natgillin/translations-raw huggingface dataset:
• She must use 2 methods of recommended contraception (see the ‘Contraception' section below and section 4.6) while she is taking Erivedge, unless she commits to not having sexual intercourse (abstinence),
(glejte spodnji odstavek ‘Kontracepcija' in poglavje 4.6), razen če se zaveže, da med tem časom ne bo imela nobenih spolnih odnosov (spolna abstinenca);
• if you are breast-feeding or plan to breast-feed during the course of treatment or during the 24 months after your final dose of this medicine.
• dojite ali načrtujete dojenje med zdravljenjem ali v 24 mesecih po zadnjem odmerku tega zdravila.
Not applicable.
= ni ocenljivo
For the laBCC cohort (n = 63), 94 % of patients had prior therapies including surgery (89 %), radiotherapy (27 %), and systemic/topical therapies (11 %).
V kohorti z lokalno napredovalim bazalnoceličnim karcinomom (n = 63) je bilo predhodno zdravljenih 94 % bolnikov; zdravljeni so bili z operacijo (89 %), radioterapijo (27 %) in sistemskimi/lokalnimi terapijami (11 %).
• Information for patients on the teratogenic risks associated with Erivedge and the need to avoid foetal exposure
• Informacijo za bolnike glede teratogenih tveganj, povezanih z zdravilom Erivedge, in potrebo po izogibanju izpostavljenosti ploda zdravilu
Due to the risk of embryo-foetal death or severe birth defects caused by vismodegib, women taking Erivedge must not be pregnant or become pregnant during treatment and for 24 months after the final dose (see sections 4.3 and 4.4).
Zaradi tveganja za embrio-fetalno smrt ali hude prirojene napake, ki jih povzroči vismodegib, ženske, ki prejemajo zdravilo Erivedge, ne smejo biti noseče ter ne smejo zanositi med zdravljenjem in še
Clinically significant PK interactions between vismodegib and pH elevating agents are not expected.
Klinično pomembnega farmakokinetičnega medsebojnega delovanja med vismodegibom in zdravili, ki zvišujejo pH, ni pričakovati.
SPECIAL STORAGE CONDITIONS Do not store above 30 °C
Shranjujte pri temperaturi do 30 °C
• Not to give Erivedge to any other person
• Opozorilo, da zdravila Erivedge ne smejo dati drugim
Musculoskeletal chest pain
Ploščatocelični karcinom kože
If you forget to take Erivedge Do not take a double dose to make up for a forgotten dose, but resume with the next scheduled dose.
Ne vzemite dvojnega odmerka, da bi nadoknadili izpuščeni odmerek.
Nervous system disorder
Organski sistem po MedDRA
What Erivedge is used for
Za kaj uporabljamo zdravilo Erivedge
Increased number of degenerating germ cells and hypospermia in sexually immature dogs observed at ≥ 50 mg/kg/day in the 4-week general toxicity study was of undetermined relationship to vismodegib.
V 4-tedenski študiji splošne toksičnosti so pri spolno nezrelih psih pri odmerkih, ≥ 50 mg/kg/dan, opazili povečano število degeneriranih zarodnih celic in hipospermijo, vendar povezave z vismodegibom niso mogli določiti.
WCBP must be able to comply with effective contraceptive measures.
Ženske v rodni dobi Ženske v rodni dobi morajo biti sposobne zadostiti vsem zahtevam glede učinkovite kontracepcije.
At least one case of Stevens-Johnson syndrome/Toxic epidermal necrolysis (SJS/TEN), 2 cases of Drug reaction with eosinophilia and systemic symptoms (DRESS) and one case of acute generalised exanthematous pustulosis (AGEP) are causally related to the treatment, based on clinical and pathological features, and the compatible temporal relationship.
Glede na klinične in patološke značilnosti ter časovno povezanost so z zdravljenjem vzročno povezani vsaj en primer Stevens-Johnsonovega sindroma/toksične epidermalne nekrolize (SJS/TEN), 2 primera reakcije na zdravilo z eozinofilijo in sistemskimi simptomi (drug reaction with eosinophilia and systemic symptoms - DRESS) ter en primer akutne generalizirane eksantemske pustuloze (AGEP).
