natgillin/translations-raw huggingface dataset:
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 May 2018
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.
Site-directed NNRTI mutant virus
Proti NNRTI odporni virusi s točkovno mutacijo
Calcium supplements, iron supplements or multivitamins must be taken at the same time as Juluca.
Dodatke kalcija, dodatke železa ali multivitaminske pripravke je treba jemati hkrati z zdravilom Juluca.
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.
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.
- 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)
- omeprazol, esomeprazol, lansoprazol, pantoprazol, rabeprazol (zdravila za preprečevanje in zdravljenje želodčnih razjed, zgage in refluksa želodčne kisline),
These medicinal products are recommended to be administered 12 hours before or 4 hours after Juluca (see section 4.5).
12 ur pred zdravilom Juluca ali 4 ure po njem (glejte poglavje 4.5).
Rilpivirine ↔ Digoxin
rilpivirin ↔ digoksin
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.
19 nosečnicah v drugem in tretjem trimesečju nosečnosti ter po porodu.
No clinically important pharmacokinetic differences of dolutegravir or rilpivirine due to race have been identified.
Ne za dolutegravir ne za rilpivirin niso ugotovili klinično pomembnih farmakokinetičnih razlik glede na raso.
Dolutegravir ↓ AUC ↓ 49% Cmax ↓ 33% Cτ ↓ 73%
karbamazepin/ rilpivirin dolutegravir ↓ AUC ↓ 49 % Cmax ↓ 33 % Cτ ↓ 73 %
• metformin, to treat diabetes
- dofetilid (zdravilo za zdravljenje srčnih bolezni),
Liver toxicity associated with liver enzyme induction was observed in rodents following rilpivirine administration.
Pri glodalcih so po uporabi rilpivirina opažali toksične učinke na jetra, povezane z indukcijo jetrnih encimov.
Lansoprazole Rabeprazole Pantoprazole Esomeprazole/ Rilpivirine
lansoprazol rabeprazol pantoprazol esomeprazol/ rilpivirin dolutegravir ↔ (Ni raziskano)
May cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes).
Lahko povzroči povečanje koncentracije rilpivirina v plazmi (zavrtje encimov CYP3A).
• sleep disorders
• občutek zaspanosti,
Rabeprazole Pantoprazole Esomeprazole/ Dolutegravir
Zeliščni pripravki šentjanževka/ dolutegravir dolutegravir ↓
Decreased exposure of rilpivirine is expected (induction of CYP3A enzymes).
Pričakovati je manjšo izpostavljenost rilpivirinu (indukcija encimov CYP3A).
Dolutegravir ↔ AUC ↓ 5% Cmax ↑ 16% Cτ ↓ 30% (induction of UGT1A1 and CYP3A enzymes).
Sočasna uporaba zdravila Juluca z rifampicinom je kontraindicirana (glejte poglavje rifabutin/dolutegravir1 dolutegravir ↔ AUC ↓ 5 % Cmax ↑ 16 % Cτ ↓ 30 % (indukcija encimov UGT1A1 in CYP3A).
Paracetamol / Rilpivirine1,2
paracetamol/ dolutegravir paracetamol/ rilpivirin1,2
Co-administration of Juluca with rifapentine is contraindicated (see section 4.3).
Sočasna uporaba zdravila Juluca z rifapentinom je kontraindicirana (glejte poglavje 4.3).
Not applicable.
Ni znano
No dose adjustment of oral contraceptives is required when co-administered with Juluca.
Med sočasno uporabo z zdravilom Juluca odmerka peroralnih kontraceptivov ni treba prilagoditi.
Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
Ena filmsko obložena tableta vsebuje 50 mg dolutegravirja v obliki natrijeve soli in 25 mg rilpivirina v obliki rilpivirinijevega klorida.
Dolutegravir1
daklatasvir/ dolutegravir1
Changes in laboratory biochemistries
Opis izbranih neželenih učinkov Spremembe laboratorijskih biokemičnih vrednosti
• wind (flatulence)
Starost (leta)
Co-administration of Juluca and other medicinal products that inhibit these enzymes may increase dolutegravir plasma concentration (see Table 1).
