FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 3: Frequency of adverse reactions with hydrochlorothiazide Hydrochlorothiazide has been extensively prescribed for many years, frequently in higher doses than those administered with Diovan Comp.
Slovenian: Pogostnosti neželenih učinkov hidroklorotiazida Hidroklorotiazid že več let široko predpisujejo, pogosto v odmerkih, ki so večji od odmerkov pri uporabi zdravila Diovan Comp.
English: The CHMP agreed on including in the harmonised PI interaction of Diovan Comp with: Metformin and iodine contrast agents.
Slovenian: CHMP se je strinjal, da se v usklajene podatke o zdravilu vključi medsebojno delovanje zdravila Diovan Comp z: metforminom in jodnimi kontrastnimi sredstvi.
English: Diovan Comp may increase the effects of other agents with antihypertensive properties (e.g. ACEI, beta blockers, calcium channel blockers).
Slovenian: Zdravilo Diovan Comp lahko poveča učinek drugih zdravil z antihipertenzivnim delovanjem (na primer zaviralcev ACE, zaviralcev adrenergičnih receptorjev beta, zaviralcev kalcijevih kanalčkov).
English: The mode of action of thiazides is through inhibition of the Na+Cl- symporter perhaps by competing for the Cl- site, thereby affecting electrolyte reabsorption mechanisms:directly increasing sodium and chloride excretion to an approximately equal extent, and indirectly by this diuretic action reducing plasma volume, with consequent increases in plasma renin activity, aldosterone secretion and urinary potassium loss, and a decrease in serum potassium.
Slovenian: Tiazidi delujejo tako, da verjetno tekmujejo za vezavno mesto za Cl- ione na skupnem prenašalcu Na+ in Cl- ionov in ga na ta način zavirajo, s tem pa vplivajo na mehanizme reabsorpcije elektrolitov: neposredno povečajo izločanje natrija in klorida v približno enaki meri, posredno pa s takim diuretičnim delovanjem zmanjšajo volumen plazme, s tem povzročijo zvišanje delovanja renina v plazmi, izločanje aldosterona in izgubljanje kalija z urinom ter znižano koncentracijo kalija v serumu.
English: If no relevant additional effect is seen with Diovan Comp 320 mg/25 mg after 8 weeks, treatment with an additional or alternative antihypertensive medicinal product should be considered (see section 5.1).
Slovenian: Če po 8 tednih uporabe zdravila Diovan Comp 320 mg/25 mg ni opaziti ustreznega dodatnega učinka, je treba razmisliti o uvedbi dodatnega ali drugega antihipertenzivnega zdravila (glejte poglavje 5.1).
English: There is no data available on the use of valsartan in patients with severe hepatic dysfunction (see section 4.3).
Slovenian: Razpoložljivih podatkov o uporabi valsartana pri bolnikih s hudo motnjo delovanja jeter ni (glejte poglavje 4.3).
English: Based on the pharmacological mechanism of action of hydrochlorothiazide its use during the second and third trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia.
Slovenian: Glede na farmakološki mehanizem delovanja hidroklorotiazida lahko njegova uporaba v drugem in tretjem trimesečju ogroža fetoplacentarni krvni obtok in pri plodu in novorojenčku povzroči učinke, kot so ikterus, motnje v ravnovesju elektrolitov in trombocitopenijo.
English: • medicines to increase blood sugar levels, such as diazoxide
Slovenian: • zdravila, ki zvišajo raven sladkorja v krvi, kot je diazoksid
English: − Refractory hypokalaemia, hyponatraemia, hypercalcaemia, and symptomatic hyperuricaemia.
Slovenian: - Refraktarna hipokaliemija, hiponatriemija, hiperkalciemija in simptomatska hiperurikemija.
English: Thiazides may reduce urinary calcium excretion and cause an intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism.
Slovenian: Tiazidi lahko zmanjšujejo izločanje kalcija z urinom in povzročajo občasno rahlo zvišanje koncentracije kalcija v serumu brez znanih motenj metabolizma kalcija.
English: − Severe renal impairment (creatinine clearance <30 ml/min), anuria.
Slovenian: - Huda okvara ledvic (očistek kreatinina <30 ml/min), anurija.
English: No findings emerged that would exclude the use of therapeutic doses in man.
Slovenian: Ugotovili niso ničesar, kar bi govorilo proti uporabi terapevtskih odmerkov pri ljudeh.
English: The data from the 2 factorial and 6 non-responders phase III clinical trials, demonstrate that valsartan administered in combination with HCTZ is effective in reducing BP in patients with essential hypertension without any added concern for safety and tolerability.
Slovenian: Podatki iz dveh kliničnih preskušanj III. faze z odzivnimi bolniki in šestih kliničnih preskušanj III. faze z neodzivnimi bolniki dokazujejo, da je valsartan, dan v kombinaciji s hidroklorotiazidom, učinkovit pri zniževanju krvnega tlaka pri bolnikih z esencialno hipertenzijo in da ob tem ni nikakršnih dodatnih zadržkov glede varnosti in prenašanja zdravila.
English: Valsartan is an orally active and specific angiotensin II (Ang II) receptor antagonist.
Slovenian: Valsartan je peroralno aktiven, močan in specifičen antagonist receptorjev angiotenzina II.
English: Digoxin and indomethacin could interact with the hydrochlorothiazide component of Diovan Comp (see interactions related to hydrochlorothiazide).
Slovenian: Z digoksinom in indometacinom bi lahko prišlo do interakcij s hidroklorotiazidno sestavino zdravila Diovan Comp (glejte interakcije v zvezi s hidroklorotiazidom).
English: • dehydration (with symptoms of thirst, dry mouth and tongue, infrequent urination, dark colored urine, dry skin)
Slovenian: • dehidracija (s simptomi žeje, suhih ust in jezika, poredkim mokrenjem, temno obarvanostjo urina in suho kožo)
English: The systemic availability of hydrochlorothiazide is reduced by about 30% when co-administered with valsartan.
Slovenian: Sistemska biološka uporabnost hidroklorotiazida je pri sočasni uporabi valsartana manjša za približno 30 %.
English: How to store Diovan Comp Further information
Slovenian: Shranjevanje zdravila Diovan Comp Dodatne informacije
English: Renal clearance of hydrochlorothiazide is composed of passive filtration and active secretion into the renal tubule.
Slovenian: Ledvični očistek hidroklorotiazida je sestavljen iz pasivne filtracije in aktivne sekrecije v ledvični tubul.
English: - the scope of the referral was the harmonisation of the Summaries of Products Characteristics, labelling and package leaflet.
Slovenian: - Predmet napotitve je bil uskladitev povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo.
English: Dose adjustment of the antidiabetic medicinal product may be necessary.
Slovenian: Včasih je treba prilagoditi odmerjanje antidiabetičnih zdravil.
English: In addition, the following signs and symptoms may occur due to an overdose of the hydrochlorothiazide component: nausea, somnolence, hypovolaemia, and electrolyte disturbances associated with cardiac arrhythmias and muscle spasms.
Slovenian: Poleg tega lahko pri prevelikem odmerjanju hidroklorotiazida pride do naslednjih znakov in simptomov: do navzee, somnolence, hipovolemije in do elektrolitskega neravnovesja, povezanega s srčnimi aritmijami in mišičnimi spazmi.
English: • medicines to treat cancer, such as methotrexate or cyclophosphamide
Slovenian: • zdravila za zdravljenje raka, kot sta metotreksat in ciklofosfamid
English: • hives and difficulties in breathing
Slovenian: • koprivnica in težave z dihanjem
English: Frequency of adverse reactions with valsartan
Slovenian: Pogostnosti neželenih učinkov valsartana
English: The above mentioned effects appear to be due to the pharmacological effects of high valsartan doses (blockade of angiotensin II-induced inhibition of renin release, with stimulation of the reninproducing cells) and also occur with ACE inhibitors.
Slovenian: Zgoraj opisane učinke pripisujejo farmakološkemu delovanju visokih odmerkov valsartana (preprečevanju zaviranja sproščanja renina, ki ga povzroča angiotenzin II, in stimulaciji celic, v katerih nastaja renin).
English: In a clinical trial of patients with a history of dry cough during ACE inhibitor therapy, 19.5% of trial subjects receiving valsartan and 19.0% of those receiving a thiazide diuretic experienced cough compared to 68.5% of those treated with an ACE inhibitor (P <0.05).
Slovenian: V kliničnem preskušanju pri bolnikih, ki so imeli v anamnezi suh kašelj v času zdravljenja z zaviralcem ACE, je do kašlja prišlo pri 19,5 % preiskovancev, ki so dobivali valsartan, pri 19,0 % tistih, ki so prejemali tiazidni diuretik, in pri 68,5 % preiskovancev, ki so dobivali zaviralec ACE (p < 0,05).
English: Valsartan does not inhibit ACE, also known as kininase II, which converts Ang I to Ang II and degrades bradykinin.
Slovenian: Valsartan ne zavira angiotenzinske konvertaze ACE (znane tudi kot kininaza II), ki pretvarja angiotenzin I v angiotenzin II in razgrajuje bradikinin.
English: − Hypersensitivity to valsartan, hydrochlorothiazide, other sulfonamide-derived medicinal products or to any of the excipients.
Slovenian: - Preobčutljivost za valsartan, hidroklorotiazid, druga sulfonamidna zdravila ali katerokoli pomožno snov.
English: The AIIR (angiotensin II receptor) antagonists should not be contraindicated during breast-feeding.
Slovenian: Antagonisti angiotenzin II receptorjev naj ne bodo kontraindicirani med dojenjem.
English: The CHMP agreed that a greater reduction in both systolic and diastolic BP were seen in the non-responder studies for all strengths from week 4 to week 8 compared to the factorial studies.
Slovenian: CHMP se je strinjal, da je bilo v primerjavi s študijami z odzivnimi bolniki v študijah z neodzivnimi bolniki opaženo večje znižanje tako sistolnega kot tudi diastolnega krvnega tlaka za vse jakosti od 4. do 8. tedna.
English: Interactions related to valsartan
Slovenian: Interakcije v zvezi z valsartanom
English: Alcohol, anaesthetics and sedatives Potentiation of orthostatic hypotension may occur.
Slovenian: Alkohol,anestetiki in pomirjevala Lahko pride do okrepljene ortostatske hipotenzije.
English: During repeated dosing, the maximum reduction in blood pressure with any dose is generally attained within 24 weeks and is sustained during long-term therapy.
Slovenian: Do največjega znižanja krvnega tlaka po večkratnem odmerjanju pride pri kateremkoli odmerku v 2-4 tednih in to znižanje se med dolgotrajnim zdravljenjem ohranja.
English: In severely sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur in rare cases after initiation of therapy with Diovan Comp.
Slovenian: Pri bolnikih s hudim pomanjkanjem natrija in/ali hipovolemijo, ki prejemajo velike odmerke diuretikov, lahko v redkih primerih po začetku zdravljenja z zdravilom Diovan Comp pride do simptomatske hipotenzije.
English: • carbamazepine, a medicine used to treat seizure conditions
Slovenian: • karbamazepin, zdravilo za zdravljenje epilepsije
English: When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately and, if appropriate, alternative therapy should be started.
Slovenian: Ob potrjeni nosečnosti je treba zdravljenje z antagonisti angiotenzina II takoj prekiniti in, če je primerno, začeti alternativno zdravljenje.
English: • elevation of liver function values
Slovenian: • zvišane vrednosti jetrnih testov
English: Regarding the concomitant use of alcohol during administration of Diovan Comp, the statement potentiation of orthostatic hypotension may occur was discussed.
Slovenian: Glede sočasnega uživanja alkohola med uporabo zdravila Diovan Comp so obravnavali stavek lahko poslabša ortostatsko hipotenzijo.
English: • swollen face, tongue or pharynx
Slovenian: • oteklina obraza, jezika ali žrela
English: Administration of valsartan to patients with hypertension results in reduction of blood pressure without affecting pulse rate.
Slovenian: Pri bolnikih s hipertenzijo valsartan zniža krvni tlak, ne da bi vplival na srčno frekvenco.
English: The CHMP, noting that the treatment effects in patients with the higher baseline blood pressure were greater, concluded that a restriction of the use of valsartan/HCTZ 160/25 and 320/25 mg to patients with severely elevated blood pressure is not anymore warranted.
Slovenian: CHMP je ob upoštevanju, da so bili učinki zdravljenja pri bolnikih z višjo mejno vrednostjo krvnega tlaka večji, zaključil, da omejitev pri uporabi valsartana/hidroklorotiazida 160/25 in 320/25 mg pri bolnikih z občutno povišanim krvnim tlakom ni več utemeljena.
English: Regarding Hepatic impairment the majority of valsartan is eliminated, mainly as unchanged drug in the bile, by hepatic clearance.
Slovenian: Kar zadeva okvaro jeter, se večina valsartana izloči preko jeter, v glavnem kot nespremenjeno zdravilo v žolču.
English: If hypotension occurs, the patient should be placed in the supine position and salt and volume supplementation should be given rapidly.
Slovenian: Če pride do hipotenzije, je treba bolnika položiti vznak in mu hitro nadomestiti elektrolite in tekočino.
English: In marmosets, damage was observed in the gastric mucosa (from 30 + 9 mg/kg/d).
Slovenian: Pri marmozetkah so opažali poškodbe želodčne sluznice (pri odmerkih 30 + 9 mg/kg/dan).
English: Based on the QRD comments on the Diovan and on the class labelling text regarding the use of AIIRAs during pregnancy the section 4.6 was implemented.
Slovenian: Na podlagi pripomb v okviru pregleda dokumentov glede kakovosti o zdravilu Diovan in besedila o oznaki skupine glede uporabe antagonistov angiotenzin II receptorjev med nosečnostjo je bilo vstavljeno poglavje 4.6.
English: The renin-aldosterone link is mediated by angiotensin II, so with co-administration of valsartan the reduction in serum potassium is less pronounced as observed under monotherapy with hydrochlorothiazide.
Slovenian: Povezavo med reninom in aldosteronom predstavlja angiotenzin II, zato je pri sočasni uporabi valsartana znižanje koncentracije kalija v serumu manj izraženo kot pri monoterapiji s hidroklorotiazidom.
English: • You can take Diovan Comp with or without food.
Slovenian: • Zdravilo Diovan Comp je mogoče jemati s hrano ali brez nje.
English: In case of diuretic-induced dehydration, there is an increased risk of acute renal failure, especially with high doses of the iodine product.
Slovenian: Pri bolnikih, ki so zaradi jemanja diuretikov dehidrirani, obstaja povečano tveganje za akutno odpoved ledvic, posebno pri uporabi velikih odmerkov jodiranih sredstev.
English: Concomitant administration with food has been reported to both increase and decrease the systemic availability of hydrochlorothiazide compared with the fasted state.
Slovenian: Za sočasno jemanje s hrano so zabeležili tako večjo kot tudi manjšo sistemsko uporabnost hidroklorotiazida v primerjavi z jemanjem na tešče.
English: Other hypersensitivity/allergic reactions including serum sickness
Slovenian: Bolezni imunskega sistema pogostnost neznana druge preobčutljivostne/alergijske reakcije, vključno s serumsko boleznijo
English: Diovan Comp is contraindicated in patients with severe hepatic impairment (see sections 4.3, 4.4 and 5.2).
Slovenian: Zdravilo Diovan Comp je kontraindicirano pri bolnikih s hudo okvaro jeter (glejte poglavja 4.3, 4.4 in 5.2).
English: A number of areas of disharmony in the product information for Diovan have been considered by the CHMP.
Slovenian: CHMP je obravnaval več poglavij v informacijah o zdravilu Diovan, v katerih je prišlo do neskladij.
English: Patients receiving thiazide diuretics, including hydrochlorothiazide, should be observed for clinical signs of fluid or electrolyte imbalance.
Slovenian: Bolniki s pomanjkanjem natrija in/ali hipovolemijo Bolnike, ki prejemajo tiazidne diuretike, med katere sodi tudi hidroklorotiazid, je treba opazovati glede kliničnih znakov neravnovesja tekočin ali elektrolitov.
English: Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see also section 4.3 and 4.4).
Slovenian: Otroke, katerih matere so prejemale antagoniste angiotenzina II, je treba skrbno opazovati glede možnosti pojava hipotenzije (glejte tudi poglavji 4.3 in 4.4).
English: The data from the two factorial trials and the “Guidance on Clinical Investigation of Medicinal Products in the treatment of hypertension” support the direct change from monotherapy to the fixed combination of 160/25 mg or 320/12.5-25 mg in patients whose blood pressure is not adequately controlled on either valsartan or hydrochlorothiazide monotherapy.
Slovenian: Podatki iz dveh preskušanj z odzivnimi bolniki in smernic “Guidance on Clinical Investigation of Medicinal Products in the treatment of hypertension” (Smernice o klinični preiskavi zdravil pri zdravljenju hipertenzije) podpirajo neposreden prehod z monoterapije na fiksno kombinacijo 160/25 mg ali 320/12,5-25 mg pri bolnikih, pri katerih krvni tlak ni zadostno nadzorovan z monoterapijo z valsartanom ali hidroklorotiazidom.
English: The CHMP adopted the following: “Diovan Comp fixed dose-combination is indicated in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorotiazide monotherapy”
Slovenian: CHMP je sprejel sledeče: „Kombinacija fiksnih odmerkov zdravila Diovan Comp je indicirana pri bolnikih, pri katerih krvni tlak ni zadostno nadzorovan z monoterapijo z valsartanom ali hidroklorotiazidom.“
English: • muscle relaxing medicines, such as tubocurarine
Slovenian: • zdravila za preprečevanje krčenja mišic, kot je tubokurarin
English: was reduced (p <0.001) by 42% (-24.2 µg/min; 95% CI: -40.4 to -19.1) with valsartan and approximately 3% (-1.7 µg/min; 95% CI: -5.6 to 14.9) with amlodipine despite similar rates of blood pressure reduction in both groups.
Slovenian: Po 24 tednih se je izločanje albumina z urinom zmanjšalo (p <0,001) za 42 % (-24,2 µg/min; 95 % IZ: -40,4 do -19,1) z valsartanom in približno za 3 % (-1,7 µg/min; 95 % IZ: -5,6 do 14,9) z amlodipinom kljub podobnemu obsegu zmanjšanja krvnega tlaka pri obeh skupinah.
English: Thiazide-induced hypokalaemia or hypomagnesaemia may occur as unwanted effects favouring the onset of digitalis-induced cardiac arrhythmias.
Slovenian: Lahko pride do hipokaliemije ali hipomagneziemije, obe sta neželena učinka, ki ju povzročajo tiazidi in povečujeta verjetnost za nastop srčnih aritmij, ki jih povzroča digitalis.
English: • Class III antiarrhythmics (e.g. amiodarone, sotalol, dofetilide, ibutilide)
Slovenian: • antiaritmiki skupine III (na primer amiodaron, sotalol, dofetilid, ibutilid),
English: • Do not use any Diovan Comp pack that is damaged or shows signs of tampering.
Slovenian: • Ne uporabljajte zdravila Diovan Comp, če opazite, da je ovojnina poškodovana ali opazite, da je bila že odprta.
English: Patients receiving hydrochlorothiazide concomitantly with carbamazepine may develop hyponatremia.
Slovenian: Pri bolnikih, ki sočasno prejemajo hidroklorotiazid in karbamazepin, lahko pride do hiponatriemije.
English: • the level of blood urea nitrogen and creatinine increased in blood (which can indicate abnormal kidney function)
Slovenian: • zvišana raven dušika sečnine in kreatinina v krvi (kar lahko kaže na nepravilno delovanje ledvic)
English: • allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
Slovenian: • alergijske reakcije (s simptomi, kot so izpuščaj, srbenje, urtikarija, oteženo dihanje ali požiranje, omotičnost)
English: • medicines that may reduce the amount of potassium in your blood, such as corticosteroids, some laxatives
Slovenian: • zdravila, ki lahko znižajo količino kalija v krvi, kot so kortikosteroidi in nekatera odvajala
English: • if you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium or other medicines that increase the amount of potassium in your blood such as heparin.
Slovenian: • če jemljete zdravila, ki varčujejo s kalijem, kalijeve nadomestke, nadomestke soli, ki vsebujejo kalij, ali druga zdravila, ki zvišujejo količino kalija v krvi, kot je heparin.
English: Valsartan cannot be eliminated by means of haemodialysis because of its strong plasma binding behaviour whereas clearance of hydrochlorothiazide will be achieved by dialysis.
Slovenian: Valsartana ni mogoče izločati s hemodializo, ker se v plazmi močno veže, medtem ko je hidroklorotiazid mogoče očistiti iz telesa z dializo.
English: Additional information on the individual components Adverse reactions previously reported with one of the individual components may be potential undesirable effects with Diovan Comp as well, even if not observed in clinical trials or during postmarketing period.
Slovenian: Drugi neželeni dogodki, ki so jih opisovali pri vsaki posamezni učinkovini, bi lahko bili neželeni učinki tudi pri uporabi zdravila Diovan Comp, čeprav jih niso opažali v kliničnih študijah ali v času po prihodu zdravila na trg.
English: FURTHER INFORMATION What Diovan Comp contains [To be completed nationally]
Slovenian: DODATNE INFORMACIJE Kaj vsebuje zdravilo Diovan Comp [Izpolni država članica]
English: the CHMP has recommended the amendment of the Marketing Authorisation for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Diovan comp and associated names (see Annex I).
Slovenian: CHMP je priporočil dopolnitev dovoljenja za promet z zdravilom Diovan Comp in z njim povezanih imen (glejte Dodatek I), katerih povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo so navedeni v Dodatku III.
English: The difference in BP reductions between the 160/25 mg and 160/12.5 mg doses also reached statistical significance.
Slovenian: Tudi razlika znižanja krvnega tlaka med uporabo odmerkov 160/25 mg in 160/12,5 mg je bila statistično značilna.
English: Diovan Comp contains valsartan and hydroclortiazide.
Slovenian: Zdravilo Diovan Comp vsebuje valsartan in hidroklorotiazid.
English: (Calculations assume an oral dose of 320 mg/day valsartan in combination with 25 mg/day hydrochlorothiazide and a 60-kg patient.)
Slovenian: (Izračuni temeljijo na predpostavki peroralnega odmerka 320 mg/dan valsartana v kombinaciji s 25 mg/dan hidroklorotiazida za 60-kilogramskega bolnika.)
English: • You must tell your doctor if you think that you are (or might become) pregnant Your doctor will normally advise you to stop taking Diovan Comp before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Diovan Comp. Diovan Comp is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if it is used after the third month of pregnancy.
Slovenian: Zdravnik vam bo praviloma svetoval jemanje drugega zdravila namesto zdravila Diovan Comp, saj jemanje zdravila Diovan Comp v zgodnjem obdobju nosečnosti ni priporočljivo in lahko po tretjem mesecu nosečnosti povzroči resno škodo vašemu otroku.
English: When clinically appropriate direct change from monotherapy to the fixed combination may be considered in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy, provided the recommended dose titration sequence for the individual components is followed.
Slovenian: Neposreden prehod z monoterapije na fiksno kombinacijo, če je klinično primeren, lahko pride v poštev pri bolnikih, pri katerih krvni tlak ni zadostno nadzorovan z monoterapijo z valsartanom ali hidroklorotiazidom, ob upoštevanju priporočenega zaporedja titracije odmerka posameznih sestavin.
English: Sodium and/or volume depletion should be corrected before starting treatment with Diovan Comp.
Slovenian: Pomanjkanje natrija in hipovolemijo je treba pred začetkom zdravljenja z zdravilom Diovan Comp odpraviti.
English: Novartis Farma - Produtos Farmacêuticos S.A.
Slovenian: Portugalska Novartis Farma - Produtos Farmacêuticos S.A.
English: Netherlands Novartis Pharma B.V. Raapopseweg 1 Postbus 241 NL-6824 DP Arnhem
Slovenian: Raapopseweg 1 Postbus 241 NL-6824 DP Arnhem
English: Depression, sleep disturbances
Slovenian: Psihiatrične motnje redki depresija, motnje spanja