natgillin/translations-raw huggingface dataset:
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that the benefits of Abilify are greater than its risks and recommended its approval in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Abilify večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
By attaching to these receptors, it is thought that aripiprazole helps normalise the activity of the brain, reducing psychotic or manic symptoms and preventing them from returning.
Aripiprazol naj bi z vezavo na ta receptorja pomagal normalizirati delovanje možganov, zmanjšati psihotične ali manične simptome in preprečiti njihov ponoven pojav.
The exact way it works is not known but it attaches in the brain to receptors for two substances (neurotransmitters) called dopamine and serotonin (5HT), which are believed to play a role in schizophrenia and bipolar disorder.
Natančen način njegovega delovanja ni znan, vendar se veže na možganske receptorje za dve snovi (živčna prenašalca), imenovana dopamin in serotonin (5HT), ki naj bi sodelovala pri shizofreniji in bipolarni motnji.
Other information about Abilify
Druge informacije o zdravilu Abilify
With regard to safety, the medicine has side effects comparable to those of other antipsychotics.
Z vidika varnosti so neželeni učinki zdravila primerljivi s tistimi, ki se pojavljajo pri jemanju drugih antipsihotičnih zdravil.
It is also available as a solution for injection into the shoulder or buttock muscle.
Na voljo je tudi v obliki raztopine za injiciranje v ramensko ali zadnjično mišico.
In adults, the most common side effects when taking Abilify by mouth (occurring in up to 10 patients in 100) are restlessness, difficulty sleeping, anxiety, extrapyramidal disorder (uncontrolled twitching or jerking), akathisia (a constant urge to move), tremor (shaking), dizziness, sleepiness, headache, blurred vision, dyspepsia (heartburn), vomiting, nausea (feeling sick), constipation, salivary hypersecretion (increased production of saliva), tiredness and diabetes.
Pri odraslih bolnikih so najpogostejši neželeni učinki pri peroralnem jemanju zdravila Abilify (opaženi pri 1 do 10 bolnikih od 100) nemir, nespečnost, tesnobnost, ekstrapiramidne motnje (nekontrolirano trzanje ali krči), akatizija (neprestana potreba po gibanju), tremor (tresavica), omotica, zaspanost, glavobol, zamegljen vid, dispepsija (zgaga), bruhanje, navzeja (slabost), zaprtje, prekomerno slinjenje, utrujenost in sladkorna bolezen.
The most common side effects with the injection (occurring in up to 10 patients in 100) are sleepiness, dizziness and nausea.
Najpogostejši neželeni učinki pri uporabi injekcij (opaženi pri 10 bolnikih od 100) so zaspanost, omotica in slabost.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Abilify have 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 Abilify upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
What benefits of Abilify have been shown in studies?
Kakšne koristi je zdravilo Abilify izkazalo v študijah?
For more information about treatment with Abilify, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Abilify preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What is Abilify and what is it used for?
Kaj je zdravilo Abilify in za kaj se uporablja?
Why is Abilify approved?
Zakaj je bilo zdravilo Abilify odobreno?
In schizophrenia, a mental illness with symptoms such as delusions, disorganised speech, and hallucinations (hearing or seeing things that are not there), Abilify is used to treat patients from the age of 15 years.
Pri shizofreniji, tj. duševni bolezni s številnimi simptomi, kot so blodnje, nepovezani govor in halucinacije (bolnik vidi in sliši stvari, ki jih ni), se zdravilo Abilify uporablja za zdravljenje bolnikov, starejših od 15 let.
What is the risk associated with Abilify?
Kakšna tveganja so povezana z zdravilom Abilify?
For practical information about using Abilify, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Abilify naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Other studies showed that Abilify was more effective than placebo at preventing manic episodes in previously treated adults for up to 74 weeks, and when it was used as an add-on to existing treatment.
Druge študije so pokazale, da je bilo zdravilo Abilify učinkovitejše od placeba pri preprečevanju ponovitve maničnih epizod v 74 tednih pri predhodno zdravljenih odraslih in ob njegovi uporabi kot dodatek obstoječemu zdravljenju.
It is not intended to provide practical advice on how to use Abilify.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Studies comparing Abilify to placebo or other medicines (such as haloperidol and lithium) show that Abilify is effective at reducing symptoms of schizophrenia and at treating and preventing high moods in patients with bipolar I disorder.
Študije, v katerih so zdravilo Abilify primerjali s placebom ali drugimi zdravili (kot sta haloperidol in litij), kažejo, da je zdravilo Abilify učinkovito pri zmanjševanju simptomov shizofrenije ter zdravljenju in preprečevanju privzdignjenega razpoloženja pri bolnikih z bipolarno motnjo I.
In bipolar I disorder, Abilify is used in adults to treat manic episodes (periods of abnormally high mood) and to prevent new ones in those who have responded to the medicine in the past.
Pri bipolarni motnji I se zdravilo Abilify uporablja pri odraslih za zdravljenje maničnih epizod (obdobij izjemno privzdignjenega razpoloženja) ter za preprečevanje pojava novih maničnih epizod pri tistih, ki so se v preteklosti že odzvali na zdravilo.
Studies showed that Abilify is effective at treating symptoms of schizophrenia using standard rating scales (such as the Positive and Negative Syndrome Scale, PANSS).
Študije kažejo, da je zdravilo Abilify učinkovito pri zdravljenju simptomov shizofrenije, kar so izmerili s pomočjo standardne lestvice (kot je lestvica pozitivnih in negativnih simptomov PANSS).
The side effects are similar in adolescents, but sleepiness, extrapyramidal disorder, akathisia and tiredness are very common in this group (in more than 1 in 10 adolescents).
Neželeni učinki so podobni pri mladostnikih, čeprav so v tej skupini zelo pogosti zaspanost, ekstrapiramidne motnje, akatizija in utrujenost (opaženi pri več kot 1mladostniku od 10).
In addition, the injection has been shown to be effective at quickly controlling agitation or disturbing behaviour in patients with schizophrenia or bipolar I disorder.
Poleg tega je bilo ugotovljeno, da so injekcije učinkovite pri hitri vzpostavitvi nadzora nad vznemirjenim ali motenim obnašanjem pri bolnikih s shizofrenijo ali bipolarno motnjo I.
Abilify has also been studied in 302 adolescents aged between 13 and 17, with results showing Abilify to be more effective than placebo.
Zdravilo Abilify so proučevali tudi pri 302 mladostnikih, starih od 13 do 17 let, pri čemer so rezultati pokazali, da je zdravilo učinkovitejše od placeba.
In 4 out of 5 studies in 1,900 adults, Abilify was more effective than placebo at reducing manic symptoms, with two of these studies showing that Abilify has a similar effect to haloperidol and to lithium.
V štirih od petih študij s 1 900 odraslimi bolniki je bilo zdravilo Abilify pri zmanjševanju maničnih simptomov učinkovitejše od placeba, pri čemer je bilo v dveh študijah ugotovljeno, da je imelo zdravilo Abilify podoben učinek kot haloperidol in litij.
Studies in bipolar I disorder showed that Abilify is effective at treating manic episodes using standard measurements such as the Young-Mania Rating Scale (YMRS) scale.
Študije pri bipolarni motnji I so pokazale, da je zdravilo Abilify učinkovito pri zdravljenju maničnih epizod s pomočjo standardne lestvice, kot je lestvica za oceno stopnje manije pri mladih (YMRS).
Abilify is an antipsychotic medicine for patients with schizophrenia and bipolar I disorder.
Zdravilo Abilify je antipsihotično zdravilo za zdravljenje shizofrenije in bipolarne motnje I.
A study in 296 children and adolescents showed that Abilify was more effective than placebo at reducing the manic symptoms in patients aged 13 years and older.
V študiji, ki je vključevala 296 otrok in mladostnikov, je bilo ugotovljeno, da je bilo zdravilo Abilify učinkovitejše od placeba pri zmanjševanju maničnih simptomov pri bolnikih, starejših od 13 let.
Abilify is available as tablets and a liquid to be taken by mouth.
Zdravilo Abilify je na voljo v obliki tablet in tekočine za peroralno uporabo.
A study in 544 patients treated by injection for agitation and disturbed behaviour showed that improvement with Abilify over 24 hours was greater than with placebo and similar to that with haloperidol.
V študiji s 544 bolniki, ki so jih zdravili z injekcijami zaradi vznemirjenega ali motenega obnašanja, so ugotovili, da je bilo izboljšanje stanja po 24 urah večje pri jemanju zdravila Abilify kot placeba in podobno pri jemanju haloperidola.
Finally, a study in 291 patients treated by injection for agitation and disturbed behaviour showed that improvement with Abilify was greater after 2 hours than with placebo and similar to that with lorazepam (another medicine for treating agitation).
V študiji z 291 bolniki, ki so jih zdravili z injekcijami zaradi vznemirjenega ali motenega obnašanja, so ugotovili, da je bilo izboljšanje stanja po dveh urah večje pri jemanju zdravila Abilify kot placeba in podobno pri jemanju lorazepama (drugega zdravila za zdravljenje vznemirjenja).
How is Abilify used?
Kako se zdravilo Abilify uporablja?
In studies of 1,203 adults, Abilify was more effective than placebo (a dummy treatment) at reducing symptoms.
V študiji s 1 203 odraslimi bolniki je bilo zdravilo Abilify pri zmanjševanju simptomov učinkovitejše od placeba (zdravila brez zdravilne učinkovine).
Abilify can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Abilify je le na recept.
The active substance in Abilify is aripiprazole.
Zdravilna učinkovina v zdravilu Abilify je aripiprazol.
In another adult study, Abilify was as effective as haloperidol, another antipsychotic medicine, in preventing symptoms from returning over 1 year.
V drugi študiji, ki je vključevala odrasle bolnike, je bilo zdravilo Abilify pri preprečevanju ponovitve simptomov po enem letu enako učinkovito kot haloperidol, tj. drugo antipsihotično zdravilo.
The injection is used only for quickly controlling agitation or disturbed behaviour in patients with schizophrenia or bipolar I disorder.
Injiciranje zdravila se uporablja samo za hitro vzpostavljanje nadzora nad vznemirjenim ali motenim obnašanjem pri odraslih s shizofrenijo ali bipolarno motnjo I. Za dodatne informacije o odmerkih in njihovemu prilagajanju glejte navodilo za uporabo.
MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
(Izmišljeno) ime Jakost Farmacevtska oblika
The main measure of effectiveness was the doctor's assessment of how well bleeding was stopped.
Glavno merilo učinkovitosti je bila zdravnikova ocena, kako dobro je bilo krvavenje zaustavljeno.
Skin- associated hypersensitivity reactions (itching, hives and rash) may occur commonly (in between 1 and 10 patients in 100) but a severe allergic reaction is rare (between 1 and 10 in 10,000 patients).
Preobčutljivostne reakcije, povezane s kožo (srbenje, koprivnica in izpuščaj), se pojavijo pogosto (pri med 1 in 10 bolnikih od 100), toda hude alergijske reakcije so redke (pri med 1 in 10 bolnikih od 10 000).
EPAR summary for the public octocog alfa
Povzetek EPAR za javnost oktokog alfa
This is a summary of the European public assessment report (EPAR) for Helixate NexGen.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Helixate NexGen.
The full EPAR for Helixate NexGen 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 Helixate NexGen je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Octocog alfa is made by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce it.
Oktokog alfa se proizvaja z metodo, imenovano „tehnologija rekombinantne DNK“, pri kateri ga izdelajo celice, ki so prejele gen (DNK), kar jim omogoča njegovo tvorjenje.
Stopping bleeding was assessed as ‘excellent' in all 15 patients.
Prenehanje krvavenja je bilo pri vseh 15 bolnikih ocenjeno kot odlično.
The main measure of effectiveness in the studies was the number of treatments required to stop each new bleed.
Glavno merilo učinkovitosti je bilo število potrebnih zdravljenj za zaustavitev vsake posamezne krvavitve.
The data provided on immune tolerance induction in patients with inhibitors showed, that some patients benefit from the high dosage and the inhibitor could be eliminated, nevertheless the data were not considered sufficient to specifically approve the medicine for this use.
Podatki, dobljeni o indukciji imunske tolerance pri bolnikih z zaviralci, so pokazali, da nekaterim bolnikom koristijo visoki odmerki in se zaviralci odstranijo, vendar pa so bili podatki ocenjeni kot nezadostni, da bi lahko zdravilo odobrili za to uporabo.
The European Commission granted a marketing authorisation valid throughout the EU for Helixate NexGen on 4 August 2000.
Evropska komisija je dovoljenje za promet z zdravilom Helixate NexGen, veljavno po vsej Evropski uniji, izdala 4. avgusta 2000.
What measures are being taken to ensure the safe and effective use of Helixate NexGen?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Helixate NexGen?
The Agency decided that Helixate NexGen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Agencija je sklenila, da so koristi zdravila Helixate NexGen večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
Helixate NexGen is intended for either short-term or long-term use.
Zdravilo Helixate NexGen je namenjeno za kratkotrajno ali dolgotrajno uporabo.
In the previously untreated patients, about 90% of bleeding episodes responded to treatment with one or two injections into a vein.
Pri predhodno nezdravljenih bolnikih se je 90 % krvavitev odzvalo na zdravljenje z eno ali dvema injiciranjema v veno.
Helixate NexGen is similar to another medicine that was previously authorised in the EU called Helixate, but it is prepared differently so that there are no human-derived proteins in the medicine.
Zdravilo Helixate NexGen je podobno drugemu zdravilu, ki je že odobreno v EU, imenovanemu Helixate, vendar je pripravljeno na drugačen način, tako da v zdravilu ni nobenih beljakovin humanega izvora.
Patients or their carers may be able to administer Helixate NexGen themselves at home once they have been trained appropriately.
Bolniki ali njihovi negovalci lahko po ustreznem usposabljanju zdravilo Helixate NexGen dajejo sami doma.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Helixate NexGen have 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 Helixate NexGen upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
The dose and duration of treatment depend on whether Helixate NexGen is used to treat or prevent bleeding or during surgery, as well as on the patient's factor VIII levels, the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and bodyweight.
Odmerek in pogostnost injiciranja sta odvisna od tega, ali se zdravilo uporablja za zdravljenje ali preprečevanje krvavitev, kakor tudi od bolnikovih ravni faktorja VIII, resnosti hemofilije, obsega in mesta krvavitve ter bolnikovega stanja in telesne mase.
Other information about Helixate NexGen
Druge informacije o zdravilu Helixate NexGen
Because of this, Helixate NexGen has been compared with Helixate to show that the two medicines are equivalent.
Zato so zdravilo Helixate NexGen primerjali z zdravilom Helixate, da bi pokazali, da sta enakovredni.
Helixate NexGen given as an injection into a vein has been studied in 66 patients who had previously been treated with recombinant human coagulation factor VIII and 61 children who had not.
Zdravilo Helixate NexGen, dano z injiciranjem v veno, je bilo proučevano pri 66 bolnikih, ki so bili predhodno zdravljeni z rekombinantnim humanim koagulacijskim faktorjem VIII ter pri 61 predhodno nezdravljenih otrocih.
For more information about treatment with Helixate NexGen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Helixate NexGen preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Patients with haemophilia A lack factor VIII, and this causes blood clotting problems such as bleeding in the joints, muscles and internal organs.
Bolnikom s hemofilijo A primanjkuje faktorja VIII, kar povzroča težave s strjevanjem krvi, kot so krvavenje v sklepe, mišice in notranje organe.
The Agency concluded that Helixate NexGen has been shown to be effective at treating and preventing bleeding in patients with haemophilia A and has an acceptable safety profile.
Zaključila je, da se je zdravilo Helixate NexGen izkazalo kot učinkovito pri zdravljenju in preprečevanju krvavitev pri bolnikih s hemofilijo A in da ima sprejemljiv varnostni profil.
The dose may need to be adjusted if Helixate NexGen is to be given continuously as an infusion into a vein.
Odmerek bo morda treba prilagoditi, če se zdravilo Helixate NexGen daje z neprekinjenim infundiranjem v veno.
Helixate NexGen is used to correct the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.
Zdravilo Helixate NexGen se uporablja za odpravo pomanjkanja faktorja VIII z nadomeščanjem manjkajočega faktorja VIII, kar zagotovi začasno obvladovanje motnje strjevanja krvi.
The active substance in Helixate NexGen, octocog alfa (human coagulation factor VIII), is a substance that helps the blood to clot.
Zdravilna učinkovina zdravila Helixate NexGen, oktokog alfa (humani koagulacijski faktor VIII), je snov, ki pomaga pri strjevanju krvi.
For practical information about using Helixate NexGen, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Helixate NexGen naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Helixate NexGen is a medicine used for the treatment and prevention of bleeding in patients of all ages with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Helixate NexGen je zdravilo, ki se uporablja za zdravljenje in preprečevanje krvavenja pri bolnikih vseh starosti s hemofilijo A (dedno motnjo strjevanja krvi, ki jo povzroča pomanjkanje faktorja VIII).
In the previously treated patients, overall, 95% of bleeds responded to one or two injections of Helixate NexGen into a vein.
Pri predhodno zdravljenih bolnikih se je 95 % krvavitev odzvalo na eno ali dve injiciranji zdravila Helixate NexGen v veno.
What is Helixate NexGen and what is it used for?
Kaj je zdravilo Helixate NexGen in za kaj se uporablja?
Some patients may develop factor VIII inhibitors, which are antibodies (proteins) that the body's immune system produces against factor VIII and which can cause the medicine to stop working resulting in a loss of bleeding control.
Pri nekaterih bolnikih se lahko pojavijo zaviralci faktorja VIII, tj. protitelesa (beljakovine), ki jih imunski sistem proizvede proti faktorju VIII in lahko izničijo delovanje zdravila in tako povzročijo izgubo nadzora nad krvavitvijo.
Helixate NexGen given at high dose has been studied to see whether it is effective in clearing antibodies against factor VIII from the blood (a process known as immune tolerance induction) so that treatment with factor VIII remains effective.
Proučevali so, ali je zdravilo Helixate NexGen, dano v velikih odmerkih, učinkovito pri odstranjevanju protiteles proti faktorju VIII iz krvi (postopek, znan kot indukcija imunske tolerance), tako da zdravljenje s faktorjem VIII ostane učinkovito.
What benefits of Helixate NexGen have been shown in studies?
Kakšne koristi je zdravilo Helixate NexGen izkazalo v študijah?
What are the risks associated with Helixate NexGen?
Kakšna tveganja so povezana z zdravilom Helixate NexGen?
Helixate NexGen is available as a powder and solvent that are mixed together to make a solution for injection or infusion (drip) into a vein.
Zdravilo Helixate NexGen je na voljo v obliki praška in vehikla za pripravo raztopine za injiciranje ali infundiranje (kapalne infuzije) v veno.
Hypersensitivity (allergic) reactions have been reported with factor VIII medicines and may in some cases become severe.
Pri uporabi zdravil, ki vsebujejo faktor VIII, so poročali o preobčutljivostnih (alergijskih) reakcijah, ki so lahko v nekaterih premerih hude.
There is a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Pri zdravilih s faktorjem VIII obstaja tudi tveganje, da se bodo pri nekaterih bolnikih pojavili zaviralci (protitelesa) faktorja VIII, ki bodo izničili delovanje zdravila ter tako povzročili izgubo nadzora nad krvavitvijo.
Helixate NexGen as a continuous infusion has also been studied in 15 patients with haemophilia A undergoing major surgery.
Zdravilo Helixate NexGen v obliki neprekinjene infuzije je bilo proučevano tudi pri 15 bolnikih s hemofilijo A, ki so prestali zahtevnejši kirurški poseg.
Why is Helixate NexGen approved?
Zakaj je bilo zdravilo Helixate NexGen odobreno?
Helixate NexGen can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of haemophilia.
Predpisovanje in izdaja zdravila Helixate NexGen je le na recept, zdravljenje pa mora uvesti zdravnik z izkušnjami z zdravljenjem hemofilije.
For the full list of all side effects reported with Kogenate Bayer, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Helixate NexGen, glejte navodilo za uporabo.
It is not intended to provide practical advice on how to use Helixate NexGen.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
It contains the active substance octocog alfa (human coagulation factor VIII).
Zdravilo Helixate NexGen vsebuje zdravilno učinkovino oktokog alfa (humani koagulacijski faktor VIII).
How does Helixate NexGen work?
Kako zdravilo Helixate NexGen deluje?
How is Helixate NexGen used?
Kako se zdravilo Helixate NexGen uporablja?
Helixate NexGen must not be used in people who are known to be hypersensitive (allergic) to human coagulation factor VIII, to mouse or hamster protein or to any of the other ingredients.
(alergične na) humani koagulacijski faktor VIII, mišje ali hrčkove beljakovine ali katero koli drugo sestavino zdravila.
EU/1/19/1380/001 Posaconazole AHCL
EU/1/19/1380/001 Posakonazol AHCL 40 mg/ml peroralna suspenzija peroralna uporaba steklenička (steklo)
420 mg Concentrate for solution for infusion
420 mg koncentrat za intravenska viala (steklo)
Pre-filled syringe (glass) 3 ml (1 mg/ml) 4 pre-filled syringes
3 ml (1 mg/ml) 4 napolnjene injekcijske brizge
Pre-filled syringe (glass) 3 ml (1 mg/ml) 1 pre-filled syringe
3 ml (1 mg/ml) 1 napolnjena injekcijska brizga