natgillin/translations-raw huggingface dataset:
• blood clot in the portal vein (blood vessel that carries blood to the liver from the intestines)
• krvni ugrušak u portalnoj veni (krvna žila koja prenosi krv od crijeva do jetre) koji može dovesti do pojave bolova ili oticanja u gornjem dijelu trbuha
Interferon preparations have been known to reduce platelet counts, therefore, this should be considered when co-administering avatrombopag with interferon preparations.
Poznato je da pripravci interferona smanjuju broj trombocita, pa to treba uzeti u obzir kod istodobne primjene avatrombopaga s pripravcima interferona.
However, these patients should be evaluated on the day of the procedure for an unexpectedly high increase in platelet count (see section 4.2 and 5.2).
Međutim, u tih bolesnika na dan postupka treba provjeriti je li se pojavio neočekivano visok porast broja trombocita (vidjeti dio 4.2 i 5.2).
Avatrombopag should only be used in such patients if the expected benefit outweighs the expected risks (see sections 4.2 and 5.2).
Terapiju avatrombopagom u takvih bolesnika treba započeti samo ako je očekivana korist veća od očekivanih rizika (vidjeti dio 4.2 i 5.2).
The most important treatment-emergent adverse reaction associated with avatrombopag was portal vein thrombosis.
Najvažnija nuspojava nastala kod liječenja, povezana s avatrombopagom, bila je tromboza portalne vene.
Patients in the low baseline platelet count cohort received 60 mg avatrombopag or matching placebo once daily for 5 days, and patients in the high baseline platelet count cohort received 40 mg avatrombopag or matching placebo once daily for 5 days.
Bolesnici s niskom početnom vrijednošću broja trombocita su primali 60 mg avatrombopaga ili odgovarajuću dozu placeba jednom dnevno tijekom 5 dana, a bolesnici s visokom početnom vrijednošću broja trombocita 40 mg avatrombopaga ili odgovarajuću dozu placeba jednom dnevno tijekom 5 dana.
Portal vein thrombosis has been reported at an increased frequency in patients with chronic liver disease who had platelet counts > 200 x 109/L receiving a thrombopoietin receptor agonist (see section 4.8).
Tromboza portalne veni je prijavljena s većom učestalosti u bolesnika s kroničnom bolešću jetre čiji je broj trombocita bio > 200 x 109/L, a koji su primali agoniste receptora trombopoetina (vidjeti dio 4.8).
In these species, avatrombopag was associated with histopathologic changes in the fundic mucosa of the glandular stomach, characterised by degeneration of the glandular epithelium with a decrease in matured parietal cells.
U ovih vrsta je avatrombopag bio povezan s histopatološkim promjenama u sluznici fundusa žljezdanog želuca, koje karakteriziraju degeneracija žljezdanog epitela sa smanjenjem broja zrelih parijetalnih stanica.
If any of the above applies to you, or you are not sure, talk to your doctor or pharmacist before taking Doptelet.
Ako se bilo što od navedenog odnosi na Vas ili ako niste sigurni, prije uzimanja Dopteleta razgovarajte sa svojim liječnikom ili ljekarnikom.
In Study 1, a total of 231 patients were randomised; 149 patients to the avatrombopag group and 82 patients to the placebo group.
U Ispitivanju 1 je randomiziran ukupno 231 bolesnik, od čega 149 bolesnika u skupinu koja je uzimala avatrombopag, a 82 bolesnika u placebo skupinu.
- The active substance is avatrombopag.
Djelatna tvar je avatrombopag.
Avatrombopag therapy should only be initiated in patients with severe hepatic impairment if the expected benefit outweighs the expected risks (see sections 4.4 and 5.2).
Terapiju avatrombopagom u bolesnika s teškim oštećenjem jetre smije se započeti samo ako je očekivana korist veća od očekivanih rizika (vidjeti dio 4.4 i 5.2).
Doptelet contains an active substance called avatrombopag.
Doptelet sadrži djelatnu tvar pod nazivom avatrombopag.
The apparent volume of distribution of avatrombopag in patients with thrombocytopenia and chronic liver disease based on population pharmacokinetic analysis is approximately 180 L, suggesting that avatrombopag is extensively distributed.
