natgillin/translations-raw huggingface dataset:
Percentages of subjects with antibody titres ≥ assay cut-off one month after booster vaccination with Menitorix co-administered with measles-mumps-rubella vaccine (MMR)* were as follows: 
Odstotek oseb s titri protiteles, enakimi ali večjimi od mejne vrednosti testa en mesec po obnovitvenem cepljenju s cepivom Menitorix v kombinaciji s cepivom proti ošpicam, mumpsu in rdečkam (MMR)*, je naslednji:
Three doses, each of 0.5 ml, should be given with an interval of at least 1 month between doses. 
Med posameznim odmerkom mora miniti najmanj 1 mesec.
An ongoing study will generate long-term SBA data while the Applicant/MAH also committed to monitor antibody persistence for five years in subsequent studies 023, 024, 025 and 026, in line with the “Note for guidance on clinical investigation of medicinal products in the paediatric population” (CPMP/ICH/2711/99). 
Trenutno potekajoča študija bo dala podatke o dolgotrajni vrednosti SBA, predlagatelj/imetnik dovoljenja za promet z zdravilom pa se je zavezal tudi spremljati zadrževanje protiteles v času petih let z naknadnimi študijami 023, 024, 025
• Crying 
• Jok.
In children 12 to 24 months of age, the vaccine may be administered in the deltoid region. 
Pri otrocih, starih od 12 do 24 mesecev, se lahko cepivo injicira v predel deltoidne mišice (glejte tudi poglavji 4.4 in 4.5).
GMC or GMT= geometric mean antibody concentration or titre %= percentage of subjects with titres equal to or above the cut-off *= co-administered with DTPa-HBV-IPV **= co-administered with DTPa-Hib-TT containing vaccines 
GMC ali GMT= geometrijska srednja koncentracija protiteles ali geometrijski srednji titer % = odstotek oseb s titri protiteles, enakimi ali večjimi od mejne vrednosti testa *= sočasno cepljenje s cepivom DTPa-HBV-IPV **= sočasno cepljenje s cepivi s komponentami DTPa-Hib-TT
• Diarrhoea 
• Zaspanost.
METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use 
POSTOPEK IN POT(I) UPORABE ZDRAVILA
The product is used for the active immunization of infants from the age of 2 months and toddlers up to the age of 2 years for the prevention of invasive diseases caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis group C (MenC) and is administered by intramuscular injection. 
Zdravilo se uporablja za aktivno imunizacijo dojenčkov, starih 2 meseca ali več, in majhnih otrok, starih do dve leti, za preprečevanje invazivne bolezni, ki jo povzročata virus Haemophilus influenzae tipa b (Hib) in bakterija Neisseria meningitidis iz skupine C (MenC), ter se daje z intramuskularno injekcijo.
1 pre-filled syringe: Solvent 1 dose (0.5 ml) 
1 napolnjena injekcijska brizga: vehikel 1 odmerek (0,5 ml)
Your child may be asked to stay in the surgery or vaccination area for a short time after vaccination to check that he or she does not have an immediate allergic reaction. 
Zaradi možnega pojava takojšnje alergijske reakcije boste morda morali z otrokom ostati v ambulanti pod nadzorom še krajši čas po cepljenju.
Responses to all the co-administered antigens were satisfactory and were similar to those achieved in control groups that received DTPa-HBV-IPV-Hib* concomitantly with a MenC conjugate vaccine (MenCC) or DTPa-HBV-IPV* concomitantly with a Hib conjugate vaccine and no MenCC. 
V kontrolni skupini so osebe prejele cepivo DTPa-HBV-IPVHib* skupaj s konjugiranim cepivom proti MenC (MenCC) ali cepivo DTPa-HBV-IPV* skupaj s konjugiranim cepivom proti Hib, brez MenCC.
Menitorix is a vaccine that can be given to children after the age of 2 months up to 2 years to prevent infectious diseases caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis group C (MenC) bacteria. 
