FrancophonIA/ELRC3.0 huggingface dataset:
English: Paxene must not be used in patients with severe liver disease, severe uncontrolled infections or low levels of neutrophils.
Slovenian: Zdravilo Paxene se ne sme uporabljati pri bolnikih s hudimi obolenji jeter, s hudimi nenadzorovanimi okužbami ali nizkimi ravnmi nevtrofilcev.
English: In the studies, Paxene was used with other anticancer medicines and compared with other treatments.
Slovenian: V študijah je bilo zdravilo Paxene uporabljeno skupaj z drugimi zdravili proti raku, primerjali pa so ga tudi z drugimi načini zdravljenja.
English: Paxene also affects non-cancer cells such as blood cells, which causes side effects.
Slovenian: Zdravilo Paxene učinkuje tudi na nerakave celice, kot so denimo krvne celice, kar povzroči neželene učinke.
English: As Paxene is very similar to another authorised medicine containing paclitaxel called Taxol, the studies supporting the use of Taxol were used to support the use of Paxene.
Slovenian: Zdravilo Paxene je zelo podobno drugemu odobrenemu zdravilu, ki vsebuje paklitaksel, imenovanemu Taxol, tako da so v podporo zdravilu Paxene uporabili študije, ki podpirajo uporabo zdravila Taxol.
English: Treatment with Paxene should be given by an oncologist (cancer specialist) in a specialised cancer ward.
Slovenian: Zdravljenje z zdravilom Paxene mora izvajati onkolog (specialist za rakave bolezni) na specializiranem oddelku za zdravljenje raka.
English: What is the risk associated with Paxene?
Slovenian: Kakšna tveganja so povezana z zdravilom Paxene?
English: Paxene should not be used in people who may be hypersensitive (allergic) to paclitaxel or any of the other ingredients.
Slovenian: Zdravila Paxene ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) paklitaksel ali katero koli drugo sestavino zdravila.
English: The dose of Paxene, how often it is given and how long treatment continues depend on the type of cancer being treated and which other anticancer medicines are being given together with Paxene.
Slovenian: Velikost odmerka, njegova pogostost in trajanje zdravljenja so odvisni od vrste zdravljenega raka in drugih zdravil proti raku, ki se jemljejo skupaj z zdravilom Paxene.
English: Treatment with Paxene improved the response rates for various types of cancer.
Slovenian: Zdravljenje z zdravilom Paxene je izboljšalo stopnjo odzivnosti različnih vrst raka.
English: Paxene is an anticancer medicine.
Slovenian: Paxene je zdravilo proti raku.
English: • advanced cancer of the ovary (when the cancer has started to spread out of the ovary), in combination with cisplatin (another anticancer medicine);
Slovenian: • napredovalega raka jajčnikov (ko se je rak začel širiti izven jajčnikov) v kombinaciji z zdravilom cisplatin (drugim zdravilom proti raku);
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Paxene's benefits are greater than its risks for treatment of advanced AIDS-related Kaposi's sarcoma, metastatic breast cancer, advanced cancer of the ovary in combination with cisplatin, metastatic cancer of the ovary where platinum-containing combination therapy has failed, and non-small cell lung cancer.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da so koristi zdravila Paxene pri zdravljenju napredovalega Kaposijevega sarkoma, povezanega z AIDS-om, metastatskega raka dojk, napredovalega raka jajčnikov v kombinaciji s cisplatinom, metastatskega raka jajčnikov, pri katerem kombinacijsko zdravljenje z zdravili na osnovi platine ni bilo uspešno, in nedrobnoceličnega pljučnega raka, večje od z njim povezanih tveganj.
English: It contains the active substance paclitaxel.
Slovenian: Vsebuje zdravilno učinkovino paklitaksel.
English: The full EPAR for Paxene is available here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Paxene je na voljo tukaj.
English: • advanced AIDS-related Kaposi's sarcoma (a skin cancer often found in AIDS patients), when treatment with anthracyclines (another type of anticancer medicine) has failed;
Slovenian: • napredovalega Kaposijevega sarkoma, povezanega z AIDS-om (vrste raka kože, ki se pogosto pojavi pri bolnikih z AIDS-om), kjer zdravljenje z antraciklini (drugo vrsto zdravil proti raku) ni bilo uspešno,
English: For the full list of all side effects reported with Paxene, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Paxene, glejte navodilo za uporabo.
English: Why has Paxene been approved?
Slovenian: Zakaj je bilo zdravilo Paxene odobreno?
