natgillin/translations-raw huggingface dataset:
Women should be advised to use a reliable barrier method for all subsequent acts of intercourse until the next menstrual period.
Žene treba savjetovati da kod sljedećih snošaja upotrebljavaju pouzdana mehanička kontracepcijska sredstva do sljedeće menstruacije.
Tablet White to marble creamy, round curved tablet of 9 mm diameter engraved with “еllа” on both sides.
Okrugla tableta bijele do mramorno krem boje sa zaobljenim stranama promjera 9 mm s utisnutom oznakom „ella“ na obje strane.
Pregnancy, breast-feeding and fertility
Trudnoća, dojenje i plodnost Trudnoća
Ulipristal acetate inhibits or postpones ovulation (see section 5.1).
Ulipristalacetat sprječava ili odgađa ovulaciju (vidjeti dio 5.1).
<{DD/MM/YYYY}>
DATUM REVIZIJE TEKSTA <{DD/MM/GGGG}>
Common side effects (may affect up to 1 in 10 people)
Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba)
How to take the ellaOne film-coated tablet
Kako uzeti filmom obloženu tabletu ellaOne
Reporting of suspected adverse reactions after authorisation of the medicinal product is important.
Nakon dobivanja odobrenja lijeka, važno je prijavljivanje sumnji na njegove nuspojave.
Package leaflet: Information for the user ellaOne 30 mg tablet
Uputa o lijeku: Informacija za korisnika ellaOne 30 mg tableta ulipristalacetat
sucursal em Portugal Tel: +351 707 501 996
HRA Pharma Iberia S.L. sucursal em Portugal Tel: +351 707 501 996
Normal
Često
If you are currently taking hormonal contraception, continue to use it as usual after taking this medicine, but be sure to use condoms every time you have sex until your next period.
Ako trenutačno uzimate hormonsku kontracepciju, nakon uzimanja ovog lijeka nastavite je uzimati kao i obično, ali do sljedeće menstruacije pri svakom spolnom odnosu upotrebljavajte kondome.
If you are currently taking hormonal contraception, continue to use it as usual after taking the tablet, but be sure to use condoms every time you have sex until your next period.
Ako trenutačno uzimate hormonsku kontracepciju, nakon uzimanja tablete nastavite je uzimati kao i obično, ali do sljedeće menstruacije pri svakom spolnom odnosu upotrebljavajte kondome.
The effects of the P-gp substrates are unlikely to have any clinical consequences.
P-gp supstrata imaju ikakve kliničke posljedice.
Ulipristal acetate has minor or moderate influence on the ability to drive or use machines: mild to moderate dizziness is common after ellaOne intake, somnolence and blurred vision are uncommon; disturbance in attention has been rarely reported.
Nakon uzimanja ellaOne blaga do umjerena omaglica je česta, somnolencija i zamagljen vid su manje česti, a poremećaj pažnje prijavljen je rijetko.
Disorientation
Dezorijentacija
Disturbance in attention Dysgueusia
Poremećaj pažnje Disgeuzija Sinkopa
Tablet core: lactose monohydrate, povidone, croscarmellose sodium, magnesium stearate Film coating: poly(vinyl alcohol) (E1203), macrogol (E1521), talc (E553b), titanium dioxide (E171), polysorbate 80 (E433), iron oxide yellow (E172), potassium aluminium silicate (E555)
- Drugi sastojci su: - Jezgra tablete: laktoza hidrat, povidon, umrežena karmelozanatrij, magnezijev stearat - Film ovojnica: poli(vinilni alkohol) (E1203), makrogol (E1521), talk (E553b), titanijev dioksid
Uncommon side effects (may affect up to 1 in 100 people)
Manje česte nuspojave (mogu se javiti u manje od 1 na 100 osoba)
after using emergency contraception, women should be advised to use a reliable barrier method until her next menstrual period.
Stoga bi žene trebalo savjetovati da nakon uzimanja hitne kontracepcije upotrebljavaju pouzdano mehaničko kontracepcijsko sredstvo do sljedeće menstruacije.
PVC-PVDC-Aluminium blister of 1 tablet.
1 tableta u PVC-PVDC-aluminijskom blisteru.
