FrancophonIA/ELRC3.0 huggingface dataset:
English: The patients chosen for the second study were those with frequent attacks, at least two attacks per month on average.
Slovenian: Za drugo študijo so bili izbrani bolniki s pogostimi napadi, povprečno z vsaj dvema napadoma na mesec.
English: A second dose of 1,000 Units may be given if the patient has not responded adequately after one hour, or sooner for attacks in the larynx (voice box) or if the start of the treatment had been delayed.
Slovenian: Drug odmerek 1 000 enot se lahko injicira, če se bolnik po eni uri ne odziva zadostno, ali prej pri napadih v grlu (organ za govor) oziroma če je bil začetek zdravljenja uveden z zamudo.
English: The company that makes Cinryze will ensure that healthcare professionals in all Member States who are expected to prescribe Cinryze are provided with an educational pack instructing them to ensure that caregivers and patients who will give the medicine at home are properly trained.
Slovenian: Družba, ki proizvaja zdravilo Cinryze, bo zagotovila, da bodo vsi zdravstveni delavci v vseh državah članicah, za katere se pričakuje, da bodo predpisovali zdravilo Cinryze, prejeli izobraževalno gradivo z navodili, da morajo biti negovalci in bolniki, ki si bodo zdravilo injicirali sami doma, za to ustrezno usposobljeni.
English: The doctor should review the need for routine prevention on a regular basis and can adjust the frequency of the injections or the dose according to how the patient is responding.
Slovenian: Zdravnik mora redno ocenjevati potrebo po preprečevanju in lahko prilagodi pogostnost injiciranja glede na odziv bolnika.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Cinryze.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Patients with hereditary angioedema have attacks of swelling that can occur anywhere in the body, such as in the face or limbs, or around the gut, causing discomfort and pain.
Slovenian: Bolniki z dednim angioedemom imajo napade otekanja, ki se lahko pojavijo kjer koli na telesu, na primer na obrazu, udih ali okoli prebavil, ter povzročajo nelagodje in bolečino.
English: Based on the evidence from the studies, the CHMP concluded that Cinryze's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je na podlagi dokazov iz študij zaključil, da so koristi zdravila Cinryze večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: What are the risks associated with Cinryze?
Slovenian: Kakšna tveganja so povezana z zdravilom Cinryze?
English: The only common side effect seen in studies with Cinryze (seen in between 1 and 10 patients in 100) is rash, which is not serious and typically involves the arms, chest, abdomen or the injection site.
Slovenian: Edini pogosti neželeni učinek, opažen v študijah z zdravilom Cinryze (opažen pri 1 do 10 bolnikih od 100), je izpuščaj, ki pa ni resen in se običajno pojavi na rokah, prsih, trebuhu ali mestu injiciranja.
English: The C1 inhibitor protein is required to control the ‘complement' and ‘contact' systems, collections of proteins in the blood that fight against infection and cause inflammation.
Slovenian: Beljakovina zaviralec C1 je potrebna za urejanje sistema komplementa in kontaktnega sistema, skupino beljakovin v krvi, ki se borijo proti okužbam in povzročajo vnetje.
English: For the full list of all side effects and restrictions with Cinryze, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Cinryze glejte navodilo za uporabo.
English: Cinryze is used to replace the missing C1 inhibitor, correcting the deficiency and helping to prevent or treat angioedema attacks.
Slovenian: Zdravilo Cinryze se uporablja za nadomeščanje manjkajočega zaviralca C1 ter tako odpravlja pomanjkanje in pomaga pri preprečevanju ali zdravljenju napadov angioedema.
English: Over 50% of patients receiving Cinryze had started having improvements 2 hours into treatment, compared with 33% of patients given placebo.
Slovenian: V prvi študiji se je pri več kot 50 % bolnikov, ki so prejemali zdravilo Cinryze, pokazalo izboljšanje v dveh urah po začetku zdravljenja v primerjavi s 33 % bolnikov, ki so prejemali placebo.
English: C1 inhibitor (human)
Slovenian: Cinryze zaviralec C1 (humani)
English: What benefits of Cinryze have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Cinryze izkazalo med študijami?
English: The second study, involving 24 patients from the first study, looked at the number of attacks over 12week periods when patients were given Cinryze or placebo as prevention.
Slovenian: V drugi glavni študiji, v kateri je sodelovalo 24 bolnikov iz prve študije, so proučevali število napadov v 12-tedenskem obdobju, v katerem so bolniki za preprečevanje napadov prejemali zdravilo Cinryze ali placebo.
English: The active substance in Cinryze, human C1 inhibitor, is a protein extracted from human blood.
Slovenian: Zdravilna učinkovina zdravila Cinryze, humani zaviralec C1, je beljakovina, pridobljena iz človeške krvi.
English: Why has Cinryze been approved?
Slovenian: Zakaj je bilo zdravilo Cinryze odobreno?
English: Cinryze is also used for routine prevention in adults, adolescents and children from 6 years of age who have severe and frequent angioedema attacks for which prevention with oral medicines is not adequate or in patients whose attacks are not adequately treated.
Slovenian: Zdravilo Cinryze se uporablja tudi za preprečevanje hudih in pogostih napadov angioedema pri bolnikih, pri katerih preprečevanje s peroralnimi zdravili ni ustrezno, ali bolnikih, pri katerih napadi niso ustrezno zdravljeni.
English: Cinryze was effective in preventing attacks triggered by these procedures, with 98% of procedures not triggering an attack within 72 hours.
Slovenian: Zdravilo Cinryze je bilo učinkovito tudi pri preprečevanju napadov, ki jih povzročajo zdravniški, kirurški ali zobozdravstveni posegi, pri čemer kar 98 % posegov ni sprožilo napada v 72 urah.
English: Treatment should be started under the supervision of a doctor experienced in treating hereditary angioedema.
Slovenian: Zdravljenje z zdravilom Cinryze se lahko uvede le pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem dednega angioedema.
English: It is also used to prevent angioedema attacks that can be triggered by medical, dental or surgical procedures.
Slovenian: Zdravilo Cinryze se uporablja tudi za preprečevanje napadov angioedema, ki jih lahko povzročijo zdravniški, zobozdravstveni ali kirurški posegi.
English: The doctor may decide that the caregivers and patients can carry out the injection provided that they have been adequately trained.
Slovenian: Zdravnik se lahko odloči, da postopek injiciranja izvede tudi negovalec ali bolnik sam, vendar le po tem, ko se ustrezno usposobi.
English: The average number of attacks experienced in patients treated with Cinryze was 6.1 over the 12-week period compared with 12.7 for patients on placebo.
Slovenian: V drugi študiji je v obdobju 12 tednov povprečno število napadov pri bolnikih, ki so prejemali zdravilo Cinryze, znašalo 6,1, pri bolnikih, ki so prejemali placebo, pa 12,7.
English: Cinryze is available as a powder and solvent that are made up into a solution for injection into a vein.
Slovenian: Zdravilo Cinryze je prašek in vehikel za pripravo raztopine za injiciranje.
English: The company provided data on the use of Cinryze in 91 adults and children with hereditary angioedema to prevent attacks when undergoing a medical, surgical or dental procedure.
Slovenian: Družba je predložila tudi podatke o uporabi zdravila Cinryze pri 91 bolnikih za preprečevanje napadov pred zdravniškim, zobozdravstvenim ali kirurškim posegom.
English: Cinryze is a medicine used to treat angioedema (swelling) attacks in adults, adolescents and children over 2 years with hereditary angioedema.
Slovenian: Zdravilo Cinryze se uporablja za zdravljenje napadov angioedema (otekanja) pri odraslih in mladostnikih, starih od 12 do 17 let, z dednim angioedemom.
English: For prevention before a medical, dental or surgical procedure in adults, adolescents and children over 2 years and weighing more than 25 kg, Cinryze is given as 1,000 Units within the 24 hours before the procedure.
Slovenian: Za preprečevanje napadov otekanja pred zdravniškim, zobozdravstvenim ali kirurškim posegom se zdravilo Cinryze daje v odmerku 1 000 enot do 24 ur pred posegom.
English: In the first study, Cinryze or placebo (a dummy treatment) were used to treat angioedema attacks in 71 patients.
Slovenian: V eni glavni študiji so zdravilo Cinryze in placebo (zdravilo brez zdravilne učinkovine) uporabili za zdravljenje napadov angioedema pri 71 bolnikih z dednim angioedemom.
English: How does Cinryze work?
Slovenian: Kako zdravilo Cinryze deluje?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cinryze have also been included in the summary of product characteristics and the package leaflet.
Slovenian: V povzetek glavnih značilnosti zdravila in navodilo za uporabo so vključeni tudi priporočila in previdnostni ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki za varno in učinkovito uporabo tega zdravila.
English: How is Cinryze used?
Slovenian: Kako se zdravilo Cinryze uporablja?
English: For treatment of angioedema attacks in adults, adolescents and children over 2 years and weighing more than 25 kg, the patient is given 1,000 Units at the first sign of an angioedema attack.
Slovenian: Pri zdravljenju napadov angioedema bolnik prejme 1 000 enot ob prvem znaku napada.
English: Cinryze contains the active substance C1 inhibitor (human).
Slovenian: Vsebuje zdravilno učinkovino zaviralec C1 (humani).
English: What is Cinryze and what is it used for?
Slovenian: Za kaj se zdravilo Cinryze uporablja?
English: Cinryze was more effective than placebo in treating and preventing attacks of angioedema in two main studies involving patients with hereditary angioedema, most of whom were adults.
Slovenian: Zdravilo Cinryze je bilo učinkovitejše od placeba pri zdravljenju in preprečevanju napadov angioedema.
English: Cinryze can only be obtained with a prescription.
Slovenian: Zdravilo Cinryze se daje z injiciranjem v veno.
English: The dose is reduced to 500 Units in children aged 2 to 11 years weighing 10 to 25 kg. For routine prevention in adults and adolescents, Cinryze is given as 1,000 Units every 3 or 4 days.
Slovenian: Za preprečevanje napadov se zdravilo Cinryze daje v odmerku 1 000 enot vsake tri ali štiri dni.
English: Therefore, this wording may not necessarily represent the current text.
Slovenian: Zaradi tega je možno, da ta zapis ne predstavlja trenutno veljavnega besedila.
English: Following the review of the data available to the national competent authorities, the European Commission triggered an article 31 of Directive 2001/83/EC, as amended, on 17 December 2004.
Slovenian: Po pregledu podatkov, dostopnih nacionalnim pristojnim organom, je Evropska komisija sprožila postopek v skladu s členom 31 Direktive 2001/83/ES, kot je bila spremenjena 17. decembra 2004.
English: This signal was present in all products for which studies were available, and from the available evidence it could not be excluded that this signal would be class related.
Slovenian: Ta signal je prisoten pri vseh zdravilih, za katera so bile dostopne raziskave, in iz dostopnih dokazov ni bilo mogoče izključiti, da je ta signal povezan s skupinami zdravil.
English: As with other psychotropic medication, the possibility of rare, serious psychiatric adverse effects cannot be excluded.
Slovenian: Kot pri drugih psihotropnih zdravilih ni možno izključiti možnosti redkih, hudih psihiatričnih neželenih učinkov.
English: In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Slovenian: Poleg tega manjkajo podatki o varnosti na dolgi rok pri otrocih in mladostnikih v zvezi z rastjo, odraščanjem, kognitivnim in vedenjskim razvojem.
English: If your doctor has prescribed [Invented Name] for a patient under 18 and you want to discuss this, please go back to your doctor.
Slovenian: Če je vaš zdravnik predpisal zdravilo [izmišljeno ime] za bolnika, mlajšega od 18 let, in se želite pogovoriti o tem, se vrnite k zdravniku.
English: However, there was a clear suicide-related behaviours signal from the depression studies and a less strong signal from the anxiety studies.
Slovenian: Vendar je bil ugotovljen jasen signal s samomori povezanih vedenj v raziskavah depresije in manj močen signal v raziskavah anksioznosti.
English: These products are not authorised Europe-wide for the treatment of depression and anxiety disorders in children or adolescents.
Slovenian: Ta zdravila v vsej Evropi niso dovoljena za zdravljenje depresivnih in anksioznih motenj pri otrocih in mladostnikih.
English: The Committee also concluded that a different warning was more appropriate for atomoxetine, which is only indicated in the treatment of ADHD.
Slovenian: Odbor je zaključil tudi, da je za atomoksetin primernejše drugačno opozorilo, ki je edino zdravilo indicirano za zdravljenje ADHD.
English: Following a request from the European Commission, the CHMP reviewed the data from clinical trials available to the national competent authorities for the following SSRI
Slovenian: Na prošnjo iz Evropske komisije je Odbor za zdravila za uporabo v humani medicini pregledal podatke iz kliničnih preskušanj, ki so bila dostopna nacionalnim pristojnim organom, za naslednja zdravila iz skupine SSRI
English: Lilly Hungary Kft., Madách Imre út 13-15.
Slovenian: Madžarska Lilly Hungary Kft., Madách Imre út 13-15.
English: Only some of these products are authorised for the treatment of children and adolescents with obsessive-compulsive disorder and only one of them for the treatment of Attention Deficit/Hyperactivity Disorder.
Slovenian: Le nekaj teh zdravil je dovoljenih za zdravljenje otrok in mladostnikov z obsesivnokompulzivnimi motnjami in/ali eno izmed njih pa za zdravljenje motnje pomanjkanja pozornosti in hiperaktivnosti.
English: The data reviewed included short-term placebo controlled randomised clinical trials submitted to the competent authorities, randomised clinical trials published in the medical literature, observational studies and ecological studies.
Slovenian: Pregledani podatki so vsebovali krajša, s placebom nadzorovana randomizirana preskušanja, ki so bila predložena pristojnim organom, randomizirana klinična preskušanja, ki so objavljena v medicinski literaturi, opazovalne raziskave in ekološke raziskave.
English: Examination of suicide-related behaviours indicated that no completed suicide was reported in any of the reviewed studies.
Slovenian: Pri pregledu s samomori povezanih vedenj se je izkazalo, da v nobeni raziskavi ni bilo ugotovljenih izvršenih samomorov.
English: Luxembourg Chemische Tempelhof GMBH, Lengedestr.
Slovenian: Luksemburg Chemische Tempelhof GMBH, Lengedestr.
English: Lithuania Latvian JSC Grindeks, Krustpils ul.
Slovenian: Latvian JSC Grindeks, Krustpils ul.
English: Patients beginning treatment for ADHD should be carefully monitored for the appearance or worsening of hostility and emotional lability.
Slovenian: Bolnike, pri katerih uvedete zdravljenje ADHD, morate natančno spremljati za pojav ali poslabšanje sovražnosti in čustvene labilnosti.
English: Netherlands I.C.C.
Slovenian: Nizozemska I.C.C.
English: N.V. Organon Molenstraat 110.
Slovenian: Organon Molenstraat 110.
English: Teva Gyógyszergyár Rt., Pallagi útca.
Slovenian: Madžarska Teva Gyógyszergyár Rt., Pallagi útca.
English: Netherlands Niche Generics Ltd. 1 The Cam Centre
Slovenian: Nizozemska Niche Generics Ltd. 1 The Cam Centre
English: Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.
Slovenian: Portugalska Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.
English: Winthrop Farmacêutica Portugal, Lda.
Slovenian: Portugalska Winthrop Farmacêutica Portugal, Lda.
English: SSRIs are described as 'selective' because they affect only the reuptake pumps responsible for serotonin.
Slovenian: Zdravila SSRI poimenujemo „selektivna“, ker učinkujejo le na črpalke za ponovni prevzem, ki so specifične za serotonin.
English: The majority of trials included patients with major depressive disorders (MDD) while a few included patients with various anxiety disorders (Obsessive Compulsive Disorder (OCD), Generalised Anxiety Disorder (GAD), and Social Anxiety Disorder (SAD)).
Slovenian: Večina preskušanj je zajela bolnike s motnjami velike depresije (MDD), nekaj preskušanj pa tudi bolnike z raznimi anksioznimi motnjami (obsesivnokompulzivna motnja (OCD)), generalizirana anksiozna motnja (GAD), socialna anksiozna motnja (SAD)).
English: PHARMACIA ENTERPRISES S.A.6 Circuit de la Foire Internationale L-1347 Luxembourg G.D. De Luxembourg
Slovenian: PHARMACIA ENTERPRISES S.A.6 Circuit de la Foire Internationale L-1347 Luxembourg G.D.
English: [Invented Name] is not indicated for the treatment of major depressive episodes and/or anxiety as the results of clinical trials that were conducted in adults did not show any effect compare to placebo, and therefore were negative.
Slovenian: Zdravilo [izmišljeno ime] ni indicirano za zdravljenje epizod velike depresije in/ali anksioznosti, saj rezultati opravljenih kliničnih preskušanj pri odraslih niso pokazali nobenega učinka v primerjavi s placebom in so zato bili negativni.
English: [Invented Name] should normally not be used for children and adolescents under 18 years < except for patients with [approved indication]>.
Slovenian: Zdravilo [izmišljeno ime] se običajno ne sme uporabiti za otroke in mladostnike, mlajše od 18 let <razen pri bolnikih z [odobreno indikacijo]>.
English: Tablets
Slovenian: Tabletas
English: With the preliminary review of the data available to the national competent authorities the CHMP concluded that there were grounds for concerns about increased suicide-related behaviours in paediatric populations.
Slovenian: Po predhodnem pregledu podatkov, dostopnih nacionalnim pristojnim organom, je Odbor za zdravila za uporabo v humani medicini zaključil, da obstaja podlaga za zaskrbljenost glede porasta s samomori povezanih vedenj pri otrocih.
English: Glaxo Smith Kline Kft., Csörsz u. 43.
Slovenian: Madžarska Glaxo Smith Kline Kft., Csörsz u. 43.
English: Vetiquima - Produtos Químicos, Lda.
Slovenian: Portugalska Vetiquima - Produtos Químicos, Lda.
English: 1 SSRI stands for ‘Serotonin-Selective Reuptake Inhibitor'.
Slovenian: 1 SSRI pomeni „Serotonin-Selective Reuptake Inhibitor“ [zaviralec ponovnega prevzema, ki je selektiven za serotonin].
English: Alodial Farmacêutica - Comércio de Produtos Farmacêuticos, Lda.,
Slovenian: Portugalska Alodial Farmacêutica - Comércio de Produtos Farmacêuticos, Lda.,
English: Laboratórios Atral, S.A., Vala do Carregado 2600-726 Castanheira do Ribatejo Portugal
Slovenian: Portugalska Laboratórios Atral, S.A., Vala do Carregado 2600-726 Castanheira do Ribatejo Portugal
English: ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: PRILOGA 1 SEZNAM IZMIŠLJENIH IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, NAČINA UPORABE IN IMETNIKOV DOVOLJENJ ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: Belgium LAGEPHA S.A. Avenue Mercator 1 1300 Wavre, Belgium
Slovenian: LAGEPHA S.A. Avenue Mercator 1 1300 Wavre, Belgium
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
Slovenian: PRILOGA II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODIL ZA UPORABO, PREDSTAVLJENI S STRANI EVROPSKE AGENCIJE ZA ZDRAVILA
English: Netherlands Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/a, I-35031 Albano Terme - Padova
Slovenian: Nizozemska Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/a, I-35031 Albano Terme - Padova
English: Patients under 18 have an increased risk of side-effects such as hostility (predominantly aggression, oppositional behaviour and anger) and emotional lability.
Slovenian: Bolniki, mlajši od 18 let, imajo povečano tveganje za neželene učinke, npr. sovražnost (večinoma nasilno vedenje, nasprotovalno vedenje in jezo) ter čustveno labilnost.
English: Belgium 3 DDD PHARMA Diestersteenweg 349, 3510 Kermt, Belgium
Slovenian: 3 DDD PHARMA Diestersteenweg 349, 3510 Kermt, Belgium
English: Pol. Emp. La Marina.
Slovenian: Pol. Emp.
English: Despite this, your doctor may prescribe [Invented Name] for patients under 18 because he/she decides that this is in their best interests.
Slovenian: Kljub temu, lahko vaš zdravnik predpiše zdravilo [izmišljeno ime] za bolnike, mlajše od 18 let, če se odloči, da je to najbolje za bolnika.
English: Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.
Slovenian: Vedeti morate tudi, da imajo bolniki, mlajši od 18 let, večje tveganje za neželene učinke, npr. poskus samomora, samomorilne misli in sovražnost (večinoma nasilno vedenje, nasprotovalno vedenje in jezo), ko jemljejo zdravila iz te skupine.
English: Labesfal - Laboratórios Almiro, S.A., 3465-051 Campo de Besteiros Portugal
Slovenian: Portugalska Labesfal - Laboratórios Almiro, S.A., 3465-051 Campo de Besteiros Portugal
English: Note: This section of the Summary of Product Characteristics is the one that was Annexed to the Commission Decision on this Article 31 referral .
Slovenian: Opomba: Ta razdelek Povzetka glavnih značilnosti zdravila je bil priložen k odločbi Komisije v zvezi z napotitvenim postopkom, ki je bil sprožen v skladu s členom 31.
English: Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of [Invented Name] in this age group have not yet been demonstrated.
Slovenian: Poleg tega za zdravilo [izmišljeno ime] še niso dokazani varnostni učinki na dolgi rok v zvezi z rastjo, odraščanjem, kognitivnim in vedenjskim razvojem v tej starostni skupini.
English: Alter, S.A., Estrada Marco do GriloZemouto 2830 Coina Portugal
Slovenian: Portugalska Alter, S.A., Estrada Marco do GriloZemouto 2830 Coina Portugal
English: Netherlands Merck Generics BV Dieselweg 25
Slovenian: Nizozemska Merck Generics BV Dieselweg 25
English: Molteni Farmaceutici S.p.A. Strada Statale, 76 Loc. Granatieri 50018 Scandicci - Firenze Italy
Slovenian: Strada Statale, 76 Loc. Granatieri 50018 Scandicci - Firenze Italy
English: In addition there were some trials with patients suffering from Attention Deficit/Hyperactivity Disorder (ADHD).
Slovenian: Nekaj dodatnih raziskav je zajelo bolnike z motnjo pomanjkanja pozornosti in hiperaktivnostjo (ADHD).
English: The CHMP considered that there wasn't any signal of increased risk of suicide related behaviour in the atomoxetine studies, however, there was a signal of an increased risk of behavioural abnormalities with more aggression and hostility effects.
Slovenian: Odbor za zdravila za uporabo v humani medicini je mnenja, da v raziskavah atomoksetina ni bilo signala povečanega tveganja s samomori povezanih vedenj, vendar obstaja povečano tveganje nenormalnega vedenja z več učinki nasilnega vedenja in sovražnosti.
English: IIP-Institut für Industrielle Pharmacie Kreuznacher str. 1, Stromberg, D55442, Germany
Slovenian: Madžarska IIP-Institut für Industrielle Pharmacie Kreuznacher str. 1, Stromberg, D55442, Germany
English: Alpharma ApS, Rua Virgílio Correia, 11-A 1600-219 Lisboa Portugal
Slovenian: Portugalska Alpharma ApS, Rua Virgílio Correia, 11-A 1600-219 Lisboa Portugal