natgillin/translations-raw huggingface dataset:
In addition, the patients who took Daliresp had an average of 1.1 moderate or severe flare-ups of their disease, compared with 1.4 flare-ups in the patients who took placebo.
Poleg tega so imeli bolniki, ki so jemali zdravilo Daliresp, v povprečju 1,1 zmernega ali hudega izbruha bolezni v primerjavi z 1,4 izbruha pri bolnikih, ki so jemali placebo.
The company will also provide cards for patients, telling them what information that they need to give their doctor about their symptoms and past illnesses to help the doctor know whether Daliresp is appropriate for them.
Zagotovila bo tudi kartice za bolnike z informacijami, ki jih morajo sporočiti zdravniku o simptomih in preteklih boleznih, da bo ta lahko presodil, ali je zdravilo Daliresp zanje primerno.
After considering all of the available data on the effects of the medicine, the Committee decided that Daliresp's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je ob upoštevanju vseh razpoložljivih podatkov o učinkih zdravila zaključil, da so koristi zdravila Daliresp večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Daliresp is not used on its own but as an ‘add-on' to treatment with bronchodilators (medicines that widen the airways in the lungs).
Zdravilo Daliresp se ne uporablja samostojno, ampak kot „dodatek“ k zdravljenju z bronhodilatorji (zdravili, ki širijo dihalne poti v pljučih).
Daliresp is a medicine that contains the active substance roflumilast.
Daliresp je zdravilo, ki vsebuje zdravilno učinkovino roflumilast.
The card will include an area where patients can record their weight.
Na kartici bo tudi prostor, kjer bodo bolniki lahko beležili svojo telesno maso.
A risk management plan has been developed to ensure that Daliresp is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Daliresp je bil pripravljen načrt obvladovanja tveganj.
The active substance in Daliresp, roflumilast, belongs to a group of medicines called ‘phosphodiesterase type 4 (PDE4) inhibitors'.
Zdravilna učinkovina v zdravilu Daliresp, roflumilast, spada v skupino zdravil, ki jih imenujemo „zaviralci fosfodiesteraze tipa 4 (PDE4)“.
What benefit has Daliresp shown during the studies?
Kakšne koristi je zdravilo Daliresp izkazalo med študijami?
By blocking the action of PDE4, roflumilast reduces the inflammation in the lungs, helping to reduce the patient's symptoms or to prevent them from getting worse.
Ker roflumilast zavira delovanje PDE4, zmanjša vnetje pljuč, kar pripomore k zmanjšanju bolnikovih simptomov ali prepreči njihovo poslabšanje.
Because patients taking Daliresp may lose weight, they are advised to weigh themselves on a regular basis.
Ker lahko bolniki, ki jemljejo zdravilo Daliresp, shujšajo, jim je treba svetovati redno tehtanje.
The most common side effects with Daliresp (seen in between 1 and 10 patients in 100) are decreased weight, decreased appetite, insomnia (difficulty sleeping), headache, diarrhoea, nausea (feeling sick) and abdominal pain (stomach ache).
Najpogostejši neželeni učinki zdravila Daliresp (opaženi pri 1 do 10 bolnikih od 100) so zmanjšana telesna masa, zmanjšan tek, nespečnost (motnje spanca), glavobol, driska, navzeja (slabost) in bolečine v trebuhu.
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 Daliresp.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The main measure of effectiveness was the improvement in forced expiratory volumes (FEV1) and the reduction in the number of moderate or severe flare-ups of their COPD over a year of treatment.
Glavno merilo učinkovitosti je bilo izboljšanje forsiranega ekspiracijskega volumna (FEV1) in zmanjšanje števila zmernih ali hudih izbruhov kronične obstruktivne pljučne bolezni v enem letu zdravljenja.
After a year, the patients who took Daliresp had an average increase of 40 ml while those given placebo had an average decrease of 9 ml.
Po enem letu so imeli bolniki, ki so jemali zdravilo Daliresp, v povprečju 40 ml večjo vrednost FEV1, medtem ko se je pri tistih, ki so prejemali placebo, ta vrednost zmanjšala za 9 ml.
What is the risk associated with Daliresp?
Kakšna tveganja so povezana z zdravilom Daliresp?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Daliresp, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The tablets should be swallowed with water at the same time each day.