English: The active substance in Paxene, paclitaxel, belongs to the group of anticancer medicines known as the taxanes.
Slovenian: Zdravilna učinkovina v zdravilu Paxene je paklitaksel, ki spada v skupino zdravil proti raku, znanih kot taksani.
English: • metastatic cancer of the ovary, when other treatments such as platinum-containing combination therapy have failed;
Slovenian: • metastatskega raka jajčnikov pri bolnicah, kjer drugi načini zdravljenja, na primer kombinirano zdravljenje z zdravili na osnovi platine, niso bili uspešni;
English: Paxene also increased how long patients survived for some types of cancer.
Slovenian: Zdravilo Paxene je tudi podaljšalo čas preživetja pri nekaterih vrstah rakov.
English: Paxene is a concentrate that is made up into a solution for infusion (drip into a vein).
Slovenian: Zdravilo Paxene je koncentrat za pripravo raztopine za infundiranje (kapalne infuzije v veno).
English: • non-small cell lung cancer, in combination with cisplatin, when patients cannot have surgery or radiation therapy.
Slovenian: • nedrobnoceličnega pljučnega raka v kombinaciji z zdravilom cisplatin, če bolnik ne more biti operiran ali zdravljen z obsevanjem; Zdravilo se dobi samo na recept.
English: What is Paxene used for?
Slovenian: Za kaj se zdravilo Paxene uporablja?
English: What is Paxene?
Slovenian: Kaj je zdravilo Paxene?
English: How has Paxene been studied?
Slovenian: Kako je bilo zdravilo Paxene raziskano?
English: How is Paxene used?
Slovenian: Kako se zdravilo Paxene uporablja?
English: How does Paxene work?
Slovenian: Kako zdravilo Paxene deluje?
English: ‘Metastatic' means that the cancer has spread to other parts of the body;
Slovenian: • metastatskega raka dojk, kjer drugi načini zdravljenja niso bili uspešni ali niso primerni; „metastatski“ pomeni, da se je rakavo obolenje razširilo na druge dele telesa;
English: Pfdc / Portugal
Slovenian: Pfdc / Portugalska
English: Aurovitas Spain,s.A.U.
Slovenian: Aurovitas Španija,s.A.U.
English: Pharmaceuticals Ireland
Slovenian: Allergan Pharmaceuticals Ireland
English: Teva Magyarország Zrt
Slovenian: Teva Magyarország Zrt Isotretinoin Teva
English: Tretinoina Same Savoma Medicinali
Slovenian: Savoma Medicinali Spa Tretinoina Same Savoma Medicinali
English: Arrow Generiques Acnetrait
Slovenian: Arrow Generiques
English: Laboratorios Farmaceuticos Stiefel (Portugal) Ltda
Slovenian: Laboratorios Farmaceuticos Stiefel (Portugalska) Ltda
English: Pierre Fabre Iberica / Spain
Slovenian: Pierre Fabre Iberica / Španija
English: Roche (Magyarország) Kft Roaccutan
Slovenian: Roche (Magyarország) Kft
English: Genus Pharmaceuticals
Slovenian: Acitretin Genus Pharmaceuticals
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for Retinoids containing medicinal products
Slovenian: Priloga I Seznam zdravil z nacionalnim dovoljenjem za promet
English: Isotretinoin 500µg G Gel
Slovenian: Izotretinoin 500 µg/g
English: Pharmaceuticals Limited
Slovenian: Genus Pharmaceuticals Limited
English: Isotretinoin Generics [uk]
Slovenian: Generics [uk] Limited Isotretinoin Generics [uk]
English: Galderma (Uk) Limited
Slovenian: Galderma (Uk) Limited Differin
English: Mg
Slovenian: Kg
English: Laboratoires Bailleul Sa
Slovenian: Laboratoires Bailleul Sa Erylik
English: Isotretinoin Ranbaxy (Uk)
Slovenian: Ranbaxy (Uk) Limited Isotretinoin Ranbaxy (Uk)
English: Pharmaceuticals Polska Sp. Z O.O.
Slovenian: Teva Pharmaceuticals Polska Sp. Z O.O.
English: Almirall Hermal Gmbh
Slovenian: Almirall Hermal Gmbh Aknenormin
English: Societe D'etudes Et De Recherches Pharmaceutiques (Serp)
Slovenian: Societe D'etudes Et De Recherches
English: Glaxosmithkline Slovakia S.R.O.
Slovenian: Glaxosmithkline Slovaška S.R.O.
