natgillin/translations-raw huggingface dataset:
In clinical studies, Helixate NexGen has been used in the treatment of bleeding episodes in 37 previously untreated patients (PUPs) and 23 minimally treated paediatric patients (MTPs, defined as having ≤4 exposure days) with residual FVIII:C < 2 IU/dl.
U kliničkim ispitivanjima, Helixate NexGen se upotrebljavao za liječenje krvarenja u 37 prethodno neliječenih bolesnika (PNB) te 23 minimalno liječena pedijatrijska bolesnika (MLB, definirani kao izloženi lijeku ≤4 dana) s rezidualnim FVIII C < 2 IU/dl.
A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE
Example: for a 75 kg patient with a clearance of 3 ml/h/kg, the initial infusion rate would be 3 IU/h/kg to achieve a FVIII level of 100%.
Primjer: početna brzina infuzije za bolesnika težine 75 kg i klirensa od 3 ml/h/kg iznosila bi 3 IU/h/kg ako se želi postići razina faktora VIII od 100%.
Helixate NexGen is provided as a powder and solvent for solution for injection and is a dry white to slightly yellow powder or cake.
Helixate NexGen sastoji se od praška i otapala za otopinu za injekciju, a dostupan je u obliku suhog bijelog do žućkastog praška ili kolačića.
Patients with haemophilia A may develop neutralising antibodies (inhibitors) to factor VIII.
Bolesnici s hemofilijom A mogu razviti neutralizirajuća protutijela (inhibitore) na faktor VIII.
• formation of neutralising antibodies to factor VIII (inhibitors) in previously untreated patients
• stvaranje neutralizirajućih protutijela na faktor VIII (inhibitora) u prethodno neliječenih bolesnika
Even doses several fold higher than the recommended clinical dose (related to body weight) failed to demonstrate any acute or subacute toxic effects for Helixate NexGen in laboratory animals (mouse, rat, rabbit, and dog).
Čak i pri primjeni višestruko veće doze lijeka Helixate NexGen od preporučene kliničke doze (koja je povezana s tjelesnom težinom) u laboratorijskih se životinja (miša, štakora, kunića i psa) nisu očitovali nikakvi akutni ni subakutni toksični učinci.
PUPs = previously untreated patients PTPs = previously treated patients MTPs = minimally treated patients * see section below
PNB = prethodno neliječeni bolesnici PLB = prethodno liječeni bolesnici MLB = minimalno liječeni bolesnici
• This medicine is intended for intravenous administration only and should be administered within 3 hours after reconstitution.
Ovaj lijek namijenjen je isključivo za primjenu u venu te se mora primijeniti u roku od 3 sata nakon pripreme za primjenu.
Carefully remove the blister package from the Mix2Vial set by holding at the rim, and pulling vertically upwards.
Oprezno uklonite blister pakiranje s kompleta uređaja Mix2Vial držeći ga za obod i povlačeći okomito prema gore.
The rate of administration should be determined by the patient's comfort level (maximal rate of infusion: 2 ml/min).
Brzina primjene određuje se prema stupnju tolerancije bolesnika (maksimalna je brzina infuzije 2 ml/min).
• If you are allergic to mouse or hamster protein.
• ako ste alergični na bjelančevine miša ili hrčka.
With one hand grasp the product-side of the Mix2Vial set and with the other hand grasp the solvent-side and unscrew the set carefully into two pieces.
Jednom rukom primite komplet uređaja Mix2Vial za onu stranu na kojoj je lijek, a drugom za stranu na kojoj je otapalo te oprezno odvijte komplet u dva komada.
Finally, apply a small pressure dressing to the wound.
Na kraju lagano stisnite ranu previjanjem.
In clinical studies with 73 previously treated patients (PTP, defined as having ≥100 exposure days), followed over 4 years, no de-novo inhibitors were observed.
U kliničkim ispitivanjima 73 prethodno liječena bolesnika (PLB, definirani kao oni s ≥100 dana izloženosti) praćenih tijekom 4 godine nije zabilježena pojava de-novo inhibitora.
It has been shown in a clinical study performed with adult haemophilia A patients who undergo a major surgery that Helixate NexGen can be used for continuous infusion in surgeries (pre-, during and postoperative).
