natgillin/translations-raw huggingface dataset:
For this reason, the CHMP agreed to include additional information in section 4.2 and 4.4 to inform physicians about the potential disadvantages of oral versus intravenous administration of etoposide. 
Zato se je odbor CHMP strinjal, da se v poglavji 4.2 in 4.4 vključijo dodatne informacije, s katerimi se zdravnike obvesti o morebitnih slabostih peroralne uporabe etopozida v primerjavi z intravensko uporabo.
The adult dosing section contains details on monotherapy, combination therapy, an alternative dosing schedule, and dosing adjustments for a low neutrophil count. 
Poglavje o odmerjanju pri odraslih vsebuje podrobne podatke o monoterapiji, kombiniranem zdravljenju, alternativnem režimu odmerjanja in prilagajanju odmerkov pri nizkih vrednostih nevtrofilcev.
Lactation has been included as a contraindication, since breastfeeding women could replace breastfeeding by dairy products to feed their child. 
Med kontraindikacije je bilo vključeno tudi dojenje, saj doječe matere lahko nadomestijo dojenje z mlečnimi formulami.
The product was subsequently approved in AT, BE, DE, DK, EE, ES, FI, HR, IE, IT, LU, NO, RO, SE, SI and UK. 
Zdravilo je v nadaljevanju dovoljenje za promet pridobilo v Avstriji, Belgiji, Estoniji, Italiji, Luksemburgu, Nemčiji, Romuniji, Sloveniji, Španiji, na Danskem, Finskem, Hrvaškem, Irskem, Norveškem, Švedskem in v Združenem kraljestvu.
related toxicity from cycle to cycle, and potentially affecting overall efficacy of treatment in somepatients. 
zdravljenjem, med posameznimi cikli, kar lahko pri nekaterih bolnikih vpliva na skupno učinkovitost zdravljenja.
Vepesid contains etoposide, a semi-synthetic derivative of podophyllotoxin which ruptures double strand DNA by means of an interaction with DNA-topoisomerase II, or by the formation of free radicals. 
Zdravilo Vepesid vsebuje etopozid, polsintetični derivat podofilotoksina, ki reagira z DNKtopoizomerazo II ali sproži nastajanje prostih radikalov in tako prekine dvoverižno DNK.
- Hodgkin's lymphoma 
- Hodgkinov limfom;
In particular, for the concomitant use of live vaccines, immunosuppression is a common side effect of etoposide listed as very common in the SmPC. 
Imunosupresija je še zlasti pri sočasni uporabi živih cepiv pogost neželeni učinek etopozida, ki je v povzetku glavnih značilnosti zdravila naveden kot zelo pogost.
- Non-Hodgkin's lymphoma 
- ne-Hodgkinov limfom;
With regards to fertility, pregnancy and lactation, section 4.6 of the SmPC, information addressed to women of childbearing potential with regards to contraception in males and females was included. 
Kar zadeva poglavje 4.6 povzetka glavnih značilnosti zdravila o plodnosti, nosečnosti in dojenju, so bile vključene informacije, namenjene ženskam v rodni dobi, v zvezi s kontracepcijo pri moških in ženskah.
As regards the posology, all 17 SmPCs state in section 4.2 that the oral dose of etoposide capsules is based on the recommended intravenous (IV) dose and mention the need to consider bioavailability when prescribing, since it varies from patient to patient. 
Kar zadeva način odmerjanja, vseh 17 povzetkov glavnih značilnosti zdravila v poglavju 4.2 navaja, da je peroralni odmerek kapsul etopozida odvisen od priporočenega intravenskega (i.v.)
In section 4.3 of the SmPC Contraindications, the inclusions of hypersensitivity and concomitant use of live vaccines have been agreed as these are in line with the SmPC guidelines. 
Dogovorili so se, da v poglavje 4.3 povzetka glavnih značilnosti zdravila, Kontraindikacije, vključijo preobčutljivost in sočasno uporabo živih cepiv, kar je v skladu s smernicami za povzetke glavnih značilnosti zdravila.