English: Glaxosmithkline Gmbh & Co. Kg
Slovenian: Glaxosmithkline Gmbh & Co.
English: Dermapharm Ag Keraderm
Slovenian: Dermapharm Ag
English: Louis Widmer Gmbh De
Slovenian: Louis Widmer Gmbh De Wicaran
English: Glaxosmithkline Aebe
Slovenian: Glaxosmithkline Aebe Cehado
English: Galderma International
Slovenian: Galderma International Differine
English: Laboratorios Galderma SaSucursal Em Portugal
Slovenian: Laboratorios Galderma Sa - Sucursal Em Portugalska
English: Adapalene 1mg G, Benzoyl Peroxide 25mg G
Slovenian: Adapalen 1 mg/g, benzoil peroksid 25 mg/g
English: Roche Latvija Sia Roaccutane
Slovenian: Roche Latvija Sia
English: Tretinoin 15mg/30 G Cream
Slovenian: Tretinoin 15 mg/30 g krema
English: Meda Pharma
Slovenian: Meda Pharma Sas
English: Puren Pharma Gmbh & Co. Kg
Slovenian: Puren Pharma Gmbh & Co.
English: Pharmaswiss česká Republika S.R.O.
Slovenian: Pharmaswiss česká
English: Adapalene 0.1%w/W Gel
Slovenian: Adapalen 0,1 %w/W gel
English: Erythromycin 4g/100 G, Tretinoin 0.025g/100 G Gel
Slovenian: Eritromicin 4 g/100 g, tretinoin 0,025 g/100 g
English: Galderma Laboratorium Gmbh Epiduo
Slovenian: Galderma Laboratorium Gmbh
English: Laboratório Medinfar - Produtos Farmacêuticos, S.A.
Slovenian: Laboratório MedinfarProdutos Farmacêuticos, S.A.
English: Ziaja Ltd Zakład Produkcji Leków Sp Z O.O.
Slovenian: Produkcji Leków Sp Z O.O.
English: Nexus Medicals S.A. Accuran
Slovenian: Nexus Medicals S.A.
English: Adapalene 1mg G
Slovenian: Adapalen 1 mg/g
English: Farmacêuticos, S.A. Acnatac
Slovenian: Laboratorios Viñas, S.A. Acnemin
English: Adapalene 0.1% Gel
Slovenian: Adapalen 0,1 %
English: Acitretin 25mg Capsule Capsule
Slovenian: Acitretin 25 mg kapsula kapsula
English: Atrederm 0,05%
Slovenian: Tretinoin 0,05 %
English: Sapiens Pharmaceuticals Ltd Rotren
Slovenian: Sapiens Pharmaceuticals Ltd
English: Isotretinoin 1mg G Cream
Slovenian: Izotretinoin 1 mg/g krema
English: Acitretin 10mg Capsule Capsule
Slovenian: Acitretin 10 mg kapsula kapsula
English: Pharmathen Hellas S.A.
Slovenian: Pharmathen Hellas S.A. A-Cnotren
English: Tazarotene 0.1mg/100 Gel
Slovenian: Tazaroten 0,1 mg/100 mg gel
English: Adapalene 0.1g/100 G Cream
Slovenian: Adapalen 0,1g/100 g krema
English: B.V.
Slovenian: N.V.
English: Tretinoin 10mg Capsule Capsule, Soft
Slovenian: Tretinoin 10 mg kapsula kapsula, mehka
English: N.V. Roche S.A.
Slovenian: Roche S.A.
English: Actavis Group Ptc Acnenor
Slovenian: Actavis Group Ptc Ehf.
