FrancophonIA/ELRC3.0 huggingface dataset:
English: In the studies, Paxene was used with other anticancer medicines and compared with other treatments.
Latvian: Veiktos pētījumos Paxene tika lietotas kopā ar citām zālēm un salīdzinātas ar citām zālēm.
English: The full EPAR for Paxene is available here.
Latvian: Pilns Paxene EPAR teksts ir atrodams šeit.
English: Paxene also affects non-cancer cells such as blood cells, which causes side effects.
Latvian: Paxene ietekmē ne tikai audzēja šūnas, piemēram, asins šūnas, un tas izraisa blakusparādības.
English: Why has Paxene been approved?
Latvian: Kāpēc Paxene tika apstiprinātas?
English: Treatment with Paxene improved the response rates for various types of cancer.
Latvian: Ārstēšana ar Paxene uzlaboja dažāda vēža veidu reakciju.
English: Paxene also increased how long patients survived for some types of cancer.
Latvian: Paxene pagarināja arī dažu vēža veidu pacientu dzīvildzi.
English: Paxene is an anticancer medicine.
Latvian: Paxene ir pretvēža zāles.
English: Paxene is a concentrate that is made up into a solution for infusion (drip into a vein).
Latvian: Paxene ir flakons, no kura pagatavo šķīdumu infūzijai (ievadīšanai vēnā pa pilienam).
English: • metastatic breast cancer, when other treatments have failed or cannot be used.
Latvian: • metastazējošu krūts dziedzera vēzi, kad citas zāles ir izrādījušās nesekmīgas vai bijušas nelietojamas.
English: What is Paxene?
Latvian: Kas ir Paxene?
English: Paxene should not be used in people who may be hypersensitive (allergic) to paclitaxel or any of the other ingredients.
Latvian: Paxene nedrīkst lietot cilvēki ar paaugstinātu jutību (alerģiju) pret paklitakselu vai kādu citu šo zāļu sastāvdaļu.
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.
Latvian: Paxene deva, devas ievadīšanas biežums un ārstēšanas ilgums ir atkarīgs no ārstējamā vēža veida un no tām pretvēža zālēm, ko dod kopā ar Paxene.
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;
Latvian: • progresējošu AIDS atkarīgu Kapoši sarkomu (ādas vēzi, ar ko bieži slimo AIDS pacienti), kad ārstēšana ar antraciklīniem (citu pretvēža zāļu veidu) ir izrādījusies nesekmīga;
English: • metastatic cancer of the ovary, when other treatments such as platinum-containing combination therapy have failed;
Latvian: • metastazējošu olnīcu vēzi, kad cita ārstēšana, piemēram, platīnu ietveroša kombinēta ārstēšana, ir izrādījusies nesekmīga;
English: • non-small cell lung cancer, in combination with cisplatin, when patients cannot have surgery or radiation therapy.
Latvian: • nesīkšūnu plaušu vēzi, lietojot kombinācijā ar cisplatīnu, kad pacientus nevar operēt un/vai ārstēt ar apstarošanu.
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.
Latvian: Cilvēkiem paredzēto zāļu komiteja (CHMP) nolēma, ka pacienta ieguvums, lietojot Paxene progresējošas AIDS atkarīgu Kapoši sarkomas, metastazējoša krūts dziedzera vēža, progresējoša olnīcu vēža (lietojot kombinācijā ar cisplatīnu), metastazējoša olnīcu vēža, kura ārstēšanā platīnu ietveroša kombinācijas terapija bijusi nesekmīga, un nesīkšūnu plaušu vēža ārstēšanā, pārsniedz šo zāļu radīto risku.
English: The active substance in Paxene, paclitaxel, belongs to the group of anticancer medicines known as the taxanes.
Latvian: Paxene aktīvā viela paklitaksels pieder pretvēža zāļu grupai, ko dēvē par taksāniem.
