FrancophonIA/ELRC3.0 huggingface dataset:
English: <Special precautions for use in animals:>
Slovenian: <Posebni previdnostni ukrepi za uporabo pri živalih:>
English: <Shelf life after incorporation into meal or pelleted feed: ….>
Slovenian: <Rok uporabnosti po vključitvi v obrok ali peletirano hrano: ….>
English: <None.>
Slovenian: <Jih ni.>
English: Advice on correct administration
Slovenian: Nasvet o pravilni uporabi zdravila
English: Do not use this veterinary medicinal product after the expiry date which is stated on the <label> <bottle> <...> <after {abbreviation used for expiry date}>.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na <ovojnini > <steklenici> <...> po {kratica, ki se uporablja za datum izteka roka uporabnosti}.> <Rok uporabnosti zdravila se nanaša na zadnji dan v navedenem mesecu.>
English: <in order to protect from <light> <and> <moisture>.>
Slovenian: <da se zaščiti pred <svetlobo><in> <vlago>.>
English: <Consideration should be given to official guidance on the incorporation of medicated premixes in final feeds.>
Slovenian: <Upoštevati je treba uradna priporočila o dodajanju zdravilnih predmešanic v krmo.>
English: Dosage for each species, route(s) and method of administration
Slovenian: Odmerki za posamezne živalske vrste ter pot(i) in način uporabe zdravila
English: Date on which the label was last approved
Slovenian: Datum zadnje odobritve stične ovojnine
English: <Do not store above <25°C> <30°C>.> or
Slovenian: <Ne shranjujte pri temperaturi nad <25 (C> <30 (C>.>
English: Marketing authorisation number(s)
Slovenian: Številka(e) dovoljenj(a) za promet
English: <Do not <refrigerate> <or> <freeze>.>
Slovenian: <Ne <shranjujte v hladilniku> <.> <ali> <zamrzujte>.>
English: <Shelf life after first opening the container: …..>
Slovenian: <Rok uporabnosti po prvem odpiranju vsebnika: ….>
English: <Store in a refrigerator (2°C - 8°C).>
Slovenian: <Shranjujte v hladilniku (2 (C - 8 (C).>
English: <This veterinary medicinal product does not require any special temperature storage conditions.>
Slovenian: <Za shranjevanje zdravila ni posebnih temperaturnih omejitev.>
English: <Store below <25°C> <30°C>.>
Slovenian: <Shranjujte pri temperaturi pod <25 (C> <30 (C>.>
English: <Protect from frost.>
Slovenian: <Zaščitite pred zamrznitvijo.>
English: <Manufacturer responsible for batch release:>
Slovenian: <Proizvajalec odgovoren za sproščanje serij:>
English: <Store and transport frozen {temperature range}.>
Slovenian: <Shranjujte in prevažajte zamrznjeno {temperaturni interval}.>
English: <Special precautions to be taken by the person administering the veterinary medicinal product to animals:>
Slovenian: <Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo:>
English: <Shelf life after <dilution> <reconstitution> according to directions: …..>
Slovenian: <Rok uporabnosti po <razredčenju> <ali> <rekonstituciji> v skladu z navodili: ….>
English: <Protect from light.>
Slovenian: <Zaščitite pred svetlobo.>
English: <Not all pack sizes may be marketed.>
Slovenian: <Ni nujno, da so v prometu vsa navedena pakiranja.>
English: <Marketing authorisation holder <and manufacturer responsible for batch release>:>
Slovenian: <Imetnik dovoljenja za promet z zdravilom <in proizvajalec odgovoren za sproščanje serij>:>
English: <Incompatibilities:>
Slovenian: <Inkompatibilnosti:>
English: <Store and transport refrigerated (2°C - 8°C).>
Slovenian: <Shranjujte in prevažajte v hladilniku (2 (C - 8 (C)>.>
English: - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).>
Slovenian: - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).>
English: Special warning(s)
Slovenian: Posebno(a) opozorilo(a)
English: <This veterinary medicinal product does not require any special storage conditions.>
Slovenian: <Za shranjevanje zdravila niso potrebna posebna navodila.>
English: <Store in the original <container><package>>
Slovenian: <Shranjujte v originalni(em) <vsebniku> <ovojnini>.>
English: <Ask your <veterinary surgeon> <or> <pharmacist> how to dispose of medicines no longer required.
