FrancophonIA/ELRC3.0 huggingface dataset:
English: * Calculated as patients with ADR per total number of 280 trial patients, of which 190 previously treated patients (PTPs) and 90 previously untreated patients (PUPs).
Croatian: Manje često* * Izračunato kao broj bolesnika s nuspojavom na ukupni broj od 280 bolesnika u ispitivanju od kojih je 190 bilo prethodno liječenih bolesnika (PTPs), a 90 prethodno neliječenih bolesnika (PUPs).
English: Also there can be significant discrepancies between assay results obtained by aPTT-based one stage clotting assay and the chromogenic assay according to Ph. Eur.
Croatian: Također može doći do značajnih odstupanja između rezultata testa postignutih pomoću jednofaznog testa zgrušavanja temeljenog na aPTT-u i kromogenog testa prema Europskoj farmakopeji.
English: The dose and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
Croatian: Doza i trajanje nadomjesne terapije ovise o izraženosti nedostatka faktora VIII, lokalizaciji i opsegu krvarenja te o bolesnikovu kliničkom stanju.
English: The usual dose of Vihuma is 20 to 40 IU per kg body weight, given every 2 to 3 days.
Croatian: Uobičajena doza lijeka Vihuma je od 20 do 40 IU po kg tjelesne težine, a daje se svaka 2-3 dana.
English: For long-term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of factor VIII per kg body weight at intervals of 2 to 3 days.
Croatian: Za dugotrajnu profilaksu krvarenja u bolesnika s teškom hemofilijom A, uobičajena doza iznosi od 20 do 40 IU faktora VIII po kg tjelesne težine u intervalima od svaka 2 do 3 dana.
English: Paraesthesia Headache Dizziness
Croatian: Parestezija Glavobolja Omaglica
English: If any of these symptoms occur, stop the injection immediately and contact your doctor.
Croatian: Ako se pojavi bilo koji od navedenih simptoma, odmah prekinite s injekcijom i obratite se svom liječniku.
English: Do not refrigerate after reconstitution.
Croatian: Ne odlagati u hladnjak nakon rekonstitucije.
English: Prophylaxis: In a clinical study in 32 adult patients with severe haemophilia A, the median consumption of Vihuma for prophylaxis was 468.7 IU/kg/month.
Croatian: Profilaksa: U kliničkom ispitivanju na 32 odrasla bolesnika s teškom hemofilijom A, medijan potrošnje lijeka Vihuma za potrebe profilakse iznosio je 468,7 IU/kg/mjesec.
English: However depending on your body weight and your dose of Vihuma, you could receive more than one vial.
Croatian: Međutim, ovisno o tjelesnoj težini i doziranju lijeka Vihuma, možda ćete primiti više od jedne bočice.
English: Vihuma has no influence on the ability to drive and use machines.
Croatian: Vihuma ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Turn the vial attached to the syringe upside down, and slowly draw the final solution into the syringe.
Croatian: Okrenite naopako bočicu koja je pričvršćena na štrcaljku i polako uvucite završnu otopinu u štrcaljku.
English: The target factor VIII levels will depend on the severity and location of the bleeding.
Croatian: Ciljana razina faktora VIII ovisit će o količini i lokaciji krvarenja.
English: Insert the needle of the infusion set into the chosen vein.
Croatian: Uvedite iglu infuzijskog seta u željenu venu.
English: The vial adapter and the syringe are for single use only.
Croatian: Nastavak za bočicu i štrcaljka namijenjeni su samo za jednokratnu uporabu.
English: Hold the plunger rod at the end and do not touch the shaft.
Croatian: Uhvatite kraj potisnog klipa i nemojte dodirivati vrh klipa.
English: After reconstitution, the solution is clear, colourless and free from foreign particles.
Croatian: Nakon rekonstitucije, otopina je bistra, bezbojna i ne sadrži vidljive čestice.
English: During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions.
Croatian: Tijekom liječenja preporučuje se odgovarajuće određivanje razine faktora VIII kao vodiča za određivanje doze koja će se primijeniti i učestalost ponovljenih infuzija.
English: Side effects related to central venous access devices (CVAD): Catheter-related infection, general (systemic) infection and local blood clot at the catheter site.
Croatian: Nuspojave povezane s centralnim venskim kateterom Infekcija povezana s kateterom, opće (sustavne) infekcije i lokalizirani krvni ugrušak na mjestu uvođenja katetera.
English: If you have used a tourniquet to make the vein easier to see, this tourniquet should be released before you start injecting the solution.
Croatian: Ako ste koristili traku za podvezivanje radi postizanja bolje vidljivosti vene, uklonite je prije nego što započnete s ubrizgavanjem otopine.