Sočasna uporaba zdravila Juluca z drugimi zdravili, ki zavirajo te encime, lahko poveča koncentracijo dolutegravirja v plazmi
Co-administration is likely to cause significant decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes).
Verjetno je, da sočasna uporaba povzroči pomembno zmanjšanje koncentracije rilpivirina v plazmi (indukcija encimov CYP3A).
Oxcarbazepine Phenytoin Phenobarbital/ Dolutegravir
okskarbazepin fenitoin dolutegravir ↓
Significant decreases in rilpivirine plasma concentrations are expected (induction of CYP3A enzymes).
Pričakovati je pomembno zmanjšanje koncentracije rilpivirina v plazmi (indukcija encimov CYP3A).
Always take this medicine exactly as your doctor has told you.
Zdravilo Juluca jemljite, kolikor dolgo vam svetuje zdravnik.
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.
Antagonisti receptorjev H2 (na primer cimetidin, famotidin, nizatidin, ranitidin)
No dose adjustments are required when initiating co-administration of methadone with Juluca.
Ob uvedbi metadona skupaj z zdravilom Juluca prilagoditve odmerka niso potrebne.
• if they are overweight.
• ki imajo preveliko telesno maso.
Calcium supplements/ Dolutegravir1
dodatki kalcija/ dolutegravir1
Male
omeprazol
Omeprazole/ Rilpivirine1,2
Sildenafil/rilpivirin1,2
Boceprevir/ Rilpivirine
boceprevir/ rilpivirin rilpivirin ↑
Anticonvulsants Carbamazepine/ Dolutegravir1
Antiepileptiki karbamazepin/ dolutegravir1
Antimycobacterials Rifampicin/ Dolutegravir1
Učinkovine za zdravljenje infekcij z mikobakterijami rifampicin/ dolutegravir1
Co-administration of Juluca with proton pump inhibitors is contraindicated (see section 4.3).
Sočasna uporaba zdravila Juluca z zaviralci protonske črpalke je kontraindicirana (glejte poglavje 4.3).
Increased exposure of rilpivirine is expected (inhibition of CYP3A enzymes).
Pričakovati je večjo izpostavljenost rilpivirinu (zavrtje encimov CYP3A).
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).
In vivo lahko dolutegravir v plazmi poveča koncentracijo zdravil, katerih izločanje je odvisno od OCT2 ali MATE-1
• calcium supplements, iron supplements and multivitamins must be taken at the same time as Juluca with a meal.
• dodatke kalcija, dodatke železa ali multivitaminske pripravke je treba vzeti sočasno z zdravilom
Calcium or iron supplements, or multivitamins should be co-administered at the same time as Juluca, with a meal.
Kalcijeve ali železove dodatke ali multivitaminske pripravke je treba vzeti sočasno z zdravilom Juluca in z obrokom.
Calcium supplements, iron supplements or multivitamins should be co-administered at the same time as Juluca with a meal.
Dodatke kalcija, dodatke železa ali multivitaminske pripravke je treba uporabiti sočasno z zdravilom Juluca in z obrokom.
Reproductive toxicology studies
Študije o vplivih na sposobnost razmnoževanja
H2-receptor antagonists should be taken well separated in time from the administration of Juluca (minimum 4 hours after or 12 hours before)
Antacide je treba jemati časovno ločeno od zdravila Juluca (najmanj
Atorvastatin/ Rilpivirine1,2
dizoproksiltenofovirat/ rilpivirin1,2
40 mg single dose taken 4 hours after rilpivirine
famotidin/rilpivirin1,2 Enkraten 40-mg odmerek, uporabljen 4 ure po rilpivirinu cimetidin nizatidin ranitidin/ rilpivirin zaradi zvišanja pH v želodcu).
(+ 50 mg once daily rilpivirine)
300 mg enkrat na dan (+ 50 mg rilpivirina enkrat na dan)
Rilpivirine does not inhibit the human cellular DNA polymerases α, β and γ.
Rilpivirin ne zavira človeških celičnih
Rilpivirine ↓ Not studied.
rilpivirin ↓ Ni raziskano.
