natgillin/translations-raw huggingface dataset:
Do not use Memantine Merz after the expiry date which is stated on the carton and the bottle label after the EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kartonskoj kutiji i naljepnici boce nakon “Rok valjanosti”.
100 D-60318 Frankfurt/Main Germany 
Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100 D-60318 Frankfurt/Main Njemačka
half a 10 mg tablet week 2 
3. tjedan jedna i pol tableta od 10 mg
Memantine Merz 5 mg 7 film-coated tablets. 
Memantine Merz 5 mg 7 filmom obloženih tableta.
Titanium dioxide (E 171) Iron oxide yellow and red (E 172) 
Ovojnica tablete hipromeloza makrogol 400 titanijev dioksid (E 171) željezov oksid, žuti i crveni (E 172)
5 mg tablet week 2 
1. tjedan tableta od 5 mg
Week 3 (day 15-21): The patient should take one 15 mg film-coated tablet per day for 7 days. 
3. tjedan (15. - 21. dan): Bolesnik treba uzimati jednu filmom obloženu tabletu od 15 mg dnevno, tijekom 7 dana.
On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day as described above. 
Temeljem kliničkih ispitivanja, preporučena doza za bolesnike starije od 65 godina iznosi 20 mg na dan
Pale red to grey-red, oval-oblong film-coated tablets with imprint “20” on one side and imprint “MEM” on the other side. 
Blijedocrvene do sivo-crvene duguljaste ovalne filmom obložene tablete s utisnutim oznakama “20” na jednoj strani i “MEM” na drugoj strani.
Memantine Merz 20 mg film-coated tablets 
Memantine Merz 20 mg filmom obložene tablete
Memantine Merz 10 mg 7 film-coated tablets. 
Memantine Merz 10 mg 7 filmom obloženih tableta.
Administration 
SUSTAVA
Memantine Merz 5 mg film-coated tablets Memantine Merz 10 mg film-coated tablets Memantine Merz 15 mg film-coated tablets Memantine Merz 20 mg film-coated tablets Memantine hydrochloride 
Memantine Merz 5 mg filmom obložene tablete Memantine Merz 10 mg filmom obložene tablete Memantine Merz 15 mg filmom obložene tablete Memantine Merz 20 mg filmom obložene tablete memantinklorid
Memantine Merz film-coated tablets are presented as pale red to grey-red, oval-oblong film-coated tablets with imprint ‘20' on one side and imprint ‘MEM' on the other side. 
Memantine Merz filmom obložene tablete su blijedocrvene do sivo-crvene, ovalno duguljaste filmom obložene tablete s utisnutom oznakom ‘20' na jednoj strani i ‘MEM' na drugoj strani.
Memantine Merz film-coated tablets are presented as pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings "1-0" on one side and "M M" on the other side. 
Memantine Merz filmom obložene tablete su blijedožute do žute boje, filmom obložene tablete ovalnog oblika s razdjelom crtom i utisnutim oznakama “1-0” na jednoj strani te “M M” na drugoj strani.
Lundbeck Slovensko s.r.o. 
Lundbeck Italia S.p.A.
Titanium dioxide (E 171) Iron oxide yellow (E 172) 
Ovojnica tablete hipromeloza makrogol 400 titanijev dioksid (E 171) željezov oksid, žuti (E 172)
Week 2 (day 8-14): The patient should take one 10 mg film-coated tablet per day for 7 days. 
2. tjedan (8. - 14. dan): Bolesnik treba uzimati jednu filmom obloženu tabletu od 10 mg dnevno, tijekom 7 dana.
Memantine Merz 5 mg film-coated tablets Memantine Merz 10 mg film-coated tablets Memantine Merz 15 mg film-coated tablets Memantine Merz 20 mg film-coated tablets 
Memantine Merz 5 mg filmom obložene tablete Memantine Merz 10 mg filmom obložene tablete Memantine Merz 15 mg filmom obložene tablete Memantine Merz 20 mg filmom obložene tablete
Memantine Merz 10 mg film-coated tablets 
Memantine Merz 10 mg filmom obložene tablete
Memantine Merz 10 mg film-coated tablets Memantine hydrochloride 
Memantine Merz 10 mg filmom obložene tablete memantinklorid
See package leaflet for further information. 
