natgillin/translations-raw huggingface dataset:
Trevaclyn is used in addition to diet and exercise in patients with dyslipidaemia (abnormally high levels of fat in the blood), particularly ‘combined mixed dyslipidaemia' and ‘primary hypercholesterolaemia'.
Zdravilo Trevaclyn se uporablja kot dodatek k prehrani in telesni vadbi pri bolnikih z dislipidemijo (nenormalno visoka raven maščobe v krvi), zlasti pri tistih s kombinirano mešano dislipidemijo in primarno hiperholesterolemijo.
The full EPAR for Trevaclyn can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Trevaclyn je na voljo tukaj.
It should be used with caution in patients who have problems with their kidneys and should not be used in patients with liver problems.
Pri bolnikih z ledvičnimi težavami je potrebna posebna previdnost pri uporabi zdravila Trevaclyn, pri bolnikih z jetrnimi težavami pa se zdravilo Trevaclyn ne sme uporabljati.
How has Trevaclyn been studied?
Kako je bilo zdravilo Trevaclyn raziskano?
The second study compared the combination of Trevaclyn and simvastatin (a statin) with Trevaclyn alone or simvastatin alone in 1,398 patients.
V drugi študiji so pri 1398 bolnikih primerjali kombinacijo zdravila Trevaclyn in simvastatin (vrsta statina) s samostojnim zdravilom Trevaclyn ali simvastatinom.
How is Trevaclyn used?
Kako se zdravilo Trevaclyn uporablja?
What is Trevaclyn used for?
Za kaj se zdravilo Trevaclyn uporablja?
What is Trevaclyn?
Kaj je zdravilo Trevaclyn?
How does Trevaclyn work?
Kako zdravilo Trevaclyn deluje?
Previously known as Arcalyst.
1 Prej znano kot Arcalyst.
It must not be used in patients with an active, severe infection.
Zdravilo se ne sme uporabljati pri bolnikih z aktivnimi resnimi okužbami.
It contains the active substance rilonacept (80 mg/ml).
Vsebuje zdravilno učinkovino rilonacept (80 mg/ml).
Patients may inject themselves once they have been trained if their doctor believes it is appropriate.
Bolniki si lahko zdravilo injicirajo sami, če so o tem ustrezno poučeni in če njihov zdravnik oceni, da je to primerno.
The European Commission granted a marketing authorisation valid throughout the European Union for Arcalyst to Regeneron UK Limited on 23 October 2009.
Evropska komisija je dovoljenje za promet z zdravilom Arcalyst, veljavno po vsej Evropski uniji, odobrila družbi Regeneron UK Limited dne 23. oktobra 2009.
Severe disabilities such as deafness and loss of vision may also occur.
Prav tako lahko pride do resne prizadetosti, kot je naglušnost in izguba vida.
The main measure of effectiveness was how much their symptoms reduced after the six-week treatment and how much the improvements were maintained after the nine-week treatment.
Glavno merilo učinkovitosti je bila ublažitev simptomov po šesttedenskem zdravljenju in ohranitev tega izboljšanja po koncu devettedenskega zdravljenja.
The starting dose is 4.4 mg per kilogram body weight (up to a maximum of 320 mg), which is followed a week later by once weekly injections of 2.2 mg/kg (up to a maximum of 160 mg).
Začetni odmerek znaša 4,4 mg na kilogram telesne mase (do največ 320 mg), teden dni za njim pa se začnejo enkrat tedensko dajati injekcije po 2,2 mg/kg (do največ 160 mg).
Five symptoms (rash, fever or chills, joint pain, tiredness and eye redness or pain) were assessed by patients themselves on a scale from 0 to 10 points.
Pet simptomov (izpuščaji, vročina ali mrzlica, bolečine v sklepih, utrujenost in pordelost oči ali bolečina v očeh) so bolniki ocenjevali sami s točkami od 0 do 10.
The name of the medicine was changed to Rilonacept Regeneron on 23 July 2010.
