natgillin/translations-raw huggingface dataset:
• hives, increased sweating, night sweats
+alopecija urtikarija, znojenje,
Rituximab in combination with methotrexate significantly increased the proportion of patients achieving at least a 20% improvement in ACR score compared with patients treated with methotrexate alone (Table 12).
20-% izboljšanje glede na ACR oceno v primerjavi z bolniki, ki so se zdravili samo z metotreksatom (preglednica 12).
neutropenia3
pozna nevtropenija3
Dizziness Tremor
Razredčena raztopina
EFS - Event Free Survival TTP - Time to progression or death PFS - Progression-Free Survival TTF - Time to Treatment Failure OS rates - survival rates at the time of the analyses
TTP: čas do napredovanja bolezni ali smrti (Time to progression or death)
Metabolism and nutrition disorders
Presnovne in prehranske motnje hiperholesterolemija
Packs of 2 or 3 vials.
V škatli sta 2 viali ali 3 viale.
, leucopenia, +febrile neutropenia, +thrombocyt openia
+febrilna okužba, +herpes zoster, +okužbe dihal,
Table 13 Radiographic outcomes at 1 year (mITT population)
Radiološki izidi po 1 letu v študiji 1 (populacija, ki so jo nameravali zdraviti) Placebo + metotreksat
Patients treated with rituximab in combination with methotrexate had a significantly greater reduction in disease activity score (DAS28) than patients treated with methotrexate alone (Table 12).
Značilna razlika v primerjavi s kombinacijo placebo + metotreksat ob času primarnega cilja preskušanja: ***p ≤ 0,0001 V vseh študijah je bilo pri bolnikih, ki so se zdravili z rituksimabom in metotreksatom, zmanjšanje aktivnosti bolezni (DAS28, Disease Activity Score) pomembno večje kot pri bolnikih, ki so se zdravili samo z metotreksatom (preglednica 12).
Sodium chloride Sodium hydroxide Hydrochloric acid Water for injections
6.1 Seznam pomožnih snovi natrijev citrat polisorbat 80 natrijev klorid natrijev hidroksid klorovodikova kislina voda za injekcije
Patients were stratified by baseline disease severity (moderate or severe) and randomised 1:1 to receive either rituximab and low-dose prednisone or standard-dose prednisone.
Bolnike so stratificirali glede na izhodiščno izrazitost bolezni (zmerno ali hudo) in jih v razmerju 1:1
OTHER
Vse
• skin rashes, including acne or spots
• kožni izpuščaji, vključno z aknami ali lisami, • pordevanje ali rdečina kože,
Mean Cmax for serum rituximab following first infusion was 170 to 175 μg/mL for 2 x 500 mg dose and 317 to 370 μg/mL for 2 x 1,000 mg dose.
170 do 175 μg/ml za 2 x 500 mg odmerek ter 317 do 370 μg/ml za 2 x 1.000 mg odmerek.
TNLT (median) log-rank p value hazard ratio (95% CI) risk reduction
TNLT (mediana) vrednost p v testu log-rank razmerje ogroženosti (95-% IZ) zmanjšanje tveganja
Severe infections were reported in about 4% of patients treated with rituximab monotherapy.
Pri 4 % bolnikov, ki so prejemali rituksimab kot samostojno zdravljenje, so opazili hude okužbe.
In CLL, the overall incidence of grade 3 or 4 cardiac disorders was low both in the first-line study (4% R-FC, 3% FC) and in the relapsed/refractory study (4% R-FC, 4% FC).
tako v študiji v prvi liniji zdravljenja (4 % R-FC, 3 % FC) kot tudi v študiji pri bolnikih, pri katerih se je bolezen ponovila oziroma so bili neodzivni na zdravljenje (4 % R- FC, 4 % FC).
At 24 months, estimates for overall survival were 68.2% in the R-CHOP arm compared to 57.4% in the CHOP arm. A subsequent analysis of the duration of overall survival, carried out with a median follow-up duration of 60 months, confirmed the benefit of R-CHOP over CHOP treatment (p=0.0071), representing a risk reduction of
Nadaljnja analiza trajanja celokupnega preživetja, ki so jo izvedli po mediani časa sledenja 60 mesecev, je potrdila prednost zdravljenja z R-CHOP pred CHOP (p = 0,0071), kar pomeni zmanjšanje tveganja za dogodke za 32 %.
