natgillin/translations-raw huggingface dataset:
The most common side effects seen with Colobreathe in studies were: unpleasant taste, cough, throat irritation, difficulty breathing and dysphonia (difficulty speaking).
Najpogostejši neželeni učinki, ki so jih v študijah opazili pri zdravilu Colobreathe, so bili neprijeten okus, kašelj, draženje grla, težave z dihanjem in disfonija (težave z govorom).
Colobreathe must not be used in people who are hypersensitive (allergic) to colistimethate sodium or to colistin sulphate or polymyxin B.
Zdravila Colobreathe ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) natrijev kolistimetat, kolistinijev sulfat ali polimiksin B.
What benefit has Colobreathe shown during the studies?
Kakšne koristi je zdravilo Colobreathe izkazalo med študijami?
Colistimethate sodium is a well-known antibiotic that has been used for several years to treat lung infection in cystic fibrosis patients and is available in the form of a solution used with a nebuliser (a machine that changes a solution into an aerosol that the patient can breathe in).
Natrijev kolistimetat je dobro znan antibiotik, ki se že mnoga leta uporablja za zdravljenje pljučne okužbe pri bolnikih s cistično fibrozo, in je na razpolago v obliki raztopine, ki se uporablja z nebulatorjem (pripomočkom, ki raztopino spremeni v aerosol, kar bolniku omogoči inhalacijo).
The contents of Colobreathe capsules are inhaled using a powder inhaler called Turbospin.
Vsebina kapsul Colobreathe se vdihne z inhalatorjem, imenovanim Turbospin.
The side effects seen with Colobreathe were considered acceptable.
Neželeni učinki, opaženi pri zdravilu Colobreathe, so bili ocenjeni kot sprejemljivi.
Polymyxins target a group of bacteria called Gram-negative bacteria, which includes P. aeruginosa, because their cell membranes contain a high level of phospholipids.
Polimiksini napadejo skupino bakterij, imenovanih gramnegativne bakterije, ki vključujejo P. aeruginosa, saj njihove celične membrane vsebujejo visoko raven fosfolipidov.
Cystic fibrosis is an inherited disease that affects the cells in the lungs and the glands in the gut and pancreas which secrete fluids such as mucus and digestive juices.
Cistična fibroza je dedna bolezen, ki prizadene celice v pljučih ter žlezah v črevesu in trebušni slinavki, ki izločajo tekočine, kot so sluz in prebavni sokovi.
The accumulation of mucus in the lungs allows bacteria to grow more easily causing infections, lung damage and breathing problems.
Kopičenje sluzi v pljučih bakterijam olajša rast, kar povzroča okužbe, poškodbo pljuč in težave z dihanjem.
The patients' condition had been stabilised by treatment with tobramycin before the study.
Pred študijo se je stanje bolnikov stabiliziralo z zdravljenjem s tobramicinom.
In cystic fibrosis these fluids become thick and viscous, blocking the airways and the flow of digestive juices.
Pri cistični fibrozi te tekočine postanejo goste in viskozne, kar ovira dihalne poti in pretok prebavnih sokov.
Colobreathe is a medicine that contains the active substance colistimethate sodium.
Colobreathe je zdravilo, ki vsebuje zdravilno učinkovino natrijev kolistimetat.
For the full list of all side effects reported with Colobreathe, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Colobreathe, glejte navodilo za uporabo.
The active substance in Colobreathe, colistimethate sodium, is an antibiotic from the polymyxin group.
Zdravilna učinkovina v zdravilu Colobreathe, natrijev kolistimetat, je antibiotik iz skupine polimiksinov.
No more serious side effects were seen with Colobreathe than with tobramycin.
Pri zdravilu Colobreathe niso opazili več resnih neželenih učinkov kot pri tobramicinu.
Colobreathe compared well with the tobramycin treatment, considering the fact that the patients were already stabilised on tobramycin nebuliser.
Zdravilo Colobreathe je bilo dobro v primerjavi z zdravljenjem s tobramicinom ob upoštevanju, da so bili bolniki že stabilizirani z nebulatorjem s tobramicinom.