Concomitant use of ellaOne with CYP3A4 inducers (e.g. barbiturates (including primidone and phenobarbital), phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, herbal medicines containing Hypericum perforatum (St. John's wort), rifampicin, rifabutin, griseofulvin, efavirenz and nevirapine) therefore reduces plasma concentrations of ulipristal acetate and may result in a decreased efficacy of ellaOne.
Istodobna uporaba ellaOne s induktorima CYP3A4 (npr. barbiturati (uključujući primidon i fenobarbital), fenitoin, fosfenitoin, karbamazepin, okskarbazepin, biljni pripravci koji sadrže Hypericum perforatum (gospinu travu), rifampicin, rifabutin, grizeofulvin, efavirenz i nevirapin) stoga smanjuje koncentracije ulipristalacetata u plazmi i može rezultirati smanjenjem djelotvornosti ellaOne. ellaOne se ne preporučuje ženama koje su u posljednja 4 tjedna uzimale lijekove koji induciraju enzime (vidjeti dio 4.4) te je potrebno razmotriti nehormonsku hitnu kontracepciju (tj. bakreni intrauterini uložak (CuIUD)).
Package leaflet: Information for the user ellaOne 30 mg film-coated tablet
Uputa o lijeku: Informacija za korisnika ellaOne 30 mg filmom obložena tableta ulipristalacetat
Contraceptive implant
Dugotrajne metode Kontracepcijski implantat
You must take this medicine within 120 hours (5 days) of unprotected sex or contraceptive failure.
Lijek morate uzeti unutar 120 sati (5 dana) nakon nezaštićenog snošaja ili zatajenja kontracepcijske metode.
You can also report this information on your own at www.hra-pregnancy-registry.com.Your information will remain anonymous - nobody will know it is information about you.
Vaši će podaci biti anonimni - nitko neće znati da se podaci odnose na Vas.
The delay was greater than 20 days in 4 % of the women.
U 4% žena menstruacija je kasnila više od 20 dana.
How to take the ellaOne tablet
Kako uzeti tabletu ellaOne
HUNGARIA
MAĐARSKA
Τηλ: + 30-(0)210 66 83 000
ΑΡΡΙΑΝΙ ΦΑΡΜΑΚΕΥΤΙΚΗ ΑΕ Τηλ: + 30-(0)210 66 83 000
Τηλ: + 30-(0) 210 66 83 000
ΑΡΡΙΑΝΙ ΦΑΡΜΑΚΕΥΤΙΚΗ ΑΕ Τηλ: + 30-(0) 210 66 83 000
Menorrhagia Vaginal discharge Menstrual disorder Metrorrhagia Vaginitis
Iscjedak iz rodnice Poremećaj menstruacije Metroragija
Κύπρος ΑΡΡΙΑΝΙ ΦΑΡΜΑΚΕΥΤΙΚΗ ΑΕ
Κύπρος
1 film-coated tablet.
OBLIK I SADRŽAJ 1 filmom obložena tableta.
If your next period is late after taking ellaOne
Ako Vam nakon uzimanja ellaOne sljedeća menstruacija kasni
Laboratorios León Farma S.A. C/ La Vallina, s/n Pol. Ind. Navatejera 24008 Navatejera, León Spain
Laboratorios León Farma S.A. C/ La Vallina, s/n Pol.
Weekly or monthly methods
Primjeri metoda redovne kontracepcije: Dnevne metode Kontracepcijska tableta Tjedne ili mjesečne metode Kontracepcijski flaster
Visual disturbance Abnormal sensation in eye Ocular hyperaemia
Abnormalan osjet u oku Hiperemija oka Fotofobija
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can provide more information on the safety of this medicine.
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
PVC-PVDC (with UV filter) / Aluminium blister of 1 tablet.
6.5 Vrsta i sadržaj spremnika 1 tableta u PVC-PVDC-aluminijskom blisteru (s UV filtrom).
Each film-coated tablet contains 30 milligrams of ulipristal acetate.
Jedna filmom obložena tableta sadrži 30 miligrama ulipristalacetata.
Potential for other medicinal products to affect ulipristal acetate Ulipristal acetate is metabolised by CYP3A4 in vitro.
Ulipristalacetat se metabolizira putem CYP3A4 in vitro.
Therefore,
Primjerice:
ellaOne 30 mg film-coated tablet
ellaOne 30 mg filmom obložena tableta
After intake of ulipristal acetate for emergency contraception, breast-feeding is not recommended for one week.
