natgillin/translations-raw huggingface dataset:
<Ask your <veterinary surgeon> <or> <pharmacist> how to dispose of medicines no longer required.
<Pitajte vašeg <veterinara><farmaceuta> kako odlagati veterinarsko-medicinske proizvode koji vam više nisu potrebni.
<Do not store above <25°C> <30°C>.> or
<Nemojte čuvati pri temperaturi iznad <25 (C><30 (C>>ili
Advice on correct administration
11. Savjeti za ispravnu primjenu
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release , if different
Naziv i adresa nositelja odobrenja za stavljanje u promet i nositelja odobrenja za proizvodnju odgovornog za puštanje serije u promet, ako je različito
<None.>
<Nema.>
<Store in the original <container><package>>
<Čuvati u originalnom<spremniku><pakovanju>>
Special storage precautions
13. Posebne mjere čuvanja
<in order to protect from <light> <and> <moisture>.>
<radi zaštite od <svjetla> <i> <vlage>.>
<Special warnings for each target species:>
<Posebna upozorenja <za svaku od ciljnih vrsta životinja:>
<Medicines should not be disposed of via wastewater <or household waste>.>
<Veterinarsko-medicinski proizvodi se ne smiju odlagati u otvorene vode <ili kućni otpad.>
<This veterinary medicinal product does not require any special temperature storage conditions.>
<Ovaj veterinarsko-medicinski proizvod ne zahtijeva nikakve posebne temperaturne uvijete čuvanja.>
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE - COMBINED LABEL AND PACKAGE LEAFLET
OSNOVNI PODACI NA UNUTARNJEM PAKOVANJU - KOMBINIRANA ETIKETA I UPUTA O VMP
<Protect from light.>
<Zaštiti od svjetla.>
<Special precautions to be taken by the person administering the veterinary medicinal product to animals:>
<Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na životinjama:>
<Shelf life after <dilution> <reconstitution> according to directions: …..>
<Rok valjanosti poslije <razrjeđenja><rekonstitucije> prema uputi: …>
<Shelf life after incorporation into meal or pelleted feed: ….>
<Rok valjanosti poslije stavljanja u obrok ili u peletiranu hranu za životinje: …>
<This veterinary medicinal product does not require any special storage conditions.>
<Ovaj veterinarsko-medicinski proizvod ne zahtijeva nikakve posebne uvijete čuvanja.>
<Store and transport frozen {temperature range}.>
<Čuvati i prevoziti zamrznuto{temperaturni raspon
Dosage for each species, route(s) and method of administration
Doziranje za svaku ciljnu vrstu životinja, način i put(evi) primjene
<To be supplied only on veterinary prescription.>
<Izdaje se na veterinarski recept.>
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).>
- vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).>
Statement of the active substance (s) and other ingredients
Količina djelatne(ih) tvari i drugih sastojaka
<Store in a refrigerator (2°C - 8°C).>
<Čuvati u hladnjaku (2 (C - 8 (C).>
<Incompatibilities:>
<Inkompatibilnosti:>
<Marketing authorisation holder <and manufacturer responsible for batch release>:>
<Nositelj odobrenja za stavljanje u promet <i proizvođač odgovoran za puštanje serije u promet>:>
<Batch> <Lot> <BN> {number}
<Lot> <Serija> {broj}
<Store below <25°C> <30°C>.>
<Čuvati pri temperaturi do <25 (C><30 (C>.>
<Once <broached> <opened> <diluted> <reconstituted> <use by…> <use within…><use immediately.>>
<upotrijebiti do…><koristiti unutar ...><odmah upotrijebiti>.>
<Store and transport refrigerated (2°C - 8°C).>
<Čuvati i prevoziti na hladnom (2 (C - 8 (C).>
Manufacturer's batch number
22. Broj proizvodne serije
