natgillin/translations-raw huggingface dataset:
What are the risks associated with Trelegy Ellipta?
Kakšna tveganja so povezana z zdravilom Trelegy Ellipta?
Another study involving 1,810 patients whose COPD was not satisfactorily controlled with a daily maintenance treatment for their COPD found Trelegy Ellipta more effective at improving patients' breathing than an inhaled combination of budesonide, a corticosteroid, and formoterol, a long-acting beta-2 agonist.
Druga študija s 1 810 bolniki, pri katerih KOPB ni bila zadostno nadzorovana z dnevnim vzdrževalnim zdravljenjem, je pokazala, da je zdravilo Trelegy Ellipta pri izboljšanju dihanja bolnikov učinkovitejše od inhalirane kombinacije budezonida, kortikosteroida in formoterola, dolgodelujočega agonista adrenergičnih receptorjev beta2.
It is available as an inhalation powder, which the patient inhales through the mouth using a portable inhaler device; the patient should inhale the medicine once a day at around the same time each day.
Na voljo je kot prašek za inhalacijo, ki ga bolnik inhalira skozi usta s prenosnim inhalatorjem; bolnik inhalira zdravilo enkrat na dan ob približno isti uri vsak dan. Za več informacij glede uporabe zdravila Trelegy Ellipta glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
For the full list of side effects and restrictions with Trelegy Ellipta, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Trelegy Ellipta glejte navodilo za uporabo.
When umeclidinium bromide is inhaled, it causes the muscles of the airways to relax.
Inhaliranje umeklidinijevega bromida vpliva na sproščanje mišic dihalnih poti.
Trelegy Ellipta improves lung function as well as the quality of life of patients with moderate to severe COPD.
Zdravilo Trelegy Ellipta izboljšuje delovanje pljuč in kakovost življenja bolnikov z zmerno do hudo KOPB.
It works by blocking muscarinic receptors, which are involved in the contraction of muscles.
Deluje tako, da zavira muskarinske receptorje, ki nadzorujejo krčenje mišic.
When inhaled, vilanterol activates the beta-2 receptors in the airways.
Pri inhaliranju aktivira receptorje beta-2 v dihalnih poteh.
Trelegy Ellipta can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Trelegy Ellipta je le na recept.
How is Trelegy Ellipta used?
Kako se zdravilo Trelegy Ellipta uporablja?
Trelegy Ellipta was shown to improve patients' breathing and reduce exacerbations (flare-ups) of the disease in 2 main studies.
V dveh glavnih študijah je bilo dokazalo, da zdravilo Trelegy Ellipta izboljša bolnikovo dihanje in zmanjša poslabšanja (izbruhe) bolezni.
How does Trelegy Ellipta work?
Kako zdravilo Trelegy Ellipta deluje?
A study compared Trelegy Ellipta with either vilanterol given with fluticasone furoate or vilanterol with umeclidinium bromide, in 10,355 patients with advanced COPD who were at risk of exacerbations and whose disease was not satisfactorily controlled with a daily maintenance treatment.
V študiji, ki je vključevala 10 355 bolnikov z napredovalim KOPD, pri katerih je obstajalo tveganje za poslabšanje bolezni in pri katerih bolezen ni bila zadostno nadzorovana z dnevnim vzdrževalnim zdravljenjem, so zdravilo Trelegy Ellipta primerjali z vilanterolom v kombinaciji s flutikazonfuroatom ali vilanterolom v kombinaciji z umeklidinijevim bromidom.
These reactions are potentially serious and occasionally life threatening.
Te reakcije so lahko resne in občasno življenjsko ogrožajoče.
To start, take one tablet daily.
Za začetek vzemite eno tableto na dan.
The initial dose is one tablet (1-1.65 mg) per day at mealtime.
Začetni odmerek je ena tableta (1-1,65 mg) na dan v času obroka.
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The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Informacije o zdravilu bodo pristojni organi države članice v sodelovanju z referenčno državo članico morda pozneje posodobili, kot je primerno, skladno s postopki iz Poglavja 4, Naslova III Direktive 2001/83/ES.
Your doctor will review and decide if you must stop the medication.
