natgillin/translations-raw huggingface dataset:
- in patients with left ventricular dysfunction (left ventricular ejection fraction (LVEF) between 30
- Bolniki z jetrnim popuščanjem: pri bolnikih z blagim jetrnim popuščanjem (Child-Pughov seštevek do
Immediate Packaging Pack size
Farmacevtska oblika Stična ovojnina Ovojnina
The infusion should last around 15 minutes.
Infundiranje traja približno 15 minut.
The European Commission granted a marketing authorisation valid throughout the European Union for Respreeza on 20 August 2015.
Evropska komisija je dovoljenje za promet z zdravilom Respreeza, veljavno po vsej Evropski uniji, izdala 20. avgusta 2015.
What measures are being taken to ensure the safe and effective use of Respreeza?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Respreeza?
Other information about Respreeza
Druge informacije o zdravilu Respreeza
The full EPAR for Respreeza 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 Respreeza je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Allergic reactions have been observed during treatment, some of which were severe.
Med zdravljenjem so opazili alergijske reakcije, od katerih so bile nekatere hude.
The company that markets Respreeza will carry out a further study to assess whether an increased dose of 120 mg/kg may lead to improved effects compared with the currently recommended dose.
Družba, ki trži zdravilo Respreeza, bo izvedla dodatno študijo, s katero bo ocenila, ali lahko višji odmerek 120 mg/kg izboljša njegove učinke v primerjavi s trenutno priporočenim odmerkom.
The recommended dose of Respreeza is 60 mg per kilogram body weight, given once a week.
Priporočeni odmerek zdravila Respreeza je 60 mg na kilogram telesne mase, ki se daje enkrat na teden.
No other major concerns have been identified about the safety of the medicine.
Z vidika varnosti pri tem zdravilu niso ugotovili nobenih drugih večjih zadržkov.
This is a summary of the European public assessment report (EPAR) for Respreeza.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Respreeza.
What benefits of Respreeza have been shown in studies?
Kakšne koristi je zdravilo Respreeza izkazalo v študijah?
Therefore, the Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Respreeza's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zato zaključil, da so koristi zdravila Respreeza večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
What is Respreeza and what is it used for?
Kaj je zdravilo Respreeza in za kaj se uporablja?
It is not intended to provide practical advice on how to use Respreeza.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
What are the risks associated with Respreeza?
Kakšna tveganja so povezana z zdravilom Respreeza?
The decrease in lung density after 24 months was around 2.6 g/l in patients who received Respreeza, compared with a decrease of around 4.2 g/l in patients receiving placebo.
Zmanjšanje pljučne gostote v 24 mesecih je bilo pri bolnikih, ki so prejemali zdravilo Respreeza, približno 2,6 g/l, pri bolnikih, ki so prejemali placebo, pa približno 4,2 g/l.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Respreeza have also been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Respreeza upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
The most common side effects with Respreeza (which may affect up to 1 in 10 people) are dizziness, headache, dyspnoea (shortness of breath) and nausea.
Najpogostejši neželeni učinki zdravila Respreeza (ki lahko prizadenejo največ 1 osebo od 10) so omotica, glavobol, dispneja (kratka sapa) in navzeja (slabost).
Subsequent infusions can be given by a caregiver or by the patient.
Pozneje lahko zdravilo infundira negovalec ali bolnik.
For more information about treatment with Respreeza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Respreeza preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Allergic reactions were the main safety concern with Respreeza, but advice on how to manage this risk has been included in the product information.
Pri zdravilu Respreeza je bil glavni varnostni zadržek alergijska reakcija, vendar so v informacije o zdravilu vključili nasvet o tem, kako obvladovati to tveganje.
Why is Respreeza approved?
Zakaj je bilo zdravilo Respreeza odobreno?
Respreeza is used to slow down damage to the lungs in patients with severe disease.
Zdravilo Respreeza se uporablja za upočasnitev poškodbe pljuč pri bolnikih s hudo boleznijo.
Because of the risk of severe allergic reactions, Respreeza must not be used in patients who are lacking IgA, a protein in the blood, and who have developed antibodies against it because these patients are more prone to allergic reactions.
Zaradi tveganja hudih alergijskih reakcij se zdravilo Respreeza ne sme uporabljati pri bolnikih s pomanjkanjem beljakovine v krvi, imenovane IgA, in tistih, pri katerih so se razvila protitelesa proti njej, saj so ti bolniki bolj nagnjeni k alergijskim reakcijam.
For practical information about using Respreeza, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Respreeza naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
For the full list of all side effects and restrictions with Respreeza, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Respreeza glejte navodilo za uporabo.
Lung density is an indicator of the extent of lung damage: the bigger the decrease in lung density, the greater is the damage to the lung.
Pljučna gostota je pokazatelj obsežnosti pljučne poškodbe: večje kot je zmanjšanje pljučne gostote, večja je poškodba pljuč.
In the study, Respreeza was compared with placebo (a dummy treatment) and the main measure of effectiveness was the decrease in lung density.
V tej študiji so zdravilo Respreeza primerjali s placebom (zdravilom brez zdravilne učinkovine), glavno merilo učinkovitosti pa je bilo zmanjšanje pljučne gostote.
Respreeza human alpha1-proteinase inhibitor
Respreeza humani zaviralec alfa1-proteinaze
Respreeza is available as a powder and solvent to be made into a solution for infusion (drip) into a vein.
Zdravilo Respreeza je na voljo v obliki praška in vehikla za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
Respreeza is a medicine used in adults with alpha1-proteinase inhibitor deficiency, an inherited disorder that can cause lung problems such as increasing shortness of breath and which may also affect the liver.
Respreeza je zdravilo, ki se uporablja pri odraslih s pomanjkanjem zaviralca alfa1-proteinaze, tj. dedne motnje, ki lahko povzroči težave s pljuči, kot je slabšajoča kratka sapa, in lahko prizadene tudi jetra.
The active substance in Respreeza, human alpha1-proteinase inhibitor, is a natural protein in the blood which protects lung tissue from damage.
Zdravilna učinkovina v zdravilu Respreeza, humani zaviralec alfa1-proteinaze, je naravna beljakovina krvi, ki pljučno tkivo ščiti pred poškodbo.
How is Respreeza used?
Kako se zdravilo Respreeza uporablja?
The first infusion should be given under the supervision of a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency.
Prvo infundiranje je treba opraviti pod nadzorom zdravstvenega delavca z izkušnjami z zdravljenjem pomanjkanja zaviralca alfa1-proteinaze.
It is obtained from human blood and works by replacing the protein that is lacking in patients with alpha1-proteinase inhibitor deficiency.
Pridobiva se iz človeške krvi in deluje tako, da nadomesti beljakovino, ki je bolniki s pomanjkanjem zaviralca alfa1-proteinaze nimajo.
Respreeza contains the active substance human alpha1-proteinase inhibitor.
Zdravilo Respreeza vsebuje zdravilno učinkovino humani zaviralec alfa1-proteinaze.
The main study with Respreeza showed that the medicine is effective at slowing down the damage to the lungs in patients with alpha1-proteinase inhibitor deficiency, and this effect is considered relevant for patients with severe disease.
Glavna študija zdravila Respreeza je pokazala, da je zdravilo učinkovito pri upočasnitvi poškodbe pljuč pri bolnikih s pomanjkanjem zaviralca alfa1-proteinaze.
How does Respreeza work?
Kako zdravilo Respreeza deluje?
Respreeza has been shown to slow down lung damage in one main study involving 180 patients with lung damage due to alpha1-proteinase inhibitor deficiency.
V eni glavni študiji, ki je vključila 180 bolnikov s pljučno poškodbo zaradi pomanjkanja zaviralca alfa1-proteinaze, so pokazali, da je zdravilo Respreeza upočasnilo pljučno poškodbo.
It must not be used in patients with:
Ne smejo ga uporabljati bolniki z:
At the start of the studies, the patients had around 16 incontinence episodes per week.
Na začetku študije so imeli bolniki približno 16 epizod na teden.
The main measure of effectiveness was the change in the number of incontinence episodes per week.
Glavno merilo učinkovitosti je bila sprememba števila inkotinenčnih epizod na teden.
It blocks a receptor called the ‘muscarinic M3 receptor'.
Zavira receptor, imenovan „muskarinski receptor M3“.
The European Commission granted a marketing authorisation valid throughout the European Union for Emselex on 22 October 2004.
Evropska komisija je dovoljenje za promet z zdravilom Emselex, veljavno po vsej Evropski uniji, odobrila dne 22. oktobra 2004.
‘Prolonged-release' means that darifenacin is released slowly from the tablet over a few hours.
„Podaljšano sproščanje“ pomeni, da se darifenacin iz tablet počasi sprošča več ur.
EPAR summary for the public darifenacin
Povzetek EPAR za javnost darifenacin
After 12 weeks of treatment, patients receiving Emselex 7.5 mg or 15 mg had 8.8 (68%) or 10.6 (77%) fewer episodes of incontinence per week, respectively, and patients receiving placebo had 7 or 7.5 (54 or 58%) fewer episodes per week.
Po 12 tednih zdravljenja so imeli bolniki, ki so prejemali zdravilo Emselex v odmerku 7,5 mg, 8,8 (68 %), bolniki, ki so prejemali 15 mg zdravila, pa 10,6 (77 %) manj inkontinenčnih epizod na teden, medtem ko so bolniki, ki so prejemali placebo imeli 7 oziroma 7,5 (54 oziroma 58 %) manj epizod na teden.
The recommended starting dose of Emselex is 7.5 mg once a day.
Priporočeni začetni odmerek zdravila Emselex je 7,5 mg enkrat dnevno.
It is used to treat the urge incontinence (sudden lack of control over urination), increased urinary frequency (need to urinate frequently) and urgency (sudden urge to pass urine) that are associated with the syndrome.
Uporablja se za zdravljenje urgentne inkontinence (nenadne izgube nadzora nad uriniranjem), povečane pogostosti mokrenja (potrebe po pogostem uriniranju) in urgence (nenadne močne nuje po uriniranju), ki so povezane s sindromom.
It is available as prolongedrelease tablets (7.5 mg and 15 mg).
Na voljo je v obliki tablet s prirejenim sproščanjem (7,5 mg in 15 mg).
This is a summary of the European public assessment report (EPAR) for Emselex.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Emselex.
The Committee decided that Emselex's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Emselex večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The most common side effects with Emselex (seen in more than 1 patient in 10) are dry mouth and constipation.
Najpogostejša neželena učinka zdravila Emselex (opažena pri več kot 1 od 10 bolnikov) sta suha usta in zaprtje.
Other information about Emselex
Druge informacije o zdravilu Emselex
Emselex must not be taken by patients who are also taking medicines that could affect the way that Emselex is broken down in the body, such as protease inhibitors (used to treat HIV infection, such as ritonavir), or ketoconazole or itraconazole (used to treat fungal infections).
Zdravila Emselex ne smejo jemati bolniki, ki jemljejo tudi zdravila, ki bi utegnila vplivati na način, na katerega se zdravilo Emselex presnavlja v telesu, kot so zaviralci proteaze (ki se uporabljajo za zdravljenje okužbe z virusom HIV, npr. ritonavir) ali ketokonazol oziroma itrakonazol (ki se uporabljata za zdravljenje glivičnih okužb).
Emselex has been studied in four main studies in a total of 2,078 male and female patients with symptoms of overactive bladder.
Zdravilo Emselex je bilo raziskano v štirih glavnih študijah pri skupno 2 078 moških in ženskih bolnikih s simptomi čezmerno aktivnega sečnega mehurja.
When the results from all four studies were combined, Emselex was more effective in reducing the number of incontinence episodes than placebo.
Primerjava rezultatov vseh štirih študij je pokazala, da je zdravilo Emselex učinkoviteje zmanjšalo število inkotinenčnih epizod kot placebo.
• toxic megacolon (a very serious complication of colitis).
• toksičnim megakolonom (zelo resnim zapletom kolitisa).
• urinary retention (difficulty passing urine);
• zastajanjem urina (težavami pri odvajanju urina);
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Emselex.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Emselex, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
• myasthenia gravis (a disease causing muscle weakness);
• miastenijo gravis (boleznijo, ki povzroča šibkost mišic);
This helps Emselex to prevent unwanted urination.
Na ta način zdravilo Emselex pomaga preprečiti neželeno mokrenje.
• gastric retention (when the stomach does not empty properly);
• zastojem v želodcu (želodec se ne prazni na ustrezen način);
What benefit has Emselex shown during the studies?
Kakšne koristi je zdravilo Emselex izkazalo med študijami?
• severe ulcerative colitis (severe inflammation of the gut causing ulcers and bleeding);
• hudim ulceroznim kolitisom (hudim vnetjem debelega črevesa, ki povzroča razjede in krvavitve);
Emselex must not be used in people who are hypersensitive (allergic) to darifenacin or any of the other ingredients.
