natgillin/translations-raw huggingface dataset:
This is a procedure where one Member State (the ‘reference Member State', in this instance the UK) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Luxembourg, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia and Sweden).
To je postopek, v katerem ena država članica („referenčna država članica“, v tem primeru Združeno kraljestvo) oceni zdravilo zato, da se izda dovoljenje za promet, ki bo veljalo v tej državi in drugih državah članicah („zadevne države članice“, v tem primeru Avstrija, Belgija, Bolgarija, Ciper, Češka, Danska, Finska, Francija, Nemčija, Islandija, Irska, Italija, Luksemburg, Nizozemska, Norveška, Poljska, Portugalska, Romunija, Slovaška in Švedska).
The CHMP looked at all the available evidence on the benefits and risks of the medicine in the treatment of asthma and concluded that the questions raised over its long-term effectiveness had been adequately addressed.
Odbor CHMP je pregledal vse razpoložljive dokaze o koristih in tveganjih pri uporabi zdravila za zdravljenje astme ter ugotovil, da so bila vprašanja o njegovi dolgoročni učinkovitosti ustrezno obravnavana.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Flutiform and Iffeza outweigh the risks, and that the marketing authorisation can be granted in the United Kingdom and in the following Member States of the EU: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Luxembourg, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia and Sweden.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je ugotovil, da koristi zdravil Flutiform in Iffeza odtehtajo z njima povezana tveganja ter da se dovoljenje za promet lahko odobri v Združenem kraljestvu in naslednjih državah članicah EU: v Avstriji, Belgiji, Bolgariji, na Cipru, Češkem, Danskem, Finskem, v Franciji, Nemčiji, na Islandiji, v Irski, Italiji, Luksemburgu, na Nizozemskem, Norveškem, Poljskem, Portugalskem, v Romuniji, Slovaški in Švedski.
Why were Flutiform and Iffeza reviewed?
Zakaj sta bili zdravili Flutiform in Iffeza pregledani?
The grounds for the referral were concerns raised by The Netherlands over data showing that the levels of fluticasone propionate in the blood following dosing with Flutiform and Iffeza are lower than when fluticasone propionate is given alone, which may indicate a lower amount of fluticasone propionate being deposited in the lungs.
Razlogi za napotitev so bili zadržki, ki jih je izrazila Nizozemska nad podatki, ki kažejo, da so ravni flutikazon propionata v krvi po odmerjanju zdravil Flutiform in Iffeza nižje, kot če se flutikazon daje samostojno, kar je lahko znak, da se v pljuča odlaga manjša količina flutikazon propionata.
Napp Pharmaceuticals Ltd submitted marketing authorisation applications for Flutiform and Iffeza and associated names to the UK medicines regulatory agency under the decentralised procedure.
Družba Napp Pharmaceuticals Ltd je predložila vlogi za pridobitev dovoljenj za promet z zdraviloma Flutiform in Iffeza ter povezanimi imeni regulatorni agenciji za zdravila v Združenem kraljestvu po decentraliziranem postopku.
Flutiform will also be marketed as Flofera and Flutiformo.
Zdravilo Flutiform se bo tržilo tudi s tržnima imenoma Flofera in Flutiformo.
Therefore, the Committee concluded that the benefits of Flutiform and Iffeza outweigh the risks and that marketing authorisation should be granted in all concerned Member States.
Zato je sklenil, da koristi zdravil Flutiform in Iffeza odtehtajo tveganja in da se lahko dovoljenje za promet odobri v vseh zadevnih državah članicah.
They are to be used for the treatment of asthma in situations where the combination of an inhaled corticosteroid (such as fluticasone propionate) and a long-acting beta 2 agonist (such as formoterol fumarate) is appropriate.
Za zdravljenje astme se uporabljata v primerih, kadar je kombinacija inhalacijskega kortikosteroida (kot je flutikazon propionat) in beta-2-agonista z dolgotrajnim delovanjem (kot je formoterol fumarat) primerna.
