FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Croatian: Liječenje i profilaksa krvarenja u bolesnika s hemofilijom A (urođeni nedostatak faktora VIII).
English: Insert the white plastic spike through the ADVATE powder stopper.
Croatian: Ubodite bijeli plastični šiljak kroz čep bočice s praškom ADVATE.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of plasma factor VIII activity assay is indispensable.
Croatian: Osobito kod većih kirurških zahvata, nadomjesna terapija se mora pomno nadgledati određivanjem aktivnosti faktora VIII u plazmi.
English: Solvent: Clea and colourless solution.
Croatian: Otapalo: bistra i bezbojna otopina.
English: Attach a butterfly needle to the syringe.
Croatian: Stavite leptir iglu na štrcaljku.
English: Parenteral medicinal products should be inspected for particulate matter prior to administration, whenever solution and container permit.
Croatian: Lijekove za parenteralnu primjenu treba prije primjene pregledati na prisutnost vidljivih čestica, kad god to omogućavaju vrsta otopine i spremnika.
English: It is strongly recommended that every time ADVATE is administered, the name and batch number of the product are recorded.
Croatian: Strogo se preporučuje da se svaki put kada se bolesniku primijeni ADVATE zabilježi naziv i broj serije lijeka.
English: Animal reproduction studies have not been conducted with factor VIII.
Croatian: Nisu provođena ispitivanja utjecaja faktora VIII na reprodukciju životinja.
English: For the prevention of bleeding in children under the age of 6, doses of 20 to 50 IU per kg body weight 3 to 4 times weekly are recommended.
Croatian: Za prevenciju krvarenja u djece mlađe od 6 godina života, preporučuju se doze od 20 do 50 IU po kg tjelesne težine 3 do 4 puta tjedno.
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, uobičajene doze su 20 do 40 IU faktora VIII po kg tjelesne težine u razmacima od 2 do 3 dana.
English: In case of administration by a non health care professional appropriate training is needed.
Croatian: U slučaju da lijek primjenjuje osoba koja nije zdravstveni radnik, ona mora biti odgovarajuće osposobljena za to.
English: In case of the following haemorrhagic events, the factor VIII activity should not fall below the given plasma activity level (in % of normal or IU/dl) in the corresponding period.
Croatian: U primjerima niže navedenih događaja povezanih s krvarenjem, aktivnost faktora VIII ne smije pasti ispod navedene razine aktivnosti u plazmi (izraženo kao % od normalne ili IU/dl) u odgovarajućem vremenskom razdoblju.
English: Due to the decrease in injection volume for ADVATE reconstituted in 2 ml sterilised water for injections, if hypersensitivity reactions occur there is less time to react by stopping the injection.
Croatian: Zbog smanjenog volumena injiciranja lijeka ADVATE pripremljenog s 2 ml sterilizirane vode za injekcije, ako nastupi reakcija preosjetljivosti manje je vremena za reagiranje zaustavljanjem injiciranja.
English: Excipients: mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, glutathione (reduced).
Croatian: Pomoćne tvari: manitol, natrijev klorid, histidin, trehaloza, kalcijev klorid, trometamol, polisorbat 80, glutation (reducirani).
English: A MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: ADRs specific to residues from the manufacturing process Of the 229 treated patients who were assessed for antibodies to Chinese hamster ovary (CHO) cell protein, 3 showed a statistically significant upward trend in titres, 4 displayed sustained peaks or transient spikes and one patient had both but no clinical symptoms.
Croatian: Nuspojave na lijek specifične za ostatne tvari iz proizvodnog postupka Kod ispitivanja razvoja antitijela na proteine jajnih stanica kineskog hrčka (CHO), od 229 liječenih bolesnika, u 3 je uočen trend povišenja titra, što je bilo statistički značajno, u 4 bolesnika povišenje se održalo ili su vrhovi titra bili prolazni, a u jednog bolesnika opaženo je i jedno i drugo ali bez kliničkih simptoma.
English: The following table can be used to guide dosing in bleeding episodes and surgery.
Croatian: Sljedeća tablica može koristiti kao vodič za doziranje kod krvarenja i u kirurgiji.
English: In this case, this medicine expires at the end of this 6 month period or the expiration date printed on the product vial, whichever is earlier.
Croatian: U tom slučaju, ovaj lijek ističe na kraju tog šestomjesečnog razdoblja ili na datum isteka roka valjanosti otisnutom na bočici lijeka, štogod prije nastupi.
English: • Inspect the prepared solution for particulate matter and discoloration prior to administration (the solution should be clear, colourless and free from foreign particles).