Cepivo Menitorix uporabljamo pri otrocih, starih od 2 mesecev do 2 let, za preprečevanje nalezljivih bolezni, ki jih povzročata bakteriji Haemophilus influenzae tipa b (Hib) in Neisseria meningitidis skupine C (MenC).
Any other vaccines that are given at the same time as Menitorix will be injected separately at different parts of the body. 
Pri sočasnem cepljenju je treba vsa sočasno uporabljena cepiva injicirati na različna mesta.
In clinical trials that involved giving Menitorix for the first vaccinations against Hib and MenC or to boost protection against these diseases the side effects that occurred after vaccination were: 
V kliničnih preskušanjih cepiva Menitorix so po osnovnem ali obnovitvenem cepljenju proti Hib in MenC poročali o naslednjih neželenih učinkih:
Tell the doctor or nurse immediately if your child develops a rash (which may be raised or lumpy), tightness of the throat, swelling of the face or neck or shortness of breath. 
Če se pri otroku pojavi izpuščaj (ki je lahko izbokel ali grudast), stiskanje žrela, otekanje obraza ali vratu ali težko dihanje, o tem nemudoma obvestite medicinsko sestro ali zdravnika.
BEFORE YOUR CHILD RECEIVES MENITORIX 
KAJ MORATE VEDETI, PREDEN BO OTROK CEPLJEN S CEPIVOM MENITORIX
The vaccine should be given with caution to individuals with thrombocytopenia or any coagulation disorder. 
Otroke s trombocitopenijo ali z motnjami strjevanja krvi je treba cepiti previdno.
Percentages of subjects with antibody titres ≥ assay cut-off one month after booster vaccination with Menitorix administered alone or co-administered with DTPa-HBV-IPV* vaccine were as follows: 
Odstotek oseb s titri protiteles, enakimi ali večjimi od mejne vrednosti testa en mesec po obnovitvenem cepljenju s cepivom Menitorix, samim ali v kombinaciji s cepivom DTPa-HBV-IPV*, je naslednji:
Subjects primed with 3 doses of licensed Meningitec** or Menjugate** N= 96 
Osebe, ki so bile osnovno cepljene s 3 odmerki uradno potrjenega cepiva Meningitec** ali cepiva Menjugate** N = 96
Menitorix and associated names (See Annex I) powder and solvent for solution for injection [See Annex I - To be completed nationally] 
Menitorix in povezana imena (glejte Dodatek I) prašek in vehikel za raztopino za injiciranje [Glejte Dodatek I - Izpolni država članica]
HOW MENITORIX IS GIVEN 
KAKO SE CEPIVO MENITORIX UPORABLJA
Menitorix and associated names (See Annex I) powder and solvent for solution for injection Haemophilus type b and Meningococcal group C conjugate vaccine [See Annex I - To be completed nationally] 
Menitorix in povezana imena (glejte Dodatek I) prašek in vehikel za raztopino za injiciranje cepivo proti hemofilusu influence tipa b in proti meningokokom vrste C, konjugirano [Glejte Dodatek I - Izpolni država članica]
Menitorix and associated names (See Annex I) powder for solution for injection Haemophilus type b and Meningococcal group C conjugate vaccine [See Annex I - To be completed nationally] I.M. 
Menitorix in povezana imena (glejte Dodatek I) prašek in vehikel za raztopino za injiciranje cepivo proti hemofilusu influence tipa b in proti meningokokom vrste C, konjugirano [Glejte Dodatek I - Izpolni država članica] i.m.
HOW TO STORE MENITORIX 
SHRANJEVANJE CEPIVA MENITORIX
Percentages of subjects with antibody titres ≥ assay cut-off one month after primary vaccination with Menitorix co-administered with DTPa-IPV* or DTPa-HBV-IPV* vaccines were as follows: 
Odstotek oseb s titri protiteles, enakimi ali večjimi od mejne vrednosti testa en mesec po osnovnem cepljenju s cepivom Menitorix sočasno s cepivom DTPa-IPV* ali cepivom DTPa-HBV-IPV* je naslednji:
1 vial: Powder 1 pre-filled syringe: Solvent 2 needles 
1 napolnjena injekcijska brizga: vehikel 2 injekcijski igli
Antibody persistence has been demonstrated for Hib in three clinical trials (N=217) with 98.2% of subjects having an anti-PRP concentration of ≥ 0.15 microgramsml at 11-18 months of age i.e. at 7-14 months following completion of a 3-dose primary series with Menitorix. 
