FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 multipack with 30 single packs.
Croatian: 1 višestruko pakiranje s 30 pojedinačnih pakiranja.
English: • Known allergic reactions to mouse or hamster proteins.
Croatian: Poznate alergijske reakcije na proteine miša ili hrčka.
English: If no further dose is required, remove the venipuncture set and syringe.
Croatian: Ako nije potrebna druga doza, uklonite pribor za venepunkciju i štrcaljku.
English: Elevation of factor VIII levels following administration, in particular in those with existing cardiovascular risk factors, might cause a patient to have the same risk for vessel closure or myocardial infarction as for the non-haemophilic population.
Croatian: Povišenje razine faktora VIII nakon primjene, posebice u bolesnika s postojećim kardiovaskularnim faktorima rizika, može u bolesnika uzrokovati jednaki rizik za začepljenje krvne žile ili infarkt miokarda kao u populacije koje nema hemofiliju.
English: These items are not included in the Kovaltry package.
Croatian: Ovi proizvodi nisu dio pakiranja lijeka Kovaltry.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6 and the package leaflet.
Croatian: Za uputu o rekonstituciji lijeka prije primjene vidjeti dio 6.6 i uputu o lijeku.
English: If you store it at room temperature it expires after 12 months or at the expiry date if this is earlier.
Croatian: Ako ga čuvate ovaj lijek na sobnoj temperaturi, rok valjanosti mu istječe nakon 12 mjeseci ili nakon datuma isteka roka valjanosti, ako on istječe ranije.
English: Kovaltry is injected into a vein over 2 to 5 minutes depending on the total volume and your comfort level and should be used within 3 hours after reconstitution.
Croatian: Kovaltry se daje injekcijom u venu tijekom 2 do 5 minuta, ovisno o ukupnom volumenu i razini ugodnosti te se mora primijeniti u roku od 3 sata nakon pripreme za primjenu.
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed and may in some cases progress to severe anaphylaxis (including shock).
Croatian: Opažene su preosjetljivost ili alergijske reakcije (koje mogu uključivati angioedem, žarenje i peckanje na mjestu infuzije, zimicu, navale crvenila, generaliziranu urtikariju, glavobolju, koprivnjaču, hipotenziju, letargiju, mučninu, nemir, tahikardiju, stezanje u prsištu, trnce, povraćanje, piskanje pri disanju) koje u nekim slučajevima mogu napredovati do teške anafilaksije (uključujući šok).
English: The analysis of all recorded incremental recoveries in previously treated patients demonstrated a median rise of > 2% (> 2 IU/dL) per IU/kg body weight for Kovaltry.
Croatian: Analiza svih zabilježenih prirasta po jedinici doze u prethodno liječenih bolesnika pokazala je da prilikom korištenja lijeka Kovaltry dolazi do medijana porasta od > 2% (> 2 IU/dl) po IU/kg tjelesne težine.
English: * Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients ** includes injection site extravasation, hematoma, infusion site pain, pruritus, swelling *** rash, rash erythematous, rash pruritic
Croatian: *Učestalost se temelji na ispitivanjima sa svim lijekovima s FVIII koja su uključivala bolesnike s teškom hemofilijom A. PTPs = prethodno liječeni bolesnici (engl. previously-treated patients), PUPs = prethodno neliječeni bolesnici (engl. previously-untreated patients) ** uključuje ekstravazaciju na mjestu injekcije, hematom, bol na mjestu infuzije, svrbež, oticanje *** osip, eritematozni osip, osip praćen svrbežom
English: previously developed factor VIII inhibitors to a different product.
Croatian: • ste prethodno razvili inhibitore faktora VIII na drugi lijek.
English: Do not use Kovaltry if you are allergic to octocog alfa or to any of the other ingredients of this medicine (listed in section 6 and end of section 2).
Croatian: • alergični na oktokog alfa ili neki drugi sastojak ovog lijeka (naveden u dijelu 6 i na kraju dijela 2.).
