natgillin/translations-raw huggingface dataset:
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Rixathon has a highly similar structure, purity and biological activity to MabThera and is distributed in the body in the same way.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Rixathon po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu MabThera in da se enako porazdeli po telesu.
A supportive study in patients with rheumatoid arthritis also indicated similar effectiveness between MabThera and Rixathon.
Podporna študija pri bolnikih z revmatoidnim artritisom je prav tako pokazala podobno učinkovitost med zdravilom MabThera in zdravilom Rixathon.
Because Rixathon is a biosimilar medicine, the studies on effectiveness and safety of rituximab carried out with MabThera do not all need to be repeated for Rixathon.
Zdravilo Rixathon je „podobno biološko zdravilo“, zato študij o učinkovitosti in varnosti rituksimaba, izvedenih z zdravilom MabThera, z zdravilom Rixathon ni treba ponavljati.
Rixathon is a ‘biosimilar medicine'.
Zdravilo Rixathon je „podobno biološko zdravilo“.
• pemphigus vulgaris, a serious condition involving widespread blistering of the skin and lining of the mouth, nose, throat and genitals.
• navadnega pemfigusa, resne bolezni, za katero so značilni razširjeni mehurji po koži in sluznici ust,
In addition, a study in patients with follicular lymphoma has shown that the safety and effectiveness of Rixathon are equivalent to those of MabThera.
Poleg tega je študija pri bolnikih z folikularnim limfomom pokazala, da sta varnost in učinkovitost zdravila Rixathon enaki kot pri zdravilu MabThera.
Laboratory studies comparing Rixathon with the reference medicine MabThera have shown that the active substance in Rixathon is highly similar to that in MabThera in terms of structure, purity and biological activity.
Laboratorijske študije, v katerih so zdravilo Rixathon primerjali z referenčnim zdravilom MabThera, so pokazale, da je učinkovina v zdravilu Rixathin po zgradbi, čistosti in biološkem delovanju zelo podobna tisti v zdravilu MabThera.
How is Rixathon used?
Kako se zdravilo Rixathon uporablja?
When rituximab attaches to CD20, it causes the B cells to die, which helps in lymphoma and CLL (where B cells have become cancerous) and in rheumatoid arthritis and pemphigus (where B cells are involved in inflammation).
Učinkovina v zdravilu Rixathon, rituksimab, je monoklonsko protitelo, ki je zasnovano tako, da se veže na blejakovino, imenovano CD20, ki se nahaja na površini celic B. Rituksimab z vezavo na CD20 povzroči odmrtje celic B, kar pripomore pri zdravljenju limfoma in kronične limfocitne levkemije (pri katerih so celice B postale rakaste) ter pemfigusa (pri katerem celice B sodelujejo pri vnetju).
How does Rixathon work?
Kako zdravilo Rixathon deluje?
Rixathon can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Rixathon je le na recept.
Rixathon contains the active substance rituximab.
Zdravilo Rixathon vsebuje zdravilno učinkovino rituksimab.
Studies have also shown that giving Rixathon produces similar levels of the active substance in the body to giving MabThera.
Študije so pokazale tudi, da je količina učinkovine v telesu pri zdravilu Rixathon podobna kot pri zdravilu MabThera.
The European Commission granted a marketing authorisation valid throughout the European Union for Suliqua on 11 January 2017.
Evropska komisija je dovoljenje za promet z zdravilom Suliqua, veljavno po vsej Evropski uniji, izdala 11. januarja 2017.
What measures are being taken to ensure the safe and effective use of Suliqua?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Suliqua?
The full EPAR for Suliqua 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 Suliqua je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Suliqua.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Suliqua.
Other information about Suliqua
Druge informacije o zdravilu Suliqua
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Suliqua's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Suliqua večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The dose is adjusted individually for each patient, and the patient's blood glucose should be regularly tested to find the lowest effective dose.
Odmerek zdravila je treba prilagoditi posameznemu bolniku, bolnikovo raven glukoze v krvi pa je treba redno preverjati, da se določi najmanjši učinkoviti odmerek.
The company that markets Suliqua will provide educational materials for healthcare professionals and patients, explaining how to use the medicine safely, so as to reduce the risk of medication errors.
Družba, ki trži zdravilo Suliqua, bo priskrbela izobraževalno gradivo za zdravstvene delavce in bolnike, v katerem bo obrazloženo, kako varno uporabljati zdravilo, da se zmanjša tveganje za napake pri njegovi uporabi.
Suliqua has been shown to be effective at controlling blood glucose in two main studies involving 1,906 patients with type 2 diabetes.
Zdravilo Suliqua se je izkazalo za učinkovito pri uravnavanju glukoze v krvi v dveh glavnih študijah, ki sta vključevali 1 906 bolnikov s sladkorno boleznijo tipa 2.
Suliqua insulin glargine / lixisenatide
Suliqua insulin glargin/liksisenatid
By controlling the level of blood glucose, the symptoms of diabetes are reduced and complications are avoided.
Z uravnavanjem ravni glukoze v krvi zmanjšamo simptome sladkorne bolezni in preprečimo zaplete.
What benefits of Suliqua have been shown in studies?
Kakšne koristi je zdravilo Suliqua izkazalo v študijah?
What are the risks associated with Suliqua?
Kakšna tveganja so povezana z zdravilom Suliqua?
It is not intended to provide practical advice on how to use Suliqua.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Why is Suliqua approved?
Zakaj je bilo zdravilo Suliqua odobreno?
Insulin glargine enters the bloodstream more slowly than human insulin after an injection and its action is therefore longer lasting.
Insulin glargin po injiciranju vstopi v krvni obtok počasneje kot humani insulin, zato deluje dlje časa.
For more information about treatment with Suliqua, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Suliqua preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What is Suliqua and what is it used for?
Kaj je zdravilo Suliqua in za kaj se uporablja?
It acts in the same way as GLP-1 (a hormone produced in the gut) by increasing the amount of insulin that the pancreas releases in response to food.
To pomeni, da deluje enako kot GLP-1 (v črevesju proizvedeni hormoni), in sicer tako, da povečuje količino insulina, ki ga kot odziv na zaužito hrano izloči trebušna slinavka.
Results showed that Suliqua is more effective at controlling blood glucose levels than either components: average HbA1c at the start of the study was 8.1%, which fell after 30 weeks of treatment to 6.5% in the group using Suliqua, compared with 6.8% in the group using insulin glargine and 7.3% in the group using lixisenatide.
Rezultati so pokazali, da je zdravilo Suliqua učinkovitejše pri nadzoru ravni glukoze v krvi kot posamični sesstavini: povprečna vrednost HbA1c na začetku študije je bila 8,1 % in je po 30 tednih zdravljenja v skupini, ki je uporabljala zdravilo Suliqua, padla na 6,5 %, v primerjavi s 6,8 % v skupini, ki je uporabljalo insulin glargin, in 7,3 % v skupini, ki je uporabljala liksisenatid.
Type 2 diabetes is a disease in which the level of blood glucose is high because either the body does not produce enough insulin or the body is unable to use insulin effectively.
Pri sladkorni bolezni tipa 2 je raven glukoze v krvi previsoka, ker telo ne proizvaja dovolj insulina ali pa ga ne more učinkovito izrabiti.
Suliqua is a medicine that is used together with metformin (another diabetes medicine) for the treatment of adults with type 2 diabetes.
Zdravilo Suliqua se uporablja skupaj z metforminom (drugim zdravilom za zdravljenje sladkorne bolezni) za zdravljenje odraslih s sladkorno boleznijo tipa 2.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Suliqua have also been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Benepali upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
One of the active substances in Suliqua, insulin glargine, is a replacement insulin that acts in the same way as the body's own insulin and helps glucose enter cells from the blood, thereby controlling the level of glucose in the blood.
Ena od zdravilnih učinkovin v zdravilu Suliqua, insulin glargin, je nadomestek insulina, ki deluje enako kot naravno tvorjeni insulin in pomaga pri prehodu glukoze iz krvi v celice ter tako uravnava raven glukoze v krvi.
The CHMP concluded that combination treatments with a long-acting insulin and a GLP-1 agonist such as Suliqua are an important treatment option for patients who are eligible for insulin or who need intensive insulin therapy.
Odbor je zaključil, da so kombinirana zdravila z dolgodelujočim insulinom in agonistom GLP-1, kot je zdravilo Suliqua, pomembna možnost zdravljenja za bolnike, ki so primerni za insulin ali ki potrebujejo intenzivno insulinsko zdravljenje.
This helps with the control of blood glucose levels.
To pomaga pri uravnavanju ravni glukoze v krvi.
A reduction in HbA1c levels means an improvement in the control of blood sugar levels.
Znižanje ravni HbA1c pomeni boljše uravnavanje ravni glukoze v krvi.
In these patients, Suliqua was effective at controlling glucose levels and reduced the risk of problems linked to intensive insulin therapy such as hypoglycaemia and weight gain.
Pri teh bolnikih je bilo zdravilo Suliqua učinkovito pri uravnavanju ravni glukoze in je zmanjšalo tveganja za težave, povezane z intenzivnim insulinskim zdravljenjem, kot sta hipoglikemija in pridobivanje telesne mase.
After 30 weeks of treatment average HbA1c fell to 6.9% in the group taking Suliqua and to 7.5% in patients receiving insulin glargine.
Po 30 tednih zdravljenja je povprečna vrednost HbA1c v skupini, ki je jemala zdravilo Suliqua, padla na 6,9 %, pri bolnikih, ki so jemali insulin glargin, pa na 7,5 %.
It is used when blood glucose (sugar) levels are not satisfactorily controlled by metformin alone or by a combination of metformin and another medicine (either another glucose-lowering medicine taken by mouth or a long-acting insulin).
Uporablja se, kadar ravni glukoze (sladkorja) v krvi ni mogoče zadostno uravnavati samo z metforminom ali kombinacijo metformina in drugega zdravila (drugega peroralnega zdravila za zniževanje glukoze ali dolgodelujočega insulina).
In terms of safety there were no new safety concerns with the combination of insulin glargine and lixisenatide in Suliqua compared with the components used separately.
V zvezi z varnostjo pri kombinaciji insulina glargin in liksisenatida v zdravilu Suliqua ni bilo nobenih novih pomislekov o varnosti v primerjavi z ločeno uporabljenimi sestavinami.
For practical information about using Suliqua, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Suliqua naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The other active substance in Suliqua, lixisenatide, belongs to the class of diabetes medicines known as GLP-1 agonists.
Druga zdravilna učinkovina v zdravilu Suliqua, liksisenatid, spada v razred zdravil za zdravljenje sladkorne bolezni, znanih kot agonisti GLP-1.
In both studies, the main measure of effectiveness was the change after 30 weeks of treatment in the level in the blood of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
V obeh študijah je bilo glavno merilo učinkovitosti sprememba ravni snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), po 30 tednih zdravljenja.
For the full list of all side effects and restrictions with Suliqua, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Suliqua glejte navodilo za uporabo.
Before Suliqua is started the patient's insulin and diabetes medicines other than metformin must be stopped.
Pred uvedbo zdravila Suliqua je treba ukiniti bolnikov insulin in zdravila za zdravljenje sladkorne bolezni, razen metformina.
Average HbA1c was 8.1% before patients started taking Suliqua or insulin glargine.
Povprečna vrednost HbA1c pred začetkom jemanja zdravila Suliqua ali insulina glargin je bila 8,1 %.
The active substances in Suliqua are insulin glargine and lixisenatide.
Zdravilni učinkovini v zdravilu Suliqua sta insulin glargin in liksisenatid.
The first study involved 1,170 patients whose blood glucose was not adequately controlled by metformin with or without another diabetes medicine taken by mouth.
V prvo študijo je bilo vključenih 1 170 bolnikov, pri katerih raven glukoze v krvi ni bila zadostno nadzorovana z metforminom ne glede na to, ali so jemali druga zdravila za peroralno uporabo za zdravljenje sladkorne bolezni ali jih niso.
Patients who entered the study, had to stop all medicines given by mouth except metformin and were then given either Suliqua or insulin glargine.
Bolniki, vključeni v študijo, so morali prenehati jemati vsa peroralna zdravila razen metformina in so prejemali zdravilo Suliqua ali insulin glargin.
Suliqua is available as pre-filled disposable pens in two different strengths and can only be obtained with a prescription.
Zdravilo Suliqua je na voljo v napolnjenih peresnikih za enkratno uporabo v dveh jakostih.
The second study involved 736 patients whose blood glucose was not adequately controlled by a longacting insulin such as insulin glargine with or without one or two other diabetes medicines taken by mouth.
V drugo študijo je bilo vključenih 736 bolnikov, pri katerih raven glukoze v krvi ni bila zadostno uravnavana z dolgodelujočim insulinom, kot je insulin glargin, ne glede na to, ali so jemali druga zdravila za peroralno uporabo za zdravljenje sladkorne bolezni ali jih niso.
How does Suliqua work?
Kako zdravilo Suliqua deluje?
Upon entering the study, all patients had to stop their other diabetes medicines and were given Suliqua or insulin glargine or lixisenatide, all with metformin.
Ob vstopu v študijo so morali vsi bolniki prenehati jemati druga zdravila za zdravljenje sladkorne bolezni in so v kombinaciji z metforminom prejeli zdravilo Suliqua ali insulin glargin ali liksisenatid.
It is given as an injection under the skin of the belly, the thigh or the upper arm. Suliqua is given once a day, preferably at the same time each day.
Zdravilo Suliqua se daje enkrat dnevno, po možnosti vsak dan ob istem času.
How is Suliqua used?
Kako se zdravilo Suliqua uporablja?
The most common side effect with Suliqua (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose); problems with the digestive system are common and include diarrhoea, vomiting and nausea (feeling sick).
Najpogostejši neželeni učinek zdravila Suliqua (ki se lahko pojavi pri več kot 1 bolniku od 10) je hipoglikemija (nizka raven glukoze v krvi).
EU (MA) Number
EU (MA) številka Izmišljen o ime
6 bottles Not applicable
6 plastenke
1 bottle Not applicable
1 plastenka
It must also not be used in a pregnant woman.
Prav tako se ne sme uporabiti pri nosečnicah.
This will help to protect against the diseases caused by these viruses.
To mu bo pomagalo pri obrambi pred boleznimi, ki jih ti virusi povzročajo.
It must not be used in children who have severely weakened immune systems.
Ne sme se uporabljati pri otrocih, ki imajo zelo oslabljen imunski sistem.
The European Commission granted a marketing authorisation valid throughout the European Union for ProQuad on 6 April 2006.
Evropska komisija je dovoljenje za promet z zdravilom ProQuad, veljavno po vsej Evropski uniji, odobrila dne 6. aprila 2006.
Because ProQuad contains well known weakened viruses, which are already used in other vaccines, the company presented data from vaccines that are already on the market.
Ker cepivo ProQuad vsebuje dobro znane oslabljene viruse, ki se že uporabljajo v drugih cepivih, je družba predstavila podatke o cepivih, ki so že na trgu.
The full EPAR for ProQuad 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 ProQuad je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This study looked at the ability of the vaccine to trigger immune responses in these age groups.
V tej študiji so proučevali sposobnost cepiva za sprožitev imunskega odziva v omenjenih starostnih skupinah otrok.
Other information about ProQuad
Druge informacije o zdravilu ProQuad
ProQuad is a vaccine.
Zdravilo ProQuad je cepivo.
This is a summary of the European public assessment report (EPAR) for ProQuad.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo ProQuad.
The active substances are attenuated (weakened) viruses for the diseases.
Zdravilne učinkovine so atenuirani (oslabljeni) virusi za navedene bolezni.
For more information about treatment with ProQuad, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom ProQuad preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
It is only given under the skin in patients with low levels of platelets in the blood or other bleeding disorders, as they may experience bleeding if the vaccine is injected into a muscle.
Pod kožo se daje samo osebam, ki imajo nizke ravni krvnih ploščic ali druge motnje strjevanja krvi, saj lahko pride do krvavitve, če se cepivo injicira v mišico.
When a person is given the vaccine, the immune system recognises the weakened viruses as ‘foreign' and makes defences against them.
Ko oseba prejme cepivo, imunski sistem prepozna oslabljene viruse kot „tujke“ in proti njim vzpostavi obrambni mehanizem.
ProQuad is used according to official recommendations, including the number of doses and the interval between them.
Cepivo ProQuad se uporablja v skladu z uradnimi priporočili, kar velja tudi za število odmerkov in časovni razmik med njimi.
The vaccine is injected into a muscle or under the skin, preferably in the thigh in younger children and in the shoulder area in older children and adults.
Cepivo se injicira v mišico ali pod kožo, po možnosti v stegensko mišico pri mlajših otrocih ter v ramensko območje pri starejših otrocih in odraslih.
A study has also been carried out with ProQuad in 1,620 children who received the first dose at 9, 11 and 12 months of age, and the second dose three months later.
S cepivom ProQuad je bila izvedena tudi študija pri 1 620 otrocih, ki so prejeli prvi odmerek pri starosti 9, 11 in 12 mesecev, drugi odmerek pa tri mesece kasneje.
Another study also looked at the responses one year after vaccination in 2,108 children.
V drugi študiji so pri 2 108 otrocih proučevali tudi odzive eno leto po cepljenju.
In the future, the immune system will be able to respond more quickly when it is exposed to the viruses again.
Ob ponovni izpostavitvi virusom v prihodnosti se bo imunski sistem hitreje odzval nanje.
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 ProQuad.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo ProQuad, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
However, children who received the first dose at nine months of age had a lower immune response against measles.
Vendar pa so otroci, ki so prvi odmerek prejeli v 9. mesecu starosti, imeli manjši imunski odziv proti ošpicam.
What benefit has ProQuad shown during the studies?
Kakšne koristi je zdravilo ProQuad izkazalo med študijami?
The CHMP decided that ProQuad's benefits are greater than its risks and recommended that it be given marketing authorisation for use in children above 12 months of age, noting that a second vaccination against chickenpox should be given for full protection against the disease.
CHMP je zaključil, da so koristi cepiva ProQuad večje od z njim povezanih tveganj in priporočil, da se zanj odobri dovoljenje za promet za uporabo pri otrocih, starejših od 12 mesecev, pri čemer je proti noricam potreben drugi odmerek cepiva, da se zagotovi popolna zaščita proti tej bolezni.
The most common side effect with ProQuad (seen in more than 1 patient in 10) are fever, and pain and erythema (redness) at the site of injection.
Najpogostejši neželeni učinki cepiva ProQuad (opaženi pri več kot 1 od 10 bolnikov) so povišana telesna temperatura in bolečina ter eritem (pordelost) na mestu injiciranja.
What is the risk associated with ProQuad?
Kakšna tveganja so povezana z zdravilom ProQuad?
The response rates in children above 12 months of age (measuring how the immune system had responded to the viruses) were: 98% for measles, 96% to 99% for mumps, 96% for rubella and 91% for chickenpox.
Stopnje odziva pri otrocih, starejših od 12 mesecev (merilo odzivnosti imunskega sistema na viruse), so bile: 98 % pri ošpicah, od 96 % do 99 % pri mumpsu, 96 % pri rdečkah in 91 % pri noricah.
After the second dose, the rates were around 99% for measles, 100% for mumps, 98% for rubella, and 99% for chickenpox.
Po drugem odmerku so bile stopnje odziva 99 % pri ošpicah, 100 % pri mumpsu, 98 % pri rdečkah in 99 % pri noricah.
The study in children from nine to 12 months of age showed that, after two doses of ProQuad, the immune response against mumps, rubella and chickenpox in children who received the first dose at nine months of age was comparable with those who received the first dose at 12 months of age.
Študija pri otrocih, starih od 9 do 12 mesecev, je pokazala, da je bil po dveh odmerkih cepiva ProQuad imunski odziv proti mumpsu, rdečkam in noricam pri otrocih, ki so prvi odmerek prejeli v 9. mesecu starosti, primerljiv s tistim pri otrocih, ki so prvi odmerek prejeli v 12. mesecu starosti.
For the full list of all side effects reported with ProQuad, see the package leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi cepiva ProQuad, glejte navodilo za uporabo.
To protect against chickenpox, a second injection is needed, given one to three months after the first one; this can be done either by giving a second dose of ProQuad, or by giving a dose of another vaccine that only protects against chickenpox.
Za zaščito pred noricami je potrebna druga injekcija, ki jo je treba dati od enega do tri mesece po prvem odmerku, pri čemer se lahko uporabi bodisi drugi odmerek zdravila ProQuad ali pa odmerek katerega drugega cepiva, ki ščiti samo pred noricami.