Ime zdravila je bilo 23. julija 2010 spremenjeno v Rilonacept Regeneron.
CAPS are a group of diseases where patients have a defect in the gene that produces a protein called cryopyrin.
CAPS je skupina bolezni, pri katerih imajo bolniki okvaro gena, ki proizvaja beljakovino, imenovano kriopirin.
This means that because the diseases are rare, it has not been possible to obtain complete information about Rilonacept Regeneron.
To pomeni, da zaradi redkosti bolezni ni mogoče pridobiti vseh informacij o zdravilu Rilonacept Regeneron.
Because the number of patients with CAPS is low, the diseases are considered ‘rare', and Rilonacept Regeneron was designated an ‘orphan medicine' (a medicine used in rare diseases) on 10 July 2007.
Ker je število bolnikov s CAPS majhno, veljajo te bolezni za redke, zato je bilo zdravilo Rilonacept Regeneron 10. julija 2007 določeno kot „zdravilo sirota“ (zdravilo, ki se uporablja pri redkih boleznih).
This document is a summary of the European public assessment report (EPAR) for Rilonacept Regeneron.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Rilonacept Regeneron.
Rilonacept Regeneron has been authorised under ‘exceptional circumstances'.
Zdravilo Rilonacept Regeneron je bilo odobreno „v izjemnih okoliščinah“.
The full EPAR for Rilonacept Regeneron can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Rilonacept Regeneron je na voljo na spletni strani agencije po rubriko EMA website/Find medicine/Human medicines/European Public Assessment Reports.
For more information about treatment with Rilonacept Regeneron, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Rilonacept Regeneron preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
The summary of opinion of the Committee for Orphan Medicinal Products for Rilonacept Regeneron is available here.
Povzetek mnenja Odbora za zdravila sirote za zdravilo Rilonacept Regeneron je na voljo tukaj.
The CHMP decided that Rilonacept Regeneron's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Rilonacept Regeneron večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
This leads to inflammation in many parts of the body, with symptoms such as fever, rash, joint pain, and tiredness.
Zaradi tega pride do vnetja na številnih delih telesa s simptomi, kot so vročina, izpuščaji, bolečine v sklepih in utrujenost.
Rilonacept Regeneron should not be used in people who may be hypersensitive (allergic) to rilonacept or any of the other ingredients.
Zdravila Rilonacept Regeneron ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) rilonacept ali katero koli drugo sestavino zdravila.
The company that makes Rilonacept Regeneron will provide regular information on the safety and effectiveness of Rilonacept Regeneron in adults and children from a registry and will perform a study in children to further investigate what happens to the medicine in the body.
Družba, ki izdeluje zdravilo Rilonacept Regeneron, bo iz registra pridobila ustrezne informacije o varnosti in učinkovitosti zdravila Rilonacept Regeneron pri odraslih in otrocih ter izvedla študijo pri otrocih, da bo dodatno raziskala, kaj se zgodi z zdravilom v telesu.
Adults should be given a starting dose of two injections of 160 mg each in two different parts of the body on the same day.
Začetni odmerek pri odraslih je dve injekciji, vsaka po 160 mg, injicirani v dva različna dela telesa isti dan.
The most common side effects with Rilonacept Regeneron (seen in more than 1 patient in 10) are reactions at the injection site, upper respiratory tract infections (colds), sinusitis (inflammation of the sinuses) and headache.
Najpogostejši neželeni učinki zdravila Rilonacept Regeneron (opaženi pri več kot 1 bolniku od 10) so reakcije na mestu injiciranja, okužbe zgornjih dihal (prehladi), sinusitis (vnetje sinusov) in glavobol.
Patients treated with Rilonacept Regeneron must be given an alert card that summarises the key safety information about the medicine.
Bolnikom, ki prejemajo zdravilo Rilonacept Regeneron, je treba dati opozorilno kartico, ki povzema najpomembnejše varnostne informacije o zdravilu.
