natgillin/translations-raw huggingface dataset:
Striascan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called DaTSCAN.
To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje DaTSCAN.
What is Striascan and what is it used for?
Kaj je zdravilo Striascan in za kaj se uporablja?
This build-up can be seen using an imaging technique called single-photon-emission computed tomography (SPECT), which detects the radioactive iodine-123.
Kopičenje te snovi se lahko zazna s tehniko slikanja, imenovano računalniško podprta scintigrafska tomografija s sevalci gama (single-photon-emission computed tomography - SPECT), ki zaznava radioaktivni jod-123.
Ioflupane attaches specifically to structures on nerve cell endings that are responsible for the transport of dopamine.
Joflupan se veže na strukture na živčnih končičih, ki so odgovorne za prenos dopamina.
Striascan is only handled and given by people who have experience in the safe handling of radioactive materials.
Z zdravilom Striascan lahko rokujejo in ga dajejo samo osebe, ki imajo izkušnje z uporabo radioaktivnih snovi.
It contains a substance called ioflupane, which is labelled with 123I (iodine-123), a radioactive form of iodine.
Vsebuje učinkovino, imenovano joflupan, ki je radiooznačena z jodom-123 (123I), tj. radioaktivno obliko joda.
This enables diseases related to Parkinson's disease to be distinguished from essential tremor, and for Lewy body dementia to be distinguished from Alzheimer's disease.
To omogoča razločevanje bolezni, povezanih s Parkinsonovo boleznijo, od esencialnega tremorja ter demence z Lewyjevimi telesci od Alzheimerjeve bolezni.
This is because Striascan is given by injection into a vein, so the active substance is delivered straight into the bloodstream.
Razlog za to je dejstvo, da se zdravilo Striascan daje z injiciranjem v veno, zaradi česar učinkovina vstopi neposredno v krvni obtok.
Striascan can only be obtained with a prescription and should only be used in patients who have been referred by a doctor with experience in the management of movement disorders or dementia.
Predpisovanje in izdaja zdravila Striascan je le na recept, uporabljati pa se sme samo pri bolnikih, ki jih na pregled napotijo zdravniki, izkušeni na področju zdravljenja motenj gibanja ali demence.
Therefore, the Agency's view was that, as for DaTSCAN, the benefit of Striascan outweighs the identified risk and it can be authorised for use in the EU.
Zato je menila, da koristi zdravila Striascan enako kot pri zdravilu DaTSCAN odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
How has Striascan been studied?
Kako je bilo zdravilo Striascan raziskano?
How is Striascan used?
Kako se zdravilo Striascan uporablja?
Striascan (ioflupane (
Striascan (joflupan (123I))
I) is distributed by the blood and builds up in the striatum, where it attaches to the structures that transport dopamine.
Po injiciranju zdravila Striascan joflupan (123I) po krvi potuje do striatuma, kjer se nakopiči in veže na strukture za prenos dopamina.
How does Striascan work?
Kako zdravilo Striascan deluje?
It contains five live rotavirus strains, each carrying a different antigen (G1, G2, G3, G4 and P1[8]).
Vsebuje pet živih sevov rotavirusov, od katerih ima vsak drugačen antigen (G1, G2, G3, G4 in P1[8]).
The European Commission granted a marketing authorisation valid throughout the European Union for RotaTeq on 27 June 2006.
Evropska komisija je dovoljenje za promet z zdravilom RotaTeq, veljavno po vsej Evropski uniji, izdala dne 27. junija 2006.
It is available as a solution in a single-dose tube.
Na voljo je kot raztopina v enoodmerni tubi.
There are various types of rotaviruses that cause gastroenteritis.
Obstajajo različni tipi rotavirusov, ki povzročajo gastroenteritis.
The full EPAR for RotaTeq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo RotaTeq je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
It must also not be used in babies whose immune system is weakened.
Prav tako ga ne smejo prejeti otroci z oslabljenim imunskim sistemom.
It is recommended that the last dose be given to the child by the age of 20 to 22 weeks.
Priporočljivo je, da zadnji odmerek cepiva otrok dobi do dopolnjenega 20. do 22. tedna starosti.
The contents of the tube of RotaTeq are given directly into the baby's mouth.
Vsebino tube zdravila RotaTeq je treba dati neposredno v usta dojenčka.
What measures are being taken to ensure the safe and effective use of RotaTeq?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila RotaTeq?
The CHMP decided that RotaTeq's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila RotaTeq večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
This document is a summary of the European public assessment report (EPAR) for RotaTeq.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo RotaTeq.