ORR2)
Primarna učinkovitost ORR2)
Cases of posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencephalopathy syndrome (RPLS) have been reported in autoimmune conditions.
Poročali so o primerih sindroma posteriorne reverzibilne encefalopatije (PRES, posterior reversible encephalopathy syndrome) oziroma sindroma reverzibilne posteriorne levkoencefalopatije (RPLS, reversible posterior leukoencephalopathy syndrome).
Asthma, bronchiolitis obliterans, lung disorder,
bolečina v prsnem košu, dispneja, izrazitejši kašelj, rinitis astma, bronhiolitis obliterans,
The Fab domain of rituximab binds to the CD20 antigen on B lymphocytes and the Fc domain can recruit immune effector functions to mediate B cell lysis.
Domena rituksimaba Fab se veže na antigen CD20 na B-limfocitih in prek domene Fc sproži imunska dogajanja, ki privedejo do razgradnje celic B. Mogoča mehanizma celične razgradnje sta od komplementa odvisna citotoksičnost (complement-dependent cytotoxicity - CDC,), ki je posledica vezave C1q, in od protiteles odvisna celična citotoksičnost (antibody-dependent cellular cytotoxicity
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 100 mg/10 ml
You might get infections more easily during your treatment with Rixathon.
Med zdravljenjem z zdravilom Rixathon ste lahko bolj nagnjeni k okužbam.
The incidence of grade 3/4 blood and lymphatic adverse events was higher in elderly patients compared to younger patients (< 65 years), with previously untreated or relapsed/refractory CLL.
ki predhodno še niso bili zdravljeni ali pri katerih se je bolezen ponovila oziroma se na predhodno zdravljenje niso odzvali, višja pri starejših bolnikih v primerjavi z mlajšimi bolniki (< 65 let).
The recommended dose of Rixathon monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for four weeks.
• Bolniki, ki se na prejšnje zdravljenje niso odzvali ali se je pri njih bolezen ponovila Priporočeni odmerek zdravila Rixathon za samostojno indukcijsko zdravljenje odraslih bolnikov s III. in IV. stadijem folikularnih limfomov, ki so neodzivni na kemoterapijo ali se je pri njih bolezen po kemoterapiji drugič ali že večkrat ponovila, je: 375 mg/m2 telesne površine v obliki intravenske infuzije enkrat na teden 4 tedne.
Rixathon is a clear, colourless to slightly yellowish solution, supplied as a concentrate for solution for infusion.
Zdravilo Rixathon je bistra, brezbarvna do rumenkasta raztopina.
In the relapsed/refractory study, the median progression-free survival (primary endpoint) was 30.6 months in the R-FC group and 20.6 months in the FC group (p=0.0002, log-rank test).
FC in 20,6 meseca v skupini FC (p = 0,0002, test log rank).
Maintenance treatment with rituximab led to a clinically relevant and statistically significant improvement in the primary endpoint, PFS, (time from maintenance randomisation to relapse, disease progression or death) when compared to observation alone (p < 0.0001 log-rank test).The median PFS was 42.2 months in the rituximab maintenance arm compared to 14.3 months in the observation arm.
Vzdrževalno zdravljenje z rituksimabom je klinično pomembno in statistično značilno izboljšalo primarni cilj - preživetje brez napredovanja bolezni (progression free survival - PFS) (čas od randomizacije v vzdrževalno zdravljenje do ponovitve bolezni, napredovanja bolezni ali smrti) v primerjavi z opazovano skupino (p < 0,0001, test log-rank).
In the induction of remission clinical trial, 24% of patients in the rituximab group (single course) and 23% of patients in the cyclophosphamide group developed CTC grade 3 or greater neutropenia.
pojavila pri 24 % prejemnikov rituksimaba (en cikel) in pri 23 % prejemnikov ciklofosfamida.
Rixathon is used for the treatment of patients with moderate to severe pemphigus vulgaris.
e) navadnega pemfigusa Zdravilo Rixathon se uporablja za zdravljenje bolnikov z zmernim do hudim navadnim pemfigusom.