English: • the severity of your haemophilia A
Croatian: • težina hemofilije A
English: • where the bleed is and how serious it is
Croatian: • mjesto i ozbiljnost krvarenja
English: Post-authorisation Efficacy Study: In order to investigate the safety and efficacy of Kovaltry in previously untreated patients, the MAH should submit the results of the ongoing study “13400 - Leopold Kids Part B”
Croatian: Ispitivanje djelotvornosti nakon stavljanja lijeka u promet: Kako bi se ispitala sigurnosti i djelotvornost lijeka Kovaltry u prethodno neliječenih bolesnika, nositelj odobrenja treba dostaviti rezultate ispitivanja u tijeku „13400 -Leopold Kids Part B“
English: Detailed instructions for preparation and administration are contained in the package leaflet provided with Kovaltry.
Croatian: Detaljne upute za pripremu i primjenu lijeka navedene su u uputi o lijeku koja je priložena uz Kovaltry.
English: Post-authorisation Efficacy Study: In order to investigate the safety and efficacy of long term treatment with Kovaltry, the MAH should submit the results of the ongoing study “13400 - Leopold Kids extension”
Croatian: Ispitivanje djelotvornosti nakon stavljanja lijeka u promet: Kako bi se ispitala sigurnosti i djelotvornost lijeka Kovaltry u dugotrajnom liječenju, nositelj odobrenja treba dostaviti rezultate ispitivanja u tijeku „13400 -Leopold Kids extension“
English: Swirl vial gently until all material is dissolved (H).
Croatian: Nježno vrtite bočicu dok se sva tvar ne otopi (H).
English: The number of factor VIII units is expressed in International Units (IU).
Croatian: Doza faktora VIII mjeri se u međunarodnim jedinicama (IU).
English: Ensure that the full content of the vial is drawn into the syringe.
Croatian: Provjerite je li sav sadržaj bočice uvučen u štrcaljku.
English: EU/1/15/1076/002 1 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/012 - 1 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) EU/1/15/1076/004 - 1 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/014 - 1 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) EU/1/15/1076/006 - 1 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/016 - 1 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) EU/1/15/1076/008 - 1 x (Kovaltry 2000 IU - solvent (5 mL); pre-filled syringe (5 mL)) EU/1/15/1076/010 - 1 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL)) EU/1/15/1076/017 30 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/018 - 30 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) EU/1/15/1076/019 - 30 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/020 - 30 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) EU/1/15/1076/021 - 30 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/022 - 30 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) EU/1/15/1076/023 - 30 x (Kovaltry 2000 IU - solvent (5 mL); pre-filled syringe (5 mL)) EU/1/15/1076/024 - 30 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL))
Croatian: EU/1/15/1076/002 - 1 x (Kovaltry 250 IU - otapalo (2,5 ml); napunjena štrcaljka (3 ml)) EU/1/15/1076/012 - 1 x (Kovaltry 250 IU - otapalo (2,5 ml); napunjena štrcaljka (5 ml)) EU/1/15/1076/004 - 1 x (Kovaltry 500 IU - otapalo (2,5 ml); napunjena štrcaljka (3 ml)) EU/1/15/1076/014 - 1 x (Kovaltry 500 IU - otapalo (2,5 ml); napunjena štrcaljka (5 ml)) EU/1/15/1076/006 - 1 x (Kovaltry 1000 IU - otapalo (2,5 ml); napunjena štrcaljka (3 ml)) EU/1/15/1076/016 - 1 x (Kovaltry 1000 IU - otapalo (2,5 ml); napunjena štrcaljka (5 ml)) EU/1/15/1076/008 - 1 x (Kovaltry 2000 IU - otapalo (5 ml); napunjena štrcaljka (5 ml)) EU/1/15/1076/010 - 1 x (Kovaltry 3000 IU - otapalo (5 ml); napunjena štrcaljka (5 ml)) EU/1/15/1076/017 30 x (Kovaltry 250 IU - otapalo (2,5 ml); napunjena štrcaljka (3 ml)) EU/1/15/1076/018 - 30 x (Kovaltry 250 IU - otapalo (2,5 ml); napunjena štrcaljka (5 ml)) EU/1/15/1076/019 - 30 x (Kovaltry 500 IU - otapalo (2,5 ml); napunjena štrcaljka (3 ml)) EU/1/15/1076/020 - 30 x (Kovaltry 500 IU - otapalo (2,5 ml); napunjena štrcaljka (5 ml)) EU/1/15/1076/021 - 30 x (Kovaltry 1000 IU - otapalo (2,5 ml); napunjena štrcaljka (3 ml) EU/1/15/1076/022 - 30 x (Kovaltry 1000 IU - otapalo (2,5 ml); napunjena štrcaljka (5 ml) EU/1/15/1076/023 - 30 x (Kovaltry 2000 IU - otapalo (5 ml); napunjena štrcaljka (5 ml)) EU/1/15/1076/024 - 30 x (Kovaltry 3000 IU - otapalo (5 ml); napunjena štrcaljka (5 ml))
English: Determination of aPTT is a conventional in vitro assay for biological activity of factor VIII.
