natgillin/translations-raw huggingface dataset:
Draft protocol to be submitted 2 months after notification of the European Commission decision 
Osnutek protokola je treba predložiti 2 meseca po objavi sklepa Evropske komisije.
The recommended maximum number of implants is four per year. 
Največje priporočeno število implantatov je štiri na leto.
• The importance of recruiting and entering patients in the EU Registry, 
• pomembnost pridobivanja in vključevanja bolnikov v register EU;
If you are affected, do not drive or use any tools or machines. 
Če opazite kar koli od tega, ne vozite in ne upravljajte nobenih orodij ali strojev.
However, due to the lack of data caution is warranted. 
Vendar je zaradi pomanjkanja podatkov potrebna previdnost.
The safety profile is based on pooled data from clinical studies in 425 patients. 
Varnostni profil temelji na zbranih podatkih iz kliničnih študij pri 425 bolnikih.
If you have ever had any of these conditions your doctor may have to monitor you more closely during your treatment. 
Če ste kadar koli imeli ta stanja, vas bo zdravnik med zdravljenjem morda pozorneje spremljal.
Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data) 
Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Patients should not drive or use machines in case they are affected by these symptoms. 
Bolniki ne smejo voziti ali upravljati strojev, če se pri njih pojavijo ti simptomi.
Its binding lasts longer than that of α-MSH. 
Njegova vezava traja dlje kot vezava α-MSH.
Three implants per year are recommended, depending on the length of protection required. 
Priporočajo se trije implantati na leto, kar je odvisno od trajanja potrebne zaščite.
- Observe the patient for 30 minutes to ensure that you will notice if the patient develops an allergic or hypersensitivity reaction (immediate type). 
- Bolnika opazujte 30 minut in bodite pozorni, če se pri bolniku razvije alergijska ali preobčutljivostna reakcija (takojšnjega tipa).
This medicine should not be given to children and adolescents under 18 years of age because it has not been tested in this age group. 
To zdravilo se ne sme uporabljati pri otrocih in mladostnikih, starih manj kot 18 let, saj se pri tej starostni skupini ni proučevalo.
The registry should collect data from both patients and physicians. 
Register bo zbiral podatke bolnikov in zdravnikov.
• Demonstration of the correct application technique, highlighting the measures needed to ensure the implant is not damaged during use. 
• demonstracijo pravilne tehnike vsaditve s poudarkom na ukrepih, potrebnih za preprečevanje poškodbe implantata med uporabo;
A referral to a dermatology specialist might be necessary. 
Morda bo potrebna napotitev k dermatologu.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 December 2014 
Datum prve odobritve: 22. december 2014.
The safety and efficacy of afamelanotide in children and adolescents aged 0 to 17 years have not yet been established. 
Pediatrična populacija Varnost in učinkovitost afamelanotida pri otrocih in mladostnikih, starih od 0 do 17 let, še nista bili dokazani.
Intermediate reports: annual submission. 
Vmesna poročila: predložiti enkrat na leto.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/969/001 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/969/001
- Have the patient sit in a comfortable position or lie on his/her back with the upper part of the body slightly raised. 
- Bolnik naj sedi v udobnem položaju ali leži na hrbtu, pri čemer naj bo zgornji del telesa rahlo dvignjen.
Please inform your doctor about new or changing skin abnormalities. 
Zdravnika obvestite o novih ali spreminjajočih se kožnih abnormalnostih.
The face to face training material, including the educational video, shall contain the following key messages: 
Gradivo za neposredno usposabljanje, vključno z izobraževalnim videom, bo vsebovalo naslednja ključna sporočila:
- if you are allergic to afamelanotide or any of the other ingredients of this medicine (listed in section 6). 
- če ste alergični na afamelanotid ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
For patients with renal or hepatic impairment see sections 4.3 and 5.2. 
Za bolnike z okvaro ledvic ali jeter glejte poglavji 4.3 in 5.2.
- if you have liver problems. 
- če imate težave z ledvicami.
Animal studies have not shown any harmful effect on fertility and reproduction. 
Študije na živalih niso pokazale nobenega škodljivega učinka na plodnost in razmnoževanje.
EPP is a condition in which patients have an increased sensitivity to sunlight, which can cause toxic effects such as pain and burning. 