Kliničko ispitivanje provedenu u odraslih bolesnika s hemofilijom A u kojih se radi veliki kirurški zahvat pokazalo je da se Helixate NexGen može koristiti za kontinuiranu infuziju kod operacije (prije,
1 vial with 5.0 ml water for injections.
1 bočica s 5,0 ml vode za injekcije
1 vial with 2.5 ml water for injections.
1 bočica s 2,5 ml vode za injekcije
• If for the administration of Helixate NexGen you will require a central venous access device (CVAD), the risk of CVAD-related complications including local infections, bacteria in the blood (bacteremia) and the formation of a blood clot in the blood vessel (thrombosis) where the catheter is inserted should be considered by your doctor.
• Ako Vam je zbog primjene lijeka Helixate NexGen potrebno postaviti centralni venski kateter, Vaš liječnik treba uzeti u obzir rizik od komplikacija povezanih s centralnim venskim kateterom, kao što su lokalne infekcije, bakterije u krvi (bakterijemija) i stvaranje krvnog ugruška u krvnoj žili (tromboza) u koju je uveden kateter.
• formation of neutralising antibodies to factor VIII (inhibitors) in previously treated patients
• stvaranje neutralizirajućih protutijela na faktor VIII (inhibitora) u prethodno liječenih bolesnika
• an additional package with: - 1 filter transfer device 20/20 [Mix2Vial] - 1 venipuncture set - 1 disposable 5 ml syringe - 2 alcohol swabs for single use
• dodatno pakovanje koje sadrži sljedeće: - 1 uređaj za prijenos s filtrom 20/20 [Mix2Vial]
Inhibitor development in previously untreated and treated patients (PUPs / PTPs) has been reported (see section 4.4).
Razvoj inhibitora zabilježen je u prethodno neliječenih i liječenih bolesnika (PNB / PLB) (vidjeti dio
It is strongly recommended that every time that Helixate NexGen 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.
Dokumentiranje Snažno se preporučuje da se pri svakoj primjeni lijeka Helixate NexGen zabilježi naziv i serijski broj lijeka kako bi se održala veza između bolesnika i serije lijeka..
Usually, the substitution therapy with Helixate NexGen is a life-time treatment.
Nadomjesno liječenje lijekom Helixate NexGen najčešće traje tijekom cijelog života.
Helixate NexGen contains low level of polysorbate-80 as an excipient, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC) materials.
Helixate NexGen kao pomoćnu tvar sadrži malu količinu polisorbata 80, za koji je poznato da povećava brzinu ekstrakcije di-(2-etilheksil)ftalata (DEHP) iz polivinilkloridnih
Helixate NexGen should be injected intravenously over several minutes.
Helixate NexGen injicira se intravenski tijekom nekoliko minuta.
Do not use Helixate NexGen if you notice visible particulate matter or turbidity.
Helixate NexGen nemojte koristiti ako zamijetite vidljive čestice ili zamućenje.
The analysis of all recorded in vivo recoveries in previously treated patients demonstrated a mean rise of 2 % per IU/kg body weight for Helixate NexGen.
Analiza svih oporavaka in vivo zabilježenih u prethodno liječenih bolesnika pokazala je da prilikom korištenja lijeka Helixate NexGen dolazi do srednje vrijednosti porasta razine faktora od 2% po IU/kg tjelesne mase.
Duration of treatment Your doctor will tell you, how often and at what intervals this medicine is to be administered.
Trajanje liječenja Liječnik će Vam reći potrebnu učestalost i vremenske razmake primjene ovog lijeka.
Based on the rare occurrence of haemophilia A in women, experience regarding the use of Helixate NexGen during pregnancy and breast-feeding is not available.
Zbog rijetke pojave hemofilije A u žena nisu dostupni podaci o primjeni lijeka Helixate NexGen tijekom trudnoće i dojenja.
Detailed instructions for preparation and administration are contained in the package leaflet provided with Helixate NexGen.
Detaljne upute za pripremu i primjenu lijeka navedene su u Uputi o lijeku koja se isporučuje uz Helixate NexGen.
Gently swirl the product vial with the transparent adapter attached until the substance is fully dissolved.
Polako okrećite bočicu s lijekom i prozirnim adapterom dok se sadržaj potpuno ne rastopi.
