natgillin/translations-raw huggingface dataset:
The efficacy of palonosetron in the prevention of nausea and vomiting induced by highly emetogenic chemotherapy may be enhanced by the addition of a corticosteroid administered prior to chemotherapy. 
Učinkovitost palonosetrona pri preprečevanju slabosti in bruhanja, povzročenih z visoko emetogenimi kemoterapijami, se poveča, če pred kemoterapijo dodamo kortikosteroid.
What Palonosetron Accord is and what it is used for 
Kaj je zdravilo Palonosetron Accord in za kaj ga uporabljamo
6 ml Type I tubular clear glass vial, closed with chlorobutyl rubber stopper and sealed with a flip-off aluminium seal. 
6 ml cevasta viala iz prozornega stekla tipa I, zaprta z zamaškom iz klorobutilne gume in zapečatena z aluminijastim pokrovčkom.
The second paediatric, trial was a multicenter, double-blind, double-dummy, randomised, parallel group, active control, single-dose non-inferiority study, comparing intravenous palonosetron (1 mcg/kg, max 0.075 mg) versus intravenous. 
Drugo pediatrično preskušanje je bila multicentrična, dvojno slepa, dvojno zakrita randomizirana študija ne-manjvrednosti s paralelnimi skupinami, aktivnimi kontrolami in enkratnim odmerkom, v kateri so primerjali intravenski palonosetron (1 µg/kg, največji odmerek 0,075 mg) z intravenskim ondansetronom.
Accord Healthcare Limited Ground floor, Sage House 319, Pinner Road, North Harrow Middlesex HA1 4HF United Kingdom 
319, Pinner Road, North Harrow Middlesex HA1 4HF Velika Britanija
Tachycardia, bradycardia, extrasystoles, myocardial ischaemia, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles 
Srčne bolezni tahikardija, bradikardija, ekstrasistole, miokardna ishemija, sinusna tahikardiija, sinusna aritmija, supraventrikularne ekstrasistole
Emetogenic chemotherapies administered included doxorubicin, cyclophosphamide (<1500 mg/m2), ifosfamide, cisplatin, dactinomycin, carboplatin, and daunorubicin. 
Emetogene kemoterapije, ki so jih uporabljali, so vključevale doksorubicin, ciklofosfamid (<1500 mg/m2), ifosfamid, cisplatin, daktinomicin, karboplatin in davnorubicin.
The highest dose group showed a similar incidence of adverse reactions compared to the other dose groups and no dose response effects were observed. 
V skupini z najvišjim odmerkom je pogostost neželenih učinkov bila podobna pogostosti pri drugih skupinah odmerka.
Palonosetron has been administered safely with analgesics, antiemetic/antinauseants, antispasmodics and anticholinergic medicinal products. 
Palonosetron je varen pri sočasnem jemanju z analgetiki, antiemetiki/zdravili proti slabosti, spazmolitiki in antiholinergiki.
Efficacy after palonosetron 10 mcg/kg compared to palonosetron 3mcg/kg was 54.1% and 37.1% respectively. 
Učinkovitost po dajanju palonosetrona 10 mcg/kg je bila 54,1 % in učinkovitost palonosetrona 3 mcg/kg je bila 37,1 %.
SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram. 
SSRI (selektivni zaviralci privzema serotonina), ki se uporabljajo za zdravljenje depresivnosti in/ali anksioznosti, vključno s fluoksetinom, paroksetinom, sertralinom, fluvoksaminom, citalopramom, escitalopramom;
Somnolence, insomnia, paraesthesia, hypersomnia, peripheral sensory neuropathy 
Bolezni živčevja glavobol vrtoglavica zaspanost, nespečnost, parastezije, hipersomnija, periferna senzorna nevropatija
Other medicines and Palonosetron Accord 
Druga zdravila in zdravilo Palonosetron Accord
Pack size of one vial 
Pakiranje z 1 vialo.
2 to <6 y 6 to <12 y 12 to <17 y 3.0 mcg/kg 10 mcg/kg 
12 do <17 let mcg/kg mcg/kg N=3 N=5 N=7 N=10 N=6 N=5
° From post-marketing experience * Includes the following: burning, induration, discomfort and pain 
*Obsega naslednje: občutek pečenja, zatrdlino, neugodje in bolečino.
