FrancophonIA/ELRC3.0 huggingface dataset:
English: The educational pack should contain the following: Summary of Product Characteristics and Patient Information Leaflet for INOmax
Slovenian: Vsebina pakiranjain dodatne informacije Kaj vsebuje zdravilo INOmax
English: Treatment with inhaled nitric oxide might aggravate cardiac insufficiency in a situation with left-toright shunting.
Slovenian: V primeru obvoda krvnega obtoka z leve na desno lahko zdravljenje z vdihovanjem dušikovega oksida poslabša srčno insuficienco.
English: Tabulated list of adverse reactions
Slovenian: Razpredelnica z neželenimi učinki
English: Instructions for use/handling INOmax
Slovenian: B. NAVODILO ZA UPORABO
English: Do not use INOmax
Slovenian: Bodite posebno pozorni pri uporabi zdravila INOmax
English: No evidence of a carcinogenic effect was apparent, at inhalation exposures up to the recommended dose (20 ppm), in rats for 20 h/day for up to two years.
Slovenian: Pri podganah, ki so največ dve leti po 20 h/dan dobivale inhalacijske odmerke, manjše ali enake priporočenemu (20 ppm), ni bilo dokazov o karcinogenem učinku.
English: - Keep this leaflet.
Slovenian: upoštevajte naslednje.
English: INOmax 800 ppm mol/mol inhalation gas Nitric oxide
Slovenian: INOmax 800 ppm mol/mol plin za inhaliranje dušikov oksid
English: Within the pulmonary system, nitric oxide can combine with oxygen and water to produce nitrogen dioxide and nitrite, respectively, which interact with oxyhaemoglobin to produce methaemoglobin and nitrate.
Slovenian: V pljučih se dušikov oksid lahko veže s kisikom in vodo ter tvori dušikov dioksid in nitrit.
English: Keep this medicine out of the sight and reach of children
Slovenian: Zdravilo shranjujte nedosegljivo otrokom!
English: INOmax 400 ppm mol/mol inhalation gas Nitric oxide
Slovenian: INOmax 400 ppm mol/mol plin za inhaliranje dušikov oksid
English: Substances known to cause increased methaemoglobin levels should thus be used with caution during therapy with inhaled nitric oxide.
Slovenian: Torej morate med zdravljenjem z vdihavanjem dušikovega oksida previdno uporabljati snovi, za katere je znano, da povečajo koncentracije methemoglobina.
English: Common Uncommon Rare Very rare
Slovenian: Zelo redki
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Nitric oxide (NO) 400 ppm mol/mol.
Slovenian: Dušikov oksid (NO) 400 ppm mol/mol.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Nitric oxide (NO) 800 ppm mol/mol.
Slovenian: Dušikov oksid (NO) 800 ppm mol/mol.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/194/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/194/001
English: The dose of nitric oxide should be reduced if the concentration of nitrogen dioxide exceeds 0.5 ppm.
Slovenian: Če koncentracija dušikovega dioksida preseže
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/194/004
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/01/194/004
English: A 2 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a standard valve hand-wheel.
Slovenian: 2-litrska aluminijasta jeklenka (prepoznate jo po zelenomodrem vratu in belem telesu), napolnjena pod tlakom 155 bar, opremljena z nadtlačnim ventilom (ki onemogoča nenamerno popolno izpraznitev jeklenke) iz nerjavečega jekla s specifičnim izhodnim priključkom in standardnim ročnim kolesom ventila.
English: A 10 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a standard valve hand-wheel.
Slovenian: 10-litrska aluminijasta jeklenka (prepoznate jo po zelenomodrem vratu in belem telesu), napolnjena pod tlakom 155 bar, opremljena z nadtlačnim ventilom (ki onemogoča nenamerno popolno izpraznitev jeklenke) iz nerjavečega jekla s specifičnim izhodnim priključkom in standardnim ročnim kolesom ventila.
English: A 2 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a INOmeter device equipped valve hand-wheel.
Slovenian: 2-litrska aluminijasta jeklenka (prepoznate jo po zelenomodrem vratu in belem telesu), napolnjena pod tlakom 155 bar, opremljena z nadtlačnim ventilom (ki onemogoča nenamerno popolno izpraznitev jeklenke) iz nerjavečega jekla s specifičnim izhodnim priključkom in ročnim kolesom ventila z merilnikom INOmeter.
