FrancophonIA/ELRC3.0 huggingface dataset:
English: At supra-therapeutic doses (75 and 300 mg once daily), rilpivirine has been associated with prolongation of the QTc interval of the electrocardiogram (ECG) (see sections 4.5 and 5.1).
Slovenian: V supraterapevtskih odmerkih (75 in 300 mg enkrat na dan) je bil rilpivirin povezan s podaljšanjem intervala QTc na elektrokardiogramu (EKG) (glejte poglavji 4.5 in 5.1), medtem ko v priporočenem odmerku 25 mg rilpivirina enkrat na dan nima klinično pomembnega učinka na interval QTc.
English: (inhibition of CYP3A enzymes).
Slovenian: (zavrtje encimov CYP3A).
English: Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 reverse transcriptase (RT).
Slovenian: Deluje tako, da nekompetitivno zavira reverzno transkriptazo HIV-1.
English: NAME OF THE MEDICINAL PRODUCT Juluca 50 mg/25 mg film-coated tablets dolutegravir/rilpivirine
Slovenian: Navodilo za uporabo Juluca 50 mg/25 mg filmsko obložene tablete dolutegravir/rilpivirin
English: Considering all of the available in vitro and in vivo data, the following amino acid substitutions, when present at baseline, are likely to affect the activity of rilpivirine: K101E, K101P, E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, Y188L, H221Y, F227C, M230I or M230L.
Slovenian: Upoštevaje vse razpoložljive podatke in vitro in in vivo je verjetno, da na aktivnost rilpivirina vplivajo naslednje izhodiščno prisotne aminokislinske substitucije: K101E, K101P, E138A, E138G, E138K,
English: → Talk to your doctor for further advice on taking acid-lowering medicines with Juluca.
Slovenian: → Posvetujte se z zdravnikom o jemanju zdravil za zmanjševanje kisline skupaj z zdravilom Juluca.
English: Warnings and precautions Talk to your doctor or, pharmacist before taking Juluca.
Slovenian: Pred začetkom jemanja zdravila Juluca se posvetujte z zdravnikom ali farmacevtom.
English: NNRTI resistance associated substitution K101K/E mixture with no decreased susceptibility to rilpivirine (FC=1.2) was observed in one subject with identified adherence issues that received dolutegravir plus rilpivirine.
Slovenian: Pri enem preiskovancu, ki je imel ugotovljene težave z adherenco in je prejemal kombinacijo dolutegravirja in rilpivirina, so ugotovili substitucijo K101K/E, povezano z odpornostjo proti NNRTI, brez zmanjšanja občutljivosti za rilpivirin (FC = 1,2).
English: Vardenafil Tadalafil/ Dolutegravir
Slovenian: vardenafil tadalafil/dolutegravir vardenafil tadalafil/ rilpivirin dolutegravir ↔
English: • decrease in haemoglobin
Slovenian: • znižanje hemoglobina,
English: when taken by mouth or injected, except as a single dose treatment - products that contain St John's wort (Hypericum perforatum) (a herbal product used for depression).
Slovenian: - deksametazon (kortikosteroid, ki se uporablja pri številnih boleznih, na primer pri vnetnih boleznih in alergijskih reakcijah), če ga zaužijete ali prejmete v injekcijah, razen v primeru zdravljenja z enim samim odmerkom, - izdelke, ki vsebujejo šentjanževko (Hypericum perforatum) (rastlinski pripravki, ki se uporabljajo pri depresiji).
English: Antimalarials Artemether/ Lumefantrine/ Dolutegravir
Slovenian: Antimalariki artemeter/ lumefantrin/ dolutegravir artemeter/ lumefantrin/ rilpivirin dolutegravir ↔ (Ni raziskano)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 May 2018
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/18/1282/001 EU/1/18/1282/002 DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 16. maj 2018 10.
English: Site-directed NNRTI mutant virus
Slovenian: Proti NNRTI odporni virusi s točkovno mutacijo
English: Calcium supplements, iron supplements or multivitamins must be taken at the same time as Juluca.
Slovenian: Dodatke kalcija, dodatke železa ali multivitaminske pripravke je treba jemati hkrati z zdravilom Juluca.
