natgillin/translations-raw huggingface dataset:
• A statement to highlight that tacrolimus should not be applied to lesions, which are considered to be potentially malignant or pre-malignant. 
• Opozorilo, ki bo poudarilo, da takrolimusa ni dovoljeno nanašati na lezije, ki so ocenjene kot potencialno maligne ali predmaligne.
• Protopy should not be used in immunocompromised adults or children. 
• Zdravila Protopy se ne sme uporabljati pri odraslih ali otrocih z oslabljenim
Therefore the CHMP requested that the MAH should take the appropriate measures in order to ensure that Protopy is not used in this age group. 
Iz tega razloga je CHMP zahteval, da imetnik dovoljenja za promet z zdravilom sprejme ustrezne ukrepe, da bi tako zagotovil, da se zdravilo Protopy v tej starostni skupini ne uporablja.
The CHMP also concluded that the potential role of tacrolimus in the pathogenesis of CTCL should be further investigated through mechanistic studies. 
Nadalje je CHMP sklenil, da je treba potencialno vlogo takrolimusa pri patogenezi CTCL nadalje raziskati v okviru študij mehanizma delovanja.
In addition, the CHMP concluded that further data are required to better elicit the long-term safety of Protopy in respect of its association with malignancies. 
Poleg tega je CHPM sklenil, da so potrebni nadaljnji podatki za boljšo oceno dolgoročne varnosti uporabe zdravila Protopy glede na njegovo povezavo z malignimi obolenji.
However, having reviewed the available data, the CHMP concluded that not all cases could be considered to be cases of pre-existing malignancy disease, and an association with tacrolimus could not be excluded in some of the cases. 
Vendar pa je CHMP, na podlagi pregleda razpoložljivih podatkov, ocenil, da vseh primerov ni mogoče obravnavati kot predhodno obstoječa maligna obolenja ter da povezave s takrolimusom v določenih primerih ni mogoče izključiti.
As tacrolimus is an effective immunosuppressant that acts by suppressing T lymphocytes in the skin, the CHMP was of the opinion that an effect of tacrolimus on the development or progression of a variety of skin lesions could not be excluded. 
Ker je takrolimus učinkovit imunosupresiv, ki deluje preko supresije limfocitov T v koži, je bil CHMP mnenja, da učinka takrolimusa na razvoj ali napredovanje različnih kožnih lezij ni mogoče izključiti.
In order to address the safety concerns in relation to the cases of malignancies the CHMP concluded that warnings reflecting the cases of malignancies and the need for monitoring of patients treated with Protopy should be included in the product information. 
Za upoštevanje varnostnih pomislekov v zvezi s primeri malignih obolenj je CHMP zaključil, da je treba v informacije o zdravilu vključiti opozorila, ki bodo odražala primere malignih obolenj ter potrebo po spremljanju bolnikov, zdravljenih z zdravilom Protopy.
However, considering that tacrolimus is effective through its suppression of T cells which are involved in immune surveillance, it is possible that tacrolimus could have an effect on the behaviour of cutaneous lesions which were either pre-malignant or cases of early malignancy. 
Vendar pa glede na to, da takrolimus učinkuje na podlagi supresije celic T, ki so vključene v delovanje imunskega sistema, obstaja možnost, da bi takrolimus lahko imel učinek na obnašanje kožnih lezij, ki so bodisi predmaligna obolenja ali primeri malignega obolenja v zgodnji fazi.
The CHMP concluded as well that the risk of cutaneous malignancies should be assessed through case-control studies. 
CHMP je tudi sklenil, da je tveganje za kožna maligna obolenja potrebno oceniti s kontroliranimi študijami primerov.
In view of the available data (including pre clinical, clinical and epidemiological) the CHMP concluded that a potential association with the use of Protopy cannot be ruled out and therefore further data are needed to ensure an acceptable 
CHMP je na podlagi razpoložljivih podatkov (vključujočih predklinične, klinične in epidemiološke podatke) zaključil, da potencialne povezave z uporabo zdravila Protopy ni mogoče izključiti in da je zaradi tega potrebno zbrati dodatne podatke, ki bi zagotovili sprejemljiv dolgoročni varnostni profil.