EPP je stanje, pri katerem so bolniki čezmerno občutljivi za sončno svetlobo, kar lahko povzroči toksične učinke, kot sta bolečina in opeklina.
Tell your doctor if you are taking anticoagulant medicines used to prevent blood clots. 
Obvestite zdravnika, če jemljete antikoagulante, ki se uporabljajo za preprečevanje krvnih strdkov.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should not receive SCENESSE, since it is not known how it will affect your unborn baby or the breastfed infant. 
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, ne smete prejeti zdravila Scenesse, saj ni znano, kako bo to vplivalo na nerojenega otroka ali dojenca.
SCENESSE is administered subcutaneously under aseptic conditions as described below. 
Način uporabe Zdravilo Scenesse se daje subkutano v aseptičnih pogojih, kot je opisano spodaj.
Skin monitoring 
Spremljanje kože
The safety of this medicinal product has not been evaluated in clinical trials of duration longer than 2 years (see section 4.2). 
Varnosti tega zdravila niso ocenili v kliničnih preskušanjih, daljših od 2 let (glejte poglavje 4.2).
At the end of the insertion procedure, you may be able to feel the implant under your skin. 
Po koncu vsaditve boste morda občutili implantat pod kožo.
• Risk management plan (RMP) The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP. 
• Načrt za obvladovanje tveganj (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
- Take the packed implant out of the refrigerator and allow the medicinal product to warm up to ambient temperature. 
- Vzemite zapakiran implantat iz hladilnika in počakajte, da se zdravilo segreje na temperaturo okolja.
It has been demonstrated that EPP patients receiving afamelanotide had more exposure to direct sunlight (10:00 to 18:00 hours) during a 180 day trial period compared to placebo recipients (p=0.044; afamelanotide arithmetic mean: 115.6 h, median 69.4h; placebo mean 60.6h, median 40.8h). 
Izkazalo se je, da so bili bolniki z EPP, ki so prejemali afamelanotid, dlje časa izpostavljeni neposredni sončni svetlobi (od 10:00 do 18:00 ure) v 180-dnevnem preskusnem obdobju kot prejemniki placeba (p = 0,044; aritmetično povprečje za afamelanotid: 115,6 h, mediana 69,4 h; povprečje placebo 60,6 h, mediana 40,8 h).
Other medicines and SCENESSE 
Druga zdravila in zdravilo Scenesse
The second primary objective of the study should be the assessment of the compliance with risk minimization recommendations and the controlled access program for patients receiving SCENESSE. 
Drugi primarni cilj te študije je ocena upoštevanja priporočil za zmanjševanje tveganja in programa z nadzorovanim dostopom pri bolnikih, ki prejemajo zdravilo Scenesse.
No specific interaction studies have been performed with this medicinal product. 
Posebnih študij medsebojnega delovanja s tem zdravilom niso izvedli.
One implant is administered every 2 months prior to expected and during increased sunlight exposure, e.g. from spring to early autumn. 
En implantat se uporabi vsaka 2 meseca pred in med pričakovano povečano izpostavljenostjo sončni svetlobi, npr. od pomladi do zgodnje jeseni.
Do not administer a new implant unless it has been unequivocally confirmed that the first one had not been inserted. 
Ne uporabite novega implantata, dokler niste jasno potrdili, da prvega implantata niste vsadili.
Talk to your doctor before receiving SCENESSE if you are over 70 years of age. 
Preden boste prejeli zdravilo Scenesse, se posvetujte z zdravnikom, če ste starejši od 70 let.
Influenza like illness 
gripi podobna bolezen
Data on possible interactions or effects in special populations, e.g. in patients with hepatic or renal impairment are not available. 
Podatki o morebitnem medsebojnem delovanju ali učinkih pri posebnih populacijah, npr. pri bolnikih z okvaro jeter ali ledvic, niso na voljo.
Since available data in treatment of the elderly are limited, afamelanotide should not be used in patients over 70 years of age. 
Ker so razpoložljivi podatki o zdravljenju starejših bolnikov omejeni, se afamelanotid ne sme uporabljati pri bolnikih, starejših od 70 let.
The European Medicines Agency has deferred the obligation to submit the results of studies with SCENESSE in one or more subsets of the paediatric population in erythropoietic protoporphyria (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Scenesse za eno ali več podskupin pediatrične populacije pri eritropoetski protoporfiriji (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
This medicine must not be used after the expiry date which is stated on the vial and the outer carton. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli.
