natgillin/translations-raw huggingface dataset:
Ristempa 6 mg solution for injection in a pre-filled syringe pegfilgrastim
Ristempa 6 mg raztopina za injiciranje v napolnjeni injekcijski brizgi pegfilgrastim
Back- Ristempa reference guide:
Hrbtna stran - Zdravilo Ristempa: kratka navodila
The safety and efficacy of Ristempa have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g., nitrosoureas.
Pri bolnikih, ki dobivajo kemoterapijo, povezano z odloženo mielosupresijo, na primer nitrozouree, varnosti in učinkovitosti zdravila Ristempa niso ovrednotili.
Ristempa 6 mg solution for injection Pegfilgrastim
Ristempa 6 mg raztopina za injiciranje pegfilgrastim
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN
Front - Ristempa reference guide:
Ločeni dodatni vložek: Sprednja stran - zdravilo Ristempa: kratka navodila
UNBLISTERED SYRINGE LABEL
OZNAKA BRIZGE V PRETISNEM OMOTU
- The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for
Ena napolnjena injekcijska brizga vsebuje 6 mg - Pomožne snovi so natrijev acetat, sorbitol (E420), polisorbat 20 in voda za injekcije.
Investigations
Takšni ukrepi
Grab the pre-filled syringe safety guard to remove the
Napolnjeno injekcijsko brizgo vzemite iz podloge tako, da jo primete za njen varnostni ščitnik.
swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of
oteklost trebuha in občutek polnosti ter splošen občutek utrujenosti.
Upper arm
Potem brizgo
‘Advanced' means that the cancer has started to spread.
„Napredovali“ pomeni, da se je rak začel širiti.
As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 27 May 2015.
Ker je družba zagotovila dodatne zahtevane informacije so izjemne okoliščine prenehale 27. maja 2015.
Treatment carries on for as long as the patient shows a benefit.
Zdravljenje se izvaja tako dolgo, dokler še predstavlja korist za bolnika.
This can prevent the cells from dividing too quickly, slowing down the growth of various types of cancer.
To lahko prepreči prehitro delitev celic in upočasni rast različnih vrst raka.
The European Commission granted a marketing authorisation valid throughout the European Union for Yondelis on 17 September 2007.
Evropska komisija je dovoljenje za promet z zdravilom Yondelis, veljavno po vsej Evropski uniji, izdala 17. septembra 2007.
In both studies, the main measure of effectiveness was how long the patients lived without their disease getting worse.
V obeh študijah je bilo glavno merilo učinkovitosti čas do poslabšanja bolezni.
Cancer is a disease where cells divide too quickly, usually because the way their genes work is faulty.
Rak je bolezen, pri kateri se celice prehitro delijo, navadno zaradi okvare v načinu delovanja genov.
Around two-thirds of the patients had cancer that was sensitive to platinum-containing medicines.
Okoli dve tretjini bolnic je imelo raka, občutljivega na zdravila, ki vsebujejo platino.
This is a summary of the European public assessment report (EPAR) for Yondelis.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Yondelis.
The study compared two different dosing schedules of Yondelis: three times per month, or once every three weeks.
V študiji so primerjali dve različni shemi odmerjanja zdravila Yondelis: trikrat mesečno ali enkrat na tri tedne.
What measures are being taken to ensure the safe and effective use of Yondelis?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Yondelis?
The CHMP concluded that Yondelis's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Yondelis večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Trabectedin works by attaching to the DNA, the chemical molecule that makes up genes, and preventing some genes in human cells from increasing their activity.
Trabektedin deluje tako, da se veže na DNK, kemijsko molekulo, ki tvori gene, in preprečuje povečanje delovanje nekaterih genov v človeških celicah.
For the full list of restrictions, see the package leaflet.
Za celoten seznam omejitev glejte navodilo za uporabo
• ovarian cancer;
• rak jajčnikov;
All of the patients had been treated previously with an anthracycline and ifosfamide but this treatment had stopped working.
Vsi bolniki so bili predhodno zdravljeni z antraciklini in ifosfamidi, vendar je zdravljenje postalo neučinkovito.
A risk management plan has been developed to ensure that Yondelis is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Yondelis je bil pripravljen načrt obvladovanja tveganj.
