natgillin/translations-raw huggingface dataset:
It is available as a solution for injection (250 micrograms in 5 ml) and as capsules (500 micrograms).
Na voljo je v obliki raztopine za injiciranje (250 mikrogramov na 5 ml) in kapsul (500 mikrogramov).
In adults, if the capsules are used, the patient should take one capsule one hour before the start of chemotherapy.
Odrasli, ki jemljejo kapsule, morajo vzeti eno kapsulo eno uro pred začetkom kemoterapije.
Aloxi solution for injection was as effective as the comparator medicines.
Zdravilo Aloxi v obliki raztopine za injiciranje je bilo enako učinkovito kot primerjalna zdravila.
For the full list of all side effects and restrictions with Aloxi, see the package leaflet.
Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Aloxi glejte navodilo za uporabo.
Aloxi, given at two different doses, was compared with ondansetron and dolasetron (other medicines of the same type).
Zdravilo v dveh različnih odmerkih so primerjali z ondansetronom in dolasetronom (drugima zdraviloma iste vrste).
However, only the 500 microgram dose remained as effective as the solution for injection over the first five days after chemotherapy: around 59% of the patients receiving the 500 microgram capsule or the injection did not vomit during this period.
Vendar je v prvih petih dneh po kemoterapiji samo 500-mikrogramski odmerek ostal tako učinkovit kot raztopina za injiciranje: približno 59 % bolnikov, ki so prejeli 500-mikrogramsko kapsulo ali injekcijo, v tem obdobju ni bruhalo.
The solution for injection should be given by a healthcare professional about 30 minutes before the start of chemotherapy.
Zdravstveni delavec mora raztopino injicirati približno 30 minut pred začetkom kemoterapije.
The solution for injection is used in adults and children 1 month of age or older for chemotherapy with medicines that are either a strong trigger of nausea and vomiting (such as cisplatin) or a moderate trigger (such as cyclophosphamide, doxorubicin or carboplatin).
Raztopina za injiciranje se uporablja pri odraslih in otrocih, starejših od enega meseca, pri kemoterapiji z zdravili, ki povzročajo bodisi močno slabost in bruhanje (kot je cisplatin) bodisi zmerno (kot so ciklofosfamid, doksorubicin ali karboplatin).
What is the risk associated with Aloxi?
Kakšna tveganja so povezana z zdravilom Aloxi?
In the study looking at Aloxi capsules, all three doses of Aloxi were as effective as the solution for injection over 24 hours, with around three-quarters of the patients not vomiting.
V študiji, v kateri so proučevali zdravilo Aloxi v obliki kapsul, so bili vsi trije odmerki v 24 urah enako učinkoviti kot raztopina za injiciranje, pri čemer približno tri četrtine bolnikov ni bruhalo.
By blocking these receptors, Aloxi prevents the nausea and vomiting that often happen after chemotherapy.
Zdravilo Aloxi z zaviranjem teh receptorjev prepreči slabost in bruhanje, ki se pogosto pojavita po kemoterapiji.
The active substance in Aloxi, palonosetron, is a ‘5HT3 antagonist'.
Zdravilna učinkovina v zdravilu Aloxi, palonostreon, je „antagonist 5HT3“.
Aloxi is used to prevent nausea (feeling sick) and vomiting caused by chemotherapy (medicines to treat cancer).
Zdravilo Aloxi se uporablja za preprečevanje navzeje (slabosti) in bruhanja, ki ju povzroča kemoterapija (zdravila za zdravljenje raka).
The capsules are only used in adults for chemotherapy that is a moderate trigger of nausea and vomiting in adults.
Kapsule se uporabljajo le pri kemoterapiji, ki povzroča zmerno slabost in bruhanje pri odraslih.
When it was compared with dolasetron, these values were 63% for Aloxi (119 patients out of 189) and 53% for dolasetron (101 patients out of
Primerjava z dolasetronom je pokazala, da ta vrednost znaša 63 % za zdravilo Aloxi (119 bolnikov od 189) oziroma 53 % za dolasetron (101 bolnik od 191).