Croatian: • Pripremljenu otopinu morate prije primjene dobro pregledati na prisutnost čestica ili promjenu boje (otopina treba biti bistra, bezbojna i bez vidljivih čestica).
English: Due to the decrease in injection volume for ADVATE reconstituted in 2 ml, the time to react to hypersensitivity reactions during an injection is further reduced.
Croatian: Zbog smanjenog volumena injiciranja lijeka ADVATE pripremljenog s 2 ml, dodatno se smanjuje vrijeme za reagiranje na reakciju preosjetljivosti tijekom injiciranja.
English: Grip the package at its edge and pull the package off BAXJECT II (Fig. b).
Croatian: Primite pakiranje na njegovim rubovima te ga skinite s uređaja BAXJECT II (slika b).
English: Repeat injections every 8 to 24 hours (6 to 24 hours for patients under the age of 6) until adequate wound healing, then continue therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl).
Croatian: Injekcije ponavljati svakih 8 do 24 sata (6 do 24 sata u bolesnika mlađih od 6 godina života) sve do zacjeljenja rane, a nakon toga nastaviti liječenje tijekom najmanje 7 narednih dana kako bi se održala aktivnost faktora VIII između 30% i 60% (IU/dl).
English: All pharmacokinetic studies with ADVATE were conducted in previously treated patients with severe to moderately severe haemophilia A (baseline factor VIII ≤ 2%).
Croatian: Sva farmakokinetička ispitivanja lijeka ADVATE bila su provedena na prethodno liječenim bolesnicima s teškom do srednje teškom hemofilijom A (početna vrijednost faktora VIII ≤ 2%).
English: The vacuum will draw the solvent into the ADVATE powder vial (Fig. c).
Croatian: Otapalo će zbog vakuuma prijeći u bočicu s praškom ADVATE (slika c).
English: ADVATE contains recombinant coagulation factor VIII (octocog alfa), a glycoprotein that is biologically equivalent to the factor VIII glycoprotein found in human plasma.
Croatian: ADVATE sadrži rekombinantni koagulacijski faktor VIII (oktokog alfa), glikoprotein koji je biološki jednak glikoproteinu faktora VIII koji se nalazi u ljudskoj plazmi.
English: Retrospective chart review was done for 30 paediatric subjects on ITI (in study 060703).
Croatian: Za 30 pedijatrijskih bolesnika liječenih metodom imunotolerancije (u studiji 060703) proveden je retrospektivni pregled evidencije.
English: The reconstituted solution should be inspected visually for any foreign particulate matter and/or discoloration.
Croatian: Rekonstituiranu otopinu treba vizualno pregledati na prisutnost vidljivih čestica i/ili promjenu boje.
English: Attach a butterfly needle to the syringe and inject the reconstituted solution into a vein.
Croatian: Stavite leptir iglu na štrcaljku i injicirajte otopinu u venu.
English: - Use within three hours after reconstitution.
Croatian: - Primijeniti lijek u roku od tri sata od rekonstitucije otopine.
English: If the product is still stored in a refrigerator, take both the ADVATE powder and solvent vials from the refrigerator and let them reach room temperature (between 15 °C and 25 °C).
Croatian: Ako se lijek još uvijek čuva u hladnjaku, izvadite bočice s ADVATE praškom i otapalom iz hladnjaka i ostavite ih da se zagriju na sobnu temperaturu (između 15°C i 25°C).
English: Table 3 Summary of Pharmacokinetic Parameters of ADVATE per Age Group with severe haemophilia A (baseline factor VIII < 1%)
Croatian: Tablica 3 Sažetak farmakokinetičkih parametara lijeka ADVATE po dobnim skupinama bolesnika s teškom hemofilijom A (početna vrijednost faktora VIII < 1%)
English: - The other ingredients are mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, and glutathione (reduced).
Croatian: - Pomoćne tvari su manitol, natrijev klorid, histidin, trehaloza, kalcijev klorid, trometamol, polisorbat 80 i glutation (reducirani).
English: It is strongly recommended that every time ADVATE 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: Strogo se preporučuje da se svaki put kada se bolesniku primijeni ADVATE zabilježi naziv i broj serije lijeka kako bi se vodila evidencija o primijenjenom serijskom broju lijeka svakom bolesniku.
English: Do not use ADVATE if the solution is not fully clear or not completely dissolved.
Croatian: ADVATE ne smijete primijeniti ako otopina nije potpuno bistra ili ako se prašak nije u potpunosti otopio.