The CHMP concluded that the modest improvement in FEV1 seen with Colobreathe was sufficient evidence of the medicine's effectiveness, given that larger improvements would not be expected in patients whose condition was already stabilised on tobramycin nebuliser.
Odbor CHMP je zaključil, da je bilo zmerno izboljšanje FEV1, ki so ga opazili pri zdravilu Colobreathe, zadosten dokaz učinkovitosti zdravila, pri čemer je treba upoštevati, da večjih izboljšanj pri bolnikih, pri katerih je bilo stanje že stabilizirano z nebulatorjem s tobramicinom, ni pričakovati.
What is the risk associated with Colobreathe?
Kakšna tveganja so povezana z zdravilom Colobreathe?
Colobreathe is used to manage long-term lung infection caused by the bacteria Pseudomonas aeruginosa in patients aged six years and over who have cystic fibrosis.
Zdravilo Colobreathe se uporablja za obravnavo dolgotrajne pljučne okužbe, ki jo povzroča bakterija Pseudomonas aeruginosa pri bolnikih s cistično fibrozo, starih šest let in več.
Colobreathe was compared with another medicine, tobramycin nebuliser solution, in 380 cystic fibrosis patients aged six years and above with P. aeruginosa lung infection.
Zdravilo Colobreathe so primerjali z drugim zdravilom, inhalacijsko raztopino tobramicina za nebulator, pri 380 bolnikih s cistično fibrozo, starih šest let ali več, ki so imeli okužbo s P. aeruginosa.
The improvements in FEV1 seen with Colobreathe were considered sufficient proof of effectiveness, considering the fact that the patients in the study were already stabilised on tobramycin nebuliser.
Menili so, da je bilo izboljšanje vrednosti FEV1 pri zdravilu Colobreathe zadosten dokaz za učinkovitost glede na to, da so bili bolniki v študiji že stabilizirani z nebulatorjem s tobramicinom.
Colobreathe, as a powder for inhalation, is expected to be more convenient for patients than nebulisers.
Po pričakovanjih bo zdravilo Colobreathe v obliki praška za inhalacijo priročnejše kot nebulatorji.
Bacterial lung infection with P. aeruginosa is frequent in cystic fibrosis patients.
Pri bolnikih s cistično fibrozo je bakterijska pljučna okužba s P. aeruginosa pogosta.
Polymyxins work by disrupting the cell membrane of bacteria by interacting with certain components of the membrane called phospholipids.
Polimiksini skupaj z nekaterimi sestavinami membrane, imenovanimi fosfolipidi, delujejo tako, da motijo delovanje celične membrane bakterij.
How has Colobreathe been studied?
Kako je bilo zdravilo Colobreathe raziskano?
Why has Colobreathe been approved?
Za kaj je bilo zdravilo Colobreathe odobreno?
What is Colobreathe?
Kaj je zdravilo Colobreathe?
What is Colobreathe used for?
Za kaj se zdravilo Colobreathe uporablja?
How does Colobreathe work?
Kako zdravilo Colobreathe deluje?
How is Colobreathe used?
Kako se zdravilo Colobreathe uporablja?
In these studies only limited efficacy was shown.
Študiji sta pokazali zgolj omejeno učinkovitost.
After excluding one double entry, 1616 cases were considered for the analysis.
Po izključitvi enega dvojnega vnosa so za analizo uporabili 1616 primerov.
Some Members States have both indications.
V nekaterih državah članicah sta odobreni obe indikaciji.
Overall, an estimated 70%-80% of the allergy tests performed were positive.
Skupno je bilo pozitivnih približno 70-80 % alergijskih testov.
Tetrazepam containing medicinal products are authorised in Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Latvia, Lithuania, Luxembourg, Poland, Romania, Slovakia and Spain (see Annex I for the list of tetrazepam containing medicinal products authorised in the EU).
Zdravila, ki vsebujejo tetrazepam, so odobrena v Avstriji, Belgiji, Bolgariji, Češki republiki, Franciji, Nemčiji, Latviji, Litvi, Luksemburgu, na Poljskem, v Romuniji, na Slovaškem in v Španiji (za seznam zdravil, ki vsebujejo tetrazepam in so bila odobrena za uporabo v EU, glejte Prilogo I).
Allergic tests were performed in several cases.
