natgillin/translations-raw huggingface dataset:
How to store Levetiracetam Actavis 
Kako čuvati Levetiracetam Actavis
in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. 
• u liječenju miokloničkih napadaja u odraslih i adolescenata od 12. godine života s juvenilnom miokloničnom epilepsijom.
(4) Following dialysis, a 3.5 to 7 mg/kg (0.035 to 0.07 ml/kg) supplemental dose is recommended. 
Nakon dijalize preporučuje se dodatna doza od 3,5 do 7 mg/kg (0,035 do 0,07 ml/kg)
Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviour as measured in a standardised and systematic way using a validated instrument (CBCL - Achenbach Child Behaviour Checklist). 
Rezultati ocjene funkcioniranja ponašanja i emocionalnog funkcioniranja uputili su na pogoršanje u smislu agresivnijeg ponašanja u skupini koja je uzimala levetiracetam, ocijenjenog validiranim instrumentom
One tablet of Levetiracetam Actavis 250 mg contains 250 mg of levetiracetam. 
Jedna tableta Levetiracetama Actavis 250 mg sadrži 250 mg levetiracetama.
One tablet of Levetiracetam Actavis 500 mg contains 500 mg of levetiracetam. 
Jedna tableta Levetiracetama Actavis 500 mg sadrži 500 mg levetiracetama.
Normal Mild Moderate 
Blago oštećenje Umjereno oštećenje
10 to 20 mg/kg (0.10 to 0.20 ml/kg) once daily (3) (5) 
10 do 20 mg/kg (0,10 do 0,20 ml/kg) jednaput na dan (3) (5)
With continued long-term treatment, 28.6% of the patients were free of myoclonic seizures for at least 6 months and 21.0 % were free of myoclonic seizures for at least 1 year. 
28,6% bolesnika bilo je barem 6 mjeseci i 21,0% barem 1 godinu bez miokloničkih napadaja.
One tablet of Levetiracetam Actavis 750 mg contains 750 mg of levetiracetam. 
Jedna tableta Levetiracetama Actavis 750 mg sadrži 750 mg levetiracetama.
Levetiracetam Actavis 250 mg film-coated tablets Each film-coated tablet contains 250 mg levetiracetam. 
Levetiracetam Actavis 250 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 250 mg levetiracetama.
The NOAEL (No Observed Adverse Effect Level) was 3,600 mg/kg/day for pregnant female rats (x 12 the MRHD on a mg/m2 
No Observed Adverse Effect Level, razina pri kojoj se ne uočava štetni učinak) za gravidne štakorice iznosila je 3600 mg/kg/dan, a za fetuse 1200 mg/kg/dan (12-erostruka vrijednost najveće preporučene doze za čovjeka izražena u mg/m2).
Each film-coated tablet contains 1,000 mg levetiracetam. 
Jedna filmom obložena tableta sadrži 1000 mg levetiracetama.
Swallow Levetiracetam Actavis tablets with a sufficient quantity of liquid (e.g. a glass of water). 
Način primjene Progutajte Levetiracetam Actavis tablete s dovoljnom količinom tekućine (npr. s čašom vode).Levetiracetam Actavis možete uzeti s hranom ili bez nje.
Islande / Island Tel: +354 550 3300 
Actavis Group PTC ehf. Islande / Island Tel: +354 550 3300
The safety profile of levetiracetam is generally similar across age groups (adult and paediatric patients) and across the approved epilepsy indications. 
Ti podaci dopunjeni su podacima iz odgovarajućih ispitivanja otvorenog produžetka o primjeni levetiracetama, kao i postmarketinškim iskustvima Sigurnosni profil levetiracetama uglavnom je sličan u svim starosnim skupinama (odrasli i pedijatrijski bolesnici) i u svim odobrenim indikacijama epilepsije.
Levetiracetam Actavis 500 mg film-coated tablets Oval, yellow, 17.1 x 8.1 mm marked with “L” on one side and “500” on the other side. 
Levetiracetam Actavis 500 mg filmom obložene tablete su ovalne, žute tablete, veličine 17,1 x 8,1 mm s oznakom „L” na jednoj strani i „500“ na drugoj strani.
Levetiracetam Actavis 250 mg film-coated tablets are oval, light blue, 13.6 x 6.4 mm marked with “L” on one side and “250” on the other side. 