V starosti od 11 do 18 mesecev, to je od 7 do 14 mesecev po dokončanem osnovnem cepljenju s tremi odmerki cepiva Menitorix, je 98,2 % oseb imelo koncentracije anti-PRP ≥ 0,15 mikrogramov/ml.
The first dose should not be given before the age of 2 months and there should be a gap of at least four weeks between injections. 
Otrok prvega odmerka cepiva ne sme prejeti, dokler ne dopolni dveh mesecev starosti.
A single (0.5 ml) dose of Menitorix may be used to boost immunity to Hib and MenC in children who have previously completed a primary immunisation series with Menitorix or with other Hib or MenC conjugate vaccines. 
Otrok, ki je bil osnovno popolno cepljen s cepivom Menitorix ali z drugim konjugiranim cepivom proti Hib ali MenC, lahko za obnovitev imunosti proti Hib in MenC prejme enkratni (0,5 ml) odmerek cepiva Menitorix.
If Menitorix is used to boost protection against Hib and MenC: 
Obnovitveno cepljenje proti Hib in MenC s cepivom Menitorix:
If Menitorix is used in infants for the first vaccinations against Hib and MenC: 
Podatki o uporabi cepiva Menitorix pri otrocih, ki osnovno niso bili cepljeni s konjugiranimi cepivi proti Hib in MenC, niso na voljo.
<ANNEX IV 
PRILOGA IV
<one-year <marketing protection> <data exclusivity>> 
<enoletni <tržni zaščiti> <ekskluzivnosti podatkov>>
Marketing authorisation under exceptional circumstances 
pridobitvi dovoljenja za promet z zdravilom v izjemnih okoliščinah
CONCLUSIONS ON THE GRANTING OF THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES AND <SIMILARITY AND DEROGATION> <AND> < THE REQUEST FOR ONE-YEAR <MARKETING PROTECTION> <DATA EXCLUSIVITY>> PRESENTED BY THE EUROPEAN MEDICINES AGENCY 
SKLEPNE UGOTOVITVE O PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH TER <PODOBNOSTI IN ODSTOPANJU> <IN> <ZAHTEVKU ZA ENOLETNO <TRŽNO ZAŠČITO> <EKSKLUZIVNOST PODATKOV>>, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
<the applicant could establish in the application that the medicinal product, although similar to <authorised orphan medicinal product>, is safer, more effective or otherwise clinically superior (as defined in Article 3 of Commission Regulation (EC) No. 847/2000) for the same therapeutic indication> <and> 
<predlagatelj je v svoji vlogi lahko utemeljil, da je zdravilo, čeprav je podobno <odobrenemu zdravilu siroti,>, varnejše, učinkovitejše ali kako drugače klinično boljše (kot je opredeljeno v členu 3 Uredbe Komisije (ES) št. 847/2000) za isto terapevtsko indikacijo>; <in>
<The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the marketing authorisation under exceptional circumstances as further explained in the European Public Assessment Report.> 
<Odbor za zdravila za uporabo v humani medicini (CHMP) po obravnavi vloge meni, da je razmerje med tveganji in koristmi ugodno, da lahko priporoči izdajo dovoljenja za promet z zdravilom v izjemnih okoliščinah, kot je podrobneje razloženo v evropskem javnem poročilu o oceni zdravila.>
[Art 10(5)] <The CHMP reviewed the data submitted by the Marketing Authorisation Holder, taking into account the provisions of Article 10(5) of Directive 2001/83/EC, and considers that <the <pre-clinical tests> <and> <clinical studies> carried out in relation to the new indication were significant as further explained in the European Public Assessment Report. 