Nakon primjene ulipristalacetata kao hitne kontracepcije vjerojatan je brzi oporavak plodnosti.
Headache Dizziness
Poremećaji teka
See leaflet for further information
Sadržaj pakiranja i druge informacije
Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD): - medicines used to treat epilepsy (for example, primidone, phenobarbital, phenytoin,
Vam može propisati drugu vrstu (nehormonskog) hitnog kontraceptiva, tj. bakreni intrauterini uložak (Cu-IUD):
After you take emergency contraception and until your next period comes, you should use a condom every time you have sex.
Nakon što uzmete hitnu kontracepciju, do sljedeće menstruacije pri svakom spolnom odnosu upotrebljavajte kondom.
Dysmenorrhea Pelvic pain Breast tenderness
Dismenoreja Bol u zdjelici Osjetljivost dojki
- Ask your pharmacist if you need more information or advice.
- Ako trebate dodatne informacije ili savjet, obratite se svom ljekarniku.
LITUANIA
LITVA
HRA Pharma Benelux Tél/Tel: +32 2 709 2295
Tél/Tel: +32 2 709 2295
- nausea, abdominal (stomach) pain or discomfort, vomiting - painful periods, pelvic pain, breast tenderness - headache, dizziness, mood swings
• mučnina, bol ili nelagoda u trbuhu, povraćanje
NETHERLANDS www.hra-pharma.com/PIL/NL NORWAY
NIZOZEMSKA www.hra-pharma.com/PIL/NL NORVEŠKA
ellaOne 30 mg tablet Ulipristal acetate
ellaOne 30 mg tableta ulipristalacetat
BMI (kg/m2)
ITM (kg/mP2P) Pothranjenost
How to store ellaOne
Kako uzimati ellaOne
Pregnancy may occasionally occur after ulipristal acetate intake.
Nakon uzimanja ulipristalacetata ponekad može doći do trudnoće.
Long lasting methods
Ukupan broj korisnica
- The active substance is ulipristal acetate.
• Djelatna tvar je ulipristalacetat.
Psychiatric disorders Mood disorders
Psihijatrijski poremećaji
There have been no reports of harmful effects from taking a higher dose than recommended of this medicine However do ask your pharmacist, doctor or other healthcare professional for advice.
Nisu prijavljeni štetni učinci u slučaju uzimanja više doze ovog lijeka od preporučene.
Each tablet contains 30 milligrams of ulipristal acetate.
Jedna tableta sadrži 30 miligrama ulipristalacetata.
ellaOne 30 mg film-coated tablet Ulipristal acetate
ellaOne 30 mg filmom obložena tableta ulipristalacetat
QR code linking to package leaflet to be included Package leaflet online at
Mjesto za QR kôd koji se povezuje na uputu o lijeku.
NETHERLANDS www.hra-pharma.com/PIL/NL/GS NORWAY
NIZOZEMSKA www.hra-pharma.com/PIL/NL/GS NORVEŠKA
EU/1/09/522/001 EU/1/09/522/002
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/522/001
A&D Pharma Romania Tel: + 40-(0)372 072 219
Tel: + 40-(0)372 072 219
- If you get any side effects, talk to your pharmacist, doctor, or other healthcare professional.
- Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti ljekarnika, liječnika ili drugog zdravstvenog djelatnika.
After you take the tablet and until your next period comes, you should use condoms every time you have sex.
Nakon što uzmete tabletu, do sljedeće menstruacije pri svakom spolnom odnosu upotrebljavajte kondome.
- genital pain or itching, pain during sex, rupture of an ovarian cyst, unusually light period - loss of concentration, vertigo, shaking, disorientation, fainting - unusual sensation in eye, red eye, sensitivity to light - dry throat, disturbance in taste - hives (itchy rash), feeling thirsty
• bol ili svrbež spolovila, bol tijekom snošaja, prsnuće ciste jajnika, neuobičajeno oskudna menstruacija
- You can take the tablet at any time in your cycle.
• Tabletu možete uzeti u bilo kojem trenutku menstruacijskog ciklusa.
If you get any side effects, talk to your pharmacist, doctor or other healthcare professional.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti ljekarnika, liječnika ili drugog zdravstvenog djelatnika.
