FrancophonIA/ELRC3.0 huggingface dataset:
English: You may not perform strenuous physical exercises 24 hours before the test. You can drink up to 100 mL of still water within 1 hour before and within 1 hour after intake of Macimorelin Aeterna Zentaris.
Croatian: Možete popiti do 100 ml obične vode unutar 1 sata prije i 1 sata poslije primjene lijeka Macimorelin Aeterna Zentaris.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING SACHET
Croatian: PODATCI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU
English: Step 7
Croatian: 7. korak
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Croatian: Za upute o rekonstituciji lijeka prije primjene vidjeti dio 6.6. 4.3 Kontraindikacije
English: The suspension must be used within 30 minutes after preparation.
Croatian: Suspenzija se mora upotrijebiti u roku od 30 minuta nakon pripreme.
English: Discontinuation of therapy with growth hormone (GH) or medicinal products directly affecting the pituitary secretion of somatotropin Patients on replacement therapy with growth hormone (GH, somatotropin) or on medicinal products directly affecting the pituitary secretion of somatotropin (e.g. somatostatin analogues, clonidine, levopoda and dopamine agonists) should be advised to discontinue such treatment at least 1 month before receiving macimorelin.
Croatian: Bolesnicima na nadomjesnoj terapiji hormonom rasta (somatotropin) ili na terapiji lijekom koji izravno utječe na lučenje somatotropina iz hipofize (npr. analozi somatostatina, klonidin, levodopa i agonisti dopamina) treba savjetovati da prekinu to liječenje najmanje 1 mjesec prije nego što prime macimorelin.
English: The growth hormone release is to be evaluated with three blood samples collected at 45, 60 and 90 minutes after the administration of the medicinal product.
Croatian: Otpuštanje hormona rasta treba procijeniti na tri uzorka krvi uzeta 45, 60 i 90 minuta nakon primjene lijeka.
English: Step 2
Croatian: 2. korak
English: Uncommon side effects (may affect up to 1 in 100 people):
Croatian: Manje česte nuspojave (mogu se pojaviti u do 1 na 100 osoba): • bol u trbuhu
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet contains 60 mg macimorelin (as acetate).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna vrećica sadrži 60 mg macimorelina (u obliku acetata).
English: You will have three blood samples taken to measure growth hormone, one sample each at 45, 60 and 90 minutes after taking the test dose.
Croatian: Za mjerenje hormona rasta uzet će Vam tri uzorka krvi i to po jedan uzorak 45, 60 i 90 minuta nakon što ste uzeli testnu dozu.
English: Post-hoc analysis with a cut-off point of 3.0 ng/mL for the ITT
Croatian: testa od 3,0 ng/ml.
English: The most common adverse reactions associated with Macimorelin Aeterna Zentaris reported in Study 052 (see section 5.1) in 154 patients were dysgeusia (5%), headache fatigue, nausea (each 3%), dizziness (2%), as well as abdominal pain, diarrhoea, feeling hot, feeling cold, hunger, palpitations, sinus bradycardia, somnolence, thirst, tremor, and vertigo (each 1%).
Croatian: (vidjeti dio 5.1) u 154 bolesnika bile su disgeuzija (5 %), glavobolja, umor, mučnina (svaka po 3 %),
English: One sachet will be required for a patient ≤ 120 kg, two sachets will be required if the patient weighs more than 120 kg.
Croatian: Za bolesnika tjelesne težine ≤ 120 kg potrebna je jedna vrećica, a za bolesnika težine veće od 120 kg potrebne su dvije vrećice.
English: The oral bioavailability may be limited (among others) by first pass metabolism via CYP3A4 (see section 4.5).
Croatian: Oralna bioraspoloživost može biti ograničena (među ostalim) metabolizmom prvog prolaza putem
English: Macimorelin is indicated as a single-dose diagnostic test. No information is available on the safety and effects of macimorelin during long-term use.
Croatian: Nema dostupnih informacija o sigurnosti i učincima macimorelina tijekom dugotrajne primjene.
English: Long-term use
Croatian: Dugotrajna primjena
English: Step 4
Croatian: 4. korak
English: Draw venous blood samples for growth hormone determination at 45, 60 and 90 minutes after administration.