English: Tretinoin 0.025g/100 G Cream
Slovenian: Tretinoin 0,025 g/100 g krema
English: Isotretinoin 0.05g/100 G Gel
Slovenian: Izotretinoin 0,05 g/100 g gel
English: Glaxosmithkline (Cyprus) Limited Isotrexin
Slovenian: Glaxosmithkline (Ciper) Limited
English: Isotretinoin Puren
Slovenian: Isotretinoina Stiefel
English: Tazarotene 0.05g/100 G Gel
Slovenian: Tazaroten 0,05 g/100 g gel
English: Isotretinoin 0.05%w/W Gel
Slovenian: Izotretinoin 0,05 %w/W gel
English: Glaxosmithkline (Ireland) Limited Isotrexin
Slovenian: Glaxosmithkline (Ireland) Limited
English: Meda Pharmaceuticals Ltd Atralin
Slovenian: Meda Pharmaceuticals Ltd
English: Adapalene 0.1%w/W Cream
Slovenian: Adapalen 0,1 % w/W krema
English: Isotretinoin 0.5mg G Cream
Slovenian: Izotretinoin 0,5 mg/g krema
English: Tretinoin 0.25mg/Mg Cream
Slovenian: Tretinoin 0,25 mg/mg krema
English: Regiomedica Gmbh Regioderm Acitretin 25mg Capsule Capsule, Hard
Slovenian: Acitretine Aurobindo Acitretin 25 mg kapsula kapsula, trda
English: Isotretinoin 0.5mg
Slovenian: Izotretinoin 0,5 mg
English: Tazarotene 1mg G Gel
Slovenian: Tazaroten 1 mg/g
English: Tretinoin 0.05% Cream
Slovenian: Tretinoin 0,05 g krema
English: Clindamycin Phosphate 10mg G, Tretinoin 0.25mg G
Slovenian: Klindamicin fosfat 10 mg/g, tretinoin 0,25 mg/g
English: Hydrocortisone 10mg G, Tretinoin 1mg G,
Slovenian: Hidrokortizon 10 mg/g, tretinoin 1 mg/g, hidrokinon 50 mg/g krema
English: Carbamid + Vas Creme
Slovenian: Ureotop + Vas
English: Bulgaria неотигазон
Slovenian: неотигазон
English: Isotretinoin Teva
Slovenian: Adapalene Teva
English: Isotretinoin 5mg Capsule Capsule, Soft
Slovenian: Izotretinoin 5 mg kapsula, mehka
English: Isotretinoin Jenson Isotretinoin 5mg Capsule Capsule, Soft
Slovenian: Generics [uk] Limited Isotretinoin Jenson Izotretinoin 5 mg kapsula kapsula, mehka
English: Isotretinoin Ratiopharm Isotretinoin 20mg
Slovenian: Ratiopharm Gmbh Isotretinoin Ratiopharm Izotretinoin 20 mg kapsula, mehka
English: Adapalène Zentiva Adapalene 0.1g/100 G Gel
Slovenian: Sanofi-Aventis Francija Adapalène Zentiva Adapalen 0,1 g/100 g
English: Erythromycin 40mg G, Tretinoin 0.25mg G Cutaneous Solution Cutaneous Use
Slovenian: Eritromicin 40 mg/g, tretinoin 0,25 mg/g dermalna raztopina dermalna uporaba
English: Tretinoin 4mg G
Slovenian: Tretinoin 4 mg/g krema
English: Regiomedica Gmbh Regioderm Acitretin 10mg Capsule Capsule, Hard
Slovenian: Acitretine Aurobindo Acitretin 10 mg kapsula kapsula, trda
English: Meda Pharma Sia Treclinac
Slovenian: Meda Pharma Sia
English: Tretinoin 0.05g/100 G Cream
Slovenian: Tretinoin 0,05 g/100 g krema
English: Clindamycin 10mg G, Tretinoin 0.025mg G Gel
Slovenian: Klindamicin 10 mg/g, tretinoin 0,025 mg/g
English: Isotretinoin 0.5mg G
Slovenian: Izotretinoin 0,5 mg/g
English: Tazarotene 0.1g/100 G Gel
Slovenian: Tazaroten 0,1g/100 g
English: Tretinoin 0.25mg G Cream
Slovenian: Tretinoin 0,25 mg/g krema
English: Erythromycin 20mg G, Isotretinoin 0.5mg G Gel
Slovenian: Eritromicin 20 mg/g, izotretinoin 0,5 mg/g
English: Laboratoires Smb S.A.
Slovenian: Laboratoires Smb S.A. Isosupra Lidose
English: Tretinoin 0.3mg G, Urea 120mg G
Slovenian: Tretinoin 0,3 mg/g, sečnina 120 mg/g krema
English: Erythromycin 20mg G, Isotretinoin 0.05mg G Gel
Slovenian: Eritromicin 20 mg/g, izotretinoin 0,5mg/g
English: Tretinoin 0.5mg/Mg Cream
Slovenian: Tretinoin 0,5 mg/mg krema
English: Clindamycin 10mg G, Tretinoin 0.25mg G Gel
Slovenian: Klindamicin 10 mg/g, tretinoin 0,25 mg/g
English: Tretinoin 0.5mg G
Slovenian: Tazaroten 0,5 mg/g
English: Isotretinoin Alliance Pharmaceuticals Isotretinoin 5mg Capsule Capsule, Soft
Slovenian: Ratiopharm Gmbh Isotretinoin Ratiopharm Izotretinoin 10 mg kapsula kapsula, mehka
English: Aebe
Slovenian: Zanea
English: Isosupra Lidose Isotretinoin 8mg Capsule Capsule, Hard
Slovenian: Isotretinoin Ratiopharm Izotretinoin 20 mg kapsula kapsula, mehka
English: Adapalene Teva Adapalene 0.1g G
Slovenian: Adapalen 0,1 g/g
English: Panretin
Slovenian: Atralin
English: Stiefel Laboratories Toctino
Slovenian: Laboratoires Bailleul Sa Contracne
English: Isotretinoin Actavis Isotretinoin 5mg Capsule Capsule, Soft
Slovenian: Isotretinoin Puren Izotretinoin 10 mg kapsula kapsula, mehka
English: A-Cnotren
Slovenian: Neotigason
English: Acitretin Genus Pharmaceuticals Acitretin 25mg Capsule Capsule, Hard
Slovenian: Acitretin 25 mg kapsula kapsula, trda
English: Dexpanthenol 0.1mg G, Tretinoin 3µg G, Urea 1.2mg G
Slovenian: tretinoin 3 µg/g, sečnina 1,2
English: Bexarotene 75mg Capsule
Slovenian: Acitretin 25mg kapsula kapsula
English: Adapalene 0.1g/100 G Gel
Slovenian: Adapalen 0,1 g/100 g
English: Clindamycin 10mg G,
Slovenian: Dekspantenol 0,1 mg/g,
English: Meda Pharmaceuticals S.A. Acnatac
Slovenian: Meda Pharmaceuticals S.A.
English: The main measure of effectiveness was the number of patients who ‘responded' to treatment.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, ki so se „odzvali“ na zdravljenje.
English: This type of epilepsy first appears in young children during the first year of life.
Slovenian: Ta vrsta epilepsije se prvič pojavi pri majhnih otrocih v prvem letu življenja.
English: It is available as capsules and sachets (250 and 500 mg).
Slovenian: Na voljo je v obliki kapsul in vrečk (250 in 500 mg).
English: GABA is the main substance in nerve cells responsible for reducing the electrical activity of the brain.
Slovenian: GABA je glavna snov v živčnih celicah, odgovorna za zniževanje električne aktivnosti možganov.
English: The dose of valproate does not normally need to be adjusted.
Slovenian: Odmerka valproata običajno ni treba prilagajati.
English: This was switched to a full marketing authorisation on 8 January 2014.
Slovenian: To je bilo 8. januarja 2014 spremenjeno v običajno dovoljenje za promet.
English: The European Commission granted a conditional marketing authorisation valid throughout the European Union for Diacomit on 4 January 2007.
Slovenian: Evropska komisija je pogojno dovoljenje za promet z zdravilom Diacomit, veljavno po vsej Evropski uniji, izdala 4. januarja 2007.
English: EPAR summary for the public stiripentol
Slovenian: Povzetek EPAR za javnost stiripentol
English: Other information about Diacomit
Slovenian: Druge informacije o zdravilu Diacomit
English: This is a summary of the European public assessment report (EPAR) for Diacomit.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Diacomit.
English: Diacomit has been studied in two main studies involving 65 children between three and 18 years of age.
Slovenian: Zdravilo Diacomit so proučevali v dveh glavnih študijah, ki sta vključevali 65 otrok, starih od tri do 18 let.
English: The main studies of Diacomit were in children over three years of age.
Slovenian: Glavne študije zdravila Diacomit so bile opravljene pri otrocih, starejših od treh let.
English: The recommended dose is 50 mg per kilogram bodyweight, divided into two or three doses during the day.
Slovenian: Priporočeni odmerek je 50 mg na kilogram telesne mase, ki se razdeli v 2 do 3 odmerke dnevno.
English: Diacomit was originally given ‘conditional approval' because there was more evidence to come about the medicine, in particular regarding its short-term and long-term effectiveness and safety.
Slovenian: Zdravilo Diacomit je prvotno pridobilo „pogojno dovoljenje za promet“, ker so bili dodatni dokazi o njem, zlasti glede njegove kratkoročne in dolgoročne učinkovitosti in varnosti, šele v postopku priprave.
English: The sachets contain a powder that is used to make up an oral suspension (a liquid with solid particles in it).
