natgillin/translations-raw huggingface dataset:
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product other than Versican Plus DHPPi and Versican Plus Pi. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis. 
Ne postoje dostupni podaci o neškodljivosti i učinkovitosti ovog cjepiva kada se primjenjuje s bilo kojim drugim veterinarsko-medicinskim proizvodom osim s Versican Plus DHPPi i Versican Plus Pi.
− to prevent clinical signs, infection and urinary excretion caused by L. interrogans serogroup Australis serovar Bratislava, 
− sprječavanje kliničkih znakova, infekcija i izlučivanja mokraće uzrokovanih L. interrogans,
NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus L4 for dogs 
Versican Plus L4 - za pse
Suspension: 
Trajanje imunosti:
− to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae and 
interrogans, serotip Canicola, serovar Canicola i L. interrogans serotip Icterohaemorrhagiae, serovar Icterohaemorrhagiae i
ALR* titre ≥ 1:51 
ALR* titar ≥ 1:51
ALR* titre ≥ 1:40 
ALR* titar ≥ 1:40
− to prevent clinical signs and reduce infection and urinary excretion caused by L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa. 
kirschneri, serotip Grippotyphosa, serovar Grippotyphosa.
WITHDRAWAL PERIOD(S) 
DATUM REVIZIJE TEKSTA
10 July 2015 
10. srpnja 2015.
This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU). 
To znači da, iako ne postoji dovoljno dokaza iz kliničkih ispitivanja, učinkovitost ovih biljnih lijekova je vjerojatna i postoje dokazi o njihovoj sigurnoj primjeni na opisani način najmanje 30 godina (uključujući najmanje 15 godina u EU).
Mouse-ear hawkweed EMA/HMPC/331455/2015 
Zelen s korijenom male runjike EMA/HMPC/331455/2015
Information on the use and licensing of mouse-ear hawkweed medicines in EU Member States should be obtained from the relevant national authorities. 
Informacije o uporabi i odobrenju lijekova koji sadrže zelen s korijenom male runjike u državama članicama EU-a treba zatražiti od nadležnih nacionalnih tijela.
Further information on the HMPC assessment of mouse-ear hawkweed medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use. 
Dodatne informacije o HMPC-ovoj ocjeni lijekova koji sadrže zelen s korijenom male runjike, uključujući pojedinosti zaključaka Povjerenstva, nalaze se u rubrici „All documents” na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
Any applications for the licensing of medicines containing mouse-ear hawkweed have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC. 
Svi zahtjevi za odobrenje lijekova koji sadrže zelen s korijenom male runjike moraju se podnijeti nacionalnim tijelima nadležnim za lijekove, koja ocjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.
Further information on the risks associated with mouse-ear hawkweed medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use. 
Više informacija o rizicima povezanim s lijekovima koji sadrže zelen s korijenom male runjike, uključujući odgovarajuće mjere opreza za sigurnu uporabu, nalazi se u monografiji u rubrici „All documents” na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
The HMPC noted the lack of clinical studies with mouse-ear hawkweed, but took into account the well documented use of this herbal medicine for the above uses. 
HMPC je istaknuo nedostatak kliničkih ispitivanja sa zeleni s korijenom male runjike, no uzeo je u obzir dobro dokumentiranu primjenu ovog biljnog lijeka za prethodno navedene primjene.
The HMPC concluded that, on the basis of its long-standing use, mouse-ear hawkweed can be used as a mild diuretic (a medicine to increase production of urine) for the relief of minor problems of the urinary tract (the structures that carry urine). 
HMPC je zaključio da se, na temelju njezine dugogodišnje uporabe, zelen s korijenom male runjike može koristiti kao blagi diuretik (lijek za povećanje stvaranja mokraće) za ublažavanje manjih tegoba s mokraćnim sustavom (organima koji prenose mokraću).
Mouse-ear hawkweed medicines must not be used in patients with conditions in which a reduced fluid intake is recommended (such as severe heart or kidney disease). 
Lijekovi koji sadrže zelen s korijenom male runjike ne smiju se koristiti u bolesnika sa stanjima za koja se preporučuje smanjeni unos tekućine (poput teških bolesti srca ili bubrega).
Mouse-ear hawkweed should only be used in adults. 
Zelen s korijenom male runjike smije se koristiti samo u odraslih osoba.
