Do not apply other ointments, creams or lotions to the area being treated with Altargo unless specifically instructed to do so by your doctor.
Slovenian: Na predel, kjer uporabljate zdravilo Altargo, ne nanašajte drugih mazil, krem ali losjonov, razen če vam tako izrecno svetuje zdravnik.
English: $ In vitro, retapamulin was equally active against methicillin-susceptible and methicillin-resistant strains of S. aureus.
Slovenian: $ In vitro je bila učinkovitost retapamulina proti meticilinu občutljivim in proti meticilinu odpornim sevom S. aureus enaka.
English: Apply to the affected area as directed by your doctor.
Slovenian: Nanesite na prizadeti predel kože v skladu z zdravnikovimi navodili.
English: 4.4 Special warnings and precautions for use
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Preobčutljivost ali hudo lokalno draženje
English: There was no treatment-related effect on embryofetal development.
Slovenian: Z uporabo zdravila povezanih učinkov na razvoj zarodkov ali plodov niso ugotovili.
English: The area treated may be covered with sterile bandage or gauze dressing.
Slovenian: Zdravljeni predel se lahko obveže s sterilno obvezo ali prekrije s sterilno gazo.
English: The geometric mean Cmax value in plasma after application to 200 cm2 of abraded skin was 9.75 ng/ml on day 1 and 8.79 ng/ml on day 7, and the maximum individual systemic exposure (Cmax) recorded was 22.1 ng/ml.
Slovenian: Geometrijska srednja vrednost Cmax v plazmi je bila po nanosu na 200 cm2 veliko površino poškodovane kože na 1. dan 9,75 ng/ml, na 7. dan pa 8,79 ng/ml.
English: A thin layer of ointment should be applied to the affected area twice daily for five days.
Slovenian: Na prizadeti predel kože je treba nanesti tanko plast mazila dvakrat na dan. Zdravljenje traja pet dni.
English: Retapamulin ointment must be kept away from the eyes and mucous membranes.
Slovenian: Mazilo z retapamulinom ne sme priti v stik z očmi ali s sluznicami.
English: Systemic exposure to retapamulin has been low following topical application of 10 mg/g ointment in adult and paediatric patients aged 2 years and older (maximum plasma concentration < 20 ng/mL).
Slovenian: Po lokalni uporabi 10 mg/g mazila pri odraslih bolnikih in pediatričnih bolnikih, starih 2 leti ali več, je bila sistemska izpostavljenost retapamulinu majhna (največja koncentracija v plazmi < 20 ng/ml).
English: There were no treatment
Slovenian: Zdravljenje vseh okužb je bilo
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of ointment contains 10 mg retapamulin (1% w/w).
Slovenian: En gram mazila vsebuje 10 mg retapamulina (1 % m/m).
English: NAME OF THE MEDICINAL PRODUCT Altargo 10 mg/g ointment
Slovenian: IME ZDRAVILA Altargo 10 mg/g mazilo
English: Methicillin-resistant Staphylococcus aureus (MRSA) Retapamulin should not be used to treat infections known or thought likely to be due to MRSA (see In clinical studies of secondarily infected open wounds, the efficacy of retapamulin was inadequate in patients with infections caused by MRSA.
Slovenian: Proti meticilinu odporni Staphylococcus aureus (MRSA) Retapamulin se ne sme uporabljati za zdravljenje okužb, ki so ali bi lahko bile posledica okužbe z MRSA (glejte poglavje 5.1).
English: Retapamulin selectively inhibits bacterial protein synthesis by interacting at a unique site on the 50S subunit of the bacterial ribosome that is distinct from the binding sites of other non-pleuromutilin antibacterial agents that interact with the ribosome.
Slovenian: Retapamulin selektivno zavira sintezo bakterijskih proteinov z učinkovanjem na edinstveno mesto 50S
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Altargo 10 mg/g ointment
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Altargo 10 mg/g mazilo
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 24. maj 2007
English: In an embryotoxicity study in rats, developmental toxicity (decreased fetal body weight and delayed skeletal ossification) and maternal toxicity were observed at oral doses of ≥ 150 mg/kg/day
Slovenian: Pri študijah embriotoksičnoti na podganah so pri peroralnih odmerkih ≥ 150 mg/kg/dan (kar ustreza ≥ 3-kratni pričakovani izpostavljenosti človeka (glejte zgoraj)) opazili škodljiv vpliv na razvoj (manjša telesna masa plodov in zakasnela osifikacija skeleta) in škodljiv vpliv na matere.
