FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: In a lower degree bleomycin also affects the RNA and protein synthesis.
Slovenian: Bleomicin v manjši meri vpliva tudi na RNK in sintezo beljakovin.
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Slovenian: Veljavni povzetek glavnih značilnosti zdravila, ovojnine in navodila za uporabo so končne verzije, potrjene v postopku pred Koordinacijsko skupino.
English: 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.
Slovenian: 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.
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES
Slovenian: ANEKS I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, NAČINOV APLIKACIJE, klPREDLAGATELJEV IN DRŽAV ČLANIC
English: 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.
Slovenian: 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.
English: Bleomycin belongs to the cytostatic antibiotics: it is a mixture of structurally related, alkaline, water soluble, glycopeptide antibiotics with a cytostatic effect.
Slovenian: Bleomicin spada med citostatične antibiotike: je mešanica strukturno sorodnih, alkalnih, vodotopnih glikopeptidnih antibiotikov s citostatičnim učinkom.
English: 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:
Slovenian: Zaradi tega je odbor CHMP menil, da je bleomicin še vedno dragoceno kemoterapevtsko zdravilo, in sprejel vse predlagane indikacije za zdravilo Bleomycin Pharmachemie:
English: 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.
Slovenian: 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.
English: The administration of bleomycin almost always takes place in combination with other cytostatic drugs and/or radiation therapy.
Slovenian: Bleomicin se skoraj vedno daje v kombinaciji z drugimi citostatičnimi zdravili in/ali zdravljenjem z obsevanjem.
English: 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.
Slovenian: 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.
English: In the combination therapy bleomycin is also of value, even though the evidence of the sole contribution of bleomycin is not assessable.
Slovenian: Bleomicin je dragocen tudi pri kombiniranem zdravljenju, čeprav dokazov o prispevku samega bleomicina ni mogoče ovrednotiti.
English: Although response rates are in general higher with bleomycin containing regimens, the added toxicity is readily acknowledged.
Slovenian: Čeprav so ravni odziva v splošnem večje pri zdravljenju, ki vključujejo bleomicin, je potrjena tudi povečana toksičnost.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Concerns were raised on the proposed indications by an objecting member state, Germany.
Slovenian: Ugovarjajoča država članica, Nemčija, je imela zadržke glede predlaganih indikacij.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Slovenian: DODATEK III POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OVOJNINA IN NAVODILO ZA UPORABO
English: 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.
Slovenian: 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.
English: Local/Intratumoral injections
Slovenian: Lokalna/intratumorska injekcija
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Intraperitoneal administration Local/Intratumoral injections
Slovenian: Intraperitonealna aplikacija Lokalna/intratumorska injekcija
English: - Squamous cell carcinoma of Head and neck (SCCHN) - Squamous cell carcinoma of external genitalia: penile carcinoma, cervix carcinoma.
Slovenian: - 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.
English: 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).
Slovenian: 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).
English: Route of administration
Slovenian: Način aplikacije
English: Bleomycin is intended for the treatment of: - Squamous cell carcinoma (SCC) of the head and neck, external genitalia and cervix.
Slovenian: 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.
English: Intramuscular injection Intravenous administration Intra-pleural injection
Slovenian: Intramuskularna injekcija Intravenska aplikacija Intraplevralna injekcija
English: Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Local/Intratumoral injections
Slovenian: Intramuskularna injekcija Subkutana injekcija Intravenska aplikacija Intraarterijska aplikacija Intraplevralna injekcija Lokalna/intratumorska injekcija
English: Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Local injection
Slovenian: Intramuskularna injekcija Subkutana injekcija Intravenska aplikacija Intraarterijska aplikacija Intraplevralna injekcija Lokalna injekcija
English: Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration
Slovenian: Intramuskularna injekcija Subkutana injekcija Intravenska aplikacija Intraarterijska aplikacija Intraplevralna injekcija Intraperitonealna aplikacija
English: Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection
Slovenian: Intramuskularna injekcija Subkutana injekcija Intravenska aplikacija Intraarterijska aplikacija Intraplevralna injekcija
English: • if you are more than 3 months pregnant.
Slovenian: • če ste noseči dlje kot tri mesece.
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first Authorization: 13 April 2012
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve: 13 april 2012
English: The volume of distribution is 53 - 93 litres.
Slovenian: Volumen porazdelitve je 53-93 litrov.
English: 4 years
Slovenian: 4 leta.