Za dodatne informacije vidjetu Uputu o lijeku.
The 10 mg film-coated tablets are pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings "1-0" on one side and "M M" on the other side The tablet can be divided into equal halves. 
Filmom obložene tablete od 10 mg su blijedožute do žute, filmom obložene tablete ovalnog oblika, s razdjelnom crtom i utisnutom oznakom “1-0” na jednoj strani i “M M” na drugoj strani.
Memantine Merz 20 mg film-coated tablets Memantine hydrochloride 
Memantine Merz 20 mg filmom obložene tablete memantinklorid
The dosing pump head has two positions and is easy to turn: anticlockwise to unlock and clockwise to lock. 
Kako radi pumpica za doziranje: Vrh pumpice za doziranje ima dva položaja i može se lako okrenuti:
Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine. 
Svaka filmom obložena tableta sadrži 10 mg memantinklorida što odgovara 8,31 mg memantina.
Drug hypersensitivity 
Često preosjetljivost na lijek
Lundbeck Pharma d.o.o. 
Lundbeck B.V.
• Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism) 
(konfuziju, omamljenost, somnolenciju, vrtoglavicu, agitaciju, agresiju, halucinacije i poremećaj hoda) i/ili gastrointestinalne simptome (povraćanje i proljev).
Renal impairment 
UČESTALOST NUSPOJAVA
Lundbeck Hungaria Kft. Tel: +36 1 4369980 
Lundbeck Croatia d.o.o. Tel.: + 385 1 3649 210
Memantine Merz 10 mg film-coated tablets are presented as pale yellow to yellow, oval shaped filmcoated tablet with breaking line and engravings "1-0" on one side and "M M" on the other side The tablet can be divided into equal halves. 
Memantine Merz 10 mg filmom obložene tablete su blijedožute do žute, filmom obložene tablete ovalnog oblika, s razdjelnom crtom i utisnutom oznakom “1 0” na jednoj strani i “M M” na drugoj strani.
Week 1 (day 1-7): The patient should take one 5 mg film-coated tablet per day for 7 days. 
1. tjedan (1. - 7. dan): Bolesnik treba uzimati jednu filmom obloženu tabletu od 5 mg dnevno, tijekom 7 dana.
Memantine-treated patients showed a statistically significantly better effect than placebo-treated patients on the primary endpoints: Alzheimer´s disease assessment scale (ADAS-cog) (p=0.003) -and CIBIC-plus (p=0.004) at week 24 last observation carried forward (LOCF). 
Alzheimer´s disease assessment scale) (p=0,003) i CIBIC-plus (p=0,004) u 24. tjednu liječenja (zadnje opažanje preneseno dalje (LOCF; engl. last observation carried forward)).
Week 3 (day 15-21): The patient should take 1.5 ml solution (15 mg) equivalent to three pump actuations per day for 7 days. 
Bolesnik treba uzimati 1,5 ml otopine (15 mg) što odgovara tri potiska pumpice dnevno, tijekom 7 dana.
• Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism) Very rare (may affect up to 1 in 10,000 users): 
Manje često (mogu se javiti u do 1 na 100 osoba): • umor, gljivične infekcije, smetenost, halucinacije, povraćanje, poremećaj hoda, zatajenje srca i zgrušavanje venske krvi (tromboza/tromboembolija)
Somnolence 
Dojenje
Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine. 
TVARI Svaka filmom obložena tableta sadrži 10 mg memantinklorida što odgovara 8,31 mg memantina.
MARKETING AUTHORISATION NUMBER(S) 13. 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
one 10 mg tablet week 3 
2. tjedan jedna tableta od 10 mg
Week 1 (day 1-7): The patient should take 0.5 ml solution (5 mg) equivalent to one pump actuation per day for 7 days. 
Bolesnik treba uzimati 0,5 ml otopine (5 mg) što odgovara jednom potisku pumpice dnevno, tijekom 7 dana.
10 mg tablet week 3 
2. tjedan tableta od 10 mg
Week 1 (day 1-7): Take one 5 mg tablet once a day (white to off-white, oval-oblong) for 7 days. 
Uzimajte jednu tabletu od 5 mg jednom dnevno (bijelu do gotovo bijelu, duguljasto ovalnu) tijekom 7 dana.