6.6 Special precautions for disposal and other handling For instructions on correct administration and preparation see section 4.2. 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Za navodila glede pravilne uporabe in priprave glejte poglavje 4.2.
Store in a refrigerator (2˚C - 8˚C) 
Shranjujte v hladilniku (2 ˚C-8 ˚C).
Following subcutaneous administration of the implant, most of the active substance is released within the first 48 hours with over 90% released by day 5. 
Po subkutani uporabi implantata se večina učinkovine sprosti v prvih 48 urah, do 5. dneva pa 90 %.
In most clinical studies afamelanotide plasma levels were below the limit of quantitation by day 10. 
V večini kliničnih študij so bile ravni afamelanotida v plazmi do 10. dneva pod mejo kvantifikacije.
No pharmacokinetic information is available on any of its metabolites (active or inactive). 
Farmakokinetični podatki o katerem koli njegovem presnovku (aktivnem ali neaktivnem) niso na voljo.
Do not change the sun protection measures you normally follow to manage your EPP and according to your skin phototype (UV sensitivity). 
Ne spremenite ukrepov za zaščito pred soncem, ki jih navadno upoštevate pri obvladovanju EPP in so skladni s tipom vaše kože (občutljivost za UV-svetlobo).
Reporting of suspected adverse reactions after authorisation of the medicinal product is important. 
Poročanje o domnevnih neželenih učinkih Poročanje o domnevnih neželenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
Plasma levels of afamelanotide are maintained over a number of days. 
Ravni afamelanotida v plazmi se vzdržujejo več dni.
If the skin changes noted are consistent with skin cancer or its precursors, or are ambiguous to the porphyria specialist, dermatology specialist consultation should be sought. 
Če so opažene kožne spremembe skladne s kožnim rakom ali njegovimi predznaki ali če specialist za porfirijo meni, da so nejasne, se je treba posvetovati z dermatologom.
The doctor will decide with you the most suitable time and the site for inserting the implant. 
Zdravnik bo določil najprimernejši čas in mesto za vstavljanje implantata.
The pharmacokinetics of afamelanotide have not been fully characterised yet, i.e. distribution, metabolism or excretion are not clear. 
Farmakokinetičnih lastnosti afamelanotida še niso popolnoma raziskali, tj. porazdelitev, presnova in izločanje niso jasni.
This means that because of the rarity of this disease, for scientific reasons, and for ethical reasons it has been impossible to get complete information on this medicine. 
To pomeni, da zaradi redkosti bolezni, iz znanstvenih razlogov in iz etičnih razlogov ni bilo mogoče pridobiti vseh podatkov o zdravilu.
Disease registry 
Register bolezni
Women of childbearing potential have to use effective contraception during treatment with SCENESSE and for a period of three months thereafter. 
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem z zdravilom Scenesse in tri mesece po njem.
• Summary of product characteristics, 
• povzetek glavnih značilnosti zdravila,
What SCENESSE is and what it is used for 
Kaj je zdravilo Scenesse in za kaj ga uporabljamo
This results in part from afamelanotide's resistance to immediate degradation by serum or proteolytic enzymes (see section 
To je delno posledica odpornosti afamelanotida proti takojšnji razgradnji s serumskimi ali proteolitskimi encimi (glejte poglavje 5.2).
As an oligopeptide with a short half-life, afamelanotide is expected to be rapidly hydrolysed into shorter peptide fragments and into its individual amino acids. 
Ker je afamelanotid oligopeptid s kratko razpolovno dobo, je pričakovati, da se bo hitro hidroliziral v krajše peptidne delce in posamezne aminokisline.
The MAH shall ensure that in each Member State where SCENESSE is marketed, all healthcare professionals who are expected to use the product are provided with the following educational package and trained: 
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo v vsaki državi članici, kjer je v prometu zdravilo Scenesse, vsi zdravstveni delavci, za katere se pričakuje, da bodo uporabljali zdravilo, prejeli naslednji izobraževalni paket in usposabljanje:
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja); • v 60 dneh po doseženem pomembnem mejniku (farmakovigilančnem ali povezanem z zmanjševanjem tveganja).
In repeated dose toxicity studies, the only finding of relevance was an increase in melanin pigmentation in the dog, which is consistent with the active substance's pharmacological activity. 
V študijah toksičnosti s ponavljajočimi odmerki je bila edina pomembna ugotovitev povečanje melaninske pigmentacije pri psih, kar je skladno s farmakološkim delovanjem učinkovine.
Talk to your doctor before receiving SCENESSE if you have or have ever had: - heart problems or severe breathing problems; - gastrointestinal problems; - diabetes; 
Preden boste prejeli zdravilo Scenesse, se posvetujte z zdravnikom, če imate ali ste kadar koli imeli: - težave s srcem ali hude težave z dihanjem; - prebavne motnje; - sladkorno bolezen;
Concomitant disorders not studied 
Sočasne motnje, ki jih niso preučevali
Over time the implant will be absorbed by the body, this will happen within 50 to 60 days after implantation. 
Čez čas bo telo implantat absorbiralo, kar se bo zgodilo 50 do 60 dni po vsaditvi.
Pack of one vial containing one implant. 
Pakiranje z eno vialo vsebuje en implantat.
- With the catheter in place, aseptically remove the implant from the vial. 
- Ko je kateter vstavljen, aseptično odstranite implantat iz viale.
If the implant has not been administered during the procedural steps described above, discard the implant and administer a new implant. 
Če med zgoraj opisanimi koraki niste vstavili implantata, ga zavrzite in uporabite nov implantat.
Store in a refrigerator (2oC - 8oC). 
Shranjujte v hladilniku (2 oC-8 oC).
A second study on embryo-fetal development in Lister-Hooded rats did not achieve sufficient exposure. 
Druga študija razvoja zarodka in ploda pri podganah vrste Lister-Hooded ni dosegla zadostne izpostavljenosti.
Prior to launch of SCENESSE in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of the educational package, including communication media, distribution modalities, and any other aspects, with the National Competent Authority. 
Pred dajanjem zdravila Scenesse v promet v posamezni državi članici mora imetnik dovoljenja za promet z zdravilom v sodelovanju z nacionalnim pristojnim organom pripraviti vsebino in obliko izobraževalnega paketa, vključno s komunikacijskimi mediji, načini razdeljevanja in kakršnimi koli drugimi vidiki.
The implant is absorbed by the body within 50 to 60 days after administration. 
Implantat telo absorbira v 50 do 60 dneh po aplikaciji.
- Using a suitable device (such as a stylet) gently push the implant down the full length of the catheter lumen. 
- Z ustreznim pripomočkom (kot je stilet) nežno potisnite implantat navzdol po celotnem lumnu katetra.
Your doctor will need to regularly check your skin (full body) to monitor changes in moles (e.g. darkening) or other skin abnormalities. 
Zdravnik bo moral redno pregledovati kožo (po celotnem telesu), da bo spremljal spremembe kožnih znamenj (npr. potemnitev) ali druge nenormalne kožne spremembe.
Retrospective chart review study The MAH shall conduct a retrospective study comparing long term safety data and outcome endpoints in patients receiving and not receiving SCENESSE, or having discontinued SCENESSE use. 
Retrospektivna študija s pregledom kartotek Imetnik dovoljenja za promet z zdravilom bo izvedel retrospektivno študijo, ki bo primerjala dolgoročne varnostne podatke in opazovane dogodke pri bolnikih, ki so prejemali zdravilo Scenesse, bolnikih, ki ga niso prejemali ali ki so prekinili uporabo zdravila Scenesse.
- Disinfect the skin above the supra-iliac crest. 
- Razkužite kožo nad suprailiakalno kristo.
Because this medicine increases eumelanin, in most treated patients the skin will darken. 
Ker zdravilo poveča količino evmelanina, bo koža pri večini zdravljenih bolnikov potemnela.
Depression Depressed mood Insomnia 
Psihiatrične motnje depresija, depresivno razpoloženje, insomnia
SCENESSE should not be used during pregnancy and in women of childbearing potential not using effective contraception. 
Zdravila Scenesse ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
This is an expected response to this medicine, and the darkening will slowly fade unless another implant is used. 
To je pričakovan odziv na to zdravilo, potemnjena koža pa se bo počasi posvetlila, dokler ne prejmete novega implantata.
One implant is injected every 2 months during the spring and summer months. 
Pomladi in med poletnimi meseci se injicira en implantat na vsaka 2 meseca.
A careful decision must be made whether to treat patients with any of these conditions with this medicinal product. 
Pri odločanju o uporabi zdravila pri bolnikih, ki imajo katero koli od teh stanj, je potrebna previdnost.
Eumelanin contributes to photoprotection through different mechanisms including: - strong broadband absorption of UV and visible light, where eumelanin acts as a filter - antioxidant activity through scavenging of free radicals; and - inactivation of the superoxide anion and increased availability of superoxide dismutase to reduce oxidative stress. 
Evmelanin prispeva k zaščiti pred svetlobo prek različnih mehanizmov, vključno z: - močno širokopasovno absorpcijo UV- in vidne svetlobe, pri čemer evmelanin deluje kot filter; - antioksidacijsko dejavnostjo prek čiščenja prostih radikalov; - inaktivacijo superoksidnega aniona in povečano uporabnostjo superoksidne dismutaze, kar zmanjša oksidativni stres.
Common (may affect up to 1 in 10 people): 
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
Due to limited data in treatment of elderly patients, the use of afamelanotide is not recommended (see section 4.4). 
Zaradi omejenih podatkov pri zdravljenju starejših bolnikov se afamelanotida ne sme uporabljati (glejte poglavje 4.4).
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Presence of severe hepatic disease - Hepatic impairment (see section 5.2) - Renal impairment (see section 5.2) 
- Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1; - huda bolezen jeter; - okvara jeter (glejte poglavje 5.2); - okvara ledvic (glejte poglavje 5.2).
Long-term safety data for afamelanotide are limited. 
Podatki o varnosti dolgotrajne uporabe afamelanotida so omejeni.
Dose-finding studies have not been conducted. 
Študij za določanje odmerka niso izvedli.
The implant is given as injection under your skin using a catheter tube and needle (subcutaneous use). 
Implantat se daje z injiciranjem pod kožo z uporabo katetrske cevke in igle (subkutana uporaba).
Your doctor will check the expiry date before an implant is used. 
Zdravnik bo pred uporabo implantata preveril datum izteka roka uporabnosti.
By increasing the amount of eumelanin, SCENESSE can help to delay the onset of pain due to skin photosensitivity (sensitive to sunlight). 
S povečanjem količine evmelanina lahko zdravilo Scenesse pomaga upočasniti pojav bolečine zaradi občutljivosti kože za sončno svetlobo.
- Apply some pressure to the insertion area with your finger while removing the stylet and the catheter. 
- S prstom nekoliko pritisnite na mesto vboda in sočasno odstranite stilet ter kateter.
Before inserting this medicine, your doctor may decide to give you a local anaesthetic to numb the area where the implant is to be inserted. 
Pred vsaditvijo tega zdravila se lahko zdravnik odloči za uporabo anestetika, da omrtviči območje vstavljanja implantata.
The overall duration of treatment is at the specialist physician's discretion (see section 4.4). 
Skupno trajanje zdravljenja je odvisno od presoje specialista (glejte poglavje 4.4).
E. SPECIFIC OBLIGATIONS TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures: Description 
Ker gre za odobritev v izjemnih okoliščinah in ob upoštevanju člena 14(8) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet v določenem časovnem okviru izvesti naslednje ukrepe: Opis
Afamelanotide works in a way similar to the natural hormone, by making skin cells produce eumelanin which is a brown-black type of melanin pigment in the body. 
Afamelanotid deluje na podoben način kot naravni hormon, tako da v kožnih celicah spodbuja tvorbo evmelanina, ki je rjavo črni melaninski pigment v telesu.
This can be accompanied by a darkening of the skin pigmentation in areas with melanocytes which gradually fades unless a further implant is administered. 
To lahko spremlja potemnitev kožne pigmentacije na predelih z melanociti, ki sčasoma posvetli, če se ne vsadi nov implantat.
Following administration of this medicinal product, somnolence, fatigue, dizziness, and nausea have been reported. 
Po uporabi tega zdravila so poročali o somnolenci, utrujenosti, omotici in navzei.
Afamelanotide has moderate influence on the ability to drive and use machines, especially within 72 hours of administration. 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Afamelanotid ima zmeren vpliv na sposobnost vožnje in upravljanja strojev, predvsem v 72 urah po vsaditvi.