Questions and answers on Flutiform and Iffeza (fluticasone propionate/formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension)
Vprašanja in odgovori v zvezi z zdraviloma Flutiform in Iffeza (flutikazon propionat/formoterol fumarat, 50/5, 125/5 in 250/10 mikrogramov, inhalacijska raztopina pod tlakom, suspenzija)
What are Flutiform and Iffeza?
Kaj sta zdravili Flutiform in Iffeza?
Questions and answers on Flutiform and Iffeza (fluticasone propionate/formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) EMA/550822/2012
Vprašanja in odgovori v zvezi z zdraviloma Flutiform in Iffeza (flutikazon propionat/formoterol fumarat, 50/5, 125/5 in 250/10 mikrogramov, inhalacijska raztopina pod tlakom, suspenzija) EMA/264710/2012
When inhaled, formoterol fumarate helps to keep the airways open allowing the patient to breathe more easily.
Formoterol fumarat ob inhalaciji pomaga ohranjati odprte dihalne poti in tako bolniku olajšuje dihanje.
Fluticasone propionate is an inhaled corticosteroid with high local anti-inflammatory activity and has been shown to reduce symptoms of asthma and reduce exacerbations of asthma.
Flutikazon propionat je inhalacijski kortikosteroid z močnim lokalnim protivnetnim delovanjem, ki dokazano zmanjšuje simptome in poslabšanje astme.
The selective long-acting beta 2 agonist formoterol fumarate exerts an effect on beta 2 receptors on the smooth muscle in the lung to produce relaxation of the airways and bronchodilatation.
Formoterol fumarat, ki je selektiven beta-2-agonist z dolgotrajnim učinkom, z delovanjem na receptorje beta 2 v gladkem mišičnem tkivu pljuč doseže sprostitev dihalnih poti in bronhodilatacijo.
Flutiform and Iffeza are asthma medicines containing two active substances, fluticasone propionate and formoterol fumarate.
Flutiform in Iffeza sta zdravili za zdravljenje astme, ki vsebujeta zdravilni učinkovini flutikazon propionat in formoterol fumarat.
These measures should be submitted with a risk management plan (RMP):
Te ukrepe je treba predložiti skupaj z načrtom za obvladovanje tveganja (RMP):
• the new additional risk minimisation measures.
• novi dodatni ukrepi za zmanjševanje tveganja,
The controlled access program should be effectively implemented at the latest:
Program nadzorovanega dostopa mora biti učinkovito uveden najpozneje:
• a reminder of the indication, dose, duration of treatment and contraindications and the need to comply with the product information
• opomnik o indikaciji, odmerku, trajanju zdravljenja in kontraindikacijah ter nujnosti upoštevanja informacij o zdravilu,
The final study report shall be submitted for assessment by the PRAC:
Končno poročilo o študiji je treba predložiti v oceno odboru PRAC:
Each marketing authorisation holder shall complete the below conditions, within the stated timeframe, and the competent authorities shall ensure that the following is fulfilled:
Vsak imetnik dovoljenja za promet z zdravilom izpolni spodnje pogoje v navedenem roku, pristojni organi pa zagotovijo, da je izpolnjeno naslednje:
The MAHs are strongly encouraged to collaborate to perform a joint study.
Imetnike dovoljenj za promet z zdravilom se močno spodbuja k sodelovanju in izvedbi skupne študije.
Protocol to be submitted for assessment by the PRAC:
Protokol je treba predložiti v oceno odboru PRAC:
Each MAH shall develop training materials according to the following core elements:
Vsak imetnik dovoljenja za promet z zdravilom pripravi gradiva za usposabljanje v skladu z naslednjimi ključnimi elementi:
Each MAH of HES solutions for infusion shall perform a drug utilisation study to assess the effectiveness of the risk minimisation measures implemented as an outcome of this referral procedure.
