FrancophonIA/ELRC3.0 huggingface dataset:
English: Paclitaxel blocks the cell's ability to break down the ‘skeleton' that allows cells to divide and multiply.
Slovak: Paklitaxel blokuje schopnosť bunky rozbíjať tzv. skelet, ktorý bunkám umožňuje deliť sa a množiť sa.
English: It contains the active substance paclitaxel.
Slovak: Obsahuje účinnú látku paklitaxel.
English: To prevent severe allergic reactions, all patients must first be treated with corticosteroids to reduce inflammation, antihistamines to reduce swelling and itchiness, and H2 antagonists to reduce stomach acid.
Slovak: Aby sa zabránilo vážnym alergickým reakciám, musia byť všetci pacienti najprv liečení kortikosteroidmi na zníženie zápalov, antihistaminikami na zníženie opuchov a svrbenia a antagonistami H2 na zníženie žalúdočnej kyseliny.
English: The main measures of effectiveness were the number of patients whose cancer responded to treatment, how long the patients lived without their disease getting worse and how long they survived.
Slovak: Hlavnými mierami účinnosti boli počet pacientov, ktorých rakovina na liečbu reagovala, obdobie, za ktoré sa u pacientov ochorenie nezhoršilo a predĺženie času prežitia.
English: Paxene also affects non-cancer cells such as blood cells, which causes side effects.
Slovak: Liek Paxene však vplýva aj na nerakovinové bunky, ako napr. krvné bunky, čo spôsobuje vedľajšie účinky.
English: Other information about Paxene:
Slovak: Ďalšie informácie o lieku Paxene:
English: Paxene has been studied in 107 patients with Kaposi's sarcoma, 312 patients with metastatic breast cancer, 120 patients with metastatic ovarian cancer, over 900 patients with advanced ovarian cancer and over 1,000 patients with lung cancer.
Slovak: Liek Paxene bol skúmaný u 107 pacientov s Kaposiho sarkómom, u 312 pacientok s metastázujúcou rakovinou prsníka, u 120 pacientok s metastázujúcou rakovinou vaječníkov, u viac ako 900 pacientok s pokročilou rakovinou vaječníkov a u viac ako 1 000 pacientov s rakovinou pľúc.
English: The Committee recommended that Paxene be given marketing authorisation.
Slovak: Výbor odporučil udeliť povolenie na uvedenie lieku Paxene na trh.
English: • non-small cell lung cancer, in combination with cisplatin, when patients cannot have surgery or radiation therapy.
Slovak: • nemalobunková rakovina pľúc, v kombinácii s cisplatinou, u pacientov, ktorí nemôžu podstúpiť chirurgickú alebo radiačnú terapiu.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Paxene to Norton Healthcare Limited on 19 July 1999.
Slovak: Európska komisia 19. júla 1999 vydala spoločnosti Norton Healthcare Limited povolenie na uvedenie lieku Paxene na trh platné v celej Európskej únii.
English: The full EPAR for Paxene is available here.
Slovak: Úplné znenie správy EPAR o lieku Paxene sa nachádza tu.
English: In the studies, Paxene was used with other anticancer medicines and compared with other treatments.
Slovak: V štúdiách sa liek Paxene používal s inými liekmi proti rakovine a bol porovnávaný s inými typmi liečby.
English: With the skeleton still in place the cell cannot divide, and eventually die.
Slovak: S neporušeným skeletom sa bunka nemôže deliť a prípadne odumiera.
English: Paxene must not be used in patients with severe liver disease, severe uncontrolled infections or low levels of neutrophils.
Slovak: Liek Paxene nesmú užívať pacienti s vážnym ochorením pečene, ťažkými neliečenými infekciami alebo s nízkymi hladinami neutrofilov.
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.
Slovak: Liek Paxene je veľmi podobný inému povolenému lieku obsahujúcemu paklitaxel s názvom Taxol a štúdie skúmajúce použitie lieku Taxol boli použité na podporu použitia lieku Paxene.
English: Paxene is given as an infusion lasting three hours, or occasionally 24 hours.
Slovak: Liek Paxene sa podáva ako 3-hodinová alebo výnimočne 24-hodinová infúzia.
