natgillin/translations-raw huggingface dataset:
Some of the scientific literature presented showed how radiolabelling with radioactive forms of Copper, including 64Cu, were used together with imaging techniques to detect the site and spread of tumours and how it could potentially be used to treat various types of cancer.
V delu predložene znanstvene literature je bila prikazana uporaba radioaktivnega označevanja z radioaktivnimi oblikami bakra, vključno s 64Cu, skupaj s slikovnimi tehnikami z namenom odkrivanja položaja tumorjev in njihovega razširjanja ter možnosti zdravljenja različnih vrst raka.
It must not be used in people who are hypersensitive (allergic) to copper (64Cu) chloride or any of the other ingredients.
Tega zdravila ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) bakrov (64Cu) klorid ali katero koli drugo sestavino zdravila.
Given the well-known risks of exposure to radiation through radiolabeling, the Committee decided that Cuprymina is only to be used if justified by the likely medical benefit.
Glede na dobro znana tveganja izpostavljanja sevanju pri radioaktivnem označevanju CHMP meni, da se sme zdravilo Cuprymina uporabljati le, kadar je to upravičeno na podlagi predvidenih kliničnih koristi.
Cuprymina is not used on its own but is used for radiolabelling other medicines.
Zdravilo Cuprymina se ne uporablja samostojno, ampak za radioaktivno označevanje drugih zdravil.
The radiolabelled medicine is then given to the patient according to the instructions in that medicine's summary of product characteristics (SmPC).
Nato bolnik prejme radioaktivno označeno zdravilo po navodilih iz povzetka glavnih značilnosti označenega zdravila (SmPC).
The company presented information from the scientific literature on the potential uses of Cuprymina.
Predlagatelj je predstavil podatke o možnih uporabah zdravila Cuprymina iz znanstvene literature.
Cuprymina is only to be used by specialists who have experience in radiolabelling.
Zdravilo Cuprymina smejo uporabljati le zdravniki specialisti, izkušeni na področju radioaktivnega označevanja.
The intended effect of the radiation will depend on the nature of the medicine that has been radiolabelled.
Želeni učinek sevanja je odvisen od narave zdravila, ki se radioaktivno označi.
Why has Cuprymina been approved?
Zakaj je bilo zdravilo Cuprymina odobreno?
The active substance in Cuprymina, copper (64Cu) chloride, is a radioactive compound that emits a type of radiation known as beta radiation.
Zdravilna učinkovina v zdravilu Cuprymina, bakrov (64Cu) klorid, je radioaktivna spojina, ki oddaja sevanje, imenovano beta sevanje.
Cuprymina is used to radiolabel medicines that have been specially developed for use with copper (64Cu) chloride.
Zdravilo Cuprymina se uporablja za radioaktivno označevanje zdravil, ki so bila posebej razvita za uporabo z bakrovim (64Cu) kloridom.
Once the substance is radiolabelled with Cuprymina, it then carries the radioactivity to where it is needed in the body.
Ko je snov radioaktivno označena z zdravilom Cuprymina, prenese radioaktivnost do ciljnega področja v telesu.
The information supplied by the company showed that Cuprymina can be used to radiolabel medicines with 64Cu, with potential utility for detecting of the sites and spread of tumours.
Podatki, ki jih je predložil predlagatelj, kažejo, da se zdravilo Cuprymina lahko uporabi za radioaktivno označevanje zdravil s 64Cu z možno uporabnostjo pri odkrivanju položaja tumorjev in njihovega razširjanja.
Medicines to be radiolabeled with Cuprymina can only be obtained with a prescription.
Izdaja zdravil, ki se radioaktivno označijo z zdravilom Cuprymina, je le na recept.
When a medicine is radiolabelled with Cuprymina, the medicine will carry the radiation to the particular site or type of cell in the body that is targeted by the medicine.
Z zdravilom Cuprymina radioaktivno označeno zdravilo bo preneslo sevanje do ciljnega mesta zdravila: določenega dela telesa ali določene vrste celic.
Cuprymina is a solution that contains the radioactive substance copper (64Cu) chloride.
Zdravilo Cuprymina je raztopina, ki vsebuje radioaktivno snov bakrov (64Cu) klorid.