English: Infants (n=5)
Croatian: Dojenčad (n=5)
English: Half-life (h) Maximum Plasma Concentration Post Infusion (IU/dl) Mean Residence Time (h)
Croatian: Poluvijek (h) Maksimalna koncentracija u plazmi nakon infuzije (IU/dl) Srednje vrijeme zadržavanja (h)
English: Instructions for preparation and administration
Croatian: Upute za pripremu otopine i primjenu
English: Slight transient reddening at the administration site was observed after intraarterial application and after paravenous administration.
Croatian: Na mjestu uboda primijećeno je lagano prolazno crvenilo nakon intraarterijske primjene i nakon paravenske primjene.
English: Very common (PUPs)d
Croatian: d vrlo često (PUPs)
English: The plasma levels of factor VIII are increased by replacement therapy, thereby enabling a temporary correction of the factor VIII deficiency and correction of the bleeding tendency.
Croatian: Nadomjesnom terapijom, razine faktora VIII u plazmi se povećavaju, što privremeno ispravlja nedostatak faktora VIII te smanjuje sklonost krvarenju.
English: Draw the reconstituted solution into the syringe by pulling the plunger back slowly (Fig. e).
Croatian: Uvucite pripremljenu otopinu u štrcaljku polagano izvlačeći klip (slika e).
English: After reconstitution this medicinal product contains 0.45 mmol sodium (10 mg) per vial.
Croatian: Nakon rekonstitucije, ovaj lijek sadrži 0,45 mmol natrija (10 mg) po bočici.
English: ADVATE in BAXJECT III system: Keep the sealed blister in the outer carton in order to protect from light.
Croatian: ADVATE u sustavu BAXJECT III: Hermetički zatvoreni blister čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: Children (n=30)
Croatian: Djeca (n=30)
English: Turn the package over and insert the clear plastic spike through the solvent stopper.
Croatian: Okrenite pakiranje te ubodite prozirni plastični šiljak kroz čep bočice s otapalom.
English: • Do not use after the expiry date stated on the labels and carton.
Croatian: • Lijek se ne smije upotrijebiti nakon isteka roka valjanosti, koji je otisnut na naljepnicama i kutiji.
English: Fig. c
Croatian: Slika c
English: In patients under the age of 6, doses of 20 to 50 IU of factor VIII per kg body weight 3 to 4 times weekly are recommended for prophylactic therapy.
Croatian: U bolesnika mlađih od 6 godina života, preporučuju se doze od 20 do 50 IU faktora VIII po kg tjelesne težine 3 do 4 puta tjedno kao preventivna terapija.
English: Excipients with known effect: 0.45 mmol sodium (10 mg) per vial.
Croatian: Pomoćne tvari s poznatim učinkom: 0,45 mmol natrija (10 mg) po bočici.
English: Every 24 hours (12 to 24 hours for patients under the age of 6), at least 1 day, until healing is achieved.
Croatian: Svaka 24 sata (12 do 24 sata u bolesnika mlađih od 6 godina života), tijekom najmanje 1 dana, sve do zacjeljenja rane.
English: A central venous access device (CVAD) may become necessary to allow frequent infusions of factor VIII products.
Croatian: Centralni venski kateter može biti neophodan kod učestalih infuzija faktora VIII.
English: The solution should be administered slowly, at a rate as determined by the patient's comfort level, not to exceed 10 ml per minute.
Croatian: Otopinu treba primijeniti polagano, brzinom koja je ugodna bolesniku i ne većom od 10 ml po minuti.
English: The pulse rate should be determined before and during administration of ADVATE.
Croatian: Prije i za vrijeme primjene lijeka ADVATE treba izmjeriti brzinu pulsa.
English: The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all Factor VIII medicines.
Croatian: Bolesnici u kojih su se razvili inhibitori faktora VIII Stvaranje inhibitora (antitijela) poznata je komplikacija koja se može pojaviti tijekom liječenja bilo kojim lijekom koji sadrži faktor VIII.
English: Draw the reconstituted solution into the syringe by pulling the plunger back slowly.
Croatian: Uvucite rekonstituiranu otopinu u štrcaljku polagano izvlačeći klip.
English: What ADVATE contains - The active substance is octocog alfa (human coagulation Factor VIII produced by recombinant DNA technology).
Croatian: Što ADVATE sadrži - Djelatna tvar je oktokog alfa (ljudski koagulacijski faktor VIII proizveden tehnologijom rekombinantne DNK).
English: If the product is still stored in a refrigerator, take the sealed blister (contains powder and solvent vials preassembled with the system for reconstitution) from the refrigerator and let it reach room temperature (between 15 °C and 25 °C).
Croatian: Ako se lijek i dalje čuva u hladnjaku, izvadite hermetički zatvoreni blister (sadrži bočicu s praškom i bočicu s otapalom već pričvršćene na sustav za rekonstituciju) iz hladnjaka i pričekajte da postigne sobnu temperaturu (između 15 °C i 25 °C).
