natgillin/translations-raw huggingface dataset:
Duloxetine should be used with caution in patients treated with other medicinal products associated with hepatic injury.
Pri bolnikih, ki jemljejo zdravila, ki lahko povzročijo okvaro jeter, je pri uporabi duloksetina potrebna previdnost.
Nervous system disorders Headache
Bolezni živčevja glavobol zaspanost omotica letargija tremor parestezija
Talk to your doctor before you take Duloxetine Lilly if you: - are taking other medicines to treat depression (see ‘Other medicines and Duloxetine Lilly') - are taking St. John's Wort, a herbal treatment (Hypericum perforatum) - have kidney disease - have had seizures (fits) - have had mania - suffer from bipolar disorder - have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) - have a history of bleeding disorders (tendency to develop bruises) - are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly) - are currently being treated with another medicine which may cause liver damage - are taking other medicines containing duloxetine (see ‘Other medicines and Duloxetine Lilly')
- imate tveganje za nizek nivo natrija (če na primer jemljete diuretike, sploh če ste starejši) - se trenutno zdravite z drugimi zdravili, ki lahko povzročijo poškodbo jeter
Shellac
Šentjanževka
Contents of the pack and other information What Duloxetine Lilly contains
Kaj je zdravilo Duloksetin Lilly in za kaj ga uporabljamo Zdravilo Duloksetin Lilly vsebuje učinkovino duloksetin.
Dermatitis contact Cold sweat Photo-sensitivity reactions
Bolezni imunskega sistema anafilaktična reakcija preobčutljivost
Common side effects (may affect up to 1 in 10 people)
Pogosti neželeni učinki (se lahko pojavijo pri največ 1 od 10 bolnikov)
What measures are being taken to ensure the safe and effective use of Obizur?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Obizur?
Obizur has been authorised under ‘exceptional circumstances'.
Zdravilo Obizur je pridobilo dovoljenje za promet „v izjemnih okoliščinah“.
Factor VIII is one of the proteins needed for normal clotting of the blood.
Faktor VIII je ena od beljakovin, ki so potrebne za normalno strjevanje krvi.
Obizur was not compared with any other medicine.
Zdravila Obizur niso primerjali z nobenim drugim zdravilom.
All 28 patients showed a positive response within 24 hours of starting treatment with Obizur; in 24 out of 28 patients, the bleeding stopped completely.
Pri vseh 28 bolnikih so opazili pozitiven odziv v 24 urah od začetka zdravljenja z zdravilom Obizur: pri 24 od 28 bolnikov se je krvavitev v celoti ustavila.
The response to Obizur was considered positive if bleeding stopped or was reduced, while a negative response meant that the bleeding continued or worsened.
Odziv na zdravilo Obizur so šteli za pozitiven, če se je krvavitev ustavila ali zmanjšala, negativen odziv pa je pomenil, da se je krvavitev nadaljevala ali poslabšala.
The dose, and how often it is given, as well as the length of treatment, are adjusted depending on the patient's condition and requirements, and the degree of danger posed by the bleeding.
Odmerek, pogostnost dajanja in trajanje zdravljenja se prilagodijo glede na bolnikovo stanje in potrebe ter stopnjo nevarnosti, ki jo krvavitev zanj pomeni.
In some cases, reactions become severe (anaphylaxis) and may be associated with dangerously steep falls in blood pressure.
V nekaterih primerih lahko reakcije postanejo hude (anafilaksa) in so lahko povezane z nevarno strmimi padci krvnega tlaka.
Hypersensitivity (allergic) reactions may occur with Obizur, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations.
Pri uporabi zdravila Obizur se lahko pojavijo preobčutljivostne (alergijske) reakcije, ki lahko vključujejo angioedem (otekanje tkiva pod kožo), pekoč in zbadajoč občutek na mestu injiciranja, mrzlico, rdečico, srbeč izpuščaj, glavobol, koprivnico, hipotenzijo (nizek krvni tlak), občutek utrujenosti ali nemira, navzejo (slabost) ali bruhanje, tahikardijo (hiter srčni utrip), stiskanje v prsih, sopenje in občutek ščemenja.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Obizur 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 Obizur večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The full EPAR and risk management plan summary for Obizur 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) in povzetek načrta obvladovanja tveganj za zdravilo Obizur sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What benefits of Obizur have been shown in studies?
Kakšne koristi je zdravilo Obizur izkazalo v študijah?
Why is Obizur approved?
Zakaj je bilo zdravilo Obizur odobreno?
With regard to safety, the Committee considered that the potential for allergic reactions and the development of antibodies against the medicine is expected, and is outweighed by the beneficial effects.
Glede varnosti je menil, da sta možnost alergijskih reakcij in razvoj protiteles proti zdravilu pričakovana, a ju koristni učinki zdravila odtehtajo.
As a result, it will not be as easily recognised by the antibodies and it can replace the human factor VIII that has been inactivated, thereby helping the blood to clot and controlling the bleeding.
Posledično jo protitelesa ne prepoznajo tako zlahka, zato lahko nadomesti humani faktor VIII, ki je bil deaktiviran, ter tako pomaga pri strjevanju krvi in nadzoru nad krvavitvijo.
This is because it has not been possible to obtain complete information about Obizur due to the rarity of the disease.
Do tega je prišlo zato, ker zaradi redkosti bolezni ni bilo mogoče pridobiti vseh informacij o njem.
Since Obizur has been approved under exceptional circumstances, the company that markets the medicine will establish and maintain a patient registry to collect and analyse short- and long-term data on the effectiveness and safety of Obizur in patients with acquired haemophilia caused by antibodies against factor VIII.
Ker je zdravilo Obizur pridobilo dovoljenje za promet v izjemnih okoliščinah, bo družba, ki ga trži, vzpostavila in vzdrževala register bolnikov, v katerem bo zbirala in analizirala kratkoročne in dolgoročne podatke o učinkovitosti in varnosti zdravila Obizur pri bolnikih s pridobljeno hemofilijo, ki jo povzročajo protitelesa proti faktorju VIII.
It is not intended to provide practical advice on how to use Obizur.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
A risk management plan has been developed to ensure that Obizur is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Obizur je bil pripravljen načrt obvladovanja tveganj.
susoctocog alfa, works in the body in the same way as human factor VIII, but has a slightly different shape.
Zdravilna učinkovina v zdravilu Obizur, susoktokog alfa, deluje v telesu enako kot humani faktor VIII, vendar ima nekoliko drugačno obliko.
What are the risks associated with Obizur?
Kakšna tveganja so povezana z zdravilom Obizur ?
What is Obizur and what is it used for?
Kaj je zdravilo Obizur in za kaj se uporablja?
The results of the main study showed that Obizur was effective in treating serious bleeding episodes in adults with the disorder.
Rezultati glavne študije so pokazali, da je bilo zdravilo Obizur učinkovito pri zdravljenju resnih epizod krvavitev pri odraslih s to motnjo.
This is a summary of the European public assessment report (EPAR) for Obizur.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Obizur.
Additionally, the company that markets Obizur will provide healthcare professionals who are expected to use Obizur with educational material containing information on how to calculate the dose.
Poleg tega bo družba, ki trži zdravilo Obizur, zdravstvenim delavcem, za katere se pričakuje, da ga bodo uporabljali, priskrbela izobraževalno gradivo, ki bo vsebovalo informacije o izračunu odmerkov.
Obizur must not be used in patients who have had a severe allergic reaction to susoctocog alfa, any of its other ingredients, or hamster protein.
Zdravila Obizur ne smejo uporabljati bolniki, ki so imeli hudo alergijsko reakcijo na susoktokog alfa ali katero koli drugo sestavino zdravila ali na beljakovine hrčka.
Obizur can only be obtained with a prescription and treatment should be supervised by a doctor with experience in the treatment of haemophilia.
Izdaja zdravila Obizur je le na recept, zdravljenje pa mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem hemofilije.
Patients with acquired haemophilia caused by antibodies against factor VIII have blood clotting problems, such as bleeding in the joints, muscles or internal organs.
Bolniki s pridobljeno hemofilijo, ki jo povzročajo protitelesa proti faktorju VIII, imajo zaplete s strjevanjem krvi, kot so krvavitve v sklepe, mišice ali notranje organe.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Obizur, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
For more information about treatment with Obizur, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Obizur preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What information is still awaited for Obizur?
Katere informacije o zdravilu Obizur še pričakujemo?
Obizur is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Zdravilo Obizur je na voljo v obliki praška in vehikla, ki se zmešata za pripravo raztopine za injiciranje v veno.
Obizur contains the active substance susoctocog alfa.
Zdravilo Obizur vsebuje zdravilno učinkovino susoktokog alfa.
For practical information about using Obizur, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Obizur naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Other information about Obizur
Druge informacije o zdravilu Obizur
How is Obizur used?
Kako se zdravilo Obizur uporablja?
Obizur has been investigated in one main study involving 28 adult patients with acquired haemophilia caused by antibodies against factor VIII who were experiencing a serious bleeding episode.
Zdravilo Obizur so proučevali v eni glavni študiji, ki je vključevala 28 odraslih bolnikov s pridobljeno hemofilijo, ki so jo povzročila protitelesa proti faktorju VIII, ter z resno epizodo krvavitve.
Patients with acquired haemophilia caused by antibodies against factor VIII may develop antibodies against susoctocog alfa.
Pri bolnikih s pridobljeno hemofilijo, ki jo povzročajo protitelesa proti faktorju VIII, se lahko razvijejo protitelesa proti susoktokogu alfa.
For the full list of all side effects and restrictions with Obizur, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Obizur glejte navodilo za uporabo.
The CHMP noted the lack of specific treatments for acquired haemophilia caused by antibodies against factor VIII.
Odbor je upošteval pomanjkanje določenih zdravil za zdravljenje pridobljene hemofilije, ki jo povzročajo protitelesa proti faktorju VIII.
Obizur is a medicine used for the treatment of bleeding episodes in adults with acquired haemophilia, a bleeding disorder caused by the spontaneous development of antibodies that inactivate factor VIII.
Obizur je zdravilo, ki se uporablja za zdravljenje epizod krvavitev pri odraslih s pridobljeno hemofilijo, tj. motnjo strjevanja krvi, ki jo povzroča spontani razvoj protiteles, ki deaktivirajo faktor VIII.
How does Obizur work?
Kako zdravilo Obizur deluje?
--1 Recombinant Protein Q from Leishmania infantum MON-1 ≥ 36.7 ELISA Units (EU)* * Antigen content determined in an ELISA against an internal standard.
Rekombinantni protein Q iz parazita Leishmania infantum MON-1 ≥ 36,7 enot ELISA (EU)* * Vsebnost antigena je določena s testom ELISA v primerjavi z internim standardom.
EU (MA) Number Invented name
EU (MA) številka Izmišljeno ime
Lyophilisate: 1 vial; solvent:
Karenca liofilizat: 1 viala; vehikel: 1 viala liofilizat: 4 viale; vehikel: 4 viale liofilizat: 100 vial; vehikel:
Packaging Content
Pakiranje Vsebina
Subcutaneous use Vial (glass)
Subkutana uporaba viala (steklo)
10 mg/ ml Solution for injection.
INCRELEX 10 mg/ml Raztopina za injiciranje
1 Vial
1 viala
Strength Pharmaceutical Form
Izmišljeno ime Jakost farmacevtska oblika pot uporabe
Package size
Ovojnina vsebina velikost pakiranja
This summary was last updated in 10-2011.
Povzetek je bil nazadnje posodobljen 10-2011.
Similar results were seen in the second study.
Podobni rezultati so bili ugotovljeni tudi v drugi študiji.
Other information about Aerinaze
Druge informacije o zdravilu Aerinaze
The European Commission granted a marketing authorisation valid throughout the European Union for Aerinaze on 30 July 2007.
Evropska komisija je dovoljenje za promet z zdravilom Aerinaze, veljavno po vsej Evropski uniji, odobrila dne 30. julija 2007.
The effectiveness of Aerinaze was assessed in two main studies involving a total of 1,248 adult and adolescent patients.
Učinkovitost zdravila Aerinaze so proučevali v dveh glavnih študijah s skupno 1 248 odraslimi in mladostniki.
The full EPAR for Aerinaze 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 Aerinaze je na voljo na spletni strani agencije: : ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What benefit has Aerinaze shown during the studies?
Kakšne koristi je zdravilo Aerinaze izkazalo med študijami?
In adults and adolescents over 12 years of age, the recommended dose of Aerinaze is one tablet twice a day, taken whole with a full glass of water.
Pri odraslih in mladostnikih, starejših od 12 let, je priporočeni odmerek zdravila Aerinaze ena tableta dvakrat dnevno, ki jo je treba pogoltniti celo s polnim kozarcem vode.
This is a summary of the European public assessment report (EPAR) for Aerinaze.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Aerinaze.
It is available as blue and white modified-release tablets.
Na voljo je v obliki modrih in belih tablet s prirejenim sproščanjem.
The main measures of effectiveness were the change in the severity of hayfever symptoms reported by the patients between before treatment started, and over the entire 15 days of treatment.
Glavno merilo učinkovitosti je bila sprememba resnosti simptomov senenega nahoda, o katerih so bolniki poročali pred začetkom zdravljenja in v celotnem 15-dnevnem obdobju zdravljenja.
For more information about treatment with Aerinaze, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Aerinaze preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
Treatment should continue for as short a time as possible and should stop when symptoms, chiefly the congestion (blocked nose), have disappeared.
Zdravljenje naj bo čim krajše in ga je treba ustaviti, kakor hitro simptomi, zlasti kongestija (zamašen nos), izginejo.
It should not be used in people who are taking a monoamine oxidase inhibitor (such as some medicines used to treat depression) or who have stopped taking one of these medicines within the last two weeks.
Ne smejo ga uporabljati osebe, ki se zdravijo z zaviralci monoaminooksidaze (na primer z nekaterimi zdravili za zdravljenje depresije) ali ki so v zadnjih dveh tednih prenehale jemati katero izmed teh zdravil.
What is the risk associated with Aerinaze?
Kakšna tveganja so povezana z zdravilom Aerinaze?
When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.
Če so receptorji blokirani, histamin ne more učinkovati, zaradi česar se zmanjšajo simptomi alergije.
The patients recorded their symptoms in a diary every 12 hours during the study, scoring on a standard symptom scale how severe the symptoms were over the previous 12-hour period.
Bolniki so med študijo beležili simptome v dnevnik vsakih 12 ur in ocenjevali njihovo resnost v preteklem 12-urnem obdobju s pomočjo standardne lestvice za ocenjevanje simptomov.
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 Aerinaze.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Aerinaze, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
This reduces the amount of fluid released from the vessels, resulting in less swelling and less mucus production in the nose.
To zmanjša količino tekočine, ki se sprošča iz žil, kar vodi do zmanjšanja otekanja in nastajanja sluzi v nosu.
Desloratadine is released from its layer immediately after it is taken, while pseudoephedrine is released slowly over 12 hours.
Desloratadin se iz svoje plasti začne sproščati takoj po zaužitju tablete, medtem ko se psevdoefedrin sprošča počasi v obdobju 12 ur.
Why has Aerinaze been approved?
Zakaj je bilo zdravilo Aerinaze odobreno?
Aerinaze is a medicine containing the active substances desloratadine (2.5 mg) and pseudoephedrine (120 mg).
Aerinaze je zdravilo, ki vsebuje zdravilni učinkovini desloratadin (2,5 mg) in psevdoefedrin (120 mg).
When looking at nasal congestion, patients taking Aerinaze had a reduction in symptoms of 37.4%, compared with 26.7% in those taking desloratadine alone.
Z vidika obravnave kongestije nosne sluznice so se pri bolnikih, ki so jemali zdravilo Aerinaze, simptomi zmanjšali za 37,4 %, pri bolnikih, ki so jemali samo desloratadin, pa za 26,7 %.
‘Modified-release' means that the tablets have been made to allow one of the active substances to be released immediately and the other one released over a few hours.
Prirejeno sproščanje pomeni, da so tablete izdelane tako, da omogočajo sprostitev ene zdravilne učinkovine takoj, druga pa se sprošča več ur.
When looking at all hayfever symptoms except for nasal congestion, patients taking Aerinaze reported a reduction in symptoms of 46.0%, compared with 35.9% in those taking pseudoephedrine alone.
Z vidika obravnave vseh simptomov senenega nahoda z izjemo kongestije nosne sluznice so bolniki, ki so jemali zdravilo Aerinaze, poročali o zmanjšanju simptomov za 46,0 %, v primerjavi z zmanjšanjem za 35,9 % pri bolnikih, ki so jemali samo psevdoefedrin.
Aerinaze was more effective in reducing symptoms than either of the two active substances taken alone.
Zdravilo Aerinaze je bilo pri zmanjševanju simptomov učinkovitejše od obeh zdravilnih učinkovin, uporabljenih samostojno.
For the full list of all side effects reported with Aerinaze, see the Package Leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Aerinaze, glejte navodilo za uporabo.
Desloratadine/pseudoephedrine
Povzetek EPAR za javnost desloratadin/psevdoefedrin
In Aerinaze, the two active substances are used together, since an antihistamine alone may not provide adequate relief for patients with nasal congestion.
V zdravilu Aerinaze sta obe zdravilni učinkovini uporabljeni v kombinaciji, saj sam antihistaminik ne bi zagotovil ustreznega olajšanja pri bolnikih s kongestijo nosne sluznice.
The most common side effects with Aerinaze (seen in between 1 and 10 patients in 100) are tachycardia (fast heart rate), dry mouth, dizziness, psychomotor hyperactivity (restlessness), pharyngitis (sore throat), anorexia (loss of appetite), constipation, headache, fatigue (tiredness), insomnia (difficulty sleeping), somnolence (sleepiness), sleep disorders and nervousness.
Najpogostejši neželeni učinki zdravila Aerinaze (opaženi pri 1 do 10 bolnikih od 100) so tahikardija (pospešeno bitje srca), suha usta, omotica, psihomotorična hiperaktivnost (nemirnost), faringitis (vneto žrelo), anoreksija (izguba teka), zaprtje, glavobol, utrujenost, nespečnost, zaspanost, motnje spanja in živčnost.
Desloratadine has been available in the European Union (EU) since 2001, and pseudoephedrine is widely used in medicines that have been available over-the-counter for many years.
To pomeni, da morajo bolniki tableto vzeti samo dvakrat na dan. Desloratadin je na voljo v Evropski uniji (EU) od leta 2001, psevdoefedrin pa se že vrsto let pogosto uporablja v zdravilih, ki se izdajajo brez recepta.
The Committee for Medicinal Products for Human Use (CHMP) decided that Aerinaze's benefits are greater than its risks for the symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion and recommended that Aerinaze be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Aerinaze pri simptomatskem zdravljenju sezonskega alergijskega rinitisa, ki ga spremlja kongestija nosne sluznice, večje od z njim povezanih tveganj in priporočil, da se zanj odobri dovoljenje za promet z zdravilom.
Pseudoephedrine works by stimulating nerve endings to release the chemical noradrenaline, which causes the blood vessels to constrict (narrow).
Psevdoefedrin spodbuja živčne končiče, da sproščajo kemijsko snov noradrenalin, ki povzroča zožitev krvnih žil.
Aerinaze must not be used in people who are hypersensitive (allergic) to desloratadine, pseudoephedrine or any of the other ingredients, to adrenergic agents or to loratadine (another medicine used to treat allergies).
Zdravila Aerinaze ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) desloratadin, psevdoefedrin ali katero koli drugo sestavino zdravila, adrenergične učinkovine ali loratadin (drugo zdravilo za zdravljenje alergij).
Aerinaze should also not be taken by people who have narrow angle glaucoma (increased pressure inside the eye), urinary retention (difficulty in passing urine), heart or blood vessel diseases including hypertension (high blood pressure), hyperthyroidism (an overactive thyroid gland), or a history or risk of haemorrhagic stroke (stroke caused by bleeding within the brain).
Prav tako zdravila Aerinaze ne smejo jemati osebe, ki imajo glavkom ozkega zakotja (povečan tlak v notranjosti očesa), zastoj seča (težave pri izločanju seča), srčnožilne bolezni, vključno s hipertenzijo (visokim krvnim tlakom), hipertiroidizem (povečano delovanje ščitnice) ali anamnezo oziroma tveganje za hemoragično možgansko kap (kap zaradi krvavitve v možganih).
Desloratadine works by blocking the receptors on which histamine, a substance in the body that causes allergic symptoms, normally attaches itself.
Desloratadin deluje kot zaviralec receptorjev, na katere se običajno veže histamin, tj. snov v telesu, ki povzroča alergijske simptome.
Aerinaze tablets have two layers, one containing desloratadine, and the other containing pseudoephedrine.
Tablete zdravila Aerinaze so dvoplastne, ena plast vsebuje desloratadin, druga pa psevdoefedrin.
What is Aerinaze?
Kaj je zdravilo Aerinaze?