natgillin/translations-raw huggingface dataset:
The top two arrows are pointing to normal preserved grey-white contrast with the cortical activity less than the adjacent white matter.
Gornje dvije strelice pokazuju normalan, očuvan sivo-bijeli kontrast, iz kojega se vidi da je aktivnost u korteksu manja od one u susjednoj bijeloj tvari.
Advanced Accelerator Applications (Italy), S.r.l.
Advanced Accelerator Applications (Italy), S.r.l. - Venafro Via Dell'Industria
Method of administration Amyvid is for intravenous use and multidose use.
Amyvid je namijenjen za intravensku i višedoznu primjenu.
The following side effects of Amyvid are uncommon (may affect up to 1 in 100 people): - feeling sick, - altered taste, - flushing, - itching, - rash, bleeding or pain where the injection is given or rash in other places.
- izmijenjen osjet okusa, - navale crvenila, - svrbež, - osip, krvarenje ili bol na mjestu primjene injekcije ili osip na nekom drugom mjestu.
Nervous system disorders
Poremećaji živčanog sustava glavobolja disgeuzija
Renal/hepatic impairment The pharmacokinetics in patients with renal or hepatic impairment have not been characterised.
Oštećenje bubrežne/jetrene funkcije Farmakokinetika u bolesnika s oštećenjem jetrene ili bubrežne funkcije nije opisana.
If the integrity of the vial is compromised, the product should not be used.
Ako je bočica oštećena, lijek se ne smije upotrijebiti.
β-amyloid plaques are deposits present in the brains of people with Alzheimer's disease, but may also be present in the brain of people with other dementias.
PET oslikavanje primjenom lijeka Amyvid liječnicima pomaže utvrditi imate li u mozgu β-amiloidne naslage. β-amiloidne naslage su talozi koji se javljaju u mozgu ljudi s Alzheimerovom bolešću, ali mogu biti prisutni i u mozgu ljudi koji boluju od drugih oblika demencije.
Some accumulation/excretion is also observed in the urinary bladder.
Akumulacija/izlučivanje u manjoj je mjeri primijećeno i u mokraćnom mjehuru.
Amyvid 800 MBq/mL solution for injection 7.5 hours from the ToC
Amyvid 800 MBq/ml otopina za injekciju 7,5 sati od ToC-a.
The activity per vial ranges from 1900 MBq to 28500 MBq at the ToC.
Aktivnost po bočici je u rasponu od 1900 MBq do 28 500 MBq na ToC.
Using non-AD cases (cognitively normal & MCI)
(normalna kognitivna funkcija i MCI)
In a study of 47 young (<40 years) healthy volunteers, presumed to be free of β-amyloid, all Amyvid PET scans were negative.
zdravih dobrovoljaca za koje se pretpostavilo da nemaju β-amiloide, nalazi svih PET oslikavanja uz
When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.
Ako niste sigurni, važno je da razgovarate sa specijalistom nuklearne medicine koji će nadgledati postupak.
BATCH NUMBER
Broj bočice
Upper large intestine wall
Stijenka gornjeg dijela debelog crijeva Stijenka srca
As the effective dose is 7 mSv when the recommended activity of 370 MBq of florbetapir (18F) is administered, these adverse reactions are expected to occur with low probability.
Budući da kod primjene preporučene aktivnosti florbetapira (18F) od 370 MBq efektivna doza zračenja iznosi 7 mSv, pojava navedenih nuspojava smatra se malo vjerojatnom.
Image acquisition
Dobivanje slike
Close contact with infants and pregnant women should be restricted during the initial 24 hours following the injection.
Nakon postupka Treba ograničiti blizak kontakt s dojenčadi i trudnicama tijekom prvih 24 sata nakon injekcije.
The activity per vial ranges from 800 MBq to 12000 MBq at the ToC.
Aktivnost po bočici je u rasponu od 800 MBq do 12 000 MBq na ToC.
MARKETING AUTHORISATION NUMBER(S) EU/1/12/805/001 (10 mL)
12. BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/805/001 (10 ml)
How Amyvid is stored
Kako čuvati Amyvid
MARKETING AUTHORISATION NUMBER(S) EU/1/12/805/003 (10 mL)
12. BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/805/003 (10 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.