Treatment with Rilonacept Regeneron should be started and supervised by a specialist doctor experienced in diagnosing and treating CAPS.
Zdravljenje z zdravilom Rilonacept Regeneron mora uvesti in nadzirati zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem CAPS.
After the sixweek treatment, patients who received Rilonacept Regeneron had a reduction in symptoms of 2.5 points on the scale compared with 0.3 points in patients who received placebo.
Po šestih tednih zdravljenja so se pri bolnikih, ki so prejemali zdravilo Rilonacept Regeneron, simptomi ublažili za 2,5 točke v primerjavi z 0,3 točke pri bolnikih, ki so prejemali placebo.
In the second part of the study, symptoms increased more in patients switched to placebo (0.9 points) compared with patients who remained on Rilonacept Regeneron (0.1 points).
V drugem delu študije so se simptomi bolj poslabšali pri bolnikih, ki so prešli na placebo (0,9 točke), v primerjavi z bolniki, ki so nadaljevali zdravljenje z zdravilom Rilonacept Regeneron (0,1 točke).
The company that makes Rilonacept Regeneron will provide doctors in all Member States who will use Rilonacept Regeneron with a pack containing the prescribing information, a patient alert card and information for doctors explaining the risk of side effects and how to use the medicine properly.
Družba, ki izdeluje zdravilo Rilonacept Regeneron, bo zdravnikom v vseh državah članicah, ki uporabljajo zdravilo Rilonacept Regeneron, priskrbela informacije o predpisovanju zdravila, opozorilno kartico za bolnike in informacije za zdravnike, s katerimi bo pojasnila tveganja za neželene učinke in podala informacije o tem, kako zdravilo pravilno uporabljati.
Rilonacept Regeneron is used to treat cryopyrin-associated periodic syndromes (CAPS).
Zdravilo Rilonacept Regeneron se uporablja za zdravljenje s kriopirinom povezanih periodičnih sindromov (CAPS).
Rilonacept Regeneron is used to treat CAPS that are causing severe symptoms in adults and children aged 12 years and older, including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS).
Zdravilo Rilonacept Regeneron se uporablja za zdravljenje CAPS s hudimi simptomi, vključno s familiarnim avtoinflamatornim sindromom zaradi mraza (FCAS) in Muckle-Wellsovim sindromom (MWS), pri odraslih in otrocih, starejših od 12 let.
Rilonacept Regeneron was more effective than placebo at treating symptoms of CAPS.
Zdravilo Rilonacept Regeneron je bilo pri zdravljenju simptomov CAPS učinkovitejše od placeba.
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 Rilonacept Regeneron.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Rilonacept Regeneron, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
In the first part of one main study involving 47 patients with CAPS, patients were given either Rilonacept Regeneron or placebo (a dummy treatment) for six weeks.
V prvem delu glavne študije, ki je vključevala 47 bolnikov s CAPS, so bolniki šest tednov prejemali bodisi zdravilo Rilonacept Regeneron bodisi placebo (zdravilo brez zdravilne učinkovine).
Other information about Rilonacept Regeneron:
Druge informacije o zdravilu Rilonacept Regeneron :
By attaching to interleukin-1 beta, it blocks its activity, helping to relieve the symptoms of the disease.
Rilonacept z vezavo na interlevkin-1beta zavira njegovo delovanje in tako pomaga ublažiti simptome bolezni.
In the second part of the study, all patients were given Rilonacept Regeneron treatment before receiving either Rilonacept Regeneron or placebo for another nine weeks.
V drugem delu študije so vsi bolniki najprej prejemali zdravilo Rilonacept Regeneron, nato pa so naslednjih devet tednov prejemali bodisi zdravilo Rilonacept Regeneron bodisi placebo.
What measures are being taken to ensure the safe use of Rilonacept Regeneron?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Rilonacept Regeneron?
The active substance in Rilonacept Regeneron, rilonacept, is an interleukin inhibitor.