- If you get side effects, talk to your doctor or pharmacist. 
Ako pumpica ne radi ispravno, obratite se svom liječniku ili ljekarniku.
Lot {number} 
Broj serije {broj}
Week 1 (day 1-7): The patient should take one 5 mg film-coated tablet per day (white to off-white, oval-oblong) for 7 days. 
Bolesnik treba uzimati jednu filmom obloženu tabletu od 5 mg (bijelu do prljavo bijelu, duguljasto ovalnu) dnevno tijekom 7 dana.
Lundbeck Hellas A.E Τηλ. 
Lundbeck Hungaria Kft.
Confusion 
Primjena
LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS 
I SAŽETAK OPISA SVOJSTAVA LIJEKA
Fungal infections 
Manje često gljivične infekcije
98 film-coated tablets 
I 10 x 98 TABLETA)
week 1 
1. tjedan (1. - 7. dan):
On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (20 mg once a day) as described above. 
Temeljem kliničkih ispitivanja preporučena doza za bolesnike starije od 65 godina iznosi 20 mg na dan,
The use of medicinal products called amantadine (for the treatment of Parkinson´s disease), ketamine 
- barbiturata (lijekovi koji se uglavnom koriste za uspavljivanje) - dopaminergičkih agonista (lijekovi kao što su L-dopa, bromokriptin)
If the pump does not function properly, consult your doctor or a pharmacist.Lock the dosing pump after using Memantine Merz. 
Zaključajte pumpicu za doziranje nakon primjene Memantine Merza.
EU-Number 
Broj (EU) odobrenja
Package size 
Sastav Veličina pakovanja
Pharmaceutical Form Route of Administration Packaging 
Put primjene Pakovanje
Strength Pharmaceutical Form Route of Administration 
Broj (EU) odobrenja Zaštićeno ime Doza Farmaceutski oblik
1 vial + 1 vial 
Put primjene Unutarnje pakovanje Sastav (koncentracija)
This should be done right after step J. 
To treba učiniti odmah nakon koraka J.
You will also need: 
Trebat ćete i:
b Calculation based on 67 profiles. 
b Izračun na temelju 67 profila.
The package contains: 
Pakiranje sadrži:
Always wash your hands and ensure that the area around you is clean. 
Uvijek operite ruke i pobrinite se da područje oko Vas bude čisto.
You can do this by holding them in your hands until they feel as warm as your hands, see figure A. 
To se može postići tako da ih držite u rukama sve dok ne osjetite da su tople kao i Vaše ruke, pogledajte sliku A.
• Inject slowly over approximately 2 minutes. 
• Injicirajte polako tijekom otprilike 2 minute.
Use a new package instead. 
Umjesto toga upotrijebite novo pakiranje.
Repeat after 24 hours if necessary 
Po potrebi ponoviti nakon 24 sata
The equipment is for single use only. 
Pribor je namijenjen samo za jednokratnu uporabu.
• You will be monitored carefully for development of these inhibitors 
• Bit ćete detaljno praćeni na razvoj takvih inhibitora
Always use an aseptic technique. 
Uvijek treba primjenjivati aseptičku tehniku.
Within one hour before surgery 
Unutar jednog sata prije kirurškog zahvata
Osmolality: 590 mOsmol/kg. 
Osmolalnost: 590 mOsmol/kg.
Your doctor will calculate your dose for you. 
Liječnik će izračunati dozu lijeka za Vas.
• Take out the number of Esperoct packages you need. 
• Uzmite onoliki broj Esperoct pakiranja koliko trebate.
After reconstitution 
Nakon rekonstitucije
• These inhibitors, especially at high levels, stop the treatment working properly 
• Ti inhibitori, posebice pri visokim razinama, zaustavljaju pravilno liječenje
Do not use the powder if the colour has changed. 
Nemojte upotrijebiti prašak ako mu se boja promijenila.
No correlation with adverse events could be established. 
Nije ustanovljena korelacija sa štetnim događajima.
Talk to your doctor or pharmacist if you have heart disease or you are at risk of heart disease. 
Razgovarajte sa svojim liječnikom ili ljekarnikom ako imate bolest srca ili imate rizik za razvoj bolesti srca.
Proceed with the next injection as scheduled and continue as advised by your doctor. 