Aloxi should only be given before chemotherapy.
Zdravilo Aloxi se daje samo pred kemoterapijo.
It may be made more effective by the addition of a corticosteroid (a type of medicine that can be used to prevent nausea and vomiting).
Učinkovitost se lahko poveča, če pred kemoterapijo dodamo kortikosteroid (še eno zdravilo, ki se lahko uporablja za preprečevanje slabosti in bruhanja).
A further study compared three doses of Aloxi capsules (250, 500 and 750 micrograms) with the solution for injection in 651 adults receiving chemotherapy that was a moderate trigger of nausea and vomiting.
V nadaljnji študiji so primerjali tri odmerke zdravila Aloxi v obliki kapsul (250, 500 in 750 mikrogramov) z raztopino za injiciranje pri 651 odraslih, ki so prejemali kemoterapijo, ki povzročala zmerno slabost in bruhanje.
Why has Aloxi been approved?
Zakaj je bilo zdravilo Aloxi odobreno?
Aloxi solution for injection has been studied in three main studies involving 1,842 adults receiving chemotherapy that was a strong or a moderate trigger of nausea and vomiting.
Zdravilo Aloxi v obliki raztopine za injiciranje so proučevali v treh glavnih študijah, v katerih je 1 842 odraslih prejemalo kemoterapijo, ki je povzročala močno ali zmerno slabost in bruhanje.
Aloxi solution for injection has also been investigated in one study involving 502 children receiving chemotherapy that was a strong or a moderate trigger of nausea and vomiting, where Aloxi was compared with ondansetron.
Poleg tega so zdravilo Aloxi v obliki raztopine za injiciranje proučevali tudi v eni študiji, v katero sta bila vključena 502 otroka, ki sta prejemala kemoterapijo, ki je povzročala močno ali zmerno slabost in bruhanje, v kateri so zdravilo Aloxi primerjali z ondansetronom.
With the solution for injection, dizziness, constipation and diarrhoea are also seen in between 1 and 10 adults in 100.
Pri raztopini za injiciranje so bili pri enem od 10 odraslih bolnikov od 100 opaženi tudi omotica, zaprtje in driska.
In adults, the solution should be injected into a vein over 30 seconds at a dose of 250 micrograms.
Pri odraslih se raztopina v odmerku 250 mikrogramov 30 sekund injicira v veno.
In the study in children receiving chemotherapy that was a strong or moderate trigger of nausea and vomiting, 59% of the children receiving Aloxi solution for injection at a dose of 20 micrograms/kilogram did not vomit in the 24 hours after chemotherapy (98 out of 165), which was the same percentage as seen in patients receiving ondansetron (95 out of 162).
V študiji z otroki, ki so prejemali kemoterapijo, ki je povzročala močno ali zmerno slabost in bruhanje, v 24 urah po kemoterapiji ni bruhalo 59 % (98 od 165) otrok, ki so prejeli zdravilo Aloxi v obliki raztopine za injiciranje v odmerku 20 mikrogramov/kilogram telesne mase, kar je bil enak odstotek, kot je bil opažen pri bolnikih, ki so prejemali ondansetron (95 bolnikov od 162).
With chemotherapy that was a strong trigger of nausea and vomiting, 59% of the adults receiving Aloxi did not vomit in the 24 hours after chemotherapy (132 out of 223), compared with 57% of the patients receiving ondansetron (126 out of 221).
Pri kemoterapiji, ki je povzročala močno slabost in bruhanje, v 24 urah po kemoterapiji ni bruhalo 59 % (132 od 223) bolnikov, ki so prejemali zdravilo Aloxi, v primerjavi s 57 % (126 od 221) bolnikov, ki so prejemali ondansetron.
With chemotherapy that was a moderate trigger of nausea and vomiting, 81% of the adults receiving Aloxi did not vomit in the 24 hours after chemotherapy (153 out of 189) compared with 69% of those receiving ondansetron (127 out of 185).