Croatian: Izvadite uzorke venske krvi za određivanje hormona rasta 45, 60 i 90 minuta nakon primjene.
English: The suspension volume in mL equals the patient's body weight in kg. For example, a 70 kg patient will require 70 mL of the macimorelin suspension.
Croatian: Primjerice, bolesniku od 70 kg bit će potrebno 70 ml suspenzije macimorelina.
English: The suspension must be taken within 30 minutes after preparation.
Croatian: Suspenziju se mora uzeti unutar 30 minuta nakon pripreme.
English: Patients with Cushing's disease or on supra-physiologic glucocorticoid therapy
Croatian: Bolesnici s Cushingovom bolešću ili na suprafiziološkoj glukokortikoidnoj terapiji Hiperkortizolizam ima značajan utjecaj na hipotalamo-pituitarno-adrenalnu os.
English: DIRECTIONS FOR PREPARATION AND USE
Croatian: 15. UPUTE ZA UPORABU
English: In a diagnostic study comparing macimorelin with the insulin tolerance test (ITT) stimulated GH concentrations after macimorelin were on average 1.4 fold higher than in the ITT.
Croatian: stimulirane koncentracije hormona rasta bile su nakon primjene macimorelina u prosjeku 1,4 puta više od onih u ITT testu.
English: Step 6
Croatian: 6. korak
English: • tremor
Croatian: • vrtoglavica
English: Macimorelin Aeterna Zentaris is presented as white to off-white granules for oral suspension.
Croatian: Kako Macimorelin Aeterna Zentaris izgleda i sadržaj pakiranja Macimorelin Aeterna Zentaris dobiva se u obliku bijelih do bjelkastih granula za oralnu suspenziju.
English: A healthcare professional must supervise the preparation and use of Macimorelin Aeterna Zentaris.
Croatian: Pripremu i primjenu lijeka Macimorelin Aeterna Zentaris mora nadzirati zdravstveni radnik.
English: The following medicinal products may impact the accuracy of the diagnostic test. Concomitant use is to be avoided with (see also section 4.2 and section 4.4):
Croatian: Potrebno je izbjegavati istodobnu primjenu (vidjeti također dio 4.2 i dio 4.4):
English: • tiredness
Croatian: • mučnina
English: Step 3
Croatian: 3. korak
English: A potential for increased oral bioavailability and macimorelin plasma concentration with use of strong CYP3A4/P-gp-inhibitors cannot be excluded.
Croatian: Mogućnost povećane oralne bioraspoloživosti i koncentracije macimorelina u plazmi kod primjene sa snažnim inhibitorima enzima CYP3A4 / proteina P-gp Nisu provedena ispitivanja interakcija s inhibitorima enzima CYP3A4 / proteina P-gp.
English: Biotransformation
Croatian: Slično produljenje
English: What you need to know before Macimorelin Aeterna Zentaris is given
Croatian: Što morate znati prije nego primite Macimorelin Aeterna Zentaris Ne smijete primiti Macimorelin Aeterna Zentaris
English: Positive agreement is the proportion of subjects with a positive ITT (i.e., those who have GHD per the ITT) who also have a positive macimorelin test. With a high level of positive agreement, the MAC test will not wrongly diagnose an individual with GHD per the ITT as not having GHD.
Croatian: Pozitivno slaganje podrazumijeva udio ispitanika s pozitivnim ITT testom (tj. oni koji imaju nedostatak hormona rasta prema ITT testu) i pozitivnim MAC testom.
English: Macimorelin induced GH release was lower in patients with higher BMI.
Croatian: Otpuštanje hormona rasta izazvano macimorelinom bilo je manje u bolesnika s višim indeksom tjelesne mase.
English: The volume of suspension in mL needed for the recommended macimorelin dose of 0.5 mg/kg equals the patient's body weight in kg. For example, a 70 kg patient will require 70 mL of the macimorelin suspension.
Croatian: Volumen suspenzije u mililitrima potreban za preporučenu dozu macimorelina od 0,5 mg/kg jednak je bolesnikovoj tjelesnoj težini u kg.
