natgillin/translations-raw huggingface dataset:
Upadacitinib works by blocking the action of enzymes called Janus kinases.
Upadacitinib deluje tako, da zmanjša delovanje encimov, imenovanih Janusove kinaze.
The patients were being treated with conventional disease-modifying anti-rheumatic medicines (chloroquine, hydroxychloroquine, leflunomide or sulfasalazine, often combined with methotrexate).
Bolniki so bili zdravljeni z običajnimi imunomodulirajočimi antirevmatiki (klorokvinom, hidroksiklorokvinom, leflunomidom ali sulfasalazinom, pogosto v kombinaciji z metotreksatom).
As for all medicines, data on the use of Rinvoq are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Rinvoq stalno spremljajo.
For more information about using Rinvoq, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Rinvoq glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The most common side effects with Rinvoq (which may affect more than 1 in 10 people) are upper respiratory tract infections (nose and throat infections).
Najpogostejši neželeni učinki zdravila Rinvoq (ki se lahko pojavijo pri več kot 1 bolniku od 10) so okužbe zgornjih dihalnih poti (okužbe nosu in žrela).
Other information about Rinvoq
Druge informacije o zdravilu Rinvoq
Side effects reported with Rinvoq are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Rinvoq, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rinvoq have also 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 Rinvoq upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
An overview of Rinvoq and why it is authorised in the EU
Pregled zdravila Rinvoq in zakaj je odobreno v EU
Rinvoq must not be used in patients with tuberculosis or serious infections.
Zdravilo Rinvoq se ne sme uporabljati pri bolnikih s tuberkulozo ali resnimi vnetji.
What benefits of Rinvoq have been shown in studies?
Kakšne koristi zdravila Rinvoq so se pokazale v študijah?
These enzymes are involved in setting up processes that lead to inflammation, and blocking their effect brings inflammation in the joints under control.
Ti encimi so vključeni v nastajanje procesov, ki povzročajo vnetje, z zaviranjem njihovega učinka pa omogoča nadzor nad vnetjem sklepov.
In patients with rheumatoid arthritis, the immune system (the body's defences) attacks healthy tissue, causing inflammation in the joints.
Pri bolnikih z revmatoidnim artritisom imunski sistem (obrambni mehanizem telesa) napade zdravo tkivo in povzroči vnetje v sklepih.
Why is Rinvoq authorised in the EU?
Zakaj je bilo zdravilo Rinvoq odobreno v EU?
Five studies involving a total of nearly 4,400 patients found Rinvoq effective in reducing symptoms in patients with moderate to severe rheumatoid arthritis.
V petih študijah, v katerih je sodelovalo skupaj skoraj 4 400 bolnikov, je bilo ugotovljeno, da zdravilo Rinvoq učinkovito zmanjšuje simptome pri bolnikih z zmernim do hudim revmatoidnim artritisom.
The company that markets Rinvoq will provide information to healthcare professionals about the risks of infection, harm to the unborn baby if Rinvoq is taken during pregnancy, and problems affecting the heart and circulation.
Podjetje, ki trži zdravilo Rinvoq, bo zdravstvenim delavcem zagotovilo informacije o tveganjih okužbe, škodljivosti za nerojenega otroka, če se zdravilo Rinvoq jemlje med nosečnostjo, in težavah, ki vplivajo na srce in krvni obtok.
The company will also supply a patient alert card describing warning signs of Rinvoq's serious side effects and how to get help, and a reminder not to use it during pregnancy.
Pripravilo bo tudi opozorilno kartico za bolnike, na kateri bodo opisani opozorilni znaki resnih neželenih učinkov zdravila Rinvoq in navodila, kako naj bolniki poiščejo pomoč, ter opozorilo, da se zdravilo ne sme uporabljati med nosečnostjo.
Patients treated with Rinvoq may have side effects that include infection, neutropenia (low count of a type of white blood cell), and blood tests that suggest liver or muscle damage and raised blood lipids.