Pri kemoterapiji, ki je povzročala zmerno slabost in bruhanje, v 24 urah po kemoterapiji ni bruhalo 81 % (153 od 189) bolnikov, ki so prejemali zdravilo Aloxi, v primerjavi z 69 % tistih (127 od 185), ki so prejemali ondansetron.
What is Aloxi used for?
Za kaj se zdravilo Aloxi uporablja?
In children, the solution should be given by infusion (drip) into a vein over 15 minutes at a dose of 20 micrograms per kilogram body weight.
Pri otrocih se raztopina v odmerku 20 mikrogramov na kilogram telesne mase 15 minut daje z infundiranjem (kapalno infuzijo) v veno.
How does Aloxi work?
Kako zdravilo Aloxi deluje?
How has Aloxi been studied?
Kako je bilo zdravilo Aloxi raziskano?
What is Aloxi?
Kaj je zdravilo Aloxi?
How is Aloxi used?
Kako se zdravilo Aloxi uporablja?
The European Commission granted a marketing authorisation valid throughout the European Union for Fluenz on 27 January 2011.
Evropska komisija je dovoljenje za promet z zdravilom Fluenz, veljavno po vsej Evropski uniji, izdala 27. januarja 2011.
What measures are being taken to ensure the safe and effective use of Fluenz?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Fluenz?
Other information about Fluenz
Druge informacije o zdravilu Fluenz
Children who have not been previously vaccinated against seasonal flu should be given a second dose after at least four weeks.
Otroci, ki predhodno niso bili cepljeni proti sezonski gripi, naj po vsaj štirih tednih prejmejo drugi odmerek.
The full EPAR for Fluenz 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 Fluenz je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Fluenz is a vaccine.
Zdravilo Fluenz je cepivo.
The flu strains were selected according to the influenza season.
Sevi gripe so bili izbrani glede na sezono gripe.
This is a summary of the European public assessment report (EPAR) for Fluenz.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Fluenz.
Fluenz contains strains of flu virus that have first been weakened so that they do not cause disease.
Cepivo Fluenz vsebuje seve virusa gripe, ki so bili najprej oslabljeni, tako da ne povzročijo bolezni.
The viruses used in Fluenz are grown in hens' eggs.
Virusi, ki se uporabljajo v cepivu Fluenz, so vzrejeni v kokošjih jajcih.
A risk management plan has been developed to ensure that Fluenz is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Fluenz je bil pripravljen načrt obvladovanja tveganj.
These virus strains need to be included in Fluenz before it can be used.
Te seve virusov je treba vključiti v cepivo Fluenz, preden se uporabi.
It must also not be given to people with weakened immune systems due to conditions such as blood disorders, symptomatic HIV infection and cancer or as a result of certain medical treatments.
Prav tako ga ne smejo prejeti ljudje z oslabljenim imunskim sistemom zaradi bolezni, kot so krvne bolezni, simptomatska okužba z virusom HIV in rak, ali bolezni, ki so posledica nekaterih zdravljenj.
It must also not be given to children who are receiving treatment with salicylates (painkillers such as aspirin).
Ne smejo ga prejeti niti otroci, ki se zdravijo s salicilati (protibolečinskimi zdravili, kot je npr. aspirin).
It must only be used as a nasal spray and must not be injected.
Uporablja se lahko samo kot pršilo za nos in se ne sme injicirati.
What benefit has Fluenz shown during the studies?
Kakšne koristi je zdravilo Fluenz izkazalo med študijami?
In the studies in children and adolescents, Fluenz reduced the number of flu cases caused by the three flu strains by between 62% and 100% compared with placebo and by between 35% and 53% compared with the comparator inactivated vaccine.
V študijah pri otrocih in mladostnikih se je z uporabo zdravila Fluenz število primerov gripe, ki so jih povzročili izbrani trije sevi gripe, zmanjšalo za 62 % do 100 % v primerjavi s placebom in za 35 % do 53 % v primerjavi s primerjalnim inaktiviranim cepivom.
For more information about treatment with Fluenz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Fluenz preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
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 Fluenz.
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.
Fluenz is used to prevent flu in children and adolescents from 24 months to less than 18 years old.
Zdravilo Fluenz se uporablja za preprečevanje gripe pri otrocih in mladostnikih, starih od 24 mesecev do 18 let.
The main measure of effectiveness was the number of laboratory-confirmed cases of flu caused by the three strains during the given flu season, although one of the studies in adults measured the number of cases of feverish illness (as opposed to confirmed flu cases).
Glavno merilo učinkovitosti je bilo število laboratorijsko potrjenih primerov gripe, ki so jo povzročili izbrani trije sevi v določeni sezoni gripe, čeprav so v eni študiji pri odraslih merili število primerov obolelih s povišano telesno temperaturo (in ne potrjenih primerov gripe).
The most common side effects with Fluenz (seen in more than 1 patient in 10) are reduced appetite, headache, blocked or runny nose and malaise (feeling unwell).
Najpogostejši neželeni učinki zdravila Fluenz (opaženi pri več kot 1 bolniku od 10) so zmanjšan tek, glavobol, zamašen nos ali izcedek iz nosu in slabo počutje.
It contains three live attenuated (weakened) influenza (flu) virus strains: A/California/7/2009 (H1N1)pdm09-like strain; A/Victoria/361/2011 (H3N2)-like strain; and B/Massachusetts/2/2012-like strain.
Vsebuje tri žive oslabljene seve virusov gripe: sev, podoben sevu A/California/7/2009 (H1N1)pdm09; sev, podoben sevu A/Victoria/361/2011 (H3N2) in sev, podoben sevu B/Massachusetts/2/2012.
Fluenz will be updated with weakened virus strains type A-H1N1, type A-H3N2 and type B for each season, according to recommendations for the northern hemisphere from the WHO and from the European Union.
Zdravilo Fluenz bo dopolnjeno z oslabljenimi sevi virusa vrste A-H1N1, vrste A-H3N2 in vrste B za vsako sezono v skladu s priporočilom SZO in Evropske unije za severno poloblo.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Fluenz, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Fluenz in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The CHMP therefore decided that Fluenz's benefits are greater than its risks in children and adolescents from 24 months to less than 18 years old and recommended that it be given marketing authorisation in this patient group.
Zato je zaključil, da so koristi zdravila Fluenz večje od z njim povezanih tveganj pri otrocih in mladostnikih, starih od 24 mesecev do 18 let, in priporočil, da se zanj izda dovoljenje za promet za to skupino bolnikov.
Fluenz is given as a nasal spray using a single-use nasal applicator (0.1 ml sprayed into each nostril).
Zdravilo Fluenz se daje kot pršilo za nos z nosnikom za enkratno uporabo (razpršeno po 0,1 ml v vsako nosnico).
Fluenz must not be used in people who are hypersensitive (allergic) to the active substances or any of the other ingredients, to gentamicin (a type of antibiotic), or to eggs or egg proteins.
Zdravila Fluenz ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) zdravilne učinkovine ali katero koli drugo sestavino zdravila, gentamicin (vrsto antibiotika) ter jajca ali jajčne beljakovine.
When a person is given the vaccine, the immune system recognises the virus as ‘foreign' and makes defences against it.
Ko oseba prejme cepivo, imunski sistem prepozna virus kot tujek in proti njemu tvori protitelesa.
Fluenz is a vaccine which is available as a nasal spray to protect against influenza A (sub-types H1N1 and H3N2) and influenza B.
Fluenz je cepivo, ki je na voljo v obliki pršila za nos za zaščito pred virusom gripe A (podvrsti H1N1 in H3N2) ter virusom gripe B.
The studies in adults showed that Fluenz may have some benefits compared with placebo but the results were inconsistent.
Študije pri odraslih so pokazale, da ima zdravilo Fluenz v primerjavi s placebom določene koristi, vendar rezultati niso bili trdni.
The CHMP noted that the studies showed convincingly that Fluenz was more effective than placebo and the comparator inactivated vaccine in children and adolescents, but not in adults.
CHMP je menil, da so študije prepričljivo pokazale, da je zdravilo Fluenz učinkovitejše od placeba in primerjalnega inaktiviranega cepiva pri otrocih in mladostnikih, ne pa tudi pri odraslih.
Some studies also suggested that Fluenz was not as effective as the comparator inactivated vaccine in adults.
Nekatere študije so tudi nakazale, da zdravilo Fluenz pri odraslih ni tako učinkovito kot primerjalno inaktivirano cepivo.
What is the risk associated with Fluenz?
Kakšna tveganja so povezana z zdravilom Fluenz?
Fluenz influenza vaccine (live attenuated, nasal)
Fluenz cepivo proti gripi (z živimi oslabljenimi virusi, nosno)
The immune system will then be able to respond more quickly when it is exposed to the virus again.
Ob ponovni izpostavitvi virusom se bo imunski sistem hitreje odzval nanje.
For the full list of all side effects reported with Fluenz, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Fluenz, glejte navodilo za uporabo.
Why has Fluenz been approved?
Zakaj je bilo zdravilo Fluenz odobreno?
What is Fluenz?
Kaj je zdravilo Fluenz?
How has Fluenz been studied?
Kako je bilo zdravilo Fluenz raziskano?
What is Fluenz used for?
Za kaj se zdravilo Fluenz uporablja?
How does Fluenz work?
Kako zdravilo Fluenz deluje?
Nine main studies involving around 24,000 children and adolescents and four studies involving around 11,000 adults compared Fluenz with either placebo (a dummy vaccine) or another injectable flu vaccine containing inactivated (killed) viral material from the same three flu strains.
Delovanje cepiva Fluenz v primerjavi s placebom (cepivom brez zdravilne učinkovine) ali drugim cepivom proti gripi, ki se injicira in vsebuje inaktiviran (uničen) virusni material iz istih treh sevov gripe, so proučili v devetih glavnih študijah, v katerih je sodelovalo okoli 24 000 otrok in mladostnikov, ter v štirih študijah, v katerih je sodelovalo okoli 11 000 odraslih.
How is Fluenz used?
Kako se zdravilo Fluenz uporablja?
However, absolute numbers of cases are small.
Vendar so absolutne številke primerov majhne.
Date of first authorisation: 12 September 2013 Date of latest renewal: 24 April 2019
Datum prve odobritve: 12. september 2013 Datum zadnjega podaljšanja: 24. april 2019
Make sure you see your doctor for these regular examinations at least once a year.
Pazite, da obiščete zdravnika za te redne preglede vsaj enkrat letno.
The dose recommendations reflect the use in this population.
Priporočila za odmerjanje odražajo uporabo v tej populaciji.
This way, you will have to take fewer capsules at once.
Tako boste hkrati vzeli manj kapsul.
If you take these medicines, take Orphacol at least 5 hours before or at least 5 hours after taking these other medicines.
Če jemljete ta zdravila, vzemite zdravilo Orphacol vsaj 5 ur pred ali vsaj 5 ur po odmerku omenjenih drugih zdravil.
Elderly population (≥65 years old)
Starostniki (stari ≥ 65 let)
The frequency of these reactions is not known (cannot be estimated from the available data).
Pogostnost teh učinkov ni znana (ni mogoče oceniti iz razpoložljivih podatkov).
The dose will then be further adjusted by your doctor depending on your body's response.
Odmerek bo zdravnik nato dodatno prilagodil glede na odziv vašega telesa.
Patients should be monitored as follows: 3-monthly during the first year, 6-monthly during the subsequent three years and annually thereafter (see below).
Bolnike je treba spremljati po naslednjem načrtu: vsake tri mesece v prvem letu, vsakih 6 mesecev v naslednjih treh letih, zatem pa enkrat letno (glejte nadaljevanje).
Please consult your doctor if you plan to become pregnant.
Posvetujte se s svojim zdravnikom, če načrtujete nosečnost.
At each investigation, the need for dose adjustment should be considered.
Pri vsaki preiskavi je treba preučiti potrebo po prilagoditvi odmerka.
It is extremely important that pregnant women continue their therapy during pregnancy.
Izjemno pomembno je, da nosečnice nadaljujejo z zdravljenjem med nosečnostjo.
This means that due to the rarity of the disease and for ethical reasons it has not been possible to obtain complete information on this medicinal product.
To pomeni, da zaradi redkosti bolezni in iz etičnih razlogov ni bilo mogoče pridobiti vseh podatkov o zdravilu.
92100 Boulogne-Billancourt France
92100 Boulogne-Billancourt Francija
Due to the rarity of the diseases, the information about the most serious and/or most frequently occurring adverse reactions is limited.
Zaradi redkosti bolezni so podatki o najresnejših in/ali najpogostejših neželenih učinkih omejeni.
Familial hypertriglyceridemia
Družinska hipertrigliceridemija
Progress and results from the database will form the basis of the annual reassessments of the benefit/risk profile of Orphacol.
Napredek in rezultati iz zbirke bodo osnova za letne ponovne preglede profila koristi in tveganj zdravila Orphacol.
Reports on recruitment progress of the patient surveillance database will be analysed and reported to the CHMP at the time of PSURs (for safety) and of the Annual Reassessments (for efficacy and safety).
Poročila o vključevanju bolnikov v zbirko podatkov spremljanja bolnikov se analizirajo in poročajo CHMP v času priprave PSUR (za varnost) in letnega ponovnega pregleda (za učinkovitost in varnost).
• Prescription of a supratherapeutic dose (MedDRA term: drug toxicity)
• predpisovanje supraterapevtskega odmerka (izraz po MedDRA: toksičnost zdravila),
More than 90% of the primary and secondary bile acids are reabsorbed in the ileum by a specific active transporter and are recycled to the liver by the portal vein; the remainder is excreted in the faeces.
Več kot 90 % primarnih in sekundarnih žolčnih kislin se reabsorbira v ileumu preko specifičnega aktivnega prenašalca ter vrne v jetra po portalni veni; preostanek se izloči z blatom.
In adults, the daily dose should not exceed 500 mg.
Pri odraslih bolnikih dnevni odmerek ne sme preseči 500 mg.
In the case of an accidental overdose, treatment should be continued at the recommended dose after normalisation of clinical signs and/or biological abnormalities.
V primeru nenamernega prevelikega odmerjanja je treba zdravljenje nadaljevati s priporočenim odmerkom po normalizaciji kliničnih znakov in/ali bioloških nepravilnosti.
Please tell your doctor if you are taking ciclosporin.
Obvestite svojega zdravnika, če jemljete ciklosporin.
Alternative treatments should be used.
Uporabiti je treba drugačno zdravljenje.
Tell your doctor or pharmacist if you are taking, have recently taken any or might take other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
The available literature is not sufficient to detect a difference in the safety of cholic acid within paediatric age groups or between paediatric patients and adults.
Razpoložljiva literatura ne zadostuje, da bi zaznali razlike v varnosti holne kisline med pediatričnimi starostnimi skupinami ali med pediatričnimi bolniki in odraslimi bolniki.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Študije na živalih niso pokazale neposrednih ali posrednih škodljivih vplivov v povezavi z vplivom na sposobnost razmnoževanja (glejte poglavje 5.3).
You should never stop taking Orphacol unless your doctor advises you to do so.
Nikoli ne smete prekiniti jemanja zdravila Orphacol, razen če vam tako svetuje zdravnik.
This rarity also made the conduct of controlled clinical studies impossible.
Redkost bolezni tudi onemogoča izvedbo kontroliranih kliničnih študij.