natgillin/translations-raw huggingface dataset:
Targretin received a marketing authorisation valid throughout the EU on 29 March 2001.
Za zdravilo Targretin je bilo 29. marca 2001 izdano dovoljenje za promet, veljavno po vsej EU.
Targretin is available as capsules (75 mg).
Zdravilo Targretin je na voljo v obliki kapsul (75 mg).
The dose is adjusted depending on the patient's response to treatment or side effects.
Odmerek se prilagaja glede na bolnikov odziv na zdravljenje ali glede na neželene učinke.
As for all medicines, data on the use of Targretin are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Targretin stalno spremljajo.
Targretin was not compared with another medicine.
Zdravila Targretin niso primerjali z drugim zdravilom.
Other information about Targretin
Druge informacije o zdravilu Targretin
Across the two studies, among the patients who received 300 mg/m2, about half of them responded to treatment, according the doctor's grading.
V dveh študijah z bolniki, ki so prejemali odmerek 300 mg/m2, se jih je glede na zdravniško oceno na zdravljenje odzvala približno polovica.
An overview of Targretin and why it is authorised in the EU
Pregled zdravila Targretin in zakaj je odobreno v EU
Side effects reported with Targretin are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Targretin, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Sixty-one patients were treated at the starting dose of 300 mg/m2/day.
61 bolnikov so zdravili z začetnim odmerkom 300 mg/m2/dan.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Targretin 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 Targretin upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Targretin must not be used in women who are pregnant or breast-feeding, or women who could become pregnant and who are not using effective contraception; patients who have had pancreatitis (inflammation of the pancreas); patients with uncontrolled hypercholesterolaemia (high blood cholesterol), hypertriglyceridaemia (high blood triglycerides [fat]) or thyroid disease; patients with hypervitaminosis A (high levels of vitamin A); patients with liver disease; patients with an ongoing body infection.
Zdravilo Targretin se ne sme uporabljati pri nosečnicah ali doječih materah ali pri ženskah, ki bi lahko zanosile in ne uporabljajo učinkovite kontracepcije; bolnikih, ki so imeli pankreatitis (vnetje trebušne slinavke); bolnikih z nekontrolirano hiperholesterolemijo (visoka koncentracija holesterola v krvi), hipertrigliceridemijo (visoka koncentracija trigliceridov [maščob] v krvi) ali boleznijo ščitnice; bolnikih s hipervitaminozo A (visoka koncentracija vitamina A); bolnikih z boleznijo jeter; bolnikih z okužbo v telesu.
Ninety-three of these patients had advanced disease that had not responded to other treatment.
93 bolnikov je imelo bolezen v napredovalnem stadiju, ki se ni odzvala na druga zdravljenja.
Why is Targretin authorised in the EU?
Zakaj je bilo zdravilo Targretin odobreno v EU?
What benefit of Targretin have been shown in studies?
Kakšne koristi zdravila Targretin so se pokazale v študijah?
For more information about using Targretin, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Targretin glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
grading of improvement, as well as by a score of 5 clinical signs (area of skin affected, redness, raised areas, scale-like skin and colour).
je bil z zdravnikovo oceno izboljšanja in oceno petih kliničnih znakov (površina prizadete kože, pordelost, izbočena območja, luskasta koža in barva).
What are the risks associated with Targretin?
Kakšna tveganja so povezana z zdravilom Targretin?
What is Targretin and what is it used for?
Kaj je zdravilo Targretin in za kaj se uporablja?
The active substance in Targretin, bexarotene, belongs to the group of retinoids, substances that are derived from vitamin A. The exact way bexarotene works in CTCL is not known.
Učinkovina v zdravilu Targretin, beksaroten, spada v skupino retinoidov, snovi, ki so pridobljene iz vitamina A. Natančen način delovanja beksarotena pri kožnem T-celičnem limfomu ni znan.
The dose of Targretin is based on the patient's body surface area in square metres (m2).
Odmerek zdravila Targretin se določi glede na bolnikovo telesno površino v kvadratnih metrih (m2).