Animal reproduction studies have not been conducted with Helixate NexGen.
Nisu provedena reproduktivna ispitivanja lijeka Helixate NexGen na životinjama.
• one vial with powder (10 ml clear glass type 1 vial with latex-free grey halogenobutyl rubber blend stopper and aluminium seal)
• jednu bočicu s praškom (10-mililitarska bočica od prozirnog stakla tipa 1 sa sivim gumenim čepom od halogenobutila bez lateksa i aluminijskim prstenom)
Place the solvent vial on an even, clean surface and hold the vial tight.
Postavite bočicu otapala na ravnu i čistu površinu te je čvrsto držite.
MARKETING AUTHORISATION HOLDER Bayer Pharma AG 13342 Berlin Germany
Nositelj odobrenja za stavljanje gotovog lijeka u promet Bayer Pharma AG 13342 Berlin
Management of such patients should be directed by physicians with experience in the care of haemophilia and factor VIII inhibitors.
Liječenje takvih bolesnika moraju voditi liječnici s iskustvom u liječenju hemofilije i inhibitora faktora VIII.
• one vial with solvent (6 ml clear glass type 1 vial with latex-free grey chlorobutyl rubber blend stopper and aluminium seal)
• jednu bočicu s otapalom (60-mililitarska bočica od prozirnog stakla tipa 1 sa sivim gumenim čepom klorobutila bez lateksa i aluminijskim prstenom)
The reconstituted product must be filtered prior to administration to remove potential particulate matter in the solution.
Pripremljeni lijek se prije primjene mora filtrirati kako bi se iz otopine uklonile moguće čestice.
Take the Mix2Vial together with the blister package and push the spike of the blue adapter end straight down through the solvent vial stopper.
Primite Mix2Vial zajedno s blister pakiranjem te šiljak plavog kraja adaptera ugurajte ravno prema dolje kroz čep bočice otapala.
Expected factor VIII rise (% of normal) = 2 × administered IU body weight (kg)
Očekivani porast faktora VIII (% od normalne vrijednosti) = 2 × primijenjeni broj IU
Helixate NexGen should be reconstituted and administered with the components provided with each package.
Helixate NexGen treba pripremiti i primijeniti pomoću pribora priloženog u pakiranju.
• You must use aseptic conditions (meaning clean and germ free) during reconstitution and administration.
Tijekom pripreme i primjene moraju se koristiti aseptični uvjeti (što znači da okruženje mora biti čisto i bez mikroorganizma).
Method of administration Intravenous use.
Za intravensku primjenu.
What Helixate NexGen 1000 IU is and what it is used for
Što je Helixate NexGen 1000 IU i za što se koristi
Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the transparent Mix2Vial adapter from the syringe.
12. Kada je otopina prenesena u štrcaljku, čvrsto primite cilindar štrcaljke (s klipom okrenutim prema dolje) te odvojite prozirni adapter uređaja Mix2Vial od štrcaljke.
If this dose does not control your bleeding your doctor may consider giving you an additional product, factor VIIa concentrate or (activated) prothrombin complex concentrate.
liječnik će Vam možda dati dodatni lijek - koncentrat faktora VIIa ili (aktivirani) koncentrat protrombinskog kompleksa.
After reconstitution, the solution is drawn through the Mix2Vial filter transfer device into the sterile disposable syringe (both supplied).
Otopina se nakon pripreme za primjenu navlači u sterilnu jednokratnu štrcaljku kroz uređaj za prijenos s filtrom Mix2Vial (oba se pribora isporučuju uz lijek).
Additional pharmacokinetic parameters for Helixate NexGen for bolus injection are: mean residence time [MRT (0-48)] of about 22 hours and clearance of about 160 ml/h.Mean baseline clearance for 14 adult patients undergoing major surgeries with continuous infusion are 188 ml/h corresponding to 3.0 ml/h/kg (range 1.6-4.6 ml/h/kg).
Srednji ishodni klirens 14 odraslih bolesnika podvrgnutih opsežnim kirurškim zahvatima uz kontinuiranu infuziju iznosio je 188 ml/h, što odgovara 3,0 ml/h/kg (raspon od 1,6 do 4,6 ml/h/kg).
