FrancophonIA/ELRC3.0 huggingface dataset:
English: On 20 December 2013 the European Medicines Agency's Committee on Human Medicinal Products (CHMP) endorsed previous recommendations which concluded that the benefits of Kogenate Bayer and Helixate NexGen, so-called second generation factor VIII products, continue to outweigh their risks in previously untreated patients with the bleeding disorder haemophilia A, but that the product information for these medicines should be amended.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri Evropski agenciji za zdravila je dne 20. decembra 2013 potrdil predhodna priporočila s sklepom, da so koristi zdravil Kogenate Bayer in Helixate NexGen, ki sta zdravili iz tako imenovane druge generacije faktorja VIII, še naprej večje od z njima povezanih tveganj pri predhodno nezdravljenih bolnikih z motnjo strjevanja krvi, hemofilijo A, vendar pa je treba spremeniti informacije o zdravilu za ti dve zdravili.
English: • Despite concerns raised by the RODIN/PedNet study, overall the current evidence does not confirm that there is an increased risk of inhibitor development against full-length second generation factor VIII products such as Kogenate Bayer and Helixate NexGen.
Slovenian: • Kljub zadržkom, ki jih je vzbudila študija RODIN/PedNet, trenutno razpoložljivi dokazi na splošno ne potrjujejo povečanega tveganja za nastanek zaviralcev zdravil iz druge generacije faktorja VIII celotne dolžine, kot sta Kogenate Bayer in Helixate NexGen.
English: • Concerns about a potentially increased risk of factor VIII inhibitor development with full-length second generation factor VIII products were originally raised by the RODIN/PedNet study.
Slovenian: • Zadržke zaradi možnega povečanega tveganja za nastanek zaviralcev faktorja VIII pri uporabi zdravil iz druge generacije faktorja VIII celotne dolžine je prvotno vzbudila študija RODIN/PedNet.
English: They are used to replace the factor VIII that is lacking in patients with haemophilia A, an inherited bleeding disorder.
Slovenian: Uporabljata se za nadomeščanje faktorja VIII, ki ga primanjkuje bolnikom s hemofilijo A, sicer prirojeno motnjo strjevanja krvi.
English: • Haemophilia A is an inherited bleeding disorder in which there is a lack of factor VIII, which is needed for blood to clot normally.
Slovenian: • Hemofilija A je prirojena motnja strjevanja krvi, za katero je značilno pomanjkanje faktorja VIII, ki je potreben za normalno strjevanje krvi.
English: CHMP confirms PRAC recommendations on Kogenate Bayer/Helixate NexGen
Slovenian: Odbor CHMP je potrdil priporočila odbora PRAC v zvezi z zdraviloma Kogenate Bayer in Helixate NexGen
English: The recommendations, issued by the Agency's Pharmacovigilance Risk Assessment Committee (PRAC), resulted from a review of the medicines which did not confirm a higher risk of developing a type of antibody (factor VIII inhibitors) against these medicines when compared with other factor VIII products.
Slovenian: Priporočila, ki jih je izdal Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri agenciji, so nastala na osnovi pregleda zdravil, ki ni potrdil povečanega tveganja za nastanek vrste protiteles (zaviralcev faktorja VIII) proti tema zdraviloma v primerjavi z drugimi zdravili, ki vsebujejo faktor VIII.
English: Kogenate Bayer and Helixate NexGen are known as second generation factor VIII products.
Slovenian: Kogenate Bayer in Helixate NexGen sta tako imenovani zdravili iz druge generacije faktorja VIII.
English: After reviewing current available data on the development of inhibitors in previously untreated patients, the PRAC decided that these data did not support a conclusion that Kogenate Bayer or Helixate NexGen were associated with an increased risk of developing factor VIII inhibitors compared with other products.
Slovenian: Potem ko je pregledal trenutno razpoložljive podatke o nastanku zaviralcev pri predhodno nezdravljenih bolnikih, je odbor PRAC sklenil, da podatki ne podpirajo zaključka, da sta zdravili Kogenate Bayer in Helixate NexGen povezani s povečanim tveganjem za nastanek zaviralcev faktorja VIII v primerjavi z drugimi zdravili.
English: The review by the PRAC was triggered by results from a study (the RODIN/PedNet study1) in previously untreated children with haemophilia A who were given different factor VIII products, as well as preliminary data from the European Haemophilia Safety and Surveillance System (EUHASS).
Slovenian: Pregled, ki ga je opravil odbor PRAC, je bil sprožen zaradi rezultatov študije (študija RODIN/PedNet1) pri predhodno nezdravljenih otrocih s hemofilijo A, ki so jim dajali različna zdravila, ki vsebujejo faktor VIII, in predhodnih podatkov iz evropskega sistema za spremljanje varnosti zdravil za hemofilijo (EUHASS).
English: • Different forms of factor VIII are available as medicines to replace the missing clotting factor.
Slovenian: • Za nadomeščanje manjkajočega faktorja strjevanja krvi so na voljo zdravila z različnimi oblikami faktorja VIII.
English: Although existing measures to minimise all the risks from using the products were considered adequate for both Kogenate Bayer and Helixate NexGen and should be continued, the PRAC recommended that the product information should be updated to reflect results from the RODIN study.
Slovenian: Obstoječi ukrepi za zmanjšanje vseh tveganj, povezanih z uporabo zdravil Kogenate Bayer in Helixate NexGen, so zadostni in se morajo še naprej izvajati, vendar pa je odbor PRAC priporočil, da se informacije o zdravilu dopolnijo z rezultati študije RODIN.
English: Post-hoc analysis of the study showed that PUPs with severe haemophilia A given Kogenate Bayer were more likely to develop inhibitors than those given another recombinant antihaemophilic factor VIII (adjusted hazard ratio, 1.60; 95%-CI: 1.08
Slovenian: Analiza študije post hoc je pokazala, da so se zaviralci pogosteje razvili pri predhodno nezdravljenih bolnikih s hudo hemofilijo A, ki so prejemali zdravilo Kogenate Bayer, kot pri tistih, ki so prejemali drug rekombinantni koagulacijski faktor VIII (prilagojeno razmerje tveganja, 1,60; 95-odstotni IZ: 1,08-2,37).
English: This was an observational study which examined inhibitor development in previously untreated patients (PUPs) with severe haemophilia A who were given recombinant or plasma-derived factor VIII products.
Slovenian: To je bila opazovalna študija, v kateri so raziskovali nastajanje zaviralcev pri predhodno nezdravljenih bolnikih s hudo hemofilijo A, ki so prejemali rekombinantna zdravila ali zdravila iz plazme, ki vsebujejo faktor VIII.
English: A study in previously untreated patients with haemophilia A, which compared several of these, seemed to show that patients who were given Kogenate Bayer or Helixate NexGen (full-length second generation products) were more likely to develop antibodies than those given another factor VIII (a third generation product).
Slovenian: Študija na predhodno nezdravljenih bolnikih s hemofilijo A, v kateri so primerjali več takih zdravil, je pokazala, da so se pri bolnikih, ki so prejemali zdravilo Kogenate Bayer ali Helixate NexGen (zdravili iz druge generacije faktorja VIII celotne dolžine), pogosteje razvila protitelesa kot pri tistih, ki so prejemali drug faktor VIII (zdravilo tretje generacije).
English: Untreated, the deficiency of factor VIII in these patients causes bleeding problems, including bleeding into joints, muscles, and internal organs that can lead to severe damage.
Slovenian: Če se motnja ne zdravi, se lahko zaradi pomanjkanja faktorja VIII pri teh bolnikih pojavijo težave s krvavitvami, ki vključujejo krvavitve v sklepe, mišice in notranje organe, kar lahko povzroči hude poškodbe.
English: Untreated, the deficiency of factor VIII causes bleeding problems, including bleeding into joints, muscles, and internal organs that can lead to severe damage.
Slovenian: Če se motnja ne zdravi, se lahko zaradi pomanjkanja faktorja VIII pojavijo težave s krvavitvami, ki vključujejo krvavitve v sklepe, mišice in notranje organe, kar lahko povzroči hude poškodbe.
English: This is a known risk for all factor VIII products but the authors of the study concluded that children given so-called second generation fulllength recombinant factor VIII products such as Kogenate Bayer or Helixate NexGen were more likely to develop antibodies than those given a third generation recombinant product.
Slovenian: To je znano tveganje pri vseh zdravilih, ki vsebujejo faktor VIII, vendar pa so avtorji študije zaključili, da so se protitelesa pogosteje razvila pri otrocih, ki so jim dajali zdravila iz tako imenovane druge generacije rekombinatnega faktorja VIII celotne dolžine, med katere sodita tudi zdravili Kogenate Bayer in Helixate NexGen, kot pri tistih, ki so prejemali rekombinantno zdravilo tretje generacije.
English: Factor VIII is lacking in patients with haemophilia A and is given to them to allow their blood to clot normally.
Slovenian: Bolniki s hemofilijo A imajo pomanjkanje faktorja VIII, zato ga morajo dodajati, da omogočijo normalno strjevanje krvi.
English: An increase in inhibitor formation was not seen with other recombinant or plasma-derived factor VIII products.
Slovenian: Pri drugih rekombinantnih zdravilih ali zdravilih iz plazme, ki vsebujejo faktor VIII, niso opazili povečanega nastajanja zaviralcev.
English: This summary was last updated on 18 August 2011.
Slovenian: Povzetek je bil nazadnje posodobljen dne 18. 08. 2011.
English: A second dose may be given after 24 hours if required.
Slovenian: Drugi odmerek se lahko po potrebi da po 24 urah.
English: Emdocam meloxicam
Slovenian: Emdocam meloksikam
English: Other information about Emdocam:
Slovenian: Druge informacije o zdravilu Emdocam:
English: Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendation for authorisation and the conditions of use.
Slovenian: Njegov namen je pojasniti, kako je Odbor za zdravila za uporabo v veterinarski medicini (CVMP) ocenil predloženo dokumentacijo, na podlagi česar je oblikoval priporočila za odobritev zdravila in njegovo uporabo.
English: In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
Slovenian: V zelo redkih primerih lahko pride do anafilaktoidnih reakcij, ki jih je treba zdraviti simptomatsko.
English: The withdrawal period is 15 days for cattle and five days for pigs and horses.
Slovenian: Karenca za govedo je 15 dni, za prašiče in konje pa 5 dni.
English: In horses, a transient swelling at the injection site can occur but resolves without intervention.
Slovenian: Pri konjih se na mestu injiciranja lahko pojavi prehodna oteklina, ki pa izzveni brez ukrepov.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Emdocam to Emdoka bvba on 18 August 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Emdocam, veljavno po vsej Evropski uniji, odobrila družbi Emdoka bvba dne 18. 08. 2011.
English: It is available as a clear yellow solution for injection (20 mg/ml).
Slovenian: Na voljo je v obliki prozorne rumene raztopine za injiciranje (20 mg/ml).
English: Milk can be taken five days after administration in cattle.
Slovenian: Mleko goveda se lahko pomolze pet dni po uporabi zdravila.
English: No studies in cattle, pigs and horses were required as Emdocam is given by injection and has a similar composition as the reference medicine, Metacam.
Slovenian: Študije pri govedu, prašičih in konjih niso bile potrebne, saj se zdravilo Emdocam daje z injiciranjem in ima podobno sestavo kot referenčno zdravilo Metacam.
English: People who are hypersensitive (allergic) to NSAIDs should avoid contact with Emdocam.
Slovenian: Osebe, ki so preobčutljive za (alergične na) nesteroidna protivnetna zdravila, naj se izogibajo stiku z zdravilom Emdocam.
English: In cattle and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
Slovenian: Govedo in prašiči dobro prenašajo podkožno, intramuskularno in intravensko dajanje; v kliničnih študijah so opazili samo rahlo prehodno oteklino na mestu injiciranja po podkožnem dajanju pri manj kot 10 % zdravljenega goveda.
English: It can be used with oral re-hydration therapy for diarrhoea in calves of over one week of age and in young, non-lactating cattle.
Slovenian: Uporablja se lahko s peroralnim rehidracijskim zdravljenjem pri driski pri teletih, starejših od enega tedna, in mladih govedih, ki niso v obdobju laktacije.
English: What benefit has Emdocam shown during the studies?
Slovenian: Kakšne koristi je zdravilo Emdocam izkazalo med študijami?
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Slovenian: Razmerje med koristmi in tveganji najdete v znanstveni razpravi tega evropskega javnega poročila o oceni zdravila EPAR.
English: Emdocam is a medicine for cattle, pigs and horses that contains the active substance meloxicam.
Slovenian: Emdocam je zdravilo za govedo, prašiče in konje, ki vsebuje zdravilno učinkovino meloksikam.
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the doctor.
Slovenian: V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
English: Meloxicam acts by blocking an enzyme called cyclo-oxygenase which is involved in the production of prostaglandins.
Slovenian: Meloksikam deluje tako, da zavira encim, imenovan ciklooksigenaza, ki sodeluje pri nastajanju prostaglandinov.
English: Emdocam contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Slovenian: Zdravilo Emdocam vsebuje meloksikam, ki spada v skupino zdravil, imenovanih nesteroidna protivnetna zdravila (NSAID).
English: The Committee recommended that Emdocam be given a marketing authorisation.
Slovenian: Odbor je priporočil odobritev dovoljenja za promet z zdravilom Emdocam.
English: What is the risk associated with Emdocam?
Slovenian: Kakšna tveganja so povezana z zdravilom Emdocam?
English: Emdocam is a ‘generic' medicine which means that Emdocam is similar to a ‘reference veterinary medicine' already authorised in the EU (Metacam).
Slovenian: Emdocam je generično zdravilo, kar pomeni, da je podobno referenčnemu veterinarskemu zdravilu, ki je že odobreno v EU (zdravilu Metacam).
English: In cattle it is used together with appropriate antibiotics, to reduce clinical signs of acute respiratory infection (infection of the lungs and airways) and to treat acute mastitis (inflammation of the udder).
Slovenian: Pri govedu se uporablja z ustreznimi antibiotiki za zmanjšanje kliničnih znakov akutne okužbe dihal (okužbe pljuč in dihalnih poti) in zdravljenje akutnega mastitisa (vnetja vimena).
English: It is used in pigs to reduce the symptoms of lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move) and for the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome), together with appropriate antibiotic therapy.
Slovenian: Pri prašičih se uporablja za lajšanje simptomov ohromelosti in vnetja pri neinfekcijskih lokomotornih motnjah (bolezni, ki vplivajo na sposobnost gibanja) ter za zdravljenje bolezni, ki se pojavljajo po kotitvi, kot sta puerperalna septikemija in toksemija (sindrom mastitisa, metritisa in agalakcije),
English: Emdocam is ‘bioequivalent' to the reference medicine which means that it is equivalent to Metacam in the way it is absorbed and used by the body.
Slovenian: Zdravilo Emdocam je biološko enakovredno referenčnemu zdravilu, kar pomeni, da je zdravilu Metacam enakovredno glede tega, kako ga telo absorbira in uporablja.
English: Emdocam is used in horses to relieve colic (abdominal pain) and the inflammation and pain in musculo-skeletal disorders.
Slovenian: Emdocam se uporablja pri konjih za lajšanje kolike (trebušnih bolečin) ter vnetja in bolečin pri mišičnoskeletnih boleznih.
English: As the prostaglandins trigger inflammation, pain, exudation and fever, meloxicam reduces these clinical signs.
Slovenian: Prostaglandini sprožijo vnetje, bolečino, izločanje tekočine in povišano telesno temperaturo, meloksikam pa te klinične znake zmanjšuje.
English: The CVMP considered that, in accordance with European Union requirements, Emdocam is bioequivalent to Metacam.
Slovenian: CVMP je menil, da je zdravilo Emdocam v skladu z zahtevami Evropske unije biološko enakovredno zdravilu Metacam.
English: It is given as a single injection of 0.4 mg per kg body weight into a muscle.
Slovenian: Daje se kot ena injekcija 0,4 mg na kg telesne mase v mišico.
English: Emdocam is given in cattle as a single injection of 0.5 mg per kg body weight under the skin or into a vein.
Slovenian: Zdravilo Emdocam se govedu daje kot ena injekcija 0,5 mg na kg telesne mase pod kožo ali v veno.
English: Therefore the CVMP's view was that, as for Metacam, Emdocam's benefits are greater than its risks when used for the approved indications.
Slovenian: CVMP je menil, da so koristi zdravila Emdocam, tako kot pri zdravilu Metacam, večje od z njim povezanih tveganj, če se uporablja za odobrene indikacije.
English: Consequently, Emdocam's benefit is taken as being the same as that of the reference medicine.
Slovenian: Zato se šteje, da so koristi zdravila Emdocam enake kot pri referenčnemu zdravilu.
English: Why has Emdocam been approved?
Slovenian: Zakaj je bilo zdravilo Emdocam odobreno?
English: The medicine should not be used in horses producing milk for human consumption.
Slovenian: Uporaba pri konjih, katerih mleko je namenjeno prehrani ljudi, ni dovoljena
English: Emdocam was considered to be bioequivalent with the reference medicine.
Slovenian: Zdravilo Emdocam se je štelo za biološko enakovredno referenčnemu zdravilu.
English: How has Emdocam been studied?
Slovenian: Kako je bilo zdravilo Emdocam raziskano?
English: What is Emdocam used for?
Slovenian: Za kaj se zdravilo Emdocam uporablja?
English: How does Emdocam work?
Slovenian: Kako zdravilo Emdocam deluje?
English: Emdocam is given as a single injection of 0.6 mg per kg body weight into the horse's vein.
Slovenian: Daje se kot ena injekcija 0,6 mg na kg telesne mase v konjevo veno.
English: What is Emdocam?
Slovenian: Kaj je zdravilo Emdocam?
English: It is available as tablets (2.5, 5, 7.5, 10 and 15 mg).
Slovenian: Na voljo je v obliki tablet (2,5 mg, 5 mg, 7,5 mg, 10 mg in 15 mg).
English: It is known as an ‘atypical' antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s.
Slovenian: Spada med netipična antipsihotična zdravila, ker se razlikuje od starejših antipsihotkov, ki so na voljo od petdesetih let prejšnjega stoletja.
English: The full EPAR for Olanzapine Cipla can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Olanzapine Cipla je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Previously known as Olanzapine Neopharma.
Slovenian: Prej znano kot Olanzapine Neopharma.
English: Its exact mechanism of action is unknown, but it attaches to several receptors on the surface of nerve cells in the brain.
Slovenian: Natančen mehanizem delovanja zdravila ni znan, vendar pa se zdravilo veže na več receptorjev na površini živčnih celic v možganih.
English: Schizophrenia is a mental illness that has a number of symptoms including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).
Slovenian: To je duševna bolezen s številnimi simptomi, ki vključujejo neorganizirano mišljenje in govor, halucinacije (bolnik vidi in sliši stvari, ki jih ni), sumničavost in blodnje (zmotna prepričanja).
English: It can also be used to prevent the recurrence of these episodes (when symptoms come back) in adults with bipolar disorder (a mental illness causing alternating periods of high mood and depression) who have responded to an initial course of treatment.
Slovenian: Uporablja se lahko tudi za preprečevanje ponovnega pojava simptomov teh epizod pri odraslih z bipolarno motnjo (duševno boleznijo, pri kateri se izmenjujejo obdobja privzdignjenega razpoloženja in depresije), ki so se odzvali na začetno zdravljenje.
English: The recommended starting dose of Olanzapine Cipla depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Slovenian: Priporočeni začetni odmerek zdravila Olanzapine Cipla je odvisen od bolezni, ki jo zdravimo: pri shizofreniji in za preprečevanje maničnih epizod se uporablja 10-miligramski odmerek na dan, pri zdravljenju maničnih epizod pa se uporablja 15-miligramski odmerek na dan, razen ob souporabi drugih zdravil, ko lahko začetni odmerek znaša 10 mg na dan.
English: It is thought that olanzapine's beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytryptamine (also called serotonin) and dopamine.
Slovenian: Domneva se, da so koristni učinki olanzapina posledica zaviranja receptorjev za živčna prenašalca 5-hidroksitriptamin (imenovan tudi serotonin) in dopamin.
English: The European Commission granted a marketing authorisation valid throughout the EU for Olanzapine Neopharma on 14 November 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Olanzapine Neopharma, veljavno po vsej Evropski uniji, odobrila dne 14. novembra 2007.
English: The dose is adjusted depending on how well the patient responds to and tolerates the treatment.
Slovenian: Zdravnik odmerek prilagodi glede na to, kako se bolnik odziva na zdravljenje in kako zdravljenje prenaša.
English: Olanzapine Cipla is a ‘generic medicine'.
Slovenian: Olanzapine Cipla je „generično zdravilo“.
English: Since these neurotransmitters are involved in schizophrenia and bipolar disorder, olanzapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.
Slovenian: Ker ta dva živčna prenašalca običajno sodelujeta pri shizofreniji in bipolarni motnji, olanzapin pomaga normalizirati delovanje možganov in tako zmanjša simptome teh bolezni.
English: Patients over 65 years of age and patients who have problems with their liver or kidneys may need a lower starting dose of 5 mg per day.
Slovenian: Običajni razpon odmerkov je od 5 do 20 mg na dan. Bolniki, starejši od 65 let, in bolniki, ki imajo težave z jetri ali ledvicami, bodo morda potrebovali nižji začetni odmerek, in sicer 5 mg na dan.
English: For more information about treatment with Olanzapine Cipla, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Olanzapine Cipla preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: This disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
Slovenian: S tem se prekine prenos signalov med možganskimi celicami prek živčnih prenašalcev, tj. kemičnih snovi, ki omogočajo medsebojno komunikacijo med živčnimi celicami.
English: Olanzapine Cipla is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Slovenian: Zdravilo Olanzapine Cipla je prav tako učinkovito pri vzdrževanju izboljšanja stanja pri bolnikih, ki so se odzvali na začetno zdravljenje.
English: The name of the medicine was changed to Olanzapine Cipla on 16 May 2013.
Slovenian: Ime zdravila je bilo 16. maja 2013 spremenjeno v Olanzapine Cipla.