English: In the case of the following haemorrhagic events, Factor VIII activity should not fall below the given plasma activity level (in % of normal or IU/dl) in the corresponding period.
Croatian: U slučaju sljedećih pojava krvarenja, aktivnost faktora VIII ne smije pasti ispod određene razine aktivnosti u plazmi (u % u odnosu na normalnu ili IU/dl) u odgovarajućem razdoblju.
English: During clinical studies with Vihuma in previously treated paediatric (2 to 11 years, n = 58), adolescent (12 to 17 years, n = 3) and adult patients (n = 129) with severe haemophilia A, a total of 12 adverse drug reactions (ADRs) (8 in adults, 4 in children) were reported in 8 patients (4 adults, 4 children).
Croatian: godina, n = 58), adolescentima (12-17 godina, n = 3) i odraslim bolesnicima (n = 129) s teškom hemofilijom A, prijavljeno je ukupno 12 nuspojava na lijek (8 u odraslih, 4 u djece) u 8 bolesnika (4 odrasla, 4 djece).
English: Paediatric population Frequency, type and severity of adverse reactions in children are assumed to be the same as in adults.
Croatian: Pedijatrijska populacija Pretpostavlja se da su učestalost, vrsta i težina nuspojava u djece jednaki kao u odraslih.
English: Degree of haemorrhage/ Type of surgical procedure
Croatian: Stupanj krvarenja/ Vrsta kirurškog zahvata
English: After reconstitution, the solution should be drawn back into the syringe.
Croatian: Nakon rekonstitucije, izvucite otopinu natrag u štrcaljku.
English: In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.
Croatian: U nekim slučajevima, posebno kod mlađih bolesnika, mogu biti potrebni manji intervali doziranja ili veće doze.
English: Sodium chloride Calcium chloride dihydrate Arginine hydrochloride Sodium citrate dihydrate Poloxamer 188
Croatian: Natrijev klorid Kalcijev klorid dihidrat Argininklorid Natrijev citrat dihidrat Poloksamer 188
English: When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining factor VIII activity in patients' blood samples, plasma factor VIII activity results can be significantly affected by both the type of aPTT reagent and the reference standard used in the assay.
Croatian: Kada se za određivanje aktivnosti faktora VIII u uzorcima krvi bolesnika koristi in vitro jednofazni test zgrušavanja temeljen na aktiviranom parcijalnom tromboplastinskom vremenu (aPTT), na rezultate aktivnosti faktora VIII u plazmi mogu značajno utjecati vrsta reagensa za aPTT kao i referentni standard primijenjen u testu.
English: Uncommon side effects may affect up to 1 in 100 people Tingling or numbness (paraesthesia), headache, injection site inflammation, injection site pain, back pain, vertigo, dry mouth, dizziness, a vague feeling of bodily discomfort, shortness of breath.
Croatian: Manje česte nuspojave mogu se javiti u do 1 na 100 osoba Trnci ili utrnulost (parestezija), glavobolja, upala na mjestu injekcije, bol na mjestu injekcije, bol u leđima, vrtoglavica, suha usta, omaglica, neodređen osjećaj tjelesne nelagode, nedostatak zraka.
English: For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however patients who have received previous treatment with Factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients).
Croatian: bolesnika) mogu nastati inhibitorna protutijela (vidjeti dio 2); međutim, u bolesnika koji su ranije primali terapiju s faktorom VIII (više od 150 dana liječenja) rizik je manje čest (manje od 1 na 100
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with Vihuma.
Croatian: Do razvoja neutralizirajućih antitijela (inhibitora) može doći u bolesnika s hemofilijom A koji su liječeni faktorom VIII, uključujući lijek Vihuma.
English: Biotest AG (Germany) Teл.
Croatian: Biotest AG (Germany)
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Vihuma in one or more subsets of the paediatric population in treatment of haemophilia A (congenital Factor VIII deficiency) (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Vihuma u jednoj ili više podskupina pedijatrijske populacije u liječenju hemofilije A (urođeni nedostatak faktora
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Vihuma Lijek čuvajte izvan pogleda i dohvata djece.
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Croatian: Bolesnike je potrebno informirati o ranim simptomima i znakovima reakcija preosjetljivosti kao što su osip, generalizirana urtikarija, stezanje u prsištu, piskanje pri disanju, hipotenzija i anafilaksija.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su prikazane silaznim redoslijedom ozbiljnosti.
English: Visually inspect the final solution for particles before administration.
Croatian: Vizualno provjerite postoje li čestice u završnoj otopini prije primjene.
