FrancophonIA/ELRC3.0 huggingface dataset:
English: A dose of 500 IU (one vial) of Cinryze should be injected at the first sign of a swelling attack.
Croatian: Dozu od 500 IU (jedna bočica) lijeka Cinryze treba ubrizgati kod prvog znaka naglog oticanja.
English: A dose of 1000 IU (two vials) of Cinryze should be injected up to 24 hours before a medical, dental, or surgical procedure.
Croatian: Dozu od 1000 IU (dvije bočice) lijeka Cinryze treba ubrizgati unutar 24 sata prije medicinskog, zubarskog ili kirurškog zahvata.
English: Administer 1000 IU (reconstituted in 10 ml of water for injections) of Cinryze by intravenous injection at a rate of 1 ml per minute over 10 minutes.
Croatian: Primijenite 1000 IU (rekonstituiranih u 10 ml vode za injekcije) lijeka Cinryze intravenskom injekcijom brzinom od 1 ml po minuti tijekom 10 minuta.
English: • A dose of 1000 IU (two vials) of Cinryze should be injected every 3 or 4 days for routine prevention of swelling attacks.
Croatian: • Za rutinsko sprječavanje naglog oticanja dozu od 1000 IU (dvije bočice) lijeka Cinryze treba ubrizgavati svaka 3 ili 4 dana.
English: A second dose of 500 IU may be administered if the patient has not responded adequately after 60 minutes.
Croatian: Druga doza od 500 IU može se primijeniti ako bolesnik nije prikladno odgovorio nakon 60 minuta.
English: • 1000 IU of Cinryze within 24 hours before a medical, dental, or surgical procedure.
Croatian: • 1000 IU lijeka Cinryze unutar 24 sata prije medicinskog, zubarskog ili kirurškog zahvata.
English: 1000 IU of Cinryze within 24 hours before a medical, dental, or surgical procedure.
Croatian: 1000 IU lijeka Cinryze unutar 24 sata prije medicinskog, zubarskog ili kirurškog zahvata.
English: A second injection of 1000 IU may be given if your symptoms do not improve after 60 minutes.
Croatian: Druga injekcija od 1000 IU može se primijeniti ako se simptomi ne poboljšaju nakon 60 minuta.
English: A dose of 1000 IU (two vials) of Cinryze should be injected at the first sign of a swelling attack.
Croatian: Dozu od 1000 IU (dvije bočice) lijeka Cinryze treba ubrizgati kod prvog znaka naglog oticanja.
English: Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Croatian: Usprkos ovim mjerama, mogućnost prijenosa infekcije ne može se potpuno isključiti kad se primjenjuju lijekovi pripremljeni iz ljudske krvi ili plazme.
English: • A second dose of 1000 IU may be administered if the patient has not responded adequately after 60 minutes.
Croatian: • Druga doza od 1000 IU može se primijeniti ako bolesnik nije prikladno odgovorio nakon 60 minuta.
English: Baseline-corrected AUC(0-t) (U*hr/ml)
Croatian: AUC(0-t) korigiran za početnu vrijednost (U*hr/ml)
English: A dose of 500 IU (one vial) of Cinryze should be injected every 3 or 4 days for routine prevention of swelling attacks.
Croatian: Za rutinsku prevenciju naglog oticanja treba ubrizgati dozu od 500 IU (jedna bočica) lijeka Cinryze svaka 3 ili 4 dana.
English: • A dose of 1000 IU (two vials) of Cinryze should be injected at the first sign of a swelling attack.
Croatian: • Dozu od 1000 IU (dvije bočice) lijeka Cinryze treba ubrizgati kod prvog znaka oticanja.
English: For a dose of 1000 IU: Two powder vials, 2 solvent vials, 2 filter transfer devices, 1 disposable 10 ml syringe, 1 venipuncture set and 1 protective mat are needed.
Croatian: Za dozu od 1000 IU: potrebne su dvije bočice s praškom, 2 bočice s otapalom, 2 naprave za prijenos s filtrom, 1 štrcaljka od 10 ml za jednokratnu uporabu, 1 set za venepunkciju i 1 zaštitna podloga.
English: After reconstitution, one vial contains 500 IU of C1 inhibitor (human) per 5 ml, corresponding to a concentration of 100 IU/ml.
