natgillin/translations-raw huggingface dataset:
• Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Humira. 
• Povejte zdravniku, če jemljete azatioprin ali 6-merkaptopurin sočasno z zdravilom
Please check with your doctor before you receive any vaccines. 
Preden opravite kakršnokoli cepljenje, se posvetujte z zdravnikom.
If there are more than a few drops of liquid on the injection site, contact your doctor, nurse or pharmacist. 
• Če menite, da niste dali polnega odmerka, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
It is important that you tell your doctor if you have symptoms of infections, for example, fever, wounds, feeling tired, dental problems. 
Pomembno je, da zdravniku poveste, če imate simptome okužb, na primer zvišano telesno temperaturo, rane, občutek utrujenosti ali težave z zobmi.
The primary endpoint in RA study V was the percent of patients who achieved an ACR 50 response at Week 52. 
Primarna končna točka študije revmatoidnega artritisa V je bil odstotek bolnikov, ki so do
If you accidentally inject Humira more frequently than told to by your doctor or pharmacist, call your doctor or pharmacist and tell him/her that you have taken more. 
Če pomotoma injicirate zdravilo Humira pogosteje, kot vam je naročil zdravnik ali farmacevt, se morate posvetovati z njim ali s farmacevtom in mu povedati, da ste uporabili večji odmerek.
Humira 40 mg solution for injection in pre-filled syringe Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab. 
Humira 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena 0,8 ml napolnjena injekcijska brizga z enim odmerkom vsebuje 40 mg adalimumaba.
• hearing loss, buzzing 
• izguba sluha, šumenje v ušesih
In controlled Phase 3 trials of Humira in patients with Crohn's disease and ulcerative colitis with a control period ranging from 4 to 52 weeks. 
V kontroliranih preskušanjih faze 3 z zdravilom Humira pri bolnikih z revmatoidnim artritisom in psoriatičnim artritisom s trajanjem kontrolnega obdobja od 4 do 104 tedne, so se zvišanja ALT ≥ 3 x
Keep the pre-filled syringe in the outer carton in order to protect from light. 
Napolnjen peresnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
< 40 kg • 40 mg at Week 0 and 20 mg at Week 2 
40 mg 2. teden oziroma 40 mg 0. teden in 20 mg 2. teden.
• fatty liver; 
• zamaščenost jeter;
The usual dose regimen for hidradenitis suppurativa is an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by an 80 mg dose (as two 40 mg injections in one day) two weeks later. 
Običajni začetni odmerek je 160 mg (kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva zaporedna dneva), ki mu sledi 80 mg (kot dve 40 mg injekciji v enem dnevu) dva tedna kasneje.
It is important to tell your doctor if your child gets symptoms such as fever, wounds, feeling tired or dental problems. 
Pomembno je, da zdravniku poveste, če se pri vašem otroku pojavijo simptomi, kot so npr. zvišana telesna temperatura, rane, občutek utrujenosti ali težave z zobmi.
p = 0.031 
< 0,001c
Humira 40 mg solution for injection in pre-filled syringe Each 0.4 ml single dose pre-filled syringe contains 40 mg of adalimumab. 
Humira 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena 0,4 ml napolnjena injekcijska brizga z enim odmerkom vsebuje 40 mg adalimumaba.
• 2 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister. 
• 2 napolnjeni injekcijski brizgi (0,8 ml sterilne raztopine), vsaka z 1 alkoholnim zložencem, v pretisnem omotu.
DO NOT push the white plunger rod past the dose position. 
belega nosilca bata preko položaja za odmerek.
Do not remove the pre-filled pen while the injection is being given. 
Napolnjenega injekcijskega peresnika med injiciranjem ne smete odstraniti.
• Plaque psoriasis 
• luskavice (psoriaze) v plakih
After proper training, the injection can be self-administered or given by another person, for example a family member or friend. 
Po ustreznem urjenju si lahko injekcije dajete sami ali vam jih daje kdo drug, npr. svojec ali prijatelj.