Excipients: mannitol, citric acid monohydrate, sodium citrate ,disodium edetate, sodium hydroxide, hydrochloric acid concentrated, water for injections. 
Pomožne snovi: manitol, citronska kislina monohidrat, natrijev citrat, dinatrijev edetat, natrijev hidroksid, klorovodikova kislina, koncentrirana, voda za injekcije.
CLINICAL PARTICULARS 4.1 Therapeutic indications Palonosetron Accord is indicated in adults for: 
Zdravilo Palonosetron Accord je indicirano pri odraslih za:
- The other ingredients are mannitol, disodium edetate (refer section 2 for sodium content), sodium citrate, citric acid monohydrate, sodium hydroxide (refer section 2 for sodium content), hydrochloric acid, concentrated and water for injections. 
Druge sestavine zdravila so manitol, dinatrijev edetat (za vsebnost natrija glejte poglavje 2), natrijev citrat, citronska kislina monohidrat, natrijev hidroksid (za vsebnost natrija glejte poglavje 2), klorovodikova kislina, koncentrirana, in voda za injekcije.
After intravenous administration of palonosetron 0.25 mg once daily for 3 days in 12 healthy subjects, the mean (± SD) increase in plasma palonosetron concentration from Day 1 to Day 3 was 110 ± 45 % 
Po intravenskem dajanju palonosetrona 12 zdravim osebam v odmerku 0,25 mg enkrat na dan 3 dni je koncentracija palonosetrona v plazmi od 1. do 3. dne povprečno ( SD) zrasla za 110  45 %.
Following intravenous administration of palonosetron 0.25 mg once every other day for 3 doses in 11 testicular cancer patients, the mean (± SD) increase in plasma concentration from Day 1 to Day 5 was 42 ± 34 %. 
Po intravenskem dajanju palonosetrona v odmerku 0,25 mg vsak drugi dan je po 3 odmerkih pri 11 bolnikih z rakom mod koncentracija v plazmi od 1. do 5. dne povprečno ( SD) zrasla za 42  34 %.
Prevention of Post Operative Nausea and Vomiting (PONV): 
Preprečevanje pooperativne navzee in bruhanja (Post Operative Nausea and Vomiting - PONV): Opravili so dve pediatrični preskušanji.
Adults The recommended dose of palonosetron accord is 250 micrograms given as a rapid injection into a vein. 
Priporočeni odmerek zdravila Palonosetron Accord 250 mikrogramov se daje kot hitra injekcija v veno.
These may affect up to 1 in 10,000 people 
Lahko se pojavijo pri manj kot 1 od 10.000 bolnikov
Since palonosetron may induce dizziness, somnolence or fatigue, patients should be cautioned when driving or operating machines. 
Ker lahko palonosetron povzroči omotico, zaspanost in utrujenost, je potrebno bolnike, ki upravljajo s stroji in voznike na te učinke opozoriti.
In the clinical studies the following adverse reactions (ARs) were observed as possibly or probably related to palonosetron. 
V kliničnih študijah so opažali naslednje neželene učinke, ki jih je mogoče pripisati jemanju palonosetrona.
• The prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. 
• preprečevanje akutne slabosti in bruhanja, povezanih z visoko emetogenimi kemoterapijami pri zdravljenju raka in preprečevanje slabosti in bruhanja, povezanih z zmerno emetogenimi kemoterapijami pri zdravljenju raka.
If you have any further questions, ask your doctor or pharmacist or nurse. 
Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 50 micrograms of palonosetron (as hydrochloride). 
KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml raztopine vsebuje 50 mikrogramov palonosetrona (v obliki palonosetronijevega klorida).
• the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, 
• preprečevanje akutne navzee in bruhanja, povezanih z visoko emetogenimi kemoterapijami pri zdravljenju raka,
Allergic reactions to palonosetron accord 
Alergijske reakcije na zdravilo Palonosetron Accord.
Cardiac disorder 
• nenormalen srčni utrip
Children and adolescents (aged 1 month to 17 years) The doctor will decide the dose, depending on bodyweight, however the maximum dose is 1500 micrograms. 
Zdravnik bo določil odmerek, odvisen od telesne mase, največji odmerek pa je 1500 mikrogramov.