The CHMP requested that the MAH should present 6 monthly updates on the status of recruitment of this study. 
CHMP je zahteval, da imetnik dovoljenja za promet z zdravilom posreduje 6 mesečna poročila o stanju na področju pridobivanja udeležencev v okviru te raziskave.
On 21 April 2005 the European Commission in view of the potential risk of malignancies requested the Opinion of the CHMP on the benefit/risk profile of Protopy. 
Dne 21. aprila 2005 je Evropska komisija zaprosila Odbor za zdravila za uporabo v humani medicini (CHMP) za mnenje o razmerju med koristmi in tveganji za zdravilo Protopy z vidika potencialnega tveganja za maligna obolenja.
The CHMP agreed that the diagnosis of these skin malignancies is difficult and may mimic AD. 
CHMP se je strinjal, da je diagnozo teh kožnih malignih obolenj težko postaviti ter da so ta obolenja lahko podobna atopičnemu dermatitisu.
Lymphoma is a recognised and listed adverse effect for systemically administered calcineurin inhibitor products. 
Limfom je splošno poznan in v literaturi naveden neželen učinek sistemsko uporabljenih zdravil, ki vsebujejo zaviralce kalcineurina.
- The Committee acknowledged that cases of malignancy (including skin cancer and lymphoma) have been reported in patients treated with Protopy. 
- je Odbor vzel na znanje, da so pri bolnikih, zdravljenih z zdravilom Protopy, poročali o primerih malignih obolenj (vključujočih kožni rak in limfom).
Case reports of malignancies (including skin cancer, cutaneous T-Cell lymphoma (CTCL), NonHodking lymphoma (NHL) and systemic malignancies) have been received during the clinical development and post-marketing experience in association with the use of Protopy. 
V okviru kliničnega razvoja in postmarketinških izkušenj, povezanih z uporabo zdravila Protopy, so poročali o posameznih primerih malignih obolenj (vključujočih kožni rak, kožni limfom celic T (CTCL, Cutaneous T-Cell Lymphoma), ne-Hodgkinov limfom (NHL) in sistemska maligna obolenja).
- The Committee, as a consequence, concluded that the following information should be included in the Summary of Product Characteristics and relevant sections of the Package Leaflet of 
- je Odbor posledično sklenil, da je potrebno v Povzetek glavnih značilnosti zdravila in ustrezne razdelke Navodil za uporabo za zdravilo Protopy vključiti naslednje informacije:
In order to reduce the likelihood of mis-diagnosis and in order to better ensure the appropriate use of the medicinal product, the CHMP emphasised that the product information should reflect that the initial diagnosis and initial prescription should be undertaken by physicians with experience in the treatment of AD. Additionally, the CHMP concluded that Protopy should not be used in immunocompromised adults or children and that Protopy should not be applied to lesions that are considered to be potentially malignant or pre-malignant and that lymphadenopathy present at initiation of therapy should be investigated and kept under review. 
Da bi zmanjšali verjetnost napačno postavljenih diagnoz in v večji meri zagotovili ustrezno uporabo zdravila, je CHMP poudaril, da morajo informacije o zdravilu odražati zahtevo po tem, da začetno diagnozo postavi in zdravilo uvede zdravnik z izkušnjami pri zdravljenju atopičnega dermatitisa.
The CHMP has recommended the amendment to the terms of the Marketing Authorisation for Protopy for which the revised Summary of Product Characteristics and Package Leaflet are set out respectively in annexes I and IIIB. 
Revidiran Povzetek glavnih značilnosti zdravila je na voljo v Dodatku I, revidirana Navodila za uporabo pa v Dodatku IIIB.
• A warning to advise that any lymphadenopathy present prior to initiation of therapy should be investigated and kept under assessment. 
