natgillin/translations-raw huggingface dataset:
Valproate medicines are used to treat epilepsy and bipolar disorder.
Zdravila, ki vsebujejo valproat, se uporabljajo za zdravljenje epilepsije in bipolarne motnje.
The CMDh1 has endorsed new measures to avoid exposure of babies to valproate medicines in the womb, because exposed babies are at high risk of malformations and developmental problems.
Odbor CMDh1 je 21. marca 2018 sprejel nove ukrepe za preprečevanje izpostavljenosti ploda valproatu v maternici, ker izpostavljene otroke ogrožata veliko tveganje za malformacije in razvojne težave.
Companies marketing these medicines are also required to carry out additional studies on the nature and extent of the risks and to monitor valproate use and the long-term effects from affected pregnancies.
Družbe, ki tržijo ta zdravila, morajo izvesti tudi dodatne študije o naravi in obsegu tveganj ter spremljati uporabo valproata in dolgotrajne učinke na zadevne nosečnosti.
The companies that market valproate must carry out further studies to characterise the nature and extent of the risks posed by valproate and monitor ongoing valproate use and the long-term effects from affected pregnancies.
Družbe, ki tržijo valproat, morajo izvesti nadaljnje študije za opredelitev narave in obsega tveganja, ki ga predstavlja valproat, ter spremljanje njegove trenutne uporabe in dolgoročnih učinkov pri zadevnih nosečnostih.
Valproate-containing medicines have been approved nationally in the EU to treat epilepsy and bipolar disorder and in some countries for prevention of migraine.
Zdravila, ki vsebujejo valproat, so bila v EU odobrena po nacionalnih postopkih za zdravljenje epilepsije in bipolarne motnje, v nekaterih državah pa tudi za preprečevanje migrene.
Because the CMDh position was agreed by majority vote it will now be sent to the European Commission, which will take a final legally binding decision valid across the EU.
Ker je skupina svoje stališče sprejela z večino glasov, so ga poslali Evropski komisiji, ki je 31. maja 2018 izdala končni pravno zavezujoči sklep, ki velja po vsej EU.
− introduction of a new risk acknowledgement form that patients and prescribers will go through at each such annual review to confirm that appropriate advice has been given and understood.
uvedba novega obrazca za potrditev seznanjenosti s tveganji za bolnice in zdravnike, ki zdravila predpisujejo, da ga preberejo in potrdijo, da so prejeli/dali potrebne nasvete in da so jih bolnice razumele.
Watch for at least 10 seconds.
Opazujte jo vsaj 10 sekund.
These symptoms generally develop in a rapid fashion.
Ti simptomi se na splošno pojavijo hitro.
The relevance of these findings for humans is not known.
Pomen teh ugotovitev za ljudi ni znan.
There is no evidence that such an interaction would be harmful.
Ni dokazov, da bi bilo takšno medsebojno delovanje škodljivo.
• alcohol wipes or similar.
• alkoholne krpice ali podobno.
Date of first authorisation: 22 August 2002 Date of latest renewal: 16 July 2007
Datum prve odobritve: 22. avgust 2002 Datum zadnjega podaljšanja: 16. julij 2007
It is important to tell your doctor if you:
Pomembno je, da poveste zdravniku, če:
Equipment that you need
Oprema, ki jo boste potrebovali
This is ok.
To je v redu.
If the dose is complete, go to the next step.
Če je dajanje odmerka dokončano, pojdite na naslednji korak.
If there are particles in it, you must not use it.
Če so v njej delci, je ne smete uporabiti.
Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Trenutno razpoložljivi podatki so opisani v poglavjih 4.8, 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
The patient alert card shall contain the following key messages:
Opozorilna kartica za bolnika bo vsebovala naslednja ključna sporočila:
• think you may be pregnant; or
• mislite, da bi lahko bili noseči; ali
• You may hear a series of clicks.
• Morda boste slišali zaporedje klikov.
Consider wearing loose clothing and take care when changing clothes.
Nosite ohlapna oblačila in pazite, ko se preoblačite.
• Any part appears cracked or broken.
• se kateri koli del zdi počen ali zlomljen.
45 minutes
45 minut
Not working correctly
Ne deluje pravilno
• are pregnant;
• ste noseči;
27 hours
27 ur
0% (empty)
0 % (prazno)
See also section 4.8.
Glejte tudi poglavje 4.8.
You should talk to your doctor about your risks of developing cancers of the blood.
