natgillin/translations-raw huggingface dataset:
• abnormal test results relating to the liver 
• nenormalni izvidi preiskav jeter,
PHARMACEUTICAL FORM AND CONTENTS Suspension for injection in pre-filled syringe 1 pre-filled syringe 
Suspenzija za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga 1 odmerek (1 ml)
Additional side effects that occurred during routine use of very similar combined or individual hepatitis A and hepatitis B vaccines were as follows: 
Med rutinsko uporabo zelo podobnih kombiniranih ali enokomponentnih cepiv proti hepatitisu A in hepatitisu B so poročali o naslednjih dodatnih neželenih učinkih:
• aching muscles (myalgia) 
• okužba zgornjih dihal, • boleče mišice (mialgija).
Your doctor will run blood tests to see whether more injections are needed to help you be better protected. 
To pomeni, da morda ne boste zaščiteni proti enemu ali obema virusoma hepatitisa A in B. Vaš zdravnik bo izvedel krvne preiskave, da bi ugotovil, ali so potrebne dodatne injekcije, ki bi pomagale, da bi bili bolje zaščiteni.
Additional side effects that have been reported during clinical trials with very similar combined hepatitis A and hepatitis B vaccines, include: 
Med kliničnimi preskušanji z zelo podobnimi kombiniranimi cepivi proti hepatitisu A in hepatitisu B so poročali o naslednjih dodatnih neželenih učinkih:
Missing a dose 
Izpuščeni odmerek
• If you/your child gets any side effects, talk to your doctor, nurse or pharmacist. 
• Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
How much is given 
Koliko cepiva se uporabi
• Ambirix may not protect you from being ill if you have already caught the hepatitis A or B virus. 
• Cepivo Ambirix vas morda ne bo zaščitilo pred boleznijo, če ste se že okužili z virusom hepatitisa A ali B. • Cepivo Ambirix vas lahko pomaga zaščititi le pred okužbo z virusom hepatitisa A ali B, ne more pa preprečiti drugih okužb jeter, čeprav so lahko znaki teh okužb podobni tistim pri okužbi z virusom hepatitisa A ali B.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev klorid voda za injekcije
Tel: + 43 1 970 75-0 at.info@gsk.com 
Tel. +370 5 264 90 00 info.lt@gsk.com
1330 Rixensart 
1330 Rixensart Belgija
NAME OF THE MEDICINAL PRODUCT Ambirix - Suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed) 
Ambirix - suspenzija za injiciranje v napolnjeni injekcijski brizgi Cepivo proti hepatitisu A, inaktivirano, in hepatitisu B, rekombinantno (HAB), adsorbirano
Protection against hepatitis B infections may not be obtained until after the second dose (see section Therefore: - Ambirix should be used only when there is a relatively low risk of hepatitis B infection during the vaccination course. 
- Ambirix se lahko uporablja le, če je tveganje za okužbo z virusom hepatitisa B med potekom cepljenja relativno majhno.
General disorders and administration site conditions Common: malaise, injection site reaction Rare: chills, influenza like illness 
Splošne težave in spremembe na mestu aplikacije Pogosti: splošno slabo počutje, reakcija na mestu injiciranja.
The anti-hepatitis B surface antigen (anti-HBs) and anti-hepatitis A virus (anti-HAV) antibody titres observed following a primary vaccination course with Ambirix are in the range of what is seen following vaccination with the monovalent hepatitis A and B vaccines. 
Po zaključku osnovnega cepljenja s cepivom Ambirix so doseženi titri protiteles proti površinskemu antigenu virusa hepatitisa B (anti-HBs) in proti virusu hepatitisa A (anti-HAV) primerljivi s tistimi, ki se jih doseže po cepljenju z monovalentnimi cepivi proti hepatitisu A in hepatitisu B. Splošne smernice za obnovitveno cepljenje se torej lahko povzamejo iz izkušenj z monovalentnimi cepivi, kot sledi:
Metabolism and nutrition disorders 
Infekcijske in parazitske bolezni
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 30 August 2002 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
The percentages with anti-HBs antibody ≥10 mIU/ml at this time point for subjects vaccinated at the 0, 6 and 0, 12 
Delež protiteles anti-HBs ≥10 mi.e./ml je bil pri osebah, cepljenih po shemi 0., 6. mesec ali 0., 12. mesec, ob tem času 84,8 % pri prvih in
50 x 1 dose (1 ml) 
50 napolnjenih injekcijskih brizg 50 x 1 odmerek (1 ml)
• joint pain (arthralgia) 
• mravljinčenje (parestezija),
• itching (pruritus), rash 
• koprivnica (urtikarija).