Croatian: Nakon rekonstitucije, jedna bočica sadrži 500 IU inhibitora C1 (ljudskog) na 5 ml, što odgovara koncentraciji od 100 IU/ml.
English: After reconstitution, one vial contains 500 IU of C1 inhibitor (human) per 5 ml corresponding to a concentration of 100 IU/ml.
Croatian: Nakon rekonstitucije, jedna bočica sadrži 500 IU inhibitora C1 (ljudskog) na 5 ml što odgovara koncentraciji od 100 IU/ml.
English: A second dose of 1000 IU may be administered if the patient has not responded adequately after 60 minutes.
Croatian: Druga doza od 1000 IU može se primijeniti ako bolesnik nije prikladno odgovorio nakon 60 minuta.
English: Routine prevention of swelling attacks
Croatian: Rutinsko sprječavanje naglog oticanja
English: For a dose of 500 IU: One powder vial, 1 solvent vial, 1 filter transfer device, 1 disposable 10 ml syringe, 1 venipuncture set and 1 protective mat are needed.
Croatian: Za dozu od 500 IU: potrebni su jedna bočica s praškom, 1 bočica s otapalom, 1 naprava za prijenos s filtrom, 1 štrcaljka od 10 ml za jednokratnu uporabu, 1 set za venepunkciju i 1 zaštitna podloga.
English: • genitals
Croatian: • spolnih organa
English: [Historically assigned potency values were relative to an in-house reference standard whereby 1 Unit (U) is equal to the mean quantity of C1 inhibitor present in 1 ml of normal human plasma.]
Croatian: Unit, U) jednaka je srednjoj vrijednosti količine inhibitora C1 prisutnog u 1 ml normalne ljudske plazme.] Sada je uveden međunarodni referentni standard (IU) u kojem je IU također definirana kao količina inhibitora C1 prisutna u 1 ml normalne ljudske plazme.
English: 500 IU of Cinryze every 3 or 4 days is the recommended starting dose for routine prevention against angioedema attacks.
Croatian: Preporučena početna doza za rutinsku prevenciju napadaja angioedema je 500 IU lijeka Cinryze svaka 3 ili 4 dana.
English: The transfer device must be vertical prior to penetrating the stopper closure of the powder vial.
Croatian: Naprava za prijenos mora biti postavljena okomito prije probijanja čepa na bočici s praškom.
English: CLINICAL PARTICULARS
Croatian: Infektivni uzročnici
English: Remove the plastic package from the transfer device and discard it. Take care not to touch the exposed end of the transfer device.
Croatian: Pazite da ne dodirnete izloženi kraj naprave za prijenos.
English: Frequency Adverse reaction
Croatian: Često povraćanje
English: Reconstitution and method of administration
Croatian: Priprema i način primjene
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA BOČICE CINRYZE
English: Baseline-corrected Cmax (U/ml)
Croatian: Cmax korigiran za početnu vrijednost (U/ml)
English: This should be taken into account by people on a controlled sodium diet.
Croatian: O tome treba voditi računa u bolesnika s ograničenjem unosa natrija.
English: 500 IU of Cinryze at the first sign of the onset of an acute attack.
Croatian: 500 IU lijeka Cinryze kod prvog znaka početka napadaja angioedema.
English: 1000 IU of Cinryze at the first sign of the onset of an acute attack.
Croatian: 1000 IU lijeka Cinryze kod prvog znaka početka napadaja angioedema.
English: Two vials of Cinryze powder must be reconstituted to make one dose (1000 IU/10 ml).
Croatian: Da bi se pripremila jedna doza (1000 IU/10 ml), moraju se rekonstituirati dvije bočice praška Cinryze.
English: The following information is intended for healthcare professionals only:
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim djelatnicima: Rekonstitucija i primjena lijeka Cinryze
English: Disconnect the solvent vial by turning it anti-clockwise.
Croatian: 12. Odvojite bočicu s otapalom tako što ćete je zakrenuti u smjeru suprotnom od kazaljke na satu.
English: Uncommon Chest discomfort,
Croatian: Manje često nelagoda u prsištu
English: One powder vial, 1 solvent vial, 1 filter transfer device, 1 disposable 10 ml syringe, 1 venipuncture set and 1 protective mat is needed to prepare one dose of 500 IU.
