FrancophonIA/ELRC3.0 huggingface dataset:
English: The overall clearance of amifampridine is predominantly due to metabolism by N-acetylation and acetylator phenotype has a greater effect on an individual's metabolism and elimination of amifampridine than does elimination by renal function (See Table 4).
Croatian: Ukupan klirens amifampridina najvećim dijelom ovisi o metabolizmu putem N-acetilacije te fenotip acetilatora ima veći utjecaj na metabolizam i eliminaciju amifampridina u pojedinca nego što ima eliminacija putem bubrežne funkcije (vidjeti tablicu 4).
English: b SGI is a 7-point scale which rates the global impression of the effects of study treatment
Croatian: b SGI je ljestvica od 1 do 7 koja ocjenjuje opći dojam o učincima ispitivanog lijeka (1 = izrazito loš do 7 = izrazito dobar).
English: • Medicines for mental problems (e.g. haloperidol, carbamazapine, chlorpromazine, clozapine)
Croatian: • lijekove za psihičke probleme (primjerice haloperidol, karbamazepin, klorpromazin, klozapin)
English: There are no data on the pharmacokinetics of amifampridine in patients with hepatic impairment (see sections 4.2 and 4.4).
Croatian: Nema podataka o farmakokinetici amifampridina u bolesnika s oštećenjem funkcije jetre (vidjeti dijelove 4.2 i 4.4).
English: Upward dose titration should be discontinued if any adverse reaction or ECG abnormality is observed.
Croatian: Povećanje doze treba prekinuti u slučaju nuspojava ili nepravilnosti u EKG-u.
English: • Medicines to treat Parkinson's disease - anticholinergics (e.g. trihexylphenidyl, mesylate),
Croatian: • lijekove za liječenje Parkinsonove bolesti - antikolinergike (primjerice, triheksilfenidil, mesilat),
English: The concomitant use of amifampridine and medicinal products with cholinergic effects (e.g. direct or indirect cholinesterase inhibitors) may lead to an increased effect of both products and should be taken into consideration.
Croatian: Istodobna uporaba amifampridina i lijekova s kolinergičkim učincima (primjerice izravnih ili neizravnih inhibitora kolinesteraze) može uzrokovati pojačani učinak oba lijeka i to treba uzeti u obzir.
English: In contrast, the 3-N-acetyl metabolite exposure levels were affected to a greater extent by renal impairment than those for amifampridine.
Croatian: Nasuprot tome, na razine izloženosti 3-N-acetil metabolitu oštećenje funkcije bubrega imalo je značajniji utjecaj nego na izloženost amifampridinu.
English: Amifampridine exposure by AUC0-∞ was up to 2-fold higher in slow acetylators and up to 3-fold higher in fast acetylators with severe renal impairment compared to subjects with normal renal function.
Croatian: Izloženost amifampridinu prema AUC0-∞ bila je dvostruko veća u sporih acetilatora i do 3 puta veća u brzih acetilatora s teškim oštećenjem bubrežne funkcije u usporedbi s ispitanicima s normalnom funkcijom bubrega.
English: Table 3: Mean PK Parameters of Amifampridine in Healthy Subjects after Single Oral Doses (5-30mg) in Slow and Fast Acetylator Phenotypes
Croatian: Tablica 3: Srednja vrijednost farmakokinetičkih parametara amifampridina u zdravih ispitanika nakon jednokratnih peroralnih doza (5-30 mg) kod fenotipa brzih i sporih acetilatora
English: Similarly Cmax and AUC0-∞ were greater in the fasted state than in the fed state.
Croatian: Slično tome, Cmax i AUC0-∞ bile su veće nakon uzimanja natašte nego poslije jela.
English: Frequencies were estimated based on a clinical study to evaluate the effects of amifampridine on cardiac repolarization at a single dose of 30 mg or 60 mg in healthy volunteers.
Croatian: Učestalosti su procijenjene na temelju kliničkog ispitivanja za procjenu učinaka amifampridina na repolarizaciju srca u jednokratnoj dozi od 30 mg ili 60 mg u zdravih dobrovoljaca.
English: If you experience any of these symptoms, you should contact your doctor or pharmacist immediately.
Croatian: Ako se pojave ovi simptomi, odmah se obratite svom liječniku ili ljekarniku.