• If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Humira and contact your doctor immediately since, in rare cases, these reactions can be life threatening. 
• Če doživite alergijske reakcije s simptomi, kot so tiščanje v prsih, piskajoče dihanje, omotica, otekanje ali izpuščaj, zdravila Humira ne injicirajte več in se takoj posvetujte s svojim zdravnikom, saj so v redkih primerih te reakcije lahko življenje ogrožajoče.
• If your child experiences allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Humira and contact your doctor immediately since, in rare cases, these reactions can be life threatening. 
• Če vaš otrok doživi alergijske reakcije s simptomi, kot so tiščanje v prsih, piskajoče dihanje, omotica, otekanje ali izpuščaj, zdravila Humira ne injicirajte več in se takoj posvetujte s svojim zdravnikom, saj so v redkih primerih te reakcije lahko življenje ogrožajoče.
Humira Pre-filled Pen 
OVOJNINAH NALEPKA NA PERESNIKU
Hepatitis reactivation of hepatitis B 
• hepatitis • reaktivacija hepatitisa B
• 2 pre-filled syringes (0.4 ml sterile solution), each with 1 alcohol pad, in a blister. 
• 2 napolnjeni injekcijski brizgi (0,4 ml sterilne raztopine), vsaka z 1 alkoholnim zložencem, v pretisnem omotu.
Lipids increased 
• povečano potenje
• 4 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister. 
• 4 napolnjene injekcijske brizge (0,8 ml sterilne raztopine), vsaka z 1 alkoholnim zložencem, v pretisnem omotu.
• 6 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister. 
• 6 napolnjenih injekcijskih brizg (0,8 ml sterilne raztopine), vsaka z 1 alkoholnim zložencem, v pretisnem omotu.
• blood in urine 
• kri v urinu • težave z ledvicami
Hold the pre-filled syringe with the needle facing up. 
Napolnjeno injekcijsko brizgo primite, tako da je igla obrnjena navzgor.
Humira 40 mg solution for injection in pre-filled syringe is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.4 ml solution. 
Zdravilo Humira 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku je na voljo kot sterilna raztopina 40 mg adalimumaba, raztopljenega v 0,4 ml raztopine.
Humira 40 mg solution for injection in pre-filled syringe is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml solution. 
Zdravilo Humira 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku je na voljo kot sterilna raztopina 40 mg adalimumaba, raztopljenega v 0,8 ml raztopine.
• 4 pre-filled syringes (0.4 ml sterile solution), each with 1 alcohol pad, in a blister. 
• 4 napolnjene injekcijske brizge (0,4 ml sterilne raztopine), vsaka z 1 alkoholnim zložencem, v pretisnem omotu.
Some of those patients were also treated with azathioprine or 6- mercaptopurine. 
Nekateri od teh bolnikov so bili zdravljeni tudi z azatioprinom ali
Your child should not take Humira with medicines containing the following active substances due to increased risk of serious infection: 
Zaradi povečanega tveganja za resne okužbe vaš otrok zdravila Humira ne sme jemati z zdravili, ki vsebujejo naslednje učinkovine:
• inflammations 
• zardevanje
Humira 80 mg solution for injection in pre-filled syringe with automatic needle guard Humira 80 mg solution for injection in single-use pre-filled syringe with automatic needle guard. 
Zdravilo Humira 80 mg raztopina za injiciranje v napolnjeni injekcijski brizgi z avtomatskim ščitnikom za iglo za enkratno uporabo.
Packs of: 1 pre-filled syringe with needle guard (0.8 ml sterile solution) in a blister, and 1 alcohol pad. 