V številnih primerih so opravili alergijske teste.
In 10 cases, the diagnosis was confirmed by skin biopsy.
V 10 primerih so diagnozo potrdili z biopsijo kože.
Severe cutaneous adverse reactions with tetrazepam are also described in published literature1,2,3,4,5,6,7,8,9,10,11.
Resne neželene kožne reakcije na tetrazepam so opisane tudi v objavljeni literaturi 1,2,3,4,5,6,7,8,9,10,11.
The PRAC also noted that current guidelines do not refer to the use of tetrazepam in the spasticity indication.
PRAC je upošteval tudi, da trenutne smernice ne obravnavajo uporabe tetrazepama pri indikaciji spastičnosti.
The efficacy of tetrazepam was also compared to other active drugs in controlled double blind studies: these studies did not show statistically significant difference between the groups in both indications.
Učinkovitost tetrazepama so v nadzorovanih dvojno slepih študijah primerjali tudi z učinkovitostjo drugih aktivnih zdravil: v študijah niso opazili statistično pomembnih razlik med skupinama pri obeh indikacijah.
These cases concerned 31 cases of SJS and 35 cases of TEN, including one case with both reactions.
Med njimi je bilo 31 primerov SJS in 35 primerov TEN, pri čemer sta se v enem primeru pojavili obe reakciji.
Thirty-eight (38) cases were non medically-confirmed cases and 475 cases were medically-confirmed; among them, 180 cases were directly reported to the Company, 245 cases were reported by Health Authorities, and 50 cases were identified in the scientific worldwide literature.
Osemintrideset (38) primerov ni bilo zdravniško potrjenih, medtem ko jih je 475 bilo; od tega so o 180 primerih poročali neposredno družbi, o 245 primerih so poročali pristojni zdravstveni organi, 50 primerov pa so odkrili v mednarodni znanstveni literaturi.
This is confirmed by the results of the allergic tests for which in a number of cases only tetrazepam had positive results.
To so potrdili rezultati alergijskih testov, ki so bili v številnih primerih pozitivni samo za tetrazepam.
In addition the PRAC considered that the clinical data supporting the 6-day duration treatment benefit were insufficiently robust.
Poleg tega je PRAC menil, da klinični podatki, s katerimi naj bi utemeljili koristnost 6-dnevnega zdravljenja, niso bili dovolj robustni.
At the date of 30 June 2012, 2382 cases with tetrazepam were registered in the French national database.
Dne 30. junija 2012 je bilo v francoski nacionalni zbirki podatkov 2382 primerov, povezanih s tetrazepamom.
PRAC acknowledged that majority of cases reported involved the use of multiple medicinal products.
PRAC je upošteval, da je večina primerov, o katerih so poročali, vključevala sočasno uporabo več zdravil.
In most of the cases, the causal relationship of tetrazepam was reported as possible (86% of the cases) and in some cases as probable (11% of the cases).
V večini primerov je bil tetrazepam opredeljen kot možen vzrok (v 86 % primerih), v nekaterih primerih pa kot verjeten vzrok (v 11 % primerov).
Almost all cases with information about duration of treatment with tetrazepam, a duration of up to one month treatment was observed in most cases; in 9 cases, the duration was very short (less than 4 days).
V skoraj vseh primerih, za katere so na voljo podatki o trajanju zdravljenja s tetrazepamom, je zdravljenje trajalo do enega meseca; v 9 primerih je bil čas zdravljenja zelo kratek (manj kot 4 dni).
The conditions for lifting the suspension of the marketing authorisations are set out in Annex III.
Pogoji za preklic začasnega umika dovoljenj za promet so opredeljeni v Prilogi III.
Scientific conclusions and grounds for suspension of the marketing authorisations (see Annex I)
Znanstveni zaključki in podlaga za začasen umik dovoljenj za promet z zdravili (glejte Prilogo I)
Taking into account the indications of tetrazepam, the effectiveness of a reduction of duration of treatment was questioned by the PRAC in view of the potential for repeated use.
Glede na indikacije tetrazepama je PRAC podvomil o učinkovitosti skrajšanja trajanja zdravljenja zaradi verjetnosti večkratne uporabe.