English: Macimorelin Aeterna Zentaris 60 mg granules for oral suspension in sachet macimorelin
Croatian: Macimorelin Aeterna Zentaris 60 mg granule za oralnu suspenziju u vrećici macimorelin
English: • medicines to correct the heart rhythm (antiarrhythmic medicines such as amiodarone, procainamide, quinidine or sotalol)
Croatian: • lijekovi za korekciju srčanog ritma (antiaritmici kao što je amiodaron, prokainamid, kinidin ili sotalol) • svi drugi lijekovi koji mogu produljiti QT interval ili izazvati torsades de pointes.
English: What Macimorelin Aeterna Zentaris contains
Croatian: Macimorelin Aeterna Zentaris sadrži natrij
English: How Macimorelin Aeterna Zentaris is given
Croatian: Kako primjenjivati Macimorelin Aeterna Zentaris
English: STATEMENT OF ACTIVE SUBSTANCE(S) Contains 60 mg macimorelin (as acetate) After reconstitution: 500 micrograms macimorelin/mL
Croatian: Nakon rekonstitucije: 500 mikrograma macimorelina/ml
English: Tell your doctor if you are taking medicines that can alter your heart rhythm, such as:
Croatian: Obavijestite svojeg liječnika ako uzimate lijekove koji mogu promijeniti srčani ritam, kao što su: • lijekovi za liječenje psihoze (kao što je klorpromazin, haloperidol)
English: Macimorelin should be used with caution in patients with proarrhythmic condition (e.g., history of myocardial infarction, heart failure or prolonged ECG QTc interval, as defined as QTc > 500 ms).
Croatian: (npr. infarkt miokarda u anamnezi, srčano zatajenje ili produljeni QTc interval u EKG-u, definiran kao
English: The suspension must be administered within 30 minutes after preparation.
Croatian: Suspenzija se mora primijeniti unutar 30 minuta nakon pripreme.
English: NAME OF THE MEDICINAL PRODUCT Macimorelin Aeterna Zentaris 60 mg granules for oral suspension macimorelin
Croatian: Macimorelin Aeterna Zentaris 60 mg granule za oralnu suspenziju macimorelin
English: • Medicinal products that directly affect the pituitary secretion of growth hormone (such as somatostatin, insulin, glucocorticoids, and cyclooxygenase inhibitors such as acetylsalicylic acid or indometacin).
Croatian: inzulin, glukokortikoidi i inhibitori ciklooksigenaze kao što je acetilsalicilatna kiselina ili indometacin)
English: How Macimorelin Aeterna Zentaris is stored
Croatian: Kako čuvati Macimorelin Aeterna Zentaris
English: 4.4 Special warnings and precautions for use
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Interpretacija rezultata macimorelinskog testa
English: 6.6 Special precautions for disposal and other handling
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Suspenziju mora pripremiti i primijeniti zdravstveni radnik.
English: Aeterna Zentaris GmbH Weismuellerstrasse 50 60314 Frankfurt am Main Germany
Croatian: Aeterna Zentaris GmbH Weismuellerstrasse 50
English: • that could have a direct influence on growth hormone secretion by the pituitary gland: such as somatostatin, insulin, glucocorticoids, acetylsalicylic acid,
Croatian: • koji bi mogli imati izravan utjecaj na lučenje hormona rasta u hipofizi, kao što su somatostatin,
English: Macimorelin Aeterna Zentaris is indicated as a single-dose diagnostic test. No information is available on the safety and effects of macimorelin during long-term use.
Croatian: Macimorelin Aeterna Zentaris indiciran je kao dijagnostički test u jednoj dozi.
English: These ECG abnormalities consisted of T wave abnormalities and QT prolongation.
Croatian: Te abnormalnosti EKG-a činila su odstupanja
English: Common
Croatian: Njemačka
English: NAME OF THE MEDICINAL PRODUCT Macimorelin Aeterna Zentaris 60 mg granules for oral suspension in sachet
Croatian: Macimorelin Aeterna Zentaris 60 mg granule za oralnu suspenziju u vrećici
English: In patients with age up to 60 years, diagnostic performance of MAC and ITT were comparable.