Vaš zdravnik bo ocenil vaše stanje in presodil, ali morate prenehati jemati to zdravilo.
(see section 4.4 regarding the need for specialist monitoring requirements)
(za informacije o potrebi po zahtevah specialističnega spremljanja glejte poglavje 4.4)
Then increase the dose gradually according to your doctor's instructions.
Nato postopoma povečujte odmerek skladno z navodili zdravnika.
The medication must be stopped as soon as one of these symptoms or signs has been established.
Z zdravljenjem je treba prenehati takoj, ko je ugotovljen kateri od teh simptomov ali znakov.
Discontinuation of the treatment should be done gradually (in 2 or 3 weeks).
Prekinitev zdravljenja je treba izvesti postopno (v obdobju 2 do 3 tednov).
Before you take [Invented name] tell your doctor if:
Preden boste vzeli zdravilo [izmišljeno ime], povejte zdravniku, če:
You notice numbness or tingling in your fingers and toes.
opazite omrtvičenost ali ščemenje v prstih na rokah in nogah.
<[Invented name] contains lactose.
<Zdravilo [izmišljeno ime] vsebuje laktozo.
Take the tablets during a meal with some drink.
Tablete vzemite med obrokom, z nekaj tekočine.
The minimal duration of treatment before concluding failure is 2 months.
Najkrajše trajanje zdravljenja pred sklepom o neuspehu je 2 meseca.
The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the newly agreed wording as provided below.
Obstoječe informacije o zdravilu se spremenijo (vstaviti, nadomestiti ali izbrisati besedilo, kot je ustrezno) tako, da vsebujejo dogovorjeno besedilo, kot je navedeno spodaj.
In between two treatments there should be an interval of 3-4 weeks in order to check whether you still need to take [Invented name].
Med dvema cikloma zdravljenja mora biti obdobje 3-4 tednov, da se lahko prepričate, ali še vedno potrebujete zdravilo [izmišljeno ime].
What you need to know before you take [Invented name]
Kaj morate vedeti, preden boste vzeli zdravilo [izmišljeno ime]
Patients should be informed on the risk of fibrosis with methysergide therapy and should accept the need for periodic investigations as described below.
Bolnike je treba seznaniti s tveganjem za fibrozo pri zdravljenju z metizergidom in sprejeti morajo potrebo po rednih preiskavah, kot je opisano spodaj.
The maximum dose should not exceed 6 mg per day.
Največji odmerek ne sme preseči 6 mg na dan.
Valvular fibrosis may cause changes in cardiac function.
Valvularna fibroza lahko povzroči spremembe srčne funkcije.
The dosage may be gradually increased in divided daily dose until the optimal dose is reached.
Odmerjanje se sme postopoma povečevati v obliki razdeljenega dnevnega odmerka, dokler ni dosežen optimalen odmerek.
It is recommended to taper the dosage gradually over the last two to three weeks of a course of treatment, so as to prevent a rebound effect on headaches.
Priporočeno je, da se odmerjanje v zadnjih dveh do treh tednih zdravljenja postopoma zmanjšuje, da se prepreči povratni učinek na glavobole.
The need to continue treatment should be re-assessed, and the optimal timing for reintroduction discussed with the patient.
Potrebo po nadaljevanju zdravljenja je treba ponovno oceniti in se o najboljšem času za ponovno uvedbo zdravljenja pogovoriti z bolnikom.
An abrupt cessation of treatment is necessary in the event of a fibrotic reaction.
Nenadna prekinitev zdravljenja je potrebna v primeru fibrotičnih reakcij.
[Invented name] belong to a group of medicines called antimigraine drugs.
Zdravilo [izmišljeno ime] spada v skupino zdravil, ki jih imenujemo protimigrenska zdravila.
[Invented name] should not be used in children.
Zdravila [izmišljeno ime] se ne sme uporabljati pri otrocih.
[Invented name] is not effective for treating a migraine attack that is already present.
Zdravilo [izmišljeno ime] ni učinkovito pri zdravljenju migrenskega napada, ki je že prisoten.
Although symptoms may sometimes improve after cessation of therapy in some cases, fibrotic reactions may also persist.
