natgillin/translations-raw huggingface dataset:
Routine surveillance of suspected adverse reaction reports has raised questions on the potential association between the use of the vaccines and two syndromes in particular, which are known as Complex regional pain syndrome (CRPS) and Postural orthostatic tachycardia syndrome (POTS). 
Redno spremljanje poročil o domnevnih neželenih učinkih je sprožilo vprašanja o možni povezavi med uporabo cepiv in zlasti dvema sindromoma, znanima kot kompleksni regionalni bolečinski sindrom (CRPS) in sindrom posturalne ortostatske tahikardije (POTS).
Overall, comparisons of observed versus expected number of spontaneous reports, with the same scenarios as described above for CRPS, do not suggest an increased occurrence of POTS in relation to the HPV vaccines. 
Na splošno primerjave med dejanskim in pričakovanim številom spontanih poročil, z enakimi scenariji, kot so opisani zgoraj za sindrom CRPS, ne kažejo na povečano pojavnost sindroma POTS v povezavi s cepivi proti virusu HPV.
• The PRAC considered the totality of the data submitted with regard to a potential association between HPV vaccination and the occurrence of Complex regional pain syndrome (CRPS) and Postural orthostatic tachycardia syndrome (POTS). 
• odbor PRAC je preučil vse predložene podatke, ki se nanašajo na morebitno povezavo med cepljenjem proti virusu HPV ter pojavom kompleksnega regionalnega bolečinskega sindroma (CRPS) in sindroma posturalne ortostatske tahikardije (POTS).
This should include follow-up of CRPS or POTS reports to determine relevant clinical characteristics, to identify possible cases of POTS and CRPS based on broad search strategies including outcome details and to compare reporting rates against available information on the known epidemiology of POTS and CRPS. 
To spremljanje mora vključevati nadaljnje spremljanje poročil o sindromih CRPS in POTS za določanje pomembnih kliničnih značilnosti, ugotavljanje morebitnih primerov sindromov POTS in CRPS na podlagi strategij razširjenega iskanja, vključno s podatki o izidu, in za primerjavo pogostnosti navedb z razpoložljivimi informacijami o znani epidemiologiji sindromov POTS in CRPS.
The CHMP noted the recommendations to the MAHs that had been made by the PRAC in terms of future monitoring. 
Odbor CHMP se je seznanil s priporočili odbora PRAC imetnikom dovoljenj za promet z zdravilom v zvezi z nadaljnjim spremljanjem.
The PRAC therefore considered the results of a large published study which showed no link between HPV vaccine and CFS, as relevant for the current review. 
Odbor PRAC je zato presodil, da so rezultati velike objavljene študije, ki ni pokazala povezave med cepivom proti virusu HPV in sindromom CFS, pomembni za trenutni pregled.
The PRAC confirmed that the benefit-risk balance of the HPV vaccines (Cervarix, Gardasil, Gardasil 9 and Silgard) remains favourable and recommends the maintenance of the marketing authorisations. 
Odbor PRAC je potrdil, da razmerje med tveganji in koristmi cepiv proti virusu HPV (Cervarix, Gardasil, Gardasil 9 in Silgard) ostaja ugodno, in priporoča ohranitev dovoljenja za promet z zdravilom.
The Committee, having considered all the information available, concluded that the evidence does not support a causal association between HPV vaccination and CRPS and/or POTS. 
Potem ko je odbor pregledal vse razpoložljive informacije, je zaključil, da ni dokazov v podporo vzročne povezave med cepivom proti virusu HPV in sindromom CRPS oziroma POTS.
These syndromes have been subject to previous repeated review by PRAC. 
Odbor PRAC je ta dva sindroma obravnaval že pri predhodnih pregledih.
More than 80 million girls and women worldwide have now received these vaccines, and in some European countries they have been given to 90% of the age group recommended for vaccination. 
V nekaterih evropskih državah je bilo cepljenih 90 % posameznic v starostni skupini, za katero se cepljenje
The CHMP, as a consequence, considers that the benefit-risk balance of HPV vaccines (Cervarix, Gardasil, Gardasil 9 and Silgard) remains favourable and therefore recommends the maintenance of the marketing authorisations. 
