natgillin/translations-raw huggingface dataset:
Temomedac is a ‘generic medicine'.
Zdravilo Temomedac je „generično zdravilo“.
For more information about treatment with Temomedac, read the Package Leaflet (also part of the EPAR).
Za več informacij o zdravljenju z zdravilom Temomedac preberite navodilo za uporabo (ki je prav tako del EPAR).
The CHMP concluded that, in accordance with EU requirements, Temomedac has been shown to have comparable quality and to be bioequivalent to Temodal.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Temomedac primerljivo raven kakovosti kot zdravilo Temodal ter da mu je biološko enakovredno.
Because Temomedac is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal.
Ker je zdravilo Temomedac generično zdravilo, so bile študije na ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Temodal.
Temomedac is a cancer medicine that contains the active substance temozolomide.
Temomedac je zdravilo proti raku, ki vsebuje zdravilno učinkovino temozolomid.
The active substance in Temomedac, temozolomide, belongs to a group of cancer medicines called alkylating agents.
Zdravilna učinkovina zdravila Temomedac, temozolomid, spada v skupino zdravil proti raku, imenovanih alkilirajoči citostatiki.
Temomedac is used on its own in these patients.
Pri teh bolnikih se zdravilo Temomedac uporablja samostojno.
Why has Temomedac been approved?
Zakaj je bilo zdravilo Temomedac odobreno?
Patients may also need to take medicines to prevent vomiting before taking Temomedac.
Preden bolnik vzame zdravilo Temomedac, bo morda potreboval tudi zdravilo za preprečevanje bruhanja.
The dose of Temomedac depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day.
Odmerek zdravila Temomedac je odvisen od telesne površine (izračunane glede na telesno višino in maso bolnika) in znaša od 75 do 200 mg na kvadratni meter enkrat na dan. Odmerek in število odmerkov sta odvisna od vrste zdravljenega tumorja, od tega, ali je bil bolnik že zdravljen, od tega, ali se zdravilo Temomedac uporablja samostojno ali skupaj z drugimi zdravljenji, in od tega, kako se bolnik odziva na zdravljenje.
What is Temomedac used for?
Za kaj se zdravilo Temomedac uporablja?
How is Temomedac used?
Kako se zdravilo Temomedac uporablja?
How has Temomedac been studied?
Kako je bilo zdravilo Temomedac raziskano?
How does Temomedac work?
Kako zdravilo Temomedac deluje?
What is Temomedac?
Kaj je zdravilo Temomedac?
1 vial + 1 filter needle
1 viala + 1 igla s filtrom
Solution for injection Intravitreal use pre-filled syringe
1 viala raztopina za injiciranje intravitrealna uporaba napolnjena injekcijska brizga
1 vial
Jakost
Packaging Package size unit dose blister (PVC/PVDC/alu)
Pakiranje Velikost pakiranja pretisni omot za enkratni odmerek (PVC/PVDC/alu)
EMEA Number
EMEA številka
100 x 1 tablet l t o r
100 x 1 tableta o ā
It has no relevant use in patients under 18 years of age.
Ni primeren za uporabo pri bolnikih, mlajših od 18 let.
2 February 2016 EMA/822538/2015
februar 2016 EMA/822538/2015
Epilobium angustifolium L. and/or Epilobium parviflorum Schreb., herba
Epilobium angustifolium L. in/ali Epilobium parviflorum Schreb., herba
Willow herb EMA/822538/2015
Zel vrbovca EMA/822538/2015
Results from laboratory studies indicate that willow herb may have an effect on the growth of prostate cells as well as anti-inflammatory and pain-relieving activity.
Rezultati laboratorijskih preskusov kažejo, da ima zel vrbovca morda učinek na rast celic prostate ter protivnetno in protibolečinsko delovanje.
However, firm conclusions could not be drawn and the HMPC conclusions on the use of willow herb are based on their long-standing use.
Vendar trdnih zaključkov ni bilo mogoče sprejeti in zaključki odbora HMPC v zvezi z uporabo zeli vrbovca zato temeljijo na njegovi dolgotrajni uporabi.
This summary is not intended to provide practical advice on how to use medicines containing willow herb.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo zel vrbovca.