Levetiracetam Actavis 250 mg filmom obložene tablete su ovalne, svijetloplave tablete, veličine 13,6 x 6,4 mm, s oznakom „L” na jednoj strani i „250“ na drugoj strani.
Levetiracetam Actavis 750 mg film-coated tablets Oval, orange 19.0 x 9.3 mm marked with “L” on one side and “750” on the other side. 
Levetiracetam Actavis 750 mg filmom obložene tablete su ovalne, narančaste tablete, veličine 19,0 x 9,3 mm s oznakom „L” na jednoj strani i „750“ na drugoj strani.
Each tablet contains 1,000 mg levetiracetam. 
Jedna tableta sadrži 1000 mg levetiracetama.
Ca currents and by reducing the release of Ca from intraneuronal stores. 
N-tip protoka Ca2+ i smanjuje otpuštanje Ca2+ iz skladišta u neuronima.
The patients were randomized to carbamazepine CR 400--1,200 mg/day or levetiracetam 1,000--3,000 mg/day, the duration of the treatment was up to 121 weeks depending on the response. 
Bolesnici su randomizirani za dobivanje 400 do 1200 mg karbamazepina s kontroliranim otpuštanjem (CR) na dan ili 1000 do 3000 mg levetiracetama na dan,
Perforated unit dose blisters: EU/1/11/713/043 60 x 1 tablets 
Perforirani blisteri djeljivi na jedinične doze: EU/1/11/713/043 60 x 1 tableta
Levetiracetam Actavis 1,000 mg film-coated tablets Oval, white, 19.0 x 10.0 mm marked with “L” on one side and “1000” on the other side. 
Levetiracetam Actavis 1000 mg filmom obložene tablete su ovalne, bijele tablete, veličine 19,0 x 10,0 mm s oznakom „L” na jednoj strani i „1000“ na drugoj strani.
Levetiracetam Actavis 1,000 mg tablets Levetiracetam 
Levetiracetam Actavis 1000 mg tablete levetiracetam
Perforated unit dose blisters: EU/1/11/713/042 60 x 1 tablets 
Perforirani blisteri djeljivi na jedinične doze: EU/1/11/713/042 60 x 1 tableta
Each tablet contains 750 mg levetiracetam. 
Jedna tableta sadrži 750 mg levetiracetama.
Levetiracetam Actavis 1,000 mg film-coated tablets 
Levetiracetam Actavis 1 000 mg filmom obložene tablete
The starting dose for a child or adolescent of 25 kg should be 250 mg twice daily with a maximum dose of 750 mg twice daily. 
mg dva puta na dan uz maksimalnu dozu od 750 mg dva puta na dan.
250 to 500 mg twice daily 
250 do 500 mg dva puta na dan 500 do 1000 mg jedanput na dan (2)
Each film-coated tablet contains 750 mg levetiracetam. 
Jedna filmom obložena tableta sadrži 750 mg levetiracetama.
Perforated unit dose blisters: EU/1/11/713/041 60 x 1 tablets 
Perforirani blisteri djeljivi na jedinične doze: EU/1/11/713/041 60 x 1 tableta
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters for 1,000 mg film-coated tablets 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blisteri za filmom obložene tablete od 1000 mg
Each tablet contains 500 mg levetiracetam. 
Jedna tableta sadrži 500 mg levetiracetama.
Levetiracetam Actavis 1,000 mg tablets are oval, white, 19.0 x 10.0 mm marked with “L” on one side and “1000” on the other side. 
Ovalna, bijela tableta, veličine 19,0 x 10,0 mm s oznakom „L” na jednoj strani i „1000“ na drugoj strani.
Levetiracetam Actavis 250 mg tablets Levetiracetam 
Levetiracetam Actavis 250 mg tablete levetiracetam
Excretion via faeces accounted for only 0.3 % of the dose. 
Samo 0,3% doze izlučuje se fecesom.
EU/1/11/713/018 30 tablets EU/1/11/713/019 100 tablets EU/1/11/713/020 200 tablets 
EU/1/11/713/018 30 tableta EU/1/11/713/019 100 tableta EU/1/11/713/020 200 tableta
Each tablet contains 250 mg levetiracetam. 
