FrancophonIA/ELRC3.0 huggingface dataset:
English: Stable or improved CTP score b,d
Croatian: Srednja vrijednost promjene od početne vrijednosti (log10 kopija/ml)c Stabilan ili poboljšan CTP indeksb,d
English: n
Croatian: f
English: Among entecavir-treated nucleoside naive patients, post-treatment exacerbations had a median time to onset of 23-24 weeks, and most were reported in HBeAg negative patients (see section 4.8).
Croatian: Kod bolesnika liječenih entekavirom prethodno neliječenih analozima nukleozida, egzacerbacije nakon prestanka liječenja nastupile su nakon medijana od 23-24 tjedna, a većina je bila prijavljena u
English: Nervous system disorders: common : headache, dizziness, somnolence Gastrointestinal disorders: common : vomiting, diarrhoea, nausea, dyspepsia Hepatobiliary disorders: common : increased transaminases Skin and subcutaneous tissue disorders: uncommon : rash, alopecia General disorders and administration site conditions: common : fatigue
Croatian: : povraćanje, proljev, mučnina, dispepsija Poremećaji žuči i jetre: često
English: The entecavir-TP Ki for HBV DNA
Croatian: Razine ALT-a i HBV
English: B. PACKAGE LEAFLET
Croatian: Tablični prikaz nuspojava
English: Moderate
Croatian: liječeni
English: This is important because
Croatian: Teško,
English: NA
Croatian: stanju
English: UNIQUE IDENTIFIER - 2D BARCODE 18.
Croatian: 16. PODACI NA BRAILLEOVOM PISMU 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD 18. JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM
English: The active substance is entecavir.
Croatian: Djelatna tvar je entekavir.
English: Difference (95 % CI)
Croatian: Razlika (95% CI)
English: Elderly (≥65 years)
Croatian: Starije osobe (≥65 godina)
English: Complete response Overall
Croatian: Potpuni odgovor Ukupno
English: What IVEMEND is and what it is used for
Croatian: Što je IVEMEND i za što se koristi
English: Acute phase§§
Croatian: Akutna faza§§
English: C]-aprepitant.
Croatian: C]-aprepitanta.
English: Pack sizes: 1 or 10 vials.
Croatian: Veličine pakiranja: 1 ili 10 bočica.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
Croatian: DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA
English: Complete response† Delayed phase‡ Complete response† Overall§
Croatian: Potpuni odgovor† Kasnija faza‡ Potpuni odgovor† Ukupno§
English: From a microbiological point of view, the medicinal product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek se treba odmah primijeniti.
English: Your doctor may therefore have to monitor the condition of your liver.
Croatian: Vaš liječnik će zbog toga možda morati pratiti stanje
English: The safety profile of aprepitant was evaluated in approximately 6,500 adults and 184 children and adolescents.
Croatian: Sigurnosni profil aprepitanta procijenjen je u oko 6500 odraslih osoba i 184 djece i adolescenata.
English: Other medicines and IVEMEND
Croatian: Drugi lijekovi i IVEMEND
English: Aprepitant undergoes extensive metabolism.
Croatian: Aprepitant podliježe opsežnom metabolizmu.
English: Other side effects that have been reported are listed below.
Croatian: Ostale prijavljene nuspojave navedene su niže.
English: This effect was not considered clinically important.
Croatian: Ovo se djelovanje nije smatralo klinički značajnim.
English: NR = Not Reported
Croatian: NZ = nije zabilježeno
English: Do not give IVEMEND to children under 6 months of age or who weigh less than 6 kg, because it has not been studied in this population.
Croatian: Nemojte davati IVEMEND djeci mlađoj od 6 mjeseci ili djeci tjelesne težine manje of 6 kg jer nije ispitan u ovoj populaciji.
English: If you are pregnant or breast-feeding, may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine.
Croatian: Ako ste trudni ili dojite, mogli biste biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: Relationship between concentration and effect
Croatian: Odnos između koncentracije i djelovanja lijeka
English: **N: Number of adult patients included in the primary analysis of complete response.
Croatian: **N: Broj odraslih bolesnika uključenih u primarnu analizu potpunog odgovora.