English: Of the 229 treated patients who were assessed for antibodies to murine IgG, 10 showed a statistically significant upward trend, 2 displayed a sustained peak or transient spike and one patient had both.
Croatian: Od 229 bolesnika u kojih su se ispitivala antitijela protiv mišjih IgG, u 10 bolesnika uočen je trend povišenja titra, što je bilo statistički značajno, u 2 bolesnika povišenje se održalo ili su vrhovi titra bili prolazni, a u jednog bolesnika opaženo je i jedno i drugo.
English: Distribution at Steady State (dl/kg) Clearance (ml/kg*h)
Croatian: Volumen distribucije u stanju dinamičke ravnoteže (dl/kg) Klirens (ml/kg*h)
English: The frequency of administration will depend on how well ADVATE is working for you.
Croatian: Učestalost davanja ovisiti će o učinkovitosti lijeka ADVATE u Vas.
English: This medicine contains 0.45 mmol sodium (10 mg) per vial.
Croatian: Ovaj lijek sadrži 0,45 mmol natrija (10 mg) po bočici.
English: Table 2 Frequency of adverse drug reactions (ADRs) in clinical trials and from spontaneous reports MedDRA Standard System Organ Class
Croatian: Tablica 2 Učestalost nuspojava na lijek tijekom kliničkih ispitivanja i spontanih prijava MedDRA - klasifikacija organskih sustava
English: Each powder vial contains nominally 250, 500, 1000, 1500, 2000, or 3000 IU octocog alfa.
Croatian: Jedna bočica s praškom sadrži nominalno250, 500, 1000, 1500, 2000 ili 3000 IU oktokoga alfa.
English: Intravenous use, after reconstitution.
Croatian: Za intravensku primjenu, nakon pripreme otopine.
English: For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 people); 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 people).
Croatian: U djece koja ranije nisu bila liječena lijekovima koji sadrže faktor VIII, vrlo često (u više od 1 na 10 osoba) mogu nastati inhibitorna antitijela (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 osoba).
English: Older Children (n=18)
Croatian: Starija djeca (n=18)
English: Severe symptoms, including difficulty in breathing and (near) fainting, require prompt emergency treatment.
Croatian: Teški simptomi koji uključuju poteškoće u disanju te (skorašnju) nesvjesticu zahtijevaju hitnu medicinsku pomoć.
English: • Do not use if the BAXJECT II device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration as indicated by the symbol: • Do not refrigerate the solution after preparation.
Croatian: • Ne upotrebljavati ako su uređaj BAXJECT II, njegov sterilni zaštitni sustav ili pakiranje oštećeni ili pokazuju bilo koji znak dotrajalosti, u skladu sa simbolom: • Nakon pripreme otopine, lijek se ne smije vratiti u hladnjak.
English: You must contact your doctor immediately if you have any of the following early symptoms of allergic reactions: - 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: Morate se odmah obratiti svom liječniku ako se pojavi bilo koji od sljedećih ranih simptoma alergijskih reakcija: - osip, koprivnjača, opći svrbež, - naticanje usana i jezika, - poteškoće u disanju, piskanje, stezanje u prsima, - opći osjećaj slabosti, - omaglica te gubitak svijesti.
English: Influenza
Croatian: Učestalosta gripa
English: Four of these patients reported isolated events of urticaria, pruritus, rash, and slightly elevated eosinophil counts amongst repeated exposures to the study product.
Croatian: Četvero od tih bolesnika je nakon ponovljenih izlaganja lijeku prijavilo izolirane slučajeve urtikarije, svrbeža, osipa te lagano povišenje broja eozinofila.
English: Mean Residence Time (h) 11.0 ± 2.8 12.0 ± 2.7 15.1 ± 4.7
Croatian: Ukupni AUC (IU*h/dl) 1362,1 ± 311,8 1180,0 ± 432,7 1506,6 ± 530,0 1317,1 ± 438,6 1538,5 ± 519,1 Prilagođeni prirast po jedinici doze pri Cmax (IU/dl po IU/kg)a
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use, after reconstitution.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Za intravensku primjenu, nakon pripreme otopine.
English: Degree of haemorrhage/type of surgical procedure
Croatian: Stupanj krvarenja/vrsta kirurškog zahvata
English: Haemorrhage Early haemarthrosis, muscle bleeding or oral bleeding.
Croatian: Rano krvarenje u zglobove, mišićno krvarenje ili krvarenje u usnoj šupljini.
