natgillin/translations-raw huggingface dataset:
What is the risk associated with Duloxetine Boehringer Ingelheim?
Kakšna tveganja so povezana z zdravilom Duloxetine Boehringer Ingelheim?
The full EPAR for Duloxetine Boehringer Ingelheim is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Duloxetine Boehringer Ingelheim je na voljo tukaj.
Why has Duloxetine Boehringer Ingelheim been approved?
Zakaj je bilo zdravilo Duloxetine Boehringer Ingelheim odobreno?
Some patients may benefit from starting treatment at a dose of 20 mg twice a day for two weeks before increasing to 40 mg twice a day, to reduce nausea (feeling sick) and dizziness.
Pri bolnicah s stresno urinsko inkontinenco znaša priporočeni odmerek zdravila Duloxetine Boehringer Ingelheim 40 mg dvakrat na dan. Za zmanjšanje slabosti in omotice lahko nekaterim bolnicam koristi začetno zdravljenje z odmerkom 20 mg dvakrat na dan v trajanju dveh tednov, čemur sledi zvišanje odmerka na 40 mg dvakrat na dan.
Duloxetine Boehringer Ingelheim should be used with caution in elderly patients.
Pri starejših bolnikih je zdravilo Duloxetine Boehringer Ingelheim treba uporabljati previdno.
What is Duloxetine Boehringer Ingelheim?
Kaj je zdravilo Duloxetine Boehringer Ingelheim?
How has Duloxetine Boehringer Ingelheim been studied?
Kako je bilo zdravilo Duloxetine Boehringer Ingelheim raziskano?
What is Duloxetine Boehringer Ingelheim used for?
Za kaj se zdravilo Duloxetine Boehringer Ingelheim uporablja?
Combining Duloxetine Boehringer Ingelheim with pelvic floor muscle training may provide additional benefit.
Dodatne koristi prinese kombiniranje jemanja zdravila Duloxetine Boehringer Ingelheim s programom treninga mišic medeničnega dna.
How is Duloxetine Boehringer Ingelheim used?
Kako se zdravilo Duloxetine Boehringer Ingelheim uporablja?
How does Duloxetine Boehringer Ingelheim work?
Kako zdravilo Duloxetine Boehringer Ingelheim deluje?
Saw palmetto fruit should only be used in male adults and the elderly.
Plod palmeta se sme uporabljati samo pri odraslih in starejših moških.
Although a possible effect in relief of lower urinary tract symptoms related to BHP was observed, there were shortcomings in the studies such as too few patients and too short a treatment period.
Čeprav je bil zaznan možen učinek pri lajšanju simptomov v spodnjih sečilih, povezanih z BHP, je bilo pri študijah nekaj pomanjkljivosti, na primer premalo bolnikov in prekratko obdobje zdravljenja.
Saw palmetto fruit is the common name for the fruit of the plant Serenoa repens (W. Bartram) Small.
Plod palmeta je splošno ime za plod rastline Serenoa repens (W. Bartram) Small.
This summary is not intended to provide practical advice on how to use medicines containing saw palmetto fruit.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo plod palmeta.
If symptoms persist during the use of the medicine, a doctor or a qualified healthcare practitioner should be consulted.
Če simptomi med uporabo zdravila ne popustijo, se je treba posvetovati z zdravnikom ali usposobljenim zdravstvenim delavcem.
Herbal medicines containing saw palmetto fruit are usually available in solid forms to be taken by mouth.
Zdravila rastlinskega izvora, ki vsebujejo plod palmeta, so navadno na voljo v trdni obliki za jemanje skozi usta.
The way saw palmetto fruit acts is not fully known, but from laboratory studies it is thought to work by reducing the action of male sex hormones such as testosterone, which play a role in causing enlargement of the prostate gland in BPH; and it may also have anti-inflammatory effects.
Način delovanja plodu palmeta ni v celoti znan, vendar laboratorijske študije kažejo, da bi lahko zmanjševal delovanje moških spolnih hormonov, kot je testosteron, ki so vključeni v povečevanje žleze prostate pri BHP, morda pa ima tudi protivnetni učinek.
In its assessment, the HMPC also considered clinical studies with saw palmetto fruit ethanol extract.
