FrancophonIA/ELRC3.0 huggingface dataset:
English: < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Slovenian: Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
English: Each tablet contains 5 mg desloratadine.
Slovenian: Ena tableta vsebuje 5 mg desloratadina.
English: Desloratadine Teva 5 mg film-coated tablets Desloratadine
Slovenian: Desloratadin Teva 5 mg filmsko obložene tablete desloratadin
English: Desloratadine Teva 5 mg film-coated tablets
Slovenian: Desloratadin Teva 5 mg filmsko obložene tablete
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVIO UPORABO
English: In both studies, changes in exposure (AUC and Cmax) of desloratadine and 3-hydroxydesloratadine were not clinically relevant.
Slovenian: Spremembe izpostavljenosti (AUC in Cmax) desloratadinu in
English: What Desloratadine Teva looks like and contents of the pack
Slovenian: Izgled zdravila Desloratadin Teva in vsebina pakiranja
English: Microcrystalline cellulose Pregelatinised maize starch Talc
Slovenian: Jedro tablete mikrokristalna celuloza predgelirani koruzni škrob smukec koloidni brezvodni silicijev dioksid
English: Adults and adolescents (12 years of age and over) The recommended dose of Desloratadine Teva 5 mg film-coated tablets is one tablet once a day.
Slovenian: Priporočeni odmerek zdravila Desloratadin Teva 5 mg filmsko obložene tablete je ena tableta enkrat na dan.
English: Elevations of liver enzymes, increased bilirubin, hepatitis
Slovenian: Bolezni jeter, žolčnika in žolčevodov zelo redki neznana povečane vrednosti jetrnih encimov in bilirubina, hepatitis zlatenica
English: Not known:
Slovenian: NN:
English: Use caution when taking Desloratadine Teva with alcohol.
Slovenian: Pri sočasnem jemanju zdravila Desloratadin Teva in uživanju alkohola je potrebna previdnost.
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
English: Treatment with desloratadine also significantly reduced interference with sleep and daytime function, as measured by a fourpoint scale used to assess these variables.
Slovenian: Zdravljenje z desloratadinom je tudi bistveno zmanjšalo motnje spanja in dnevnih dejavnosti bolnika,
English: Pharmachemie B.V. Swensweg 5, 2031 GA Haarlem, The Netherlands or
Slovenian: Swensweg 5, 2031 GA Haarlem, Nizozemska ali
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Slovenian: Če ste prenehali jemati zdravilo Desloratadin Teva Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali farmacevtom.
English: There is limited clinical trial efficacy experience with the use of desloratadine in adolescents 12 through 17 years of age (see sections 4.8 and 5.1).
Slovenian: 12 do 17 let, je malo (glejte poglavji 4.8 in 5.1).
English: ● liver inflammation ● abnormal liver function tests body movement Not known: frequency cannot be estimated from the available data
Slovenian: Neznana: pogostnost: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti ● neobičajna šibkost
English: If you take more Desloratadine Teva than you should
Slovenian: Če ste vzeli večji odmerek zdravila Desloratadin Teva, kot bi smeli Zdravilo Desloratadin Teva jemljite le tako, kot vam je bilo predpisano.
English: 105 film-coated tablets
Slovenian: 105 filmsko obloženih tablet
English: When Desloratadine Teva should be used
Slovenian: Kdaj je treba uporabljati zdravilo Desloratadin Teva
English: 21 film-coated tablets
Slovenian: 21 filmsko obloženih tablet
English: How to store Desloratadine Teva
Slovenian: Kako jemati zdravilo Desloratadin Teva
English: - The active substance is 5 mg desloratadine.
Slovenian: - Zdravilna učinkovina je desloratadin 5 mg.
English: EU/1/11/732/011 90 film-coated tablets
Slovenian: EU/1/11/732/011 90 filmsko obloženih tablet
English: Nervous system disorders
Slovenian: urnega intervala odmerjanja.
English: Desloratadine
Slovenian: astenija
English: Hungary or
Slovenian: Madžarska ali
English: EU/1/11/732/012 100 film-coated tablets
Slovenian: EU/1/11/732/012 100 filmsko obloženih tablet
English: In a single dose trial using a 7.5 mg dose of desloratadine, there was no effect of food (high-fat, high caloric breakfast) on the disposition of desloratadine.
Slovenian: V študiji uporabe enkratnega 7,5 mg odmerka desloratadina niso ugotavljali nobenega vpliva hrane
English: Gastrointestinal disorders
Slovenian: ● nenormalni izvidi preiskav delovanja jeter
English: ● restlessness with increased
Slovenian: ● povečan tek
English: EU/1/11/732/006 28 film-coated tablets
Slovenian: EU/1/11/732/006 28 filmsko obloženih tablet
English: EU/1/11/732/010 60 film-coated tablets
Slovenian: EU/1/11/732/010 60 filmsko obloženih tablet
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Slovenian: Navodilo za uporabo Desloratadin Teva 5 mg filmsko obložene tablete desloratadin Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: EU/1/11/732/007 30 film-coated tablets
Slovenian: EU/1/11/732/007 30 filmsko obloženih tablet
English: EU/1/11/732/008 40 film-coated tablets
Slovenian: EU/1/11/732/008 40 filmsko obloženih tablet
English: EU/1/11/732/009 50 film-coated tablets
Slovenian: EU/1/11/732/009 50 filmsko obloženih tablet
English: EU/1/11/732/004 20 film-coated tablets
Slovenian: EU/1/11/732/004 20 filmsko obloženih tablet
English: EU/1/11/732/005 21 film-coated tablets
Slovenian: EU/1/11/732/005 21 filmsko obloženih tablet
English: EU/1/11/732/002 10 film-coated tablets
Slovenian: EU/1/11/732/002 10 filmsko obloženih tablet
English: EU/1/11/732/003 14 film-coated tablets
Slovenian: EU/1/11/732/003 14 filmsko obloženih tablet
English: Talk to your doctor or pharmacist before taking Desloratadine Teva
Slovenian: Pred začetkom jemanja zdravila Desloratidin Teva se posvetujte z zdravnikom ali farmacevtom:
English: How Desloratadine Teva works
Slovenian: Kako deluje zdravilo Desloratadin Teva
English: Desloratadine Teva contains lactose.
Slovenian: Zdravilo Desloratadin Teva vsebuje laktozo
English: Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria) Asthenia
Slovenian: Splošne težave in spremembe na mestu aplikacije pogosti zelo redki neznana utrujenost preobčutljivostne reakcije (kot so anafilaksija, angioedem, dispneja, pruritus,
English: EU/1/11/732/001 7 film-coated tablets
Slovenian: EU/1/11/732/001 7 filmsko obloženih tablet
English: However, if you take more Desloratadine Teva than you were told to, tell your doctor, pharmacist or nurse immediately.
Slovenian: Pri nenamernem prevelikem odmerjanju zdravila ni pričakovati resnejših težav, kljub temu pa se v primeru, da ste zaužili več zdravila Desloratadin Teva, kot bi morali, posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: During the marketing of Desloratadine Teva, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely.
Slovenian: Med trženjem zdravila Desloratadin Teva so zelo redko poročali o primerih hudih alergijskih reakcij
English: Desloratadine has no or negligible influence on the ability to drive and use machines based on clinical trials.
Slovenian: Zdravilo Desloratadin Teva 5 mg filmsko obložene tablete glede na klinične študije nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: ● weight increased ● increased appetite
Slovenian: ● povečana telesna masa
English: Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea
Slovenian: Bolezni prebavil pogosti zelo redki suha usta trebušne bolečine, navzeja, bruhanje,
English: The frequency of the clinical trial adverse reactions reported in excess of placebo and other undesirable effects reported during the post-marketing period are listed in the following table Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to
Slovenian: V kliničnih študijah z zdravilom Desloratadin Teva so poročali o naslednjih neželenih učinkih: Pogosti: naslednji se lahko pojavijo pri največ 1 od 10 bolnikov
English: Strength Pharmaceutical Form
Slovenian: Številka (EU) dovoljenja za promet Izmišljeno ime Jakost Farmacevtska oblika
English: EXP: {MM/YYYY}
Slovenian: EXP: {mm/llll}
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (European Medicines Agency) http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/.
English: More than 97% of meloxicam is bound to plasma proteins.
Slovenian: Več kot 97% meloksikama se veže na beljakovine v plazmi.
English: In dogs, these side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
Slovenian: Pri psih se našteti neželeni učinki pretežno pojavijo v prvem tednu zdravljenja, so večinoma prehodni in po končanem zdravljenju izginejo, vendar so lahko v zelo redkih primerih tudi resni ali smrtno nevarni.
English: Flexicam 5 mg/ml solution for injection for dogs and cats
Slovenian: Flexicam 5 mg/ml, raztopina za injiciranje za pse in mačke
English: Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 3 leti.
English: 1 ml of solution for injection contains 5 mg of meloxicam.
Slovenian: 1 ml raztopine za injiciranje vsebuje 5 mg meloksikama.
English: Lot: {number}
Slovenian: Lot:{številka}
English: Approximately 75% of the administered dose is eliminated via faeces and the remainder via urine.
Slovenian: Približno 75% vnesenega odmerka se izloči z blatom, preostala količina pa z urinom.
English: Other substances: Ethanol anhydrous 150 mg/ml.
Slovenian: Druge sestavine: Brezvodni etanol 150 mg/ml.
English: Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects.
Slovenian: Druga nesteroidna protivnetna zdravila, diuretiki, antikoagulanti, aminoglikozidni antibiotiki in snovi z visoko vezavo na beljakovine se lahko kompetitivno vežejo, kar lahko povzroči toksične učinke.
English: If side effects occur, treatment should be discontinued.
Slovenian: Če se pojavijo neželeni učinki, je treba zdravljenje prekiniti.
English: DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT IN NAČIN UPORABE
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with
Slovenian: Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili za
English: Dogs: Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Slovenian: Psi: Umirjanje vnetja in lajšanje bolečine pri akutnih in kroničnih mišično-skeletnih obolenjih.
English: Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
Slovenian: Farmakoterapevtska skupina: protivnetna in protirevmatična zdravila, nesteroidna (oksikami).
English: Flexicam must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Slovenian: Flexicama ne smemo dajati z drugimi nesteroidnimi protivnetnimi zdravili ali glukokortikosteroidi.
English: Colourless type I glass injection vial of 10 ml, closed with a grey EPDM rubber stopper and sealed with a flip-off aluminium violet seal.
Slovenian: Brezbarvne steklene injekcijske viale tipa I po 10 ml, zaprte z zamaškom iz sive EPDM gume in
English: Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma concentrations of 0.73 µg/ml in dogs and 1.1 µg/ml in cats were reached approximately 2.5 hours and 1.5 hours post administration, respectively.
Slovenian: Meloksikam je po podkožnem dajanju v celoti biološko uporaben in doseže največjo srednjo koncentracijo v plazmi, ki je 0,73 µg/ml pri psih in 1,1 µg/ml pri mačkah, približno 2,5 ure oz. 1,5 ure
English: Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Slovenian: Ne uporabite pri živalih z obolenji prebavil, kot so vzdraženost prebavil in krvavitev, pri motnjah delovanja jeter, srca ali ledvic in hemoragičnih obolenjih.
English: Do not use an oral follow-up therapy using meloxicam or other NSAIDs in cats, as no safe dosage for repeated oral administration has been established.
Slovenian: Pri mačkah zdravljenja ne smete nadaljevati s peroralno obliko meloksikama ali drugega nesteroidnega protivnetnega zdravila, ker varni odmerek za takšno nadaljevalno zdravljenje še ni določen.
English: Pack sizes: Single 10 ml injection vial.
Slovenian: Velikosti ovojnin: Injekcijska viala po 10 ml.
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or
Slovenian: V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za
English: Shelf-life after first opening the container: 28 days.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: 28 dneh.
English: MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR
Slovenian: IMETNIK DOVOLJENJ ZA IZDELAVO ZDRAVILA, ODGOVORNI ZA
English: For post-operative pain relief in cats, safety has only been documented after thiopental/halothane anaesthesia.
Slovenian: Pri lajšanju pooperativne bolečine pri mačkah je varnost dokumentirana samo po uporabi anestezije s tiopentalom in halotanom.
English: When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be excluded.
Slovenian: Kadar dajemo nesteroidna protivnetna zdravila sočasno z anestezijo, ni mogoče izključiti tveganja za škodljive učinke na
English: Name and address of the manufacturers responsible for batch release
Slovenian: Ime in naslov izdelovalcev zdravila, odgovornih za sprostitev serije
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGEIH SESTAVINE
English: Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.
Slovenian: Lajšanje pooperativne bolečine in zmanjšanje vnetja po ortopedskih operacijah in operacijah mehkega
English: Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood and apathy have occasionally been reported.
Slovenian: Občasno so poročali o značilnih neželenih učinkih nesteroidnih protivnetnih zdravil, kot so izguba teka, bljuvanje, driska, okultna kri v blatu in apatija.
English: A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH
Slovenian: A. IMETNIK DOVOLJENJ ZA IZDELAVO ZDRAVILA, ODGOVORNI ZA
English: The safety of the veterinary medicinal product has not been established during pregnancy and
Slovenian: Varnost zdravila v obdobju brejosti in laktacije ni bila ugotovljena.
English: For post-operative pain relief in cats, safety has only been documented after thiopental/halothane
Slovenian: Pri lajšanju pooperativne bolečine pri mačkah je varnost dokumentirana samo pri uporabi po
English: The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
Slovenian: Pri določanju časa, v katerem ne smemo dajati drugih zdravil, je treba upoštevati tudi farmakokinetične lastnosti teh
English: Single subcutaneous injection at a dosage of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg body weight) before surgery, for example at the time of induction of anaesthesia.
Slovenian: Enkratna podkožna injekcija v odmerku 0,3 mg meloksikama na kilogram telesne mase (to je 0,06 ml/kg telesne mase) pred operacijo, na primer ob indukciji anestezije.
English: Single intravenous or subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body weight) before surgery, for example at the time of induction of anaesthesia.
Slovenian: Enkratna intravenska ali podkožna injekcija v odmerku 0,2 mg meloksikama na kilogram telesne mase (to je 0,4 ml/10 kg telesne mase) pred operacijo, na primer ob indukciji anestezije.
English: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class, which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects.
Slovenian: Njegovo delovanje temelji na zaviranju tvorbe prostaglandinov in tako deluje protivnetno, analgetično, antieksudativno in antipiretično.
English: Cats: single administration of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg).
Slovenian: Mačke: enkratni odmerek 0,3 mg meloksikama na kilogram telesne mase (to je 0,06 ml/kg).
English: Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body weight).
Slovenian: Enkratna podkožna injekcija v odmerku 0,2 mg meloksikama na kilogram telesne mase (to je 0,4 ml/10 kg telesne mase).
English: Dogs: single administration of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg).
Slovenian: Psi: enkratni odmerek 0,2 mg meloksikama na kilogram telesne mase (to je 0,4 ml/10 kg).
English: DK-7171 Uldum Denmark
Slovenian: Brezvodni etanol Poloksamer 188 Glikofurol Meglumin Glicin
English: Concurrent administration of potential nephrotoxic drugs should be avoided.
Slovenian: Izogibati se je treba sočasnega dajanja zdravil, ki lahko imajo nefrotoksične učinke.
English: Accidental self-injection may give rise to pain.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Nenamerno samoinjiciranje lahko povzroči bolečino.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
Slovenian: Zaradi možne povečane toksičnosti za ledvice zdravila ne dajemo dehidriranim, hipovolemičnim ali hipotenzivnim živalim.
English: MARKETING AUTHORISATION NUMBER
Slovenian: Imetnik dovoljenja za promet z zdravilom
English: 6.5 Nature and composition of immediate packaging
Slovenian: 6.1 Seznam pomožnih snovi
English: Metabolism:
Slovenian: Natrijev klorid
English: Do not use after the expiry date stated on the carton and the vial after EXP. Shelf-life after first opening the container: 28 days.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini in viali po EXP.
English: Patients must also not use oral contraceptives.
Slovenian: Bolniki prav tako ne smejo uporabljati peroralnih kontracepcijskih sredstev.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Glybera on 25 October 2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Glybera, veljavno po vsej Evropski uniji, izdala 25. oktobra 2012.
English: This is a subgroup of severely affected patients with a high unmet medical need.
Slovenian: Gre za podskupino resno prizadetih bolnikov, pri katerih obstaja velika potreba po zdravljenju.
English: The amount of the medicine to inject and the number of injections depend on the patient's weight.
Slovenian: Količina zdravila, ki ga je treba injicirati, in število injekcij sta odvisna od bolnikove telesne mase.
English: This is a summary of the European public assessment report (EPAR) for Glybera.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Glybera.
English: What measures are being taken to ensure the safe and effective use of Glybera?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Glybera?
English: The medicine will only be supplied to doctors who have received the appropriate educational materials and will only be used to treat patients participating in the registry.
Slovenian: Zdravilo se bo dostavilo samo tistim zdravnikom, ki bodo prejeli ustrezno izobraževalno gradivo in ga bodo uporabljali za zdravljenje samo tistih bolnikov, ki so zabeleženi v registru.
English: Glybera alipogene tiparvovec
Slovenian: Glybera alipogentiparvovek
English: The majority of patients who received Glybera also received immunosuppressive treatment.
Slovenian: Večina bolnikov, ki so prejemali zdravilo Glybera, je prejemala tudi imunosupresivno terapijo.
English: For three days before Glybera treatment and for twelve weeks after, patients are given immunosuppressive treatment to reduce the reaction of the body's immune system against the medicine.
Slovenian: Tri dni pred zdravljenjem z zdravilom Glybera in dvanajst tednov po njem je treba bolnikom dajati imunosupresivno terapijo, ki zmanjša reakcijo imunskega sistema telesa na zdravilo.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Glybera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Glybera je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The CHMP therefore recommended that the medicine be granted marketing authorisation.
Slovenian: Odbor je zato priporočil, da se za zdravilo izda dovoljenje za promet.
English: The enzyme produced by these cells can then help to break down fats in the blood, reducing the number of pancreatitis attacks and the severity of the disease.
Slovenian: Encim, ki ga te celice izdelajo, lahko nato pomaga razgrajevati maščobe v krvi, s čimer zmanjšuje število napadov pankreatitisa in resnost bolezni.
English: Under the terms of the authorisation, the company is required to provide further data on fat levels in the blood after meals and on the immune response to Glybera in new patients.
Slovenian: V skladu s pogoji odobritve mora družba predložiti dodatne podatke o ravneh maščobe v krvi po obrokih in o imunskem odzivu na zdravilo Glybera pri novih bolnikih.
English: After careful consideration of all the evidence and the circumstances of the disease, including its extreme rarity, the CHMP concluded that the results from studies showed that the benefits of Glybera outweigh its risks in patients with severe or multiple pancreatitis attacks despite following a low-fat diet.
Slovenian: Po skrbni proučitvi vseh dokazov in okoliščin bolezni, vključno z njeno izjemno redkostjo, je odbor CHMP zaključil, da so rezultati študij pokazali, da so koristi zdravila Glybera večje od z njim povezanih tveganj pri bolnikih z resnimi ali multiplimi napadi pankreatitisa kljub dieti z majhnim vnosom maščob.
English: Glybera must not be used in patients with immunodeficiency (weakened immunity), increased risk of bleeding and muscle disease.
Slovenian: Zdravila Glybera ne smejo uporabljati bolniki z imunsko pomanjkljivostjo (oslabljenim imunskim sistemom), povečanim tveganjem za krvavitve in mišičnim obolenjem.
English: Because the number of patients with lipoprotein lipase deficiency is low, the disease is considered ‘rare', and Glybera was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 March 2004.
Slovenian: Ker je število bolnikov s pomanjkanjem lipoproteinske lipaze malo, velja ta bolezen za „redko“, zato je bilo zdravilo Glybera 8. marca 2004 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: The main measures of effectiveness were the reduction in blood fat levels after meals and the reduction in the number of pancreatitis attacks.
Slovenian: Glavni merili učinkovitosti sta bili znižanje ravni maščob v krvi po jedi in zmanjšanje števila napadov pankreatitisa.