Neke snimke može biti teško interpretirati zbog šuma na snimkama, atrofije sa stanjenim slojem korteksa
Diagnostic performance values of florbetapir (18F) PET are tabulated below:
Dijagnostičke vrijednosti uspješnosti PET oslikavanja uz primjenu florbetapira (18F) prikazane su u sljedećoj tablici:
Regional analyses show slightly higher levels of retention in the caudate, putamen and hippocampus.
Analize po regijama pokazuju nešto veće razine retencije u nucleus caudatusu,
Amyvid is a radiopharmaceutical 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.
gustoće β-amiloidnih neuritičkih plakova u mozgu odraslih bolesnika s oštećenjem kognitivne funkcije u kojih se pretraga provodi radi utvrđivanja Alzheimerove bolesti i drugih uzroka oštećenja kognitivne funkcije.
Ethanol, anhydrous Sodium ascorbate Sodium chloride Water for injections
6.1 Popis pomoćnih tvari etanol, bezvodni natrijev askorbat natrijev klorid voda za injekcije
Amyvid 800 MBq/mL: One multidose vial of 10 mL capacity containing 1 to 10 mL of solution, corresponding to 800 to 8000 MBq at date and time of calibration.
Amyvid 800 MBq/ml: Jedna višedozna bočica od 10 ml koja sadrži 1 do 10 ml otopine, što odgovara 800 do 8000 MBq na dan i sat kalibriranja.
Amyvid 1900 MBq/mL: One multidose vial of 10 mL capacity containing 1 to 10 mL of solution, corresponding to 1900 to 19000 MBq at date and time of calibration.
Amyvid 1900 MBq/ml: Jedna višedozna bočica od 10 ml koja sadrži 1 do 10 ml otopine, što odgovara 1900 do 19 000 MBq na dan i sat kalibriranja.
Stomach wall
Stijenka želuca
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Intravenous use
NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
This should be taken into account in patients with a low sodium diet.
tome treba voditi računa u bolesnika na prehrani s malim unosom natrija.
Amyvid 800 MBq/mL: 1 mL of solution for injection contains 800 MBq of florbetapir (18F) at the date and time of calibration.
Amyvid 800 MBq/ml: 1 ml otopine za injekciju sadrži 800 MBq florbetapira (18F) na dan i sat kalibriranja.
Advanced Accelerator Applications, 62660, Beuvry, France Advanced Accelerator Applications, 01630, Saint Genis Pouilly, France
Radioaktivan materijal Advanced Accelerator Applications, 62660, Beuvry, Francuska
PETNET Solutions (Siemens Healthcare Limited), Nottingham, NG5 1PB, United Kingdom PETNET Solutions (Siemens Healthcare Limited), Northwood, HA6 2RN, United Kingdom PETNET Solutions, 91090, Lisses, France
Advanced Accelerator Applications, 50100, Zaragoza, Španjolska Catalana de Dispensación SAU, 08950, Barcelona, Španjolska PETNET Solutions (Siemens Healthcare Limited), Nottingham, NG51PB, Ujedinjeno Kraljevstvo PETNET Solutions (Siemens Healthcare Limited), Northwood, HA6 2RN, Ujedinjeno Kraljevstvo PETNET Solutions, 91090 Lisses, Francuska
Amyvid 1900 MBq/mL: 1 mL of solution for injection contains 1900 MBq of florbetapir (18F) at the date and time of calibration.
Amyvid 1900 MBq/ml: 1 ml otopine za injekciju sadrži 1900 MBq florbetapira (18F) na dan i sat kalibriranja.
Pruritus Urticaria
Stijenka žučnog mjehura
One multidose vial of 15 mL capacity containing 1 to 15 mL of solution, corresponding to 1900 to 28.500 MBq at date and time of calibration.
Jedna višedozna bočica od 15 ml koja sadrži 1 do 15 ml otopine, što odgovara 1900 do 28 500 MBq na dan i sat kalibriranja.
Amyvid 1900 MBq/mL solution for injection
Amyvid 1900 MBq/ml otopina za injekciju
One multidose vial of 10 mL capacity contains 1 to 10 mL of solution, corresponding to 1900 to 19000 MBq at ToC.
Jedna višedozna bočica od 10 ml sadrži 1 do 10 ml otopine, što odgovara 1900 do 19 000 MBq na ToC.