English: NAME OF THE MEDICINAL PRODUCT INOmax 400 ppm mol/mol inhalation gas Nitric oxide
Slovenian: Navodilo za uporabo INOmax 400 ppm mol/mol plin za inhaliranje dušikov oksid
English: Nitric oxide is genotoxic in some test systems.. No evidence of a carcinogenic effect was apparent, at inhalation exposures up to the recommended dose (20 ppm), in rats for 20 h/day for up to two years.
Slovenian: 20 h/dan dobivale inhalacijske odmerke, manjše ali enake priporočenemu (20 ppm), ni bilo dokazov o karcinogenem učinku.
English: NAME OF THE MEDICINAL PRODUCT INOmax 800 ppm mol/mol inhalation gas Nitric oxide
Slovenian: Navodilo za uporabo INOmax 800 ppm mol/mol plin za inhaliranje dušikov oksid
English: A 10 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a INOmeter device equipped valve hand-wheel.
Slovenian: 10-litrska aluminijasta jeklenka (prepoznate jo po zelenomodrem vratu in belem telesu), napolnjena pod tlakom 155 bar, opremljena z nadtlačnim ventilom (ki onemogoča nenamerno popolno izpraznitev jeklenke) iz nerjavečega jekla s specifičnim izhodnim priključkom in ročnim kolesom ventila z merilnikom INOmeter.
English: Side effects that may be seen, but uncommonly (affects between 1 user in 100 and 1 user in 1000) are: increase in methaemoglobin, thus reduced oxygen carrying capacity.
Slovenian: Neželeni učinki, ki se pojavijo občasno (med 1 od 100 bolnikov in 1 od 1000 bolnikov), so:
English: Weaning
Slovenian: Odmerjanje
English: Vascular disorders
Slovenian: Drugi viri infromacij
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenija a methemoglobinemija a
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26 January 2018
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Slovenian: Dve zdravili sta biološko enakovredni, kadar dosegata enake ravni učinkovine v telesu in se zato pričakuje, da bosta imeli enak učinek.
English: The Committee was also concerned that the studies on how the patch sticks to the skin had only been done in young adults.
Slovenian: Zaskrbljen je bil tudi glede dejstva, da so bile študije o tem, kako se obliž drži kože, opravljene samo pri mlajših odraslih.
English: Since Parkinson's disease usually occurs in people over 60 years, studies in older people would be required because the skin structure changes due to aging.
Slovenian: Ker se Parkinsonova bolezen običajno pojavlja pri ljudeh, starejših od 60 let, bi bile potrebne študije pri starejših ljudeh, saj se struktura kože s staranjem spreminja.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it would be unable to provide the required additional data in the time available.
Slovenian: Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da v zahtevanem časovnem okviru ne bi mogla zagotoviti potrebnih dodatnih podatkov.
English: Withdrawal of the marketing authorisation application for Rotigotine Mylan (rotigotine) EMA/43037/2018
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Rotigotine Mylan (rotigotin) EMA/43037/2018
English: Dopamine is a messenger substance in the parts of the brain that control movement and coordination.
Slovenian: Dopamin je prenašalec v tistem delu možganov, ki nadzira gibanje in koordinacijo.
English: The CHMP was concerned that insufficient data had been provided on the quality of the medicine and its manufacturing process.
Slovenian: Imel je pomisleke, da o kakovosti zdravila in njegovem proizvodnem postopku ni bilo predloženih dovolj podatkov.
English: It was to be available as transdermal patches (patches that deliver a medicine across the skin).
Slovenian: Na voljo naj bi bilo v obliki transdermalnih obližev (obližev, ki dovajajo zdravilo skozi kožo).
English: The way rotigotine works in restless-legs syndrome is not fully understood.
Slovenian: Način delovanja rotigotina pri sindromu nemirnih nog ni v celoti znan.
English: Rotigotine Mylan was expected to be used to treat adults with Parkinson's disease and adults with restless-leg syndrome (a disorder where the patient has uncontrollable urges to move the legs to stop uncomfortable, painful or odd sensations in the body, usually at night).
Slovenian: Zdravilo Rotigotine Mylan naj bi se uporabljalo za zdravljenje odraslih s Parkinsonovo boleznijo in odraslih s sindromom nemirnih nog (motnje, pri kateri bolnik čuti nenadzorovano potrebo po premikanju nog, da bi prekinil neprijetne, boleče ali nenavadne občutke v telesu, običajno ponoči).
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Neupro, and did not need to be repeated for Rotigotine Mylan.
Slovenian: Študije o koristih in tveganjih učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Neupro, zato jih ni treba ponoviti za zdravilo Rotigotine Mylan.