English: Paxene is a concentrate that is made up into a solution for infusion (drip into a vein).
Slovak: Paxene je koncentrát, z ktorého sa pripravuje infúzny roztok (na kvapkanie do žily).
English: What benefit has Paxene shown during the studies?
Slovak: Aký prínos preukázal liek Paxene v týchto štúdiách?
English: Paxene is an anticancer medicine.
Slovak: Paxene je liek proti rakovine.
English: Paxene should not be used in people who may be hypersensitive (allergic) to paclitaxel or any of the other ingredients.
Slovak: Liek Paxene by nemali užívať osoby, ktoré môžu byť precitlivené (alergické) na paklitaxel alebo na iné zložky lieku.
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.
Slovak: Výbor pre lieky na humánne použitie (CHMP) rozhodol, že prínos lieku Paxene je väčší než riziká spojené s jeho užívaním pri liečbe pokročilého Kaposiho sarkómu pri AIDS, metastázujúcej rakoviny prsníka, pokročilej rakoviny vaječníkov v kombinácii s cisplatinou, metastázujúcej rakoviny vaječníkov po zlyhaní kombinovanej terapie s platinou a nemalobunkovej rakoviny pľúc.
English: • advanced cancer of the ovary (when the cancer has started to spread out of the ovary), in combination with cisplatin (another anticancer medicine);
Slovak: • pokročilá rakovina vaječníkov (keď sa rakovina začala šíriť mimo vaječníkov) v kombinácii s cisplatinou (iný liek proti rakovine);
English: The active substance in Paxene, paclitaxel, belongs to the group of anticancer medicines known as the taxanes.
Slovak: Účinná látka lieku Paxene, paklitaxel, patrí do skupiny liekov proti rakovine známych ako taxány.
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;
Slovak: • pokročilý Kaposiho sarkóm pri AIDS (rakovina kože často zistená u pacientov s AIDS) po zlyhaní liečby antracyklínmi (iný typ liekov proti rakovine);
English: Treatment with Paxene should be given by an oncologist (cancer specialist) in a specialised cancer ward.
Slovak: Liečbu liekom Paxene by mal začať onkológ (odborník na liečbu rakoviny) v špecializovaných oddeleniach na liečbu rakoviny.
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.
Slovak: Dávka lieku Paxene, frekvencia dávkovania a dĺžka liečby závisia od typu liečenej rakoviny a od iných liekov proti rakovine podávaných spolu s liekom Paxene.
English: Why has Paxene been approved?
Slovak: Prečo bol liek Paxene schválený?
English: What is the risk associated with Paxene?
Slovak: Aké riziká sa spájajú s užívaním lieku Paxene?
English: It must not be used in women who are pregnant or breastfeeding.
Slovak: Liek Paxene nesmú užívať tehotné alebo dojčiace ženy.
English: • metastatic cancer of the ovary, when other treatments such as platinum-containing combination therapy have failed;
Slovak: • metastázujúca rakovina vaječníkov po zlyhaní iných typov liečby ako napr. kombinovanej liečby obsahujúcej platinu;
English: Treatment with Paxene improved the response rates for various types of cancer.
Slovak: Paxene zlepšila stupeň klinickej odpovede u rôznych typov rakoviny.
English: • metastatic breast cancer, when other treatments have failed or cannot be used.
Slovak: • metastázujúca rakovina prsníka po zlyhaní iných typov liečby, alebo ak sú tieto typy liečby nevhodné.
English: Paxene paclitaxel EPAR summary for the public
Slovak: Paxene paklitaxel
English: For the full list of all side effects reported with Paxene, see the Package Leaflet.
Slovak: Zoznam všetkých vedľajších účinkov pozorovaných pri používaní lieku Paxene sa nachádza v písomnej informácii pre používateľov.
English: Paxene also increased how long patients survived for some types of cancer.
Slovak: Liek Paxene predĺžil v prípade niektorých typov rakoviny aj čas prežitia.
English: How has Paxene been studied?
Slovak: Ako bol liek Paxene skúmaný?
English: What is Paxene?