Čeprav se simptomi v nekaterih primerih po prenehanju zdravljenja izboljšajo, lahko fibrotične reakcije vztrajajo.
[Invented name] should not be used in the paediatric population.
Zdravila [izmišljeno ime] se ne sme uporabljati pri pediatrični populaciji.
Edema and vasoconstriction of the large and small arteries can occur.
Lahko pride do edema in vazokonstrikcije velikih in majhnih arterij.
Your doctor will perform some tests before the start of treatment and then every 6 months to ensure that you do not have or develop fibrosis (scarring within body organs).
Zdravnik bo opravil nekaj preizkusov pred začetkom zdravljenja in nato vsakih 6 mesecev, da se prepriča, da nimate fibroze (brazgotinjenja v telesnih organih) oziroma da se ta ni pozneje razvila.
Methysergide treatment should be initiated and supervised by specialised physicians with experience in the treatment of migraine and cluster headache.
Zdravljenje z metizergidom morajo začeti in nadzorovati specializirani zdravniki z izkušnjami z zdravljenjem migrene in glavobola v rafalih.
Nausea and vomiting may occur, but these undesirable effects are often less severe if [Invented name] is taken at mealtime.
Lahko pride do navzee in bruhanja, vendar so ti neželeni učinki pogosto manj hudi, če se zdravilo [izmišljeno ime] jemlje v času obroka.
Serious intolerance or contra-indication to a first line drug is regarded as treatment failure.
Huda intoleranca na zdravilo prvega reda ali kontraindikacija nanj velja za neuspeh zdravljenja.
[Invented name] is taken by people who get severe migraines, with or without an aura, that affect their ability to go about their normal lives.
Zdravilo [izmišljeno ime] jemljejo ljudje, ki imajo hude migrene z avro ali brez nje, ki prizadenejo njihovo zmožnost za normalno življenje.
The treatment should be stopped in patients who have not responded adequately in the first 2-3 months.
Pri bolnikih, ki se v prvih 2-3 mesecih ne odzovejo v zadostni meri, je treba z zdravljenjem prenehati.
[Invented name] is to be used only following unsuccessful treatment with other standard classes of drugs (see section 4.4) after sufficient treatment duration (at least 4 months) at the maximal tolerated dose.
Zdravilo [izmišljeno ime] se sme uporabljati le po neuspešnem zdravljenju z drugimi standardnimi razredi zdravil (glejte poglavje 4.4) po zadostnem trajanju zdravljenja (najmanj 4 mesece) z največjim toleriranim odmerkom.
[This section should be amended to reflect the following wording]
[To poglavje je treba spremeniti tako, da vsebuje naslednje besedilo.]
The duration of continuous administration must not exceed six months because of the risk of fibrosis (see section 4.8).
Zaradi tveganja za fibrozo trajanje neprekinjene uporabe ne sme preseči šestih mesecev (glejte poglavje 4.8).
Take special care with [Invented name]
Bodite posebej previdni pri uporabi zdravila [izmišljeno ime]
For chronic cluster headache, the therapeutic dose would normally be 6 mg but a higher dose may sometimes be required.
Pri kroničnem glavobolu v rafalih je običajen terapevtski odmerek 6 mg, vendar je včasih lahko potreben večji odmerek.
• Prophylactic treatment of episodic and chronic cluster headache in adults.
• Profilaktično zdravljenje epizodnega in kroničnega glavobola v rafalih pri odraslih.
It is taken regularly as a preventative measure to reduce how often they get these headaches.
To zdravilo se jemlje redno kot preventivni ukrep za zmanjšanje pogostosti teh glavobolov.
You must not take methysergide continuously (without a break) for longer than six months.
Metizergida ne smete neprekinjeno (brez odmora) jemati več kot šest mesecev.
There have been isolated reports of myocardial infarct, especially in patients who do not pay attention to the contraindications regarding coronary disorders or the use of vasoconstrictive medications.
Obstajajo osamljena poročila o miokardnem infarktu, še posebej pri bolnikih, ki niso pozorni na kontraindikacije v zvezi s koronarnimi boleznimi ali uporabo vazokonstriktivnih zdravil.