English: At baseline, in the pooled analysis, characteristics were similar between treatment arms with the median age of subjects of 43 years (28%, 50 years of age or older; 3%, 65 years of age or older), 22% female, 20% nonwhite and 77% were CDC Class A. Median CD+cell count was about 600 cells per mm3 with 11% having CD4+ cell count less than 350 cells per mm3.
Slovenian: 20 % nebelcev in 77 % v CDC razredu A. Mediano število celic CD+ je bilo približno 600 celic na mm3, 11 % preiskovancev pa je imelo število celic CD4+ manj kot 350 celic na mm3.
English: - omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole, (medicines to prevent and treat stomach ulcers, heartburn or acid reflux disease) - dexamethasone (a corticosteroid used in many conditions such as inflammation and allergic reactions)
Slovenian: - omeprazol, esomeprazol, lansoprazol, pantoprazol, rabeprazol (zdravila za preprečevanje in zdravljenje želodčnih razjed, zgage in refluksa želodčne kisline),
English: These medicinal products are recommended to be administered 12 hours before or 4 hours after Juluca (see section 4.5).
Slovenian: 12 ur pred zdravilom Juluca ali 4 ure po njem (glejte poglavje 4.5).
English: Rilpivirine ↔ Digoxin
Slovenian: rilpivirin ↔ digoksin
English: Rilpivirine in combination with a background regimen was evaluated in a clinical trial of 19 pregnant women during the second and third trimesters, and postpartum.
Slovenian: 19 nosečnicah v drugem in tretjem trimesečju nosečnosti ter po porodu.
English: No clinically important pharmacokinetic differences of dolutegravir or rilpivirine due to race have been identified.
Slovenian: Ne za dolutegravir ne za rilpivirin niso ugotovili klinično pomembnih farmakokinetičnih razlik glede na raso.
English: Dolutegravir ↓ AUC ↓ 49% Cmax ↓ 33% Cτ ↓ 73%
Slovenian: karbamazepin/ rilpivirin dolutegravir ↓ AUC ↓ 49 % Cmax ↓ 33 % Cτ ↓ 73 %
English: • metformin, to treat diabetes
Slovenian: - dofetilid (zdravilo za zdravljenje srčnih bolezni),
English: Liver toxicity associated with liver enzyme induction was observed in rodents following rilpivirine administration.
Slovenian: Pri glodalcih so po uporabi rilpivirina opažali toksične učinke na jetra, povezane z indukcijo jetrnih encimov.
English: Lansoprazole Rabeprazole Pantoprazole Esomeprazole/ Rilpivirine
Slovenian: lansoprazol rabeprazol pantoprazol esomeprazol/ rilpivirin dolutegravir ↔ (Ni raziskano)
English: May cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes).
Slovenian: Lahko povzroči povečanje koncentracije rilpivirina v plazmi (zavrtje encimov CYP3A).
English: • sleep disorders
Slovenian: • občutek zaspanosti,
English: Rabeprazole Pantoprazole Esomeprazole/ Dolutegravir
Slovenian: Zeliščni pripravki šentjanževka/ dolutegravir dolutegravir ↓
English: Decreased exposure of rilpivirine is expected (induction of CYP3A enzymes).
Slovenian: Pričakovati je manjšo izpostavljenost rilpivirinu (indukcija encimov CYP3A).
English: Nizatidine
Slovenian: Antacidi
English: Dolutegravir ↔ AUC ↓ 5% Cmax ↑ 16% Cτ ↓ 30% (induction of UGT1A1 and CYP3A enzymes).
Slovenian: Sočasna uporaba zdravila Juluca z rifampicinom je kontraindicirana (glejte poglavje rifabutin/dolutegravir1 dolutegravir ↔ AUC ↓ 5 % Cmax ↑ 16 % Cτ ↓ 30 % (indukcija encimov UGT1A1 in CYP3A).
English: Paracetamol / Rilpivirine1,2
Slovenian: paracetamol/ dolutegravir paracetamol/ rilpivirin1,2
English: Co-administration of Juluca with rifapentine is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba zdravila Juluca z rifapentinom je kontraindicirana (glejte poglavje 4.3).
English: Not applicable.
Slovenian: Ni znano
English: No dose adjustment of oral contraceptives is required when co-administered with Juluca.