For more information about treatment with RotaTeq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom RotaTeq preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
Other information about RotaTeq:
Druge informacije o zdravilu RotaTeq:
If necessary it may be given up to the age of 32 weeks.
Po potrebi se cepivo lahko da vse do 32. tedna starosti.
RotaTeq should never be injected under any circumstances.
Cepiva RotaTeq se v nobenem primeru ne sme injicirati.
When a baby is given the vaccine, the immune system (the system that fights diseases) makes antibodies against these antigens, which help prevent infections caused by rotaviruses that occur naturally and carry the same or very similar antigens.
Ko otrok prejme cepivo, imunski sistem (obrambni sistem proti boleznim) izdela protitelesa proti tem antigenom, s čimer pripomore k preprečevanju okužb, ki jih povzročajo naravno prisotni rotavirusi z enakimi ali zelo podobnimi antigeni.
The number of cases of rotavirus gastroenteritis due to viruses with the same antigens as in the vaccine decreased following vaccination with RotaTeq.
Število primerov rotavirusnega gastroenteritisa zaradi virusov z enakim antigenom, kot je v cepivu, se je po cepljenju s cepivom RotaTeq zmanjšalo.
The first dose should be given six weeks after birth at the earliest.
Prvi odmerek morajo prejeti najmanj šest tednov po rojstvu.
RotaTeq rotavirus vaccine, live
RotaTeq cepivo proti rotavirusu, živo
RotaTeq contains viruses that carry the antigens for some of the most commonly occurring types of rotaviruses.
Cepivo RotaTeq vsebuje viruse, ki nosijo antigene za nekaj najpogostejših tipov rotavirusov.
The first dose is given when the baby is between 6 and 12 weeks of age.
S prvim odmerkom je treba dojenčka cepiti pri starosti med 6 in 12 tednov.
About half of the babies received RotaTeq, and the others received placebo (a dummy vaccine).
Približno polovica dojenčkov je prejemala cepivo RotaTeq, drugi pa so prejemali placebo (cepivo brez zdravilne učinkovine).
RotaTeq is used in babies from 6 to 32 weeks of age to protect against gastroenteritis (diarrhoea and vomiting) caused by rotavirus infections.
Zdravilo RotaTeq se uporablja pri dojenčkih, starih od 6 do 32 tednov, za preprečevanje gastroenteritisa (driske in bruhanja), ki ga povzroča okužba z rotavirusi.
A risk management plan has been developed to ensure that RotaTeq is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila RotaTeq je bil pripravljen načrt obvladovanja tveganj.
Overall, the studies of RotaTeq involved over 72,000 babies, including about 2,000 premature babies.
V študije cepiva RotaTeq je bilo vključenih skupno 72 000 dojenčkov, med katerimi je bilo približno 2 000 nedonošenčkov.
The main measure of effectiveness, which was studied in 6,000 babies, was the number of babies who developed rotavirus gastroenteritis during the following rotavirus season (the time of the year when rotaviruses are known to circulate and cause infection, generally during the cooler months in winter to early spring).
Glavno merilo učinkovitosti, ki so ga proučevali pri 6 000 dojenčkih, je bilo število otrok, pri katerih se je v naslednji rotavirusni sezoni (obdobju v letu, ko se pričakuje širjenje rotavirusov in pojav okužb, po navadi v hladnejših mesecih - od zime do zgodnje pomladi) pojavil rotavirusni gastroenteritis.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for RotaTeq, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
RotaTeq is given according to official recommendations.
Cepivo RotaTeq se daje v skladu z uradnimi priporočili.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for RotaTeq.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What benefit has RotaTeq shown during the studies?
Kakšne koristi je zdravilo RotaTeq izkazalo med študijami?
Among the almost 6,000 babies in whom the main measure of effectiveness was studied, 82 of the babies vaccinated with RotaTeq developed rotavirus gastroenteritis (one with severe gastroenteritis) compared with 315 of the babies who received placebo (51 severe cases).
Od skoraj 6 000 dojenčkov, pri katerih so proučevali glavno merilo učinkovitosti cepiva, se je rotavirusni gastroenteritis pojavil pri 82 dojenčkih, cepljenih s cepivom RotaTeq (pri enem hud gastroenteritis), v primerjavi s 315 dojenčki, ki so prejemali placebo (51 hudih primerov).
RotaTeq can be given at the same time as other vaccinations (except the oral polio vaccine, when a two-week interval is needed between the two vaccines).
Cepivo RotaTeq se lahko daje sočasno z drugimi cepivi (izjema je peroralno cepivo proti otroški ohromelosti (polio), v tem primeru je časovni razmik med cepljenji s tema cepivoma dva tedna).