More information on the restrictions on the use of medicines radiolabelled with Cuprymina will be found in their package leaflets.
Za več podatkov o omejitvah uporabe zdravil, radioaktivno označenih z zdravilom Cuprymina, glejte njihova navodila za uporabo.
How has Cuprymina been studied?
Kako je bilo zdravilo Cuprymina raziskano?
What is Cuprymina?
Kaj je zdravilo Cuprymina?
What is Cuprymina used for?
Za kaj se zdravilo Cuprymina uporablja?
How is Cuprymina used?
Kako se zdravilo Cuprymina uporablja?
The side effects with Cuprymina depend largely on the medicine it has been used to radiolabel and will be described in that medicine's package leaflet.
Neželeni učinki pri uporabi zdravila Cuprymina so odvisni predvsem od zdravila, ki je bilo radioaktivno označeno.
How does Cuprymina work?
Kako zdravilo Cuprymina deluje?
This takes around 30 minutes.
To traja približno 30 minut.
96 to 144 weeks
96 do 144 tednov
52 weeks
52 tednov
Read and follow the advice given in section 7.
Preberite in upoštevajte nasvete v poglavju 7.
The median duration was similar between the treatment groups.
Mediana trajanja je bila med skupinami zdravljenja podobna.
It should include the following elements:
Vsebovati mora naslednje elemente:
This stops nerves from working properly.
Zaradi tega živci prenehajo delovati pravilno.
It has not been determined whether these patients respond differently compared with younger patients.
Ni bilo ugotovljeno, ali se ti bolniki odzivajo drugače kot mlajši bolniki.
- if you have a serious infection, such as pneumonia.
- če imate resno okužbo, kot je pljučnica.
Efficacy in patients with highly active disease Highly active disease was defined as follows:
Učinkovitost pri bolnikih z zelo aktivno boleznijo Zelo aktivna bolezen je bila opredeljena kot sledi:
This is normal and will not affect your dose.
To je normalno in ne vpliva na odmerek.
You will hear the clicking sounds start.
Slišali boste, ko se bo začelo klikanje.
The incidence of the adverse reactions is expressed according to the following categories:
Incidenca neželenih učinkov je izražena po naslednjih kategorijah:
Following a recovery period of up to 12 weeks, there was evidence of reversibility.
Po do 12-tedenskem obdobju okrevanja so opazili dokaze reverzibilnosti.
- if you have ever had tuberculosis (also called TB) or live in a region where TB infections are common, you may be at greater risk of TB.
- če ste kadar koli imeli tuberkulozo (imenovano tudi TB) ali živite na območju, kjer so okužbe s TB pogoste, imate lahko večje tveganje za TB.
• The need to exercise caution regarding concomitant use of other hepatotoxic medications;
• potrebni previdnosti glede sočasne uporabe drugih hepatotoksičnih zdravil;
The rate of infections and serious infections did not increase over time.
Stopnja okužb in resnih okužb se sčasoma ni povečala.
For additional information on storage at room temperature, see section 6.3.
Za dodatne informacije o shranjevanju pri sobni temperaturi glejte poglavje 6.3.
• Be designed to enable physicians to present patient-friendly information;
• biti oblikovana tako, da omogoči zdravnikom predstavitev informacij na bolniku prijazen način;
• Very rare (<1/10,000) • Not known (cannot be estimated from the available data)
• zelo redki (<1/10.000) • neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov)
• Acknowledgment Form.
• potrditveni obrazec.
This is a type of medicine called a monoclonal antibody.
To je vrsta zdravila, ki se imenuje monoklonsko protitelo.
• changes in your blood (anaemia) which may make you feel weak
• spremembe na krvi (anemija), zaradi česar ste lahko šibki
This loss of myelin is called demyelination.
Izguba mielina se imenuje demielinizacija.
In the absence of compatibility studies, this medicinal product should not be mixed with other products.
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
• thoughts of hurting yourself or suicide
• misli o samopoškodovanju ali samomoru
Do not use this medicine if you notice that:
Ne uporabljajte tega zdravila, če opazite, da:
Percent ≥ 2 relapses in the year prior to study
Odstotek ≥ 2 recidivov v letu pred študijo
Do not freeze or expose to high temperatures.
