natgillin/translations-raw huggingface dataset:
The patient's head should be tilted so that the anterior commissure-posterior commissure (ACPC) plane is at right angles to the bore-axis of the PET scanner with the head positioned in a suitable head support.
Glava bolnika mora biti nagnjena, tako da je ravnina sprednje komisure - zadnje komisure, (ravnina AC-PC), pravokotna na os odprtine PET skenerja, pri tem pa mora biti glava nameščena na ustrezni opori za glavo.
VIZAMYL contains a maximum of 41 mg of sodium (main component of cooking/table salt) in each dose.
Zdravilo VIZAMYL vsebuje največ 41 mg natrija (glavne sestavine kuhinjske soli) na odmerek.
Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.
Pri teh bolnikih je treba skrbno premisliti o razmerju med koristmi in tveganji, saj je lahko izpostavljenost sevanju večja.
You must stop breast-feeding for 24 hours after the injection.
Z dojenjem morate prenehati za 24 ur po injiciranju.
400 MBq at reference time.
YYYY MBq na referenčni čas.
NAME OF THE MEDICINAL PRODUCT VIZAMYL 400 MBq/mL solution for injection
IME ZDRAVILA VIZAMYL 400 MBq/ml raztopina za injiciranje
In vivo, quantitative correlation was assessed in end-of-life patients between flutemetamol (18F) uptake in cortical grey matter and the total β-amyloid burden in autopsied samples using 4G8 anti-amyloid antibody that stains β-amyloid found in both neuritic and diffuse plaques.
In vivo je bila pri bolnikih ob koncu življenja ocenjena kvantitativna korelacija med privzemom flutemetamola (18F) v kortikalno sivo možganovino in celokupnim β-amiloidnim bremenom v vzorcih odvzetih z avtopsijo, z uporabo 4G8 protitelesa proti amiloidu, ki obarva β-amiloid v obeh, nevritičnih in difuznih lehah.
For an administered activity of 185 MBq the typical radiation doses delivered to the critical organs, gallbladder, urinary bladder wall, upper large intestine wall, lower large intestine wall, small intestine and liver are 53.1 mGy, 26.8 mGy, 21.6 mGy, 7.8 mGy, 18.9 mGy and 10.5 mGy, respectively.
Za odmerjeno aktivnost 185 MBq so značilni odmerki sevanja za kritične organe, žolčnik, sečni mehur, steno zgornjega debelega črevesa, steno spodnjega debelega črevesa, tankega črevesa in jeter 53,1 mGy, 26,8 mGy, 21,6 mGy, 7,8 mGy, 18,9 mGy in 10,5 mGy, v istem vrstnem redu.
Osteogenic cells Ovaries
Mišice osteogene celice
Flutemetamol (18F) is distributed throughout the body within several minutes of injection.
Flutemetamol (18F) se v nekaj minutah po injiciranju porazdeli po celem telesu.
Vial No: xxx
Št. viale: xxx
Common - may affect up to 1 in 10 people looking flushed increased blood pressure
Drugi neželeni učinki vključujejo Pogosti - pojavijo se lahko pri največ 1 od 10 bolnikov zardel izgled, zvišan krvni tlak.
Volume: xx.x mL
Prostornina: xx,x ml
In a longitudinal study, 232 patients clinically diagnosed with amnestic mild cognitive impairment (aMCI), underwent baseline flutemetamol (18F) PET scans, and were followed for 36 months to evaluate the relationship between flutemetamol (18F) imaging and changes in diagnostic status.
V longitudinalni študiji je 232 bolnikov s klinično diagnozo amnestičnega blagega upada kognitivnih sposobnosti (aMCI - amnestic mild cognitive impairment) opravilo osnovno slikanje PET s flutemetamolom (18F), ti so bili nato spremljani 36 mesecev zaradi ocene povezave posnetkov s flutemetamolom (18F) in sprememb statusa diagnoze.
The reader should compare the cortical grey matter signal intensity to the maximum white matter signal intensity.
Odčitovalec mora primerjati intenzivnost signalov kortikalne sive možganovine z največjo intenziteto signalov bele možganovine.
See special handling precautions in section 6.6.
Glejte posebne varnostne ukrepe za rokovanje z zdravilom v poglavju 6.6.
