natgillin/translations-raw huggingface dataset:
EU/2/13/158/016 (112.5 mg, 1 pipette) EU/2/13/158/017 (112.5 mg, 2 pipettes) EU/2/13/158/020 (250 mg, 1 pipette) EU/2/13/158/021 (250 mg, 2 pipettes) EU/2/13/158/024 (500 mg, 1 pipette) EU/2/13/158/025 (500 mg, 2 pipettes) EU/2/13/158/028 (1,000 mg, 1 pipette) EU/2/13/158/029 (1,000 mg, 2 pipettes) EU/2/13/158/030 (1,400 mg, 1 pipette) EU/2/13/158/031 (1,400 mg, 2 pipettes)
EU/2/13/158/016 ( 112,5 mg, 1 pipeta) EU/2/13/158/017 ( 112,5 mg, 2 pipete) EU/2/13/158/020 ( 250 mg, 1 pipeta) EU/2/13/158/021 ( 250 mg, 2 pipete) EU/2/13/158/024 ( 500 mg, 1 pipeta) EU/2/13/158/025 ( 500 mg, 2 pipete) EU/2/13/158/028 ( 1000 mg, 1 pipeta) EU/2/13/158/029 ( 1000 mg, 2 pipete) EU/2/13/158/030 ( 1400 mg, 1 pipeta) EU/2/13/158/031 ( 1400 mg, 2 pipeta)
The twist-and-use cap should be rotated clockwise or counter clockwise one full turn.
Zatvarač treba okrenuti u smjeru kazaljke na satu ili obrnuto cijeli krug.
Bravecto chewable tablets
Bravecto otopina za nakapavanje
Can be used in breeding, pregnant and lactating dogs.
Može se primjenjivati kod uzgojnih pasa te kuja u graviditetu i laktaciji.
The onset of efficacy is within 12 hours for fleas (C. felis) and within 48 hours for ticks (I. ricinus).
Početak djelovanja je unutar 12 sati za buhe (C. felis) i 48 sati za krpelje (I. ricinus).
Pork liver flavour Sucrose
Aroma svinjske jetre Saharoza
Pregnancy, lactation and fertility:
Primjena tijekom graviditeta, laktacije ili nesenja
The onset of efficacy is within 8 hours for fleas (C. felis) and 12 hours for ticks (I. ricinus).
Početak djelovanja je unutar 8 sati za buhe (C. felis) i 12 sati za krpelje (I. ricinus).
EU/2/13/158/018 (112.5 mg, 1 pipette) EU/2/13/158/019 (112.5 mg, 2 pipettes) EU/2/13/158/022 (250 mg, 1 pipette) EU/2/13/158/023 (250 mg, 2 pipettes) EU/2/13/158/026 (500 mg, 1 pipette) EU/2/13/158/027 (500 mg, 2 pipettes)
EU/2/13/158/018 (112,5 mg, 1 pipeta) EU/2/13/158/019 (112,5 mg, 2 pipete) EU/2/13/158/022 ( 250 mg, 1 pipeta) EU/2/13/158/023 (250 mg, 2 pipete) EU/2/13/158/026 ( 500 mg, 1 pipeta) EU/2/13/158/027 ( 500 mg, 2 pipete)
The safety of the veterinary medicinal product in breeding, pregnant and lactating dogs has been demonstrated.
Neškodljivost primjene ovog veterinarsko medicinskog proizvoda dokazana je kod uzgojnih pasa te kuja u graviditetu i laktaciji.
No adverse reactions were observed following topical administration to kitten aged 11-13 weeks and weighing 1.2-1.5 kg treated with overdoses of up to 5 times the maximum recommended dose (93 mg, 279 mg and 465 mg fluralaner/kg body weight) on three occasions at shorter intervals than recommended (8-week intervals).