Any unused material should be disposed of in accordance with local requirements.
Neiskorišteni lijek potrebno je zbrinuti sukladno nacionalnim propisima.
In vitro binding studies have not shown interference of florbetapir (18F) binding to β-amyloid plaques in the presence of other common medicinal products taken by AD patients.
Ispitivanja vezivanja in vitro nisu pokazala da drugi lijekovi koje uobičajeno uzimaju bolesnici s Alzheimerovom bolešću ometaju vezivanje florbetapira (18F) za β-amiloidne plakove.
Amyvid is supplied in 10 mL or 15 mL clear Type I borosilicate glass vials with FluroTec-coated chlorobutyl elastomeric stoppers and aluminium seals.
Amyvid dolazi u bočici od 10 ml ili 15 ml od prozirnog borosilikatnog stakla tipa
(precuneus, frontal, anterior cingulate, posterior cingulate, parietal and temporal) was measured quantitatively using standardised uptake values (SUV).
U završenim kliničkim ispitivanjima nakupljanje florbetapira (18F) u 6 prethodno definiranih kortikalnih područja mozga (precuneus, čeono, prednji dio cingularne vijuge, stražnji dio cingularne vijuge, tjemeno i sljepoočno) izmjereno je kvantitativno primjenom standardiziranih vrijednosti nakupljanja (engl. standardized uptake values, SUV).
A recent co-registered computed tomography (CT) scan or magnetic resonance (MR) imaging of the patient to get a fused PET-CT or PET-MR image is recommended in cases of uncertainty about the location of grey matter and of the grey/white matter border in the PET scan (see section 4.4.
Ako se na PET snimci ne može sa sigurnošću odrediti lokacija sive tvari te granica između sive i bijele tvari, preporučuje se PET snimku fuzionirati s nedavno učinjenim snimkama kompjuterizirane tomografije (CT) ili magnetske rezonancije (MR) kako bi se dobila kombinirana PET-CT ili PET-MR snimka (vidjeti dio 4.4 Interpretacija snimke).
One multidose vial of 10 mL capacity contains 1 to 10 mL of solution, corresponding to 800 to 8000 MBq at ToC.
Jedna višedozna bočica od 10 ml sadrži 1 do 10 ml otopine, što odgovara 800 do 8000 MBq na ToC.
One multidose vial of 15 mL capacity containing 1 to 15 mL of solution, corresponding to 800 to 12000 MBq at date and time of calibration.
Jedna višedozna bočica od 15 ml koja sadrži 1 do 15 ml otopine, što odgovara 800 do 12 000 MBq na dan i sat kalibriranja.
Amyvid 800 MBq/mL solution for injection florbetapir (18F)
Amyvid 800 MBq/ml otopina za injekciju florbetapir (18F)
Kidneys
Doziranje
Using non-MCI cases (cognitively normal & clinical AD)
(normalna kognitivna funkcija i klinički AB)
Amyvid 800 MBq/mL solution for injection
Amyvid 800 MBq/ml otopina za injekciju
One multidose vial of 15 mL capacity contains 1 to 15 mL of solution, corresponding to 1900 to 28500 MBq at ToC.
Jedna višedozna bočica od 15 ml sadrži 1 do 15 ml otopine, što odgovara 1900 do 28 500 MBq na ToC.
the regions corresponding to the ROIs with elevated SUVR should be examined to determine whether there is a loss of grey/white contrast in these areas.
U slučaju negativnog prvobitnog vizualnog nalaza nakupljanja amiloida i pozitivnog nalaza kvantifikacije, potrebno je pregledati područja koja odgovaraju regijama od interesa s povišenim SUVR-om kako bi se utvrdilo je li u tim područjima došlo do gubitka sivo-bijelog kontrasta.
One multidose vial of 15 mL capacity contains 1 to 15 mL of solution, corresponding to 800 to 12000 MBq at ToC.
Jedna višedozna bočica od 15 ml sadrži 1 do 15 ml otopine, što odgovara 800 do 12 000 MBq na ToC.
NAME OF THE MEDICINAL PRODUCT Amyvid 800 MBq/mL solution for injection Amyvid 1900 MBq/mL solution for injection
Amyvid 800 MBq/ml otopina za injekciju Amyvid 1900 MBq/ml otopina za injekciju
If you get any side effects talk to your nuclear medicine doctor.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika specijalista nuklearne medicine.