Vsak imetnik dovoljenja za promet z zdravilom za raztopine HES za infundiranje izvede študijo o uporabi zdravila in z njo oceni učinkovitost ukrepov za zmanjševanje tveganja, uvedenih kot izid tega napotitvenega postopka.
The MAH should submit and agree with the National Competent Authorities: - the details of the controlled access program and the modalities of its implementation - the final training materials, including communication media and distribution modalities.
Imetnik dovoljenja za promet z zdravilom mora pristojnim nacionalnim organom predložiti in se z njimi dogovoriti o naslednjem: - podrobnosti programa nadzorovanega dostopa in načini njegovega izvajanja, - končna različica gradiv za usposabljanje, vključno s sredstvi obveščanja in načini razdeljevanja.
• the risks related to the use of HES solutions for infusion outside the terms of the MA
• tveganja, povezana z uporabo raztopin HES za infundiranje zunaj pogojev dovoljenja za promet z zdravilom,
The MAH shall implement a controlled access program to ensure that HES solutions for infusion are only delivered to accredited hospitals / centres where healthcare professionals expected to prescribe / administer these medicinal products have been trained on their appropriate use.
Imetnik dovoljenja za promet z zdravilom uvede program nadzorovanega dostopa za zagotavljanje, da se raztopine HES za infundiranje dobavljajo samo akreditiranim bolnišnicam/centrom, v katerih so zdravstveni delavci, ki naj bi predpisovali/dajali ta zdravila, usposobljeni za njihovo pravilno uporabo.
- managing the accreditation system - ensuring HES solutions for infusion are only delivered to accredited hospital/centres, i.e where all relevant HCPs have been trained.
Usposabljanje je treba redno ponavljati, - vodenje sistema akreditacij, - zagotavljanje, da se raztopine HES za infundiranje dobavljajo samo akreditiranim bolnišnicam/centrom, tj. tja, kjer so vsi zadevni zdravstveni delavci usposobljeni.
As a consequence, the MAH shall be responsible of: - delivering the training to all relevant HCPs prescribing / administering HES solutions for infusion through agreed training material.
Posledično je imetnik dovoljenja za promet z zdravilom odgovoren za: - izvedbo usposabljanja za vse zadevne zdravstvene delavce, ki predpisujejo/dajejo raztopine HES za infundiranje, s pomočjo dogovorjenega gradiva za usposabljanje.
• the results from the DUSs
• rezultati študij o uporabi zdravil.
It is available as blue (20 mg) and orange (40 mg) capsules.
Na voljo je v kapsulah modre (20 mg) in oranžne (40 mg) barve.
Other information about Yentreve:
Druge informacije o zdravilu Yentreve:
The benefit of treatment should be re-assessed at regular intervals.
Koristi zdravljenja je treba redno preverjati.
Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Živčni prenašalci so kemikalije, ki živčnim celicam omogočajo medsebojno sporazumevanje.
What benefit has Yentreve shown during the studies?
Kakšne koristi je zdravilo Yentreve izkazalo med študijami?
The European Commission granted a marketing authorisation valid throughout the European Union for Yentreve to Eli Lilly Nederland B.V. on 11 August 2004.
Evropska komisija je dovoljenje za promet z zdravilom Yentreve, veljavno po vsej Evropski uniji, odobrila družbi Eli Lilly Nederland B.V.
The Committee recommended that Yentreve be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Yentreve odobri dovoljenje za promet.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) YENTREVE EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) YENTREVE Povzetek EPAR za javnost
Treatment with Yentreve should not be started in patients with uncontrolled high blood pressure, because of a risk of hypertensive crisis (sudden, dangerously high blood pressure).
Zdravljenje z zdravilom Yentreve se ne sme uvesti pri bolnicah z nenadzorovanim visokim krvnim tlakom zaradi tveganja za hipertenzivno krizo (nenadni, nevaren visok krvni tlak).
