natgillin/translations-raw huggingface dataset:
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). 
- dofetilidom - karbamazepinom, okskarbazepinom, fenobarbitalom, fenitoinom - rifampicinom, rifapentinom - inhibitorima protonske pumpe, kao što su omeprazol, esomeprazol, lanzoprazol, pantoprazol,
No dosage adjustment is required in patients with mild or moderate renal impairment. 
Nije potrebno prilagođavati dozu u bolesnika s blagim ili umjerenim oštećenjem jetrene funkcije
common decreased white blood cell count decreased haemoglobin decreased platelet count 
Poremećaji krvi i limfnog sustava često smanjen broj bijelih krvnih stanica smanjena vrijednost hemoglobina smanjen broj trombocita
Co-administration of Juluca with medicinal products that increase gastric pH may result in decreased plasma concentrations of rilpivirine which could potentially reduce the therapeutic effect of Juluca. 
Istodobna primjena lijeka Juluca s lijekovima koji povisuju želučanu pH vrijednost može smanjiti koncentracije rilpivirina u plazmi, što može smanjiti terapijski učinak lijeka Juluca.
AUC ↓ 14% Cmin NA Cmax ↓ 14% 
AUC ↓ 14% Cmin NP Cmax ↓ 14%
Macrolide antibiotics Clarithromycin Erythromycin /Dolutegravir 
Makrolidni antibiotici klaritromicin eritromicin / dolutegravir klaritromicin eritromicin / rilpivirin dolutegravir ↔ (Interakcija se nije ispitivala)
Skin and subcutaneous tissue disorders common rash pruritus 
Poremećaji kože i potkožnog tkiva često osip pruritus
Iron oxide yellow (E172) Iron oxide red (E172) 
Ovojnica tablete poli(vinilni alkohol) - djelomično hidroliziran titanijev dioksid (E171) makrogol talk željezov oksid, žuti (E172) željezov oksid, crveni (E172) 6.2 Inkompatibilnosti
In limited data from small numbers of women in study IMPAACT P1026 who received dolutegravir 50 mg once daily during the 2nd trimester of pregnancy, mean intra-individual values for total dolutegravir Cmax, AUC24h and C24h values were, respectively, 26%, 37% and 51% lower as compared to postpartum; during the 3rd trimester of pregnancy, Cmax, AUC24h and Cmin values were, respectively, 25%, 29% and 34% lower as compared to postpartum (see sections 4.2, 4.4. and 4.6). 
Prema ograničenim podacima prikupljenima u malog broja žena iz ispitivanja IMPAACT P1026 koje su primale dolutegravir u dozi od 50 mg jedanput na dan tijekom drugog tromjesečja trudnoće, srednja intraindividualna vrijednost Cmax, AUC24h i C24h ukupnog dolutegravira bila je 26%, 37% odnosno
Do not take an antacid during the 6 hours before you take Juluca, or for at least 4 hours after you take it (see also section 3, ‘How to take Juluca') 
Ne smijete uzeti antacid unutar 6 sati prije primjene lijeka Juluca ni najmanje 4 sata nakon njegove primjene (pogledajte i dio 3. ‘Kako uzimati lijek Juluca')
The clinical status of the patient and the adverse reaction profile of Juluca should be borne in mind when considering the patient's ability to drive or operate machinery. 
Kada se razmatra bolesnikova sposobnost upravljanja vozilima ili rada sa strojevima, treba imati na umu kliničko stanje bolesnika i profil nuspojava lijeka Juluca.
Co-administration of Juluca with rifampicin is contraindicated (see section 4.3). 
Istodobna primjena lijeka Juluca i rifampicina je kontraindicirana (vidjeti dio 4.3).
(induction of CYP3A enzymes). 
(Indukcija enzima iz obitelji CYP3A)
The pharmacokinetics of dolutegravir in 10 antiretroviral treatment-experienced HIV-1 infected adolescents (12 to <18 years of age and weighing ≥40 kg) showed that dolutegravir 50 mg once daily oral dosage resulted in dolutegravir exposure comparable to that observed in adults who received dolutegravir 50 mg orally once daily. 
≥ 40 kg) s HIV-1 infekcijom koji su prethodno bili liječeni antiretroviroticima pokazala je da peroralna primjena dolutegravira u dozi od 50 mg jedanput na dan dovodi do izloženosti dolutegraviru usporedive s onom primijećenom u odraslih bolesnika koji su primali dolutegravir u peroralnoj dozi od
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). 