Odbor PRAC je posledično presodil, da razmerje med tveganji in koristmi cepiv proti virusu HPV (Cervarix, Gardasil, Gardasil 9 in Silgard) ostaja ugodno, in zato priporoča ohranitev dovoljenja za promet z zdravilom.
Overall, the comparisons of observed versus expected number of spontaneous reports do not suggest an increased occurrence of CRPS in relation to the HPV vaccines. 
Na splošno primerjave med dejanskim in pričakovanim številom spontanih poročil ne kažejo na povečano pojavnost sindroma CRPS v povezavi s cepivi proti virusu HPV.
The incidence of CRPS in the Gardasil/Silgard and Gardasil 9 clinical trials was less than 1 case per 10,000 person-years and comparable in the Gardasil/Silgard and Gardasil 9 and corresponding placebo cohorts. 
Pojavnost sindroma CRPS v kliničnih preskušanjih s cepivom Gardasil/Silgard in Gardasil 9 je bila manj kot en primer na 10 000 oseb-let, pojavnost med kohortami, cepljenimi s cepivom Gardasil/Silgard, Gardasil 9 in ustreznim placebom, pa je bila primerljiva.
The incidence of POTS in the Gardasil/Silgard and Gardasil 9 clinical trials was less than 1 case per 10,000 person-years and comparable in the Gardasil/Silgard/Gardasil 9 and corresponding placebo cohorts. 
Pojavnost sindroma POTS v kliničnih preskušanjih s cepivom Gardasil/Silgard in Gardasil 9 je bila manj kot en primer na 10 000 oseb-let, pojavnost med kohortami, cepljenimi s cepivom Gardasil/Silgard, Gardasil 9 in ustreznim placebom, pa je bila primerljiva.
Available estimates suggest that at least 150 girls and young women per million may develop POTS each year. 
Razpoložljive ocene kažejo, da se sindrom POTS na leto lahko pojavi pri vsaj 150 deklicah in mladih ženskah na milijon.
The study found no association between HPV vaccine and any of the conditions studied. 
V študiji niso našli povezave med cepivom proti virusu HPV in preučevanimi bolezenskimi stanji.
The results of a large published study2 showed no link between HPV vaccine and CFS. 
Rezultati velike objavljene študije2 niso pokazali povezave med cepivom proti virusu HPV in sindromom CFS.
No cases were identified in the Cervarix and comparator cohorts. 
V kohorti, cepljeni s cepivom Cervarix, in primerjalni kohorti ni bilo nobenega primera.
Available estimates suggest that in the general population around 150 girls and young women per million aged 10 to 19 years may develop CRPS each year. 
Razpoložljive ocene kažejo, da se sindrom CRPS v splošnem prebivalstvu na leto pojavi pri približno 150 deklicah in mladih ženskah, starih od 10 do 19 let, na milijon.
Furthermore, the detailed review of the reports of CRPS did not show a consistent pattern regarding time-to-onset (TTO) following vaccination or clinical characteristics. 
Poleg tega podroben pregled poročil o sindromu CRPS ni pokazal skladnega vzorca glede časa do pojava (ang.
general population around 150 girls and young women per million aged 10 to 19 years may develop CRPS each year, and at least 150 girls and young women per million may develop POTS each year. 
Vendar pa razpoložljive ocene kažejo, da se sindrom CRPS v splošnem prebivalstvu na leto pojavi pri približno 150 deklicah in mladih ženskah, starih od 10 do 19 let, na milijon, sindrom POTS pa se na leto pojavi pri vsaj 150 deklicah in mladih ženskah na milijon.
Furthermore, the detailed review of the reports did not show a consistent pattern regarding time-toonset (TTO) following vaccination or clinical characteristics. 
Poleg tega podroben pregled poročil ni pokazal skladnega vzorca glede časa do pojava (ang.