English: • advanced cancer of the ovary (when the cancer has started to spread out of the ovary), in combination with cisplatin (another anticancer medicine);
Latvian: • progresējošu olnīcu vēzi (vēzis, kas ir sācis izplatīties no olnīcām uz citam ķermeņa daļām), lietojot kombinācijā ar cisplatīnu (citām pretvēža zālēm);
English: What benefit has Paxene shown during the studies?
Latvian: Kāds ir Paxene iedarbīgums šajos pētījumos?
English: What is the risk associated with Paxene?
Latvian: Kāds pastāv risks, lietojot Paxene?
English: It is used for the treatment of the following types of cancer:
Latvian: Paxene lieto, lai ārstētu šādus vēža veidus:
English: For the full list of all side effects reported with Paxene, see the Package Leaflet.
Latvian: Pilns visu Paxene izraisīto nevēļamo blakusparādību apraksts ir atrodams zāļu lietošanas pamācībā.
English: How is Paxene used?
Latvian: Kā lieto Paxene?
English: How does Paxene work?
Latvian: Kā Paxene darbojas?
English: How has Paxene been studied?
Latvian: Kā noritēja Paxene izpēte?
English: What is Paxene used for?
Latvian: Kāpēc lieto Paxene?
English: Pierre Fabre Italia S.P.A.
Latvian: Pierre Fabre Italia S.P.
English: Galderma Italia S.P.A.
Latvian: Galderma Italia S.P.
English: Tretinoina Same Savoma Medicinali
Latvian: Savoma Medicinali Spa Tretinoina Same Savoma Medicinali
English: Pharmaceuticals Ireland
Latvian: Allergan Pharmaceuticals Ireland
English: Aurovitas Spain,s.A.U.
Latvian: Aurovitas Spain,s.
English: Teva Magyarország Zrt
Latvian: Teva Magyarország Zrt Isotretinoin Teva
English: Arrow Generiques Acnetrait
Latvian: Arrow Generiques
English: Genus Pharmaceuticals
Latvian: Acitretin Genus Pharmaceuticals
English: Dr. R. Pfleger Chemische Fabrik Gmbh
Latvian: R. Pfleger Chemische Fabrik Gmbh
English: Laboratorios Farmaceuticos Stiefel (Portugal) Ltda
Latvian: Laboratorios Farmaceuticos Stiefel (Portugal)
English: Laboratorios Galderma SaSucursal Em Portugal
Latvian: Laboratorios Galderma Sa - Sucursal Em Portugal
English: Capsule
Latvian: Cietā kapsula
English: Pharmaceuticals Limited
Latvian: Genus Pharmaceuticals Limited
English: Ichthyol-Gesellschaft Cordes, Hermanni & Co. (Gmbh & Co.) Kg
Latvian: Ichthyol-Gesellschaft Cordes, Hermanni & Co.
English: Stiefel Laboratories (Ireland) Ltd
Latvian: Stiefel Laboratories (Ireland)
English: Isotretinoin Generics [uk]
Latvian: Generics [uk] Limited Isotretinoin Generics [uk]
English: Galderma (Uk) Limited
Latvian: Galderma (Uk) Limited Differin
English: Laboratoires Bailleul Sa
Latvian: Laboratoires Bailleul Sa Erylik
English: Acitretin 10mg
Latvian: Acitretinum 10 mg
English: Isotretinoin Ranbaxy (Uk)
Latvian: Ranbaxy (Uk) Limited Isotretinoin Ranbaxy (Uk)
English: Pharmaceuticals Polska Sp. Z O.O.
Latvian: Teva Pharmaceuticals Polska Sp. Z O.O.
English: Almirall Hermal Gmbh
Latvian: Almirall Hermal Gmbh Aknenormin
English: Mg
Latvian: Kg
English: Societe D'etudes Et De Recherches Pharmaceutiques (Serp)
Latvian: Societe D'etudes Et De Recherches
English: Dexpanthenol 0.1mg G, Tretinoin 3µg G, Urea 1.2mg G
Latvian: Dexpanthenolum 0,1mg G, Tretinoinum 3 µg G, Ureum 1,2 mg G
English: Adapalene 1mg G, Benzoyl Peroxide 25mg G
Latvian: Adapalenum 1 mg G, Benzoylis peroxidum 25 mg G
English: Ehf.