Helixate NexGen powder should only be reconstituted with the supplied solvent (5.0 ml water for injections) using the supplied sterile Mix2Vial filter transfer device.
Prašak Helixate NexGen smije se pripremati samo otapalom (5,0 ml vode za injekcije) priloženim u sterilnom uređaju za prijenos s filtrom Mix2Vial.
16 Let blood flow back to the open end of the venipuncture set and then attach the syringe with the solution.
16 Pustite da krv poteče u otvoreni kraj kompleta za venepunkciju te priključite štrcaljku s otopinom.
LIST OF EXCIPIENTS Glycine, sodium chloride, calcium chloride, histidine, polysorbate 80, sucrose.
Glicin, natrijev klorid, kalcijev klorid, histidin, polisorbat 80, saharoza.
The solvent will automatically flow into the product vial.
Otapalo će automatski poteći u bočicu s lijekom.
Helixate NexGen powder should only be reconstituted with the supplied solvent (2.5 ml water for injections) using the supplied sterile Mix2Vial filter transfer device.
Prašak Helixate NexGen smije se pripremati samo otapalom (2,5 ml vode za injekcije) priloženim u sterilnom uređaju za prijenos s filtrom Mix2Vial.
Discard the solvent vial with the blue Mix2Vial adapter attached.
Bacite bočicu s otapalom zajedno s plavim adapterom uređaja Mix2Vial.
After administration of Helixate NexGen, peak factor VIII activity decreased by a two-phase exponential decay with a mean terminal half-life of about 15 hours.
Vršna vrijednost aktivnosti faktora VIII nakon primjene lijeka Helixate NexGen opada tijekom njegove dvofazne razgradnje, a prosječni terminalni poluvijek iznosi oko 15 sati.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL WITH 2.5 ML WATER FOR INJECTIONS
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BOČICA S 2,5 ML VODE ZA INJEKCIJE
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.
Ti su inhibitori najčešće IgG imunoglobulini usmjereni na prokoagulacijsku aktivnost faktora VIII i izražavaju se u Bethesda jedinicama (BU) na ml plazme primjenom izmijenjenog testa.
Experience regarding fertility or the use of Helixate NexGen during pregnancy and breast-feeding is not available.
Nisu dostupni podaci o uzimanju lijeka Helixate NexGen tijekom trudnoće i dojenja, kao niti iskustvo u pogledu plodnosti.
While keeping the syringe plunger pressed, turn the system upside down and draw the solution into the syringe by pulling the plunger back slowly.
Klip štrcaljke držite potisnutim, a zatim preokrenite sustav te povucite otopinu u štrcaljku polaganim povlačenjem klipa.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL WITH 5.0 ML WATER FOR INJECTIONS
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BOČICA S 5,0 ML VODE ZA INJEKCIJE
If bleeding is not controlled
Ako se krvarenje ne zaustavi ni većom dozom,
If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for the presence of factor VIII inhibitor should be performed.
Ako se ne postignu očekivane razine aktivnosti faktora VIII u plazmi ili ako se krvarenje ne može kontrolirati odgovarajućom dozom, potrebno je provesti pretragu na prisutnost inhitora faktora VIII.
In this case, the product expires at the end of this 12-month period or the expiration date on the product vial, whichever is earlier.
Rok valjanosti ovog lijeka u tom slučaju ističe nakon 12-mjesečnog razdoblja ili datuma isteka roka valjanosti na bočici, ovisno o tome koji nastupi ranije.
• You must filter the reconstituted product before administration to remove potential particulate matter in the solution.
Pripremljeni lijek prije primjene morate filtrirati kako biste uklonili moguće čestice iz otopine.
Data show that Helixate NexGen has been used to induce immune tolerance.
NexGen primjenjivao za izazivanje imunološke tolerancije.
If you use more Helixate NexGen 250 IU than you should No cases of overdose with recombinant coagulation factor VIII have been reported.
Ako primijenite više lijeka Helixate NexGen 250 IU nego što ste trebali Nije zabilježen niti jedan slučaj predoziranja rekombinantnim koagulacijskim faktorom VIII.
Under certain circumstances larger amounts than those calculated may be required, especially for the initial dose.
U određenim okolnostima, pogotovo za početnu dozu, može biti potrebna primjena većih količina od izračunatih.