Slovenian: Med sočasno uporabo z zdravilom Juluca odmerka peroralnih kontraceptivov ni treba prilagoditi.
English: Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
Slovenian: Ena filmsko obložena tableta vsebuje 50 mg dolutegravirja v obliki natrijeve soli in 25 mg rilpivirina v obliki rilpivirinijevega klorida.
English: Dolutegravir1
Slovenian: daklatasvir/ dolutegravir1
English: Changes in laboratory biochemistries
Slovenian: Opis izbranih neželenih učinkov Spremembe laboratorijskih biokemičnih vrednosti
English: • wind (flatulence)
Slovenian: Starost (leta)
English: Co-administration of Juluca and other medicinal products that inhibit these enzymes may increase dolutegravir plasma concentration (see Table 1).
Slovenian: Sočasna uporaba zdravila Juluca z drugimi zdravili, ki zavirajo te encime, lahko poveča koncentracijo dolutegravirja v plazmi
English: Co-administration is likely to cause significant decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes).
Slovenian: Verjetno je, da sočasna uporaba povzroči pomembno zmanjšanje koncentracije rilpivirina v plazmi (indukcija encimov CYP3A).
English: Oxcarbazepine Phenytoin Phenobarbital/ Dolutegravir
Slovenian: okskarbazepin fenitoin dolutegravir ↓
English: Significant decreases in rilpivirine plasma concentrations are expected (induction of CYP3A enzymes).
Slovenian: Pričakovati je pomembno zmanjšanje koncentracije rilpivirina v plazmi (indukcija encimov CYP3A).
English: Always take this medicine exactly as your doctor has told you.
Slovenian: Zdravilo Juluca jemljite, kolikor dolgo vam svetuje zdravnik.
English: H2 receptor antagonists (for example cimetidine, famotidine, nizatidine, ranitidine) H2 receptor antagonist medicines can stop Juluca being absorbed into your body and make it less effective.
Slovenian: Antagonisti receptorjev H2 (na primer cimetidin, famotidin, nizatidin, ranitidin)
English: No dose adjustments are required when initiating co-administration of methadone with Juluca.
Slovenian: Ob uvedbi metadona skupaj z zdravilom Juluca prilagoditve odmerka niso potrebne.
English: • if they are overweight.
Slovenian: • ki imajo preveliko telesno maso.
English: Calcium supplements/ Dolutegravir1
Slovenian: dodatki kalcija/ dolutegravir1
English: Male
Slovenian: omeprazol
English: Omeprazole/ Rilpivirine1,2
Slovenian: Sildenafil/rilpivirin1,2
English: Boceprevir/ Rilpivirine
Slovenian: boceprevir/ rilpivirin rilpivirin ↑
English: Anticonvulsants Carbamazepine/ Dolutegravir1
Slovenian: Antiepileptiki karbamazepin/ dolutegravir1
English: Antimycobacterials Rifampicin/ Dolutegravir1
Slovenian: Učinkovine za zdravljenje infekcij z mikobakterijami rifampicin/ dolutegravir1
English: Co-administration of Juluca with proton pump inhibitors is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba zdravila Juluca z zaviralci protonske črpalke je kontraindicirana (glejte poglavje 4.3).
English: Increased exposure of rilpivirine is expected (inhibition of CYP3A enzymes).
Slovenian: Pričakovati je večjo izpostavljenost rilpivirinu (zavrtje encimov CYP3A).
English: In vivo, dolutegravir may increase plasma concentrations of medicinal products in which excretion is dependent upon OCT2 or MATE-1 (e.g. dofetilide, metformin) (see Table 1 and sections 4.3 and 4.4).
Slovenian: In vivo lahko dolutegravir v plazmi poveča koncentracijo zdravil, katerih izločanje je odvisno od OCT2 ali MATE-1
English: • calcium supplements, iron supplements and multivitamins must be taken at the same time as Juluca with a meal.
Slovenian: • dodatke kalcija, dodatke železa ali multivitaminske pripravke je treba vzeti sočasno z zdravilom
English: Rilpivirine ↔
Slovenian: rilpivirin ↔
English: Calcium or iron supplements, or multivitamins should be co-administered at the same time as Juluca, with a meal.