V svoji oceni je odbor HMPC prav tako upošteval klinične študije z etanolnim ekstraktom plodu palmeta.
Further information on the risks associated with saw palmetto fruit 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 plod palmeta, 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.
How does saw palmetto fruit work as a medicine?
Kako plod palmeta deluje kot zdravilo?
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of saw palmetto fruit.
To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo plodu palmeta.
In its assessment, the HMPC considered a number of clinical studies with saw palmetto fruit hexane extract some of which showed that it is as effective as finasteride and tamsulosin (other medicines approved to treat BPH) at treating BPH symptoms for periods up to 1 year.
V svoji oceni je odbor HMPC upošteval več kliničnih študij s heksanskim ekstraktom plodu palmeta, od katerih so nekatere pokazale, da je pri zdravljenju simptomov BHP v obdobju do enega leta enako učinkovit kot finasterid in tamsulozin (drugi zdravili, odobreni za zdravljenje BHP).
Information on the use and licensing of saw palmetto fruit medicines in EU Member States should be obtained from the relevant national authorities.
Za informacije o uporabi in registraciji zdravil, ki vsebujejo plod palmeta, v državah članicah EU se obrnite na pristojni nacionalni organ.
Any applications for the licensing of medicines containing saw palmetto fruit 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 plod palmeta, 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.
Further information on the HMPC assessment of saw palmetto fruit 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 plod palmeta, 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.
The HMPC also concluded that, on the basis of its long-standing use, saw palmetto fruit (extracted with ethanol) can be used for the relief of lower urinary tract symptoms (such as difficulty starting urination or a frequent need to urinate) related to BPH, after serious conditions have been excluded by a doctor.
Odbor HMPC je na podlagi dolgotrajne uporabe prav tako zaključil, da se plod palmeta (ekstrahiran z etanolom) lahko uporablja za lajšanje simptomov v spodnjih sečilih (kot so težaven začetek uriniranja in pogosto uriniranje), povezanih z BHP, potem ko zdravnik izključi hujše bolezni.
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing saw palmetto fruit.
Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenj za promet z zdravili rastlinskega izvora, ki vsebujejo plod palmeta.
Saw palmetto fruit
Plod palmeta
How are saw palmetto fruit medicines approved in the EU?
Kako so zdravila, ki vsebujejo plod palmeta, odobrena v EU?
The HMPC concluded that saw palmetto fruit (extracted with hexane) can be used to treat the symptoms of benign prostatic hyperplasia (BPH).
Odbor HMPC je zaključil, da se plod palmeta (ekstrahiran s heksanom) lahko uporablja za zdravljenje simptomov benigne hiperplazije prostate (BHP).
Common side effects (seen between 1 and 10 patients in 100) reported with saw palmetto fruit are abdominal (belly) pain and headache.
Pri uporabi plodu palmeta so poročali o pogostih neželenih učinkih (opaženih pri 1 do 10 bolnikih od 100), in sicer o trebušnih bolečinah in glavobolu.
Other information about saw palmetto fruit medicines
Druge informacije o zdravilih, ki vsebujejo plod palmeta
What evidence supports the use of saw palmetto fruit medicines?
Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo plod palmeta?
For more information about treatment with saw palmetto fruit 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 plod palmeta, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
What is saw palmetto fruit?
Kaj je plod palmeta?
What are the risks associated with saw palmetto fruit medicines?
Kakšna tveganja so povezana z zdravili, ki vsebujejo plod palmeta?
Saw palmetto fruit preparations may be obtained by using a technique to extract compounds from plant material by dissolving them in a solvent (hexane or ethanol), which is then partially evaporated to obtain a soft extract.
Pripravki s plodom palmeta se pridobivajo z uporabo tehnike, s katero se spojine ekstrahirajo tako, da se svež rastlinski material najprej namoči v topilo (heksan ali etanol), v katerem se raztopijo spojine.
The HMPC conclusions on the use of ethanol-extracted saw palmetto fruit 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 z etanolom ekstrahiran plod palmeta, za lajšanje simptomov v spodnjih sečilih, povezanih z BHP, temeljijo na njihovi „tradicionalni uporabi“ pri tej bolezni.
Therefore, the HMPC conclusions on the use of saw palmetto medicines are based on their long-standing use.