English: Table 2: PK Parameters for Amifampridine in Fed and Fasted Subjects Following Administration of a Single Oral Dose of Amifampridine Phosphate
Croatian: Tablica 2: PK parametri za amifampridin kod uzimanja poslije jela ili natašte nakon primjene jednokratne peroralne doze amifampridin fosfata
English: INFORMATION IN BRAILLE FIRDAPSE
Croatian: 16. PODACI NA BRAILLEOVOM PISMU FIRDAPSE
English: Concomitant diseases
Croatian: Istodobne bolesti
English: It is not known whether FIRDAPSE is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se FIRDAPSE u majčino mlijeko kod ljudi.
English: Exposure by Cmax was marginally affected by renal impairment regardless of acetylation status.
Croatian: Na izloženost prema Cmax oštećenje funkcije bubrega imalo je neznatan utjecaj, neovisno o statusu acetilatora.
English: Potent cytochrome P450 (CYP450) enzyme inhibitors e.g. cimetidine, ketoconazole are not likely to inhibit the metabolism of amifampridine by human N-acetyl-transferase enzymes (NATs) giving rise to increased amifampridine exposure.
Croatian: Tvari koje su potentni inhibitori enzima koji metaboliziraju lijekove (vidjeti dio 5.2) Nije vjerojatno da će potentni inhibitori enzima P450 (CYP450) poput cimetidina i ketokonazola inhibirati metabolizam amifampridina putem humanih enzima N-acetiltransferaza (NAT) što uzrokuje porast izloženosti amifampridinu.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains amifampridine phosphate equivalent to 10 mg of amifampridine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži 10 mg amifampridina u obliku amifampridinfosfata.
English: The pharmacokinetics of amifampridine has been assessed in a single dose Phase I study in patients with renal impairment (see section 5.2).
Croatian: Farmakokinetika amifampridina bila je ocijenjena u ispitivanju faze I primjene jednokratne doze u bolesnika s oštećenjem funkcije bubrega (vidjeti dio 5.2).
English: • Concomitant use with medicinal products with a narrow therapeutic window (see section 4.5)
Croatian: • Istodobna primjena s lijekovima uskog terapijskog raspona (vidjeti dio 4.5).
English: Psychiatric disorders Sleep disorders, anxiety
Croatian: Poremećaji spavanja, anksioznost
English: 1 Adverse reactions reported in a clinical study to evaluate the effects of amifampridine on cardiac repolarization at a single dose of 30 mg or 60 mg in healthy volunteers.
Croatian: 1Nuspojave zabilježene u kliničkom ispitivanju za procjenu učinka amifampridina na repolarizaciju srca u jednokratnoj dozi od 30 mg ili 60 mg u zdravih dobrovoljaca.
English: NAME OF THE MEDICINAL PRODUCT FIRDAPSE 10 mg tablets amifampridine
Croatian: NAZIV LIJEKA FIRDAPSE 10 mg tablete amifampridin
English: Concomitant use of medicinal products with a narrow therapeutic window is contraindicated (see section 4.3).
Croatian: Istodobna primjena s lijekovima uskog terapijskog raspona (vidjeti dio 4.3) je kontraindicirana.
English: • Medicines that may change the electrical activity of your heart (QT-interval prolongation detectable in the electrocardiogram) e.g., sultopride, disopyramide, cisapride, domperidone,
Croatian: • lijekovi koji mogu promijeniti električnu aktivnost Vašeg srca (produljeni QT-interval - može se otkriti elektrokardiogramom), npr. sultoprid, dizopiramid, cisaprid, domperidon, rifampicin i ketokonazol (pogledajte „Nemojte uzimati FIRDAPSE“)
English: The primary endpoints were change from baseline (CFB) in Patient Global Impression (SGI) and Quantitative Myasthenia Gravis (QMG) score at Day 4.
Croatian: Mjere primarnog ishoda bili su promjena u odnosu na početnu vrijednost (engl. change from baseline, CFB) na ljestvici općeg dojma bolesnika (subject global impression, SGI) i kvantitativnoj ljestvici miastenije gravis (engl. quantitative myasthenia gravis, QMG) na dan 4. Mjera sekundarnog ishoda djelotvornosti bila je promjena u općem kliničkom dojmu poboljšanja u odnosu na početnu vrijednosti (engl. clinical global impression - improvement, CGI-I) na dan 4, koju su odredili nadležni liječnici.