Yondelis must not be used in patients who have any serious or uncontrolled infection, in combination with the vaccine for yellow fever, or in breast-feeding women.
Zdravilo Yondelis se ne sme uporabljati pri bolnikih, ki imajo resno ali nenadzorovano okužbo, v kombinaciji s cepivom za rumeno mrzlico ali pri doječih ženskah.
Yondelis is used to treat adults with two types of cancer:
Zdravilo Yondelis se uporablja za zdravljenje odraslih z dvema vrstama raka:
The most common side effects of any severity were neutropenia (low levels of neutrophils, a type of white blood cell), nausea (feeling sick), vomiting, increase in liver enzymes, anaemia (low red blood cell counts), tiredness, thrombocytopenia (low blood platelet counts), loss of appetite and diarrhoea.
Najpogostejši neželeni učinki različnih stopenj resnosti so bili nevtropenija (nizke ravni nevtrofilcev, vrste belih krvnih celic), navzeja (slabost), bruhanje, povečano število jetrnih encimov, anemija (nizka raven rdečih krvničk), utrujenost, trombocitopenija (nizka raven krvnih ploščic), izguba teka in driska.
Other information about Yondelis
Druge informacije o zdravilu Yondelis
The summary of the opinion of the Committee for Orphan Medicinal Products for Yondelis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
Povzetek mnenja Odbora za zdravila sirote o zdravilu Yondelis je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
• ovarian cancer (cancer of the ovaries) that has relapsed (come back after previous treatment) and is sensitive to medicines containing platinum.
• rakom jajčnikov, ki se je ponovil (znova pojavil po predhodnem zdravljenju) in je občutljiv za zdravila, ki vsebujejo platino.
If the patient's blood counts are abnormal, infusion with Yondelis should be delayed, the dose of Yondelis should be reduced or other medicines can be used to treat the blood problems.
Če je bolnikova krvna slika nenormalna, je treba infundiranje zdravila Yondelis odložiti, njegov odmerek zmanjšati ali uporabiti druga zdravila za zdravljenje težav s krvjo.
For more information about treatment with Yondelis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Yondelis preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
It should only be used by qualified oncologists (cancer specialists) or other health professionals who are specialised in giving cytotoxic (cell-killing) medicines.
Uporabljati ga smejo samo usposobljeni onkologi (specialisti za zdravljenje raka) ali drugi zdravstveni delavci, ki so specializirani za dajanje citotoksičnih zdravil (zdravil, ki uničujejo celice).
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 Yondelis.
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.
EPAR summary for the public trabectedin
Povzetek EPAR za javnost
Yondelis must be given under the supervision of a doctor who is experienced in the use of chemotherapy (medicines to treat cancer).
Zdravilo Yondelis se mora dajati pod nadzorom zdravnika, ki ima izkušnje z uporabo kemoterapije (zdravil za zdravljenje raka).
Most patients treated with Yondelis can be expected to have side effects.
Pri večini bolnikov, ki se zdravijo z zdravilom Yondelis, je mogoče pričakovati neželene učinke.
What benefit has Yondelis shown during the studies?
Kakšne koristi je zdravilo Yondelis izkazalo med študijami?
The full EPAR for Yondelis 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 Yondelis je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
• advanced soft-tissue sarcoma, a type of cancer that develops from the soft, supporting tissues of the body.
• napredovalim sarkomom mehkega tkiva, vrsto raka, ki se začne razvijati na mehkih vezivnih tkivih v telesu.
The effect of Yondelis was more pronounced in the women whose cancer was sensitive to platinum-containing medicines.
Učinek zdravila Yondelis je bil izrazitejši pri bolnicah, pri katerih je rak občutljiv na zdravila, ki vsebujejo platino.
Yondelis is used when treatment with anthracyclines and ifosfamide (other cancer medicines) have stopped working, or in patients who cannot be given these medicines;
Zdravilo Yondelis se uporablja, ko je zdravljenje z antraciklini in ifosfamidi (drugimi zdravili proti raku) postalo neučinkovito, ali pri bolnikih, pri katerih uporaba teh zdravil ni primerna;
Yondelis was originally authorised under ‘exceptional circumstances', because, limited information was available at the time of approval on soft-tissue sarcoma.
