natgillin/translations-raw huggingface dataset:
Pandemrix was originally authorised under ‘exceptional circumstances', because, for scientific reasons, limited information was available at the time of approval.
Zdravilo Pandemrix je prvotno pridobilo dovoljenje v „izjemnih okoliščinah“, saj so bile zaradi znanstvenih razlogov ob odobritvi na voljo le omejene informacije.
The European Commission granted a marketing authorisation valid throughout the European Union for Pandemrix on 20 May 2008.
Evropska komisija je dovoljenje za promet z zdravilom Pandemrix, veljavno po vsej Evropski uniji, izdala 20. maja 2008.
Side effects are similar in children.
Pri otrocih prihaja do podobnih neželenih učinkov.
The full EPAR for Pandemrix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Pandemrix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It contains parts of influenza (flu) viruses that have been inactivated.
Vsebuje delce virusov influence (gripe), ki so bili inaktivirani.
The resulting ‘emulsion' is then injected.
Tako dobljena „emulzija“ se nato injicira.
What measures are being taken to ensure the safe and effective use of Pandemrix?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pandemrix?
In all of the studies, the vaccine was shown to bring about protective levels of antibodies to a satisfactory level, in line with the criteria laid down by the CHMP.
V vseh študijah je bilo dokazano, da cepivo povzroči nastanek zadovoljivih zaščitnih ravni protiteles v skladu z merili, ki jih je določil odbor CHMP.
The solvent contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Vehikel vsebuje tudi „adjuvans“ (spojino, ki vsebuje olje) za povečanje imunskega odziva.
Six main studies have been carried out that looked at the ability of a two-dose schedule of the vaccine to trigger an immune response in the following groups (the numbers given are for those who received Pandemrix in the studies):
Izvedenih je bilo šest glavnih študij, v katerih so proučevali sposobnost cepiva, da po shemi dveh odmerkov sproži imunski odziv pri naslednjih skupinah (navedene številke veljajo za tiste osebe, ki so v študijah prejele zdravilo Pandemrix):
The CHMP noted that a single dose was able to trigger immunity to a satisfactory level in adults (including the elderly), adolescents and children from 10 years of age.
Ta je poudaril, da je enojni odmerek sprožil imunost na zadovoljivi ravni pri odraslih (vključno s starostniki), mladostnikih in otrocih, starejših od 10 let.
Vaccination should be postponed in subjects with severe fever or an acute (short-lived) infection.
Cepljenje je treba prestaviti pri osebah z močno povišano telesno temperaturo ali akutno (kratkotrajno) okužbo.
For more information about treatment with Pandemrix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Pandemrix preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This document is a summary of the European Public Assessment Report (EPAR) for Pandemrix.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pandemrix.
The CHMP decided that Pandemrix's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Pandemrix večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Following rare cases of narcolepsy (a rare sleep disorder that causes a person to fall asleep suddenly and unexpectedly) among people given the vaccine, it was concluded that Pandemrix should only be used if the recommended seasonal influenza vaccine is not available and if immunisation against H1N1 is still needed.
Po ugotovljenih redkih primerih narkolepsije (redke motnje spanja, ki povzroča, da oseba nenadoma in nepričakovano zaspi) pri cepljenih osebah, so sklenili, da se naj cepivo Pandemrix uporabi samo, če priporočeno cepivo proti sezonski gripi ni na voljo in če je imunizacija proti virusu H1N1 še potrebna.
It should only be used if the recommended annual seasonal trivalent/quadrivalent influenza vaccine is not available and if immunisation against (H1N1)v is considered necessary.
Uporablja se lahko le, če letno sezonsko trivalentno/štirivalentno cepivo proti gripi ni na voljo in če je imunizacija proti virusu (H1N1)v še potrebna.
A risk management plan has been developed to ensure that Pandemrix is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Pandemrix je bil pripravljen načrt obvladovanja tveganj.
Other information about Pandemrix
Druge informacije o zdravilu Pandemrix
When a person is given the vaccine, the immune system recognises the virus as ‘foreign' and makes antibodies against it.
Ko oseba prejme cepivo, imunski sistem prepozna virus kot „tujek“ in proti njemu tvori protitelesa.
Pandemrix must not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as egg or chicken protein, ovalbumin (a protein in egg white), formaldehyde, gentamicin sulphate (an antibiotic) and sodium deoxycholate.
Cepivo Pandemrix se ne sme dajati osebam, ki so imele anafilaktično reakcijo (resno alergijsko reakcijo) na katero koli sestavino cepiva ali na katero koli od snovi, ki se v sledeh (v zelo nizkih količinah) nahajajo v cepivu, kot so jajca, piščančje beljakovine, ovalbumin (beljakovina v beljaku), formaldehid, gentamicinijev sulfat (antibiotik) in natrijev deoksiholat.
Before use, the vaccine is made up by mixing together a suspension that contains the virus particles with a solvent.
Pred uporabo se cepivo pripravi z mešanjem suspenzije, ki vsebuje delce virusa, in vehikla.
• healthy children (210 aged between three and 17 years, and 50 aged between six and 35 months, in three studies).
• zdravih otrocih (210 otrok, starih od treh do 17 let, in 50 otrok, starih od šest do 35 mesecev, ki so sodelovali v treh študijah).
Pandemrix influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Pandemrix cepivo proti gripi (H1N1) (z delci virionov, inaktivirano, z adjuvansom)
• healthy elderly subjects over the age of 60 years (120 subjects in one study);
• zdravih starostnikov, starejših od 60 let (120 ljudi, ki so sodelovali v eni študiji);
• healthy adults aged between 18 and 60 years (180 subjects in two studies);
• zdravih odraslih, starih od 18 do 60 let (180 ljudi, ki so sodelovali v dveh študijah);
What benefit has Pandemrix shown during the studies?
Kakšne koristi je zdravilo Pandemrix izkazalo med študijami?
The most common side effects with Pandemrix in adults (seen with more than 1 in 10 doses of the vaccine) are headache, arthralgia (joint pain), myalgia (muscle pain), swelling and pain at the site of the injection, shivering, increased sweating and fatigue (tiredness).
Najpogostejši neželeni učinki zdravila Pandemrix pri odraslih (opaženi pri več kot enem odmerku cepiva od 10) so glavobol, artralgija (bolečine v sklepih), mialgija (bolečine v mišicah), oteklina in bolečina na mestu injiciranja, drhtenje, povečano znojenje in utrujenost.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pandemrix.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The studies in children also allowed the effectiveness of Pandemrix as a 0.5 ml dose to be compared with that of a 0.25 ml dose.
Študije na otrocih so omogočile tudi, da se je učinkovitost 0,5-mililitrskega odmerka cepiva Pandemrix primerjala z 0,25-mililitrskim odmerkom.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pandemrix, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Pandemrix is a vaccine.
Zdravilo Pandemrix je cepivo.
In children aged between six months and nine years, 0.25 ml doses were as effective as 0.5 ml doses.
Pri otrocih, starih od šest mesecev do devet let, je bil 0,25-mililitrski odmerek enako učinkovit kot 0,5-mililitrski odmerek.
From 10 years of age the dose is 0.5 ml; younger children aged from six months to nine years receive 0.25 ml per dose.
Od 10. leta starosti dalje znaša odmerek 0,5 ml, mlajši otroci, stari od šest mesecev do devet let, pa prejmejo 0,25-mililitrski odmerek.
Pandemrix was originally developed as a pandemic vaccine, and was used during the influenza A (H1N1) pandemic declared in June 2009.
Zdravilo Pandemrix je bilo prvotno pripravljeno kot pandemsko cepivo, ki naj bi se uporabljalo med pandemijo gripe A(H1N1), razglašeno junija 2009.
Pandemrix is given as one dose, injected into the muscle of the shoulder or thigh.
Cepivo Pandemrix se daje v enkratnem odmerku z injiciranjem v ramensko ali stegensko mišico.
For the full list of all side effects reported with Pandemrix, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Pandemrix, glejte navodilo za uporabo.
Pandemrix contains a flu strain called A/California/7/2009 (H1N1)v-like strain (X-179A).
Cepivo Pandemrix vsebuje sev gripe, ki je podoben sevu A/California/7/2009 (H1N1)v (X-179A).
The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again.
Ob ponovni izpostavitvi virusu jih bo imunski sistem tako lahko tvoril hitreje.
What is the risk associated with Pandemrix?
Kakšna tveganja so povezana z zdravilom Pandemrix?
Why has Pandemrix been approved?
Zakaj je bilo zdravilo Pandemrix odobreno?
Pandemrix is a vaccine to protect against flu caused by the A (H1N1)v 2009 virus.
Zdravilo Pandemrix je cepivo za zaščito pred gripo, ki jo povzroča virus A(H1N1)v 2009.
Pandemrix is a vaccine that is given by injection.
Zdravilo Pandemrix je cepivo za injiciranje.
Pandemrix contains small amounts of haemagglutinins (proteins from the surface) of a virus called A(H1N1)v 2009.
Zdravilo Pandemrix vsebuje majhno količino hemaglutininov (beljakovin s površine) virusa A(H1N1)v 2009.
Pandemrix is given according to official recommendations.
Cepivo se daje le v skladu z uradnimi priporočili.
How has Pandemrix been studied?
Kako je bilo zdravilo Pandemrix raziskano?
What is Pandemrix used for?
Za kaj se zdravilo Pandemrix uporablja?
How does Pandemrix work?
Kako zdravilo Pandemrix deluje?
What is Pandemrix?
Kaj je zdravilo Pandemrix?
How is Pandemrix used?
Kako se zdravilo Pandemrix uporablja?
50 (5 x 10) pre-filled syringes (multipack)
50(5x10)napolnjenih injekcijskih brizg ž
Intramuscular use vial (glass)
Velikost pakiranja viala (steklo)
--1 One dose1 (0.5 ml) contains: Diphtheria Toxoid
--1 En odmerek1 (0,5 ml) vsebuje: davični toksoid ne manj kot 20 i. e.2
Pack size
injekc.
1 pre-filled syringe + 1 needle
brizga 1+ 1 igla napolnjena injekcijska brizga (steklo)ka
Poliovirus (Inactivated)3 Type 1 (Mahoney)
tetanusni toksoid antigene Bordetelle pertussis toksoid oslovskega kašlja ne manj kot 40 i. e.2 25 mikrogramov filamentozni hemaglutinin poliovirus (inaktiviran)3 tip 1 (sev Mahoney)
Activity: {Y} MBq in {Z}mL ToC: {DD/MM/YYYY} {hh:mm}{Time Zone} Vial No.
Aktivnost: {Y} MBq v {Z} ml ToC: {DD/MM/LLLL}{hh:mm}{Time Zone} Št. viale
Image interpretation).
Interpretacija slik).
This may be harmful to those suffering from alcoholism.
To lahko škoduje osebam, ki trpijo za alkoholizmom.
Date of latest renewal: 21 September 2017
Datum zadnjega podaljšanja: 21. september 2017
It might be helpful to estimate the effective dose that was applied.
Koristno je, če ocenite učinkoviti odmerek, ki je bil uporabljen.
Radioactive material
Radioaktivni material
Training should include a sufficient number of clearly positive and negative cases as well as intermediate level cases.
Izobraževanje mora vključevati zadostno število jasno pozitivnih in negativnih primerov ter vmesne primere.
The volume of the injection should not be less than 1 mL and not exceed 10 mL.
Prostornina injekcije ne sme biti manj kot 1 ml in ne sme preseči 10 ml.
An updated RMP should be submitted:
Posodobljen RMP je treba predložiti
It will be the smallest quantity necessary to get the desired information.
To bo najmanjša potrebna količina, s katero bodo pridobili potrebne informacije.
Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.
Za njihovo sprejemanje, shranjevanje, uporabo, prenos in odstranjevanje veljajo predpisi in/ali ustrezne licence pristojnega organa.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 January 2013
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 14. januar 2013
There are strict laws on the use, handling and disposal of radiopharmaceutical products.
Obstajajo strogi zakoni za uporabo, ravnanje in odstranjevanje radiofarmakov.
If the quantitation result is inconsistent with the initial visual interpretation:
Če je rezultat kvantifikacije neskladen z začetno vizualno interpretacijo:
The cognitive status of the subjects could not be reliably measured.
Kognitivnega stanja preiskovancev ni bilo mogoče zanesljivo izmeriti.
Withdrawals should be performed under aseptic conditions.
Odvzem je treba opraviti v aseptičnih pogojih.
See also section 1.
Glejte tudi poglavje 1.
08950 Espluges de Llobregat, Barcelona Spain
08950 Espluges de Llobregat, Barcelona Španija
Cases should be histopathologically confirmed, if possible.
Če je le mogoče, naj bodo primeri histopatološko potrjeni.
The physician training course should contain the following key elements:
Izobraževanje za zdravnike mora vsebovati naslednje ključne sestavne dele:
Volume: {Z} mL
Prostornina: {Z} ml
The following information is intended for the specialist only.
Naslednje informacije so namenjene samo specialistu.
• Expertise and qualification of trainers in both electronic and in-person training should be ensured.
• Zagotoviti je treba, da imajo vodje izobraževanja tako pri elektronskem kot pri osebnem izobraževanju strokovno znanje in so usposobljeni.
The radioactive half-life of 18F is 110 minutes.
Radioaktivni razpolovni čas 18F je 110 minut.
Possible structural anomalies that could influence quantitation of the cerebellar region should be considered.
Razmislite o mogočih strukturnih anomalijah, ki bi lahko vplivale na kvantifikacijo regije malih možganov.
Children and adolescents Amyvid is not intended for use in children and adolescents.
Otroci in mladostniki Zdravilo Amyvid ni namenjeno uporabi pri otrocih in mladostnikih.
No studies have been conducted in pregnant women.
Na nosečnicah študije niso bile opravljene.
Paediatric population For information on the use in the paediatric population, see sections 4.2 or 5.1.
Pediatrična populacija Za informacije o uporabi pri pediatrični populaciji glejte poglavje 4.2 ali 5.1.
Each vial is enclosed in a shielded container of appropriate thickness to minimise external radiation exposure.
Vsaka viala je zaprta v zaščitenem vsebniku primerne debeline, da se čim bolj zmanjša zunanja izpostavljenost sevanju.
Only essential investigations should therefore be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and foetus.
Med nosečnostjo se zato izvajajo samo nujne preiskave, pri katerih verjetne koristi bistveno presegajo tveganje za mater in plod.
Megabecquerel (MBq) is the unit used to express radioactivity.
Megabequerel (MBq) je enota za izražanje radioaktivnosti.
The efficacy of Amyvid for predicting development of AD or monitoring response to therapy has not been established (see section 5.1).
Učinkovitost zdravila Amyvid pri napovedovanju razvoja AB ali spremljanju odziva na zdravljenje ni bila ugotovljena (glejte poglavje 5.1).
The use of Amyvid does involve exposure to small amounts of radioactivity.
Uporaba zdravila Amyvid vključuje izpostavljenost majhnim količinam radioaktivnosti.
These persons will take special care for the safe use of this medicine and will keep you informed of their actions.
Ti bodo zlasti pozorni na varno uporabo zdravila in vas bodo sproti obveščali o svojem ravnanju.
Extensive dose-range and adjustment studies with the medicinal product in normal and special populations have not been performed.
Študije z obširnim razponom odmerkov in prilagoditvene študije z zdravilom pri normalnih in posebnih skupinah bolnikov niso bile opravljene.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Za vse informacije o tem zdravilu se obrnite na lokalnega predstavnika imetnika dovoljenja za promet z zdravilom:
Amyvid will only be used in specially controlled areas.
Zdravilo Amyvid se uporablja samo v posebno nadzorovanih prostorih.
This medicine will only be handled and given to you by people who are trained and qualified to use it safely.
Z zdravilom bodo ravnali in vam ga dajali le strokovnjaki, usposobljeni za njegovo varno uporabo.
It is recommended that review of images include all transaxial slices of the brain using a black-white scale with the maximum intensity of the scale set to the maximum intensity of all brain pixels.
Priporoča se, da pregled slik vključuje vse transaksialne rezine možganov s črno-belo lestvico, pri čemer se maksimalna intenzivnost lestvice nastavi na maksimalno intenzivnost vseh slikovnih pik možganov.
The nuclear medicine doctor supervising the procedure will decide on the quantity of Amyvid to be used in your case.
Odmerek Zdravnik nuklearne medicine, ki nadzira postopek, bo določil količino zdravila Amyvid, ki bo uporabljena v vašem primeru.
The European Medicines Agency has waived the obligation to submit the results of studies with Amyvid in all subsets of the paediatric population as there is no intended use in the paediatric population.
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom Amyvid za vse podskupine pediatrične populacije, ker pri pediatrični populaciji uporaba ni predvidena.
Reconstruction should include attenuation correction with resulting transaxial pixel sizes between 2.0 and 3.0 mm.
Rekonstrukcija mora vključevati popravek zaradi atenuacije z nastalo velikostjo transaksialnih slikovnih pik med 2,0 in 3,0 mm.
β-amyloid plaques are deposits present in the brains of people with Alzheimer's disease, but may also be present in the brain of people with other dementias.