RotaTeq must not be used in babies who are hypersensitive (allergic) to the active substance or any of the other ingredients, or who showed signs of allergy after receiving a dose of RotaTeq or another vaccine against rotavirus in the past.
Zdravilo RotaTeq se ne sme uporabiti pri dojenčkih, ki so preobčutljivi za (alergični na) zdravilno učinkovino ali katero koli drugo sestavino zdravila, ali dojenčkih, ki so v preteklosti kazali znake alergije po prejemu odmerka cepiva RotaTeq ali drugega cepiva proti rotavirusom.
The most common side effects with RotaTeq (seen in more than 1 patient in 10) are pyrexia (fever), diarrhoea and vomiting.
Najpogostejši neželeni učinki cepiva RotaTeq (opaženi pri več kot 1 bolniku od 10) so bili pireksija (povišana telesna temperatura), driska in bruhanje.
RotaTeq is given as three doses, with at least four weeks between each dose.
Zdravilo RotaTeq se daje v treh odmerkih, pri čemer mora biti razmik med posameznima odmerkoma vsaj štiri tedne.
For the full list of all side effects reported with RotaTeq, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila RotaTeq, glejte navodilo za uporabo.
An antigen is a specific structure that the body can recognise as ‘foreign' and against which the body can make an antibody, a special protein that can neutralise or destroy the antigen.
Antigeni so posebne strukture, ki jih telo lahko prepozna kot „tujek“ in lahko proti njim tvori protitelesa.
Vaccination with RotaTeq should be postponed in babies who have a sudden high fever, diarrhoea or vomiting.
Cepljenje s cepivom Rotarix je treba preložiti pri dojenčkih, ki imajo nenadno povišano telesno temperaturo, drisko ali bruhajo.
What is the risk associated with RotaTeq?
Kakšna tveganja so povezana z zdravilom RotaTeq?
The study also showed that there were fewer hospital admissions or visits to emergency clinics for rotavirus gastroenteritis in babies vaccinated with RotaTeq.
Študija je pokazala tudi, da je bilo v skupini dojenčkov, ki so bili cepljeni s cepivom RotaTeq, manj sprejemov v bolnišnico oziroma obiskov klinik za nujno pomoč zaradi rotavirusnega gastroenteritisa.
RotaTeq must not be given to babies who have had intussusception in the past or who have problems with their bowel that could put them at risk of intussusception.
Cepivo RotaTeq se ne sme uporabiti pri dojenčkih, ki so imeli uvihanje črevesja v preteklosti, ali pri dojenčkih, ki imajo težave s črevesjem, ki lahko pomenijo nagnjenost k tej bolezni.
Why has RotaTeq been approved?
Zakaj je bilo zdravilo RotaTeq odobreno?
They vary in that they may carry different antigens.
Razlikujejo se v antigenih, ki jih nosijo.
RotaTeq is a vaccine that is taken by mouth.
Zdravilo RotaTeq je cepivo, ki se jemlje peroralno.
What is RotaTeq?
Kaj je zdravilo RotaTeq?
What is RotaTeq used for?
Za kaj se zdravilo RotaTeq uporablja?
RotaTeq can be given to premature babies, as long as the pregnancy lasted at least 25 weeks.
Cepivo lahko prejmejo tudi nedonošenčki, ki so bili rojeni najmanj v 25. tednu nosečnosti.
How has RotaTeq been studied?
Kako je bilo zdravilo RotaTeq raziskano?
How does RotaTeq work?
Kako zdravilo RotaTeq deluje?
How is RotaTeq used?
Kako se zdravilo RotaTeq uporablja?
Ref. EMEA/270168/2008
EMEA/331188/2008
It was hoped that this would make it easier for patients to stick to their treatment.
Cilj tega je bil, da bi bilo bolnikom lažje držati se predvidenega zdravljenja.
On 23 May 2008, Bristol Myers Squibb Pharma EEIG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for DuoCover for the prevention of atherothrombotic events.
Družba Bristol Myers Squibb Pharma EEIG je dne 23. maja 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom DuoCover, namenjenim za preprečevanje aterotrombotičnih dogodkov.
It was to be available as tablets containing 75 mg clopidogrel plus 75 mg acetylsalicylic acid, and as tablets containing 75 mg clopidogrel plus 100 mg acetylsalicylic acid.
Naj voljo naj bi bilo v tabletah s 75 mg klopidogrela in 75 mg acetilsalicilne kisline in v tabletah s 75 mg klopidogrela in 100 mg acetilsalicilne kisline.