Priporočeni odmerek zdravila Daliresp je ena tableta enkrat na dan. Tablete je treba pogoltniti z vodo vsak dan ob isti uri.
The CHMP noted that there was a need for new COPD treatments and that the main studies showed a modest benefit of Daliresp in patients with severe COPD.
CHMP je ugotovil, da obstaja potreba po novih načinih zdravljenja kronične obstruktivne pljučne bolezni in da sta glavni študiji pokazali skromno korist zdravila Daliresp pri bolnikih s hudo kronično obstruktivno pljučno boleznijo.
Daliresp has been compared with placebo (a dummy treatment) in two main studies involving over 3,000 adults with severe COPD who had had at least one flare-up of their disease in the past year.
Zdravilo Daliresp so primerjali s placebom (zdravilom brez zdravilne učinkovine) v dveh glavnih študijah, v kateri je bilo vključenih več kot 3 000 odraslih bolnikov s hudo kronično obstruktivno pljučno boleznijo, ki so imeli najmanj en izbruh bolezni v preteklem letu.
Daliresp is used to treat severe chronic obstructive pulmonary disease (COPD) in adults who have chronic bronchitis (long-term inflammation of the airways), and whose COPD flares up frequently.
Zdravilo Daliresp se uporablja za zdravljenje hude kronične obstruktivne pljučne bolezni (KOPB) pri odraslih bolnikih, ki imajo kronični bronhitis (dolgotrajno vnetje dihalnih poti) in pri katerih se izbruhi kronične obstruktivne pljučne bolezni pogosto pojavijo.
Why has Daliresp been approved?
Zakaj je bilo zdravilo Daliresp odobreno?
COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing air in and out of the lungs.
Kronična obstruktivna pljučna bolezen je dolgotrajna bolezen, pri kateri se dihalne poti in pljučni mešički poškodujejo ali zamašijo, kar oteži vdihavanje in izdihavanje zraka.
How has Daliresp been studied?
Kako je bilo zdravilo Daliresp raziskano?
For the full list of all side effects reported with Daliresp, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Daliresp, glejte navodilo za uporabo.
What is Daliresp used for?
Za kaj se zdravilo Daliresp uporablja?
It blocks the action of the PDE4 enzyme, which is involved in the inflammation process that leads to COPD.
Zavira delovanje encima PDE4, ki sodeluje pri vnetju, kar povzroči kronično obstruktivno pljučno bolezen.
Daliresp was shown to be more effective than placebo at treating COPD.
Zdravilo Daliresp je bilo učinkovitejše od placeba pri zdravljenju bolnikov s kronično obstruktivno pljučno boleznijo.
What is Daliresp?
Kaj je zdravilo Daliresp?
The doctor may stop treatment with Daliresp if the patient loses too much weight.
Če bolnik izgubi preveč telesne mase, se bo zdravnik morda odločil, da prekine zdravljenje z zdravilom Daliresp.
How is Daliresp used?
Kako se zdravilo Daliresp uporablja?
How does Daliresp work?
Kako zdravilo Daliresp deluje?
These side effects occurred in more than 1 in 4 patients.
Ti neželeni učinki so se pojavili pri več kot 1 od 4 bolnikov.
Further information on Braftovi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije o zdravilu Braftovi so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Braftovi is available as capsules (50 mg and 75 mg).
Zdravilo Braftovi je na voljo v obliki kapsul (50 mg in 75 mg).
What measures are being taken to ensure the safe and effective use of Braftovi?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Braftovi?
The European Medicines Agency therefore decided that Braftovi's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Braftovi večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
For the full list of side effects and restrictions, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev glejte navodilo za uporabo.
Patients who took this combination lived on average for nearly 15 months without the disease getting worse.
Bolniki, ki so se zdravili s to kombinacijo, so brez poslabšanja bolezni povprečno preživeli skoraj 15 mesecev.
Patients normally take 450 mg (six 75 mg capsules) once a day but can have the dose reduced or treatment stopped temporarily if they experience troublesome side effects.
Bolniki navadno vzamejo 450 mg (šest kapsul po 75 mg) enkrat dnevno, vendar se ta odmerek lahko zmanjša ali zdravljenje začasno prekine, če se pri bolniku pojavijo neprijetni neželeni učinki.
As for all medicines, data on the use of Braftovi are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Braftovi stalno spremljajo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Braftovi have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Braftovi upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Braftovi is a medicine for treating melanoma (a skin cancer) that has spread or cannot be removed by surgery.
