natgillin/translations-raw huggingface dataset:
• in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of diabetes medicine) when metformin is not suitable in patients who are not satisfactorily controlled on a sulphonylurea alone;
• v kombinaciji z metforminom pri bolnikih, pri katerih zgolj z metforminom ni mogoče zadovoljivo uravnati bolezni, ali v kombinaciji s sulfonilsečnino (drugo vrsto zdravila za zdravljenje sladkorne bolezni), če metformin ni primeren pri tistih bolnikih, pri katerih sladkorna bolezen zgolj s sulfonilsečnino ni zadovoljivo uravnana;
• together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
• skupaj z insulinom pri bolnikih, pri katerih bolezen ni zadovoljivo uravnavana zgolj z insulinom in za katere metformin ni primeren.
Therefore, the CHMP's view was that, as for Actos, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi enako kot pri zdravilu Actos odtehtajo znana tveganja.
For practical information about using Pioglitazone Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Pioglitazone Accord naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
• on its own in patients for whom metformin (another diabetes medicine) is not suitable.
• kot samostojno zdravilo pri bolnikih, za katere metformin (drugo zdravilo za zdravljenje sladkorne bolezni) ni primeren;
It is not intended to provide practical advice on how to use Pioglitazone Accord.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
• together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite treatment with two medicines by mouth;
• skupaj z metforminom in sulfonilsečnino pri bolnikih, pri katerih kljub peroralnemu zdravljenju s tema dvema zdraviloma bolezen ni zadovoljivo uravnana;
At subsequent reviews prescribers should confirm that benefits to patients are maintained.
Pri nadaljnjih pregledih morajo zdravniki, ki zdravilo predpisujejo, preveriti, ali še vedno zagotavlja enake koristi.
Pioglitazone Accord contains the active substance pioglitazone.
Zdravilo Pioglitazone Accord vsebuje zdravilno učinkovino pioglitazon.
Why is Pioglitazone Accord approved?
Zakaj je bilo zdravilo Pioglitazone Accord odobreno?
Pioglitazone Accord can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Pioglitazone Accord je le na recept.
How has Pioglitazone Accord been studied?
Kako je bilo zdravilo Pioglitazone Accord raziskano?
How does Pioglitazone Accord work?
Kako zdravilo Pioglitazone Accord deluje?
How is Pioglitazone Accord used?
Kako se zdravilo Pioglitazone Accord uporablja?
Women should also not become pregnant for one month after stopping treatment.
Ženske prav tako ne smejo zanositi še en mesec po koncu zdravljenja.
What measures are being taken to ensure the safe and effective use of Opsumit?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Opsumit?
The medicine is available as 10 mg tablets and taken at a dose of one tablet every day.
Zdravilo je na voljo v obliki 10-miligramskih tablet in se jemlje v odmerku ena tableta vsak dan.
Opsumit received a marketing authorisation valid throughout the EU on 20 December 2013.
Za zdravilo Opsumit je bilo 20. decembra 2013 izdano dovoljenje za promet, veljavno po vsej EU.
The European Medicines Agency decided that Opsumit's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Opsumit večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What is Opsumit and what is it used for?
Kaj je zdravilo Opsumit in za kaj se uporablja?
Other information about Opsumit
Druge informacije o zdravilu Opsumit
As for all medicines, data on the use of Opsumit are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Opsumit stalno spremljajo.
Further information on Opsumit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije o zdravilu Opsumit so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What benefits of Opsumit have been shown in studies?
Kakšne koristi zdravila Opsumit so se pokazale v študijah?
Why is Opsumit authorised in the EU?
Zakaj je bilo zdravilo Opsumit odobreno v EU?
What are the risks associated with Opsumit?
Kakšna tveganja so povezana z zdravilom Opsumit?
These are part of a natural mechanism in the body that can cause arteries to narrow.
Ti so del naravnega telesnega mehanizma, ki lahko povzroči zožitev arterij.
An overview of Opsumit and why it is authorised in the EU
Pregled zdravila Opsumit in zakaj je odobreno v EU
In a main study involving 742 patients, Opsumit has been shown to reduce the risk of PAH-related illness, particularly the worsening of PAH symptoms.