Jedna tableta sadrži 250 mg levetiracetama.
Levetiracetam Actavis 750 mg tablets Levetiracetam 
Levetiracetam Actavis 750 mg tablete levetiracetam
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters for 750 mg film-coated tablets 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blisteri za filmom obložene tablete od 750 mg
Each film-coated tablet contains 500 mg levetiracetam. 
Jedna filmom obložena tableta sadrži 500 mg levetiracetama.
Each film-coated tablet contains 250 mg levetiracetam. 
Jedna filmom obložena tableta sadrži 250 mg levetiracetama.
Levetiracetam Actavis 500 mg tablets Levetiracetam 
Levetiracetam Actavis 500 mg tablete levetiracetam
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters for 250 mg film-coated tablets 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blisteri za filmom obložene tablete od 250 mg
reduction from baseline in average daily partial onset seizure frequency) assessed by a blinded central reader using a 48-hour video EEG. 
Primarna mjera učinkovitosti bila je stopa bolesnika s odgovorom (postotak bolesnika u kojih je dnevna prosječna učestalost napadaja smanjena za ≥ 50% u odnosu na početno stanje) određena središnjim pregledavanjem 48-satnog video EEG-a od strane ocjenjivača koji nije znao tko je dobivao placebo, a tko lijek.
Levetiracetam Actavis 750 mg tablets are oval, orange, 19.0 x 9.3 mm marked with “L” on one side and “750” on the other side. 
Ovalna, narančasta tableta, veličine 19,0 x 9,3 mm s oznakom „L” na jednoj strani i „750“ na drugoj strani.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters for 500 mg film-coated tablets 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blisteri za filmom obložene tablete od 500 mg
EU/1/11/713/008 30 tablets EU/1/11/713/009 100 tablets EU/1/11/713/010 200 tablets 
EU/1/11/713/008 30 tableta EU/1/11/713/009 100 tableta EU/1/11/713/010 200 tableta
EU/1/11/713/028 30 tablets EU/1/11/713/029 100 tablets EU/1/11/713/030 200 tablets 
EU/1/11/713/028 30 tableta EU/1/11/713/029 100 tableta EU/1/11/713/030 200 tableta
Levetiracetam Actavis 500 mg tablets are oval, yellow, 17.1 x 8.1 mm marked with “L” on one side and “500” on the other side. 
Ovalna, žuta tableta, veličine 17,1 x 8,1 mm s oznakom „L” na jednoj strani i „500“ na drugoj strani.
Infants 6 to 23 months, children and adolescents weighing less than 50 kg 
djeca i adolescenti teški manje od 50 kg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 1,000 mg film-coated tablets in tablet containers 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za spremnike s filmom obloženim tabletama od 1000 mg
EU/1/11/713/038 30 tablets EU/1/11/713/039 100 tablets EU/1/11/713/040 200 tablets 
EU/1/11/713/038 30 tableta EU/1/11/713/039 100 tableta EU/1/11/713/040 200 tableta
Levetiracetam Actavis 750 mg film-coated tablets 
Levetiracetam Actavis 750 mg filmom obložene tablete
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 1,000 mg film-coated tablets in tablet containers 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Naljepnica na spremnicima s filmom obloženim tabletama od 1000 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 250 mg film-coated tablets in tablet containers 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za spremnike s filmom obloženim tabletama od 250 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 750 mg film-coated tablets in tablet containers 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za spremnike s filmom obloženim tabletama od 750 mg
Rare cases of decreased blood cell counts (neutropenia, agranulocytosis, leucopenia, thrombocytopenia and pancytopenia) have been described in association with levetiracetam administration, generally at the beginning of the treatment. 