- deksametazon (kortikosteroid koji se koristi kod mnogih stanja kao što su upala i alergijske reakcije) kada se uzima kroz usta ili primjenjuje injekcijom, osim u slučaju liječenja samo jednom dozom - pripravke koji sadrže gospinu travu (Hypericum perforatum) (biljni lijek koji se koristi za liječenje depresije)
If calcium or iron supplements, or multivitamins cannot be taken at the same time as Juluca, these supplements are recommended to be administered 6 hours before or 4 hours after taking Juluca (see section 
Ako se nadomjesci kalcija ili željeza ili multivitaminski pripravci ne mogu uzeti istodobno s lijekom Juluca, preporučuje se primijeniti ih 6 sati prije ili 4 sata nakon uzimanja lijeka
The single INI-resistance substitutions T66K, I151L, and S153Y conferred a greater than 2-fold decrease in dolutegravir susceptibility (range: 2.3fold to 3.6-fold from reference). 
S153Y smanjile su osjetljivost na dolutegravir više od 2 puta (raspon od 2,3 puta do 3,6 puta u odnosu na referentnu vrijednost).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (INDIVIDUAL PACKS ONLY) 
KUTIJA (SAMO POJEDINAČNA PAKIRANJA)
The combination of Juluca and supplements should be used with particular caution. 
Kombinaciju lijeka Juluca i dodataka prehrani treba primjenjivati uz osobit oprez.
AUC ↔ Cmin NA 
AUC ↔ Cmin NP
Paracetamol / Rilpivirine1,2 
paracetamol / dolutegravir paracetamol / rilpivirin1,2
The combination of Juluca and dabigatran etexilate should be used with caution. 
Kombinaciju lijeka Juluca i dabigatraneteksilata treba primjenjivati uz oprez.
- carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines to treat epilepsy and to prevent fits) - rifampicin, rifapentine (medicines to treat some bacterial infections such as tuberculosis) 
- rifampicin, rifapentin (lijekovi za liječenje nekih bakterijskih infekcija, kao što je tuberkuloza) - omeprazol, esomeprazol, lanzoprazol, pantoprazol, rabeprazol (lijekovi za sprječavanje i liječenje želučanih vrijedova, žgaravice ili bolesti refluksa kiseline)
Antacids, to treat indigestion and heartburn, can stop Juluca being absorbed into your body and make it less effective. 
Antacidi, lijekovi za probavne smetnje i žgaravicu, mogu spriječiti apsorpciju lijeka Juluca u tijelo i tako umanjiti njegovu djelotvornost.
Rilpivirine ↓ 
rilpivirin ↓
Rilpivirine ↔ 
rilpivirin ↔
Dolutegravir ↔ (Not studied) 
dolutegravir ↔ (Interakcija se nije ispitivala)
This may result in 
Ako je moguće,
Increased exposure of rilpivirine is expected (inhibition of CYP3A enzymes). 
Očekuje se povećana izloženost rilpivirinu (inhibicija enzima iz obitelji CYP3A).
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. 
U jednog ispitanika liječenog dolutegravirom plus rilpivirinom kod kojeg su utvrđeni problemi s pridržavanjem liječenja primijećena je miješana supstitucija K101K/E povezana s rezistencijom na NNRTI, bez smanjene osjetljivosti na rilpivirin (FC = 1,2).
The combination of Juluca and antacids should be used with particular caution. 
Kombinaciju lijeka Juluca i antacida treba primjenjivati uz osobit oprez.
• calcium supplements, iron supplements and multivitamins must be taken at the same time as Juluca with a meal. 
• nadomjeske kalcija, nadomjeske željeza i multivitaminske pripravke, koji se moraju uzimati istodobno s lijekom Juluca, uz obrok.
Vardenafil Tadalafil/ Dolutegravir 
vardenafil tadalafil / dolutegravir vardenafil tadalafil / rilpivirin dolutegravir ↔
Antiviral active substances Tenofovir disoproxil / Dolutegravir1 
Antivirusne djelatne tvari tenofovirdizoproksil / dolutegravir1
Antimycobacterials Rifampicin/ Dolutegravir1 
Antimikobakterijski lijekovi rifampicin / dolutegravir1
A higher incidence of liver chemistry elevations (Grade 1) were observed in patients treated with dolutegravir and rilpivirine co-infected with hepatitis C compared to those who were not co-infected. 