Erivedge may cause embryo-foetal death or severe birth defects when administered to a pregnant woman (see section 4.4).
Nosečnost Če je zdravilo Erivedge uporabljeno pri nosečnici, lahko povzroči embrio-fetalno smrt ali hude prirojene napake (glejte poglavje 4.4).
She must use two methods of recommended contraception including one highly effective method and a barrier method during Erivedge therapy and for 24 months after the final dose.
Med zdravljenjem z zdravilom Erivedge in še 24 mesecev po zadnjem odmerku tega zdravila morajo uporabljati dva načina priporočene kontracepcije, vključno z enim visokoučinkovitim načinom in enim pregradnim načinom.
The major elimination pathways of vismodegib involve hepatic metabolism and biliary/intestinal secretion.
Glavne poti izločanja vismodegiba vključujejo jetrno presnovo in izločanje preko žolča/črevesja.
See leaflet for further information
Za dodatne informacije glejte navodilo za uporabo
Clinically significant PK interactions between vismodegib and P-gp inhibitors are not expected.
Klinično pomembnega farmakokinetičnega medsebojnega delovanja med vismodegibom in zaviralci P-glikoproteina (P-gp) ni pričakovati.
There was no evidence of genotoxicity in in vitro assays (reverse bacterial mutagenesis [Ames] and human lymphocyte chromosome aberration assays) or in the in vivo rat bone marrow micronucleus assay.
Preskusi in vitro (preskus reverzne bakterijske mutageneze [Ames] in aberacije človeških limfocitnih kromosomov) in mikrojedrni preskus v podganjem kostnem mozgu in vivo niso pokazali znakov genotoksičnosti.
mBCC (n = 33)
metastatski bazalnocelični karcinom (n = 33)
• stomach pain,
• bolečine v želodcu,
Erivedge 150 mg hard capsules vismodegib
Erivedge 150 mg trde kapsule vismodegib
For the mBCC cohort, 97 % of patients had prior therapy including surgery (97 %), radiotherapy (58 %), and systemic therapies (30 %).
V kohorti z metastatskim bazalnoceličnim karcinomom je bilo predhodno zdravljenih 97 % bolnikov; zdravljeni so bili z operacijo (97 %), radioterapijo (58 %) in sistemskimi terapijami (30 %).
• At the end of your treatment you should return all unused capsules.
Po končanem zdravljenju neporabljene kapsule vrnite
Figure 1 SHH4476g Metastatic BCC Cohort
SHH4476g.
To avoid potential foetal exposure during pregnancy, a male patient must understand that:
Da bi preprečil morebitno izpostavljenost ploda med nosečnostjo,
Read the specific instructions given to you by your doctor, particularly on the effects of Erivedge on unborn babies.
Kaj morate vedeti, preden boste vzeli zdravilo Erivedge Preberite posebna navodila glede učinkov zdravila Erivedge na nerojene otroke, ki ste jih prejeli s strani vašega zdravnika.
Hedgehog pathway inhibitors (see section 5.1) such as vismodegib, have been demonstrated to be embryotoxic and/or teratogenic in multiple animal species and can cause severe malformations, including craniofacial anomalies, midline defects and limb defects (see section 5.3).
Zaviralci signalne poti Hedgehog (glejte poglavje 5.1), kot je vismodegib, so se pri številnih živalskih vrstah izkazali za embriotoksične in/ali teratogene.
It has not been determined whether cuSCC is related to Erivedge treatment.
Ni bilo dokazano, da je ploščatocelični karcinom kože povezan z zdravilom Erivedge.
Male patients must always use a condom (with spermicide, if available), even after a vasectomy, when having sex with a female partner while taking Erivedge and for 2 months after the final dose (see section 4.6).