Lamivudine/ Rilpivirine
šentjanževka/rilpivirin rilpivirin ↓
Table 3:
PRILOGA III
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).
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)
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).
- dofetilid; - karbamazepin, okskarbazepin, fenobarbital, fenitoin; - rifampicin, rifapentin;
Excipients
Smukec
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).
ni verjetno, da bi ju bilo mogoče v pomembnem obsegu odstraniti s hemodializo ali s peritonealno dializo (glejte poglavje 4.2).
HMG CO-A reductase inhibitors Atorvastatin/
Zaviralci reduktaze HMG Co-A atorvastatin/ dolutegravir atorvastatin/ rilpivirin1,2
Iron supplements/ Dolutegravir1
dodatki železa/ dolutegravir1
Co-administration of Juluca with rifampicin is contraindicated (see section 4.3).
Sočasna uporaba zdravila Juluca s šentjanževko je kontraindicirana (glejte poglavje 4.3).
Juluca must be taken with a meal (see section
Zdravilo Juluca je treba vzeti z obrokom (glejte poglavje 5.2).
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.
V študije dvojne kombinacije dolutegravirja in rilpivirina niso bili vključeni bolniki, sočasno okuženi s hepatitisom B
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.
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 %
• a high temperature (fever)
• zvišana telesna temperatura (vročina), • pomanjkanje energije (utrujenost),
If you vomit more than 4 hours after taking Juluca you do not need to take another tablet until your next scheduled dose.
4 ure po zaužitju zdravila Juluca, vam ni treba vzeti dodatne tablete.
Corticosteroids Prednisone/ Dolutegravir1
Kortikosteroidi prednizon/ dolutegravir1
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.
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,
Multivitamin/ Dolutegravir1
multivitaminski pripravki/ dolutegravir1
Sofosbuvir/ Velpatasvir/ Rilpivirine
sofosbuvir/ velpatasvir/ rilpivirin dolutegravir ↔ (Ni raziskano)
How to store Juluca
Shranjevanje zdravila Juluca
Antiviral active substances Tenofovir disoproxil / Dolutegravir1
Protivirusne učinkovine dizoproksiltenofovirat/ dolutegravir1
Significant decreases in rilpivirine plasma concentrations are expected
Pričakovati je mogoče od odmerka odvisno zmanjšanje koncentracije rilpivirina v plazmi
Omeprazole
Odmerjanje
Simeprevir/ Dolutegravir
simeprevir/ dolutegravir simeprevir/rilpivirin dolutegravir ↔
Ranitidine/
Juluca.
Lamivudine/ Dolutegravir
lamivudin/ dolutegravir lamivudin/rilpivirin dolutegravir ↔
Antidiabetics
Starejši bolniki
Ledipasvir/Sofosbuvir / Rilpivirine
ledipasvir/sofosbuvir/ rilpivirin dolutegravir ↔ (Ni raziskano)
• feeling sick (nausea)
• tesnobnost (anksioznost),
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).
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
If you are pregnant
Če ste noseči
The doctor will choose the smallest amount necessary.
Zdravnik bo izbral najmanjšo količino, ki je potrebna.
Otherwise it should be classified as negative (normal).
V nasprotnem primeru jo ocenite kot negativno (normalna).
Date of first authorisation: 22 August 2014 Date of latest renewal: 25 July 2019
Datum prve odobritve: 22 avgust 2014 Datum zadnjega podaljšanja: 25 julij 2019
The cognitive status of the patients was not determined.
Kognitivni status bolnikov ni bil določen.
Radioactive material.
Radioaktivni material.
Training should include a sufficient number of clearly positive and negative cases as well as intermediate level cases.
Usposabljanje mora vključevati zadostno število jasno pozitivnih in negativnih primerov, kot tudi primere vmesne stopnje.
Eight hours from the reference date and time.
Osem ur od referenčnega datuma in časa.
This amount may be harmful for those suffering from alcoholism.
Škodljivo je za tiste, ki trpijo za alkoholizmom.
The training course for healthcare professionals should contain the following key elements:
Usposabljanje za zdravstvene delavce mora vsebovati naslednje ključne elemente:
However, in the case of an overdose, you would receive the appropriate treatment.