Slovenian: <Glede odstranjevanja zdravil, ki jih ne uporabljate več, se posvetujte z <veterinarjem> <ali> <farmacevtom>.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE - COMBINED LABEL AND PACKAGE LEAFLET
Slovenian: PODATKI KI MORAJO BITI NAVEDENE NA ZUNANJI OZ. STIČNI OVOJNINI - ZDRUŽENA STIČNA OVOJNINA IN NAVODILO ZA UPORABO
English: <Fertility:>
Slovenian: <Plodnost:>
English: {active substance(s)}
Slovenian: {učinkovina(e)}
English: <Store in a dry place>
Slovenian: <Shranjujte na suhem mestu.>
English: <Store in a freezer {temperature range}.>
Slovenian: <Shranjujte v zamrzovalniku {temperaturni interval}.>
English: <Lactation:>
Slovenian: <Laktacija:>
English: The words “Keep out of the sight and reach of children”
Slovenian: Besedilo “zdravilo shranjujte nedosegljivo otrokom”
English: - common (more than 1 but less than 10 animals in 100 animals treated)
Slovenian: - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali)
English: - rare (more than 1 but less than 10 animals in 10,000 animals treated)
Slovenian: - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali)
English: {NATURE/TYPE}
Slovenian: {VRSTA/TIP}
English: - uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
Slovenian: - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali)
English: <Pregnancy and lactation:>
Slovenian: <Brejost in laktacija:>
English: <Lay:>
Slovenian: <Brejost:>
English: - very common (more than 1 in 10 animals treated displaying adverse reaction(s))
Slovenian: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali)
English: Thursday 22 January 2015
Slovenian: 22. januar 2015
English: Pharmacovigilance Risk Assessment Committee
Slovenian: Odbor za oceno tveganja na področju farmakovigilance
English: Adopted at the 6-9 January 2015 PRAC
Slovenian: Sprejeto na seji odbora PRAC 6.-9. januarja 2015
English: In addition, routine pharmacovigilance should be performed in order to better characterise the risk.
Slovenian: Poleg tega je treba izvajati rutinske farmakovigilančne dejavnosti, da bi bolje opredelili tveganje.
English: Additional tests and medicines may be needed to diagnose and treat this.
Slovenian: Za diagnozo in zdravljenje bodo morda potrebni dodatne preiskave in zdravila.
English: PRAC recommendations on signals for update of the product information
Slovenian: Priporočila odbora PRAC o signalih za posodobitev informacij o zdravilu
English: Also tell your doctor or pharmacist if you have a muscle weakness that is constant.
Slovenian: Svojemu zdravniku ali farmacevtu prav tako povejte, če se vam pojavi stalna oslabelost mišic.
English: Frequency ‘not known': aggression
Slovenian: Neznana pogostnost: agresivnost
English: • in neonates up to 4 weeks of age (see section 4.4).
Slovenian: • pri novorojenčkih, starih do štiri tedne (glejte poglavje 4.4).
English: POLG mutation testing should be performed in accordance with current clinical practice for the diagnostic evaluation of such disorders (see section 4.3).
Slovenian: Opraviti je treba testiranje za mutacije gena POLG v skladu s trenutno klinično prakso za diagnostično oceno takšnih motenj (glejte poglavje 4.3).
English: Side effects of unknown frequency: Muscle weakness that is constant.
Slovenian: Neželeni učinki neznane pogostnosti: stalna oslabelost mišic.
English: Section 4.4 - Special warnings and precautions for use:
Slovenian: Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi:
English: The package leaflets should be updated accordingly.
Slovenian: Ustrezno je treba posodobiti tudi navodila za uporabo.