Moški bolnik mora med jemanjem zdravila Erivedge in še 2 meseca po zadnjem odmerku tega zdravila med spolnim odnosom s partnerko vedno uporabiti kondom (s spermicidom, če je na voljo),
• She must have a negative pregnancy test, conducted by a health care provider within 7 days before starting Erivedge treatment,
• ne sme jemati zdravila Erivedge, če je noseča ali načrtuje nosečnost; • mora imeti negativen test nosečnosti, ki ga je opravil zdravstveni delavec 7 dni pred začetkom zdravljenja z zdravilom Erivedge;
Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX43.
Oznaka ATC: L01XX43.
• Methodology to collect information on the use of Erivedge and the compliance with the pregnancy pharmacovigilance programme and its effectiveness
• nacionalni del obvestila DHPC • metodologijo za zbiranje informacij o uporabi zdravila Erivedge in preverjanje skladnosti s farmakovigilančnim programom preprečevanja nosečnosti in njegovo učinkovitost • obliko in vsebino izobraževalnih gradiv za zdravstvene delavce in bolnike.
Semen donation Male patients should not donate semen while taking Erivedge and for 2 months after the final dose.
Bolniki med zdravljenjem z zdravilom Erivedge in 2 meseca po zadnjem odmerku ne smejo darovati sperme.
Stop using Erivedge and seek medical attention immediately if you notice any of the symptoms described in section 4.
Če opazite katerega od simptomov, opisanih v poglavju 4, prenehajte uporabljati zdravilo Erivedge in nemudoma poiščite zdravniško pomoč.
Patients were treated with oral daily dosing of Erivedge at 150 mg.
Bolnike so zdravili s 150 mg peroralnim odmerkom zdravila Erivedge.
Female patients must use two methods of recommended contraception including one highly effective method and a barrier method during Erivedge therapy and for 24 months after the final dose (see section 4.6).
Ženske bolnice morajo uporabljati dva priporočena načina kontracepcije (to obsega en visokoučinkovit način in en pregradni način) med zdravljenjem z zdravilom Erivedge in še
• Vasectomy,
• mišični krči,
• The need for adequate contraceptive measures (even if the woman has amenorrhoea) during treatment and for 24 months after Erivedge treatment
• potreba po ustrezni kontracepciji med zdravljenjem in 24 mesecev po prenehanju zdravljenja z zdravilom Erivedge (tudi če ima ženska amenorejo)
• The need to contact the healthcare professional if the female partner suspects that she is pregnant while the patient is treated with Erivedge or in the 2 months following treatment
• potrebo po obveščanju zdravnika, če gre za sum na nosečnost pri partnerki bolnika medtem, ko je jemal zdravilo Erivedge ali v 2 mesecih po prenehanju zdravljenja
ADRs are presented in table 1 below by system organ class (SOC) and absolute frequency.
Neželeni učinki so prikazani po organskih sistemih in absolutni pogostnosti v preglednici 1 spodaj.
• within a maximum of 7 days before starting treatment - to make sure that you are not already pregnant
Vaš zdravnik bo poskrbel, da boste opravili test nosečnosti: • v največ 7 dneh pred začetkom zdravljenja - za izključitev morebitne že prisotne nosečnosti,
There are limited data in non-Caucasian patients.
Podatki bolnikov, ki niso belci, so zelo omejeni.
In the same study there were no histopathological findings in male reproductive organs and no effects on male fertility endpoints, including percent motile sperm, observed at 100 mg/kg/day at the end of dosing or recovery phase (corresponding to 1.3-fold of the steady-state AUC0-24h at the recommended human dose).
Pri odmerkih 100 mg/kg/dan ob koncu odmerjanja ali v fazi okrevanja (kar ustreza 1,3-kratniku površine pod krivuljo AUC0-24h v stanju dinamičnega ravnovesja pri priporočenem odmerku za človeka) v isti študiji ni bilo histopatoloških najdb v reproduktivnih organih samcev in nobenih učinkov na opazovane dogodke njihove plodnosti, vključno z odstotkom gibljivih semenčic.
How to store Erivedge
Shranjevanje zdravila Erivedge
• Intrauterine device (IUD).