• The product information proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee, 
• odbor CHMP je na podlagi predložene dokumentacije in znanstvene razprave v odboru ocenil informacije o zdravilu, ki so jih predlagali imetniki dovoljenj za promet z zdravilom;
- Recurrent or refractory testicular cancer 
- ponavljajoči se ali refraktarni rak mod;
Other information about Firmagon: 
Druge informacije o zdravilu Firmagon:
Which measures are being taken to ensure the safe use of Firmagon? 
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Firmagon?
The European Commission granted a marketing authorisation valid throughout the European Union for Firmagon to Ferring Pharmaceuticals A/S on 17 February 2009. 
Evropska komisija je dovoljenje za promet z zdravilom Firmagon, veljavno po vsej Evropski uniji, odobrila družbi Ferring Pharmaceuticals A/S dne 17. februarja 2009.
Treatment starts with two 120-mg injections, followed by single 80-mg injections every month. 
Zdravljenje se začne z dvema 120-miligramskima injekcijama, ki jima sledi ena 80-miligramska injekcija vsak mesec.
The company that makes Firmagon will make sure that educational materials are provided to all doctors in all Member States who will prescribe the medicine. 
Družba, ki proizvaja zdravilo Firmagon, bo poskrbela, da bo z učnim gradivom oskrbela vse zdravnike v vseh državah članicah, kjer se bo predpisovalo zdravilo.
Similar results were seen in patients receiving Firmagon at the higher dose of 160 mg once a month. 
Podobne rezultate so opazili pri bolnikih, ki so zdravilo Firmagon prejemali v večjem odmerku 160 mg enkrat mesečno.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) FIRMAGON EPAR summary for the public 
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) FIRMAGON Povzetek EPAR za javnost
The most common side effects with Firmagon (seen in more than 1 patient in 10) are hot flushes and problems at the injection site such as pain and redness. 
Najpogostejši neželeni učinki zdravila Firmagon (opaženi pri več kot 1 bolniku izmed 10) so vročinski valovi in težave na mestu injiciranja, kot sta bolečina in rdečina.
What benefit has Firmagon shown during the studies? 
Kakšne koristi je zdravilo Firmagon izkazalo med študijami?
However, because the main study looked at the medicine's effects on testosterone levels rather than the cancer or the patient's outcome directly, and because leuprorelin is only used for prostate cancer that is advanced, the Committee decided to restrict the use of Firmagon to advanced prostate cancer. 
Ker pa so v glavni študiji raziskovali učinke zdravila na koncentracijo testosterona in ne neposredno na raka ali izid za bolnika ter ker se levprorelin uporablja samo za napredovalega raka prostate, se je Odbor odločil omejiti uporabo zdravila Firmagon na napredovalega raka prostate.
The Committee recommended that Firmagon be given marketing authorisation 
Odbor je priporočil, da se za zdravilo Firmagon odobri dovoljenje za promet.
This means that patients do not need to take other medicines to block testosterone at the start of treatment. 
To pomeni, da bolnikom na začetku zdravljenja ni treba jemati drugih zdravil za zaviranje testosterona.
It contains the active substance degarelix. 
Vsebuje zdravilno učinkovino degareliks.
During the first year, 97% of the patients receiving Firmagon at the approved dose of 80 mg once a month dose had testosterone levels below the required level. 
Med prvim letom je imelo 97 % bolnikov, ki so prejemali zdravilo Firmagon pri odobrenem odmerku 80 mg enkrat mesečno, nižjo koncentracijo testosterona od zahtevane.
Firmagon must not be injected into a vein or a muscle. 
Zdravilo Firmagon se ne sme injicirati v veno ali mišico.
‘Advanced' means that the cancer has spread beyond the gland to some lymph nodes, but not to other organs. 
Izraz „napredovali“ pomeni, da se je rak iz žleze razširil na nekatere bezgavke, ne pa tudi na druge organe.
The materials will include information on Firmagon's safety and remind doctors how to administer the medicine. 