Zdravilna učinkovina zdravila Rilonacept Regeneron, rilonacept, je zaviralec interlevkina.
What benefit has Rilonacept Regeneron shown during the studies?
Kakšne koristi je zdravilo Rilonacept Regeneron izkazalo med študijami?
For the full list of all side effects reported with Rilonacept Regeneron, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Rilonacept Regeneron, glejte navodilo za uporabo.
It works by attaching to chemical messengers in the body called interleukin-1beta and interleukin-1 alpha. One of these messengers, interleukin-1 beta, is produced at high levels in patients with CAPS, causing inflammation.
Deluje tako, da se veže na kemična prenašalca v telesu, imenovana interlevkin-1beta in interlevkin-1alfa.
Rilonacept Regeneron is a powder and solvent that are made up into a solution for injection.
Zdravilo Rilonacept Regeneron sestavljata prašek in vehikel, ki se zmešata v raztopino za injiciranje.
What information is still awaited for Rilonacept Regeneron?
Katere informacije o zdravilu Rilonacept Regeneron še pričakujemo?
Rilonacept Regeneron rilonacept
Rilonacept Regeneron1
What is the risk associated with Rilonacept Regeneron?
Kakšna tveganja so povezana z zdravilom Rilonacept Regeneron?
Blocking interleukin-1 may interfere with the body's immune response to infection and there have been reports of serious infections in patients taking Rilonacept Regeneron.
Zaviranje interlevkina-1 lahko ovira imunski odziv telesa na okužbe.
Why has Rilonacept Regeneron been approved?
Zakaj je bilo zdravilo Rilonacept Regeneron odobreno?
Rilonacept Regeneron is given as injections under the skin.
Zdravilo Rilonacept Regeneron se injicira v podkožje.
A week later, the patient should start receiving once weekly injections of 160 mg. For children aged from 12 to 17 years, the dose will depend on the patient's weight.
Teden dni kasneje mora bolnik začeti prejemati injekcije po 160 mg enkrat tedensko.
How has Rilonacept Regeneron been studied?
Kako je bilo zdravilo Rilonacept Regeneron raziskano?
How is Rilonacept Regeneron used?
Kako se zdravilo Rilonacept Regeneron uporablja?
What is Rilonacept Regeneron?
Kaj je zdravilo Rilonacept Regeneron?
What is Rilonacept Regeneron used for?
Za kaj se zdravilo Rilonacept Regeneron uporablja?
How does Rilonacept Regeneron work?
Kako zdravilo Rilonacept Regeneron deluje?
Date of first authorisation: 28 October 2010 Date of latest renewal: 18 September 2015
Datum prve odobritve: 28. oktober 2010 Datum zadnjega podaljšanja: 18. september 2015
5 minutes.
5 minutah.
Do not give this medicine to children under 12 years old.
Tega zdravila ne dajajte otrokom, mlajšim od 12 let.
This testing should be provided free of charge.
To testiranje je treba zagotoviti brezplačno.
• Wash your hands carefully.
• Dobro si umijte roke.
Genotoxic and carcinogenic potential is not expected.
Ne pričakuje se genotoksičnosti in kancerogenega potenciala.
Small amounts of foam are acceptable.
Majhne količine pene so sprejemljive.
Data in patients older than 65 years are limited.
Podatkov pri bolnikih, starejših od 65 let, je malo.
• Inspect vials and other components.
• Preglejte viale in druge komponente.
All adapters supplied with the kit are identical.
Vsi adapterji, dobavljeni v kompletu, so enaki.
The medicinal product should be used immediately (see section 6.3).
Zdravilo je treba uporabiti takoj (glejte poglavje 6.3).
Chemical and physical in-use stability has been demonstrated for 48 hours between 5˚C and 25˚C.
Kemična in fizikalna stabilnost med uporabo je bila dokazana do 48 ur med 5 ˚C in 25 ˚C.