Table 3: Percentage of patients a responding by treatment group and phase in the Highly Emetogenic Chemotherapy study versus ondansetron 
Preglednica 3: Odstotek bolnikova, ki reagirajo na zdravljenje, glede na vrsto zdravljenja in stopnjo zdravljenja v študiji visoko emetogene kemoterapije v primerjavi z ondansetronom
There have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic drugs (including SSRIs and SNRIs). 
Po sočasni uporabi antagonistov serotoninskih 5-HT3 receptorjev in drugih serotoninergičnih zdravil (vključno z SSRI in SNRI) so poročali o serotoninskem sindromu.
These may affect up to 1 in 100 people 
Lahko se pojavijo pri manj kot 1 od 100 bolnikov
Hypotension, hypertension, vein discolouration, vein distended 
Žilne bolezni hipotenzija, hipertenzija, obarvanje ven, razširitev ven
Electrocardiogram, QT prolonged conduction disorder, sinus tachycardia 
Srčne bolezni podaljšanje intervala QT v elektrokardiogramu prevodna motnja, sinusna tahikardija
Marketing Authorisation Holder Accord Healthcare S.L.U. 
Imetnik dovoljenja za promet z zdravilom in izdelovalec Accord Healthcare S.L.U.
How Palonosetron Accord is given 4. 
Kako se daje zdravilo Palonosetron Accord 4.
Adults Cancer Patientsb 
Odrasli bolniki z rakomb
One vial of 5 ml of solution contains 250 micrograms of palonosetron. 
Ena viala, v kateri je 5 ml raztopine, vsebuje 250 mikrogramov palonosetrona.
Palonosetron 250 micrograms (n= 189) 
Palonosetron 250 mikrogramov (n = 189)
Each ml of solution contains 50 micrograms of palonosetron. 
En ml raztopine vsebuje 50 mikrogramov palonosetrona.
Talk to your doctor, pharmacist or nurse before using Palonosetron Accord. 
Če dojite, se pred uporabo zdravila Palonosetron Accord posvetujte z zdravnikom ali farmacevtom.
Constipation Diarrhoea Dyspepsia, abdominal pain, abdominal pain upper, dry mouth, 
Bolezni prebavil zaprtje driska dispepsija, bolečine v trebuhu, bolečine v zgornjem delu trebuha, suha usta, napenjanje
Dermatitis, allergic, pruritus, skin disorder, urticaria. 
Bolezni kože in podkožja alergijski dermatitis, pruritus, kožna bolezen, urtikarija
Hypersensitivity, anaphylaxis, anaphylactic/ anaphylactoid reactions and shock 
Bolezni imunskega sistema preobčutljivost, anafilaksija, anafilaktične/anafil aktoidne reakcije in šok
A total of 493 paediatric patients, aged 64 days to 16.9 years, receiving moderately (69.2%) or highly emetogenic chemotherapy (30.8%) were treated with palonosetron 10 mcg/kg (maximum 0. 
Vsega skupaj 493 pediatričnih bolnikov, starih od 64 dni do 16,9 let, ki so prejemali zmerno (69,2 %) ali visoko emetogeno kemoterapijo (30,8 %), so zdravili s palonosteronom 10 mcg/kg (največji odmerek 0,75 mg), palonosetronom 20 mcg/kg (največji odmerek 1,5 mg) ali ondansetronom (3 x 0,15 mg/kg , največji celotni odmerek 32 mg) 30 minut pred začetkom emetogene kemoterapije med ciklom 1.
Single use only, any unused solution should be discarded. 
Za enkratno uporabo, vso neporabljeno raztopino zavrzite.
NAME OF THE MEDICINAL PRODUCT Palonosetron Accord 250 micrograms solution for injection 
IME ZDRAVILA Palonosetron Accord 250 mikrogramov raztopina za injiciranje
In a randomised, double-blind study with a total of 667 patients receiving highly emetogenic chemotherapy that included cisplatin ≥ 60 mg/m2, cyclophosphamide > 1,500 mg/m2 and dacarbazine, palonosetron 250 
V randomizirani, dvojno slepi študiji, v kateri je sodelovalo 667 bolnikov, ki so prejemali visoko emetogeno kemoterapijo, ki je vključevala cisplatin >60 mg/m2, ciklofosfamid >1500 mg/m2 in dakarbazin, so primerjali odmerka 250 mikrogramov in 750 mikrogramov palonosetrona v primerjavi z ondansetronom 32 mg, danim prvi dan kemoterapije.