This summary is not intended to provide practical advice on how to use medicines containing mouseear hawkweed. 
Svrha ovog sažetka nije pružanje praktičnih savjeta o načinu uporabe lijekova koji sadrže zelen s korijenom male runjike.
Herbal medicines containing mouse-ear hawkweed are usually available as a herbal tea to be drunk and in solid forms to be taken by mouth. 
Biljni lijekovi koji sadrže zelen s korijenom male runjike obično su dostupni kao biljni čaj koji se pije i u čvrstom obliku za primjenu kroz usta.
The HMPC conclusions on the use of mouse-ear hawkweed medicines for the relief of minor urinary problems are based on their ‘traditional use'. 
Zaključci HMPC-a o primjeni lijekova koji sadrže zelen s korijenom male runjike za ublažavanje blažih tegoba mokraćnog sustava temelje se na njihovoj „tradicionalnoj uporabi”.
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing mouse-ear hawkweed. 
Države članice EU-a uzimaju u obzir zaključke HMPC-a prilikom ocjenjivanja zahtjeva za odobrenje biljnih lijekova koji sadrže zelen s korijenom male runjike.
Detailed instructions on how to take mouse-ear hawkweed medicines and who can use them can be found in the package leaflet that comes with the medicine. 
Detaljne upute o načinu primjene lijekova koji sadrže zelen s korijenom male runjike kao i o tome tko ih može koristiti navedene su u uputi o lijeku priloženoj uz lijek.
Mouse-ear hawkweed preparations are obtained by comminuting (reducing into tiny pieces) or powdering the dried plant parts. 
Pripravci koji sadrže zelen s korijenom male runjike pripremaju se usitnjavanjem (smanjivanjem na male komadiće) ili pulveriziranjem (pretvaranjem u prah) sušenih dijelova biljke.
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of mouse-ear hawkweed. 
Ovaj dokument predstavlja sažetak znanstvenih zaključaka Povjerenstva za biljne lijekove (HMPC) u pogledu medicinske uporabe zeleni s korijenom male runjike.
For more information about treatment with mouse-ear hawkweed medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist. 
Više informacija o terapiji lijekovima koji sadrže zelen s korijenom male runjike pročitajte u uputi o lijeku priloženoj uz lijek, odnosno obratite se svom liječniku ili ljekarniku.
Mouse-ear hawkweed is the common name for the above-ground parts (which may include flowers) and parts of the root of the plant Hieracium pilosella L. The plant is cultivated or gathered to obtain the plant parts for medicinal use. 
Zelen s korijenom male runjike je uobičajeni naziv za nadzemne dijelove biljke (koji mogu sadržavati i cvijetove) te dijelove korijena biljke Hieracium pilosella L.
For practical information about using mouse-ear hawkweed medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist. 
Za praktične informacije o uporabi lijekova koji sadrže zelen s korijenom male runjike bolesnici trebaju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svojem liječniku ili ljekarniku.
What are the risks associated with mouse-ear hawkweed medicines? 
Koji su rizici povezani s lijekovima koji sadrže zelen s korijenom male runjike?
Mouse-ear hawkweed medicines are generally well tolerated. 
Lijekovi koji sadrže zelen s korijenom male runjike općenito se dobro podnose.
What evidence supports the use of mouse-ear hawkweed medicines? 
Koji dokazi potkrjepljuju uporabu lijekova koji sadrže zelen s korijenom male runjike?
Other information about mouse-ear hawkweed medicines 
Ostale informacije o lijekovima koji sadrže zelen s korijenom male runjike
How are mouse-ear hawkweed medicines approved in the EU? 
Kako se u EU-u odobravaju lijekovi koji sadrže zelen s korijenom male runjike?
What is mouse-ear hawkweed? 
Što je zelen s korijenom male runjike?
Further information on Posaconazole Accord can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/posaconazole-accord. 
Više informacija o lijeku Posaconazole Accord dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/posaconazole-accord.
Posaconazole Accord (posaconazole) EMA/320670/2019 
Posaconazole Accord (posakonazol) EMA/320670/2019
It works by preventing the formation of ergosterol, which is an important part of fungal cell walls. 
Djeluje tako da sprječava stvaranje ergosterola, važnog sastavnog dijela stanične stijenke gljivica.
Without ergosterol, the fungus dies or is prevented from spreading. 