1 napolnjena injekcijska brizga s ščitnikom za iglo (0,8 ml sterilne raztopine) v pretisnem omotu in
• liver failure 
• odpoved jeter
During the controlled portions of pivotal Humira trials in adults of at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis, malignancies, other than lymphoma and non-melanoma skin cancer, 
Ta preskušanja so vključila bolnike z revmatoidnim artritisom (tako tiste, ki so imeli bolezen kratek čas, kot tiste, ki so jo imeli že dolgo), juvenilnim idiopatskim artritisom (poliartikularnim juvenilnim idiopatskim artritisom in artritisom, povezanim z entezitisom), aksialnim spondiloartritisom, (ankilozirajočim sponditisom in aksialnim spondiloartritisom brez radiografskega dokaza za AS), psoriatičnim artritisom, Crohnovo boleznijo, ulceroznim kolitisom, psoriazo, hidradenitis suppurativa in uveitisom.
• 6 pre-filled syringes (0.4 ml sterile solution), each with 1 alcohol pad, in a blister. 
• 6 napolnjenih injekcijskih brizg (0,4 ml sterilne raztopine), vsaka z 1 alkoholnim zložencem, v pretisnem omotu.
Ελλάδα 
vnetje občasni
Needle Cover 
Pokrovček igle
Humira 40 mg solution for injection in pre-filled syringe with needle guard Humira 40 mg solution for injection in single-use pre-filled syringe (type I glass) with needle guard for hospital and caregiver use. 
Zdravilo Humira 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi (steklo tipa I) za enkratno uporabo, opremljeni s ščitnikom za iglo, za zdravniško in bolnišnično uporabo.
Humira b/ MTX n=63 
Zdravilo Humirab/ MTXc n = 63
This will include a thorough medical evaluation including your medical history and appropriate screening tests (for example chest X-ray and a tuberculin test). 
To bo vključevalo natančno zdravniško oceno vključno s poizvedbo o vašem zdravju v preteklosti in ustrezne preiskave (npr. rentgensko slikanje prsnih organov in tuberkulinski test).
If you develop a fever that does not go away, develop light bruises or bleed very easily or look very pale, call your doctor right away. 
Če se pri vas pojavi zvišana telesna temperatura, ki ne mine, če se vam pojavljajo blage podplutbe, zlahka zakrvavite ali ste zelo bledi, takoj pokličite svojega zdravnika.
Humira/methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 11). 
Pri bolnikih, ki so dobivali zdravilo Humira in metotreksat, je bilo po 6 in 12 mesecih (glejte preglednico 11)
• If you get allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Humira and contact your doctor immediately since, in rare cases, these reactions can be life threatening. 
• Če se pri vas pojavijo alergijske reakcije s simptomi, kot so tiščanje v prsih, piskajoče dihanje, omotica, otekanje ali izpuščaj, zdravila Humira ne injicirajte več in se takoj posvetujte s svojim zdravnikom, saj so v redkih primerih te reakcije lahko življenje ogrožajoče.
In Psoriasis Study I, 28% of patients who were PASI 75 responders and were re-randomised to placebo at Week 33 compared to 5% continuing on Humira, p < 0.001, experienced “loss of adequate response” (PASI score after Week 33 and on or before Week 52 that resulted in a <PASI 50 response relative to baseline with a minimum of a 6-point increase in PASI score relative to Week 33). 
V študiji pri psoriazi I so 33. teden "izgubo ustreznega odziva" zabeležili pri 28 % bolnikov, ki so dosegli odziv PASI 75 in so bili ob ponovni randomizaciji razvrščeni na placebo, in pri 5 % bolnikov,
• Advise your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections. 
• Zdravniku povejte, če ste imeli v preteklosti ponavljajoče se okužbe ali druge bolezni, ki zvečujejo tveganje za okužbe.
What you need to know before you use humira 
Kaj morate vedeti, preden boste uporabili zdravilo Humira Ne uporabljajte zdravila Humira:
d score methotrexate 
Activity Score)
Do not freeze. 
Ne drgnite.
• respiratory tract infections (including cold, runny nose, sinus infection, pneumonia); 
• reakcije na mestu injiciranja (vključno z bolečino, oteklostjo, pordelostjo ali srbenjem); • okužbe dihalnega trakta (vključno s prehladom, izcedkom iz nosu, okužbo sinusov, pljučnico);
Humira therapy should not be continued in patients failing to respond within this time period. 
