natgillin/translations-raw huggingface dataset:
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).
Varnost je bila dokazana pri psičkih, starih 8-9 tednov in težkih 2,0-3,6 kg, ki so jim dajali odmerke, ki so bili do 5krat večji od priporočenega odmerka, trikrat v krajših razmikih, kot je priporočeno (8tedenski razmiki).
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).
Varnost pri mačkah, starih 11-13 tednov in težkih 1,2-1,5 kg, zdravljenih z do 5krat večjimi odmerki od največjega priporočenega trikrat v krajših razmikih, kot je priporočeno (8-tedenski razmiki), je bila dokazana.
Do not use this veterinary medicinal product after the expiry date which is stated on the blister after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini za EXP. Rok uporabnosti zdravila se nanaša na zadnji dan v navedenem mesecu.
For spot-on use
Za peroralno uporabo
Bravecto should be administered in accordance with the following table (corresponding to a dose of 40 - 94 mg fluralaner/kg body weight):
Bravecto je treba dajati v skladu z naslednjo preglednico (en odmerek 40-94 mg fluralanerja/kg telesne teže ):
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).
Ko so mačkam, starim 11-13 tednov in težkim 1,2-1,5 kg, dajali lokalno do 5krat večje odmerke od največjega priporočenega (93 mg, 279 mg in 465 mg fluralanerja/kg telesne teže) trikrat v krajših razmikih, kot je priporočeno (8-tedenski razmiki), niso opazili nobenih neželenih učinkov.
During clinical field testing, no interactions between Bravecto chewable tablets for dogs and routinely used veterinary medicinal products were observed.
Med kliničnimi testiranji niso opazili medsebojnih delovanj med Bravecto žvečljivimi tabletami za pse in drugimi zdravili za uporabo v veterinarski medicini, ki se uporabljajo rutinsko.
The onset of effect is within 8 hours of attachment for fleas (C. felis) and 12 hours of attachment for ticks (I. ricinus).
Učinkovanje se začne v 8 urah po pritrditvi za bolhe (C. felis) in v 12 urah po pritrditvi za klope (I. ricinus).
Bravecto chewable tablets
Bravecto žvečljive tablete
For optimal control of tick and flea infestation, the product should be administered at intervals of 12 weeks.
Za optimalni nadzor infestacije s klopi in bolhami je treba zdravilo za uporabo v veterinarski medicini dajati v 12-tedenskih razmikih.
112.5 mg fluralaner 250 mg fluralaner 500 mg fluralaner
112,5 mg fluralaner
For the treatment of tick and flea infestations in cats.
INDIKACIJA(E) Za zdravljenje infestacije z bolhami in klopi pri mačkah.
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, 1merilna kapalka) EU/2/13/158/017 (112.5 mg, 2 merilni kapalki) EU/2/13/158/020 (250 mg, 1 merilna kapalka) EU/2/13/158/021 (250 mg, 2 merilni kapalki) EU/2/13/158/024 (500 mg, 1 merilna kapalka) EU/2/13/158/025 (500 mg, 2 merilni kapalki) EU/2/13/158/028 (1000 mg, 1 merilna kapalka) EU/2/13/158/029 (1000 mg, 2 merilni kapalki) EU/2/13/158/030 (1400 mg, 1 merilna kapalka) EU/2/13/158/031 (1400 mg, 2 merilni kapalki)
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.
To zdravilo za uporabo v veterinarski medicini je sistemski insekticid in akaricid, ki zagotavlja takojšnje in trajno ubijanje bolh (Ctenocephalides felis) in klopov (Ixodes ricinus) skozi 12 tednov.
Each chewable tablet of Bravecto contains:
NAVEDBA UČINKOVIN(E) IN DRUG(E)IH SESTAVIN Vsaka žvečljiva tableta Bravecto vsebuje:
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.
To zdravilo za uporabo v veterinarski medicini je sistemski insekticid in akaricid, ki zagotavlja - takojšnje in trajno ubijanje bolh (Ctenocephalides felis in Ctenocephalides canis) skozi 12 Tednov in - takojšnje in trajno ubijanje klopov skozi 12 tednov (Ixodes ricinus, Rhipicephalus sanguineus in Dermacentor reticulatus).
The cap should be rotated clockwise or counter clockwise one full turn.
Zaporko zavrtite v smeri urnega kazalca ali v nasprotni smeri urnega kazalca za en cel obrat.
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, 1merilna kapalka) EU/2/13/158/019 (112.5 mg, 2 merilni kapalki) EU/2/13/158/022 (250 mg, 1 merilna kapalka) EU/2/13/158/023 (250 mg, 2 merlni kapalki) EU/2/13/158/026 (500 mg, 1 merilna kapalka) EU/2/13/158/027 (500 mg, 2 merilni kapalki)
Intervet International B.V.
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Intervet International B.V.
Pork liver flavour Sucrose
Aroma svinjskih jeter Saharoza
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
KONTRAINDIKACIJE Ne uporabljajte v primeru preobčutljivosti na zdravilno učinkovino ali na katero od pomožnih snovi.
The onset of efficacy is within 8 hours for fleas (C. felis) and 12 hours for ticks (I. ricinus).
Učinkovanje se zaćne v 8 urah na muhe (C. felis) in v 12 urah na klope (L. ricinus).
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 zelo majhne pse (2-4,5 kg) za majhne pse (>4.5-10 kg) za srednje velike pse (>10-20 kg) za velike pse (>20-40 kg) za zelo velike pse (>40-56 kg)
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.
To zdravilo za uporabo v veterinarski medicini je sistemski insekticid in akaricid, ki zagotavlja - takojšnje in trajno ubijanje bolh (Ctenocephalides felis in C. cnmis ) skozi 12 tednov, - takojšnje in trajno ubijanje klopov (Ixodes ricinus in Dermacentor reticulatus skozi 12 tednov.
QUANTITY OF THE ACTIVE SUBSTANCE
KOLIČINA UČINKOVINE fluralaner
Can be used in breeding, pregnant and lactating dogs.
Zdravilo se lahko uporablja pri psih za vzrejo, v dobi brejosti in laktacije.
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 zelo majne pse 2-4,5 kg za majhne pse >4.5-10 kg za srednje velike pse >10-20 kg za velike pse >20-40 kg za zelo velike pse >40-56 kg
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).
Ko so psičkom, starim 8-9 tednov in težkim 2,0-3,6 kg, dajali lokalno do 5krat večje odmerke od največjega priporočenega (56 mg, 168 mg in 280 mg fluralanerja/kg telesne teže ) trikrat v krajših razmikih, kot je priporočeno (8-tedenski razmiki), niso opazili nobenih neželenih učinkov.
Bravecto should be administered in accordance with the following table (corresponding to a dose of 25-56 mg fluralaner/kg bodyweight within one weight band):
Bravecto je treba dajati v skladu z naslednjo preglednico (en odmerek 25-56 mg fluralanerja /kg telesne teže v eni skupini):
Bravecto should be administered in accordance with the following table (corresponding to a dose of 25-56 mg fluralaner/kg body weight):
Bravecto je treba dajati v skladu z naslednjo preglednico (en odmerek 25-56 mg fluralanerj/kg telesne teže):
During laboratory and clinical field testing, no interactions between Bravecto spot-on solution for cats and routinely used veterinary medicinal products were observed.
Med laboratorijskimi in kliničnimi testiranji niso opazili medsebojnih delovanj med zdravilom Bravecto kožni nanos, raztopina za mačke, in drugimi zdravili za uporabo v veterinarski medicini, ki se uporabljajo rutinsko.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
KOLIČINA UČINKOVIN(E) fluralaner
During laboratory and clinical field testing, no interactions between Bravecto spot-on solution for dogs and routinely used veterinary medicinal products were observed.
Med laboratorijskimi in kliničnimi testiranji niso opazili medsebojnih delovanj med zdravilom Bravecto kožni nanos, raztopina za pse in drugimi zdravili za uporabo v veterinarski medicini, ki se uporabljajo rutinsko.
Pregnancy, lactation and fertility: The veterinary medicinal product can be used in breeding, pregnant and lactating dogs.
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Varnost zdravila za uporabo v veterinarski medicini pri psih za vzrejo, v dobi brejosti in laktacije je bila dokazana.
Hypersensitivity reactions to the product have been reported in a small number of people.
Pri majhni skupini ljudi so poročali o preobčutljivostnih reakcijah pri drugem zdravilu za uporabo v veterinarski medicini.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Sachet
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
The product contributes towards the control of the environmental flea populations in areas to which treated cats have access.
Zdravilo prispeva k obvladovanju okoljske populacije bolh na področjih, kamor imajo dostop zdravljene mačke.
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 in prehodne kožne reakcije na mestu nanosa kot na primer rdečina in srbenje ali izpadanje dlake so pogosto opaženi med kliničnimi testiranji ( 2,2% zdravljenih mačk).
Mild and transient skin reactions at the application site such as erythema or alopecia were commonly observed in clinical trials (1.2% of treated dogs).
Blage in prehodne kožne reakcije na mestu nanosa kot na primer rdečina ali izpadanje dlake so pogosto opaženi med kliničnimi testiranji ( 1,2% zdravljenih psov).
The product contributes towards the control of the environmental flea populations in areas to which treated dogs have access.
Zdravilo prispeva k obvladovanju okoljske populacije bolh na področjih, kamor imajo dostop zdravljeni psi.
Dimethylacetamide Glycofurol
Seznam pomožnih snovi dimetilacetamid glikofurol dietiltoluamid ( DEET) aceton
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 žvečljive tablete za zelo majhne pse (2-4,5 kg) Bravecto 250 mg žvečljive tablete za majhne pse (>4.5-10 kg) Bravecto 500 mg žvečljive tablete za srednje velike pse (>10-20 kg) Bravecto 1000 mg žvečljive tablete za velike pse (>20-40 kg) Bravecto 1400 mg žvečljive tablete za zelo 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 žvečljive tablete za zelo majhne pse (2-4,5 kg) Bravecto 250 mg žvečljive tablete za majhne pse (>4.5-10 kg) Bravecto 500 mg žvečljive tablete za srednje velike pse (>10-20 kg) Bravecto 1000 mg žvečljive tablete za velike pse (>20-40 kg) Bravecto 1400 mg žvečljive tablete za zelo velike pse (>40-56 kg)
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)
NAVODILO ZA UPORABO: Bravecto 112,5 mg kožni nanos, raztopina za majhne mačke (1,2 - 2,8 kg) Bravecto 250 mg kožni nanos, raztopina za srednje velike mačke (>2,8 - 6,25 kg) Bravecto 500 mg kožni nanos, raztopina za velike mačke (>6,25 - 12,5 kg)
Pipette content (ml)
Volumen (ml)
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 kožni nanos, raztopina za majhne mačke (1,2 - 2,8 kg) Bravecto 250 mg kožni nanos, raztopina za srednje velike mačke (>2,8 - 6,25 kg) Bravecto 500 mg kožni nanos, raztopina za velike mačke (>6,25 - 12,5 kg) fluralaner
There were no findings on reproductive performance and no findings of concern on offspring viability when fluralaner was administered orally to Beagle dogs at overdoses of up to 3 times the maximum recommended dose (up to 168 mg/kg bodyweight of fluralaner).
Ko so fluralaner dajali peroralno biglom v odmerkih, ki so bili do 3krat večji od največjega priporočenega odmerka (do 168 mg fluralanerja na kg telesne teže), niso ugotovili vplivov na reprodukcijo in tudi ne zaskrbljujočih vplivov na življenjsko sposobnost potomcev.
0.4 ml 0.89 ml 1.79 ml
VSEBINA PO TEŽI, VOLUMNU ALI ŠTEVILU ODMERKOV 0,4 ml 0,89 ml 1,79 ml
CONTRAINDICATIONS
KLINIČNI PODATKI
The acknowledgement form needs to be provided by physicians to all patients, including those currently on treatment.
Potrditveni obrazec morajo zdravniki posredovati vsem bolnikom, vključno s tistimi, ki se trenutno že zdravijo.
The existing educational materials should also be updated with these recommendations and complemented with an acknowledgement form.
Obstoječe izobraževalno gradivo je prav tako treba posodobiti s temi priporočili in ga dopolniti s potrditvenim obrazcem.
The educational material in place should also be updated.
Posodobiti je treba tudi obstoječe izobraževalno gradivo.
This view was supported by the PRAC who recommended that this stricter discontinuation criterion, regardless of bilirubin levels, should be applied.
Odbor PRAC je podprl to stališče in priporočil, da se uporabi strožji kriterij za prekinitev, ne glede na ravni bilirubina.
The PRAC also considered the views expressed by experts consulted during the course of the procedure (scientific advisory group (SAG) on neurology).
Odbor PRAC je proučil tudi stališča strokovnjakov, s katerimi se je posvetoval med postopkom (znanstvena svetovalna skupina (SAG) za nevrologijo).
Patients should also be explained the importance of adhering to the periodic liver monitoring.
Bolnikom je treba tudi pojasniti, kako pomembno se je držati rednega spremljanja delovanja jeter.
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.
Zato je Evropska komisija 9. junija 2017 na podlagi farmakovigilančnih podatkov sprožila postopek v skladu z členom 20 Uredbe (ES) št. 726/2004 in odbor PRAC zaprosila, da oceni vpliv zgoraj navedenih pomislekov na razmerje med tveganji in koristmi zdravila Zinbryta (daklizumab) ter izda priporočilo o tem, ali naj se dovoljenje za promet z zdravilom ohrani, spremeni, začasno umakne ali ukine.
Subgroup analyses of these studies, although of limited robustness, did not identify statistically significant differences in key efficacy outcomes in MS patients with high disease activity compared to patients with low disease activity.
Analize podskupin pri teh študijah so imele sicer omejeno robustnost, vendar z njimi niso prepoznali statistično značilnih razlik v ključnih izidih učinkovitosti pri bolnikih z MS z visoko aktivno boleznijo v primerjavi z bolniki z nizko aktivno boleznijo.
The PRAC also considered the views expressed by the scientific advisory group on neurology.
Odbor PRAC je proučil tudi stališča znanstvene svetovalne skupine za nevrologijo;
Patients tested positive should be recommended to consult with a physician with expertise in the treatment of these conditions.
Priporočljivo je, da se bolniki s pozitivnim rezultatom preiskave posvetujejo z zdravnikom, ki ima izkušnje z zdravljenjem teh bolezni.
In addition the frequency of transaminase increases and liver function tests abnormal should be updated to very common.
Poleg tega je treba pogostnost testiranj zvišanja ravni transaminaz in nenormalnega delovanja jeter posodobiti na zelo pogosto.
• The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for Zinbryta (daclizumab).
• odbor PRAC je obravnaval postopek v skladu s členom 20 Uredbe (ES) št. 726/2004, ki je bil na podlagi farmakovigilančnih podatkov sprožen za zdravilo Zinbryta (daklizumab);
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.
Odbor PRAC je zato menil, da so potrebni nadaljnji ukrepi za zmanjšanje tega tveganja, vključno z omejitvijo uporabe zdravila na primere, pri katerih ni primerna nobena druga možnost zdravljenja;
Daclizumab is not expected to be metabolised by the liver and the experts noted that it would be unfeasible to completely exclude hepatotoxic medications from the clinical management of MS patients.
Ni pričakovati, da bi se daklizumab presnavljal v jetrih, in strokovnjaki so opozorili, da ne bi bilo primerno popolnoma izključiti hepatotoksičnih zdravil iz klinične obravnave bolnikov z MS.
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.
Za lažjo komunikacijo med zdravniki in bolniki o tej temi in za zagotavljanje, da so bolniki razumeli informacije o tveganju, je skladno s stališčem znanstvene svetovalne skupine odbor PRAC zahteval uvedbo potrditvenega obrazca.
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.
Bolniki z virusom hepatitisa C (HCV) ali hepatitisa B (HBV) so bili izključeni iz kliničnih preskušanj in zaenkrat še niso ugotovili obstoja povezave med obstoječimi okužbami s temi virusi in poškodbami jeter, ki jih povzroča daklizumab.
• 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.
• odbor PRAC je presodil tudi, da je treba uvesti potrditveni obrazec za zagotavljanje, da so bili bolniki ustrezno seznanjeni o tveganjih za poškodbe jeter, povezane z daklizumabom.
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.
Prepoznati ni bilo mogoče nobenega časovnega okna za povečano tveganje in primeri poškodb jeter so se pojavljali ves čas zdravljenja in do šest mesecev po zadnjem odmerku 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.
• poleg tega je treba bolnike pred uvedbo zdravljenja presejati tudi glede okužbe s hepatitisom B in C, uvedba zdravljenja pa pri bolnikih z drugimi avtoimunskimi stanji ni priporočljiva.
These clinical effects were supported by robust and substantial treatment effects in reducing all key brain magnetic resonance imaging (MRI) parameters of acute and chronic inflammatory and destructive central nervous system disease activity.
Ti klinični učinki so bili podprti z obsežnimi in precejšnjimi učinki zdravljenja pri zmanjševanju vseh ključnih parametrov akutne in kronične vnetne aktivnosti bolezni in uničevanja osrednjega živčnega sistema pri magnetnoresonančnem slikanju (MRS) možganov.
The CHMP concluded that the summary of products characteristics should be amended accordingly.
Odbor CHMP je zaključil, da je treba v skladu s tem posodobiti povzetek glavnih značilnosti zdravila.
Finally the threshold of transaminases elevation for patients not included in clinical trials, and therefore in which treatment initiation is not recommended, should be corrected from above two times the upper normal limit to above or equal to two times that limit.
Končno je treba prag dviga vrednosti transaminaz pri bolnikih, ki niso vključeni v klinična preskušanja, in zato pri njih uvedba zdravljenja ni priporočena, popraviti z več kot dvakratne vrednosti zgornje normalne meje na več ali enako dvakratni vrednosti te meje.
Although it was recognised that this measure has no predictive value on the risk of developing severe and potential fatal liver injury, the SAG considered that as a precautionary measure discontinuation of therapy should be recommended when patients levels of ALT or AST reach over 3 times the upper limit of normal.
Čeprav je bilo sprejeto, da ta ukrep nima napovedne vrednosti na tveganje za razvoj resne in potencialno usodne poškodbe jeter, je znanstvena svetovalna skupina menila, da je treba kot previdnostni ukrep priporočiti prekinitev zdravljenja, kadar ravni ALT ali AST pri bolnikih presežejo trikratno zgornjo mejo normalne vrednosti.
Discontinuation should also be considered if an adequate response has not been achieved or if the liver function monitoring is not adhered to.
O prekinitvi zdravljenja je treba razmisliti tudi ob nedoseganju zadostnega odziva ali neupoštevanju spremljanja delovanja jeter.
On 7 June 2017, the European Commission (EC) was informed of a fatal case of fulminant liver failure in a patient treated with daclizumab in an ongoing observational study, despite monthly liver function testing performed in accordance with recommendations in the product information.
Evropska komisija je 7. junija 2017 prejela obvestilo o smrtnem primeru zaradi fulminantne odpovedi jeter pri bolniku, zdravljenim z daklizumabom v okviru tekoče opazovalne študije, kljub mesečnim pregledom delovanja jeter v skladu s priporočili v informacijah o zdravilu.
It was also noted that autoimmune thyroiditis was reported in the recent fatal case as well as in one of the adjudicated cases.
Opozorili so tudi, da so v nedavnem usodnem primeru in v enem od primerov, o katerih se presoja, poročali o avtoimunskem tiroiditisu.
Overall, considering the data available, the occurrence of daclizumab induced liver injury is considered to be unpredictable.
Z upoštevanjem razpoložljivih podatkov velja pojav z daklizumabom povzročenih poškodb jeter za nepredvidljivega.