Prividni volumen distribucije avatrombopaga u bolesnika s trombocitopenijom i kroničnom bolešću jetre temeljen na farmakokinetičkoj analizi populacije je približno 180 L, što upućuje na to da se avatrombopag opsežno distribuira.
Doptelet is not recommended during pregnancy and in women of childbearing potential not using contraception.
Ne preporučuje se primjena Dopteleta tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
Concomitant use of avatrombopag with strong CYP3A4/5 or CYP2C9 inhibitors increases avatrombopag exposure.
Istodobna primjena avatrombopaga sa snažnim inhibitorima CYP3A4/5 ili CYP2C9 povećava izloženost avatrombopagu.
Tablet core: lactose monohydrate (see section 2 “Doptelet contains lactose”); microcrystalline cellulose [E460(i)]; crospovidone type B [E1202]; silica, colloidal anhydrous [E551]; magnesium stearate [E470b].
Jezgra tablete: laktoza hidrat (vidjeti dio 2. „Doptelet sadrži laktozu”), mikrokristalična celuloza [E460(i)]; krospovidon vrsta B [E1202]; silicijev dioksid, koloidni, bezvodni [E551]; magnezijev stearat [E470b].
Film coating: poly(vinyl alcohol) [E1203]; talc [E553b]; macrogol 3350 [E1521]; titanium dioxide [E171]; iron oxide yellow [E172].
Film ovojnica: poli(vinilni alkohol) [E1203]; talk [E553b]; makrogol 3350 [E1521]; titanijev dioksid [E171]; željezov oksid, žuti [E172].
Table 1 Daily dose recommendation for avatrombopag
Tablica 1 Dnevno preporučena doza avatrombopaga
In Study 2, a total of 204 patients were randomised; 128 patients to the avatrombopag treatment group and 76 patients to the placebo treatment group.
U Ispitivanju 2 je randomizirano ukupno 204 bolesnika, od čega 128 bolesnika u skupinu koja je uzimala avatrombopag, a 76 bolesnika u placebo skupinu.
Population pharmacokinetic analysis of avatrombopag plasma concentrations from clinical studies with healthy subjects and patients with thrombocytopenia due to chronic liver disease, that included 11% (84/787) of the study population ≥ 65 years of age, suggested that avatrombopag exposures are not affected by age (see section 4.2).
Starije osobe Populacijska farmakokinetička analiza koncentracije avatrombopaga u plazmi u kliničkim ispitivanjima u zdravih ispitanika i bolesnika s trombocitopenijom nastalom zbog kronične bolesti jetre, što je uključivalo 11% (84/787) ispitivane populacije ≥ 65 godina, upućuje na to kako na izlaganje avatrombopagu ne utječe dob (vidi dio 4.2).
Concomitant use of strong CYP3A4/5 or CYP2C9 inducers reduces avatrombopag exposure, and may result in a decreased effect on platelet counts; however, no dose adjustment is recommended (see section 5.2).
Snažni induktori CYP3A4/5 ili CYP2C9 Istodobna primjena snažnih CYP3A4/5 ili CYP2C9 induktora smanjuje izloženost avatrombopagu i može dovesti do smanjenja učinka na broja trombocita; no ne preporučuje se prilagodba doze (vidjeti dio 5.2).
Pale yellow, round biconvex film-coated 7.6 mm tablet debossed with “AVA” on one side and “20” on the other.
Svijetložuta, okrugla, bikonveksna filmom obložena tableta veličine 7,6 mm s utisnutom oznakom „AVA” s jedne i „20” s druge strane.
There are no or limited amount of data from the use of avatrombopag in pregnant women.
Nema podataka ili su podaci o primjeni avatrombopaga u trudnica ograničeni.
Co. Dublin
Dublin 2
If you have any questions on the use of this medicine, ask your doctor or pharmacist.
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku.
Obtain a platelet count prior to the administration of Doptelet therapy and on the day of a procedure to ensure an adequate increase in platelet count, and no unexpectedly high increase in platelet count in the patient populations specified in sections 4.4 and 4.5.
Prije primjene terapije Dopteletom kao i na sam dan invazivnog postupka potrebno je provjeriti broj trombocita kako biste osigurali da je porast trombocita odgovarajući, i da ne postoji neočekivano visok porast razine trombocita u populaciji bolesnika navedenoj u dijelu 4.4 i 4.5.