Braftovi je zdravilo, ki se uporablja za zdravljenje melanoma (kožnega raka), ki se je razširil ali ga ni mogoče odstraniti s kirurškim posegom.
What benefits of Braftovi have been shown in studies?
Kakšne koristi zdravila Braftovi so se pokazale v študijah?
Other information about Braftovi
Druge informacije o zdravilu Braftovi
Side effects reported with Braftovi are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Braftovi, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Why is Braftovi authorised in the EU?
Zakaj je bilo zdravilo Braftovi odobreno v EU?
Treatment with Braftovi can last for as long as the patient is benefiting from it and does not have unacceptable side effects.
Zdravljenje z zdravilom Braftovi traja, dokler ima bolnik od njega korist in se pri njem ne pojavljajo nesprejemljivi neželeni učinki.
The most common side effects with Braftovi and binimetinib taken together at the highest recommended doses are tiredness, nausea (feeling sick), diarrhoea, vomiting, retinal detachment (an eye problem that leads to poor vision), abdominal pain, joint pain, muscle pain and high levels of an enzyme called creatine kinase, which may indicate muscle problems.
Najpogostejši neželeni učinki kombinacije zdravila Braftovi in binimetiniba pri največjih priporočenih odmerkih so utrujenost, navzeja (slabost), driska, bruhanje, odstop mrežnice (težava z očmi, ki privede do poslabšanja vida), bolečine v trebuhu, bolečine v sklepih, bolečine v mišicah in povečane vrednosti encima, imenovanega kreatin kinaza, kar lahko kaže na težave z mišicami.
An overview of Braftovi and why it is authorised in the EU
Pregled zdravila Braftovi in zakaj je odobreno v EU
Up to 50% of patients with metastatic melanoma have a mutation in BRAF with the V600 mutation being the most common.
Do 50 % bolnikov z metastatskim melanomom ima mutacijo beljakovine BRAF, med katerimi je mutacija V600 najpogostejša.
For more information about using Braftovi, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Braftovi glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
What is Braftovi and what is it used for?
Kaj je zdravilo Braftovi in za kaj se uporablja?
It contains the active substance encorafenib.
Zdravilo vsebuje učinkovino enkorafenib.
A study of 577 patients with melanoma with the BRAF V600 mutation that had spread or could not be removed surgically showed that Braftovi with binimetinib can prolong the length of time patients lived without their disease getting worse.
Študija pri 577 bolnikih z melanomom z mutacijo BRAF V600, ki se je razširil ali ga ni bilo mogoče odstraniti s kirurškim posegom, je pokazala, da lahko kombinacija zdravila Braftovi in binimetiniba podaljša obdobje, ki ga bolniki preživijo brez poslabšanja bolezni.
What are the risks associated with Braftovi?
Kakšna tveganja so povezana z zdravilom Braftovi?
Braftovi can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in prescribing cancer medicines.
Predpisovanje in izdaja zdravila Braftovi je le na recept, zdravljenje pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje s predpisovanjem zdravil za zdravljenje raka.
The dose of the other medicine, binimetinib, may also be reduced but if binimetinib is stopped Braftovi must be stopped too.
Odmerek druge učinkovine, binimetiniba, se prav tako lahko zmanjša, vendar je treba v primeru prekinitve zdravljenja z binimetinibom prekiniti tudi zdravljenje z zdravilom Braftovi.
This encourages cancers to develop by allowing uncontrolled division of cells.
To omogoči nenadzorovano delitev celic in s tem razvoj raka.
The side effects seen with Braftovi are similar to those seen with other medicines in the same class and are considered manageable.
Neželeni učinki zdravila Braftovi so podobni neželenim učinkom drugih zdravil istega razreda in veljajo za obvladljive.
Braftovi in combination with binimetinib can help prolong the time that these patients live without their disease getting worse.
Zdravilo Braftovi lahko skupaj z binimetinibom pomaga podaljšati čas, ki ga bolniki preživijo brez poslabšanja bolezni.
The active substance in Braftovi, encorafenib, works by blocking the BRAF protein thereby stopping its activation by MEK and slowing down the growth and spread of the cancer.