Slovenian: Kalcijeve ali železove dodatke ali multivitaminske pripravke je treba vzeti sočasno z zdravilom Juluca in z obrokom.
English: Calcium supplements, iron supplements or multivitamins should be co-administered at the same time as Juluca with a meal.
Slovenian: Dodatke kalcija, dodatke železa ali multivitaminske pripravke je treba uporabiti sočasno z zdravilom Juluca in z obrokom.
English: Reproductive toxicology studies
Slovenian: Študije o vplivih na sposobnost razmnoževanja
English: H2-receptor antagonists should be taken well separated in time from the administration of Juluca (minimum 4 hours after or 12 hours before)
Slovenian: Antacide je treba jemati časovno ločeno od zdravila Juluca (najmanj
English: Atorvastatin/ Rilpivirine1,2
Slovenian: dizoproksiltenofovirat/ rilpivirin1,2
English: 40 mg single dose taken 4 hours after rilpivirine
Slovenian: famotidin/rilpivirin1,2 Enkraten 40-mg odmerek, uporabljen 4 ure po rilpivirinu cimetidin nizatidin ranitidin/ rilpivirin zaradi zvišanja pH v želodcu).
English: (+ 50 mg once daily rilpivirine)
Slovenian: 300 mg enkrat na dan (+ 50 mg rilpivirina enkrat na dan)
English: Rilpivirine does not inhibit the human cellular DNA polymerases α, β and γ.
Slovenian: Rilpivirin ne zavira človeških celičnih
English: Rilpivirine ↓ Not studied.
Slovenian: rilpivirin ↓ Ni raziskano.
English: Lamivudine/ Rilpivirine
Slovenian: šentjanževka/rilpivirin rilpivirin ↓
English: Table 3:
Slovenian: PRILOGA III
English: In limited data from small numbers of women who received dolutegravir 50 mg once daily in combination with a background regimen, the total exposure (AUC) to dolutegravir was 37% lower during the 2nd trimester of pregnancy, and 29% lower during the 3rd trimester of pregnancy, compared with postpartum (612 weeks).
Slovenian: Maloštevilni podatki, zbrani pri majhnem številu žensk, ki so prejemale 50 mg dolutegravirja enkrat na dan v kombinaciji z osnovno shemo, kažejo, da je bila celotna izpostavljenost dolutegravirju (AUC)
English: Co-administration with the following medicinal products: - dofetilide; - carbamazepine, oxcarbazepine, phenobarbital, phenytoin; - rifampicin, rifapentine; - proton pump inhibitors, such as omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole; - systemic dexamethasone, except as a single dose treatment; - St John's wort (Hypericum perforatum).
Slovenian: - dofetilid; - karbamazepin, okskarbazepin, fenobarbital, fenitoin; - rifampicin, rifapentin;
English: Excipients
Slovenian: Smukec
English: As dolutegravir and rilpivirine are highly bound to plasma proteins, it is unlikely that they will be significantly removed by haemodialysis or peritoneal dialysis (see section 4.2).
Slovenian: ni verjetno, da bi ju bilo mogoče v pomembnem obsegu odstraniti s hemodializo ali s peritonealno dializo (glejte poglavje 4.2).
English: HMG CO-A reductase inhibitors Atorvastatin/
Slovenian: Zaviralci reduktaze HMG Co-A atorvastatin/ dolutegravir atorvastatin/ rilpivirin1,2
English: Iron supplements/ Dolutegravir1
Slovenian: dodatki železa/ dolutegravir1
English: Co-administration of Juluca with rifampicin is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba zdravila Juluca s šentjanževko je kontraindicirana (glejte poglavje 4.3).
English: Juluca must be taken with a meal (see section
Slovenian: Zdravilo Juluca je treba vzeti z obrokom (glejte poglavje 5.2).
English: Subjects with hepatitis B co-infection or hepatitis C infection in need of anti-HCV therapy were excluded from studies with the dual combination of dolutegravir and rilpivirine.
Slovenian: V študije dvojne kombinacije dolutegravirja in rilpivirina niso bili vključeni bolniki, sočasno okuženi s hepatitisom B
English: Rilpivirine AUC(0-∞) was increased by 57% and 72% and Cmax by 89% and 117%, with moderate and high fat meals respectively, compared to fasted conditions.