Talk to your pharmacist, doctor or other healthcare professional before taking this medicine - if your period is late or you have symptoms of pregnancy (heavy breasts, morning sickness), as you may already be pregnant (see section “Pregnancy, breast-feeding and fertility”); - if you suffer from severe asthma; - if you suffer from severe liver disease.
− ako Vam menstruacija kasni ili ako imate simptome trudnoće (osjećaj težine u dojkama, jutarnje mučnine) jer biste već mogli biti trudni (pogledajte dio „Trudnoća, dojenje i plodnost”);
- diarrhoea, heartburn, wind, dry mouth - unusual or irregular vaginal bleeding, heavy/prolonged periods premenstrual syndrome, vaginal irritation or discharge, lesser or greater sex drive - hot flushes - appetite changes, emotional disorders, anxiety, agitation, trouble sleeping, sleepiness, migraine visual disturbances - influenza - acne, skin lesions, itching - fever, chills, malaise
• promjene teka, emocionalni poremećaji, tjeskoba, uznemirenost, smetnje spavanja, pospanost,
www.hra-pharma.com/PIL/GR/GS CZECH REPUBLIC www.hra-pharma.com/PIL/CZ/GS DENMARK
www.hra-pharma.com/PIL/GR/GS ČEŠKA REPUBLIKA www.hra-pharma.com/PIL/CZ/GS DANSKA
Contains lactose.
ellaOne sadrži laktozu
www.hra-pharma.com/PIL/GR CZECH REPUBLIC www.hra-pharma.com/PIL/CZ DENMARK
www.hra-pharma.com/PIL/GR ČEŠKA REPUBLIKA www.hra-pharma.com/PIL/CZ DANSKA
Croscarmellose sodium Magnesium stearate
Jezgra tablete: laktoza hidrat povidon umrežena karmelozanatrij magnezijev stearat
Posology
Vaginitis
Contents of the pack and other information What ellaOne contains
Što ellaOne sadrži
1 tablet.
OBLIK I SADRŽAJ 1 tableta.
Hepatic impairment
Glavobolja Omaglica
Aramis Pharma Kft. Tel.: + 36-(0)1 219 0775
Tel.: + 36-(0)1 219 0775
Each film-coated tablet contains 30 mg ulipristal acetate
NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 30 mg ulipristalacetata
www.hra-pharma.com/PIL/RO SLOVAK REPUBLIC www.hra-pharma.com/PIL/SK SLOVENIA
www.hra-pharma.com/PIL/PT RUMUNJSKA www.hra-pharma.com/PIL/RO SLOVAČKA
<Not applicable.>
POSEBNE MJERE ČUVANJA <Nije primjenjivo.>
www.hra-pharma.com/PIL/RO/GS SLOVAK REPUBLIC www.hra-pharma.com/PIL/SK/GS SLOVENIA
www.hra-pharma.com/PIL/PT/GS RUMUNJSKA www.hra-pharma.com/PIL/RO/GS SLOVAČKA
n=22 NS†
n=22
www.hra-pharma.com/PIL/SI
www.hra-pharma.com/PIL/SE
Poly(vinyl alcohol) (E1203) Macrogol (E1521) Talc (E553b)
Film ovojnica: poli(vinilni alkohol) (E1203) makrogol (E1521) talk (E553b) titanijev dioksid (E171) polisorbat 80 (E433) žuti željezov oksid (E172) kalijev aluminijev silikat (E555) 6.2 Inkompatibilnosti
www.hra-pharma.com/PIL/SI/GS
www.hra-pharma.com/PIL/SE/GS
www.hra-pharma.com/PIL/SE UNITED-KINGDOM www.hra-pharma.com/PIL/UK
www.hra-pharma.com/PIL/FI FRANCUSKA www.hra-pharma.com/PIL/FR NJEMAČKA
www.hra-pharma.com/PIL/SE/GS UNITED-KINGDOM www.hra-pharma.com/PIL/UK/GS
www.hra-pharma.com/PIL/FI/GS FRANCUSKA www.hra-pharma.com/PIL/FR/GS NJEMAČKA
www.hra-pharma.com/PIL/PT
www.hra-pharma.com/PIL/SK
Pregnancy
Pretilost
LIST OF EXCIPIENTS
Proizvođač Cenexi
(Two medicines are bioequivalent when they produce the same levels of the active substance in the body.)
(Dva su lijeka bioekvivalentna ako u tijelu proizvode iste razine djelatne tvari.)
With the skeleton still in place, the cells cannot divide and they eventually die.
Ako im je kostur netaknut, stanice se ne mogu dijeliti i naposljetku umiru.
On 6 June 2016, Sun Pharmaceutical Industries Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Docetaxel Sun, for the treatment of various types of cancer.
Dana 6. lipnja 2016., tvrtka Sun Pharmaceutical Industries Europe B.V. službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoju prijavu za odobrenje za stavljanje u promet za Docetaxel Sun, za liječenje različitih vrsta raka.
What is Docetaxel Sun?
Što je Docetaxel Sun?
It was to be available as a concentrate to make a solution for infusion (drip) into a vein.
Trebao je biti dostupan kao koncentrat od kojeg se priprema otopina za intravensku infuziju (drip).
It was intended to be used on its own or in combination with other cancer medicines, depending on the type of cancer and the response to previous treatments.
Trebao se primjenjivati kao monoterapija ili u kombinaciji s drugim lijekovima protiv raka, zavisno o vrsti raka i reakciji bolesnika na prethodne terapije.
Docetaxel Sun was developed as a ‘generic medicine'.
Docetaxel Sun razvijen je kao „generički lijek”.
Docetaxel Sun was to be used to treat breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma (a type of stomach cancer) and cancer of the head and neck.
Docetaxel Sun bio je predviđen za liječenje raka dojke, raka pluća nemalih stanica, raka prostate, želučanog adenokarcinoma (vrsta raka želuca) i raka glave i vrata.
Because Docetaxel Sun was developed as a generic medicine, the company presented the results of studies from the literature, and studies to show the quality of the medicine.
Budući da je lijek Docetaxel Sun razvijen kao generički lijek, tvrtka je predstavila rezultate ispitivanja iz literature, i ispitivanja kojima se dokazuje kvaliteta lijeka.
The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Zahtjev je povučen nakon što je CHMP ocijenio inicijalnu dokumentaciju koju je tvrtka dostavila te je sastavio popis pitanja.
In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing the application for Docetaxel Sun for commercial reasons.
U dopisu kojim obavještava Agenciju o povlačenju zahtjeva tvrtka je navela da povlači zahtjev za lijek Docetaxel Sun iz komercijalnih razloga.
In particular, the CHMP noted that the docetaxel in Docetaxel Sun and in Taxotere is contained in tiny droplets (micelles) made with another substance, polysorbate 80, that helps the docetaxel to dissolve.
Konkretno, CHMP je istaknuo kako je docetaksel u lijekovima Docetaxel Sun i Taxotere sadržan u sitnim kapljicama (micelama) koje su načinjene s drugom tvari, polisorbatom 80, koji pomaže u razgrađivanju docetaksela.
Withdrawal of the marketing authorisation application for Docetaxel Sun (docetaxel)
Povlačenje zahtjeva za odobrenje za stavljanje u promet lijeka Docetaxel Sun (docetaksel)
However, solutions containing micelles may behave differently from one another, and the CHMP considered that more information was needed to show that the Docetaxel Sun solution was similar enough in its composition and behaviour to Taxotere solution to allow a bioequivalence study to be omitted.
Međutim, otopine koje sadrže micele mogu različito reagirati, i CHMP je smatrao da je potrebno više informacija kako bi se dokazalo da su sastav i djelovanje otopine lijeka Docetaxel Sun dovoljno slični otopini lijeka Taxotere da bi neprovođenje ispitivanja bioekvivalencije bilo opravdano.
This means that Docetaxel Sun was intended to be similar to a ‘reference medicine' already authorised in the European Union called Taxotere.
To znači da je Docetaxel Sun sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Taxotere.
Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Docetaxel Sun could not have been approved for the treatment of cancer.
Na temelju pregleda podataka, u trenutku povlačenja, CHMP je smatrao da postoje problemi te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Docetaxel Sun za liječenje raka.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Docetaxel Sun.
Sukladno navedenome, u vrijeme povlačenja CHMP je smatrao kako tvrtka nije dostavila dostatne podatke koji bi poduprli zahtjev za Docetaxel Sun.
The company had not carried out a study to demonstrate that Docetaxel Sun is bioequivalent to the reference medicine, because this is not required if the medicines are simple solutions that are given into a vein.