Zdravilo Yondelis je pridobilo dovoljenje za promet „v izjemnih okoliščinah“, ker so bilio v času izdaje dovoljenja na voljo omejeni podatki o sarkomu mehkega tkiva.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Yondelis, 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.
Because the numbers of patients with soft-tissue sarcoma and ovarian cancer are low, the diseases are considered ‘rare', and Yondelis was designated an ‘orphan medicine' (a medicine used in rare diseases) on 30 May 2001 (for soft-tissue sarcoma) and on 17 October 2003 (for ovarian cancer).
Ker je bolnikov s sarkomom mehkega tkiva in rakom jajčnikov malo, veljata ti bolezni za redki, zato je bilo zdravilo Yondelis 30. maja 2001 (za sarkom mehkega tkiva) in 17. oktobra 2003 (za rak jajčnikov) določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
For soft-tissue sarcoma, Yondelis has been studied in one main study involving 266 patients with liposarcoma (a sarcoma originating in fat cells) or leiomyosarcoma (a sarcoma originating in ‘smooth' or involuntary muscle cells) that was advanced or metastatic (had spread to other parts of the body).
Pri sarkomu mehkega tkiva so zdravilo Yondelis proučevali v eni glavni študiji, v katero je bilo vključenih 266 bolnikov z liposarkomom (sarkomom, ki se začne razvijati v maščobnih celicah) ali leiomiosarkomom (sarkomom, ki se začne razvijati v gladkih ali nehotnih mišičnih celicah), ki je napredoval ali je bil metastatski (se je razširil na druge dele telesa).
It is available as a powder that is made up into a solution for infusion (drip into a vein).
Na voljo je v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije v veno).
Yondelis is used in combination with pegylated liposomal doxorubicin (PLD, another cancer medicine).
Zdravilo Yondelis se uporablja v kombinaciji s pegiliranim liposomskim doksorubicinom (PLD, drugim zdravilom proti raku).
The active substance in Yondelis, trabectedin, is a synthetic version of a substance that was originally extracted from a species of tunicate or ‘sea squirt' (a marine animal).
Zdravilna učinkovina zdravila Yondelis, trabektedin, je sintetična različica snovi, ki so jo prvotno pridobivali iz vrste plaščarja oziroma mehkega kozolnjaka (morske živali).
• soft-tissue sarcoma.
• sarkom mehkega tkiva.
For soft-tissue sarcoma, the recommended dose of Yondelis is 1.5 mg per square metre of body surface area (calculated using the patient's height and weight), given as a single infusion lasting 24 hours every three weeks.
Priporočeni odmerek zdravila Yondelis pri sarkomu mehkega tkiva je 1,5 mg/m2 telesne površine (izračunano na podlagi bolnikove telesne višine in mase), ki se da kot enkratna infuzija v trajanju 24 ur vsake tri tedne.
Patients receiving it once every three weeks lived for an average of 3.8 months without their disease getting worse, compared with 2.1 months in those receiving Yondelis three times per month.
Pri bolnikih, ki so zdravilo Yondelis prejemali enkrat na tri tedne, je bil čas do poslabšanja bolezni v povprečju 3,8 meseca v primerjavi z 2,1 meseca pri bolnikih, ki so zdravilo prejemali trikrat na mesec.
Around 10% of those patients treated with Yondelis as a single agent and 25% treated with Yondelis in combination therapy can be expected to have serious side effects.
Pri približno 10 % bolnikov, ki se zdravijo z zdravilom Yondelis, vzetim samostojno, in 25 % bolnikov, ki se zdravijo z zdravilom Yondelis kot del kombiniranega zdravljenja, je mogoče pričakovati resne neželene učinke.
What is the risk associated with Yondelis?
Kakšna tveganja so povezana z zdravilom Yondelis?
For ovarian cancer, it is given at a dose of 1.1 mg/m2 every three weeks as an infusion lasting three hours, immediately after the PLD infusion.
Pri raku jajčnikov se zdravilo Yondelis daje v odmerku 1,1 mg/m2 kot infuzija v trajanju tri ure vsake tri tedne, takoj po infuziji pegiliranega liposomskega doksorubicina (PLD).
For soft-tissue sarcoma, Yondelis was more effective when it was given once every three weeks than when it was given with the alternative dosing schedule.