English: In patients with Parkinson's disease, the cells that produce dopamine die and the amount of dopamine in the brain decreases.
Slovenian: Pri bolnikih s Parkinsonovo boleznijo celice, ki proizvajajo dopamin, odmirajo, zato se količina dopamina v možganih zmanjša.
English: As for every medicine, the company provided studies on the quality of Rotigotine Mylan, including studies on how the patch sticks to the skin.
Slovenian: Tako kot za vsako zdravilo je družba predložila študije o kakovosti zdravila Rotigotine Mylan, vključno s študijami o tem, kako se obliž drži kože.
English: The syndrome is thought to be caused by problems in the way dopamine works in the brain, which may be improved by rotigotine.
Slovenian: Sindrom naj bi povzročile težave pri delovanju dopamina v možganih, kar je mogoče izboljšati z jemanjem rotigotina.
English: Rotigotine stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Slovenian: Rotigotin stimulira možgane enako kot dopamin, tako da lahko bolniki spet nadzirajo svoje gibe in kažejo manj znakov in simptomov Parkinsonove bolezni, kot sta okorelost in upočasnjeno izvajanje gibov.
English: Rotigotine Mylan was developed as a ‘generic medicine'.
Slovenian: Zdravilo Rotigotine Mylan je bilo razvito kot „generično zdravilo“.
English: On 22 December 2017, Mylan SAS officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Rotigotine Mylan, for the treatment of Parkinson's disease and restless-leg syndrome.
Slovenian: je 22. decembra 2017 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Rotigotine Mylan, namenjenim zdravljenju Parkinsonove bolezni in sindroma nemirnih nog.
English: The company informed the CHMP that there are no ongoing clinical trials with Rotigotine Mylan.
Slovenian: Družba je odbor CHMP obvestila, da trenutno ne potekajo nobena klinična preskušanja z zdravilom Rotigotine Mylan.
English: The active substance in Rotigotine Mylan, rotigotine, is a dopamine agonist, which means that it imitates the action of dopamine.
Slovenian: Učinkovina v zdravilu Rotigotine Mylan, rotigotin, je dopaminski agonist, kar pomeni, da posnema delovanje dopamina.
English: The company also carried out studies to investigate whether Rotigotine Mylan is ‘bioequivalent' to the reference medicine.
Slovenian: Družba je opravila tudi študije za proučitev, ali je zdravilo Rotigotine Mylan biološko enakovredno referenčnemu zdravilu.
English: This means that Rotigotine Mylan contains the same active substance and was intended to work in the same way as a ‘reference medicine' already authorised in the European Union called Neupro.
Slovenian: To pomeni, da vsebuje enako učinkovino in naj bi delovalo enako kot „referenčno zdravilo“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilo Neupro.
English: Withdrawal of the marketing authorisation application for Rotigotine Mylan (rotigotine)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Rotigotine Mylan (rotigotin)
English: Rotigotine Mylan is a medicine that contains the active substance rotigotine.
Slovenian: Rotigotine Mylan je zdravilo, ki vsebuje učinkovino rotigotin.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Rotigotine Mylan could not have been approved for the treatment Parkinson's disease and restless-leg syndrome.
Slovenian: Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Rotigotine Mylan ni mogoče odobriti za zdravljenje Parkinsonove bolezni in sindroma nemirnih nog.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Rotigotine Mylan did not outweigh its risks.
Slovenian: Zato je odbor CHMP ob umiku vloge menil, da koristi zdravila Rotigotine Mylan ne odtehtajo z njim povezanih tveganj.
English: What is Rotigotine Mylan?
Slovenian: Kaj je zdravilo Rotigotine Mylan?
English: How does Rotigotine Mylan work?
Slovenian: Kako zdravilo Rotigotine Mylan deluje?
English: What was Rotigotine Mylan expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Rotigotine Mylan uporabljalo?
English: 26 May 2016
Slovenian: 26. maj 2016
English: This is particularly important for the following medicines:
Slovenian: Navedeno je zlasti pomembno pri uporabi naslednjih zdravil:
English: It is advisable to take your medicine at the same time each day.
Slovenian: Priporočljivo je, da vzamete zdravilo vsak dan ob istem času.
English: Both components contributed to the risk reduction.
Slovenian: K zmanjšanju tveganja sta prispevali obe sestavini zdravila.
English: The clinical relevance of these findings is unknown.
Slovenian: Klinični pomen teh ugotovitev ni znan.