The most common side effects with Targretin (which may affect more than 1 patient in 10) are leucopenia (reduced white cell count), hypothyroidism (underactive thyroid gland), hyperlipaemia (high levels of fats in the blood), hypercholesterolaemia (high blood cholesterol), exfoliative dermatitis (skin peeling), pruritus (itching), rash, pain, headache and weakness.
Najpogostejši neželeni učinki zdravila Targretin (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so levkopenija (zmanjšano število belih krvničk), hipotiroidizem (zmanjšana funkcija ščitnice), hiperlipemija (visoke koncentracije maščob v krvi), hiperholesterolemija (visoke koncentracije holesterola v krvi), eksfoliativni dermatitis (luščenje kože), pruritus (srbenje), izpuščaji, bolečina, glavobol in šibkost.
The effectiveness of Targretin has been examined in two studies involving a total of 193 patients with CTCL who received at least two previous treatments.
Učinkovitost zdravila Targretin so proučevali v dveh študijah, v kateri je bilo vključenih 193 bolnikov s kožnim T-celičnim limfomom, pri katerih sta se najmanj dve predhodni zdravljenji izkazali za neuspešni.
The Agency recommended that Targretin be given marketing authorisation.
Priporočila je, da se za zdravilo Targretin izda dovoljenje za promet.
Targretin is a cancer medicine used for the treatment of the visible signs on the skin of cutaneous Tcell lymphoma (CTCL).
Targretin je zdravilo proti raku, ki se uporablja za zdravljenje na koži vidnih znakov kožnega Tceličnega limfoma (CTCL).
The European Medicines Agency decided that Targretin's benefits are greater than its risks for the treatment of the skin manifestations of advanced-stage CTCL patients refractory to at least one treatment.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Targretin večje od z njim povezanih tveganj pri zdravljenju kožnih manifestacij pri bolnikih s kožnim T-celičnim limfomom v napredovalem stadiju, ki se ni odzval na najmanj eno zdravljenje.
Targretin can only be obtained with a prescription and treatment should only be initiated and maintained by a doctor who has experience in the treatment of patients with CTCL.
Predpisovanje in izdaja zdravila Targretin je le na recept, zdravljenje z njim pa lahko uvede in nadzoruje le zdravnik z izkušnjami z zdravljenjem bolnikov s kožnim T-celičnim limfomom.
Targretin is used in patients who have an advanced disease and have had at least one other treatment.
Targretin se uporablja pri bolnikih z napredovalo boleznijo, pri katerih je bila neuspešna najmanj ena druga vrsta zdravljenja.
CTCL is a rare type of lymphoma (cancer of the lymph tissue) where some white blood cells (T-cells) grow in the skin.
Kožni T-celični limfom je redka oblika limfoma (raka limfatičnega tkiva), pri kateri se v koži razraščajo nekatere bele krvne celice (celice T).
For the full list of side effects reported with Targretin, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Targretin, glejte navodilo za uporabo.
How does Targretin work?
Kako zdravilo Targretin deluje?
How is Targretin used?
Kako se zdravilo Targretin uporablja?
This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one side of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear.
To je vrsta epilepsije, pri kateri prevelika električna aktivnost na eni strani možganov povzroči simptome, kot so nenadni sunkoviti gibi ene strani telesa, motnje sluha, voha ali vida, odrevenelost ali nenaden občutek strahu.
Epilepsy is caused by excessive electrical activity in the brain.
Epilepsija je posledica prekomerne električne aktivnosti v možganih.
The full EPAR for Levetiracetam Hospira 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 Levetiracetam Hospira je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam Hospira on the 08 January 2014.
Evropska komisija je dovoljenje za promet z zdravilom Levetiracetam Hospira, veljavno po vsej Evropski uniji, izdala 08 januarja 2014.
This is a summary of the European public assessment report (EPAR) for Levetiracetam Hospira.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Levetiracetam Hospira.
The Committee recommended that Levetiracetam Hospira be approved for use in the EU.
Priporočil je, da se zdravilo Levetiracetam Hospira odobri za uporabo v EU.
• primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
• primarno generaliziranih tonično-kloničnih napadov (daljših napadov, vključno z izgubo zavesti) pri bolnikih od 12 leta dalje, z idiopatsko generalizirano epilepsijo (vrsto epilepsije, za katero se domneva, da je genetskega izvora).
It can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partialonset seizures (fits) with or without secondary generalisation.
Uporablja se lahko kot samostojno zdravilo pri bolnikih od 16 leta starosti z na novo diagnosticirano epilepsijo, za zdravljenje napadov parcialnega izvora s sekundarno generalizacijo ali brez nje.
This helps Levetiracetam Hospira to stabilise electrical activity in the brain and prevent seizures.
To omogoča zdravilu Levetiracetam Hospira, da stabilizira električno aktivnost v možganih in prepreči napade.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Levetiracetam Hospira has been shown to have comparable quality and to be bioequivalent to Keppra.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Levetiracetam Hospira primerljivo raven kakovosti kot referenčno zdravilo Keppra ter da mu je biološko enakovredno.
• partial-onset seizures with or without generalisation in patients from four years of age;
• napadov parcialnega izvora z generalizacijo ali brez nje pri bolnikih od četrtega leta starosti dalje;
This means that Levetiracetam Hospira is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Keppra.
What measures are being taken to ensure the safe and effective use of Levetiracetam Hospira?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Levetiracetam Hospira?
A risk management plan has been developed to ensure that Levetiracetam Hospira is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Levetiracetam Hospira je bil pripravljen načrt obvladovanja tveganj.
• myoclonic seizures (short, shock-like jerks of a muscle or a group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;
• miokloničnih napadov (kratkih, krčem podobnih sunkovitih gibov mišice ali skupine mišic) pri bolnikih z juvenilno mioklonično epilepsijo od 12. leta starosti dalje;
Levetiracetam Hospira can only be obtained with a prescription and is available as a concentrate (100 mg/ml) that is made up into a solution for infusion (drip) into a vein.
Izdaja zdravila Levetiracetam Hospira je le na recept in je na voljo v obliki koncentrata (100 mg/ml) za pripravo raztopine za infundiranje (kapalno infuzijo) v veno.
Because Levetiracetam Hospira is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Levetiracetam Hospira generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The daily dose can be increased up to 1,500 mg twice a day.
Dnevni odmerek se lahko poveča do največ 1.500 mg dvakrat na dan.
What are the benefits and risks of Levetiracetam Hospira?
Kakšne so koristi in tveganja, povezani z zdravilom Levetiracetam Hospira?
For more information about treatment with Levetiracetam Hospira, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Levetiracetam Hospira preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Levetiracetam Hospira infusion should only be used temporarily, while treatment by mouth is not feasible.
Infuzijo zdravila Levetiracetam Hospira je treba uporabljati le začasno, kadar peroralno dajanje zdravila ni mogoče.
In patients aged between four and 17 years weighing less than 50 kg, the starting dose is 10 mg per kilogram body weight twice a day, which can be increased up to 30 mg/kg twice a day.
Pri bolnikih, starih od 4 do 17 let, ki tehtajo manj kot 50 kg, je začetni odmerek 10 mg/kg telesne mase dvakrat na dan, ki se lahko poveča vse do 30 mg/kg telesne mase dvakrat na dan.
What is Levetiracetam Hospira and what is it used for?
Kaj je zdravilo Levetiracetam Hospira in za kaj se uporablja?
Other information about Levetiracetam Hospira
Druge informacije o zdravilu Levetiracetam Hospira
Lower doses are used in patients who have reduced kidney function.
Pri bolnikih z okvarjenim delovanjem ledvic se uporabljajo manjši odmerki.
For practical information about using Levetiracetam Hospira, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Levetiracetam Hospira naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The company provided data from the published literature on levetiracetam.
Družba je predstavila podatke o levetiracetamu iz objavljene literature.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Levetiracetam Hospira, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Levetiracetam Hospira in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Levetiracetam Hospira can also be used as an add-on to other anti-epileptic medicines to treat:
Zdravilo Levetiracetam Hospira se lahko uporablja tudi kot dopolnilno zdravljenje k drugim zdravilom proti epilepsiji za zdravljenje:
When Levetiracetam Hospira is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing 50 kg or more is 500 mg twice a day.