Bez ergosterola gljivica odumire ili je onemogućeno njezino širenje.
Gastro-resistant means that the tablets pass through the stomach without being broken down until they reach the intestine. 
Želučanootporne tablete prolaze kroz želudac, ali se ne razgrađuju sve dok ne dođu do crijeva.
Posaconazole Accord (posaconazole) 
Posaconazole Accord (posakonazol)
• chromoblastomycosis and mycetoma (long-term fungal infections of the skin or the tissue just below the skin, usually caused by fungal spores infecting wounds due to thorns or splinters), 
• kromoblastomikoze i micetoma (dugotrajnih gljivičnih infekcija kože ili tkiva tik ispod kože, koje obično uzrokuju gljivične spore inficiranjem rana od trnja ili krhotina),
The recommended dose is 300 mg twice a day on the first day followed by 300 mg once a day thereafter; the duration of treatment depends on the severity of the disease and the patient's response. 
Preporučena doza iznosi 300 mg dvaput dnevno, a potom 300 mg jednom dnevno.
Posaconazole Accord is an antifungal medicine used to treat adults with the following fungal diseases, when treatments with other antifungal medicines (amphotericin B, itraconazole or fluconazole) cannot be tolerated or have failed: 
Posaconazole Accord je antimikotik koji se primjenjuje za liječenje odraslih osoba oboljelih od sljedećih gljivičnih bolesti, kada bolesnik ne može podnijeti terapiju drugim antimikoticima (amfotericin B, itrakonazol ili flukonazol) ili kada terapija nije djelovala:
Side effects reported with Posaconazole Accord are carefully evaluated and any necessary action taken to protect patients. 
Nuspojave prijavljene za lijek Posaconazole Accord pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Noxafil, and do not need to be repeated for Posaconazole Accord. 
Ispitivanja koristi i rizika djelatne tvari u odobrenim primjenama već su provedena s referentnim lijekom Noxafil i stoga ih nije potrebno ponavljati za Posaconazole Accord.
Posaconazole Accord is also used to prevent invasive fungal infections in patients whose immune system is weakened because of treatments they are receiving for blood or bone marrow cancers or medicines used in haematopoietic stem cell transplantation (a procedure where the patient's bone marrow is replaced by stem cells from a donor to form new bone marrow). 
Posaconazole Accord primjenjuje se i za sprječavanje invazivnih gljivičnih infekcija u bolesnika čiji je imunosni sustav oslabljen zbog terapija koje primaju za liječenje raka krvi ili koštane srži ili zbog lijekova koje uzimaju zbog transplantacije hematopoetskih matičnih stanica (zahvata tijekom kojeg se koštana srž bolesnika zamjenjuje matičnim stanicama darivatelja radi stvaranja nove koštane srži).
This means that Posaconazole Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Noxafil. 
To znači da Posaconazole Accord sadrži istu djelatnu tvar i djeluje na jednak način kao i „referentni lijek” koji je već odobren u EU-u pod nazivom Noxafil.
Posaconazole Accord can only be obtained with a prescription and treatment should be started by a doctor who has experience in managing fungal infections or in treating patients at high risk of invasive fungal infections. 
Lijek Posaconazole Accord izdaje se samo na recept, a liječenje treba započeti liječnik s iskustvom u liječenju gljivičnih infekcija ili u liječenju bolesnika izloženih visokom riziku od invazivnih gljivičnih infekcija.
Because Posaconazole Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Budući da je Posaconazole Accord generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
The European Medicines Agency concluded that, in accordance with EU requirements, Posaconazole Accord has been shown to have comparable quality and to be bioequivalent to Noxafil. 
Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, utvrđeno da lijek Posaconazole Accord ima usporedivu kakvoću te da je bioekvivalentan s lijekom Noxafil.
What measures are being taken to ensure the safe and effective use of Posaconazole Accord? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Posaconazole Accord?
• invasive aspergillosis (fungal infection caused by Aspergillus), 
• invazivne aspergiloze (gljivične infekcije koju uzrokuje gljivica Aspergillus),
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Posaconazole Accord have been included in the summary of product characteristics and the package leaflet. 
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Posaconazole Accord nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
Posaconazole Accord is available as gastro-resistant tablets (100 mg). 
Lijek Posaconazole Accord dostupan je u obliku želučanootpornih tableta (100 mg).