English: Date of first authorisation: 11 January 2008 Date of latest renewal: 11 January 2013
Croatian: Datum prvog odobrenja: 11. siječnja 2008.
English: The brain has a specific area that controls nausea and vomiting.
Croatian: Mozak ima određeno područje koje kontrolira mučninu i povraćanje.
English: Before treatment with this medicine, tell your doctor if you have liver disease because the liver is important in breaking down the medicine in the body.
Croatian: Prije liječenja ovim lijekom recite svom liječniku ako imate bolest jetre jer je jetra vrlo važna za razgradnju lijeka u tijelu.
English: The safety and efficacy of IVEMEND in infants below 6 months of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka IVEMEND u dojenčadi mlađe od 6 mjeseci nisu ustanovljene.
English: Do not throw away any medicines via wastewater or house hold waste.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: For information regarding birth control, see ‘Other medicines and IVEMEND'.
Croatian: Za informacije o kontroli začeća, vidjeti dio „Drugi lijekovi i IVEMEND“.
English: White to off-white amorphous powder.
Croatian: Bijeli do bjelkasti amorfni prašak.
English: What you need to know before you use IVEMEND
Croatian: Što trebate znati prije nego počnete primjenjivati IVEMEND
English: This medicine should not be used during pregnancy unless clearly necessary.
Croatian: Ovaj lijek se ne smije uzimati u trudnoći, osim ako je to nužno.
English: Swirl the vial gently.
Croatian: Kružnim pokretima nježno zavrtite bočicu.
English: P-Value
Croatian: P-vrijednost
English: Please talk to your doctor or pharmacist if you are taking any of the following medicines:
Croatian: Obavijestite svog liječnika ako uzimate bilo koji od slijedećih lijekova:
English: The first 2 numbers indicate the month; the next 4 numbers indicate the year.
Croatian: Prve dvije znamenke odnose se na mjesec, a druge četiri na godinu.
English: Frequencies are defined as: 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) and very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Nuspojave su razvrstane prema učestalosti pojavljivanja, definiranoj kao: 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) te nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Occupancy of brain NK1 receptors, in this study, correlate well with aprepitant plasma concentrations.
Croatian: Zaokupljenost NK1 receptora u mozgu, u ovom ispitivanju, je dobro povezana s koncentracijom aprepitanta u plazmi.
English: If signs or symptoms of local irritation occur, the injection or infusion should be terminated and restarted in another vein.
Croatian: Pojave li se znakovi ili simptomi lokalne iritacije, treba prekinuti davanje infuzije i ponovno započeti infuziju u drugu venu.
English: The contribution of fosaprepitant to the overall antiemetic effect has not fully been characterised, but a transient contribution during the initial phase cannot be ruled out.
Croatian: Nije još potpuno utvrđen doprinos fosaprepitanta ukupnom antiemetičkom djelovanju, ali se ne može isključiti privremeni doprinos u početnoj fazi.
English: Do not use IVEMEND:
Croatian: Nemojte primjenjivati IVEMEND
English: For short term treatment, these findings are considered unlikely to be clinically relevant.
Croatian: Za kratkotrajno liječenje, malo je vjerojatno da su ovi nalazi klinički značajni.
English: IVEMEND 150 mg is given as part of a combination therapy (see section 4.2).
Croatian: IVEMEND 150 mg primjenjuje se kao dio kombiniranog liječenja (vidjeti dio 4.2).
English: *Reported in patients taking a higher dose of aprepitant.
Croatian: *Prijavljeno u bolesnika koji su uzimali više doze aprepitanta.
English: The efficacy of fosaprepitant was evaluated based on the primary and secondary endpoints listed in Table 8 and was shown to be superior to the control regimen with regard to complete response in the delayed and overall phases.
Croatian: Djelotvornost fosaprepitanta bila je procijenjena na temelju primarnih i sekundarnih mjera ishoda navedenih u Tablici 8 i pokazalo se da je superiorna djelotvornosti kontrolnog režima u pogledu potpunog odgovora u kasnijoj fazi i ukupno svim fazama.
English: **N: Number of adult patients included in the intention to treat population.
Croatian: **N: Broj odraslih bolesnika uključenih u populaciju predviđenu za liječenje.