S svojim zdravnikom se posvetujte o tveganjih za nastanek krvnega raka.
Your doctor will tell you what you can take to ease the bone pain.
Zdravnik vam bo povedal, kaj lahko vzamete za lajšanje bolečin v kosteh.
• some changes may occur in your blood, but these will be detected by routine blood tests.
• pojavijo se lahko nekatere spremembe v krvi, vendar jih zaznamo z rutinskimi krvnimi preiskavami.
It may harm them, even if their symptoms of illness are the same as yours.
Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.
Step 2: Get ready A Wash your hands thoroughly.
2. korak: Pripravite se A Temeljito si umijte roke.
The patient should also be given the Patient Alert Card.
Bolnik mora dobiti tudi opozorilno kartico za bolnika.
The number of cases is small, but because of the seriousness of the ADR, the PRAC recommends that the Product Information should be updated accordingly.
Število primerov je majhno, vendar zaradi resnosti NUZ odbor PRAC priporoča, da se informacije o zdravilu ustrezno posodobijo.
• You should see a black line next to the 0% (empty) indicator to confirm you have received a full dose.
• Na kazalniku morate videti črno črto poleg oznake 0 % (prazno) kot potrditev, da ste prejeli celoten odmerek.
Your doctor or nurse will show you how to inject yourself.
Zdravnik ali medicinska sestra vam bosta pokazala, kako si boste sami dajali injekcije.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve glede predložitve posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in na vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
• Only expose the on-body injector to temperatures between 5°C - 40°C.
• Injektor izpostavljajte le temperaturam od 5 do 40 °C.
Latex may be transferred to your skin.
Lateks se vam lahko prenese na kožo.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Znotraj posamezne skupine pogostnosti so neželeni učinki navedeni po padajoči resnosti.
• Even with a leak, the status light may remain green and the fill indicator may be at 0% (empty).
• Tudi v primeru puščanja lahko lučka stanja ostane zelena in kazalnik polnosti lahko kaže 0 % (prazno).
• if you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients of this medicine.
• če ste alergični na pegfilgrastim, filgrastim, ali katero koli sestavino tega zdravila.
Tell your doctor if you experience those symptoms.
Povejte zdravniku, če se pri vas pojavijo ti simptomi.
The frequency category was estimated from a statistical calculation based upon 1,576 patients receiving Neulasta in nine randomised clinical trials.
Kategorija pogostnosti je ocenjena s statističnim izračunom na podlagi podatkov o 1.576 bolnikih, ki so prejemali zdravilo Neulasta v devetih randomiziranih kliničnih preskušanjih.
Get emergency medical help right away.
Takoj poiščite nujno zdravniško pomoč.
B Carefully pull the grey needle cap straight out and away from your body.
B Skrbno potegnite sivi pokrovček igle naravnost z nje in proč od vašega telesa.
Check to see if your on-body injector is empty.
Preverite, da boste videli, ali je telesni injektor prazen.
If it is exposed to direct sunlight for more than 1 hour, it may affect your medicine.
Če je neposredni sončni svetlobi izpostavljen več kot 1 uro, lahko to škoduje zdravilu.
The concentration is 10 mg/mL based on protein only**.
Koncentracija je 10 mg/ml na podlagi beljakovine same **.
White blood cells are important as they help your body fight infection.
Bele krvničke so pomembne, ker se pomagajo vašemu telesu boriti proti okužbam.
What Neulasta is and what it is used for
Kaj je zdravilo Neulasta in za kaj ga uporabljamo
100% (full)
100 % (polno)
B PUSH the plunger with slow and constant pressure until you feel or hear a “snap”.
B POTISKAJTE bat počasi in s stalnim pritiskom povsem do konca, dokler ne začutite ali zaslišite "tlesk".
Do not warm Neulasta in any other way (for example, do not warm it in a microwave or in hot water).
Zdravila Neulasta ne smete segrevati na kak drug način (na primer, ne segrevajte v mikrovalovni pečici ali v vroči vodi).
• Check your status light again.
• Znova preverite lučko stanja.
These cells are very sensitive to the effects of chemotherapy which can cause the number of these cells in your body to decrease.
Te celice so zelo občutljive za učinke kemoterapije, ki lahko povzroči zmanjšanje števila teh celic v vašem telesu.
• breathing problems.
• težave pri dihanju.
Do not reapply it.
Ne nameščajte ga nazaj.
These elevations are transient and return to baseline.