• maternični vložek (spiralo ali IUV),
Capsule shell Iron oxide black (E172) Iron oxide red (E172) Titanium dioxide (E171) Gelatine
Ovojnica kapsule črni železov oksid (E172) rdeči železov oksid (E172)
Package leaflet: Information for the patient
Erivedge ne dojijo • Informacije za moške
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
PODATKI NA PRIMARNI OVOJNINI NALEPKA ZA PLASTENKO
• Not to donate semen during treatment and for 2 months after the final dose
• naj ne darujejo sperme med zdravljenjem in 2 meseca po zaključku zdravljenja
• The need for the patient to report a suspected pregnancy immediately to the treating healthcare professional
• potrebo po takošnjem poročanju bolnice svojemu lečečemu zdravniku glede suma na nosečnost
Severe cutaneous adverse reactions (SCARs) including cases of Stevens-Johnson syndrome/Toxic epidermal necrolysis (SJS/TEN), Drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP), which can be life-threatening, have been reported during post-marketing use (see section 4.8).
Pri uporabi zdravila po prihodu na trg so poročali o hudih kožnih neželenih učinkih (severe cutaneous adverse reactions - SCAR), vključno s Stevens-Johnsonovim sindromom (SJS) / toksično epidermalno nekrolizo (TEN), reakcijo na zdravilo z eozinofilijo in sistemskimi simptomi (drug reaction with eosinophilia and systemic symptoms - DRESS) in akutno generalizirano eksantemsko pustulozo
Do not take Erivedge
Ne jemljite zdravila Erivedge, če:
Among patients who achieved tumour reduction, the median time to maximum tumour reduction occurred in 5.6 and 5.5 months for laBCC and mBCC patients respectively, based on the IRF assessment.
Po oceni IRF je bila med bolniki, pri katerih je prišlo do zmanjšanja tumorja, mediana časa do največjega zmanjšanja tumorja 5,6 meseca za lokalno napredovali bazalnocelični karcinom in 5,5
Erivedge can pass into semen.
Za moške, ki jemljejo zdravilo Erivedge Zdravilo Erivedge lahko prehaja v seme.
Do not breast-feed during your treatment and for 24 months after your final dose of this medicine.
Med zdravljenjem in v 24 mesecih po zadnjem odmerku tega zdravila ne smete dojiti.
Additional findings at clinically relevant exposures included faecal changes; skeletal muscle twitching or tremors; alopecia; swelling, follicular hyperkeratosis, and inflammation in paw pads; and increased LDL and HDL cholesterol.
alopecija, oteklost, folikularna hiperkeratoza in vnetje blazinic na šapah ter zvišanje holesterola LDL
Vismodegib is predominant in plasma, with concentrations representing greater than 98 %
Vismodegib v plazmi prevladuje; njegova koncentracija pomeni več kot 98 % vseh koncentracij v obtoku (vključno s povezanimi presnovki).
Table 1 ADRs occurring in patients treated with Erivedge MedDRA SOC Very common
Neželeni učinki, ki so se pojavili pri bolnikih, zdravljenih z zdravilom Erivedge Organski sistem po
Other side effects are presented in order of severity and frequency:
Drugi neželeni učinki so predstavljeni glede na resnost in pogostnost: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
• eyelashes falling out (madarosis)
• izpadanje trepalnic (madaroza),
Always use a condom (with spermicide, if available) even after a vasectomy, when you have sex with a female partner.
(s spermicidom, če je na voljo), tudi če ste imeli vazektomijo.
• That the patient should not donate blood during treatment and for 24 months after their final dose
• Da bolniki ne smejo darovati krvi med zdravljenjem in 24 mesecev po končanem zdravljenju
• If you are male, you should not donate semen at any time during treatment and for 2 months after the final dose.
• Če ste moški, med zdravljenjem z zdravilom Erivedge in 2 meseca po zadnjem odmerku ne smete darovati sperme.
Responders
Svetovanje
NAME OF THE MEDICINAL PRODUCT Erivedge 150 mg hard capsules vismodegib
Navodilo za uporabo Erivedge 150 mg trde kapsule vismodegib
• She must not breast-feed while taking Erivedge and for 24 months after the final dose.