Slovenian: Vrečke vsebujejo prašek, ki se uporablja za pripravo peroralne suspenzije (tekočine s trdimi delci v njej).
English: More patients responded to treatment with Diacomit than to placebo.
Slovenian: Na zdravljenje z zdravilom Diacomit se je odzvalo več bolnikov kot na placebo.
English: After starting Diacomit, the dose of clobazam may need to be reduced.
Slovenian: Z uvedbo zdravila Diacomit bo morda treba zmanjšati odmerek klobazama.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Diacomit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Slovenian: Povzetek mnenja Odbora za zdravila sirote za zdravilo Diacomit je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: Treatment starts with a dose of 20 mg per kg bodyweight, which is gradually increased to the recommended dose over a number of weeks depending on the patient's age.
Slovenian: Zdravljenje se začne z odmerkom 20 mg na kilogram telesne mase, ki se nekaj tednov postopno povečuje, dokler ne doseže priporočenega odmerka.
English: A patient was classified as a ‘responder' if the number of seizures in the second month of treatment was at least 50% lower than the number in the month before treatment was started.
Slovenian: Bolnik je bil razvrščen kot „odziven“, če se je število epileptičnih napadov v drugem mesecu zdravljenja z zdravilom Diacomit zmanjšalo vsaj za 50 % v primerjavi z mesecem pred uvedbo zdravila Diacomit.
English: Diacomit should be given at the same time as food, but not with dairy products, carbonated drinks, fruit juice, or food or drinks that contain caffeine or theophylline (a substance found in black and green tea, among other products).
Slovenian: Zdravilo Diacomit je treba jemati sočasno s hrano, toda ne z mlečnimi izdelki, gaziranimi pijačami, sadnimi sokovi ali živili oziroma pijačami, ki vsebujejo kofein ali teofilin (snov, ki se nahaja na primer v črnem in zelenem čaju).
English: It is also known to amplify the effects of other anti-epileptic medicines and to slow down the rate at which they are broken down by the liver.
Slovenian: Znano je tudi, da poveča dejavnost drugih zdravil proti epilepsiji in upočasni njihovo razgrajevanje v jetrih.
English: See the package leaflet for the full list of restrictions.
Slovenian: Za celoten seznam omejitev glejte navodilo za uporabo.
English: It decided that Diacomit's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor je menil, da so koristi zdravila Diacomit večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: What benefit has Diacomit shown during the studies?
Slovenian: Kakšne koristi je zdravilo Diacomit izkazalo med študijami?
English: The exact way in which stiripentol, the active substance in Diacomit, acts as an anti-epileptic medicine is not fully known.
Slovenian: Natančen način delovanja stiripentola, zdravilne učinkovine v zdravilu Diacomit, kot antiepileptika ni popolnoma znan.
English: It has been shown in experimental models to increase the levels of a ‘neurotransmitter' called gamma aminobutyric acid (GABA) in the brain.
Slovenian: Študije na poskusnih modelih so pokazale, da utegne zvišati raven živčnega prenašalca, imenovanega gama-aminomaslena kislina (GABA), v možganih.
English: 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 Diacomit.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Diacomit, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: For more information about treatment with Diacomit, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Diacomit preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Diacomit is an anti-epileptic medicine that contains the active substance stiripentol.
Slovenian: Diacomit je zdravilo proti epilepsiji, ki vsebuje zdravilno učinkovino stiripentol.
English: The most common side effects with Diacomit (seen in more than 1 in 10 patients) are loss of appetite, weight loss, insomnia (difficulty sleeping), drowsiness, ataxia (inability to co-ordinate muscle movements), hypotonia (low muscle strength) and dystonia (muscle disorders).
Slovenian: Najpogostejši neželeni učinki zdravila Diacomit (opaženi pri več kot 1 od 10 bolnikov) so izguba teka, izguba telesne mase, nespečnost, zaspanost, ataksija (nezmožnost usklajenega gibanja mišic), hipotonija (zmanjšana moč mišičja) in distonija (obolenje mišičja).
English: In the first study, 71% of the patients taking Diacomit responded to treatment (15 out of 21), compared with 5% of the placebo group (1 out of 20).
Slovenian: V prvi študiji se je na zdravljenje odzvalo 71 % bolnikov (15 bolnikov od 21), ki so prejemali zdravilo Diacomit, v primerjavi s 5 % bolnikov (1 bolnik od 20) v skupini, ki je prejemala placebo.
English: The full EPAR for Diacomit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Diacomit je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.