V glavni študiji, v katero je bilo vključenih 742 bolnikov, so pokazali, da zdravilo Opsumit zmanjša tveganje za težave, povezane s PAH, zlasti pri poslabšanje simptomov te bolezni.
Further information on the orphan designation can be found on the European Medicines Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Nadaljnje informacije glede določitve zdravila sirote lahko najdete na spletni strani Evropske agencije za zdravila: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The most common side effects with Opsumit (which may affect more than 1 in 10 people) include nasopharyngitis (inflammation of the nose and throat), anaemia (low red blood cell counts) and headache.
Najpogostejši neželeni učinki zdravila Opsumit (ki se lahko pojavijo pri več kot 1 bolniku od 10) so nazofaringitis (vnetje nosu in žrela), anemija (majhno število rdečih krvnih celic) in glavobol.
Side effects reported with Opsumit are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Opsumit, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Opsumit is a medicine used for the long-term treatment of pulmonary arterial hypertension (PAH).
Opsumit je zdravilo, ki se uporablja za dolgotrajno zdravljenje pljučne arterijske hipertenzije (PAH).
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Opsumit have also 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 Opsumit upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The company that markets Opsumit will send educational material to patients and healthcare professionals with information on the precautions to be taken when using Opsumit.
Podjetje, ki trži zdravilo Opsumit, bo bolnikom in zdravstvenim delavcem poslalo izobraževalno gradivo z informacijami o previdnostnih ukrepih, ki jih je treba upoštevati pri uporabi tega zdravila.
Because more pressure is needed to force blood through the narrowed artery, this leads to high blood pressure in the lungs.
Ker je za pretok krvi skozi zoženo arterijo potrebna večja sila, to povzroča visok krvni tlak v pljučih.
Most side effects are mild to moderate in severity.
Neželeni učinki so večinoma blagi do zmerni.
Opsumit is used for adults whose PAH is classified as WHO functional class II to class III.
Zdravilo Opsumit se uporablja pri odraslih, pri katerih je PAH razvrščena v funkcionalni razred II do III po klasifikaciji SZO.
PAH is a condition in which there is abnormally high blood pressure in the arteries of the lungs, causing symptoms such as breathlessness and fatigue.
PAH je bolezen, za katero je značilen nenormalno visok tlak v arterijah pljuč, kar povzroča simptome, kot sta pomanjkanje sape in utrujenost.
Opsumit can be used alone or in combination with other PAH medicines; for further information, see the package leaflet.
Zdravilo Opsumit se lahko uporablja samostojno ali v kombinaciji z drugimi zdravili za zdravljenje PAH; za nadaljnje informacije glejte navodila za uporabo.
Around 37% of patients taking placebo had a worsening of their PAH symptoms compared with 24% of those who took Opsumit 10 mg.
Simptomi so se poslabšali pri približno 37 % bolnikov, ki so jemali placebo, medtem ko so se pri bolnikih, ki so jemali zdravilo Opsumit v odmerku 10 mg, poslabšali pri 24 % bolnikov.
PAH is ‘rare', and Opsumit was designated an ‘orphan medicine' (a medicine used in rare diseases) for PAH on 27 September 2011.
PAH je redka bolezen, zato je bilo zdravilo Opsumit 27. septembra 2011 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
For more information about using Opsumit, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Opsumit glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
In patients with PAH, this mechanism is overactive and, by blocking these receptors, macitentan helps widen the arteries in the lungs and thereby bring down the blood pressure.
Pri bolnikih s PAH je ta mehanizem čezmerno aktiven, macitentan pa te receptorje zavira in tako pripomore k razširitvi arterij v pljučih in s tem k znižanju krvnega tlaka.
Opsumit can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in treating PAH.
Predpisovanje in izdaja zdravila Opsumit je le na recept, zdravljenje pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem PAH.
In animal studies, Opsumit was shown to have an adverse effect on the development of embryos.
V študijah na živalih se je pokazalo, da zdravilo Opsumit škodljivo vpliva na razvoj zarodkov.
The class reflects the seriousness of the disease: patients with class II PAH have slight limitation of physical activity and those with class III disease have marked limitation of physical activity.
Razred opredeljuje resnost bolezni: telesna zmogljivost bolnikov s PAH razreda II je blago omejena, telesna zmogljivost bolnikov z razredom III pa je močno omejena.
Opsumit has been shown to be effective in reducing illness or deaths due to PAH and the side effects reported are similar to those reported with other medicines of its class and are considered to be manageable.
Zdravilo Opsumit se je izkazalo za učinkovito pri zmanjševanju bolezni ali smrti zaradi PAH, neželeni učinki pa so podobni, kot jih vidimo pri drugih zdravilih tega razreda, in veljajo za obvladljive.
Patients' reminder cards will include a warning that the medicine must never be used in pregnant women and that women who could become pregnant must be using reliable contraception and should undergo monthly pregnancy tests.
Opozorilne kartice za bolnike bodo vključevale opozorilo, da se to zdravilo ne sme nikoli uporabljati pri nosečih ženskah in da morajo ženske, ki bi lahko zanosile, uporabljati zanesljiva kontracepcijska sredstva in opravljati mesečne teste nosečnosti.
How is Opsumit used?
Kako se zdravilo Opsumit uporablja?
The active substance in Opsumit, macitentan, works by blocking endothelin receptors.
Učinkovina v zdravilu Opsumit, macitentan, deluje tako, da zavira receptorje za endotelin.
It must also not be used in patients with severe reduction in liver function or high levels of liver enzymes in the blood.
Zdravilo se ne sme uporabljati pri doječih materah in bolnikih, ki imajo hude težave z jetri ali visoke vrednosti jetrnih encimov v krvi.
Opsumit contains the active substance macitentan.
Zdravilo Opsumit vsebuje učinkovino macitentan.
In PAH there is severe narrowing of the arteries of the lungs.
Pri PAH so pljučne arterije močno zožene.
Patients in the study received either Opsumit or placebo (a dummy treatment) in addition to other PAH treatments for an average of 2 years.
Bolniki v študiji so poleg drugih zdravil za zdravljenja te bolezni povprečno dve leti prejemali bodisi zdravilo Opsumit bodisi placebo (zdravilo brez učinkovine).
Opsumit must therefore not be used in pregnant or breastfeeding women or in women who could become pregnant and who are not using reliable contraception.
Zdravila Opsumit ne smejo uporabljati nosečnice, doječe matere ali ženske, ki bi lahko zanosile, ter ženske, ki ne uporabljajo zanesljivih kontracepcijskih sredstev.
For the full list of side effects reported with Opsumit, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Opsumit, glejte navodilo za uporabo.
However, as animal studies showed an adverse effect on the development of embryos, Opsumit must never be used in pregnant women or women who could become pregnant and are not using reliable contraception.
Zdravilo Opsumit se ne sme nikoli uporabljati pri nosečnicah ali ženskah, ki bi lahko zanosile in ne uporabljajo zanesljivih kontracepcijskih sredstev.
How does Opsumit work?
Kako zdravilo Opsumit deluje?
The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCPCh on 23 February 2005.
Evropska komisija je dovoljenje za promet z zdravilom Purevax RCPCh, veljavno po vsej Evropski uniji, izdala 23. februarja 2005.
The antibodies will help to protect against the diseases caused by these viruses or bacteria.
Ta mu bodo pomagala pri zaščiti pred boleznimi, ki jih povzročajo ti virusi ali bakterije.
If the kitten has high levels of antibodies received from the mother in the womb and in the milk, the first vaccination should be delayed until 12 weeks of age.
Če ima mucka visoke ravni protiteles, ki jih je prejela od matere v maternici in z mlekom, je treba s prvim cepljenjem počakati do starosti 12 tednov.
They included young and adult cats of various breeds, but not young kittens.
V študije so vključili mlade in odrasle mačke različnih pasem, ne pa mladih muck.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo“ obrambe pred boleznimi.
The main measure of effectiveness was the level of antibodies in the blood against the viruses and bacteria in the vaccine.
Glavno merilo učinkovitosti je bila raven protiteles v krvi proti virusom in bakterijam iz cepiva.
It was not possible to detect a rise in antibodies against C. felis because of high levels of antibodies in the cats at the beginning of the study.
Povišanja ravni protiteles proti C. felis zaradi visoke ravni protiteles pri mačkah ob začetku študije ni bilo mogoče zaznati.
The cat should be revaccinated for all components one year after the first vaccination course, then every year for chlamydiosis, and every three years for rhinotracheitis, calicivirosis and panleucopenia.
Mačko je treba ponovno cepiti za vse sestavine cepiva eno leto po prvem cepljenju, nato pa vsako leto proti klamidiozi ter vsaka tri leta proti rinotraheitisu, kalicivirozi in panlevkopeniji.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCPCh exceed the risks for the approved indications and recommended that Purevax RCPCh be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Purevax RCPCh večje od z njim povezanih tveganj za odobrene indikacije, in priporočil, da se zanj izda dovoljenje za promet.
When a cat is given the vaccine, the immune system recognises the weakened or killed viruses and the weakened bacteria as ‘foreign' and makes antibodies against them.
Ko mačko cepimo, imunski sistem prepozna oslabljene ali uničene viruse in oslabljene bakterije kot „tujke“ ter proti njim razvije protitelesa.
If self-injection does occur in these people, tell the doctor that self-injection with a living chlamydial vaccine has occurred.
V primeru samo-injiciranja pri taki osebi zdravniku povejte, da je prišlo do samo-injiciranja z živim cepivom, ki vsebuje klamidijo.
In laboratory conditions Purevax RCPCh was demonstrated to provide protection against the diseases listed above.
V laboratorijskih pogojih je bilo dokazano, da zdravilo Purevax RCPCh zagotavlja zaščito pred zgoraj navedenimi boleznimi.
Purevax RCPCh is used to vaccinate cats from the age of 8 weeks against the following diseases:
Zdravilo Purevax RCPCh se uporablja za cepljenje mačk, starih osem tednov ali več, proti naslednjim boleznim:
In the field, the studies of Purevax RCPCh looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination.
V terenskih študijah zdravila Purevax RCPCh so preučevali osnovno shemo cepljenja (dve injekciji v tri- do štiritedenskem razmiku) in obnovitveno cepljenje.
Purevax RCPCh is a vaccine.
Zdravilo Purevax RCPCh je cepivo.
For a full list of the side-effects reported with Purevax RCPCh, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Purevax RCPCh, glejte navodilo za uporabo.
Purevax RCPCh should not be used in pregnant cats.
Zdravilo Purevax RCPCh se ne sme uporabljati pri brejih mačkah.
Other information about Purevax RCPCh:
Druge informacije o zdravilu Purevax RCPCh:
The effectiveness of Purevax RCPCh has been studied in several trials in laboratory conditions where cats were vaccinated and infected with herpesvirus, calicivirus, C. felis or parvovirus.
Učinkovitost zdravila Purevax RCPCh so preučevali v več preskušanjih v laboratorijskih pogojih, kjer so mačke cepili in okužili s herpesvirusom, kalicivirusom, C. felis ali parvovirusom.
Purevax RCPCh is available as a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Zdravilo Purevax RCPCh je na voljo v obliki liofilizata (pelet, posušenih v zamrznjenem stanju) in vehikla za pripravo suspenzije za injiciranje.
Purevax RCPCh is a veterinary vaccine that contains:
Zdravilo Purevax RCPCh je cepivo za uporabo v veterinarski medicini, ki vsebuje:
Purevax RCPCh contains small amounts of weakened or killed viruses and bacteria that cause feline rhinotracheitis, calicivirosis, chlamydiosis and panleucopenia.
Zdravilo Purevax RCPCh vsebuje majhne količine oslabljenih ali uničenih virusov, ki povzročajo rinotraheitis, kalicivirozo, klamidiozo in panlevkopenijo mačk.
In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus, calicivirus infection, feline panleucopenia and C. felis remained stable at a high level or increased slightly.
V študiji obnovitvenega cepljenja je bilo ugotovljeno, da so ravni protiteles proti herpesvirusu rinotraheitisa, okužbam s kalicivirusi, panlevkopeniji mačk in C. felis ostale stabilne na visoki ravni ali pa so se nekoliko zvišale.
What benefit has Purevax RCPCh shown during the studies?
Kakšne koristi je zdravilo Purevax RCPCh izkazalo v študijah?
In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus, calicivirus infection, and feline panleucopenia viruses.
V terenski študiji osnovnega cepljenja je bilo ugotovljeno povečanje protiteles proti herpesvirusu rinotraheitisa mačk, okužbam s kalicivirusi in virusom panlevkopenije mačk.
Why has Purevax RCPCh been approved?