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for DUOCOVER
VPRAŠANJA IN ODGOVORI V ZVEZI Z UMIKOM VLOGE ZA DOVOLJENJE ZA PROMET z zdravilom DUOCOVER
There are no consequences on the use of Iscover/Plavix with acetylsalicylic acid in the authorised indications, for which the balance of benefits and risks remains unchanged.
Umik nima nobenih posledic za uporabo zdravil Iscover/Plavix z acetilsalicilno kislino za odobreno indikacijo, pri kateri ostaja razmerje med koristmi in tveganji nespremenjeno.
What is DuoCover?
Kaj je zdravilo DuoCover?
When the blood clots, this is due to special cells in the blood, the platelets, sticking together (aggregating).
Kri se strjuje zaradi posebnih celic v krvi, trombocitov, ki se zlepljajo (agregirajo) med seboj.
What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with DuoCover?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe z zdravilom DuoCover?
The active substances in DuoCover, clopidogrel and acetylsalicylic acid, are combined into one tablet in DuoCover to reduce the number of tablets the patients need to take every day.
Zdravilni učinkovini v zdravilu DuoCover, klopidogrel in acetilsalicilna kislina, sta v zdravilu DuoCover kombinirani v eno tableto, da bi s tem zmanjšali število tablet, ki jih mora bolnik jemati vsak dan.
This included patients who were having an acute myocardial infarction (heart attack) with an ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG) when the doctor thought that they would have benefited from the treatment.
Mednje spadajo bolniki, ki so imeli akutni miokardni infarkt (srčni napad) z elevacijo spojnice ST (nenormalni zapis na elektrokardiogramu ali EKG), če bi zdravnik menil, da bi zdravilo lahko bolniku pomagalo.
It was also expected to be used in patients who did not have this abnormal reading on the ECG, if they had unstable angina (a severe type of chest pain) or a ‘non-Q-wave' myocardial infarction and who had a stent inserted (a short tube placed in an artery to prevent it closing up).
Uporabljalo naj bi se tudi pri bolnikih, ki nimajo tega nenormalnega zapisa na EKG, če imajo nestabilno angino (resno obliko bolečine v prsih) ali miokardni infarkt brez zobca Q in ki jim je bil vstavljen stent (v arterijo vstavljena kratka cevčica, ki preprečuje, da bi se arterija zaprla).
However the CHMP thought that the company could have addressed these concerns and was of the provisional opinion that DuoCover could have been approved for the prevention of atherothrombotic events.
Vendar pa je Odbor menil, da bi družba na te zadržke lahko odgovorila, in je začasno menil, da bi se zdravilo DuoCover lahko odobrilo za preprečevanje aterotrombotičnih dogodkov.
Furthermore, the studies of Iscover and Plavix used with acetylsalicylic acid as separate tablets were used to support the use of DuoCover in the same indication.
Poleg tega so bile študije z zdraviloma Iscover in Plavix, uporabljenima skupaj z acetilsalicilno kislino v ločenih tabletah uporabljene v podporo uporabi zdravila DuoCover za enako indikacijo.
The CHMP was concerned that the bioequivalence studies that were carried out did not use the recommended methods and did not provide sufficient evidence that the combined tablet was absorbed in the body in the same way as the two medicines given separately.
CHMP je skrbelo, da pri izvedenih študijah biološke enakovrednosti niso bile uporabljene priporočene metode in da niso zagotovile zadostnih dokazov, da telo kombinirano tableto absorbira na enak način kot dve ločeno dani zdravili.
Based on the review of the data and the company's responses to the CHMP lists of questions at the time of the withdrawal, the CHMP had some concerns.
Na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke.
It was expected to be used to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) in patients who have a condition known as ‘acute coronary syndrome'.
Uporabljalo naj bi se za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdevanje arterij) pri bolnikih z akutnim koronarnim sindromom.
The company informed the CHMP that there are no consequences for patients who are planned to be included in clinical trials with DuoCover or patients currently included in clinical trials with clopidogrel and acetylsalicylic acid as separate medicines.
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki bodo vključeni v klinična preskušanja zdravila DuoCover, ali bolnike, ki že sodelujejo v kliničnih preskušanjih s klopidogrelom in acetilsalicilno kislino kot ločenima zdraviloma.
Clopidogrel on its own has been approved by the EU under the names Iscover and Plavix, for the prevention of atherothrombotic events, in combination with acetylsalicylic acid, in patients with acute coronary syndrome.