Kljub temu boste v primeru prevelikega odmerka prejeli ustrezno zdravljenje.
Each vial is stored in a container.
Vsaka viala je shranjena v vsebniku.
Organ/Tissue
Organ/tkivo
The histopathology regions included, but were not restricted to the CERAD regions.
Histopatološka območja so vključevala, vendar niso bila omejena le na območja CRED.
The volume of the injection should be not less than 1 mL and not more than 10 mL.
Prostornina injekcije ne sme biti manj kot 1 ml in ne sme preseči 10 ml.
Any clinically relevant mutagenic potential is therefore considered highly unlikely.
Zaradi tega se šteje, da je kakršen koli klinično pomemben mutageni potencial zelo malo verjeten.
Megabecquerel (MBq) is the unit used to measure radioactivity.
Megabecquerel (MBq) je enota, ki se uporablja za merjenje radioaktivnosti.
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.
Temu sledi hitro izločanje iz možganov v prvih 90 minutah (priporočen čas za preiskavo), čemur sledi postopno izločanje.
It might be helpful to estimate the effective dose that was applied.
Morda bo v pomoč ocena učinkovitega uporabljenega odmerka.
They will provide you with the necessary information on the procedure.
O postopku boste prejeli ustrezne informacije.
Based on the majority read, the positive and negative likelihood ratios were 2.04 and 0.52 respectively.
Na osnovi večine odčitavanj slik je bilo pozitivno in negativno razmerje verjetnosti 2,04 in 0,52.
This is about the same as 14 mL of beer or 6 mL of wine.
To ustreza 14 ml piva ali 6 ml vina.
Cases should be histopathologically confirmed, if possible.
Če je možno, naj bodo primeri potrjeni histopatološko.
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
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
Each dose contains up to 552 mg alcohol.
Vsak odmerek vsebuje do 552 mg alkohola.
One injection is sufficient to carry out the scan that your doctor needs.
Eno injiciranje je dovolj, da se lahko opravi slikanje, ki ga potrebuje zdravnik.
There are strict laws on the use, handling and disposal of radiopharmaceutical products.
Obstajajo strogi zakoni za uporabo in odstranjevanje radiofarmakov ter ravnanje z njimi.
The design of this study does not allow estimating the risk of MCI progression to clinical AD.
Zasnova te študije ne omogoča ocene tveganja napredovanja MCI v AB.
The marketing authorisation holder shall submit the first periodic safety update report for this product within six months following authorisation.
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.
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).
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).
Do not use this medicine after the expiry date and time, which are stated on the label after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki poleg oznake ‘EXP'.
The following adverse reactions are listed in the Table 1 below:
Naslednji neželeni učinki so navedeni v spodnji preglednici 1:
Any unused medicinal product or waste material should be disposed of in accordance with local requirements (see section 6.6).
Vse neuporabljeno zdravilo ali odpadni material je treba odstraniti v skladu z lokalnimi zahtevami (glejte poglavje 6.6).
Children and adolescents VIZAMYL is not intended for use in children and adolescents below the age of 18 years old.
Otroci in mladostniki Zdravila VIZAMYL se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
If any one of these regions is clearly positive (abnormal) then the image should be classified as positive (abnormal).
Če je katero koli izmed teh območij jasno pozitivno (nenormalno), morate sliko oceniti kot pozitivno.
Histopathology from the pivotal study was used.
Uporabljena je bila histopatologija iz ključne študije.
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The nuclear medicine doctor supervising the procedure will decide on the amount of VIZAMYL to be used in your case.
Zdravnik nuklearne medicine, ki nadzira postopek, se bo odločil o količini zdravila VIZAMYL, ki bo uporabljena v vašem primeru.
The activity administered should, in every case, be as low as reasonably achievable to obtain the required diagnostic information.
Uporabljena aktivnost mora biti v vsakem primeru najmanjša možna, ki še omogoča pridobitev potrebnih diagnostičnih informacij.
If you have received more VIZAMYL than you should An overdose is unlikely since you will only receive a single dose of VIZAMYL from the nuclear medicine doctor under controlled conditions.
Če ste prejeli večji odmerek zdravila VIZAMYL, kot bi smeli Prevelik odmerek je malo verjeten, saj boste prejeli le en odmerek zdravila VIZAMYL, ki vam ga bo dal zdravnik nuklearne medicine v kontroliranih pogojih.
You should not drive, use machines or engage in other potentially hazardous activities until these effects have completely disappeared.
Ne vozite, ne uporabljajte strojev ter ne sodelujte v potencialno nevarnih dejavnostih, dokler ti učinki v ne izzvenijo v celoti.
To enable immediate action in emergencies the necessary medicinal products and equipment such as endotracheal tube and ventilator must be readily available.
Za takojšnje ukrepanje v nujnih primerih morajo biti na voljo nujna zdravila in oprema, kot sta na primer endotrahealni tubus in respirator.
Note also the medial regions where higher levels of intensity in the grey matter are seen in the positive images on the right.
Upoštevajte tudi medialna področja, kjer so višji nivoji intenzitete v sivi možganovini opazni na pozitivnih posnetkih na desni strani.
Remaining organs Effective dose (mSv/MBq)
Maternica ostali organi učinkovit odmerek (mSv/MBq)
Treatment consists of increasing the passing of urine and stools in order to help remove radioactivity from your body.
Zdravljenje vključuje povečanje odvajanja urina in blata kot pomoč pri odstranjevanju radioaktivnosti iz vašega telesa.
Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients (see section 4.4).
Treba je skrbno premisliti o količini aktivnosti, namenjeni za uporabo, saj je pri teh bolnikih izpostavljenost sevanju lahko večja (glejte poglavje 4.4).
Expertise and qualification of trainers in both electronic and in-person training should be ensured.
Zagotoviti je treba znanje in usposobljenost izvajalcev usposabljanja tako pri usposabljanjih v elektronski obliki kot pri usposabljanjih v živo.
Extensive dose-range and adjustment studies with the medicinal product in normal and special populations have not been performed.
Ekstenzivne študije razpona odmerkov in prilagoditev odmerka pri normalnih in posebnih populacijah niso bile izvedene.
It must not be diluted.
Ne smete ga redčiti.
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The usual amount recommended for an adult is 185 MBq.
Običajna količina, ki je priporočena za odraslo osebo, znaša 185 MBq.
β-Amyloid plaques are deposits sometimes present in the brains of people with dementias (such as Alzheimer's disease).
βamiloidne lehe so depoziti, ki včasih prisotni v možganih oseb z demencami (kot je Alzheimerjeva bolezen).
These are uncommon side effects and may affect up to 1 in 100 people.
Ti neželeni učinki so občasni in se lahko pojavijo pri največ 1 od 100 bolnikov.
Activity: 400 MBq/mL at {hh:mm} {Time Zone} on {dd-mm-yyyy} Activity: YYYY MBq {at hh:mm} {Time Zone} on {dd-mm-yyyy}
Aktivnost: 400 MBq/ml ob {hh:mm} {časovni pas} dne {dd-mm-llll} Aktivnost: LLLL MBq {ob hh:mm} {časovni pas} v {dd-mm-llll}
The European Medicines Agency has waived the obligation to submit the results of studies with flutemetamol (18F) in all subsets of the paediatric population as the disease or condition for which the specific medicinal product is intended only occurs in adults (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitve rezultatov študij s flutemetamolom (18F) za vse podskupine pediatrične populacije, ker se bolezen ali stanje, za katero je določeno zdravilo namenjeno, pojavlja samo pri odraslih (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
This scan, along with other brain function tests, can help your doctor determine whether or not you may have β-amyloid plaques in your brain.
Ta posnetek, lahko skupaj z drugimi testi delovanja možganov vašemu zdravniku pomaga ugotoviti, ali imate v možganih β-amiloidne lehe.
For the limitations of use in patients with mild cognitive impairment (MCI), see section 5.1.
Glede omejitev uporabe pri bolnikih z zmerno kognitivno okvaro (MCI), glejte poglavje 5.1.