Pri sarkomu mehkega tkiva je bilo zdravilo Yondelis, vzeto enkrat na tri tedne, učinkovitejše od alternativne sheme odmerjanja.
For ovarian cancer, the combination of Yondelis and PLD was more effective than PLD alone: patients receiving the combination treatment lived for an average of 7.3 months without their disease getting worse, compared with 5.8 months in those receiving PLD alone.
Pri raku jajčnikov je bila kombinacija zdravila Yondelis in pegiliranega liposomskega doksorubicina učinkovitejša od pegiliranega liposomskega doksorubicina, vzetega samostojno: bolnice, ki so prejemale kombinirano zdravljenje, so v povprečju živele 7,3 meseca brez poslabšanja bolezni v primerjavi s 5,8 meseca pri tistih, ki so pegilirani liposomski doksorubicin jemale samostojno.
For the full list of all side effects reported with Yondelis, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Yondelis, glejte navodilo za uporabo
To prevent vomiting and to protect the liver, patients must receive an infusion of corticosteroids such as dexamethasone before treatment.
Za preprečevanje bruhanja in zaščito jeter je treba pred posameznim odmerkom zdravila Yondelis bolniku dati infuzijo kortikosteroidov, kot je deksametazon.
It is recommended that Yondelis be given through a central venous line (a thin tube leading from the skin into the large veins just above the heart).
Priporočljivo je, da se zdravilo Yondelis daje po centralnem venskem katetru (tanki cevki, speljani od kože v velike vene nad srcem).
Why has Yondelis been approved?
Zakaj je bilo zdravilo Yondelis odobreno?
Fatal side effects have occurred in 1.9% and 0.9% of patients treated with Yondelis as a single agent and combination therapy, respectively.
Neželeni učinki s smrtnim izidom so se zgodili pri 1,9 % bolnikov, ki so se zdravili z zdravilom Yondelis, vzetim samostojno, oziroma 0,9 % bolnikov, ki so se zdravili z zdravilom Yondelis kot del kombiniranega zdravljenja.
Yondelis is a cancer medicine that contains the active substance trabectedin.
Zdravilo Yondelis je zdravilo proti raku, ki vsebuje zdravilno učinkovino trabektedin.
How has Yondelis been studied?
Kako je bilo zdravilo Yondelis raziskano?
What is Yondelis used for?
Za kaj se zdravilo Yondelis uporablja?
What is Yondelis?
Kaj je zdravilo Yondelis?
How does Yondelis work?
Kako zdravilo Yondelis deluje?
How is Yondelis used?
Kako se zdravilo Yondelis uporablja?
For ovarian cancer, Yondelis in combination with PLD was compared with PLD alone in one main study involving 672 women whose disease had come back or got worse after previous treatment.
Pri raku jajčnikov so v eni glavni študiji, v katero je bilo vključenih 672 žensk, pri katerih se je bolezen po predhodnem zdravljenju ponovila ali poslabšala, zdravilo Yondelis v kombinaciji s pegiliranim liposomskim doksorubicinom primerjali s pegiliranim liposomskim doksorubicinom, vzetim samostojno.
What measures are being taken to ensure the safe and effective use of Namuscla?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Namuscla?
After 18 days of treatment, the average score for patients treated with Namuscla decreased from 66 to 24, while the score for patients given placebo went from 75 to 66.
Po 18 dneh zdravljenja se je povprečna ocena pri bolnikih, ki so prejemali zdravilo Namuscla, zmanjšala s 66 na 24, medtem kot se je ocena pri bolnikih, ki so prejemali placebo, zmanjšala s 75 na 66.
Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/EU3141353.
Nadaljnje informacije glede določitve zdravila sirote lahko najdete tukaj: ema.europa.eu/medicines/human/orphan-designations/EU3141353.
The European Medicines Agency therefore decided that Namuscla'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 Namuscla večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Further information on Namuscla can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Namuscla.
Nadaljnje informacije o zdravilu Namuscla so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Namuscla.
The company also provided supportive data on the effectiveness of Namuscla from the literature.
Družba je predložila tudi podporne podatke o učinkovitosti zdravila Namuscla iz literature.
Because it has a similar effect on the heart muscle, mexiletine has also been used for many years in patients with abnormal heart rhythm.