English: Elderly (aged 65 and older)
Slovenian: Starejši bolniki (stari 65 let in starejši) Odmerka ni treba prilagajati.
English: However, there were no systemic effects on juvenile rats with topical application of retapamulin ointment.
Slovenian: Pri mladih podganah pri lokalni uporabi retapamulina v obliki mazila niso opazili sistemskih učinkov.
English: Immune system disorders
Slovenian: Protibakterijski spekter
English: NAME OF THE MEDICINAL PRODUCT Altargo 10 mg/g ointment Retapamulin
Slovenian: IME ZDRAVILA Altargo 10 mg/g mazilo retapamulin
English: Co-administration of oral ketoconazole 200mg twice daily increased mean retapamulin AUC(0-24) and Cmax by 81% after topical application of retapamulin 10 mg/g ointment on the abraded skin of healthy adult males.
Slovenian: Pri sočasni peroralni uporabi ketokonazola v odmerku 200 mg dvakrat na dan in lokalni uporabi retapamulin 10 mg/g mazila na poškodovani koži sta se pri zdravih odraslih moških srednji vrednosti
English: Pruritus Erythema
Slovenian: Srbenje Eritem
English: Retapamulin was given as a continuous intravenous infusion to pregnant rabbits from day 7 to day 19 of gestation.
Slovenian: Breje kunčje samice so prejemale retapamulin v obliki kontinuirane intravenske infuzije od 7. do
English: In clinical studies in which 2150 patients with superficial skin infections applied Altargo, the most commonly reported adverse reaction was application site irritation, which affected approximately 1%
Slovenian: V kliničnih študijah je zdravilo Altargo uporabljalo 2.150 bolnikov s povrhnjimi okužbami kože.
English: Systemic exposure following topical application of retapamulin through intact skin was very low.
Slovenian: Pri lokalni uporabi retapamulina na zdravi koži je bila sistemska izpostavljenost zelo majhna.
English: Talk to your doctor or pharmacist before using Altargo.
Slovenian: Pred začetkom jemanja zdravila Altargo se posvetujte z zdravnikom ali farmacevtom.
English: Clinical Success rates at Follow-up for Intent to Treat Bacteriological Evaluable SIOW subjects with S. aureus and S. pyogenes
Slovenian: Deleži klinične uspešnosti med spremljanjem pri preizkušancih s sekundarnimi okužbami odprtih ran s S. aureus in S. pyogenes, ki so jih nameravali zdraviti in pri katerih je bila mogoča
English: There was no evidence of impaired fertility in male or female rats at oral doses of 50, 150, or 450 mg/kg/day, resulting in exposure margins of up to 5-times the highest human estimated exposure (topical application to 200 cm2 abraded skin: AUC 238 ng.h/ml).
Slovenian: Pri samcih in samicah podgan, ki so peroralno prejemali odmerke 50, 150 ali 450 mg/kg/dan, kar predstavlja do 5-krat večjo mejno izpostavljenost od največje pričakovane izpostavljenosti človeka
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients White soft paraffin
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi beli vazelin butilhidroksitoluen (E321) 6.2 Inkompatibilnosti Navedba smiselno ni potrebna.
English: • contact your doctor or pharmacist immediately.
Slovenian: • zdravilo Altargo prenehajte uporabljati; • nemudoma se posvetujte s svojim zdravnikom ali farmacevtom.
English: Cephalexin n/N Success
Slovenian: Cefaleksin n/N Delež uspešnosti natančen IZ
English: See sections 4.4 and 5.1 for important information regarding the clinical activity of retapamulin against different types of Staphylococcus aureus.