<Shelf life after first opening the container: …..>
<Rok valjanosti poslije prvog otvaranja pakovanja: …>
<Protect from frost.>
<Čuvati od zamrzavanja
<Special precautions for use in animals:>
<Posebne mjere opreza prilikom primjene na životinjama:>
Special warning(s)
14. Posebno(a) upozorenje(a)
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e))
<Pregnancy:>
<Graviditet:>
<Manufacturer responsible for batch release:>
<Proizvođač odgovoran za puštanje serije u promet:>
<Consideration should be given to official guidance on the incorporation of medicated premixes in final feeds.>
<Stavljanje ljekovitih premiksa u gotovu hranu za životinje, trebalo bi razmotriti u službenim vodičima.>
<Lactation:>
<Laktacija:>
<Pregnancy and lactation:>
<Graviditet i laktacija:>
<Store in a freezer {temperature range}.>
<Čuvati u zamrzivaču{temperaturni raspon}.>
- common (more than 1 but less than 10 animals in 100 animals treated)
- česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja)
<The frequency of adverse reactions is defined using the following convention:
<Učestalost nuspojava je određena sukladno sljedećim pravilima:
<Store in a dry place>
<Čuvati na suhom mjestu.>
<Withdrawal period(s):>
<Karencija(e):>
Marketing authorisation number(s)
21. Broj(evi) odobrenja za stavljanje u promet
{NATURE/TYPE}
{OSOBINE/TIP}
<Lay:>
<Nesenje:>
Indication(s)
12. Karencija(e)
{active substance(s)}
{djelatna(e) tvar(i)}
Thursday 22 January 2015
22. siječnja 2015
Frequency ‘not known': aggression
Učestalost „nepoznata“: agresija
In addition, routine pharmacovigilance should be performed in order to better characterise the risk.
Osim toga, treba provoditi rutinsku farmakovigilanciju kako bi se bolje okarakterizirao rizik.
Additional tests and medicines may be needed to diagnose and treat this.
Možda će biti potrebni dodatni testovi i lijekovi kako bi se to dijagnosticiralo i liječilo.
Adopted at the 6-9 January 2015 PRAC
Usvojeno na sjednici PRAC-a 6. - 9. siječnja 2015.
Pharmacovigilance Risk Assessment Committee
Povjerenstvo za ocjenu rizika na području farmakovigilancije
Also tell your doctor or pharmacist if you have a muscle weakness that is constant.
Također obavijestite svog liječnika ili ljekarnika ako imate konstantnu mišićnu slabost.
• in neonates up to 4 weeks of age (see section 4.4).
• u novorođenčadi starosti do 4 tjedna (vidjeti dio 4.4).
Optimark is contraindicated
Optimark je kontraindiciran
POLG mutation testing should be performed in accordance with current clinical practice for the diagnostic evaluation of such disorders (see section 4.3).
Testiranje mutacije POLG-a treba provesti u skladu s aktualnom kliničkom praksom za dijagnostičku evaluaciju takvih poremećaja (vidjeti dio 4.3).
Side effects of unknown frequency: Muscle weakness that is constant.
Nuspojave nepoznate učestalosti: Mišićna slabost koja je konstantna.
Atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, simvastatin - Immune-mediated necrotizing myopathy (IMNM) (EPITT no 18140)
Atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, simvastatin - imunološki posredovana nekrotizirajuća miopatija (IMNM) (EPITT br. 18140)
Following the variation of the marketing authorisation for these products, the MAHs for any product with the same active substance should submit a respective variation application.
Nakon izmjene odobrenja za stavljanje lijeka u promet za ove lijekove, nositelji odobrenja za bilo koji lijek s istom djelatnom tvari trebaju predati zahtjev za odgovarajuću izmjenu.