Tvrtka nije provela ispitivanje kojim bi se dokazala bioekvivalentnost lijeka Docetaxel Sun s referentnim lijekom jer to nije potrebno ako su lijekovi jednostavne otopine koje se primjenjuju u venu.
No further studies were carried out because Docetaxel Sun is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Taxotere.
Nisu provedena dodatna ispitivanja jer je Docetaxel Sun generički lijek koji se daje infuzijom i koji sadrži istu djelatnu tvar kao i referentni lijek Taxotere.
The active substance in Docetaxel Sun and Taxotere, docetaxel, belongs to the group of cancer medicines known as taxanes.
Djelatna tvar u lijekovima Docetaxel Sun i Taxotere, docetaksel, pripada skupini lijekova za liječenje raka pod nazivom taksani.
Docetaxel Sun is a medicine that contains the active substance docetaxel.
Docetaxel Sun je lijek koji sadrži djelatnu tvar docetaksel.
Docetaxel Sun is expected to work in the same way as the reference medicine, Taxotere.
Docetaxel Sun je trebao djelovati na isti način kao i referentni lijek, Taxotere.
Withdrawal of the marketing authorisation application for Docetaxel Sun (docetaxel) EMA/396891/2016
(docetaksel) EMA/396891/2016
The CHMP was assessing the company's responses to the questions at the time of the withdrawal.
U trenutku povlačenja CHMP je ocjenjivao odgovore na pitanja koje je tvrtka dostavila.
What was Docetaxel Sun expected to be used for?
Za što se Docetaxel Sun trebao koristiti?
How is Docetaxel Sun expected to work?
Kako je Docetaxel Sun trebao djelovati?
Docetaxel blocks the ability of cells to destroy the internal ‘skeleton' that allows them to divide and multiply.
unutarnji„kostur” koji im omogućuje diobu i umnožavanje.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom29 January 2016
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom29. siječnja 2016.
EMEA/H/C/004236
EMA/55039/2016 EMEA/H/C/004236
What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Koje posljedice ima ovo povlačenje za pacijente u kliničkim ispitivanjima ili u programima milosrdnog davanja lijekova?
It was to be available as tablets (5, 10, 15 and 30 mg) and as 10 and 15 mg orodispersible tablets (tablets that dissolve in the mouth).
Trebao je biti dostupan u obliku tableta (od 5, 10, 15 i 30 mg) te u obliku orodisperzibilnih tableta od 10 i 15 mg (tableta koje se otapaju u ustima).
Its exact mechanism of action is unknown, but it attaches to several types of receptors on nerve cells in the brain.
Točan mehanizam njegova djelovanja nije poznat, ali poznato je da se veže na nekoliko vrsta receptora na živčanim stanicama u mozgu.
This action disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that nerve cells use to communicate with neighbouring cells.
To djelovanje ometa signale koje između moždanih stanica prenose „neurotransmiteri”, kemikalije koje živčane stanice koriste radi komunikacije sa susjednim stanicama.
This may help to reduce psychotic and manic symptoms and prevent them from returning.
To može pomoći u smanjenju psihotičnih i maničnih simptoma te u sprečavanju ponovnog javljanja tih simptoma.
The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Zahtjev je povučen nakon što je CHMP ocijenio prvotnu dokumentaciju koju je tvrtka dostavila i sastavio popis pitanja.
Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Dva su lijeka bioekvivalentna kada u tijelu proizvode iste razine djelatne tvari.
The company informed the CHMP that there were no consequences for patients in clinical trials.
Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su uključeni u klinička ispitivanja.
This means that Aripiprazole Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Abilify.
To znači da je Aripiprazole Mylan sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Abilify.
This means that aripiprazole acts like dopamine and 5-hydroxytryptamine by activating these receptors, but it has a weaker effect than the natural neurotransmitters.
To znači da aripiprazol djeluje kao dopamin i 5hidroksitriptamin aktivacijom tih receptora, ali ima manji učinak od prirodnih neurotransmitera.
In its letter notifying the Agency of the withdrawal of application, the company stated that the reason for withdrawal was identification of manufacturing issues.
U svom dopisu kojim obavještava Agenciju o povlačenju zahtjeva tvrtka je navela da povlači zahtjev zbog utvrđivanja problema u proizvodnji.