EMA's Human Medicines Committee (CHMP) e se e qalile tlhahlobo ea meriana e nang le sodium oxybate e sebelisoang ho batho ba lemaletseng joala ho phekola lefu la ho khaotsa ho noa joala le ho ts'ehetsa ho ila nako e telele.
Tlhahlobo e hlahisitsoe ke tlhahlobo ea kopo ea tumello ea ho bapatsa Fora bakeng sa moriana o akaretsang o nang le sodium oxybate. Nakong ea tlhahlobo, lefapha la meriana la Fora le ne le tšoenyehile ka katleho ea sodium oxybate ho itšetleheng ka joala, ho ipapisitse le lintlha tse tsoang lithutong tse tharo.1, 2, 3 Ho ne ho boetse ho e-na le matšoenyeho mabapi le kotsi ea tlhekefetso kapa tšebeliso e mpe ka lebaka la thepa ea psychoactive ea moriana (liphello bokong), le hore na mehato ea hajoale ea ho fokotsa likotsi tsena e lekane.
E ipapisitse le lintlha tsena, EMA joale e tla lekola tekanyo ea kakaretso ea kotsi ea sodium oxybate ho phekola lefu la ho khaotsa ho noa joala le ho tšehetsa ho ila tahi ka nako e telele 'me e tla hlahloba mehato ea ho fokotsa kotsi ea tlhekefetso kapa tšebeliso e mpe. Joale Setsi se tla etsa qeto ea hore na ho na le mehato efe ea taolo e lokelang ho nkuoa.
Tse ling ka moriana
Meriana e nang le sodium oxybate (175 mg/ml) e sebelisoa ho batho ba baholo ba nang le bokhoba ba tahi ka bobona kapa e le moriana oa tlatsetso ho phekola lefu la ho tlohela joala le ho ts'ehetsa ho ila nako e telele tlas'a taolo ea bongaka, hammoho le kalafo ea kelello (boeletsi) le ntlafatso ea sechaba.
Sodium oxybate e khomarela li-receptors (lipheo) liseleng tsa methapo ea boko le lesapo la mokokotlo bakeng sa ntho e bitsoang gamma-aminobutyric acid (GABA), e lebisang ho khutsitseng mosebetsi oa lisele tsena. Kaha e lebisa li-receptor tsena ka tsela e tšoanang le ea joala, sodium oxybate e sebelisoa ho phekola matšoao a ho tlohela joala ho bakuli ba itšetlehileng ka joala, ho akarelletsa le ho ferekana, ho thothomela (ho sisinyeha) le mathata a ho robala, le ho tšehetsa ho ithiba.
Sodium oxybate 175 mg/ml e lumelletsoe naha ka bophara Austria le Italy hore e sebelisoe ho bakuli ba itšetlehileng ka joala, tlasa lebitso la Alcover. Austria, e fumaneha e le sirapo bakeng sa ho phekola lefu la ho khaotsa ho noa joala le ho tšehetsa ho itima nako e telele tlas'a tlhokomelo ea bongaka hammoho le psychotherapy (boeletsi) le tsosoloso ea sechaba. Italy, e fumaneha e le tharollo ea molomo bakeng sa tšebeliso e le moriana oa adjuvant (add-on) ho laola lefu le matla la ho tlohela joala.
Sodium oxybate oral solution (500 mg/ml) e boetse e sebelisoa ho phekola lefu la ho nyekeloa ke pelo. Tlhahlobo ha e kenyelletse meriana ena.
Tse ling ka mokhoa ona
Tlhahlobo ea meriana e nang le sodium oxybate taolong ea ho itšetleha ka joala e qalile ka kopo ea setsi sa meriana sa Fora tlasa Article 31 ea Directive 2001/83/EC.
Tlhahlobo e ntse e etsoa ke Komiti ea Lihlahisoa tsa Meriana bakeng sa Tšebeliso ea Batho (CHMP), e ikarabellang lipotsong tse mabapi le meriana e sebelisoang ke batho, e tla amohela maikutlo a Mokhatlo. Maikutlo a CHMP joale a tla fetisetsoa ho Khomishene ea Europe, e tla fana ka qeto ea ho qetela e tlamang ka molao e sebetsang Linaheng tsohle tsa Litho tsa EU.
- 1 Nimmerrichter AA, Walter H, Gutierrez-Lobos KE, Lesch OM. Teko e laoloang ka bofofu habeli ea gamma-hydroxybutyrate le clomethiazole kalafong ea ho tlohela joala. Joala Joala. 2002 Jan-Feb;37(1):67-73.
- 2 Caputo F, Skala K, Mirijello A, Ferrulli A, Walter H, Lesch O, Addolorato G. Sodium oxybate ha ho phekoloa lefu la ho khaotsa ho noa joala: thuto ea ho bapisa e sa boneng habeli khahlanong le oxazepam. Teko ea GATE 1. Lithethefatsi tsa CNS. 2014 Aug;28(8):743-52.
- 3 Guiraud J, Addolorato G, Antonelli M, le ba bang. Sodium oxybate bakeng sa ho boloka ho ithiba ho bakuli ba itšetlehileng ka joala: Teko ea machaba, e mengata, e sa tloaelehang, e sa boneng habeli, e laoloang ke placebo. J Psychopharmacol. 2022 Oct;36(10):1136-1145.