Doptelet should not be administered to patients with chronic liver disease in an attempt to normalize platelet counts.
Doptelet se ne smije primjenjivati u bolesnika s kroničnom bolešću jetre kao pokušaj normaliziranja broja trombocita.
Dova Pharmaceuticals Ireland, Limited
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Dova Pharmaceuticals Ireland, Limited
Avatrombopag inhibits organic anion transporter (OAT) 1 and 3 and breast cancer resistance protein (BCRP) but not organic anion transporter polypeptide (OATP) 1B1 and 1B3, and organic cation transporter (OCT) 2 in vitro.
Avatrombopag inhibira OAT (engl. organic anion transporter) 1 i 3 te BCRP (engl.,breast cancer resistance protein) ali ne i OATP (engl. organic anion transporter polypeptide) 1B1 i 1B3 ni OCT
Avatrombopag was not mutagenic in an in vitro bacterial reverse mutation (AMES) assay or clastogenic in an in vitro human lymphocyte chromosomal aberrations assay or in an in vivo rat bone marrow micronucleus assay.
Avatrombopag nije bio mutagen u in vitro testu bakterijske reverzne mutacije (AMES), niti klastogen u in vitro testu kromosomskih aberacija ljudskih limfocita niti u in vivo mikronukleus testu koštane srži štakora.
A measured increase in platelet counts was observed in both avatrombopag treatment groups over time beginning on Day 4 post-dose, which peaked on Day 10-13 and then returned to near baseline values by Day 35 (Figure 1); mean platelet count remained greater than or equal to 50 x 109/L on Day 17 (Visit 5).
počevši od 4. dana nakon doziranja, koje je dosegnulo vrhunac na 10.-13. dan, a zatim se vratilo na vrijednosti slične početnim vrijednostima na 35. dan (Slika 1); srednja vrijednost broja trombocita je ostala veća od ili jednaka 50 x 109/L na 17. dan (Posjet 5).
Table 2: Efficacy results by baseline platelet count cohort and treatment group - Study 1 and Study 2
Tablica 2: Rezultati djelotvornosti za kohorte prema početnoj vrijednosti broja trombocita i terapijske skupine - Ispitivanje 1 i Ispitivanje 2
Co-administration of avatrombopag with either a high-fat or low-fat meal did not result in clinically important changes in rate or extent of absorption of avatrombopag.
Istovremena primjena avatrombopaga i hrane s visokim ili hrane s niskim udjelom masnoća nije dovela do klinički značajnih promjena u stopi ili opsegu apsorpcije avatrombopaga.
Musculoskeletal & connective tissue disorders
Poremećaji mišićno-koštanog sustava i vezivnog tkiva
Dova Pharmaceuticals Ireland, Limited 6th Floor, 2 Grand Canal Square Dublin 2
Nositelj odobrenja za stavljanje lijeka u promet Dova Pharmaceuticals Ireland, Limited 6th Floor, 2 Grand Canal Square Dublin 2
10 film-coated tablets 15 film-coated tablets
15 filmom obloženih tableta
No clinically important difference in avatrombopag exposures were observed between patients with Child-Turcotte-Pugh Scores (Range = 5 to 12) or MELD scores (Range = 4 to 23) and healthy subjects.
Nisu uočene klinički značajne razlike u izloženosti avatrombopagu u bolesnika s rezultatima prema ChildTurcottePugh klasifikaciji (raspon = od 5 do 12) i MELD rezultatima (raspon = od 4 do 23) nasuprot zdravim ispitanicima.
However, administration of avatrombopag with both a high- and low-fat meal reduced inter-subject and intra-subject pharmacokinetic variability of avatrombopag by approximately 50%.
No istovremena primjena avatrombopaga i hrane bilo s visokim ili niskim udjelom masnoća je smanjila farmakokinetičku varijabilnost avatrombopaga interindividualno i intraindividualno za približno 50%.
High baseline platelet count (≥ 40 to < 50 x 109/L)
Skupina s visokom početnom vrijednosti broja trombocita (≥ 40 do < 50 x 109/L)
Each blister contains either 10 or 15 tablets.
10 ili 15 tableta.
CYP3A4/5 and CYP2C9 inhibitors
Inhibitori CYP3A4/5 i CYP2C9
If you are not sure, talk to your doctor or pharmacist before taking Doptelet.