Nastavite s idućom injekcijom prema rasporedu i nastavite kako Vam je savjetovao Vaš liječnik.
In case of shock, standard medical treatment for shock should be implemented. 
U slučaju šoka, treba primijeniti standardno liječenje šoka.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 10. 
DATUM PRVOG ODOBRENJA / DATUM OBNOVE ODOBRENJA
Protective paper 
Zaštitni papir
If such inhibitors occur, the condition will manifest itself as an insufficient clinical response. 
Ako se pojave takvi inhibitori, stanje će se manifestirati kao nedovoljan klinički odgovor.
Prophylaxis in adults/adolescents 
Profilaksa u odraslih/adolescenata
• Wash your hands and dry them properly using a clean towel or let them air dry. 
• Operite ruke i dobro ih osušite čistim ručnikom ili pustite da se osuše na zraku.
• Check the name, strength and colour of the package to make sure it contains the correct product. 
• Provjerite naziv, jačinu i boju na pakiranju kako biste bili sigurni da sadrži odgovarajući lijek.
Check with your doctor if you are not sure about how to use Esperoct. 
Provjerite s liječnikom ako niste sigurni kako primijeniti lijek Esperoct.
• headache, nausea or vomiting. 
• glavobolja, mučnina ili povraćanje.
The safety and efficacy of Esperoct in previously untreated patients have not yet been established. 
Sigurnost i djelotvornost lijeka Esperoct u prethodno neliječenih bolesnika još nisu ustanovljene.
This corresponds to a higher volume of distribution per kilo body weight in children compared to adults (table 4). 
To odgovara većem volumenu distribucije po kilogramu tjelesne težine u djece u usporedbi s odraslima (tablica 4).
This is of importance particularly when changing the laboratory and/or reagents used in the assay. 
To je osobito važno kada se mijenja laboratorij i/ili testni reagens.
Nine of these patients reverted back to prophylaxis every 4 days during the randomised study phase. 
Devet od tih bolesnika vratilo se na profilaksu svaka 4 dana tijekom randomizirane faze ispitivanja.
Do not use Esperoct if either of the above applies to you. 
Nemojte primijeniti Esperoct ako se nešto od gore navedenog odnosi na Vas.
Caution: The pre-filled syringe is made of glass and is designed to be compatible with standard luer-lock connections. 
Oprez: Napunjena štrcaljka izrađena je od stakla i oblikovana da bude kompatibilna sa standardnim luer-lock nastavcima.
* PTPs: Previously-treated patients. 
* PTP: Prethodno liječeni bolesnici.
If you are not sure, talk to your doctor before using this medicine. 
Ako niste sigurni, obratite se svom liječniku prije nego primijenite ovaj lijek.
• redness and/or swelling of the lips, tongue, face or hands 
• crvenilo i/ili oticanje usana, jezika, lica ili šaka
Do not reuse the equipment. 
Pribor nemojte ponovno koristiti.
• pale and cold skin, fast heartbeat, or dizziness (low blood pressure) 
• blijeda i hladna koža, ubrzani otkucaji srca ili omaglica (niski krvni tlak).
Do not throw it out with the ordinary household waste. 
Nemojte to baciti u običan kućni otpad.
Therefore, factor VIII should be used during pregnancy and lactation only if clearly indicated. 
Stoga se faktor VIII u trudnoći i tijekom dojenja smije primjenjivati samo ako za to postoje jasne indikacije.
From a microbiological point of view, the product should be used immediately. 
S mikrobiološkog stajališta, lijek se treba odmah primijeniti.
(pre- and post-operative) 
(prije i nakon zahvata)
Esperoct was effective in maintaining haemostasis during major surgery with a success rate of 95.6% in all major surgeries performed (43 out of 45 had the effect rated as ‘excellent‘ or ‘good‘). 
Esperoct je bio djelotvoran u održavanju hemostaze tijekom većih kirurških zahvata sa stopom uspješnosti od 95,6% u svim velikim kirurškim zahvatima (43 od 45 imala su učinak ocijenjen kao „odličan“ ili „dobar“).
Non-clinical data reveal no special concern for humans based on conventional studies of safety pharmacology and repeated dose toxicity. 
Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije i toksičnosti ponovljenih doza.
Do not inject a double dose to make up for a forgotten dose. 
Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
Heart disease 
Bolest srca
Repeat every 8 to 24 hours to maintain factor VIII activity within the target range 
Ponoviti svakih 8 do 24 sata za održavanje aktivnosti faktora VIII unutar ciljnog raspona
Factor VIII is a protein found in the blood that helps to prevent and stop bleeding. 
Faktor VIII je protein koji se nalazi u krvi, a pomaže spriječiti i zaustaviti krvarenje.
If you forget a dose, inject the missed dose as soon as you remember. 
Ako ste zaboravili primijeniti dozu, injicirajte propuštenu dozu čim se sjetite.
Animal reproduction studies have not been conducted with factor VIII. 
Nisu provedena ispitivanja reprodukcije na životinjama s faktorom VIII.
Spike (under protective paper) 
Šiljak (ispod zaštitnog papira)
Pharmacokinetic parameters 
Farmakokinetički parametri
Anti-PEG antibodies 
Anti-PEG protutijela
Consider to continue therapy for another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dL) 
Razmotrite nastavak terapije idućih 7 dana za održavanje aktivnosti faktora VIII od 30% do 60% (IU/dl)
Repeat injection every 8 to 24 hours as necessary until adequate wound healing is achieved 
Ponoviti injekciju svakih 8 do 24 sata, po potrebi, dok se ne postigne prikladno zacjeljivanje rane
Follow the instructions for proper use for your connector and CVAD in consultation with your doctor or nurse. 
Slijedite upute o pravilnoj uporabi Vašeg konektora i CVAD-a u suradnji s liječnikom ili medicinskom sestrom.
common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000); not known (cannot be estimated from the available data). 
Učestalosti su procijenjene na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
Before reconstitution (before the powder is mixed with the solvent): 
Prije pripreme za primjenu (prije nego se prašak pomiješa s otapalom):
The product contains traces of hamster proteins, which in some patients may cause allergic reactions. 
Ovaj lijek sadrži proteine hrčka u tragovima, što u nekih bolesnika može izazvati alergijske reakcije.
What Esperoct looks like and contents of the pack 
Kako Esperoct izgleda i sadržaj pakiranja
Single dose or repeat injection every 24 hours for at least 1 day until healing is achieved 
Jednokratna doza ili ponoviti injekciju svakih 24 sata najmanje 1 dan do zacjeljenja.
The dose level and dosing intervals for surgery depend on the procedure and local practice. 
Razina doze i intervali doziranja za kirurški zahvat ovise o postupku i lokalnoj praksi.
If you stop using Esperoct, you may no longer be protected against bleeding or a current bleed may not stop. 
Ako prestanete primjenjivati lijek Esperoct, možda više nećete biti zaštićeni od krvarenja ili trenutno krvarenje možda neće prestati.
Other medicines and Esperoct 
Drugi lijekovi i Esperoct
When you prepare and inject medicine directly into a vein, it is important to use a clean and germ- free (aseptic) technique. 
Kada pripremate i injicirate lijek izravno u venu, važno je koristiti čistu tehniku bez mikroorganizama (aseptička tehnika).
If you have previously received more than 150 days of treatment with factor VIII, inhibitors (antibodies) may develop (may affect up to 1 in 100 people). 
Ako ste ranije, više od 150 dana liječenja, primali lijekove koji sadrže faktor VIII, mogu se razviti inhibitori (antitijela) (mogu se javiti do 1 na 100 osoba).
This will depend on your body weight and whether it is used to prevent or to treat a bleeding. 
Ona će ovisiti o Vašoj tjelesnoj težini i o tome koristi li se lijek za sprječavanje ili liječenje krvarenja.
Patients received a single dose of 50 IU/kg, and blood samples were collected prior to dosing and at multiple time points up to 96 hours after dosing. 
Bolesnici su primili jednu dozu od 50 IU/kg, a uzorci krvi prikupljeni su prije doziranja i u više navrata do 96 sati nakon doziranja.
Your doctor may choose another dose or how often the injections should be given, based on your need. 
Vaš liječnik može odabrati drugu dozu ili učestalost primjene injekcije, ovisno o Vašoj potrebi.
In children below 12 years long-term safety has not been established. 
U djece mlađe od 12 godina sigurnost dugotrajne primjene nije ustanovljena.