Ne zamrzujte in ne izpostavljajte visokim temperaturam.
Table 5 and Figures 1-2 show the results for the DECIDE study.
Preglednica 5 in sliki 1-2 prikazujeta rezultate študije DECIDE.
It is very important that you do not miss this blood test.
Pomembno je, da te krvne preiskave ne izpustite.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01 July 2016
Datum prve odobritve: 01. julij 2016
Reported experience with overdose is limited.
Poročane izkušnje s prevelikim odmerjanjem so omejene.
This medicinal product should not be used if:
Tega zdravila se ne sme uporabiti, če:
This information does not take the place of talking to your doctor or nurse about your medical condition or your treatment.
Te informacije ne morejo nadomestiti pogovora z zdravnikom ali medicinsko sestro o vašem zdravstvenem stanju ali zdravljenju.
Try to keep to a set day for it each month.
Poskušajte si določiti dan za to vsak mesec.
Percent prior DMT use (%)
Odstotek pred uporabo DMT (%)
Do not make changes unless your doctor tells you to.
Ne spreminjajte ničesar, če vam tako ne naroči zdravnik.
You should then contact your doctor, nurse or pharmacist.
Potem morate stopiti v stik z zdravnikom, medicinsko sestro ali farmacevtom.
However, Zinbryta's effect on other vaccines (live vaccines) is not known.
Vendar pa učinek zdravila Zinbryta na druga cepiva (živa cepiva) ni znan.
Do not use this medicine after the expiry date which is stated on the carton and the label after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki poleg oznake »EXP«.
Although human IgG is secreted into human milk, published data suggest that antibodies in breast milk do not enter the neonatal and infant circulations in substantial amounts.
Čeprav se humani IgG izloča v materino mleko, objavljeni podatki kažejo, da protitelesa v materinem mleku ne vstopajo v obtok pri novorojencu in dojenčku v znatnih količinah.
Disease history
Zgodovina bolezni
Additional supplies which are not included in the pack (See Figure B):
Dodatni pripomočki, ki niso priloženi pakiranju (glejte sliko B):
Symptoms may disappear completely after the relapse is over but, over time, some problems may remain between relapses and interfere with daily activities.
Simptomi lahko po recidivu povsem izginejo, toda sčasoma nekatere težave med recidivi ostanejo in ovirajo vsakodnevne dejavnosti.
It is very important that you have these regular blood tests.
Redno izvajanje teh krvnih preiskav je zelo pomembno.
Component of a multipack, cannot be sold separately.
Sestavni del skupnega pakiranja, ni za posamično prodajo.
• Patient details, signature and date;
• bolnikovi podatki, podpis in datum;
In case of overdose, patients may require medical attention and appropriate supportive treatment should be given.
V primeru prevelikega odmerka bo morda treba bolnike zdravniško oskrbeti in jim nuditi ustrezno podporno zdravljenje.
Keep this Card with you during treatment and for 6 months afterwards.
Kartico shranite med zdravljenjem in še 6 mesecev potem.
The magnitude of the immune response to the seasonal influenza vaccine, and proportion of patients with seroconversion and seroprotection were consistent with those observed in healthy volunteer populations.
Velikost imunskega odziva na sezonsko cepivo proti gripi in delež bolnikov s serokonverzijo in serozaščito je bil skladen s tistim pri populaciji zdravih prostovoljcev.
In either case, do not use two injections to make up for a missed dose.
V nobenem primeru ne uporabite dveh injekcij odmerka, da bi nadomestili izpuščeni odmerek.
• feeling unusually sad, hopeless or bad about yourself
• neobičajen občutek žalosti, brezupa ali nezadovoljstva s seboj
Doses up to this level were well tolerated with no evidence of acute toxicity.
Odmerke do te ravni so bolniki dobro prenašali brez dokazov akutne toksičnosti.
If you do not hear clicking sounds or you do not see green ticks in the injection status window after attempting to inject, the pen may have locked and you may not have received your injection.