• Opozorilni nasvet, da je potrebno raziskati in nadzorovati limfoadenopatije,
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET 
PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODIL ZA UPORABO
Get medical help immediately. 
Nemudoma poiščite zdravniško pomoč.
The following is a general description. 
Naslednje je splošen opis.
But you must use it only if it looks like water. 
Uporabiti ga smete le, če je videti kot voda.
These instructions are only for you. 
Ta navodila veljajo izključno za vas.
Check your blood sugar. 
Preverite krvni sladkor.
(Needles are not included). 
(Igle niso priložene).
- Are you exercising more than usual? 
- Ste telesno bolj dejavni kot po navadi?
But your doctor will have told you exactly how much to use, when to use it, and how often. 
Zdravnik vam bo natančno povedal, koliko zdravila morate uporabiti, kdaj ga morate uporabiti in kako pogosto.
If no insulin appears: 
Če se insulin ne pojavi:
Extra items you will need: 
Dodatna oprema, ki jo boste potrebovali:
See the section below for help. 
Za pomoč glejte poglavje spodaj.
Dispose of after 4 weeks. 
Zavrzite po 4 tednih.
Follow them exactly and visit your diabetes clinic regularly. 
Natančno jih upoštevajte in redno obiskujte diabetološko ambulanto.
Read this first 
To preberite najprej
If you do not follow all of these instructions, you may get too much or too little insulin. 
Če ne upoštevate vseh teh navodil, lahko dobite preveč ali premalo insulina.
If your dose is more than 80 units, you will need to give yourself more than one injection. 
Če je vaš odmerek večji od 80 enot, si boste morali dati več kot eno injekcijo.
• You may need to repeat this step up to 3 times before seeing insulin. 
• Boste morda morali ta korak ponoviti do 3-krat, preden se bo pojavil insulin.
• eating a lot more than your diet allows; or 
• pojedli ste veliko več, kot dopušča vaša dieta, ali
• Only use your pen for up to 28 days after its first use. 
• Peresnik uporabljajte le do 28 dni po prvi uporabi.
• First wash your hands. 
• Najprej si umijte roke.
- Do you have trouble with your kidneys or liver? 
- Imate težave z ledvicami ali jetri?
This might just be for the first injection or it may be a gradual change over several weeks or months. 
To lahko velja le za prvo injekcijo ali pa bo potrebna postopna sprememba v teku več tednov ali mesecev.
Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. 
Potem pojejte še sadje, kekse ali sendvič, kot vam je svetoval zdravnik, in počivajte.
• Always carry sugar with you. 
• Vedno imejte pri sebi nekaj sladkorja.
This is especially important if you have other injector pens. 
To je posebej pomembno, če imate še druge peresnike za injiciranje.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 july 2017 
Datum prve odobritve: 19. julij 2017
For single patient use only. 
Za uporabo pri enem samem bolniku.
DC5, Campona utca 1., Budapest, 1225, Hungary 
DC5, Campona utca 1., Budapest, 1225, Madžarska
Adjustment of dosage may also be necessary if patients undertake increased physical activity or change their usual diet. 
Prilagoditev odmerjanja je lahko potrebna tudi, če se bolnik poveča telesno dejavnost ali spremeni svojo običajno prehrano.
Each pen contains more than one dose. 
Vsak peresnik vsebuje več kot en odmerek.
Therefore the amount of insulin needed may change. 
Zato se lahko spremeni količina potrebnega insulina.
Even when you are not eating normally, you still need insulin. 
Tudi če ne jeste normalno, še vedno potrebujete insulin.
Alcohol and some medicines can affect your blood sugar levels (see section 2). 
Alkohol in nekatera zdravila lahko vplivajo na koncentracijo sladkorja v krvi (glejte poglavje 2).
Systemic allergy, which is rare but potentially more serious, is a generalised allergy to insulin. 
Sistemska alergija, ki je redka, a potencialno resnejša, je generalizirana alergija na insulin.
Take a new pen out of the fridge at least 1 hour before you inject. 