By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between these nerve cells, increasing the level of communication between the cells.
Duloksetin s tem, ko prepreči njihovo ponovno vezavo, zviša količino teh živčnih prenašalcev v prostorih med živčnimi celicami, s čimer se poveča stopnja sporazumevanja med celicami.
The main measures of effectiveness were incontinence episode frequency (IEF, the number of episodes of incontinence per week) recorded in patient diaries and the patients' scores on an incontinence-specific quality-of-life questionnaire (I-QOL).
Glavni merili učinkovitosti sta bili pogostnost inkontinenčnih epizod (IEF, tj. število inkontinenčnih epizod na teden), razvidno iz dnevnikov zdravljenja ter bolnikovega števila točk po vprašalniku o kakovosti življenja, specifičnem za inkontinenco (I-QOL).
Yentreve is a medicine containing the active substance duloxetine.
Yentreve je zdravilo, ki vsebuje zdravilno učinkovino duloksetin.
The most common side effects with Yentreve (seen in more than 1 patient in 10) are nausea, dry mouth, constipation and fatigue (tiredness).
Najpogostejši neželeni učinki zdravila Yentreve (opaženi pri več kot 1 bolnici od 10) so slabost, suha usta, zaprtje in utrujenost.
Yentreve is used to treat moderate to severe stress urinary incontinence (SUI) in women.
Zdravilo Yentreve se uporablja za zdravljenje zmerne do hude stresne urinske inkontinence (SUI) pri ženskah.
What is the risk associated with Yentreve?
Kakšna tveganja so povezana z zdravilom Yentreve?
In all four studies, the patients treated with Yentreve had fewer episodes of incontinence after 12 weeks, with about four or five fewer episodes of incontinence per week, in comparison with the number before the study.
V vseh štirih študijah so imele bolnice, ki so prejemale zdravilo Yentreve, manj inkontinenčnih epizod po 12 tednih, in sicer približno štiri ali pet inkontinenčnih epizod manj na teden v primerjavi z obdobjem pred študijo.
Yentreve should not be used with monoamine oxidase inhibitors (a group of antidepressants), fluvoxamine (another antidepressant), or ciprofloxacin or enoxacin (types of antibiotic).
Zdravilo Yentreve se ne sme uporabljati z zaviralci monoamin-oksidaze (skupino zdravil proti depresiji), fluvoksaminom (drugim zdravilom proti depresiji) ali ciprofloksacinom in enoksacinom (vrsti antibiotika).
Why has Yentreve been approved?
Zakaj je bilo zdravilo Yentreve odobreno?
How duloxetine works in SUI is not clear but it is thought that, by increasing the levels of 5-hydroxytryptamine and noradrenaline at the level of the nerves that control the muscle of the urethra (the tube that leads from the bladder to outside), duloxetine causes a stronger closure of the urethra during urine storage.
Način delovanja zdravila pri stresni urinski inkontinenci ni jasen, vendar se domneva, da duloksetin s povečevanjem ravni 5-hidroksitriptamina in noradrenalina na raven v živcih, ki nadzorujejo mišice sečnice (izvodilo iz sečnega mehurja navzven), okrepi stisk mišic zapiralk sečnice med shranjevanjem urina.
It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Deluje tako, da živčnim prenašalcem 5-hidroksitriptamina (imenovanim tudi serotonin) in noradrenalinu preprečuje ponovno vezavo na živčne celice v možganih in hrbtenjači.
Yentreve should not be used in people who may be hypersensitive (allergic) to duloxetine or any of the other ingredients.
Zdravila Yentreve ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) duloksetin ali katero koli drugo sestavino zdravila.
Yentreve was more effective than placebo only in patients who had more than 14 incontinence episodes per week (moderate to severe SUI) at the start of the study.
Zdravilo Yentreve je bilo učinkovitejše od placeba le pri bolnicah, ki so imele na začetku študije več kot 14 inkontinenčnih epizod na teden (zmerna do huda SUI).