Zdravila Emselex ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) darifenacin ali katero koli drugo sestavino zdravila.
The CHMP concluded that Emselex showed an effectiveness similar to that of other anticholinergic medicines used in overactive bladder syndrome.
CHMP je sklenil, da je zdravilo Emselex izkazalo podobno učinkovitost kot ostala antiholingerična zdravila, ki se uporabljajo za zdravljenje sindroma čezmerno aktivnega sečnega mehurja.
Emselex was used at various doses (from 3.75 mg to 30 mg a day) and compared with placebo (a dummy treatment) or with tolterodine (another medicine used in this condition).
Uporabljeni so bili različni odmerki zdravila (od 3,75 mg do 30 mg na dan), ki so jih primerjali z jemanjem placeba (zdravila brez zdravilne učinkovine) ali s tolterodinom (drugim zdravilom za zdravljenje te bolezni).
This leads to an increase in the capacity of the bladder and changes in the way the bladder contracts, resulting in fewer bladder contractions.
Posledica tega je povečanje zmogljivosti sečnega mehurja in spremembe, tj. zmanjšanje krčenja mišic sečnega mehurja.
The active substance in Emselex, darifenacin, is an anticholinergic medicine.
Zdravilna učinkovina zdravila Emselex, darifenacin, je antiholinergično zdravilo.
For the full list of all side effects reported with Emselex, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Emselex, glejte navodilo za uporabo.
What is the risk associated with Emselex?
Kakšna tveganja so povezana z zdravilom Emselex?
• uncontrolled narrow-angle glaucoma (increased eye pressure even with treatment);
• neobvladanim glavkomom z zaprtim zakotjem (povišanim tlakom v očesu kljub zdravljenju);
Emselex is used in adults with overactive bladder syndrome.
Zdravilo Emselex se uporablja pri odraslih s sindromom čezmerno aktivnega sečnega mehurja.
The full EPAR for Emselex 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 Emselex je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.. Za več informacij o zdravljenju z zdravilom Emselex preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Emselex is a medicine that contains the active substance darifenacin.
Emselex je zdravilo, ki vsebuje zdravilno učinkovino darifenacin.
Why has Emselex been approved?
Zakaj je bilo zdravilo Emselex odobreno?
• severe liver problems;
• hudimi boleznimi jeter;
The tablets should be swallowed whole with some liquid, and not chewed, divided or crushed.
Pri bolnikih, ki potrebujejo večje lajšanje simptomov, je odmerek mogoče povečati na 15 mg. Tablete se pogoltnejo cele z nekaj tekočine in se ne smejo žvečiti, deliti ali zdrobiti.
How does Emselex work?
Kako zdravilo Emselex deluje?
How has Emselex been studied?
Kako je bilo zdravilo Emselex raziskano?
What is Emselex?
Kaj je zdravilo Emselex?
How is Emselex used?
Kako se zdravilo Emselex uporablja?
What is Emselex used for?
Za kaj se zdravilo Emselex uporablja?
EMA/32301/2010 EMEA/H/C/1221
20. januar 2010 EMA/393200/2010 EMEA/H/C/1221
Secondary generalisation occurs when the overactivity later reaches the whole brain.
Sekundarna generalizacija se pojavi, ko prekomerno delovanje pozneje zajame celotne možgane.
The main measures of effectiveness were the reduction in the average number of seizures every month and the number of patients who had their monthly number of seizures reduced by at least a half.
Glavni merilo učinkovitosti sta bili zmanjšanje povprečnega števila napadov na mesec ter število bolnikov, pri katerih se je število napadov na mesec zmanjšalo vsaj za polovico.
This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness or a sudden sense of fear.
To je vrsta epilepsije, pri kateri preveliko električno delovanje na samo eni strani možganov povzroči simptome, kot so nenadni sunkoviti gibi enega dela telesa, motnje sluha, voha ali vida, odrevenelost ali nenaden občutek strahu.
The company also presented data from three main studies involving 1,664 patients with partial-onset seizures who were already treated with up to three other anti-epileptic medicines.
Družba je predstavila tudi rezultate treh glavnih študij, v katerih je sodelovalo 1 664 bolnikov z napadi parcialnega izvora, ki so že bili zdravljeni z največ tremi drugimi zdravili proti epilepsiji.