Nov peresnik vzemite iz hladilnika vsaj 1 uro pred injiciranjem.
This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines). 
To je lahko nevarno v okoliščinah, v katerih sta ti sposobnosti posebej pomembni (npr. pri vožnji avtomobila ali upravljanju strojev).
The first symptoms come on slowly over many hours or days. 
Prvi simptomi se pojavijo postopoma v več urah ali celo dneh.
21 units selected 
Izbranih je 21 enot
Then remove the needle from your skin. 
Potem iglo potegnite iz kože.
If you do not respond to glucagon, you will have to go to hospital. 
Če se ne odzovete na glukagon, boste morali v bolnišnico.
In addition, insulins have several anabolic and anti-catabolic actions on a variety of different tissues. 
Poleg tega imajo insulini številne anabolične in antikatabolične učinke na različna tkiva.
Tell your doctor if you are taking, have recently taken or might take any other medicines (see also section “Warnings and precautions”). 
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo (glejte tudi "Opozorila in previdnostni ukrepi").
The first symptoms of low blood sugar usually come on quickly and include the following: 
Prvi simptomi nizkega krvnega sladkorja se po navadi pojavijo hitro in obsegajo:
How to care for your pen 
Kako skrbeti za peresnik
You should contact your doctor about the advisability of driving if you have: 
Z zdravnikom se pogovorite, ali je priporočljivo, da vozite, če imate:
Local allergy in patients is common. 
Lokalna alergija je pri bolnikih pogosta.
If you need to, you can inject soon after a meal. 
Če je treba, ga lahko injicirate tudi kmalu po obroku.
The symptoms are as follows: • rash over the whole body 
Simptomi so: • izpuščaj po vsem telesu
Do not inject directly into a vein. 
Ne injicirajte neposredno v veno.
• If you think that your pen may be damaged, do not try to repair it, use a new one. 
• Če menite, da je peresnik morda poškodovan, ga ne poskušajte popraviti, ampak uporabite novega.
E After holding and slowly counting to 10, release the injection button. 
E Potem, ko ste gumb držali in počasi prešteli do 10, gumb za injiciranje spustite.
Warning signs are listed later in this leaflet. 
Opozorilni znaki so navedeni v nadaljevanju tega navodila.
Patients must be educated to use the proper injection techniques. 
Bolnike je treba naučiti uporabe pravilnih načinov injiciranja.
If you find it hard to press the button in: 
Če gumb težko pritisnete noter:
• If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse - Have you recently become ill? 
• Če na katero koli od naslednjih vprašanj odgovorite "DA", morate to povedati svojemu zdravniku, farmacevtu ali diabetološki medicinski sestri: - Ste pred kratkim zboleli?
Do not change your insulin unless your doctor tells you to. 
Ne menjajte svojega insulina, če vam tega ne naroči zdravnik.
This helps stop blocked needles, contamination and infection. 
To pomaga preprečiti zamašitev igle, onesnaženje in okužbe.
Ask your doctor to tell you about glucagon. 
Zdravnika prosite za pojasnilo o glukagonu.
He will only do this under special circumstances such as surgery or if you are ill and your glucose levels are too high. 
Tako bo ravnal le v posebnih okoliščinah, na primer v primeru operacije ali če ste bolni in imate previsoko koncentracijo glukoze.
Industriepark Höchst 65926 Frankfurt am Main Germany 
Industriepark Höchst 65926 Frankfurt am Main Nemčija
SPECIAL STORAGE CONDITIONS Before first use: 
POSEBNA NAVODILA ZA SHRANJEVANJE Pred prvo uporabo:
The dosage should be determined by the physician, according to the requirement of the patient. 
Odmerjanje mora določiti zdravnik glede na bolnikove potrebe.
• Always carry something to show you are diabetic. 
• Vedno imejte pri sebi nekaj, iz česar bo razvidno, da imate sladkorno bolezen.
The amount of insulin you need usually falls during the first three months of pregnancy and increases for the remaining six months. 