Latvian: A.U.
English: S.A. Meda Pharma N.V.
Latvian: Meda Pharma N.V.
English: Glaxosmithkline Gmbh & Co. Kg
Latvian: Glaxosmithkline Gmbh & Co.
English: Sun-Farm Sp. Z.O.O.
Latvian: Sun-Farm Sp. Z.O.O. Acitren
English: Dermapharm Ag Keraderm
Latvian: Dermapharm Ag
English: Louis Widmer Gmbh De
Latvian: Louis Widmer Gmbh De Wicaran
English: Glaxosmithkline Aebe
Latvian: Glaxosmithkline Aebe Cehado
English: Puren Pharma Gmbh & Co. Kg
Latvian: Puren Pharma Gmbh & Co.
English: Galderma International
Latvian: Galderma International Differine
English: Galderma Hellas S.A. Epiduo
Latvian: Galderma Hellas S.A.
English: Roche Latvija Sia Roaccutane
Latvian: Roche Latvija Sia
English: Meda Pharma
Latvian: Meda Pharma Sas
English: Pharmaswiss česká Republika S.R.O.
Latvian: Pharmaswiss česká
English: Erythromycin 4g/100 G, Tretinoin 0.025g/100 G Gel
Latvian: Erythromycinum 4 g/100 G, Tretinoinum 0,025 g/100 G
English: Actavis Group Ptc Acnenor
Latvian: Actavis Group Ptc Ehf. неотигазон
English: Isoriac
Latvian: A. Isoriac
English: Tretinoin 15mg/30 G Cream
Latvian: Tretinoinum 15 mg/30 G Krēms
English: Isotretinoin Ratiopharm Isotretinoin 20mg
Latvian: Ratiopharm Gmbh Isotretinoin Ratiopharm Isotretinoinum 20 mg
English: Galderma Hellas S.A. Adaferin
Latvian: Galderma International Adaferin
English: Ziaja Ltd Zakład Produkcji Leków Sp Z O.O.
Latvian: Produkcji Leków Sp Z O.O.
English: Nexus Medicals S.A. Accuran
Latvian: Nexus Medicals S.A.
English: Tretinoin 0.5mg/Ml
Latvian: Tretinoinum 0,5 mg/ml
English: Galderma Laboratorium Gmbh Epiduo
Latvian: Galderma Laboratorium Gmbh
English: Tazarotene 0.5mg G Gel
Latvian: Tazarotenum 0,5 mg G Gels
English: Tretinoin 0.3mg G, Urea 120mg G
Latvian: Tretinoinum 0,3 mg G, Ureum 120 mg G
English: Tazarotene 1mg G Gel
Latvian: Tazarotenum 1 mg G Gels
English: Sapiens Pharmaceuticals Ltd Rotren
Latvian: Sapiens Pharmaceuticals Ltd
English: Glaxosmithkline (Cyprus) Limited Isotrexin
Latvian: Glaxosmithkline (Cyprus) Limited
English: Acitretin 25mg Capsule Capsule
Latvian: Acitretinum 25 mg kapsula Cietā kapsula
English: Tretinoin 500µg/Ml, DlAlpha Tocopherol Acetate 100µg/Ml
Latvian: Atrederm 0,05% Tretinoinum 500 µg/ml, Dlalfa-tocopherylis acetas 100 µg/ml
English: B.V.
Latvian: N.V.
English: Isotretinoin 0.05g/100 G Gel
Latvian: Isotretinoinum 0,05 g/100 G Gels
English: N.V. Roche S.A.
Latvian: Roche S.A.
English: Isotretinoin 1mg G Cream
Latvian: Isotretinoinum 1 mg G Krēms
English: Teva
Latvian: Dr.
