natgillin/translations-raw huggingface dataset:
Following this request, the CHMP reviewed the available data on this safety issue, including post-marketing reports, data from nonclinical studies, clinical trials and epidemiological studies.
Na podlagi te zahteve je CHMP pregledal razpoložljive podatke v zvezi s tem vidikom varnosti, vključno s postmarketinškimi poročili, podatki iz nekliničnih raziskav, kliničnih raziskav in epidemioloških raziskav.
• A statement reflecting the cases of malignancies reported in the post-marketing
• Navedbo, ki odraža primere malignih obolenj, o katerih so poročali v postmarketinškem obdobju.
The CHMP also expressed concerns about the degree of use of Protopy in children under the age of 2 (not approved) when the immune system is still developing.
CHMP je tudi izrazil zaskrbljenost v zvezi s stopnjo uporabe zdravila Protopy pri otrocih, starih manj kot dve leti (uporaba ni odobrena), pri katerih se imunski sistem šele razvija.
Protopy is a dermatological medicinal product that contains the calcineurin inhibitor tacrolimus at a 0.1% and 0.03% concentration.
Protopy je dermatološko zdravilo, ki vsebuje takrolimus, zaviralec kalcineurina, v koncentraciji 0,1 % in 0,03 %.
• The treatment with Protopy should only be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis.
• Zdravljenje z zdravilom Protopy sme uvesti le zdravnik, ki ima izkušnje z diagnostiko in z zdravljenjem atopičnega dermatititsa.
The mode of action of tacrolimus is stated to be by inhibition of calcium dependent signal transduction pathways in T cells which results in prevention of transcription and synthesis of IL-2, IL3, IL-4, IL-5 and other cytokines.
Način delovanja takrolimusa naj bi bil po navedbah zaviranje od kalcija odvisnih poti prevajanja v celicah T, kar prepreči transkripcijo in sintezo IL-2, IL-3, IL-4, IL-5 ter drugih citokinov.
However there appeared to be an increase in numbers of patients with CTCL, relative to what would be expected.
Kljub temu pa se zdi, da se bolniki s CTCL pojavljajo v večjem številu, kot bi pričakovali.
Protopy 0.1% is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults who are not adequately responsive to or are intolerant of conventional therapies and Protopy 0.03% is indicated for the treatment of moderate to severe AD in adults or children (2 years of age and above) who failed to respond adequately to conventional therapies.
Zdravilo Protopy 0,1 % je namenjeno zdravljenju zmernega do hudega atopičnega dermatitisa (AD) pri odraslih, ki se na konvencionalne terapije ne odzovejo ustrezno ali jih ne prenesejo, zdravilo Protopy 0,03 % pa je namenjeno zdravljenju zmernega do hudega atopičnega dermatitisa (AD) pri odraslih ali otrocih (starih 2 leti ali več), ki se na konvencionalne terapije ne odzovejo ustrezno.
This effect is thought to be mediated by the immunosuppression caused as a result of systemic treatment with the product.
Do tega učinka domnevno prihaja zaradi imunosupresije, povzročene s sistemsko uporabo tega zdravila.
Systemic exposure is limited with the topical use of tacrolimus, however a local immunosuppressive effect in the skin cannot be excluded.
Sistemska izpostavljenost se z lokalno uporabo takrolimusa omeji, kljub temu pa lokalnega imunosupresivnega učinka na koži ne moremo izključiti.
The CHMP endorsed the ongoing registry study presented by the Marketing Authorisation Holder - APPLES study (paediatric registry).
CHMP je odobril potekajočo pripravo registrske študije, ki jo je predstavil imetnik dovoljenja za promet z zdravilomraziskava APPLES (pediatrični register).
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET PRESENTED BY THE EMEA
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODIL ZA UPORABO, PREDSTAVLJENI S STRANI EMEA
The data presented did not show a definite association with lymphoma or any malignancy.
Predloženi podatki niso pokazali nedvoumne povezave z limfomom ali katerim drugim malignim obolenjem.
After reviewing the available data the CHMP concluded that the balance of risks and benefits for Protopy is considered favourable.
Po pregledu razpoložljivih podatkov je CHMP sklenil, da je razmerje med tveganji in koristmi za zdravilo Protopy mogoče oceniti kot ugodno.
With regard to the skin cancers, the CHMP concluded that treatment with tacrolimus was not likely to have caused these skin malignancies.
V zvezi s kožnim rakom je CHMP sklenil, da ni verjetno, da bi zdravljenje s takrolimusom povzročilo tovrstna kožna maligna obolenja.
• A statement that Protopy should not be used in children under 2 years.
• Navedbo, da zdravila Protopy ni dovoljeno uporabljati pri otrocih, starih manj kot 2 leti.
• 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.