Neškodljivost je dokazana kod mačića starosti 11 - 13 tjedana i težine 1,2 - 1,5 kg tretiranih trokratno s 5 x većim dozama od maksimalno preporučene doze (93 mg, 279 mg i 465 mg fluralanera/kg tjelesne težine) i u kraćim intervalima od preporučenih (8-tjedni intervali).
for very small dogs 2 - 4.5 kg for small dogs >4.5 - 10 kg for medium-sized dogs >10 - 20 kg for large dogs >20 - 40 kg for very large dogs >40 - 56 kg
za vrlo male pse 2 - 4,5 kg za male pse >4,5 - 10 kg za srednje velike pse >10 - 20 kg za velike pse >20 - 40 kg za vrlo velike pse >40 - 56 kg
It is efficacious against ticks (Ixodes spp.)
Učinkovit je protiv krpelja (Ixodes spp.) i buha (Ctenocephalides spp.) na mačkama.
EU/2/13/158/016-017 112.5 mg EU/2/13/158/020-021 250 mg EU/2/13/158/024-025 500 mg EU/2/13/158/028-029 1,000 mg EU/2/13/158/030-031 1,400 mg
EU/2/13/158/020-021 250 mg EU/2/13/158/024-025 500 mg EU/2/13/158/028-029 1000 mg EU/2/13/158/030-031 1400 mg
No adverse reactions were observed following oral administration to puppies aged 8-9 weeks and weighing 2.0-3.6 kg treated with overdoses of up to 5 times the maximum recommended dose (56 mg, 168 mg and 280 mg fluralaner/kg bodyweight) on three occasions at shorter intervals than recommended (8-week intervals).
Nisu se pokazale nikakve nuspojave prilikom peroralne primjene na štencima u starosti 8 do 9 tjedana i težine 2,0-3,6 kg, tretiranih 5 puta većim dozama od maksimalne preporučene doze (56 mg, 168 mg i 280 mg fluralanera/ kg tjelesne težine) u 3 navrata, s kraćim intervalima od preporučenog (8-tjedni intervali).
No adverse reactions were observed following topical administration to puppies aged 8-9 weeks and weighing 2.0-3.7 kg treated with overdoses of up to 5 times the maximum recommended dose (56 mg, 168 mg and 280 mg fluralaner/kg bodyweight) on three occasions at shorter intervals than recommended (8-week intervals).
Nisu uočene nikakve nuspojave prilikom primjene na koži, na štencima starosti 8 do 9 tjedana i težine 2,0 - 3,7 kg tretiranih 5 puta većim dozama od maksimalne preporučene doze (56 mg, 168 mg i 280 mg fluralanera/kg tjelesne težine) u 3 navrata, s kraćim intervalima od preporučenog (8-tjedni intervali).
Dog
Pas
Mild and transient skin reactions such as erythema or alopecia at the application site were commonly observed in clinical trials (1.2% of treated dogs).
Blage i prolazne kožne reakcije kao što su eritem ili gubitak dlake na mjestu aplikacije uočene su često u kliničkim ispitivanjima (1,2 % tretiranih pasa).
1 chewable tablet 2 chewable tablets 4 chewable tablets
VELIČINA PAKOVANJA 1 tableta za žvakanje
The product should not be administered at intervals shorter than 8 weeks as the safety for shorter intervals has not been tested.
Proizvod se ne smije primjenjivati u intervalima kraćim od 8 tjedana zbog nedostatka ispitivanja neškodljivosti.
Individual variation in Cmax and t1/2 was observed.
Primijećena je individualna varijacija Cmax i t1/2 . Glavni put eliminacije je izlučivanje nepromijenjenog fluralanera u fecesu (~ 90% doze).
EU/2/13/158/014 EU/2/13/158/015
EU/2/13/158/011 EU/2/13/158/012 EU/2/13/158/013 EU/2/13/158/014 EU/2/13/158/015
Each chewable tablet of Bravecto contains:
Svaka Bravecto tableta za žvakanje sadrži: Bravecto tablete za žvakanje
For dogs above 56 kg body weight, use a combination of two pipettes that most closely matches the body weight.