Pri bolnikih, ki se zdravijo z zdravilom Rinvoq, se lahko pojavijo neželeni učinki, ki vključujejo okužbo, nevtropenijo (nizko število vrste belih krvnih celic), krvne preiskave pa kažejo na okvaro jeter ali poškodbe mišic in povečano raven krvnih lipidov.
It can be used on its own or with methotrexate, another medicine for rheumatoid arthritis.
Zdravilo se lahko uporablja samostojno ali v kombinaciji z metotreksatom, tj. drugim zdravilom za zdravljenje revmatoidnega artritisa.
Rinvoq is used for moderate or severe rheumatoid arthritis that cannot be controlled well enough with disease-modifying anti-rheumatic medicines or if the patient cannot take these medicines.
Zdravilo Rinvoq se uporablja pri zmernem ali hudem revmatoidnem artritisu, ki ga ni mogoče dovolj dobro nadzorovati z imunomodulirajočimi antirevmatiki, ali kadar bolnik teh zdravil ne more jemati.
The fifth study involved patients for whom a biological disease-modifying anti-rheumatic medicine was either not suitable or did not work well enough.
V peto študijo so bili vključeni bolniki, za katere biološki imunomodulirajoči antirevmatik ni bil primeren ali pa ni bil dovolj učinkovit.
Rinvoq is a medicine for treating adults with rheumatoid arthritis, a disease that causes inflammation of the joints.
Rinvoq je zdravilo za zdravljenje odraslih z revmatoidnim artritisom, tj. boleznijo, ki povzroča vnetje sklepov.
What are the risks associated with Rinvoq?
Kakšna tveganja so povezana z zdravilom Rinvoq?
What is Rinvoq and what is it used for?
Kaj je zdravilo Rinvoq in za kaj se uporablja?
Upadacitinib, the active substance in Rinvoq, is an immunosuppressant.
Upadacitinib, učinkovina v zdravilu Rinvoq, je imunosupresiv.
The first study was in patients who had not previously been treated with methotrexate.
Prva študija je vključevala bolnike, ki predhodno niso bili zdravljeni z metotreksatom.
Of the patients who also received Rinvoq, 43% had low disease activity compared with 14% of patients receiving placebo.
Med bolniki, ki so prejemali tudi zdravilo Rinvoq, jih je 43 % imelo nizko aktivnost bolezni v primerjavi s 14 % bolnikov, ki so prejemali placebo.
Rinvoq was effective at controlling moderate to severe rheumatoid arthritis in patients whose disease had not improved enough with other disease-modifying anti-rheumatic medicines.
Zdravilo Rinvoq je bilo učinkovito pri nadzoru zmernega do hudega revmatoidnega artritisa pri bolnikih, pri katerih zdravljenje z drugimi imunomodulirajočimi antirevmatiki ni zagotovilo zadostnega izboljšanja.
It found that 45% of the patients treated with Rinvoq on its own had low disease activity after 14 weeks compared with 19% of patients continuing their methotrexate treatment.
Ugotovljeno je bilo, da je imelo 45 % bolnikov, zdravljenih samo z zdravilom Rinvoq, po 14 tednih nizko aktivnost bolezni v primerjavi z 19 % bolnikov, ki so se še naprej zdravili z metotreksatom.
How is Rinvoq used?
Kako se zdravilo Rinvoq uporablja?
It found that 45% of patients treated with methotrexate plus Rinvoq had low disease activity after 12 weeks compared with 29% of patients treated with methotrexate plus adalimumab (a biological diseasemodifying anti-rheumatic medicine) and 14% of patients receiving methotrexate plus placebo.
Ugotovljeno je bilo, da je imelo 45 % bolnikov, zdravljenih z metotreksatom in zdravilom Rinvoq, po 12 tednih nizko aktivnost bolezni v primerjavi z 29 % bolnikov, zdravljenih z metotreksatom in adalimumabom (biološkim imunomodulirajočim antirevmatikom), in 14 % bolnikov, ki so prejemali metotreksat in placebo.
For the full list of side effects of Rinvoq, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Rinvoq, glejte navodilo za uporabo.
Rinvoq can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Rinvoq je le na recept.