English: Relative risk reduction p-value ***
Slovenian: relativno zmanjšanje tveganja vrednost p***
English: This period coincides with 36 weeks of gestation in humans, which could occasionally extend up to 44 weeks after conception in humans.
Slovenian: To obdobje ustreza 36 tednom gestacije pri ljudeh, kar bi v nekaterih primerih pri ljudeh lahko razširili tudi na 44 tednov po spočetju.
English: Time since randomisation (days)
Slovenian: čas od randomizacije (dnevi)
English: CYP 450 interactions
Slovenian: S CYP 450 povezane interakcije
English: What Neparvis is and what it is used for
Slovenian: Kaj je zdravilo Neparvis in za kaj ga uporabljamo
English: Effect of gender
Slovenian: Vpliv spola
English: Not to be sold separately.
Slovenian: Ni namenjen ločeni prodaji.
English: The safety and efficacy of Neparvis in children and adolescents aged below 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Neparvis pri otrocih in mladostnikih, starih manj kot 18 let, nista bili dokazani.
English: It may be necessary to change the dose, to take other precautions, or even to stop taking one of the medicines.
Slovenian: Morda bo treba spremeniti odmerjanje, upoštevati druge previdnostne ukrepe ali celo prekiniti jemanje katerega od zdravil.
English: P<0.0001 HR (95%CI):
Slovenian: P<0,0001 HR (95% IZ):
English: Component of a multipack.
Slovenian: Sestavni del skupnega pakiranja.
English: This effect was observed early and was sustained throughout the duration of the study (see Figure 1).
Slovenian: Učinek zdravila je bil opazen že zgodaj in se je ohranil v celotnem poteku študije (glejte sliko 1).
English: Some side effects may be serious.
Slovenian: Nekateri neželeni učinki so lahko resni.
English: When driving vehicles or operating machines it should be taken into account that occasionally dizziness or fatigue may occur.
Slovenian: Pri vožnji in upravljanju s stroji je treba upoštevati, da občasno lahko pride do omotičnosti ali utrujenosti.
English: If you feel dizzy or very tired while taking this medicine, do not drive a vehicle, cycle or use any tools or machines.
Slovenian: Če ste v času jemanja tega zdravila omotični ali zelo utrujeni, ne smete voziti, kolesariti, uporabljati orodja ali naprav.
English: Frequency category
Slovenian: Kategorija pogostnosti
English: Fertility, reproduction and development
Slovenian: Plodnost, razmnoževanje in razvoj
English: Symptomatic treatment should be provided.
Slovenian: V tem primeru bi bilo treba poskrbeti za simptomatsko zdravljenje.
English: The tablets must be swallowed with a glass of water.
Slovenian: Tablete je treba zaužiti s kozarcem vode.
English: Do not take Neparvis:
Slovenian: Ne jemljite zdravila Neparvis:
English: The mean age of the population studied was 64 years of age and 19% were 75 years of age or older.
Slovenian: Povprečna starost študijske populacije je bila 64 let, 19 % bolnikov je bilo starih 75 let ali več.
English: This type of heart failure occurs when the heart is weak and cannot pump enough blood to the lungs and the rest of the body.
Slovenian: Do takšnega srčnega popuščanja pride, kadar je srce prešibko in ne zmore črpati dovolj krvi skozi pljuča in po preostalem telesu.
English: Your doctor will then adjust the dose depending on how you respond to the treatment until the best dose for you is found.
Slovenian: Nato vam bo zdravnik prilagajal odmerjanje glede na to, kako se boste odzivali na zdravljenje, dokler ne bo našel za vas najbolj primernega odmerka.
English: Swallow the tablets with a glass of water.
Slovenian: Tablete zaužijte s kozarcem vode.
English: These may be signs of angioedema (an uncommon side effect which may affect up to 1 in 100 people).
Slovenian: To so lahko znaki angioedema (neželenega učinka, ki se pojavlja občasno in lahko prizadene največ 1 od 100 ljudi).
English: KM estimate of cumulative failure rate (%)
Slovenian: Kaplan Meierjeva ocena kumulativne stopnje neuspeha (%)
English: Neparvis may be administered with or without food (see section 5.2).
Slovenian: Neparvis je mogoče jemati skupaj s hrano ali brez nje (glejte poglavje 5.2).
English: OATP and MRP2 transporters
Slovenian: Prenašalci OATP in MRP2
English: • Stop taking Neparvis and seek immediate medical attention if you notice any swelling of the face, lips, tongue and/or throat, which may cause difficulties in breathing or swallowing.