Če ne slišite zvokov klikanja ali če ne vidite zelenih kljukic v oknu za stanje injiciranja, potem ko ste poskusili injicirati, se je napolnjeni injekcijski peresnik mogoče zaklenil in injekcije mogoče niste prejeli.
Clinical trial data from the DECIDE study demonstrated consistent treatment effects in the highly active disease subgroup.
Podatki kliničnih preskušanj za študijo DECIDE so dokazali skladne učinke zdravljenja v podskupini z zelo aktivno boleznijo.
People with relapsing MS have repeated attacks (relapses) of symptoms caused by their nerves not working properly.
Ljudje z recidivno MS imajo ponavljajoče napade (recidive) simptomov, ki jih povzročajo nepravilno delujoči živci.
Exposures (AUC) in these studies ranged from 55 to 140 times that observed with the clinical dose.
Izpostavljenosti (AUC) v teh študijah so bile v razponu od 55- do 140-krat večje od opaženih pri kliničnih odmerkih.
Total exposure (subject-years) ≥ 3 x ULN > 5 x ULN > 10 x ULN > 20 x ULN
Celotna izpostavljenost (osebe-leta) 7011 ≥ 3 x ULN > 5 x ULN > 10 x ULN > 20 x ULN
Skin reactions generally resolved with standard care, including treatment with topical or systemic steroids.
Kožne reakcije so običajno izzvenele s standardno oskrbo, vključno z zdravljenjem z lokalnimi ali sistemskimi steroidi.
Even if you have had no previous liver problems, your doctor will carry out blood tests to test your liver function.
Tudi če prej še niste imeli težav z jetri, bo vaš zdravnik opravil krvne preiskave, da testira delovanje vaših jeter.
Results for the SELECT study are shown in Table 4.
Rezultati za študijo SELECT so prikazani v preglednici 4.
- if you have liver problems.
- če imate težave z jetri.
Contact your doctor immediately if you get any serious side effects.
Takoj se obrnite na zdravnika, če se pojavi kateri koli resen neželeni učinek.
In patients who have had tuberculosis or who live in endemic areas of the disease, screening for active tuberculosis should be performed before starting treatment, and patients should be monitored during treatment.
Pri bolnikih, ki so že imeli tuberkulozo ali ki živijo na endemičnih področjih te bolezni, so pred začetkom zdravljenja potrebne preiskave za aktivno tuberkulozo, bolnike pa je treba med zdravljenjem spremljati.
Race No pharmacokinetic differences were observed between Japanese and Caucasian healthy volunteers.
Rasa Razlik v farmakokinetiki med zdravimi japonskimi in belskimi prostovoljci niso opazili.
Pharmacotherapeutic group: immunosuppressants, interleukin inhibitors, ATC code: L04AC01
Farmakoterapevtska skupina: zdravila za zaviranje imunske odzivnosti, zaviralci interlevkinov, oznaka ATC: L04AC01
Daclizumab pharmacokinetics are well described by a two-compartment model with first-order absorption and elimination.
Farmakokinetika daklizumaba je dobro opisana v dvoprostornem modelu z absorpcijo in izločanjem prvega reda.
Interferon beta-1a (intramuscular) 30 micrograms
Interferon beta-1a (intramuskularno) 30 mikrogramov
b. Wash your hands with soap and water.
b. Umijte si roke z milom in vodo.
The Acknowledgment Form aims at providing information on the risk of serious hepatic injury to patients.
Potrditveni obrazec ima namen zagotavljanja informacij bolnikom o tveganju za resne poškodbe jeter.
There was no effect on foetal development and no evidence of teratogenicity.
Učinka na razvoj fetusa in dokazov o teratogenosti ni bilo.
Hold
Držite
Table 5: DECIDE study clinical and MRI results (96 to 144 weeks) (Values refer to results at 96 weeks, unless otherwise indicated.)
Preglednica 5: Klinični rezultati in rezultati MR slikanja v študiji DECIDE (96 do 144 tednov) (Vrednosti se nanašajo na rezultate pri 96 tednih, razen kjer je navedeno drugače.)
Vaccination with live vaccines is not advised during treatment and up to 4 months after discontinuation.