PRAC recommendations on signals for update of the product information
Preporuke PRAC-a vezane uz signale za ažuriranje informacija o lijeku
Footnote - cases of aggression were observed in post marketing experience Package Leaflet:
Bilješka - slučajevi agresije uočeni su u iskustvu prikupljenom nakon stavljanja lijeka u promet Uputa o lijeku:
Paroxetine - Aggression (EPITT no 18089)
Paroksetin - agresija (EPITT br. 18089)
What you need to know before you <take> <use> <product name> Do not <take> <use> <product name>:
Što morate znati prije nego počnete <uzimati> <primjenjivati> <naziv lijeka> Nemojte <uzimati> <primjenjivati> <naziv lijeka>:
What you need to know before you <take> <use> <product name> Warnings and Precautions:
Što morate znati prije nego počnete <uzimati> <primjenjivati> <naziv lijeka> Upozorenja i mjere opreza:
Patients with known or suspected mitochondrial disease
Bolesnici s poznatom mitohondrijskom bolesti ili sumnjom na mitohondrijsku bolest
Valproate and related substances - Mitochondrial toxicity (EPITT no 17956)
- Mitohondrijska toksičnost (EPITT br. 17956)
• in patients who have had liver transplantation or
• u bolesnika koji su se podvrgnuli transplantaciji jetre ili
POLG-related disorders should be suspected in patients with a family history or suggestive symptoms of a POLG-related disorder, including but not limited to unexplained encephalopathy, refractory epilepsy (focal, myoclonic), status epilepticus at presentation, developmental delays, psychomotor regression, axonal sensorimotor neuropathy, myopathy, cerebellar ataxia, ophthalmoplegia, or complicated migraine with occipital aura.
Na poremećaje povezane s POLG-om treba posumnjati u bolesnika s obiteljskom anamnezom ili sugestivnim simptomima poremećaja povezanog s POLG-om, koji obuhvaćaju, ali nisu ograničeni na neobjašnjenu encefalopatiju, refraktornu epilepsiju (fokalnu, miokloničnu), kliničku sliku epileptičkog statusa, zaostajanje u razvoju, psihomotoričku regresiju, aksonalnu senzorimotornu neuropatiju, miopatiju, cerebelarnu ataksiju, oftalmoplegiju ili kompliciranu migrenu s okcipitalnom aurom.
• in patients in the perioperative liver transplantation period and
• u bolesnika u perioperativnom razdoblju kod transplantacije jetre i
Optimark is contraindicated in these patients (see section 4.3).
Optimark je kontraindiciran u ovih bolesnika (vidjeti dio 4.3).
Patients who have had or are undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group.
Bolesnici koji su imali ili se podvrgavaju transplantaciji jetre pod posebnim su rizikom s obzirom na to da je incidencija akutnog zatajenja bubrega u ovoj skupini bolesnika visoka.
Possible side effects:
Moguće nuspojave:
If you have a genetic problem causing a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome) Warnings and precautions
Ako imate genetski problem koji uzrokuje mitohondrijski poremećaj (primjerice Alpers-Huttenlocherov sindrom)
In light of the data submitted by the marketing authorisation holders and the advice provided by the Pharmacogenomics Working Party, the PRAC concluded that the evidence is sufficient to support a causal association between valproate and aggravation of underlying mitochondrial diseases, including risk of hepatotoxicity occurring mainly in patients suffering from POLG (polymerase gamma) mutations.
U svjetlu podataka dostavljenih od strane nositelja odobrenja za stavljanje lijeka u promet i savjeta od strane Radne grupe za farmakogenomiku, PRAC je zaključio da su dokazi dostatni kako bi podržali uzročno-posljedičnu povezanost između valproata i pogoršanja podležećih mitohondijskih bolesti, uključujući rizik od hepatotoksičnosti koji se pojavljuje uglavnom u bolesnika koji pate od mutacija POLG-a (polimeraze gama).
Gadodiamide; gadopentetic acid; gadoversetamideNephrogenic systemic fibrosis in patients with acute kidney injury (EPITT no 408)
Gadodiamid; gadopentetatna kiselina; gadoversetamidnefrogena sistemska fibroza u bolesnika s akutnom ozljedom bubrega (EPITT br. 408)
Therefore, Optimark must not be used in patients who have had or are undergoing liver transplantation and in neonates (see section 4.3).
Stoga se Optimark ne smije koristiti u bolesnika koji su imali ili se podvrgavaju transplantaciji jetre i u novorođenčadi (vidjeti dio 4.3).
Homeopathic products containing lithium are not affected by this PRAC recommendation.
Ova preporuka PRAC-a ne odnosi se na homeopatske lijekove koji sadrže litij.
Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group.
Bolesnici koji se podvrgavaju transplantaciji jetre pod posebnim su rizikom s obzirom na to da je incidencija akutnog zatajenja bubrega u toj skupini bolesnika visoka.