Croatian: Određivanje aPTV-a je uobičajen in vitro test određivanja biološke aktivnosti faktora VIII.
English: 1 vial with powder, 1 pre-filled syringe with water for injections, 1 vial adapter and 1 venipuncture set.
Croatian: 1 bočica s praškom, 1 napunjena štrcaljka s vodom za injekcije, 1 nastavak za bočicu i 1 pribor za venepunkciju.
English: A safety and efficacy study has been performed in children of 012 years (see section 5.1); limited data are available for children below 1 year.
Croatian: Ispitivanje sigurnosti i djelotvornosti provedeno je u djece u dobi 0-12 godina (vidjeti dio 5.1).
English: The venipuncture set provided with the product must not be used for drawing blood because it contains an in line filter.
Croatian: Pribor za venepunkciju priložen uz lijek ne smije se koristiti za uzimanje krvi zato što sadrži ugrađeni filter.
English: Kovaltry should be reconstituted and administered with the components (vial adapter, prefilled syringe, venipuncture set) provided with each package.
Croatian: Kovaltry treba rekonstituirati i primijeniti pomoću pribora (nastavak za bočicu, napunjena štrcaljka, pribor za venepunkciju) priloženog u pakiranju.
English: Sucrose, histidine, glycine, sodium chloride, calcium chloride dihydrate, polysorbate 80, acetic acid glacial and water for injections.
Croatian: Saharoza, histidin, glicin, natrijev klorid, kalcijev klorid dihidrat, polisorbat 80, ledena acetatna kiselina i voda za injekcije.
English: This medicine contains less than 1 mmol (23 mg) sodium per dose, and is therefore considered essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi te se stoga smatra da sadrži zanemarive količine natrija.
English: 3000 IU) solvent (clear glass cylinder type 1 with grey bromobutyl rubber blend stopper)
Croatian: 3000 IU) otapala (tijelo od prozirnog stakla tipa 1 sa sivim čepom od bromobutilne gume)
English: Do not remove the adapter from the plastic housing.
Croatian: Nemojte vaditi nastavak iz plastičnog pakiranja.
English: to use a central venous access device for the administration of Kovaltry.
Croatian: • morate imati postavljen centralni venski kateter za primjenu lijeka Kovaltry.
English: After reconstitution, the product must be used within 3 hours.
Croatian: Lijek se nakon rekonstitucije mora primijeniti u roku od 3 sata.
English: Do not use this medicine if you notice any particles in the solution or if the solution is cloudy.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite vidljive čestice u otopini ili ako je otopina zamućena.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE WITH WATER FOR INJECTIONS NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION water for injections METHOD OF ADMINISTRATION EXPIRY DATE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NAPUNJENA ŠTRCALJKA S VODOM ZA INJEKCIJE NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA voda za injekcije NAČIN PRIMJENE LIJEKA ROK VALJANOSTI
English: Administer your next dose immediately and continue at regular intervals as advised by your doctor.
Croatian: •Ubrizgajte odmah sljedeću dozu te nastavite uzimati lijek u redovitim vremenskim razmacima koje
English: Stop administering the product immediately and seek medical advice if this occurs.
Croatian: U tom slučaju odmah prestanite ubrizgavati lijek i zatražite liječničku pomoć.
English: If your or your child's bleeding is not being controlled with Kovaltry, tell your doctor immediately.
Croatian: Vašeg djeteta ne može kontrolirati pomoću lijeka Kovaltry, odmah se obratite liječniku.
English: Inject the solvent by slowly pushing down on the plunger rod (G).
Croatian: Ubrizgajte otapalo potiskujući polagano potisnik klipa prema dolje (G).
English: Kovaltry contains the active substance human recombinant coagulation factor VIII, also called octocog alfa.
Croatian: Kovaltry sadrži djelatnu tvar rekombinantni ljudski koagulacijski faktor VIII, također zvan oktokog alfa.
English: Finally, apply a small pressure dressing to the injection site and consider if a plaster is necessary.
Croatian: Na kraju lagano pritisnite mjesto ubrizgavanja zavojem te flaster, ako je potrebno.
English: Kovaltry powder should only be reconstituted with the supplied solvent (2.5 mL or 5 mL water for injections) in the prefilled syringe and the vial adapter.
Croatian: Kovaltry prašak smije se rekonstituirati samo s otapalom (2,5 ml ili 5 ml vode za injekcije) priloženim u napunjenoj štrcaljki i pomoću nastavka za bočicu.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.5 mL [for reconstitution of strengths 250/500/1000 IU]
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 2,5 ml [za rekonstituciju jačina 250/500/1000 IU]
English: Holding the adapter housing, place over the product vial and firmly press down (B).
Croatian: Držeći pakiranje nastavka, namjestite ga iznad bočice s lijekom i čvrsto pritisnite prema dolje (B).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL OF MULTIPACK WITH 30 SINGLE PACKS (INCLUDING BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE VIŠESTRUKOG PAKIRANJA S 30 POJEDINAČNIH PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR)
English: The other ingredients are sucrose, histidine, glycine, sodium chloride, calcium chloride dihydrate, polysorbate 80, acetic acid glacial and water for injections.
Croatian: Pomoćne tvari su saharoza, histidin, glicin, natrijev klorid, kalcijev klorid dihidrat, polisorbat 80, ledena acetatna kiselina i voda za injekcije.
English: Kovaltry can be used for all age groups.
Croatian: Kovaltry se može primjenjivati u bolesnika svih dobnih skupina.
English: Hold the vial on end above the vial adapter and syringe (I).
Croatian: 11. Držite bočicu za kraj iznad nastavka za bočicu i štrcaljke (I).
English: Holding the syringe by the barrel, snap the syringe cap off the tip (D).
Croatian: Držeći štrcaljku za tijelo, otkinite zatvarač štrcaljke s vrha (D).
English: Fill the syringe by drawing the plunger out slowly and smoothly.
Croatian: Napunite štrcaljku polaganim i ravnomjernim povlačenjem klipa.
English: Kovaltry is provided as a powder and solvent for solution for injection.
Croatian: Kovaltry se sastoji od praška i otapala za otopinu za injekciju.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
Croatian: 10. POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI OTPADNIH
English: After reconstitution the solution is clear.
Croatian: Nakon rekostitucije otopina je bistra.
English: After reconstitution, the solution is drawn back into the syringe.
Croatian: Otopina se nakon rekostitucije uvlači nazad u štrcaljku.
English: Kovaltry contains sodium
Croatian: Kovaltry sadrži natrij
English: PHARMACEUTICAL FORM AND CONTENTS powder and solvent for solution for injection
Croatian: OBLIK I SADRŽAJ prašak i otapalo za otopinu za injekciju.
English: Bayer AG 51368 Leverkusen Germany
Croatian: Bayer AG 51368 Leverkusen Njemačka
English: Keep the vial and the pre filled syringe in the outer carton in order to protect from light.
Croatian: Bočicu i napunjenu štrcaljku držite u vanjskom pakiranju radi zaštite od svjetlosti.
English: Allergic type hypersensitivity reactions are possible with Kovaltry.
Croatian: Na lijek Kovaltry moguće su reakcije preosjetljivosti alergijskog tipa.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 mL [for reconstitution of strengths 2000/3000 IU]
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 5 ml [za rekonstituciju jačina 2000/3000 IU]
English: In this case, the product expires at the end of this 12 month period or the expiry date on the product vial, whichever is earlier.
Croatian: Rok valjanosti lijeka u tom slučaju ističe nakon tog razdoblja od 12 mjeseci ili nakon datuma isteka roka valjanosti navedenog na bočici s lijekom, ovisno o tome koji nastupi ranije.
English: Kovaltry 250 IU powder and solvent for solution for injection Kovaltry 500 IU powder and solvent for solution for injection Kovaltry 1000 IU powder and solvent for solution for injection Kovaltry 2000 IU powder and solvent for solution for injection Kovaltry 3000 IU powder and solvent for solution for injection
Croatian: Kovaltry 250 IU prašak i otapalo za otopinu za injekciju Kovaltry 500 IU prašak i otapalo za otopinu za injekciju Kovaltry 1000 IU prašak i otapalo za otopinu za injekciju Kovaltry 2000 IU prašak i otapalo za otopinu za injekciju Kovaltry 3000 IU prašak i otapalo za otopinu za injekciju
English: For reconstitution read package leaflet before use.
Croatian: Za rekonstituciju prije uporabe pročitajte uputu o lijeku.
English: Pack sizes 1 single pack.
Croatian: Veličine pakiranja: 1 pojedinačno pakiranje.
English: If you use more Kovaltry than you should Tell your doctor if this occurs.
Croatian: Ako primijenite više lijeka Kovaltry nego što ste trebali
English: Grasp the plunger rod as per the diagram and attach the rod by turning it firmly clockwise into the threaded stopper (C).
Croatian: Uhvatite potisnik klipa kao na slici i pričvrstite potisnik čvrstim uvrtanjem u čep s navojem u smjeru kazaljke na satu (C).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON OF A MULTIPACK (WITHOUT BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA U VIŠESTRUKOM PAKIRANJU (BEZ PLAVOG OKVIRA)
English: allergic to mouse or hamster proteins.
Croatian: • alergični na bjelančevine miša ili hrčka.
English: For major surgery in particular, your blood clotting must be closely monitored.
Croatian: Zgrušavanje krvi mora se pozorno pratiti osobito u slučaju velikih kirurških zahvata.
English: How to use Kovaltry
Croatian: Kako primjenjivati Kovaltry
English: Kovaltry 250 IU powder and solvent for solution for injection Kovaltry 500 IU powder and solvent for solution for injection Kovaltry 1000 IU powder and solvent for solution for injection Kovaltry 2000 IU powder and solvent for solution for injection Kovaltry 3000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa)
Croatian: Kovaltry 250 IU prašak i otapalo za otopinu za injekciju Kovaltry 500 IU prašak i otapalo za otopinu za injekciju Kovaltry 1000 IU prašak i otapalo za otopinu za injekciju Kovaltry 2000 IU prašak i otapalo za otopinu za injekciju Kovaltry 3000 IU prašak i otapalo za otopinu za injekciju rekombinantni ljudski koagulacijski faktor VIII (oktokog alfa)
English: Remove the protective cap from the vial (A).Wipe the rubber stopper on the vial with an alcohol swab and allow the stopper to air dry before use.
Croatian: Obrišite gumeni čep jastučićem natopljenim alkoholom i pustite ga da se osuši prije primjene.
English: How to store Kovaltry
Croatian: Kako čuvati Kovaltry
English: Holding the vial adapter in place, remove the syringe from the vial adapter (the adapter should remain attached to the vial).
Croatian: 15. Držeći nastavak za bočicu na mjestu, odvojite štrcaljku od nastavka za bočicu (nastavak treba ostati pričvršćen za bočicu).
English: Peel off the paper cover on the plastic housing of the vial adapter.
Croatian: Odlijepite papirnati pokrov s plastičnog pakiranja nastavka za bočicu.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF A SINGLE PACK (INCLUDING BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE POJEDINAČNOG PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR)
English: INFORMATION IN BRAILLE Kovaltry 2000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Kovaltry 2000
English: Remove tourniquet.
Croatian: Uklonite povesku.
English: The reconstituted product must be filtered by using the vial adapter before administration to remove any possible particles in the solution.
Croatian: Pripremljeni se lijek prije injekcije mora filtrirati pomoću nastavka za bočicu kako bi se iz otopine uklonile moguće čestice.
English: INFORMATION IN BRAILLE Kovaltry 250
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Kovaltry 250
English: If you get any side effects, talk to your doctor.
Croatian: Ako se ti dijelovi ne mogu uporabiti, obratite se svom liječniku.
English: The solvent is a clear liquid.
Croatian: Otapalo je bistra tekućina.
English: Place the powder vial on a firm, non slip surface.
Croatian: Postavite bočicu s praškom na čvrstu podlogu koja nije skliska.
English: • one venipuncture set
Croatian: • jedan pribor za venepunkciju
English: INFORMATION IN BRAILLE Kovaltry 1000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Kovaltry 1000
English: Warnings and precautions Talk to your doctor or pharmacist if you have: tightness in the chest, dizziness (including when you get up from sitting or lying down), itchy nettle-rash, wheezing, feeling sick or faint.
Croatian: • imate stezanje u prsnom košu, omaglicu (koja se javlja i nakon ustajanja iz sjedećeg ili ležećeg položaja), koprivnjaču praćenu svrbežom, piskanje pri disanju, mučninu ili nesvjesticu.
English: Attach the pre filled syringe to the threaded vial adapter by turning clockwise (F).
Croatian: Pričvrstite napunjenu štrcaljku na nastavak za bočicu s navojem okrećući ju u smjeru kazaljke na satu (F).
English: How Kovaltry is prepared for administration
Croatian: Kako se lijek Kovaltry priprema za injekciju
English: INFORMATION IN BRAILLE Kovaltry 500
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Kovaltry 500
English: STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 250 IU contains (250 IU / 2.5 mL) = 100 IU octocog alfa per mL after reconstitution.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Kovaltry 250 IU sadrži (250 IU / 2,5 ml) = 100 IU oktokoga alfa po ml nakon pripreme za primjenu.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 3000 IU contains (3000 IU / 5 mL) = 600 IU octocog alfa per mL after reconstitution.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Kovaltry 3000 IU sadrži (3000 IU / 5 ml) = 600 IU oktokoga alfa po ml nakon pripreme za primjenu.
English: Calcium chloride dihydrate Polysorbate 80
Croatian: Prašak saharoza histidin glicin natrijev klorid kalcijev klorid dihidrat polisorbat 80 acetatna kiselina, ledena (za podešavanje pH)
English: INFORMATION IN BRAILLE Kovaltry 3000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Kovaltry 3000
English: Dysgeusia uncommon
Croatian: • disgeuzija (poremećaj osjeta okusa)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 2000 IU contains (2000 IU / 5 mL) = 400 IU octocog alfa per mL after reconstitution.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Kovaltry 2000 IU sadrži (2000 IU / 5 ml) = 400 IU oktokoga alfa po ml nakon pripreme za primjenu.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 500 IU contains (500 IU / 2.5 mL) = 200 IU octocog alfa per mL after reconstitution.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Kovaltry 500 IU sadrži (500 IU / 2,5 ml) = 200 IU oktokoga alfa po ml nakon pripreme za primjenu.
English: EU/1/15/1076/024 - 30 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL))
Croatian: EU/1/15/1076/024 - 30 x (Kovaltry 3000 IU - otapalo (5 ml); napunjena štrcaljka (5 ml))
English: • syringe plunger rod
Croatian: • navale crvenila (crvenilo lica)
English: EU/1/15/1076/023 - 30 x (Kovaltry 2000 IU - solvent (5 mL); pre-filled syringe (5 mL))
Croatian: EU/1/15/1076/023 - 30 x (Kovaltry 2000 IU - otapalo (5 ml); napunjena štrcaljka (5 ml))