TNCT (median) log-rank p value hazard ratio (95% CI) risk reduction
TNCT (mediana) vrednost p v testu log-rank razmerje ogroženosti (95-% IZ) zmanjšanje tveganja
The reported cases had recognised risk factors for PRES/RPLS, including the patients' underlying disease, hypertension, immunosuppressive therapy and/or chemotherapy.
Pri primerih PRES/RPLS, o katerih so poročali, so bili prisotni znani dejavniki tveganja za PRES/RPLS, vključno z bolnikovo osnovno boleznijo,
• Abnormal sensations of the skin, such as numbness, tingling, pricking or burning, sciatica,
• zvečana koncentracija holesterola v krvi, • nenormalni občutki v koži, kot je otrplost, mravljinčenje, zbadanje ali žarjenje, išias, migrena,
They were characterised by pulmonary events and in some cases included rapid tumour lysis and features of tumour lysis syndrome in addition to fever, chills, rigors, hypotension, urticaria, angioedema and other symptoms (see section 4.8).
drgetanja, hipotenzije, urtikarije, angioedema in drugih simptomov (glejte poglavje 4.8).
Secondary efficacy Overall survival (median) log-rank p value hazard ratio (95% CI) risk reduction
Celokupno preživetje (mediana) vrednost p v testu log-rank razmerje ogroženosti (95-% IZ) zmanjšanje tveganja
Duration of response * Disease free survival (DFS)** Time to new CLL treatment
TTF: čas do neuspeha zdravljenja (Time to Treatment Failure)
Packs of 1 or 2 vials.
V škatli sta 1 viala ali 2 viali.
Methotrexate (MTX) naïve populations with rheumatoid arthritis The use of rituximab is not recommended in MTX-naïve patients since a favourable benefit risk relationship has not been established.
Uporaba rituksimaba pri bolnikih, ki še niso prejemali metotreksata, ni priporočljiva, ker ni bilo dokazano ugodno razmerje med koristjo in tveganji.
Event-free survival (median) log-rank p value hazard ratio (95% CI) risk reduction
Preživetje brez dogodka (mediana) vrednost p v testu log-rank razmerje ogroženosti (95-% IZ) zmanjšanje tveganja
Table 17 Complete remission at 6-months by disease status Rituximab Cyclophosphamide Difference (CI 95%)
Popolna remisija po 6 mesecih glede na stanje bolezni Rituksimab
• Indigestion, diarrhoea, acid reflux, irritation and /or ulceration of the throat and the mouth
• slaba prebava, driska, zgaga, vnetje in/ali razjede v žrelu in ustih,
Renal failure4
odpoved dihal4
Measure blood neutrophils prior to each course of Rixathon, and regularly up to 6-months after cessation of treatment, and upon signs or symptoms of infection (see section 4.8).
6 mesecev po končanem zdravljenju ter pri znakih ali simptomih okužbe (glejte poglavje 4.8).
Patients who have clinically significant cardiovascular disease, including arrhythmias, or previous serious infusion reactions to any prior biologic therapy or to rituximab, should not be administered the more rapid infusion.
povezano z infuzijo na katero koli biološko zdravilo ali na rituksimab, ne smejo prejeti hitrejše infuzije.
Infusion site pain
bolečina na mestu infundiranja
Rixathon is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Zdravilo Rixathon je indicirano za zdravljenje bolnikov z zmernim do hudim navadnim pemfigusom.
OS rates,
• izpadanje las,
Late
Občasni
Nervous System Disorders
Bolezni živčevja glavobol omotica
Malignancies
ZDRAVILOM
Number of Subjects with Major Relapse
(ODGOVORNI) ZA SPROŠČANJE SERIJ
• short term increase in the amount of some types of anti-bodies in the blood (called
Zelo redki neželeni učinki (pojavijo se lahko pri 1 od 10.000 bolnikov): • kratkotrajno povečanje količine nekaterih vrst protiteles v krvi (imenujemo jih imunoglobulini
Severe cardiac disorders 4 and
Bolezni sečil ledvična odpoved4
All physicians who are expected to prescribe Rixathon for NHL/CLL are provided with the following to reduce the risk of administration route errors: - Product information - HCP Alert card addressing the correct use of Rixathon
• Dodatni ukrepi za zmanjševanje tveganj Za indikacije ne-Hodgkinovega limfoma (NHL) in kronične levkocitne levkemije (KLL): Vsi zdravniki, ki lahko predpišejo zdravilo Rixathon za NHL in KLL, za zmanjševanje tveganja za napake v dajanju, prejmejo:
Closely monitor patients with pre-existing cardiac conditions and those who experienced prior cardiopulmonary adverse reactions.