[Art 10(5)] <Odbor za zdravila za uporabo v humani medicini (CHMP) je pregledal podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom, pri čemer je upošteval določbe člena 10(5) Direktive 2001/83/ES, in meni, da so bili(-e) <predklinični testi> <in> <klinične študije>, ki so bili(-e) izvedeni(-e) v zvezi z novo indikacijo pomembni(-e), kot je podrobneje razloženo v evropskem javnem poročilu o oceni zdravila.>>
<The CHMP is of the opinion that <name of product> is similar to authorised orphan medicinal product(s) within the meaning of Article 3 of Commission Regulation (EC) No. 847/2000 as further explained in the European Public Assessment Report. 
<Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da je zdravilo <ime zdravila> podobno odobrenemu zdravilu siroti/odobrenim zdravilom sirotam v smislu opredelitve iz člena 3 Uredbe Komisije (ES) št. 847/2000, kot je podrobneje razloženo v evropskem javnem poročilu o oceni zdravila.>
This overview was last updated in February 2019. 
Ta povzetek je bil nazadnje posodobljen februarja 2019.
These reactions resolve without treatment in 2 to 5 days. 
Te reakcije izzvenijo brez zdravljenja v dveh do petih dneh.
Protection starts at the beginning of pregnancy and lasts for 6 months. 
Zaščita se začne na začetku brejosti in traja šest mesecev.
A single booster injection can be given every 6 months to maintain immunity. 
Enkratna obnovitvena injekcija se lahko daje vsakih šest mesecev, da se ohranja imunost.
An increase in body temperature can occur after vaccination (which may affect up to 1 in 10 animals) but this resolves within 24 to 48 hours. 
Po cepljenju lahko pride do zvišanja telesne temperature (ki lahko prizadene največ 1 žival od 10), vendar ta izzveni v 24 do 48 urah.
Further information on ReproCyc ParvoFLEX can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/reprocyc-parvoflex. 
Nadaljnje informacije o zdravilu ReproCyc ParvoFLEX so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/reprocyc-parvoflex.
The initial vaccination course is two injections given 3 weeks apart, with the second injection given at least 3 weeks before mating. 
Začetni program cepljenja obsega dve injekciji v razmiku treh tednov, pri čemer se druga injekcija da vsaj tri tedne pred parjenjem.
It is given into the muscle of female pigs from 5 months of age. 
Daje se v mišico samic prašiča od petega meseca starosti.
The European Medicines Agency decided that ReproCyc ParvoFLEX's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je odločila, da so koristi zdravila ReproCyc ParvoFLEX večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
If the animals come into contact with the virus the immune system will be able to respond quickly. 
Ob ponovni izpostavitvi živali virusu se bo imunski sistem tako hitro odzval.
The vaccine contains a porcine parvovirus protein that does not cause disease. 
Cepivo vsebuje beljakovino prašičjega parvovirusa, ki ne povzroča bolezni.
The most common side effect with ReproCyc ParvoFLEX (which may affect more than 1 in 10 animals) is short lived redness or swelling (up to 4 cm) at the injection site. 
Najpogostejši neželeni učinek zdravila ReproCyc ParvoFLEX (ki lahko prizadene več kot 1 žival od 10) je kratkotrajna rdečina ali oteklina (do 4 cm) na mestu injiciranja.
For more information about using ReproCyc ParvoFLEX, see the package leaflet or contact your veterinarian or pharmacist. 
Za več informacij glede uporabe zdravila ReproCyc ParvoFLEX glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
The withdrawal period for meat from pigs treated with ReproCyc ParvoFLEX is ‘zero' days, which means that there is no mandatory waiting time. 
Karenca za meso prašičev, zdravljenih z zdravilom ReproCyc ParvoFLEX, je „nič“ dni, kar pomeni, da ni obvezne čakalne dobe.
ReproCyc ParvoFLEX also contains the adjuvant (ingredient that strengthens the immune response) carbomer. 
ReproCyc ParvoFLEX vsebuje tudi adjuvant (učinkovino, ki krepi imunski odziv) karbomer.