Ta gradiva bodo vključevala informacije o varnosti zdravila Firmagon in zdravnike opominjala na pravilen način dajanja zdravila.
Firmagon should not be used in people who may be hypersensitive (allergic) to degarelix or any of the other ingredients. 
Zdravila Firmagon ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) degareliks ali katero koli drugo sestavino zdravila.
Firmagon can be used if the cancer is ‘hormone-dependent', which means that it responds to treatments that reduce the levels of the hormone testosterone. 
Zdravilo Firmagon se lahko uporablja, če je rak „hormonsko odvisen“, kar pomeni, da se odziva na zdravljenja, ki zmanjšajo koncentracijo hormona testosterona.
What is the risk associated with Firmagon? 
Kakšna tveganja so povezana z zdravilom Firmagon?
The main measure of effectiveness was the number of patients whose testosterone levels were below those seen in men whose testes were producing no testosterone, over the first year of treatment. 
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih je bila koncentracija testosterona v prvem letu zdravljenja nižja od tiste pri moških, katerih modi nista proizvajali testosterona.
The effects of Firmagon were first tested in experimental models before being studied in humans. 
Učinki zdravila Firmagon so bili najprej preskušeni s pomočjo izkustvenih modelov, nato pa so jih raziskali pri ljudeh.
Firmagon should be used with caution in patients who have severe kidney or liver problems. 
Zdravilo Firmagon je treba uporabljati previdno pri bolnikih s hudimi ledvičnimi ali jetrnimi težavami.
The Committee for Medicinal Products for Human Use (CHMP) noted that Firmagon was as effective as leuprorelin in the main study. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je ugotovil, da je bilo zdravilo Firmagon v glavni študiji enako učinkovito kot levprorelin.
By blocking these processes, Firmagon reduces the amount of testosterone in the body and slows down the growth of the cancer cells. 
Zdravilo Firmagon z zaviranjem teh procesov zmanjša količino testosterona v telesu in upočasni rast rakastih celic.
This was compared with 96% of patients receiving leuprorelin. 
Pri bolnikih, ki so prejemali levprorelin, je bila ta vrednost 96 %.
Why has Firmagon been approved? 
Zakaj je bilo zdravilo Firmagon odobreno?
Firmagon is used to treat patients with advanced prostate cancer. 
Zdravilo Firmagon se uporablja za zdravljenje bolnikov z napredovalim rakom prostate.
The active substance in Firmagon, degarelix, is a gonadotrophin-releasing hormone antagonist, which means that it blocks the effects of a natural hormone called gonadotrophin-releasing hormone (GnRH). 
Zdravilna učinkovina zdravila Firmagon, degareliks, je antagonist gonadotropin sproščujočega hormona, kar pomeni, da zavira učinkovanje naravnega hormona, imenovanega gonadotropin sproščujoči hormon.
The Committee also noted that treatment with Firmagon does not trigger the temporary sharp rise in testosterone levels seen with ‘GnRH agonists' (other medicines for prostate cancer that stimulate the production of GnRH). 
Odbor je prav tako ugotovil, da zdravljenje z zdravilom Firmagon ne sproži začasnega hitrega dviga koncentracije testosterona, ki je značilna za „agoniste gonadotropin sproščujočega hormona“ (druga zdravila za raka prostate, ki spodbujajo tvorjenje gonadotropin sproščujočega hormona).
PSA is a protein that is produced by the prostate gland and is often found at high levels in men with prostate cancer. 
Za prostato specifični antigen je beljakovina, ki jo tvori prostata in je pogosto prisotna v visokih koncentracijah pri moških z rakom prostate.
Doctors should monitor the effectiveness of Firmagon treatment by looking at blood levels of testosterone and prostate-specific antigen (PSA). 
Zdravniki morajo spremljati učinkovitost zdravljenja z zdravilom Firmagon, tako da opazujejo krvne koncentracije testosterona in za prostato specifičnega antigena.
When injected, Firmagon forms a gel under the skin that releases the active substance slowly over a few weeks. 