Bolnike, ki imajo težave s srcem, in tiste, pri katerih so v preteklosti opazili kardio- pulmonalne neželene učinke, je treba pozorno spremljati.
A small number of cases of hepatitis-B reactivation, some with fatal outcome, have been reported in granulomatosis with polyangiitis and microscopic polyangiitis patients receiving rituximab in the postmarketing setting.
Pri bolnikih z granulomatozo s poliangiitisom in mikroskopskim poliangiitisom, ki so rituksimab prejemali v obdobju trženja, so poročali o majhnem številu primerov reaktivacije hepatitisa B; nekateri od teh primerov so se končali s smrtjo.
There are no adequate and well-controlled data from studies in pregnant women, however transient B-cell depletion and lymphocytopenia have been reported in some infants born to mothers exposed to rituximab during pregnancy.
Pri nekaterih dojenčkih, katerih matere so med nosečnostjo prejemale rituksimab, pa so poročali o prehodnem zmanjšanju števila celic B in limfocitopeniji.
You will always be given Rixathon as a drip (intra-venous infusion).
Zdravilo Rixathon boste dobili v intravenski infuziji.
Psychiatric Disorders
KLINIČNI PODATKI
Possible mechanisms of effector-mediated cell lysis include complement-dependent cytotoxicity (CDC) resulting from C1q binding, and antibody-dependent cellular cytotoxicity (ADCC) mediated by one or more of the Fcγ receptors on the surface of granulocytes, macrophages and NK cells.
ADCC), ki jo posreduje eden ali več receptorjev Fcγ na površini granulocitov, makrofagov ali naravnih celic ubijalk.
1) Estimates were calculated by hazard ratios
Ocena po prirejeni Sharpovi lestvici Ocena erozij
Severe bullous skin reactions, StevensJohnson Syndrome toxic epidermal necrolysis (Lyell's Syndrome)
nočno znojenje, +bolezen kože hude bulozne kožne reakcije, StevensJohnsonov sindrom,
• IRRs (including cytokine-release syndrome, tumour-lysis syndrome), see section 4.4.
Najpogosteje zabeleženi ali opaženi resni neželeni učinki so bili: • z infuzijo povezane reakcije (vključno s sindromom sproščanja citokinov, sindromom razpada tumorja), glejte poglavje 4.4;
This includes rheumatoid arthritis and off-label autoimmune diseases, including Systemic Lupus Erythematosus (SLE) and vasculitis.
Pri uporabi rituksimaba za zdravljenje revmatoidnega artritisa in avtoimunskih bolezni, ki vključujejo sistemski eritematozni lupus (SLE) in vaskulitis, so poročali o zelo redkih primerih smrtne progresivne multifokalne levkoencefalopatije (PML).
• eating disorders, not eating enough, leading to weight loss
zaprtost, težave z želodcem, • motnje hranjenja, nezadostno uživanje hrane, kar povzroči hujšanje,
Primary efficacy Progression-free survival (median) log-rank p value hazard ratio (95% CI) risk reduction
Preživetje brez napredovanja bolezni (mediana) vrednost p v testu log-rank razmerje ogroženosti (95-% IZ) zmanjšanje tveganja
All physicians who are expected to prescribe Rixathon for non-oncology indications are provided with the following: - Product information - HCP educational leaflet - Patient educational leaflet
Za neonkološke indikacije: Vsi zdravniki, ki lahko predpišejo zdravilo Rixathon za neonkološke indikacije, prejmejo:
vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 15) every 3 weeks for 8 cycles or rituximab 375 mg/m2 in combination with CVP (R-CVP).