Croatian: Za pripremu jedne doze od 500 IU potrebna je jedna bočica s praškom, 1 bočica s otapalom, 1 naprava za prijenos s filtrom, 1 štrcaljka od 10 ml za jednokratnu uporabu, 1 set za venepunkciju i 1 zaštitna podloga.
English: An attack usually lasts between 2 to 5 days.
Croatian: Napadaj obično traje između 2 i 5 dana.
English: When and how often should you use Firazyr?
Croatian: Kada i koliko često trebate primjenjivati Firazyr?
English: (Unknown)
Croatian: (Nepoznato)
English: No therapeutic intervention was necessary.
Croatian: Nije bila potrebna nikakva terapijska intervencija.
English: Important information for healthcare professionals and caregivers:
Croatian: Važne informacije za zdravstvene radnike i njegovatelje:
English: The time to maximum concentration is approximately 30 minutes.
Croatian: Vrijeme do maksimalne koncentracije iznosi otprilike 30 minuta.
English: Statistic Firazyr
Croatian: Statistika Firazyr
English: D02 Y754, Ireland
Croatian: D02 Y754, Irska
English: • Press slowly so that this takes approximately 30 seconds.
Croatian: • Polako pritišćite tako da cijeli postupak potraje otprilike 30 sekundi
English: Your doctor has determined the exact dose of Firazyr and will tell you how often it should be used.
Croatian: Vaš je liječnik odredio točnu dozu Firazyra i on će Vam reći koliko ga često treba primjenjivati.
English: - If your symptoms get worse or do not improve, you must seek immediate medical help.
Croatian: - Ako Vam se simptomi pogoršavaju ili se ne poboljšavaju, morate odmah zatražiti medicinsku pomoć.
English: Each syringe should only be used once.
Croatian: Svaku štrcaljku treba upotrijebiti samo jedanput.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Croatian: 9 DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA
English: Do not choose an area that is bruised, swollen, or painful.
Croatian: Nemojte odabrati područje na kojem su modrice, koje je natečeno ili bolno.
English: Other medicines and Firazyr
Croatian: Drugi lijekovi i Firazyr
English: - You should not have more than 3 injections in a 24 hour period and if you require more than 8 injections in a month, you should seek medical advice.
Croatian: - Ne biste trebali uzeti više od 3 injekcije u razdoblju od 24 sata, a ako trebate više od 8 injekcija na mjesec, trebate potražiti liječnički savjet.
English: Difference between treatments (95% CI, p-value)
Croatian: Razlika između liječenja (95% CI, p-vrijednost)
English: • The syringe is now ready for injection.
Croatian: • Štrcaljka je sada spremna za injekciju.
English: There are no data on administering subsequent doses for the same attack in adolescents or children.
Croatian: Nema podataka o primjeni sljedećih doza za isti napadaj u adolescenata ili djece.
English: • Adapter (proximal and/or distal female luer lock connector/coupler)
Croatian: • Adapter (proksimalni i/ili distalni ženski luer lock konektor/spojnik)
English: Preferred Term
Croatian: Preferirani pojam
English: Information on individual race effect is limited.
Croatian: Informacije o utjecaju koji ima pripadnost pojedinoj rasi su ograničene.
English: Not known (frequency cannot be estimated from the available data) : Hives (urticaria)
Croatian: Nepoznate (učestalost se ne može procijeniti iz dostupnih podataka): Koprivnjača (urtikarija)
English: The terminal plasma half-life is about 1-2 hours.
Croatian: Poluvijek u plazmi iznosi oko 1-2 sata.
English: Very common (may affect more than 1 in 10 people) :
Croatian: Vrlo česte (mogu se javiti u više od 1 na 10 osoba):
English: • Clean the work area (surface) to be used before beginning the process.
Croatian: • Očistite predviđeno radno područje (radnu površinu) prije početka postupka.
English: It is a synthetic decapeptide with a structure similar to bradykinin, but with 5 non-proteinogenic amino acids.
Croatian: To je sintetski dekapeptid sa strukturom koja je slična bradikininu, ali s 5 neproteinogenskih aminokiselina.