Each mL of solution for injection contains 800 MBq of florbetapir (18F) at date and time of calibration (ToC).
Jedan ml otopine za injekciju sadrži 800 MBq florbetapira (18F) na dan i sat kalibriranja (ToC).
Reporting of side effects
Pomoćne tvari s poznatim učinkom
- If you get any side effects, talk to your nuclear medicine doctor.
Ako imate bilo kakvih pitanja, obratite se liječniku specijalistu nuklearne medicine.
Lower large intestine wall
Stijenka donjeg dijela debelog crijeva Tanko crijevo
A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD. For the limitations in the interpretation of a positive scan, see sections 4.4 and 5.1.
Za ograničenja kod interpretacije pozitivnog nalaza oslikavanja vidjeti dijelove 4.4
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Amyvid 800 MBq/mL solution for injection florbetapir (18F)
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Amyvid 800 MBq/ml otopina za injekciju florbetapir (18F)
Renal and hepatic impairment
putamenu i hipokampusu.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Amyvid 1900 MBq/mL solution for injection florbetapir (18F)
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Amyvid 1900 MBq/ml otopina za injekciju florbetapir (18F)
Pack size
Višedozno pakiranje
Please refer to the SmPC {SmPC should be included in the box}.
Pročitajte Sažetak opisa svojstava lijeka {Sažetak opisa svojstava lijeka mora se priložiti u kutiji}.
Lungs
Bubrezi
Amyvid 1900 MBq/mL solution for injection Amyvid 800 MBq/mL solution for injection florbetapir (18F)
Amyvid 1900 MBq/ml otopina za injekciju florbetapir (18F)
Gallbladder wall
Štitnjača Stijenka mokraćnog mjehura
Headache
- glavobolja
Each mL of solution for injection contains 1900 MBq of florbetapir (18F) at the ToC.
Jedan ml otopine za injekciju sadrži 1900 MBq florbetapira (18F) na dan i sat kalibriranja (ToC).
Half-life
Poluvijek
Multidose
Doza
Solution for injection
NAČIN PRIMJENE LIJEKA
Left to right panels show sagittal, coronal, and transverse PET image slices.
Stupci slijeva nadesno prikazuju PET snimke sagitalnih,
You should take both tablets at the same time, one after the other.
Obje tablete morate uzeti u isto vrijeme, jednu za drugom.
- have had a heart attack in the last 3 months.
- ako ste u posljednja 3 mjeseca imali srčani udar
The result of this is an improved ability to do physical activity.
Rezultat toga je poboljšanje sposobnosti za obavljanje fizičke aktivnosti.
This leaflet was last approved in
Ova uputa je zadnji puta odobrena u
Do NOT take these tablets if you are already taking nitrates.
NEMOJTE uzimati ove tablete ako već uzimate nitrate.
For those patients for which there are data, the survival rate at 1 year is 96.4 %.
Za bolesnike za koje postoje podaci, preživljenje nakon godinu dana iznosi 96,4%.
ADCIRCA with alcohol
ADCIRCA s alkoholom
Other medicines and ADCIRCA
Drugi lijekovi i ADCIRCA
- have low blood pressure.
- ako imate nizak krvni tlak
- sudden loss of vision (rarely reported).
- iznenadan gubitak vida (rijetko prijavljeno)
Currently available data are described in section 5.1.
Trenutno dostupni podaci opisani su u dijelu 5.1.
Take your dose as soon as you remember if it is within 8 hours of when you should have taken your dose.
Uzmite dozu čim se sjetite, pod uvjetom da je to unutar 8 sati od kada ste trebali uzeti dozu.
(2) Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors.
(2) U većine bolesnika u kojih su prijavljeni ovi događaji već su postojali kardiovaskularni faktori rizika.
Before taking the tablets, tell your doctor if you have:
Prije uzimanja tableta, obavijestite svog liječnika ako imate:
Children and adolescents ADCIRCA is not indicated for use by children and adolescents under the age of 18.
ADCIRCA nije namijenjena za primjenu u djece i adolescenata mlađih od 18 godina.
In cases of overdose, standard supportive measures should be adopted as required.