Ta zvišanja so prehodna in vrednosti se vrnejo na izhodiščne.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Bolniki z redko prirojeno motnjo intolerance za fruktozo ne smejo dobiti tega zdravila.
Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Zato moramo skrbno spremljati velikost vranice (npr. s kliničnim pregledom, ultrazvokom).
If white blood cells fall to a low level there may not be enough left in the body to fight bacteria and you may have an increased risk of infection.
Če bele krvničke padejo na nizko raven, jih lahko v telesu ne ostane dovolj, da bi se lahko borile proti bakterijam, in nevarnost okužb se bo pri vas zvečala.
Wear the on-body injector under your clothing.
Injektor nosite pod oblačili.
Store in a refrigerator (2°C - 8°C).
Shranjujte v hladilniku (2 °C - 8 °C).
Important: If at any time you hear beeping, check the status light.
Pomembno: Če kadar koli zaslišite piskanje, preverite lučko stanja.
If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days.
V primeru resne alergijske reakcije je treba poskrbeti za ustrezno zdravljenje in pazljivo spremljanje bolnika še nekaj dni.
Ask your caregiver to be nearby for the first use.
Prosite skrbnika, naj bo v bližini, ko zdravilo prvič uporabite.
9/L) have been reported (see section 4.4).
9/l) (glejte poglavje 4.4).
Your white blood cell count may become high for a short period of time.
Število belih krvničk se vam lahko za krajše časovno obdobje poveča.
Neulasta is for use in adults aged 18 and over.
Zdravilo Neulasta je namenjeno uporabi pri odraslih, starih 18 ali več let.
Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present.
Vezavna protitelesa se pojavijo po pričakovanjih pri vseh bioloških zdravilih, vendar jih doslej niso povezali z nevtralizacijskim delovanjem.
Check the instructions at the end of this leaflet and contact your healthcare provider if:
Preverite navodila na koncu tega navodila in se posvetujte z zdravstvenim delavcem:
Comprehensive instructions for use for healthcare professionals and patients are given in the package leaflet.
Izčrpna navodila za uporabo za zdravstvene delavce in bolnike so navedena v navodilu za uporabo.
The most suitable places to inject yourself are:
Najprimernejši mesti za samoinjiciranje sta:
Do not try to warm the syringe by using a heat source such as hot water or microwave.
Ne poskušajte ogrevati brizge z viri toplote kot sta vroča voda ali mikrovalovna pečica.
However, the long-term effects of pegfilgrastim have not been established in AML; therefore, it should be used with caution in this patient population.
Vendar dolgoročni učinki pegfilgrastima pri AML niso ugotovljeni, zato ga je treba pri tej populaciji bolnikov uporabljati previdno.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Median Absolute Neutrophil Count (cells x 109/l)
mediana absolutnega števila nevtrofilcev (celice x 109/l)
• Keep the on-body injector at least 10 cm (4 inches) away from electrical equipment such as mobile phones, cordless telephones, microwaves and other common appliances.
• Injektor naj bo vsaj 10 cm odmaknjen od električnih naprav, kot so mobilni telefoni, brezžični telefoni, mikrovalovne pečice in druge pogoste naprave.
Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from AML.
Posebno pozornost je treba nameniti razlikovanju diagnoze blastne transformacije kronične mieloične levkemije od AML.
2 This adverse reaction was identified through post-marketing surveillance but not observed in randomised, controlled clinical trials in adults.
2 Ti neželeni učinki so bili ugotovljeni med spremljanjem v obdobju trženja zdravila, niso pa jih opažali v randomiziranih, kontroliranih kliničnih preskušanjih pri odraslih.
Remove from the refrigerator.
Shranjujte v hladilniku.
Such elevation in white blood cells is transient, typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic effects of this medicine.
Takšno zvišanje belih krvničk je prehodno, opazimo ga tipično 24 do 48 ur po uporabi zdravila in se sklada s farmakodinamskimi učinki tega zdravila.
C Pinch your injection site to create a firm surface.
C Stisnite mesto injiciranja, da boste ustvarili trdno površino.
• Dose delivery will start and take about 45 minutes to complete.
• Injiciranje odmerka se bo začelo in bo trajalo približno 45 minut, preden bo dokončano.
Important: Do not grasp the on-body injector itself to try to pull it off of your body.
Pomembno: Ne primite za sam injektor, da bi ga tako poskusili odstraniti s telesa.
Note: It is normal to see a few drops of fluid at the application site, but not normal to see a noticeably wet (saturated) adhesive.
