FrancophonIA/ELRC3.0 huggingface dataset:
English: • Regarding its efficacy, four studies showed no difference between tetrazepam and other active medicines when used for spasticity.
Slovenian: • Glede učinkovitosti štiri študije niso pokazale nikakršne razlike med tetrazepamom in drugimi aktivnimi zdravili, ki so jih uporabljali proti spastičnosti.
English: • In the pharmacovigilance database of the originator product, Myolastan, a total of 513 cutaneous (or allergic) reactions were identified.
Slovenian: • V zbirki podatkov o farmakovigilanci originatorskega zdravila Myolastan so odkrili skupno 513 kožnih (ali alergijskih) reakcij.
English: You should make an appointment with your treating doctor to discuss your treatment.
Slovenian: Dogovorite se za obisk pri svojem lečečem zdravniku, da se boste dogovorili o zdravljenju.
English: Because the CMDh took this position by majority it was sent to the European Commission, which endorsed it and adopted a legally binding decision on 29 May 2013.
Slovenian: Ker je CMDh to stališče sprejela z večino, je bilo poslano Evropski Komisiji, ki ga je potrdila in dne 29. maja 2013 sprejela pravno zavezujočo odločbo.
English: The full list is available in Annex I on the EMA website, under the ‘All documents' tab.
Slovenian: Celoten seznam je na voljo v Prilogi I na spletni strani Evropske agencije za zdravila, v zavihku ‘All documents'.
English: The review was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Slovenian: Pregled je najprej opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC), torej odbor, ki je odgovoren za presojo varnostnih vprašanj o zdravilih za humano uporabo, in sestavil niz predlogov.
English: Tetrazepam belongs to a group of medicines called benzodiazepines.
Slovenian: Tetrazepam spada v skupino zdravil, imenovanih benzodiazepini.
English: • As a result of the risk of unpredictable, serious skin reactions identified, tetrazepam-containing medicines will no longer be available in the EU.
Slovenian: • Zaradi tveganja za ugotovljene nepredvidljive, resne kožne reakcije, zdravila, ki vsebujejo tetrazepam, v EU ne bodo več na voljo.
English: The suspension of the marketing authorisations can be lifted if the companies that market these medicines provide data identifying a specific group of patients for whom the benefits of tetrazepamcontaining medicines outweigh the risks.
Slovenian: Začasen umik dovoljenj za promet z zdravili je mogoče razveljaviti, če podjetja, ki tržijo ta zdravila, predložijo podatke, ki določajo specifično skupino bolnikov, pri katerih koristi zdravil, ki vsebujejo tetrazepam, odtehtajo z njimi povezana tveganja.
English: Although the majority of cases occurred in patients taking concomitant medications, the causal link with tetrazepam was strong in a high number of cases.
Slovenian: Čeprav je do večine teh primerov prišlo pri bolnikih, ki so sočasno jemali druga zdravila, je bila vzročna povezava s tetrazepamom v velikem številu primerov močna.
English: The review of tetrazepam was triggered by the French National Agency for the Safety of Medicine and Health Products (ANSM), following reports of serious skin reactions with this medicine in France.
Slovenian: Pregled tetrazepama je sprožila francoska nacionalna agencija za varnost zdravil in medicinskih pripomočkov (ANSM) zaradi poročil o resnih kožnih reakcijah ob uporabi tega zdravila v Franciji.
English: • The risk of skin reaction is higher with tetrazepam than with other benzodiazepines.
Slovenian: • Tveganje za kožne reakcije je pri tetrazepamu večje kot pri drugih benzodiazepinih.
English: • The review found that half of the reported reactions with tetrazepam are skin disorders, which are sometimes serious, life-threatening or fatal.
Slovenian: • Pri pregledu so ugotovili, da je polovica reakcij, o katerih so poročali pri uporabi tetrazepama, kožnih bolezni, ki so včasih resne, življenjsko nevarne ali smrtne.
English: This is possibly explained by a structural difference between tetrazepam and other benzodiazepines (i.e. the substituted cyclohexenyl ring of tetrazepam).
Slovenian: To je mogoče razložiti s strukturno razliko med tetrazepamom in drugimi benzodiazepini (torej s substituiranim cikloheksenilovim obročem tetrazepama).
English: The efficacy of tetrazepam for painful contractures is supported mainly by two small double-blind placebo-controlled clinical trials showing limited efficacy.
Slovenian: Učinkovitost tetrazepama za zdravljenje bolečih mišičnih krčev podpirata predvsem dve manjši dvojno slepi klinični preskušanji, nadzorovani s placebom, ki sta pokazali omejeno učinkovitost.