Opisani su rijetki slučajevi smanjenog broja krvnih stanica (neutropenija, agranulocitoza, leukopenija,
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 750 mg film-coated tablets in tablet containers 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Naljepnica na spremnicima s filmom obloženim tabletama od 750 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton of 500 mg film-coated tablets in tablet containers 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za spremnike s filmom obloženim tabletama od 500 mg
EU/1/11/713/001 20 tablets EU/1/11/713/002 30 tablets EU/1/11/713/003 50 tablets EU/1/11/713/004 60 tablets EU/1/11/713/005 100 tablets EU/1/11/713/006 120 tablets EU/1/11/713/007 200 tablets 
EU/1/11/713/001 20 tableta EU/1/11/713/002 30 tableta EU/1/11/713/003 50 tableta EU/1/11/713/004 60 tableta EU/1/11/713/005 100 tableta EU/1/11/713/006 120 tableta EU/1/11/713/007 200 tableta
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 250 mg film-coated tablets in tablet containers 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Naljepnica na spremnicima s filmom obloženim tabletama od 250 mg
Levetiracetam Actavis 500 mg film-coated tablets 
Levetiracetam Actavis 500 mg filmom obložene tablete
Silica colloidal anhydrous Magnesium stearate Polyvinyl alcohol - part. hydrolyzed Macrogol 4000 
Levetiracetam Actavis 1,000 mg filmom obložene tablete krospovidon povidon silicijev dioksid, koloidni, bezvodni magnezijev stearat polivinilni alkohol - djelomično hidroliziran makrogol 4000 talk titanijev dioksid (E171)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 500 mg film-coated tablets in tablet containers 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Naljepnica na spremnicima s filmom obloženim tabletama od 500 mg
EU/1/11/713/021 20 tablets EU/1/11/713/022 30 tablets EU/1/11/713/023 50 tablets EU/1/11/713/024 60 tablets EU/1/11/713/025 100 tablets EU/1/11/713/026 120 tablets EU/1/11/713/027 200 tablets 
EU/1/11/713/021 20 tableta EU/1/11/713/022 30 tableta EU/1/11/713/023 50 tableta EU/1/11/713/024 60 tableta EU/1/11/713/025 100 tableta EU/1/11/713/026 120 tableta EU/1/11/713/027 200 tableta
Levetiracetam Actavis 1,000 mg film-coated tablets Levetiracetam 
Levetiracetam Actavis 1000 mg filmom obložene tablete levetiracetam
EU/1/11/713/011 20 tablets EU/1/11/713/012 30 tablets EU/1/11/713/013 50 tablets EU/1/11/713/014 60 tablets EU/1/11/713/015 100 tablets EU/1/11/713/016 120 tablets EU/1/11/713/017 200 tablets 
EU/1/11/713/011 20 tableta EU/1/11/713/012 30 tableta EU/1/11/713/013 50 tableta EU/1/11/713/014 60 tableta EU/1/11/713/015 100 tableta EU/1/11/713/016 120 tableta EU/1/11/713/017 200 tableta
EU/1/11/713/031 20 tablets EU/1/11/713/032 30 tablets EU/1/11/713/033 50 tablets EU/1/11/713/034 60 tablets EU/1/11/713/035 100 tablets EU/1/11/713/036 120 tablets EU/1/11/713/037 200 tablets 
EU/1/11/713/031 20 tableta EU/1/11/713/032 30 tableta EU/1/11/713/033 50 tableta EU/1/11/713/034 60 tableta EU/1/11/713/035 100 tableta EU/1/11/713/036 120 tableta EU/1/11/713/037 200 tableta
Description of selected adverse reactions 
Opći poremećaji i reakcije na mjestu primjene
in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy. 
• u liječenju primarno generaliziranih toničko-kloničkih napadaja u odraslih i adolescenata od 12.
Levetiracetam Actavis 500 mg film-coated tablets Levetiracetam 
Levetiracetam Actavis 500 mg filmom obložene tablete levetiracetam
Serum Creatinine (mg/dl) 
Maximum Recommended Human Dose, izraženom u mg/m2).
България Актавис ЕАД 
Varvara Atena
Titanium dioxide (E171) Indigo carmine (E132) Sunset yellow (E110) Iron oxide red (E172) 
Levetiracetam Actavis 750 mg filmom obložene tablete krospovidon povidon silicijev dioksid, koloidni, bezvodni magnezijev stearat polivinilni alkohol - djelomično hidroliziran makrogol 4000 talk titanijev dioksid (E171) indigo carmine (E132) sunset yellow (E110) crveni željezov oksid (E172)
7 to 14 mg/kg (0.07 to 0.14 ml/kg) once daily 
7 do 14 mg/kg (0,07 do 0,14 ml/kg) jedanput na dan (2) (4)
Levetiracetam Actavis 750 mg film-coated tablets Levetiracetam 
Levetiracetam Actavis 750 mg filmom obložene tablete levetiracetam
Choreoathetosis, dyskinesia, hyperkinesia, gait disturbance, encephalopathy 
Koreoatetoza, diskinezija, hiperkinezija,
Levetiracetam Actavis 250 mg film-coated tablets Levetiracetam 
Levetiracetam Actavis 250 mg filmom obložene tablete levetiracetam
Levetiracetam Actavis 250 mg film-coated tablets 
Levetiracetam Actavis 250 mg filmom obložene tablete
This will be checked by your doctor. 
To će provjeriti Vaš liječnik.
2304 Orth an der Donau AUSTRIA 
2304 Orth an der Donau AUSTRIJA
[hours], 
[sati],
EXP: Use immediately or within 3 hours after reconstitution. 
EXP: Koristiti odmah nakon ili unutar 3 sata od rekonstitucije.
This effect occurs immediately and is known to depend to a large extent on the level of polymerisation of the protein. 
Taj se učinak odmah javlja i poznato je da uvelike ovisi o razini polimerizacije proteina.
Filtration does not influence dosage calculations. 
Filtracija ne utječe na izračun doze.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6 
Lijek se ne smije miješati s drugim lijekovima osim onih navedenih u dijelu 6.6.
Minimum Duration of treatment 
Minimalno trajanje liječenja
In case of shock, standard medical treatment for shock should be implemented. 
U slučaju šoka, potrebno je provesti standardnu medicinsku terapiju šoka.
Chemical and physical in-use stability has been demonstrated for 3 hours at 25°C. 
Kemijska i fizikalna stabilnost lijeka u primjeni dokazana je tijekom 3 sata pri 25 °C.
In all three studies, subjects were evaluated in the non-bleeding state. 
U sva tri ispitivanja ispitanici su ocjenjivani u stanju bez krvarenja.
You will be monitored carefully for the possibility of having developed these inhibitors. 
Bit ćete pod pažljivim praćenjem zbog mogućeg razvoja tih inhibitora.
Neutralizing antibodies (Inhibitors) 
Neutralizirajuća antitijela (inhibitori)
Do not infuse any faster than 4 mL per minute. 
Infuzija ne smije biti brža od 4 ml po minuti.
Discard after three hours. 
Bacite nakon tri sata.
Like all medicines, this medicine may cause side effects, although not everybody gets them. 
Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se neće javiti kod svakoga.
In all such cases, it is recommended that a specialised haemophilia centre be contacted. 
U svim takvim slučajevima, preporučuje se kontaktirati specijalizirani centar za hemofiliju.
ATC code: B02BD10 
ATK oznaka: B02BD10
Severe symptoms, including difficulty in breathing and dizziness, require prompt emergency treatment. 
Teški simptomi, uključujući poteškoće pri disanju i omaglicu, zahtijevaju hitno medicinsko liječenje.
If such inhibitors occur, the condition may manifest itself as an inadequate clinical response. 
Ako se pojave takvi inhibitori, to se stanje može očitovati kao neadekvatan klinički odgovor.
Be careful not to touch the clear plastic spike. 
Pazite da ne dotičete prozirni plastični šiljak.
It is used when treatment with another medicine, desmopressin, is not effective or cannot be given. 
Koristi se kada liječenje drugim lijekom, desmopresinom, nije učinkovito ili se ne može primijeniti.
Wash your hands and put on clean exam gloves (the use of gloves is optional). 
Operite ruke i navucite čiste rukavice za pregled (korištenje rukavica nije obavezno).
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 
S obzirom da su te reakcije prijavljene dobrovoljno iz populacije neodređene veličine, nije uvijek moguće pouzdano procijeniti njihovu učestalost ili utvrditi uzročnu povezanost s izloženosti lijeku.
Your doctor will calculate the dose that is most appropriate for you, how often you should receive VEYVONDI and for how long. 
Vaš će liječnik izračunati dozu lijeka koja Vam najbolje odgovara, koliko često trebate primiti VEYVONDI i koliko dugo.
Baxalta Manufacturing Sarl Route de Pierre-a-Bot 111 CH-2000 Neuchatel SWITZERLAND 
Baxalta Manufacturing Sarl Route de Pierre-a-Bot 111 CH-2000 Neuchatel ŠVICARSKA
Frequency categories are defined according to the following convention: very common (≥ 1/10), 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). 