Pri bolnikih, ki se v tem času ne odzovejo, zdravljenja ni priporočljivo nadaljevati.
Adverse Reaction bacterial infections, eye infections, diverticulitis 
raztopina za injiciranje (injekcija) bistra, brezbarvna raztopina
Humira 40 mg Weekly 
Humira 40 mg vsak teden placebo
Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis studies I − V. In these trials, 11.9% of patients treated with Humira and 8.1% of placebo and active control − treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at Week 24. 
prejemnikov zdravila Humira in 8,1 % prejemnikov placeba in kontrolne učinkovine, ki so imeli izhodiščno negativne titre teh protiteles.
• low blood measurements for platelets 
• nizke krvne vrednosti za trombocite
Disease flares at the end of 32weeks a (n/N) 
32-tedenskega obdobjaa (n/N)
You should not take Humira with medicines containing the following active substances due to increased risk of serious infection: 
Zaradi povečanega tveganja pojava resnih okužb zdravila Humira ne smete jemati skupaj z zdravili, ki vsebujejo naslednje učinkovine:
Exposure-response relationship in paediatric population On the basis of clinical trial data in patients with JIA (pJIA and ERA), an exposure-response relationship was established between plasma concentrations and PedACR 50 response. 
Razmerje med izpostavljenostjo in odzivom pri pediatrični populaciji Na podlagi podatkov iz kliničnih preskušanj pri bolnikih z juvenilnim idiopatskim artritisom (JIA)
• Keep this container out of the sight and reach of children 
• Ta vsebnik shranjujte nedosegljivo otrokom.
It is important to tell your doctor if your child gets symptoms of infections, such as fever, wounds, feeling tired or dental problems. 
Pomembno je, da zdravniku poveste, če se pri vašem otroku razvijejo znaki okužbe, kot so zvišana telesna temperatura, rane, utrujenost ali problemi z zobmi.
Erectile dysfunction 
Ocena erozij
• haematoma; 
• nevropatija;
Deafness, tinnitus 
KG Knollstrasse
a 20 
Preglednica 20
If a faster response is required, the doctor may prescribe a first dose of 160 mg (two 80 mg injections in one day or one 80 mg injection per day for two consecutive days), followed by 80 mg (one 80 mg injection) two weeks later. 
Če je potreben hitrejši odziv na zdravljenje, lahko uporabite shemo 160 mg 0. teden (odmerek lahko aplicirate z dvema 80 mg injiciranjema na en dan ali z enim 80 mg injiciranjem na dan dva dni zapored) in 80 mg 2. teden.
p-value a p-value b p-value 
b 2-stranska vrednost p testa log-rank.
33.5% respectively, p < 0.001) and Humira monotherapy (50.7%, p < 0.002 and 44.5%, p < 0.001 respectively). 
(30,6 % proti 4,3 %, v tem zaporedju [P = 0,014]).
Squeeze the skin at your child's injection site with your other hand to make a raised area and hold it firmly. 
Z drugo roko stisnite otrokovo kožo na mestu injiciranja,
One 0.8 ml pre-filled syringe with needle guard contains 40 mg adalimumab. 
Ena 0,8 ml napolnjena injekcijska brizga vsebuje 40 mg adalimumaba.
Whereas 
Ker
Furosemide has been authorised in the EU for more than 40 years. 
Furosemid ima dovoljenje za promet v EU že več kot 40 let.
1 Dormans et al. 
Dormans in sod.
Scientific conclusions and grounds for refusal presented by the European Medicines Agency 
Znanstveni zaključki in razlogi za zavrnitev, ki jih je predstavila Evropska agencija za zdravila
Grounds for refusal 
Razlogi za zavrnitev
The detailed grounds for re-examination were submitted on 21 December 2012. 
Podrobne razloge za ponovni pregled je predlagatelj predložil 21. decembra 2012.
