natgillin/translations-raw huggingface dataset:
• purple or reddish-purple bumps on the skin (lichen planus), serious skin rashes (erythema multiforme) 
• ljubičaste ili crvenoljubičaste izbočine na koži (lichen planus), ozbiljni kožni osipi (multiformni eritem) • smanjenje broja krvnih pločica (trombocita), što povećava rizik od krvarenja ili nastanka modrica
General disorders and administration site conditions Immediate injection site pain, stinging and burning sensation 
Opći poremećaji i reakcije na mjestu primjene Trenutna bol na mjestu primjene, osjećaj probadanja i pečenja
GlaxoSmithKline S.p.A. Tel: + 39 04 59 21 81 11 
ГлаксоСмитКлайн ЕООД Тел.: + 359 2 953 10 34
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. 
Zaštita protiv infekcija hepatitisom B možda se neće postići prije primitka druge doze (vidjeti dio 5.1).
Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44 diam@gsk.com 
Tél: + 33 (0) 1 39 17 84 44
Hypersensitivity after previous administration of hepatitis A and/or hepatitis B vaccines. 
Preosjetljivost nakon prethodne primjene cjepiva protiv hepatitisa
The latter contained 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen. 
A inaktiviranog formalinom i 10 mikrograma rekombinantnog površinskog antigena hepatitisa B.
Side effects that occurred during clinical trials with Ambirix were as follows: 
Tijekom kliničkog ispitivanja cjepiva Ambirix pojavile su se sljedeće nuspojave:
Ambirix Combined HAB vaccine (360/10) 
Ambirix Kombinirano HAB
Skin and subcutaneous tissue disorders Erythema multiforme, lichen planus 
Erythema multiforme, lichen planus Poremećaji mišićno-koštanog sustava i vezivnog tkiva
In addition, the following adverse reactions were reported during clinical trials with GlaxoSmithKline's other combined hepatitis A and hepatitis B vaccines (given as a 3 or 4 dose schedule) 
A i hepatitisa B tvrtke GlaxoSmithKline (primijenjenih po rasporedu cijepljenja 3 ili 4 doze), prijavljene su sljedeće nuspojave
50 x 1 dose (1 ml) 
50 napunjenih štrcaljki 50 x 1 doza (1 ml)
Posology 
Cjepivo
• swelling or infection of the brain (encephalitis) 
• poremećaj u nalazima pretraga koje se odnose na rad jetre • oticanje ili infekcija mozga (encefalitis)
Concomitant immunoglobulin administration may result in lower antibody titres. 
Takva primjena može rezultirati nižim titrima protutijela.
Tel: + 31 (0)30 69 38 100 nlinfo@gsk.com 
Tel: + 31 (0)30 69 38 100
Blood and lymphatic system disorders Thrombocytopenic purpura, thrombocytopenia 
Trombocitopenična purpura, trombocitopenija
General disorders and administration site conditions Very common: fatigue, pain and redness at the injection site Common: fever, swelling at the injection site 
Opći poremećaji i reakcije na mjestu primjene Vrlo često: umor, bolnost i crvenilo na mjestu primjene
The vaccine should be re-suspended following the steps below. 
Resuspendiranje cjepiva kako bi se dobila jednolična mutno bijela suspenzija Cjepivo se treba resuspendirati slijedeći korake opisane ispod: 1.
GlaxoSmithKline (GSK) SRL Tel: + 40 (0)21 3028 208 
Tel: + 40 (0)21 3028 208
3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate, 
0,05 miligrama Al3+ 3proizveden tehnologijom rekombinantne DNA na stanicama kvasca (Saccharomyces cerevisiae) adsorbiran na aluminijev fosfat,
Anti-HBs Month 7 SP (%) 
7. mjesec SP (%)
Cases of overdose with GlaxoSmithKline's combined hepatitis A and hepatitis B vaccine have been reported during post-marketing surveillance. 
4.9 Predoziranje Tijekom praćenja nakon stavljanja cjepiva u promet zabilježeni su slučajevi predoziranja kombiniranim cjepivom protiv hepatitisa A i hepatitisa B tvrtke GlaxoSmithKline.