English: Available exposure data suggest no difference in the clearance between non-White (n=40) and White (n=132) subjects.
Croatian: Dostupni podaci o izloženosti ukazuju da nema razlike u klirensu između ispitanika koji nisu bijelci (n=40) i bijelaca (n=132).
English: Limited information is available on patients older than 65 years of age.
Croatian: Podaci o bolesnicima starijim od 65 godina su ograničeni.
English: What Firazyr is and what it is used for
Croatian: Što je Firazyr i za što se koristi
English: Do not use this medicine if you notice that the syringe or needle packaging is damaged or if there are any visible signs of deterioration, for example if the solution is cloudy, if it has floating particles, or if the colour of the solution has changed.
Croatian: Nemojte upotrijebiti ovaj lijek ako primijetite da je pakiranje štrcaljke ili igle oštećeno ili ako postoje vidljivi znakovi propadanja, na primjer, ako je otopina zamućena, ako u njoj plutaju čestice ili ako je promijenila boju.
English: Avoid touching the ends of the connector and syringe tips, to prevent contamination
Croatian: Izbjegavajte dirati krajeve adaptera i vrhove štrcaljki, kako biste spriječili kontaminaciju
English: • Clean the injection site with a rubbing alcohol pad and allow it to dry.
Croatian: • Očistite mjesto primjene injekcije blazinicom natopljenom alkoholom i pustite da se osuši.
English: • Push the plunger of the graduated syringe so that any air is transferred back into the pre-filled syringe (this step may need to be repeated several times).
Croatian: • Gurnite klip graduirane štrcaljke tako da se sav zrak prebaci natrag u napunjenu štrcaljku (ovaj korak možda treba ponoviti nekoliko puta).
English: If you are taking a medicine known as an Angiotensin Converting Enzyme (ACE) inhibitor (for example: captopril, enalapril, ramipril, quinapril, lisinopril) which is used to lower your blood pressure or for any other reason, you should inform your doctor before receiving Firazyr.
Croatian: Ako uzimate lijek poznat kao inhibitor angiotenzin konvertirajućeg enzima (ACE inhibitor) (na primjer: kaptopril, enalapril, ramipril, kvinapril, lizinopril) koji se koristi za snižavanje krvnog tlaka ili iz bilo kojeg drugog razloga, trebate obavijestiti svog liječnika prije primanja Firazyra.
English: • Hold syringe between 45-90 degrees angle to skin with needle facing the skin.
Croatian: • Držite štrcaljku pod kutom od 45-90 stupnjeva u odnosu na kožu s iglom usmjerenom prema koži
English: Response was also consistent across repeated attacks in the controlled Phase III trials.
Croatian: Odgovor je također bio dosljedan kod svih ponavljanih napadaja u kontroliranim ispitivanjima faze III.
English: Data suggest an age-related decline in clearance resulting in about 50-60% higher exposure in older people (75-80 years) compared to patients aged 40 years.
Croatian: Podaci ukazuju na smanjenje klirensa povezano s dobi koje ima za posljedicu oko 50-60% višu izloženost kod starijih osoba (75-80 godina) u usporedbi s bolesnicima u dobi od 40 godina.
English: Although there is evidence to support a beneficial effect of B2 receptor blockade immediately following a stroke, there is a theoretical possibility that icatibant may attenuate the positive late phase neuroprotective effects of bradykinin.
Croatian: Iako nema dokaza koji bi poduprli koristan učinak blokade B2 receptora neposredno nakon moždanog udara, postoji teoretska mogućnost da ikatibant može umanjiti pozitivne neuroprotektivne učinke bradikinina u kasnoj fazi.
English: Table 3 shows the efficacy results for these studies.
Croatian: U tablici 3 prikazani su rezultati djelotvornosti za ta ispitivanja.
English: The appropriate dose to be administered is based on body weight (see section 4.2).
Croatian: Odgovarajuća doza koju treba primijeniti temelji se na tjelesnoj težini (vidjeti dio 4.2).
English: Response rate (%, CI) at 4 hours after start of treatment
Croatian: (%, CI) od 4 sata nakon početka liječenja
English: Icatibant is a selective competitive antagonist at the bradykinin type 2 (B2) receptor.