Kategorije učestalosti definirane su prema sljedećoj konvenciji: 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).
- Use the reconstituted product within 3 hours to avoid the risk of microbial contamination because the product does not contain preservatives. 
- Primijenite rekonstituirani lijek u roku od 3 sata kako bi se izbjegla opasnost od kontaminacije mikroorganizmima jer lijek ne sadrži konzervanse.
The rate of administration should be slow enough to ensure the comfort of the patient, up to a maximum of 4 mL/min. 
Primjena treba biti dovoljno spora da bi se osigurala udobnost bolesnika, do najviše 4 ml/min.
- Proceed with the next infusion as scheduled and continue as advised by your doctor. 
- Nastavite sa sljedećom Infuzijom prema rasporedu, onako kako Vam je preporučio liječnik.
You can have an allergic reaction to VEYVONDI. 
Možete imati alergijsku reakciju na VEYVONDI.
In the 2 spontaneous post-marketing cases reported, the symptoms resolved and the patients fully recovered in 20 minutes to 4 hours upon stopping the infusion. 
U prijavljena 2 spontana slučaja nakon stavljanja lijeka u promet, simptomi su se povukli, a pacijenti u potpunosti oporavili u 20 minuta do 4 sata nakon prekida infuzije.
Patients should be closely monitored and carefully observed for any symptoms throughout the infusion period. 
Bolesnike je potrebno pomno pratiti i pažljivo promatrati radi bilo kakvih simptoma tijekom razdoblja infuzije.
Healthcare professionals should balance the potential risks and only prescribe VEYVONDI if needed 
Zdravstveni radnici trebaju odvagnuti potencijalne rizike i VEYVONDI propisati samo ako je to potrebno.
Lack of VWF increases the tendency to bleed. 
Nedostatak VWF-a povećava sklonosti krvarenju.
VEYVONDI should not be used in the treatment of Haemophilia A. 
VEYVONDI se ne smije koristiti u liječenju hemofilije A.
Check that all the solvent has transferred. 
Provjerite da se otapalo potpuno prenijelo.
Do not dispose of these supplies in ordinary household trash. 
Te predmete ne bacajte u običan kućni otpad.
If you forget to use VEYVONDI - Do not infuse a double dose to make up for a forgotten dose. 
Ako ste zaboravili primijeniti VEYVONDI - Nemojte infuzijom davati dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
Dosing guidance should be done based on the IR. 
Smjernice za doziranje trebaju se temeljiti na IR-u.
If you use VEYVONDI at home, your doctor will make sure that you are shown how to infuse it and how much to use. 
Ako VEYVONDI primjenjujete kod kuće, Vaš liječnik će se pobrinuti da Vam se objasni kako ćete si davati infuziju i u kojoj količini.
Patients developing inhibitors 
Bolesnici koji razviju inhibitore
Disconnect the empty syringe. 
Odvojite praznu štrcaljku.
Image example 
Primjer slike
Dose based on bodyweight may require adjustment in underweight or overweight patients. 
Doza koja se temelji na tjelesnoj težini može zahtijevati prilagodbu u bolesnika s premalenom ili prekomjernom težinom.
Subsequent infusions: 
Naknadne infuzije:
In a human ex vivo placenta perfusion model, it has been demonstrated that VEYVONDI does not cross the human placenta barrier. 
Na modelu perfuzije ljudske placente ex vivo pokazano je da VEYVONDI ne prelazi barijeru ljudske placente.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
Start of treatment 
Početak liječenja
AUC0inf/Dose e 
AUC0inf/Doza e
Trehalose dihydrate Mannitol 
Trehaloza dihidrat Manitol
If you previously had problems with blood clots or vessel occlusion (thromboembolic complications), tell your doctor immediately. 
Ako ste ranije imali problema s krvnim ugršcima ili začepljenom žilom (tromboembolijske komplikacije), odmah obavijestite liječnika.
No investigations on carcinogenicity, fertility impairment and fetal development have been conducted. 
Nisu provedena nikakva istraživanja kancerogenosti, oštećenja plodnosti i fetalnog razvoja.