English: Medicinal products with cholinergic effects
Croatian: Lijekovi s kolinergičkim učincima
English: Medicinal products with atropinic effects include tricyclic anti-depressants, most H1 atropinic anti-histamines, anticholinergic,
Croatian: Lijekovi s atropinskim učincima uključuju tricikličke antidepresive, većinu H1 atropinskih antihistaminika, antikolinergika, lijekova protiv Parkinsonove bolesti, atropinskih antispazmodika, dizopiramida, fenotiazinskih neuroleptika i klozapina.
English: A double-blind, placebo-controlled, randomized withdrawal Study to evaluate the efficacy and safety of amifampridine phosphate in Patients with LEMS was conduct in adult patients 18 years of age or older (n=26).
Croatian: Dvostruko slijepo, randomizirano placebom kontrolirano ispitivanje s prekidom uzimanja lijeka bilo je provedeno u odraslih bolesnika s LEMS-om u dobi od 18 i više godina (n = 26) radi ocjene djelotvornosti i sigurnosti amifampridinfosfata.
English: If you have any doubts, ask your doctor or pharmacist for advice.
Croatian: Ako niste sigurni, obratite se za savjet svom liječniku ili ljekarniku.
English: Table 4: Mean PK Parameters of Amifampridine in Normal and Renal Impaired Subjects after Single Oral Dose Administration (10mg) in Slow and Fast Acetylator Phenotypes
Croatian: Tablica 4: Srednje vrijednosti farmakokinetičkih parametara amifampridina u ispitanika s normalnom i oštećenom funkcijom bubrega nakon primjene jednokratne peroralne doze (10 mg) kod fenotipa sporih i brzih acetilatora
English: • Liver problems
Croatian: • poteškoće s jetrom
English: Upward dose titration should be discontinued if any adverse reaction occurs (see section 4.2).
Croatian: Ako se javi bilo koja nuspojava, titriranje doze naviše treba prekinuti (vidjeti dio 4.2).
English: AUC0-∞ (ng·hr/ml) Mean (S.D.), range
Croatian: AUC0-∞ (ng·hr/ml) srednja vrijednost (S.D.), raspon
English: FIRDAPSE should be used with caution in patients with renal or hepatic impairment.
Croatian: FIRDAPSE treba primijeniti s oprezom u bolesnika s oštećenjem funkcije bubrega ili jetre.
English: For patients with mild impairment of renal or hepatic function, a starting dose of 10 mg amifampridine (5 mg twice a day) per day is recommended.
Croatian: U bolesnika s blagim oštećenjem funkcije bubrega ili jetre preporučuje se početna doza od 10 mg (5 mg dvaput na dan) amifampridina dnevno.
English: (ng/ml) mean (S.D.), range
Croatian: (ng/ml) srednja vrijednost (S.D.), raspon
English: Mean (SD) p-valuee a
Croatian: Rezultati CGI-I-ac Srednja vrijednost (SD) p-vrijednoste a
English: Non depolarising muscle relaxant acting medicinal products The concomitant use of amifampridine and medicinal products with non-depolarising muscle relaxant effects (e.g. mivacurium, pipercurium) may lead to a decreased effect of both products and should be taken into consideration.
Croatian: Lijekovi koji djeluju kao nedepolarizirajući miorelaksansi Istodobna primjena amifampridina i lijekova s učincima nedepolarizirajućih miorelaksansa (primjerice mivakurij, piperkurij) može uzrokovati smanjeni učinak oba lijeka i to treba uzeti u obzir.
English: Patients with recent use of immunomodulatory therapies (e.g., azathioprine, mycophenolate, cyclosporine), rituximab, intravenous immunoglobulin G, and plasmapheresis were excluded from the study.
Croatian: ciklosporin), rituksimab, intravenski imunoglobulin G ili bili podvrgnuti plazmaferezi isključeni su iz ispitivanja.
English: • Medicines to relax your muscles - (e.g. mivacurium, pipercurium, suxamethonium)
Croatian: • lijekove za opuštanje mišića - (primjerice, mivakurij, piperkurij, suksametonij)
English: For patients with mild liver or kidney problems a starting dose of 10 mg (5 mg twice a day) FIRDAPSE daily is recommended.
