natgillin/translations-raw huggingface dataset:
Below is a list of examples of these types of medicines: - other opioid containing medicines such as methadone, certain pain killers and cough suppressants - some anti-depressants (used to treat depression) such as isocarboxazid, phenelzine, selegiline, tranylcypromine, valproate and monoamine oxidase inhibitors (MAOIs) may increase the effects of this medicine - sedative Hı receptor antagonists (used to treat allergic reactions) such as diphenhydramine and chlorphenamine - barbiturates (used to cause sleep or sedation) such as phenobarbital, secobarbital - tranquilisers (used to cause sleep or sedation) such as chloral hydrate - clonidine (used to treat high blood pressure) and related medicines may extend the effects of this medicine 
- barbiturati (ki se uporabljajo za lažje spanje ali pomiritev), kot sta fenobarbital in sekobarbital; - pomirjevala (ki se uporabljajo za lažje spanje ali pomiritev), kot je kloralhidrat; - klonidin (za zdravljenje visokega krvnega tlaka) in podobna zdravila lahko podaljšajo čas učinkovanja tega zdravila;
Decreased appetite Hyperglycaemia Hyperlipidaemia Hypoglycaemia 
Presnovne in prehranske motnje zmanjšan tek hiperglikemija hiperlipidemija hipoglikemija
Zubsolv 5.7 mg / 1.4 mg sublingual tablets buprenorphine / naloxone 
Zubsolv 5,7 mg/1,4 mg podjezične tablete buprenorfin/nalokson
Clear signs of withdrawal should be evident before taking your first dose of Zubsolv. 
Preden vzamete prvi odmerek zdravila Zubsolv, morajo biti jasno vidni odtegnitveni simptomi.
Each sublingual tablet contains 8.6 mg buprenorphine (as hydrochloride) and 2.1 mg naloxone (as hydrochloride dihydrate). 
Ena podjezična tableta vsebuje 8,6 mg buprenorfina (v obliki klorida) in 2,1 mg naloksona (v obliki klorida dihidrata).
Heat stroke 
• vročinska kap.
Each sublingual tablet contains 11.4 mg buprenorphine (as hydrochloride) and 2.9 mg naloxone (as hydrochloride dihydrate). 
Ena podjezična tableta vsebuje 11,4 mg buprenorfina (v obliki klorida) in 2,9 mg naloksona (v obliki klorida dihidrata).
In comparative bioavailability studies Zubsolv 11.4/2.9 mg displayed equivalent buprenorphine exposure to 16/4mg (2 x 8/2mg) buprenorphine/naloxone administered as conventional sublingual tablets however Zubsolv 2 x 1.4/0.36 mg displayed 20% lower buprenorphine exposure to 2 x 2/0.5 mg buprenorphine/naloxone administered as conventional sublingual tablets. 
2 x 1,4 mg/36 mg je bila izpostavljenost buprenorfinu za 20 % nižja kot pri buprenorfinu/naloksonu 2 x 2 mg/0,5 mg v obliki konvencionalne podjezične tablete.
• abnormal blood tests swollen, glands (lymph nodes) 
• nenormalni izvidi krvnih testov, otekle bezgavke,
Each 2.9 mg / 0.71 mg sublingual tablet contains 2.9 mg buprenorphine (as hydrochloride) and 0.71 mg naloxone (as hydrochloride dihydrate). 
Ena podjezična tableta 2,9 mg/0,71 vsebuje 2,9 mg buprenorfina (v obliki klorida) in 0,71 mg naloksona (v obliki klorida dihidrata).
Each sublingual tablet contains 1.4 mg buprenorphine (as hydrochloride) and 0.36 mg naloxone (as hydrochloride dihydrate). 
Ena podjezična tableta vsebuje 1,4 mg buprenorfina (v obliki klorida) in 0,36 mg naloksona (v obliki klorida dihidrata).
Zubsolv 0.7 mg / 0.18 mg sublingual tablets buprenorphine / naloxone 
Zubsolv 0,7 mg/0,18 mg podjezične tablete buprenorfin/nalokson
• weakness, chest pain, chills, fever, feeling of general discomfort, pain, swelling (hands and feet) 
• šibkost, bolečine v prsih, mrzlica, povišana telesna temperatura, občutek splošnega nelagodja,
There are other strengths that are available to be used by your doctor who will decide what is the best treatment for you. 
