natgillin/translations-raw huggingface dataset:
• The committee considered the referral under Article 30 of Directive 2001/83/EC concerning the medicinal product Durogesic transdermal patches;
• Odbor je obravnaval napotitev v skladu s členom 30 Direktive 2001/83/ES v zvezi z zdravilom Durogesic transdermalni obliži; • Odbor je obravnaval razlike, prepoznane v obvestilu za zdravilo Durogesic in povezana imena ter preostale razdelke povzetka glavnih značilnosti zdravila, označevanju in navodilu za uporabo.
ANNEX II SCIENTIFIC CONCLUSIONS
Znanstveni zaključki
The vaccine is injected into the shoulder muscle.
Cepivo se injicira v ramensko mišico.
The fourth injection is given four months after the third.
Četrto injekcijo bolnik prejme štiri mesece po tretji.
The antibodies will help to protect against the disease caused by the virus.
Protitelesa bodo pomagala ščititi proti bolezni, ki jo povzroča ta virus.
The European Commission granted a marketing authorisation valid throughout the European Union for Fendrix on 2 February 2005.
Evropska komisija je dovoljenje za promet z zdravilom Fendrix, veljavno po vsej Evropski uniji, izdala 2. februarja 2005.
There should be a gap of one month between the first and second, and between the second and third injections.
Med prvo in drugo ter med drugo in tretjo injekcijo mora miniti en mesec.
The full EPAR for Fendrix 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 cepivo Fendrix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This system enhances the response of the immune system, which can help when vaccines are used in patients who may have a lower response, such as those with kidney problems.
Ta sistem okrepi odziv imunskega sistema, kar lahko pomaga, če se cepiva uporabljajo pri bolnikih, ki imajo morda slabši odziv, kot so na primer bolniki, ki imajo težave z ledvicami.
This is a summary of the European public assessment report (EPAR) for Fendrix.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Fendrix.
Other information about Fendrix
Druge informacije o zdravilu Fendrix
For more information about treatment with Fendrix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Fendrix preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The active substance in Fendrix has been available in other vaccines that have been authorised in the European Union (EU) for a number of years.
Zdravilna učinkovina cepiva Fendrix je na voljo v drugih cepivih, ki so v Evropski uniji (EU) odobrena že vrsto let.
It can be used in patients from the age of 15 years, including patients needing haemodialysis (a blood clearance technique used in patients with kidney disease).
Uporablja se lahko pri bolnikih od 15. leta starosti dalje, vključno z bolniki, ki potrebujejo hemodializo (tj. tehnika čiščenja krvi pri bolnikih z obolenjem ledvic).
The CHMP decided that Fendrix's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi cepiva Fendrix večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
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 Fendrix.
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 company also presented information on the use of Fendrix in liver transplant patients, but it withdrew the application for the use of Fendrix in these patients during the assessment of the vaccine.
Družba je predstavila tudi podatke o uporabi cepiva Fendrix pri bolnikih s presajenimi jetri, vendar je vlogo za uporabo cepiva Fendrix pri teh bolnikih med ocenjevanjem cepiva umaknila.
Fendrix is a vaccine, which is available as a suspension for injection.
Zdravilo Fendrix je cepivo, ki je na voljo v obliki suspenzije za injiciranje.
Fendrix has also been studied in one main study involving 165 patients aged 15 years and above who had kidney disease and needed haemodialysis.
Cepivo Fendrix so raziskovali tudi v eni glavni študiji, ki je vključevala 165 bolnikov, starih 15 let in več, ki so imeli obolenje ledvic in so zato potrebovali hemodializo.
What benefit has Fendrix shown during the studies?
Kakšne koristi je zdravilo Fendrix izkazalo med študijami?
The most common side effects with Fendrix (seen in more than 1 patient in 10) are headache, pain, redness, swelling at the injection site and fatigue (tiredness).
Najpogostejši neželeni učinki cepiva Fendrix (opaženi pri več kot 1 bolniku od 10) so glavobol, bolečina, rdečina, otekanje na mestu injiciranja in utrujenost.
Fendrix is a vaccine.
Zdravilo Fendrix je cepivo.
Because the active substance in Fendrix has been available in the EU in other vaccines, some of the information used to support the use of the other vaccines was used to support the use of Fendrix.