English: Use in Children
Slovenian: Uporaba pri otrocih
English: • if you suffer from heart problems
Slovenian: • če imate težave s srcem
English: • if you are taking any of the following medicines used to treat high blood pressure:
Slovenian: • če jemljete katero od naslednjih zdravil, ki se uporabljajo za zdravljenje visokega krvnega tlaka:
English: This medicine should not be used in children and adolescents (under 18 years) because the safety and efficacy have not yet been fully established.
Slovenian: Tega zdravila se ne sme uporabljati pri otrocih in mladostnikih (mlajši od 18 let), ker varnost in učinkovitost še nista bili popolnoma ugotovljeni.
English: The terminal elimination half-life of irbesartan is 11 - 15 hours.
Slovenian: Končni razpolovni eliminacijski čas irbesartana je 11-15 ur.
English: Risk Management Plan (RMP) Not applicable
Slovenian: Načrt za obvladovanje tveganja (RMP)
English: See leaflet for further information
Slovenian: Glejte navodilo za dodatne informacije
English: Tell your doctor if any of the following apply to you:
Slovenian: Obvestite svojega zdravnika, če se karkoli od naslednjega nanaša na vas:
English: Paediatric population: the safety and efficacy of Sabervel in children aged 0 to 18 has not been established.
Slovenian: Pediatrična populacija: varnost in učinkovitost zdravila Sabervel pri otrocih, starih od 0 do 18 let, nista bili dokazani.
English: orthostatic hypotension*
Slovenian: ortostatska hipotenzija*
English: • to treat high blood pressure (essential hypertension)
Slovenian: • za zdravljenje povečanega krvnega tlaka (primarne hipertenzije).
English: • if you are allergic (hypersensitive) to irbesartan or any other ingredients of Sabervel
Slovenian: • če ste alergični na (preobčutljivi za) irbesartan ali katerokoli sestavino zdravila Sabervel
English: • The active substance is irbesartan.
Slovenian: • Zdravilna učinkovina je irbesartan.
English: When driving vehicles or operating machines, it should be taken into account that dizziness or weariness may occur during treatment.
Slovenian: Pri upravljanju z vozili ali s stroji se mora upoštevati, da se med zdravljenjem lahko pojavita omotica ali utrujenost.
English: 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.
Slovenian: Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje (laktozo), se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: It is important that you continue to take Sabervel until your doctor tells you otherwise.
Slovenian: Pomembno je, da zdravilo Sabervel jemljete redno, vse dokler vam zdravnik ne predpiše drugače.
English: • if you are going to have an operation (surgery) or be given anaesthetics.
Slovenian: • če imate predvideno operacijo (kirurški poseg) ali boste dobili anestetik
English: Other medicines and Sabervel
Slovenian: Druga zdravila in zdravilo Sabervel
English: Like all medicines, Sabervel can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Sabervel neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: • if you receive Sabervel for diabetic kidney disease.
Slovenian: • če zdravilo Sabervel jemljete zaradi diabetične bolezni ledvic.
English: Rodopi Prefecture, Block No 5, Rodopi 69300, Greece
Slovenian: Rodopi Prefecture, Block No 5, Rodopi 69300, Grčija
English: The total body and renal clearance are 157 - 176 and 3 - 3.5 ml/min, respectively.
Slovenian: Celokupni telesni in ledvični očistek je 157176 oziroma 3-3,5 ml/min.
English: Mechanism of action: Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist.
Slovenian: Mehanizem delovanja: Irbesartan je močan, peroralno delujoč, selektivni antagonist receptorjev za angiotenzin II (tip AT1).
English: Irbesartan AUC and Cmax values were also somewhat greater in elderly subjects (≥ 65 years) than those of young subjects (18 - 40
Slovenian: Vrednosti AUC in Cmax irbesartana so bile pri starejših osebah (≥65 let) nekoliko večje kot pri mlajših (18-40 let).
English: The PSUR submission schedule should follow the PSUR submission schedule for the reference medicinal product.
Slovenian: Predložitev PSUR mora slediti časovnici predložitve PSUR referenčnega zdravila
English: • potassium-sparing medicines (such as certain diuretics)
Slovenian: • zdravila, ki varčujejo s kalijem (kot so nekateri diuretiki)
English: Elderly patients: although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
Slovenian: Starejši bolniki: čeprav je treba pretehtati možnost uporabe začetnega odmerka 75 mg pri bolnikih starejših od 75 let, običajno pri starejših prilagajanje odmerka ni potrebno.
English: Sabervel at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Slovenian: Na splošno zagotavlja odmerek 150 mg zdravila Sabervel enkrat na dan boljši 24 urni nadzor krvnega tlaka kot 75 mg.
English: C.V. MEDILINE LTD
Slovenian: MEDILINE LTD
English: Hyperkalaemia* occurred more often in diabetic patients treated with irbesartan than with placebo.
Slovenian: Hiperkaliemija* se je pojavljala pri diabetičnih bolnikih zdravljenih z irbesartanom pogosteje kot pri bolnikih, ki so dobivali placebo.
English: Taking Sabervel with food and drink Sabervel can be taken with or without food.
Slovenian: Jemanje zdravila Sabervel skupaj s hrano in pijačo Zdravilo Sabervel lahko jemljete s hrano ali brez nje.
English: C irbesartan, about 20% of the radioactivity is recovered in the urine, and the remainder in the faeces.
Slovenian: C irbesartana, se približno 20% radioaktivnosti izloči z urinom in preostanek z blatom.
English: • If you have any further questions, ask your doctor or pharmacist.
Slovenian: • Če imate dodatna vprašanja, se posvetujete z zdravnikom ali s farmacevtom.
English: Such conditions should be corrected before the administration of Sabervel.
Slovenian: Ta stanja se mora korigirati, preden se uporabi zdravilo Sabervel.
English: Cartons of 28, 56, 90 or 98 film-coated tablets in PVC/PVDC-aluminium/PVDC blisters.
Slovenian: Škatle s 28, 56, 90 ali 98 filmsko obloženimi tabletami: v PVC/PVDC-aluminija/PVDC.
English: No specific information is available on the treatment of overdose with Sabervel.
Slovenian: Specifični podatki o zdravljenju prevelikega odmerjanja z zdravilom Sabervel niso na voljo.
English: This medicinal product does not require any special storage conditions.
Slovenian: Za shranjevanje zdravila niso potrebna posebna navodila
English: You can take Sabervel with or without food.
Slovenian: Zdravilo Sabervel lahko jemljete s hrano ali brez nje.
English: Results showed that Cmax, AUC and clearance rates were comparable to those observed in adult patients receiving 150 mg irbesartan daily.
Slovenian: Cmax, AUC in očistek primerljivi tistim pri odraslih, ki so dobivali 150 mg irbesartana na dan.
English: Hypersensitivity to the active substance, or to any of the excipients (see section 6.1).
Slovenian: Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov (glejte poglavje 6.1).
English: • potassium supplements
Slovenian: • dodatke kalija
English: Renal impairment and kidney transplantation: when Sabervel is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Slovenian: Ledvična okvara in presaditev ledvic: pri dajanju zdravila Sabervel bolnikom s prizadeto ledvično funkcijo se priporoča redno nadzorovanje ravni kalija in kreatinina v serumu.
English: Irbesartan is excreted in the milk of lactating rats.
Slovenian: Irbesartan se izloča z mlekom doječih podgan.
English: Therefore, the use of Sabervel is not recommended.
Slovenian: Zato uporaba zdravila Sabervel ni priporočljiva.
English: 28 film-coated tablets 56 film-coated tablets 90 film-coated tablets 98 film-coated tablets
Slovenian: 28 filmsko obloženih tablet 56 filmsko obloženih tablet 90 filmsko obloženih tablet 98 filmsko obloženih tablet
English: Children should not take Sabervel
Slovenian: Otroci ne smejo jemati zdravila Sabervel
English: (It is also better to avoid Sabervel in early pregnancy
Slovenian: (Jemanju zdravila Sabervel se je bolje izogniti tudi med zgodnjo nosečnostjo - glejte poglavje o nosečnosti)
English: The study examined the long-term effects (2 years) of irbesartan on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/day, and an increase in UAER of at least 30% from baseline).
Slovenian: V raziskavi so proučevali dolgotrajne učinke (2 leti) zdravila irbesartana na napredovanje v klinično proteinurijo (hitrost izločanja albuminov z urinom -“urinary albumin excretion rate”-UAER >300 mg/dan in povečanje UAER-a najmanj za 30% začetne vrednosti).
English: Your doctor will normally advise you to stop taking Sabervel before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Sabervel.
Slovenian: Zdravnik vam bo praviloma svetoval, da zdravljenje z zdravilom Sabervel prekinete še preden zanosite ali takoj, ko se izkaže, da ste zanosili in vam predpisal zdravljenje z drugim zdravilom.
English: Lactose: this medicinal product contains lactose.
Slovenian: Laktoza: to zdravilo vsebuje laktozo.
English: Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Sabervel (see section 4.4).
Slovenian: Predhodno zdravljenje z visokimi odmerki diuretikov lahko povzroči zmanjšanje volumna in tveganje za hipotenzijo ob uvedbi zdravljenja z zdravilom Sabervel (glejte poglavje 4.4).