An overview of Posaconazole Accord and why it is authorised in the EU 
Pregled informacija o lijeku Posaconazole Accord i zašto je odobren u EU-u
For more information about using Posaconazole Accord, see the package leaflet or contact your doctor or pharmacist. 
Za više informacija o primjeni lijeka Posaconazole Accord pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
The active substance in Posaconazole Accord, posaconazole, is an antifungal medicine that belongs to the triazole group. 
Djelatna tvar lijeka Posaconazole Accord, posakonazol, jest antimikotik koji spada u skupinu triazola.
What is Posaconazole Accord and what is it used for? 
Što je Posaconazole Accord i za što se koristi?
• fusariosis (fungal infection caused by Fusarium), 
• fuzarioze (gljivične infekcije koju uzrokuje gljivica Fusarium),
Other information about Posaconazole Accord 
Ostale informacije o lijeku Posaconazole Accord
What are the benefits and risks of Posaconazole Accord? 
Koje su koristi i rizici lijeka Posaconazole Accord?
As for every medicine, the company provided studies on the quality of Posaconazole Accord. 
Kao i za svaki lijek, tvrtka je dostavila podatke o ispitivanjima kakvoće za lijek Posaconazole Accord.
Therefore, the Agency's view was that, as for Noxafil, the benefit of Posaconazole Accord outweighs the identified risk and it can be authorised for use in the EU. 
Stoga je stav Agencije da korist od lijeka Posaconazole Accord, kao i od lijeka Noxafil, nadmašuje identificirani rizik te da lijek može biti odobren za primjenu u EU-u.
Why is Posaconazole Accord authorised in the EU? 
Zašto je lijek Posaconazole Accord odobren u EU-u?
Posaconazole Accord contains the active substance posaconazole and is a ‘generic medicine'. 
Posaconazole Accord sadrži djelatnu tvar posakonazol te je „generički lijek”.
As for all medicines, data on the use of Posaconazole Accord are continuously monitored. 
Kao i za sve lijekove, podatci o primjeni lijeka Posaconazole Accord kontinuirano se prate.
• coccidioidomycosis (fungal infection of the lungs caused by breathing in spores). 
• kokcidioidomikoze (gljivične infekcije pluća uzrokovane udisanjem spora).
How does Posaconazole Accord work? 
Kako djeluje Posaconazole Accord?
The list of fungi Posaconazole Accord is active against can be found in the summary of product characteristics. 
Popis gljivica protiv kojih je utvrđena djelotvornost lijeka Posaconazole Accord dostupan je u sažetku opisa svojstava lijeka.
How has Posaconazole Accord been studied? 
Kako je Posaconazole Accord ispitivan?
Radioactive material. 
Radioaktivan materijal.
The training programme should contain the following key elements: 
Program obuke treba sadržavati sljedeće ključne elemente:
Up to 10 hours from the end of the synthesis. 
Do 10 sati od završetka sinteze.
20052 Monza Italy 
20052 Monza Italija
The histopathology criteria did not match the CERAD criteria. 
Histopatološki kriteriji nisu se poklapali s CERAD kriterijima.
Individual benefit/risk justification 
Obrazloženje koristi/rizika za pojedinca
Activity: {XXX} MBq in {XX} mL ToC: {DDMMYYYY} {XX}h{XX} {Time zone} Volume: {XX} mL 
Aktivnost: {XXX} MBq u {XX} ml ToC: {DDMMGGGG}{XX}h{XX} {vremenska zona} Volumen: {XX} ml
• Expertise and qualification of trainers should be ensured. 
• Potrebno je osigurati stručnost i kvalificiranost instruktora.
<Not applicable> 
<Nije primjenjivo.>
Cases should be histopathologically confirmed, if possible. 
Slučajeve je potrebno potvrditi histopatološkim nalazima, ako je moguće.
Training should include a sufficient number of clearly positive and negative cases as well as intermediate level cases. 
Obuka bi trebala uključivati dovoljan broj jasno pozitivnih i jasno negativnih slučajeva kao i nejasne slučajeve.
Neuraceq is not intended for use in children and adolescents below the age of 18 years old. 
Neuraceq nije namijenjen za primjenu u djece i adolescenata u dobi ispod 18 godina.
Possible side effects include: 
Moguće nuspojave uključuju:
Neuraceq will only be used in specially controlled areas. 
Neuraceq se primjenjuje samo u posebno kontroliranim prostorima.
Dosimetry calculations were adapted to the adult model (with a body weight of 70 kg). 
Dozimetrijski izračuni su prilagođeni za model odrasle osobe (s tjelesnom težinom od 70 kg).
It will be the smallest amount necessary to get the desired information. 
Bit će to najniža količina lijeka potrebna za dobivanje željenih informacija.
1081 HV Amsterdam The Netherlands 
1081 HV Amsterdam Nizozemska
Repeat dosing in yearly intervals showed that there was no difference in safety profile after first, second or third dosing. 
Ponovljeno davanje doza u godišnjim intervalima nije pokazalo nikakve razlike u sigurnosnom profilu nakon primjene prve, druge ili treće doze.
There are strict laws on the use, handling and disposal of radiopharmaceutical products. 
Postoje strogi zakoni o uporabi, rukovanju i odlaganju radiofarmaceutika.
Germany e-mail: gra@life-mi.com 
Njemačka e-mail: gra@life-mi.com
One injection is sufficient to carry out the scan that your doctor needs. 
Jedna injekcija je dovoljna za oslikavanje koje je potrebno liječniku.
Act.: ≤ 3000 MBq at ToC (see outer label) 
Akt.: ≤ 3000 MBq na ToC (vidjeti vanjsko pakiranje)
Effective dose (mSv/MBq) 
Efektivna doza (mSv/MBq)
ATC code: V09AX06 
ATK oznaka: V09AX06
EXP: ToC + 6 h 
Rok valjanosti: ToC + 6 h
Studies on reproduction toxicity have not been performed. 
Ispitivanja o reproduktivnoj toksičnosti nisu provedena.
After administration of Neuraceq, you should: 
Nakon primjene Neuraceqa, morate:
Time points beyond that time frame did not allow for further quantitation of activity in urine. 
Vremenske točke izvan tog vremenskog okvira nisu omogućile daljnje određivanje količine aktivnosti u mokraći.
The cognitive status of the subjects could not be determined reliably. 
Kognitivni status ispitanika nije se mogao pouzdano izmjeriti.
Contents of the pack and other information What Neuraceq contains 
Sadržaj pakiranja i druge informacije Što Neuraceq sadrži
If you have been given more Neuraceq than you should 
Ako primite više Neuraceqa nego što ste trebali
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advise before you are given this medicine. 
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se liječniku specijalistu nuklearne medicine za savjet prije nego primite ovaj lijek.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity and genotoxicity. 
Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije te toksičnosti i genotoksičnosti jednokratnih i ponovljenih doza.
In vitro studies using human liver microsomes did not indicate any potential to inhibit the cytochrome P450 enzyme system. 
In vitro ispitivanja s mikrosomima ljudske jetre ne ukazuju na bilo kakav potencijal inhibicije citokrom P450 enzimskog sustava.
Fluorine (18F) has a physical half-life of 110 minutes. 
Fluor (18F) ima fizički poluvijek od 110 minuta.
Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational programme with the National Competent Authority. 
Prije puštanja lijeka u promet u svakoj državi članici nositelj odobrenja će usuglasiti konačni obrazovni program s nadležnim nacionalnim tijelom.
A brain scan is usually taken 90 minutes after Neuraceq is given. 
Oslikavanje mozga provodi se obično 90 minuta nakon primjene Neuraceqa.
- if you are allergic to florbetaben (18F) or any of the other ingredients of this medicine (listed in section 6). 
- ako ste alergični na florbetaben (18F) ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
At 12 hours post injection 98.93% of the activity is decayed, at 24 hours post injection 99.99 % of the activity is decayed. 
Dvanaest sati nakon injekcije 98,93 % aktivnosti se raspada, a 24 sati nakon injekcije 99,99 % aktivnosti je raspadnuto.
Neuraceq has no influence on the ability to drive and use machines. 
Neuraceq ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
This is equivalent to 1.6% of the recommended maximum daily dietary intake of sodium for an adult. 
To odgovara 1,6 % preporučenog maksimalnog dnevnog unosa soli za odraslu osobu.
Residual activity in the midsagittal sinus can be sometimes observed likely due to the presence of tracer in the blood pool. 
Rezidualna aktivnost u sagitalnom sinusu može se ponekad opaziti najvjerojatnije zbog prisustva obilježivača u krvi.