Croatian: Ikatibant je selektivni kompetitivni antagonist bradikininskog receptora tipa 2 (B2).
English: Firazyr has minor influence on the ability to drive and use machines.
Croatian: Firazyr ima manji utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: Firazyr solution for injection should be injected slowly due to the volume to be administered.
Croatian: Firazyr otopinu za injekciju je potrebno ubrizgavati polako zbog volumena koji treba primijeniti.
English: Children and adolescents aged 2 to 17 years
Croatian: Djeca i adolescenti u dobi od 2 do 17 godina
English: Icatibant is mainly eliminated by metabolism with less than 10% of the dose eliminated in the urine as unchanged drug.
Croatian: Ikatibant se uglavnom eliminira metabolizmom uz manje od 10% doze koja se eliminira u urinu kao nepromijenjen lijek.
English: Data suggest that there is no difference in the clearance between females and males after correcting for body weight.
Croatian: Podaci ukazuju da nema razlike u klirensu između ženskog i muškog spola nakon korekcije za tjelesnu težinu.
English: For adults, subsequent doses that may be required for the same attack should be administered within a medical institution (see section 4.2).
Croatian: U odraslih, sljedeće doze koje će možda biti potrebne za isti napadaj smiju se primijeniti samo unutar zdravstvene ustanove (vidjeti dio 4.2).
English: Step-by-Step Instructions for Injection 1) General Information
Croatian: Upute po koracima za injekciju 1) Opće informacije
English: In a standard battery of in vitro and in vivo tests icatibant was not genotoxic.
Croatian: U standardnom nizu in vitro i in vivo testova ikatibant nije bio genotoksičan.
English: Animal studies showed effects on uterine implantation and parturition (see section 5.3), but the potential risk for humans is unknown.
Croatian: Ispitivanja na životinjama pokazala su učinke na implantaciju u maternici i porod (vidjeti dio 5.3), no mogući rizik za ljude nije poznat.
English: All patients maintained efficacy.
Croatian: Djelotvornost je bila zadržana kod svih bolesnika.
English: Efficacy data were obtained from an initial open-label Phase II study and from three controlled Phase III studies.
Croatian: Podaci o djelotvornosti dobiveni su iz početnog otvorenog ispitivanja faze II i iz tri kontrolirana ispitivanja faze III.
English: Two paediatric patients experienced injection site reactions which were assessed as severe and which were completely resolved within 6 hours.
Croatian: U dva pedijatrijska bolesnika pojavile su se reakcije na mjestu injekcije koje su ocijenjene kao teške i koje su se potpuno povukle u roku od 6 sati.
English: 92.4% of these attacks of HAE were treated with a single dose of Firazyr.
Croatian: 92,4% tih napadaja nasljednog angioedema (HAE) liječeno je jednom dozom lijeka Firazyr.
English: This patient was followed for 5 months and further samples were negative for anti-icatibant antibodies.
Croatian: Taj je bolesnik praćen 5 mjeseci i kasniji su uzorci bili negativni na anti-ikatibant protutijela.
English: A hypodermic needle (25 G; 16 mm) is included in the pack.
Croatian: Igla za potkožnu primjenu (25 G; 16 mm) uključena je u pakiranje.
English: Date of first authorisation: 11 July 2008 Date of latest renewal: 13 March 2013
Croatian: Datum posljednje obnove odobrenja: 13. ožujka 2013.
English: Results do not indicate a carcinogenic potential for icatibant.
Croatian: Rezultati ne upućuju na kancerogeni potencijal ikatibanta.
English: Dose (Injection Volume)
Croatian: Doza (volumen injekcije)
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor before starting to use Firazyr.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego što počnete primjenjivati Firazyr.
English: Patients should be advised not to drive and use machines if they feel tired or dizzy.
Croatian: Bolesnike treba upozoriti da ne upravljaju vozilima i ne rade sa strojevima ako osjećaju umor ili omaglicu.
English: Icatibant is excreted in the milk of lactating rats at concentrations similar to those in maternal blood.
Croatian: Ikatibant se izlučuje u mlijeko ženki štakora koje doje u koncentracijama sličnim onima u majčinoj krvi.
English: What Firazyr looks like and contents of the pack
Croatian: Kako Firazyr izgleda i sadržaj pakiranja
English: Clearance is about 15-20 l/h and independent of dose.
Croatian: Klirens iznosi oko 15-20 l/sat i neovisan je o dozi.
English: Following subcutaneous administration, the absolute bioavailability of icatibant is 97%.
Croatian: Nakon supkutane primjene, apsolutna bioraspoloživost ikatibanta iznosi 97%.
English: In vitro studies have confirmed that icatibant is not degraded by oxidative metabolic pathways and is not an inhibitor of major cytochrome P450 (CYP) isoenzymes (CYP 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4) and is not an inducer of CYP 1A2 and 3A4.
Croatian: Ispitivanja in vitro potvrdila su da se ikatibant ne razgrađuje oksidativnim metaboličkim putevima i da nije inhibitor glavnih izoenzima citokroma (CYP) P450 (CYP 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 i 3A4) te da ne inducira CYP 1A2 i 3A4.
English: Firazyr should be used during pregnancy only, if the potential benefit justifies the potential risk for the foetus, (e.g for treatment of potentially life threatening laryngeal attacks).
Croatian: Firazyr treba primjenjivati tijekom trudnoće samo ako moguća korist opravdava mogući rizik za fetus (npr. za liječenje potencijalno po život opasnih laringealnih napadaja).
English: Time to symptom relief was defined as the duration of time (in hours) taken for improvement of symptoms to occur by a magnitude of 20%.
Croatian: Vrijeme do ublažavanja simptoma definirano je kao vrijeme trajanja (u satima) do poboljšanja simptoma za 20%.
English: 2b) Preparing the syringe and needle for injection: All patients (adults, adolescents and children)
Croatian: 2b) Priprema štrcaljke i igle za injekciju: svi bolesnici (odrasli, adolescenti i djeca)
English: These reactions were generally mild to moderate in severity, transient, and resolved without further intervention.
Croatian: Te su reakcije uglavnom bile blage do umjerene jakosti, prolazne i riješene bez dodatne intervencije.
English: The dosing regimen used for this study is unlikely to be sustained in the clinical setting.
Croatian: Nije vjerojatno da će se režim doziranja upotrijebljen za ovo ispitivanje održati u kliničkom kontekstu.
English: Patients weighing more than 65 kg will use the full contents of the pre-filled syringe (3 ml).
Croatian: Bolesnici s tjelesnom težinom većom od 65 kg iskoristit će cijeli sadržaj napunjene štrcaljke (3 ml).
English: It is unknown whether icatibant is excreted in human breast milk but it is recommended that breastfeeding women, who wish to take Firazyr, should not breastfeed for 12 hours after treatment.
Croatian: Nije poznato izlučuje li se ikatibant u majčino mlijeko kod ljudi, no preporučuje se da žene koje žele uzeti Firazyr ne bi trebale dojiti 12 sati nakon uzimanja lijeka.
English: Talk to your doctor before taking Firazyr: - if you are suffering from angina (reduced blood flow to the heart muscle) - if you have recently suffered a stroke
Croatian: Obratite se svom liječniku prije nego uzmete Firazyr: - ako bolujete od angine (smanjeni dotok krvi u srčani mišić) - ako ste nedavno imali moždani udar
English: FAST-3 was a randomized, placebo-controlled, parallel-group study of 98 adult patients with a median age of 36 years.
Croatian: FAST-3 bilo je randomizirano, placebom kontrolirano ispitivanje s paralelnim skupinama od 98 odraslih bolesnika prosječne dobi od 36 godina.
English: If you have never received Firazyr previously, your first dose of Firazyr will always be injected by your doctor or nurse.
Croatian: Ako nikad prije niste primali Firazyr, prvu dozu Firazyra uvijek će Vam dati liječnik ili medicinska sestra.
English: No dosage regimen for children aged less than 2 years or weighing less than 12 kg can be recommended as the safety and efficacy in this paediatric group has not been established.
Croatian: U djece mlađe od 2 godine ili tjelesne težine manje od 12 kg ne može se preporučiti shema doziranja jer sigurnost i djelotvornost u toj pedijatrijskoj skupini nije još ustanovljena.