English: The CMDh agreed with the PRAC conclusion that the benefits of these medicines do not outweigh their risks, and adopted a final position that the marketing authorisations should be suspended throughout the EU.
Slovenian: CMDh se je strinjala s sklepom odbora PRAC, da koristi teh zdravil ne odtehtajo z njimi povezanih tveganj, ter sprejela dokončno stališče, da je treba dovoljenja za promet z zdravili po vsej Evropski uniji začasno umakniti.
English: Tetrazepam-containing medicines suspended across the EU
Slovenian: Zdravila, ki vsebujejo tetrazepam, začasno umaknjena v vsej EU
English: • Pharmacists should refer patients on a new or repeat prescription for tetrazepam to their treating physician.
Slovenian: • Farmacevti morajo bolnike, ki imajo nov ali obnovljiv recept za tetrazepam, napotiti k njihovim lečečim zdravnikom.
English: The Committee also noted that, in the light of the risks identified, the available data on the effectiveness of tetrazepam were not sufficiently robust to support its use in the authorised indications.
Slovenian: Odbor je opozoril tudi na to, da glede na ugotovljena tveganja razpoložljivi podatki o učinkovitosti tetrazepama niso dovolj zanesljivi, da bi lahko podprli uporabo zdravila za odobrene indikacije.
English: In particular, tetrazepam is used for its muscle relaxant effects.
Slovenian: Tetrazepam se zlasti uporablja zaradi svojih učinkov sproščanja mišic.
English: As tetrazepam-containing medicines are all authorised nationally, the PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Slovenian: Ker so vsa zdravil, ki vsebujejo tetrazepam, odobrena na nacionalni ravni, so bila priporočila odbora PRAC posredovana skupini za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila za uporabo v humani medicini (CMDh), ki je sprejela dokončno stališče.
English: • If you are taking a tetrazepam-containing medicine, you should not suddenly stop taking tetrazepam without your doctor's advice.
Slovenian: • Če jemljete zdravila, ki vsebujejo tetrazepam, ne smete takoj prenehati z jemanjem tetrazepama, ne da bi se pred tem posvetovali z zdravnikom.
English: Having assessed all available data on the risk of skin reactions, including post-marketing data in the EU and the published literature, the PRAC concluded that tetrazepam is associated with a low but increased risk of serious skin reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis and DRESS syndrome) compared with other benzodiazepines.
Slovenian: PRAC je po preučitvi vseh razpoložljivih podatkov o tveganju kožnih reakcij, vključno s podatki iz obdobja trženja v EU in iz objavljene literature, zaključil, da je tetrazepam povezan z nizkim, a povečanim tveganjem za resne kožne reakcije (vključno s Stevens-Johnsonovim sindromom, toksično epidermalno nekrolizo in sindromom DRESS) v primerjavi z drugimi benzodiazepini.
English: Serious skin reactions include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), erythema multiforme and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome.
Slovenian: Resne kožne reakcije vključujejo Stevens-Johnsonov sindrom (SJS), toksično epidermalno nekrolizo (TEN), multiformni eritem in kožni izpuščaj z eozinifilijo in sistematskimi simptomi (sindrom DRESS).
English: The CMDh position is based on the PRAC review of all available data on the risk of skin reactions with tetrazepam, including post-marketing data in the EU and the published literature, and the available information on efficacy in licensed indications:
Slovenian: Stališče CMDh temelji na pregledu vseh razpoložljivih podatkov o tveganju za kožne reakcije ob uporabi tetrazepama, ki ga je opravil odbor PRAC, vključno s podatki iz obdobja trženja v EU in iz objavljene literature, ter z razpoložljivimi informacijami o učinkovitosti pri indikacijah, za katere je zdravilo odobreno:
English: Benzodiazepines work by attaching to certain receptors in the brain, thereby increasing the activity of a substance called gamma-amino butyric acid (GABA).
Slovenian: Benzodiazepini delujejo tako, da se pritrdijo na določene receptorje v možganih in tako spodbujajo delovanje snovi, imenovane gama-aminomaslena kislina (GABA).
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Slovenian: CMDh, organ, ki zastopa države članice EU, je odgovoren za zagotavljanje usklajenih varnostnih standardov za zdravila, ki so bila odobrena prek nacionalnih postopkov v vsej Evropski uniji.
English: As the CMDh position was adopted by majority vote, the CMDh position was sent to the European Commission, which endorsed it and adopted an EU-wide legally binding decision.
Slovenian: Ker je bilo stališče CMDh sprejeto z večino glasov, je bilo poslano Evropski Komisiji, ki ga je potrdila in sprejela pravno zavezujočo odločbo, ki velja za celotno EU.