Anti-HBs Month 6 SP (%) 
6. mjesec SP (%)
Anti-HBs Month 2 SP (%) 
2. mjesec SP (%)
Following widespread use of either GlaxoSmithKline's combined hepatitis A and hepatitis B vaccines or the monovalent hepatitis A and/or hepatitis B vaccines, the following adverse reactions have additionally been reported. 
A i/ili hepatitisa B tvrtke GlaxoSmithKline, dodatno su prijavljene sljedeće nuspojave.
What Ambirix contains 
Što Ambirix sadrži • Djelatne tvari su:
PHARMACEUTICAL PARTICULARS 6.1 List of excipients 
FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari natrijev klorid voda za injekcije
• feeling drowsy 
• proljev, mučnina
- Hepatitis A virus (inactivated) 1,2 
- inaktivirani virus hepatitisa A1,2
The following adverse reactions were reported during clinical trials with Ambirix. 
Tijekom kliničkih ispitivanja cjepiva Ambirix, prijavljene su sljedeće nuspojave:
If any of the above apply (or you are not sure), talk to your doctor, nurse or pharmacist before having Ambirix. 
Ako se nešto od gore navedenoga odnosi na Vas (ili ako niste sigurni), obratite se svom liječniku,
• Hepatitis A: Infection with the hepatitis A virus may cause the liver to become swollen (inflamed). 
• Hepatitis A: Infekcija virusom hepatitisa
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/. 
(EMA): http://www.ema.europa.eu/
• joint pain (arthralgia) 
• koprivnjača (urtikarija)
When Ambirix was administered concomitantly with, but as a separate injection to a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTPa-IPV+Hib) or with a combined Measles-Mumps-Rubella vaccine in the second year of life, immune responses to all antigens were satisfactory (see section 5.1). 
ili s kombiniranim cjepivom protiv ospica, zaušnjaka i rubeole u drugoj godini života, primijenjenim odvojenim injekcijama, postignut je zadovoljavajući imunološki odgovor na sve antigene (vidjeti dio
The percentages with anti-HBs antibody ≥10 mIU/ml at this time point for subjects vaccinated at the 0, 6 and 0, 12 
Postotak ispitanika s anti-HBs protutijelima ≥10 mIU/ml u tom trenutku za ispitanike cijepljene prema rasporedu 0, 6 mjeseci odnosno 0, 12 mjeseci bili su 84,8% odnosno 92,9%.
Ambirix 
Vaskulitis
• swelling of the spinal cord (myelitis) 
• oticanje kralježnične moždine (mijelitis)
This is usually into the upper arm. 
Injekcija se obično daje u nadlakticu.
Nervous system disorders Very common: headache Common: drowsiness 
Poremećaji metabolizma i prehrane Vrlo često: gubitak apetita
GlaxoSmithKline (Cyprus) Ltd Τηλ: + 357 22 39 70 00 gskcyprus@gsk.com 
GlaxoSmithKline (Cyprus) Ltd
• fainting • loss of skin sensitivity to pain or touch (hypoaesthesia) 
• utrnulost ili slabost ruku i nogu (neuropatija) • trenutna bol na mjestu primjene injekcije, osjećaj probadanja i žarenja
However the anterolateral thigh may be used in very young subjects if preferred. 
Međutim, u jako mladih osoba cjepivo se može primijeniti u anterolateralni dio bedra.
10 November 2017 EMA/736863/2017 EMEA/H/C/003874 
EMA/736863/2017 EMEA/H/C/003874
What is Onzeald? 
Što je Onzeald?
The company that applied for authorisation is Nektar Therapeutics UK Limited. 
Zahtjev za izdavanje odobrenja podnijela je tvrtka Nektar Therapeutics UK Limited.
The company informed the CHMP that patients receiving the medicine in clinical trials will continue to do so as planned. 
Tvrtka je obavijestila CHMP da će bolesnici koji primaju lijek u kliničkim ispitivanjima nastaviti primati ga prema planu.
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. 
Nakon razmatranja razloga za ovaj zahtjev CHMP je preispitao prvotno mišljenje i potvrdio odbijanje izdavanja odobrenja za stavljanje lijeka u promet dana 9. studenoga 2017.
The CHMP refusal was confirmed after re-examination. 
Odbijanje CHMP-a potvrđeno je nakon preispitivanja.