Croatian: U bolesnika u dobi do 60 godina, dijagnostička uspješnost macimorelinskog testa (MAC) i testa tolerancije inzulina (engl. insulin tolerance test, ITT) bila je slična.
English: Negative agreement is the proportion of subjects with a negative ITT (i.e., those who do not have GHD per the ITT) who also have a negative MAC test. With a high level of negative agreement, the MAC test will not wrongly diagnose an individual without GHD per the ITT as having GHD.
Croatian: ITT testom (tj. one koji nemaju nedostatak hormona rasta prema ITT testu) te negativnim MAC
English: In patients with high BMI up to 40 kg/m2, diagnostic performance of MAC and of ITT were comparable.
Croatian: U bolesnika s visokim indeksom tjelesne mase do 40 kg/m2
English: Aeterna Zentaris GmbH Weismüllerstrasse 50 D-60314 Frankfurt am Main Germany
Croatian: Aeterna Zentaris GmbH Weismüllerstrasse 50
English: An exploratory analysis was conducted on the performance of the MAC based on an ITT cut-off point of 3.0 ng/mL.
Croatian: Post hoc analiza s graničnom vrijednošću od 3,0 ng/ml za ITT test Eksploratorna analiza provedena je za učinkovitost MAC testa na temelju granične vrijednosti ITT
English: Driving and using machines Dizziness can occur with Macimorelin Aeterna Zentaris.
Croatian: Prilikom primjene lijeka Macimorelin Aeterna Zentaris može se pojaviti omaglica.
English: Point estimates for sensitivity and specificity were 87% and 96% from not matched Group A subjects, respectively.
Croatian: Točkovne procjene osjetljivosti i specifičnosti u nepodudarnih ispitanika skupine
English: Abdominal pain
Croatian: Poremećaji probavnog sustava mučnina bol u abdomenu proljev
English: Feeling cold Hunger Thirst
Croatian: Opći poremećaji i reakcije na mjestu primjene umor osjećaj vrućine osjećaj hladnoće glad žeđ
English: What Macimorelin Aeterna Zentaris is and what it is used for
Croatian: Što je Macimorelin Aeterna Zentaris i za što se koristi Lijek sadržava djelatnu tvar koja se naziva macimorelin.
English: Elderly
Croatian: DJECE
English: MARKETING AUTHORISATION HOLDER
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač
English: Vial (glass)
Croatian: Bočica (staklo)
English: EU Number
Croatian: Broj (EU) odobrenja Ime
English: Pharmaceutical form Route of administration Immediate Packaging Content Pack size EU/1/13/873/001 Xofigo 1100 kBq/mL Solution for injection Intravenous use
Croatian: EU/1/13/873/001
English: Name Strength
Croatian: Sastav Veličina pakovanja
English: Packaging
Croatian: Libertek
English: Package size l t o r
Croatian: EU/1/11/666/001
English: Action is needed in the following circumstances:
Croatian: Potrebno je reagirati u sljedećim okolnostima:
English: Your doctor can advise you what would be best.
Croatian: Vaš će Vas liječnik savjetovati što bi bilo najbolje.
English: Date of first authorisation: 23 june 2017
Croatian: Datum prvog odobrenja: 23. lipanj 2017
English: 9/L, then treatment must be stopped immediately.
Croatian: 9/L, tada se liječenje mora odmah prekinuti.
English: A risk to newborns or infants cannot be excluded.
Croatian: Ne može se isključiti rizik za novorođenče ili dojenče.
English: No specific antidote is known.
Croatian: Nije poznat specifičan antidot.
English: It is not known how commonly they occur.
Croatian: Nije poznato koliko se često one javljaju.
English: This leaflet was last revised in .
Croatian: Ova uputa je zadnji puta revidirana u
English: In particular, tell your doctor if you are taking the following:
Croatian: Posebice recite liječniku ako uzimate sljedeće:
English: Children and adolescents below the age of 18 years should not take this medicine because it has not been studied in this age group.
Croatian: Djeca i adolescenti mlađi od 18 godina ne smiju uzimati ovaj lijek jer nije ispitan u ovoj dobnoj skupini.
English: White blood cells help your body to fight infections.
Croatian: Bijele krvne stanice pomažu Vašem tijelu da se bori protiv infekcija.