Overall, available data do not provide support for a causal relation between HPV vaccines and POTS. 
Na sploh razpoložljivi podatki ne kažejo na vzročno povezavo med cepivi proti virusu HPV in sindromom POTS.
Overall, available data do not provide support for a causal association between HPV vaccines and CRPS. 
Na sploh razpoložljivi podatki ne kažejo na vzročno povezavo med cepivi proti virusu HPV in sindromom CRPS.
Further information on Lenvima can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Nadaljnje informacije o zdravilu Lenvima so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The medicine is available as capsules (4 mg and 10 mg). 
Zdravilo je na voljo v obliki kapsul (4 mg in 10 mg).
What measures are being taken to ensure the safe and effective use of Lenvima? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lenvima?
Lenvima received a marketing authorisation valid throughout the EU on 28 May 2015. 
Za zdravilo Lenvima je bilo 28. maja 2015 izdano dovoljenje za promet, veljavno po vsej EU.
The European Medicines Agency decided that Lenvima's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zaključila, da so koristi zdravila Lenvima večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What is Lenvima and what is it used for? 
Kaj je zdravilo Lenvima in za kaj se uporablja?
An overview of Lenvima and why it is authorised in the EU 
Pregled zdravila Lenvima in zakaj je odobreno v EU
Lenvima must not be taken by breastfeeding women. 
Zdravila Lenvima ne smejo jemati ženske, ki dojijo.
The main measure of effectiveness was how long the patients lived without their disease getting worse: in the patients taking Lenvima this was an average of 18.3 months, compared with 3.6 months in those taking placebo. 
Glavno merilo učinkovitosti je bil čas preživetja bolnikov brez poslabšanja bolezni: povprečni čas pri bolnikih, ki so jemali zdravilo Lenvima, je bil 18,3 meseca, v primerjavi s 3,6 meseca pri bolnikih, ki so jemali placebo.
Lenvima is used when the cancer has progressed or spread locally or to other parts of the body, and does not respond to treatment with radioactive iodine. 
Zdravilo Lenvima se uporablja, kadar rak napreduje ali se širi lokalno ali na druge dele telesa ter se ne odziva na zdravljenje z radioaktivnim jodom;
What benefits of Lenvima have been shown in studies? 
Kakšne koristi zdravila Lenvima so se pokazale v študijah?
To manage side effects, the doctor may decide to reduce the dose or stop treatment temporarily. 
Za obvladanje neželenih učinkov se lahko zdravnik odloči, da bo zmanjšal odmerek ali začasno prekinil zdravljenje.
Treatment is continued as long as the patient continues to benefit from it without too many side effects. 
Zdravljenje traja tako dolgo, dokler še koristi bolniku in ne povzroča preveč neželenih učinkov.
By blocking these enzymes, lenvatinib can block the formation of new blood vessels and hence cut off the blood supply that keeps cancer cells growing, and reduce their growth. 
Lenvatinib lahko z zaviranjem teh encimov zavira nastajanje novih krvnih žil in tako prekine dotok krvi, ki omogoča rast rakavih celic, ter zmanjša njihovo rast.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lenvima have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Lenvima upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Why is Lenvima authorised in the EU? 
Zakaj je bilo zdravilo Lenvima odobreno v EU?
As for all medicines, data on the use of Lenvima are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Lenvima stalno spremljajo.
Regarding safety, the Agency considered that the majority of adverse effects with Lenvima can be adequately managed by reducing the dose or temporarily interrupting treatment. 
Kar zadeva varnost, je agencija presodila, da je večina neželenih učinkov zdravila Lenvima ustrezno obvladljivih z zmanjšanjem odmerka ali začasno prekinitvijo zdravljenja.
The most important serious side effects are kidney failure and impairment; problems with the heart and circulation such as heart failure, blood clots in the arteries leading to stroke or heart attack, bleeding in the brain, a syndrome known as ‘posterior reversible encephalopathy syndrome' characterised by headache, confusion, fits and loss of vision, liver failure, hepatic encephalopathy (brain damage due to liver failure), stroke and heart attack. 