English: Valproate and related substances - Mitochondrial toxicity (EPITT no 17956)
Slovenian: Valproat in sorodne učinkovine - mitohondrijska toksičnost (EPITT no 17956)
English: Paroxetine - Aggression (EPITT no 18089)
Slovenian: Paroksetin - agresivnost (EPITT no 18089)
English: Atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, simvastatin - Immune-mediated necrotizing myopathy (IMNM) (EPITT no 18140)
Slovenian: Atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, simvastatin - imunsko posredovana nekrotizirajoča miopatija (IMNM) (EPITT no 18140)
English: • in patients in the perioperative liver transplantation period and
Slovenian: • pri bolnikih v perioperativnem obdobju presaditve jeter in
English: Optimark is contraindicated
Slovenian: Zdravilo Optimark je kontraindicirano
English: What you need to know before you <take> <use> <product name> Do not <take> <use> <product name>:
Slovenian: Kaj morate vedeti, preden <boste vzeli> <boste uporabili> <ime zdravila> Ne <jemljite> <uporabljajte> <ime zdravila>:
English: Section 4.8 - Undesirable effects:
Slovenian: Poglavje 4.8 - Neželeni učinki:
English: What you need to know before you <take> <use> <product name> Warnings and Precautions:
Slovenian: Kaj morate vedeti, preden <boste vzeli> <boste uporabili> <ime zdravila> Opozorila in previdnostni ukrepi:
English: Footnote - cases of aggression were observed in post marketing experience Package Leaflet:
Slovenian: Opomba - V okviru izkušenj v obdobju trženja so bili zabeleženi primeri agresivnosti.
English: Homeopathic products containing lithium are not affected by this PRAC recommendation.
Slovenian: To priporočilo odbora PRAC ne velja za homeopatske izdelke, ki vsebujejo litij.
English: 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.
Slovenian: Po spremembi dovoljenja za promet za ta zdravila morajo imetniki dovoljenja za promet s katerim koli zdravilom z isto zdravilno učinkovino predložiti zadevno vlogo za spremembo.
English: Gadodiamide; gadopentetic acid; gadoversetamideNephrogenic systemic fibrosis in patients with acute kidney injury (EPITT no 408)
Slovenian: Gadodiamid; gadopentetna kislina; gadoversetamidnefrogena sistemska fibroza pri bolnikih z akutno poškodbo ledvic (EPITT no 408)
English: 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.
Slovenian: Na podlagi podatkov, ki so jih predložili imetniki dovoljenja za promet, in nasvetov delovne skupine za farmakogenomiko je odbor PRAC zaključil, da so na voljo zadostni dokazi v podporo vzročni povezavi med valproatom in poslabšanjem osnovnih mitohondrijskih bolezni, vključno s tveganjem za hepatotoksičnost, do katere prihaja predvsem pri bolnikih z mutacijami POLG (polimeraza gama).
English: Section 2:
Slovenian: Poglavje 2:
English: 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.
Slovenian: Na motnje, povezane z genom POLG, je treba posumiti pri bolnikih s pozitivno družinsko anamnezo ali značilnimi simptomi za motnjo, povezano s POLG, kamor med drugim spadajo nepojasnjena encefalopatija, neodzivna epilepsija (fokalna, mioklonična), epileptični status pri pregledu, zaostanki v razvoju, psihomotorično nazadovanje, aksonalna senzorično-motorična nevropatija, miopatija, cerebralna ataksija, oftalmoplegija ali komplicirana migrena z okcipitalno avro.
English: 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.
Slovenian: Na podlagi razpoložljivih podatkov se je odbor PRAC strinjal, da so na voljo zadostni dokazi za zaključek, da dolgotrajna uporaba litija lahko povzroči mikrociste, onkocitome in karcinome Bellinijevih vodov.
English: 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.
Slovenian: Valproat lahko izzove ali poslabša klinične znake osnovnih mitohondrijskih bolezni, ki jih povzročajo mutacije mitohondrijske DNK in jedrnega gena POLG.
English: SmPC changes for Optimark (gadoversetamide) 4.2 Posology and method of administration
Slovenian: Spremembe povzetka glavnih značilnosti za zdravilo Optimark (gadoversetamid) 4.2 Odmerjanje in način uporabe
English: Optimark is contraindicated in these patients (see section 4.3).
Slovenian: Zdravilo Optimark je pri teh bolnikih kontraindicirano (glejte poglavje 4.3).
English: IMNM is clinically characterized by persistent proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment.
Slovenian: Klinična znaka IMNM sta trdovratna oslabelost proksimalnih mišic in povišana vrednost serumske kreatin kinaze, ki kljub ukinitvi zdravljenja s statini ne izzvenita.