Cepljenje z živimi cepivi se med zdravljenjem in še do 4 mesece po prekinitvi zdravljenja odsvetuje.
If you experience any of the following, contact your doctor immediately:
Če opazite kar koli od naslednjega, takoj obvestite zdravnika:
This small volume of distribution indicates that daclizumab is primarily confined to the vascular and interstitial spaces.
Ta majhen volumen porazdelitve kaže, da je daklizumab primarno omejen na ožilje in intersticijski prostor.
• increases in body temperature (fever)
• zvišana telesna temperatura (vročina)
The most common types of infections were upper respiratory tract infections and viral infections.
Najpogostejše vrste okužb so bile okužbe zgornjih dihal in virusne okužbe.
AST or ALT ≥ 3 x ULN AND total bilirubin ≥ x 2 ULN
AST ali ALT ≥ 3 x ULN IN celotni bilirubin ≥ x 2 ULN
Daclizumab had no effect on peri- and post-natal development from birth to up to 6 months in the offspring.
Daklizumab nima vpliva na perinatalni in postnatalni razvoj potomcev od rojstva do 6 mesecev starosti.
Patients have received double the recommended dose of Zinbryta with no serious extra side effects.
Bolniki so prejeli dvojni priporočeni odmerek zdravila Zinbryta brez resnih dodatnih neželenih učinkov.
Side effects may occur even after stopping treatment (see serious side effects in section 4).
Neželeni učinki se lahko pojavijo tudi po koncu zdravljenja (glejte resne neželene učinke v poglavju 4).
Mutagenesis Genotoxicity studies have not been conducted.
Mutageneza Študij genotoksičnosti niso izvajali.
Table 3: Study design and baseline characteristics for SELECT study and DECIDE study Study name
Preglednica 3: Zasnova študije in izhodiščne značilnosti za študijo SELECT in študijo DECIDE Ime študije
When you have any medical treatment, even if it is not for your MS, show the Patient Card to the doctor, pharmacist or nurse.
Ko se kakor koli zdravite, tudi če ni zaradi MS, to Opozorilno kartico za bolnika pokažite zdravniku, farmacevtu ali medicinski sestri.
Cumulative incidences of peak ALT or AST increase (based on laboratory data) observed in clinical trials
Kumulativne incidence največjih zvišanj ALT ali AST (na podlagi laboratorijskih podatkov), ki so jih ugotovili v kliničnih preskušanjih.
Quickly insert the needle straight into the skin fold until the needle is fully under the skin.
Iglo hitro vbodite naravnost v kožno gubo tako, da je igla povsem pod kožo.
Name and address of the manufacturer of the biological active substance:
Ime in naslov izdelovalca biološke učinkovine:
For DECIDE, at least 2 relapses (one of which was a clinical relapse) within the prior 3 years was also required
Za študijo DECIDE sta bila potrebna vsaj 2 recidiva (med katerim je bil en klinični recidiv) v predhodnih 3 letih.
• Recommended storage is controlled refrigeration 2°C to 8°C in the closed original carton to protect from light.
• Zdravilo je priporočljivo shranjevati v nadzorovanem hladilniku med 2 °C in 8 °C v zaprti originalni škatli za zagotovitev zaščite pred svetlobo.
In MS, the body's immune system causes inflammation which damages the protective sheath (called myelin) around the nerves in the central nervous system (including the brain and spinal cord).
Pri MS telesni imunski sistem povzroča vnetje, ki poškoduje zaščitno ovojnico (imenovano mielin) okoli živcev v osrednjem živčnem sistemu (vključno z možgani in hrbtenjačo).
Check the medicine window.
Preverite okno za zdravilo.
This tells you that the injection is happening (see Figure G).
To vam bo povedalo, da je injiciranje v teku (glejte sliko G).
Zinbryta is not to be used in children and adolescents younger than 18 years old.
Zdravila Zinbryta ne smejo uporabljati otroci in mladostniki, mlajši od 18 let.
Do not share the pen with anyone else to avoid giving an infection to them or getting an infection from them.
Napolnjenega injekcijskega peresnika ne delite z nikomer, da ne bi od koga dobili infekcije ali da ne bi kdo dobil infekcije od vas.