As the CHMP was evaluating the initial documentation provided by the company, it had not yet made any recommendations.
Ker je CHMP še ocenjeval začetno dokumentacijo, ki jo je predložila družba, še ni podal nobenih priporočil.
The exact way in which carisbamate works in the body is not known, but some of its activity might be explained by the blocking of sodium channels (pores on the surface of nerve cells) that allow electrical impulses to be transmitted between nerve cells.
Natančen način delovanja karisbamata v telesu ni znan, vendar se nekaj njegove aktivnosti morda lahko pojasni z zaviranjem dejavnosti kalcijevih kanalčkov (por na površini celic), ki omogočajo, da se električni impulzi prenašajo med živčnimi celicami.
Comfyde was expected to be used to treat patients aged 16 years and above.
Zdravilo Comfyde na bi se uporabljalo za zdravljenje bolnikov, starejših od 16 let.
The letter from the company notifying the Agency of the withdrawal of the application is available here.
Dopis, s katerim družba CHMP obvešča o umiku vloge, je na voljo tukaj.
The effects of Comfyde were first tested in experimental models before being studied in humans.
Učinki zdravila Comfyde so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
On 15 January 2010, Janssen-Cilag International NV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Comfyde, for use in the treatment of partial-onset seizures in patients with epilepsy.
Družba Janssen-Cilag International NV je dne 15. januarja 2010 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Comfyde, namenjenim za uporabo pri zdravljenju napadov parcialnega izvora pri bolnikih z epilepsijo.
What are the consequences for patients in clinical trials or compassionate use programmes with Comfyde?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe z zdravilom Comfyde?
Withdrawal of the marketing authorisation application for Comfyde (carisbamate) EMA/32301/2010
Umik vloge za pridobitev dovoljenja za promet z zdravilom Comfyde (karisbamat) EMA/393200/2010
Comfyde was expected to be used as an add-on to existing treatments for partial-onset seizures (fits) with or without secondary generalisation in patients with epilepsy.
Zdravilo Comfyde naj bi se uporabljalo kot dodatek obstoječemu zdravljenju napadov parcialnega izvora s sekundarno generalizacijo ali brez nje pri bolnikih z epilepsijo.
As this is being done, other medicines the patients are receiving for epilepsy may be adjusted as needed.
Druga zdravila, ki jih bolniki prejemajo za zdravljenje epilepsije, bodo nato po potrebi ustrezno prilagojena.
By reducing the activity of sodium channels and through its other possible actions, carisbamate was expected to prevent abnormal electrical activity spreading through the brain, reducing the chance of an epileptic fit happening.
Karisbamat naj bi z zmanjševanjem dejavnosti kalcijevih kanalčkov in drugim morebitnim delovanjem preprečeval širjenje nepravilnega električnega delovanja po možganih in tako zmanjševal možnost pojava epileptičnega napada.
Comfyde is a medicine that contains the active substance carisbamate.
Comfyde je zdravilo, ki vsebuje zdravilno učinkovino karisbamat.
Withdrawal of the marketing authorisation application for Comfyde (carisbamate)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Comfyde (karisbamat)
The active substance in Comfyde, carisbamate, is an anti-epileptic medicine.
Zdravilna učinkovina zdravila Comfyde, karisbamat, je zdravilo proti epilepsiji.
The patients added either Comfyde or placebo (a dummy treatment) to their existing treatment.
Bolniki so k obstoječemu zdravljenju dodali zdravilo Comfyde ali placebo (zdravilo brez zdravilne učinkovine).
The company has informed the CHMP that patients in epilepsy clinical trials will have their Comfyde treatment discontinued gradually.
Družba je obvestila CHMP, da bodo bolniki z epilepsijo, ki sodelujejo v kliničnih preskušanjih, z uporabo zdravila Comfyde prenehali postopoma.
What is Comfyde?
Kaj je zdravilo Comfyde?
How is Comfyde expected to work?
Kako naj bi zdravilo Comfyde delovalo?
What was Comfyde expected to be used for?
Za kaj naj bi se zdravilo Comfyde uporabljalo?
ATCvet code: QI04AA02.
Oznaka ATC vet: QI04AA02.
Adjuvants: Aluminium hydroxide (Al
Dodatka: aluminijev hidroksid (Al