The speed of administration should be based on the patient's comfort, but should not be faster than 2ml/min maximum rate of infusion.
Brzina injiciranja određuje se prema tome koju brzinu bolesnik može podnijeti, ali ne smije biti veća od 2 ml/min.
Place the product vial on an even and firm surface.
Postavite bočicu s lijekom na ravnu i čvrstu površinu.
For calculation of ml/hour, multiply infusion rate in IU/h/kg by kg bw/concentration of solution (IU/ml).
Da biste izračunali brzinu izraženu u ml/h, brzinu infuzije izraženu u IU/h/kg pomnožite s tjelesnom težinom/koncentracija otopine (IU/ml).
Inject air into the product vial.
Ubrizgajte zrak u bočicu s lijekom.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Parenteralne lijekove prije primjene treba vizualno pregledati na prisutnost čestica i promjenu boje.
What Helixate NexGen 250 IU contains
Što Helixate NexGen 250 IU sadrži
• dysgeusia
• omaglicu
If the inhibitor is present at levels less than 10 Bethesda Units (BU) per ml, administration of additional recombinant coagulation factor VIII may neutralise the inhibitor and permit continued clinically effective therapy with Helixate NexGen.
Ako je prisutna razina inhibitora manja od 10 Bethesda jedinica (BU) po ml, dodatna primjena rekombinantnog koagulacijskog faktora VIII
Other medicines and Helixate NexGen 250 IU
Drugi lijekovi i Helixate NexGen 250 IU
On demand treatment
Trajanje liječenja
Five out of 37 (14%) PUP and 4 out of 23 (17%) MTP patients treated with Helixate NexGen developed inhibitors within 20 exposure days.
Inhibitori su se razvili unutar 20 dana izloženosti u 5 od 37 (14%) prethodno neliječenih bolesnika te u 4 od 23 (17%) minimalno liječena pedijatrijska bolesnika koji su primali Helixate NexGen.
What Helixate NexGen 250 IU is and what it is used for What you need to know before you use Helixate NexGen 250 IU How to use Helixate NexGen 250 IU Possible side effects
Što je Helixate NexGen 250 IU i za što se koristi Što morate znati prije nego počnete primjenjivati Helixate NexGen 250 IU
What Helixate NexGen 2000 IU contains
Što Helixate NexGen 2000 IU sadrži
If you forget to use Helixate NexGen 250 IU
Ako ste zaboravili primijeniti Helixate NexGen 250 IU
Common: may affect up to 1 in 10 users:
Često: mogu se javiti u do 1 na 10 korisnika
Do not use Helixate NexGen 2000 IU
Nemojte primjenjivati Helixate NexGen 2000 IU
INFORMATION IN BRAILLE Helixate NexGen 2000
16. PODACI NA BRAILLEOVOM PISMU Helixate NexGen 2000
Do not use Helixate NexGen 250 IU
Nemojte primjenjivati Helixate NexGen 250 IU
Inhibitor Formation to FVIII (reported in PUPs and MTPs)*
Razvoj inhibitora faktora VIII (zabilježen u PNB i
INFORMATION IN BRAILLE Helixate NexGen 250
16. PODACI NA BRAILLEOVOM PISMU Helixate NexGen 250
Do not use Helixate NexGen 500 IU
Nemojte primjenjivati Helixate NexGen 500 IU
The formation of neutralising antibodies to factor VIII (inhibitors) is a known complication in the treatment of patients with haemophilia A. Your doctor may wish to carry out tests to monitor inhibitor development.
Stvaranje neutralizirajućih antitijela za faktor VIII (inhibitora) poznata je komplikacija prilikom terapije za oboljele od hemofilije A.
Open the Mix2Vial package by peeling away the lid. Do not remove the Mix2Vial from the blister package!
Nemojte vaditi Mix2Vial iz blister pakovanja!
While the product vial is upright, connect the syringe to the Mix2Vial´s Luer Lock fitting.
Bočicu s lijekom držite uspravno te priključite štrcaljku na priključak "luer" uređaja Mix2Vial.
What you need to know before you use Helixate NexGen 250 IU
Što morate znati prije nego počnete primjenjivati Helixate NexGen 250 IU
METHOD OF ADMINISTRATION For reconstitution of Helixate NexGen, see package leaflet.