English: Although a 32 mg intravenous dose of ondansetron was used in clinical trials, this is no longer the recommended dose.
Croatian: Premda se doza od 32 mg ondanzetrona primijenjenog intravenski koristila u kliničkim ispitivanjima, to više nije preporučena doza.
English: There were no treatment-related effects on mating, fertility or embryonic/foetal survival, and no pathological changes in the reproductive organs.
Croatian: Nije bilo učinaka povezanih s liječenjem na parenje, plodnost ili embrionalno/fetalno preživljavanje, te nisu zabilježene patološke promjene na reproduktivnim organima.
English: What IVEMEND is and what it is used for What you need to know before you use IVEMEND How to use IVEMEND
Croatian: Što je IVEMEND i za što se koristi Što morate znati prije nego počnete primjenjivati IVEMEND Kako primjenjivati IVEMEND Moguće nuspojave
English: Gently invert the bag 2-3 times (see ‘How to use IVEMEND').
Croatian: Nježno 2-3 puta preokrenite vrećicu (vidjeti dio 3. „Kako primjenjivati IVEMEND“).
English: If necessary, for volumes less than 150 ml, the calculated volume can be transferred to an appropriate size bag or syringe prior to administration by infusion.
Croatian: Ako je potrebno, za volumene manje od 150 ml, izračunati volumen može se prije primjene infuzijom prenijeti u vrećicu ili štrcaljku odgovarajuće veličine.
English: Talk to your doctor, pharmacist, or nurse before using IVEMEND.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite IVEMEND.
English: It belongs to a group of medicines called "neurokinin 1 (NK1) receptor antagonists".
Croatian: Pripada skupini lijekova nazvanih „antagonisti neurokinin 1 (NK1) receptora“.
English: IVEMEND works by blocking signals to that area, thereby reducing nausea and vomiting.
Croatian: IVEMEND djeluje tako da blokira signale koji odlaze u to područje mozga, čime smanjuje mučninu i povraćanje.
English: There were no margins to clinically relevant exposure of aprepitant.
Croatian: Nije bilo granica za klinički značajnu izloženost aprepitantu.
English: IVEMEND should not be used during pregnancy unless clearly necessary.
Croatian: IVEMEND se ne smije uzimati u trudnoći, osim ako to nije nužno.
English: Upon conversion of
Croatian: Nakon pretvorbe
English: Aprepitant cannot be removed by haemodialysis.
Croatian: Aprepitant se ne može ukloniti hemodijalizom.
English: The estimated time to first emesis is depicted by the Kaplan-Meier plot in Figure 1.
Croatian: Procijenjeno vrijeme do prvog povraćanja prikazano je Kaplan-Meierovom krivuljom na Slici 1.
English: Pharmacotherapeutic group: Antiemetics and antinauseants, ATC code: A04AD12.
Croatian: Farmakoterapijska skupina: Antiemetici i pripravci za suzbijanje mučnine, ATK oznaka: A04AD12
English: If you get dizzy or get sleepy, avoid driving or using machines after using this medicine (see ‘Possible side effects').
Croatian: Ako osjetite omaglicu ili pospanost nakon što primite ovaj lijek, izbjegavajte upravljanje vozilima i rad sa strojevima (vidjeti dio „Moguće nuspojave“).
English: IVEMEND can affect other medicines both during and after treatment with IVEMEND.
Croatian: IVEMEND može utjecati na djelovanje drugih lijekova i u vrijeme i nakon liječenja.
English: Data are lacking regarding effects on CYP2C8 and CYP2C19.
Croatian: Nema dovoljno podataka o učincima na CYP2C8 i CYP2C19.
English: *Nausea and vomiting were efficacy parameters in the first 5-days of post-chemotherapy treatment and were reported as adverse reactions only thereafter.
Croatian: *Mučnina i povraćanje uzeti su kao parametri djelotvornosti u prvih pet dana nakon kemoterapije, a tek nakon toga su prijavljeni kao nuspojave.
English: Tell your doctor if you are taking these medicines since the treatment must be modified before you start using IVEMEND.
Croatian: Obavijestite svog liječnika ako uzimate ove lijekove jer je potrebno prilagoditi liječenje prije nego što počnete uzimati IVEMEND.