Količina insulina, ki ga potrebujete, se v prvih treh mesecih nosečnosti po navadi zmanjša, v preostalih šestih mesecih pa se poveča.
However, a consistent routine must be followed. 
Vendar pa se je treba vedno ravnati po enakem postopku.
Push them out with the plunger and withdraw the correct dose. 
Iztisnite jih z batom in potegnite pravilni odmerek.
Never use your pen if it is damaged or if you are not sure that it is working properly. 
Peresnika ne uporabite, če je poškodovan ali če niste prepričani, da deluje pravilno.
The vial is to be used in conjunction with an appropriate syringe (100 units markings). 
Vialo je treba uporabiti skupaj z ustrezno brizgo (oznake 100 enot).
Local allergy 
Lokalna alergija
Exercise taken immediately after a meal may increase the risk of hypoglycaemia. 
Telesna dejavnost takoj po obroku lahko poveča tveganje za hipoglikemijo.
• You can clean the outside of your pen by wiping it with a damp cloth (water only). 
• Zunanjost peresnika lahko očistite tako, da ga obrišete z vlažno krpico (samo voda).
When considering the clinical relevance of these kinetics, it is more appropriate to examine the glucose utilisation curves (as discussed in section 5.1). 
Za oceno kliničnega pomena te kinetike je primerneje upoštevati krivulji utilizacije glukoze (kot je obravnavano v poglavju 5.1).
The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence (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). 
Naslednji povezani neželeni učinki, ugotovljeni v kliničnih raziskavah, so navedeni spodaj po organskih sistemih in razvrščeni po padajoči pogostnosti zelo pogosti (≥ 1/10), pogosti (≥ 1/100, < 1/10), občasni (≥ 1/1.000, < 1/100), redki (≥ 1/10.000, < 1/1.000), zelo redki (< 1/10.000), ne znana pogostost (pogostosti ni mogoče oceniti na podlagi podatkov, ki so na voljo).
• This pen is not recommended for use by the blind or visually impaired without the help of someone trained to use the pen. 
• Ni priporočljivo, da bi slepe ali slabovidne osebe ta peresnik uporabljale brez pomoči nekoga, ki je usposobljen za njegovo uporabo.
• If your injection is given by another person, or if you are giving an injection to another person, special caution must be taken by this person when removing and disposing of the needle. 
• Če vam injekcijo daje kdo drug, ali če vi dajete injekcijo komu drugemu, je pri odstranjevanju in odlaganju igle potrebna posebna previdnost.
While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a car, in which you or others would be put at risk by hypoglycaemia. 
Dokler niste prepričani, da lahko prepoznate opozorilne simptome, se izogibajte okoliščinam (npr. vožnji avtomobila), v katerih bi zaradi hipoglikemije ogrozili sebe ali druge.
• you exercise or work too hard just before or after a meal; 
• če ste telesno preveč dejavni ali preveč delate tik pred obrokom ali po njem,
• angiotensin II receptor blockers. 
• blokatorje receptorjev angiotenzina II.
Severe cases of generalised allergy may be life-threatening. 
Hudi primeri generalizirane alergije so lahko smrtno nevarni.
• rash over the whole body 
• izpuščaj po vsem telesu
Subcutaneous and intravenous use 
subkutana in intravenska uporaba
Severe symptoms are heavy breathing and a rapid pulse. 
Huda simptoma sta težko dihanje in hitro bitje srca.
It works more quickly than normal human insulin because the insulin molecule has been changed slightly. 
Deluje hitreje kakor običajni humani insulin, ker je molekula insulina v njem nekoliko spremenjena.
Three simple steps to avoid hypoglycaemia or hyperglycaemia are: 
Trije preprosti koraki za preprečevanje hipoglikemije ali hiperglikemije so:
Wipe the top of the vial with an alcohol swab. 
Vrh viale obrišite z alkoholnim lističem.
• using less insulin than your doctor tells you to; 
• uporabili ste manj insulina, kot vam je predpisal zdravnik,
Store below 30°C and protect from direct heat and light. 