Slovenian: Za pomembne informacije o klinični učinkovitosti retapamulina proti različnim tipom
English: See package leaflet for further information
Slovenian: Za dodatne informacije glejte navodilo za uporabo.
English: Distribution
Slovenian: Absorpcija
English: No development of resistance was observed during treatment with retapamulin in the clinical study programme and all clinical isolates were inhibited by retapamulin concentrations of <2 µg/ml.
Slovenian: Pri vseh kliničnih izolatih je bila inhibicija dosežena pri koncentraciji retapamulina ≤ 2 µg/ml.
English: Package leaflet: Information for the patient Altargo 10 mg/g ointment Retapamulin
Slovenian: Navodilo za uporabo Altargo 10 mg/g mazilo retapamulin
English: The maximum measured plasma concentration of retapamulin was 10.7 ng/ml in adults and 18.5 ng/ml in paediatric patients
Slovenian: Pri odraslih je bila največja izmerjena koncentracija retapamulina v plazmi 10,7 ng/ml, pri otrocih, starih od 2 do 17 let, pa 18,5 ng/ml.
English: Clinical Success Rates at Follow up for SIOW patients with S. aureus Phenotype/PFGE type
Slovenian: Deleži klinične uspešnosti pri spremljanju bolnikov s sekundarnimi okužbami odprtih ran s S. aureus
English: Retapamulin MICs of 2-64 µg/ml have been reported for clinical isolates of S. aureus possessing either the efflux or cfr resistance mechanisms described above.
Slovenian: V kliničnih izolatih S. aureus, ki so imeli zgoraj opisana mehanizma iztočne odpornosti ali odpornosti
English: Among the children aged from 9 months to 2 years plasma concentrations of retapamulin were measurable in 32% (16/50) of samples.
Slovenian: Pri otrocih v starosti od 9 mesecev do 2 let je bila koncentracija retapamulina v plazmi merljiva v
English: Each gram of ointment contains 10 milligrams of - The other ingredients are white soft paraffin and butylated hydroxytoluene (E321), a
Slovenian: - Pomožni snovi sta beli vazelin in konzervans butilhidroksitoluen (E321).
English: - If you have any further questions, ask your doctor or pharmacist - This medicine has been prescribed for you only.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
English: GlaxoSmithKline Pharmaceuticals s.a./n.v.
Slovenian: GlaxoSmithKline - Produtos Farmacêuticos, Lda
English: What Altargo looks like and contents of the pack Altargo is a smooth, off-white ointment.
Slovenian: Izgled zdravila Altargo in vsebina pakiranja
English: - The active substance is retapamulin.
Slovenian: Kaj vsebuje zdravilo Altargo - Zdravilna učinkovina je retapamulin.
English: Epistaxis has been reported with use of Altargo on nasal mucosa.
Slovenian: Ob uporabi zdravila Altargo na nosni sluznici so poročali o epistaksi.
English: If you use more Altargo than you should
Slovenian: Če ste uporabili večji odmerek zdravila Altargo, kot bi smeli Preveliko količino mazila previdno obrišite.
English: No differences were observed in the in vitro activity of retapamulin versus S. aureus whether the isolates were susceptible or resistant to methicillin.
Slovenian: Pri in vitro ugotavljanju učinkovitosti retapamulina proti meticilinu občutljivim in proti meticilinu odpornim sevom S. aureus
English: • Impetiginous lesions >10 in number and exceeding 100 cm2 in total surface area.
Slovenian: Pri naslednjih stanjih varnosti in učinkovitosti niso dokazali: • impetiginizirane spremembe, katerih število je večje od 10, in skupaj presegajo 100 cm2
English: − early recognition and intervention may improve outcome
Slovenian: − zgodnje prepoznavanje in ukrepanje lahko izboljša izid.
English: Currently available data are described in sections 4.8 and 5.1
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavjih 4.8 in 5.1.
English: Date of first authorisation: 27th June 2006 Date of latest renewal: 18th April 2016
Slovenian: Datum prve odobritve: 27. junij 2006 Datum zadnjega podaljšanja: 18. april 2016
English: Effects on laboratory tests
Slovenian: Učinki na laboratorijske teste
English: Median age was 37 years, with a median disease duration of 5 years.
Slovenian: Povprečna starost je bila 37 let, povprečno trajanje bolezni pa 5 let.
English: • Information about any registry or other monitoring system set up in the Member State and how to enter patients
Slovenian: • Informacije o kateremkoli registru ali drugem sistemu spremljanja, ki je bil uveden v državi članici, in o načinu vključevanja bolnikov.
English: The diagnosis and management of IRIS is a controversial issue and there is no consensus concerning its treatment.
Slovenian: Diagnoza in obvladovanje IRIS sta sporni temi in ni soglasja glede zdravljenja.
English: Mean EDSS scores remained stable over 5 years.
Slovenian: Srednji rezultati EDSS so ostali stabilni 5 let.
English: Combination with other DMTs.
Slovenian: Kombinacija z drugimi DMT.
English: Teriflunomide is eliminated slowly from the plasma.
Slovenian: Teriflunomid se počasi izloča iz plazme.
English: Serious cases of ARN, either affecting one or both eyes, led to blindness in some patients.
Slovenian: Resni primeri ARN, bodisi na enem bodisi na obeh očesih, so pri nekaterih bolnikih povzročili slepoto.
English: • If your doctor tells you that you have a serious problem with your immune system (due to disease for example, HIV or due to a medicine you are taking or have previously taken
Slovenian: • če vam je zdravnik povedal, da imate resne težave s svojim imunskim sistemom (zaradi bolezni, npr. HIV, ali zaradi zdravil, ki jih jemljete ali ste jih jemali).
English: It is important that you keep this Alert Card and show it to your partner or caregivers.
Slovenian: Pomembno je, da to opozorilno kartico za bolnika shranite in jo pokažete svojemu partnerju ali negovalcu.
English: The treatment initiation form should contain the following elements:
Slovenian: Obrazec za uvedbo zdravljenja naj vsebuje naslednje elemente:
English: Prophylactic steroid treatment is currently not recommended.
Slovenian: Profilaktično zdravljenje s steroidi trenutno ni priporočljivo.
English: No prospective clinical studies have been completed to validate these findings.
Slovenian: Za potrditev teh ugotovitev niso bile opravljene nobene prospektivne klinične študije.
English: To switch from some MS medicines, your doctor may advise you to wait for a certain time to ensure that most of the previous medicine has left your body.
Slovenian: Pri prehodu z nekaterih zdravil za MS vam bo zdravnik mogoče svetoval, da določen čas počakate, da bo večina predhodnega zdravila odstranjena iz vašega telesa.
English: • Possibility of other opportunistic infections
Slovenian: • Možnost drugih oportunističnih okužb.
English: Without an accelerated elimination procedure, clearance of teriflunomide from plasma can take from several months up to 2 years.
Slovenian: Brez pospešenega postopka izločanja lahko očistek teriflunomida iz plazme traja od več mesecev do 2 leti.
English: • The need to inform the National Competent Authority about any cases of PML
Slovenian: • Potreba po obveščanju pristojnih nacionalnih organov o vseh primerih PML.
English: Within the limitations of these data, there were no new safety signals identified in this patient population.
Slovenian: Upoštevajoč omejitve teh podatkov v tej skupini bolnikov niso ugotovili nobenih novih varnostnih signalov.
English: • Switching usually occurred after 1 year (median of 25 standard interval doses) in the secondary definition
Slovenian: • Do zamenjave je običajno prišlo po enem letu (mediana 25 standardnih intervalov odmerjanja) v sekundarni opredelitvi.
English: Alemtuzumab has profound prolonged immunosuppressive effects.
Slovenian: Alemtuzumab ima močne dolgotrajne imunosupresivne učinke.
English: Tell your doctor if you are taking or have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: The safety and efficacy of TYSABRI in children and adolescents up to 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila TYSABRI pri otrocih in mladostnikih, starih do 18 let, nista bili dokazani.
English: • If you are taking medicines that suppress or modulate the immune system including other medicines used to treat MS disease.
Slovenian: • če jemljete zdravila, ki zavirajo ali uravnavajo imunski sistem, vključno z drugimi zdravili, ki se uporabljajo za zdravljenje MS.