Zdravnik, ki se odloči o najprimernejšem zdravljenju za vas, vam lahko predpiše druge jakosti zdravila.
Each sublingual tablet contains 5.7 mg buprenorphine (as hydrochloride) and 1.4 mg naloxone (as hydrochloride dihydrate). 
Ena podjezična tableta vsebuje 5,7 mg buprenorfina (v obliki klorida) in 1,4 mg naloksona (v obliki klorida dihidrata).
Each sublingual tablet contains 0.7 mg buprenorphine (as hydrochloride) and 0.18 mg naloxone (as hydrochloride dihydrate). 
Ena podjezična tableta vsebuje 0,7 mg buprenorfina (v obliki klorida) in 0,18 mg naloksona (v obliki klorida dihidrata).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 5.7 mg / 1.4 mg STRENGTH 
PAKIRANJE PO 7, 28, in 30 TABLET Z JAKOSTJO 5,7 mg / 1,4 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 1.4 mg / 0.36 mg STRENGTH 
PAKIRANJE PO 7, 28, in 30 TABLET Z JAKOSTJO 1,4 mg / 0,36 mg
Each sublingual tablet contains 2.9 mg buprenorphine (as hydrochloride) and 0.71 mg naloxone (as hydrochloride dihydrate). 
Ena podjezična tableta vsebuje 2,9 mg buprenorfina (v obliki klorida) in 0,71 mg naloksona (v obliki klorida dihidrata).
Amblyopia Lacrimal disorder 
Očesne bolezni ambliopija motnje solznih žlez konjunktivitis mioza
Migraine Dizziness Hypertonia Paraesthesia Somnolence 
Bolezni živčevja glavobol migrena omotica hipertonija parestezija somnolenca amnezija hiperkinezija epileptični napadi motnje govora tremor hepatična encefalopatija sinkopa
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 2.9 mg / 0.71 mg STRENGTH 
PAKIRANJE PO 7, 28, in 30 TABLET Z JAKOSTJO 2,9 mg / 0,71 mg
Orthostatic hypotension 
Žilne bolezni hipertenzija vazodilatacija hipotenzija ortostatska hipotenzija
11.3-fold increase 
Podobno kot kontrola 2,7-kratno povečanje 11,3-kratno povečanje
• back pain, joint pain, muscle pain, leg cramps (muscle spasm) 
• bolečine v hrbtu, bolečine v sklepih, bolečine v mišicah, krči v nogah (mišični krči),
The long half-life of methadone should be considered when starting buprenorphine/naloxone. 
Ob uvedbi zdravljenja z buprenorfinom/naloksonom je treba upoštevati dolgo razpolovno dobo metadona.
Talk to your doctor before taking Zubsolv if you: 
Pred začetkom jemanja zdravila Zubsolv se posvetujte z zdravnikom:
White, diamond shaped tablet, length 9.5 mm and width 8.2 mm 
8,6 mg/2,1 mg bela tableta v obliki romba z dolžino 9,5 mm in širino
Tell your doctor as soon as possible if you miss a dose. 
Če pozabite vzeti odmerek, se čim prej posvetujte z zdravnikom.
Do not swallow or consume food or any drink until the tablet is completely dissolved. 
Dokler se tableta popolnoma ne raztopi, je ne smete pogoltniti ali zaužiti hrane oziroma pijače.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 2.9 mg / 0.71 mg STRENGTH 
PAKEIRANJE PO 7, 28, in 30 TABLET Z JAKOSTJO 2,9 mg / 0,71 mg
Liver damage has been reported after taking buprenorphine/naloxone, especially when the medicine is misused. 
Po jemanju buprenorfina/naloksona, še posebej ob njegovi napačni uporabi, so poročali o poškodbah jeter.