Zakaj je bilo zdravilo Purevax RCPCh odobreno?
What is the risk associated with Purevax RCPCh?
Kakšna tveganja so povezana z zdravilom Purevax RCPCh?
What is Purevax RCPCh?
Kaj je zdravilo Purevax RCPCh?
How has Purevax RCPCh been studied?
Kako je bilo zdravilo Purevax RCPCh raziskano?
Feline viral rhinotracheitis, feline chlamydiosis, feline panleucopenia (live attenuated) and feline calicivirosis (inactivated) vaccine
Cepivo proti virusnemu rinotraheitisu mačk, (živo oslabljeno) cepivo proti panlevkopeniji mačk in (inaktivirano) cepivo proti kalicivirozi mačk
What is Purevax RCPCh used for?
Za kaj se zdravilo Purevax RCPCh uporablja?
How does Purevax RCPCh work?
Kako zdravilo Purevax RCPCh deluje?
As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 20 July 2015.
Ker je družba predložila zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati dne 20. julija 2015.
A further study was carried out in 15 female patients.
Dodatna študija je bila izvedena pri 15 ženskih bolnicah.
Replagal agalsidase alfa
Replagal agalsidaza alfa
The European Commission granted a marketing authorisation valid throughout the European Union for Replagal on 3 August 2001.
Evropska komisija je dovoljenje za promet z zdravilom Replagal, veljavno po vsej Evropski uniji, izdala 3. avgusta 2001.
Replagal has also been evaluated in additional studies involving 38 children aged 7 years or above.
Zdravilo Replagal so ocenili tudi v dodatnih študijah, v katerih je sodelovalo 38 otrok, starih sedem let ali več.
The full EPAR for Replagal 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 Replagal je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What benefit has Replagal shown during the studies?
Kakšne koristi je zdravilo Replagal izkazalo med študijami?
The effect of giving doses weekly rather than every two weeks was also investigated.
Proučevali so tudi učinke dajanja odmerkov vsak teden namesto vsaka dva tedna.
For more information about treatment with Replagal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Replagal preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This is a summary of the European public assessment report (EPAR) for Replagal.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Replagal.
Children who received Replagal had no unexpected increase in heart mass, and the levels of Gb3 in their blood were reduced.
Pri otrocih, ki so prejemali zdravilo Replagal, se srčna masa ni nepričakovano povečala, ravni Gb3 v krvi pa so se znižale.
The most common side effects with Replagal (seen in more than 1 patient in 10) are infusionassociated reactions.
Najpogostejši neželeni učinki zdravila Replagal (opaženi pri več kot 1 bolniku od 10) so reakcije, povezane z infundiranjem.
These include chills, headache, nausea, pyrexia (fever), pain and discomfort, flushing and fatigue (tiredness), and are rarely severe.
Med njimi so mrzlica, glavobol, slabost, pireksija (povišana telesna temperatura), bolečina in nelagodje, zardevanje in utrujenost in so redko resni.
Replagal is given once every 2 weeks as an infusion of 0.2 mg per kilogram body weight over 40 minutes.
Zdravilo se daje vsaka dva tedna v obliki 40-minutne infuzije v odmerku 0,2 mg/kg telesne mase.
Other information about Replagal
Druge informacije o zdravilu Replagal
Patients with Fabry disease do not have enough of an enzyme called alpha-galactosidase A. This enzyme normally breaks down a fatty substance called globotriaosylceramide (Gb3 or GL-3).
Bolniki s Fabryjevo boleznijo nimajo dovolj encima, imenovanega alfa-galaktozidaza A. Ta encim običajno razgrajuje maščobno snov, imenovano globotriaozilceramid (Gb3 ali GL-3 ).
What is the risk associated with Replagal?
Kakšna tveganja so povezana z zdravilom Replagal?
Replagal was originally authorised under ‘exceptional circumstances', because as the disease is rare, limited information was available at the time of approval.
Zdravilo Replagal je pridobilo dovoljenje za promet v „izjemnih okoliščinah“, saj so bile zaradi redkosti bolezni ob odobritvi zdravila na voljo le omejene informacije.
The replacement enzyme helps to break down the Gb3 and stops it building up in the cells.
Nadomestni encim pomaga razgraditi Gb3 in preprečiti njegovo kopičenje v celicah.