English: Your doctor may ask you to take other medicines including a corticosteroid (such as dexamethasone) and a ‘5HT3 antagonist' (such as ondansetron) for preventing nausea and vomiting.
Croatian: Liječnik može tražiti da uzimate druge lijekove uključujući kortikosteroide (kao što je deksametazon) i „antagoniste 5-HT3“ (kao što je ondanzetron) za sprečavanje mučnine i povraćanja.
English: What IVEMEND looks like and contents of the pack IVEMEND is a white to off-white powder for solution for infusion.
Croatian: Kako IVEMEND izgleda i sadržaj pakiranja IVEMEND je bijeli do bjelkasti prašak za otopinu za infuziju.
English: Adults The entire volume of the prepared infusion bag (150 ml) should be administered.
Croatian: Odrasli Primjenjuje se cjelokupni volumen pripremljene vrećice za infuziju (150 ml).
English: A population pharmacokinetic analysis of aprepitant in paediatric patients (aged 6 months through 17 years) suggests that gender and race have no clinically meaningful effect on the pharmacokinetics of aprepitant.
Croatian: Populacijska farmakokinetička analiza aprepitanta u pedijatrijskih bolesnika (u dobi od 6 mjeseci do 17 godina) ukazuje na to da spol i rasa nemaju klinički značajan učinak na farmakokinetiku aprepitanta.
English: Fosaprepitant does not seem to interact with the P-glycoprotein transporter, as demonstrated by the lack of interaction of oral aprepitant with digoxin.
Croatian: Fosaprepitant ne ulazi u interakciju s transporterom P-glikoproteina, na što ukazuje nedostatak interakcije peroralnog aprepitanta s digoksinom.
English: 80 mg intravenously OR 80 mg orally (EMEND capsules)
Croatian: 80 mg intravenski ILI 80 mg peroralno (EMEND kapsule)
English: 1-Day Regimen of Fosaprepitant in Adults
Croatian: Jednodnevni režim fosaprepitanta u odraslih
English: Standard dose of 5-HT3 antagonists.
Croatian: Standardna doza 5-HT3 antagonista.
English: In children and adolescents (6 months to 17 years of age), the recommended dose of IVEMEND is based on the patient's age and weight.
Croatian: U djece i adolescenata (u dobi od 6 mjeseci do 17 godina), preporučena doza lijeka IVEMEND temelji se na dobi i tjelesnoj težini bolesnika.
English: The effects of IVEMEND or other medicines might be influenced if you take IVEMEND together with other medicines including those listed below.
Croatian: Djelovanje lijeka IVEMEND ili drugih lijekova može se promijeniti ako uzimate IVEMEND zajedno s drugim lijekovima, uključujući sljedeće lijekove.
English: These hypersensitivity reactions have generally responded to discontinuation of the infusion and administration of appropriate therapy.
Croatian: Te su se reakcije preosjetljivosti obično povukle nakon prekida infuzije i primjene odgovarajuće terapije.
English: It is not recommended to reinitiate the infusion in patients who experience hypersensitivity reactions.
Croatian: Nije preporučljivo ponovno započinjati infuziju u bolesnika u kojih je nastupila reakcija preosjetljivosti.
English: Paediatric patients 12 years and older
Croatian: Pedijatrijski bolesnici u dobi od 12 godina i stariji
English: Delayed phase No vomiting Overall
Croatian: Kasnija faza Bez povraćanja
English: The safety profile of fosaprepitant in adult and paediatric patients was generally similar to that observed with aprepitant.
Croatian: Sigurnosni profil fosaprepitanta u odraslih i pedijatrijskih bolesnika uglavnom je bio sličan onom opaženom za aprepitant.
English: †Difference and confidence interval (CI) were calculated using the method proposed by Miettinen and Nurminen and adjusted for gender.
Croatian: Razlika i interval pouzdanosti (CI) izračunati su pomoću metode po Miettinenu i Nurminenu i prilagođene prema spolu.
English: Rifampicin decreased the mean terminal half-life of oral aprepitant by 68 %.
Croatian: Rifampicin je skratio srednji terminalni poluvijek peroralnog aprepitanta za 68%.