Healthy controls show low levels of flutemetamol (18F) retention in cerebral cortex.
Zdrave kontrolne osebe kažejo nizke ravni zadržanega flutemetamola (18F) v cerebralni skorji.
Administration of VIZAMYL and conduct of the procedure VIZAMYL is given as an injection into your vein (intravenous injection) followed by a flush of sodium chloride solution to ensure full delivery of the dose.
Odmerjanje zdravila VIZAMYL in izvajanje postopka Zdravilo VIZAMYL se daje z injekcijo v veno (intravensko injiciranje), čemur sledi spiranje z raztopino natrijevega klorida, kar pomaga zagotoviti, da prejmete cel odmerek.
back pain feeling hot or cold increased breathing rate pain at the injection site heart pounding (palpitations) pain in muscles or bones shaking movements (tremor) puffy and swollen skin fever over breathing (hyperventilation) change in the way you taste things a spinning feeling (vertigo) reduced sense of touch or sensation feeling tired or weak inability to get or maintain an erection indigestion, stomach ache or sore mouth vomiting decreased feeling or sensitivity especially in your skin or your face increase in “blood lactate dehydrogenase” or “neutrophils” in blood tests skin tightness
razbijanje srca (palpitacije), bolečine v mišicah ali kosteh, tresenje (tremor), zabuhla ali otečena koža, povišana telesna temperatura, čezmerno dihanje (hiperventilacija), spremenjen okus, občutek vrtenja (vrtoglavica), zmanjšan občutek za dotik ali zmanjšana občutljivost čutil, utrujenost ali šibkost, nezmožnost erekcije ali ohranjanja erekcije, prebavne težave, bolečine v trebuhu ali vneta usta, bruhanje, zmanjšana občutljivost ali preobčutljivost, še posebej na koži ali obrazu, zvišana količina laktat-dehidrogenaze v krvi ali nevtrofilcev pri krvnih testih, občutek, da vas koža veže.
Axial (a), Sagittal (b) and coronal (c) views of a negative and positive flutemetamol (18F)
Aksialni (a), sagitalni (b) in koronalni (c) pogledi negativne in pozitivne slike z flutemetamolom (18F) (levo oziroma desno).
Data suggest that flutemetamol (18F) is able to label cored and diffuse amyloid β deposits and neuritic plaques.
Podatki kažejo, da lahko flutemetamol (18F) označi združene in difuzne βamiloidne depozite in nevritične lehe.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity.
Neklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, ne kažejo posebnega tveganja za človeka.
Flutemetamol (18F) must not be diluted.
Flutemetamola (18F) ne smete redčiti.
VIZAMYL contains alcohol (ethanol) and sodium VIZAMYL contains alcohol (ethanol).
Zdravilo VIZAMYL vsebuje alkohol (etanol) in natrij Zdravilo VIZAMYL vsebuje alkohol (etanol).
No dose adjustment is recommended based on age.
Ni priporočil glede prilagoditev odmerka pri starejših.
Lot: Vial No: xxx
Lot: Št. viale: xxx
MARKETING AUTHORISATION NUMBER(S) EU/1/14/941/001
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/941/001
The images should be viewed in a systematic manner (Figure 1) starting at the level of pons (p) and scrolling up through The frontal lobes and anterior cingulate (f, ac, axial review) Posterior cingulate and precuneus (pc, sagittal review) Temporo-parietal aspects including Insula (in, axial review and tp-in, coronal review) Lateral temporal lobes (lt, axial review) Striatal region (s, axial review)
Posnetke je treba pregledati sistematično (slika 1) in začeti na višini ponsa (p) ter se pomikati navzgor po čelnih režnjih in anteriornem cingulatnem korteksu (f, ac, aksialni pregled); posteriornem cingulatnem kortes in prekuneus (pc, sagitalni pregled); temporo-parietalnem pogledu vključno z insulo (in, aksialni pregled in tp-in, koronalni pregled); striatnem območju (s, aksialni pregled).
Summary of the safety profile The overall safety profile of VIZAMYL is based on data from its administrations to 831 subjects.
Celovit varnostni profil zdravila VIZAMYL temelji na podatkih 831 oseb, ki so prejele zdravilo.
In vitro binding studies have not shown interference of flutemetamol (18F) binding to β-amyloid plaques in the presence of other common medicinal products taken by AD patients.
Študije vezave in vitro niso prikazale motenj vezave flutemetamola (18F) na β-amiloidne lehe v prisotnosti drugih pogostih zdravil, ki jih jemljejo bolniki z AB.
As a result of the manufacturing process some vials are distributed with punctured rubber stoppers.
Zaradi razlik pri proizvodnem procesu obstaja možnost, da imajo viale nekaterih serij zdravila prebodene gumijaste zamaške.
Dizziness Headache Hypoaesthesia Hypotonia Dysgeusia Tremor
Bolezni živčevja omotica glavobol hipestezija hipotonija disgevzija tresavica
The negative images show a sulcal/gyral white matter pattern.
Negativni posnetki kažejo vzorec sulkusov/girusov bele možganovine.
What VIZAMYL looks like and contents of the pack VIZAMYL is a clear, colourless to slightly yellow solution for injection.
Izgled zdravila VIZAMYL in vsebina pakiranja Zdravilo VIZAMYL je čista, brezbarvna do rahlo rumena raztopina za injiciranje.
You must inform the nuclear medicine doctor before you are given VIZAMYL if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding.
Preden prejmete zdravilo, morate zdravnika nuklearne medicine obvestiti, če obstaja možnost, da ste noseči, če ste imeli izpad mesečnega perila ali če dojite.
What you need to know before VIZAMYL is used
Kaj morate vedeti, preden boste uporabili zdravilo VIZAMYL
A region is considered positive (abnormal) if the tracer signal in cortical regions appears high (i.e., approximately at the same or higher signal intensity as adjacent white matter and greater than the grey matter-rich regions of the cerebellum).
Območje ima pozitiven (nenormalen) vzorec, če je signal označevalnega sredstva v kortikalnih območjih na videz močan (npr. približno enake ali višje intenzivnosti kot signal sosednje bele možganovine in večji kot v območjih sive možganovine v bogatih območjih malih možganov).
No animal studies have been conducted to investigate the reproductive effects of flutemetamol (18F) (see section 5.3).
Študij na živalih, s katerimi bi preučili učinke flutemetamola (18F) na razmnoževanje, niso izvedli (glejte poglavje 5.3).
Serious side effects Tell your doctor straight away, if you notice any of the following, as you may need urgent medical treatment: Allergic reactions - the signs may include swelling of your face or eyes, having pale, itchy or tight skin or having a rash, feeling short of breath, tightness in the chest, irritation in your throat or being sick.
Resni neželeni učinki Če opazite kateri koli neželeni učinek, takoj obvestite zdravnika, morda boste potrebovali nujno zdravniško pomoč: Alergijske reakcije - znaki vključujejo otekanje obraza ali oči, bleda, srbeča ali napeta koža ali izpuščaj, težave z dihanjem, stiskanje v prsnem košu, draženje v grlu ali občutek slabosti.
Tell your doctor straight away if you notice any of the signs above.
Če opazite katerega koli od zgornjih znakov, nemudoma obvestite zdravnika.
After 20 minutes approximately 20 % of the active compound flutemetamol (18F) remains in the circulation,
Po 20 minutah ostane v krvnem obtoku približno 20 % aktivne učinkovine flutemetamol (18F) v 180 minutah pa se vsebnost zniža na 10 %.
The following adverse reactions may occur as symptoms and signs of a hypersensitivity reaction to VIZAMYL or any of its excipients (see section 6.1): eye/face swelling, pallor, dyspnoea, throat irritation, vomiting, rash, pruritus, skin tightness, chest tightness (see also section 4.4).
Naslednji neželeni učinki se lahko pojavijo kot simptomi ali znaki preobčutljivostne reakcije na zdravilo VIZAMYL ali katero koli pomožno snov (glejte poglavje 6.1): zatekanje oči/obraza, bledica, dispneja, draženje grla, bruhanje, izpuščaj, pruritus, napetost kože, stiskanje v prsnem košu (glejte tudi poglavje 4.4).
The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting etc.
Dajanje radiofarmakov pomeni tveganje za druge osebe zaradi izpostavljenosti zunanjemu sevanju ali kontaminacije zaradi razlitja urina, bruhanja, itd. Previdnostni ukrepi za zaščito pred sevanjem morajo biti v skladu z nacionalnimi predpisi.
A region is considered as having a negative (normal) pattern if the tracer signal in cortical regions is low (i.e. distinctly lower signal intensity compared with adjacent white matter and similar in intensity to the grey matter-rich regions of the cerebellum).
Območje ima negativen (normalen) vzorec, če je signal označevalnega sredstva v kortikalnih območjih nizek (npr. jasno nižja intenzivnost signala v primerjavi s signalom sosednje bele možganovine in ima podobno intenzivnost kot signal sive možganovine-bogata območja malih možganov).
MARKETING AUTHORISATION NUMBER(S) EU/1/14/941/002
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/941/002
Breast-feeding It is not known whether flutemetamol (18F) is excreted in human milk during breast-feeding.
Ni znano, ali se flutemetamol (18F) med dojenjem izloča v materino mleko.
VIZAMYL is a radiopharmaceutical medicinal product indicated for Positron Emission Tomography (PET) imaging of β-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment.
Zdravilo VIZAMYL je radiofarmak, indiciran za slikanje gostote β-amiloidnih nevritičnih leh s pozitronsko emisijsko tomografijo (PET) v možganih odraslih bolnikov s kognitivno motnjo, pri katerih se ugotavlja Alzheimerjeva bolezen (AB) in drugi vzroki kognitivne motnje.
A PET scan with flutemetamol (18F) should be requested by clinicians experienced in the clinical management of neurodegenerative disorders.
Preiskavo PET s flutemetamolom (18F) mora naročiti zdravnik, ki je usposobljen za klinično obravnavo nevrodegenerativnih bolezni.
The in vivo binding of flutemetamol (18F) to other β-amyloid structures or other brain structures or receptors remains unknown.
Vezava flutemetamola (18F) in vivo na druge β-amiloidne strukture ali druge strukture v možganih ostaja nepoznana.
At the 36-month follow-up, 81 (35%) converted to clinical AD. Of the 97 aMCI patients who had a positive PET scan and at least one committee assessment, 52 (54%) were classified clinically as converted to clinical AD after 36 months compared to 29 (23%) of 127 who had a negative scan and at least one committee assessment.
V spremljanju po 36 mesecih je 81 (35 %) bolnikov dobilo diagnozo AB. Od 97 bolnikov z diagnozo aMCI, pri katerih je bila PET slika pozitivna in so imeli vsaj eno oceno neodvisne komisije, jih je bilo 52 (54 %) klinično ocenjenih s spremenjeno diagnozo v AB po 36 mesecih, v primerjavi z 29 (23 %) od 127 bolnikov, pri katerih je bila slika negativna in so imeli vsaj eno oceno neodvisne komisije.
The pharmacokinetics of flutemetamol (18F) in patients with renal or hepatic impairment has not been characterised.
Farmakokinetika flutemetamola (18F) pri bolnikih z ledvično ali jetrno okvaro ni bila določena.
This is equivalent to approximately 2% of the adult recommended maximum daily dietary intake for sodium These amounts may need to be considered for people on a low sodium diet.
To je enako 2 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
MAP Medical Technologies, Saukonpaadenranta 2, 00180 Helsinki, Finland ITEL Telecomunicazioni, Via Labriola (ZI, Lotto 40), 70037, Ruvo di Puglia, Italy Helmholtz-Zentrum Dresden-Rossendorf e.V., Zentrum für Radiopharmazeutische Tumorforschung, 01328 Dresden, Germany
MAP Medical Technologies, Saukonpaadenranta 2, 00180 Helsinki, Finska ITEL Telecomunicazioni, Via Labriola (ZI, Lotto 40), 70037, Ruvo di Puglia, Italija Helmholtz-Zentrum Dresden-Rossendorf e.V., Zentrum für Radiopharmazeutische Tumorforschung, 01328 Dresden, Nemčija
SPECIAL STORAGE CONDITIONS Storage in accordance with national regulation on radiopharmaceuticals.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjevanje v skladu z nacionalnimi predpisi za radioaktivne materiale.
In AD patients, as in controls, there is high retention in pons and other white matter areas.
Pri bolnikih z AB in pri kontrolnih osebah je zadrževanje večje v mostu in drugih območjih bele možganovine.
To be taken into account in pregnant or breast-feeding women and high-risk groups such as patients with liver disease or epilepsy.
Na vsebnost etanola (alkohola) morajo biti pozorne nosečnice ali doječe matere in skupine z velikim tveganjem, kot so bolniki z jetrnimi obolenji ali epilepsijo.
VIZAMYL is for intravenous use.
Način uporabe Zdravilo VIZAMYL je namenjeno intravenski uporabi.
Your nuclear medicine doctor may ask you to drink plenty of water before the start of the examination and the 24 hours after the study in order to urinate as often as possible to help remove it from your body faster.
Zdravnik nuklearne medicine vas bo morda prosil, da pred začetkom preiskave in 24 ur po njej pijete veliko vode.
Elimination of flutemetamol (18F) is approximately 37% renal and 52% hepatobiliary.
Približno 37 % flutemetamola (18F) se izloči renalno, 52 % pa skozi jetra, žolčnik in žolčevode.
Position the patient supine with the patient's brain (including the cerebellum) within a single field of view.
Bolnika namestite v ležeč položaj, tako da so njegovi možgani (skupaj z malimi možgani) v enem samem vidnem polju.
A positive scan indicates a moderate to frequent density.
Pozitiven rezultat posnetka kaže na zmerno do veliko gostoto.
The other ingredients are sodium chloride and ethanol anhydrous, polysorbate 80, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate and water for injections, see section 2.
Druge sestavine zdravila so natrijev klorid in brezvodni etanol, polisorbat 80, natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dodekahidrat in voda za injekcije, glejte poglavje 2.
How VIZAMYL is stored Contents of the pack and other information
Shranjevanje zdravila VIZAMYL Vsebina pakiranja in dodatne informacije
Image interpretation errors in the estimation of brain β-amyloid neuritic plaque density, including false negatives and false positives, have been observed.
Pri interpretaciji posnetkov v oceni možganske gostote βamiloidnih nevritičnih leh so opazili napake, ki so vključevale lažno negativne in lažno pozitivne rezultate.
In a re-reading study that increased the patient population of the pivotal study to include 38 additional autopsied patients (i.e., 106 in total), sensitivity and specificity for detection of moderate-frequent βamyloid neuritic plaque density in the primary analysis were 91% (95% CI: 82% to 96%) and 90% (95% CI: 74% to 98%), respectively, based on the majority read (i.e., the image interpretation reached by at least 3 of the 5 readers after electronic training).
V študiji vnovičnega odčitavanja, v kateri je bila populacija bolnikov klinični študiji, ki podpira vlogo za pridobitev dovoljenja za promet povečana, da je bilo vključenih dodatnih 38 bolnikov, pri katerih je bila opravljena obdukcija (tj. skupno 106), sta bili občutljivost in specifičnost za določitev zmernepogoste gostote β-amiloidninih nevritičnih leh v primarni analizi 91 % (95 % IZ: 82 % do 96 %) oziroma 90 % (95 % IZ: 74 % do 98 %) pri večini odčitavanj slik (tj. interpretacija slik je bila dosežena pri vsaj 3 od 5 odčitovalcev po opravljenem usposabljanju v elektronski obliki).
The majority read sensitivity and specificity were 93% (95% CI: 81% to 99%) and 84% (95% CI: 64% to 96%), respectively.
Občutljivost in specifičnost sta bili 93 % (95 % IZ: 81% do 99%) oziroma 84 % (95 % IZ: 64 % do 96%) pri večini odčitavanj slik.
VIZAMYL PET cases showing examples of negative flutemetamol (18F) PET scan (left) and positive scan (right).
Primeri posnetkov PET ob uporabi zdravila VIZAMYL, kjer sta prikazana negativen flutemetamol (18F) posnetek PET (levo) in pozitivna slika (desno).
Other medicines and VIZAMYL
Druga zdravila in zdravilo VIZAMYL
SHIELD LABEL / 15 mL
OZNAKA NA ZAŠČITI / 15 ml
Some scans may be difficult to interpret due to image noise, atrophy with a thinned cortical ribbon or image blur, which could lead to interpretation errors.
Nekatere posnetke je zaradi atrofije s stanjšanim kortikalnim trakom (angl.: cortical ribbon), šuma na sliki ali zamegljenosti slike težko tolmačiti, zato lahko pride do napak pri interpretaciji.
VIZAMYL is for multidose use.
Zdravilo VIZAMYL je za večodmerno uporabo.
One multidose vial of 15-mL capacity contains 1 to 15 mL of solution, corresponding to 400 to 6000 MBq at reference date and time.
Ena večodmerna viala s prostornino 15 ml vsebuje 1 do 15 ml raztopine, kar ustreza 400 do 6000 MBq ob referenčnem datumu in času.
A negative scan indicates none or a sparse density of cortical β-amyloid neuritic plaques.
Negativen rezultat preiskave kaže na odsotne ali redko raztresene kortikalne β-amiloidne nevritične lehe.
The biophysical basis of the white matter retention of flutemetamol (18F) in the living human brain has not been definitively explained.
Zadrževanje flutemetamola (18F) v biofizčni osnovi bele možganovine v aktivnih človeških možganih ni bilo povsem razjasnjeno.
The highest level of uptake is in pons and other white matter regions.
Najvišja raven privzemanja je v mostu in drugih delih bele možganovine.
At 36 months, sensitivity of flutemetamol (18F) scans for predicting conversion from aMCI to AD in 81 converters was 64 % (95% CI: 54% to 75 %), specificity in 143 non-converters was 69% (95% CI: 60% to 76 %).
Po 36 mesecih je bila občutljivost posnetkov s flutemetamolom (18F) za napoved spremembe diagnoze iz aMCI v AB pri 81 bolnikih s spremenjeno diagnozo 64 % (95% IZ: 54 do 75 %), specifičnost pri 143 bolnikih, pri katerih se diagnoza ni spremenila pa 69 % (95 % IZ: 60 % do 76 %).
Excipients: ethanol anhydrous, polysorbate 80, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, water for injections.
Pomožne snovi: brezvodni etanol, polisorbat 80, natrijev klorid, natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dodekahidrat, voda za injekcije.
One multidose vial of 10-mL capacity contains 1 to 10 mL of solution, corresponding to 400 to 4000 MBq at reference date and time.
Ena večodmerna viala s prostornino 10 ml vsebuje 1 do 10 ml raztopine, kar ustreza 400 do 4.000 MBq ob referenčnem datumu in času.
In vitro, flutemetamol (18F) binds to β-amyloid neuritic plaques in the brain, with negligible binding to neurofibrillary tangles.
In vitro se flutemetamol (18F) veže na β-amiloidne nevritične lehe v možganih z zanemarljivo vezavo na nevrofibrilarne vozle.
When in doubt, it is important to consult the nuclear medicine doctor who will supervise the procedure.
Če ste v dvomih, je pomembno, da se posvetujete z zdravnikom nuklearne medicine, ki nadzira postopek.
In the event of administration of a radiation overdose, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by frequent micturition and defecation.
V primeru uporabe prevelikega odmerka sevanja je treba bolnika spodbujati k povečanju izločanja iz telesa s pogostim uriniranjem in odvajanjem blata za zmanjšanje odmerka sevanja.
Flutemetamol (18F) binds to β-amyloid neuritic plaques in the brain.
Flutemetamol (18F) se veže na β-amiloidne nevritične lehe v možganih.
Renal/hepatic impairment The pharmacokinetics in patients with renal or hepatic impairment have not been characterised.
Ledvična/jetrna okvara Farmakokinetika pri bolnikih z ledvično ali jetrno okvaro ni bila določena.
Pharmacodynamic effects At the low concentrations present in VIZAMYL, flutemetamol (18F) has no detectable pharmacodynamic activity.
Farmakodinamični učinki Pri nizkih koncentracijah, ki so prisotne v zdravilu VIZAMYL, za flutemetamol (18F) ni mogoče zaznati farmakodinamičnega delovanja.
VIZAMYL 400 MBq/mL solution for injection flutemetamol (18F)
VIZAMYL 400 MBq/mL raztopina za injiciranje flutemetamol (18F)
QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution for injection contains 400 MBq of flutemetamol (18F) at reference date and time.
KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml raztopine za injiciranje vsebuje 400 MBq flutemetamola (18F) na referenčni datum in čas.