U slučaju predoziranja, treba po potrebi primijeniti standardne suportivne mjere.
It is not possible to determine whether these events were related directly to tadalafil.
Nije moguće utvrditi jesu li ti događaji bili izravno povezani s tadalafilom.
Avda de la Industria 30 28108 Alcobendas (Madrid) Spain
Avda de la Industria 30 28108 Alcobendas (Madrid) Španjolska
Headache may occur at the beginning of therapy; and decreases over time even if treatment is continued.
Glavobolja se može pojaviti na početku liječenja, a vremenom se smanjuje čak i ako se liječenje nastavi.
Severe hypotension (<90/50 mm Hg).
Teška hipotenzija (< 90/50 mmHg).
Adverse reactions were similar to those seen at lower doses.
Nuspojave su bile slične onima opaženima pri manjim dozama.
Do NOT take a double dose to make up for the one that you have forgotten.
NEMOJTE uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
Therefore, this combination is not recommended (see section 4.4).
Stoga se ova kombinacija ne preporučuje (vidjeti dio 4.4).
If you have taken or are planning to take ADCIRCA, avoid excessive drinking (over 5 units of alcohol), since this may increase the risk of dizziness when standing up.
Ako ste uzeli ili planirate uzeti lijek ADCIRCA, izbjegavajte prekomjernu konzumaciju alkohola (više od 5 jedinica alkohola), jer to može povećati rizik od omaglice pri ustajanju.
This interaction lasted for more than 24 hours and was no longer detectable when 48 hours had elapsed after the last tadalafil dose.
Ova je interakcija trajala dulje od 24 sata, a nije više bila mjerljiva nakon 48 sati od posljednje doze tadalafila.
Cardiopulmonary hemodynamics was performed in 93 patients.
Kardiopulmonalna hemodinamika ispitana je u 93 bolesnika.
Acute myocardial infarction within the last 90 days.
Akutni infarkt miokarda u prethodnih 90 dana.
These effects were not associated with changes in other parameters such as motility, morphology and FSH.
Ovi učinci nisu bili povezani s promjenama drugih parametara, kao što su pokretljivost, morfologija i FSH.
You may experience any of the side effects described in section 4.
Može se pojaviti bilo koja od nuspojava opisanih u dijelu 4.
A risk to the breastfed child cannot be excluded.
Ne može se isključiti rizik za dojenče.
Patients should be informed not to take ADCIRCA with these medicinal products.
Bolesnicima treba napomenuti da ne uzimaju lijek ADCIRCA s tim lijekovima.
Date of latest renewal: 1 October 2013
Datum posljednje obnove odobrenja: 1. listopada 2013.
There were no clinically relevant differences in Cmax compared to healthy volunteers.
Nije bilo klinički značajnih razlika u Cmax u odnosu na zdrave dobrovoljce.
Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance.
Bolesnike koji imaju erekcije u trajanju od četiri sata ili dulje treba uputiti da odmah potraže liječničku pomoć.
ADCIRCA has been shown to increase the effects of these medicines.
Pokazalo se da ADCIRCA pojačava učinke tih lijekova.
Stevens-Johnson Syndrome, Exfoliative dermatitis
Stevens-Johnsonov sindrom, eksfolijativni dermatitis
A reduction in sperm was seen in some men.
Smanjenje količine sperme primijećeno je i u nekih muškaraca.
Do not take ADCIRCA when pregnant, unless it is strictly necessary and you have discussed this with your doctor.
Nemojte uzimati lijek ADCIRCA u trudnoći, osim ako je to nužno potrebno i ako ste o tome razgovarali sa svojim liječnikom.
As a precautionary measure, it is preferable to avoid the use of tadalafil during pregnancy.
Kao mjeru opreza poželjno je izbjegavati primjenu tadalafila u trudnoći.
If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
Ako imate takvu erekciju koja traje neprekidno dulje od 4 sata, odmah se obratite liječniku.
The improvement in walk distance was apparent from 8 weeks of treatment.
Povećanje prijeđene udaljenosti bilo je primjetno nakon 8 tjedana liječenja.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.
Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti i reproduktivne toksičnosti.
More than half (53.3 %) of the patients in the study were receiving concomitant bosentan therapy.
Više od polovice (53,3%) bolesnika u ispitivanju istodobno je primalo bosentan.
What ADCIRCA is and what it is used for What you need to know before you take ADCIRCA How to take ADCIRCA
Što je ADCIRCA i za što se koristi Što morate znati prije nego počnete uzimati lijek ADCIRCA Kako uzimati lijek ADCIRCA
Treatments for erectile dysfunction
Lijekovi za liječenje erekcijske disfunkcije
Swallow the tablets whole with a drink of water.
Tablete progutajte cijele s vodom.
If you forget to take ADCIRCA
Ako ste zaboravili uzeti lijek ADCIRCA
Two subsequent clinical studies suggest that this effect is unlikely in humans, although a decrease in sperm concentration was seen in some men (see sections 5.1 and 5.3).
Dva kasnija klinička ispitivanja pokazuju da pojava tog učinka nije vjerojatna u ljudi, iako je u nekih muškaraca primijećena smanjena koncentracija sperme (vidjeti dijelove 5.1 i 5.3).
ADCIRCA 20 mg is available in blister packs containing 28 or 56 tablets.
ADCIRCA 20 mg je dostupna u blister pakiranjima koja sadrže 28 ili 56 tableta.
Between 20 mg to 40 mg, a less than proportional increase in exposure is observed.
Između 20 mg do 40 mg opaža se povećanje izloženosti koje je manje od proporcionalnog.
Significant improvement (p<0.01) in the 6MWD was demonstrated at week 12 when the patients were asked to delay taking study medicinal product in order to reflect trough active substance concentration.
Značajno poboljšanje (p <0,01) 6MWD-a dokazano je u 12. tjednu, kada su bolesnici zamoljeni da odgode uzimanje ispitivanog lijeka kako bi test odražavao najniže koncentracije djelatne tvari.
Some medicines may be affected by ADCIRCA or they may affect how well ADCIRCA will work.
ADCIRCA može utjecati na neke lijekove ili oni mogu utjecati na djelovanje lijeka ADCIRCA.
This difference in exposure does not warrant a dose adjustment.
Ova razlika u izloženosti ne zahtijeva prilagodbu doze.
Of these, 311 patients had been treated with tadalafil for at least 6 months and 293 for 1 year (median exposure 365 days; range 2 days to 415 days).
Od tih je bolesnika njih 311 liječeno tadalafilom najmanje 6 mjeseci, a 293 godinu dana (medijan izloženosti 365 dana; raspon od 2 do 415 dana).
Adverse reaction data are limited in patients over 75 years of age.
Podaci o nuspojavama u bolesnika starijih od 75 godina su ograničeni.
The safety and efficacy of ADCIRCA in the paediatric population has not yet been established.
Sigurnost i djelotvornost lijeka ADCIRCA u pedijatrijskoj populaciji još nisu ustanovljene.
Orange and almond shaped film-coated tablets, marked "4467" on one side.
Narančaste filmom obložene tablete u obliku badema, s oznakom "4467" na jednoj strani.
Elderly patients Dose adjustments are not required in elderly patients.
Nije potrebno prilagođavati dozu u starijih bolesnika.
The European Medicines Agency has deferred the obligation to submit the results of studies with ADCIRCA in one or more subsets of the paediatric population in the treatment of pulmonary arterial hypertension (see section 4.2 for information on paediatric use).
Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka ADCIRCA u jednoj ili više podskupina pedijatrijske populacije u liječenju plućne arterijske hipertenzije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
There was no evidence of teratogenicity, embryotoxicity or foetotoxicity in rats or mice that received up to 1000 mg/kg/day tadalafil.
Nije bilo znakova teratogenosti, embriotoksičnosti ni fetotoksičnosti u štakora i miševa koji su primili do 1000 mg/kg na dan tadalafila.
The mean volume of distribution is approximately 77 l at steady state, indicating that tadalafil is distributed into tissues.
Prosječan volumen distribucije iznosi približno 77 l u stanju dinamičke ravnoteže, što pokazuje da se tadalafil raspodjeljuje u tkiva.
Therefore, the combination of tadalafil and doxazosin is not recommended.
Stoga se ne preporučuje istodobna primjena tadalafila i doksazosina.
Each film-coated tablet contains 233 mg lactose (as monohydrate).
Jedna filmom obložena tableta sadrži 233 mg laktoze (u obliku hidrata).