The tests will include a heart ultrasound, tests on how well your lungs are functioning and an abdominal scan such as a MRI.
Ti preizkusi bodo vključevali ultrazvok srca, preizkuse tega, kako dobro delujejo vaša pljuča, in slikanje trebušnega predela, kot je preiskava MRI.
An initial screen must be performed prior to commencing methysergide therapy to exclude patients with pre-existent fibrosis or any other pathology that might put them at increased risk of developing fibrosis.
Pred začetkom zdravljenja z metizergidom je treba opraviti začetno presejanje, da se izloči bolnike z že obstoječo fibrozo ali katero koli drugo patologijo, ki bi jih lahko izpostavila povečanemu tveganju za razvoj fibroze.
Heart valve fibrosis may cause increased heart rate, swelling in the hands and feet and can be identified by clinical examination.
Fibroza srčne zaklopke lahko povzroči povišan srčni utrip ter zatekanje dlani in stopal, ugotoviti pa jo je mogoče s kliničnim pregledom.
- For prophylactic treatment of severe intractable migraine a number of other classes of treatment may be considered (e.g. beta-blockers, anticonvulsivants, calcium channel blocker or tricyclic antidepressants).
- Pri profilaktičnem zdravljenju hude neobvladljive migrene lahko pridejo v poštev številni drugi razredi zdravil (npr. zaviralci beta receptorjev, antikonvulzivi, zaviralci kalcijevih kanalov ali triciklični antidepresivi).
Once treatment is commenced the patient must be examined for occurrence of fibrosis at 6-monthly intervals, this examination should include a reassessment of the benefit: risk balance in the individual patient.
Po začetku zdravljenja je treba bolnika zaradi možnosti pojava fibroze pregledovati v 6-mesečnih intervalih, ti pregledi pa morajo vključevati ponovno oceno razmerja med koristmi in tveganji pri posameznem bolniku.
• Prophylactic treatment of severe intractable migraine (with or without aura) with functional disability in adults.
• Profilaktično zdravljenje hude neobvladljive migrene (z avro ali brez nje) s funkcionalno nezmožnostjo pri odraslih.
Fibrotic reactions have been reported, especially of the pleura and retro-peritoneum, and also of the pericardium and cardiac valves.
Poročali so o fibrotičnih reakcijah, še posebej plevre in retroperitoneja ter tudi perikardija in srčnih zaklopk.
However, it should only be used after at least two other types of medication for treating this type of headache have been tried for at least 2 months and failed to adequately treat the cluster headaches.
Vendar pa ga smejo uporabiti šele potem, ko so jemali vsaj dve drugi vrsti zdravil za zdravljenje te vrste glavobola, in sicer vsaj 2 meseca, a ta zdravila niso v zadovoljivi meri ozdravila glavobolov v rafalih.
- For prophylactic treatment of episodic and chronic cluster headache at least two other classes of treatment should be considered first (e.g. verapamil, topiramate or lithium).
- Pri profilaktičnem zdravljenju epizodnega in kroničnega glavobola v rafalih je treba prej razmisliti o uporabi vsaj dveh drugih razredov zdravil (npr. verapamil, topiramat ali litij).
If symptoms suggestive of a fibrosis occur, treatment with methysergide should be discontinued unless an alternative aetiology is confirmed.
Če nastopijo simptomi, ki kažejo na fibrozo, je treba zdravljenje z metizergidom prekiniti, razen če je potrjena druga etiologija.
Nausea and vomiting, particularly if [Invented name] is taken outside meals.
Siljenje na bruhanje in bruhanje, še posebej, če zdravila [izmišljeno ime] ne jemljete z obroki.
It is taken regularly as a preventative measure to reduce how often they get the migraines.
To zdravilo se jemlje redno kot preventivni ukrep za zmanjšanje pogostosti migren.
[Invented name] should not be used to stop a headache once it has started.
Zdravila [izmišljeno ime] ne smete uporabiti zato, da bi ustavili glavobol, ki se je že začel.
Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Dopolnitev ustreznih poglavij v povzetkih glavnih značilnosti zdravil in navodilih za uporabo
Patients should have failed at least 2 classes of drugs before starting methysergide (see section 4.4).
