natgillin/translations-raw huggingface dataset:
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.
V študiji uporabe enkratnega 7,5 mg odmerka desloratadina niso ugotavljali nobenega vpliva hrane
Gastrointestinal disorders
● nenormalni izvidi preiskav delovanja jeter
● restlessness with increased
● povečan tek
EU/1/11/732/006 28 film-coated tablets
EU/1/11/732/006 28 filmsko obloženih tablet
EU/1/11/732/010 60 film-coated tablets
EU/1/11/732/010 60 filmsko obloženih tablet
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Navodilo za uporabo Desloratadin Teva 5 mg filmsko obložene tablete desloratadin Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
EU/1/11/732/007 30 film-coated tablets
EU/1/11/732/007 30 filmsko obloženih tablet
EU/1/11/732/008 40 film-coated tablets
EU/1/11/732/008 40 filmsko obloženih tablet
EU/1/11/732/009 50 film-coated tablets
EU/1/11/732/009 50 filmsko obloženih tablet
EU/1/11/732/004 20 film-coated tablets
EU/1/11/732/004 20 filmsko obloženih tablet
EU/1/11/732/005 21 film-coated tablets
EU/1/11/732/005 21 filmsko obloženih tablet
EU/1/11/732/002 10 film-coated tablets
EU/1/11/732/002 10 filmsko obloženih tablet
EU/1/11/732/003 14 film-coated tablets
EU/1/11/732/003 14 filmsko obloženih tablet
Talk to your doctor or pharmacist before taking Desloratadine Teva
Pred začetkom jemanja zdravila Desloratidin Teva se posvetujte z zdravnikom ali farmacevtom:
How Desloratadine Teva works
Kako deluje zdravilo Desloratadin Teva
Desloratadine Teva contains lactose.
Zdravilo Desloratadin Teva vsebuje laktozo
Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria) Asthenia
Splošne težave in spremembe na mestu aplikacije pogosti zelo redki neznana utrujenost preobčutljivostne reakcije (kot so anafilaksija, angioedem, dispneja, pruritus,
EU/1/11/732/001 7 film-coated tablets
EU/1/11/732/001 7 filmsko obloženih tablet
However, if you take more Desloratadine Teva than you were told to, tell your doctor, pharmacist or nurse immediately.
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.
During the marketing of Desloratadine Teva, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely.
Med trženjem zdravila Desloratadin Teva so zelo redko poročali o primerih hudih alergijskih reakcij
Desloratadine has no or negligible influence on the ability to drive and use machines based on clinical trials.
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.
● weight increased ● increased appetite
● povečana telesna masa
Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea
Bolezni prebavil pogosti zelo redki suha usta trebušne bolečine, navzeja, bruhanje,
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
V kliničnih študijah z zdravilom Desloratadin Teva so poročali o naslednjih neželenih učinkih: Pogosti: naslednji se lahko pojavijo pri največ 1 od 10 bolnikov
Strength Pharmaceutical Form
Številka (EU) dovoljenja za promet Izmišljeno ime Jakost Farmacevtska oblika
EXP: {MM/YYYY}
EXP: {mm/llll}
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/.
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/.
More than 97% of meloxicam is bound to plasma proteins.
Več kot 97% meloksikama se veže na beljakovine v plazmi.
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.
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.
Flexicam 5 mg/ml solution for injection for dogs and cats
Flexicam 5 mg/ml, raztopina za injiciranje za pse in mačke
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Rok uporabnosti zdravila v pakiranju za prodajo: 3 leti.
1 ml of solution for injection contains 5 mg of meloxicam.
1 ml raztopine za injiciranje vsebuje 5 mg meloksikama.
Lot: {number}
Lot:{številka}
Approximately 75% of the administered dose is eliminated via faeces and the remainder via urine.
Približno 75% vnesenega odmerka se izloči z blatom, preostala količina pa z urinom.
Other substances: Ethanol anhydrous 150 mg/ml.
Druge sestavine: Brezvodni etanol 150 mg/ml.
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects.
Druga nesteroidna protivnetna zdravila, diuretiki, antikoagulanti, aminoglikozidni antibiotiki in snovi z visoko vezavo na beljakovine se lahko kompetitivno vežejo, kar lahko povzroči toksične učinke.
If side effects occur, treatment should be discontinued.
Če se pojavijo neželeni učinki, je treba zdravljenje prekiniti.
DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT IN NAČIN UPORABE
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with
Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili za
Dogs: Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Psi: Umirjanje vnetja in lajšanje bolečine pri akutnih in kroničnih mišično-skeletnih obolenjih.
Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
Farmakoterapevtska skupina: protivnetna in protirevmatična zdravila, nesteroidna (oksikami).
Flexicam must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Flexicama ne smemo dajati z drugimi nesteroidnimi protivnetnimi zdravili ali glukokortikosteroidi.
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.
Brezbarvne steklene injekcijske viale tipa I po 10 ml, zaprte z zamaškom iz sive EPDM gume in
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.
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
Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Ne uporabite pri živalih z obolenji prebavil, kot so vzdraženost prebavil in krvavitev, pri motnjah delovanja jeter, srca ali ledvic in hemoragičnih obolenjih.
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.
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.
Pack sizes: Single 10 ml injection vial.
Velikosti ovojnin: Injekcijska viala po 10 ml.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or
V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za
Shelf-life after first opening the container: 28 days.
Rok uporabnosti po prvem odpiranju stične ovojnine: 28 dneh.
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR
IMETNIK DOVOLJENJ ZA IZDELAVO ZDRAVILA, ODGOVORNI ZA
For post-operative pain relief in cats, safety has only been documented after thiopental/halothane anaesthesia.
Pri lajšanju pooperativne bolečine pri mačkah je varnost dokumentirana samo po uporabi anestezije s tiopentalom in halotanom.
When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be excluded.
Kadar dajemo nesteroidna protivnetna zdravila sočasno z anestezijo, ni mogoče izključiti tveganja za škodljive učinke na
Name and address of the manufacturers responsible for batch release
Ime in naslov izdelovalcev zdravila, odgovornih za sprostitev serije
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGEIH SESTAVINE
Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.
Lajšanje pooperativne bolečine in zmanjšanje vnetja po ortopedskih operacijah in operacijah mehkega
Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood and apathy have occasionally been reported.
Občasno so poročali o značilnih neželenih učinkih nesteroidnih protivnetnih zdravil, kot so izguba teka, bljuvanje, driska, okultna kri v blatu in apatija.
A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH
A. IMETNIK DOVOLJENJ ZA IZDELAVO ZDRAVILA, ODGOVORNI ZA
The safety of the veterinary medicinal product has not been established during pregnancy and
Varnost zdravila v obdobju brejosti in laktacije ni bila ugotovljena.
For post-operative pain relief in cats, safety has only been documented after thiopental/halothane
Pri lajšanju pooperativne bolečine pri mačkah je varnost dokumentirana samo pri uporabi po
The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
Pri določanju časa, v katerem ne smemo dajati drugih zdravil, je treba upoštevati tudi farmakokinetične lastnosti teh
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.
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.
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.
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.
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.
Njegovo delovanje temelji na zaviranju tvorbe prostaglandinov in tako deluje protivnetno, analgetično, antieksudativno in antipiretično.
Cats: single administration of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg).
Mačke: enkratni odmerek 0,3 mg meloksikama na kilogram telesne mase (to je 0,06 ml/kg).
Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body weight).
Enkratna podkožna injekcija v odmerku 0,2 mg meloksikama na kilogram telesne mase (to je 0,4 ml/10 kg telesne mase).
Dogs: single administration of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg).
Psi: enkratni odmerek 0,2 mg meloksikama na kilogram telesne mase (to je 0,4 ml/10 kg).
DK-7171 Uldum Denmark
Brezvodni etanol Poloksamer 188 Glikofurol Meglumin Glicin
Concurrent administration of potential nephrotoxic drugs should be avoided.
Izogibati se je treba sočasnega dajanja zdravil, ki lahko imajo nefrotoksične učinke.
Accidental self-injection may give rise to pain.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Nenamerno samoinjiciranje lahko povzroči bolečino.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
Zaradi možne povečane toksičnosti za ledvice zdravila ne dajemo dehidriranim, hipovolemičnim ali hipotenzivnim živalim.
MARKETING AUTHORISATION NUMBER
Imetnik dovoljenja za promet z zdravilom
6.5 Nature and composition of immediate packaging
6.1 Seznam pomožnih snovi
Metabolism:
Natrijev klorid
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.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini in viali po EXP.
Patients must also not use oral contraceptives.
Bolniki prav tako ne smejo uporabljati peroralnih kontracepcijskih sredstev.
The European Commission granted a marketing authorisation valid throughout the European Union for Glybera on 25 October 2012.
Evropska komisija je dovoljenje za promet z zdravilom Glybera, veljavno po vsej Evropski uniji, izdala 25. oktobra 2012.
This is a subgroup of severely affected patients with a high unmet medical need.
Gre za podskupino resno prizadetih bolnikov, pri katerih obstaja velika potreba po zdravljenju.
The amount of the medicine to inject and the number of injections depend on the patient's weight.
Količina zdravila, ki ga je treba injicirati, in število injekcij sta odvisna od bolnikove telesne mase.
This is a summary of the European public assessment report (EPAR) for Glybera.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Glybera.
What measures are being taken to ensure the safe and effective use of Glybera?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Glybera?
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.
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.
Glybera alipogene tiparvovec
Glybera alipogentiparvovek
The majority of patients who received Glybera also received immunosuppressive treatment.
Večina bolnikov, ki so prejemali zdravilo Glybera, je prejemala tudi imunosupresivno terapijo.
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.
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.
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.
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.
The CHMP therefore recommended that the medicine be granted marketing authorisation.
Odbor je zato priporočil, da se za zdravilo izda dovoljenje za promet.
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.
Encim, ki ga te celice izdelajo, lahko nato pomaga razgrajevati maščobe v krvi, s čimer zmanjšuje število napadov pankreatitisa in resnost bolezni.
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.
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.
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.
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.
Glybera must not be used in patients with immunodeficiency (weakened immunity), increased risk of bleeding and muscle disease.
Zdravila Glybera ne smejo uporabljati bolniki z imunsko pomanjkljivostjo (oslabljenim imunskim sistemom), povečanim tveganjem za krvavitve in mišičnim obolenjem.
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.
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).
The main measures of effectiveness were the reduction in blood fat levels after meals and the reduction in the number of pancreatitis attacks.
Glavni merili učinkovitosti sta bili znižanje ravni maščob v krvi po jedi in zmanjšanje števila napadov pankreatitisa.
What benefit has Glybera shown during the studies?
Kakšne koristi je zdravilo Glybera izkazalo med študijami?
Other information about Glybera
Druge informacije o zdravilu Glybera
There was also a reduction in the number of pancreatitis attacks in some patients, as well as fewer hospital admissions and stays in intensive care units.
Pri nekaterih je prišlo tudi do zmanjšanja števila napadov pankreatitisa ter zmanjšanja števila sprejemov v bolnišnico in obravnav na oddelkih za intenzivno nego.
Anticoagulant medicines, which can increase bleeding, must not be used from the week before Glybera treatment to one day after.
Zdravila za preprečevanje strjevanja krvi, ki lahko povečajo krvavitev, se ne smejo uporabljati vsaj teden dni pred zdravljenjem z zdravilom Glybera in še dan po njem.
The most common side effect reported with Glybera was pain in the legs following the injections, which occurred in a third of patients.
Najpogostejši neželeni učinek, o katerem so poročali pri uporabi zdravila Glybera, je bila bolečina v nogah po injiciranju, ki se je pojavila pri tretjini bolnikov.
The modified viral material used in Glybera does not cause infections and cannot make copies of itself.
Prilagojeni virusni material, ki ga uporabljajo za zdravilo Glybera, ne povzroča okužb in se ne morejo podvajati.
For more information about treatment with Glybera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Glybera preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The full EPAR for Glybera 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 Glybera je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
For more information on the dose of Glybera to be given, see the summary of product characteristics (also part of the EPAR).
Za več informacij o odmerku zdravila Glybera, ki ga je treba dati bolniku, glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
A risk management plan has been developed to ensure that Glybera is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Glybera je bil pripravljen načrt obvladovanja tveganj.
Other common side effects reported include headache, tiredness, hyperthermia (high body temperature), contusion (bruising) and increased levels of the enzyme creatine kinase in the blood (a measure of damage to muscle tissue).
Drugi pogosti neželeni učinki, o katerih so poročali, so glavobol, utrujenost, hipertermija (povišana telesna temperatura), kontuzija (podplutbe) in povišane ravni encima kreatin kinaze v krvi (merilo okvare mišičnih vlaken).
Given the small number of patients treated, these side effects do not provide a complete picture of the frequency and nature of the side effects of Glybera.
Glede na majhno število zdravljenih bolnikov, ti podatki ne omogočajo celovite slike pogostnosti in narave neželenih učinkov zdravila Glybera.
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 Glybera.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Glybera is given as a single treatment involving multiple injections into the muscles of the upper and lower legs.
Zdravilo Glybera se daje kot enkratno zdravljenje, ki vključuje več injekcij v mišice zgornjega in spodnjega dela nog.
In addition, the company has put in place a restricted access programme to ensure that Glybera is used appropriately when the diagnosis is confirmed.
Poleg tega mora družba vzpostaviti program omejenega dostopa do zdravila Glybera, s čimer bo zagotovila, da se bo ob postavljeni diagnozi pravilno uporabljalo.
Although there were data for only a small number of patients, the results indicate that Glybera would be of benefit to those patients with severe or multiple pancreatitis attacks.
Čeprav so bili na voljo le podatki za manjše število bolnikov, rezultati kažejo, da bi zdravilo Glybera lahko pomagalo bolnikom z resnimi ali multiplimi napadi pankreatitisa.
Due to the multiple injections required, it is advisable to give it with a spinal or regional anaesthetic (medicines which numb certain parts of the body to block pain).
Zaradi velikega števila injiciranj se priporoča spinalna ali lokalna anestezija (zdravila, ki omrtvičijo določene dele telesa in tako ustavijo bolečino).
The company will also provide data from a registry to monitor the outcome of patients treated with Glybera, and will add a step to the manufacturing of the product to improve the safety profile.
Družba bo predložila tudi podatke iz registra za spremljanje izida pri bolnikih, zdravljenih z zdravilom Glybera, in dodala dodaten nadzor pri proizvodnji zdravila za izboljšanje njegovega varnostnega profila.
Patients with this disease need to be on a strict low-fat diet and are prone to recurring attacks of pancreatitis, which is a severe and life-threatening complication.
Bolniki s to boleznijo morajo imeti strogo dieto z majhnim vnosom maščob in so nagnjeni k ponavljajočim se napadom pankreatitisa, ki je resen in smrtno nevaren zaplet.
What information is still awaited for Glybera?
Katere informacije o zdravilu Glybera še pričakujemo?
One patient was diagnosed with pulmonary embolism (clots in blood vessels supplying the lungs) seven weeks after treatment.
Pri enem bolniku so sedem tednov po zdravljenju postavili diagnozo pljučne embolije (strdkov v krvnih žilah, ki oskrbujejo pljuča s krvjo).
Glybera is a type of advanced therapy medicine called a ‘gene therapy product'.
Zdravilo Glybera spada v skupino zdravil za napredno zdravljenje, ki se imenujejo „zdravila za gensko zdravljenje“.
The data showed a reduction in blood fat levels after meals in some patients.
Podatki so pri nekaterih bolnikih pokazali znižanje ravni maščob v krvi po jedi.
What is the risk associated with Glybera?
Kakšna tveganja so povezana z zdravilom Glybera?