English: Isotretinoin 500µg G Gel
Latvian: Tretinoinum 500 µg G Krēms
English: Isotretinoin 0.5mg
Latvian: Isotretinoinum 0,5 mg
English: Tretinoin 250µg/Ml, DlAlpha Tocopherol Acetate 50µg/Ml
Latvian: Atrederm 0,025% Tretinoinum 250 µg/ml, Dlalfa-tocopherylis acetas 50 µg/ml
English: Gmbh & Co. Kg
Latvian: (Gmbh & Co.)
English: Erythromycin 20mgg, Isotretinoin 0.5mgg Gel
Latvian: Erythromycinum 20 mgg, Isotretinoinum 0,5 mgg
English: Hydrocortisone 10mg G, Tretinoin 1mg G,
Latvian: Hydrocortisonum 10 mg G, Tretinoinum 1 mg G, Hydroquinonum 50 mg G
English: Tazarotene 0.1mg/100 Gel
Latvian: Tazarotenum 0,1 mg/100 mg Gels
English: Adapalene 0.1% Cream
Latvian: Adapalenum 0,1% Krēms
English: Isotretinoin Jenson Isotretinoin 5mg Capsule Capsule, Soft
Latvian: Generics [uk] Limited Isotretinoin Jenson Isotretinoinum 5 mg kapsula Mīkstā kapsula
English: Tretinoin 0.1g
Latvian: Tretinoinum 0,1 g
English: Isotretinoin 10mg
Latvian: Isotretinoinum 5 mg
English: Isotretinoin Puren
Latvian: Isotretinoina Stiefel
English: Clindamycin Phosphate 10mg G, Tretinoin 0.25mg G
Latvian: Clindamycini phosphas 10 mg G, Tretinoinum 0,25 mg G
English: Tretinoin 0.05g
Latvian: Tretinoinum 0,05 g
English: Meda Pharmaceuticals Ltd Atralin
Latvian: Meda Pharmaceuticals Ltd
English: Glaxosmithkline Kft. Isotrexin
Latvian: Glaxosmithkline S.R.O. Isotrexin
English: Adapalène Zentiva Adapalene 0.1g/100 G Gel
Latvian: Sanofi-Aventis France Adapalène Zentiva Adapalenum 0,1g/100 G Gels
English: Adapalene 1mg G
Latvian: Adapalenum 1 mg G Krēms
English: Tazarotene 0.05g/100 G Gel
Latvian: Tazarotenum 0,05 g/100 G Gels
English: Glaxosmithkline D.O.O.
Latvian: Glaxosmithkline D.O.O. Toctino
English: Tazarotene 0.1g/100 G Gel
Latvian: Tazarotenum 0,1g/100 G Gels
English: Glaxosmithkline (Ireland) Limited Isotrexin
Latvian: Glaxosmithkline (Ireland) Limited
English: Acitretin 10mg Capsule Capsule
Latvian: Isotretinoinum 10 mg kapsula Kapsula
English: Isotretinoin Teva
Latvian: Adapalene Teva
English: Carbamid + Vas Creme
Latvian: Ureotop + Vas
English: Tretinoin 4mg G
Latvian: Tretinoinum 4 mg G Krēms
English: Tretinoin 0.025g/100 G Cream
Latvian: Tretinoinum 0,025 g/100 G Krēms
English: Isotretinoin 0.5mgg Gel
Latvian: Isotretinoinum 0,5 mgg Gels
English: Isotretinoin Alliance Pharmaceuticals Isotretinoin 5mg Capsule Capsule, Soft
Latvian: Pharmachemie B.V Isotretinoïne Pch Isotretinoinum 10 mg kapsula Kapsula
English: Erythromycin 20mg G, Isotretinoin 0.5mg G Gel
Latvian: Erythromycinum 20 mg G, Isotretinoinum 0,5 mg G
English: Meda Pharma Sia Treclinac
Latvian: Meda Pharma Sia
English: Tretinoin 0.25mg/Mg Cream
Latvian: Tretinoinum 0,25 mg/mg Krēms
English: Adapalene 1mgg
Latvian: Adapalenum 1 mgg
English: Pharmachemie B.V Isotretinoïne Pch
Latvian: Pharmachemie B.V Isotretinoïne Pch Isotretinoinum 20 mg kapsula Kapsula