250 micrograms (n= 223) 
Palonosetron 250 mikrogramov (n = 223)
The study demonstrated no effect on QT/QTc interval duration as well as any other ECG interval at doses up to 2.25 mg. No clinically significant changes were shown on heart rate, atrioventricular (AV) conduction and cardiac repolarisation. 
Študija ni pokazala nikakršnega učinka na trajanje intervala QT/QTc ali na kakšen drug EKG interval v odmerkih do 2,25 mg.
b PK parameters expressed as Arithmetic mean (SD) c Clearance and Volume of distribution in paediatric patients were calculated weight-adjusted from both 10 mcg /kg and 20 mcg /kg dose groups combined. 
c Očistek in volumen porazdelitve pri pediatričnih bolnikih sta bila izračunana za skupino, združeno iz skupin z odmerkoma 10 mcg/kg in 20 mcg/kg, popravljeni za telesno maso.
Palonosetron Accord 250 micrograms solution for injection palonosetron 
Palonosetron Accord 250 mikrogramov raztopina za injiciranje palonosetron
Ask your doctor or pharmacist for advice before using any medicine if you are pregnant or think you might be. 
Če ste noseči ali menite, da bi lahko bili noseči, se posvetujte z zdravnikom ali farmacevtom, preden uporabite to zdravilo.
No dosage adjustment is necessary in elderly patients. 
Za starejše bolnike ni potrebno prilagajati odmerka.
These may affect up to 1 in 10 people 
Lahko se pojavijo pri manj kot 1 od 10 bolnikov
How Palonosetron Accord is given 
Kako se daje zdravilo Palonosetron Accord
Each vial of 5 ml of solution contains 250 micrograms of palonosetron (as hydrochloride). 
Ena viala (5 mililitrov raztopine) vsebuje 250 mikrogramov palonosetrona (v obliki palonosetronijevega klorida).
In two randomised, double-blind studies with a total of 1,132 patients receiving moderately emetogenic chemotherapy that included cisplatin ≤50 mg/m2, carboplatin, cyclophosphamide ≤1,500 mg/m2 and doxorubicin >25 mg/m2, palonosetron 250 micrograms and 750 micrograms were compared with ondansetron 32 mg (half-life 4 hours) or dolasetron 100 mg (half-life 7.3 hours) administered intravenously on Day 1, without dexamethasone. 
V dveh randomiziranih, dvojno slepih študijah v katerih je sodelovalo 1132 bolnikov, ki so prejemali zmerno emetogeno kemoterapijo, ki je vključevala cisplatin 50 mg/m2, karboplatin, ciklofosfamid 1500 mg/m2 in doksorubicin >25 mg/m2, so primerjali odmerka palonosetrona 250 mikrogramov in
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Palonosetron Accord 250 micrograms solution for injection palonosetron (as hydrochloride) 
IME ZDRAVILA IN POT(I) UPORABE Palonosetron Accord 250 mikrogramov raztopina za injiciranje palonosetron (v obliki palonosetronijevega klorida) za intravensko uporabo
Accord Healthcare Ltd Ground Floor Sage House 319 Pinner Road North Harrow Middlesex 
319, Pinner Road, North Harrow Middlesex HA1 4HF
Table 2: Percentage of patients a responding by treatment group and phase in the Moderately Emetogenic Chemotherapy study versus dolasetron Palonosetron 
Preglednica 1: Odstotek bolnikova, ki reagirajo na zdravljenje, glede na vrsto zdravljenja in stopnjo zdravljenja v študiji zmerno emetogene kemoterapije v primerjavi z ondansetronom
Uncommon ARs (≥1/1,000 to <1/100) 
občasni neželeni učinki (1/1.000 do <1/100)
After a single intravenous dose of 10 micrograms/kg [14C]-palonosetron, approximately 80 % of the dose was recovered within 144 hours in the urine with palonosetron representing approximately 40 % of the administered dose, as unchanged active substance. 
144 urah izloči v urinu, kjer je 40 % danega odmerka palonosetrona aktivna nespremenjena substanca.