Most patients had mild elevations that were below or up to 3 x ULN and resolved spontaneously.
Pri večini bolnikov so bila povišanja blaga, pod ali do 3 x ULN, in so spontano izzvenela.
Some side effects may require your doctor to interrupt your treatment and refer you to a specialist.
Zaradi nekaterih neželenih učinkov bo zdravnik moral vaše zdravljenje prekiniti in vas napotiti k specialistu.
This has important safety information that you need to know before and during treatment with Zinbryta.
Vsebuje pomembne informacije o varnosti, ki jih morate vedeti pred zdravljenjem z zdravilom Zinbryta in med njim.
Chronic administration of daclizumab at all doses increased the incidence of skin findings (compared to those observed in control animals).
Kronično dajanje daklizumaba pri vseh odmerkih je povečalo incidenco izsledkov na koži (v primerjavi z opaženimi pri kontrolnih živalih).
• The recommendation not to initiate treatment in patients with autoimmune disorders (other than multiple sclerosis);
• priporočilu, naj se zdravljenje ne uvaja pri bolnikih z avtoimunskimi boleznimi (razen multiple skleroze);
Time on study (weeks) Number of patients at risk
Čas v študiji (tedni) Število bolnikov s tveganjem
Do not try to treat any side effects yourself.
Neželenih učinkov ne poskušajte zdraviti sami.
Time on study (weeks) Average number of patients at risk
Čas v študiji (tedni) Povprečno število bolnikov s tveganjem
Your doctor will decide whether Zinbryta is the right medicine for you.
Zdravnik bo odločil o tem, ali je zdravilo Zinbryta pravo zdravilo za vas.
If your doctor has told you to stop using your medicine, do not restart unless your doctor tells you to.
Če vam je zdravnik povedal, da naj zdravilo prenehate uporabljati, ga ne začnite uporabljati ponovno,
Study design Treatment
Zasnova študije Zdravljenje
Zinbryta has had very little testing in people older than 55 years old.
Z zdravilom Zinbryta so pri osebah, starejših od 55 let, opravili zelo malo testov.
• If some areas are too difficult for you to reach, ask a carer who has been trained to help you.
o Če nekatere predele pretežko dosežete, prosite usposobljenega negovalca, naj vam pomaga.
Seasonal flu vaccines (inactive vaccine) have been shown to be effective when given to patients taking Zinbryta.
Pokazalo se je, da so sezonska cepiva proti gripi (inaktivirana cepiva) učinkovita, ko se dajejo bolnikom, ki uporabljajo zdravilo Zinbryta.
Possible liver problems
Možne težave z jetri
Zinbryta is used to treat relapsing forms of multiple sclerosis (MS) in adults who have failed to respond despite therapy with at least two MS treatment and who cannot be given other treatments.
Zdravilo Zinbryta se uporablja za zdravljenje recidivne oblike multiple skleroze (MS) pri odraslih, ki se niso odzvali na zdravljenje kljub zdravljenju z vsaj dvema zdraviloma za MS in ki ne morejo prejemati drugih zdravil.
In vitro investigative studies suggest that microglial aggregates are not due to a direct effect of daclizumab on microglial cells but are likely to be attributable to an increase in local IL-2 bioavailability.
Raziskovalne študije in vitro kažejo, da agregati celic mikroglije ne nastajajo kot neposredni učinek daklizumaba na mikroglijske celice, temveč so verjetno posledica povečanja biološke uporabnosti lokalnega IL-2.
As renal excretion is not a major route of elimination, no dose adjustments are considered necessary (see section 5.2).
Ker ledvično izločanje ni glavna pot izločanja, odmerka ni treba prilagajati (glejte poglavje 5.2).
The risk of Progressive Multifocal Leukoencephalopathy (PML) associated to the treatment with Zinbryta has not been established.
Tveganje za progresivno multifokalno levkoencefalopatijo (PML), povezano z zdravljenjem z zdravilom Zinbryta, ni bilo ugotovljeno.
• diarrhoea that does not go away
• driska, ki ne mine
Note: You might see air bubbles in the medicine window.
Opomba: V oknu za zdravilo mogoče vidite zračne mehurčke.