natgillin/translations-raw huggingface dataset:
People with Fabry disease may have a wide range of signs and symptoms, including severe conditions such as kidney failure, heart problems, and stroke.
Ljudje z Fabryjevo boleznijo imajo številne znake in simptome, vključno s hudimi zdravstvenimi težavami, kot so odpoved ledvic, težave s srcem in možganska kap.
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 Replagal.
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.
The first study measured the effects of Replagal on pain while the second study measured its effect on the mass of the left ventricle (heart muscle), a measure of the amount of Gb3 in the heart cells.
V prvi študiji so merili učinke zdravila Replagal na bolečino, v drugi pa so proučevali njegov učinek na maso levega prekata (srčne mišice), kar je merilo količine Gb3 v srčnih celicah.
If the enzyme is not present, Gb3 cannot be broken down and it builds up in the body's cells, such as kidney cells.
Če encima ni, se Gb3 ne more razgraditi in se začne kopičiti v telesnih celicah, kot so na primer ledvične celice.
Why has Replagal been approved?
Zakaj je bilo zdravilo Replagal odobreno?
It is available as a concentrate to be made into solution for infusion (drip) into a vein.
Na voljo je v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
Replagal has been compared with placebo (a dummy treatment) in two main studies involving a total of 40 male patients.
Zdravilo Replagal so primerjali s placebom (zdravilom brez zdravilne učinkovine) v dveh glavnih študijah, ki so vključevale skupaj 40 bolnikov moškega spola.
Replagal is designed to replace the human enzyme alpha-galactosidase A, which is lacking in people with Fabry disease.
Zdravilo Replagal je namenjeno nadomeščanju človeškega encima alfa-galaktozidaze A, ki ga primanjkuje osebam s Fabryjevo boleznijo.
The CHMP decided that Replagal's benefits are greater than its risks and recommended that it be given marketing authorisation.
Zaključil je, da so koristi zdravila Replagal večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Replagal reduced left ventricle mass by an average of 11.5 g while patients receiving placebo had an increase in left ventricular mass of 21.8 g. The effects in female patients were comparable to those in male patients and weekly dosing had no advantage over standard doses.
Zdravilo Replagal je maso levega prekata zmanjšalo povprečno za 11,5 g, medtem ko se je masa levega prekata pri bolnikih, ki so prejemali placebo, povečala za 21,8 g. Učinki zdravila so bili pri ženskah in moških primerljivi.
The active substance in Replagal, agalsidase alfa, is a copy of the human enzyme, produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce the enzyme.
Zdravilna učinkovina zdravila Fabrazyme, agalzidaza beta, je kopija človeškega encima, in se proizvaja z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri celica prejme gen (DNK), s katerim lahko tvori encim.
The CHMP decided that for patients with Fabry disease treatment with Replagal might provide longterm clinical benefits.
CHMP je menil, da lahko zdravljenje z zdravilom Replagal bolnikom s Fabryjevo boleznijo zagotovi dolgotrajne klinične koristi.
After 6 months of treatment, Replagal significantly reduced pain in patients compared with placebo.
Po šestih mesecih zdravljenja so imeli bolniki, ki so prejemali zdravilo Replagal, občutno manj bolečin kot tisti, ki so prejemali placebo.
For the full list of all side effects and restrictions with Replagal, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Replagal glejte navodilo za uporabo.
Replagal is an enzyme replacement therapy.
Zdravilo Replagal je encimska nadomestna terapija.
Replagal is medicine that contains the active substance agalsidase alfa.
Replagal je zdravilo, ki vsebuje zdravilno učinkovino agalzidaza alfa.
Replagal is used to treat patients who have Fabry disease, a rare inherited disorder.
Zdravilo Replagal se uporablja za zdravljenje bolnikov s Fabryjevo boleznijo, ki je redka dedna bolezen.
How has Replagal been studied?
Kako je bilo zdravilo Replagal raziskano?
Only a doctor who has experience in treating patients with Fabry disease or other inherited metabolic diseases should give Replagal.
Zdravilo Replagal lahko predpiše samo zdravnik, ki ima izkušnje z obravnavo bolnikov s Fabryjevo boleznijo ali drugimi dednimi presnovnimi boleznimi.
What is Replagal used for?
Za kaj se zdravilo Replagal uporablja?
How is Replagal used?
Kako se zdravilo Replagal uporablja?
What is Replagal?
Kaj je zdravilo Replagal?
How does Replagal work?
Kako zdravilo Replagal deluje?
Because consensus could not be reached, the CMD(h) referred the procedure to the CHMP.