Pred začetkom zdravljenja z metizergidom mora pri bolnikih priti do neuspeha z najmanj 2 razredoma zdravil (glejte poglavje 4.4.).
Cardiac and vascular disorders
Srčne in žilne bolezni
Valvular fibrosis (see General disorders).
Valvularna fibroza (glejte Splošne težave).
Section 4.8 Undesirable effects [This section should be amended to reflect the following wording]
Poglavje 4.8 Neželeni učinki [To poglavje je treba spremeniti tako, da vsebuje naslednje besedilo.]
Treatment must not begin until after the patient has been examined for any pre-existing fibrotic conditions.
Zdravljenje se ne sme začeti, dokler ni bila pri bolniku s pregledom ovržena možnost že obstoječih fibrotičnih stanj.
Section 4.1 Therapeutic indications [The wording of this section should be read as below]
Poglavje 4.1 Terapevtske indikacije [Besedilo tega poglavja mora biti naslednje.]
However, it should only be used after other standard treatments have failed, those treatments should have been tried for at least 4 months at the maximum dose without success before [Invented name] is started.
Vendar pa smete to zdravilo vzeti šele potem, ko druga standardna zdravljenja niso bila uspešna; ta zdravljenja z največjim odmerkom morajo trajati vsaj 4 mesece brez uspeha, preden vzamete zdravilo [izmišljeno ime].
The following investigations should be performed prior to initiation of treatment with methysergide and at 6-monthly intervals thereafter: cardiac ultrasound, pulmonary function tests, abdominal MRI.
Pred začetkom zdravljenja z metizergidom in ob 6-mesečnih intervalih po njem je treba opraviti naslednje preiskave: ultrazvok srca, teste pljučne funkcije, MRI trebuha.
Treatment duration should not exceed 6 months.
Trajanje zdravljenja ne sme preseči 6 mesecev.
For chronic cluster headaches, treatment duration should not exceed 6 months.
Pri kroničnih glavobolih v rafalih trajanje zdravljenja ne sme preseči 6 mesecev.
This Summary of Product Characteristics and package leaflet is the outcome of the referral procedure.
Ta povzetek glavnih značilnosti zdravila in navodilo za uporabo sta bila dogovorjena v postopku napotitve.
Insomnia, somnolence, dizziness, minor mood changes (nervousness, restlessness, depression and confusion in rare cases).
Nespečnost, zaspanost, omotičnost, manjše spremembe razpoloženja (živčnost, nemirnost, depresija in zmedenost v redkih primerih).
Insomnia, drowsiness, dizziness, minor psychological changes of a temporary nature (nervousness, restlessness, depression and confusion in rare cases).
Nespečnost, somnolenca, omotica, manjše psihološke spremembe začasnega značaja (nervoza, nemirnost, depresija in zmedenost v redkih primerih).
[Invented name] is also taken by people who have episodes or regular ‘cluster' headaches.
Zdravilo [izmišljeno ime] jemljejo tudi ljudje, ki redno ali epizodično dobivajo »glavobol v rafalih«.
For episodic cluster headache, the treatment duration should be adjusted according to the usual duration of the episodes, which would normally be no longer than 2 or 3 months.
Pri epizodnem glavobolu v rafalih bo trajanje zdravljenja prilagojeno glede na običajno trajanje epizod, in sicer ponavadi ne bo daljše od 2 ali 3 mesecev.
Retro-peritoneal fibrosis (see General disorders).
Retroperitonealna fibroza (glejte Splošne težave).
[The wording of this section should be read as below]
[Besedilo tega poglavja mora biti naslednje.]
A treatment-free interval of at least 4 weeks must be allowed between courses.
Med posameznimi cikli zdravljenja mora biti interval brez zdravljenja v dolžini najmanj 4 tednov.
Section 4.2 Posology and method of administration [This section should be amended to reflect the following wording]
Poglavje 4.2 Odmerjanje in način uporabe [To poglavje je treba spremeniti tako, da vsebuje naslednje besedilo.]
This may be observed as heart or vascular murmurs, tachycardia, peripheral oedema, raised JVP or palpitations.