Među bolesnicima liječenima dolutegravirom i rilpivirinom koji su imali istodobnu infekciju virusom hepatitisa C primijećena je viša incidencija povišenih vrijednosti rezultata testova jetrene funkcije (1. stupnja) nego u onih koji nisu imali istodobnu infekciju virusom hepatitisa C.
Co-administration is likely to cause significant decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes). 
Istodobna primjena će vjerojatno dovesti do značajnih smanjenja koncentracija rilpivirina u plazmi (indukcija enzima iz obitelji CYP3A).
If you notice after 12 hours, then skip that dose and take the next doses as usual. 
preskočite tu dozu i uzmite sljedeću prema uobičajenom rasporedu.
Dolutegravir ↔ AUC ↑ 7% Cmax ↑ 5% Cτ ↑ 8% 
Cmax ↑ 5% Cτ ↑ 8%
A risk for increases in dabigatran plasma concentrations cannot be excluded 
Ne može se isključiti rizik od povećanja koncentracija dabigatrana u plazmi (inhibicija P-gp-a u crijevima).
Dolutegravir had a <10 FC against 94% of the 705 clinical isolates. 
FC dolutegravira iznosio je < 10 u 94% od
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. 
E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, Y188L, H221Y, F227C, M230I ili M230L.
NAME OF THE MEDICINAL PRODUCT Juluca 50 mg/25 mg film-coated tablets dolutegravir/rilpivirine 
Uputa o lijeku: Informacije za bolesnika Juluca 50 mg/25 mg filmom obložene tablete dolutegravir/rilpivirin
Analgesics Methadone/ Dolutegravir1 
Analgetici metadon / dolutegravir1
Nizatidine 
Antacidi
Significant decreases in rilpivirine plasma concentrations are expected (induction of CYP3A enzymes). 
Očekuju se značajna smanjenja koncentracija rilpivirina u plazmi (indukcija enzima iz obitelji CYP3A).
Juluca must be taken with a meal (see section 
Juluca se mora uzeti uz obrok (vidjeti dio 5.2).
Decreased exposure of rilpivirine is expected (induction of CYP3A enzymes). 
Očekuje se smanjena izloženost rilpivirinu (indukcija enzima iz obitelji CYP3A).
Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and rilpivirine hydrochloride equivalent to 25 mg rilpivirine. 
Jedna filmom obložena tableta sadrži 50 mg dolutegravira u obliku dolutegravirnatrija i 25 mg rilpivirina u obliku rilpivirinklorida.
• low white blood cell count 
• nizak broj bijelih krvnih stanica • smanjenje vrijednosti hemoglobina
Rilpivirine 
rilpivirin
→ Talk to your doctor for further advice on taking calcium supplements, iron supplements or multivitamins with Juluca. 
Za dodatne savjete o uzimanju nadomjestaka kalcija, nadomjestaka željeza ili multivitaminskih pripravaka zajedno s lijekom Juluca, razgovarajte sa svojim liječnikom.
Do not take Juluca if you are taking any of the following medicines as they may affect the way Juluca works: - dofetilide (a medicine to treat heart conditions). 
- ako ste alergični na dolutegravir, rilpivirin ili neki drugi sastojak ovoga lijeka (naveden u dijelu 6.) Nemojte uzimati lijek Juluca ako uzimate bilo koji od sljedećih lijekova, jer oni mogu utjecati na način na koji Juluca djeluje: - dofetilid (lijek za srčane bolesti) - karbamazepin, okskarbazepin, fenobarbital, fenitoin (lijekovi za liječenje epilepsije i sprječavanje napadaja)
If you notice within 12 hours of the time you usually take Juluca, you must take the tablet as soon as possible. 
Ako shvatite da ste zaboravili uzeti lijek Juluca unutar 12 sati nakon uobičajenog vremena primjene,
(+ 50 mg once daily rilpivirine) 
300 mg jedanput na dan (+ 50 mg rilpivirina jedanput na dan)
Dolutegravir ↔ AUC ↑ 11% Cmax ↑ 6% Cτ ↑ 17% 
Cmax ↑ 6% Cτ ↑ 17%
Each tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and rilpivirine hydrochloride equivalent to 25 mg rilpivirine. 
Jedna tableta sadrži 50 mg dolutegravira u obliku dolutegravirnatrija i 25 mg rilpivirina u obliku rilpivirinklorida.
The combination of Juluca and H2-receptor antagonists should be used with particular caution. 
H2-receptora treba primjenjivati uz osobit oprez.
Rilpivirine ↑ Not studied. 
rilpivirin ↑ Interakcija se nije ispitivala.
→ Talk to your doctor for further advice on taking these medicines with Juluca. 
Za dodatne savjete o uzimanju tih lijekova zajedno s lijekom Juluca, razgovarajte sa svojim liječnikom.
Calcium or iron supplements, or multivitamins should be co-administered at the same time as Juluca, with a meal. 
Nadomjeske kalcija ili željeza ili multivitaminske pripravke treba primijeniti istodobno s lijekom Juluca, uz obrok.
Atorvastatin/ Rilpivirine1,2 
tenofovirdizoproksil / rilpivirin1,2
In lactating rats that received a single oral dose of dolutegravir 50 mg/kg at 10 days postpartum, dolutegravir was detected in milk at concentrations typically higher than blood. 
U ženki štakora u laktaciji koje su primile jednu peroralnu dozu dolutegravira od 50 mg/kg 10 dana postpartalno,
If you can't take these supplements at the same time as Juluca, do not take a calcium supplements, iron supplements or multivitamins during the 6 hours before you take Juluca, or for at least 4 hours after you take it. 
Ako ne možete uzeti nadomjeske kalcija, nadomjeske željeza ili multivitaminske pripravke istodobno s lijekom Juluca, nemojte ih uzeti unutar 6 sati prije uzimanja lijeka Juluca ni najmanje 4 sata nakon njegove primjene.
• increase in pancreatic amylase (a digestive enzyme). 
• povišene vrijednosti gušteračne amilaze (probavnog enzima) Česte nuspojave
Calcium supplements, iron supplements or multivitamins must be taken at the same time as Juluca. 
Nadomjesci kalcija, nadomjesci željeza ili multivitaminski pripravci moraju se uzeti istodobno s lijekom Juluca.
NGMN ↔ AUC ↓ 2% Cmax ↓ 11% 
NGMN ↔ AUC ↓ 2%
Antidiabetics 
dabigatraneteksilat
Antimalarials Artemether/ Lumefantrine/ Dolutegravir 
Antimalarici artemeter / lumefantrin / dolutegravir artemeter/ lumefantrin / rilpivirin dolutegravir ↔ (Interakcija se nije ispitivala)
Ranitidine/ 
Nuspojave
Dose dependent decreases in rilpivirine plasma concentrations are expected (induction of CYP3A enzymes). 
Očekuju se smanjenja koncentracija rilpivirina u plazmi ovisno o dozi (indukcija enzima iz obitelji CYP3A).
Dolutegravir ↔ AUC ↑ 1% Cmax ↓ 3% Cτ ↓ 8% 
Cmax ↓ 3% Cτ ↓ 8%
If you take rifabutin, your doctor may need to give you an additional dose of rilpivirine to treat your HIV infection (see section 3, ‘How to take Juluca') 
Ako uzimate rifabutin, liječnik će Vam možda morati dati dodatnu dozu rilpivirina za liječenje
HMG CO-A reductase inhibitors Atorvastatin/ 
Inhibitori HMG-CoA reduktaze atorvastatin / dolutegravir atorvastatin / rilpivirin1,2
Oxcarbazepine Phenytoin Phenobarbital/ Rilpivirine 
okskarbazepin fenitoin fenobarbital / dolutegravir okskarbazepin fenitoin fenobarbital / rilpivirin dolutegravir
Co-administration of Juluca with rifapentine is contraindicated (see section 4.3). 
Istodobna primjena lijeka Juluca i rifapentina je kontraindicirana (vidjeti dio 4.3).
In the pooled analysis, 54%, 26%, and 20% of subjects were receiving an NNRTI, PI, or INI (respectively) as their baseline third treatment agent class prior to randomisation. 
Prema analizi objedinjenih podataka, 54% ispitanika je prije randomizacije primalo NNRTI-je, 26% inhibitore proteaze, a 20%
Decrease expected due to induction of UGT1A1 and CYP3A enzymes, a similar reduction in exposure as observed with carbamazepine is expected. 
Očekuje se smanjenje koncentracija zbog indukcije enzima UGT1A1 i CYP3A
Joint pain, stiffness and bone problems 
Bol i ukočenost u zglobovima te tegobe s kostima
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). 
6. do 17. dana gestacije nije uzrokovala toksičnost za majku, razvojnu toksičnost ni teratogenost (izloženost 38 puta veća od kliničke izloženosti pri primjeni doze od 50 mg u ljudi, što je utvrđeno na temelju AUC-a).
A single dose of 50 mg of dolutegravir was administered to 8 subjects with moderate hepatic impairment (Child-Pugh score B) and to 8 matched healthy adult controls. 
Jedna doza dolutegravira od 50 mg primijenjena je u 8 ispitanika s umjerenim oštećenjem jetrene funkcije
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 H2-receptora (npr. cimetidin, famotidin, nizatidin, ranitidin)
Calcium supplements, iron supplements or multivitamins should be co-administered at the same time as Juluca with a meal. 
Nadomjeske kalcija, nadomjeske željeza ili multivitaminske pripravke treba primijeniti istodobno s lijekom Juluca, uz obrok.
Juluca should not be administered with other antiretroviral medicinal products for the treatment of HIV (see section 4.5). 
Juluca se ne smije primjenjivati s drugim antiretrovirusnim lijekovima za liječenje HIV infekcije
Ribavirin/ Rilpivirine 
vrijednosti) rilpivirin
Investigations common creatine phosphokinase (CPK) elevations * Frequencies are assigned based on the maximum frequencies observed in the pooled SWORD studies or studies with the individual components ** This adverse reaction was identified through post-marketing surveillance for dolutegravir in combination with other ARVs. 
* Učestalost je određena na temelju najveće učestalosti prema objedinjenim podacima iz ispitivanja SWORD ili ispitivanja pojedinačnih sastavnica
• stomach ache 
• tjeskoba • suha usta
• dizziness 
digoksin
Proton pump inhibitors Omeprazole Lansoprazole 
Inhibitori protonske pumpe omeprazol lanzoprazol rabeprazol pantoprazol esomeprazol / dolutegravir omeprazol / rilpivirin1,2
Metformin/ Dolutegravir1 
Antidijabetici metformin / dolutegravir1
Dolutegravir ↓ AUC ↓ 39% Cmax ↓ 37% C24 ↓ 39% (Complex binding to polyvalent ions). 
Cmax ↓ 37% C24 ↓ 39%
In a study of healthy subjects, supratherapeutic doses of rilpivirine (75 mg once daily and 300 mg once daily) have been shown to prolong the QTc interval of the ECG (see section 5.1). 
U ispitivanju provedenom u zdravih ispitanika pokazalo se da doze rilpivirina veće od terapijskih (75 mg jedanput na dan i 300 mg jedanput na dan)
Lansoprazole Rabeprazole Pantoprazole Esomeprazole/ Rilpivirine 
Biljni lijekovi gospina trava / dolutegravir gospina trava / rilpivirin dolutegravir
Dolutegravir ↔ Methadone ↔ AUC ↓ 2% Cmax ↔ 0% Cτ ↓ 1% 
dolutegravir ↔ metadon ↔ AUC ↓ 2%
Antacid medicines 
UPUTA O LIJEKU
Rilpivirine ↔ Not studied. 
rilpivirin ↔ Interakcija se nije ispitivala.
→ Talk to your doctor for further advice on taking acid-lowering medicines with Juluca. 
Za dodatne savjete o uzimanju antacida zajedno s lijekom Juluca, razgovarajte sa svojim liječnikom.
GlaxoSmithKline, s.r.o. 
Slovenská republika GlaxoSmithKline Slovakia s. r. o.
Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (Complex binding to polyvalent ions). 
Cmax ↓ 57% C24 ↓ 56%
Opportunistic infections 
HIV infekcijom.
Sofosbuvir metabolite GSAUC ↔ 
metabolit sofosbuvira GS-331007 ↔ AUC ↔
Dolutegravir ↔ EE ↔ AUC ↑ 3% Cmax ↓ 1% 
daklatazvir / rilpivirin dolutegravir ↔ AUC ↑ 33%
Cmax ↑ 17% Norethindrone ↔ AUC ↔ 
Cτ ↓ 73% rilpivirin↓
Cimetidine 
• mučnina
Dolutegravir ↓ AUC ↓ 74% Cmax ↓ 72% C24 ↓ 74% (Complex binding to polyvalent ions). 