V odprtem randomiziranem preskušanju so skupaj 332 predhodno še nezdravljenih bolnikov s folikularnimi limfomi randomizirali na prejemanje kemoterapije CVP (750 mg/m2 ciklofosfamida, 1,4 mg/m2 vinkristina do največ 2 mg 1. dan in 40 mg/m2/dan prednizolona od 1. do 5. dneva) na 3 tedne 8 ciklov, ali na 375 mg/m2 rituksimaba v kombinaciji s CVP (R-CVP).
• Additional risk minimisation measures For the indications non-Hodgkin´s lymphoma (NHL) and Chronic lymphocytic leukaemia
Kontraindikacije za uporabo pri ne-Hodgkinovem limfomu in kronični limfocitni levkemiji
ACR20 ACR50 ACR70 EULAR response (good/moderate) Mean change in DAS
Odziv po EULAR (dober/zmeren)
migraine, dizziness
zardevanje, splošno slabo počutje,
Severe vision loss5
bolečine v ušesu izguba sluha5
Disease-free survivala Subgroup analysis PFS
Analiza podskupin Preživetje brez napredovanja bolezni (PFS)
The following terms have been reported as adverse events during clinical trials, however, were reported at a similar or lower incidence in the rituximab arms compared to control arms: haematotoxicity, neutropenic infection, urinary tract infection, sensory disturbance, pyrexia.
Naslednji izrazi so bili med kliničnimi preskušanji zabeleženi kot neželeni učinki, a so imeli v skupinah, ki so prejemale rituksimab, podobno ali nižjo incidenco kot v kontrolnih skupinah:
Study Treatment, N
čas do novega zdravljenja KLL
A total of 6/34 (18%) of rituximab treated patients from the maintenance therapy clinical trial developed ADA.
V kliničnem preskušanju vzdrževalnega zdravljenja so se ADA pojavila pri skupno 6 od 34 (18 %) bolnikov, zdravljenih z rituksimabom.
• muscle problems - such as tight muscles, joint or muscle pain, back and neck pain
• koprivnica, močnejše znojenje, nočno znojenje, • težave z mišicami - na primer napete mišice, bolečine v sklepih ali mišicah, bolečine v hrbtu in vratu, • splošno nelagodje, neprijetno počutje ali utrujenost, tresenje, znaki gripe,
Rate
Delež
< 10 cells/μL after two weekly infusions of rituximab 375 mg/m2, and remained at that level in most patients up to the 6 month time point.
Pri bolnikih z granulomatozo s poliangiitisom in mikroskopskim poliangiitisom se je število perifernih celic B zmanjšalo na < 10 celic/µl po dveh infundiranjih 375 mg/m2 rituksimaba (po enem na teden) in je na tej ravni ostalo do 6 mesecev.
Immunoglobulins - IgM), chemical disturbances in the blood caused by break-down of dying cancer cells
IgM), snovi v krvi, ki nastajajo zaradi razgradnje odmirajočih rakavih celic, • okvara živcev v rokah in nogah, paraliza obraza,
(CLL):
ml volumnu).
• respiratory failure
• odpoved dihanja,
Pneumocystis jirovecii
Navadni pemfigus
30 ml (10 mg/ml) 1 vial
300 mg koncentrat za pripravo raztopine za infundiranje intravenska uporaba viala (steklena) 30 ml (10 mg/ml) 1 viala
MA (EU)-number (Invented) Name Strength Pharmaceutical Form
(Izmišljeno) ime Jakost
(Invented) name
Zaščiteno ime Jakost
London, 23 October 2008 Doc.
London, 23. oktobra 2008 Sklic dok.
Ref. EMEA/544525/2008
EMEA/180879/2009
It was to be available as prolonged-release tablets (50, 100 and 200 mg).
Zdravilo naj bi bilo v obliki tablet s podaljšanim sproščanjem (50, 100 in 200 mg).
International non-proprietary name (INN): desvenlafaxine
Mednarodno nelastniško ime (INN): desvenlafaksin
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Če ste vključeni v klinično preskušanje in potrebujete več podatkov o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
In all of the studies, the effectiveness of the medicine was measured using standard questionnaires for depression.
V vseh teh študijah so učinkovitost zdravila merili s standardnimi vprašalniki za depresijo.
The CHMP was assessing the responses given by the company to a list of questions.
