natgillin/translations-raw huggingface dataset:
Rasilez HCT received a marketing authorisation valid throughout the EU on 16 January 2009.
Za zdravilo Rasilez HCT je bilo 16. januarja 2009 izdano dovoljenje za promet, veljavno po vsej EU.
Rasilez HCT can only be obtained with a prescription and it is available as tablets (150 mg/12.5 mg; 150 mg/25 mg; 300 mg /12.5 mg; 300 mg/25 mg).The recommended dose of Rasilez HCT is one tablet per day.
Predpisovanje in izdaja zdravila Rasilez HCT je le na recept, zdravilo pa je na voljo v obliki tablet (150 mg/12,5 mg; 150 mg/25 mg; 300 mg /12,5 mg; 300 mg/25 mg).Priporočeni odmerek zdravila Rasilez HCT je ena tableta na dan. Odmerek je odvisen od odmerkov aliskirena ali hidroklorotiazida, ki ju je bolnik jemal prej.
The European Medicines Agency decided that Rasilez HCT'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 Rasilez HCT večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Taking the two active substances in one tablet is expected to help patients to stick to their treatment.
Jemanje dveh učinkovin v eni tableti naj bi bolnikom pomagalo, da se bodo lahko držali svojega zdravljenja.
After two to four weeks of taking Rasilez HCT, the dose can be increased in patients whose blood pressure remains uncontrolled.
Po dveh do štirih tednih jemanja zdravila Rasilez HCT se lahko odmerek poveča pri bolnikih, katerih krvni tlak še vedno ni nadzorovan.
What measures are being taken to ensure the safe and effective use of Rasilez HCT?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Rasilez HCT?
The studies lasted for between 8 weeks and a year, and the main measure of effectiveness was the change in blood pressure either during the resting phase of the heartbeat (diastolic) or when the chambers of the heart were contracting (systolic).
Študije so trajale od osem tednov do enega leta, glavno merilo učinkovitosti pa je bila sprememba krvnega tlaka med mirovalno fazo srčnega utripa (diastolični tlak) ali med krčenjem srčnih komor (sistolični tlak).
Rasilez HCT (aliskiren / hydrochlorothiazide)
Rasilez HCT (aliskiren/hidroklorotiazid)
As for all medicines, data on the use of Rasilez HCT are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Rasilez HCT stalno spremljajo.
Rasilez HCT should not be taken together with fruit juice or drinks containing plant extracts such as herbal teas.
Zdravilo Rasilez HCT se ne sme jemati skupaj s sadnim sokom ali pijačami, ki vsebujejo rastlinske izvlečke, kot so na primer zeliščni čaji.
The most common side effect with Rasilez HCT (which may affect between 1 and 10 patients in 100) is diarrhoea.
Najpogostejši neželeni učinek zdravila Rasilez HCT (ki se lahko pojavi pri 1 do 10 bolnikih od 100) je driska.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rasilez HCT 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 Rasilez HCT upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Rasilez HCT is a medicine used to treat essential hypertension (high blood pressure) in adults.
Zdravilo Rasilez HCT se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka) pri odraslih.
For more information about using Rasilez HCT, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Rasilez HCT glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Side effects reported with Rasilez HCT are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Rasilez HCT, se skrbno ovrednotijo in po potrebi sprejmejo ukrepi za zaščito bolnikov.
Three additional studies showed that the active substances were absorbed in the body in the same way when taken as separate tablets and as Rasilez HCT.
V treh dodatnih študijah so dokazali, da sta se učinkovini absorbirali v telo enako, če sta bili vzeti v obliki ločenih tablet ali kot zdravilo Rasilez HCT.
What benefits of Rasilez HCT have been shown in studies?
Kakšne koristi zdravila Rasilez HCT so se pokazale v študijah?
What is Rasilez HCT and what is it used for?
Kaj je zdravilo Rasilez HCT in za kaj se uporablja?
Other common side effects (which may affect more than 1 in 10 patients) that have been observed with hydrochlorothiazide alone are hypokalaemia (low blood potassium levels) and increases in blood cholesterol and triglyceride (a type of fat) levels.
Druga najpogostejša neželena učinka (ki se lahko pojavita pri več kot 1 bolniku od 10) pri uporabi samo hidroklorotiazida sta hipokaliemija (nizka raven kalija v krvi) in povišanje ravni holesterola ter triglicerida (vrste maščobe) v krvi.
Other information about Rasilez HCT
Druge informacije o zdravilu Rasilez HCT
It must not be taken with ciclosporin, itraconazole or other medicines known as ‘potent P-glycoprotein inhibitors' (such as quinidine).
Ne sme se jemati skupaj s ciklosporinom, itrakonazolom ali drugimi zdravili, za katere je znano, da so močni zaviralci P-glikoproteina (kot je kinidin).
The studies compared the combination of aliskiren and hydrochlorothiazide with placebo (a dummy treatment), with aliskiren or hydrochlorothiazide taken alone, or with other medicines for hypertension (valsartan, irbesartan, lisinopril or amlodipine).
V študijah so primerjali kombinacijo aliskirena in hidroklorotiazida s placebom (zdravilom brez učinkovine), aliskirenom ali hidroklorotiazidom kot samostojnima zdraviloma ali drugimi zdravili za zdravljenje hipertenzije (valsartanom, irbesartanom, lizinoprilom ali amlodipinom).
The company presented information used in the assessment of aliskiren and from the published literature to support its application for Rasilez HCT, as well as information from additional studies.
Podjetje je v podporo svoji vlogi za zdravilo Rasilez HCT predstavilo informacije, ki so bile uporabljene pri oceni aliskirena, ter informacije iz objavljene literature in dodatnih študij.
Why is Rasilez HCT authorised in the EU?
Zakaj je bilo zdravilo Rasilez HCT odobreno v EU?
Rasilez HCT is used in patients whose blood pressure is not adequately controlled by aliskiren or hydrochlorothiazide taken alone.
Zdravilo Rasilez HCT se uporablja pri bolnikih, pri katerih krvni tlak ni ustrezno nadzorovan z uporabo samo aliskirena ali hidroklorotiazida.
Rasilez HCT must not be used in patients who have had angioedema (swelling under the skin) with aliskiren, hereditary angioedema or angioedema of no obvious cause, who have anuria (a condition in which a patient cannot make or pass urine), severe kidney or liver impairment, or whose blood potassium levels are too low or blood calcium levels are too high.
Zdravilo Rasilez HCT se ne sme uporabljati pri bolnikih, pri katerih se je zaradi jemanja aliskirena pojavil angioedem (podkožno otekanje), pri bolnikih z dednim angioedemom ali angioedemom, za katerega ni očitnega vzroka, pri bolnikih z anurijo (bolezenskim stanjem, pri katerem bolnik ne more odvajati urina), s hudo okvaro ledvic ali jeter, ali pri bolnikih, pri katerih je raven kalija v krvi prenizka oziroma raven kalcija v krvi previsoka.
An overview of Rasilez HCT and why it is authorised in the EU
Pregled zdravila Rasilez HCT in zakaj je odobreno v EU
What are the risks associated with Rasilez HCT?
Kakšna tveganja so povezana z zdravilom Rasilez HCT?
It can also be used in patients whose blood pressure is adequately controlled with aliskiren and hydrochlorothiazide taken as separate tablets, to replace the same doses of the two active substances.
Lahko pa se uporablja tudi pri bolnikih, pri katerih je krvni tlak ustrezno nadzorovan z aliskirenom in hidroklorotiazidom, ki ju bolniki jemljejo kot ločeni tableti, za nadomestitev istih odmerkov dveh učinkovin.
Patients previously taking only aliskiren or hydrochlorothiazide may need to take the two substances as separate tablets and adjust the doses before switching to Rasilez HCT.
Bolniki, ki so predhodno jemali samo aliskiren ali hidroklorotiazid, bodo morda morali vzeti obe učinkovini v ločenih tabletah in odmerke pred prehodom na zdravilo Rasilez HCT prilagoditi.
By lowering blood pressure, the risk caused by high blood pressure, such as having a stroke, is reduced.
Z znižanjem krvnega tlaka se zmanjša tveganje za bolezni, povezane z visokim krvnim tlakom, kot je na primer kap.
Rasilez HCT is for use in adults only; it must not be used in children aged less than 2 years and is not recommended for older children.
Ne sme se uporabljati pri otrocih, mlajših od dveh let, medtem ko njegova uporaba pri starejših otrocih ni priporočljiva.
In patients whose blood pressure was not adequately controlled on either aliskiren or hydrochlorothiazide alone, switching to the combination resulted in greater falls in blood pressure than remaining on one active substance alone.
Pri bolnikih, pri katerih krvni tlak ni bil ustrezno uravnan samo z aliskirenom ali samo s hidroklorotiazidom, je prehod na kombinacijo zdravil povzročil večji padec krvnega tlaka kot jemanje samo ene učinkovine.
Results showed that Rasilez HCT was more effective than placebo in reducing blood pressure.
Rezultati so pokazali, da zdravilo Rasilez HCT krvni tlak znižuje učinkoviteje od placeba.
The two active substances in Rasilez HCT, aliskiren and hydrochlorothiazide, work in different ways to reduce blood pressure.
Učinkovini v zdravilu Rasilez HCT, aliskiren in hidroklorotiazid, različno znižujeta krvni tlak.
For the full list of all side effects reported with Rasilez HCT, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Rasilez HCT, glejte navodilo za uporabo.
The medicine has been shown to reduce blood pressure more than each active substance alone.
Dokazali so, da to zdravilo znižuje krvni tlak bolj kot katera koli od njegovih učinkovin posamezno.
Side effects are similar to those of the two active substances.
Neželeni učniki so podobni kot pri obeh učinkovinah.
In patients already adequately controlled with the two active substances, the dose of Rasilez HCT must contain the same doses of aliskiren and hydrochlorothiazide that the patient was taking before.
Pri bolnikih, katerih krvni tlak je že nadzorovan z obema učinkovinama, mora odmerek zdravila Rasilez HCT vsebovati enake odmerke aliskirena in hidroklorotiazida, kot ju je bolnik jemal prej.
Rasilez HCT in combination with an ‘angiotensin converting enzyme (ACE) inhibitors' or ‘angiotensin receptor blockers' (ARBs) must not be used in patients with diabetes,
Zdravilo Rasilez HCT se v kombinaciji z zaviralci angiotenzinske konvertaze (ACE) ali zaviralci angiotenzinskih receptorjev (ARB) ne sme uporabljati pri sladkornih bolnikih ali bolnikih z zmerno ali hudo ledvično okvaro.
The medicine contains the active substances aliskiren and hydrochlorothiazide.
Zdravilo Rasilez HCT vsebuje učinkovini aliskiren in hidroklorotiazid.
Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (a substance that narrows blood vessels).
Zavira dejavnost človeškega encima, imenovanega renin, ki v telesu sodeluje pri tvorjenju angiotenzina I. Angiotenzin I se pretvori v hormon angiotenzin II, ki deluje kot močan vazokonstriktor (učinkovina, ki oži krvne žile).
The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone.
Kombinacija obeh učinkovin daje pri zniževanju krvnega tlaka boljše rezultate kot posamezni učinkovini, uporabljeni kot samostojni zdravili.
How is Rasilez HCT used?
Kako se zdravilo Rasilez HCT uporablja?
How does Rasilez HCT work?
Kako zdravilo Rasilez HCT deluje?
It is available as capsules (290 micrograms).
Na voljo je v obliki kapsul (290 mikrogramov).
It has also been shown to have a beneficial impact on the quality of life of patients.
Prav tako ima koristen vpliv na kakovost življenja bolnikov.
The doctor should periodically assess the need of continued treatment.
Zdravnik mora redno ocenjevati potrebo po nadaljevanju zdravljenja.
The European Commission granted a marketing authorisation valid throughout the European Union for Constella on 26 November 2012.
Evropska komisija je dovoljenje za promet z zdravilom Constella, veljavno po vsej Evropski uniji, odobrila dne 26. novembra 2012.
The recommended dose of Constella is one capsule once a day, taken at least 30 minutes before a meal.
Priporočeni odmerek zdravila Constella je ena kapsula enkrat dnevno vsaj 30 minut pred obrokom.
Other information about Constella
Druge informacije o zdravilu Constella
One of the studies also looked at the effects of Constella following 26 weeks of treatment.
V eni študiji so proučevali tudi učinek zdravila Constella po 26 tednih zdravljenja.
The effects of Constella were first tested in experimental models before being studied in humans.
Učinki zdravila Constella so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
EPAR summary for the public linaclotide
Povzetek EPAR za javnost linaklotid
The full EPAR for Constella 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 Constella je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
However, the Committee also noted that about half of the patients did not adequately benefit from treatment, and therefore recommended that the need for continued treatment should be reconsidered after four weeks.
Odbor je zabeležil tudi, da približno polovica bolnikov ni imela ustreznih koristi zaradi zdravljenja, zato priporoča, da se po štirih tednih razmisli o nadaljevanju zdravljenja.
If the patient has not experienced an improvement in symptoms after four weeks of treatment, the benefits and risks of continuing treatment should be reconsidered.
Če se pri bolniku v štirih tednih zdravljenja simptomi ne izboljšajo, je treba znova razmisliti o koristih in tveganjih nadaljevanja zdravljenja.
For more information about treatment with Constella, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Constella 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 Constella.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Constella.
It must also not be used in patients with a known or suspected blockage in their stomach or gut.
Zdravila prav tako ni dovoljeno uporabljati pri bolnikih z znano ali morebitno blokado v želodcu ali črevesju.
What benefit has Constella shown during the studies?
Kakšne koristi je zdravilo Constella izkazalo med študijami?
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 Constella.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Constella, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Constella must not be used in people who are hypersensitive (allergic) to linaclotide or any of the other ingredients.
Zdravila Constella ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) linaklotid ali katero koli drugo sestavino zdravila.
In rare and more severe cases, diarrhoea may lead to dehydration, hypokalaemia (low blood potassium levels), decrease in blood bicarbonate, dizziness and orthostatic hypotension (low blood pressure on standing up).
V redkih in hudih primerih lahko to povzroči dehidracijo, hipokaliemijo (nizko raven kalija v krvi), znižane ravni bikarbonata v krvi, omotico in ortostatsko hipotenzijo (nizek krvni tlak pri vstajanju).
Constella is a medicine that contains the active substance linaclotide.
Constella je zdravilo, ki vsebuje zdravilno učinkovino linaklotid.
What is the risk associated with Constella?
Kakšna tveganja so povezana z zdravilom Constella?
The CHMP therefore decided that Constella's benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Constella večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Constella was investigated in two main studies involving a total of 1,608 patients with IBS with constipation, where it was compared with placebo (a dummy treatment).
Zdravilo Constella so proučevali v dveh glavnih študijah, v kateri je bilo vključenih 1.608 bolnikov z IBS z zaprtostjo, pri katerih so primerjali zdravilo Constella s placebom (zdravilom brez zdravilne učinkovine).
The active substance in Constella, linaclotide, attaches to some receptors in the gut called guanylate cyclase C. By attaching to these receptors, it reduces pain and increases the secretion of fluid into the gut, thereby loosening the stools and increasing bowel movements.
Zdravilna učinkovina zdravila Constella, linaklotid, se veže na nekatere receptorje v črevesju, imenovane gvanilat ciklaze C. Z vezavo nanje zmanjša bolečino in poveča izločanje tekočine v črevesje ter s tem zmehča blato in poveča njegovo izločanje.
Constella was shown to be more effective than placebo at improving the symptoms of IBS.
Zdravilo Constella je bilo pri izboljšanju simptomov IBS učinkoviteje od placeba.
Why has Constella been approved?
Zakaj je bilo zdravilo Constella odobreno?
The most common side effect with Constella is diarrhoea, mainly mild to moderate, occurring in between 10 and 20 patients in 100.
Najpogostejši neželeni učinek zdravila Constella je blaga do zmerno huda driska, ki se pojavi pri 10 do 20 bolnikih od 100.
Constella is used to treat the symptoms of moderate to severe irritable bowel syndrome (IBS) with constipation in adults.
Zdravilo Constella se uporablja za zdravljenje simptomov zmerno hudega do hudega sindroma razdražljivega črevesja z zaprtostjo (IBS-C − irritable bowel syndrome with constipation) pri odraslih.
The CHMP noted that Constella has been shown to have clinically relevant, beneficial effects in patients with IBS with constipation in the long term (for up to six months).
CHMP je zaključil, da ima zdravilo Constella dolgoročne (do šest mesecev) klinično pomembne koristne učinke pri bolnikih z IBS z zaprtostjo.
IBS is a long-term disorder of the gut characterised by pain or discomfort in the abdomen and bloating together with altered bowel habit.
IBS je dolgotrajna bolezen črevesja, za katero so značilni bolečina, neugodje v trebuhu in napenjanje s spremembami v delovanju črevesja.
The main measures of effectiveness were the number of patients who experienced at least a 30% improvement in their pain and discomfort and the number of patients who were considerably or completely relieved from all IBS symptoms for at least 6 out of the 12 weeks of treatment.
Glavni merili učinkovitosti sta bili število bolnikov z vsaj 30 % zmanjšanjem bolečine in neugodja ter število bolnikov, pri katerih so se vsi simptomi IBS znatno izboljšali ali so popolnoma izginili za vsaj 6 od 12 tednov zdravljenja.
How has Constella been studied?
Kako je bilo zdravilo Constella raziskano?
The results after 26 weeks of treatment showed an improvement in pain (for at least 13 weeks out of the 26 weeks) in 54% of patients taking Constella compared with 36% of patients taking placebo, as well as relief from symptoms for at least 13 weeks in 37% of Constella patients, compared with 17% of patients in the placebo group.
Rezultati po 26 tednih zdravljenja so pokazali zmanjšanje bolečine (za vsaj 13 od 26 tednov) pri 54 % bolnikov, ki so prejemali zdravilo Constella, v primerjavi s 36 % bolnikov, ki so prejemali placebo, kakor tudi zmanjšanje simptomov za vsaj 13 tednov pri 37 % bolnikov, ki so prejemali zdravilo Constella, v primerjavi s 17 % bolnikov, ki so prejemali placebo.
In the first study, 55% of patients who received Constella experienced a 30% or higher improvement in their pain and discomfort for at least 6 out of the 12 weeks of treatment, compared with 42% of patients who received placebo.
V prvi študiji sta se pri 55 % bolnikov, ki so prejemali zdravilo Constella, bolečina in neugodje zmanjšala za 30 % ali več za vsaj 6 od 12 tednov zdravljenja v primerjavi z 42 % bolnikov, ki so prejemali placebo.
What is Constella used for?
Za kaj se zdravilo Constella uporablja?
In addition, 37% of patients who received Constella were considerably or completely relieved from symptoms for at least 6 out of the 12 weeks of treatment, compared with 19% of patients who received placebo.
Poleg tega so se pri 37 % bolnikih, ki so prejemali zdravilo Constella, simptomi znatno izboljšali ali popolnoma izginili za vsaj 6 od 12 tednov zdravljenja v primerjavi z 19 % bolnikov, ki so prejemali placebo.
Regarding safety, the CHMP concluded that the side effects with Constella, mainly diarrhoea, are manageable.
menil, da so neželeni učinki zdravila Constella, v glavnem driska, obvladljivi.
How is Constella used?
Kako se zdravilo Constella uporablja?
Similar results were obtained in the second study, with 54% of Constella patients experiencing an improvement in their pain and discomfort and 39% of them feeling considerably or completely relieved from symptoms for at least 6 out of the 12 weeks of treatment, compared with 39% and 17% of patients in the placebo group, respectively.
O podobnih rezultatih so poročali v drugi študiji, kjer sta se bolečina in neugodje zmanjšala pri 54 % bolnikov, ki so prejemali zdravilo Constella, pri 39 % bolnikov pa so se simptomi znatno izboljšali ali popolnoma izginili za vsaj 6 od 12 tednov zdravljenja v primerjavi z 39 % oz. 17 % bolnikov, ki so prejemali placebo.
What is Constella?
Kaj je zdravilo Constella?
How does Constella work?
Kako zdravilo Constella deluje?
This overview was last updated in December 2018.
Povzetek je bil nazadnje posodobljen decembra 2018.
Further information on Melosus can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/melosus.
Nadaljnje informacije o zdravilu Melosus so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/melosus.
As for every medicine, the company provided studies on the quality of Melosus.
Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Melosus.
Melosus received a marketing authorisation valid throughout the EU on21 February 2011.
Za zdravilo Melosus je bilo 21. februarja 2011 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
What are the benefits and risks of Melosus?
Kakšne so koristi in tveganja, povezani z zdravilom Melosus?
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Metacam, and do not need to be repeated for Melosus.
Študije o koristih in tveganjih učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Metacam, zato jih ni treba ponoviti za zdravilo Melosus.
Other information about Melosus
Druge informacije o zdravilu Melosus
Why is Melosus authorised in the EU?
Zakaj je zdravilo Melosus odobreno v EU?
An overview of Melosus and why it is authorised in the EU
Pregled zdravila Melosus in zakaj je odobreno v EU
The European Medicines Agency concluded that, in accordance with EU requirements, Melosus has been shown to have comparable quality and to be bioequivalent to Metacam.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Melosus primerljivo raven kakovosti in je bioekvivalentno zdravilu Metacam.