English: On 24 April 2013, following the recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC), the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh) endorsed by majority the PRAC recommendation to suspend the marketing authorisations of tetrazepam-containing medicines across the European Union (EU).
Slovenian: Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila za uporabo v humani medicini (CMDh) je po priporočilu Odbora za oceno tveganja na področju farmakovigilance (PRAC) dne 24. aprila 2013 z večino sprejela priporočilo PRAC, naj začasno umakne dovoljenja za promet z zdravili, ki vsebujejo tetrazepam, v vsej Evropski uniji (EU).
English: In view of the serious, potentially fatal, skin reactions and the limited efficacy of tetrazepam, the benefit-risk balance of tetrazepam-containing medicines is considered no longer favourable.
Slovenian: Zaradi resnih in potencialno smrtnih kožnih reakcij ter omejene učinkovitosti tetrazepama razmerja med tveganji in koristmi zdravil, ki vsebujejo tetrazepam, ni mogoče oceniti kot ugodnega.
English: Tetrazepam, a medicine of the benzodiazepine class, is used in several EU Member States to treat painful contractures (such as in low back pain and neck pain) and spasticity (excessive stiffness of muscles).
Slovenian: Tetrazepam, zdravilo iz razreda benzodiazepinov, se uporablja v več državah članicah EU za zdravljenje bolečih mišičnih krčev (npr. bolečin v križu in bolečin v vratu) in spastičnosti (pretirane otrdelosti mišic).
English: By increasing GABA activity, benzodiazepines have a calming effect on various functions of the brain.
Slovenian: S spodbujanjem delovanja gama-aminomaslene kisline benzodiazepini delujejo pomirjevalno na različne možganske funkcije.
English: It is taken by mouth to treat painful contractures (sustained shortening of muscle tissue), and spasticity (excessive stiffness of muscles).
Slovenian: Jemlje se peroralno za zdravljenje bolečih mišičnih krčev (vztrajno krčenje mišičnega tkiva) in spastičnosti (pretirana otrdelost mišic).
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national marketing authorisation procedures across the EU.
Slovenian: CMDh, organ, ki zastopa države članice EU, je odgovoren za zagotavljanje usklajenih varnostnih standardov za zdravila, ki so bila odobrena prek nacionalnih postopkov za pridobitev dovoljenja za promet v vsej Evropski uniji.
English: • Tetrazepam is a muscle relaxant used in painful conditions such as low back pain and neck pain as well as spasticity (excessive stiffness of muscles).
Slovenian: • Tetrazepam je mišični relaksant, ki se uporablja ob bolečinah, npr. bolečinah v križu in vratu, ter pri spastičnosti (pretirana otrdelost mišic).
English: Date of first authorisation: 21 September 2009 Date of latest renewal: 19 June 2014
Slovenian: Datum prve odobritve: 21. september 2009 Datum zadnjega podaljšanja: 19. junij 2014
English: Vial before opening 30 months.
Slovenian: Viala pred odprtjem 30 mesecev
English: In some cases you may need a blood transfusion.
Slovenian: V nekaterih primerih je potrebna transfuzija krvi.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Zdravila ne smemo mešati z drugimi zdravili, razen tistimi, ki so omenjena v poglavju 6.6.
English: Response rate (%)
Slovenian: Delež odziva (%)
English: Severe infection (sepsis).
Slovenian: - Huda okužba (sepsa).
English: 3 Reactions have been mild and have not generally required specific therapy.
Slovenian: 3 Reakcije so bile blage, specifično zdravljenje pa običajno ni bilo potrebno.
English: Liquid waste may be flushed with large amounts of water.
Slovenian: Odpadno tekočino lahko sperete z veliko količino vode.
English: This treatment cycle will normally be repeated every three weeks.
Slovenian: Tak cikel zdravljenja boste praviloma prejemali vsake tri tedne.
English: If you are or think you might be pregnant, tell your doctor immediately.
Slovenian: Če ste noseči ali menite, da bi lahko bili noseči, morate to nemudoma sporočiti zdravniku.
English: Volume of distribution was slightly decreased and thus half-life only increased by 14 %.
Slovenian: Volumen porazdelitve je bil malo manjši, zato se je razpolovna doba podaljšala le za 14 %.
English: They may require hospitalisation and could even be life threatening.
Slovenian: Morda boste sprejeti v bolnišnico, lahko pa je celo ogroženo vaše življenje.
English: Male patients who may wish to father a child should ask their doctor for family planning advice or treatment.
Slovenian: Bolniki, ki bi želeli zaploditi otroka, se morajo z zdravnikom posvetovati glede načrtovanja družine oziroma zdravljenja.
English: Currently available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made.
Slovenian: Pediatrična populacija Trenutno razpoložljivi podatki so opisani v poglavjih 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
English: This leaflet was last revised in MM/YYYY.
Slovenian: Navodilo je bilo nazadnje revidirano dne MM/YYYY.
English: In these studies, there were no apparent differences in the pharmacokinetics of topotecan among children, adolescents, and young adult patients with solid tumours or leukaemia, but data are too limited to draw definite conclusions.
Slovenian: V teh študijah ni bilo zaznati očitnih razlik v farmakokinetiki topotekana pri otrocih, mladostnikih in mlajših odraslih s solidnim tumorjem ali levkemijo, vendar pa je podatkov premalo, da bi lahko podali definitivne zaključke.
English: Of the patients who received more than 6 cycles of therapy, 91 % completed the study as planned or were treated until disease progression with only 3 % withdrawn for adverse events.
Slovenian: Od bolnic, ki so prejele več kot 6 ciklusov zdravljenja, jih je 91 % dokončalo študijo, kot je bilo predvideno, ali pa so jih zdravili, dokler bolezen ni napredovala.
English: Itching (pruritus).
Slovenian: - Srbenje (pruritus).
English: Median survival (weeks)
Slovenian: Mediano preživetje (tedni)
English: Topotecan Teva should not be used in pregnant women, unless clearly necessary.
Slovenian: Zdravilo Topotekan Teva se ne sme uporabljati pri nosečnicah, razen če je nujno potrebno.
English: Store in a refrigerator (2°C - 8°C).
Slovenian: Shranjujte v hladilniku (2°C -8°C).
English: Hair loss.
Slovenian: - Izpadanje las.
English: Discharge of blood into tissues (extravasation).
Slovenian: - Izliv krvi v tkiva (ekstravazacija)
English: Topotecan also had a high volume of distribution, about 132 1 (SD 57), and a relatively short half-life of 2-3 hours.
Slovenian: Topotekan ima tudi velik volumen porazdelitve, približno 132 l (s standardno deviacijo 57), in sorazmerno kratko razpolovno dobo, 2-3 ure.
English: For storage conditions of the diluted medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja pripravljenega zdravila glejte poglavje 6.3.
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodiumfree'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na vialo, kar v bistvu pomeni ‘brez natrija'.
English: Women of child-bearing potential should use effective contraception to avoid becoming pregnant while on treatment.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito metodo kontracepcije, da med zdravljenjem ne bi zanosile.
English: • Infections (very common (may affect more than 1 in 10 people)), with signs such as:
Slovenian: • Okužbe (zelo pogoste (pojavijo se lahko pri več kot 1 od 10 bolnikov)) z znaki, kot so:
English: As would be expected, patients with poor performance status (PS>1) have a lower response rate and an increased incidence of complications such as fever, infection and sepsis (see section 4.8).
Slovenian: Kot je mogoče pričakovati, se bolniki s slabšo telesno zmogljivostjo (performance status, PS > 1) slabše odzivajo na zdravilo, večja pa je tudi pogostnost zapletov, kot so zvišana telesna temperatura, okužbe in sepsa (glejte poglavje 4.8).
English: The following information is intended for healthcare professionals only: Instructions on how to dilute, store and dispose of Topotecan Teva Instructions for dilution
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: Navodila za redčenje, shranjevanje in odstranjevanje zdravila Topotekan Teva
English: The concentrate must be diluted before administration.
Slovenian: Koncentrat je potrebno pred dajanjem razredčiti.
English: Total or pronounced alopecia was observed in 30 % of patients and partial alopecia in 15 % of patients.
Slovenian: Popolna ali izrazita alopecija se je pojavila pri 30 % bolnikov, delna pa pri 15 % bolnikov.
English: In addition, 5 % of all patients treated (1 % of courses) developed sepsis (see section 4.4).
Slovenian: Poleg tega je pri 5 % vseh zdravljenih bolnikov (v 1 % ciklusov zdravljenja) prišlo do sepse (glejte poglavje 4.4).
English: In clinical studies, topotecan was discontinued if the dose had been reduced to 1.0 mg/m2/day and a further dose reduction was required to manage adverse effects.
Slovenian: V kliničnih študijah so topotekan prenehali uporabljati, če je bil odmerek že zmanjšan na 1,0 mg/m2/dan in bi ga bilo treba zaradi neželenih učinkov še dodatno zmanjšati.
English: However as with other cytotoxic medicinal products topotecan is genotoxic and effects on fertility, including male fertility, cannot be excluded.