Slovenian: Zmerno oziroma zelo mastni obroki v primerjavi z zaužitjem na prazen želodec so povečali AUC(0-∞) rilpivirina za 57 % oziroma 72 % in njegovo Cmax za 89 %
English: • a high temperature (fever)
Slovenian: • zvišana telesna temperatura (vročina), • pomanjkanje energije (utrujenost),
English: If you vomit more than 4 hours after taking Juluca you do not need to take another tablet until your next scheduled dose.
Slovenian: 4 ure po zaužitju zdravila Juluca, vam ni treba vzeti dodatne tablete.
English: Corticosteroids Prednisone/ Dolutegravir1
Slovenian: Kortikosteroidi prednizon/ dolutegravir1
English: In this analysis, the resistance-associated mutations (RAMs) associated with NNRTI resistance that developed in at least 2 rilpivirine virologic failures were: V90I, K101E, E138K, E138Q, V179I, Y181C, V189I, H221Y, and F227C.
Slovenian: V tej analizi so bile sledeče z odpornostjo povezane mutacije (RAM - resistance-associated mutations), povezane z odpornostjo proti NNRTI, ki so se pojavile pri vsaj 2 primerih virološkega neuspeha z rilpivirinom: V90I, K101E,
English: Multivitamin/ Dolutegravir1
Slovenian: multivitaminski pripravki/ dolutegravir1
English: Sofosbuvir/ Velpatasvir/ Rilpivirine
Slovenian: sofosbuvir/ velpatasvir/ rilpivirin dolutegravir ↔ (Ni raziskano)
English: How to store Juluca
Slovenian: Shranjevanje zdravila Juluca
English: Antiviral active substances Tenofovir disoproxil / Dolutegravir1
Slovenian: Protivirusne učinkovine dizoproksiltenofovirat/ dolutegravir1
English: Significant decreases in rilpivirine plasma concentrations are expected
Slovenian: Pričakovati je mogoče od odmerka odvisno zmanjšanje koncentracije rilpivirina v plazmi
English: Omeprazole
Slovenian: Odmerjanje
English: Simeprevir/ Dolutegravir
Slovenian: simeprevir/ dolutegravir simeprevir/rilpivirin dolutegravir ↔
English: Ranitidine/
Slovenian: Juluca.
English: Lamivudine/ Dolutegravir
Slovenian: lamivudin/ dolutegravir lamivudin/rilpivirin dolutegravir ↔
English: Antidiabetics
Slovenian: Starejši bolniki
English: Ledipasvir/Sofosbuvir / Rilpivirine
Slovenian: ledipasvir/sofosbuvir/ rilpivirin dolutegravir ↔ (Ni raziskano)
English: • feeling sick (nausea)
Slovenian: • tesnobnost (anksioznost),
English: Oral administration of dolutegravir to pregnant rats at doses up to 1000 mg/kg daily from days 6 to 17 of gestation did not elicit maternal toxicity, developmental toxicity or teratogenicity (38 times the 50 mg human clinical exposure based on AUC).
Slovenian: dne gestacije ni povzročila toksičnih učinkov pri samicah materah, toksičnih učinkov na razvoj ali teratogenih učinkov (38-kratnik klinične izpostavljenosti pri človeku med uporabo 50 mg na podlagi
English: If you are pregnant
Slovenian: Če ste noseči
English: The doctor will choose the smallest amount necessary.
Slovenian: Zdravnik bo izbral najmanjšo količino, ki je potrebna.
English: Otherwise it should be classified as negative (normal).
Slovenian: V nasprotnem primeru jo ocenite kot negativno (normalna).
English: Date of first authorisation: 22 August 2014 Date of latest renewal: 25 July 2019
Slovenian: Datum prve odobritve: 22 avgust 2014 Datum zadnjega podaljšanja: 25 julij 2019
English: The cognitive status of the patients was not determined.
Slovenian: Kognitivni status bolnikov ni bil določen.
English: Radioactive material.
Slovenian: Radioaktivni material.
English: Training should include a sufficient number of clearly positive and negative cases as well as intermediate level cases.
Slovenian: Usposabljanje mora vključevati zadostno število jasno pozitivnih in negativnih primerov, kot tudi primere vmesne stopnje.