Section 4 Possible side effects:
Dio 4. Moguće nuspojave:
SmPC changes for Omniscan (gadodiamide) and Magnevist (gadopentetic acid)
Izmjene u Sažetku opisa svojstava lijeka za Omniscan (gadodiamid) i Magnevist (gadopentetatna kiselina)
Musculoskeletal disorders:
Poremećaji mišićno-koštanog sustava:
Valproate may trigger or worsen clinical signs of underlying mitochondrial diseases caused by mutations of mitochondrial DNA as well as the nuclear encoded POLG gene.
Valproat može potaknuti ili pogoršati kliničke znakove podležeće mitohondrijske bolesti uzrokovane mutacijama mitohondrijske DNK kao i nuklearnog gena koji kodira za POLG.
<invented name> is contraindicated in these patients (see section 4.3).
<Zaštićeno ime> je kontraindiciran u ovih bolesnika (vidjeti dio 4.3).
IMNM is clinically characterized by persistent proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment.
IMNM je klinički karakterizirana perzistentnom slabošću proksimalnih mišića te povišenim razinama kreatin kinaze u serumu koje se ne povlače unatoč prekidu liječenja statinom.
Section 2:
Dio 2:
Valproate is contraindicated in patients known to have mitochondrial disorders caused by mutations in the nuclear gene encoding the mitochondrial enzyme polymerase γ (POLG), e.g. Alpers-Huttenlocher Syndrome, and in children under two years of age who are suspected of having a POLG-related disorder (see section 4.4).
Valproat je kontraindiciran u bolesnika za koje je poznato da imaju mitohondrijske poremećaje uzrokovane mutacijama nuklearnog gena koji kodira za mitohondrijski enzim polimerazu γ (POLG), poput Alpers-Huttenlocherova sindroma, te u djece mlađe od dvije godine za koje se sumnja da boluju od poremećaja povezanog s POLG-om (vidjeti dio 4.4).
Prior to administration of Optimark, all patients should be screened for renal dysfunction by obtaining laboratory tests.
Prije primjene lijeka Optimark, za sve bolesnike treba provesti laboratorijske testove kako bi se otkrila bubrežna disfunkcija.
In light of the data available, the PRAC has agreed that the evidence is sufficient to conclude that longterm use of lithium may induce microcysts, oncocytomas and collecting duct renal carcinomas.
U svjetlu dostupnih podataka PRAC je zaključio da postoje dostatni dokazi kako bi se zaključilo da dugotrajna primjena litija može uzrokovati mikrociste, onkocitome i karcinome sabirnih kanalića bubrega.
Frequency not known: Immune-mediated necrotizing myopathy (see section 4.4) Package Leaflet:
Učestalost nepoznata: Imunološki posredovana nekrotizirajuća miopatija (vidjeti dio 4.4) Uputa o lijeku:
Kidney tumours: Patients with severe kidney impairment who received lithium for more than 10 years may have a risk of developing a benign or malignant kidney tumour (microcysts, oncocytoma or collecting duct renal carcinoma).
Tumori bubrega: Bolesnici s teškim oštećenjem bubrega koji su primali litij tijekom više od 10 godina mogu biti pod rizikom od razvoja benignih ili malignih tumora bubrega (mikrocisti, onkocitoma ili karcinoma sabirnih kanalića bubrega).
The package leaflets should be updated accordingly.
Uputu o lijeku treba ažurirati u skladu s tim.