Slovak: Čo je liek Paxene?
English: What is Paxene used for?
Slovak: Na čo sa liek Paxene používa?
English: Doc.
Slovak: Liečba liekom
English: How does Paxene work?
Slovak: Akým spôsobom liek Paxene účinkuje?
English: How is Paxene used?
Slovak: Ako sa liek Paxene užíva?
English: Eurogenerics Sa
Slovak: Eurogenerics
English: Uab "roche Lietuva" Roaccutane
Slovak: Uab "roche Lietuva"
English: Tretinoina Same Savoma Medicinali
Slovak: Savoma Medicinali Spa Tretinoina Same Savoma Medicinali
English: Aurovitas Spain,s.A.U.
Slovak: Aurovitas Spain,s.
English: Teva Magyarország Zrt
Slovak: Teva Magyarország Zrt Isotretinoin Teva
English: Isotretinoin Ranbaxy (Uk)
Slovak: Limited Isotretinoin Ranbaxy (Uk)
English: Arrow Generiques Acnetrait
Slovak: Arrow Generiques
English: Genus Pharmaceuticals
Slovak: Acitretin Genus Pharmaceuticals
English: Roche Bulgaria Eood Roaccutane
Slovak: Roche Bulgaria Eood
English: Ratiopharm Arzneimittel Vertriebs-Gmbh
Slovak: Ratiopharm Arzneimittel VertriebsGmbh
English: Ichthyol-Gesellschaft Cordes, Hermanni & Co. (Gmbh & Co.) Kg
Slovak: Ichthyol-Gesellschaft Cordes, Hermanni & Co.
English: Isotretinoin Jenson
Slovak: Limited Isotretinoin Jenson
English: Isotretinoin Generics [uk]
Slovak: Limited Isotretinoin Generics [uk]
English: Sτιefoτrex
Slovak: Aebe Sτιefoτrex
English: Stiefel Laboratories (Ireland) Ltd
Slovak: Stiefel Laboratories (Ireland)
English: Acitretin 25mg Piece
Slovak: Acitretín 25mg piece
English: Tretinoin 250µg/Ml, DlAlpha Tocopherol Acetate 50µg/Ml
Slovak: Tretinoín 250 µg/Ml, DlAlpha Tokoferol Acetát 50 µg/Ml
English: Adapalene 1mgg
Slovak: Adapalén 1 mgg
English: Acitretin 10mg Piece
Slovak: Acitretín 10mg piece
English: United Kingdom Roche Products Ltd Roaccutane
Slovak: Spojené kráľovstvo Roche Products Ltd Roaccutane
English: Ennogen Healthcare Limited
Slovak: Spojené kráľovstvo Ennogen Healthcare
English: Louis Widmer Gmbh De
Slovak: Louis Widmer Gmbh
English: Adapalene 0.1% Gel
Slovak: Adapalén 0.1%
English: Societe D'etudes Et De Recherches Pharmaceutiques (Serp)
Slovak: Societe D'etudes Et De Recherches
English: Isotretinoin 0.05%w/W Gel
Slovak: Izotretinoín 0.05%w/W
English: Capsule
Slovak: Kapsuly
English: Tretinoin 0.1g
Slovak: Tretinoín 0.1g
English: Axxon Sp. Z O.O.
Slovak: Axxon Sp.
English: Pierre Fabre Benelux Isocural
Slovak: Pierre Fabre Benelux
English: Pfdc / Portugal
Slovak: Pfdc /
English: Acitretin 25mg Tablet
Slovak: Acitretín 25 mg Tablet
English: Acitretin 10mg Tablet
Slovak: Acitretín 10 mg Tablet
English: Tretinoin 15mg/30 G Cream
Slovak: Tretinoín 15 mg/30 G Krém
English: Roche Latvija Sia Roaccutane
Slovak: Roche Latvija Sia
English: Dexpanthenol 0.1mg G, Tretinoin 3µg G, Urea 1.2mg G
Slovak: Dexpantenol 0.1 mg G, Tretinoín 3 µg G, Urea 1.2 mg G
English: S.A. Meda Pharma N.V.
Slovak: Meda Pharma N.V.