English: Tretinoin 10mg Capsule Capsule, Soft
Latvian: Tretinoinum 10 mg kapsula Mīkstā kapsula
English: Tretinoin 0.05% Cream
Latvian: Tretinoinum 0,05% Krēms
English: Erythromycin 20mg G, Isotretinoin 0.05mg G Gel
Latvian: Erythromycinum 20 mg G, Isotretinoinum 0,05 mg G
English: Isotretinoin Sandoz Isotretinoin 20mg
Latvian: Isotretinoin Sandoz Ltd Isotretinoinum 20 mg kapsula Mīkstā kapsula
English: Clindamycin 10mg G, Tretinoin 0.025mg G Gel
Latvian: Clindamycinum 10 mg G, Tretinoinum 0,025 mg G
English: Isosupra Lidose Isotretinoin 8mg Capsule Capsule, Hard
Latvian: Isotretinoinum 8 mg kapsula Cietā kapsula
English: Adapalene Zentiva Adapalene 0.1% Cream
Latvian: Adapalenum 0,1 masas % Krēms
English: Adapalene 0.1g/100 G Cream
Latvian: Adapalenum 0,1g/100 G Krēms
English: Isotretinoin 0.5mg G Cream
Latvian: Isotretinoinum 0,5 mg G Krēms
English: Isotretinoin 0.05%w/W Gel
Latvian: Isotretinoinum 0,05 masas % Gels
English: Isotretinoin 0.5mg G
Latvian: Isotretinoinum 0,5 mg G Gels
English: Tretinoin 0.25mg G Cream
Latvian: Tretinoinum 0,25 mg G Krēms
English: Adapalene 0.1% Gel
Latvian: Adapalenum 0,1 masas % Gels
English: Clindamycin 10mg G, Tretinoin 0.25mg G Gel
Latvian: Clindamycinum 10 mg G, Tretinoin 0,25 mg G
English: Topical Application
Latvian: Lokālai lietošanai
English: Acitren
Latvian: Accuran
English: Aebe
Latvian: Zanea
English: Tretinoin 0.05%w/W Gel
Latvian: Tretinoinum 0,05 masas % Gels
English: Adapalene 0.1g/100g Gel
Latvian: Adapalenum 0,1g/100 g Gels
English: Meda Pharmaceuticals S.A. Acnatac
Latvian: Meda Pharmaceuticals S.A.
English: Panretin
Latvian: Atralin
English: Roche (Magyarország) Kft Roaccutan
Latvian: Roche (Magyarország)
English: Alitretinoin 1mg G
Latvian: Adapalenum 1 mg G Gels
English: Stiefel Laboratories Toctino
Latvian: Laboratoires Bailleul Sa Contracne
English: Acitretin Genus Pharmaceuticals Acitretin 25mg Capsule Capsule, Hard
Latvian: Acitretinum 25 mg kapsula Kapsula
English: Isotretinoin 0.05mg G Gel
Latvian: Isotretinoinum 0,05 mg G Gels
English: Adapalene 0.1g/100 G Gel
Latvian: Adapalenum 0,1 g/100 G Gels
English: Isotretinoin Actavis Isotretinoin 5mg Capsule Capsule, Soft
Latvian: Isotretinoína Generis Isotretinoinum 10 mg kapsula Mīkstā kapsula
English: It is available as capsules and sachets (250 and 500 mg).
Latvian: Tās ir pieejamas kapsulās un maisiņos (250 un 500 mg).
English: This type of epilepsy first appears in young children during the first year of life.
Latvian: Šis epilepsijas veids pirmoreiz parādās bērniem pirmajā dzīves gadā.
English: As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Latvian: Tā kā uzņēmums iesniedza vajadzīgo papildu informāciju, reģistrācija ar nosacījumiem tika aizstāta ar pilnīgu apstiprinājumu.
English: The dose of valproate does not normally need to be adjusted.
Latvian: Valproāta devu parasti nevajag pielāgot.