• Response to treatment
• Odziv na zdravljenje
Hypersensitivity reactions cannot be excluded.
Preobčutljivostnih reakcij ni mogoče izključiti.
The adapter must remain in its plastic packaging.
Adapter mora ostati v svoji plastični ovojnini.
Step 9: Required components
9. korak: Zahtevane komponente
The instructions for use are clearly described in the doctor's information leaflet and are attached.
Navodila za uporabo so jasno opisana v navodilih za uporabo za zdravnika in so priložena.
Elderly (≥65 years old)
Starejši (≥65 let):
The efficacy and safety in adolescent patients were consistent with that seen in adults.
Učinkovitost in varnost pri mladoletnih bolnikih sta bili enaki kot pri odraslih.
The table below shows the results (primary and secondary endpoints) of the two randomized controlled trials:
Spodnja preglednica prikazuje rezultate (primarni in sekundarni opazovani dogodek) dveh randomiziranih, nadzorovanih študij:
Marketing Authorisation Holder: Pharming Group N.V.
Imetnik dovoljenja za promet: Pharming Group N.V.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik
Paediatric population The safety and efficacy of Ruconest in children (age 0 to 12 years) have not yet been established.
Pediatrična populacija Varnost in učinkovitost zdravila Ruconest pri otrocih, starih 0 do 12 let, še nista dokazani.
The elimination half-life of conestat alfa was approximately 2 hours.
Razpolovni čas izločanja konestata alfa je bil približno 2 uri.
No formal distribution studies have been performed.
Formalne študije o porazdelitvi niso bile izvedene.
Time (minutes) to minimal symptoms median (95% CI)
Povprečni čas do minimalnih simptomov (95 % CI)
This can lead to repeated attacks of swelling, pain in the abdomen, difficulty breathing and other symptoms.
To lahko vodi k ponavljajočim se napadom otekanja, bolečinam v trebuhu, težavam pri dihanju in drugim simptomom.
Step 14: Documenting the administration Please record (e.g. in your diary):
14. korak: Dokumentiranje injiciranja Prosimo, zabeležite (npr. v svojem dnevniku):
No clinical information on overdose is available.
Klinične informacije o prevelikem odmerjanju niso na voljo.
Mostly a single dose is sufficient, but a second dose may be needed.
V večini primerov zadostuje enkratni odmerek, vendar bo morda potreben drugi odmerek.
Very rare (<1/10,000), Not known (cannot be estimated from the available data).
neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
For IV use.
Za IV uporabo.
Ruconest is not recommended for use during pregnancy or breast-feeding, unless the treating physician judges the benefits to outweigh the possible risks.
Ruconest se ne priporoča za uporabo med nosečnostjo ali dojenjem, razen če lečeči zdravnik oceni, da pričakovane koristi prevladajo nad možnimi tveganji.
(pharmacovigilance or risk minimisation) milestone being reached.
(farmakovigilančni ali povezan z zmanjševanjem tveganja).
- check the expiry date.
- preverite datum izteka roka uporabnosti.
Preparation of solution Step 1: Cleaning and other requirements
1. korak: Čiščenje in druge zahteve
• The risk of formation of anti-C1INH antibodies and therefore the potential risk of formation of neutralising antibodies.
• Tveganje tvorbe protiteles anti-C1INH in s tem morebitno tveganje za tvorjenje nevtralizirajočih protiteles.
It is very important that the prepared solution is injected directly into a vein and not into an artery or the surrounding tissue.
Pomembno je, da se pripravljena raztopina injicira neposredno v veno in ne v arterijo ali okoliško tkivo.
Each vial of Ruconest is for single use only.
Vsaka viala zdravila Ruconest je samo za enkratno uporabo.
Continue to fill the syringe with the volume required.
Nadaljujte s polnjenjem brizge s potrebno količino.
Patients must be closely monitored and carefully observed for any symptoms of hypersensitivity throughout the administration period.