English: Tretinoin 500µg/Ml, DlAlpha Tocopherol Acetate 100µg/Ml
Slovak: Tretinoín 500 µg/Ml, DlAlpha Tokoferol Acetát 100 µg/Ml
English: Isotretinoin Alliance Pharmaceuticals
Slovak: Isotretinoin Alliance
English: Capsule, Hard
Slovak: Tvrdé kapsuly
English: Ehf.
Slovak: A.U.
English: Almirall Hermal Gmbh
Slovak: Almirall Hermal Gmbh Aknenormin
English: Meda Pharma
Slovak: Meda Pharma Sas
English: Galderma Polska Sp. Z O.O.
Slovak: Galderma Polska Sp.
English: Galderma Hellas S.A. Epiduo
Slovak: Galderma Hellas S.A.
English: Pharmaceuticals Ireland
Slovak: Spojené kráľovstvo Allergan Pharmaceuticals Ireland
English: Erythromycin 4g/100 G, Tretinoin 0.025g/100 G Gel
Slovak: Erytromycín 4g/100 G, Tretinoín 0.025g/100
English: Acitretin 10mg
Slovak: Acitretín 10 mg
English: Tretinoin 0.3mg G, Urea 120mg G
Slovak: Tretinoín 0.3 mg G, Urea 120mg G
English: Pharmaswiss česká Republika S.R.O.
Slovak: Pharmaswiss česká
English: Galderma Hellas S.A. Adaferin
Slovak: Galderma International Adaferin
English: Isotretinoin 20mg
Slovak: Izotretinoín 20 mg
English: Isotretinoin 10mgg
Slovak: Izotretinoín 10 mgg
English: Mg
Slovak: Kg
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
Slovak: Príloha I Zoznam národne registrovaných liekov
English: Adapalene 1mg G
Slovak: Adapalén 1mg G
English: Galenpharma Gmbh Isogalen
Slovak: Gmbh Isogalen
English: Laboratório Medinfar - Produtos Farmacêuticos, S.A.
Slovak: Laboratório MedinfarProdutos Farmacêuticos, S.A.
English: Ziaja Ltd Zakład Produkcji Leków Sp Z O.O.
Slovak: Produkcji Leków Sp Z O.O.
English: Nexus Medicals S.A. Accuran
Slovak: Nexus Medicals S.A.
English: Pharmaceuticals Limited
Slovak: Spojené kráľovstvo Genus Pharmaceuticals Limited
English: Actavis Group Ptc Acnenor
Slovak: Actavis Group Ptc Ehf. неотигазон
English: Sapiens Pharmaceuticals Ltd Rotren
Slovak: Sapiens Pharmaceuticals Ltd
English: Topical Application
Slovak: Lokálna aplikácia
English: Galderma (Uk) Limited
Slovak: Galderma (Uk)
English: Isotretinoin Sandoz Isotretinoin 20mg
Slovak: Isotretinoin Sandoz Ltd Izotretinoín 20 mg kapsula
English: Cheplapharm Arzneimittel Gmbh
Slovak: Arzneimittel Gmbh
English: Produtos
Slovak: Pharmaceuticals
English: Acitretine Cf
Slovak: Cf
English: Tretinoin 0.5mg/Ml
Slovak: Tretinoín 0.5 mg/Ml
English: Aurobindo Pharma (Italia) S.R.L.
Slovak: Aurobindo Pharma (Italia)
English: Pharmaceuticals Polska Sp. Z O.O.
Slovak: Teva Pharmaceuticals Polska Sp.
English: Galderma Nordic Ab Tactuo
Slovak: Ab Tactuo
English: Carbamid + Vas Creme
Slovak: Ureotop + Vas
English: Alitretinoin 10mg
Slovak: Alitretinoín 30 mg
English: N.V. Roche S.A.
Slovak: Roche S.A.
English: Hydrocortisone 10mg G, Tretinoin 1mg G,
Slovak: Hydrokortizón 10 mg G, Tretinoín 1 mg G, Hydrochinón 50 mg G
English: B.V.
Slovak: N.V.