Učinkovina v zdravilu Braftovi, enkorafenib, deluje tako, da zavira beljakovino BRAF in s tem prepreči aktivacijo beljakovin MEK, s čimer upočasni rast in širjenje raka.
In melanoma tumours with the BRAF V600 mutation, an abnormal form of the protein BRAF is present, which switches on another protein called MEK involved in stimulating cell division.
Pri melanomskih tumorjih z mutacijo BRAF V600 je prisotna nenormalna oblika beljakovine BRAF, ki aktivira drugo beljakovino, imenovano MEK, ki sodeluje pri spodbujanju delitve celic.
Braftovi is used in combination with another medicine, binimetinib (Mektovi), and is only for patients whose cancer cells have a specific mutation (change) in their genes called 'BRAF V600'.
Zdravilo Braftovi se uporablja v kombinaciji z učinkovino binimetinib (zdravilom Mektovi), in sicer samo pri bolnikih, ki imajo rakave celice s posebno gensko mutacijo (spremembo), imenovano BRAF V600.
How is Braftovi used?
Kako se zdravilo Braftovi uporablja?
How does Braftovi work?
Kako zdravilo Braftovi deluje?
This compared with over 9.5 months for patients who took encorafenib alone and just over 7 months for patients taking a different medicine called vemurafenib.
Tisti bolniki, ki so jemali samo enkorafenib, so brez poslabšanja bolezni preživeli 9,5 meseca, bolniki, ki so jemali drugo učinkovino, vemurafenib, pa zgolj nekaj več kot sedem mesecev.
Content (concentration)
Stična ovojnina Vsebina (koncentracija)
Wash hands after use.
Po uporabi si umijte roke.
Food increases the bioavailability to 80 to 90%.
Hrana poviša biodostopnost od 80% do 90 %.
ATCvet code: QC09BA07.
oznaka ATC vet: QC09BA07.
Each chewable tablet contains:
Vsaka žvečljiva tableta vsebuje:
Do not use in dogs intended or used for breeding.
Ne uporabite pri psih, ki se jih uporablja ali so namenjeni za vzrejo.
The result is an improvement in heart function.
Rezultat je izboljšanje srčne funkcije.
However, this very slight decrease was transient, the red cell mass remained within the normal range, and the finding was not considered to be of clinical importance.
Ta zelo zmeren padec je bil prehodnega značaja, masa rdečih krvnih celic je ostala znotraj normale in ugotovitev ne šteje za klinično pomembno.
This is thought to be due to activation of feedback mechanisms without adverse clinical consequence.
To naj bi se pojavilo zaradi aktivacije povratnih mehanizmov brez neželenih kliničnih posledic.
It also allowed a quicker improvement of cough and activity and a slower degradation of cough, heart sounds and appetite.
Prav tako je opaženo hitrejše izboljšanje kašlja in aktivnosti in počasnejša degradacija kašlja, srčnih zvokov in apetita.
D-73614 Schorndorf Germany
D-73614 Schorndorf Nemčija
Do not use during pregnancy and lactation (see section 4.7).
Ne uporabite v obdobju brejosti in laktacije (glej poglavje 4.7).
Tres le Bois 22600 Loudeac France
Tres le Bois 22600 Loudeac Francija
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMA) http://www.ema.europa.eu/.
This hypertrophy does not seem to be linked to any pathology and was observed to be reversible upon discontinuation of the treatment.
Ta hipertrofija ni povezana z nobeno patologijo in je bila reverzibilna po prekinitvi zdravljenja.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti.
Manufacturers responsible for batch release: Ceva Santé Animale
Izdelovalec, odgovoren za sprostitev serije: Ceva Santé Animale
White plastic (HDPE) bottle with a child-resistant closure in a cardboard box.
Bela plastična (HDPE) plastenka z zapiralom varnim pred otroki v kartonski škatli.
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
V natisnjenem navodilu za uporabo zdravila mora biti navedeno ime in naslov izdelovalca, odgovornega za sproščanje zadevne serije.
Symptomatic treatment, e.g., fluid therapy, should also be provided.
Prav tako se uvede simptomatsko zdravljenje, npr. tekočinsko terapijo.
It is therefore recommended to induce vomiting, and then carry out gastric lavage (depending on the risk assessment) and monitor electrolytes.
Priporočljivo je sprožiti bruhanje in izprati želodec (odvisno od ocene tveganja) in kontrolirati elektrolite.