Najpomembnejši resni neželeni učinki so odpoved in okvara ledvic, težave s srcem in ožiljem, kot so srčno popuščanje in krvni strdki v arterijah, ki lahko povzročijo možgansko ali srčno kap, krvavitev v možganih, sindrom, imenovan „sindrom posteriorne reverzibilne encefalopatije“, za katerega so značilni glavobol, zmedenost, epileptični napadi in izguba vida, odpoved jeter, hepatična encefalopatija (poškodba možganov zaradi odpovedi jeter), možganska kap in srčni infarkt.
Side effects reported with Lenvima are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Lenvima, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Lenvima is a cancer medicine used on its own to treat: 
Lenvima je zdravilo proti raku, ki se uporablja samostojno za zdravljenje:
For treatment of differentiated thyroid carcinoma, the recommended dose is 24 mg taken once a day at approximately the same time every day. 
Pri zdravljenju diferenciranega karcinoma ščitnice je priporočeni odmerek 24 mg, ki se jemlje enkrat na dan, vsak dan ob približno istem času.
These enzymes can be found in certain receptors (such as VEGF, FGFR and RET receptors) in cancer cells, where they activate several processes including cell division and the growth of new blood vessels. 
Ti encimi so prisotni v nekaterih receptorjih (kot so receptorji VEGF, FGFR in RET) v rakavih celicah, v katerih spodbujajo številne procese, vključno z delitvijo celic in rastjo novih žil.
For treatment of hepatocellular carcinoma, the recommended daily dose is either 8 or 12 mg depending on bodyweight. 
Pri zdravljenju hepatocelularnega karcinoma je priporočeni dnevni odmerek 8 mg ali 12 mg, odvisno od telesne mase.
For more information about using Lenvima, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Lenvima glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Differentiated thyroid carcinoma 
Diferencirani karcinom ščitnice
The study involved 392 adult patients with differentiated thyroid carcinoma that had shown signs of progression in the previous year and did not respond to treatment with radioactive iodine. 
V študiji je sodelovalo 392 odraslih bolnikov z diferenciranim karcinomom ščitnice, ki so v preteklem letu kazali znake napredovanja in se niso odzivali na zdravljenje z radioaktivnim jodom.
Lenvima can only be obtained with a prescription and treatment must be started and supervised by a doctor who is experienced in using cancer medicines. 
Predpisovanje in izdaja zdravila Lenvima je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
The most common side effects with Lenvima (which may affect more than 3 in 10 people) are hypertension (high blood pressure), diarrhoea, decreased appetite and weight, tiredness, nausea (feeling sick), proteinuria (protein in the urine), stomatitis (inflammation of the lining of the mouth), vomiting, dysphonia (speech disturbances), headache and palmar-plantar erythrodysaesthesia syndrome (PPE - rash and numbness on the palms and soles). 
Najpogostejši neželeni učinki zdravila Lenvima (ki se lahko pojavijo pri več kot 3 bolnikih od 10) so hipertenzija (visok krvni tlak), driska, zmanjšanje teka in telesne mase, utrujenost, navzeja (slabost), proteinurija (beljakovine v urinu), stomatitis (vnetje ustne sluznice), bruhanje, disfonija (motnje govora), glavobol in sindrom palmarno-plantarne eritrodizestezije (PPE - izpuščaj in odrevenelost, ki prizadeneta dlani in podplate).
In patients with advanced hepatocellular carcinoma who have a poor prognosis and few treatment options, Lenvima was as effective as sorafenib in prolonging their life. 
Pri bolnikih z napredovalim hepatocelularnim karcinomom, ki imajo slabo prognozo in malo možnosti zdravljenja, je bilo zdravilo Lenvima pri podaljševanju preživetja enako učinkovito kot sorafenib.
In patients with differentiated thyroid carcinoma, the medicine showed a clinically relevant improvement in the time patients lived without their disease getting worse. 