English: Tretinoin 0.25mg G Cream
Slovak: Tretinoín 0.25 mg G Krém
English: Tazarotene 0.1mg/100 Gel
Slovak: Tazarotén 0.1 mg/100 Mg Gél
English: Tazarotene 1mg G Gel
Slovak: Tazarotén 1 mg G
English: Tazarotene 0.1g/100 G Gel
Slovak: Tazarotén 0.1g/100 G Gél
English: Tazarotene 0.5mg G Gel
Slovak: Tazarotén 0.5 mg G
English: Isotretinoin 0.5mg G Cream
Slovak: Izotretinoín 0.5 mg G Krém
English: Ranbaxy (Uk) Limited
Slovak: Spojené kráľovstvo Ranbaxy (Uk)
English: Tretinoin 4mg G
Slovak: Tretinoín 4 mg G
English: Adapalene Teva Adapalene 0.1g G
Slovak: Adapalén 0.1g G
English: Glaxosmithkline Pharma Gmbh.
Slovak: Glaxosmithkline Gmbh
English: Adapalene 1mg G, Benzoyl Peroxide 25mg G
Slovak: Adapalén 1mg G, Benzoylperoxid 25mg G
English: Verisfield (Uk) Ltd Treticlin
Slovak: Ltd Treticlin
English: Acitretin 25mg Capsule Capsule
Slovak: Acitretín 25 mg kapsula
English: Acitretin 10mg Capsule Capsule
Slovak: Izotretinoin 10 mg kapsula
English: Isotretinoin
Slovak: Isotretinoïne
English: Glaxosmithkline (Cyprus) Limited Isotrexin
Slovak: Glaxosmithkline (Cyprus)
English: Adapalène Zentiva Adapalene 0.1g/100 G Gel
Slovak: Sanofi-Aventis France Adapalène Zentiva Adapalén 0.1g/100 G Gél
English: Adapalene 0.1g/100 G Cream
Slovak: Adapalén 0.1g/100 G Krém
English: Tretinoin 0.5mg G
Slovak: Tretinoín 0.5 mg G
English: Isotretinoin 0.5mgg
Slovak: Izotretinoín 0.5 mgg
English: Verisfield (Uk) Ltd Retmicin
Slovak: Ltd Retmicin
English: Meda Pharmaceuticals Ltd Atralin
Slovak: Meda Pharmaceuticals Ltd
English: Isotretinoin 500µg G Gel
Slovak: Izotretinoín 500 µg G Gél
English: Isotretinoin 0.5mg
Slovak: Izotretinoín 0.5 mg
English: Erythromycin 20mgg, Isotretinoin 0.5mgg Gel
Slovak: Erythromycín 20mgg, Izotretinoín 0.5mgg
English: Isotretinoin 20mgg
Slovak: Izotretinoín 20 mgg
English: Tazarotene 0.05g/100 G Gel
Slovak: Tazarotén 0.05g/100
English: Ketrel
Slovak: Gél
English: Isotretinoin 0.05g/100 G Gel
Slovak: Izotretinoín 0.05g/100
English: Clindamycin Phosphate 10mg G, Tretinoin 0.25mg G
Slovak: Klindamycín fosfát 10mg G, Tretinoín 0.25mg G
English: Adapalene 0.1g/100 G Gel
Slovak: Adapalén 0.1g/100 G Gél
English: Laboratorios Galderma SaSucursal Em Portugal
Slovak: Sa - Sucursal Em Portugal
English: Glaxosmithkline Eood токтино
Slovak: Eood токтино
English: Isotrétinoïne Eg
Slovak: Isotrétinoïne
English: Isotretinoin Alliance Pharmaceuticals Isotretinoin 5mg Capsule Capsule, Soft
Slovak: Pharmachemie B.V Isotretinoïne Pch Izotretinoín 10 mg kapsula Kapsuly
English: Adapalene Zentiva Adapalene 0.1% Cream
Slovak: Sanofi-Aventis France Adapalene Zentiva Adapalén 0.1%
English: Meda Pharma Sia Treclinac
Slovak: Meda Pharma Sia
English: Tretinoin 0.25mg/Mg Cream
Slovak: Tretinoín 0.25 mg/Mg
English: Png Gerolymatos Medical A.E.