Ker je zdravilna učinkovina cepiva Fendrix v EU že na voljo v drugih cepivih, so bili za podporo cepivu Fendrix uporabljeni tudi nekateri podatki, ki podpirajo uporabo drugih cepiv.
The recommended vaccination schedule for Fendrix is four doses.
Priporočeno shemo cepljenja s cepivom Fendrix sestavljajo štirje odmerki.
Fendrix was as effective as a double dose of the comparator vaccine.
Cepivo Fendrix je bilo učinkovitejše od dvojnega odmerka primerjalnega cepiva.
The surface antigens are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Površinske antigene proizvajajo z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri kvasovka prejeme gen (DNK), s katerim lahko tvori beljakovine.
The effect of Fendrix lasted longer than that of the comparator vaccine: 80% of the patients receiving Fendrix maintained protective levels of antibody for up to three years, compared with 51% of those receiving the comparator.
Učinek cepiva Fendrix je trajal dlje kot učinek primerjalnega cepiva: 80 % bolnikov, ki so prejemali cepivo Fendrix, je obdržalo zaščitne ravni protiteles do tri leta, pri bolnikih, ki so prejemali primerjalno cepivo, pa je bil ta delež 51 %.
It is recommended that individuals who receive the first dose should complete the course with Fendrix.
Priporočeno je, da posamezniki, ki prejmejo prvi odmerek cepiva Fendrix, končajo celoten program zdravljenja.
In the future, the immune system will be able to make antibodies more quickly when it is exposed to the hepatitis B virus.
V prihodnosti lahko imunski sistem ob izpostavitvi virusu hepatitisa B hitreje ustvarja protitelesa.
In Fendrix, it is used with an ‘adjuvant system' which contains ‘MPL', a purified fat from bacteria, and an aluminium compound.
V cepivu Fendrix se uporablja s „sistemom adjuvansov”, ki vsebuje „MPL”, prečiščeno maščobo iz bakterij in aluminijevo spojino.
What is the risk associated with Fendrix?
Kakšna tveganja so povezana z zdravilom Fendrix?
One month after the last dose, 91% of the patients receiving Fendrix had protective levels of antibodies against the hepatitis B virus, compared with 84% of those receiving the comparator.
En mesec po zadnjem odmerku je imelo 91 % bolnikov, ki so prejemali cepivo Fendrix, zaščitne ravni protiteles proti virusu hepatitisa B, pri bolnikih, ki so prejemali primerjalno cepivo, pa je bil ta delež 84 %.
Fendrix is used to protect patients with kidney problems against hepatitis B (a disease of the liver due to infection with the hepatitis B virus).
Cepivo Fendrix se uporablja za zaščito bolnikov z ledvičnimi težavami proti virusu hepatitisa B (obolenju jeter zaradi okužbe z virusom hepatitisa B).
The main measure of effectiveness was the proportion of patients who developed protective levels of antibodies against the hepatitis B virus.
Glavno merilo učinkovitosti je bil delež oseb, pri katerih se je pojavila zaščitna raven protiteles proti virusu hepatitisa B.
A booster dose of Fendrix may be given, according to official recommendations.
Bolnik lahko skladno z uradnimi priporočili prejme tudi poživitveni odmerek cepiva Fendrix.
It contains parts of the hepatitis B virus as the active substance.
Kot zdravilno učinkovino vsebuje dele virusa hepatitisa B.
Why has Fendrix been approved?
Zakaj je bilo zdravilo Fendrix odobreno?
For the full list of side effects reported with Fendrix, see the package leaflet.
Za celoten opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Fendrix, glejte navodilo za uporabo.
Fendrix hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
Fendrix adsorbirano cepivo proti hepatitisu B (rDNA) z adjuvansom
Fendrix must not be used in people who are hypersensitive (allergic) to the active substance or any of the other ingredients or have had an allergic reaction after being given a hepatitis B vaccine.
Cepiva Fendrix ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) zdravilno učinkovino ali katero koli drugo sestavino zdravila ali pri katerih so se pojavile alergijske reakcije po tem, ko so prejeli cepivo proti hepatitisu B. Cepivo Fendrix se ne sme dajati bolnikom s hudo in nenadno visoko telesno temperaturo.
Fendrix was compared with a double dose of Engerix B (another hepatitis B vaccine).