Pri bolnikih z diferenciranim karcinomom ščitnice je zdravilo povzročilo klinično pomembno izboljšanje časa preživetja bolnikov brez poslabšanja bolezni.
The study involved 954 patients with hepatocellular carcinoma who had not previously been treated for their cancer and whose cancer could not be removed by surgery. 
V študiji je sodelovalo 954 bolnikov s hepatocelularnim karcinomom, ki se predhodno še niso zdravili zaradi raka in pri katerih raka ni bilo mogoče odstraniti s kirurškim posegom.
What are the risks associated with Lenvima? 
Kakšna tveganja so povezana z zdravilom Lenvima?
Patients given Lenvima lived on average 13.6 months compared with 12.3 months in patients on sorafenib. 
Bolniki, ki so prejemali zdravilo Lenvima, so povprečno živeli 13,6 meseca, tisti, ki so prejemali sorafenib, pa 12,3 meseca.
• adults with hepatocellular carcinoma (a type of liver cancer) who did not previously receive a cancer medicine by mouth or by injection and whose cancer is advanced or cannot be removed by surgery. 
• odraslih s hepatocelularnim karcinomom (vrsto raka jeter), ki predhodno še niso prejemali zdravil za zdravljenje raka, peroralno ali z injiciranjem, in pri katerih je rak napredoval ali ga ni mogoče odstraniti s kirurškim posegom.
The active substance in Lenvima, lenvatinib, is a ‘tyrosine-kinase inhibitor'. 
Učinkovina v zdravilu Lenvima, lenvatinib, je zaviralec tirozin-kinaze.
• adults with differentiated thyroid carcinoma, a type of cancer originating from the follicular cells of the thyroid gland. 
• odraslih z diferenciranim karcinomom ščitnice, tj. vrste raka, ki nastane iz folikularnih celic ščitnice.
Other information about Lenvima 
Druge informacije o zdravilu Lenvima
Lenvima has been shown to be more effective than placebo (a dummy treatment) at slowing down disease progression in one main study. 
Zdravilo Lenvima se je v eni glavni študiji izkazalo za učinkovitejše od placeba (zdravila brez učinkovine) pri upočasnitvi napredovanja bolezni.
How is Lenvima used? 
Kako se zdravilo Lenvima uporablja?
Lenvima has been shown to be at least as effective as the cancer medicine sorafenib at prolonging the time patients lived in one main study. 
Zdravilo Lenvima se je v eni glavni študiji izkazalo za vsaj tako učinkovito kot drugo zdravilo za zdravljenje raka sorafenib pri podaljševanju preživetja bolnikov.
How does Lenvima work? 
Kako zdravilo Lenvima deluje?
For the full list of side effects with Lenvima, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Lenvima, glejte navodilo za uporabo.
Lenvima contains the active substance lenvatinib. 
Zdravilo Lenvima vsebuje učinkovino lenvatinib.
If not, you can do it easily yourself. 
Če pa tega ni storil, ga lahko preprosto pripravite sami.
You will not need to prepare it again unless you start a new bottle. 
Tega ne boste pripravljali ponovno, razen če boste začeli z novo steklenico.
The difference is how often it is given. 
Razlika je v tem, kako pogosto ga vzamete.
• if you are allergic to other medicines 
· če ste alergični na druga zdravila;
However, 
Vendar pa,
• Patients, especially children and adolescents, should be closely monitored for the behavioural changes described above. 
· Bolnike, še posebej otroke in mladostnike, je treba skrbno spremljati glede pojava sprememb v vedenju, ki so opisane zgoraj.
• Give the medicine into the mouth 
· Zdravilo dajte v usta
You will need to do this every time you need a dose. 
To boste morali ponoviti vsakič, ko boste potrebovali odmerek.
• Close the bottle again 
· Ponovno zaprite steklenico
Always shake well before use. 
Pred uporabo vedno dobro pretresite.
Always use 55 ml of water, whatever the dose you need. 
Vedno vzemite 55 ml vode, ne glede na odmerek, ki ga potrebujete.
These may be signs of rare but serious side effects. 
To so lahko znaki redkih toda resnih neželenih učinkov.
Draw it up carefully so as not to include air bubbles. 
Povlecite previdno, tako da ne bo vsebovala zračnih mehurčkov.
You only need to do this once, at the beginning of your course. 
To morate narediti samo enkrat, in sicer na začetku zdravljenja.
• if you have problems with your kidneys. 
· če imate težave z ledvicami.
Step 5: Sweeten and give to the child 
Korak 5: sladkajte in dajte otroku
This is usually suitable for children over 1 year. 
Takšna priprava je ponavadi primerna za otroke, starejše od 1 leta.
This includes medicines obtained without a prescription. 
vključno z zdravili, ki ste jih dobili brez recepta.
PHARMACEUTICAL FORM AND CONTENTS 1 bottle 
FARMACEVTSKA OBLIKA IN VSEBNOST 1 steklenica
(Note: This compounded suspension should be gently shaken prior to administration to minimise the tendency for air entrapment.) 
(Opomba: pripravljeno suspenzijo je treba pred uporabo nežno pretresti, da zmanjšamo ujeti zrak na minimum.)
Imprints are blue. 
Napisi so modre barve.
* Depending on the capsule strength used. 
* Odvisno od jakosti kapsule, ki jo uporabimo.
The contribution of Tamiflu to those events is unknown. 
Prispevek zdravila Tamiflu k pojavu teh dogodkov ni znan.
Information for healthcare professionals only 
Informacije samo za zdravstveno osebje
Final volume of the bottle after reconstitution is 65 ml. 
Končni volumen steklenice po rekonstituciji je 65 ml.
• if you notice changes in behaviour or mood (neuropsychiatric events), especially in children and adolescents). 
· če ste opazili spremembe v obnašanju ali razpoloženju (nevropsihiatrični dogodki), še posebej pri otrocih in mladostnikih.
* This table is not intended to contain all possible weights for this population. 
*Preglednica ne predvideva vseh možnih mas te populacije.
Pour all of the powder into the bowl, whatever the dose you are making. 
Ves prašek stresite v posodo, ne glede na odmerek, ki ga pripravljate.
Instruct the parent or caregiver that any remaining material following completion of therapy must be discarded. 
Poučite starše ali skrbnike, da je po končani terapiji treba ves preostali material zavreči.
• Confusion, abnormal behaviour 
· zmedenost, nenormalno vedenje,
Step 1: Check the dose is correct 
Korak 1: preverite, če je odmerek pravilen
In general, the safety profile in the patients “at risk” was qualitatively similar to that in otherwise healthy adults/adolescents. 
V splošnem je bil varnostni profil pri “ogroženih” bolnikih kakovostno podoben tistemu pri drugače zdravih odraslih/mladostnikih.
For details on how to prepare the oral suspension and how to measure and take the medicine, read Instructions for the user, over the page. 
Za podrobnosti o tem, kako pripraviti peroralno suspenzijo in kako odmeriti in vzeti zdravilo, si preberite Navodila za uporabnika na naslednjih straneh.
For treating flu, take two doses daily. 
Za zdravljenje gripe jemljite dva odmerka na dan.
Use of Tamiflu must not affect the evaluation of individuals for annual influenza vaccination. 
Uporaba zdravila Tamiflu ne sme vplivati na evaluacijo posameznikov za letno cepljenje proti gripi.
0 - 12 months 
0 do 12 mesecev
Triplex blister pack (PVC/PE/PVDC, sealed with aluminium foil). 
Pretisni omot tripleks (PVC/PE/PVDC, zavarjen z aluminijasto folijo).
Place a pharmacy label on the bottle that includes the patient's name, dosing instructions, use by date, name of medicinal product and any other required information to be in compliance with local pharmacy regulations. 
Na steklenico nalepite nalepko, ki vključuje bolnikovo ime, navodila za odmerjanje, rok uporabnosti zdravila, ime zdravila in katero koli drugo potrebno informacijo, ki je v skladu z lokalnimi predpisi v lekarni.