Alopecia Dermatitis exfoliative Dry skin Skin mass 
Bolezni kože in podkožja hiperhidroza pruritus izpuščaj urtikarija akne alopecija eksfoliativni dermatitis suha koža kožni vozliči angioedem
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 11.4 mg / 2.9 mg STRENGTH 
PAKIRANJE PO 7, 28, in 30 TABLET Z JAKOSTJO 11,4 mg / 2,9 mg
White, D-shaped tablet, height 7.3 mm and width 5.65 mm 
2,9 mg/0,71 mg bela tableta v obliki črke D z višino 7,3 mm in širino 5,65 mm z oznako »2.9« na eni strani
How to store Zubsolv 
Kako jemati zdravilo Zubsolv
White, oval tablet, length 6.8 mm and width 4.0 mm 
0,7 mg 0,18 mg bela ovalna tableta dolžine 6,8 mm in širine 4,0 mm z oznako ».7« na eni strani
Description of selected adverse reactions 
Poročanje o neželenih učinkih
An additional tablet of the Zubsolv 1.4 mg / 0.36 mg or 2.9 mg / 0.71 mg may be administered on Day 1 depending on your needs. 
Na 1. dan vam lahko glede na vaše potrebe dajo dodatno tableto zdravila Zubsolv 1,4 mg/0,36 mg ali 2,9 mg/0,71 mg.
Medical withdrawal 
Uvajanje zdravljenja
An additional Zubsolv 1.4 mg / 0.36 mg or 2.9 mg / 0.71 mg may be administered on day one depending on the individual patient's requirement. 
ena tableta zdravila Zubsolv 1,4 mg/0,36 mg na dan ali - ena tableta zdravila Zubsolv 2,9 mg/0,71 mg na dan.
AUClast 
AUCkončni
Metabolites of buprenorphine accumulate in patients with renal failure. 
Pri bolnikih z odpovedjo ledvic se presnovki buprenorfina kopičijo.
White, triangular tablet, base 7.2 mm and height 6.9 mm 
1,4 mg/0,36 mg bela trikotna tableta z dolžino stranice 7,2 mm in višino 6,9 mm z oznako »1.4« na eni strani
- Keep this leaflet. 
Prepogni tukaj
• constipation, nausea 
• glavobol, • zaprtost, slabost,
• have poor adrenal gland function (e.g. Addison's disease) 
• če imate okvare v delovanju nadledvične žleze (npr. Addisonova bolezen), • če imate težave z biliarnim traktom (npr. žolčnik, žolčevod),
Severe hepatic impairment. 
Huda okvara jeter.
LIST OF EXCIPIENTS 
• vnetje sklepov,
• pain and sores in mouth, tongue discolouration 
• astma, zasoplost, zehanje, • bolečine in razjede v ustih, obarvanje jezika,
Ear and labyrinth disorders 
vključno z motnjami labirinta vrtoglavica
Hypertension Vasodilatation 
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
How Zubsolv works 
Kako zdravilo Zubsolv deluje
Within 2 years after Commission Decision. 
V dveh letih po sprejetju sklepa Komisije
Date of first authorisation: 26 November 2009 Date of latest renewal: 11 November 2014 
Datum prve odobritve: 26. november 2009 Datum zadnjega podaljšanja: 11. november 2014
Monday Tuesday Wednesday Thursday Friday Saturday Sunday 
DRUGI PODATKI Ponedeljek Torek Sreda Četrtek Petek Sobota Nedelja
This is the background to the current referral procedure. 
To je ozadje trenutnega napotitvenega postopka.
Your doctor may need to change your dose and/or to take other precautions: 
Zdravnik vam bo morda moral spremeniti odmerek in/ali upoštevati druge previdnostne ukrepe:
You may need to have blood checks if you take: 
Morda bodo potrebne krvne preiskave, če jemljete:
Assessment of the excess risk of cancer 
Ocena čezmernega tveganja za raka
Try to take your daily dose at about the same time each day. 
Dnevni odmerek poskušajte vzeti vsak dan ob približno istem času.
Do not take a double dose to make up for a forgotten dose. 
Ne vzemite dvojnega odmerka, da bi nadomestili pozabljenega.
However, it should be noted that nitrosamines can also be formed in many other situations, including in biological processes. 
Treba pa je opozoriti, da lahko nitrozamini nastajajo tudi v številnih drugih razmerah, vključno z biološkimi procesi.
Compared to the lifetime cancer risk in the European population of approximately 50%, this additional risk is considered to be very low. 
V primerjavi z doživljenjskim tveganjem za raka v evropski populaciji, ki je približno 50-odstotno, je to dodatno tveganje zelo majhno.
Some of these effects may be serious and may require medical attention. 
Nekateri neželeni učinki so lahko resni in lahko zahtevajo zdravniško pomoč.
No data are available.. 
Podatkov ni na voljo.
If possible, another class of diuretics should be used; 
Če je mogoče, je treba uporabiti drugo skupino diuretikov.
Based on all available data, the CHMP requires the following: 
Na podlagi razpoložljivih podatkov odbor CHMP zahteva naslednje:
This limit is considered a sufficiently robust threshold for APIs that can technically be reached. 
Ta meja velja za dovolj trden prag za učinkovine, ki ga je tehnično mogoče doseči.
These interim limits are based on the maximum daily dose authorised in the EU for each of the sartans and therefore vary between them, as outlined in the table below: 
Te začasne meje temeljijo na največjem dnevnem odmerku, odobrenem v EU za vsakega od sartanov, zato se med seboj razlikujejo, kot je prikazano v spodnji preglednici:
Considerations on monitoring of exposed patients 
Razmisleki o spremljanju izpostavljenih bolnikov
Manufacturers: 
Izdelovalci:
Similar effects have been very rarely reported with irbesartan so far. 
O podobnih učinkih so do sedaj pri irbesartanu poročali zelo redko.
This results in an increase in blood pressure. 
Posledica je zvišan krvni tlak.
This leaflet was last revised in {MM/YYYY}. 
Navodilo je bilo nazadnje revidirano dne {MM/YYYY}.
NDMA and NDEA are two of the most potent mutagenic carcinogens known. 
NDMA in NDEA sta dve od najmočnejših znanih mutagenih karcinogenih snovi.
• Risk Management plan 
• Načrt za obvladovanje tveganja (RMP)
Initially, this was only necessary for valsartan containing APIs from few manufacturers but later also for some other sartans with a tetrazole ring. 
Na začetku je bilo to potrebno samo za valsartan, ki je vseboval učinkovine nekaterih proizvajalcev, pozneje pa tudi za nekatere druge sartane s tetrazolnim obročem.
The volume of distribution for irbesartan is 53-93 litres. 
Porazdelitveni volumen irbesartana je 53-93 litrov.
The impact of NDMA and NDEA on human health is currently only extrapolated from animal studies. 
Vpliv NDMA in NDEA na zdravje človeka je trenutno samo ekstrapolirano iz študij pri živalih.
Measures to mitigate the risk 
Ukrepi za zmanjševanje tveganja
Efficacy and safety of sartancontaining medicines in these indications are per se well-established and are not questioned in this referral. 
Učinkovitost in varnost zdravil, ki vsebujejo sartan, pri teh indikacijah sta sami po sebi dobro dokazani in v tej napotitvi nista sporni.
Additional measures are needed to minimise prospectively the reoccurrence of such contamination. 
Potrebni so dodatni ukrepi za zmanjšanje ponovnega pojava tovrstnega onesnaženja v prihodnje.
The primary treatment is to discontinue drug intake as rapidly as possible. 
Osnovni ukrep je ukinitev uporabe zdravila v najkrajšem možnem času.
Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). 
Tablete morate pogoltniti z zadostno količino tekočine (npr. z enim kozarcem vode).
Specifically, CHMP considered that NDMA and NDEA limits should be as low as technically possible. 
Odbor CHMP je menil, da morajo biti meje za NDMA in NDEA tako nizke, kot je to tehnično mogoče.
For an individual risk assessment, data on the exact drug products and batches used by each individual patient would be necessary. 
Pri oceni tveganja pri posamezniku bi bili potrebni podatki o točnih zdravilih in serijah, ki jih je uporabljal posamezni bolnik.
For these reasons, CHMP could not identify cancer screening methods that patients would benefit from. 
Zato odbor CHMP ni mogel določiti metod za presejanje raka, ki bi bolnikom koristile.
The ICH M7(R1) guideline sets out principles for determining limits for mutagenic / DNA-reactive impurities. 
V smernicah ICH M7(R1) so podana načela za določanje mej za mutagene/DNK-reaktivne nečistote.
However, as the DNA damage mechanisms documented in these studies are also relevant in humans and in vitro data in human cells are not significantly different from those in animal cells, it is prudent to assume that effects seen in animals may also occur in humans after exposure to sufficiently large amounts of these nitrosamines. 
Ker pa so dokumentirani mehanizmi poškodb DNK pomembni tudi za človeka in ker se podatki in vitro za človeške celice ne razlikujejo bistveno od podatkov za živalske celice, je razumno domnevati, da se učinki, opaženi pri živalih, po izpostavljenosti dovolj veliki količini teh nitrozaminov lahko pojavijo tudi pri človeku.
Overall, taking into account the available data assessed in this procedure, the benefit risk balance of medicines containing a sartan with a tetrazole ring remains positive subject to the conditions imposed. 
Na splošno je z upoštevanjem razpoložljivih podatkov, ocenjenih v tem postopku, razmerje med tveganji in koristmi zdravil, ki vsebujejo sartan s tetrazolnim obročem, še naprej pozitivno ob upoštevanju zahtevanih pogojev.
The underlying concept of the proposed approach is to keep the amount of N-nitrosamine impurities as low as possible, irrespective of the type of sartan or dose. 
Osnovno bistvo predlaganega pristopa je čim bolj zmanjšati količino N-nitrozaminskih nečistot, ne glede na vrsto sartana ali odmerek.
Irbesartan did not affect survival, development, or reproduction of offspring. 
Irbesartan ni vplival na preživetje, razvoj ali sposobnost razmnoževanja potomcev.
The most common signs and symptoms of overdose are nausea and somnolence. 
Najpogostejši znaki in simptomi prevelikega odmerjanja so navzea in somnolenca.
The maximal blood pressure lowering effect should be reached 6-8 weeks after beginning treatment. 
Največji učinek na znižanje krvnega tlaka se običajno pojavi v 6-8 tednih po začetku zdravljenja.
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 
• Redno posodobljena poročila o varnosti zdravila (PSUR) Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
- aliskiren if you have had skin cancer or if you develop an unexpected skin lesion during the treatment. 
- aliskiren če ste imeli kožnega raka ali če se vam med zdravljenjem pojavijo nepričakovane kožne spremembe.
However the terminal half-life was not significantly altered. 
Končna razpolovna časa pa se bistveno ne razlikujeta.
The terminal elimination half-life of irbesartan is 11-15 hours. 
Končni razpolovni čas izločanja irbesartana je 11 do 15 ur.
During the 8-week treatment period, there were no reported cases of syncope in either treatment group. 
Med 8-tedenskim zdravljenjem niso v nobeni skupini poročali o pojavu sinkope.
Hydrochlorothiazide should not be used for essential hypertension in pregnant women except in rare situations where no other treatment could be used. 
Hidroklorotiazida se ne sme uporabljati za zdravljenje esencialne hipertenzije pri nosečnicah, razen v redkih primerih, ko ni možno uporabiti nobenega drugega zdravljenja.
• A two-year transition period) is considered acceptable to change production processes to achieve syntheses in which N-nitrosamines are not formed, to adopt analytical methods for the control strategy and in order to avoid product shortages. 
• dveletno prehodno obdobje je sprejemljivo za spremembo postopkov proizvodnje, da se vzpostavijo sinteze, v katerih N-nitrozamini ne nastajajo, za uvedbo analitskih metod za strategijo nadzora ter za preprečitev pomanjkanja zdravil;
The frequency of adverse reactions listed below is defined 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). 
Pogostnost neželenih učinkov je v nadaljevanju navedena v skladu z naslednjim dogovorom: 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).
Chloride deficit is generally mild and usually does not require treatment. 
Pomanjkanje klorida je običajno blago in ga običajno ni treba zdraviti.
• The CHMP reviewed data on quality regarding the manufacturing processes of sartans with a tetrazole group, analytical data including test results and available methods, and toxicological data available for the N-nitrosamines found in some of these products. 
• odbor CHMP je pregledal podatke o kakovosti v zvezi s postopki proizvodnje sartanov s tetrazolno skupino, analitske podatke, vključno z rezultati testov in razpoložljivimi metodami, ter razpoložljive toksikološke podatke za N-nitrozamine, prisotne v nekaterih od teh zdravil.
As soon as the problem of nitrosamine-contamination became known, immediate, precautionary measures were taken by competent authorities across the EU such as recalls of affected batches from pharmacies. 
Takoj ko je problematika onesnaženja z nitrozamini postala znana, so pristojni organi v EU uvedli takojšnje previdnostne ukrepe, kot so odpoklici zadevnih serij iz lekarn.
For these reasons, N-nitrosamine impurities in pharmaceuticals such as sartans intended for long-term use should be reduced as much as possible. 
Zato je treba vsebnost N-nitrozaminskih nečistot v zdravilih, kot so sartani, namenjenih dolgotrajni uporabi, čim bolj zmanjšati.
During this time period, MAHs and manufacturers are requested to introduce relevant changes to the manufacturing processes of the drug substances, as well as develop appropriate analytical methods while ensuring adequate supply of the market for these essential medicinal products. 
V tem času bodo morali imetniki dovoljenj za promet z zdravili in proizvajalci uvesti potrebne spremembe postopkov proizvodnje učinkovin in razviti ustrezne analitske metode, hkrati pa zagotoviti ustrezno oskrbo trga s temi pomembnimi zdravili.
Electrolyte imbalance 
Elektrolitsko neravnovesje
Implement a control strategy to detect and control N-nitrosamine impurities in the API (or intermediate, if justified). 
3. uvedba strategije nadzora za odkrivanje in nadzor N-nitrozaminskih nečistot v učinkovini (ali intermediatu, če je to utemeljeno).
Appropriate regulatory actions (such as quarantine or batch recalls) have been taken where relevant. 
Kjer je bilo primerno, so bili izvedeni ustrezni regulativni ukrepi (kot so karantena in odpoklici serij).
The above stated very small theoretical risk has to be balanced against the risks of potential measures to monitor patients such as colonoscopy or gastroscopy which may exceed the theoretical excess cancer risk. 
Zgoraj navedeno zelo majhno teoretično tveganje je treba pretehtati glede na tveganja morebitnih ukrepov za spremljanje bolnikov, kot sta kolonoskopija in gastroskopija, ki lahko presegajo teoretično čezmerno tveganje za raka.
Sartan-containing medicinal products are important treatment options of serious or potentially serious conditions such as hypertension or certain heart or kidney diseases. 
Zdravila, ki vsebujejo sartan, so pomembna možnost za zdravljenje resnih in morebitno resnih stanj, kot so hipertenzija in določene bolezni srca ali ledvic.
Nitrosamines are chemically simple molecules and can be formed in pharmaceutical manufacturing steps whenever there is a presence of a secondary (or tertiary) amines and nitrites, usually in acidic conditions. 
Nitrozamini so kemijsko preproste molekule in lahko nastajajo med farmacevtsko proizvodnjo, kadar koli so prisotni sekundarni (ali terciarni) amini in nitriti, običajno v kislih pogojih.
Risks resulting from multiple exposures are considered to add up in patients as mutagenic carcinogens are currently considered as summation toxins. 
Tveganja, ki izhajajo iz večkratne izpostavljenosti, naj bi se pri bolnikih seštevala, saj se mutagene karcinogene snovi trenutno obravnavajo kot strupi, ki se seštevajo.
Grounds for CHMP opinion 
Razlogi za mnenje odbora CHMP
The limit of 0.03 ppm for NDMA and NDEA will be enforceable after a transitional period of 2 years from the notification of the Commission Decision. 
Meja 0,03 ppm za NDMA in NDEA se bo začela uporabljati po dveletnem prehodnem obdobju po uradnem obvestilu o sprejetju sklepa Komisije.
• After the transition period, a limit for NDMA and NDEA of maximum 0.03 ppm should be implemented, which reflects the lowest quantifiable level based on capability of the available analytical methods. 
• po prehodnem obdobju je treba za NDMA in NDEA uvesti mejo največ 0,03 ppm, ki odraža najnižjo določljivo raven na podlagi zmogljivosti razpoložljivih analitskih metod;
Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. 
Simptomi vključujejo akuten pojav zmanjšane ostrine vida ali bolečine v očesu in se običajno pojavijo v nekaj urah ali tednih po začetku zdravljenja.
The mean age of patients was 52.5 years, 13 % were ≥ 65 years of age, and just 2 % were ≥ 75 years of age. 
Srednja starost bolnikov je bila 52,5 let, 13 % bolnikov je bilo starih 65 let ali starejših.