Te so lahko opazne kot srčni ali žilni šumi, tahikardija, periferni edem, povečan tlak v jugularni veni ali palpitacije.
If you notice any of the following symptoms you must immediately inform your doctor: pain in your chest or abdomen, awareness of your heart beat, difficulty in breathing, dry cough, nausea, general weakness, fatigue, loss of appetite/weight loss, urinary symptoms, pain/coldness/numbness in limbs.
Če opazite katerega koli od naslednjih simptomov, morate o tem takoj obvestiti svojega zdravnika: bolečina v prsih ali trebuhu, zavedanje svojega srčnega utripa, težave z dihanjem, suh kašelj, siljenje na bruhanje, splošna slabotnost, utrujenost, izguba apetita/izguba telesne mase, težave s sečili, občutek bolečine, hladu ali omrtvičenosti v udih.
Depending on the location of the affected blood vessel, this complication may be expressed as precordial (angina) or abdominal pain, as cold, dull, and painful sensations in the extremities, with or without paresthesia, as reduced or absence of a pulse, and theoretically, through arterial hypertension.
Glede na lokacijo prizadete krvne žile se ta zaplet lahko izrazi kot prekordialna (angina pektoris) ali abdominalna bolečina; kot hladni, topi in boleči občutki v okončinah s parestezijo ali brez nje; kot zmanjšan pulz ali njegova odsotnost in teoretično kot arterijska hipertenzija.
Skin reactions (e.g. rash, urticaria)
Kožne reakcije (npr. izpuščaj, urtikarija)
Depending on the location of the affected blood vessel, this complication may be expressed as chest pain or abdominal pain, as cold, dull, and painful sensations in the extremities, with or without numbness, as reduced or absence of a pulse, and theoretically, through arterial tension increase.
Glede na mesto prizadete krvne žile se ta zaplet lahko izrazi kot bolečina v prsih ali trebuhu; kot hladni, topi in boleči občutki v okončinah z omrtvičenostjo ali brez nje; kot zmanjšan pulz ali njegova odsotnost in teoretično kot povečanje arterijskega tlaka.
[This section should be amended to reflect the following wording] Like all medicines, [Invented name] can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo [izmišljeno ime] neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
If [Invented name] is taken uninterruptedly for a long time, fibrosis (accumulation of scarring in the body organs) was seen at the pleural site (membrane covering the lungs), the peritoneum (membrane covering the abdominal cavity as well as the abdominal organs) and the heart valves.
Ob dolgem in neprekinjenem jemanju zdravila [izmišljeno ime] so opazili fibrozo (brazgotinjenje v telesnih organih) pri pljučni mreni (membrani, ki obdaja pljuča), trebušni mreni (membrani, ki obdaja trebušno votlino in organe trebušne votline) in srčnih zaklopkah.
Retroperitoneal fibrosis may cause obstruction of the urinary tract with symptoms such as general asthenia, back pain, lumbar pain, dysuria, oliguria, raised blood nitrogen, nausea, anorexia, and vascular insufficiency, weak pulse and skin discolouration in the lower limbs.
Retroperitonealna fibroza lahko povzroči obstrukcijo sečil s simptomi, kot so splošna astenija, bolečina v hrbtu, bolečina v lumbalnem predelu, disurija, oligurija, povečana vrednost dušika v krvi, navzea, anoreksija, vaskularna insuficienca, slaboten pulz in razbarvanje kože na nogah.
Patients should be examined regularly for the presence of: peripheral oedema, leg discolouration, digital clubbing, weak/irregular pulse(s), tachycardia, cardiac murmur, vascular bruits, raised jugular vein pressure, lung basal crepitations, pleural/pericardial friction rubs, abdominal/flank masses/tenderness.
Bolnike je treba redno pregledovati glede prisotnosti: perifernega edema, razbarvanja kože na nogah, betičastih prstov, slabotnega/nerednega pulza oz. pulzov, tahikardije, srčnega šuma, žilnih hropcev, povečanega tlaka v jugularni veni, pljučnih bazalnih krepitacij, plevralnega/perikardnega trenja, abdominalnih/ledvenih zatrdlin/občutljivosti.