Opomba: Normalno je, da se na mestu dajanja zdravila pojavi nekaj kapljic tekočine, ni pa normalno, da je lepilo opazno mokro (napojeno).
Your doctor has given you Neulasta to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.
Vaš zdravnik vam je predpisal zdravilo Neulasta, da bi spodbudilo vaš kostni mozeg (tisti del kosti, ki izdeluje krvničke) k izdelavi več belih krvničk, ki pomagajo vašemu telesu boriti se proti okužbam.
If you see the status light is flashing red, your on-body injector is not functioning properly.
Če vidite, da lučka stanja rdeče utripa, injektor ne deluje pravilno.
Wash your hands thoroughly with soap and water.
Skrbno si umijte roke z milom in vodo.
• The on-body injector contains batteries, electronics, and a needle.
• Injektor vsebuje baterije, elektronske elemente in iglo.
- Radiation treatment.
- Obsevalnemu zdravljenju (radioterapiji).
Your doctor may monitor your condition more closely.
Zdravnik bo lahko natančneje kontroliral vaše stanje.
What you need to know before you use Neulasta
Kaj morate vedeti, preden boste uporabili zdravilo Neulasta
If leukocyte counts exceed 50 x 10
Če število levkocitov po pričakovanem najmanjšem številu preseže 50 x 10
Step 4: Finish
4 korak: Končajte
This can be a sign of Acute Respiratory Distress Syndrome (ARDS).
To je lahko znak sindroma akutne dihalne stiske (ARDS).
How do you, or the person injecting you, use Neulasta pre-filled syringe?
Kako naj vi sami ali oseba, ki vam injicira zdravilo, uporabite napolnjeno injekcijsko brizgo zdravila Neulasta?
• The medicine is cloudy or there are particles in it.
• je zdravilo motno ali so v njem delci.
C RELEASE your thumb.
C DVIGNITE palec.
Do not use this medicine if you notice it is cloudy or there are particles in it.
Ne uporabite tega zdravila, če opazite, da je zdravilo motno ali da v njem plavajo delci.
The safety and efficacy of Neulasta in children has not yet been established.
Varnost in učinkovitost zdravila Neulasta pri otrocih še nista bili dokazani.
Bone pain was generally of mild to moderate severity, transient and could be controlled in most patients with standard analgesics.
Bolečina v kosteh je bila na splošno blage do zmerne stopnje, prehodna in jo je bilo pri večini bolnikov mogoče obvladati s standardnimi analgetiki.
• nausea and headaches.
• slabost in glavoboli.
For example AVOID, travelling, driving, or operating heavy machines during 26-29 hours following application of the on-body injector (this includes the 45-minute dose delivery period plus an hour post-delivery).
Tako se na primer IZOGIBAJTE potovanju, upravljanju vozil ali težkih strojev v obdobju od 26 do 29 ur po namestitvi injektorja (to obsega 45-minutno obdobje injiciranja odmerka in še eno uro po injiciranju).
Neulasta therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
Zdravljenje z zdravilom Neulasta morajo uvesti in nadzorovati zdravniki, izkušeni v onkologiji in/ali hematologiji.
Excessive shaking may aggregate pegfilgrastim, rendering it biologically inactive.
Zaradi čezmernega stresanja se lahko pegfilgrastim agregira, s čimer postane biološko neaktiven.
It belongs to a group of proteins called cytokines, and is very similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body.
Spada v skupino beljakovin, imenovanih citokini, in je zelo podobna naravni beljakovini (t. i. granulocitne kolonije spodbujajočemu faktorju), ki nastaja v telesu.
Uncommon cases of Sweet's syndrome have been reported, although in some cases underlying haematological malignancies may play a role.
Občasno so poročali o primerih Sweetovega sindroma, vendar ima v nekaterih primerih lahko pri tem vlogo osnovna maligna hematološka bolezen.
What should I do before I give myself a subcutaneous injection of Neulasta?
Kaj moram narediti, preden si dam subkutano injekcijo zdravila Neulasta?
Specific interaction or metabolism studies have not been performed, however, clinical trials have not indicated an interaction of Neulasta with any other medicinal products.
Posebnih študij medsebojnega delovanja ali presnove niso izvedli, vendar klinična preskušanja niso pokazala medsebojnega delovanja zdravila Neulasta s kakšnimi drugimi zdravili.
Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
Poiščite si udoben, dobro osvetljen, čist prostor in si pripravite vso opremo, ki jo boste potrebovali, tako da bo pri roki.
Therefore, physicians should use caution when prescribing pegfilgrastim in patients with sickle cell trait or sickle cell disease, should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of this medicine with splenic enlargement and vaso-occlusive crisis.
Zato morajo biti zdravniki previdni, kadar predpisujejo pegfilgrastim bolnikom s srpastocelično dispozicijo ali s srpastocelično anemijo, spremljati morajo ustrezne klinične parametre in laboratorijski status in biti pozorni na morebitno povezavo tega zdravila z zvečanjem vranice in vazookluzivno krizo.
To give yourself a subcutaneous injection you will need:
Za subkutano samoinjiciranje boste potrebovali:
• Outer area of upper arm (only if someone else is giving you the injection).
• zunanji del nadlakta (le v primeru, če vam injekcijo da kdo drug).
What to do if the on-body injector adhesive becomes noticeably wet (saturated) with fluid, or you see dripping.
Kaj storiti, če postane lepilo injektorja opazno mokro (napojeno) s tekočino, ali če opazite kapljanje.
Step 1: Monitor your on-body injector A For the next 27 hours, occasionally check the status light for at least 10 seconds.
1. korak: Nadzorujte injektor A Naslednjih 27 ur občasno preverite lučko stanja; opazujte jo vsaj 10 sekund.
The potency of this product should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class.
Učinkovitosti tega zdravila se ne sme primerjati z učinkovitostjo drugih pegiliranih ali nepegiliranih proteinov iz iste terapevtske skupine.
- Oxygen rich environments, such as hyperbaric chambers (a transparent chamber with an increase in atmospheric pressure).
- S kisikom bogatemu okolju, npr. hiperbaričnim komoram (prozornim komoram z zvišanim atmosferskim tlakom).
Please tell your doctor immediately if you have any of the following or combination of the following side effects:
Zdravniku morate nemudoma povedati, če se vam pojavi kateri od naslednjih neželenih učinkov ali kombinacija teh neželenih učinkov:
• how to recognise signs from the device (e.g. adhesion issues, fill indicator not moved, no beeping sound, status light has not flashed etc.) that there has been a failure in the delivery of the intended dose
• kako prepoznati znake z naprave (npr. težave z lepilom, kazalnik polnosti ni premaknjen, brez zvoka piskanja, lučka stanja ni utripala itd.), da je prišlo do odpovedi pri injiciranju predvidenega odmerka
• Serious allergic reactions can happen with Neulasta.
• Med uporabo zdravila Neulasta se lahko pojavijo resne alergijske reakcije.
In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of GCSF.
Aortitis so v večini primerov diagnosticirali s slikanjem s CT, na splošno pa je minil po ukinitvi G-CSF.
• after the injection is complete you are concerned that you may not have received the full dose.
• če vas po dokončanem injiciranju skrbi, da morda niste dobili celotnega odmerka.
• a pre-filled syringe of Neulasta; and
• napolnjeno injekcijsko brizgo zdravila Neulasta; in
Your doctor may want to monitor you more closely.
Zdravnik vas bo morda moral natančneje kontrolirati.
Hypersensitivity to the active substance or to any of the excipients.
Preobčutljivost na učinkovino ali katero koli pomožno snov.
• inflammation of aorta (the large blood vessel which transports blood from the heart to the body), see section 2.
• vnetje aorte (velike žile, ki prenaša kri od srca po telesu), glejte poglavje 2.
On the basis of the scientific conclusions for pegfilgrastim the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing pegfilgrastim is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za pegfilgrastim odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) pegfilgrastim, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Before you use a Neulasta pre-filled syringe with automatic needle guard, read this important information:
Pred uporabo zdravila Neulasta v napolnjeni injekcijski brizgi z avtomatskim ščitnikom igle preberite te pomembne informacije:
Amgen Europe B.V. Minervum 7061
Amgen Europe BV Minervum 7061
Do not touch the needle or push the plunger.
Ne dotaknite se igle in ne pritiskajte na bat.
• how to monitor the on-body injector
• kako nadzirati injektor
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Podrobni podatki o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu
The most common adverse reaction reported was bone pain (see section 5.1 and 5.2).
Najpogosteje poročan neželen učinek je bil bolečina v kosteh (glejte poglavji 5.1 in 5.2).
The potential for interaction with lithium, which also promotes the release of neutrophils, has not been specifically investigated.
Potenciala za medsebojno delovanje z litijem, ki tudi pospešuje sproščanje nevtrofilcev, niso posebej raziskali.