English: One-sided 97.5% repeated CI (lower limit)
Croatian: Jednostrani 97,5% ponovljeni CI (donja granica)
English: Two-sided 99.24% CI
Croatian: Dvostrani 99,24 % CI
English: 9/L, which would represent
Croatian: 9/L, što bi odgovaralo
English: Brain infection called PML
Croatian: Infekcija mozga nazvana PML
English: Response to Skilarence can be generally seen as early as week 3 and improves over time.
Croatian: Odgovor na Skilarence se općenito može vidjeti već u 3. tjednu i poboljšava se s vremenom.
English: Most patients (91%) were <65 years of age.
Croatian: Većina bolesnika (91 %) bila je u dobi od <65 godina.
English: The only adverse reactions that led to discontinuation of treatment in >5% of patients were gastrointestinal reactions.
Croatian: Jedine nuspojave koje su dovele do prekida liječenja u > 5 % bolesnika bile su gastrointestinalne reakcije.
English: You may not need the maximum dose of 720 mg per day.
Croatian: Moguće je da nećete trebati najvišu dozu od 720 mg dnevno.
English: Talk to your doctor if you think you may have an infection.
Croatian: Obratite se svom liječniku ako mislite da imate infekciju.
English: Take the next dose at the usual time and continue taking the medicine exactly as described in this leaflet or exactly as agreed with your doctor.
Croatian: Uzmite sljedeću dozu u uobičajeno vrijeme i nastavite uzimati lijek točno onako kako je opisano u ovoj uputi ili kako ste dogovorili sa svojim liječnikom.
English: Skilarence may reduce the number of your white blood cells.
Croatian: Skilarence Vam može smanjiti broj bijelih krvnih stanica.
English: How many tablets to take during the day Number of tablets per day
Croatian: Koliko tableta uzeti tijekom dana Broj tableta na dan
English: Skilarence with alcohol
Croatian: Skilarence s alkoholom
English: PML is probably caused by a combination of factors.
Croatian: PML je vjerojatno posljedica kombinacije više čimbenika.
English: The safety and efficacy of Skilarence in paediatric patients below the age of 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka Skilarence u pedijatrijskih bolesnika u dobi ispod 18 godina nisu ustanovljene.
English: Lunch Evening meal
Croatian: Doručak Ručak Večera
English: Take your tablets during or immediately after a meal.
Croatian: Uzmite tablete tijekom ili odmah nakon obroka.
English: Fanconi syndrome
Croatian: Fanconijev sindrom
English: Other medicines and Skilarence
Croatian: Drugi lijekovi i Skilarence
English: Tell your doctor if you have or have had problems with your stomach or intestines.
Croatian: Obratite se liječniku ako imate ili ste imali problema sa želucem ili crijevima.
English: The demographic and baseline characteristics were well balanced between the treatment groups.
Croatian: Demografske i početne karakteristike bile su dobro usklađene između liječenih skupina.
English: Non-clinical safety pharmacology and genotoxicity data reveal no special hazard for humans.
Croatian: Neklinički podaci o sigurnosnoj farmakologiji i genotoksičnosti ne ukazuju na poseban rizik za ljude.
English: You will have blood and urine tests before treatment and then regularly during your treatment to make sure that you are not getting these complications and can continue to take this medicine.
Croatian: Napravit ćete pretrage krvi i urina prije početka liječenja i zatim redovito tijekom liječenja kako bi se uvjerili da nemate takve komplikacije i da možete nastaviti uzimati ovaj lijek.
English: A modified or weakened immune system as well as genetic or environmental factors can also constitute risk factors.
Croatian: Promijenjen ili oslabljen imunosni sustav, kao i genetski ili okolišni čimbenici, također mogu predstavljati rizične čimbenike.
English: If you forget to take Skilarence
Croatian: Ako ste zaboravili uzeti Skilarence
English: Reddening of the face or body (flushing) is a very common side effect which may affect more than 1 in 10 people.
Croatian: Crvenilo lica ili tijela (navale crvenila) je vrlo česta nuspojava koja može zahvatiti više od 1 od 10 osoba.
English: Your doctor will advise you on what care you need to take during Skilarence treatment.