Upute za pripremu za primjenu lijeka Helixate NexGen pročitajte u uputi o lijeku.
Do not use Helixate NexGen 1000 IU
Nemojte primjenjivati Helixate NexGen 1000 IU
Hold a swab firmly over the injection site on the outstretched arm for approx. 2 minutes.
Otprilike 2 minute na ispruženoj ruci čvrsto držite rupčić na mjestu injiciranja.
Other medicines and Helixate NexGen 2000 IU
Drugi lijekovi i Helixate NexGen 2000 IU
Not known: frequency cannot be estimated from the available data
Učestalost se ne može procijeniti iz dostupnih podataka • disgeuzija (poremećaj osjeta okusa)
METHOD OF ADMINISTRATION Read the package leaflet before use.
NAČIN PRIMJENE LIJEKA Prije uporabe pročitati Uputu o lijeku.
Other medicines and Helixate NexGen 1000 IU
Drugi lijekovi i Helixate NexGen 1000 IU
Invert the solvent vial with the Mix2Vial set attached and push the spike of the transparent adapter end straight down through the product vial stopper.
Preokrenite bočicu s otapalom i priključenim kompletom uređaja Mix2Vial te šiljak prozirnog kraja adaptera ugurajte ravno prema dolje kroz čep bočice s lijekom.
He/she should always adjust the amount of this medicine to be administered and the frequency of administration according to your individual needs.
Količinu i učestalost primjene ovog lijeka liječnik uvijek mora odrediti prema potrebama pojedinačnog bolesnika.
Take special care with Helixate NexGen 250 IU
Budite posebno oprezni s lijekom Helixate NexGen 250 IU
• hypersensitivity reactions including severe sudden allergic reaction (which may include hives, nausea, urticaria, angioedema, chills, flushing, headache, lethargy, wheezing or difficulty breathing, restlessness, tachycardia, tingling or anaphylactic shock, e.g. tightness of the chest/general feeling of being unwell, dizziness and nausea and mildly reduced blood pressure, which may make you feel faint upon standing)
letargiju, piskanje pri disanju ili otežano disanje, nemir, ubrzani otkucaji srca, trnce ili anafilaktički šok, npr. stezanje u prsima/osjećaj opće slabosti, omaglica i mučnina te blago sniženi krvni tlak zbog kojeg je moguća omaglica prilikom ustajanja)
What Helixate NexGen 250 IU looks like and content of the pack
Kako Helixate NexGen 250 IU izgleda i sadržaj pakiranja
Do not use Helixate NexGen 3000 IU
Nemojte primjenjivati Helixate NexGen 3000 IU
Very common: may affect more than 1 in 10 users
mogu se javiti u više od 1 na 10 korisnika
Other medicines and Helixate NexGen 500 IU
Drugi lijekovi i Helixate NexGen 500 IU
What Helixate NexGen 2000 IU looks like and content of the pack
Kako Helixate NexGen 2000 IU izgleda i sadržaj pakiranja
Take special care with Helixate NexGen 500 IU
Budite posebno oprezni s lijekom Helixate NexGen 500 IU
INFORMATION IN BRAILLE Helixate NexGen 1000
16. PODACI NA BRAILLEOVOM PISMU Helixate NexGen 1000
If you forget to use Helixate NexGen 1000 IU
Ako ste zaboravili primijeniti Helixate NexGen 1000 IU
What Helixate NexGen 1000 IU contains
Što Helixate NexGen 1000 IU sadrži
If you forget to use Helixate NexGen 2000 IU
Ako ste zaboravili primijeniti Helixate NexGen 2000 IU
How to store Helixate NexGen 250 IU Contents of the pack and other information
Kako čuvati Helixate NexGen 250 IU Sadržaj pakiranja i druge informacije
The vial with powder contains 250 IU (International Units) of octocog alfa.
Bočica s praškom sadrži 250 IU (međunarodnih jedinica) oktokoga alfa.
Take special care with Helixate NexGen 1000 IU
Budite posebno oprezni s lijekom Helixate NexGen 1000 IU
Uncommon may affect up to 1 in 100 users
mogu se javiti u do 1 na 100 korisnika