Willow herb preparations are obtained by drying and comminuting (reducing into tiny pieces) the aerial parts of the plant.
Pripravki z zeljo vrbovca se pridobivajo s sušenjem in drobljenjem (zmanjševanjem na majhne delce) nadzemnih delov rastline.
Willow herb should only be used after serious conditions have been excluded by a medical doctor.
Zel vrbovca se sme uporabljati šele, ko zdravnik izključi resnejša bolezenska stanja.
The HMPC noted the lack of clinical studies with willow herb.
Odbor HMPC je ugotovil pomanjkanje kliničnih študij z zeljo vrbovca.
BPH is a non-cancerous increase in size of the prostate gland which surrounds the urethra, the tube that carries urine from the bladder out of the body.
BHP je nerakavo povečanje žleze prostate, ki obdaja sečevod, to je cev, ki odvaja urin iz sečnega mehurja ven iz telesa.
Further information on the risks associated with willow herb medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo zel vrbovca, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
The HMPC concluded that, on the basis of its long-standing use, willow herb can be used by patients with benign prostatic hyperplasia (BPH) for the relief of lower urinary tract symptoms such as difficulty starting urination or a frequent need to urinate.
Odbor HMPC je na podlagi dolgotrajne uporabe zaključil, da lahko zel vrbovca uporabljajo bolniki z benigno hiperplazijo prostate (BHP) za lajšanje simptomov v spodnjih sečilih, kot sta težaven začetek uriniranja in pogosto uriniranje.
Herbal medicines containing willow herb are usually available as herbal tea to be drunk.
Zdravila rastlinskega izvora, ki vsebujejo zel vrbovca, so navadno na voljo kot zdravilni čaj, ki se popije.
The HMPC conclusions on the use of willow herb medicines for the relief of lower urinary tract symptoms related to BPH are based on their ‘traditional use' in this condition.
Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo zel vrbovca, za lajšanje simptomov v spodnjih sečilih, povezanih z BHP, temeljijo na njihovi „tradicionalni uporabi“ pri tej bolezni.
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of willow herb.
To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo zeli vrbovca.
Willow herb is the common name for the aerial parts of the plant Epilobium angustifolium L. and/or Epilobium parviflorum Schreb., collected before or during flowering time.
Zel vrbovca je splošno ime za nadzemne dele rastline Epilobium angustifolium L. in/ali Epilobium parviflorum Schreb., ki se nabirajo pred ali med cvetenjem.
Willow herb may be taken long term.
Zel vrbovca se lahko uporablja dolgotrajno.
Willow herb can also be found in combination with other herbal substances in some herbal medicines.
Zel vrbovca je v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing willow herb.
Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo zel vrbovca.
Any applications for the licensing of medicines containing willow herb have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo zel vrbovca, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
What is willow herb?
Kaj je zel vrbovca?
How are willow herb medicines approved in the EU?
Kako so zdravila, ki vsebujejo zel vrbovca, odobrena v EU?
Further information on the HMPC assessment of willow herb medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Dodatne informacije o oceni zdravil, ki vsebujejo zel vrbovca, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
Information on the use and licensing of willow herb medicines in EU Member States should be obtained from the relevant national authorities.
Za informacije o uporabi in registraciji zdravil, ki vsebujejo zel vrbovca, v državah članicah EU se obrnite na pristojni nacionalni organ.
Willow herb
Zel vrbovca
Detailed instructions on how to take willow herb medicines and who can use them can be found in the package leaflet that comes with the medicine.
Podrobna navodila o jemanju zdravil, ki vsebujejo zel vrbovca, in o tem, kdo sme ta zdravila jemati, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
Other information about willow herb medicines
Druge informacije o zdravilih, ki vsebujejo zel vrbovca
What evidence supports the use of willow herb medicines?
Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo zel vrbovca?
For more information about treatment with willow herb medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravili, ki vsebujejo zel vrbovca, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
What are the risks associated with willow herb medicines?
Kakšna tveganja so povezana z zdravili, ki vsebujejo zel vrbovca?
For practical information about using willow herb medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
14 July 2017 EMA/463868/2017
14. julij 2017 EMA/463868/2017
More information can be found here.
Dodatne informacije so na voljo tukaj.
The review of Zinbryta has been initiated at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Pregled zdravila Zinbryta se je začel na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
• If an adequate therapeutic response has not been achieved, discontinuation of therapy should be considered.
• Če ni bil dosežen ustrezen terapevtski odziv, je treba razmisliti o prekinitvi zdravljenja.
These were forwarded to the European Commission (EC), which on 14 July 2017 issued a provisional legally binding decision applicable in all EU Members States.
Priporočila so bila predložena Evropski komisiji, ki je 14. julija 2017 izdala začasno pravno zavezujočo odločbo, ki velja za vse države članice EU.
• Patients should be informed about the potential risk of serious liver problems and how to recognise them.
• Bolnike je treba seznaniti z morebitnim tveganjem za resne težave z jetri in kako jih prepoznati.
The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
Končna faza postopka pregleda je pravno zavezujoča odločba, ki jo sprejme Evropska komisija in je veljavna v vseh državah članicah EU.
Healthcare professionals have been informed in writing about the provisional measures to be followed by doctors.
Zdravstveni delavci so bili pisno obveščeni o začasnih ukrepih, ki jih morajo izvajati zdravniki.
As a precaution, changes have been made to the way the medicine is used while this review is ongoing:
Kot previdnostni ukrep so bile uvedene spremembe v načinu uporabe zdravila v času, ko pregled poteka:
If you are being given Zinbryta and have any questions or concerns, speak to your doctor or pharmacist.
Če prejemate zdravilo Zinbryta in imate kakršna koli vprašanja ali pomisleke, se pogovorite z zdravnikom ali farmacevtom.
During the review, the PRAC made a set of provisional recommendations to protect public health.
Medtem ko pregled poteka, je odbor PRAC pripravil vrsto začasnih priporočil za zaščito javnega zdravja.
Once the review is concluded, EMA will communicate further and provide updated guidance to patients and healthcare professionals.
Po koncu pregleda bo agencija EMA sporočila še več informacij ter bolnikom in zdravstvenim delavcem posredovala posodobljena navodila.
• Patients who already have liver injury will not be treated with this medicine.
• Bolniki, ki že imajo poškodbe jeter, se s tem zdravilom ne bodo zdravili.
Once the PRAC review is concluded, any further recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for evaluating medicines for human use, which will adopt a final opinion.
Ko bo odbor PRAC zaključil pregled, bodo vsa nadaljnja priporočila posredovana Odboru za zdravila za uporabo v humani medicini (CHMP), odgovornemu za ovrednotenje zdravil za uporabo v humani medicini, ki bo sprejel končno mnenje.
The risk of liver damage with the medicine was already known at time of its approval in the EU, and several measures were in place to manage this risk, including the requirement to monitor liver function and provide educational materials to healthcare professionals and patients on the risk of liver damage.
Tveganje za poškodbe jeter zaradi zdravila je bilo v času njegove odobritve v EU že znano, in za obvladovanje tega tveganja je bilo uvedenih že več ukrepov, vključno z zahtevo po spremljanju delovanja jeter in posredovanju izobraževalnega gradiva zdravstvenim delavcem in bolnikom glede tveganja za poškodbe jeter.
• If you are already being treated with this medicine, your doctor will check whether you should continue or switch to an alternative treatment.
• Če se že zdravite s tem zdravilom, bo vaš zdravnik preveril, ali se boste še naprej zdravili z njim ali pa boste zdravilo zamenjali.
The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines.
Pregled opravlja Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC), ki je odgovoren za presojo varnostnih vprašanj o zdravilih za uporabo v humani medicini.
• While on treatment with this medicine, you should contact your doctor immediately if you develop any symptoms of liver problems, such as unexplained nausea (feeling sick), vomiting, abdominal pain, tiredness, loss of appetite, yellowing of the skin and eyes and dark urine.
• Med zdravljenjem s tem zdravilom se takoj obrnite na zdravnika, če se pojavijo simptomi težav z jetri, kot so nepojasnjena slabost (siljenje na bruhanje), bruhanje, bolečine v trebuhu, utrujenost, izguba apetita, rumeno obarvanje kože in oči ter temen urin.
Serum transaminase and bilirubin levels should be monitored at least monthly, and more frequently if clinically indicated, during treatment and for up to 4 months after the last dose.
Koncentracije serumskih transaminaz in bilirubina je treba spremljati vsaj enkrat mesečno oziroma pogosteje, če je klinično indicirano, in sicer med zdravljenjem in še do štiri mesece po zadnjem odmerku.
• Further information will also be provided once the review is concluded.
• Po zaključku pregleda bodo na voljo dodatne informacije.
• You should not stop treatment before speaking to your doctor.
• Zdravila ne prenehajte jemati, dokler se ne posvetujete z zdravnikom.
This medicine was authorised in the EU in July 2016 to treat adults with relapsing forms of multiple sclerosis (a disease in which inflammation damages the protective sheath around the nerve cells in the brain and spinal cord).
To zdravilo je bilo v EU odobreno julija 2016 za zdravljenje odraslih z recidivno obliko multiple skleroze (bolezni, pri kateri vnetje poškoduje zaščitno ovojnico okrog živčnih celic v možganih in hrbtenjači).
Relapsing means that the patient has flare-ups of the symptoms.
Recidivna pomeni, da imajo bolniki ponovne izbruhe simptomov.
• Prior to treatment initiation, ALT, AST and bilirubin levels should be measured.
• Pred uvedbo zdravljenja je treba izmeriti koncentracije ALT, AST in bilirubina.
• Healthcare professionals should review promptly any patients who are currently taking Zinbryta to assess whether this medicine continues to be appropriate for them.
• Zdravstveni delavci morajo takoj pregledati vse bolnike, ki trenutno jemljejo zdravilo Zinbryta, in oceniti, ali je zdravilo še naprej primerno zanje.
In case of signs and symptoms suggestive of hepatic injury, the patient should be promptly referred to a hepatologist.
Če se pojavijo znaki in simptomi, ki kažejo na poškodbe jeter, je treba bolnika nemudoma napotiti k hepatologu.
Restrictions are provisional measures while review of liver safety is ongoing
Omejitve so začasni ukrepi v času, ko poteka pregled varnosti za jetra.
If you have signs of liver injury, your doctor will refer you to a liver specialist.
Če imate znake poškodb jeter, vas bo zdravnik napotil k specialistu za bolezni jeter.
These provisional measures have been taken, as a precaution, to ensure that Zinbryta continues to be used as safely as possible while a review of its liver safety is ongoing.
Ti začasni ukrepi so bili sprejeti kot previdnostni ukrep, in sicer za zagotovitev, da se zdravilo Zinbryta v času pregleda varnosti za jetra še naprej uporablja čim varneje.
• Once the review of Zinbryta is concluded, further information will be provided.
• Po zaključenem pregledu zdravila Zinbryta bodo na voljo dodatne informacije.
The safety of the multiple sclerosis medicine Zinbryta is being reviewed.
Varnost zdravila za multiplo sklerozo Zinbryta se pregleduje.
• Your doctor will test your liver function at least monthly, and check for signs and symptoms of liver injury.
• Zdravnik bo vsaj enkrat mesečno preverjal delovanje vaših jeter ter vas pregledal glede znakov in simptomov poškodb jeter.
• In addition, the medicine has been contraindicated in patients with pre-existing hepatic disease or hepatic impairment.
• Poleg tega je bila uvedena kontraindikacija pri bolnikih z obstoječo jetrno boleznijo ali jetrno okvaro.
EMA restricts use of multiple sclerosis medicine Zinbryta
Agencija EMA omejuje uporabo zdravila za multiplo sklerozo Zinbryta
• Further details on these provisional measures have been provided in writing to healthcare professionals and the product information has been updated accordingly.
• Zdravstveni delavci so v pisni obliki prejeli več podrobnosti o začasnih ukrepih, v skladu s tem pa so bile posodobljene tudi informacije o zdravilu.
• Cases of liver injury with Zinbryta have occurred early after treatment initiation, following repeated treatment courses and several months after discontinuation.
• Primeri poškodb jeter med zdravljenjem z zdravilom Zinbryta so se pojavili kmalu po začetku zdravljenja, po večkratnih ciklih zdravljenja in več mesecev po prenehanju.
Doctors should continue to monitor the liver function of patients receiving the medicine and closely watch patients for signs and symptoms of liver injury.