• Detailed grounds for re-examination submitted by the applicant 
• Podrobni razlogi za ponovni pregled, ki jih je predložil predlagatelj
The results have shown that furosemide absorption is highly variable (AUC value varies from 793.8 to 3953 ng*h/ml, Cmax from 283,6 to 2636 ng/ml and ln Cmax values are almost a tenfold difference). 
Rezultati so pokazali, da je absorpcija furosemida zelo različna (vrednost AUC niha od 793,8 do 3953 ng*h/ml, vrednost Cmax od 283,6 do 2636 ng/ml, vrednosti ln Cmax pa so skoraj desetkratno različne).
However, it is noted that the CHMP is a scientific committee and that while it operates within the legal framework, it cannot discuss the specific merits of procedural and legal aspects of administrative procedures laid down in the legislation. 
Upošteva se, da je CHMP znanstveni odbor in da kljub delovanju v pravnem okviru ne more razpravljati o konkretnih prednostih postopkovnih in pravnih vidikov administrativnih postopkov, opredeljenih z zakonodajo.
The decentralised procedure was closed on day 210, with most of the Concerned Member States agreeing with the conclusions of the Reference Member State's assessment report except Poland and Lithuania which raised a potential serious risk to public health (PSRPH). 
Decentralizirani postopek se je končal na 210. dan, ko je večina zadevnih držav članic soglašala z zaključki poročila o oceni referenčne države članice z izjemo Poljske in Litve, ki sta izrazili zaskrbljenost zaradi možnega resnega tveganja za javno zdravje (PSRPH).
At the request of the applicant, an ad-hoc expert meeting was convened. 
Na zahtevo predlagatelja je bila sklicana ad-hoc seja strokovnjakov.
Overall summary of the scientific evaluation of Furosemide Vitabalans and associated names (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravila Furosemide Vitabalans in povezanih imen (glejte Prilogo I)
The applicant expressed its disagreement on some procedural aspects of the mutual recognition procedure, the CMDh procedure and the referral procedure under Article 29(4) of Directive 2001/83/EC. 
Predlagatelj je izrazil nestrinjanje z nekaterimi postopkovnimi vidiki postopka medsebojnega priznavanja, postopkom CMDh in napotitvenim postopkom v skladu s členom 29(4) Direktive 2001/83/ES.
• It has not been sufficiently demonstrated by the applicant that a potentially lower or higher exposure to furosemide would not influence the efficacy or safety. 
• predlagatelj ni zadovoljivo prikazal, da potencialno manjša ali večja izpostavljenost furosemidu ne vpliva na učinkovitost ali varnost;
Considering the foreseeable high variability of the product, the main risk with furosemide would be a lack of efficacy. 
Glede na predvideno veliko spremenljivost zdravila bi bilo glavno tveganje s furosemidom pomanjkanje učinkovitosti.
Furosemide is a loop diuretic which acts along the entire nephron with the exception of the distal exchange site. 
Furosemid je diuretik zanke, ki deluje vzdolž celotnega nefrona z izjemo distalnega mesta izmenjave.
It cannot be excluded that the bioavailability of the applied product may be lower or higher than the bioavailability of these products. 
Ni mogoče izključiti, da bo morda biološka uporabnost zdravila, za katerega je vloga predložena, manjša ali večja od biološke uporabnosti teh zdravil.
In view of this lack of evidence the Committee found merit on the concerns raised by the Member States on the potential serious risk to public health. 
Zaradi tega pomanjkanja dokazov je Odbor ugotovil utemeljenost zadržkov, ki sta jih izpostavili državi članici glede potencialno resnega tveganja za javno zdravje.