Slovenian: Ker pa je topotekan - tako kot druga citotoksična zdravila - genotoksičen, ni mogoče izključiti učinkov na plodnost, vključno z učinki na plodnost samcev.
English: Topotecan Teva may reduce your ability to fight infections.
Slovenian: Zdravilo Topotekan Teva lahko zmanjša vašo odpornost proti okužbam.
English: Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Slovenian: Ob nehotenem stiku zdravila s kožo ali z očmi jih je treba takoj sprati z veliko količino vode.
English: Other severe events that were recorded as related or possibly related to topotecan treatment were anorexia (12 %), malaise (3 %) and hyperbilirubinaemia (1 %).
Slovenian: Drugi močno izraženi neželeni dogodki, ki so jih ocenili kot posledico ali možno posledico zdravljenja s topotekanom, so bili anoreksija (12 %), splošno slabo počutje (3 %) in hiperbilirubinemija (1 %).
English: Detailed information on this medicine is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu/.
English: Topotecan must be further diluted before use (see section 6.6).
Slovenian: Način uporabe Pred uporabo je treba topotekan še nadalje razredčiti (glejte poglavje 6.6).
English: Metabolism accounts for <10 % of the elimination of topotecan.
Slovenian: Presnova predstavlja < 10 % izločanja topotekana.
English: The risk of developing this severe condition (interstitial lung disease) is higher if you currently have lung problems, or if you have received previous radiation treatment or medicines that affected your lungs (also see section 2 ‘What you need to know before you use Topotecan Teva').
Slovenian: Tveganje za to resno stanje (intersticijska pljučna bolezen) je večje, če že imate težave s pljuči ali če ste se pred tem zdravili z obsevanjem ali pa ste prejemali zdravila, ki lahko vplivajo na pljuča (glejte poglavje 2 »Kaj morate vedeti, preden boste vzeli zdravilo Topotekan Teva«).
English: Yellow skin (jaundice) caused by abnormal liver function.
Slovenian: - Rumeno obarvanje kože (zlatenica), ki jo povzroči nenormalno delovanje jeter.
English: Underlying risk factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to radiation and use of pneumotoxic substances and/or colony stimulating factors.
Slovenian: Dejavniki tveganja vključujejo IBP v anamnezi, pljučno fibrozo, pljučnega raka, obsevanje prsnega koša in uporabo pnevmotoksičnih snovi in/ali kolonije stimulirajočih faktorjev.
English: Your dose of Topotecan Teva may need to be adjusted.
Slovenian: Odmerek zdravila Topotekan Teva bo morda treba prilagoditi.
English: Median survival was 30.3 weeks (95 % CI: 27.6, 33.4).
Slovenian: Mediana časa preživetja je bila 30,3 tedna (95-odstotni interval zaupanja: 27,6, 33,4).
English: An N-desmethyl metabolite, which was shown to have similar or less activity than the parent in a cell-based assay, was found in urine, plasma, and faeces.
Slovenian: Presnovek N-desmetil( za katerega so v celičnem testu dokazali, da ima podobno ali manjšo aktivnost kot matična učinkovina) so odkrili v urinu, plazmi in blatu.
English: This should be taken into account when prescribing Topotecan Teva, e.g. if patients at increased risk of tumour bleeds are considered for therapy.
Slovenian: To je treba upoštevati pri predpisovanju zdravila Topotekan Teva, npr. pri odločanju za zdravljenje bolnikov, pri katerih obstaja večje tveganje za krvavitve tumorja.
English: What Topotecan Teva is and what it is used for
Slovenian: Kaj je zdravilo Topotekan Teva in za kaj ga uporabljamo
English: Fever.
Slovenian: - Vročina.
English: In patients presenting with fever, neutropenia, and a compatible pattern of abdominal pain, the possibility of neutropenic colitis should be considered.
Slovenian: Pri bolnikih s povišano telesno temperaturo, nevtropenijo in odgovarjajočo obliko bolečine v trebuhu je treba pomisliti na možnost nevtropeničnega kolitisa.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10);
Slovenian: Pogostnosti so opredeljene takole: zelo pogosti (≥ 1/10), pogosti
English: Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents, ATC code: L01XX17.
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), druga zdravila z delovanjem na novotvorbe (citostatiki), oznaka ATC: L01XX17
English: Overall recovery of topotecan-related material following five daily doses of topotecan was 71 to 76 % of the administered IV dose.
Slovenian: Celokupno izločanje s topotekanom povezanih snovi po petih dnevnih odmerkih topotekana je bilo od 71 do 76 % intravensko prejetega odmerka.