In case of the accidental ingestion by a dog of many Cardalis chewable tablets, there is no specific antidote or treatment.
V primeru, da pes nenamerno zaužije večje število Cardalis žvečljivih tablet, ni specifičnega protistrupa ali zdravljenja.
In the cardiovascular system, spironolactone prevents the detrimental effects of aldosterone.
V kardiovaskularnem sistemu spironolakton prepreči škodljive učinke aldosterona.
Do not use this veterinary medicinal product after the expiry date which is stated on the bottle.
Zdravila za uporabo v veterinarski medicini ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na plastenki.
After oral administration of spironolactone to dogs, it was demonstrated that the three metabolites achieved levels of 32 to 49% of the administered dose.
Po peroralnem dajanju spironolaktona psom se je pokazalo, da trije metaboliti dosežejo nivoje od 32% do 49% danega odmerka.
Due to the antiandrogenic effect of spironolactone, it is not recommended to administer the veterinary medicinal product to growing dogs.
Zaradi antiandrogenega učinka spironolaktona, ni priporočljiva uporaba zdravila za uporabo v veterinarski medicini pri rastočih psih.
The tablets are packed bottles of 30 tablets or 90 tablets, and each bottle is presented in an outer cardboard box.
Tablete so pakirane v plastenki po 30 tablet ali 90 tablet, vsaka plastenka je v kartonski škatli.
The mean residence time of the metabolites ranges from 9 to 14 hours and they are preferentially distributed to the gastro-intestinal tract, kidney, liver and adrenal glands.
Čas obstanka metabolitov je od 9 do 14 ur in se preferenčno distribuirajo v gastrointestinalni trakt, ledvice, jetra in nadledvične žleze.
Therefore, dogs treated concomitantly with an NSAID should be closely monitored and correctly hydrated.
Zato je potrebno pse, sočasno zdravljene z NSAIDi, pazljivo kontrolirati in pravilno hidrirati.
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
DODATEK I POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Steady-state conditions are reached by day 2.
Stabilno stanje je doseženo v 2 dneh.
Spironolactone may cause both induction and inhibition of cytochrome P450 enzymes and could affect the metabolism of other substances utilizing these metabolic pathways.
Spironolakton lahko povzroči indukcijo in inhibicijo encima citokroma P450 in lahko vpliva na presnovo drugih snovi v tej metabolični poti.
The systemic bioavailability of benazepril is incomplete due to incomplete absorption and first pass metabolism.
Sistemska biorazpoložljivost benazeprila je nepopolna zaradi nepopolne absorpcije in metabolizma prvega prehoda.
Do not administer in conjunction with Non Steroidal Anti-Inflammatory Drugs (NSAIDs) to dogs with renal insufficiency.
Ne uporabite skupaj z nesteroidnimi protivnetnimi zdravili (NSAID) pri psih z insuficienco ledvic.
There is no significant difference in the pharmacokinetics of benazeprilat when benazepril (as hydrochloride) is administered to fed or fasted dogs.
Ni pomembne razlike v farmakokinetiki benazeprila, če benazepril (kot hidroklorid) damo nahranjenemu ali teščemu psu.
However, aldosterone release is not fully controlled by ACE Inhibitors because Angiotensin-II is also produced by non-ACE pathways such as chymase (phenomenon known as “aldosterone breakthrough”).
Vendar spročanje aldosterona ni popolnoma kontrolirano z zaviralci ACE, saj angiotenzin II nastaja tudi v ne ACE poteh kot je himaza (fenomen poznan kot “preboj aldosterona”).
The association of spironolactone and benazepril is beneficial as both act on the renin-angiotensinaldosterone system (RAAS) but at different levels along the cascade.
Kombinacija spironolaktona in benazeprila je koristna, saj oba delujeta na renin-angiotenzinaldosteron sistem (RAAS), vendar na različnih nivojih kaskade.
Do not use in cases of cardiac output failure due to aortic or pulmonary stenosis.
Ne uporabite v primeru srčnega popuščanja zaradi aortne ali pulmonarne stenoze.
The product should be used with caution in dogs with hepatic dysfunction because it may alter the extensive biotransformation of spironolactone in liver.
Pri psih z motnjami v delovanju jeter je potrebna previdna uporaba, saj lahko pride do sprememb obsežne biotransformacije spironolaktona v jetrih.