Of the 175 adults/adolescents on prophylaxis, 70 (40%) did not have any bleeds. 
Od 175 odraslih/adolescenata na profilaksi, 70 (40%) nije imalo nikakvih krvarenja.
Pharmacotherapeutic group: antihemorrhagics, blood coagulation factor VIII, ATC code: B02BD02. 
Farmakoterapijska skupina: antihemoragici, krvni koagulacijski faktor VIII, ATK oznaka: B02BD02.
Esperoct is available in packs containing 500 IU, 1000 IU, 1500 IU, 2000 IU, or 3000 IU. 
Esperoct je dostupan u pakiranjima koja sadrže 500 IU, 1000 IU, 1500 IU, 2000 IU ili 3000 IU.
Of the 68 children below 12 years on prophylaxis, 29 (42.6%) did not have any bleeds. 
Od 68 djece mlađe od 12 godina na profilaksi, 29 (42,6%) nije imalo nikakvih krvarenja.
Prophylaxis in children (below 12 years) 
Profilaksa u djece (mlađe od 12 godina)
Wide top end 
Široki gornji dio
Plastic cap 
Plastična kapica
The overall success rate for the treatment of bleeds was 87.7% and 94.4% of all bleeds treated with 1-2 injections. 
Ukupna stopa uspjeha za liječenje krvarenja bila je 87,7% i 94,4% svih krvarenja liječenih s 1-2 injekcije.
• Injecting into a CVAD may require using a sterile 10 mL plastic syringe for withdrawal of the reconstituted solution. 
• Injiciranje u CVAD možda će zahtijevati uporabu sterilne plastične štrcaljke od 10 ml za uvlačenje pripremljene otopine.
Stop the injection immediately if you develop severe and sudden allergic reactions (anaphylactic reactions). 
Odmah prekinite injiciranje ako razvijete teške i iznenadne alergijske reakcije (anafilaktičke reakcije).
You must contact your doctor or an emergency unit immediately if you have signs of an allergic reaction such as: 
Odmah se obratite liječniku ili hitnoj medicinskoj službi ako imate znakove alergijske reakcije kao što su:
This is equivalent to 1.5% of the recommended maximum daily dietary intake of sodium for an adult. 
To odgovara 1,5 % preporučenog maksimalnog dnevnog unosa natrija za odraslu osobu.
If, at any point, there is air in the syringe, inject the air back into the vial. 
Ako se u bilo kojem trenutku u štrcaljki pojavi zrak, ubrizgajte ga natrag u bočicu.
Including tooth extraction 
Uključujući vađenje zuba
Once the product has been taken out of the refrigerator, the product must not be returned to the refrigerator. 
Kada se lijek jednom izvadi iz hladnjaka, lijek se ne smije ponovno vraćati u hladnjak.
The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions. 
Kompleks faktora VIII/von Willebrandova faktora sastoji se od dviju molekula (faktora VIII i von Willebrandova faktora) različitih fizioloških funkcija.
Thrombin then converts fibrinogen into fibrin and a clot can be formed. 
Trombin zatim pretvara fibrinogen u fibrin i tako omogućuje stvaranje krvnog ugruška.
Each reconstituted vial contains 30.5 mg of sodium (see section 4.4). 
Jedna rekonstituirana bočica sadrži 30,5 mg natrija (vidjeti dio 4.4).
Of note, annualized bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies. 
Treba napomenuti kako anualizirana stopa krvarenja (ASK) nije usporediva između različitih koncentrata faktora niti između različitih kliničkih ispitivanja.
Overall, including all extensions parts, 31 of 61 patients on every 7 days prophylaxis switched back to every 4 days treatment. 
Sveukupno, uključujući sve nastavke ispitivanja, 31 od 61 bolesnika na profilaksi svakih 7 dana ponovno se vratilo na liječenje svaka 4 dana.
The single dose pharmacokinetic parameters determined after 28 weeks of prophylactic treatment with Esperoct were consistent with the initial pharmacokinetic parameters. 
Farmakokinetički parametri jednokratne doze određeni nakon 28 tjedana profilaktičkog liječenja lijekom Esperoct bili su u skladu s inicijalnim farmakokinetičkim parametrima.
• gauze pads and plasters. 
• gaze i flastere.