English: This is a summary of the European public assessment report (EPAR) for Diacomit.
Latvian: Šis ir Eiropas Publiskā novērtējuma ziņojuma (EPAR) kopsavilkums par Diacomit.
English: Other information about Diacomit
Latvian: Cita informācija par Diacomit
English: The main measure of effectiveness was the number of patients who ‘responded' to treatment.
Latvian: Galvenais iedarbīguma rādītājs bija to pacientu skaits, kuri reaģēja uz ārstēšanu.
English: EPAR summary for the public stiripentol
Latvian: EPAR kopsavilkums plašākai sabiedrībai stiripentols
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.
Latvian: Ārstēšanu uzsāk ar devu 20 mg uz 1 kg ķermeņa svara, ko pakāpeniski palielina līdz ieteicamajai devai vairāku nedēļu laikā atkarībā no pacienta vecuma.
English: GABA is the main substance in nerve cells responsible for reducing the electrical activity of the brain.
Latvian: GASS ir pamatviela nervu šūnās, kas atbild par elektriskās aktivitātes samazināšanu smadzenēs.
English: Care must be taken when Diacomit is used at the same time as other medicines.
Latvian: Jābūt piesardzīgam, lietojot Diacomit vienlaikus ar citām zālēm.
English: After starting Diacomit, the dose of clobazam may need to be reduced.
Latvian: Pēc Diacomit lietošanas uzsākšanas var būt nepieciešams samazināt klobazāma devu.
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.
Latvian: CHMP secināja, ka ir parādīts Diacomit iedarbīgums SMEI ārstēšanā, taču pētījumi bija ierobežoti un nebija tik ilgi, kā Komiteja sagaidīja.
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).
Latvian: Diacomit jādod vienlaikus ar ēdienu, bet ne ar piena produktiem, gāzētiem dzērieniem, augļu sulu vai ēdieniem vai dzērieniem, kas satur kofeīnu vai teofilīnu (vielu, kas bez citiem produktiem, ir atrodama arī melnā un zaļā tējā).
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.
Latvian: Sākotnēji Diacomit tika piemērota „reģistrācija ar nosacījumiem”, jo bija sagaidāmi papildu dati par šīm zālēm, jo īpaši attiecībā uz šo zāļu iedarbīgumu un nekaitīgumu īstermiņā un ilgtermiņā.
English: Diacomit has been studied in two main studies involving 65 children between three and 18 years of age.
Latvian: Diacomit iedarbību izskatīja divos pamatpētījumos, iesaistot 65 bērnus no trīs līdz 18 gadu vecumam.
English: More patients responded to treatment with Diacomit than to placebo.
Latvian: Uz ārstēšanu ar Diacomit reaģēja lielāks pacientu skaits nekā uz placebo.
English: The recommended dose is 50 mg per kilogram bodyweight, divided into two or three doses during the day.
Latvian: Ieteicamā deva ir 50 mg uz 1 kg ķermeņa svara, sadalīta divās līdz trīs devās dienas garumā.
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.
Latvian: Pilns Diacomit EPAR teksts ir atrodams aģentūras tīmekļa vietnē: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
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.
Latvian: Pacients tika klasificēts kā reaģējošs, ja lēkmju skaits otrajā ārstēšanas mēnesī ar Diacomit bija vismaz par 50 % mazāks nekā mēnesī, pirms tika uzsākta ārstēšana ar Diacomit.
English: The European Commission granted a conditional marketing authorisation valid throughout the European Union for Diacomit on 4 January 2007.
Latvian: Eiropas Komisija 2007. gada 4. janvārī izsniedza Diacomit reģistrācijas apliecību, kas ir derīga visā Eiropas Savienībā.
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).
Latvian: Pirmajā pētījumā 71% Diacomit lietojošo pacientu reaģēja uz ārstēšanu (15 no 21), salīdzinot ar 5% placebo grupā (1 no 20).
English: Similar results were seen in the second study, with 67% responding to Diacomit (8 out of 12) and 9% to placebo (1 out of 9).