Z injiciranjem zdravila Firmagon se pod kožo ustvari gel, iz katerega se zdravilna učinkovina nekaj tednov počasi sprošča.
Firmagon is a powder and solvent that are made up into a solution for injection. 
Zdravilo Firmagon sestavljata prašek in vehikel, iz katerih se pripravi raztopina za injiciranje.
For the full list of all side effects reported with Firmagon, see the Package Leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Firmagon, glejte navodilo za uporabo.
Firmagon is injected under the skin of the abdomen. 
Zdravilo Firmagon se injicira pod kožo trebuha.
GnRH normally stimulates the pituitary gland at the base of the brain to produce two hormones which cause the testes to produce testosterone. 
Gonadotropin sproščujoči hormon običajno spodbuja hipofizo na dnu možganov k tvorjenju dveh hormonov, ki delujeta na modi in njuno proizvajanje testosterona.
This is cancer that affects the prostate gland, the gland below the bladder in men that produces the liquid in the semen. 
Ta vrsta raka prizadene prostato, žlezo pod sečnim mehurjem pri moških, v kateri nastaja semenska tekočina.
Therefore, the CHMP decided that Firmagon's benefits are greater than its risks for the treatment of adult male patients with advanced hormone-dependent prostate cancer. 
Zaradi tega je CHMP zaključil, da so koristi zdravila Firmagon pri zdravljenju odraslih moških bolnikov z napredovalim rakom prostate, ki je odvisen od hormonov, večje od z njim povezanih tveganj.
How has Firmagon been studied? 
Kako je bilo zdravilo Firmagon raziskano?
Two doses of Firmagon have been compared with leuprorelin in one main study involving 610 men with prostate cancer at all stages of the disease. 
V eni glavni študiji, ki je vključevala 610 moških z rakom prostate v vseh stadijih te bolezni, so dva odmerka zdravila Firmagon primerjali z levprorelinom.
Firmagon was as effective as leuprorelin at reducing testosterone levels. 
Zdravilo Firmagon je bilo pri nižanju koncentracije testosterona enako učinkovito kot levprorelin.
How does Firmagon work? 
Kako zdravilo Firmagon deluje?
What is Firmagon? 
Kaj je zdravilo Firmagon?
The full EPAR for Firmagon can be found here. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Firmagon je na voljo tukaj.
What is Firmagon used for? 
Za kaj se zdravilo Firmagon uporablja?
How is Firmagon used? 
Kako se zdravilo Firmagon uporablja?
Testosterone can make prostate cancer cells grow. 
Rakaste celice v prostati lahko začnejo pod vplivom testosterona rasti.
Prevention of rejection 
Preprečevanje zavrnitve organa
Treatment of S-LAM 
Zdravljenje S-LAM
Further information on Rapamune can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Nadaljnje informacije o zdravilu Rapamune so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The most common side effects with Rapamune (which may affect more than 1 in 10 people) are infections, fever, slow wound healing, low counts of various blood cells, blood tests showing altered levels of various substances (including low potassium and phosphate; raised fats, cholesterol, glucose and markers for tissue breakdown and for liver and kidney function), diabetes, lymphocele (collection of lymph fluid usually in the lower belly), pain in various parts of the body, rapid heartbeat, raised blood pressure, problems affecting the gut, proteinuria (protein in the urine), menstrual disorders, oedema (swelling because of fluid build-up), rash and acne. 
Najpogostejši neželeni učinki zdravila Rapamune (ki se lahko pojavijo pri več kot 1 bolniku od 10) so okužbe, vročina, počasno celjenje ran, majhno število različnih krvnih celic, krvne preiskave, ki pokažejo spremenjene ravni različnih snovi (vključno z nizko ravnijo kalija in fosfata; zvišane ravni maščob, holesterola, glukoze in označevalcev razkroja tkiv ter delovanja jeter in ledvic), sladkorna bolezen, limfokela (nabiranje tekočine, običajno v spodnjem predelu trebuha), bolečina v različnih delih telesa, pospešen srčni utrip, zvišan krvni tlak, težave s črevesjem, proteinurija (beljakovine v seču), menstruacijske motnje, edemi (otekanje zaradi nabiranja tekočine), izpuščaj in akne.
