natgillin/translations-raw huggingface dataset:
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.
- če vam menstruacija zamuja ali imate simptome nosečnosti (težke prsi, jutranja slabost), saj ste morda že noseči (glejte poglavje »Nosečnost, dojenje in plodnost«); - če imate hudo astmo; - če imate hudo bolezen jeter.
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.
Če trenutno jemljete hormonsko kontracepcijo, jo po uporabi tega zdravila še naprej uporabljajte kot običajno, vendar morate do naslednje menstruacije uporabiti kondom vsakič, ko imate spolne odnose.
Adverse reactions (frequency) System organ class Common
Neželeni učinki (pogostnost)
Placebo n=50
Preprečitev ovulacije1,§ Placebo n = 50
Film-coated tablet
FARMACEVTSKA OBLIKA filmsko obložena tableta
Poly(vinyl alcohol) (E1203) Macrogol (E1521) Talc (E553b)
- Filmska obloga: polivinilalkohol (E1203), makrogol (E1521), smukec (E553b), titanov dioksid
The treatment consists of one tablet to be taken orally as soon as possible, but no later than 120 hours (5 days) after unprotected intercourse or contraceptive failure.
Zdravljenje poteka peroralno, in sicer se zaužije ena tableta čim prej, vendar najkasneje 120 ur (5 dni) po nezaščitenem spolnem odnosu ali neučinkoviti kontracepciji.
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.
O tem lahko poročate tudi sami na spletnem naslovu www.hra-pregnancy-registry.com.
- Take one tablet by mouth as soon as possible and no later than 5 days (120 hours) after unprotected sex or contraceptive failure.
- Zaužijte eno tableto čim prej, najpozneje pa 5 dni (120 ur) po nezaščitenem spolnem odnosu ali neučinkoviti kontracepciji.
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.
Če trenutno jemljete hormonsko kontracepcijo, jo po uporabi tablete še naprej uporabljajte kot običajno, vendar morate do naslednje menstruacije uporabiti kondom vsakič, ko imate spolne odnose.
In vitro data indicate that ulipristal acetate may be an inhibitor of P-gp at clinically relevant concentrations.
Podatki in vitro kažejo, da je lahko ulipristalacetat v klinično pomembnih koncentracijah zaviralec Pglikoproteina.
No differences in safety or efficacy have been shown compared to adult women aged 18 and older (see section 5.1).
V varnosti in učinkovitosti niso opazili nobenih razlik v primerjavi z odraslimi ženskami, starimi
A.
NS*
Speak to your doctor or pharmacist before using ellaOne.
Pred uporabo zdravila ellaOne se posvetujte z zdravnikom ali farmacevtom.
What ellaOne looks like and contents of the pack ellaOne is a golden film-coated tablet of shield shape (around 10.8 mm diameter) with “ella” engraved on both sides.
Izgled zdravila ellaOne in vsebina pakiranja Zdravilo ellaOne je filmsko obložena tableta zlate barve v obliki ščita (približnega premera 10,8 mm)
What ellaOne looks like and contents of the pack ellaOne is a white to marble creamy, round curved tablet of 9 mm diameter engraved with “еllа” on both sides.
Zdravilo ellaOne je bela do kremasta marmorirana, okrogla, zaobljena tableta premera 9 mm z oznako „ella“ na obeh straneh.
If you have unprotected sex after taking this medicine, it will not stop you from becoming pregnant.
Če imate nezaščiten spolni odnos po zaužitju tega zdravila, zdravilo ne bo preprečilo zanositve.
Deutschland
NEMČIJA
PVC-PVDC-Aluminium blister of 1 tablet.
Pretisni omot iz PVC-PVDC-aluminija z eno tableto.
How to take the ellaOne tablet
Kako jemati zdravilo ellaOne
HRA Pharma Benelux Tél/Tel: +32 2 709 2295
Luxembourg/Luxemburg HRA Pharma Benelux Tél/Tel: +32 2 709 2295
You are advised to speak to a healthcare professional if you are concerned about any problems related to taking emergency contraception.
Če ste zaskrbljeni glede kakršnih koli težav, povezanih z jemanjem nujne kontracepcije, je priporočljivo, da se posvetujete z zdravstvenim delavcem.
After you take the tablet and until your next period comes, you should use condoms every time you have sex.
Po tem, ko ste vzeli tableto in do naslednje menstruacije morate uporabiti kondom vsakič, ko imate spolne odnose.
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov izdelovalcev, odgovornih za sproščanje serij Cenexi
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
- nausea, abdominal (stomach) pain or discomfort, vomiting - painful periods, pelvic pain, breast tenderness - headache, dizziness, mood swings
- siljenje na bruhanje, bolečine ali neprijeten občutek v trebuhu, bruhanje - boleče menstruacije, bolečine v medenici, občutljive dojke - glavobol, omotica, nihanje razpoloženja - bolečine v mišicah, bolečine v hrbtu, utrujenost
after using emergency contraception, women should be advised to use a reliable barrier method until her next menstrual period.
Zato je treba ženski svetovati, naj po uporabi nujne kontracepcije uporablja zanesljivo pregradno metodo do naslednje menstruacije.
- 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
nenavadno šibka menstruacija - poslabšanje koncentracije, vrtoglavica, tresenje, dezorientacija, omedlevica - nenormalen občutek v očesu, rdeče oči, občutljivost oči na svetlobo - suho grlo, motnje v okušanju - koprivnica (srbeč izpuščaj), občutek žeje
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora suho grlo
After single dose administration induction of CYP1A2 and CYP3A4 by ulipristal acetate or its active metabolite is not likely.
Indukcija CYP1A2 in CYP3A4 z ulipristalacetatom ali njegovim aktivnim presnovkom po enkratnem odmerjanju ni verjetna, zato tudi ni verjetno, da bo ulipristalacetat spremenil očistek zdravil, ki jih presnavljajo ti encimi.
Common side effects (may affect up to 1 in 10 people)
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov):
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM LABORATOIRE HRA PHARMA
NAME OF THE MARKETING AUTHORISATION HOLDER
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM HRA Pharma
Each film-coated tablet contains 30 milligrams of ulipristal acetate.
Ena filmsko obložena tableta vsebuje 30 mg ulipristalacetata.
ellaOne 30 mg film-coated tablet
ellaOne 30 mg filmsko obložena tableta
Infections and infestations
Infekcijske in parazitske bolezni gripa
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.
Po zaužitju zdravila ellaOne se pogosto pojavi blaga do zmerna omotica, občasno pa zaspanost in zamegljen vid. O motnjah pozornosti pa so poročali redko.
- If you get any side effects, talk to your pharmacist, doctor, or other healthcare professional.
- Če opazite kateri koli neželeni učinek, se posvetujte s farmacevtom, zdravnikom ali drugim zdravstvenim delavcem.
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.
Ni poročil o tem, da bi zaužitje večjega odmerka tega zdravila od priporočenega imelo škodljive učinke.
<{DD/MM/YYYY}>
DATUM ZADNJE REVIZIJE BESEDILA <{DD/MM/LLLL}>
2D barcode carrying the unique identifier included.
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.>
If you have unprotected sex after taking the tablet, it will not stop you from becoming pregnant.
Če imate nezaščiten spolni odnos po zaužitju tablete, zdravilo ne bo preprečilo zanositve.
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja akne kožne lezije pruritus koprivnica
Always take this medicine exactly as described in this leaflet or as your pharmacist, doctor or other healthcare professional has told you.
Pri jemanju tega zdravila natančno upoštevajte napotke v tem navodilu ali navodila farmacevta, zdravnika ali drugega zdravstvenega delavca.
Genital pruritus Dyspareunia Ruptured ovarian cyst Vulvovaginal pain Hypomenorrhea*
Motnje reprodukcije in dojk dismenoreja bolečine v medenici občutljive dojke menoragija vaginalni izcedek menstruacijske motnje metroragija vaginitis vročinski oblivi predmenstruacijski sindrom genitalni pruritus bolečine med spolnim odnosom počena cista na jajčniku vulvovaginalne bolečine hipomenoreja*
Results from two independent randomised controlled trials (see Table) showed the efficacy of ulipristal acetate to be non-inferior to that of levonorgestrel in women who presented for emergency contraception between 0 and 72 hours after unprotected intercourse or contraceptive failure.
Rezultati dveh neodvisnih randomiziranih kontroliranih kliničnih preskušanj (poglej tabelo spodaj) so pokazali, da učinkovitost ulipristalacetata ni nižja od učinkovitosti levonorgestrela.
Somnolence Migraine
migrena, motnje vida
A rapid return of fertility is likely following treatment with ulipristal acetate for emergency contraception.
Po zdravljenju z ulipristalacetatom za namene nujne kontracepcije je verjetno, da bo plodnost hitro znova vzpostavljena.
Each tablet contains 30 mg ulipristal acetate.
Ena tableta vsebuje 30 mg ulipristalacetata.
After you take emergency contraception and until your next period comes, you should use a condom every time you have sex.
Od uporabe nujne kontracepcije do naslednje menstruacije morate uporabiti kondom vsakič, ko imate spolni odnos.
If you get any side effects, talk to your pharmacist, doctor or other healthcare professional.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte s farmacevtom, zdravnikom ali drugim zdravstvenim delavcem.
However, it does not interrupt an existing pregnancy (see section ellaOne does not prevent pregnancy in every case
Zdravilo ellaOne ne prepreči nosečnosti v vsakem primeru
- CYP3A4 inducers
Ulipristalacetat se in vitro presnavlja s CYP3A4: − Induktorji CYP3A4
How to take the ellaOne film-coated tablet
Kako vzeti filmsko obloženo tableto zdravila ella One
Hyperactivity disorder Libido changes
Psihiatrične motnje motnje razpoloženja čustvene motnje tesnoba nespečnost hiperaktivne motnje spremembe v libidu dezorientacija
If your next period is late after taking ellaOne
Če vam po zaužitju zdravila ellaOne zamuja naslednja menstruacija
4.4 Special warnings and precautions for use ellaOne is for occasional use only.
Zdravilo ellaOne je namenjeno občasni uporabi.
Musculoskeletal and connective tissue disorders
Bolezni mišičnoskeletnega sistema in vezivnega tkiva mišične bolečine bolečine v hrbtu
MedDRA
Po MedDRA
Croscarmellose sodium Magnesium stearate
Jedro tablete: laktoza monohidrat povidon premreženi natrijev karmelozat magnezijev stearat
- The active substance is ulipristal acetate.
- Učinkovina je ulipristalacetat.
Headache Dizziness
Huda okvara jeter
ellaOne 30 mg film-coated tablet Ulipristal acetate
ellaOne 30 mg filmsko obložena tableta ulipristalacetat
In such cases ritonavir might reduce plasma concentrations of ulipristal acetate.
V takih primerih lahko ritonavir zmanjša koncentracije ulipristalacetata v plazmi, zato sočasna uporaba nie priporočljiva (glejte poglavje 4.4).
Ask a healthcare professional for advice if you are worried about this.
Če vas to skrbi, se posvetujte z zdravstvenim delavcem.
1 film-coated tablet.
FARMACEVTSKA OBLIKA IN VSEBINA 1 filmsko obložena tableta
Abdominal pain* Abdominal discomfort Vomiting*
Bolezni prebavil navzea* bolečine v trebuhu* nelagodje v želodcu bruhanje*
General disorders and administration site conditions
Navodilo za uporabo na spletnem mestu DRŽAVA
The active substance is ulipristal acetate.
• Učinkovina je ulipristalacetat.
Disorientation
Odmerjanje
www.hra-pharma.com/PIL/SE/GS UNITED-KINGDOM www.hra-pharma.com/PIL/UK/GS
www.hra-pharma.com/PIL/SE/GS VELIKA BRITANIJA www.hra-pharma.com/PIL/UK/GS
Ear and labyrinth disorders
Ušesne bolezni, vključno z motnjami labirinta vrtoglavica
LIST OF EXCIPIENTS
Izdelovalec Cenexi
What ellaOne is and what it is used for ellaOne is an emergency contraceptive ellaOne is a contraceptive intended to prevent pregnancy after unprotected sex or if your contraceptive method has failed.
Kaj je zdravilo ellaOne in za kaj ga uporabljamo Zdravilo ellaOne je nujno kontracepcijsko sredstvo
www.hra-pharma.com/PIL/SE UNITED-KINGDOM www.hra-pharma.com/PIL/UK
www.hra-pharma.com/PIL/SE VELIKA BRITANIJA www.hra-pharma.com/PIL/UK
Nervous system disorders
Organski sistemi
Long lasting methods
Metode z dolgim časom delovanja Kontracepcijski vsadek
ellaOne film-coated tablet
PODATKI V BRAILLOVI PISAVI ellaOne filmsko obložena tableta
Dry throat
Okvara jeter
www.hra-pharma.com/PIL/GR/GS CZECH REPUBLIC www.hra-pharma.com/PIL/CZ/GS DENMARK
www.hra-pharma.com/PIL/GR/GS MADŽARSKA www.hra-pharma.com/PIL/HU/GS
www.hra-pharma.com/PIL/RO SLOVAK REPUBLIC www.hra-pharma.com/PIL/SK SLOVENIA
www.hra-pharma.com/PIL/PL PORTUGALSKA www.hra-pharma.com/PIL/PT
www.hra-pharma.com/PIL/RO/GS SLOVAK REPUBLIC www.hra-pharma.com/PIL/SK/GS SLOVENIA
www.hra-pharma.com/PIL/PL/GS PORTUGALSKA www.hra-pharma.com/PIL/PT/GS
Appetite disorders
PODATKI NA ZUNANJI OVOJNINI
Package leaflet: Information for the user ellaOne 30 mg film-coated tablet
Navodilo za uporabo ellaOne 30 mg filmsko obložena tableta ulipristalacetat
www.hra-pharma.com/PIL/PT/GS
www.hra-pharma.com/PIL/SK/GS
www.hra-pharma.com/PIL/HU/GS
www.hra-pharma.com/PIL/CZ/GS
Menorrhagia Vaginal discharge Menstrual disorder Metrorrhagia Vaginitis
Bolezni živčevja glavobol omotica somnolenca migrena tremor motnje pozornosti motnje v okušanju sinkopa
(Two medicines are bioequivalent when they produce the same levels of the active substance in the body.)
(Dve zdravili sta biološko enakovredni, kadar proizvedeta enake ravni zdravilne učinkovine v telesu.)
With the skeleton still in place, the cells cannot divide and they eventually die.
Dokler je ogrodje prisotno, se celice ne morejo deliti in sčasoma odmrejo.
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.
Uporabljalo naj bi se samostojno ali v kombinaciji z drugimi zdravili za zdravljenje raka, odvisno od vrste raka in odziva na predhodna zdravljenja.
Withdrawal of the marketing authorisation application for Docetaxel Sun (docetaxel) EMA/396891/2016
Umik vloge za pridobitev dovoljenja za promet z zdravilom Docetaxel Sun (docetaksel) EMA/396891/2016
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.
Zdravilo Docetaxel Sun naj bi se uporabljalo za zdravljenje bolnikov z rakom dojke, nedrobnoceličnim pljučnim rakom, rakom prostate, adenokarcinomom želodca (vrsto želodčnega raka) in rakom glave in vratu.
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.
Ker je bilo zdravilo Docetaxel Sun razvito kot generično zdravilo, je družba predložila rezultate študij iz literature in študij, ki dokazujejo kakovost zdravila.
It was to be available as a concentrate to make a solution for infusion (drip) into a vein.
Na voljo naj bi bilo v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
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.
Družba ni izvedla študije, s katero bi dokazala, da je zdravilo Docetaxel Sun biološko enakovredno referenčnemu zdravilu, ker to ni zahtevano, kadar so zdravila preproste raztopine, ki se dajejo v veno.
Withdrawal of the marketing authorisation application for Docetaxel Sun (docetaxel)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Docetaxel Sun (docetaksel)
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.
je 6. junija 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Docetaxel Sun, namenjenim zdravljenju različnih vrst raka.
Docetaxel Sun was developed as a ‘generic medicine'.
Zdravilo Docetaxel Sun je bilo razvito kot „generično zdravilo“.
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.
Zato je CHMP v času umika vloge menil, da družba ni predložila zadostnih podatkov v podporo vlogi za zdravilo Docetaxel Sun.
This means that Docetaxel Sun was intended to be similar to a ‘reference medicine' already authorised in the European Union called Taxotere.
To pomeni, da naj bi bilo zdravilo Docetaxel Sun podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Taxotere.
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.
Vendar pa se obnašanje posameznih raztopin, ki vsebujejo micele, lahko razlikuje, zato je CHMP presodil, da je potrebnih več informacij za dokaz, da je raztopina zdravila Docetaxel Sun po sestavi in obnašanju dovolj podobna raztopini zdravila Taxotere, da študija biološke enakovrednosti ni potrebna.
Docetaxel blocks the ability of cells to destroy the internal ‘skeleton' that allows them to divide and multiply.
Docetaksel zavira sposobnost celic, da uničijo notranje „ogrodje“, ki celicam
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.
Odbor je zlasti poudaril, da je docetaksel v zdravilu Docetaxel Sun in v zdravilu Taxotere vsebovan v drobnih kapljicah (micelih), narejenih iz druge snovi, polisorbata 80, ki docetakselu pomaga pri raztapljanju.
The CHMP was assessing the company's responses to the questions at the time of the withdrawal.
V času umika je CHMP ocenjeval odgovore družbe na posredovana vprašanja.
What is Docetaxel Sun?
Kaj je zdravilo Docetaxel Sun?
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 podlagi pregleda podatkov je Odbor v času umika vloge izrazil določene zadržke in je začasno menil, da zdravila Docetaxel Sun ni mogoče odobriti za zdravljenje raka.
The active substance in Docetaxel Sun and Taxotere, docetaxel, belongs to the group of cancer medicines known as taxanes.
Zdravilna učinkovina v zdravilu Docetaxel Sun, docetaksel, spada v skupino zdravil za zdravljenje raka, ki so znana kot taksani.
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.
Družba je v dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da se je za umik vloge za zdravilo Docetaxel Sun odločila zaradi poslovnih razlogov.
Docetaxel Sun is expected to work in the same way as the reference medicine, Taxotere.
Zdravilo Docetaxel Sun naj bi delovalo na enak način kot referenčno zdravilo Taxotere.
Docetaxel Sun is a medicine that contains the active substance docetaxel.
Docetaxel Sun je zdravilo, ki vsebuje zdravilno učinkovino docetaksel.
What was Docetaxel Sun expected to be used for?
Za kaj naj bi se zdravilo Docetaxel Sun uporabljalo?
How is Docetaxel Sun expected to work?
Kako naj bi zdravilo Docetaxel Sun delovalo?
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.
Ker je zdravilo Docetaxel Sun generično zdravilo, ki se daje z infundiranjem in vsebuje enako zdravilno učinkovino kot referenčno zdravilo Taxotere, niso bile opravljene nobene dodatne študije.
This may help to reduce psychotic and manic symptoms and prevent them from returning.
To lahko pripomore k zmanjšanju psihotičnih in maničnih simptomov ter prepreči, da bi se ponovili.
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).
Na voljo naj bi bilo v obliki tablet (5, 10, 15 in 30 mg) ter 10- in 15-miligramskih orodisperzibilnih tablet (tablet, ki se raztopijo v ustih).
Its exact mechanism of action is unknown, but it attaches to several types of receptors on nerve cells in the brain.
Natančen mehanizem njegovega delovanja ni znan, znano pa je, da se veže na več različnih vrst receptorjev na živčnih celicah v možganih.
What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila?
This action disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that nerve cells use to communicate with neighbouring cells.
S tem prekine signale, ki jih med možganskimi celicami prenašajo „živčni prenašalci“, tj. kemične snovi, ki jih živčne celice uporabljajo za komunikacijo z bližnjimi celicami.
This means that Aripiprazole Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Abilify.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Abilify.
The company informed the CHMP that there were no consequences for patients in clinical trials.
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki sodelujejo v kliničnih preskušanjih.
In its letter notifying the Agency of the withdrawal of application, the company stated that the reason for withdrawal was identification of manufacturing issues.
Družba je v dopisu, s katerim je Agencijo obvestila o umiku vloge, navedla, da se je za umik vloge odločila zaradi ugotovljenih težav v proizvodnji.
It was also expected to be used to treat moderate to severe manic episodes and to prevent new manic episodes in adults with bipolar I disorder who have responded to the medicine in the past, and for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over with bipolar I disorder.
Prav tako naj bi se uporabljalo za zdravljenje zmernih do hudih maničnih epizod in preprečevanje novih maničnih epizod pri odraslih z bipolarno motnjo I, ki so se v preteklosti že odzvali na zdravilo, največ 12 tednov pa tudi za zdravljenje zmernih do hudih maničnih epizod pri bolnikih z bipolarno motnjo I, starejših od 13 let.
Aripiprazole Mylan was expected to be used to treat schizophrenia in patients aged 15 years or over.
Zdravilo Aripiprazole Mylan naj bi se uporabljalo za zdravljenje shizofrenije pri bolnikih, starejših od 15 let.