Croatian: U bolesnika s blagim problemima s bubrezima ili jetrom preporučuje se početna doza od 10 mg lijeka FIRDAPSE dnevno (5 mg dvaput na dan).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains amifampridine phosphate equivalent to 10 mg of amifampridine.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 10 mg amifampridina u obliku amifampridinfosfata.
English: CGI-I Scoresc
Croatian: I DOHVATA DJECE
English: Depolarising muscle relaxant acting medicinal products The concomitant use of amifampridine and medicinal products with depolarising muscle relaxant effects (e.g. suxamethonium) may lead to a decreased effect of both products and should be taken into consideration.
Croatian: Lijekovi koji djeluju kao depolarizirajući miorelaksansi Istodobna primjena amifampridina i lijekova s učincima depolarizirajućih miorelaksansa (primjerice suksametonij) može uzrokovati smanjeni učinak oba lijeka i to treba uzeti u obzir.
English: Table 1 below lists the adverse reactions reported with amifampridine.
Croatian: Nuspojave prijavljene s amifampridinom navedene su u Tablici 1 u nastavku:
English: Mean 3-N-acetyl Amifampridine PK Parameters
Croatian: Srednje vrijednosti farmakokinetičkih parametara 3-N-acetil amifampridina
English: Please see section 5.2 for further information about bioavailability of amifampridine in the fed and fasted state.
Croatian: Za dodatne informacije o bioraspoloživosti amifampridina nakon jela i natašte vidjeti dio 5.2.
English: • A history of fits (convulsions)
Croatian: • nekada ste imali napadaje (konvulzije)
English: • Blurred vision
Croatian: • zamagljeni vid
English: Each tablet contains amifampridine phosphate equivalent to 10 mg of amifampridine.
Croatian: Jedna tableta sadrži 10 mg amifampridina u obliku amifampridinfosfata.
English: Mean Amifampridine PK Parameters
Croatian: Srednje vrijednosti farmakokinetičkih parametara amifampridina
English: Slow
Croatian: Spori
English: BioMarin International Limited Shanbally, Ringaskiddy, Co. Cork, P43 R298 Ireland
Croatian: BioMarin International Limited Shanbally, Ringaskiddy, Co.
English: Tabulated list of adverse reactions
Croatian: Tabelarni prikaz nuspojava
English: Renal Status
Croatian: Status funkcije bubrega
English: Fasted (N=45) 59.1 (34.4), 16-137 117 (76.6), 22.1-271 0.637 (0.247), 0.25-1.5 2.5 (0.73), 1.23-4.31
Croatian: Cmax (ng/ml) 7,65 38,6 Tmax (h) t1/2 (h)
English: FIRDAPSE should be used with caution in patients with liver or kidney problems.
Croatian: U bolesnika s oštećenjem bubrega ili jetre FIRDAPSE treba primijeniti s oprezom.
English: Amifampridi ne Dose (mg) Subjects (N) Acetylator Phenotype
Croatian: Srednja vrijednost farmakokinetičkih parametara amifampridina AUC0-t (ng*hr/ml)
English: Calcium stearate
Croatian: Fenotip acetilatora Brzi
English: Proposed review period: Materials will be reviewed annually.
Croatian: Predloženo razdoblje pregleda: Materijali će se pregledavati jednom godišnje.
English: What are the symptoms?
Croatian: Koji su simptomi?
English: • if you are seriously overweight (especially if you are a woman)
Croatian: • ako ste ozbiljno pretili (posebice ako ste žena)
English: It is very important that you read and understand the information about this serious reaction.
Croatian: Vrlo je važno da je pročitate i razumijete informacije o toj ozbiljnoj reakciji.
English: Who gets these reactions?
Croatian: Tko može zadobiti ovakve reakcije?
English: See sections 4.4 and 4.8.
Croatian: Vidjeti dijelove 4.4 i 4.8.
English: WARNING!
Croatian: UPOZORENJE!
English: If you do, within hours, your blood pressure could fall dangerously low, which could result in death.
Croatian: Ako to učinite, već unutar nekoliko sati krvni tlak Vam može pasti opasno nisko, što može uzrokovati smrt.
English: The remainder is eliminated in the faeces.
Croatian: Ostatak se eliminira fecesom.