The applicant expressed its disagreement with the CHMP opinion, focusing its scientific grounds on the following points, for which the applicant argued that clear justification or evidence had not been presented to explain: 
Predlagatelj je izrazil nestrinjanje z mnenjem CHMP in pri tem svoje znanstvene utemeljitve osredotočal na spodaj navedene točke, glede katerih predlagatelj meni, da niso bili predstavljeni zadostni dokazi ali utemeljitve, da bi razložili naslednje:
Following the adoption of the CHMP opinion and recommendations during the October 2012 CHMP meeting, a request for a re-examination was received from the applicant Vitabalans Oy on 12 
Po sprejetju mnenja in priporočil odbora CHMP na srečanju Odbora oktobra 2012 je predlagatelj Vitabalans Oy 12. novembra prosil za ponovni pregled.
As a result, procedural and legal considerations are outside the remit of the CHMP, and therefore the re-examination of the referral procedure under Article 29(4) of Directive 2001/83/EC focussed only on the scientific points addressed in the grounds for reexamination. 
Iz tega sledi, da postopkovni in pravni zadržki niso v pristojnosti odbora CHMP, zato se je ponovni pregled napotitvenega postopka v skladu s členom 29(4) Direktive 2001/83/ES osredotočal samo na znanstvene točke, opredeljene v razlogih za ponovni pregled.
• CHMP conclusion on grounds for re-examination 
• Sklep odbora CHMP na osnovi ponovnega pregleda
In addition, it is also noted that according to the Guideline on the Definition of a Potential Serious Risk to Public Health, a potential serious risk to public health in relation to a particular medicinal product can be considered to exist if the data submitted to support therapeutic efficacy do not provide sound justification for the claims of efficacy and/or the clinical safety data does not provide adequate support for the conclusion that all potential safety issues have been appropriately and adequately addressed. 
Prav tako je ugotovljeno, da je v skladu s smernico o potencialno resnih tveganjih za javno zdravje mogoče sklepati o potencialno resnem tveganju za javno zdravje v povezavi z določenim zdravilom samo, če predloženi podatki za podporo terapevtske učinkovitosti ne zagotavljajo ustrezne utemeljitve za zahtevke o učinkovitosti in/ali če klinični varnostni podatki ne zagotavljajo ustrezne podpore za sklep, da so bila vsa potencialna vprašanja o varnosti ustrezno in primerno pojasnjena.
The clinical part of the dossier referred to 77 publications up to 2009 supporting the effect of furosemide in the treatment of oedema associated with congestive heart failure, cirrhosis of the liver and renal disease, including nephrotic syndrome and mild to moderate hypertension. 
Klinični del dokumentacije se je nanašal na 77 objav do leta 2009, ki podpirajo učinek furosemida pri zdravljenju edema, povezanega s kongestivnim srčnim popuščanjem, cirozo jeter in boleznijo ledvic, vključno z nefrotskim sindromom in blago do zmerno hipertenzijo.
The decentralised marketing authorisation application for Furosemide Vitabalans was made in accordance with Article 10(a) of Directive 2001/83/EC, which is a well-established use application. 
Vloga za pridobitev dovoljenja za promet z zdravilom Furosemide Vitabalans po decentraliziranem postopku je bila predložena v skladu s členom 10(a) Direktive 2001/83/ES, ki predstavlja vlogo na osnovi dobro uveljavljene rabe.
• Ad-hoc expert meeting 
• Ad-hoc seja strokovnjakov
The application for Furosemide Vitabalans is therefore based on publicly available bibliographic data as it is possible to replace results of the pre-clinical and clinical trials by detailed references to published scientific literature (information available in the public domain) if it can be demonstrated that the active substances of a medicinal product have been in well-established medicinal use within the Community for at least ten years, with recognized efficacy and an acceptable level of safety. 
Vloga za zdravilo Furosemide Vitabalans tako temelji na javno dostopnih bibliografskih podatkih, saj je mogoče nadomestiti rezultate predkliničnih in kliničnih preskušanj s podrobnimi sklici na objavljeno znanstveno literaturo (informacije, ki so v splošni rabi), če je mogoče dokazati, da so zdravilne učinkovine zdravila v dobro uveljavljeni medicinski uporabi v Skupnosti vsaj deset let, s priznano učinkovitostjo in sprejemljivo stopnjo varnosti.