English: Calculated as (Cmax - baseline Factor VIII) divided by the dose in IU/kg, where Cmax is the maximal post-infusion Factor VIII measurement.
Croatian: Izračunato kao (Cmax - početna vrijednost faktora VIII) podijeljeno s dozom u IU/kg, gdje je Cmax maksimalna izmjerena vrijednost faktora VIII nakon infuzije.
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma using the modified assay.
Croatian: Ti inhibitori su obično IgG imunoglobulini koji djeluju protiv prokoagulacijske aktivnosti faktora VIII, a njihova količina se određuje u Bethesda jedinicama (BU) po ml plazme pomoću modificiranog testa.
English: Do not use if the BAXJECT II device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration.
Croatian: Ne upotrebljavati ako su uređaj BAXJECT II, njegov sterilni zaštitni sustav ili pakiranje oštećeni ili pokazuju bilo koji znak dotrajalosti.
English: Repeat injections every 8 to 24 hours (6 to 12 hours for patients under the age of 6) until threat is resolved.
Croatian: Injekcije ponavljati svakih 8 do 24 sata (6 do 12 sati u bolesnika mlađih od 6 godina života) sve do otklanjanja životne opasnosti.
English: If you or your child's bleeding is not being controlled with ADVATE, tell your doctor immediately.
Croatian: Ako krvarenje niste uspjeli staviti pod nadzor s lijekom ADVATE, odmah se obratite svom liječniku.
English: Powder: White to off-white friable powder.
Croatian: Prašak: bijeli do gotovo bijeli rastresiti prašak.
English: - Do not use if the BAXJECT II device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration.
Croatian: - Ne upotrebljavati ako su uređaj BAXJECT II, njegov sterilni zaštitni sustav ili pakiranje oštećeni ili pokazuju bilo koji znak dotrajalosti.
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 treba upoznati s ranim znacima reakcija preosjetljivosti kao što su koprivnjača, generalizirana urtikarija, stezanje u prsima, piskanje, hipotenzija i anafilaksija.
English: Fig. 1
Croatian: Slika 1
English: After reconstitution, from a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek je potrebno primijeniti odmah nakon rekonstitucije.
English: Fig. b
Croatian: Slika b
English: Factor VIII inhibition
Croatian: Infekcije i infestacije laringitis inhibicija faktora VIII
English: Instructions for injection For administration the use of a luer-lock syringe is required.
Croatian: Upute za primjenu injekcije Za primjenu lijeka koristiti luer-lock štrcaljku.
English: Each powder vial contains nominally 250, 500, 1000, or 1500 IU octocog alfa.
Croatian: Jedna bočica s praškom sadrži nominalno 250, 500, 1000 ili 1500 IU oktokoga alfa.
English: Haemostasis was maintained at all times during this period and both plasma factor VIII levels and clearance rates returned to appropriate levels by postoperative day 15.
Croatian: Tijekom cijelog tog vremena održavala se hemostaza te su se do 15. dana nakon kirurškog zahvata razine faktora VIII u plazmi i klirens vratili u normalne vrijednosti.
English: Repeat injections every 12 to 24 hours (8 to 24 hours for patients under the age of 6) for at least 1 day, until the bleeding episode, as indicated by pain, is resolved or healing is achieved.
Croatian: Injekcije ponavljati svakih 12 do 24 sata (8 do 24 sata u bolesnika mlađih od 6 godina života) tijekom najmanje 1 dana, sve dok se krvarenje, na koje ukazuje bol, ne zaustavi ili ne dođe do zacjeljenja.
English: Solvent vial: 2 ml sterilised water for injections
Croatian: Bočica s otapalom: 2 ml sterilizirane vode za injekcije
English: Solvent vial: 5 ml sterilised water for injections
Croatian: Bočica s otapalom: 5 ml sterilizirane vode za injekcije
English: ADVATE with BAXJECT II device: Keep the product vial in the outer carton in order to protect from light.
Croatian: ADVATE s uređajem BAXJECT II: Bočicu lijeka čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: For reconstitution only the sterilised water for injections and the reconstitution device provided in the pack should be used.
Croatian: Za rekonstituciju se smiju koristiti samo sterilizirana voda za injekcije i uređaj za rekonstituciju priloženi u pakiranju.
English: Haematocrit decreased
Croatian: Tablični sažetak nuspojava
English: How ADVATE is given
Croatian: Kako se daje ADVATE
English: Remove the BAXJECT III system from the blister.
Croatian: Izvadite sustav BAXJECT III iz blistera.
English: Connect the syringe to BAXJECT II (Fig. d).
Croatian: Spojite štrcaljku na uređaj BAXJECT II (slika d).
English: B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).