Croatian: Vaš će Vas liječnik savjetovati koje mjere trebate poduzeti tijekom liječenja lijekom Skilarence.
English: To improve tolerability, it is recommended to begin treatment with a low initial dose with subsequent gradual increases.
Croatian: Kako bi se poboljšala podnošljivost, preporučuje se početi liječenje niskom početnom dozom s kasnijim postupnim povećanjem.
English: Symptomatic treatment is indicated in the case of an overdose.
Croatian: Simptomatsko liječenje indicirano je u slučaju predoziranja.
English: What you need to know before you take Skilarence 3.
Croatian: Što morate znati prije nego počnete uzimati Skilarence 3.
English: 3/279 (1.1%) of the patients started on Skilarence.
Croatian: 3/279 (1,1 %) bolesnika koji su počeli primati Skilarence.
English: Use effective methods of contraception to avoid becoming pregnant during treatment with Skilarence (see also “Other medicines and Skilarence” above).
Croatian: Koristite djelotvorne metode kontracepcije kako biste izbjegli trudnoću tijekom liječenja lijekom Skilarence (pogledajte također „Drugi lijekovi i Skilarence“ iznad).
English: Prior to launch of Skilarence in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja lijeka Skilarence u promet u svakoj državi članici, nositelj odobrenja za stavljanje lijeka u promet mora dogovoriti sadržaj i oblik edukacijskog programa, uključujući komunikacijski medij, načine distribucije i sve druge aspekte programa, s nacionalnim regulatornim tijelom.
English: If you take more Skilarence than you should If you think you have taken too many Skilarence tablets, talk to your doctor or pharmacist.
Croatian: Ako uzmete više lijeka Skilarence nego što ste trebali Ako mislite da ste uzeli previše tableta Skilarence obratite se liječniku ili ljekarniku.
English: Summary of clinical efficacy after 16 weeks treatment in Study 1102 Assessment
Croatian: Sažetak kliničke djelotvornosti nakon 16 tjedana liječenja u Ispitivanju 1102 Procjena
English: Psoriasis is a disease causing thickened, inflamed, red areas on the skin, often covered by silvery scales.
Croatian: Psorijaza je bolest koja izaziva zadebljana, upaljena, crvena područja na koži, često pokrivena srebrnastim ljuskama.
English: Dimethyl fumarate works on cells of the immune system (the body's natural defences).
Croatian: Dimetilfumarat djeluje na stanice imunosnog sustava (prirodnu obranu tijela).
English: 9/L or other pathological results are identified.
Croatian: 9/L ili neki druga patološka vrijednost.
English: Progressive multifocal leukoencephalopathy*
Croatian: Progresivna multifokalna leukoencefalopatija*
English: - Dimethyl fumarate or other fumarates.
Croatian: - Dimetilfumarat ili druge fumarate.
English: PML is an opportunistic infection caused by the John-Cunningham virus (JCV) that can be fatal or cause severe disabilities.
Croatian: PML je oportunistička infekcija uzrokovana John-Cunningham virusom (JC virusom) koja može biti smrtonosna ili uzrokovati tešku onesposobljenost.
English: Pharmacotherapeutic group: Other immunosuppressants, ATC code: L04AX07
Croatian: Farmakoterapijska skupina: ostali imunosupresivi, ATK oznaka: L04AX07
English: Your doctor will start your treatment with a low dose (using 30 mg Skilarence tablets).
Croatian: Liječnik će Vaše liječenje započeti niskom dozom (tabletama Skilarence od 30 mg).
English: Do not crush, break, dissolve or chew your tablets, as they have a special coating to help prevent irritation of your stomach.
Croatian: Nemojte drobiti, lomiti, otapati ili žvakati tablete jer imaju posebnu ovojnicu koja pomaže spriječiti iritaciju želuca.
English: The frequency of adverse reactions 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); and not known (cannot be estimated from available data).
Croatian: Učestalost nuspojava definirana je na sljedeći način: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000); i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Skilarence is an immunomodulator and may affect the way the immune system responds to infection.
Croatian: Skilarence je imunomodulator i može utjecati na način odgovora imunosnog sustava na infekciju.