NAME OF THE MEDICINAL PRODUCT Ambirix suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed). 
Ambirix suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti hepatitisu A, inaktivirano, in hepatitisu B, rekombinantno (HAB), adsorbirano
• feeling drowsy 
• omedlevica,
Very rare (These may occur with up to 1 in 10,000 doses of the vaccine): • hives (urticaria) 
Pogosti (pojavijo se lahko pri največ 1 od 10 odmerkov cepiva): • zvišana telesna temperatura,
However, exceptionally Ambirix can be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these subjects. 
Ker pri osebah s trombocitopenijo ali z motnjami hemostaze obstaja nevarnost krvavitve po intramuskularnem dajanju, se takšnim osebam cepivo Ambirix lahko izjemoma daje subkutano.
Tel: + 49 (0)89 360448701 produkt.info@gsk.com 
KG Tel: + 49 (0)89 360448701
Rare (These may occur with up to 1 in 1,000 doses of the vaccine) : 
Zelo redki (pojavijo se lahko pri največ 1 od 10,000 odmerkov cepiva):
- Booster dose 
- Obnovitveni odmerek
However some official vaccination programmes currently include a recommendation for a booster dose of hepatitis B vaccine and these should be respected. 
Pri zdravih posameznikih, ki so bili popolno osnovno cepljeni, ni bila dokazana potreba po obnovitvenem odmerku cepiva proti hepatitisu B. Nekateri uradni programi cepljenja kljub temu priporočajo obnovitveni odmerek cepiva proti hepatitisu B in jih je treba upoštevati.
It is used to prevent two diseases: hepatitis A and hepatitis B. 
Cepivo Ambirix se uporablja pri od 1 do vključno 15 let starih dojenčkih, otrocih in mladostnikih za preprečevanje dveh bolezni: hepatitisa A in hepatitisa B.
• you need to be fully protected against hepatitis A and B infection within the next 6 monthsyour doctor may recommend a different vaccine 
če: • morate biti popolnoma zaščiteni pred okužbo z virusom hepatitisa A in B v naslednjih
Anti-HBs Month 2 SP (%) 
Anti-HBs 2. mesec
Uncommon (These may occur with up to 1 in 100 doses of the vaccine) : 
Občasni (pojavijo se lahko pri največ 1 od 100 odmerkov cepiva):
How the injection is given 
NAPOLNJENA INJEKCIJSKA BRIZGA
Common (These may occur with up to 1 in 10 doses of the vaccine) : 
Pogosti (pojavijo se lahko pri največ 1 od 10 odmerkov cepiva):
Anti-HBs Month 7 SP (%) 
Anti-HBs 7. mesec
The standard primary course of vaccination consists of two doses, the first administered at the elected date and the second between 6 and 12 months after the first dose. 
Standardno osnovno cepljenje je sestavljeno iz dveh odmerkov.
However, this route of administration may result in suboptimal immune response to the vaccine. 
Pri bolnikih s trombocitopenijo ali z motnjami hemostaze se lahko cepivo izjemoma aplicira subkutano, vendar je lahko posledica takšnega načina dajanja suboptimalen imunski odziv na cepivo
PHARMACOLOGICAL PROPERTIES 
FARMACEVTSKA OBLIKA
Anti-HBs Month 6 SP (%) 
Anti-HBs 6. mesec
GlaxoSmithKline S.p.A. Tel: + 39 04 59 21 81 11 
GlaxoSmithKline BV Tel: + 31 (0)30 69 38 100
This includes medicines obtained without a prescription and herbal medicines. 