English: The pharmacological effect of fosaprepitant is attributed to aprepitant.
Croatian: Farmakološki učinak fosaprepitanta pripisuje se aprepitantu.
English: IVEMEND may have minor influence on the ability to drive and use machines.
Croatian: IVEMEND može malo utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: CYP3A4 interactions
Croatian: Interakcije s izoenzimima CYP3A4
English: However, it should be noted that the value of the toxicity studies carried out with rodents, rabbits and monkeys, including the reproduction toxicity studies, are limited since systemic exposures to fosaprepitant and aprepitant were only similar or even lower than therapeutic exposure in adult humans.
Croatian: Treba, međutim, istaknuti da je vrijednost istraživanja toksičnosti u glodavaca, kunića i majmuna, uključujući i reproduktivnu toksičnost, ograničena jer je sistemska izloženost fosaprepitantu i aprepitantu bila tek slična ili čak i niža od terapijske izloženosti u odraslih ljudi.
English: In adults (18 years of age and older), the recommended dose of IVEMEND is 150 mg fosaprepitant on Day 1 (day of chemotherapy).
Croatian: U odraslih (u dobi od 18 godina i starijih), preporučena doza lijeka IVEMEND je 150 mg fosaprepitanta 1. dana (dan kemoterapije).
English: • Volume to administer (ml) equals the recommended dose (mg)
Croatian: • volumen koji će se primijeniti (ml) jednak je preporučenoj dozi (mg)
English: Aprepitant is a selective high-affinity antagonist at human substance P neurokinin 1 (NK1) receptors.
Croatian: Aprepitant je u ljudi selektivan antagonist visokog afiniteta za ljudski receptor neurokinina 1 (NK1) supstancije P.
English: Stop taking IVEMEND and see a doctor immediately if you notice any of the following side effects, which may be serious, and for which you may need urgent medical treatment: - Hives, rash, itching, difficulty breathing or swallowing, or a serious decrease of blood pressure (frequency not known, cannot be estimated from the available data); these are signs of a serious allergic reaction.
Croatian: Prestanite uzimati IVEMEND i odmah posjetite liječnika ako primjetite bilo koju od sljedećih nuspojava, koje bi mogle biti ozbiljne, i za koje ćete možda trebati hitnu medicinsku pomoć: - koprivnjača, osip, svrbež, otežano disanje ili gutanje ili ozbiljan pad krvnog tlaka (učestalost nepoznata, ne može se procijeniti iz dostupnih podataka); ovo su znakovi ozbiljne alergijske reakcije.
English: The metabolism of aprepitant occurs largely via oxidation at the morpholine ring and its side chains and the resultant metabolites were only weakly active.
Croatian: Aprepitant se pretežno metabolizira oksidacijom na morfolinskom prstenu i njegovim postraničnim lancima, a nastali metaboliti su pokazali tek slabu aktivnost.
English: There are no clinical or pharmacokinetic data in patients with severe hepatic impairment (Child-Pugh class C).
Croatian: Nema kliničkih niti farmakokinetičkih podataka o bolesnicima s teškim oštećenjem funkcije jetre (Child-Pugh stadij C).
English: Efficacy data in combination with other corticosteroids and 5-HT3 antagonists are limited.
Croatian: Saznanja o djelotvornosti pri istodobnoj primjeni s drugim kortikosteroidima i antagonistima 5-HT3 su ograničena.
English: For additional information on the co-administration with corticosteroids, see section 4.5.
Croatian: Za više podataka o istodobnoj primjeni s kortikosteroidima vidjeti dio 4.5.
English: Furthermore, fosaprepitant underwent rapid and nearly complete conversion to aprepitant in S9 preparations from other human tissues including kidney, lung and ileum.
Croatian: Osim toga, fosaprepitant se brzo i gotovo potpuno pretvarao u aprepitant u pripravcima sa S9 frakcijom dobivenom iz drugih ljudskih tkiva, uključujući bubreg, pluća i ileum.
English: An alternative dose regimen that may be used with single-day chemotherapy regimens is shown in Table 4.