The main measure of effectiveness was a change of FEV1 (the maximum volume of air a person can breathe out in 1 second). 
Glavno merilo učinkovitosti je bila sprememba FEV1 (največja količina zraka, ki jo oseba lahko izdihne v 1 sekundi).
The main measure of effectiveness was the number of treatment failures (rejection or loss of the new kidney, or death) after 6 months. 
Glavno merilo učinkovitosti je bilo število neuspelih zdravljenj (zavrnitve ali izgube presajene ledvice ali smrti) po šestih mesecih.
Rapamune received a marketing authorisation valid throughout the EU on 14 March 2001. 
Za zdravilo Rapamune je bilo 14. marca 2001 izdano dovoljenje za promet, veljavno po vsej EU.
What measures are being taken to ensure the safe and effective use of Rapamune? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Rapamune?
It is used in adults who are at a low to moderate risk of rejection. 
Uporablja se pri odraslih z majhnim do zmernim tveganjem za zavrnitev.
S-LAM is a rare lung disease that causes worsening symptoms such as shortage of breath and occurs mainly in women who are at an age when they can have children. 
S-LAM je redka pljučna bolezen, ki povzroča poslabšanje simptomov, kot je pomanjkanje sape, in se pojavlja predvsem pri ženskah v starosti, ko imajo lahko otroke.
Rapamune is available as an oral solution (1 mg/ml) and tablets (0.5, 1 and 2 mg). 
Zdravilo Rapamune je na voljo v obliki peroralne raztopine (1 mg/ml) in tablet (0,5 mg, 1 mg in 2 mg).
Other information about Rapamune 
Druge informacije o zdravilu Rapamune
To prevent organ rejection, the first dose is usually 6 mg given soon after the transplantation followed by 2 mg once a day. 
Za preprečitev zavrnitve organov se prvi odmerek, običajno v jakosti 6 mg, da kmalu po presaditvi, čemur sledi odmerek v jakosti 2 mg enkrat na dan.
As for all medicines, data on the use of Rapamune are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Rapamune stalno spremljajo.
The Agency decided that Rapamune's benefits are greater than its risks and it can be authorised for use in the EU. 
Zato je zaključila, da so koristi zdravila Rapamune večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Rapamune can then be used for continuing treatment with corticosteroids, but only if ciclosporin treatment can be stopped. 
Zdravilo Rapamune se nato lahko uporablja za nadaljevalno zdravljenje s kortikosteroidi, vendar le, če se lahko prekine zdravljenje s ciklosporinom.
What benefits of Rapamune have been shown in studies? 
Kakšne koristi zdravila Rapamune so se pokazale v študijah?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rapamune 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 Rapamune upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Since mTOR is involved in the multiplication of activated T-lymphocytes (white blood cells that are responsible for attacking the transplanted organ), Rapamune reduces the number of these cells, reducing the risk of organ rejection. 
Ker mTOR sodeluje pri množenju aktiviranih limfocitov T (belih krvnih celic, ki so odgovorne za napadanje presajenega organa), zdravilo Rapamune zmanjšuje število teh celic, s tem pa tudi tveganje za zavrnitev organa.
The doctor will adjust the dose to achieve appropriate levels of sirolimus in the patient's blood. 
Zdravnik bo odmerek prilagodil tako, da bo dosežena ustrezna raven sirolimusa v bolnikovi krvi.
This complex then blocks another protein called ‘mammalian target of rapamycin' (mTOR). 
Ta kompleks nato zavira drugo beljakovino, imenovano „tarča rapamicina pri sesalcih“ (mTOR).
Why is Rapamune authorised in the EU? 
Zakaj je bilo zdravilo Rapamune odobreno v EU?
Side effects reported with Rapamune are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Rapamune, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
An overview of Rapamune and why it is authorised in the EU 
Pregled zdravila Rapamune in zakaj je odobreno v EU
What is Rapamune and what is it used for? 
Kaj je zdravilo Rapamune in za kaj se uporablja?
For more information about using Rapamune, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Rapamune glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
In the body, sirolimus attaches to a protein inside cells to make a ‘complex'. 
Sirolimus se v telesu veže na beljakovino v celicah in z njo tvori „kompleks“.
It is recommended that Rapamune is used with ciclosporin and corticosteroids (other medicines to prevent organ rejection) for two to three months. 
Priporočeno je, da se dva do tri mesece uporablja skupaj s ciklosporinom in kortikosteroidi (drugimi zdravili za preprečevanje zavrnitve organov).
All patients were also treated with ciclosporin and corticosteroids and were at low to moderate risk of rejection. 
Vse bolnike so zdravili tudi s ciklosporinom in kortikosteroidi, vsi pa so imeli majhno do srednje veliko tveganje za zavrnitev.
To treat patients with S-LAM, the dose of Rapamune is 2 mg daily and after 10 to 20 days the doctor will adjust the dose to achieve appropriate levels of sirolimus in the patient's blood. 
Za zdravljenje bolnikov s S-LAM je odmerek zdravila Rapamune 2 mg na dan, po 10 do 20 dneh pa bo zdravnik odmerek prilagodil tako, da bo dosežena ustrezna raven sirolimusa v bolnikovi krvi.
The active substance in Rapamune, sirolimus, is an immunosuppressant (a medicine that reduces the activity of the immune system). 
Učinkovina v zdravilu Rapamune, sirolimus, je imunosupresiv (zdravilo, ki zmanjšuje dejavnost imunskega sistema).
FEV1 improved by an average of 1 ml per month in patients treated with Rapamune compared with a worsening by 12 ml per month in patients receiving placebo. 
FEV1 se je pri bolnikih, zdravljenih z zdravilom Rapamune, izboljšal za povprečno 1 ml na mesec, v primerjavi s poslabšanjem za 12 ml na mesec pri bolnikih, zdravljenih s placebom.
Patients allergic to peanut or soya must not take Rapamune oral solution because the solution contains soya oil. 
Bolniki, ki so alergični na arašide ali sojo, ne smejo jemati zdravila Rapamune v obliki peroralne raztopine, ker vsebuje sojino olje.
In S-LAM, mTOR is overactive, causing excessive multiplication of cells that cause the disease. 
Pri S-LAM je mTOR čezmerno dejaven in povzroča čezmerno razmnoževanje celic, ki povzročajo bolezen.
What are the risks associated with Rapamune? 
Kakšna tveganja so povezana z zdravilom Rapamune?
Rapamune was more effective than placebo (a dummy treatment) or azathioprine (another immunosuppressive medicine) in two main studies involving a total of 1,295 patients who were having a kidney transplant. 
Zdravilo Rapamune je bilo učinkovitejše od placeba (zdravila brez učinkovine) ali azatioprina (drugega imunosupresivnega zdravila) v dveh glavnih študijah, v kateri je bilo skupno vključenih 1 295 bolnikov, ki so jim presadili ledvico.
Two additional studies looked at Rapamune as continuing treatment for up to 5 years in 765 patients who were able to stop ciclosporin after 2 to 3 months. 
V dveh dodatnih študijah so zdravilo Rapamune kot nadaljevalno zdravljenje do pet let opazovali pri skupno 765 bolnikih, ki so se odzvali na prvotno dva- do trimesečno zdravljenje in ki so lahko prenehali jemati ciklosporin.
Rapamune is also used for treating patients with sporadic lymphangioleiomyomatosis (S-LAM) with moderate lung disease or worsening lung function. 
Zdravilo Rapamune se uporablja tudi za zdravljenje bolnikov s sporadično limfangioleiomiomatozo (S-LAM) z zmerno pljučno boleznijo ali slabšanjem delovanja pljuč.