Cmax ↓ 72% C24 ↓ 74%
Simeprevir/ Dolutegravir 
simeprevir / dolutegravir simeprevir / rilpivirin dolutegravir ↔
H2-recepter antagonists Famotidine 
Kombinaciju lijeka Juluca i antagonista
Dolutegravir 
Peroralna primjena
This may result in loss of therapeutic effect of Juluca (induction of CYP3A enzymes). 
Juluca (indukcija enzima iz obitelji CYP3A).
Adjusted difference (95% CI) -0.6 (-1.7, 0.6). 
O srednja vrijednost IC50 iznosila je 0,2 nM (raspon: 0,02 - 2,14).
Anticoagulants Dabigatran etexilate/ Dolutegravir 
Antikoagulansi dabigatraneteksilat / dolutegravir dabigatraneteksilat / rilpivirin dolutegravir ↔ (Interakcija se nije ispitivala)
(as a bolus within approximately 40 seconds). 
(kao bolus unutar otprilike 40 sekundi).
They will provide you with the necessary information on the procedure. 
One će Vam dati sve potrebne informacije o postupku.
Eight hours from the reference date and time. 
Osam sati od referentnog datuma i vremena.
The doctor will choose the smallest amount necessary. 
Liječnik će odrediti najmanju potrebnu količinu.
Cases should be histopathologically confirmed, if possible. 
Slučajevi trebaju biti histopatološki potvrđeni, ukoliko je moguće.
Otherwise it should be classified as negative (normal). 
U protivnom, trebalo bi ju klasificirati kao negativnu (normalnu).
VIZAMYL will only be used in special controlled areas. 
VIZAMYL će se koristiti samo u posebno kontroliranim područjima.
It might be helpful to estimate the effective dose that was applied. 
Bilo bi od koristi procijeniti učinkovitu dozu koja je primijenjena.
It must not be diluted. 
Ne smije se razrjeđivati.
Radioactive material. 
Radioaktivni materijal.
The volume of the injection should be not less than 1 mL and not more than 10 mL. 
Volumen injekcije ne smije biti manji od 1 ml niti veći od 10 ml.
This amount may be harmful for those suffering from alcoholism. 
Ta količina može biti štetna za osobe koje boluju od alkoholizma.
Training should include a sufficient number of clearly positive and negative cases as well as intermediate level cases. 
Obuka treba uključivati dovoljan broj očito pozitivnih i negativnih slučajeva kako i slučajeva koji su srednjeg nivoa.
No studies have been conducted in pregnant women. 
Nisu provedena istraživanja na trudnicama.
Individual benefit/risk justification 
Pojedinačna procjena koristi/rizika
The training course for healthcare professionals should contain the following key elements: 
Obuka za zdravstvene djelatnike treba sadržavati slijedeće ključne elemente:
One injection is sufficient to carry out the scan that your doctor needs. 
Jedna injekcija je dovoljna za snimku koja je potrebna Vašem liječniku.
This is about the same as 14 mL of beer or 6 mL of wine. 
To je otprilike jednako kao 14 ml piva ili 6 ml vina.
The cognitive status of the patients was not determined. 
Kognitivni status bolesnika nije utvrđivan.
Children and adolescents VIZAMYL is not intended for use in children and adolescents below the age of 18 years old. 
Djeca i adolescenti VIZAMYL nije namijenjen za primjenu kod djece i adolescenata mlađih od 18 godina.
Appropriate aseptic precautions should be taken. 
Potrebno je poduzeti odgovarajuće aseptične mjere opreza.
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). 
Vrlo često (≥1/10), često (≥1/100 do <1/10), manje često (≥1/1000 do <1/100), rijetko (≥1/10 000 do <1/1000), vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
Limitations of use 
Ograničenja pri uporabi
If any one of these regions is clearly positive (abnormal) then the image should be classified as positive (abnormal). 
Ako je bilo koje od tih područja jasno pozitivno (abnormalno), snimku bi trebalo klasificirati kao pozitivnu (abnormalnu).
There are strict laws on the use, handling and disposal of radiopharmaceutical products. 
Postoje strogi zakoni o uporabi, rukovanju i odlaganju radiofarmaceutskih proizvoda.
Organ/Tissue 
Organ/Tkivo
Based on the majority read, the positive and negative likelihood ratios were 2.04 and 0.52 respectively. 
Na temelju većine očitanja, pozitivni i negativni omjeri vjerojatnosti iznosili su približno 2,04 i 0,52.