Latvian: Līdzīgus rezultātus novēroja otrajā pētījumā, kur 67% pacientu reaģēja uz Diacomit (8 no 12) un 9% pacientu reaģēja uz placebo (1 no 9).
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.
Latvian: Retu slimību ārstēšanai paredzēto zāļu komitejas atzinuma kopsavilkums par Diacomit ir atrodams aģentūras tīmekļa vietnē: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: Diacomit is an anti-epileptic medicine that contains the active substance stiripentol.
Latvian: Diacomit ir pretepilepsijas zāles, kas satur aktīvo vielu stiripentolu.
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).
Latvian: Visbiežāk novērotās Diacomit blakusparādības (vairāk nekā 1 pacientam no 10) bija ēstgribas zudums, svara zudums, bezmiegs, miegainība, ataksija (nespēja koordinēt muskuļu kustību), hipotonija (mazs muskuļu spēks) un distonija (muskuļu darbības traucējumi).
English: Decisions regarding the use of Diacomit in younger children should be made on a patient-by-patient basis: it can only be given to younger children if the diagnosis of SMEI has been confirmed.
Latvian: Lēmumu par Diacomit lietošanu jaunākiem bērniem ir jāpieņem katram pacientam individuāli: tās var dot jaunākiem bērniem tikai tad, ja SMEI diagnoze ir apstiprināta.
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.
Latvian: Tajā ir paskaidrots, kā Cilvēkiem paredzēto zāļu komiteja (CHMP) novērtēja šīs zāles, pirms sniegt pozitīvu atzinumu par reģistrācijas apliecības piešķiršanu un ieteikumus par Diacomit lietošanu.
English: It has been shown in experimental models to increase the levels of a ‘neurotransmitter' called gamma aminobutyric acid (GABA) in the brain.
Latvian: Eksperimentālos modeļos noskaidroja, ka tas palielina neirotransmitera, ko dēvē par gamma aminosviestskābi (GASS), līmeni smadzenēs.
English: The main studies of Diacomit were in children over three years of age.
Latvian: Diacomit pamatpētījumus veica ar bērniem, kas vecāki par trīs gadiem.
English: Because the number of patients with SMEI is low, the disease is considered ‘rare', and Diacomit was designated as an ‘orphan medicine' (a medicine used in rare diseases) on 5 December 2001.
Latvian: Sakarā ar to, ka SMEI pacientu skaits ir mazs, šo slimību uzskata par retu, un 2001. gada 5. decembrī Diacomit tika apstiprinātas kā zāles retu slimību ārstēšanai.
English: Treatment with Diacomit should only be given under the supervision of a doctor who specialises in the diagnosis and management of epilepsy in children (a paediatrician or paediatric neurologist).
Latvian: Ārstēšanu ar Diacomit drīkst veikt tikai tāda ārsta uzraudzībā, kas specializējas zīdaiņu un bērnu epilepsijas diagnostikā un ārstēšanā (pediatrs vai pediatrs neirologs).
English: Why has Diacomit been approved?
Latvian: Kāpēc Diacomit tika apstiprinātas?
English: Diacomit is used in children with a very rare type of epilepsy called ‘severe myoclonic epilepsy in infancy' (SMEI), also known as Dravet's syndrome.
Latvian: Diacomit lieto bērniem ar ļoti retu epilepsijas veidu, ko sauc par smagu mioklonisku epilepsiju agrā bērnībā (SMEI), kas pazīstama arī kā Dravet sindroms.
English: The exact way in which stiripentol, the active substance in Diacomit, acts as an anti-epileptic medicine is not fully known.
Latvian: Mehānisms, kā stiripentols, Diacomit aktīvā viela, darbojas kā pretepilepsijas zāles, nav pilnībā zināms.
English: The sachets contain a powder that is used to make up an oral suspension (a liquid with solid particles in it).
Latvian: Maisiņi satur pulveri, no kura pagatavo suspensiju iekšķīgai lietošanai (šķidrumu ar tajā izkliedētām cietvielas daļiņām).