• ne sme zanositi med jemanjem zdravila Erivedge in še 24 mesecev po zadnjem odmerku tega zdravila;
• Remind patients not to donate blood during treatment and for 24 months after the final dose
• Opozoriti bolnike, naj ne darujejo krvi med zdravljenjem in 24 mesecev po zaključku zdravljenja.
• Inform patients that they should not donate blood during treatment with Erivedge and for 24 months after their final dose
• Bolnike je treba obvestiti, da med zdravljenjem z zdravilom Erivedge in 24 mesecev po končanem zdravljenju z zdravilom Erivedge ne smejo darovati krvi.
Patients were treated with oral daily dosing of Erivedge at 150mg.
Bolniki so se zdravili z zdravilom Erivedge, ki so ga prejemali vsak dan peroralno v odmerku 150 mg. Mediana starosti vseh bolnikov je bila 72 let.
A.
N.o.
Metabolism and nutrition disorders
Presnovne in prehranske motnje zmanjšanje teka dehidracija
• constipation,
• izpuščaj,
Renal excretion of orally administered vismodegib is low.
Pri peroralnem dajanju vismodegiba je njegovo izločanje preko ledvic majhno.
Musculoskeletal pain Blood creatine phosphokinase increased***
Bolezni mišičnoskeletnega sistema in vezivnega tkiva mišični krči artralgija bolečine v okončini bolečine v hrbtu mišično-skeletna bolečina v prsnem košu mialgija bolečina v ledvenem predelu mišično-skeletne bolečine zvišanje kreatinfosfokinaze v krvi***
• She must tell her healthcare provider if any of the following occur during treatment and for 24 months after her final dose:
• mora svojega zdravnika obvestiti, če se ji med zdravljenjem ali v 24 mesecih po zadnjem odmerku zdravila zgodi kaj od naslednjega: • zanosi ali iz kakršnega koli razloga domneva, da bi lahko bila noseča,
• That the patient should not breastfeed during treatment and for 24 months after their final dose
• Da bolnice ne smejo dojiti med zdravljenjem in 24 mesecev po končanem zdravljenju
• Measures to ensure that all appropriate actions have been performed prior to Erivedge being prescribed and dispensed The MAH shall continuously ensure that all physicians who are expected to prescribe Erivedge are provided with the following: Product information Healthcare professional educational material Healthcare professional reminder card Patient educational material Patient reminder card The healthcare professional educational material for Erivedge should contain the following key elements:
Imetnik dovoljenja za promet mora konstantno zagotavljati, da vsi zdravniki, za katere se pričakuje, da bodo predpisovali zdravilo Erivedge, prejmejo naslednje: Informacije o zdravilu
Use one highly effective method, such as: • a contraceptive depot injection
Uporabljajte enega od visoko učinkovitih načinov, na primer:
• Not to donate blood during treatment and for 24 months after the final dose
• Da ne smejo darovati krvi med zdravljenjem in 24 mesecev po končanem zdravljenju
Nausea Diarrhoea Constipation Vomiting Dyspepsia
Bolezni prebavil navzea driska zaprtost bruhanje dispepsija bolečine v zgornjem delu trebuha bolečine v trebuhu
NAME OF THE MEDICINAL PRODUCT Erivedge 150 mg hard capsules
Erivedge 150 mg trde kapsule
What Erivedge is and what it is used for What you need to know before you take Erivedge How to take Erivedge
Kaj je zdravilo Erivedge in za kaj ga uporabljamo Kaj je zdravilo Erivedge
• Not to breastfeed during treatment and for 24 months after Erivedge treatment
• naj bolnice med zdravljenjem in 24 mesecev po končanem zdravljenju z zdravilom
Sodium lauril sulfate Povidone (K29/32) Sodium starch glycolate (Type A) Talc
Vsebina kapsule mikrokristalna celuloza laktoza monohidrat natrijev lavrilsulfat povidon (K29/32)
• You should not donate blood at any time during treatment and for 24 months after your final dose of this medicine.
• Med zdravljenjem in v 24 mesecih po zadnjem odmerku tega zdravila ne smete darovati krvi.
Cases of cuSCC have been reported in advanced BCC patients treated with Erivedge.