Za pse iznad 56 kg tjelesne težine primjenjivati kombinaciju od 2 tablete koje najviše odgovaraju tjelesnoj težini.
for very small dogs (2-4.5 kg) for small dogs (>4.5-10 kg) for medium-sized dogs (>10-20 kg) for large dogs (>20-40 kg) for very large dogs (>40-56 kg)
za vrlo male pse (2-4,5 kg) za male pse (>4,5-10 kg) za srednje velike pse (>10-20 kg) za velike pse (>20-40 kg) za vrlo velike pse (>40-56 kg)
Safety was demonstrated in kitten aged 11-13 weeks and weighing 1.2-1.5 kg treated with overdoses of up to 5 times the maximum recommended dose on three occasions at shorter intervals than recommended (8-week intervals).
Neškodljivost je dokazana kod mačića starosti 11 - 13 tjedana i težine 1,2 - 1,5 kg tretiranih trokratno s 5 x većim dozama od maksimalno preporučene doze i u kraćim intervalima od preporučenih (8tjedni intervali).
0.4 ml 0.89 ml 1.79 ml 3.57 ml 5.0 ml
3,57 ml 5,0 ml
During laboratory and clinical field testing, no interactions between Bravecto spot-on solution for cats and routinely used veterinary medicinal products were observed.
Tijekom terenskih ispitivanja, nisu primijećene interakcije između Bravecto otopine za nakapavanje za mačke i rutinski korištenih veterinarsko-medicinskih proizvoda.
For the treatment of tick and flea infestations in cats.
Za liječenje infestacije mačaka krpeljima i buhama.
For dogs above 56 kg bodyweight, use a combination of two tablets that most closely matches the bodyweight.
Psima iznad 56 kg primjenjuje se kombinacija od 2 tablete koje najviše odgovaraju tjelesnoj težini.
For the treatment of tick and flea infestations in dogs.
Za liječenje infestacije pasa krpeljima i buhama.
112.5 mg fluralaner 250 mg fluralaner 500 mg fluralaner
SASTAV DJELATNIH TVARI 112,5 mg fluralaner 250 mg fluralaner 500 mg fluralaner
Safety was demonstrated in puppies aged 8-9 weeks and weighing 2.0-3.6 kg treated with overdoses of up to 5 times the maximum recommended dose on three occasions at shorter intervals than recommended (8-week intervals).
Neškodljivost je dokazana u štenadi stare 8 do 9 tjedana i težine 2,0-3,6 kg tretiranih trokratno s 5 x većim dozama od maksimalno preporučene doze i u kraćim intervalima od preporučenih (8-tjedni intervali).
Safety was demonstrated in puppies aged 8-9 weeks and weighing 2.0-3.7 kg treated with overdoses of up to 5 times the maximum recommended dose on three occasions at shorter intervals than recommended (8-week intervals).
Neškodljivost je dokazana u štenadi stare 8 do 9 tjedana i težine 2,0 - 3,7 kg tretiranih trokratno s 5 x većim dozama od maksimalno preporučene doze i u kraćim intervalima od preporučenih (8-tjedni intervali).
During laboratory and clinical field testing, no interactions between Bravecto spot-on solution for dogs and routinely used veterinary medicinal products were observed.
Tijekom terenskih ispitivanja, nisu primijećene interakcije između Bravecto otopine za nakapavanje za pse i rutinski korištenih veterinarsko-medicinskih proizvoda.
This veterinary medicinal product is a systemic insecticide and acaricide that provides immediate and persistent flea (Ctenocephalides felis) and tick (Ixodes ricinus) killing activity for 12 weeks.
Ovaj veterinarsko - medicinski proizvod je sustavni insekticid i akaricid koji trenutno i kontinuirano ubija buhe (Ctenocephalides felis) i krpelje (Ixodes ricinus), tijekom 12 tjedana.