English: However, it has recently been suggested that corticosteroids may be useful to treat IRIS, particularly in patients with severe to life-threatening IRIS (Tan et al., 2009, Clifford et al., 2010).
Slovenian: Kljub temu se je nedavno pojavilo mnenje, da so lahko pri zdravljenju IRIS koristni kortikosteroidi, zlasti pri bolnikih s hudo do življenje ogrožajočo obliko IRIS (Tan et al., 2009, Clifford et al., 2010).
English: Analysis of STRATIFY JCV showed the prevalence of anti-JCV antibodies to be approximately 55%.
Slovenian: Analiza STRATIFY JCV je pokazala, da prevalenca protiteles proti JCV znaša približno 55 %.
English: This active ingredient is called a monoclonal antibody.
Slovenian: Ta učinkovina se imenuje monoklonsko protitelo.
English: • A reminder regarding serious infections and the need to speak to their doctor if they have severe persistent infection
Slovenian: • Navodilo glede resnih okužb in potrebe po posvetovanju z zdravnikom v primeru vztrajne hude okužbe.
English: Show the Alert Card and this package leaflet to any doctor involved with your treatment, not only to your neurologist.
Slovenian: Opozorilno kartico za bolnika pokažite vsem zdravnikom, ki sodelujejo pri vašem zdravljenju, ne samo vašemu nevrologu.
English: The majority (85%) of patients dosed with EID had received the approved dosing for ≥1 year prior to switching to EID.
Slovenian: Večina (85 %) bolnikov, ki so prejemali PIO, je pred prehodom na PIO prejemala odobreno odmerjenje ≥ 1 leto.
English: Before you start treatment with TYSABRI, it is important that you and your doctor have discussed the benefits you would expect to receive from this treatment and the risks that are associated with it.
Slovenian: Preden začnete z zdravljenjem z zdravilom TYSABRI, je pomembno, da se z zdravnikom pogovorite o pričakovanih koristih tega zdravljenja in o tveganjih, ki so z njim povezana.
English: In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.
Slovenian: Z namenom izboljšanja sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
English: • Severe allergy (hypersensitivity)
Slovenian: • huda alergija (preobčutljivost)
English: concentrate for solution for infusion 1 x 15 ml vial
Slovenian: koncentrat za raztopino za infundiranje 1 x 15 ml viala
English: In the MS population, anti-JCV antibody prevalence increased with age and was lower in women than in men in all cohorts tested.
Slovenian: V populaciji z MS se je prevalenca protiteles proti JCV zviševala s starostjo in je bila v vseh testiranih kohortah nižja pri ženskah kot pri moških.
English: In the postmarketing setting, the risk of PML has been well characterized over the first 6 years of treatment with the identification of different levels of PML risk in different patient subgroups.
Slovenian: V obdobju trženja je bilo tveganje za razvoj PML dobro opredeljeno za prvih 6 let zdravljenja z določitvijo različnih stopenj tveganja za PML pri različnih podskupinah bolnikov.
English: If utilising extended interval dosing, caution is required because the efficacy of extended interval dosing has not been established and the associated benefit risk balance is currently unknown (see section 5.1).
Slovenian: V primeru uporabe podaljšanega intervala odmerjanja je potrebna previdnost, saj učinkovitost podaljšanega intervala odmerjanja ni bila ugotovljena, razmerje med koristmi in tveganji pa je trenutno neznano (glejte poglavje 5.1).
English: The MAH shall implement agreed measures for monitoring within a time frame agreed with the National Competent Authorities.
Slovenian: Imetnik dovoljenja za promet z zdravilom dogovorjene ukrepe za spremljanje izpolni v časovnem okviru, določenem v dogovoru s pristojnimi nacionalnimi organi.
English: Proportion progressed1(12-week confirmation; primary outcome)
Slovenian: Prizadetosti Delež napredovanja1 (potrditev po 12 tednih; primarni izid)
English: • Risk management plan (RMP)
Slovenian: ZDRAVILA • Načrt za obvladovanje tveganj (RMP)