Kadar se zdravilo Levetiracetam Hospira dodaja k drugemu zdravilu proti epilepsiji, je začetni odmerek pri bolnikih, starejših od 12 let, ki tehtajo 50 kg ali več, 500 mg dvakrat na dan.
It is not intended to provide practical advice on how to use Levetiracetam Hospira.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Levetiracetam Hospira is a ‘generic medicine'.
Zdravilo Levetiracetam Hospira je „generično zdravilo“.
Therefore, the CHMP's view was that, as for Keppra, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi enako kot pri zdravilu Keppra odtehtajo znana tveganja.
The active substance in Levetiracetam Hospira, levetiracetam, is an anti-epileptic medicine.
Zdravilna učinkovina v zdravilu Levetiracetam Hospira, levetiracetam, je zdravilo proti epilepsiji.
Why is Levetiracetam Hospira approved?
Zakaj je bilo zdravilo Levetiracetam Hospira odobreno?
Levetiracetam Hospira is an anti-epileptic medicine that contains the active substance levetiracetam.
Levetiracetam Hospira je zdravilo proti epilepsiji, ki vsebuje zdravilno učinkovino levetiracetam.
When Levetiracetam Hospira is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Kadar se zdravilo Levetiracetam Hospira uporablja samostojno, je začetni odmerek 250 mg dvakrat na dan, ki se dva tedna pozneje poveča na 500 mg dvakrat na dan. Odmerek se lahko glede na bolnikov odziv še naprej povečuje v dvotedenskih presledkih do največjega odmerka 1 500 mg dvakrat na dan.
How has Levetiracetam Hospira been studied?
Kako je bilo zdravilo Levetiracetam Hospira raziskano?
How is Levetiracetam Hospira used?
Kako se zdravilo Levetiracetam Hospira uporablja?
No additional studies were needed as Levetiracetam Hospira is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Keppra.
Ker je zdravilo Levetiracetam Hospira generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Keppra, niso bile potrebne nobene dodatne študije.
How does Levetiracetam Hospira work?
Kako zdravilo Levetiracetam Hospira deluje?
The medicine is used in:
Zdravilo se uporablja pri:
Further information on Myalepta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije za zdravilo Myalepta so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
However, the medicine does not restore fat tissue under the skin.
Vendar zdravilo ne obnavlja maščobnega tkiva v pod kožo.
It also results in insulin resistance (when the body is unable to recognise insulin, a hormone that helps regulate blood sugar levels).
Prav tako povzroča odpornost na insulin (ko telo ne more prepoznati insulina, hormona, ki pomaga uravnavati ravni sladkorja v krvi).
Patients or carers can inject the medicine themselves once they have been trained.
Bolniki ali njihovi skrbniki lahko po ustreznem usposabljanju zdravilo injicirajo sami.
What measures are being taken to ensure the safe and effective use of Myalepta?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Myalepta?
The European Medicines Agency therefore decided that Myalepta's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Myalepta večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Myalepta has been shown to be effective at lowering blood fat levels in 2 main studies involving a total of 107 adults and children with generalised or partial lipodystrophy.
Zdravilo Myalepta se je izkazalo za učinkovito pri zmanjševanju ravni maščob v krvi v dveh glavnih študijah, v kateri je bilo vključenih skupaj 107 odraslih in otrok z generalizirano ali parcialno lipodistrofijo.
Myalepta has been authorised under ‘exceptional circumstances'.
Zdravilo Myalepta je pridobilo dovoljenje za promet „v izjemnih okoliščinah“.
The recommended daily dose depends on the patient's bodyweight and is adjusted based on the patient's response to treatment.
Priporočeni dnevni odmerek je odvisen od telesne mase bolnika in se prilagaja glede na njegov odziv na zdravljenje.
After 12 months of treatment, blood levels of fats (triglycerides) decreased from around 15 mmol/l to around 5 mmol/l in patients with generalised disease, and from around 16 mmol/l to around 6 mmol/l in patients with partial disease.