English: Can be stored at room temperature (up to 25°C) for a single period up to 1 month.
Croatian: Može se čuvati na sobnoj temperaturi (do 25°C) tijekom jednokratnog razdoblja od najviše 1 mjesec.
English: How to use Vihuma
Croatian: Kako primjenjivati Vihuma
English: Make sure that the entire content of the vial is transferred to the syringe.
Croatian: Provjerite jeste li čitav sadržaj bočice uvukli u štrcaljku.
English: Animal reproduction studies have not been conducted with Vihuma.
Croatian: Nisu provedena ispitivanja na životinjama za lijek Vihuma.
English: Excipient related considerations (sodium content)
Croatian: Napomene povezane s pomoćnom tvari (sadržaj natrija)
English: If your plasma factor VIII fails to reach expected levels with Vihuma, or if bleeding is not adequately controlled, it could be due to the development of factor VIII inhibitors.
Croatian: Ako faktor VIII u plazmi ne dostigne očekivanu razinu uz lijek Vihuma, ili ako se ne postigne odgovarajuća kontrola krvarenja, možda ste razvili inhibitore faktora VIII.
English: AUC (hr*IU/ml)
Croatian: AUC (h*IU/ml)
English: Adipose (n=2)
Croatian: Pretilost (n=2)
English: Inject the solution into the vein at a slow speed, not faster than 4 ml per minute.
Croatian: 17. Polako ubrizgajte otopinu u venu, brzinom do 4 ml po minuti.
English: A higher median dose of Vihuma was required to treat bleedings in children (43.9 IU/kg) than in adults (33.0 IU/kg), and a higher median dose was required to treat moderate to major than minor bleedings (78.2 IU/kg vs. 41.7 IU/kg).
Croatian: Veći medijan doze lijeka Vihuma bio je potreban za liječenje krvarenja u djece (43,9 IU/kg) u odnosu na odrasle (33,0 IU/kg) te je veći medijan doze bio potreban za liječenje srednjih do obilnih krvarenja u odnosu na slabija krvarenja
English: The solvent is water for injections in a pre-filled glass syringe.
Croatian: Otapalo je voda za injekcije u napunjenoj staklenoj štrcaljki.
English: Excipient(s) with known effect 7.35 mg sodium per ml reconstituted solution (18.4 mg sodium per vial).
Croatian: 7,35 mg natrija po ml rekonstituirane otopine (18,4 mg natrija po bočici).
English: Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries.
Croatian: Moguće su razlike u odgovoru pojedinačnih bolesnika na faktor VIII u smislu razlika u poluvijeku lijeka te in vivo povrata.
English: The potency (IU) is determined using the European Pharmacopoeia chromogenic assay.
Croatian: Potentnost (IU - međunarodne jedinice) se određuje kromogenim testom prema Europskoj farmakopeji.
English: Name and address of the manufacturer(s) of the biological active substance
Croatian: Naziv(i) i adresa(e) proizvođača biološke(ih) djelatne(ih) tvari
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Nisu provedena ispitivanja interakcija za lijek Vihuma.
English: Before the Vihuma powder is reconstituted it may be kept at room temperature (up to 25°C) for a single period not exceeding 1 month.
Croatian: Prije rekonstitucije Vihuma prašak može se čuvati na sobnoj temperaturi (do najviše 25°C) tijekom jednokratnog razdoblja od najviše 1 mjesec.
English: CL (ml/hr/kg)
Croatian: CL (ml/h/kg)
English: It is strongly recommended that every time that Vihuma is administered, the name and batch number of the product are recorded in order to maintain a link between you and the batch of the medicinal product.
Croatian: Izrazito se preporučuje da se prilikom svake primjene lijeka Vihuma zabilježe naziv i broj serije lijeka kako bi se održala poveznica između Vas i primijenjene serije lijeka.
English: Patients developing factor VIII inhibitors
Croatian: Razvoj inhibitora faktora VIII kod bolesnika
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava Hemoragična anemija
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Croatian: Ako postoji potreba za centralnim venskim kateterom, potrebno je razmotriti rizik od komplikacija povezanih s takvim uređajem, uključujući lokalne infekcije, bakterijemiju i trombozu na mjestu ulaska katetera.
English: Driving and using machines Vihuma has no influence on your ability to drive and use machines.
Croatian: Vihuma ne utječe na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: Check with your doctor or nurse if you are not sure.
Croatian: Provjerite navedeno s liječnikom ili medicinskom sestrom u slučaju dvojbi.
English: Only the provided injection sets should be used because treatment failure can occur as a consequence of human coagulation factor VIII adsorption to the internal surfaces of some injection equipment.