Three laboratory studies showed that ReproCyc ParvoFLEX protects against transplacental porcine parvovirus infection, since more than 95% of piglets from vaccinated female pigs were protected from infection, as shown by absence of parvovirus. 
Tri laboratorijske študije so pokazale, da zdravilo ReproCyc ParvoFLEX ščiti pred okužbo s prašičjim parvovirusom skozi posteljico, saj je bilo več kot 95 % pujskov cepljenih samic prašiča zaščitenih pred okužbo, kar se kaže z odsotnostjo parvovirusa.
A field study in Spain showed that ReproCyc ParvoFLEX, when given to female pigs, was as effective as an authorised porcine parvovirus vaccine, Parvoseng, as measured by the fertility of vaccinated animals, the number of still births and the size of the litters. 
Terenska študija v Španiji je pokazala, da je bilo zdravilo ReproCyc ParvoFLEX, ki so ga dajali samicam prašiča, enako učinkovito kot odobreno cepivo proti prašičjemu parvovirusu, Parvoseng, kar so merili s plodnostjo cepljenih živali, številom mrtvih rojstev in velikostjo mladičev.
ReproCyc ParvoFLEX (inactivated porcine parvovirosis vaccine) 
ReproCyc ParvoFLEX (inaktivirano cepivo proti prašičjemu parvovirusu)
Other information about ReproCyc ParvoFLEX 
Druge informacije o zdravilu ReproCyc ParvoFLEX
ReproCyc ParvoFLEX is a vaccine. 
Zdravilo ReproCyc ParvoFLEX je cepivo.
Porcine parvovirus causes infertility, still births and small litters in female pigs. 
Prašičji parvovirus povzroča neplodnost, mrtvorojenost in majhne mladiče pri samicah prašiča.
When ReproCyc ParvoFLEX is given to female pigs the animals' immune system recognises the viral protein as ‘foreign' and makes antibodies against it. 
Ko samice prašiča prejmejo zdravilo ReproCyc ParvoFLEX, imunski sistem živali prepozna virusne beljakovine kot „tujke“ in začne proti njim tvoriti protitelesa.
ReproCyc ParvoFLEX can only be obtained with a prescription and is available as an injection. 
Predpisovanje in izdaja zdravila ReproCyc ParvoFLEX je le na recept, na voljo pa je v obliki injekcije.
An overview of ReproCyc ParvoFLEX and why it is authorised in the EU 
Pregled zdravila ReproCyc ParvoFLEX in zakaj je odobreno v EU
Why is ReproCyc ParvoFLEX authorised in the EU? 
Zakaj je zdravilo ReproCyc ParvoFLEX odobreno v EU?
ReproCyc ParvoFLEX contains inactivated (killed) porcine parvovirus strain 27a viral protein 2. 
Zdravilo ReproCyc ParvoFLEX vsebuje inaktivirano (uničeno) virusno beljakovino 2 prašičjega parvovirusa seva 27a.
What is ReproCyc ParvoFLEX and what is it used for? 
Kaj je zdravilo ReproCyc ParvoFLEX in za kaj se uporablja?
What benefits of ReproCyc ParvoFLEX have been shown in studies? 
Kakšne koristi je zdravilo ReproCyc ParvoFLEX izkazalo v študijah?
What are the risks associated with ReproCyc ParvoFLEX? 
Kakšna tveganja so povezana z zdravilom ReproCyc ParvoFLEX?
ReproCyc ParvoFLEX is a veterinary vaccine given to female pigs to protect their unborn piglets from porcine parvovirus infection via the placenta. 
Zdravilo ReproCyc ParvoFLEX je cepivo za uporabo v veterinarski medicini, ki se daje samicam prašiča za zaščito nerojenih pujskov pred okužbo s prašičjim parvovirusom skozi posteljico.
ReproCyc ParvoFLEX received a marketing authorisation valid throughout the EU on 26 April 2019. 
Zdravilo ReproCyc ParvoFLEX je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji,
This will help protect the unborn piglets against porcine parvovirus infections during pregnancy. 
Nerojene pujske bo pomagal zaščititi pred okužbami s prašičjim parvovirusom med brejostjo.