Bolnike je treba skrbno spremljati in pozorno opazovati glede kakršnihkoli simptomov preobčutljivosti skozi celotno obdobje dajanja zdravila.
Within a single kit box, different components may have different expiry dates.
V posameznem pakiranju imajo lahko različne komponente različne datume izteka roka uporabnosti.
= body weight (kg)
= telesna masa (kg)
Nine adolescent HAE patients (aged 13 to 17 years) were treated with 50 U/kg for 26 acute angioedema attacks, and 7 (aged 16 to 17 years) with 2100 U for 24 acute angioedema attacks.
Devet bolnikov mladostnikov s HAE (starih 13 do 17 let) je bilo zdravljenih s 50 e./kg zaradi 26 akutnih napadov angioedema in 7 (starih 16 do 17 let) z 2100 e. zaradi 24 akutnih napadov angioedema.
The complement component (protein) C4, is a substrate for activated C1s.
Sestavina komplementa (beljakovina) C4 je substrat za aktivirane C1.
There is no rationale for patients older than 65 years to respond differently to Ruconest.
Ne pričakuje se, da bi se bolniki, starejši od 65 let, na zdravilo Ruconest odzivali drugače.
Preparation and handling
Priprava in rokovanje
If undissolved powder is still present, repeat the procedure.
Če je v viali še neraztopljen prašek, postopek ponovite.
• If blood is present, gently inject the solution into the vein, as shown in the picture.
• Če je prisotna kri, raztopino nežno injicirajte v žilo, kot je prikazano na sliki.
Based on the known pharmacology and adverse reaction profile of Ruconest, effects on the ability to drive and use machines are not expected.
Na podlagi znane farmakologije in profila neželenih učinkov zdravila Ruconest ni pričakovati vpliva na sposobnost vožnje in upravljanja s stroji.
As a result they may suffer from uncontrolled activation of contact and complement systems, with formation of inflammatory mediators, which clinically becomes manifest as the occurrence of acute angioedema attacks.
Posledično lahko trpijo zaradi nenadzorovane aktivacije sistemov kontakta in komplementa z nastankom vnetnih mediatorjev, ki se klinično pokažejo kot pojav akutnih napadov angioedema.
This may indicate that you have developed an allergy to Ruconest.
To lahko kaže, da ste razvili alergijo na zdravilo Ruconest.
What Ruconest is and what it is used for What you need to know before you use Ruconest How to use Ruconest
Kaj je zdravilo Ruconest in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Ruconest Kako uporabljati zdravilo Ruconest
• Any adverse events
• Kakršni koli neželeni dogodki
- Batch number and dose - Response to treatment - Any adverse events
- Številko serije in odmerek zdravila - Odziv na zdravljenje - Kakršne koli neželene dogodke
The clinical experience supporting safety of Ruconest consists of 300 administrations (83 administrations to healthy subjects or asymptomatic HAE patients and 217 administrations to 119 HAE patients).
Klinične izkušnje, ki podpirajo varnost zdravila Ruconest, zajemajo 300 dajanj (83 dajanj zdravim osebam ali asimptomatičnim bolnikom s HAE in 217 dajanj 119 bolnikom s HAE).
• If there is no blood in the tubing, remove the needle, repeat all steps from beginning of step 11 and reposition the needle.
• Če v cevki ni krvi, odstranite iglo, ponovite vse korake od 11. koraka naprej in znova vstavite iglo.
The incidence of adverse reactions was similar for all dose groups and did not increase upon repeated administrations.
Pojavnost neželenih učinkov je bila podobna za vse skupine z različnimi odmerki in se ni povečala po večkratnem dajanju.
• Use one alcohol pad to disinfect all vial stoppers and wait for at least 30 seconds until the stoppers have dried.
• Z alkoholno blazinico razkužite vse zaporke vial in počakajte vsaj 30 sekund, da se zaporke osušijo.
Adverse reactions were usually mild to moderate in severity.
Neželeni učinki so bili običajno blagi do zmerni.