The second study was in patients whose disease was not well controlled with disease-modifying antirheumatic medicines.
Druga študija je zajela bolnike, pri katerih bolezen ni bila dobro nadzorovana z imunomodulirajočimi antirevmatiki.
The fourth study was also in patients whose disease was not controlled well enough with methotrexate.
Tudi četrta študija je vključevala bolnike, pri katerih bolezen ni bila dobro nadzorovana z metotreksatom.
How does Rinvoq work?
Kako zdravilo Rinvoq deluje?
The third study was in patients whose disease was not controlled well with methotrexate.
Tretja študija je vključevala bolnike, pri katerih bolezen ni bila dobro nadzorovana z metotreksatom.
It found that of patients treated with Rinvoq, 48% had low disease activity after 12 weeks compared with 17% of patients receiving placebo (a dummy treatment).
Ugotovljeno je bilo, da je imelo 48 % bolnikov, zdravljenih z zdravilom Rinvoq, po 12 tednih nizko aktivnost bolezni v primerjavi s 17 % bolnikov, ki so prejemali placebo (zdravilo brez učinkovine).
It found that after 24 weeks, 48% of patients were in remission (clear of symptoms) after treatment with Rinvoq compared with 19% of patients receiving methotrexate.
Ugotovljeno je bilo, da je po 24 tednih zdravljenja z zdravilom Rinvoq remisijo (stanje brez simptomov) doseglo 48 % bolnikov, v primerjavi z 19 % bolnikov, ki so prejemali metotreksat.
Rinvoq contains the active substance upadacitinib.
Zdravilo Rinvoq vsebuje učinkovino upadacitinib.
Unopened: 3 years.
Neodprto: 3 leti.
No action required except continued monitoring.
Ukrepi niso potrebi, razen nadaljevanja spremljanja.
Date of first authorization: 11 October 2000 Date of latest renewal: 27 September 2010
Datum pridobitve podaljšanja dovoljenja: 11. oktober 2000 Datum zadnjega podaljšanja dovoljenja: 27.september 2010
• Women planning a pregnancy.
• Ženske, ki načrtujejo nosečnost.
0 = No reaction
0 = Brez reakcije
There are no specific recommendations for use in elderly men (above 65 years of age).
Ni določenih priporočil za uporabo pri starejših moških (nad starostjo 65 let).
Infection, including bacterial infection
okužba, vključno z bakterijsko okužbo
Apply the next dose at the usual time.
Naslednji odmerek nanesite ob običajnem času.
Grade 0, 1 or 2
Stopnja 0, 1 ali 2
It is important that you consult your doctor, who will tell you what to do.
Pomembno je, da se obrnete na svojega zdravnika, ki vam bo razložil, kaj je potrebno storiti.
• Do not be discouraged if you do not see immediate improvement.
• Ne odnehajte, če ne opazite takojšnjega izboljšanja.
• Do not stop treatment at the first sign of improvement.
• Ne prenehajte z zdravljenjem po prvih znakih izboljšanja.
In-use: Any remaining tube should be discarded 90 days after first opening.
Med uporabo: Preostanek vsebine v tubi je treba 90 dni po prvem odprtju zavreči.
Safety and effectiveness in women have not been established because of the paucity of clinical data.
Varnost in učinkovitost pri ženskah nista bili ugotovljeni zaradi majhnega obsega kliničnih podatkov.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Obvestite zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo, tudi če ste jih dobili brez recepta.
No specific studies on fertility have been conducted in men or women.
Specifičnih študij plodnosti pri moških ali ženskah niso izvajali.
The medicinal product was not genotoxic.
Zdravilo se ni izkazalo kot genotoksično.
Study 2 (BD)
Študija 2 (BD)
In Study 2a (N = 99), the overall response rate increased to 56.1%.
V študiji 2a (N = 99) se je skupna stopnja odziva povečala na 56,1 %.
The frequency of adverse events are classified as very common (≥1/10), common (≥1/100 to <1/10), and uncommon (≥1/1,000 to <1/100).
Pogostnost pojavljanja neželenih učinkov je uvrščena kot zelo pogosta (≥1/10), pogosta (≥1/100 do <1/10) in občasna (≥1/1.000 do <1/100) .
However there could be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure.
Vendar pa lahko posamezni dejavniki (npr. poškodovana kožna pregrada, prekomerna uporaba) prispevajo k povečani sistemski izpostavljenosti.
System Organ Class (MedDRA terminology)
Organski sistem (terminologija po MedDRA)
Stable Disease %
Stabilna bolezen %
No case of overdose has been reported.
O primerih prevelikega odmerjanja niso poročali.
TREATMENT ADJUSTMENTS
PRILAGODITEV ZDRAVLJENJA
4 = Very severe
4 = Zelo hudo
At Least One At Least Four
Najmanj štiri
Definite pink to red coloration
Razločna rožnata do rdeča barva
- Panretin contains alcohol.
- Zdravilo Panretin vsebuje alkohol.
Pharmacotherapeutic group: other antineoplastic agents, ATC code: LO1XX22
Farmakoterapevtska skupina: drugi antineoplastiki, Oznaka ATC: LO1XX22
In study 1, of 110 responding patients, 36 (33%) relapsed, while all but four still being on active treatment.
V študiji 1 je od 110 bolnikov, ki so se odzvali, 36 (33 %) ponovno zbolelo, medtem ko so z izjemo štirih bili še vsi na aktivnem zdravljenju.
Therefore, there is a low potential for interactions with systemic medicinal products.
Zato obstaja le majhna možnost medsebojnega delovanja s sistemskimi snovmi.
Study 2 was followed by an open label study (Study 2a), which included only patients electing to continue from Study 2.
Za študijo 2 je sledila odprta faza (študija 2a), v kateri so sodelovali le bolniki, ki so bili izbrani za nadaljevanje študije 2.
Clinical Complete Response (CCR) %
Celotni klinični odziv (CCR) %
Only two serious adverse reactions were reported (sepsis and cellulitis in the same patient).
Poročali so le o dveh hudih neželenih učinkih (sepsa in celulit pri istem bolniku).
DEFINING CLINICAL SIGNS
OPREDELITEV KLINIČNIH ZNAKOV
• Treatment of KS lesions in close proximity to other skin disorders.
• Zdravljenje KS lezij, ki se pojavijo v neposredni bližini drugih bolezni kože.
The incidence of severe skin rash was independent of the duration of treatment (10% in both cases).
Pojav hudih izpuščajev ni bil povezan s trajanjem zdravljenja (10 % v obeh primerih).
A subset of these patients were followed during treatment of up to 64 lesions (range 4-64, median 11.5 lesions) for up to 44 weeks (range 2-44, median 15 weeks).
Del teh bolnikov so spremljali za zdravljenje do 64 lezij (razpon 4-64, povprečje 11,5 lezij) in do 44 tednov (razpon 2-44, povprečje 15 tednov).
However, an increased rate of fused sternebrae was observed.
Vendar pa so opazili povečano pogostnost fuzije prsnice (sternebrae).
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Pred začetkom jemanja uporabo natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
In the open label phase of Study 1 (N = 184), the overall response rate increased to 66.7%.
V odprti fazi študije 1 (N = 184) se je skupna stopnja odziva povečala na 66,7 %.
The incidence of mild/moderate rash (all events regardless of causality) was less in patients treated for less than 16 weeks than in those treated for 16 weeks or more (mild, 33% v 63%; moderate, 29% v 43%).
Rahli/zmerni izpuščaji (vsi primeri ne glede na vzročnost) so se pojavljali redkeje pri bolnikih, ki so se zdravili manj kot 16 tednov v primerjavi s tistimi, ki so se zdravili za čas 16 tednov ali dlje (rahlo: 33 % napram 63 %; zmerno: 29 % napram 43 %).
After that, your doctor will decide how often you should apply the gel depending on the response of your KS and any side effects.
Za tem bo zdravnik določil, kolikokrat boste gel nanesli, in sicer odvisno od odziva KS ter morebitnih stranskih učinkov.
Each carton contains one tube of gel.
Vsaka škatla vsebuje eno tubo z gelom.
Carcinogenesis, mutagenesis, impairment of fertility
Karcinogeneza, mutageneza, oslabitev plodnosti
Once activated, these receptors function as ligand dependent transcription factors that regulate the expression of specific genes.
Ko so aktivirani, delujejo ti receptorji kot od liganda odvisni transkripcijski faktorji in uravnavajo izražanje specifičnih genov.
Studies have not been performed to determine the carcinogenic potential of alitretinoin.
Ni izvršenih študij za določitev kancerogenega potenciala alitretinoina.
Lesions responding during the first 12 weeks on study, initial blinded phase, confirmed over at least four study weeks (confirmation of response may have occurred after 12 weeks for some lesions in Study 1).
Lezije, ki so se odzvale v času prvih 12 tednov študije, začetna slepa faza, potrjeno za čas najmanj štirih tednov študije (dokaz odziva se je lahko pojavil po 12 tednih pri nekaterih lezijah v študiji 1).
How to apply Panretin: For cutaneous use (on the skin) only Apply Panretin twice a day to start with, once in the morning and once in the evening.
Kako uporabljamo zdravilo Panretin gel: samo za kožno uporabo (nanos na kožo) Na začetku nanesite dvakrat dnevno, enkrat zjutraj in enkrat zvečer.
Observed increases in mean heart-to-final body weight differences were attributed principally to the difference in the terminal body weights.
Opažena povečanja v povprečnih razlikah vrednosti razmerja »srce / končna telesna teža« so predpisali predvsem razliki v končnih telesnih težah.
Study 1, 6 index lesions; Study 2, up to 8 index lesions Each index lesion assessed individually for response.
Študija 1, 6 indeksnih lezij; študija 2, do 8 indeksnih lezij Odziv vsake indeksne lezije je bil ocenjen posebej.
For cutaneous use.
Za dermalno uporabo.
- Do not apply the gel on or near sensitive parts of your body such as eyes, nostrils, mouth,
- Gela ne nanašajte na ali blizu občutljivih delov telesa, kot so oči, nosnice, usta, ustnice, vagina,
The projected time for lesions that were in partial response (PR) to later attain clinical complete response (CCR) was 168 days.
Napovedani čas za lezije, ki so naprej pokazale delni odziv (PR) in dosegle kasnejši celotni klinični odziv (CCR), je bil 168 dni.
Percentages calculated as number of patients with responding lesions divided by total number of patients in the initial blinded phase.
Odstotek izračunan kot število bolnikov z odzivajočimi se lezijami, deljeno s skupnim številom bolnikov v začetni slepi fazi.
Very red, with oedema, with or without vesiculation
Zelo rdeče, z edemom, z ali brez mehurjenja
Do not cover the treated lesions with any bandage or other material.
Ne pokrivajte oskrbljene lezije s povojem ali drugim materialom.
DO NOT use Panretin if you are pregnant or thinking of becoming pregnant.
NE uporabljajte zdravila Panretin gel, če ste noseči ali če nameravate zanositi.
Your doctor will tell you how long your treatment will last.
Zdravnik vas bo seznanil s trajanjem zdravljenja.
The regulation of gene expression by alitretinoin controls the process of cellular differentiation and proliferation in both normal and neoplastic cells.
Regulacija izražanja genov z alitretinoinom nadzoruje proces celične diferenciacije in proliferacije v tako normalnih kot tudi neoplastičnih celicah.
However, treatment should not be restarted if Grade 4 toxicity occurred at an application frequency of less than twice a day.
Zdravljenje pa se ne sme ponovno uvesti, če se je pojavila toksičnost stopnje 4 pri pogostosti nanosa manj kot dvakrat dnevno.
Store in the original container in order to protect from light.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
Treatment of lesions that have not shown a decrease in area and/or height by week 12 should be discontinued.
Zdravljenje lezij, ki se niso zmanjšale po površini oz. višini do 12. tedna, je treba prekiniti.
Do not use after the expiry date which is stated on the end of the tube.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na tubi.
The safety of Panretin gel has been assessed in clinical studies of more than 469 patients with AIDS-related KS, 439 of whom were treated with an alitretinoin concentration of 0.1%.
Varnost zdravila Panretin gel je bila ocenjena v kliničnih raziskavah z več kot 469 bolniki, obolelimi z AIDS povezanim KS, od katerih je bilo 439 zdravljenih z alitretinoinom v koncentraciji 0,1 %.
Do not use Panretin: - if you are allergic to alitretinoin or to similar medicines containing retinoids - if you are allergic to any of the other ingredients of this medicine (listed in section 6) - if you are pregnant - if you are planning a pregnancy - if you are breast-feeding - on KS lesions close to any other skin complaint
Ne uporabljajte zdravila Panretin - če ste alergični na alitretinoin ali podobna zdravila, ki vsebujejo retinoide, - če ste alergični na katero koli sestavino tega zdravila (navedeno v poglavju 6), - če ste noseči, - če načrtujete nosečnost, - če dojite, - za nanos na KS lezije, ki se nahajajo v neposredni bližini drugih obolenj kože.
If application site toxicity occurs, the application frequency can be reduced as described below.
Če se pojavi toksičnost na predelu nanosa, se lahko pogostost uporabe zmanjša tako kot je opisano spodaj.
Local dermal toxicity associated with Panretin gel therapy generally resolved with treatment adjustment or discontinuation (see section 4.2).
Lokalna dermalna toksičnost, ki je povezana s terapijo z zdravilom Panretin gel, je bila večinoma odpravljena s prilagoditvijo zdravljenja ali s prekinitvijo (glejte poglavje 4.2).
Wash your hands using soap and water and wipe the healthy skin touched by the gel.
Z milom in vodo si umijte roke ter obrišite zdravo kožo, ki je prišla v stik z gelom.
Increased redness, possible oedema
Povečana pordelost, morebitni edem
Duration of application
Trajanje uporabe
Alitretinoin (9-cis-retinoic acid), a naturally-occurring endogenous hormone related to vitamin A, binds to and activates all known intracellular retinoid receptor subtypes (RAR, RAR, RAR, RXR, RXR, RXR).
Alitretinoin (9-cis-retinoidna kislina), je naravno prisoten endogeni hormon, soroden z vitaminom A, ki se veže na in aktivira vse znane znotrajcelične podtipe retinoidne receptorje (RARα, RAR, RAR, RXRα, RXRβ, RXRγ).
Other medicines and Panretin
Druga zdravila in zdravilo Panretin
It is recommended that HIV-infected mothers do not breast-feed their children to exclude the risk of transmission of the virus.
Matere, ki so okužene z virusom HIV, naj ne dojijo svojih otrok, saj v nasprotnem primeru obstaja nevarnost prenosa virusa.
The frequency of application should be adjusted for each lesion independently.
Pogostost uporabe je treba določiti za vsako lezijo posebej.
There are no data on the efficacy of Panretin applied less frequently than twice daily.
Ni podatkov o učinkovitosti zdravila Panretin, če se ta nanaša manj kot dvakrat dnevno.
Patients should initially apply Panretin twice a day to cutaneous KS lesions.
Bolniki naj na začetku nanesejo zdravilo Panretin dvakrat dnevno na kožne KS lezije.
What Panretin is and what it is used for
Kaj je zdravilo Panretin in za kaj ga uporabljamo
If you forget to take Panretin
Če ste pozabili vzeti zdravilo Panretin
- lesions are not ulcerated or lymphoedematous - treatment of visceral KS is not required - lesions are not responding to systemic antiretroviral therapy - radiotherapy or chemotherapy are not appropriate
- lezije niso zagnojene in se niso razvili limfedemi, - zdravljenje visceralnega KS ni potrebno, - če se lezije ne odzovejo na sistemsko antiretrovirusno terapijo, - če radioterapija ali kemoterapija nista primerni.
For any information about this medicine please contact the local representative of the Marketing Authorisation Holder.
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.