Shranjujte pri temperaturi do 30°C in zaščiteno pred neposredno toploto ali svetlobo.
In some studies, reduction of nocturnal hypoglycaemia was associated with increased episodes of daytime hypoglycaemia. 
V nekaterih študijah je bilo zmanjšanje števila nočnih hipoglikemij povezano z večjim številom dnevnih hipoglikemij.
• blood pressure dropping 
• padec krvnega tlaka
After injection, the site of injection should not be massaged. 
Po injiciranju se mesta injiciranja ne sme masirati.
Choose a site for injection. 
Izberite mesto za injiciranje.
The reduction of HbA1c would also be expected with other insulin products e.g. soluble or isophane insulins. 
Znižanje HbA1c bi pričakovali tudi pri drugih insulinih, npr. pri topnem ali izofanem insulinu.
This can be caused if: 
To se lahko pojavi:
Patients with diabetes should be advised to inform their doctor if they are pregnant or are contemplating pregnancy. 
Bolnicam s sladkorno boleznijo je treba svetovati, naj obvestijo svojega zdravnika, če zanosijo ali načrtujejo zanositev.
The typical activity profile following subcutaneous injection is illustrated below. 
Značilni profil delovanja po subkutanem injiciranju je prikazan spodaj.
Illness 
Bolezen
Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema). 
Čim prej obvestite svojega zdravnika, če se vam pojavijo znaki srčnega popuščanja, npr. nenavadno kratka sapa, hitro povečanje telesne teže ali lokalizirano otekanje (edem).
A Choose a place to inject as shown in the picture 
A Izberite mesto za injiciranje, kot prikazuje slika.
Severe hypoglycaemia may lead to loss of consciousness, and in extreme cases, death. 
Huda hipoglikemija lahko povzroči izgubo zavesti, v skrajnih primerih celo v smrt.
If you often have hypoglycaemia or have difficulty recognising it, please discuss this with your doctor. 
Če imate hipoglikemije pogosto, ali če jih težko prepoznate, se morate o tem posvetovati z zdravnikom.
Press the knob. 
Pritisnite na gumb.
• Follow recommended safety measures for removal and disposal of needles (contact your doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and transmission of infectious diseases. 
• Upoštevajte priporočene varnostne ukrepe za odstranjevanje in odlaganje igel (obrnite se na zdravnika, farmacevta ali medicinsko sestro), da boste zmanjšali tveganje za naključno poškodbo z iglo in prenos nalezljivih bolezni.
Patients who are blind or have poor vision must be instructed to always get help/assistance from another person who has good vision and is trained in using the insulin device. 
Slepim ali slabovidnim bolnikom je treba naročiti, naj vedno poskrbijo za pomoč druge osebe, ki dobro vidi in je usposobljena za uporabo pripomočka za insulin.
Systemic allergy 
Sistemska alergija
• If you cannot select your full prescribed dose, use a new pen or inject the remaining units and use a new pen to complete your dose. 
• Če ne morete nastaviti celotnega predpisanega odmerka, uporabite nov peresnik ali injicirajte preostanek enot, nato pa za dokončanje odmerka uporabite nov peresnik.
For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. 
Zdravljenje odraslih in otrok s sladkorno boleznijo, ki potrebujejo insulin za vzdrževanje normalne homeostaze glukoze.
Please get rid of it carefully - your pharmacist or diabetes nurse will tell you how to do this. 
Zavrzite ga ustrezno - farmacevt ali diabetološka medicinska sestra vam bosta povedala, kako to storiti.
Here are some reminders. 
Tukaj je nekaj pomembnih opozoril.
• a puncture resistant container for used needles and pens (see Throwing your pen away). 
• vsebnik za ostre odpadke za uporabljene igle in peresnike (glejte Kako zavreči peresnik).
You should only inject it into a muscle if your doctor has told you to. 
V mišico ga smete injicirati le, če vam tako naroči zdravnik.