Having considered the available evidence from the literature, the PRAC has agreed that the MAHs for medicinal products containing atorvastatin, simvastatin, pravastatin, fluvastatin, pitavastatin or lovastatin should submit a variation within 2 months to amend the product informations as described below (new text underlined):
Razmotrivši dostupne dokaze iz literature, PRAC je zaključio da nositelji odobrenja za lijekove koji sadrže atorvastatin, simvastatin, pravastatin, fluvastatin, pitavastatin ili lovastatin trebaju podnijeti izmjenu u roku od 2 mjeseca kako bi se nadopunile informacije o lijeku kako je to opisano u nastavku (novi tekst podcrtan):
Summary of Product Characteristics (SmPC):
Sažetak opisa svojstava lijeka (SmPC)
SmPC changes for Optimark (gadoversetamide) 4.2 Posology and method of administration
Izmjene u Sažetku opisa svojstava lijeka za Optimark (gadoversetamid) 4.2. Doziranje i način primjene
Lithium - Solid renal tumours (EPITT no 18090)
Litij - solidni tumori bubrega (EPITT br. 18090)
In particular, valproateinduced acute liver failure and liver-related deaths have been reported at a higher rate in patients with hereditary neurometabolic syndromes caused by mutations in the gene for the mitochondrial enzyme polymerase γ (POLG), e.g. Alpers-Huttenlocher Syndrome.
Posebice, prijavljene su više stope akutnog zatajenja jetre induciranog valproatom i smrti povezane s jetrom u bolesnika s nasljednim neurometaboličkim sindromima uzrokovanima mutacijama u genu za mitohondrijski enzim polimerazu γ (POLG), poput Alpers-Huttenlocherova sindroma.
Prior to administration of <invented name>, all patients should be screened for renal dysfunction by obtaining laboratory tests.
Prije primjene lijeka <zaštićeno ime>, za sve bolesnike treba provesti laboratorijske testove kako bi se otkrila bubrežna disfunkcija.
Frequency unknown: Benign/malignant kidney tumours (microcysts, oncocytoma, or collecting duct renal carcinoma) (in long-term therapy).
Učestalost nepoznata: Benigni/maligni tumori bubrega (mikrociste, onkocitomi ili karcinom sabirnih kanalića bubrega) (kod dugotrajne terapije).
Frequency unknown: Microcysts, oncocytoma and collecting duct renal carcinoma (in long-term therapy) (see Section 4.4).
Učestalost nepoznata: Mikrociste, onkocitomi i karcinom sabirnih kanalića bubrega (u dugotrajnoj terapiji) (vidjeti dio 4.4).
• in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute kidney injury.
• u bolesnika s teškim oštećenjem bubrega (GFR < 30 ml/min/1,73 m2) i/ili akutnom ozljedom bubrega.
Talk to your doctor <or> , <pharmacist> <or nurse> before <taking> <using> <product name>: You know that there is a genetic problem causing a mitochondrial disorder in your family.
Obratite se svom liječniku <ili> , <ljekarniku> <ili medicinskoj sestri> prije <uzimanja>
Having considered the available evidence the PRAC has agreed that the MAH of Omniscan, Optimark and Magnevist should submit a variation within 2 months, to amend the product information as described below (new text underlined / text to be removed strikethrough).
Razmotrivši dostupne dokaze, PRAC je zaključio da nositelji odobrenja za Omniscan, Optimark i Magnevist trebaju podnijeti izmjenu u roku od 2 mjeseca kako bi se nadopunile informacije o lijeku kako je to opisano u nastavku (novi tekst podcrtan / tekst koji će se ukloniti prekrižen).
Renal tumours: Cases of microcysts, oncocytomas and collecting duct renal carcinoma have been reported in patients with severe renal impairment who received lithium for more than 10 years (see Section 4.8).
Posebna upozorenja i mjere opreza pri uporabi Tumori bubrega: Slučajevi mikrocisti, onkocitoma i karcinoma sabirnih kanalića bubrega prijavljeni su u bolesnika s teškim oštećenjem bubrega koji su primali litij više od 10 godina (vidjeti dio 4.8).
Therefore <invented name> must not be used in patients with severe renal impairment, in patients in the perioperative liver transplantation period and in neonates (see section 4.3).
Stoga se <zaštićeno ime> ne smije primjenjivati u bolesnika s teškim oštećenjem funkcije bubrega, u bolesnika u perioperativnom razdoblju kod transplantacije jetre i u novorođenčadi (vidjeti dio 4.3).
4.4 Special warnings and precautions for use
Posebna upozorenja i mjere opreza za uporabu
There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of Optimark and some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR <30ml/min/1.73m²) and/or acute kidney injury.