English: Week 4 (n = 166)
Croatian: 4. tjedan (n = 166)
English: Swallow the tablets whole, with some water.
Croatian: Tabletu progutajte cijelu s malo vode.
English: When do these reactions happen?
Croatian: Kada se javljaju ovakve reakcije?
English: Currently available data are described in section 4.8, 5.1 and 5.2 but no recommendation on posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 4.8, 5.1. i 5.2, međutim ne mogu se dati preporuke o doziranju.
English: • if they have been taking combination therapy for a long time
Croatian: • ako su uzimali kombiniranu terapiju kroz duže razdoblje
English: So it is very important to talk to your doctor about any changes in your health.
Croatian: Zato je vrlo važno da svog liječnika obavijestite o svim promjenama svog zdravstvenog stanja.
English: Date of latest renewal: 17 November 2014
Croatian: Datum posljednje obnove odobrenja: 17. studenog 2014.
English: These reactions have often been transitory.
Croatian: Ti su događaji često bili prolazni.
English: • difficulty in sleeping (insomnia)
Croatian: • teškoće pri spavanju (nesanica)
English: Kivexa is not recommended for use during pregnancy.
Croatian: Kivexa se ne preporučuje za primjenu tijekom trudnoće.
English: The educational material includes 3 model case studies to demonstrate different clinical scenarios and their management.
Croatian: Edukacijski materijali uključuju 3 primjera prikaza slučaja kako bi se prikazali različiti klinički scenariji i njihovo zbrinjavanje.
English: Genotypic SS in OBT
Croatian: Genotipska SS u OBT
English: Risk of heart attack
Croatian: Rizik od srčanog napada
English: What Kivexa is and what it is used for
Croatian: Što je Kivexa i za što se koristi
English: • if they are also taking anti-inflammatory medicines called corticosteroids
Croatian: • ako također uzimaju protuupalne lijekove zvane kortikosteroidi
English: In vivo resistance
Croatian: In vivo rezistencija
English: You need to keep taking it every day to stop your illness getting worse.
Croatian: Uvijek nastojte uzimati terapiju svakodnevno, kako se bolest ne bi pogoršala.
English: A similar effect was not seen in rats even at very high systemic exposure.
Croatian: Sličan učinak nije uočen u štakora čak niti pri izuzetno visokoj sistemskoj izloženosti.
English: Precautions to prevent transmission should be taken in accordance with national guidelines.
Croatian: Mjere opreza za sprječavanje prijenosa bolesti moraju se poduzeti u skladu s nacionalnim smjernicama.
English: You may need extra check-ups, including blood tests, while you are taking your medicine.
Croatian: Možda ćete trebati dodatne pretrage, uključujući krvne pretrage, dok uzimate terapiju.
English: Kivexa can be taken with or without food.
Croatian: Kivexa se može uzimati s ili bez hrane.
English: Your methadone dose may need to be changed.
Croatian: Vaša doza metadona će se trebati prilagoditi.
English: Old infections may flare up
Croatian: Stare infekcije mogu se razbuktati
English: • methadone, used as a heroin substitute.
Croatian: • metadon, koji se koristi kao nadomjesna terapija za heroin.
English: Component of a multipack, not to be sold separately
Croatian: Sastavni dio višestrukog pakiranja, nije za prodaju odvojeno
English: You may still develop other infections and illnesses linked to HIV infection.
Croatian: No, i dalje možete razviti druge infekcije ili bolesti povezane s HIV infekcijom.
English: The list below should not be considered exhaustive but is representative of the classes studied.
Croatian: Niže navedena lista ne bi trebala označavati i krajnji popis, već ona predstavlja reprezentativan popis prema klasama studija.
English: (Inhibition of alcohol dehydrogenase)
Croatian: (inhibicija alkoholdehidrogenaze)
English: Conclusions supported non-inferiority regardless of analysis method.
Croatian: Zaključci su potvrdili neinferiornost neovisno o metodi analize.
English: You should have been tested for this gene before Kivexa was prescribed for you.
Croatian: Trebali ste biti testirani na taj gen prije nego što Vam je Kivexa propisana.
English: Tell your doctor if you have heart problems, if you smoke, or have other illnesses that may increase your risk of heart disease such as high blood pressure, or diabetes.