English: Prior to administration of Optimark, all patients should be screened for renal dysfunction by obtaining laboratory tests.
Slovenian: Pred apliciranjem zdravila Optimark je treba pri vseh bolnikih z laboratorijskimi preiskavami ugotoviti morebitno ledvično disfunkcijo.
English: Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group.
Slovenian: Pri bolnikih, pri katerih so opravili presaditev jeter, je tveganje še zlasti veliko, saj je v tej skupini pogostost akutne ledvične odpovedi visoka.
English: <invented name> is contraindicated in these patients (see section 4.3).
Slovenian: Kontrastno sredstvo <izmišljeno ime> je pri teh bolnikih kontraindicirano (glejte poglavje 4.3).
English: Frequency not known: Immune-mediated necrotizing myopathy (see section 4.4) Package Leaflet:
Slovenian: Neznana pogostnost: imunsko posredovana nekrotizirajoča miopatija (glejte poglavje 4.4.)
English: • in patients who have had liver transplantation or
Slovenian: • pri bolnikih, pri katerih so opravili presaditev jeter, ali
English: Possible side effects:
Slovenian: Možni neželeni učinki:
English: If you have a genetic problem causing a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome) Warnings and precautions
Slovenian: Če imate genetsko motnjo, ki povzroča mitohondrijsko bolezen(npr. sindrom Alpers-Huttenlocher).
English: 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.
Slovenian: Pri bolnikih, pri katerih so opravili ali opravljajo presaditev jeter, je tveganje še zlasti veliko, saj je v tej skupini incidenca akutne ledvične odpovedi visoka.
English: 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).
Slovenian: Valproat je kontraindiciran pri bolnikih z ugotovljenimi mitohondrijskimi motnjami, ki jih povzročajo mutacije jedrnega gena, ki kodira mitohondrijski encim polimerazo γ (POLG), npr. sindromom AlpersHuttenlocher, in pri otrocih, starih manj kot dve leti, pri katerih sumijo na motnjo, povezano s POLG (glejte poglavje 4.4).
English: SmPC changes for Omniscan (gadodiamide) and Magnevist (gadopentetic acid)
Slovenian: Spremembe povzetka glavnih značilnosti za zdravili Omniscan (gadodiamid) in Magnevist (gadopentetna kislina)
English: Prior to administration of <invented name>, all patients should be screened for renal dysfunction by obtaining laboratory tests.
Slovenian: Pred uporabo kontrastnega sredstva <izmišljeno ime> je treba pri vseh bolnikih na podlagi laboratorijskih preiskav oceniti delovanje ledvic.
English: Musculoskeletal disorders:
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva:
English: Lithium - Solid renal tumours (EPITT no 18090)
Slovenian: Litij - čvrsti ledvični tumorji (EPITT no 18090)
English: 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).
Slovenian: Ledvični tumorji: Pri bolnikih s hudo okvaro ledvic, ki so jemali litij več kot 10 let, lahko obstaja povečano tveganje za razvoj benignega ali malignega tumorja ledvic (mikrocist, onkocitomov ali karcinomov Bellinijevih vodov).
English: 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):
Slovenian: Po preučitvi razpoložljivih dokazov v literaturi se je odbor PRAC strinjal, da morajo imetniki dovoljenja za promet z zdravili, ki vsebujejo atorvastatin, simvastatin, pravastatin, fluvastatin, pitavastatin ali lovastatin v dveh mesecih predložiti vlogo za spremembo informacij o zdravilu, kot je opisano spodaj (novo besedilo podčrtano):
English: Patients with known or suspected mitochondrial disease
Slovenian: Bolniki z ugotovljeno mitohondrijsko boleznijo ali sumom nanjo
English: Package leaflet:
Slovenian: Bolezni sečil:
English: Therefore, Optimark must not be used in patients who have had or are undergoing liver transplantation and in neonates (see section 4.3).
Slovenian: Zato se zdravilo Optimark pri bolnikih, pri katerih so opravili ali opravljajo presaditev jeter, in pri novorojenčkih ne sme uporabljati (glejte poglavje 4.3).
English: Frequency unknown: Benign/malignant kidney tumours (microcysts, oncocytoma, or collecting duct renal carcinoma) (in long-term therapy).