β-amiloidne lehe so obloge, ki so prisotne v možganih ljudi z alzheimerjevo boleznijo, lahko pa so prisotne tudi v možganih ljudi z drugimi demencami.
NG5 1PB
NG51PB Velika Britanija
Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Radiofarmake je treba pripraviti na način, ki bo zadoščal zaščiti pred sevanjem in tudi farmacevtskim zahtevam po kakovosti.
This is the most common appearance of a positive scan; or b) One or more areas in which grey matter activity is intense and clearly exceeds activity in adjacent white matter.
To je najpogostejši videz pozitivnega rezultata preiskave; ali b) eno ali več območij, kjer je aktivnost sive možganovine intenzivna in jasno presega aktivnost sosednje bele možganovine.
Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings.
Radiofarmake sme sprejemati, uporabljati in dajati samo pooblaščeno osebje v temu namenjenih kliničnih ustanovah.
• Review of the PET reading criteria, including method of image review, criteria for interpretation, and images demonstrating the binary read methodology
• Pregled kriterijev za odčitavanje PET-posnetkov, vključno z metodo pregledovanja slik, kriteriji za interpretacijo in slikami, ki prikazujejo metodologijo binarnega odčitavanja
The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine.
Zdravnik nuklearne medicine vam bo povedal, če morate biti po prejemu tega zdravila na kaj še posebno pozorni.
Amyvid should be used in conjunction with a clinical evaluation.
Zdravilo Amyvid je treba uporabiti skupaj s kliničnim vrednotenjem.
Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus.
Postopki z radionuklidi, opravljeni na nosečnicah, pomenijo odmerek sevanja tudi za plod.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom nuklearne medicine, preden prejmete to zdravilo.
This medicine is a radiopharmaceutical product for diagnostic use only.
To zdravilo je radiofarmak, namenjeno samo za diagnostično uporabo.
While they may in reality occur at lower frequencies than indicated below, the size of the source database did not allow for the assignment of frequency categories lower than the category “uncommon” (≥1/1,000 to <1/100).
Čeprav se v resnici pojavljajo z nižjo pogostnostjo, kot je navedeno spodaj, velikost izvorne podatkovne zbirke ni omogočila uvrščanja v kategorije pogostnosti, nižje kot »občasni«
If in doubt about her potential pregnancy (if the woman has missed a period, if the period is very irregular, etc.), alternative techniques not using ionising radiation (if there are any) should be offered to the patient.
Če obstaja negotovost glede možne nosečnosti (če ni dobila menstruacije, če je menstruacija zelo neredna itd.), je treba bolnici ponuditi alternativno tehniko (če je na voljo), ki ne vključuje uporabe ionizirajočega sevanja.
Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational programme with the National Competent Authority.
Pred vpeljavo zdravila na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom dogovoriti z nacionalnim pristojnim organom o končnem izobraževalnem programu.
A final interpretation of the scan should be made based on the final visual read after conducting resolution steps 1-3 above.
Podajte končno interpretacijo posnetka na osnovi končnega vizualnega odčitka, ko izvedete zgornje korake 1-3 za razjasnitev.
Your doctor and the nuclear medicine doctor have considered that the benefit of this procedure with the radiopharmaceutical outweighs the risk of being exposed to radiation.
Vaš osebni zdravnik in zdravnik nuklearne medicine sta pretehtala, da koristi tega postopka z radiofarmakom odtehtajo tveganja zaradi izpostavitve sevanju.
The vials must not be opened before disinfecting the stopper, the solution should be withdrawn via the stopper using a single dose syringe fitted with suitable protective shielding and a disposable sterile needle or using an authorised automated application system.
Vial ne smete odpreti, dokler ne razkužite zamaška, raztopino pa morate odvzeti prek zamaška z enoodmerno injekcijsko brizgo, opremljeno z ustrezno zaščito in sterilno iglo za enkratno uporabo, ali z uporabo odobrenega avtomatskega sistema apliciranja.
The residual 18F in circulation during the 30-90 minute imaging window is principally in the form of polar 18F species.
Preostali 18F v obtoku med 30-90-minutnim oknom slikanja je v glavnem v obliki polarne vrste 18F.
The highest level of uptake is in regions mainly composed of white matter (pons and centrum semiovale).
Največji privzem je na področjih, ki jih večinoma sestavlja bela možganovina (pons in centrum semiovale).