Ker ima meksiletin podoben učinek na srčno mišico, se je veliko let uporabljal tudi pri bolnikih z nenormalnim srčnim ritmom.
As for all medicines, data on the use of Namuscla are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Namuscla stalno spremljajo.
The dose can be increased up to 3 capsules a day, depending on the intensity of the symptoms and how the patient responds to treatment.
Priporočeni začetni odmerek je ena kapsula na dan. Odmerek se lahko poveča do tri kapsule na dan, odvisno od intenzivnosti simptomov in bolnikovega odziva na zdravljenje.
What benefits of Namuscla have been shown in studies?
Kakšne koristi je zdravilo Namuscla izkazalo v študijah?
The safety profile of Namuscla is well known and its side effects affecting the heart are considered to be manageable with restrictions in use and monitoring during treatment.
Varnostni profil zdravila Namuscla je dobro znan, njegovi neželeni učinki, ki vplivajo na srce, pa veljajo za obvladljive z omejitvami pri uporabi in spremljanjem med zdravljenjem.
An overview of Namuscla and why it is authorised in the EU
Pregled zdravila Namuscla in zakaj je odobreno v EU
Why is Namuscla authorised in the EU?
Zakaj je bilo zdravilo Namuscla odobreno v EU?
The company that markets Namuscla will provide educational material for doctors and a ‘patient alert card' with important information about the risks associated with the medicine, in particular the risk of arrhythmias.
Družba, ki trži zdravilo Namuscla, bo zagotovila izobraževalno gradivo za zdravnike in opozorilno kartico za bolnike s pomembnimi informacijami o tveganjih, povezanih z zdravilom, zlasti o tveganju za nastanek aritmij.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Namuscla have also 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 Namuscla upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Patients should have tests to check how well their heart is working before beginning treatment and regularly during treatment.
Pred začetkom zdravljenja je treba bolnikom preveriti delovanje srca in s preverjanjem nadaljevati redno med zdravljenjem.
The most serious side effects reported (which may affect up to 1 in 10,000 people) are arrhythmias (disturbances of heart rhythm) and a severe reaction affecting skin, blood and internal organs, known as drug reaction with eosinophilia and systemic symptoms (DRESS).
Najresnejši neželeni učinki, o katerih so poročali (ki lahko prizadenejo največ 1 od 10 000 bolnikov), so aritmije (motnje srčnega ritma) in huda reakcija, ki prizadene kožo, kri in notranje organe, znana kot reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS).
Side effects reported with Namuscla are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Namuscla, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Namuscla must also not be used in patients with various heart problems, or together with certain medicines.
Prav tako se ne sme uporabljati pri bolnikih z različnimi težavami s srcem ali sočasno z določenimi zdravili.
For more information about using Namuscla, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Namuscla glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Other information about Namuscla
Druge informacije o zdravilu Namuscla
Myotonic disorders are rare, and Namuscla was designated an ‘orphan medicine' (a medicine used in rare diseases) on 19 November 2014.
Miotonične motnje so redke, zato je bilo zdravilo Namuscla 19. novembra 2014 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
What is Namuscla and what is it used for?
Kaj je zdravilo Namuscla in za kaj se uporablja?
What are the risks associated with Namuscla?
Kakšna tveganja so povezana z zdravilom Namuscla ?
Patients with non-dystrophic myotonic disorders experience muscle stiffness and pain because their muscles are slow to relax after contraction.
Pri bolnikih z nedistrofičnimi miotoničnimi motnjami se pojavljajo otrdelost mišic in bolečine, ker se njihove mišice po krčenju prepočasi sproščajo.
Namuscla must not be used in patients who are hypersensitive (allergic) to the active substance, mexiletine, to any other ingredients of the medicine, or to local anaesthetics (medicines that block out sensation used to prevent pain in a part of the body).
Zdravilo Namuscla se ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) učinkovino meksiletin, katero koli drugo sestavino zdravila ali lokalne anestetike (zdravila, ki zavirajo zaznavanje občutka bolečine v delu telesa).
By blocking them, the medicine helps to reduce the stiffness that occurs when the contractions are prolonged.
Zdravilo z zaviranjem kanalčkov pomaga zmanjšati otrdelost, ki se pojavi pri podaljšanem krčenju.