How is ReproCyc ParvoFLEX used? 
Kako se zdravilo ReproCyc ParvoFLEX uporablja?
How does ReproCyc ParvoFLEX work? 
Kako zdravilo ReproCyc ParvoFLEX deluje?
The recommended starting dose is 1 mg per kilogram body weight per day. 
Priporočeni začetni odmerek znaša 1 mg na kilogram telesne mase dnevno.
Further information on Nityr can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Nadaljnje informacije za zdravilo Nityr so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Nityr? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Nityr?
What are the benefits and risks of Nityr? 
Kakšne so koristi in tveganja zdravila Nityr?
As for every medicine, the company provided studies on the quality of Nityr. 
Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Nityr.
Nityr is intended for long-term use. 
Zdravilo Nityr je namenjeno dolgotrajni uporabi.
Because Nityr 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. 
Ker je zdravilo Nityr generično zdravilo in je bioekvivalentno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
This is a rare disease in which the body is unable to completely break down the amino acid tyrosine and, as a result, harmful substances are formed, causing serious liver problems and liver cancer. 
To je redka bolezen, pri kateri telo ni sposobno popolnoma razgraditi aminokisline tirozin, zaradi česar nastajajo škodljive snovi, ki povzročajo hude težave z jetri in raka jeter.
An overview of Nityr and why it is authorised in the EU 
Pregled zdravila Nityr in zakaj je odobreno v EU
Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Orfadin, and do not need to be repeated for Nityr. 
Študije o koristih in tveganjih učinkovine pri odobrenem načinu uporabe so že bile izvedene z referenčnim zdravilom Orfadin, zato jih ni treba ponoviti za zdravilo Nityr.
Why is Nityr authorised in the EU? 
Zakaj je bilo zdravilo Nityr odobreno v EU?
Other information about Nityr 
Druge informacije o zdravilu Nityr
Side effects reported with Nityr are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Nityr, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The European Medicines Agency concluded that, in accordance with EU requirements, Nityr has been shown to have comparable quality and to be bioequivalent to Orfadin. 
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Nityr primerljivo raven kakovosti in je bioekvivalentno z zdravilom Orfadin.
Treatment should be started as early as possible and the dose of Nityr adjusted according to the patient's response and body weight. 
Zdravljenje je treba začeti čim prej, odmerek zdravila Nityr pa je treba prilagoditi bolnikovemu odzivu in telesni masi.
As for all medicines, data on the use of Nityr are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Nityr stalno spremljajo.
Patients with HT-1 lack one of these enzymes, so tyrosine is not properly eliminated but is converted into harmful substances. 
Bolniki z dedno tirozinemijo tipa 1 nimajo enega od teh encimov, zato se tirozin v njihovem telesu ne razgradi ustrezno, ampak se pretvori v škodljive snovi.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nityr have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Nityr upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
What is Nityr and what is it used for? 
Kaj je zdravilo Nityr in za kaj se uporablja?
Nityr is a medicine used to treat hereditary tyrosinaemia type 1 (HT-1). 
Nityr je zdravilo za zdravljenje dedne tirozinemije tipa 1 (HT-1).
For more information about using Nityr, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Nityr glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
This means that Nityr contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Orfadin. 
To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Orfadin.
Nityr contains the active substance nitisinone and is a ‘generic medicine'. 
Zdravilo Nityr vsebuje učinkovino nitizinon in je „generično zdravilo“.
Nityr can only be obtained with a prescription and treatment should be started and monitored by doctors who have experience in the treatment of patients with HT-1. 
Predpisovanje in izdaja zdravila Nityr je le na recept, zdravljenje z njim pa lahko uvede in nadzoruje le zdravnik z izkušnjami z zdravljenjem bolnikov z dedno tirozinemijo tipa 1.
The active substance in Nityr, nitisinone, blocks an enzyme that converts tyrosine into harmful substances. 
Učinkovina v zdravilu Nityr, nitizinon, zavira encim, ki pretvarja tirozin v škodljive snovi.