In view of the safety concerns in relation to serious, potentially fatal, skin reactions and the limited efficacy of tetrazepam, the PRAC concluded that pursuant to Article 116 of Directive 2001/83/EC the benefit-risk balance of tetrazepam containing medicines is considered no longer favourable.
V zvezi z varnostnimi zadržki, povezanimi z resnimi in potencialno smrtnimi kožnimi reakcijami ter majhno učinkovitostjo tetrazepama, je PRAC zaključil, da v skladu s členom 116 Direktive 2001/83/ES razmerje med tveganji in koristmi za zdravila, ki vsebujejo tetrazepam, ni več pozitivno.
Further risk minimisation measures such as additional amendments to the product information (contraindications, warnings), communication material (patient alert card, dear Health Care Professional Letter) and reduction of pack size were also considered during the discussions.
Prav tako so med razpravo preučili dodatne ukrepe za zmanjšanje tveganja, kot so dodatne spremembe informacij o zdravilu (kontraindikacije, opozorila), gradivo za obveščanje (opozorilna kartica za bolnika, dopis za zdravstvene delavce) in zmanjšanje velikosti pakiranja.
Time to onset ranged from 1 to 3 weeks in 14 patients, while 9 cases were reported with a shorter time to onset (< 7 days) including 6 cases with a very short time to onset between 1- 3 days.
Čas do pojava reakcij je bil pri 14 bolnikih od 1 do 3 tedne, medtem ko so v 9 primerih poročali o krajšem času (< 7 dni), pri čemer so se v 6 primerih reakcije pojavile že po 1-3 dneh.
• The PRAC considered the procedure under Article 107i of Directive 2001/83/EC, for tetrazepam containing products.
• PRAC je obravnaval postopek v skladu s členom 107i Direktive 2001/83/ES za zdravila, ki vsebujejo tetrazepam;
Tetrazepam was the only suspected drug or had a causality score higher than the concomitant treatments in 18 out 81 cases of SJS, TEN or DRESS.
Tetrazepam je bil edini domnevni vzrok ali pa je imel višjo oceno vzročnosti kot sočasno uporabljana zdravila v 18 od 81 primerov SJS, TEN ali DRESS.
Overall summary of the scientific evaluation of Tetrazepam containing medicinal products by PRAC
Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo tetrazepam
The potential for nucleophilic attack proposed in the literature (by Barbaud et al, 2009) is consistent with the mechanism proposed by in silico analysis, and may explain the reported lack of cross-reactivity between tetrazepam and other benzodiazepines in patients with cutaneous hypersensitivity reactions.
Potencial za nukleofilni napad, ki je obravnavan v literaturi (Barbaud et al, 2009), je skladen z mehanizmom, opaženim v analizi in silico, in bi lahko pojasnil opaženo odsotnost navzkrižne reaktivnosti med tetrazepamom in drugimi benzodiazepini pri bolnikih s preobčutljivostnimi kožnimi reakcijami.
Many of the skin adverse events were maculopapular, but they were also vesicular, pustular, purpuric or bullous at times.
Mnogi neželeni učinki na kožo so bili makulopapularni, nekateri pa so bili tudi vezikularni, pustularni, purpurni ali bulozni.
The PRAC considered available data including data from the French pharmacovigilance survey, data provided by other Member States, stakeholder's submissions and data submitted by MAHs, as well as published data.
PRAC je proučil razpoložljive podatke, vključno s podatki iz francoske raziskave farmakovigilance, podatke, ki so jih predložile druge države članice, vloge zainteresiranih strani in podatke, ki so jih predložili imetniki dovoljenj za promet s tetrazepamom, ter tudi objavljene podatke.
Of these, 1617 had a "suspected” or “interaction” WHO code.
Med njimi je bilo 1617 primerov označenih s kodo SZO „domnevno‟ ali „medsebojno delovanje‟.
This is indicative that serious cutaneous reactions with tetrazepam are probably linked to a type IV delayed hypersensitivity mechanism, as supported by positive patch tests in 79 out of 115 cases having had an allergy test.
To kaže na to, da so resni neželeni učinki na kožo pri uporabi tetrazepama verjetno povezani z mehanizmom pozne preobčutljivosti tipa IV, kar so potrdili tudi pozitivni testi z obliži pri 79 od 115 primerov z opravljenim alergijskim testom.
Concerning the SJS/TEN cases described by the MAH 65 medically-confirmed serious cases of SJS/TEN were reported.
V zvezi s primeri SJS/TEN, ki jih je opisal imetnik dovoljenja za promet s tetrazepamom, je bilo ugotovljeno, da so zabeležili 65 zdravniško potrjenih resnih primerov SJS/TEN.
The CMDh, having considered the PRAC recommendation dated 11 April 2013 with regards to the tetrazepam containing medicinal products, agrees with the recommendation therein as stated below:
CMDh se je po preučitvi priporočila, ki ga je za zdravila, ki vsebujejo tetrazepam, dne 11. aprila 2013 izdal PRAC, strinjal s priporočilom, ki je navedeno v nadaljevanju:
The option of a patient alert card was also discussed but this was not considered effective in preventing these types of SCARs.
Odbor je preučil tudi možnost uvedbe opozorilne kartice za bolnika, vendar je menil, da z njo ne bi bilo mogoče učinkovito preprečiti omenjenih vrst resnih neželenih učinkov na kožo.
The PRAC therefore concluded that the benefit-risk balance of tetrazepam containing medicinal products is not favourable.
Zato je PRAC zaključil, da razmerje med tveganji in koristmi za zdravila, ki vsebujejo tetrazepam, ni pozitivno.
During the French national pharmacovigilance survey an analysis of cutaneous cases reported in the national pharmacovigilance database since the initial Marketing Authorisation up to 30 June 2012 was performed.
Francija je med nacionalno raziskavo farmakovigilance izvedla analizo primerov kožnih reakcij, zabeleženih v nacionalni zbirki podatkov farmakovigilance od odobritve prvega dovoljenja za promet do 30. junija 2012.
Having assessed the totality of the risk minimisation measures proposed, the PRAC concluded that given the risk and the unpredictability of serious cutaneous adverse reactions with tetrazepam the proposed measures were not sufficient to reduce the risk to a clinically acceptable level.
Po preučitvi vseh predlaganih ukrepov za zmanjšanje tveganja je PRAC zaključil, da glede na tveganje in nepredvidljivost resnih neželenih učinkov na kožo, povezanih z uporabo tetrazepama, predlagani ukrepi ne bi zadostovali za zmanjšanje tveganja na klinično sprejemljivo raven.
In addition, cases of rechallenge with new skin disorders episodes were reported.
Poleg tega so poročali o primerih ponovne uporabe tetrazepama z novimi epizodami bolezni kože.
Following reporting of new serious cutaneous reactions with the use of tetrazepam, the French National Competent Authority reviewed in November 2012 the cutaneous risk associated with tetrazepam based on results of a national pharmacovigilance survey.
Zaradi poročil o novih resnih neželenih učinkih na kožo, povezanih z uporabo tetrazepama, je francoski nacionalni pristojni organ novembra 2012 na podlagi rezultatov nacionalne raziskave farmakovigilance ponovno pregledal tveganje za kožne reakcije, povezano z uporabo tetrazepama.
The CMDh, having considered the PRAC recommendation dated 11 April 2013 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC and the oral explanation attended by a Marketing Authorisation Holder on 22 April 2013, reached a position on the suspension of the marketing authorisations of tetrazepam containing medicinal products.
CMDh je na podlagi preučitve priporočila, ki ga je dne 11. aprila 2013 v skladu s členom 107k(1) in (2) Direktive 2001/83/ES podal PRAC, in ustnih obrazložitev, ki jih je dne 22. aprila 2013 podal imetnik dovoljenja za promet z zdravilom, sprejel stališče o začasnem umiku dovoljenj za promet z zdravili, ki vsebujejo tetrazepam.
These included 33 cases of SJS (including 1 fatal case), 33 cases of Lyell's Syndrome (TEN) (including 9 fatal cases), 59 cases of EM (including 1 fatal case), 15 cases of DRESS Syndrome, 3 possible cases of DRESS Syndrome and 5 cases of acute generalised exanthematous pustulosis.