Pri bolnikih z napredovalim bazalnoceličnim karcinomom, ki so se zdravili z zdravilom Erivedge, so poročali o primerih ploščatoceličnega karcinoma kože.
You should not donate semen at any time during treatment and for 2 months after your final dose of this medicine.
Med zdravljenjem in 2 meseca po zadnjem odmerku tega zdravila ne smete darovati semena.
Printing ink Shellac glaze Iron oxide black (E172)
Tiskarsko črnilo šelakova glazura črni železov oksid (E172) 6.2 Inkompatibilnosti
• Widespread rash, fever, and enlarged lymph nodes (DRESS-syndrome or drug hypersensitivity syndrome).
• razširjen izpuščaj, zvišana telesna temperatura in povečane bezgavke (reakcija na zdravilo z eozinofilijo in sistemskimi simptomi - DRESS ali preobčutljivostna reakcija na zdravilo),
• if you are pregnant, think you may be pregnant, or are planning to become pregnant during the course of treatment or during the 24 months after your final dose of this medicine.
• ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev med zdravljenjem ali v
The cap liner is aluminum foil-lined waxed pulp board.
Zaporka plastenke je iz polipropilena, na notranji strani pa ima z aluminijevo folijo obložen povoskan karton.
Post approval study results
Rezultati študije, ki je bila zaveza pri pridobitvi dovoljenja za promet
Even if your periods have stopped, it is essential to ask your doctor if there is any risk that you could become pregnant.
Z zdravnikom se morate nujno posvetovati o tem, ali obstaja kakšno tveganje, da zanosite, tudi če menstruacij nimate več.
Blood donation Patients should not donate blood while taking Erivedge and for 24 months after the final dose.
Bolnice in bolniki med jemanjem zdravila Erivedge in še 24 mesecev po zadnjem odmerku tega zdravila ne smejo darovati krvi.
Madarosis Abnormal hair growth
Bolezni kože in podkožja alopecija pruritus izpuščaj madaroza nenormalna rast dlak
Talk to your doctor if you are not sure.
Če ste negotovi, se posvetujte z zdravnikom.
Contraceptive steroids
Darovanje sperme
Median OS, (months) (95 % CI)
(meseci) (95-% interval zaupanja)
• The format and content of the Healthcare professional and patient material
FARMACEVTSKA OBLIKA IN VSEBINA
• rash,
• srbenje.
• Patient Reminder Card
Opozorilno kartico za bolnika
• Adverse event reporting forms
• Obrazci za poročanje neželenih učinkov
The European Commission granted a marketing authorisation valid throughout the European Union for Actrapid on 7 October 2002.
Evropska komisija je dovoljenje za promet z zdravilom Actrapid, veljavno po vsej Evropski uniji, odobrila 7. oktobra 2002.
EPAR summary for the public human insulin
Povzetek EPAR za javnost humani insulin
Actrapid is given 30 minutes before a meal.
Zdravilo Actrapid se daje 30 minut pred obrokom.
The full EPAR for Actrapid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Actrapid je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Other information about Actrapid
Druge informacije o zdravilu Actrapid
The CHMP decided that Actrapid's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Actrapid večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
This is a summary of the European public assessment report (EPAR) for Actrapid.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Actrapid.
For more information about treatment with Actrapid, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Actrapid preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
HbA1c levels remained fairly steady over the six months of treatment with Actrapid.
Ravni HbA1c so v šestih mesecih zdravljenja z zdravilom Actrapid ostale dokaj ustaljene.
Actrapid has been studied in patients with type 1 diabetes, when the pancreas cannot produce insulin (two studies involving 1,954 patients), and type 2 diabetes, when the body is unable to use insulin effectively (one study involving 182 patients).
Zdravilo Actrapid se preučevali pri bolnikih s sladkorno boleznijo tipa 1, pri kateri trebušna slinavka ne more tvoriti insulina (dve študiji, 1 954 bolnikov), in s sladkorno boleznijo tipa 2, pri kateri telo ne more učinkovito izrabiti insulina (ena študija, 182 bolnikov).
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 Actrapid.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Actrapid, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.