Refusal of the marketing authorisation for Onzeald (etirinotecan pegol) EMA/736863/2017 
Odbijanje odobrenja za stavljanje u promet lijeka Onzeald (etirinotekan pegol) EMA/736863/2017
How does Onzeald work? 
Kako djeluje Onzeald?
By blocking the enzyme, cancer cells are prevented from multiplying and they eventually die. 
Blokiranjem enzima sprečava se umnožavanje stanica raka i one naposljetku umiru.
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 smatrao da podatci za tu podskupinu, koji nisu poduprti dodatnim ispitivanjima, nisu pružili dovoljno dokaza o učinkovitosti lijeka Onzeald, čak i kada ih se analiziralo različitim metodama.
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). 
U tom je ispitivanju djelovanje lijeka Onzeald uspoređeno s djelovanjem standardnih lijekova protiv raka koje je odabrao nadležni liječnik, a glavna mjera djelotvornosti bilo je ukupno preživljenje (koliko su dugo bolesnici živjeli).
Irinotecan has been authorised in the EU for a number of years for the treatment of colorectal cancer. 
Irinotekan je u EU-u odobren već niz godina za liječenje kolorektalnog karcinoma (raka debelog crijeva).
What was Onzeald expected to be used for? 
Za što se Onzeald trebao koristiti?
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. 
Tvrtka je predstavila rezultate jednog glavnog ispitivanja koje je obuhvatilo 852 bolesnika oboljelih od raka dojke koji se proširio na druge dijelove tijela, a koji su već primili najmanje dva druga lijeka protiv raka.
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. 
Tvrdnja o učinkovitosti temelji se na podatcima za podskupinu bolesnika iz glavnog ispitivanja, no ti podatci zajedno nisu uspjeli uvjerljivo dokazati učinkovitost lijeka Onzeald.
Refusal of the marketing authorisation for Onzeald (etirinotecan pegol) 
Odbijanje odobrenja za stavljanje u promet lijeka Onzeald (etirinotekan pegol)
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). 
Djelatna tvar u lijeku Onzeald, etirinotekan pegol, sadržava irinotekan (lijek protiv raka koji pripada skupini „inhibitora topoizomeraze”) koji je prošao postupak „pegilacije” (vezanje za kemijski spoj polietilen glikol).
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. 
Budući da je irinotekan u etirinotekan pegolu pegiliran, njegovo uklanjanje iz tijela je usporeno, što omogućava rjeđe davanje lijeka.
Irinotecan blocks topoisomerase I, an enzyme that is involved in copying cell DNA, which is needed to make new cells. 
Irinotekan blokira enzim naziva topoizomeraza I, koji je uključen u kopiranje stanične DNK, koja je potrebna za stvaranje novih stanica.
Onzeald is a cancer medicine that contains the active substance etirinotecan pegol. 
Onzeald je lijek protiv raka koji sadrži djelatnu tvar etirinotekan pegol.
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 lijekove za humanu uporabu (CHMP) donio je negativno mišljenje i preporučio odbijanje izdavanja odobrenja za stavljanje u promet lijeka Onzeald, koji je namijenjen liječenju uznapredovalog raka dojke koji se proširio na mozak.
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. 
Stoga je CHMP smatrao da ispitivanjem nije izneseno dovoljno dokaza o koristima lijeka Onzeald te je preporučio odbijanje izdavanja odobrenja za stavljanje u promet.
It was to be available as a powder to be made into a solution for infusion (drip) into a vein. 
Lijek je trebao biti dostupan u obliku praška od kojeg se priprema otopina za intravensku infuziju (drip).
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. 
Onzeald se trebao koristiti za liječenje uznapredovalog raka dojke koji se proširio na mozak i druge dijelove tijela u odraslih osoba koje su već bile podvrgnute drugim oblicima liječenja.
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. 
CHMP je smatrao da koristi lijeka Onzeald za liječenje raka dojke koji se proširio na mozak i druge dijelove tijela nisu dokazane u dovoljnoj mjeri.
Both groups had off periods of about 36-37% at the start of the study. 
Obje su grupe imale razdoblja isključenosti od otprilike 36-37% na početku ispitivanja.
Numient levodopa / carbidopa 
Numient levodopa / karbidopa
Patients who took placebo had an average improvement of 0.6 points. 
Bolesnici koji su primili placebo imali su prosječno poboljšanje od 0,6 bodova.
Other information about Numient 
Ostale informacije o lijeku Numient
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. 
Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Numient nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Numient capsules are taken with a glass of water. 
Kapsule lijeka Numient uzimaju se sa čašom vode.
These types of capsules are known as modifiedrelease capsules. 
Ovi tipovi kapsula su poznati kao kapsule s modificiranim otpuštanjem.
Patients who have difficulty swallowing can have the content of the capsules sprinkled on soft food such as apple sauce, yoghurt or pudding. 
Bolesnici koji imaju poteškoća s gutanjem mogu posipati sadržaj kapsula na mekanu hranu poput soka od jabuke, jogurta ili pudinga.
What measures are being taken to ensure the safe and effective use of Numient? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Numient?
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. 
Početna doza za bolesnike koji prethodno nisu uzimali tvar levodopa je jedna kapsula koja sadrži 95 mg levodopa i 23,75 mg karbidopa, tri puta dnevno tijekom prva tri dana.
The doctor may then increase the dose depending on how the condition responds to treatment. 
Liječnik zatim može povećati dozu ovisno o tome kako bolesnik reagira na terapiju.
This study looked at how well the treatments reduced the time when patients have more difficulty moving about, called ‘off periods'. 
Ovo je ispitivanje istražilo koliko su dobro terapije skratile vrijeme u kojem su bolesnici imali više poteškoća prilikom kretanja, koji se zovu"razdoblja isključenosti".
It is not intended to provide practical advice on how to use Numient. 
Svrha sažetka nije davati praktične savjete o korištenju lijeka Numient.
What is Numient and what is it used for? 
Što je Numient i za što se koristi?
The patient should then swallow the food immediately without chewing. 
Bolesnici trebaju zatim progutati hranu bez žvakanja.
Numient is available as capsules to be taken by mouth. 
Numient je dostupan kao kapsule koje se uzimaju na usta.
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. 
Kapsule se mogu uzimati sa ili bez hrane, no ne smiju se uzimati istovremeno s obrocima bogatima bjelančevina, jer to smanjuje apsorpciju.
Why is Numient approved? 
Zašto je Numient odobren?
The combination of levodopa and carbidopa is used in other medicines for Parkinson's disease. 
Kombinacija levodopa i karbidopa koristi se i u drugim lijekovima za liječenje Parkinsonove bolesti.
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). 
Nakon 30 tjedana, kod bolesnika koji su uzimali Numient simptomi su se poboljšali prosječno između 11,7 i 14,9 bodova (ovisno o dozi) na standardnoj ljestvici simptoma (unificirana skala ocjene Parkinsonove bolesti, UPDRS dijelovi II i dio III).
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). 
Najčešće nuspojave lijeka Numient su mučnina (u 12% bolesnika), vrtoglavica, glavobolja i nenamjerni pokreti (od kojih je svaki nastupio u 8% bolesnika), te nesanica (u 6% bolesnika).
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 lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Numient nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
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. 
Nakon 13 tjedana, bolesnici koji su uzimali Numient imali su razdoblja isključenosti od otprilike 24% u odnosu na njihova razdoblja hodanja u usporedbi s 30% satova hodanja u bolesnika koji su uzimali usporedni lijek.
This is a summary of the European public assessment report (EPAR) for Numient. 
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Numient.
A risk management plan has been developed to ensure that Numient is used as safely as possible. 
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Numient.
What are the risks associated with Numient? 
Koji su rizici povezani s lijekom Numient?
It must also not be used in patients taking medicines known as non-selective monoamine oxidase (MAO) inhibitors or in patients with a history of certain medical conditions. 
Ne smije se koristiti u bolesnika koji uzimaju lijekove poznate kao inhibitori neselektivne monoamin oksidaze (MAO) ili u bolesnika s određenim zdravstvenim stanjima.
In a study of 381 patients with early stage Parkinson's disease, Numient at various doses was more effective at improving symptoms than placebo (a dummy treatment). 
U ispitivanju provedenom na 381 bolesnika s ranim stadijem Parkinsonove bolesti, Numient u različitim dozama bio je djelotvorniji u poboljšavanju simptoma od placeba (prividno liječenje).
It contains the active substances levodopa and carbidopa. 