Slovenian: • Prenehajte jemati zdravilo Neparvis in takoj poiščite zdravniško pomoč, če opazite otekanje obraza, ustnic, jezika in/ali grla oziroma žrela, kar lahko oteži dihanje ali požiranje.
English: Adverse reactions are ranked by System organ class and then by frequency with the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Slovenian: Neželeni učinki so navedeni po organskih sistemih in nato po pogostnosti, pri čemer so najpogostejši učinki navedeni najprej, in sicer po naslednjem dogovoru: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000).
English: • Second and third trimester of pregnancy (see section 4.6).
Slovenian: • Drugo in tretje trimesečje nosečnosti (glejte poglavje 4.6).
English: This medicine is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if it is used after the third month of pregnancy.
Slovenian: Uporaba tega zdravila v zgodnji nosečnosti ni priporočena, po 3. mesecu nosečnosti pa se tega zdravila ne sme več jemati, ker lahko resno škoduje vašemu otroku, če ga jemljete po 3. mesecu nosečnosti.
English: In these patients, exposure may be increased and safety is not established.
Slovenian: Pri teh bolnikih je lahko izpostavljenost zdravilu povečana, varnost uporabe pa ni dokazana.
English: • if you are allergic to sacubitril, valsartan or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na sakubitril, valsartan ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: NT-proBNP is not a neprilysin substrate and is therefore a more suitable biomarker.
Slovenian: NT-proBNP pa ni substrat neprilizina in je zato bolj primeren kot biološki označevalec.
English: • if you have ever had angioedema (see “Do not take Neparvis” and section 4 “Possible side effects”).
Slovenian: • če ste že kadarkoli imeli angioedem (glejte pod naslovom "Ne jemljite zdravila Neparvis" in poglavje 4 "Možni neželeni učinki").
English: One blister contains either 10 or 14 film-coated tablets.
Slovenian: En pretisni omot vsebuje 10 ali 14 filmsko obloženih tablet.
English: At the time of Commission Decision
Slovenian: Ob sprejetju sklepa Komisije
English: Neprilysin is one of multiple enzymes involved in the clearance of amyloid-β (Aβ) from the brain and cerebrospinal fluid (CSF).
Slovenian: Neprilizin je eden od številnih encimov, ki so vpleteni v odstranjevanje amiloida-β (Aβ) iz možganov in cerebrospinalnega likvorja.
English: Do not stop taking your medicine unless your doctor tells you to.
Slovenian: Ne prenehajte jemati tega zdravila, razen če vam tako naroči zdravnik.
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Slovenian: Dvojno zaviranje sistema renin-angiotenzin-aldosteron (sistema RAA)
English: If you experience severe dizziness and/or fainting, tell your doctor as quickly as possible and lie down.
Slovenian: Če pride do hude omotičnosti in/ali izgube zavesti, kar najhitreje sporočite zdravniku in se ulezite.
English: The clinical relevance of this finding is not known (see section 5.3).
Slovenian: Klinični pomen te ugotovitve ni znan (glejte poglavje 5.3).
English: In cases of confirmed angioedema where swelling has been confined to the face and lips, the condition has generally resolved without treatment, although antihistamines have been useful in relieving symptoms.
Slovenian: V primerih potrjenega angioedema, pri katerem je bilo otekanje omejeno le na obraz in ustnice, se je stanje večinoma popravilo brez zdravljenja, pri tem pa je bila uporaba antihistaminikov koristna za lajšanje simptomov.
English: • if you are more than 3 months pregnant (it is also better to avoid this medicine in early pregnancy, see “Pregnancy and breastfeeding”).
Slovenian: • če ste noseči več kot 3 mesece (temu zdravilu se je bolje izogibati tudi v zgodnji nosečnosti,
English: Preferred term
Slovenian: Prednostni izraz
English: INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
Slovenian: VMESNA ŠKATLA SKUPNEGA PAKIRANJA (BREZ "BLUE BOX" PODATKOV)
English: The MAH must ensure that the manufacturing processes of the drug substances used for their drug products are reviewed for the potential risk of formation of N-nitrosamines and changed as necessary to minimise nitrosamine contamination as much as possible.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora pregledati postopke proizvodnje učinkovin, uporabljenih za svoja zdravila, glede morebitnega tveganja za nastajanje N-nitrozaminov in jih po potrebi spremeniti tako, da se onesnaženje z nitrozamini čim bolj zmanjša.