Po 12 mesecih zdravljenja se je raven maščob v krvi (trigliceridov) znižala s približno 15 mmol/l na približno 5 mmol/l pri bolnikih z generalizirano boleznijo in s približno 16 mmol/l na približno 6 mmol/l pri bolnikih s parcialno boleznijo.
In the studies Myalepta was not compared with any other treatment.
V študijah zdravila Myalepta niso primerjali z nobenim drugim zdravilom.
Insulin resistance was also improved: blood levels of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled, fell from 8.6% to 6.4% in patients with generalised lipodystrophy, and from 8.8% to 8.0% in patients with partial lipodystrophy.
Izboljšala se je tudi odpornost na insulin: ravni glikoziliranega hemoglobina (HbA1c) v krvi, ki kaže, kako dobro se nadzira glukoza v krvi, so se znižale z 8,6 % na 6,4 % pri bolnikih z generalizirano lipodistrofijo in z 8,8 % na 8,0 % pri bolnikih s parcialno lipodistrofijo.
As for all medicines, data on the use of Myalepta are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Myalepta stalno spremljajo.
Patients with lipodystrophy have low levels of a human hormone called leptin, which plays a key role in regulating the break-down of fats and sugars in the body.
Bolniki z lipodistrofijo imajo nizke ravni človeškega hormona, imenovanega leptin, ki ima ključno vlogo pri uravnavanju razgradnje maščob in sladkorjev v telesu.
Because the number of patients with the various forms of lipodystrophy is low, the diseases are considered ‘rare', and Myalepta was designated an ‘orphan medicine' (a medicine used in rare diseases) on 17 July 2012.
Ker je bolnikov z različnimi oblikami lipodistrofije malo, veljajo bolezni za „redke“, zato je bilo zdravilo Myalepta 17. julija 2012 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
This leads to loss of fat from under the skin and its build-up in places such as the liver and muscles, as well as high levels of fat in the blood.
To povzroča izgubo maščobe pod kožo in njeno kopičenje na mestih, kot so jetra in mišice, ter visoko raven maščob v krvi.
The most common side effects with Myalepta (which may affect more than 1 in 10 people) are hypoglycaemia (low blood glucose) and weight loss.
Najpogostejša neželena učinka zdravila Myalepta (ki se lahko pojavita pri več kot 1 od 10 bolnikov) sta hipoglikemija (nizka raven glukoze v krvi) in izguba telesne mase.
It replaces leptin and increases fat breakdown in the blood, muscles and liver, thereby correcting some abnormalities in patients with lipodystrophy, including insulin resistance.
Ta nadomešča leptin in povečuje razgradnjo maščob v krvi, mišicah in jetrih, s tem pa odpravlja nekatere nepravilnosti pri bolnikih z lipodistrofijo, vključno z odpornostjo na insulin.
Why is Myalepta authorised in the EU?
Zakaj je bilo zdravilo Myalepta odobreno v EU?
Side effects reported with Myalepta are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Myalepta, se skrbno ovrednotijo in po potrebi sprejmejo ukrepi za zaščito bolnikov.
Other information about Myalepta
Druge informacije o zdravilu Myalepta
An overview of Myalepta and why it is authorised in the EU
Pregled zdravila Myalepta in zakaj je odobreno v EU
Myalepta has been shown to correct some abnormalities caused by leptin deficiency in patients with lipodystrophy, a rare condition for which few treatments are available.
Pokazalo se je, da zdravilo Myalepta odpravlja nekatere nepravilnosti, ki jih povzroča pomanjkanje leptina pri bolnikih z lipodistrofijo, redko boleznijo, za katero je na voljo malo možnosti zdravljenja.
Myalepta is given as a daily injection under the skin of the abdomen (belly), thigh or upper arm, at the same time every day.
Zdravilo Myalepta je v obliki injekcije, ki se enkrat na dan daje pod kožo abdomna (trebuha), stegna ali nadlahti, vsak dan ob enakem času.
What benefits of Myalepta have been shown in studies?
Kakšne koristi zdravila Myalepta so se pokazale v študijah?