Slovak: Medical A.E.
English: Tretinoin 0.05g
Slovak: Tretinoín 0.05 g
English: Acitretin Genus Pharmaceuticals Acitretin 25mg Capsule Capsule, Hard
Slovak: Izotretinoín 25 mg kapsula Tvrdé kapsuly
English: Tretinoin 0.05g/100 Ml
Slovak: Tretinoín 0.05g/100
English: Adapalene 0.1g/100g Gel
Slovak: Adapalén 0.1g/100g
English: Puren Pharma Gmbh & Co. Kg
Slovak: Puren Pharma Gmbh
English: Tretinoin 0.025g/100 G Cream
Slovak: Tretinoín 0.05 g/100 G Krém
English: Erythromycin 20mg G, Isotretinoin 0.5mg G Gel
Slovak: Erytromycin 20 mg G, Izotretinoin 0.5 mg G
English: Tretinoin 500µg G
Slovak: Tretinoín 500 µg G
English: Dermapharm Ag Isoderm
Slovak: Regiomedica Gmbh Regioderm
English: Galderma Laboratorium Gmbh Epiduo
Slovak: Galderma Laboratorium
English: Roche (Magyarország) Kft Roaccutan
Slovak: Roche (Magyarország)
English: Tretinoin 1mg G
Slovak: Tretinoín 1 mg G
English: Tretinoin 0.03g/100 G, Urea 12g/100 G
Slovak: Louis Widmer Gmbh At Keratosis + Tretinoin Tretinoín 0.03g/100 G, Urea 12g/100 G
English: Tretinoin 0.5mg/Mg Cream
Slovak: Tretinoín 0.5 mg/Mg
English: Clindamycin 10mg G, Tretinoin 0.25mg G Gel
Slovak: Klindamycín 10mg G, Tretinoín 0.25mg G
English: Pharmachemie B.V Isotretinoïne Pch
Slovak: Pharmachemie B.V Isotretinoïne Pch Izotretinoín 20 mg kapsula Kapsuly
English: Curacné Gé
Slovak: Kožný roztok
English: Isotretinoin 0.05mg G Gel
Slovak: Izotretinoín 0.05 mg G Gél
English: Clindamycin 10mg G, Tretinoin 0.025mg G Gel
Slovak: Klindamycín 10 mg G, Tretinoín 0.025 mg G
English: Isosupra Lidose Isotretinoin 8mg Capsule Capsule, Hard
Slovak: Isotretinoína Orotrex Izotretinoín 10 mg kapsula
English: Tretinoin 0.05g/100g Cream
Slovak: Tretinoín 0.05g/100g
English: Aebe
Slovak: Zanea
English: Tretinoin 10mg Capsule Capsule, Soft
Slovak: Izotretinoín 10 mg kapsula Kapsuly
English: Isotretinoin 0.5mg G
Slovak: Izotretinoín 0.5 mg G Gél
English: Carinopharm Gmbh Balisa Vas
Slovak: Gmbh Balisa
English: Meda Pharmaceuticals S.A. Acnatac
Slovak: Meda Pharmaceuticals S.A.
English: Meda Pharma Gmbh & Co. Kg
Slovak: Meda Pharma Gmbh
English: Erythromycin 20mg G, Isotretinoin 0.05mg G Gel
Slovak: Erytromycín 20 mg G, Izotretinoín 0.05 mg G
English: Panretin
Slovak: Atralin
English: Cordes Vas
Slovak: Cordes
English: Glaxosmithkline (Ireland) Limited Isotrexin
Slovak: Glaxosmithkline (Ireland)
English: Laboratoires Bailleul Sa
Slovak: Bailleul Sa Contracne
English: Alitretinoin 1mg G
Slovak: Izotretinoín 1 mg G
English: Isotretinoin 5mg Capsule Capsule, Soft
Slovak: Izotretinoín 5 mg kapsula
English: Isotretinoin Jenson Isotretinoin 5mg Capsule Capsule, Soft
Slovak: Isotretinoïne Mylan Izotretinoín 10 mg kapsula
English: Isotretinoína Pierre Isotretinoin 10mg
Slovak: Isotretinoïne Aurobindo Izotretinoín 10 mg kapsula
English: EMA/476469/2014 EMEA/H/C/000664
Slovak: EMEA/H/C/000664
English: This type of epilepsy first appears in young children during the first year of life.