Cepivo Fendrix so primerjali s cepivom Engerix B (drugim cepivom proti virusu hepatitisa B), ki so ga uporabljali v dvojnem odmerku.
How has Fendrix been studied?
Kako je bilo zdravilo Fendrix raziskano?
How does Fendrix work?
Kako zdravilo Fendrix deluje?
What is Fendrix?
Kaj je zdravilo Fendrix?
What is Fendrix used for?
Za kaj se zdravilo Fendrix uporablja?
How is Fendrix used?
Kako se zdravilo Fendrix uporablja?
When a patient is given the vaccine, the immune system recognises the surface antigens as ‘foreign' and makes antibodies against them.
Cepivo Fendrix vsebuje majhno količino „površinskega antigena“ (beljakovine iz površine) virusa hepatitisa B. Ko oseba prejme cepivo, imunski sistem prepozna površinske beljakovine kot „tujke“ in začne proti njim tvoriti protitelesa.
(Invented) name Strength Pharmaceutical Form Route of Administration
(Izmišljeno) ime Jakost
Higher doses were no more effective than this dose.
Višji odmerki niso bili učinkovitejši od tega odmerka.
Doses of FSH are adjusted according to the response, and treatment may continue for up to five weeks.
Odmerki FSH se prilagajajo glede na odziv, pri čemer lahko zdravljenje traja do pet tednov.
The European Commission granted a marketing authorisation valid throughout the European Union for Luveris to Merck Serono Europe Limited on 29 November 2000.
Evropska komisija je dovoljenje za promet z zdravilom Luveris, veljavno po vsej Evropski uniji, odobrila družbi Merck Serono Europe Limited dne 29. novembra 2000.
If the powder and solvent are used, they should be mixed together just before use.
Če se uporabljata prašek in vehikel, ju je treba zmešati tik pred uporabo.
Because the number of patients with this condition is low, Luveris was not compared with any other medicines.
Ker je bilo število bolnic s tem stanjem majhno, zdravila Luveris niso primerjali z nobenim drugim zdravilom.
The patient's response to treatment is monitored to check how the egg development in the ovary is progressing.
Odziv bolnice na zdravljenje se spremlja, da bi preverili, kako napreduje razvoj jajčec v jajčniku.
The full EPAR for Luveris 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 Luveris je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Lutropin alfa is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce human LH.
Lutropin alfa je izdelan z metodo, imenovano „tehnologija rekombinantne DNK“: izdela ga celica, ki je prejela gen (DNK), s katerim lahko tvori humani LH.
The patient may carry out the injection herself if she is well-motivated, has been adequately trained and has access to expert advice.
Bolnica lahko injiciranje izvede sama, če je dovolj motivirana, če je bila za to ustrezno usposobljena ali če ima možnost posvetovanja s strokovnjakom.
In the main study, 67% of the women who received the approved dose of Luveris (75 International Units) together with FSH produced functional follicles (6 out of 9).
V glavni študiji so pri 67 % žensk, ki so prejele odobreni odmerek zdravila Luveris (75 internacionalnih enot) v kombinaciji s FSH, nastali funkcionalni folikli (6 od 9).
The main measure of effectiveness was the number of women who produced functional follicles (eggs in the ovaries that are ready for release).
Glavno merilo učinkovitosti je bilo število žensk, pri katerih so nastali funkcionalni folikli (jajčeca v jajčnikih, ki so pripravljena na ovulacijo).
The resulting solution can be mixed with FSH in the same syringe.
Nastalo raztopino je mogoče zmešati s FSH v isti brizgi.
FSH, which is used together with Luveris, also stimulates ovulation.
FSH, ki se uporablja skupaj z zdravilom Luveris, prav tako spodbuja ovulacijo.
EPAR summary for the public lutropin alfa
Povzetek EPAR za javnost lutropin alfa
For more information about treatment with Luveris, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Luveris preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
In the body, LH causes the release of eggs (ovulation) during the menstrual cycle.
LH v telesu povzroči sprostitev jajčec (ovulacijo) med menstrualnim ciklom.
Other information about Luveris
Druge informacije o zdravilu Luveris
The CHMP decided that Luveris's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Luveris večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The most common side effects with Luveris (seen in between 1 and 10 patients in 100) are reactions at the injection site (pain, redness, bruising or swelling), headache,, nausea (feeling sick), vomiting, diarrhoea, abdominal pain and discomfort, pelvic (lower abdominal) pain, mild to moderate ovarian hyperstimulation syndrome, ovarian cyst (development of a fluid-filled cavity in the ovary) and breast pain.
Najpogostejši neželeni učinki zdravila Luveris (opaženi pri 1 do 10 bolnicah od 100) so reakcije na mestu injiciranja (bolečina, rdečina, modrice, ali otekanje), glavobol, navzeja (slabost), bruhanje, driska, bolečina in neprijeten občutek v trebuhu, bolečine v medenici, blag do zmeren sindrom ovarijske hiperstimulacije, ovarijska cista in bolečine v dojkah.
Treatment with Luveris should be carried out by a doctor who has experience in the treatment of fertility problems.
Zdravljenje z zdravilom Luveris mora izvajati zdravnik z izkušnjami pri zdravljenju težav s plodnostjo.
What benefit has Luveris shown during the studies?
Kakšne koristi je zdravilo Luveris izkazalo med študijami?
It must also not be used when there is enlargement of the ovaries or cysts that are not related to polycystic ovarian disease and are of unknown origin, or unexplained bleeding from the vagina.
Ne sme se uporabljati ob povečanju jajčnikov ali prisotnosti cist, ki niso povezane s policističnim obolenjem jajčnikov in so neznanega izvora, ali nepojasnjenem krvavenju iz nožnice.
It is used with follicle stimulating hormone (FSH) to stimulate the development of eggs in the ovaries of adult women who have severe deficiency (very low levels) of luteinising hormone (LH) and FSH.
Uporablja se s folikle stimulirajočim hormonom (FSH) za spodbujanje nastajanja jajčec v jajčnikih pri odraslih ženskah s hudim pomanjkanjem (zelo nizko ravnjo) luteinizirajočega hormona (LH) in FSH.
This is a summary of the European public assessment report (EPAR) for Luveris.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Luveris.
Luveris, given together with FSH, has been studied in one main study involving 38 women with severe LH and FSH deficiency.
Zdravilo Luveris, ki so ga bolniki jemali skupaj s FSH, je bilo raziskano v eni glavni študiji, v katero je bilo vključenih 38 žensk s hudim pomanjkanjem LH in FSH.
Luveris is given once a day together with FSH.
Zdravilo Luveris se daje enkrat dnevno skupaj s FSH.
Luveris should not be used in people who may be hypersensitive (allergic) to LH, FSH or any of the other ingredients.
Zdravila Luveris ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) LH, FSH ali katero koli drugo sestavino zdravila.
Luveris is given by injection under the skin.
Zdravilo Luveris se injicira pod kožo.
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 Luveris.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Luveris, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What is the risk associated with Luveris?
Kakšna tveganja so povezana z zdravilom Luveris?
Ovarian hyperstimulation syndrome occurs when the ovaries over respond to treatment, especially when medicines to trigger ovulation have been used, and can cause nausea, weight gain and diarrhoea.
Sindrom ovarijske hiperstimulacije nastopi, kadar je odziv jajčnikov na zdravljenje prevelik, zlasti če so uporabljena zdravila za sprožitev ovulacije, in lahko povzroči navzejo, povečanje telesne mase in drisko.
The active substance in Luveris, lutropin alfa, is a copy of the natural hormone LH.
Učinkovina zdravila Luveris, lutropin alfa, je kopija naravnega luteinizirajočega hormona (LH).
It is available as a powder and solvent that are made up into a solution for injection, and as a solution for injection in a pre-filled pen.
Na voljo je v obliki praška in vehikla, ki se zmešata v raztopino za injiciranje, ter v obliki raztopine za injiciranje v napolnjenem peresniku.
Luveris is a medicine that contains the active substance lutropin alfa.
Luveris je zdravilo, ki vsebuje zdravilno učinkovino lutropin alfa.
Why has Luveris been approved?
Zakaj je bilo zdravilo Luveris odobreno?
For the full list of all side effects reported with Luveris, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Luveris, glejte navodilo za uporabo.
It must not be used in women who have tumours of the pituitary gland, hypothalamus (a region of the brain), breast, womb or ovary.
Ne smejo ga uporabljati bolnice s tumorji hipofize, hipotalamusa, dojk, maternice ali jajčnikov.
What is Luveris?
Kaj je zdravilo Luveris?
What is Luveris used for?
Za kaj se zdravilo Luveris uporablja?
How has Luveris been studied?
Kako je bilo zdravilo Luveris raziskano?
How is Luveris used?
Kako se zdravilo Luveris uporablja?
Luveris is a fertility treatment.
Zdravilo Luveris je namenjeno za zdravljenje težav s plodnostjo.
How does Luveris work?
Kako zdravilo Luveris deluje?
This overview was last updated in 04-2019.
Pregled je bil nazadnje posodobljen 04-2019.
Adempas is available as tablets (0.5, 1, 1.5, 2 and 2.5 mg).
Na voljo je v obliki tablet (0,5, 1, 1,5, 2 in 2,5 mg).
It also noted that no other medicines have been authorised for CTEPH.
Izpostavila je tudi, da za CTEPH ni odobreno nobeno drugo zdravilo.
The usual recommended starting dose is 1 mg three times a day (approximately 6 to 8 hours apart) for two weeks.
Običajni priporočeni začetni odmerek je 1 mg trikrat na dan (približno vsakih šest do osem ur) v obdobju dveh tednov.
The dose is then increased every two weeks until the appropriate dose for the individual patient is established.
Odmerek se nato vsaka dva tedna povečuje do odmerka, ki je primeren za posameznega bolnika.
What measures are being taken to ensure the safe and effective use of Adempas?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Adempas?
Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations/eu307518.
Nadaljnje informacije glede določitve zdravila sirote lahko najdete tukaj: ema.europa.eu/en/medicines/human/orphan-designations/eu307518.
The Agency therefore decided that Adempas's benefits are greater than its risks and that it can be authorised for use in the EU.
Agencija je zato zaključila, da so koristi zdravila Adempas večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Adempas received a marketing authorisation valid throughout the European Union on 27 March 2014.
Za zdravilo Adempas je bilo 27. marca 2014 izdano dovoljenje za promet, veljavno po vsej EU.
An overview of Adempas and why it is authorised in the EU
Pregled zdravila Adempas in zakaj je odobreno v EU
The ‘class' reflects the seriousness of the disease: ‘class II' involves slight limitation of physical activity while ‘class III' involves marked limitation of physical activity.
Razred opredeljuje resnost bolezni: „razred II“ vključuje rahlo omejeno telesno zmogljivost, „razred III“ pa izrazito omejeno telesno zmogljivost.
Other information about Adempas
Druge informacije o zdravilu Adempas
As for all medicines, data on the use of Adempas are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Adempas stalno spremljajo.
What benefits of Adempas have been shown in studies?
Kakšne koristi zdravila Adempas so se pokazale v študijah?
Further information on Adempas can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/adempas.
Nadaljnje informacije o zdravilu Adempas so na voljo na spletni strani agencije: ema.europa.eu/en/medicines/human/EPAR/adempas.
For patients unable to swallow whole tablets, the tablets may be crushed and mixed with water or soft food such as apple sauce.
Če bolniki ne morejo pogoltniti celih tablet, se lahko tablete zdrobijo in zmešajo z vodo ali mehko hrano, na primer jabolčno čežano.
• The medicine was also compared with placebo in another main study in 445 patients with PAH.
• Zdravilo so s placebom primerjali še v eni glavni študiji s 445 bolniki s PAH.
This helps to lower the blood pressure in the lungs and improve symptoms of CTEPH and PAH.
To pomaga pri znižanju krvnega tlaka v pljučih in izboljšanju simptomov CTEPH in PAH.
Side effects reported with Adempas are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Adempas, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What is Adempas and what is it used for?
Kaj je zdravilo Adempas in za kaj se uporablja?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Adempas 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 Adempas upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
What are the risks associated with Adempas?
Kakšna tveganja so povezana z zdravilom Adempas?
Regarding safety it considered that side effects of concern, including haemoptysis and pulmonary haemorrhage, have been adequately reflected in the product information and risk management plan.
V zvezi z varnostjo je agencija menila, da so zadevni neželeni učinki, kot so hemoptiza in pljučne krvavitve, ustrezno obravnavani v informacijah o zdravilu in načrtu obvladovanja tveganj.