Zaključki odbora HMPC v zvezi z uporabo zdravil, ki vsebujejo plod palmeta, zato temeljijo na njihovi dolgotrajni uporabi.
The HMPC conclusions on the use of hexane-extracted saw palmetto fruit medicines for the symptomatic treatment of BPH are based on their ‘well-established use' in this condition.
Zaključki odbora HMPC v zvezi z uporabo zdravil, ki vsebujejo s heksanom ekstrahiran plod palmeta, za simptomatsko zdravljenje BHP temeljijo na njihovi „dobro uveljavljeni medicinski uporabi“ pri tej bolezni.
For practical information about using saw palmetto fruit 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.
23 January 2015
23. januar 2015
The withdrawal letter is available here.
Dopisu o umiku je na voljo tukaj.
Teysuno has been authorised in the EU since March 2011.
Zdravilo Teysuno je v EU odobreno od marca 2011.
The full European Public Assessment Report for Teysuno 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 Teysuno je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
As a result, it prevents the growth of cancer cells and eventually kills them.
Posledično preprečuje rast rakavih celih in jih nazadnje uniči.
On 6 January 2015, Nordic Group BV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the indication for Teysuno.
Družba Nordic Group BV je 6. januarja 2015 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za spremembo indikacije zdravila Teysuno.
5-FU is similar to pyrimidine, a substance found in the genetic material of cells (DNA and RNA).
5-FU je podoben pirimidinu, tj. snovi, ki se nahaja v genskem materialu celic (DNK in RNK).
Tegafur is a ‘prodrug' that is converted in the body to another medicine called 5-fluorouracil (5-FU).
Zdravilo Tegafur je „predzdravilo“, ki se v telesu pretvori v drugo zdravilo, imenovano 5-fluorouracil (5-FU).
The two other active substances in Teysuno allow tegafur to be effective at lower doses and with fewer side effects: gimeracil by preventing the breakdown of 5-FU, and oteracil by reducing the activity of 5FU in normal, non-cancerous tissue in the gut.
Drugi dve zdravilni učinkovini zdravila Teysuno zagotavljata učinkovitost tegafurja pri manjših odmerkih in z manj neželenimi učinki: gimeracil preprečuje razgradnjo 5-FU, oteracil pa zmanjšuje delovanje 5-FU v normalnem, nerakavem tkivu v črevesju.
There are no consequences on the use of Teysuno in its authorised indication.
Umik nima nobenih posledic za uporabo zdravila Teysuno pri njegovi odobreni indikaciji.
The company informed the CHMP that there are no consequences for patients in clinical trials or compassionate use programmes.
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe.
It is used in combination with cisplatin (a platinum-based cancer medicine).
Uporablja se v kombinaciji s cisplatinom (zdravilom proti raku na osnovi platine).
Teysuno contains the active substances tegafur, gimeracil and oteracil.
Zdravilo Teysuno vsebuje zdravilne učinkovine tegafur, gimeracil in oteracil.
The main active substance in Teysuno, tegafur, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the ‘anti-metabolites' group.
Glavna zdravilna učinkovina zdravila Teysuno, tegafur, je citotoksik (zdravilo, ki uničuje celice, ki se delijo, kot na primer rakave celice) iz skupine antimetabolitov.
The company presented data from two studies involving a total of 43 patients with advanced gastric cancer or other tumours, in which Teysuno was used in combination with oxaliplatin and other cancer medicines.
Družba je predložila podatke iz dveh študij, v katerih je sodelovalo skupno 43 bolnikov z napredovalim rakom želodca ali drugimi tumorji, ki so prejemali zdravilo Teysuno v kombinaciji z oksaliplatinom in drugimi zdravili proti raku.
What was Teysuno expected to be used for?
Za kaj naj bi se zdravilo Teysuno uporabljalo?
Data from published studies on the use of Teysuno in combination with platinum-based medicines were also provided.
Zagotovila je tudi podatke iz objavljenih študij o uporabi zdravila Teysuno v kombinaciji z zdravili na osnovi platine.
In particular very limited data were provided on the combination of Teysuno with oxaliplatin and no data were provided on the use with carboplatin.