No Nausea (Likert Scale) 
Brez slabosti (Likertova lestvica) 0 - 24 ur
Asthenia, pyrexia, fatigue, feeling hot, influenza like illness 
• šibkost, utrujenost, vročina ali gripi podobni simptomi
Palonosetron Accord 250 micrograms solution for injection palonosetron (as hydrochloride) 
Palonosetron Accord 250 mikrogramov raztopina za injiciranje palonosetron (v obliki palonosetronijevega klorida) 2.
Each vial contains 250 micrograms of palonosetron (as hydrochloride) in 5 ml (50 micrograms/ml). 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje 250 mikrogramov palonosetrona (v obliki palonosetronijevega klorida) v 5 ml (50 mikrogramov/ml).
How to store Palonosetron Accord 6. 
Shranjevanje zdravila Palonosetron Accord 6.
4.2 Posology and method of administration Palonosetron Accord should be used only before chemotherapy administration. 
Zdravilo Palonosetron Accord se sme uporabiti samo pred dajanjem kemoterapije.
Injection site reaction* 
• bolečina na mestu infuzije
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI Vso neuporabljeno raztopino je potrebno zavreči.
- high or low blood pressure - abnormal heart rate or lack of blood flow to the heart - change in the color of the vein and/or veins becoming larger - abnormally high or low levels of potassium in the blood - high levels of sugar in the blood or sugar in the urine 
• nenormalna frekvenca srca ali premajhen dotok krvi v srce
Paediatric Cancer Patientsa 
Pediatrični bolniki z rakoma
Palonosetron 
• vročina
a Intent-to-treat cohort. 
a Kohorta z namenom zdravljenja.
75 mg), palonosetron 20 mcg/kg (maximum 1.5 mg) or ondansetron (3 x 0.15 mg/kg , maximum total dose 32 mg) 30 minutes prior to the start of emetogenic chemotherapy during Cycle 1. 
750 mikrogramov v primerjavi z ondansetronom 32 mg (razpolovni čas 4 ure) ali dolasetronom 100 mg (razpolovni čas 7,3 ure), danih intravensko prvi dan kemoterapije, brez deksametazona.
- low levels of calcium in the blood - high levels of the pigment bilirubin in the blood - high levels of certain liver enzymes - elevated moods or feeling of anxiousness - sleepiness or trouble sleeping - decrease or loss of appetite - weakness, tiredness, fever or flu like symptoms - numbness, burning, prickling or tingling sensations on the skin - itchy skin rash - impaired vision or eye irritation - motion sickness - ringing in the ear - hiccups, flatulence, dry mouth or indigestion - abdominal (stomach) pain - difficulty urinating - joint pain - electrocardiogram abnormalities (QT prolongation) 
Pred začetkom uporabe zdravila Palonosetron Accord se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če imate akutno zaporo črevesa ali anamnezo ponavljajočih se zaprtij; če poleg zdravila Palonosetron Accord uporabljate druga zdravila, ki lahko povzročijo motnje srčnega ritma, na primer amiodaron, nikardipin, kinidin, moksifloksacin, eritromicin, haloperidol, klorpromazin, kvetiapin, tioridazin, domperidon; če imate osebno ali družinsko anamnezo sprememb srčnega ritma (podaljšanega intervala QT); če imate druge težave s srcem; če imate v krvi neravnovesje določenih mineralov, na primer kalija in magnezija, zaradi katerega se niste zdravili.
No dose adjustment is necessary for patients with impaired hepatic function. 
Pri bolnikih z jetrno okvaro odmerjanja ni potrebno prilagajati.
What Palonosetron Accord contains - The active substance is palonosetron (as hydrochloride). 
Zdravilna učinkovina je palonosetron (v obliki palonosetronijevega klorida).
Pyrexia, infusion site pain, infusion site reaction, pain 
Splošne težave in spremembe na mestu aplikacije zvišana telesna temperatura, bolečina na mestu infuzije, reakcija na mestu infuzije, bolečina
Cough, dyspnoea, epistaxis 
• kašelj in kratka sapa
- If you have a personal or family history of alterations in heart rhythm (QT prolongation). 
• nenormalnosti elektrokardiograma (podaljšanje intervala QT)
Sodium hydroxide (for pH adjustment), Hydrochloric acid, concentrated (for pH adjustment), Water for injections. 
6.1 Seznam pomožnih snovi manitol citronska kislina monohidrat natrijev citrat dinatrijev edetat natrijev hidroksid (za uravnavanje pH) klorovodikova kislina, koncentrirana (za uravnavanje pH) voda za injekcije
Arthralgia 
VIALA
Eye disorders 
• zvonjenje v ušesih
Hepatic impairment 
• sunkoviti telesni gibi
- Dizziness - jerky body movement - abnormal heart rate - cough and shortness of breath - nose bleed - itchy skin rash or hives - fever - pain at the site of infusion 
Splošne težave in spremembe na mestu aplikacije astenija, zvišana telesna temperatura, utrujenost, občutek vročine, gripi podobna bolezen reakcija na mestu injiciranja*
Skin and subcutaneous tissue disorders 
Bolezni kože in podkožja alergijski dermatitis, srbeč izpuščaj
Dizziness, dyskinesia 
• zaspanost ali nespečnost
- If you have acute bowel obstruction or a history of repeated constipation. 
• obdobja vznesenega razpoloženja ali občutek zaskrbljenosti
Pack size bottle (HDPE) 
Stična ovojnina Velikost pakiranja peroralna uporaba plastenka (HDPE)
Immediate Packaging 
30 tablet
The procedure started on 15 November 2007. 
Postopek se je začel dne 15. novembra 2007.
A Decision was issued by the European Commission on 15 September 2008. 
Evropska komisija je Odločbo izdala dne 15. septembra 2008.
The Marketing Authorisation Holder provided supplementary information on 19 March 2008 
Imetnik dovoljenja za promet z zdravilom je priskrbel dodatne informacije dne 19. marca 2008.
Remeron and associated names, 15, 30 and 45 mg tablets, 15, 30 and 45 mg orodispersible tablets, 15 mg/ml oral solution, is a noradrenergic and specific serotonergic antidepressant indicated for the treatment of episodes of major depression. 
Zdravilo Remeron in z njim povezana imena, 15-, 30- in 45-miligramske tablete, 15-, 30- in 45miligramske orodisperzibilne tablete, 15 mg/ml peroralna raztopina, je noradrenergično in specifično serotonergično zdravilo proti depresiji, ki je namenjeno za zdravljenje epizod hude depresije.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Remeron and associated names International Non-Proprietary Name (INN): mirtazapine 
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 30 ZA zdravilo Remeron in z njim povezana imena Mednarodno nelastniško ime (INN): mirtazapin
On 11 October 2007, N.V. Organon presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet, including quality aspects of the medicinal product Remeron and associated names. 
Organon je dne 11. oktobra 2007 agenciji EMEA predložila napotitev v skladu s členom 30 Direktive 2001/83/ES, kakor je bila spremenjena, da bi uskladila nacionalno odobrene povzetke glavnih značilnosti zdravila, označevanje in navodilo za uporabo, vključno z vidiki kakovosti zdravila Remeron in z njim povezana imena.
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) including quality aspects of Remeron and associated names approved across EU Member States, with respect to treatment of major depressive episodes. 
Podlaga za napotitev so bila razhajanja med povzetki glavnih značilnosti zdravila, vključno z vidiki kakovosti zdravila Remeron in z njim povezana imena, pri zdravljenju epizod hude depresije, ki so bili odobreni v državah članicah EU.
During its June 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet including the quality aspects was acceptable and that they should be amended. 
Med zasedanjem junija 2008 je CHMP na podlagi vseh predloženih podatkov in znanstvene razprave v ookviru Odbora menil, da je predlog za uskladitev povzetkov glavnih značilnosti zdravila, označevanja in navodila za uporabo, vključno z vidiki kakovosti, sprejemljiv in da bi bilo treba navedene dokumente spremeniti.
The CHMP gave a positive opinion on 26 June 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet including quality aspects for Remeron and associated names. 
CHMP je dne 26. junija 2008 izdal pozitivno mnenje, s katerim priporoča uskladitev povzetkov glavnih značilnosti zdravila, označevanj in navodila za uporabo za zdravilo Remeron ter z njim povezana imena.
It can be used in adults and children above the age of 6 years. 
Uporablja se lahko pri odraslih in otrocih, starejših od 6 let.