Prijavljeni su slučajevi nefrogene sistemske fibroze (NSF) povezane s primjenom lijeka Optimark i nekim kontrastnim sredstvima koja sadrže gadolinij u bolesnika s akutnim ili kroničnim teškim oštećenjem bubrega (GFR <30ml/min/1,73m²) i/ili akutnom ozljedom bubrega.
The marketing authorisation holders for valproate (and related substances) containing medicinal products should submit a variation within 2 months to amend the product information as described below (new text underlined).
Nositelji odobrenja za lijekove koji sadrže valproat (i srodne tvari) trebaju podnijeti izmjenu u roku od 2 mjeseca kako bi se nadopunile informacije o lijeku kako je to opisano u nastavku (novi tekst podcrtan).
There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of <invented name> and some other gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute kidney injury.
Prijavljeni su slučajevi nefrogene sistemske fibroze (NSF) povezane s primjenom lijeka <zaštićeni naziv> i nekim drugim kontrastnim sredstvima koja sadrže gadolinij u bolesnika s akutnim ili kroničnim teškim oštećenjem bubrega (GFR <30 ml/min/1,73m²) i/ili akutnom ozljedom bubrega.
Therefore, the Marketing Authorisation Holders of lithium containing medicinal products should submit a variation within 2 months, to amend the product information as described below (new text underlined).
Stoga nositelji odobrenja za lijekove koji sadrže litij trebaju podnijeti izmjenu u roku od 2 mjeseca kako bi se nadopunile informacije o lijeku kako je to opisano u nastavku (novi tekst podcrtan).
There have been very rare reports of an immune-mediated necrotizing myopathy (IMNM) during or after treatment with some statins.
Tijekom ili nakon liječenja nekim statinima vrlo rijetko je prijavljena imunološki posredovana nekrotizirajuća miopatija (IMNM).
Patients with iImpaired renal function
Bolesnici s oštećenjem funkcije bubrega
Package leaflet:
- Nuspojave:
4.3 Contraindications <invented name> is contraindicated in patients with severe renal impairment (GFR <30ml/min/1.73m2) and/or acute kidney injury, in patients in the perioperative liver transplantation period and in neonates up to 4 weeks of age (see section 4.4).
4.3. Kontraindikacije <zaštićeno ime> je kontraindiciran u bolesnika s teškim oštećenjem bubrega (GFR < 30ml/min/1,73m2) i/ili akutnom ozljedom bubrega i u bolesnika u perioperativnom razdoblju kod transplantacije jetre te u novorođenčadi starosti do 4 tjedna (vidjeti dio 4.4).
Optimark is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period (see section 4.3).
Optimark je kontraindiciran u bolesnika s teškim oštećenjem bubrega (GFR < 30 ml/min/1,73m2) i/ili akutnom ozljedom bubrega te u bolesnika koji su se podvrgnuli transplantaciji jetre ili u bolesnika u perioperativnom razdoblju kod transplantacije jetre (vidjeti dio 4.3).
Package Leaflet
Nuspojave
Renal impairment <invented name> is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute kidney injury and in patients in the perioperative liver transplantation period (see section 4.3).
<zaštićeno ime> je kontraindiciran u bolesnika s teškim oštećenjem bubrega (GFR < 30 ml/min/1,73m2) i/ili akutnom ozljedom bubrega te u bolesnika u perioperativnom razdoblju kod transplantacije jetre (vidjeti dio 4.3).
Section 4.4 - Special warnings and precautions for use:
- Posebna upozorenja i mjere opreza pri uporabi:
Taken into account all available data PRAC agreed that all MAHs for paroxetine containing products should submit a variation within 2 months to amend the product information (section 4.8 of the SmPC and package leaflet) as described below (new text underlined).
Uzimajući u obzir sve dostupne podatke, PRAC je zaključio da nositelji odobrenja za lijekove koji sadrže paroksetin trebaju podnijeti izmjenu u roku od 2 mjeseca kako bi se nadopunile informacije o lijeku (dio 4.8.
Renal and hepatic impairment
Valproat i srodne tvari
Renal and urinary disorders:
Poremećaji bubrega i mokraćnog sustava: