natgillin/translations-raw huggingface dataset:
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.
The majority of these ARs were reported on a single occasion on either the first or second treatment day and resolved spontaneously within 1-2 days.
Večina teh neželenih učinkov se je pojavila le enkrat, bodisi prvi ali drugi dan zdravljenja in je spontano prenehala v enem do dveh dneh.
Stage 1 Prepare a new bottle of the medicine
Faza 1 Pripravite novo steklenico zdravila
• if the influenza symptoms get worse or the fever continues Tell your doctor as soon as possible.
• če se simptomi gripe poslabšajo ali, če se zvišana telesna temperatura ne zniža, čim prej obvestite zdravnika.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite zdravnika ali farmacevta.
Open the stated amount of Tamiflu capsules and transfer the content of each capsule directly to the preserved water in the glass beaker.
Odprite navedeno količino kapsul zdravila Tamiflu in prenesite vsebino vsake kapsule neposredno v vodo s konzervansom v stekleni čaši.
You may drink and eat something after taking the medicine.
Po zaužitju zdravila lahko nekaj spijete ali pojeste.
Draw up the correct amount of liquid mixture from the first bowl.
Povlecite pravilno količino tekoče mešanice iz prve posode.
The protection against influenza lasts only as long as Tamiflu is administered.
Zaščita proti gripi traja samo, dokler jemljemo zdravilo Tamiflu.
For example: If a 6-month-old weighs 8 kg, the dose is 8 kg x 3mg per kg = 24 mg
Na primer: če ima 6-mesečni dojenček 8 kg, je odmerek 8 kg x 3 mg na kg = 24 mg
This medicine contains sorbitol, which is a form of fructose.
To zdravilo vsebuje sorbitol, ki je oblika fruktoze.
Method of administration Swallow the capsules whole with water.
Način uporabe Pogoltnite cele kapsule z vodo.
- The appropriate use of Tamiflu for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection.
· Primernost uporabe zdravila Tamiflu za preprečevanje gripe moramo določiti za vsak posamezen primer posebej, odvisno od okoliščin in skupine ljudi, ki potrebuje zaščito.
Always complete the course that your doctor prescribed.
Vedno končajte zdravljenje tako, kot vam je predpisal zdravnik.
The lower predicted exposure however, remains above inhibitoy concentrations (IC95 values) and at a therapeutic level for a range of influenza virus strains.
Manjša predvidena izpostavljenost pa je še vedno nad inhibitornimi koncentracijami (vrednosti IC 95) in v terapevtskem nivoju za vrsto sevov virusa gripe.
For preventing flu or after being exposed to an infected person, take one dose daily for 10 days.
Za preprečevanje gripe ali po stiku z okuženo osebo jemljite en odmerek na dan 10 dni.
Your pharmacist may have prepared the medicine for you when you collected your prescription.
Farmacevt vam je morda ob izdaji že pripravil zdravilo.
Instructions for the user
Navodila za uporabnika
The column on the right of the table shows how much of the liquid mixture you will need to draw up.
Stolpec na desni strani preglednice prikazuje, koliko tekoče mešanice boste morali odvzeti.
* There is no combination of this capsule strength that can be used to achieve the target concentration; therefore, please use an alternative capsule strength.
* Iz te jakosti kapsul ne moremo pripraviti kombinacije, da bi dosegli ciljne koncentracije, zato prosimo, da uporabite drugo jakost kapsul.
Shown on the oral dispenser are millilitre (ml) markings of the medicine (see figures in Instructions for the user).
Na peroralnem odmerniku so oznake za odmerjanje zdravila v mililitrih (ml) (glejte slike v Navodilih za uporabnika).
The powder is a granulate or clumped granulate with a white to light yellow colour.
Prašek je v obliki granulata ali grobozrnatega granulata bele do rahlo rumene barve.
Considering the margins of exposure in relation to the expected exposure in the human use, these findings do not change the benefit-risk of Tamiflu in its adopted therapeutic indications.
Če primerjamo meje izpostavljenosti s pričakovanimi mejami izpostavljenosti pri ljudeh, te ugotovitve ne spremenijo razmerja med koristjo in tveganjem zdravila Tamiflu pri odobrenih terapevtskih indikacijah.
It is recommended that this information be provided by either affixing an ancillary label to the bottle or adding a statement to the pharmacy label instructions.
Priporočljivo je, da se ta informacija ali doda na pomožno nalepko na steklenici ali pa se doda izjava k navodilom farmacevta.
Stop at the mark that shows the dose you need.
Ustavite se pri oznaki, ki označuje vaš odmerek.
Always use the oral dispenser that is provided in the box and has markings indicating the dose in millilitres (ml).
Vedno uporabite peroralni odmernik, ki je priložen v škatli in ima označene odmerke v mililitrih (ml).
Stir the mixture with the teaspoon for about 2 minutes.
Mešanico mešajte s čajno žličko približno 2 minuti.
Outside epidemic periods, flu-like symptoms are usually caused by a different type of illness.
V obdobjih, ko ni epidemije, so gripi podobni simptomi ponavadi posledica drugih bolezni.
Fill it with water to the indicated level.
Napolnite jo z vodo do označenega roba.
During treatment with Tamiflu, tell a doctor immediately:
Med zdravljenjem z zdravilom Tamiflu takoj obvestite zdravnika:
Adults, adolescents or children (> 40 kg) who are able to swallow capsules may receive appropriate doses of Tamiflu capsules.
Odrasli, mladostniki ali otroci (težji od 40 kg), ki lahko pogoltnejo kapsule, lahko prejmejo ustrezen odmerek kapsul zdravila Tamiflu.
Be careful with the powder: it may irritate your skin and eyes.
S praškom ravnajte previdno: lahko draži vašo kožo in oči.
If you notice any of these symptoms, especially in younger people, get medical help immediately.
Če opazite katerega koli od teh simptomov, posebej pri mlajših osebah, takoj poiščite medicinsko pomoč.
Add the water to the powder in the bowl.
Vodo dodajte prašku v posodi.
Date of last renewal: 22 May 2012
Datum prve odobritve: 28. november 2011 Datum zadnjega podaljšanja: 22. maj 2012
But if Tamiflu is stopped earlier than your doctor told you, the symptoms of flu may come back.
Vendar, če prenehate z jemanjem zdravila Tamiflu prej, kot vam je predpisal zdravnik, se lahko simptomi gripe ponovijo.
This will make sure that the bottle adapter fits in the bottle in the right position.
To bo zagotovilo, da bo nastavek za steklenico, nameščen na steklenici, v pravilnem položaju.
Giving Tamiflu to infants less than 1 year old for preventing flu during flu pandemic should be based upon the judgment of a doctor after considering the potential benefit versus any potential risk to the infant.
Uporaba zdravila Tamiflu za preprečevanje gripe med pandemijo gripe pri dojenčkih, mlajših od 1 leta, mora temeljiti na presoji zdravnika, po preučitvi možne koristi zdravljenja v primerjavi z možnim tveganjem za dojenčka.
PHARMACEUTICAL FORM AND CONTENTS 10 hard capsules
FARMACEVTSKA OBLIKA IN VSEBNOST 10 trdih kapsul
With a suitable stirring device, stir for 2 minutes.
Z ustrezno mešalno napravo mešajte 2 minuti.
How much mixture to draw up
Koliko mešanice odvzeti
Very limited information is available on children breast-fed by mothers taking oseltamivir and on excretion of oseltamivir in breast milk.
Na voljo so zelo omejene informacije o dojenih otrocih, katerih matere jemljejo oseltamivir, in o izločanju oseltamivirja v materino mleko.
In special situations, such as widespread flu or for patients with a weak immune system, treatment will continue for up to 6 or 12 weeks.
V posebnih primerih, kot je v primeru široko razširjene gripe ali pri bolnikih s šibkim imunskim sistemom, se z zdravljenjem nadaljuje še do 6 ali 12 tednov.
Older people and patients with chronic cardiac and/or respiratory disease The population included in the influenza treatment studies is comprised of otherwise healthy adults/adolescents and patients “at risk” (patients at higher risk of developing complications associated with influenza, e.g. older people and patients with chronic cardiac or respiratory disease).
Starejši ljudje in bolniki s kroničnimi srčnimi boleznimi in/ali boleznimi dihal Populacijo, vključeno v študije zdravljenja gripe, sestavljajo drugače zdravi odrasli/mladostniki in “ogroženi” bolniki (bolniki z večjim tveganjem za razvoj zapletov, povezanih z gripo, npr. starejši ljudje in bolniki s kronično srčno ali respiratorno boleznijo).