Croatian: Koristite isključivo isporučene setove za injekcije jer adsorpcija ljudskog faktora zgrušavanja VIII na unutarnje površine neke opreme za injekcije može dovesti do neuspjeha liječenja.
English: Slowly inject all solvent into the powder vial by pressing down the plunger rod.
Croatian: Polako ubrizgajte sve otapalo u bočicu s praškom tako da pritisnete potisni klip.
English: Expected factor VIII rise (% of normal) = 2 x administered IU body weight (kg)
Croatian: Očekivano povećanje faktora VIII (% u odnosu na normalni) = 2 x primijenjene IU
English: However depending on the body weight and posology, the patient could receive more than one vial.
Croatian: Međutim, ovisno o tjelesnoj težini i doziranju, možda ćete primiti više od jedne bočice.
English: These data were corroborated by a long-term follow-up of 49 of these children who were treated for an additional median period of approximately 30 months (range from 9.5 to 52 months); during this period 45% of children had no spontaneous bleeds
Croatian: Ove rezultate potvrdilo je dugoročno praćenje 49 od te djece koja su bila liječena tijekom dodatnog razdoblja s medijanom od približno 30 mjeseci (raspon od
English: rash, hives, wheals, generalised itching, swelling of lips and tongue, difficulty in breathing, wheezing, tightness in the chest, general feeling of being unwell, dizziness and loss of consciousness.
Croatian: osip, koprivnjača, crvenilo, generalizirani svrbež, oticanje usana i jezika, teškoće prilikom disanja, zviždanje pri disanju, stezanje u prsnom košu,
English: Turn the plunger rod clockwise until a slight resistance is felt.
Croatian: Okrećite potisni klip u smjeru kazaljke na satu dok ne osjetite blagi otpor.
English: Please record the beginning of storage at room temperature on the product carton.
Croatian: Zabilježite datum početka čuvanja lijeka na sobnoj temperaturi na kutiji lijeka.
English: The vial should be gently rotated until all powder is dissolved.
Croatian: Nježno zakrećite bočicu dok se ne otopi sav prašak.
English: Wipe the top of the vial with an alcohol swab.
Croatian: Obrišite vrh bočice jastučićem natopljenim alkoholom.
English: Injection site inflammation Injection site pain Malaise
Croatian: Upala na mjestu injekcije Bol na mjestu injekcije Malaksalost
English: If you or your child´s bleeding is not being controlled with Vihuma, tell your doctor immediately.
Croatian: Vašeg djeteta ne može kontrolirati pomoću lijeka Vihuma, odmah se obratite liječniku.
English: Please record the date from when you start to store Vihuma at room temperature on the product carton.
Croatian: Zabilježite datum početka čuvanja lijeka Vihuma na sobnoj temperaturi na kutiji lijeka.
English: Excipients: Sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188
Croatian: Pomoćne tvari: saharoza, natrijev klorid, kalcijev klorid dihidrat, argininklorid, natrijev citrat dihidrat, poloksamer 188
English: If you require a central venous access device (CVAD), risk of CVAD-related complications including local infections, presence of bacteria in the blood and catheter site thrombosis should be considered.
Croatian: Ako morate upotrijebiti centralni venski kateter, potrebno je razmotriti rizik od komplikacija povezanih sa centralnim venskim kateterom, uključujući lokalne infekcije, prisutnost bakterija u krvi i trombozu na mjestu uvođenja katetera.
English: Common*
Croatian: Često*
English: factor VIII binds to von Willebrand factor in the patient's circulation.
Croatian: Nakon infuzije bolesniku s hemofilijom faktor VIII veže se na von Willebrandov faktor u bolesnikovoj cirkulaciji.
English: Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast feeding is not available.
Croatian: Zbog rijetke pojave hemofilije A kod žena nema dostupnih iskustva u pogledu primjene faktora VIII
English: It is strongly recommended that every time that Vihuma is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Croatian: Preporučuje se da prilikom svake primjene lijeka Vihuma bolesniku evidentirate naziv i broj serije lijeka kako bi se mogla utvrditi veza između bolesnika i serije lijeka.
English: If you stop using Vihuma Do not stop using Vihuma without consulting your doctor or pharmacist.
Croatian: Nemojte prestati s primjenom lijeka Vihuma bez prethodnog savjetovanja s liječnikom ili ljekarnikom.
English: Detach the filled syringe from the vial adapter by turning counter clockwise and discard the empty vial.
Croatian: Odvojite napunjenu štrcaljku od nastavka za bočicu okretanjem u smjeru suprotnom od kazaljke na satu i zatim bacite praznu bočicu.
English: Firmly connect the solvent syringe to the vial adapter by turning clockwise until resistance is felt.
Croatian: Čvrsto spojite štrcaljku s otapalom na nastavak za bočicu tako da je okrećete u smjeru kazaljke na satu dok ne osjetite otpor.
English: AUC (hr*IU/ml) 22.6 ± 8.0 T1/2 (hr)
Croatian: AUC(h*IU/ml) T1/2 (h)
English: Each powder vial contains 250, 500, 1000, 2000, 2500, 3000 or 4000 IU of simoctocog alfa.
Croatian: Jedna bočica praška sadrži 250, 500, 1000, 2000, 2500, 3000 ili 4000 IU simoktokoga alfa.
English: How often you need an injection will depend on how well Vihuma is working for you.
Croatian: Učestalost potrebe za injekcijom ovisit će o učinku lijeka Vihuma na Vas.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Chromogenic assay Median (range)
Croatian: Kromogeni test Medijan (raspon)
English: Do not store Vihuma in the refrigerator again after it has been stored at room temperature.
Croatian: Nakon čuvanja na sobnoj temperaturi, Vihuma se ne smije ponovno čuvati u hladnjaku.
English: Haemorrhagic anaemia Factor VIII inhibition
Croatian: Inhibicija faktora VIII
English: If you use more Vihuma than you should
Croatian: Ako ste ubrizgali više lijeka Vihuma nego što ste trebali,
English: IVR (%/IU/kg) 2.5 ± 0.4 CL (ml/hr/kg)
Croatian: IVP (%/IU/kg) CL (ml/h/kg)
English: Remove the plastic flip-top cap from the powder vial to expose the central portions of the rubber stopper.
Croatian: Uklonite plastični zatvarač s bočice s praškom tako da se vidi središnji dio gumenog čepa.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Vihuma
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Otapalo za Vihuma
English: Each pack of Vihuma contains: - 1 powder vial with 250, 500, 1000, 2000, 2500, 3000 or 4000 IU simoctocog alfa - 1 pre-filled syringe with 2.5 ml water for injections - 1 vial adapter - 1 butterfly needle - 2 alcohol swabs
Croatian: Svako pakiranje lijeka Vihuma sadrži: - 1 bočicu praška s 250, 500, 1000, 2000, 2500, 3000 ili 4000 IU simoktokoga alfa - 1 napunjenu štrcaljku s 2,5 ml vode za injekcije
English: - The other ingredients are sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate and poloxamer 188.
Croatian: - Drugi sastojci su saharoza, natrijev klorid, kalcijev klorid dihidrat, argininklorid, natrijev citrat dihidrat i poloksamer 188. Pogledajte dio 2, "Vihuma sadrži natrij".
English: In case the solution is not used immediately close the filled syringe with the tamper-proof plastic tip for storage.
Croatian: Ako nećete odmah upotrijebiti otopinu, zatvorite punu štrcaljku sigurnosnim plastičnim vrškom i pohranite je.
English: During the shelf-life, the product may be kept at room temperature (up to 25°C) for a single period not exceeding 1 month.
Croatian: Unutar roka valjanosti lijek se može čuvati na sobnoj temperaturi (do 25°C) tijekom jednokratnog razdoblja od najviše 1 mjesec.
English: Press down firmly the adapter package until the adapter spike penetrates the rubber stopper.
Croatian: Čvrsto pritisnite pakiranje s nastavkom prema dolje dok šiljak nastavka ne probode gumeni čep.
English: Vihuma contains the active substance human recombinant coagulation factor VIII (simoctocog alfa).
Croatian: Vihuma sadrži djelatnu tvar ljudski rekombinantni koagulacijski faktor VIII (simoktokog alfa).
English: Early haemarthrosis, muscle bleeding or oral bleeding
Croatian: Rana hemartroza, krvarenje u mišiće ili usta
English: Hypersensitivity or allergic reactions (which may include angiooedema, burning and stinging at the infusion site, chills, flushing, headache, hives, hypotension, lethargy, nausea, rash, restlessness, tachycardia, tightness of the chest, tingling, urticaria, including generalised urticaria, vomiting, wheezing) have rarely been observed with FVIII preparations and may in some cases progress to severe anaphylaxis (including shock).
Croatian: tahikardiju, stezanje u prsištu, trnce, urtikariju, uključujući generaliziranu urtikariju, povraćanje, piskanje pri disanju) koje se u nekim slučajevima mogu razviti u tešku anafilaksiju (uključujući anafilaktički šok).
English: Powder: white to off-white friable powder.
Croatian: Prašak: rastresit prašak bijele do prljavo bijele boje.