CHMP je ocenjeval odgovore, ki jih je družba podala na vprašanja s seznama vprašanj.
Two of the flexible-dose studies also included venlafaxine (however, the studies were not designed to compare the two medicines).
Dve od študij s prilagodljivimi odmerki zdravila sta vključevali tudi uporabo venlafaksina (vendar ti študiji nista bili zasnovani za primerjavo obeh zdravil).
The effects of Ellefore were first tested in experimental models before being studied in humans.
Učinki zdravila Ellefore so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
On 13 October 2008, Wyeth Europa Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ellefore, for the treatment of major depressive disorder.
Družba Wyeth Europa Ltd. je dne 13. oktobra 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Ellefore, namenjenim zdravljenju hudih depresivnih motenj.
In these short-term studies, the main measure of effectiveness was the change in depressive symptoms over the eight weeks of treatment.
V teh kratkoročnih študijah je bilo glavno merilo učinkovitosti sprememba simptomov depresije v osmih tednih zdravljenja.
Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Nevrotransmiterji so kemične spojine, ki živčnim celicam omogočajo medsebojno komunikacijo.
Ellefore was compared with placebo (a dummy treatment) in nine main studies involving a total of over 3,000 adults with major depression.
Zdravilo Ellefore so primerjali s placebom (zdravilom brez zdravilne učinkovine) v devetih glavnih študijah, ki so vključevale vsega skupaj več kot 3 000 odraslih s hudo depresijo.
Information on the short and long-term effectiveness of Ellefore was also considered to be insufficient, because too few patients in the studies took the doses of Ellefore that were intended for use and because the studies' results were inconsistent.
Zaradi tega so podatke o kratkoročni in dolgoročni učinkovitosti zdravila Ellefore prav tako označili za nezadostne, saj je premalo bolnikov v študijah vzelo odmerke zdravila Ellefore, ki so bili namenjeni za uporabo, in ker rezultati študij niso bili dosledni.
The substance has been slightly modified with the aim of reducing side effects in patients who have problems breaking venlafaxine down.
Spojino so malce spremenili, da bi zmanjšali neželene učinke pri bolnikih, ki imajo težave z razgrajanjem venlafaksina.
Questions and answers on the withdrawal of the marketing application for Ellefore
Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Ellefore
Desvenlafaxine is derived from venlafaxine, an SNRI that has been used as an antidepressant since the 1990s.
Desvenlafaksin se pridobiva iz venlafaksina, SNRI, ki so ga uporabljali kot zdravilo proti depresiji od 1990-ih.
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Ellefore?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih ali programih sočutne uporabe zdravila Ellefore?
It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain.
Deluje tako, da preprečuje ponovno privzemanje nevrotransmiterjev 5hidroksitriptamina (imenovanega tudi serotonin) in noradrenalina v možganske celice.
What documentation did the company present to support its application to the CHMP?
Katero dokumentacijo je družba predstavila CHMP v podporo svoji vlogi?
The application was at day 166 when the company withdrew.
Družba je vlogo umaknila na 166. dan postopka.
‘Prolonged release' means that the active substance is released from the tablets over a few hours.
Izraz podaljšano sproščanje pomeni, da se zdravilna učinkovina iz tablet sprošča več ur.
Four of the studies involving 1,814 patients used a fixed dose of Ellefore, and another four involving 1,229 patients used doses of Ellefore that could be adjusted.
V štirih študijah, ki so vključevale 1 814 bolnikov, so uporabljali stalni odmerek zdravila Ellefore, v drugih štirih študijah, ki so vključevale 1 229 bolnikov, pa so uporabljali prilagodljive odmerke zdravila Ellefore.
Ellefore was expected to be used to treat major depression in adults.
Zdravilo Ellefore naj bi se bilo uporabljalo za zdravljenje hudih depresivnih motenj pri odraslih.
Since these neurotransmitters are involved in the control of mood, blocking their re-uptake into nerve cells is expected to improve the symptoms of major depression.
Ker omenjena nevrotransmiterja sodelujeta pri nadzorovanju razpoloženja, je bilo pričakovati, da se bodo z blokado njihovega ponovnega privzema v živčne celice izboljšali simptomi hude depresije.