Ako niste sigurni, prije uzimanja Dopteleta razgovarajte sa svojim liječnikom ili ljekarnikom.
If you are breast-feeding, ask your doctor or pharmacist for advice before taking Doptelet.
Ako dojite, zatražite savjet svog liječnika ili ljekarnika prije uzimanja Dopteleta.
Low baseline platelet count cohort (< 40 x 109/L)
Kohorta s niskom početnom vrijednošću broja trombocita (< 40 x 109/L)
Doptelet 20 mg film-coated tablets
Doptelet 20 mg filmom obložene tablete
60 mg (3 tablets) every day for 5 days in a row.
Uobičajena preporučena doza je 40 mg (2 tablete) ili 60 mg (3 tablete) svakog dana, 5 dana za redom.
In each study, patients were assigned to the low baseline platelet count cohort (˂ 40 x 109/L) or the high baseline platelet count cohort (≥ 40 to ˂ 50 x 109/L) based on their platelet count at baseline.
U svakom su ispitivanju bolesnici bili svrstani u skupinu s niskom početnom vrijednošću broja trombocita (˂ 40 x 109/L) ili u skupinu s visokom početnom vrijednošću broja trombocita (≥ 40 do ˂ 50 x 109/L) na temelju njihove početne vrijednosti broja trombocita.
Adverse reactions are classified by Preferred Term and System Organ Class, and by frequency.
Nuspojave su klasificirane prema preporučenom pojmu i klasifikaciji organskih sustava te po učestalosti.
A population pharmacokinetic analysis evaluated avatrombopag plasma exposures in patients with mild to moderate hepatic impairment based on Model for End-Stage Liver Disease (MELD) scores and Child-Turcotte-Pugh scores.
Populacijska farmakokinetička analiza je procjenjivala izloženost avatrombopagu u plazmi u bolesnika s blagim do srednje teškim oštećenjem jetre na temelju rezultata modela za završni stadij bolesti jetre (MELD) i rezultata prema Child-Turcotte-Pugh klasifikaciji.
Portal vein thrombosis
Tromboza portalne vene
Co-administered drug*
Istodobno primijenjeni lijek *
There is limited information on the use of avatrombopag in patients previously exposed to avatrombopag.
Podaci o uporabi avatrombopaga u bolesnika koji su mu već bili izloženi su ograničeni.
Cmax
Cmaks
Based on in vitro studies, no other transporting proteins (OATP1B1, OATP1B3, OCT2, OAT1, and OAT3) are expected to play a significant role in the disposition of avatrombopag.
(OATP1B1, OATP1B3, OCT2, OAT1 i OAT3) igrati važnu ulogu u dispoziciji avatrombopaga.
What Doptelet is and what it is used for 2.
Što se nalazi u ovoj uputi: 1. Što je Doptelet i za što se koristi
In vitro studies suggest that avatrombopag is highly bound to human plasma proteins (> 96%).
In vitro ispitivanja upućuju na to kako se avatrombopag jako vezuje na proteine ljudske plazme
The population pharmacokinetic analysis of avatrombopag in healthy subjects and subjects with thrombocytopenia due to chronic liver disease indicated similar exposures between healthy subjects and subjects with mild and moderate renal impairment (CrCL ≥ 30 mL/min, Cockcroft-Gault).
Populacijska farmakokinetička analiza avatrombopaga u zdravih ispitanika i blesnika s trombocitopenijom uzrokovanom kroničnom bolešću jetre je ukazala na sličnu izloženost u zdravih ispitanika i ispitanika s blagim ili umjerenim oštećenjem funkcije bubrega (CrCL ≥ 30 ml/min,
Mean platelet count (+/- standard error) by days from start of dosing by baseline platelet count cohort and treatment group - pooled Study 1 and Study 2
Slika 1: Srednja vrijednost broja trombocita (+/- standardna pogreška) od početka doziranja prikazano po danima, za kohorte prema početnoj vrijednosti broja trombocita i terapijske skupine, s obuhvaćenim podacima iz Ispitivanja 1 i Ispitivanja 2
There is limited information on the use of avatrombopag in patients with severe (Child-Pugh class C, MELD score > 24) hepatic impairment.