EU/2/13/158/018-019 112.5 mg EU/2/13/158/022-023 250 mg EU/2/13/158/026-027 500 mg
BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/13/158/018-019 112,5 mg EU/2/13/158/022-023 250 mg EU/2/13/158/026-027 500 mg
Pharmacotherapeutic group: Ectoparasiticides for systemic use.
FARMAKOLOŠKA SVOJSTVA Farmakoterapijska grupa: Ektoparaziticidi za sustavnu upotrebu ATCvet kod: QP53BE02
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Ne primjenjivati kod slučajeva preosjetljivosti na djelatnu tvar ili na bilo koju pomoćnu tvar.
Mild and transient skin reactions at the application site, such as erythema and pruritus or alopecia were commonly observed in clinical trials (2.2% of treated cats).
Blage i prolazne kožne reakcije na mjestu aplikacije, kao što su eritem, svrbež ili gubitak dlake često su uočene u kliničkim ispitivanjima (2,2 % tretiranih mačaka).
Spot-on use.
Otopina za nakapavanje.
In the absence of available data, this veterinary medicinal product should not be used on puppies less than 8 weeks old and /or dogs weighing less than 2 kg.
U nedostatku dostupnih informacija, ovaj veterinarsko medicinski proizvod ne treba upotrebljavati kod štenadi mlađoj od 8 tjedana i/ili psima lakšim od 2 kg.
The onset of effect is within 8 hours of attachment for fleas (C. felis) and 12 hours of attachment for ticks (I. ricinus).
Do početka učinka dolazi unutar 8 sati nakon prihvaćanja buha (C. felis) i unutar 12 sati nakon prihvaćanja krpelja (I. ricinus).
The veterinary medicinal product was well tolerated in Collies with a deficient multidrug-resistanceprotein 1 (MDR1 -/-) following single oral administration at 3 times the recommended dose (168 mg/kg bodyweight).
Ovčari pasmine Collie s deficijentnim proteinom (multidrug - resistance - protein 1, MDR1 -/-) nakon jedne peroralne primjene doze 3 puta više od preporučene (168 mg/kg tjelesne težine) dobro su podnijeli veterinarsko - medicinski proizvod.
Rotate cap (cap cannot be removed).
2. Okrenite kapicu (kapica se ne može odstraniti) 3. Primijenite na kožu.
Fluralaner was well tolerated in Collies with a deficient multidrug-resistance-protein 1 (MDR1 -/-) following single oral administration at 3 times the maximum recommended dose (168 mg/kg bodyweight).
Ovčari pasmine Collie s deficijentom proteina (multidrug - resistance - protein 1, MDR1 -/-) nakon primjene jedne peroralne doze, 3 x veće od preporučene (168 mg/kg tjelesne težine) dobro su podnijeli veterinarsko - medicinski proizvod.
This veterinary medicinal product is a systemic insecticide and acaricide that provides: - immediate and persistent flea (Ctenocephalides felis and Ctenocephalides canis) killing activity for 12 weeks, and - immediate and persistent tick (Ixodes ricinus, Rhipicephalus sanguineus and Dermacentor reticulatus) killing activity for 12 weeks.
Ovaj veterinarsko-medicinski proizvod je sustavni insekticid i akaricid koji omogućuje: - trenutno i kontinuirano ubijanje buha (Ctenocephalides felis i Ctenocephalides canis) tijekom 12 tjedana, - trenutno i kontinuirano ubijanje krpelja tijekom 12 tjedana za Ixodes ricinus, Dermacentor reticulatus i Rhipicephalus sanguineus.
This veterinary medicinal product is a systemic insecticide and acaricide that provides: - immediate and persistent flea (Ctenocephalides felis and C. canis) killing activity for 12 weeks, - immediate and persistent tick (Ixodes ricinus, Rhipicephalus sanguineus and Dermacentor reticulatus) killing activity for 12 weeks.
Ovaj veterinarsko - medicinski proizvod je sustavni insekticid i akaricid koji: - trenutno i kontinuirano ubija buhe (Ctenocephalides felis), tijekom 12 tjedana, - trenutno i kontinuirano ubija krpelje tijekom 12 tjedana (Ixodes ricinus, Rhipicephalus sanguineus, Dermacentor reticulatus).
PACKAGE LEAFLET: Bravecto 112.5 mg spot-on solution for small cats (1.2 - 2.8 kg) Bravecto 250 mg spot-on solution for medium-sized cats (>2.8 - 6.25 kg) Bravecto 500 mg spot-on solution for large cats (>6.25 - 12.5 kg)
UPUTA O VMP: Bravecto 112,5 mg otopina za nakapavanje za male mačke (1,2 - 2,8 kg) Bravecto 250 mg otopina za nakapavanje za srednje velike mačke (>2,8 - 6,25 kg) Bravecto 500 mg otopina za nakapavanje za velike mačke (>6,25 - 12,5 kg)
Bravecto 112.5 mg spot-on solution for small cats (1.2 - 2.8 kg) Bravecto 250 mg spot-on solution for medium-sized cats (>2.8 - 6.25 kg) Bravecto 500 mg spot-on solution for large cats (>6.25 - 12.5 kg) fluralaner
Bravecto 112,5 mg otopina za nakapavanje za male mačke (1,2 - 2,8 kg) Bravecto 250 mg otopina za nakapavanje za srednje velike mačke (>2,8 - 6,25 kg) Bravecto 500 mg otopina za nakapavanje za velike mačke (>6,25 - 12,5 kg) fluralaner
Bravecto 112.5 mg chewable tablets for very small dogs (2-4.5 kg) Bravecto 250 mg chewable tablets for small dogs (>4.5 -10 kg) Bravecto 500 mg chewable tablets for medium-sized dogs (>10-20 kg) Bravecto 1,000 mg chewable tablets for large dogs (>20-40 kg) Bravecto 1,400 mg chewable tablets for very large dogs (>40-56 kg)
Bravecto 112,5 mg tablete za žvakanje za vrlo male pse (2-4,5 kg) Bravecto 250 mg tablete za žvakanje za male pse (>4,5 -10 kg) Bravecto 500 mg tablete za žvakanje za srednje velike pse (>10-20 kg) Bravecto 1000 mg tablete za žvakanje za velike pse (>20-40 kg) Bravecto 1400 mg tablete za žvakanje za vrlo velike pse (>40-56 kg)
Bravecto 112.5 mg chewable tablets for very small dogs (2-4.5 kg) Bravecto 250 mg chewable tablets for small dogs (>4.5-10 kg) Bravecto 500 mg chewable tablets for medium-sized dogs (>10-20 kg) Bravecto 1,000 mg chewable tablets for large dogs (>20-40 kg) Bravecto 1,400 mg chewable tablets for very large dogs (>40-56 kg)
Bravecto 112,5 mg tablete za žvakanje za vrlo male pse (2-4,5 kg) Bravecto 250 mg tablete za žvakanje za male pse (>4,5-10 kg) Bravecto 500 mg tablete za žvakanje za srednje velike pse (>10-20 kg) Bravecto 1000 mg tablete za žvakanje za velike pse (>20-40 kg) Bravecto 1400 mg tablete za žvakanje za vrlo velike pse (>40-56 kg)
NAME OF THE MARKETING AUTHORISATION HOLDER
BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET
SPECIAL WARNINGS
4.4 Posebna upozorenja
For spot-on use
SAŽETAK OPISA SVOJSTAVA
The acknowledgement form needs to be provided by physicians to all patients, including those currently on treatment.
Liječnici trebaju osigurati obrazac potvrde za sve bolesnike, uključujući one koji su trenutačno u postupku liječenja.
The educational material in place should also be updated.
Također je potrebno ažurirati postojeći edukativni materijal.
The existing educational materials should also be updated with these recommendations and complemented with an acknowledgement form.
Također je potrebno ažurirati postojeće edukativne materijale s navedenim preporukama i nadopuniti ih obrascem potvrde.
Patients should also be explained the importance of adhering to the periodic liver monitoring.
Bolesnicima također treba objasniti važnost periodičkog praćenja rada jetre.
It was also noted that autoimmune thyroiditis was reported in the recent fatal case as well as in one of the adjudicated cases.
Također je uočeno da je zabilježen autoimuni tireoiditis u nedavnom slučaju sa smrtnim ishodom, kao i u jednom od riješenih slučajeva.
• The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for Zinbryta (daclizumab).
• PRAC je razmotrio postupak u skladu s člankom 20. Uredbe (EZ) br. 726/2004 na osnovi podataka za farmakovigilanciju za lijek Zinbryta (daklizumab).
The PRAC also considered the views expressed by experts consulted during the course of the procedure (scientific advisory group (SAG) on neurology).
PRAC je također razmotrio stajališta stručnjaka iznesena tijekom postupka savjetovanja (znanstvena savjetodavna skupina (SAG) za područje neurologije).
Patients tested positive should be recommended to consult with a physician with expertise in the treatment of these conditions.
Bolesnicima za koje se pokaže da su pozitivni treba preporučiti da se obrate liječniku s iskustvom u liječenju tih bolesti.
• The PRAC also considered it necessary to introduce an acknowledgement form to ensure patients have been adequately informed on the risks of liver injury associated to daclizumab.
• PRAC je također zaključio da je potrebno uvesti obrazac potvrde kako bi se zajamčilo da su bolesnici odgovarajuće obaviješteni o rizicima od oštećenja jetre povezanima s primjenom daklizumaba.
To facilitate the discussion between physicians and patients on this topic and ensure patients have understood information provided on the risk, following the view of the SAG, the PRAC required the introduction of an acknowledgment form.
Kako bi se olakšala rasprava o toj temi između liječnika i bolesnika i zajamčilo da bolesnici razumiju navedene informacije o riziku, PRAC je sukladno mišljenju SAG-a zatražio uvođenje obrasca potvrde.
Patients with hepatitis C virus (HCV) or hepatitis B virus (HBV) were excluded from clinical trials and no correlation has been established between pre-existing infections with these viruses and daclizumab-induced serious liver injury at present.
Bolesnici zaraženi virusom hepatitisa C (HCV) ili virusom hepatitisa B (HBV) nisu bili uključeni u klinička ispitivanja te trenutačno nije utvrđena veza između prethodnih infekcija tim virusima i teškog oštećenja jetre induciranog daklizumabom.
Zinbryta (daclizumab) is a centrally authorised medicinal product indicated at the start of this review in adult patients for the treatment of relapsing forms of multiple sclerosis (RMS).
Zinbryta (daklizumab) centralno je odobren lijek indiciran na početku ovog pregleda u odraslih bolesnika za liječenje relapsnih oblika multiple skleroze (RMS).
In addition, 4 cases of serious liver injury were reported from clinical trials, in the first periodic safety update report (PSUR).
Osim toga, u kliničkim ispitivanjima zabilježena su četiri slučaja teškog oštećenja jetre, u prvom periodičkom izvješću o neškodljivosti lijeka (PSUR).
The efficacy of daclizumab was demonstrated in two pivotal studies in subjects with relapsing remitting multiple sclerosis (RRMS) that led to the indication in relapsing multiple sclerosis.
Djelotvornost daklizumaba dokazana je u dvama glavnim ispitivanjima na bolesnicima s relapsima multiple skleroze (RRMS) koji su doveli do indikacije relapsne multiple skleroze.
The PRAC also considered the views expressed by the scientific advisory group on neurology.
PRAC je također razmotrio stajališta koja je iznijela znanstvena savjetodavna skupina za područje neurologije.
• The PRAC concluded that daclizumab is associated, during the treatment and for several months after the end of treatment, with an unpredictable and potentially fatal risk of immune-mediated liver injury.
• PRAC je zaključio da je daklizumab povezan, tijekom liječenja i nekoliko mjeseci nakon završetka liječenja, s nepredvidivim i potencijalno smrtonosnim rizikom od oštećenja jetre posredovanog imunosnim sustavom.
Results from both studies demonstrated clinically meaningful and statistically significant reductions in relapse rate, the primary efficacy endpoint in each study.
Rezultati obaju ispitivanja pokazali su klinički i statistički značajna smanjenja stope relapsa, primarnog ishoda djelotvornosti u obama ispitivanjima.
The description of hepatic injury in the product information should be brought up to date in line with current knowledge.
Opis oštećenja jetre u informacijama o lijeku potrebno je ažurirati u skladu s postojećim saznanjima.
The PRAC thus considered that further measures are needed to minimise this risk including limiting the use of the product to situations where no other therapeutic options are suitable.
Stoga je PRAC zaključio da su potrebne dodatne mjere kako bi se taj rizik sveo na najmanju moguću mjeru, uključujući ograničenje primjene lijeka na slučajeve kada druga terapijska rješenja nisu prikladna.
The PRAC concluded therefore that caution should be exercised when using such medicines concomitantly with daclizumab.
Stoga je PRAC zaključio da je potreban oprez pri istodobnoj primjeni takvih lijekova i daklizumaba.
No time window of a higher risk could be identified and cases of liver injury have occurred throughout treatment and up to 6 months after the last dose of daclizumab.
Nije utvrđen vremenski okvir za povećani rizik, a slučajevi oštećenja jetre zabilježeni su tijekom trajanja liječenja i do šest mjeseci nakon posljednje doze daklizumaba.
• In addition, prior to treatment initiation, patients should be screened for hepatitis B and C infection and initiation is not recommended in patients with other autoimmune conditions.
• Osim toga, prije početka liječenja bolesnici moraju napraviti pretrage radi utvrđivanja moguće infekcije virusom hepatitisa B i C, a u bolesnika s drugim autoimunim bolestima započinjanje liječenja ne preporučuje se.
Overall, considering the data available, the occurrence of daclizumab induced liver injury is considered to be unpredictable.
Sveukupno gledajući, s obzirom na dostupne podatke zaključeno je da je oštećenje jetre inducirano daklizumabom nepredvidivo.
On 9 June 2017 the EC therefore triggered a procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of Zinbryta (daclizumab) and to issue a recommendation on whether the marketing authorisation should be maintained, varied, suspended or revoked.
Uredbe (EZ) br. 726/2004 na osnovi podataka o farmakovigilanciji, te je od Odbora za ocjenu rizika na području farmakovigilancije (PRAC) zatražio procjenu učinka prethodno navedenih razloga za zabrinutost na omjer koristi i rizika za lijek Zinbryta (daklizumab) i izdavanje preporuke o tome treba li odobrenje za stavljanje u promet biti zadržano, izmijenjeno, obustavljeno ili uskraćeno.
However, in view of the seriousness of the reactions reported, leading in one case to a fatal outcome despite adherence to the RMMs, the EC considered that the impact of the risk of liver injury on the benefit-risk balance of the medicinal product and the adequacy of the related RMMs should be reviewed.
Međutim, s obzirom na ozbiljnost zabilježenih reakcija, koje su u jednom slučaju dovele do smrtnog ishoda unatoč pridržavanju RMM-u, EK smatra da je potrebno ponovo ispitati učinak rizika od oštećenja jetre na omjer koristi i rizika lijeka i prikladnost povezanih mjera smanjenja rizika.
As the risk has been shown to persist for up to six months after the last dose of daclizumab, this monitoring should be continued for the same period after the end of treatment.
Budući da je dokazano da je rizik prisutan i do šest mjeseci nakon posljednje doze daklizumaba, potreban je nastavak praćenja tijekom tog razdoblja nakon završetka liječenja.