EU je klopidogrel kot samostojno zdravilo odobrila pod imenoma Iscover in Plavix za preprečevanje aterotrombotičnih dogodkov v kombinaciji z acetilsalicilno kislino pri bolnikih z akutnim koronarnim sindromom.
DuoCover was expected to be used in adult patients already taking clopidogrel and acetylsalicylic acid as separate tablets.
Zdravilo DuoCover naj bi se uporabljalo pri odraslih bolnikih, ki že jemljejo klopidogrel in acetilsalicilno kislino v ločenih tabletah.
What was DuoCover expected to be used for?
Za kaj naj bi se zdravilo DuoCover uporabljalo?
Therefore, at the time of the withdrawal, the CHMP's view was that the company had not fully addressed their concerns and the benefit of the DuoCover combined tablet compared with the separate medicines had not been demonstrated.
CHMP je ob umiku menil, da se družba ni v zadostni meri posvetila zadržkom in da korist kombinirane tablete DuoCover v primerjavi z ločenima zdraviloma ni bila dokazana.
How is DuoCover expected to work?
Kako naj bi zdravilo DuoCover delovalo?
DuoCover is a medicine containing two active substances clopidogrel and acetylsalicylic acid in one tablet.
Zdravilo DuoCover vsebuje v eni tableti dve zdravilni učinkovini, klopidogrel in acetilsalicilno kislino.
‘bioequivalence' studies to establish whether the combined tablet was absorbed in the body in the same way as the two medicines given separately.
Družba je v podporo svoji vlogi za zdravilo DuoCover izvedla študijo biološke enakovrednosti, da bi ugotovila, ali telo kombinirano tableto absorbira na enak način kot dve ločeni zdravili.
Elderly (≥ 65 years old)
Starejši ( ≥ 65 let)
* See Section 4.4.
* Glejte poglavje 4.4.
It also lowers the amount of sugar made by your body.
Prav tako zmanjša količino sladkorja, ki nastane v telesu.
• low blood sugar
• nizek krvni sladkor.
• kidney problems (sometimes requiring dialysis)
• težave z ledvicami (včasih je potrebna dializa),
It is not known if this medicine passes into breast milk.
Ni znano, ali to zdravilo prehaja v materino mleko.
Hispanic or Latino patients comprised 15.6% to 36.1% of the population.
Latinoameričani so predstavljali od 15,6 % do 36,1 % populacije.
Steglujan should be taken orally once daily in the morning, with or without food.
Zdravilo Steglujan je treba jemati peroralno enkrat na dan zjutraj, s hrano ali brez nje.
• if you are taking digoxin (a medicine used to treat irregular heart beat and other heart problems).
• če jemljete digoksin (zdravilo, ki se uporablja za zdravljenje nepravilnega bitja srca in drugih težav s srcem).
• Swallow the tablet; if you have difficulties with swallowing the tablet can be broken or crushed.
• Tableto pogoltnite; če imate težave s požiranjem, lahko tableto prelomite ali zdrobite.
Treatment with Steglujan may be restarted when the ketone values are normal and the patient's condition has stabilised.
Zdravljenje z zdravilom Steglujan je mogoče znova uvesti, ko so vrednosti ketonov normalne in se bolnikovo stanje stabilizira.
• The dose of Steglujan that you take will depend on your condition and the amount of ertugliflozin and sitagliptin needed to control your blood sugar.
• Odmerek zdravila Steglujan, ki ga boste jemali, bo odvisen od vašega stanja in količine ertugliflozina in sitagliptina, potrebne za uravnavanje vašega krvnega sladkorja.
The mean age of the patients across these 3 studies ranged from 55.1 to 59.1 years (range 21 years to 85 years).
Povprečna starost bolnikov v teh 3 študijah je bila od 55,1 do 59,1 leta (razpon od 21 do 85 let).
What you need to know before you take Steglujan 3.
Kaj morate vedeti, preden boste vzeli zdravilo Steglujan 3.
Patients should not take two doses of Steglujan on the same day.
Bolnik ne sme vzeti dveh odmerkov zdravila Steglujan na isti dan.
*Incidence rate per 100 patient-years is calculated as 100 × (total number of patients with ≥ 1 event during eligible exposure period per total patient-years of follow-up).
* Pojavnost na 100 bolnik-let je izračunana kot 100 × (celotno število bolnikov z ≥ 1 dogodkom med ustreznim obdobjem izpostavljenosti na celotno število bolnik-let spremljanja).
Exfoliative skin conditions including Stevens-Johnson syndrome a,
eksfoliativna stanja na koži, vključno s Stevens-Johnsonovim sindromom a,