Podaci o uporabi avatrombopaga u bolesnika s teškim (Child-Pugh C, MELD vrijednost > 24)
Doptelet 20 mg film-coated tablets avatrombopag
Doptelet 20 mg filmom obložene tablete avatrombopag
Population pharmacokinetic analysis of avatrombopag plasma concentrations from the clinical studies with healthy subjects and patients with thrombocytopenia due to chronic liver disease indicated that avatrombopag exposures were similar across the different races studied.
Rasne ili etničke skupine Farmakokinetička analiza populacije vezano uz koncentracije avatrombopaga u plazmi iz kliničkih ispitivanja u zdravih ispitanika i bolesnika s trombocitopenijom zbog kronične bolesti jetre je pokazala kako su izloženosti avatrombopagu bile slične kod svih ispitanih rasa.
Doptelet 20 mg tablets avatrombopag
NAZIV LIJEKA Doptelet 20 mg tablete avatrombopag
Duration of dosing
Trajanje doziranja
Each film-coated tablet contains avatrombopag maleate equivalent to 20 mg of avatrombopag.
Jedna filmom obložena tableta sadrži 20 mg avatrombopaga u obliku avatrombopagmaleata.
Lactose monohydrate Microcrystalline cellulose (E460(i)) Crospovidone type B (E1202) Silica, colloidal anhydrous (E551) Magnesium stearate (E470b)
Krospovidon vrsta B (E1202) Silicijev dioksid, koloidni, bezvodni (E551) Magnezijev stearat (E470b)
Patients with severe hepatic impairment should be supported in line with clinical practice by close monitoring for early signs of worsening or new onset hepatic encephalopathy, ascites, and thrombotic or bleeding tendency, through monitoring of liver function tests, tests used for assessing clotting status and through imaging of portal vasculature as needed.
ascitesa i tendencije tromboze ili krvarenja praćenjem testova funkcije jetre, testova za procjenu koagulacije i putem snimanja portalne vaskulature po potrebi.
Due to limited information available, the safety and efficacy of avatrombopag in patients with severe hepatic impairment (Child-Pugh class C, MELD score > 24) have not been established (see section 4.4).
Zbog ograničenosti dostupnih podataka o sigurnost i djelotvornosti avatrombopaga u bolesnika s teškim oštećenje jetre (Child-Pugh C, MELD (engl.
Package leaflet: Information for the patient Doptelet 20 mg film-coated tablets avatrombopag This medicine is subject to additional monitoring.
Uputa o lijeku: Informacije za bolesnika Doptelet 20 mg filmom obložene tablete avatrombopag
Avatrombopag 40 mg (n = 58) Proportion of subjects not requiring a platelet transfusion or rescue procedure for bleeding Responders 95% CIa P-valueb Proportion of subjects who achieved a platelet count ≥ 50 × 109/L on procedure day Responders 95% CIa P-valueb Change in platelet count from baseline to procedure day Mean (SD) x 109/L Median x 109/L P-valuec a Two-sided 95% confidence interval based on normal approximation.
Srednja vrijednost (SD) x 109/L Medijan x 109/L P vrijednostc a Dvostrani interval pouzdanosti od 95% utemeljen na normalnoj aproksimaciji.
The efficacy and safety of avatrombopag for the treatment of adult patients with chronic liver disease and a platelet count ˂ 50 x 109/L who were scheduled to undergo a procedure were studied in 2 identically-designed multicenter, randomised, double-blind, placebo-controlled Phase 3 studies (Study 1 and Study 2).
Klinička djelotvornost i sigurnost Djelotvornost i sigurnost avatrombopaga u liječenju odraslih bolesnika s kroničnom bolešću jetre i brojem trombocita ˂ 50 x 109/L koji će biti podvrgnuti nekom invazivnom postupku ispitivane su u 2
In the low baseline platelet count cohort, the mean baseline platelet count for the avatrombopag-treated group was 31.1 x 109/L and for placebo-treated patients was 30.7 x 109/L.
U skupini s niskom početnom vrijednošću broja trombocita srednja početna vrijednost broja trombocita za skupinu liječenu avatrombopagom je bila 31,1 x 109/L, a za bolesnike liječene placebom 30,7 x 109/L.
In the low baseline platelet count cohort, the mean baseline platelet count for the avatrombopag-treated group was 32.7 x 109/L and for placebo-treated patients was 32.5 x 109/L.