Croatian: Alternativni režim doziranja koji se može primijeniti s jednodnevnim kemoterapijskim režimima prikazan je u tablici 4.
English: How to store IVEMEND
Croatian: Kako čuvati IVEMEND
English: In patients 12 years and older, the volume to be administered is calculated as follows:
Croatian: U bolesnika u dobi od 12 godina i starijih, volumen koji će se primijeniti izračunava se na sljedeći način:
English: The potential effects on reproduction of alterations in neurokinin regulation are unknown.
Croatian: Nije poznato mogu li promjene u regulaciji neurokinina utjecati na reprodukciju.
English: Death of skin tissue (necrosis) has happened in some people getting this type of chemotherapy medicine.
Croatian: Odumiranje kožnog tkiva (nekroza) javilo se u nekih osoba koje su primale ovu vrstu kemoterapije.
English: Ketoconazole increased the terminal half-life of oral aprepitant about 3-fold.
Croatian: Ketokonazol je produljio terminalni poluvijek peroralnog aprepitanta oko 3 puta.
English: EU/1/07/437/003 1 x 1 vial EU/1/07/437/004 1 x 10 vials
Croatian: EU/1/07/437/003 1 x 1 bočica EU/1/07/437/004 1 x 10 bočica
English: Pharmacokinetics in special populations
Croatian: Farmakokinetika u posebnim skupinama bolesnika
English: IVEMEND 150 mg should be administered intravenously and should not be given by the intramuscular or subcutaneous route.
Croatian: IVEMEND 150 mg mora se primjenjivati intravenski i ne smije se davati intramuskularno niti supkutano.
English: Haemodialysis conducted 4 or 48 hours after dosing had no significant effect on the pharmacokinetics of aprepitant; less than 0.2 % of the dose was recovered in the dialysate.
Croatian: Hemodijaliza provedena 4 sata ili 48 sati nakon primjene aprepitanta nije značajno utjecala na njegovu farmokinetiku; u dijalizatu je pronađeno tek manje od 0,2% doze.
English: The recommended dose is 150 mg administered as an infusion over 20-30 minutes on Day 1, initiated approximately 30 minutes prior to chemotherapy (see section 6.6).
Croatian: Preporučena doza je 150 mg primijenjena u obliku infuzije u trajanju od 20-30 minuta 1. dana, a primjena započinje oko 30 minuta prije same kemoterapije (vidjeti dio 6.6).
English: IVEMEND 150 mg was shown to be non-inferior to that of the 3-day regimen of aprepitant.
Croatian: IVEMEND 150 mg nije bio manje djelotvoran od trodnevnog režima liječenja aprepitantom.
English: IVEMEND should be administered in conjunction with a corticosteroid and a 5-HT3 antagonist as specified in the tables below.
Croatian: IVEMEND se mora primijeniti u kombinaciji s kortikosteroidom i antagonistom 5-HT3, kako je detaljno prikazano u tablicama niže.
English: In vitro studies using human liver microsomes indicate that aprepitant is metabolised primarily by CYP3A4 and potentially with minor contribution by CYP1A2 and CYP2C19.
Croatian: In vitro ispitivanja na mikrosomima ljudske jetre ukazuju da aprepitant prvenstveno razgrađuje izoenzim CYP3A4, uz tek manji mogući doprinos izoenzima CYP1A2 i CYP2C19.
English: 8 mg orally twice daily
Croatian: 8 mg peroralno dvaput na dan
English: 12 mg orally
Croatian: 12 mg peroralno
English: IVEMEND should not be given as a bolus injection, but should always be diluted and given as a slow intravenous infusion (see section 4.2).
Croatian: IVEMEND se ne smije davati bolus injekcijom, već ga uvijek treba razrijediti i davati putem spore intravenske infuzije (vidjeti dio 4.2).
English: In patients 6 months to less than 12 years, the volume to be administered is calculated as follows:
Croatian: U bolesnika u dobi od 6 mjeseci do manje od 12 godina, volumen koji će se primijeniti izračunava se na sljedeći način:
English: Immune system disorders hypersensitivity reactions including anaphylactic reactions not known
Croatian: Poremećaji imunološkog sustava reakcije preosjetljivosti uključujući anafilaktičke reakcije nepoznato