Slovenian: Neznana pogostnost:benigni/maligni ledvični tumorji (mikrociste, onkocitomi in karcinomi Bellinijevih vodov (pri dolgotrajnem zdravljenju).
English: Section 4 Possible side effects:
Slovenian: Poglavje 4 Možni neželeni učinki:
English: 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.
Slovenian: O akutni odpovedi jeter in smrti, povezani z jetri, ki ju je povzročil valproat, so pogosteje poročali pri bolnikih z dednimi nevrometabolnimi motnjami, ki jih povzročajo mutacije gena za mitohondrijski encim polimerazo γ (POLG), npr. sindromom AlpersHuttenlocher.
English: 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).
Slovenian: Kontrastno sredstvo <izmišljeno ime> se ne sme uporabljati pri bolnikih s hudo okvaro ledvic, pri bolnikih v perioperativnem obdobju presaditve jeter in pri novorojenčkih (glejte poglavje 4.3).
English: • in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute kidney injury.
Slovenian: • pri bolnikih s hudo ledvično okvaro (GFR < 30 ml/min/1,73 m²) in/ali akutno poškodbo ledvic,
English: Frequency unknown: Microcysts, oncocytoma and collecting duct renal carcinoma (in long-term therapy) (see Section 4.4).
Slovenian: Neznana pogostnost: mikrociste, onkocitomi in karcinomi Bellinijevih vodov (pri dolgotrajnem zdravljenju) (glejte poglavje 4.4).
English: There have been very rare reports of an immune-mediated necrotizing myopathy (IMNM) during or after treatment with some statins.
Slovenian: Med zdravljenjem z nekaterimi statini oziroma po njem so zelo redko poročali o imunsko posredovani nekrotizirajoči miopatiji (IMNM).
English: 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.
Slovenian: Poročali so o nefrogeni sistemski fibrozi (NSF), povezani z uporabo kontrastnega sredstva <izmišljeno ime> in nekaterih drugih kontrastnih sredstev, ki vsebujejo gadolinij, pri bolnikih z akutno ali kronično hudo okvaro ledvic (GFR < 30 ml/min/1,73 m2) in/ali akutno poškodbo ledvic.
English: Patients with iImpaired renal function
Slovenian: Bolniki z Okvarjeno delovanje okvarjenim delovanjem ledvic
English: Package Leaflet
Slovenian: Okvara ledvic
English: 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).
Slovenian: Po preučitvi razpoložljivih dokazov se je odbor PRAC strinjal, da morajo imetniki dovoljenja za promet z zdravili Omniscan, Optimark in Magnevist v dveh mesecih predložiti vlogo za spremembo informacij o zdravilu, kot je opisano spodaj (novo besedilo podčrtano/besedilo za izbris prečrtano).
English: 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).
Slovenian: Ob upoštevanju vseh razpoložljivih podatkov se je odbor PRAC strinjal, da morajo vsi imetniki dovoljenja za promet z zdravili, ki vsebujejo paroksetin, v 2 mesecih predložiti vlogo za spremembo informacij o zdravilu (poglavja 4.8 v povzetku glavnih značilnosti zdravila in navodila za uporabo), kot je opisano spodaj (novo besedilo je podčrtano).
English: 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.
Slovenian: Pred začetkom <jemanja> <uporabe> <ime zdravila> se posvetujte <z> zdravnikom <ali> <farmacevtom> <ali> <medicinsko sestro>.
English: 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).
Slovenian: Imetniki dovoljenja za promet z zdravili, ki vsebujejo valproat (in sorodne učinkovine), morajo v 2 mesecih predložiti vlogo za spremembo informacij o zdravilu, kot je opisano spodaj (novo besedilo je podčrtano).
English: 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).
Slovenian: Ledvični tumorji: Pri bolnikih s hudo okvaro ledvic, ki so prejemali litij več kot 10 let, so poročali o mikrocistah, onkocitomih in karcinomih Bellinijevih vodov (glejte poglavje 4.8).
English: 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).
Slovenian: Imetniki dovoljenja za promet z zdravili, ki vsebujejo litij (in sorodne učinkovine), morajo zato v dveh mesecih predložiti vlogo za spremembo informacij o zdravilu, kot je opisano spodaj (novo besedilo podčrtano).