O kombinaciji zdravila Teysuno in oksaliplatina so bili predloženi zelo omejeni podatki, o uporabi zdravila Teysuno skupaj s karboplatinom pa niso bili predloženi nobeni podatki.
How is Teysuno expected to work?
Kako naj bi zdravilo Teysuno delovalo?
Teysuno is a cancer medicine that is used to treat adults with advanced gastric (stomach) cancer.
Zdravilo Teysuno je zdravilo proti raku, ki se uporablja za zdravljenje odraslih z napredovalim rakom želodca.
In its letter notifying the Agency of the withdrawal of the application, the company stated that it withdrew the application because, in its preliminary assessment report, the CHMP considered that the data provided were insufficient to conclude that the benefits outweigh the risks when Teysuno is used in combination with other platinum-based cancer medicines.
Družba je v dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da vlogo umika, ker je CHMP v svojem predhodnem poročilu o oceni zdravila menil, da predloženi podatki ne zadostujejo za zaključek, da so koristi uporabe zdravila Teysuno v kombinaciji z drugimi zdravili proti raku na osnovi platine večje od z njo povezanih tveganj.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Teysuno could not have been approved for the treatment of advanced gastric cancer in combination with platinumbased medicines other than cisplatin.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP, je Odbor v času umika izrazil določene zadržke in je začasno menil, da zdravila Teysuno ni mogoče odobriti za zdravljenje napredovalega raka želodca v kombinaciji z zdravili na osnovi platine, ki ne vključujejo cisplatina.
Teysuno was also expected to be used in combination with platinum-based cancer medicines other than cisplatin, such as oxaliplatin.
Zdravilo Teysuno naj bi se uporabljalo tudi v kombinaciji z drugimi zdravili proti raku na osnovi platine, kot je oksaliplatin, in ne le s cisplatinom.
What is happening with Teysuno for the treatment of patients with advanced gastric cancer in combination with cisplatin?
Kakšne so posledice za zdravilo Teysuno, indicirano za zdravljenje bolnikov z napredovalim rakom želodca v kombinaciji s cisplatinom?
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the data provided were too scarce to allow adequate evaluation of the benefits and risks of Teysuno in combination with platinumbased medicines other than cisplatin in patients with advanced gastric cancer.
Zato je CHMP v času umika menil, da so bili predloženi podatki preveč omejeni, da bi omogočali ustrezno oceno koristi in tveganj uporabe zdravila Teysuno v kombinaciji z zdravili na osnovi platine, ki ne vključujejo cisplatina, pri bolnikih z napredovalim rakom želodca.
The change concerned extending the use of Teysuno to treat advanced gastric cancer in combination with platinum-based cancer medicines other than cisplatin.
Sprememba je zadevala razširitev uporabe zdravila Teysuno na zdravljenje napredovalega raka želodca v kombinaciji z zdravili proti raku na osnovi platine, ki ne vključujejo cisplatina.
The data provided were too limited to allow a benefit-risk evaluation of Teysuno in combination with other platinum-based medicines in patients with advanced gastric cancer.
Predloženi podatki so bili preveč omejeni, da bi omogočali oceno razmerja med koristmi in tveganji uporabe zdravila Teysuno v kombinaciji z drugimi zdravili na osnovi platine pri bolnikih z napredovalim rakom želodca.
Send a question via our website www.ema.europa.eu/contact the place of pyrimidine and interferes with the enzymes involved in making new DNA.
5-FU v telesu zavzame mesto pirimidina in ovira encime, vključene v tvorjenju nove DNK.
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Prior to the lifting of the suspension of the marketing authorisations, the national competent authorities, coordinated by the reference Member State, shall ensure that the following conditions are fulfilled by the marketing authorisation holder:
Pred preklicem začasnega umika dovoljenj za promet z zdravilom bodo nacionalni pristojni organi, ki jih usklajuje referenčna država članica, zagotovili, da imetnik dovoljenja za promet z zdravilom izpolni naslednji pogoj:
The marketing authorisation holder demonstrates bioequivalence in the fed state, in compliance with the guidance on the investigation of bioequivalence in place at the time of lifting the suspension.
Imetnik dovoljenja za promet z zdravilom mora ob preklicu začasnega umika dokazati biološko enakovrednost pri jemanju zdravila s hrano v skladu s smernicami za proučevanje biološke enakovrednosti.