U skupini s niskom početnom vrijednošću broja trombocita srednja početna vrijednost broja trombocita za skupinu liječenu avatrombopagom je bila 32,7 x 109/L, a za bolesnike liječene placebom 32,5 x 109/L.
Doptelet is used in adults with chronic liver disease to treat low platelet count (called thrombocytopenia) before having a medical procedure where there is a risk of bleeding.
(stanje zvano trombocitopenija) prije podvrgavanja medicinskom postupku u kojem postoji rizik od krvarenja.
5 years.
6.3 Rok valjanosti 5 godina.
In the high baseline platelet count cohort, the mean baseline platelet count for the avatrombopag-treated patients was 44.3 x 109/L and for placebo-treated patients was 44.9 x 109/L.
U skupini s visokom početnom vrijednošću broja trombocita srednja početna vrijednost broja trombocita za skupinu liječenu avatrombopagom je bila 44,3 x 109/L, a za bolesnike liječene placebom 44,9 x 109/L.
In the high baseline platelet count cohort, the mean baseline platelet count for the avatrombopag-treated patients was 44.3 x 109/L and for placebo-treated patients was 44.5 x 109/L.
U skupini s visokom početnom vrijednošću broja trombocita srednja početna vrijednost broja trombocita za skupinu liječenu avatrombopagom je bila 44,3 x 109/L, a za bolesnike liječene placebom 44,5 x 109/L.
Doptelet 20 mg
16. PODACI NA BRAILLEOVOM PISMU Doptelet 20 mg
Avatrombopag 60 mg (n = 70) Proportion of subjects not requiring a platelet transfusion or rescue procedure for bleeding Responders 95% CIa P-valueb Proportion of subjects who achieved a platelet count ≥ 50 × 109/L on procedure day Responders 95% CIa P-valueb Change in platelet count from baseline to procedure day Mean (SD) x 109/L Median x 109/L P-valuec
Udio ispitanika koji su postigli broj trombocita ≥ 50 × 109/L na dan postupka Bolesnici s odgovorom
Verapamil
OBLIK
Retreatment
Ponovljeno liječenje
Use in patients with chronic liver disease undergoing invasive procedures The objective of treatment with Doptelet is to increase platelet counts.
Cilj liječenja Dopteletom je povećanje broja trombocita.
Memantine Accord should be given once a day at the same time every day.
Memantin Accord treba primjenjivati jednom dnevno i potrebno ga je uzimati svaki dan u isto vrijeme.
It is used to treat patients with moderate to severe Alzheimer's disease, a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour.
Koristi se za liječenje bolesnika s umjerenom do ozbiljnom Alzheimerovom bolesti, tipom demencije (moždanog poremećaja) koji postepeno utječe na pamćenje, intelektualnu sposobnost i ponašanje.
Memantine Accord is available as tablets (5 mg, 10 mg, 15 mg and 20 mg) and can only be obtained with a prescription.
Memantine Accord dostupan je kao tablete (5 mg, 10 mg, 15 mg i 20 mg) i izdaje se samo na liječnički recept.
Neurotransmitters are chemicals in the nervous system that allow nerve cells to communicate with one another.
Neurotransmiteri su kemikalije u živčanom sustavu koje omogućuju međusobnu komunikaciju živčanih stanica.
Treatment should be started and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease.
Liječenje treba započeti i nadzirati liječnik koji ima iskustva u dijagnosticiranju i liječenju Alzheimerove bolesti.
This means that Memantine Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Axura.
To znači da je Memantine Accord sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Axura.
The full EPAR for Memantine Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za Memantine Accord može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
To prevent side effects, the dose of Memantine Accord is gradually increased over the first three weeks of treatment: during the first week, the daily dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Da bi se spriječile nuspojave, doza lijeka Memantine Accord postepeno se povećava tijekom prva tri tjedna liječenja: tijekom prvog tjedna dnevna doza iznosi 5 mg, u drugom tjednu doza iznosi 10 mg, a tijekom trećeg tjedna 15 mg.
The company provided data on the medicine's solubility, composition and absorption in the body.
Farmaceutska tvrtka dostavila je podatke o topljivosti lijeka, sastavu i apsorpciji u tijelu.