Predpisovanje in izdaja zdravila je le na recept.
Seropositivity rates for anti-HAV were 99.0% and seropositivity rates for anti-HBs were 99.0% at month 13 with seroprotection rates of 97.0%. 
V klinični študiji s 102 osebama, ki so bile stare od 12 do vključno 15 let in so prejele drugi odmerek cepiva Ambirix 12 mesecev po danem prvem odmerku, je bil v 13. mesecu odstotek seropozitivnosti za anti-HAV in za anti-HBs 99,0 %, odstotek serozaščite pa 97,0 %.
Vascular disorders Rare: hypotension 
Redki: hipotenzija Bolezni prebavil Pogosti: driska, navzea.
The anti-HBs seroprotection rates (titers ≥ 10 mlU/ml) at these time points were 37.4% and 98.2% respectively. 
Odstotek serozaščite s protitelesi anti-HBs (titer ≥ 10 i.e./l) je bil en mesec po prejemu prvega odmerka 37,4 %, po prejemu drugega odmerka čez 6 mesecev pa 98,2 %.
• fever 
• bruhanje,
However, others can become very ill. 
Večina odraslih popolnoma ozdravi.
GENERAL CLASSIFICATION FOR SUPPLY 
POSEBNA NAVODILA ZA SHRANJEVANJE
• stomach and digestive problems 
• občutek omotičnosti, • težave z želodcem in s prebavo,
Gastrointestinal disorders Common: diarrhoea, nausea Uncommon: vomiting, abdominal pain* 
Občasni: bruhanje, bolečine v trebuhu*.
• diarrhoea, feeling sick (nausea) 
• driska, občutek slabosti (navzea), • reakcija na mestu injiciranja.
At 10 years following the initiation of a 0, 6 month schedule of Ambirix in children aged 1-15 years, 
10 let po cepljenju otrok, starih od 1 do 15 let, s cepivom Ambirix po shemi 0., 6. mesec so vse osebe ohranile ≥15 mi.e./ml protiteles anti-HAV.
Irinotecan has been authorised in the EU for a number of years for the treatment of colorectal cancer. 
V EU je irinotekan že več let odobren za zdravljenje kolorektalnega raka.
After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 9 November 2017. 
Po proučitvi razlogov za to zahtevo je odbor CHMP ponovno pregledal mnenje in dne 9. novembra 2017 potrdil zavrnitev vloge za dovoljenje za promet.
The company informed the CHMP that patients receiving the medicine in clinical trials will continue to do so as planned. 
Družba je odbor CHMP obvestila, da bodo bolniki, ki prejemajo to zdravilo v kliničnih študijah, zdravljenje še naprej prejemali, kot je bilo načrtovano.
The Committee considered that the data from this subgroup, which were not supported by additional studies, were not sufficient to prove the effectiveness of Onzeald, even when analysed by different methods. 
Odbor je menil, da podatki iz te podskupine, ki niso bili podprti z dodatnimi študijami, niso zadostovali za dokazovanje učinkovitosti zdravila Onzeald, tudi če so bili analizirani z različnimi metodami.
In this study, Onzeald was compared with standard cancer medicines chosen by the treating doctor, and the main measure of effectiveness was overall survival (how long the patients lived). 
Zdravljenje z zdravilom Onzeald so primerjali s standardnim zdravilom za zdravljenje raka, ki ga je izbral lečeči zdravnik, glavno merilo učinkovitosti pa je bilo celokupno preživetje (kako dolgo so bolniki živeli).
The claim of effectiveness relied on data from a subgroup of patients from a main study which, overall, failed to convincingly show the effectiveness of Onzeald. 
Trditev o učinkovitosti se je opirala na podatke podskupine bolnikov iz glavne študije, ki na splošno niso uspeli prepričljivo dokazati učinkovitosti zdravila Onzeald.
The company presented the results of one main study involving 852 patients with breast cancer that had spread to other parts of the body who had been treated with at least 2 other cancer medicines. 
Družba je predstavila rezultate ene glavne študije, v katero je bilo vključenih 852 bolnikov z rakom dojke, pri katerih se je rak razširil v druge dele telesa in so bili zdravljeni z vsaj dvema drugima zdraviloma za zdravljenje raka.
Refusal of the marketing authorisation for Onzeald (etirinotecan pegol) EMA/736863/2017 
Zavrnitev vloge za dovoljenje za promet z zdravilom Onzeald (etirinotekanpegol) EMA/736863/2017
On 20 July 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Onzeald, intended for the treatment of advanced breast cancer that has spread to the brain. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 20. julija 2017 priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Onzeald, namenjenim zdravljenju napredovalega raka dojke, ki se je razširil v možgane.
How does Onzeald work? 
Kako zdravilo Onzeald deluje?
The CHMP refusal was confirmed after re-examination. 
Zavrnitev odbora CHMP glede izdaje dovoljenja za promet je bila po ponovnem pregledu potrjena.
What was Onzeald expected to be used for? 
Za kaj naj bi se zdravilo Onzeald uporabljalo?
Because it is pegylated in etirinotecan pegol, the medicine is removed from the body at a slower rate, allowing the medicine to be given less often. 
Ker je pegiliran v učinkovini etirinotekanpegol, je izločanje zdravila iz telesa upočasnjeno, zaradi česar se lahko daje manj pogosto.
Therefore, the CHMP was of the opinion that the study did not provide enough evidence on the benefits of Onzeald and recommended that the marketing authorisation be refused. 
Zato je menil, da študija ni zagotovila dovolj dokazov o koristih zdravila Onzeald, in priporočil, da se dovoljenje za promet z zdravilom zavrne.
What is Onzeald? 
Kaj je zdravilo Onzeald?
It was to be available as a powder to be made into a solution for infusion (drip) into a vein. 
Na voljo naj bi bilo v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
The active substance in Onzeald, etirinotecan pegol, consists of irinotecan (a cancer medicine that belongs to the group ‘topoisomerase inhibitors') that has been ‘pegylated' (attached to a chemical called polyethylene glycol). 
Zdravilna učinkovina v zdravilu Onzeald, etirinotekanpegol, je irinotekan (zdravilo za zdravljenje raka, ki spada v skupino „zaviralcev topoizomeraze“), ki je „pegiliran“ (vezan na spojino, imenovano polietilenglikol).
Irinotecan blocks topoisomerase I, an enzyme that is involved in copying cell DNA, which is needed to make new cells. 
Irinotekan zavira encim, imenovan topoizomeraza I, ki sodeluje pri podvajanju celične DNK, ki je potrebna za nastanek novih celic.
Onzeald was expected to be used to treat adults with advanced breast cancer that had spread to the brain and other parts of the body and who have already received other treatments. 
Zdravilo Onzeald naj bi se uporabljalo za zdravljenje odraslih bolnikov z napredovalim rakom dojke, pri katerih se je rak razširil v možgane in druge dele telesa ter so že prejeli druge oblike zdravljenja.
Onzeald is a cancer medicine that contains the active substance etirinotecan pegol. 
Onzeald je zdravilo za zdravljenje raka, ki vsebuje zdravilno učinkovino etirinotekanpegol.
The CHMP considered that the benefit of Onzeald in the treatment of advanced breast cancer that had spread to the brain and other parts of the body had not been sufficiently demonstrated. 
Odbor CHMP je menil, da koristi zdravila Onzeald pri zdravljenju napredovalega raka dojk, ki se je razširil v možgane in druge dele telesa, niso bile zadostno dokazane.
The company that applied for authorisation is Nektar Therapeutics UK Limited. 
Vlogo za pridobitev dovoljenja za promet z zdravilom je predložila družba Nektar Therapeutics UK Limited.
Refusal of the marketing authorisation for Onzeald (etirinotecan pegol) 
Zavrnitev vloge za dovoljenje za promet z zdravilom Onzeald (etirinotekanpegol)
By blocking the enzyme, cancer cells are prevented from multiplying and they eventually die. 
Z zaviranjem encima prepreči rakavim celicam, da bi se razmnoževale, zato te sčasoma odmrejo.
5 August 2011 
5. avgust 2011
The mutual recognition procedure (UK/V/0354/001/MR) started on 26 November 2009. 
Postopek medsebojnega priznavanja (UK/V/0354/001/MR) se je začel 26. novembra 2009.
On 2 July 2010, the United Kingdom, as Reference Member State, referred the matter to the European Medicines Agency under Article 33(4) of Directive 2001/82/EC, due to concerns raised by the Concerned Member State, Ireland, that the safety and efficacy of the product had not been sufficiently demonstrated. 
Združeno kraljestvo je kot referenčna država članica 2. julija 2010 v skladu s členom 33(4) Direktive 2001/82/ES zadevo napotilo na Evropsko agencijo za zdravila zaradi zadržkov, ki jih je izpostavila zadevna država članica Irska, in sicer da varnost in učinkovitost zdravila nista bili zadostno dokazani.
The marketing authorisation holder, Norbrook Laboratories Ltd, submitted an application for Combimox via a mutual recognition procedure in Ireland on the basis of the marketing authorisation granted by the United Kingdom. 
Imetnik dovoljenja za promet z zdravilom družba Norbrook Laboratories Ltd je predložila vlogo za zdravilo Combimox prek postopka medsebojnega priznavanja na Irskem na podlagi dovoljenja za promet z zdravilom, ki je bilo odobreno v Združenem kraljestvu.
Combimox Lactating Cow Intramammary Suspension (Combimox) is an intramammary suspension containing amoxicillin, clavulanic acid and prednisolone. 
Zdravilo Combimox Lactating Cow Intramammary Suspension (Combimox) je intramamarna suspenzija, ki vsebuje amoksicilin, klavulansko kislino in prednizolon.
Combimox is intended for the treatment of mastitis in lactating cows. 
Zdravilo Combimox je namenjeno zdravljenju mastitisa pri kravah v obdobju laktacije.
Based on the evaluation of the rapporteur's assessment of the currently available data, the CVMP considered that the benefit/risk profile of Combimox Lactating Cow Intramammary Suspension is 
CVMP je zato po presoji ocene trenutno razpoložljivih podatkov, ki jo je opravil poročevalec, menil, da je razmerje med koristmi in tveganji za zdravilo Combimox Lactating Cow Intramammary Suspension negativno, in 6. aprila 2011 sprejel mnenje, v katerem priporoča zavrnitev odobritve dovoljenja za promet z zdravilom in začasen umik obstoječega dovoljenja za promet.
Other information about Numient 
Druge informacije o zdravilu Numient
What measures are being taken to ensure the safe and effective use of Numient? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Numient?
They can be taken with or without food, but should not be taken at the same time as high protein meals, which can reduce absorption. 
Lahko se jemljejo s hrano ali brez nje, vendar se ne smejo jemati hkrati z obroki, bogatimi z beljakovinami, saj lahko te zmanjšajo absorpcijo zdravila.
The patient should then swallow the food immediately without chewing. 
Bolnik mora nato hrano pogoltniti takoj in brez žvečenja.
Numient capsules are taken with a glass of water. 
Kapsule zdravila Numient se jemljejo s kozarcem vode.
The full EPAR and risk management plan summary for Numient can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Numient sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
95 mg/23.75 mg, 145 mg/36.25 mg, 195 mg/48.75 mg and 245 mg/61.25 mg. For further information on how to use Numient, see the summary of product characteristic (also part of the EPAR). 
Na voljo je v naslednjih jakostih: 95 mg/23,75 mg, 145 mg/36,25 mg, 195 mg/48,75 mg in 245 mg/61,25 mg. Za več informacij o uporabi zdravila Numient glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
Patients who took placebo had an average improvement of 0.6 points. 
Pri bolnikih, ki so prejemali placebo, so zabeležili povprečno izboljšanje za 0,6 točke.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Numient's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Numient večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The doctor may then increase the dose depending on how the condition responds to treatment. 
Zdravnik lahko nato poveča odmerek glede na to, kako se bolezen odzove na zdravljenje.
The starting dose for patients who have not previously taken levodopa is one capsule containing 95 mg of levodopa and 23.75 mg of carbidopa, three times daily for the first three days. 
Začetni odmerek pri bolnikih, ki še niso prejemali levodope, je ena kapsula, ki vsebuje 95 mg levodope in 23,75 mg karbidope, trikrat dnevno prve tri dni.
What is Numient and what is it used for? 
Kaj je zdravilo Numient in za kaj se uporablja?
It is not intended to provide practical advice on how to use Numient. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
This is a summary of the European public assessment report (EPAR) for Numient. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Numient.
The combination of levodopa and carbidopa is used in other medicines for Parkinson's disease. 
Kombinacija levodope in karbidope se uporablja tudi v drugih zdravilih za Parkinsonovo bolezen.
A risk management plan has been developed to ensure that Numient is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Numient je bil pripravljen načrt obvladovanja tveganj.
For patients already taking levodopa, the doctor will determine the dose of Numient based on their current treatment. 
Pri bolnikih, ki že prejemajo levodopo, bo zdravnik odmerek zdravila Numient določil na podlagi njihovega trenutnega zdravljenja.
What benefits of Numient have been shown in studies? 
Kakšne koristi je zdravilo Numient izkazalo v študijah?
Patients who have difficulty swallowing can have the content of the capsules sprinkled on soft food such as apple sauce, yoghurt or pudding. 
Pri bolnikih, ki imajo težave s požiranjem, se lahko vsebina kapsule iztrese na mehko hrano, na primer jabolčno kašo, jogurt ali puding.
What are the risks associated with Numient? 
Kakšna tveganja so povezana z zdravilom Numient?
This study looked at how well the treatments reduced the time when patients have more difficulty moving about, called ‘off periods'. 
V tej študiji so preučevali, kako učinkoviti sta bili zdravili pri zmanjševanju časa, ko so imeli bolniki več težav z gibanjem - ta pojav imenujemo „obdobja izklopa“.
After 13 weeks, patients taking Numient had off periods of about 24% of their waking hours compared with 30% of waking hours in patients taking the comparator medicine. 
Po 13 tednih so obdobja izklopa pri bolnikih, ki so prejemali zdravilo Numient, predstavljala približno 24 % časa, ko so bili budni, v primerjavi s 30 % pri bolnikih, ki so prejemali primerjalno zdravilo.
After 30 weeks, patients taking Numient had their symptoms improve by an average of between 11.7 and 14.9 points (depending on dose) on a standard symptom scale (Unified Parkinson's Disease Rating Scale, UPDRS Part II and Part III). 
Po 30 tednih so se pri bolnikih, ki so prejemali zdravilo Numient, simptomi v povprečju izboljšali za 11,7 do 14,9 točke (odvisno od odmerka) na standardni lestvici za oceno simptomov (enotna ocenjevalna lestvica za Parkinsonovo bolezen (UPDRS), II.
The most frequent side effects with Numient are nausea in (12% of patients), dizziness, headache and involuntary movements (each occurring in 8% of patients), and insomnia (in 6% of patients). 
Najpogostejši neželeni učinki zdravila Numient so slabost (pri 12 % bolnikov), omotica, glavobol in nehoteni gibi (vsak od teh pri 8 % bolnikov) ter nespečnost (pri 6 % bolnikov).
Why is Numient approved? 
Zakaj je bilo zdravilo Numient odobreno?
More serious side effects include bleeding from the gut and allergic reactions, and have been reported uncommonly. 
Resnejši neželeni učinki vključujejo krvavitve iz črevesja in alergijske reakcije, o njih pa so poročali občasno.
These types of capsules are known as modifiedrelease capsules. 
Tovrstne kapsule imenujemo kapsule s prirejenim sproščanjem.
Studies show that Numient is effective at reducing symptoms in patients with early and late stage Parkinson's disease. 
Študiji kažeta, da je zdravilo Numient učinkovito pri zmanjševanju simptomov pri bolnikih s Parkinsonovo boleznijo v zgodnji in pozni fazi.