English: Eight hours from the reference date and time.
Slovenian: Osem ur od referenčnega datuma in časa.
English: This amount may be harmful for those suffering from alcoholism.
Slovenian: Škodljivo je za tiste, ki trpijo za alkoholizmom.
English: The training course for healthcare professionals should contain the following key elements:
Slovenian: Usposabljanje za zdravstvene delavce mora vsebovati naslednje ključne elemente:
English: However, in the case of an overdose, you would receive the appropriate treatment.
Slovenian: Kljub temu boste v primeru prevelikega odmerka prejeli ustrezno zdravljenje.
English: Nucleis SA Allée du Six-Août, 8 4000 Liège Belgium
Slovenian: Nucleis SA Allée du Six-Août, 8 4000 Liège Belgija
English: Each vial is stored in a container.
Slovenian: Vsaka viala je shranjena v vsebniku.
English: Organ/Tissue
Slovenian: Organ/tkivo
English: The histopathology regions included, but were not restricted to the CERAD regions.
Slovenian: Histopatološka območja so vključevala, vendar niso bila omejena le na območja CRED.
English: The volume of the injection should be not less than 1 mL and not more than 10 mL.
Slovenian: Prostornina injekcije ne sme biti manj kot 1 ml in ne sme preseči 10 ml.
English: Any clinically relevant mutagenic potential is therefore considered highly unlikely.
Slovenian: Zaradi tega se šteje, da je kakršen koli klinično pomemben mutageni potencial zelo malo verjeten.
English: Megabecquerel (MBq) is the unit used to measure radioactivity.
Slovenian: Megabecquerel (MBq) je enota, ki se uporablja za merjenje radioaktivnosti.
English: This is followed by rapid clearance from the brain in the first 90 minutes (the recommended time to start scanning), followed by more gradual clearance.
Slovenian: Temu sledi hitro izločanje iz možganov v prvih 90 minutah (priporočen čas za preiskavo), čemur sledi postopno izločanje.
English: It might be helpful to estimate the effective dose that was applied.
Slovenian: Morda bo v pomoč ocena učinkovitega uporabljenega odmerka.
English: They will provide you with the necessary information on the procedure.
Slovenian: O postopku boste prejeli ustrezne informacije.
English: Based on the majority read, the positive and negative likelihood ratios were 2.04 and 0.52 respectively.
Slovenian: Na osnovi večine odčitavanj slik je bilo pozitivno in negativno razmerje verjetnosti 2,04 in 0,52.
English: This is about the same as 14 mL of beer or 6 mL of wine.
Slovenian: To ustreza 14 ml piva ali 6 ml vina.
English: Cases should be histopathologically confirmed, if possible.
Slovenian: Če je možno, naj bodo primeri potrjeni histopatološko.
English: ANNEX II A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: PRILOGA II A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: Each dose contains up to 552 mg alcohol.
Slovenian: Vsak odmerek vsebuje do 552 mg alkohola.
English: One injection is sufficient to carry out the scan that your doctor needs.
Slovenian: Eno injiciranje je dovolj, da se lahko opravi slikanje, ki ga potrebuje zdravnik.
English: There are strict laws on the use, handling and disposal of radiopharmaceutical products.
Slovenian: Obstajajo strogi zakoni za uporabo in odstranjevanje radiofarmakov ter ravnanje z njimi.
English: The design of this study does not allow estimating the risk of MCI progression to clinical AD.
Slovenian: Zasnova te študije ne omogoča ocene tveganja napredovanja MCI v AB.
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within six months following authorisation.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora prvo redno posodobljeno poročilo o varnosti zdravila za to zdravilo predložiti v šestih mesecih po pridobitvi dovoljenja za promet.
English: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Slovenian: Pogostnosti neželenih učinkov so opredeljene kot: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Do not use this medicine after the expiry date and time, which are stated on the label after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki poleg oznake ‘EXP'.
English: Seibersdorf Labor GmbH Grundstuck.
Slovenian: Siebersdorf Labor GmbH Grundstuck.
English: The following adverse reactions are listed in the Table 1 below:
Slovenian: Naslednji neželeni učinki so navedeni v spodnji preglednici 1: