natgillin/translations-raw huggingface dataset:
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Abilify Maintena's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Abilify Maintena večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
This is a summary of the European public assessment report (EPAR) for Abilify Maintena. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Abilify Maintena.
The European Commission granted a marketing authorisation valid throughout the European Union for Abilify Maintena on 15 November 2013. 
Evropska komisija je dovoljenje za promet z zdravilom Abilify Maintena, veljavno po vsej Evropski uniji, izdala 15. novembra 2013.
Its exact mechanism of action is unknown, but it attaches to several receptors on the surface of nerve cells in the brain. 
Natančen mehanizem delovanja zdravila sicer ni znan, znano pa je, da se zdravilo veže na več receptorjev na površini živčnih celic v možganih.
This disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other. 
S tem se prekine prenos signalov med možganskimi celicami prek živčnih prenašalcev, tj. kemičnih snovi, ki omogočajo sporazumevanje med celicami.
Abilify Maintena is available as a powder (300 mg and 400 mg) and solvent to be made into a prolonged-release suspension for injection. 
Zdravilo Abilify Maintena je na voljo v obliki praška (300 mg in 400 mg) in vehikla za pripravo suspenzije za injiciranje s podaljšanim sproščanjem.
Since dopamine and 5hydroxytryptamine are involved in schizophrenia, aripiprazole helps to normalise the activity of the brain, reducing psychotic symptoms and preventing them from returning. 
Ker dopamin in 5-hidroksitriptamin sodelujeta v bolezenskem procesu shizofrenije, aripiprazol pomaga normalizirati delovanje možganov, zmanjšati psihotične simptome in preprečiti njihov ponoven pojav.
Treatment beyond 2 weeks with medicines that speed up the breakdown of aripiprazole should be avoided. 
Izogibati se je treba več kot dvotedenskemu zdravljenju z zdravili, ki pospešujejo razgradnjo aripiprazola.
Aripiprazole is thought to act mainly by being a ‘partial agonist' for the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin). 
Aripiprazol domnevno deluje predvsem kot delni agonist za receptorje za živčna prenašalca dopamin in 5-hidroksitriptamin (imenovanega tudi serotonin).
The medicine is given once a month by slow injection into the buttock or deltoid (shoulder) muscle by a doctor or nurse. 
Zdravilo se daje enkrat na mesec, tako da ga zdravnik ali medicinska sestra počasi injicira v zadnjično ali deltoidno (ramensko) mišico.
The most common side effects with Abilify Maintena (which may affect 5 or more people in 100) are increased weight, akathisia (a constant urge to move), insomnia (difficulty sleeping) and injection site pain. 
Najpogostejši neželeni učinki zdravila Abilify Maintena (ki lahko prizadenejo več kot 5 oseb od 100) so povečana telesna masa, akatizija (neprestana potreba po gibanju), nespečnost (težave s spanjem) in bolečina na mestu injiciranja.
After the first injection, daily treatment with 10 to 20 mg aripiprazole by mouth should be continued for 2 weeks. 
Po prvem injiciranju je treba zdravljenje dva tedna nadaljevati z vsakodnevnim peroralnim 10- do 20-miligramskim odmerkom aripiprazola.
What measures are being taken to ensure the safe and effective use of Abilify Maintena? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Abilify Maintena?
It is used for the maintenance treatment of schizophrenia in adults whose disease has already been stabilised on treatment with aripiprazole taken by mouth. 
Uporablja se za vzdrževalno zdravljenje shizofrenije pri odraslih, pri katerih je bila bolezen stabilizirana med peroralnim zdravljenjem z aripiprazolom.
For more information about treatment with Abilify Maintena, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Abilify Maintena preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
A risk management plan has been developed to ensure that Abilify Maintena is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Abilify Maintena je bil pripravljen načrt obvladovanja tveganj.
The CHMP noted that Abilify Maintena is as effective as aripiprazole taken by mouth, and has a similar safety profile with the exception of injection pain, which was considered manageable. 
Izpostavil je, da je zdravilo Abilify Maintena enako učinkovito kot peroralni aripiprazol in ima tudi podoben varnostni profil, z izjemo bolečine na mestu injiciranja, ki pa je obvladljiva.
This means that aripiprazole acts like dopamine and 5-hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters. 
To pomeni, da z aktiviranjem teh receptorjev deluje kot dopamin in 5-hidroksitriptamin, vendar šibkeje kot živčni prenašalci.
The Committee considered that the monthly administration may help patients to adhere to their treatment. 
Menil je, da bi vsakomesečno dajanje zdravila lahko bolnikom pomagalo, da bi se držali predpisanega zdravljenja.
Other information about Abilify Maintena 
Druge informacije o zdravilu Abilify Maintena
What is Abilify Maintena and what is it used for? 
Kaj je zdravilo Abilify Maintena in za kaj se uporablja?
For practical information about using Abilify Maintena, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Abilify Maintena naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Abilify Maintena, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
For the full list of all side effects reported with Abilify Maintena, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Abilify Maintena, glejte navodilo za uporabo.
The active substance in Abilify Maintena, aripiprazole, is an antipsychotic medicine. 
Zdravilna učinkovina zdravila Abilify Maintena, aripiprazol, je antipsihotično zdravilo.
What benefits of Abilify Maintena have been shown in studies? 
Kakšne koristi je zdravilo Abilify Maintena izkazalo v študijah?
What are the risks associated with Abilify Maintena? 
Kakšna tveganja so povezana z zdravilom Abilify Maintena?
Abilify Maintena is a medicine that contains the active substance aripiprazole. 
Abilify Maintena je zdravilo, ki vsebuje zdravilno učinkovino aripiprazol.
Why is Abilify Maintena approved? 
Zakaj je bilo zdravilo Abilify Maintena odobreno?
The dose may also need to be lowered in patients who are taking certain other medicines that slow the breakdown of aripiprazole in the body. 
V primeru neželenih učinkov se lahko odmerek zmanjša na 300 mg. Včasih ga bo morda treba zmanjšati tudi pri bolnikih, ki jemljejo nekatera druga zdravila, ki upočasnjujejo razgradnjo aripiprazola v telesu.
It is not intended to provide practical advice on how to use Abilify Maintena. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Abilify Maintena was shown to be as effective as aripiprazole taken by mouth at preventing symptoms of schizophrenia from returning. 
Zdravilo Abilify Maintena se je pri preprečevanju ponovnega pojava simptomov shizofrenije izkazalo za enako učinkovito kot peroralni aripiprazol.
How is Abilify Maintena used? 
Kako se zdravilo Abilify Maintena uporablja?
It must not be injected into a vein or under the skin. 
Zdravilo Abilify Maintena se ne sme vbrizgati v veno ali podkožje.
How does Abilify Maintena work? 
Kako zdravilo Abilify Maintena deluje?
MA (EU) number (Invented) name 
(Izmišljen o) ime
Strength Pharmaceutical Form 
Jakost Farmacevtska oblika Pot uporabe
This summary was last updated in 09/2014. 
Povzetek je bil nazadnje posodobljen 09-2014.
The European Commission granted a marketing authorisation valid throughout the European Union for Fortacin on 15 November 2013. 
Evropska komisija je dovoljenje za promet z zdravilom Fortacin, veljavno po vsej Evropski uniji, izdala 15. novembra 2013.
Doses should not be repeated more frequently than every 4 hours, and no more than three doses should be used in 24 hours. 
Odmerek se ne sme ponovno uporabiti pogosteje kot vsake štiri ure, v 24 urah pa je dovoljeno uporabiti največ tri odmerke.
Some patients were monitored for up to 9 months in an extension of the initial studies and continued to show similar benefit. 
Nekatere bolnike so do devet mesecev spremljali v podaljških prvotnih študij, v katerih so opažali podobno korist.
This reduces sensitivity to stimulation, helping to increase the time taken to ejaculate. 
To zmanjša občutljivost za stimulacijo in pomaga podaljšati čas do ejakulacije.
Fortacin lidocaine / prilocaine 
Fortacin lidokain/prilokain
The full EPAR for Fortacin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Fortacin je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Fortacin? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Fortacin?
There were positive psychological benefits to patients and their partners, and side effects were local and generally manageable. 
Ugotovili so pozitivne psihološke koristi za bolnike in njihove partnerje, neželeni učinki pa so bili lokalni in na splošno obvladljivi.
Fortacin must also not be used in patients whose partners are hypersensitive to these substances. 
Zdravilo Fortacin se ne sme uporabljati pri bolnikih, katerih partnerji so preobčutljivi za te snovi.
It is not intended to provide practical advice on how to use Fortacin. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
A risk management plan has been developed to ensure that Fortacin is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Fortacin je bil pripravljen načrt obvladovanja tveganj.
In the first study, the average time to ejaculation in patients treated with Fortacin was 2.6 minutes, compared with 0.8 minutes in those using placebo; in the second study, average ejaculation time in patients using the medicine was 3.8 minutes compared with 1.1 minutes in the placebo group. 
V prvi študiji je bil povprečni čas do ejakulacije pri bolnikih, zdravljenih z zdravilom Fortacin, 2,6 minute v primerjavi z 0,8 minute pri bolnikih, ki so uporabljali placebo; v drugi študiji je bil povprečni čas do ejakulacije pri bolnikih, ki so uporabljali to zdravilo, 3,8 minute v primerjavi z 1,1 minuto v skupini s placebom.
What benefits of Fortacin have been shown in studies? 
Kakšne koristi je zdravilo Fortacin izkazalo v študijah?
Why is Fortacin approved? 
Zakaj je bilo zdravilo Fortacin odobreno?
The CHMP therefore decided that Fortacin's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor je zato zaključil, da so koristi zdravila Fortacin večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Other information about Fortacin 
Druge informacije o zdravilu Fortacin
It is used to treat men with primary (lifelong) premature ejaculation (when ejaculation regularly occurs before, or too early during, penetration). 
Uporablja se za zdravljenje moških s primarno (doživljenjsko) prezgodnjo ejakulacijo (kadar do ejakulacije navadno pride pred penetracijo ali prezgodaj med njo).
This is a summary of the European public assessment report (EPAR) for Fortacin. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Fortacin.
The recommended dose is three sprays onto the head (glans) of the penis before intercourse. 
Priporočeni odmerek so trije razprški na glavico (glans) penisa pred spolnim odnosom.
The most common side effects with Fortacin (which may affect up to 1 in 10 people) are hypoaesthesia (reduced sensation) and a burning sensation in the genital area in both men and their female sexual partners, and erectile dysfunction (inability to maintain a normal erection) in men. 
Najpogostejši neželeni učinki zdravila Fortacin (ki lahko prizadenejo največ 1 osebo od 10) so hipoestezija (zmanjšana sposobnost čutenja), pekoč občutek na spolovilih pri moških in njihovih spolnih partnerkah ter erektilna disfunkcija (nezmožnost vzdrževanja normalne erekcije) pri moških.
The main measures of effectiveness were the time taken to ejaculate after penetration and the amount of control over ejaculation, sexual satisfaction and distress reported by the patients. 
Glavni merili učinkovitosti sta bili čas do ejakulacije po penetraciji in obseg nadzora nad ejakulacijo, zadovoljnost s spolnostjo ter stiska, o katerih so poročali bolniki.
The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the active ingredients are a well-known local anaesthetic combination, and the use of a local spray minimises the amount of active substance absorbed and hence the risk of side effects affecting the body as a whole. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je menil, da sta zdravilni učinkovini dobro znana kombinacija lokalnih anestetikov in da uporaba lokalnega pršila zelo zmanjša količino absorbirane zdravilne učinkovine ter posledično tveganje neželenih učinkov, ki prizadenejo telo kot celoto.
In both studies, patients given the medicine reported substantially greater improvements in reported control, sexual satisfaction and distress than patients given the placebo. 
V obeh študijah so bolniki, ki so prejemali zdravilo, poročali o pomembno večjem izboljšanju nadzora, zadovoljnosti s spolnostjo in stiske v primerjavi z bolniki, ki so prejemali placebo.
What is Fortacin and what is it used for? 
Kaj je zdravilo Fortacin in za kaj ga uporabljamo?
The active substances in the medicine, lidocaine and prilocaine, are local anaesthetics that temporarily numb the contact area by reversibly blocking the transmission of signals in the nerves. 
Zdravilni učinkovini v zdravilu, lidokain in prilokain, sta lokalna anestetika, ki začasno omrtvita stično območje, tako da reverzibilno zavirata prenos signalov v živcih.
What are the risks associated with Fortacin? 
Kakšna tveganja so povezana z zdravilom Fortacin?
Fortacin is a medicine containing the active substances lidocaine and prilocaine. 
Fortacin je zdravilo, ki vsebuje zdravilni učinkovini lidokain in prilokain.
Fortacin must not be used in patients who are hypersensitive (allergic) to any of the ingredients of the medicine or to other local anaesthetics with a structure related to the active ingredients (amide-type local anaesthetics). 
Zdravilo Fortacin se ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) katero koli sestavino zdravila ali na druge lokalne anestetike s strukturo, podobno zdravilnima učinkovinama (na lokalne anestetike amidnega tipa).
For more information about treatment with Fortacin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Fortacin preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Fortacin can only be obtained with a prescription and is available as a spray-on solution that supplies 7.5 mg of lidocaine and 2.5 mg of prilocaine per spray. 
Izdaja zdravila Fortacin je le na recept; zdravilo je na voljo v obliki raztopine za pršenje, s katero se z enim razprškom nanese 7,5 mg lidokaina in 2,5 mg prilokaina.
The effectiveness of Fortacin has been shown in two main studies involving a total of 256 and 300 heterosexual adult men with premature ejaculation, respectively; both studies compared the medicine with a placebo (dummy) spray over 12 weeks. 
Učinkovitost zdravila Fortacin so dokazali v dveh glavnih študijah, ki sta vključili 256 oziroma 300 heteroseksualnih odraslih moških s prezgodnjo ejakulacijo; v obeh študijah sta to zdravilo 12 tednov primerjali s pršilom s placebom (zdravilom brez zdravilne učinkovine).
For practical information about using Fortacin, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Fortacin naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Fortacin, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Fortacin in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
For the full list of all side effects reported with Fortacin, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Fortacin, glejte navodilo za uporabo.
How is Fortacin used? 
Kako se zdravilo Fortacin uporablja?
How does Fortacin work? 
Kako zdravilo Fortacin deluje?
21months 
21 mesecev
Adults (18 years and over in age) 
Odrasli (stari 18 let in več)
Absorption and elimination 
Absorpcija in izločanje
Treatment duration will depend on the severity of iron deficiency but generally at least 12-weeks treatment is required. 
Trajanje zdravljenja je odvisno od resnosti pomanjkanja železa, vendar je običajno potrebno vsaj 12tedensko zdravljenje.
This leaflet was last revised in xxx <Other sources of information> 
Navodilo je bilo nazadnje revidirano dne xxx. <Drugi viri informacij>
• Patients receiving repeated blood transfusions. 
• Bolniki, ki večkrat prejmejo transfuzijo krvi.
No clinical studies are available to date. 
Kliničnih študij do zdaj ni na voljo.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 February 2016 
Datum prve odobritve: 18. februar 2016
No data are available (see section 4.4). 
Podatkov ni na voljo (glejte poglavje 4.4).
• Supplements or medicines that contain magnesium or calcium. 
• dodatki ali zdravila, ki vsebujejo magnezij ali kalcij,
Do not use this medicine for more than 45 days after first opening the bottle. 
Tega zdravila ne uporabljajte več kot 45 dni po prvem odprtju plastenke.
No single method of assessment is entirely satisfactory - clinical features as well as laboratory analysis must be taken into account. 
Nobena metoda ocenjevanja ni popolnoma zadovoljiva, treba je upoštevati klinične znake in laboratorijske preiskave.
EXP: Use within 45 days of first opening. 
EXP: Uporabite v 45 dneh po prvem odprtju.
Make sure that you take this leaflet and any remaining capsules with you to show to the doctor. 
S seboj vzemite to navodilo in vse preostale kapsule ter jih pokažite zdravniku.
The vomit and stools may be grey or black. 
Bruhanje in blato sta lahko siva ali črna.
Skip the missed dose and take the next dose as normal. 
Izpustite pozabljeni odmerek in vzemite naslednji odmerek kot običajno.
The use of desferroxamine should be considered: for detailed information see product information provided by the manufacturer. 
Razmisliti je treba o uporabi desferoksamina: za več informacij glejte informacije o zdravilu, ki jih zagotovi izdelovalec.
The recommended dose is one capsule (30 mg) taken twice a day, morning and evening. 
Priporočeni odmerek je ena kapsula (30 mg) dvakrat na dan, zjutraj in zvečer.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene na seznamu referenčnih datumov Unije (seznam EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
The recommended dose is one capsule twice daily, morning and evening, on an empty stomach (see section 4.5). 
Priporočeni odmerek je ena kapsula dvakrat na dan, zjutraj in zvečer, na prazen želodec (glejte poglavje 4.5).
A possible potential genotoxic potential for maltol could not be fully ruled out. 
Morebitnega genotoksičnega potenciala pri maltolu ni bilo mogoče popolnoma izključiti.
Do not give Feraccru to children or adolescents 17 years and under as it has not been studied in this age group. 
Zdravila Feraccru ne dajajte otrokom in mladostnikom, starim 17 let in manj, ker ga v tej starostni skupini niso proučevali.
Low iron causes anaemia (too few red blood cells). 
Zmanjšana količina železa povzroča anemijo (premalo rdečih krvnih celic).
Table 2: Summary of Other Key Efficacy Endpoints (AEGIS 1/2) 
Preglednica 2: Povzetek drugih ključnih opazovanih dogodkov učinkovitosti (AEGIS 1/2)
The results for the other key efficacy endpoints are shown in Table 2. 
Rezultati drugih ključnih opazovanih dogodkov učinkovitosti so prikazani v preglednici 2.
However, the conducted reproductive toxicity studies are insufficient to discard any risk in humans. 
Vendar opravljene študije o vplivu na razmnoževanje ne zadoščajo, da bi lahko ovrgli vsakršno tveganje pri ljudeh.
Patheon France 40 boulevard de champaret 38300 Bourgoin-Jallieu FRANCE 
Patheon France 40 boulevard de champaret 38300 Bourgoin-Jallieu Francija
All patients had discontinued from prior oral ferrous product (OFP) treatment: more than 60 % of the subjects stopped taking prior OFP due to adverse events. 
Vsi bolniki so prenehali jemati predhodna peroralnazdravila z železom (PZŽ): več kot 60 % preiskovancev je predhodne PZŽprenehalo jemati zaradi neželenih učinkov.
Swallow the capsules whole. 
Kapsulo pogoltnite celo.
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
• Discomfort or bloating in the stomach 
• neugodje ali napihovanje v želodcu,
The elderly and patients with Heaptic or renal impairment 
Starejši in bolniki z jetrno ali ledvično okvaro
These effects were not observable in a second study in dogs receiving up to 300 mg/kg/day. 
Teh učinkov v drugi študiji na psih, ki so prejemali do 300 mg/kg/dan, niso opazili.
The most common side effects (may affect up to 1 in 10 people) of Feraccru are: 
Najpogostejši neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) zdravila Feraccru so:
Do not take a double dose to make up for a forgotten capsule. 
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek kapsul.
Shelf-life after first opening container: 45 days. 
Rok uporabnosti po prvem odprtju vsebnika: 45 dni.
Reporting of suspected adverse reactions: 
Poročanje o domnevnih neželenih učinkih:
1083 HP Amsterdam Netherlands 
1083 HP Amsterdam Nizozemska
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
• Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1,
The pharmacokinetic profiles of maltol/maltol glucuronide and iron parameters were independent of one another. 
Farmakokinetična profila maltola/maltolovegaglukuronida in parametri železa so bili med seboj neodvisni.