Slovak: Tento druh epilepsie sa prvýkrát objavuje u detí počas prvého roku života.
English: As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Slovak: Keďže spoločnosť predložila potrebné dodatočné informácie, povolenie bolo zmenené z tzv. podmienečného na úplné.
English: It is available as capsules and sachets (250 and 500 mg).
Slovak: Je dostupný vo forme kapsúl a vreciek (250 a 500 mg).
English: GABA is the main substance in nerve cells responsible for reducing the electrical activity of the brain.
Slovak: GABA je hlavná látka v nervových bunkách zodpovedná za znižovanie elektrickej activity mozgu.
English: The dose of valproate does not normally need to be adjusted.
Slovak: Dávka valproátu sa zvyčajne nemusí upravovať.
English: EPAR summary for the public stiripentol
Slovak: Súhrn správy EPAR pre verejnosť stiripentol
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.
Slovak: Pacient bol klasifikovaný ako odpovedajúci na liečbu, ak počet záchvatov počas druhého mesiaca liečby bol minimálne o 50 % nižší ako ich počet v mesiaci pred začatím liečby.
English: This was switched to a full marketing authorisation on 8 January 2014.
Slovak: Dňa 8. januára 2014 bolo toto povolenie zmenené na úplné.
English: The recommended dose is 50 mg per kilogram bodyweight, divided into two or three doses during the day.
Slovak: Odporúčaná dávka je 50 mg na kilogram telesnej hmotnosti, ktorá je rozdelená na dve alebo tri dávky užívané počas dňa.
English: Diacomit has been studied in two main studies involving 65 children between three and 18 years of age.
Slovak: Diacomit sa skúmal v dvoch hlavných štúdiách, do ktorých bolo zapojených 65 detí vo veku od troch do 18 rokov.
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.
Slovak: Diacomit bol pôvodne povolený s podmienkou, keďže bolo potrebné predložiť ďalšie informácie týkajúce sa tohto lieku, najmä v súvislosti s jeho krátkodobou a dlhodobou účinnosťou a bezpečnosťou.
English: This is a summary of the European public assessment report (EPAR) for Diacomit.
Slovak: Tento dokument je súhrn Európskej verejnej hodnotiacej správy (EPAR) o lieku Diacomit.
English: After starting Diacomit, the dose of clobazam may need to be reduced.
Slovak: Po začatí liečby liekom Diacomit možno bude potrebné znížiť dávku klobazamu.
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).
Slovak: Diacomit sa má podávať súčasne s jedlom, nie však s mliečnymi výrobkami, sýtenými nápojmi, ovocným džúsom ani jedlom a nápojmi, ktoré obsahujú kofeín alebo teofylín (látku, ktorá sa okrem iných výrobkov nachádza v čiernom a zelenom čaji).
English: The CHMP concluded that Diacomit had shown its effectiveness in SMEI, albeit studies were limited and did not last as long as the Committee expected.
Slovak: Výbor CHMP dospel k záveru, že v prípade lieku Diacomit sa preukázala účinnosť pri liečbe SMEI, aj keď štúdie boli obmedzené a netrvali tak dlho, ako výbor očakával.
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.
Slovak: 20 mg na kg telesnej hmotnosti, ktorá sa počas niekoľkých týždňov postupne zvyšuje na odporúčanú dávku, v závislosti od veku pacienta.
English: More patients responded to treatment with Diacomit than to placebo.
Slovak: Na liečbu liekom Diacomit odpovedalo viac pacientov ako na placebo.
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.
Slovak: Vysvetľuje, akým spôsobom Výbor pre lieky na humánne použitie (CHMP) vyhodnotil liek a dospel k stanovisku v prospech vydania povolenia na uvedenie na trh, ako aj k odporúčaniam, ako používať liek Diacomit.