natgillin/translations-raw huggingface dataset:
Both studies showed that Mirvaso applied once a day was more effective than placebo at reducing the facial redness in these patients.
Obe študiji sta pokazali, da je bilo zdravilo Mirvaso, ki so ga nanašali enkrat na dan, učinkovitejše od placeba pri zmanjšanju rdečine obraza pri teh bolnikih.
For more information about treatment with Mirvaso, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Mirvaso preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Mirvaso is a medicine that contains the active substance brimonidine tartrate.
Mirvaso je zdravilo, ki vsebuje zdravilno učinkovino brimonidinijev tartrat.
Why is Mirvaso approved?
Zakaj je bilo zdravilo Mirvaso odobreno?
The main measure of effectiveness was the percentage of patients who achieved a marked reduction of facial redness at different time points (3, 6, 9 and 12 hours) on days 1, 15 and 29 after the start of the treatment.
Glavno merilo učinkovitosti je bil odstotek bolnikov, pri katerih so zabeležili izrazito zmanjšanje rdečine obraza ob različnih časovnih točkah (3, 6, 9 in 12 ur) 1., 15. in 29. dan po začetku zdravljenja.
The most common side effects with Mirvaso (which may affect more than 1 in 100 people), which are usually mild to moderate in severity, are erythema (redness), pruritus (itching), flushing and a burning sensation of the skin.
Najpogostejši neželeni učinki zdravila Mirvaso (ki lahko prizadenejo več kot 1 osebo od 100), ki so običajno blagi do zmerni, so eritem (rdečina), pruritus (srbenje), vročinski vali in občutek skelenja na koži.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Mirvaso, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Mirvaso in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Symptoms include episodes of redness that have been linked to the widening of small blood vessels in the skin of the face, which increases the blood flow to the area.
Simptomi vključujejo epizode rdečine, ki so povezane z razširitvijo majhnih krvnih žil v koži na obrazu, zaradi katere se poveča pretok krvi v ta predel.
The active substance in Mirvaso, brimonidine tartrate, works by attaching to receptors called alpha2adrenergic receptors on the cells of blood vessels of the skin and activating them.
Zdravilna učinkovina v zdravilu Mirvaso, brimonidinijev tartrat, deluje tako, da se veže na receptorje na celicah krvnih žil v koži, imenovane alfa2-adrenergični receptorji, in jih aktivira.
It is used to treat the facial erythema (redness of the skin of the face) in adults with rosacea, a long-term skin condition that often causes flushing and redness.
Uporablja se za zdravljenje obraznega eritema (pordelosti kože na obrazu) pri odraslih z rozaceo, tj. dolgotrajno boleznijo kože, ki pogosto povzroča zardevanje in rdečino.
Other information about Mirvaso
Druge informacije o zdravilu Mirvaso
For practical information about using Mirvaso, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Mirvaso naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
This causes these blood vessels to narrow, which reduces the blood flow to the face, thus decreasing the redness.
S tem povzroči, da se krvne žile zožijo, s čimer se zmanjša pretok krvi v obraz in posledično tudi rdečina.
Both studies compared Mirvaso with placebo (a dummy gel) over four weeks of treatment.
V obeh študijah so zdravilo Mirvaso primerjali s placebom (gelom brez zdravilne učinkovine) med štiritedenskim zdravljenjem.
Effects were also maintained for 12 hours after application and started to wear off after 6 hours.
Učinki so prav tako trajali še 12 ur po nanosu in so po 6 urah začeli popuščati.
For the full list of side effects reported with Mirvaso, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Mirvaso, glejte navodilo za uporabo.
The CHMP concluded that Mirvaso improves the facial redness in patients with rosacea.
Odbor CHMP je zaključil, da zdravilo Mirvaso zmanjša rdečino obraza pri bolnikih z rozaceo.
Small amounts of gel (about pea size) are applied to the skin of the forehead, chin, nose and cheeks once a day as a thin layer.
Majhne količine gela (približno v velikosti grahovega zrna) se enkrat na dan v tanki plasti nanesejo na kožo na čelu, bradi, nosu in licih.
Effects were maintained for 12 hours after application although the effects started to wear off after 6 hours.
Učinki so trajali še 12 ur po nanosu, vendar so po 6 urah začeli popuščati.
The areas should be left to dry out before applying other creams or cosmetics.
Pred nanosom drugih krem ali kozmetičnih izdelkov je treba počakati, da se ti predeli posušijo.
How is Mirvaso used?
Kako se zdravilo Mirvaso uporablja?
How does Mirvaso work?
Kako zdravilo Mirvaso deluje?
• In the first study, on day 1 the percentage or patients who had reduction of facial redness 3 hours after application was 16.3% (21 out of 129) for Mirvaso compared with 3.1% (4 out of 131) for placebo.
• V prvi študiji je na 1. dan odstotek bolnikov, pri katerih se je 3 ure po nanosu rdečina obraza zmanjšala, znašal 16,3 % (21 od 129) za zdravilo Mirvaso in 3,1 % (4 od 131) za placebo.
• In the second study, on day 1 the percentage or patients who had reduction of facial redness 3 hours after application was 19.6% (29 out of 148 patients) for Mirvaso compared with 0 % (none out of 145 patients) for placebo.
• V drugi študiji je na 1. dan odstotek bolnikov, pri katerih se je rdečina obraza zmanjšala 3 ure po nanosu, znašal 19,6 % (29 od 148 bolnikov) za zdravilo Mirvaso in 0 % (nobeden od 145 bolnikov) za placebo.
On day 29, 25.4% (36 out of 142) of patients had reduction of facial redness 3 hours after application with Mirvaso compared with a response of 9.2 % (13 out of 142) for placebo.
Na 29. dan se je 3 ure po nanosu rdečina obraza zmanjšala pri 25,4 % (36 od 142) bolnikov, ki so uporabljali zdravilo Mirvaso, v primerjavi z 9,2 % (13 od 142) bolnikov, ki so uporabljali placebo.
On day 29, 31.5% (40 out of 127) patients had reduction of facial redness 3 hours after application with Mirvaso compared with a response of 10.9% (14 out of 128) for placebo.
Na 29. dan se je 3 ure po nanosu rdečina obraza zmanjšala pri 31,5 % (40 od 127) bolnikov, ki so uporabljali zdravilo Mirvaso, v primerjavi z 10,9 % (14 od 128) bolnikov, ki so uporabljali placebo.
This overview was last updated in 08-2018.
Pregled je bil nazadnje posodobljen 08-2018.
Further information on Dexdor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Nadaljnje informacije o zdravilu Dexdor so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What measures are being taken to ensure the safe and effective use of Dexdor?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Dexdor?
In some cases, the patient is also given a local anaesthetic, painkillers and other sedative medicines.
V nekaterih primerih bolnik prejme tudi lokalni anestetik, protibolečinska zdravila in druga sedativna zdravila.
The European Medicines Agency therefore decided that Dexdor's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Dexdor večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Dexdor received a marketing authorisation valid throughout the EU on 16 September 2011.
Za zdravilo Dexdor je bilo 16. septembra 2011 izdano dovoljenje za promet, veljavno po vsej EU.
Sedation in intensive care
Sedacija v intenzivni negi
• in hospital intensive care units to bring about a light level of sedation in which the patient can still respond to verbal stimulation (corresponding to a score of between 0 and -3 on the Richmond Agitation-Sedation Scale);
• na bolnišničnih oddelkih za intenzivno nego za doseganje sorazmerno blage stopnje sedacije, pri kateri se bolnik še vedno lahko odziva na verbalno stimulacijo (kar ustreza rezultatu med 0 in -3 po Richmondovi lestvici agitacije - sedacije);
Patients in the Dexdor group received either 0.5 or 1 microgram/kg bodyweight.
Bolniki v skupini, zdravljeni z zdravilom Dexdor, so prejemali 0,5 ali 1 mikrograma/kg telesne mase.
The main measures of effectiveness were how well the medicines maintained the required sedation level and the time patients needed to spend on a mechanical ventilator (a machine that ‘breathes' for the patient).
Glavni merili učinkovitosti sta bili, kako dobro je zdravilo vzdrževalo želeno stopnjo sedacije, in čas, ki ga je bolnik moral preživeti na mehanski ventilaciji (napravi, ki pomaga bolniku dihati).
The studies also showed that Dexdor reduced the duration of mechanical ventilation.
Študiji sta pokazali tudi, da zdravilo Dexdor skrajša trajanje mehanske ventilacije.
• before or during diagnostic or surgical procedures where the patient remains awake (awake sedation).
• pred ali med diagnostičnimi ali kirurškimi posegi, pri katerih bolnik ostane buden (sedacija v budnem stanju).
As dexmedetomidine has been in use in several countries as a sedative agent, its risks are well known and are considered to be manageable.
Ker se deksmedetomidin kot sedativ že uporablja v več državah, so njegova tveganja dobro znana in obvladljiva.
As for all medicines, data on the use of Dexdor is continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Dexdor stalno spremljajo.
Other information about Dexdor
Druge informacije o zdravilu Dexdor
Awake sedation during diagnostic or surgical procedures
Sedacija v budnem stanju med diagnostičnim ali kirurškim posegom
It works by blocking receptors in the brain called alpha-2 receptors and reduces the activity of the sympathetic nervous system which is involved in controlling anxiety, arousal and sleep as well as blood pressure and heart rate.
Deluje tako, da zavira receptorje v možganih, imenovane receptorji alfa-2, in zmanjša delovanje simpatičnega živčnega sistema, ki vpliva na nadzorovanje tesnobe, vznemirjenosti in spanja ter na krvni tlak in srčni utrip.
Why is Dexdor authorised in the EU?
Zakaj je bilo zdravilo Dexdor odobreno v EU?
The active substance in Dexdor, dexmedetomidine, is a selective alpha-2 receptor agonist.
Učinkovina v zdravilu Dexdor, deksmedetomidin, je selektivni agonist receptorjev alfa-2.
What benefits of Dexdor have been shown in studies?
Kakšne koristi zdravila Dexdor so se pokazale v študijah?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dexdor have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Dexdor upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
If sedation with the maximum dose is not adequate, the patient can be switched to other medicines.
Če stopnja sedacije z največjim odmerkom ni zadostna, se lahko uporabijo druga zdravila.
An overview of Dexdor and why it is authorised in the EU
Pregled zdravila Dexdor in zakaj je odobreno v EU
The first study involved patients undergoing surgery or a procedure under an anaesthetic block (where sensation to a part of the body is blocked).
Prva študija je vključevala bolnike, pri katerih je bil opravljen kirurški poseg ali postopek pod anestetično blokado (pri kateri je zavrto zaznavanje v določenem delu telesa).
Dexdor must not be used in patients with advanced heart block (a type of heart rhythm disorder), patients with uncontrolled low blood pressure and in patients with conditions such as stroke that affect the blood supply to the brain.
Zdravilo Dexdor se ne sme uporabljati pri bolnikih z napredovalim srčnim blokom (vrsto motnje srčnega ritma), pri bolnikih z nenadzorovanim nizkim krvnim tlakom in bolnikih z boleznimi, kot je možganska kap, ki prizadenejo oskrbo možganov s krvjo.
For more information about using Dexdor, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Dexdor glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Dexdor was compared with placebo (a dummy treatment) in two main studies involving 431 patients.
Zdravilo Dexdor so primerjali s placebom (zdravilom brez učinkovine) v dveh glavnih študijah, ki sta vključevali 431 bolnikov.
Side effects reported with Dexdor are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Dexdor, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
It is effective for awake sedation during procedures but sometimes an additional sedative medicine as well as Dexdor may be needed.
Učinkovito je za sedacijo v budnem stanju med posegi, vendar je včasih poleg zdravila Dexdor morda potrebno dodatno sedativno zdravilo.
Dexdor is a medicine used to sedate (calm or make sleepy) adult patients in the following settings:
Zdravilo Dexdor se uporablja za doseganje sedacije (stanja umirjenosti ali zaspanosti) odraslih bolnikov v naslednjih primerih:
What is Dexdor and what is it used for?
Kaj je zdravilo Dexdor in za kaj se uporablja?
What are the risks associated with Dexdor?
Kakšna tveganja so povezana z zdravilom Dexdor?
The studies in intensive care showed that Dexdor compared well with other sedatives.
Študije pri intenzivni negi so pokazale dobro primerljivost zdravila Dexdor z drugimi sedativi.
The second study involved patients undergoing a fibreoptic intubation (inserting a breathing tube through the nose or the mouth into the windpipe) while patients are awake.
Druga študija je vključevala bolnike, ki so prestali fiberoptično intubacijo (vstavitev dihalne cevke skozi nos ali usta v sapnik) v budnem stanju.
Dexdor is an additional alternative medicine for achieving lighter levels of sedation in suitable patients.
Zdravilo Dexdor je dodatno alternativno zdravilo za doseganje blage stopnje sedacije pri primernih bolnikih.
The most common side effects with Dexdor (which may affect more than 1 in 10 people) when it is used in intensive care are low or high blood pressure and bradycardia (slow heart rate).
Najpogostejši neželeni učinki zdravila Dexdor (ki se lahko pojavijo pri več kot 1 bolniku od 10) pri njegovi uporabi v intenzivni negi so nizek ali visok krvni tlak in bradikardija (počasen srčni utrip).
The patient's blood pressure, heart rate, breathing and oxygen levels should be monitored closely during the procedure.
Med posegom je treba skrbno spremljati bolnikov krvni tlak, srčni utrip, dihanje in ravni kisika.
The most common side effects when it is used for awake sedation are low blood pressure, respiratory depression (reduced ability to breathe) and bradycardia.
Najpogostejši neželeni učinki pri uporabi zdravila za sedacijo v budnem stanju so nizek krvni tlak, depresija dihanja (zmanjšana zmogljivost dihanja) in bradikardija.
A higher proportion of patients treated with Dexdor did not require additional treatment with midazolam (another sedative medicine) to maintain the desired sedation level.
Večji delež bolnikov, zdravljenih z zdravilom Dexdor, za ohranjanje želene stopnje sedacije ni potreboval dodatnega zdravljenja z midazolamom (drugim sedativnim zdravilom).
When Dexdor is used for awake sedation in diagnostic or surgical procedures, the starting dose depends on the type of procedure and the dose is adjusted to achieve the desired effect.
Kadar se zdravilo Dexdor uporablja za sedacijo v budnem stanju pri diagnostičnih ali kirurških posegih, je začetni odmerek odvisen od vrste posega, odmerek pa se prilagodi tako, da se doseže želeni učinek.
Dexdor can only be obtained with a prescription and should be given by a healthcare professional skilled in managing patients in intensive care or giving anaesthetic during diagnostic or surgical procedures.
Predpisovanje in izdaja zdravila Dexdor je le na recept, zdravilo pa smejo uporabljati le zdravstveni delavci, ki so izurjeni za zdravljenje bolnikov na intenzivni negi ali dajanje anestetikov med diagnostičnimi ali kirurškimi posegi.
When Dexdor is used in intensive care, the dose is adjusted to achieve the desired level of sedation.
Kadar se zdravilo Dexdor uporablja v intenzivni negi, se odmerek prilagodi tako, da se doseže želena stopnja sedacije.
Dexdor is given by infusion (drip) into a vein using a controlled infusion device.
Zdravilo Dexdor se daje z infundiranjem (kapalno infuzijo) v veno s pripomočkom za nadzorovano infundiranje.
For the full list of side effects and restrictions with Dexdor, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Dexdor glejte navodilo za uporabo.
Midazolam treatment was not required in 40% of patients receiving the lower dose of Dexdor and 54% of those receiving the higher dose compared with 3% of patients receiving placebo.
Zdravljenje z midazolamom ni bilo potrebno pri 40 % bolnikov, ki so prejemali manjši odmerek zdravila Dexdor, in pri 54 % bolnikov, ki so prejemali večji odmerek, v primerjavi s 3 % bolnikov, ki so prejemali placebo.
By reducing the activity of the sympathetic nervous system, dexmedetomidine helps to make patients calm or sleepy.
Deksmedetomidin z zmanjševanjem delovanja simpatičnega živčnega sistema vpliva na doseganje umirjenosti ali zaspanosti pri bolnikih.
Midazolam treatment was not required in 53% of patients receiving Dexdor compared with 14% receiving placebo.
Zdravljenje z midazolamom ni bilo potrebno pri 53 % bolnikov, ki so prejemali zdravilo Dexdor, in pri 14 % bolnikov, ki so prejemali placebo.
How does Dexdor work?
Kako zdravilo Dexdor deluje?
How is Dexdor used?
Kako se zdravilo Dexdor uporablja?
In the second study, 61% of patients given Dexdor maintained the required level of sedation compared with 57% of those receiving midazolam.
V drugi študiji je želeno stopnjo sedacije ohranilo 61 % bolnikov, ki so prejeli zdravilo Dexdor, in 57 % tistih, ki so prejeli midazolam.
Dexdor contains the active substance dexmedetomidine.
Zdravilo Dexdor vsebuje učinkovino deksmedetomidin.
In the first study, 65% of patients given Dexdor maintained the required level of sedation compared with 65% of those receiving propofol.
V prvi študiji je želeno stopnjo sedacije ohranilo 65 % bolnikov, ki so prejeli zdravilo Dexdor, in 65 % tistih, ki so prejeli propofol.
Care should be taken when using Dexdor in patients with reduced liver function and the dose may be reduced.
Kadar se zdravilo Dexdor uporablja pri bolnikih z zmanjšanim delovanjem jeter, je potrebna previdnost, odmerek pa se lahko prilagodi.
Dexdor was compared with other sedative medicines (propofol or midazolam) in two main studies involving 1,000 patients who required sedation in intensive care units.
Zdravilo Dexdor so v dveh glavnih študijah, v katerih je sodelovalo 1 000 bolnikov na oddelkih za intenzivno nego, ki so potrebovali sedacijo, primerjali z drugimi sedativnimi zdravili (propofolom ali midazolamom).
In 11 out of 12 patients, symptoms, including those affecting vision and movement, improved or did not get worse.
Pri 11 od 12 bolnikov so se simptomi, vključno s prizadetim vidom ali gibanjem, izboljšali ali se niso poslabšali.
The recommended dose for each infusion is 4 mg per kilogram of body weight.
Priporočeni odmerek pri posameznem infundiranju je 4 mg na kilogram telesne mase.
Treatment should also be supervised by a healthcare professional with experience in the treatment of MPS VII.
Zdravljenje mora tudi nadzorovati zdravstveni delavec z izkušnjami v zdravljenju MPS VII.
Before the infusion the patient is given antihistamine treatment to reduce the risk of allergic reactions.
Pred infundiranjem bolnik prejme antihistaminsko zdravilo, ki zmanjša tveganje za alergijske reakcije.
What measures are being taken to ensure the safe and effective use of Mepsevii?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Mepsevii?
Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
Nadaljnje informacije glede določitve zdravila sirote lahko najdete tukaj: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
The medicine can only be obtained with a prescription and should be given by an appropriately trained healthcare professional who can manage medical emergencies.
Predpisovanje in izdaja zdravila je le na recept, dajati pa ga mora ustrezno usposobljeni zdravstveni delavec, ki zna obvladovati nujne zdravstvene primere.
As for all medicines, data on the use of Mepsevii are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Mepsevii stalno spremljajo.
Since Mepsevii has been authorised under exceptional circumstances, the company that markets Mepsevii will conduct a study to provide data on the long-term effectiveness and safety of Mepsevii as well as on the disease itself, including its progression and development of symptoms.
Ker je zdravilo Mepsevii pridobilo dovoljenje za promet v izjemnih okoliščinah, bo podjetje, ki ga trži, izvedlo študijo, s katero bodo pridobili podatke o dolgoročni učinkovitosti in varnosti zdravila Mepsevii ter o sami bolezni, vključno z njenim napredovanjem in razvojem simptomov.
Side effects reported with Mepsevii are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Mepsevii, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Mepsevii is given every two weeks as an infusion (drip) into a vein lasting 4 hours.
Zdravilo Mepsevii se daje vsaka dva tedna kot (kapalna) infuzija v veno, ki traja štiri ure.
Further information on Mepsevii can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije za zdravilo Mepsevii so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
In addition, most adverse reactions are mild to moderate in severity.
Poleg tega je večina neželenih učinkov blagih do zmernih.
An overview of Mepsevii and why it is authorised in the EU
Pregled zdravila Mepsevii in zakaj je odobreno v EU
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mepsevii have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Mepsevii upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Mepsevii has been authorised under ‘exceptional circumstances'.
Zdravilo Mepsevii je pridobilo dovoljenje za promet „v izjemnih okoliščinah“.
Mepsevii must not be used in patients who have ever had anaphylactic reaction to vestronidase alfa or any of the other ingredients of the medicine.
Zdravila Mepsevii ne smejo uporabljati bolniki, ki so kadar koli imeli anafilaktično reakcijo na vestronidazo alfa ali katero koli drugo sestavino zdravila.
Other information about Mepsevii
Druge informacije o zdravilu Mepsevii
In a main study of 12 patients with MPS VII, patients treated with Mepsevii for 6 months had a 65% reduction in their urine levels of GAGs.
V glavni študiji pri 12 bolnikih z MPS VII se je raven glikozaminoglikanov v urinu pri bolnikih, ki so se šest mesecev zdravili z zdravilom Mepsevii, znižala za 65 %.
MPS VII is rare, and Mepsevii was designated an ‘orphan medicine' (a medicine used in rare diseases) on 21 March 2012.
Bolezen MPS VII je redka, zato je bilo zdravilo Mepsevii 21. marca 2012 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).