Croatian: Obavijestite svog liječnika ako imate problema sa srcem, ako pušite ili imate druge bolesti koje mogu povisiti rizik za srčanu bolest kao što su visoki krvni tlak ili dijabetes.
English: Methadone: CL/F ↑22%
Croatian: metadon: CL/F ↑22%
English: Ask your doctor or pharmacist for advice.
Croatian: Upitajte svog liječnika ili ljekarnika za savjet.
English: Unknown 8/14 (57%) 6/14 (43%) 2/14 (14%) 0 All
Croatian: Nepoznato 8/14 (57%) 6/14 (43%) 2/14 (14%) 0 Svi
English: • weakness beginning in the hands and feet and moving up towards the trunk of the body
Croatian: • slabost koja počinje u šakama i stopalima i širi se prema trupu.
English: Other medicines and Kivexa
Croatian: Drugi lijekovi i Kivexa
English: • if their immune systems are very weak
Croatian: • ako im je imunološki sustav vrlo oslabljen
English: ATC code: J05AR02.
Croatian: ATK šifra: J05AR02
English: CD4 cells are a type of white blood cells that are important in helping your body to fight infection.
Croatian: CD4 stanice su vrsta bijelih krvnih stanica koje imaju važnu ulogu pomaganja Vašem organizmu u obrani od infekcije.
English: Criteria to be used to verify the success of proposed risk minimisation activity: Implementation of the education program will be monitored by the MAH via auditing.
Croatian: Kriteriji koji će se koristiti za provjeru uspjeha mjere minimalizacije rizika: Implementacija edukacijskog programa će se pratiti kroz revizije od strane nositelja odobrenja.
English: Not everyone responds to treatment with Kivexa in the same way.
Croatian: Ne odgovaraju svi bolesnici na liječenje lijekom Kivexa na isti način.
English: Like all medicines, this medicine can cause side effects, although not everyone gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: If you take more Kivexa than you should
Croatian: Ako uzmete više lijeka Kivexa nego što ste trebali
English: From these results, it can be concluded with 95% confidence that the true difference is no greater than 8.4% in favour of the twice daily regimen.
Croatian: Iz tih rezultata može se zaključiti s 95%-tnom vjerojatnošću (CI) da stvarna razlika nije veća od 8,4% u korist doziranja dvaput na dan.
English: The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection.
Croatian: Simptomi autoimunih poremećaja mogu se razviti i više mjeseci nakon što počnete uzimati lijek za liječenje HIV infekcije.
English: Clinically significant interaction unlikely.
Croatian: Klinički značajna interakcija je malo vjerojatna.
English: While the clinical relevance of these findings is unknown, these data suggest that a carcinogenic risk to humans is outweighed by the potential clinical benefit.
Croatian: Iako klinički značaj ovih rezultata nije poznat, ovi podaci ukazuju da potencijalna klinička dobrobit nadmašuje kancerogeni rizik za ljude.
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Croatian: HIV virus možete prenijeti čak i dok uzimate ovaj lijek, iako je rizik smanjen zbog učinkovite antiretrovirusne terapije.
English: Kivexa does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level.
Croatian: Kivexa ne liječi u potpunosti infekciju HIV-a, već smanjuje količinu virusa u Vašem tijelu i održava je na niskoj razini.
English: The recommended dose of Kivexa is one tablet once daily.
Croatian: Preporučena doza lijeka Kivexa je jedna tableta jedanput na dan.
English: Your doctor will check whether your symptoms were related to a hypersensitivity reaction.
Croatian: Liječnik će provjeriti jesu li Vaši simptomi povezani s reakcijom preosjetljivosti.
English: Such infections may have been “silent” and not detected by the weak immune system before treatment was started.
Croatian: Takve su infekcije možda bile ''tihe'' pa ih oslabljen imunološki sustav nije prepoznao prije početka liječenja.
English: Children Under 25 kg:
Croatian: Djeca tjelesne težine manje od 25 kg:
English: Indeed, the available clinical data are very limited and preclude any reliable conclusion in the field.
Croatian: Štoviše, dostupni klinički podaci su vrlo ograničeni i ne dozvoljavaju nikakav pouzdan zaključak.
English: Detach this card and keep it with you at all times.
Croatian: Odvojite tu karticu i uvijek je nosite sa sobom.