Sadrži djelatne tvari levodopa i karbidopa.
More serious side effects include bleeding from the gut and allergic reactions, and have been reported uncommonly. 
Ozbiljnije nuspojave uključuju krvarenje iz crijeva i alergijske reakcije, te su prijavljene kao rijetke nuspojave.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Numient, including the appropriate precautions to be followed by healthcare professionals and patients. 
Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Numient nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
Studies show that Numient is effective at reducing symptoms in patients with early and late stage Parkinson's disease. 
Ispitivanja su pokazala da je Numient djelotvoran u smanjivanju simptoma u bolesnika u ranom i kasnom stadiju Parkinsonove bolesti.
Another benefit is the way the active substances are formulated in Numient, which helps maintain more steady levodopa levels. 
Druga korist je način na koji se djelatne tvari formuliraju u lijeku Numient, što pomaže pri održavanju stabilnijih koncentracija levodopa.
For patients already taking levodopa, the doctor will determine the dose of Numient based on their current treatment. 
U slučaju bolesnika koji uzimaju tvar levodopa, liječnik utvrđuje dozu lijeka Numient na temelju njihove postojeće terapije.
In patients with Parkinson's disease, the cells in the brain that produce dopamine, a neurotransmitter important for controlling movement, begin to die and the amount of dopamine in the brain decreases. 
U bolesnika s Parkinsonovom bolešću, stanice mozga koje proizvode dopamin, neurotransmiter koji je važan za kontroliranje pokreta, počinju odumirati te se smanjuje količina dopamina u mozgu.
Numient is used in adults to treat the symptoms of Parkinson's disease, a progressive brain disorder that causes shaking and muscular stiffness and slows down movement. 
Numient se koristi za liječenje odraslih sa simptomima Parkinsonove bolesti, progresivne bolesti mozga koja uzrokuje treskavicu, usporene pokrete i ukočenost mišića.
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). 
Numient se izdaje samo na liječnički recept i dostupan je u sljedećim jačinama: 95 mg/23,75 mg; 145 mg/36,25 mg; 195 mg/48,75 mg i 245 mg/61,25 mg.
In Numient, a portion of the active substances is released immediately, while the remaining is released gradually, leading to more steady levodopa levels. 
Kod lijeka Numient, udio djelatnih tvari se otpušta odmah, dok se preostali dio postepeno otpušta, što rezultira stabilnijim koncentracijama levodopa.
For practical information about using Numient, patients should read the package leaflet or contact their doctor or pharmacist. 
Praktične informacije o primjeni lijeka Numient bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
Numient must not be used in patients with narrow angle glaucoma (an eye disorder) or pheochromocytoma (a tumour of the adrenal glands). 
Numient se ne smije koristiti u bolesnika s glaukomom suženoga kuta (poremećajem oka) ili feokromokitomijom (tumorom nadbubrežne žlijezde).
For more information about treatment with Numient, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Više informacija o terapiji lijekom Numient pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
What benefits of Numient have been shown in studies? 
Koje su koristi lijeka Numient utvrđene u ispitivanjima?
Numient contains levodopa which converts into dopamine in the brain and helps to restore dopamine levels. 
Numient sadrži tvar levodopa koji se pretvara u dopamin u mozgu i pomaže pri održavanju koncentracija dopamina.
How is Numient used? 
Kako se Numient koristi?
The carbidopa in Numient stops the levodopa from converting into dopamine while still in the general circulation, before it has reached the brain. 
Karbidopa u lijeku Numient sprječava tvar levodopa da se pretvori u dopamin dok se nalazi u krvi, prije nego dođe u mozak.
How does Numient work? 
Kako djeluje Numient?
A second study compared Numient with another treatment containing levodopa and carbidopa in 393 patients with advanced Parkinson's disease. 
Drugo je ispitivanje usporedilo Numient s drugom terapijom koja je sadržavala tvari levodopa i karbidopa.
These local reactions gradually reduce and disappear without need for treatment. 
Te lokalne reakcije se postepeno smanjuju i nestaju bez potrebe za tretmanom.
No available data. 
Nema dostupnih podataka.
Keep the bottle in the outer carton in order to protect from light. 
Držite bočicu u vanjskom kartonu radi zaštite od svjetla.