Zdravniki morajo pri bolnikih, ki prejemajo zdravilo, še naprej spremljati delovanje jeter ter jih skrbno opazovati glede znakov in simptomov poškodb jeter.
In addition, patients with liver injury must not be given the medicine.
Poleg tega se zdravilo ne sme dajati bolnikom s poškodbami jeter.
Zinbryta is a medicine used to treat adults with relapsing forms of multiple sclerosis.
Zdravilo Zinbryta se uporablja za zdravljenje odraslih z recidivno obliko multiple skleroze.
• Treatment initiation is not recommended in patients with concurrent autoimmune conditions other than multiple sclerosis and in patients with serum transaminases (ALT or AST) that are at least twice the upper limit of normal (≥ 2 times the ULN).
• Uvedba zdravljenja ni priporočljiva pri bolnikih, ki imajo poleg multiple skleroze še druga sočasna avtoimunska stanja, in pri bolnikih z vrednostmi serumskih transaminaz (ALT ali AST), ki so vsaj dvakratnik zgornje meje normalne vrednosti (≥ 2-krat ULN).
The review of Zinbryta started after the death from liver injury (fulminant liver failure) of a patient involved in an ongoing observational study, as well as four cases of serious liver injury.
Pregled zdravila Zinbryta se je začel po smrti zaradi poškodb jeter (fulminantne jetrne odpovedi) pri bolniku, vključenem v potekajočo opazovalno študijo, in po štirih primerih resnih poškodb jeter.
• All patients on Zinbryta should also be monitored for signs and symptoms of hepatic injury during treatment.
• Vse bolnike, ki se zdravijo z zdravilom Zinbryta, je treba med zdravljenjem spremljati glede znakov in simptomov poškodb jeter.
• The ongoing safety review was triggered following the death from fulminant liver failure of a patient who was treated with Zinbryta in an ongoing observational study, as well as four cases of serious liver injury.
• Potekajoči pregled varnosti je bil sprožen po smrti zaradi fulminantne jetrne odpovedi pri bolniku, ki se je zdravil z zdravilom Zinbryta v potekajoči opazovalni študiji, in po štirih primerih resnih poškodb jeter.
• As a precaution and while the review is ongoing, Zinbryta's use has been restricted to adult patients with highly active relapsing disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) or with rapidly evolving severe relapsing multiple sclerosis who are unsuitable for treatment with other DMTs.
• Kot previdnostni ukrep v času, ko pregled poteka, je bila uporaba zdravila Zinbryta omejena na odrasle bolnike z visoko aktivno recidivno multiplo sklerozo, ki je prisotna kljub celovitemu in primernemu zdravljenju z vsaj enim zdravilom, ki spreminja potek bolezni (DMT), in na odrasle bolnike s hitro napredujočo hudo recidivno multiplo sklerozo, ki niso primerni za zdravljenje z drugimi zdravili DMT.
Starting treatment with Zinbryta is not recommended for patients with autoimmune diseases other than multiple sclerosis and caution should be used when giving Zinbryta together with medicines that can damage the liver.
Uvedba zdravljenja z zdravilom Zinbryta ni priporočena pri bolnikih, ki imajo poleg multiple skleroze še druge avtoimunske bolezni, pri dajanju zdravila Zinbryta skupaj z zdravili, ki lahko poškodujejo jetra, pa je potrebna previdnost.
• Zinbryta treatment is not recommended in multiple sclerosis patients who have autoimmune diseases other than multiple sclerosis.
• Zdravljenje z zdravilom Zinbryta ni priporočeno pri bolnikih, ki imajo poleg multiple skleroze še druge avtoimunske bolezni.
The European Medicines Agency (EMA) has provisionally restricted the use of the multiple sclerosis medicine Zinbryta (daclizumab) to patients with highly active relapsing disease that has failed to respond to certain other treatment, and to patients with rapidly evolving relapsing disease who cannot be treated with other medicines.
Evropska agencija za zdravila (EMA) je začasno omejila uporabo zdravila za multiplo sklerozo Zinbryta (daklizumab) na bolnike z visoko aktivno recidivno boleznijo, ki se ni odzvala na določena druga zdravila, in na bolnike s hitro napredujočo recidivno boleznijo, ki se ne morejo zdraviti z drugimi zdravili.