Conditions for the lifting of the marketing authorisations suspension
Pogoji za preklic začasnega umika dovoljenj za promet z zdravilom
Long term effects are not yet known.
Dolgoročni učinki še niso znani.
Long term safety
Dolgoročna varnost
Peri- and postnatal development has not been studied.
Peri- in postnatalnega razvoja niso proučevali.
5550 Airport Boulevard Boulder, Colorado 80301 United States of America
5550 Airport Boulevard Boulder, Colorado 80301 ZDA
Not known (frequency cannot be estimated from available data):
Neznana (pogostosti iz razpoložljivih podatkov ni mogoče oceniti):
It is important to tell your doctor if you: - are pregnant; - think you may be pregnant; or - plan to have a baby.
Zdravniku morate povedati, če: - ste noseči, - mislite, da ste morda noseči, ali
For information on preparation and administration of Kepivance, please see information for healthcare professionals at the end of this leaflet.
Za informacije o pripravi in dajanju zdravila Kepivance glejte informacije za zdravstveno osebje na koncu teh navodil.
The long-term safety of Kepivance has not been fully evaluated with respect to overall survival, progression free survival and secondary malignancies.
Dolgoročna varnost zdravila Kepivance ni povsem ugotovljena, kar zadeva celotno preživetje, preživetje brez napredovanja in sekundarne malignome.
These events were consistent with those observed at the recommended dose but were generally more severe.
Ti dogodki so se skladali z dogodki, zabeleženimi ob priporočenih odmerkih, a so bili na splošno hujši.
Safety and efficacy has not been evaluated in older people.
Varnost in učinkovitost pri starejših osebah nista bili ovrednoteni.
Palifermin (60 micrograms/kg/day) n = 106
Palifermin (60 mikrogramov/kg/dan) n = 106
Generally, dissolution of Kepivance takes less than 5 minutes.
Praviloma traja raztapljanje zdravila Kepivance manj kot 5 minut.
Systemic exposure did not appear to increase with the dose.
Prav tako ni bilo videti, da bi se sistemska izpostavljenost povečevala z odmerkom.
Adverse reactions from clinical trials and spontaneous reporting
Neželeni učinki iz kliničnih preskušanj in spontanega poročanja
Once reconstituted, store in a refrigerator and use within 24 hours.
Ko je zdravilo pripravljeno, ga shranjujte v hladilniku in porabite v 24 urah.
Kepivance should only be used in adults over the age of 18 years.
Zdravilo Kepivance smejo dobivati le odrasli, starejši od 18 let.
Each pack contains 6 vials.
Eno pakiranje vsebuje 6 vial.
Please inform your doctor if you are receiving or have recently received heparin.
Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali heparin.
These reactions were primarily mild to moderate in severity and were reversible.
Učinki so bili predvsem blagi do zmerni in so bili reverzibilni.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Pred uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi to Kepivance neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Date of latest renewal: 23 September 2010
Datum prve odobritve: 25. oktober 2005 Datum zadnjega podaljšanja: 23. september 2010
The safety and efficacy of Kepivance in children aged 0 to 18 years have not been established.
Varnost in učinkovitost zdravila Kepivance pri otrocih, starih od 0 do 18 let, še nista bili dokazani.
Although palifermin was safe at all doses tested the incidence of skin reactions increased with the dose.
Čeprav je bil palifermin varen pri vseh testiranih odmerkih, je incidenca kožnih reakcij naraščala z odmerkom.
In the absence of compatibility studies, this medicinal product must not be mixed with other
Zaradi pomanjkanja študij o kompatibilnosti zdravila ne smete mešati z drugimi zdravili.
What Kepivance is and what it is used for
Kaj je zdravilo Kepivance in za kaj ga uporabljamo
If you are pregnant you should not use Kepivance unless clearly necessary.
Če ste noseči, zdravila Kepivance ne uporabljajte, razen če je to nujno potrebno.
Lack of efficacy and risk of infection with high dose melphalan conditioning regimen
Pomanjkanje učinkovitosti in tveganje za okužbo ob pripravljalnem režimu z visokimi odmerki melfalana