Ker ni bilo mogoče doseči soglasja, je (CMD(h)) postopek predal odboru CHMP.
Content (concentrati on)
Vsebnost (koncentraci ja)
In the Netherlands bleomycin is currently approved for the following indications:
Bleomicin je na Nizozemskem trenutno odobren za naslednje indikacije:
The CHMP therefore considered the indication to be acceptable.
CHMP je zato to indikacijo upošteval kot sprejemljivo.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF BLEOMYCIN PHARMACHEMIE AND ASSOCIATED NAMES (SEE ANNEX I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA BLEOMYCIN PHARMACHEMIE IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
Pharmaceutical Form
Farmacetska oblika
The CHMP assessed the available data in order to establish whether the two indications can be supported.
CHMP je ovrednotil razpoložljive podatke, da bi ugotovil, ali je mogoče zadevni indikaciji podpreti.
The same is applicable for the indication penile cancer; the indication is supported by reports suggesting a modest efficacy for this disease.
Enako velja tudi za indikacijo raka penisa; indikacijo podpirajo poročila, ki nakazujejo na skromno učinkovitost pri tej bolezni.
In conclusion, the CHMP considered that this efficacy outweighs the toxicity of the product, and that the benefit/risk balance is positive.
Odbor CHMP je na koncu menil, da ta učinkovitost odtehta toksičnost zdravila in da je razmerje med koristmi in tveganji pozitivno.
GROUNDS FOR OPINION
PODLAGA ZA MNENJE
The Application for Bleomycin Pharmachemie was submitted as a generic application based on the marketing authorisation granted for the reference product in the Netherlands on 18 November 1997.
Vloga za zdravilo Bleomycin Pharmachemie je bila predložena kot generična vloga, ki je temeljila na dovoljenju za promet z zdravilom, odobrenem za referenčno zdravilo na Nizozemskem dne 18. novembra 1997.
The CHMP noted that bleomycin is in clinical use since the 1960ies, thereby explaining the lack of a clinical development programme.
Odbor CHMP je ugotovil, da je bleomicin v klinični uporabi od šestdesetih let prejšnjega stoletja, in s tem pojasnil, zakaj ni kliničnega razvojnega programa.
(Invented) Name
(Lastniško) ime
Because the benefit/risk assessment for these indications was negative for the originator product and because the indications were consequently deleted from the authorised indications for all bleomycin-containing products in Germany, the indications were regarded as new indications, and the objecting member state considered that the submitted data was insufficient for granting a marketing authorisation for the proposed new indications.
Ker je bilo ocena koristi in tveganj teh indikacij za originatorsko zdravilo negativno in ker so v Nemčiji te indikacije posledično izbrisali iz odobrenih indikacij vseh zdravil, ki vsebujejo bleomicin, so indikacije upoštevali kot nove indikacije, ugovarjajoča država članica pa je menila, da predloženi podatki ne zadostujejo za odobritev dovoljenja za promet z zdravilom za predlagane nove indikacije.
The CHMP also noted that bleomycin is still in use and also mentioned in current treatment guidelines in Europe and North America, such as the SCCHN: Practice Guidelines in Oncology-v.2.2008 (HCCN, USA), the CCO (Cancer Care Ontario) Formulary, revised 2006/2007, and the Guidelines on penile cancer (March 2004) of the European Association of Urology.
Odbor CHMP je prav tako ugotovil, da je bleomicin še vedno v uporabi in je tudi omenjen v trenutno veljavnih smernicah za zdravljenje ploščatoceličnega karcinoma glave in vratu v Evropi in Severni Ameriki: Practice Guidelines in Oncology-v.2.2008 (Smernice za prakso v onkologiji) (HCCN, ZDA), CCO (Cancer Care Ontario) Formulary , revidirano 2006/2007, in Guidelines on penile cancer (Smernice za raka penisa) (marec 2004) Evropskega urološkega združenja.
In a lower degree bleomycin also affects the RNA and protein synthesis.
Bleomicin v manjši meri vpliva tudi na RNK in sintezo beljakovin.
The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Veljavni povzetek glavnih značilnosti zdravila, ovojnine in navodila za uporabo so končne verzije, potrjene v postopku pred Koordinacijsko skupino.
The effect of bleomycin rests on intercalation with single and double strands of DNA, resulting in single and double strand ruptures, which inhibit cell division, growth and DNA synthesis.
Učinek bleomicina je posledica njegovega vrivanja v enojne¸in dvojne verige DNK, kar povzroči prekinitve enojnih in dvojnih verig, to pa zavre celično deljenje, razmnoževanje in sintezo DNK.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES
ANEKS I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, NAČINOV APLIKACIJE, klPREDLAGATELJEV IN DRŽAV ČLANIC
Most of the presented data describe bleomycin as component of multidrug chemotherapy including cisplatin and therefore the individual contribution of bleomycin cannot be unequivocally determined, however a number of studies and publications clearly indicate that bleomycin demonstrates efficacy.
Večina predloženih podatkov opisuje bleomicin kot sestavni del kemoterapije z več zdravili, med katerimi je vključen tudi cisplatin, zato posameznega prispevka bleomicina ni mogoče jasno določiti, vendar pa večje število študij in publikacij jasno kaže na učinkovitost bleomicina.
Bleomycin belongs to the cytostatic antibiotics: it is a mixture of structurally related, alkaline, water soluble, glycopeptide antibiotics with a cytostatic effect.
Bleomicin spada med citostatične antibiotike: je mešanica strukturno sorodnih, alkalnih, vodotopnih glikopeptidnih antibiotikov s citostatičnim učinkom.
Therefore the CHMP is of the opinion that bleomycin is still a valuable chemotherapeutic drug, and adopted the totality of the proposed indications, for Bleomycin Pharmachemie:
Zaradi tega je odbor CHMP menil, da je bleomicin še vedno dragoceno kemoterapevtsko zdravilo, in sprejel vse predlagane indikacije za zdravilo Bleomycin Pharmachemie:
Although the applicant was willing to remove the indications objected to by the objecting CMS, the RMS and the other positive CMSs were in favour of retaining these indications.
Čeprav je bil predlagatelj pripravljen odstraniti indikacije, ki jim je nasprotovala ugovarjajoča zadevna država članica, so referenčna država članica in zadevne države članice, ki so bile pozitivnega mnenja, zagovarjale ohranitev teh indikacij.
The administration of bleomycin almost always takes place in combination with other cytostatic drugs and/or radiation therapy.
Bleomicin se skoraj vedno daje v kombinaciji z drugimi citostatičnimi zdravili in/ali zdravljenjem z obsevanjem.
Therefore, despite overt toxicity and modest efficacy, the CHMP considered that bleomycin is a valuable treatment option for systemic treatment, if deemed necessary for these indications.
Zaradi tega je odbor CHMP kljub očitni toksičnosti in skromni učinkovitosti menil, da je bleomicin dragocena možnost zdravljenja za sistemsko zdravljenje pri teh indikacijah, kadar se to zdi potrebno.
In the combination therapy bleomycin is also of value, even though the evidence of the sole contribution of bleomycin is not assessable.
Bleomicin je dragocen tudi pri kombiniranem zdravljenju, čeprav dokazov o prispevku samega bleomicina ni mogoče ovrednotiti.
Although response rates are in general higher with bleomycin containing regimens, the added toxicity is readily acknowledged.
Čeprav so ravni odziva v splošnem večje pri zdravljenju, ki vključujejo bleomicin, je potrjena tudi povečana toksičnost.
In addition to the documentation already provided during the decentralised procedure, supporting a modest but certain role for bleomycin in the treatment of SCCHN, a number of recent reports support the role of bleomycin in conjunction with other chemotherapeutic moieties, identifying both a recovery ratio (RR) of 34% in second line treatment and the improvement of loco-regional control and survival in patients with advanced HNC through concomitant postoperative radio- and chemotherapeutical treatment with mitomycin C and bleomycin.
Poleg dokumentacije, ki je bila že predložena med decentraliziranim postopkom v podporo skromni, a gotovi vlogi bleomicina pri zdravljenju ploščatoceličnega karcinoma glave in vratu, številna novejša poročila podpirajo vlogo bleomicina v povezavi z drugimi sestavnimi deli kemoterapije, v katerih sta bila ugotovljena 34-odstotna stopnja ozdravljenja, kadar so zdravilo uporabljali pri zdravljenju druge izbire, in izboljšanje lokoregionalnega nadzora ter preživetja bolnikov z napredovalim rakom glave in vratu pri sočasnem pooperacitivnem zdravljenju z obsevanjem in kemoterapijo z mitomicinom C in bleomicinom.
Although bleomycin is currently not regarded as an essential component in the first line systemic treatment of SCCHN, it still constitutes a treatment option for (concomitant) chemotherapy, or in conjunction with RT, and can therefore not be considered obsolete for this indication.
Čeprav se bleomicin trenutno ne upošteva kot bistveni sestavni del sistemskega zdravljenja prve izbire pri ploščatoceličnemu karcinomu glave in vratu, je še vedno sestavni del možnosti zdravljenja s (sočasno) kemoterapijo ali zdravljenja v povezavi z radioterapijo, tako da ga za to indikacijo ni mogoče upoštevati kot zastarelega.
Regarding the indication in Head and Neck cancer, the CHMP is of the opinion that although bleomycin has obvious disadvantages related to its toxicity (pulmonitis, pulmonary fibrosis, stomatitis and skin changes), there is still a role for bleomycin in (neoadjuvant) treatment of the disease.
Kar zadeva indikacijo raka glave in vratu, CHMP meni, da ima bleomicin kljub očitnim slabim stranem, ki so povezane z njegovo toksičnostjo (pljučnica, pljučna fibroza, vnetje ustne sluznice in kožne spremembe), še vedno vlogo pri (neoadjuvantnem) zdravljenju te bolezni.
Furthermore the difficulty to assess the sole efficacy of bleomycin when results are obtained with combination regimens is recognized, however the overall favourable efficacy of bleomycin containing regimen supports the indication for bleomycin.
Poleg tega gre opaziti težavo pri oceni učinkovitosti bleomicina samega, kadar so rezultati dobljeni s kombiniranim zdravljenjem, vendar celokupna pozitivna učinkovitost zdravljenja, ki vključuje bleomicin, podpira indikacijo za bleomicin.
Concerns were raised on the proposed indications by an objecting member state, Germany.
Ugovarjajoča država članica, Nemčija, je imela zadržke glede predlaganih indikacij.
ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
DODATEK III POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OVOJNINA IN NAVODILO ZA UPORABO
Regarding the indication in Epidermoid carcinoma of external genitalia, the CHMP noted that bleomycin is currently still in use in cervical cancer, and it was agreed that although the clinical efficacy is modest in this indication, as well as in penile cancer, several recent trials have illustrated the significance of bleomycin in these indications.
Kar zadeva indikacijo pri epidermoidnem karcinomu zunanjih spolovil, je odbor CHMP ugotovil, da je bleomicin trenutno še vedno v uporabi pri raku materničnega vratu, ter prišel do sklepa, da je več novejših preskušanj kljub njegovi skromni klinični učinkovitosti pri tej indikaciji kot tudi pri raku penisa pokazalo pomembnost bleomicina pri teh indikacijah.
Local/Intratumoral injections
Lokalna/intratumorska injekcija
The CHMP considered that although bleomycin is not an obvious first line component for systemic treatment of cervical cancer, bleomycin remains a useful cytostatic drug that has to remain available to patients for this indication.
Odbor CHMP je menil, da kljub očitni neprimernosti bleomicina za sistemsko zdravljenje prve izbire pri raku materničnega vratu bleomicin ostaja uporabno citostatično zdravilo, ki mora ostati na voljo bolnikom za to indikacijo.
The combination of bleomycin, vindesine, mitomycin C and cisplatin in patients with recurrent and/or metastatic squamous cell carcinoma of the cervix was recently shown to be of benefit with regards to survival and a phase II study showed bleomycin to be part of a clinically relevant alternative treatment regimen for cisplatin, in patients with recurrent cervical cancer.
Kombinacija bleomicina, vindezina, mitomicina C in cisplatina pri bolnicah s ponovljenim in/ali metastatskim ploščatoceličnim karcinomom materničnega vratu se je v zadnjem času izkazala kot koristna glede na preživetje, v študiji II.
Intraperitoneal administration Local/Intratumoral injections
Intraperitonealna aplikacija Lokalna/intratumorska injekcija
- Squamous cell carcinoma of Head and neck (SCCHN) - Squamous cell carcinoma of external genitalia: penile carcinoma, cervix carcinoma.
- ploščatocelični karcinom glave in vratu (SCCHN), - ploščatocelični karcinom zunanjih spolovil: karcinom penisa, karcinom materničnega vratu, - (ne-)Hodgkinov limfom in drugi maligni limfomi, - karcinom testisov, - intraplevralno zdravljenje malignega plevralnega izliva.
the CHMP has recommended the granting of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination Group procedure as mentioned in Annex III for Bleomycin Pharmachemie and associated names (see Annex I).
Ob upoštevanju, da: - ugotovljena učinkovitost bleomicina odtehta tveganja glede ugotovljene toksičnosti, - se učinkovitost bleomicina lahko šteje za ugotovljeno prek izdane literature in trenutno veljavnih smernic za zdravljenje v Evropi in Severni Ameriki, - ter ob upoštevanju trenutne terapevtske uporabe bleomicina, je odbor CHMP priporočil odobritev dovoljenja za promet z zdravilom, katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostanejo enaki kot končne različice, dogovorjene med postopkom Usklajevalne skupine, kakor je omenjeno v Dodatku III za zdravilo Bleomycin Pharmachemie in z njim povezana imena (glejte Dodatek I).
Route of administration
Način aplikacije
Bleomycin is intended for the treatment of: - Squamous cell carcinoma (SCC) of the head and neck, external genitalia and cervix.
Bleomicin je namenjen za: - zdravljenje ploščatoceličnega karcinoma (SCC) glave in vratu, zunanjih spolovil in materničnega vratu, - zdravljenje Hodgkinovega limfoma, - zdravljenje ne-Hodgkinovega limfoma srednje in visoke stopnje malignosti pri odraslih, - zdravljenje karcinoma testisov (seminomski in neseminomski), - intraplevralno zdravljenje malignega plevralnega izliva.
Intramuscular injection Intravenous administration Intra-pleural injection
Intramuskularna injekcija Intravenska aplikacija Intraplevralna injekcija
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Local/Intratumoral injections
Intramuskularna injekcija Subkutana injekcija Intravenska aplikacija Intraarterijska aplikacija Intraplevralna injekcija Lokalna/intratumorska injekcija
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Local injection
Intramuskularna injekcija Subkutana injekcija Intravenska aplikacija Intraarterijska aplikacija Intraplevralna injekcija Lokalna injekcija
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration
Intramuskularna injekcija Subkutana injekcija Intravenska aplikacija Intraarterijska aplikacija Intraplevralna injekcija Intraperitonealna aplikacija
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection
Intramuskularna injekcija Subkutana injekcija Intravenska aplikacija Intraarterijska aplikacija Intraplevralna injekcija
• if you are more than 3 months pregnant.
• če ste noseči dlje kot tri mesece.
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first Authorization: 13 April 2012
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve: 13 april 2012
The volume of distribution is 53 - 93 litres.
Volumen porazdelitve je 53-93 litrov.
4 years
4 leta.
Use in Children
Uporaba pri otrocih
• if you suffer from heart problems
• če imate težave s srcem
• if you are taking any of the following medicines used to treat high blood pressure:
• če jemljete katero od naslednjih zdravil, ki se uporabljajo za zdravljenje visokega krvnega tlaka:
This medicine should not be used in children and adolescents (under 18 years) because the safety and efficacy have not yet been fully established.
Tega zdravila se ne sme uporabljati pri otrocih in mladostnikih (mlajši od 18 let), ker varnost in učinkovitost še nista bili popolnoma ugotovljeni.
The terminal elimination half-life of irbesartan is 11 - 15 hours.
Končni razpolovni eliminacijski čas irbesartana je 11-15 ur.
Risk Management Plan (RMP) Not applicable
Načrt za obvladovanje tveganja (RMP)
See leaflet for further information
Glejte navodilo za dodatne informacije
Tell your doctor if any of the following apply to you:
Obvestite svojega zdravnika, če se karkoli od naslednjega nanaša na vas:
Paediatric population: the safety and efficacy of Sabervel in children aged 0 to 18 has not been established.
Pediatrična populacija: varnost in učinkovitost zdravila Sabervel pri otrocih, starih od 0 do 18 let, nista bili dokazani.
• to treat high blood pressure (essential hypertension)
• za zdravljenje povečanega krvnega tlaka (primarne hipertenzije).
• if you are allergic (hypersensitive) to irbesartan or any other ingredients of Sabervel
• če ste alergični na (preobčutljivi za) irbesartan ali katerokoli sestavino zdravila Sabervel
• The active substance is irbesartan.
• Zdravilna učinkovina je irbesartan.
When driving vehicles or operating machines, it should be taken into account that dizziness or weariness may occur during treatment.
Pri upravljanju z vozili ali s stroji se mora upoštevati, da se med zdravljenjem lahko pojavita omotica ali utrujenost.
If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.
Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje (laktozo), se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
It is important that you continue to take Sabervel until your doctor tells you otherwise.
Pomembno je, da zdravilo Sabervel jemljete redno, vse dokler vam zdravnik ne predpiše drugače.
• if you are going to have an operation (surgery) or be given anaesthetics.
• če imate predvideno operacijo (kirurški poseg) ali boste dobili anestetik
Other medicines and Sabervel
Druga zdravila in zdravilo Sabervel
Like all medicines, Sabervel can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Sabervel neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
• if you receive Sabervel for diabetic kidney disease.
• če zdravilo Sabervel jemljete zaradi diabetične bolezni ledvic.