Med temi je bilo 33 primerov SJS (vključno z 1 smrtnim primerom), 33 primerov Lyellovega sindroma (TEN) (vključno z 9 smrtnimi primeri), 59 primerov multiformnega eritema (vključno z 1 smrtnim primerom), 15 primerov sindroma DRESS, 3 domnevni primeri sindroma DRESS in 5 primerov akutne generalizirane eksantemske pustuloze.
Benzodiazepines (BZP) facilitate the inhibitory activity of gamma-aminobutyric acid (GABA) leading to sedative, hypnotic, anticonvulsant and muscle relaxant properties.
Benzodiazepini (BZP) spodbujajo zaviralno delovanje gama-aminomaslene kisline (GABA) in posledično delujejo pomirjevalno, hipnotično in antikonvulzivno ter sproščajo mišice.
Therefore, following the provisions under Article 107i of Directive 2001/83/EC, the PRAC recommends the suspension of the marketing authorisations for all medicinal products referred to in Annex I.
Zato je PRAC v skladu z določbami člena 107i Direktive 2001/83/ES priporočil začasen umik dovoljenj za promet z vsemi zdravili, navedenimi v Prilogi I.
As provided by the Marketing Authorisation Holder of the originator medicinal product in their written response to the PRAC list of questions, according to the MAH's pharmacovigilance database since the product launch in 1969 up to the 31 of May 2012 (Data Lock Point), 513 cutaneous or allergic distinct cases referring to 748 reactions were reported with tetrazepam.
Kot je v pisnem odgovoru na seznam vprašanj, ki jih je zastavil PRAC, navedel imetnik dovoljenja za promet z izvornim zdravilom, so v zbirki podatkov farmakovigilance imetnika dovoljenja od prihoda zdravila na trg leta 1969 do 31. maja 2012 (zaključek vnosa podatkov) zabeležili 513 različnih primerov neželenih učinkov na kožo ali alergij, ki so bili povezani s 748 reakcijami.
On 20 December 2012 France informed the European Medicines Agency, pursuant to Article 107i of Directive 2001/83/EC, of their consideration to revoke the marketing authorisations for Tetrazepam containing medicines further to the evaluation of data resulting from pharmacovigilance activities.
Dne 20. decembra 2012 je Francija v skladu s členom 107i Direktive 2001/83/ES obvestila Evropsko agencijo za zdravila, da na podlagi ocene podatkov, pridobljenih iz dejavnosti farmakovigilance, razmišlja o razveljavitvi dovoljenj za promet z zdravili, ki vsebujejo tetrazepam.
Cases of anaphylaxis were also reported.
Poročali so tudi o primerih anafilaksije.
In addition, 10 cases of angioedema evoking an immediate hypersensitivity mechanism and 67 cases of drug eruption, in addition to the previous cases, with or without the involvement of at least one organ were described.
Poleg zgoraj omenjenih primerov so opazili še 10 primerov angioedema, ki je izzval takojšnjo preobčutljivostno reakcijo, in 67 primerov izpuščaja zaradi delovanja zdravila, ki so ali niso bili povezani z vsaj enim organom.
Within these 1616 cases, 805 (49.80 %) ADRs involved “skin and subcutaneous tissue disorders” SOC, of which 305 (37.9%) were serious cases including life threatening and fatal cases.
Med temi primeri je bilo 805 (49,8 %) neželenih učinkov zdravila povezanih z organskim sistemom „bolezni kože in podkožja”, od katerih je bilo 305 (37,9 %) resnih primerov, vključno z življenjsko nevarnimi in smrtnimi primeri.
Annex II Scientific conclusions and grounds for suspension of the marketing authorisations
Znanstveni zaključki in podlaga za začasen umik dovoljenj za promet z zdravili
This review of pharmacovigilance concerned skin adverse drug reactions (ADRs) recorded in the French National Pharmacovigilance database since the granting of the first marketing authorisations of tetrazepam in 1967 in that Member State.
Pregled farmakovigilance je bil namenjen oceni neželenih učinkov zdravila na kožo, ki so jih v francoski zbirki podatkov farmakovigilance zabeležili od odobritve prvih dovoljenj za promet s tetrazepamom v tej državi članici leta 1967.