For the full list of all side effects reported with Yentreve, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Yentreve, glejte navodilo za uporabo.
The four main studies involved 1,913 women and lasted 12 weeks, comparing Yentreve (mostly as 40 mg twice daily) with placebo (a dummy treatment).
V štiri glavne študije, ki so trajale 12 tednov, je bilo vključenih 1913 žensk, v njih pa so primerjali zdravilo Yentreve (večinoma v odmerku 40 mg dvakrat na dan) s placebom (zdravilom brez zdravilne učinkovine).
The I-QOL questionnaire scores were also improved in the Yentreve group compared with the placebo group.
V skupini bolnic, ki so prejemale zdravilo Yentreve, se je izboljšal tudi rezultat po vprašalniku I-QOL v primerjavi s skupino bolnic, ki so prejemale placebo.
The active substance in Yentreve, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor (SNRI).
Zdravilna učinkovina zdravila Yentreve, duloksetin, je zaviralec ponovnega prevzema serotonina in noradrenalina (SNRI).
By closing the urethra more powerfully, Yentreve prevents the unwanted loss of urine during physical stress such as coughing or laughing.
Zdravilo Yentreve z močnejšim stiskom mišic zapiralk sečnice preprečuje neželeno uhajanje urina med telesnim naporom, npr. kašljanjem ali smejanjem.
The IEF decreased by 52% in the Yentreve group, compared with a decrease of 33% in the placebo-treated group.
Pogostnost inkontinenčnih epizod se je v skupini bolnic, ki so prejemale zdravilo Yentreve, zmanjšala za 52 %, v primerjavi s skupino bolnic, ki so prejemale placebo, pa se je zmanjšala za 33 %.
The full EPAR for Yentreve is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Yentreve je na voljo tukaj.
Yentreve should not be used in patients with certain types of liver disease or with severe kidney disease.
Zdravilo Yentreve se ne sme uporabljati pri osebah z določenimi vrstami obolenj jeter ali hudim obolenjem ledvic.
SUI is accidental leaks of urine during physical exertion or when coughing, laughing, sneezing, lifting or exercising.
Huda stresna urinska inkontinenca je nenamerno uhajanje urina med telesnim naporom, kašljanjem, smejanjem, kihanjem, dviganjem ali telesno vadbo.
Yentreve has been studied in a total of 2,850 women with SUI.
Zdravilo Yentreve so preučevali na skupno 2850 ženskah s stresno urinsko inkontinenco.
The Committee for Medicinal Products for Human Use (CHMP) decided that Yentreve's benefits are greater than its risks for the treatment of moderate to severe SUI.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Yentreve pri zdravljenju zmerne do hude stresne urinske inkontinence večje od z njim povezanih tveganj.
How is Yentreve used?
Kako se zdravilo Yentreve uporablja?
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.
Priporočeni odmerek zdravila Yentreve je 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.
What is Yentreve used for?
Za kaj se zdravilo Yentreve uporablja?
Combining Yentreve with pelvic floor muscle training may provide additional benefit.
Dodatne koristi lahko prinese kombiniranje jemanja zdravila Yentreve s programom treninga mišic medeničnega dna.
How does Yentreve work?
Kako zdravilo Yentreve deluje?
How has Yentreve been studied?
Kako je bilo zdravilo Yentreve raziskano?
What is Yentreve?
Kaj je zdravilo Yentreve?
Some of these serious side effects may lead to death.
Nekateri od teh resnih neželenih učinkov lahko vodijo v smrt.
• Your doctor will tell you how many tablets to take each time.
• Vaš zdravnik vam bo povedal, koliko tablet vzeti vsakokrat.
ANNEX IV CONCLUSIONS ON THE REQUEST FOR ONE-YEAR MARKETING PROTECTION PRESENTED BY THE EUROPEAN MEDICINES AGENCY
PRILOGA IV SKLEPNE UGOTOVITVE O ZAHTEVKU ZA ENOLETNO TRŽNO ZAŠČITO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 April 2016
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 25. april 2016
• It is used when other treatments have not worked - or when other treatments are not suitable for you.
• Uporablja se potem, ko druga zdravila niso pomagala, ali v primeru, da druga zdravila za vas niso primerna.
• changes in the menstrual cycle
• spremembe menstrualnega cikla
Efficacy and safety data in patients over 75 years old is limited.
Podatkov o učinkovitosti in varnosti pri bolnikih, starejših od 75 let, je malo.
• Swallow the tablets whole with a glass of water.
• Tablete pogoltnite cele s kozarcem vode.
System Organ Class (MedDRA)a
Razred organskega sistema (MedDRA)a
• It is used when the cancer has spread to other parts of the body.
• Uporabljamo ga za zdravljenje raka, ki se je razširil na druge dele telesa.
Therefore, Lonsurf should be treated as a potential carcinogen.
Zdravilo Lonsurf je zato treba obravnavati kot potencialen karcinogen.
• pain, including pain from the cancer
• bolečina, vključno z bolečino zaradi raka
• one-year marketing protection
• enoletni tržni zaščiti
Patients with severe renal impairment were not enrolled in the study.
Bolniki s hudo ledvično okvaro v študijo niso bili vključeni.
You start a new cycle every 4 weeks.
Z novim ciklom zdravljenja boste začeli vsake 4 tedne.
Therefore, caution is required when using medicinal products that interact with these transporters.
Zato je pri uporabi zdravil, ki vstopajo v interakcije s temi prenašalci, potrebna previdnost.
• Your doctor will decide the right dose for you - the dose depends on your weight and height.
• Vaš zdravnik bo odločil, kateri je pravi odmerek za vas - odmerek je odvisen od vaše telesne mase in višine.
• Take this medicine by mouth.
• Zdravilo jemljite skozi usta.
If you become pregnant, you and your doctor will have to decide if the benefits of Lonsurf are greater than the risk of harm to the baby.
Če zanosite, se boste morali vi in vaš zdravnik odločiti, ali so koristi zdravila Lonsurf večje od tveganja za škodljive učinke na vašega otroka.
Read all of this leaflet carefully before you start taking this medicine - because it contains important information for you.
Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
The dosage must not exceed 80 mg/dose.
Odmerjanje ne sme preseči 80 mg/odmerek.
Tumor assessments, according to the Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1, were performed by the investigator/local radiologist every 8 weeks.
Ocene tumorja je v skladu z merili za ocenjevanje odziva pri solidnih tumorjih (RECIST - Response Evaluation Criteria in Solid Tumors), različica 1.1, izvajal raziskovalec/ lokalni radiolog vsakih 8 tednov.
Your doctor may prescribe both strengths for your prescribed dose.
Vaš zdravnik vam bo za vaš predpisani odmerek lahko predpisal obe jakosti.
DATE OF REVISION OF THE TEXT MM/YYYY
DATUM ZADNJE REVIZIJE BESEDILA MM/LLLL
• problem with sleeping or falling asleep
• težave s spanjem in uspavanjem.
Survival Probability (%)
Verjetnost preživetja (%)
See Section 4.8 for how to report adverse reactions.
Glejte poglavje 4.8, kako poročati o neželenih učinkih.
• Do not increase dose after it has been reduced.
• Ne povečajte odmerka, potem ko ste ga že zmanjšali.
• if you are allergic to trifluridine or tipiracil or any of the other ingredients of this medicine (listed in section 6).
• Če ste alergični na trifluridin ali tipiracil ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
This includes medicines obtained without a prescription and herbal medicines.
To vključuje tudi zdravila, ki ste jih dobili brez recepta, ter zdravila rastlinskega izvora.
92284 Suresnes Cedex France
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• You will take a dose 2 times a day.
• Odmerek boste vzeli 2-krat na dan.