natgillin/translations-raw huggingface dataset:
Thromboembolis m (arterial)b,d, Haemorrhageb,d, Deep vein thrombosis
Žilne bolezni hipertenzijaa,b arterijska trombembolijaa,b, krvaviteva,b, (venska) trombembolijaa,b, globoka venska tromboza renalna trombotična mikroangio-patijab,c, anevrizme in disekcije arterij
The recommended dose of MVASI is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Priporočeni odmerek zdravila MVASI je 15 mg/kg telesne mase v enkratnem odmerku na 3 tedne, v obliki intravenske infuzije.
Each single use vial contains 100 mg of bevacizumab in 4 mL of concentrate.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala za enkratno uporabo vsebuje 100 mg bevacizumaba v 4 ml koncentrata.
• constipation,
• utrujenost,
7.5 mg/kg IV 30-90 min Day 1, prior to XELOX, q 3 weeks
30-90 min 1. dan, pred XELOX, vsake 3 tedne 5-fluorouracil: kot i.v.
• heart failure,
• srčno popuščanje,
Paclitaxel (n = 273)
paklitaksel (n = 273)
Progression-free survival Median time (months) Hazard ratio
Preživetje brez napredovanja bolezni mediana časa (meseci) razmerje ogroženosti
• Topotecan 4 mg/m2 as a 30-minute IV infusion on days 1, 8, and 15 every 4 weeks.
topotekan 4 mg/m2 s 30-minutno intravensko infuzijo 1., 8. in 15. dan vsake 4 tedne; lahko se daje tudi v odmerku 1,25 mg/m2 v 30 minutah od 1. do 5. dne vsake 3 tedne.
Each single use vial contains 400 mg of bevacizumab in 16 mL of concentrate.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala za enkratno uporabo vsebuje 400 mg bevacizumaba v 16 ml koncentrata.
A doctor or nurse will give you this diluted MVASI solution by intravenous infusion (a drip into your vein).
MVASI dala z intravensko infuzijo (kapalno infuzijo v veno).
• Superiority of the bevacizumab-containing arms versus the chemotherapy alone arms in the overall comparison was demonstrated in terms of progression-free survival in the ITT population (Table 7).
• V populaciji bolnikov, ki so jo nameravali zdraviti (ITT - intent to treat population), je bilo v celokupni primerjavi glede na preživetje brez napredovanja bolezni dokazano, da so skupine, ki so prejemale bevacizumab, superiorne skupinam, ki so prejemale samo kemoterapijo (preglednica 7).
200 mg/m2 IV 2 h
Levkovorin 200 mg/m2 i.v.
Efficacy results for study JO25567
Rezultati učinkovitosti študije JO25567 erlotinib n = 77#
• Gastrointestinal perforations (see section 4.4).
• perforacije prebavil (glejte poglavje 4.4),
a patients with measurable disease at baseline Overall survival Median (months)
Število bolnikov Celokupno preživetje Mediana časa (meseci)
Haemorrhage
Mehkotkivni sarkom
(11.9 vs.14.3 months; p = 0.4825)
(11,9 proti 14,3 meseca; p =
Congestive heart failure (CHF)
Srčne bolezni kongestivn o srčno popuščanjeb
The typical value for peripheral volume (Vp) was 1.69 L and 2.35 L for female and male patients respectively, when bevacizumab is co-administered with anti-neoplastic agents.
Tipična vrednost za periferni volumen (Vp), če so bevacizumab dajali sočasno z drugimi antineoplastičnimi zdravili, je pri bolnicah znašala 1,69 l, pri bolnikih pa 2,35 l. Po prilagoditvi glede na telesno maso so imeli bolniki večji volumen osrednjega prostora (+ 20 %) kot bolnice.
Effect of antineoplastic agents on bevacizumab pharmacokinetics
Vpliv zdravil za zdravljenje novotvorb na farmakokinetiko bevacizumaba
Febrile neutropenia, Leucopenia, Neutropeniaa, Thrombocytope nia
Bolezni krvi in limfatičnega sistema febrilna nevtropenija, levkopenija, nevtropenijaa, trombocitopenij a anemija, limfopenija
How to store MVASI
Shranjevanje zdravila MVASI
This was a phase III randomised double-blind trial conducted to evaluate the efficacy and safety of bevacizumab in combination with interferon (IFN) alfa-2a versus IFN alfa-2a alone as first-line treatment in mRCC.
Učinkovitost in varnost bevacizumaba v kombinaciji z interferonom alfa-2a v primerjavi s samim interferonom alfa-2a v prvi liniji zdravljenja metastatskega raka ledvičnih celic sta bili ovrednoteni v randomiziranem, dvojno slepem kliničnem preskušanju faze III.
Musculoskeletal and connective tissue disorders
Bolezni mišičnoskeletnega sistema in vezivnega tkiva artralgija, mialgija,
Febrile neutropenia, Leucopenia, Neutropeniab Thrombocytope nia
Bolezni krvi in limfatičnega sistema febrilna nevtropenija, levkopenija, nevtropenijab trombocitopenija anemija, limfopenija
Intestinal perforation, Ileus,
• perforacijo črevesja,
MVASI, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).
Zdravilo MVASI je indicirano za zdravljenje odraslih bolnic z rakom materničnega vratu, pri katerih je bolezen prisotna tudi po zaključenem primarnem zdravljenju, se je ponovila ali je metastatska, v kombinaciji s paklitakselom in cisplatinom ali, alternativno, s paklitakselom in topotekanom pri bolnicah, ki ne morejo dobivati zdravljenja s platino (glejte poglavje 5.1).
Reactions consistent with CHF were reported in clinical trials.
* Kjer je pogostnost navedena, so jo pridobili iz podatkov kliničnih preskušanj.
Increased rates of severe neutropenia, febrile neutropenia, or infection with or without severe neutropenia (including some fatalities) have been observed in patients treated with some myelotoxic chemotherapy regimens plus bevacizumab in comparison to chemotherapy alone.
Pri bolnikih, zdravljenih z nekaterimi mielotoksičnimi kemoterapevtskimi shemami in bevacizumabom, so v primerjavi s samo kemoterapijo opazili večji pojav hude nevtropenije, febrilne nevtropenije ali okužbe s hudo nevtropenijo ali brez nje (vključno s smrtnimi primeri).
Median PFS (months)
percentila (meseci)
Intestinal obstruction, Recto-vaginal fistulaec,d, Gastrointestinal disorder, Stomatitis, Proctalgia
Bolezni prebavil diareja, navzea, bruhanje, bolečine v trebuhu perforacija črevesja, ileus, intestinalna obstrukcija, rektovaginalne fistulec,d, bolezen prebavil, stomatitis, proktalgija perforacija prebavila,b, ulkus v prebavilihc, rektalna krvavitev
A large phase III trial was designed to investigate the treatment effect of bevacizumab in combination with paclitaxel, as measured by the primary endpoint of PFS. A clinically meaningful and statistically significant improvement in PFS was observed.
Za preučevanje učinka zdravljenja z bevacizumabom v kombinaciji s paklitakselom je bilo zasnovano veliko preskušanje faze III, v katerem je bil primarni cilj preživetje brez napredovanja bolezni (PFS, progression free survival).
MVASI is a medicine used for the treatment of adult patients with advanced cancer in the large bowel, i.e., in the colon or rectum.
Zdravilo MVASI uporabljamo za zdravljenje odraslih bolnikov z napredovalim rakom debelega črevesa in danke.
Non-GI Fistulae (see section 4.4)
Fistule izven prebavil (glejte poglavje 4.4)
Respiratory, thoracic and mediastinal disorders
Presnovne in prehranske motnje anoreksija, hipomagneziemij a hiponatriemija dehidracija
Patients with measurable disease at baseline.
Bolnice z merljivo boleznijo na začetku zdravljenja.
• sickness,
• slabost,
Mucosal inflammation
Nedrobnocelični rak pljuč
No clinically relevant interaction of co-administered chemotherapy on bevacizumab pharmacokinetics was observed based on the results of population pharmacokinetic analyses.
Populacijske farmakokinetične analize so pokazale, da klinično pomembnega medsebojnega delovanja sočasno dane kemoterapije na farmakokinetiko bevacizumaba ni.
No significant difference was observed in the duration of overall survival between patients who received bevacizumab monotherapy compared to patients treated with FOLFOX-4.
Med bolniki, ki so prejemali bevacizumab kot samostojno zdravljenje, in bolniki, ki so jih zdravili po shemi FOLFOX-4, niso opazili pomembne razlike v trajanju celokupnega preživetja.
Individual cases and clusters of serious ocular adverse reactions have been reported following unapproved intravitreal use of bevacizumab compounded from vials approved for intravenous administration in cancer patients.
Po neodobreni intravitrealni uporabi vial bevacizumaba, ki so odobrene za intravensko uporabo pri rakavih bolnikih, so poročali o posameznih primerih in o skupini resnih neželenih učinkov, povezanih z očmi.
Hypertensiona,b Thromboembolism arteriala,b,
Bolezni jeter, žolčnika in žolčevodov perforacija žolčnikaa,b
• a hole in your gut wall,
• predrtje stene črevesja,
Rectal haemorrhage, Stomatitis, Constipation, Diarrhoea, Nausea,
Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja, rinitis, epistaksa, kašelj krvavitev v pljučih/hem optizab,d,
Median OS (months) Hazard ratio (95% CI)2 p-value3
mediana celokupnega preživetja (meseci) razmerje ogroženosti (95-% interval zaupanja)2 p-vrednost3
Posterior reversible encephalopath y syndromea,b,c, Hypertensive encephalopath yc
Bolezni živčevja periferna senzorična nevropatijaa cerebrovaskularni zaplet, sinkopa, somnolenca, glavobol sindrom posteriorne reverzibilne encefalopatijea,b,c,
Gallbladder perforationb,c
Bolezni jeter, žolčnika in žolčevodov perforacija žolčnikab,c
Median (months)
(meseci)
Intestinal obstruction, Recto-vaginal fistulaed,e, Gastrointestinal disorder, Proctalgia
hipoksija, disfonijaa pljučna hipertenzijaa, perforacija nosnega pretinaa
Follow-up analysis was performed with a data cut-off date of 07 March 2014. p-value displayed for descriptive purpose only.
Analizo po spremljanju so opravili s podatki, zajetimi do 7. marca 2014.
MVASI, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO)
Zdravilo MVASI je v kombinaciji s karboplatinom in paklitakselom indicirano za prvo zdravljenje odraslih bolnic z napredovalim epitelijskim rakom jajčnikov (Klasifikacija Mednarodnega združenja ginekologov in porodničarjev (FIGO): stadij III B, III C in IV), karcinomom jajcevodov ali primarnim peritonealnim karcinomom (glejte poglavje 5.1).
Capecitabine oral bid for 2 weeks (followed by 1 week off treatment)
Kapecitabin 1.000 mg/m2 peroralno dvakrat na dan kapecitabin peroralno dvakrat na dan 2 tedna (sledi 1-tedenski odmor)
Gastrointestinal disorders Gastrointestinal ulcer (not known) Hepatobiliary disorders
Bolezni jeter, žolčnika in žolčevodov perforacija žolčnika (ni znana)
Patients were randomised to platinum-based chemotherapy (paclitaxel 200 mg/m2) and carboplatin AUC = 6.0, both by IV infusion (PC) on day 1 of every 3-week cycle for up to 6 cycles or PC in combination with bevacizumab at a dose of 15 mg/kg IV infusion day 1 of every 3-week cycle.
Randomizirani bolniki so na dan 1 vsakega tritedenskega cikla do skupno 6 ciklov prejeli kemoterapijo na osnovi platine (paklitaksel 200 mg/m2 in karboplatin AUC = 6,0, oboje z i.v.
The percentage of patients with an ECOG PS of 1 or ≥ 2 was 38.7% and 5.0% in the CT arm, and 29.8% and 9.0% in the CT + BV arm. Information on race exists for 29.3% of patients and nearly all patients were white.
V skupini s kemoterapijo in bevacizumabom je imelo 29,8 % bolnic stanje zmogljivosti po ECOG 1, 9,0 % bolnic pa stanje zmogljivosti po ECOG ≥ 2.
Number of patients Overall survival Median time (months) 95% CI
Število bolnikov Celokupno preživetje mediana časa (meseci) 95-% interval zaupanja razmerje ogroženostib
No increase in the incidence of other reactions, including gastrointestinal perforation, wound healing complications, congestive heart failure, and haemorrhage was observed in elderly patients (> 65 years) receiving bevacizumab as compared to those aged ≤ 65 years treated with bevacizumab.
Pri starejših bolnikih (> 65 let), zdravljenih z bevacizumabom, v primerjavi z bolniki, starimi 65 let ali manj, zdravljenimi z bevacizumabom, ni bilo opaziti povečanja incidence drugih neželenih učinkov, vključno s perforacijami prebavil, zapleti pri celjenju ran, kongestivnim srčnim popuščanjem in krvavitvami.
Tumour-associated haemorrhage (see section 4.4)
Perforacije in fistule prebavil (glejte poglavje 4.4)
Primary analysis Overall survival
Primarni opazovani dogodek
From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG-0240), grade 3-5 infections have been reported in up to 24% of patients treated with bevacizumab in combination with paclitaxel and topotecan compared with up to 13% of patients treated with paclitaxel and topotecan.
so o okužbah stopnje 3 do 5 poročali pri do 24 % bolnic, ki so prejemale bevacizumab v kombinaciji s paklitakselom in topotekanom, in pri do 13 % bolnic, ki so prejemale paklitaksel in topotekan.
CT + BV (n = 179)
kemoterapija + bevacizumab (n = 179)
p-value Overall response rate Rate (n) p-value Overall survival* (months) Median HR (95% CI) p-value A total of 154 patients (ECOG Performance Status 0 or 1) were randomised.
Skupno je bilo randomiziranih 154 bolnikov (s stanjem zmogljivosti po ECOG 0 ali 1).
Asthenia, Fatigue, Pyrexia, Pain,
Splošne težave in spremembe na mestu aplikacije astenija, utrujenost, pireksija, bolečina, vnetje sluznic letargija
METHOD OF ADMINISTRATION For intravenous use after dilution
Za intravensko uporabo po razredčitvi.
These patients often do not have other treatment options.
Druge možnosti zdravljenja za te bolnike pogosto niso na voljo.
Tablets must not be chewed or swallowed whole.
Tablete se ne smejo žvečiti ali pogoltniti cele.
What measures are being taken to ensure the safe and effective use of Jorveza?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Jorveza?
After 6 weeks, around 58% of the patients taking Jorveza (34 out of 59 patients) had reduced eosinophils and no symptoms or only minimal symptoms, whereas none of the 29 patients taking placebo had these effects.
Po šestih tednih je bilo pri približno 58 % (34 od 59) bolnikov, ki so prejemali zdravilo Jorveza, število eozinofilcev manjše, poleg tega ti bolniki niso imeli nobenih simptomov ali so imeli le redke simptome; teh učinkov pa ni bilo pri nobenem od 29 bolnikov, ki so prejemali placebo.
This is a summary of the European public assessment report (EPAR) for Jorveza.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Jorveza.
The European Medicines Agency decided that Jorveza's benefits are greater than its risks and recommended that it be approved for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Jorveza večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
Jorveza is available as orodispersible tablets (1 mg).
Zdravilo Jorveza je na voljo v obliki orodisperzibilnih tablet (1 mg).
Other information about Jorveza
Druge informacije o zdravilu Jorveza
The tablet is placed on the tongue and pressed against the roof of the mouth for around two minutes until it dissolves.
Tableto je treba položiti na jezik in za približno dve minuti pritisniti ob ustno nebo, da se raztopi.
Side effects with Jorveza are mainly the same as those of other similar medicines.
Neželeni učinki zdravila Jorveza so v glavnem enaki kot pri drugih podobnih zdravilih.
The main measure of effectiveness was the level of eosinophils in the oesophagus and improvement in symptoms.
Glavno merilo učinkovitosti sta bila raven eozinofilcev v požiralniku in izboljšanje simptomov.
The summary of the opinion of the Committee for Orphan Medicinal Products for Jorveza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Jorveza je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Corticosteroids help reduce inflammation by attaching to receptors of immune cells and reducing the release of substances that are involved in the inflammation process.
Kortikosteroidi pomagajo zmanjševati vnetje tako, da se vežejo na receptorje imunskih celic in zmanjšajo sproščanje snovi, vključenih v vnetni proces.
Treatment is continued for 6 weeks, but may be extended for up to another 6 weeks if needed.
Priporočeni odmerek je ena tableta dvakrat na dan. Zdravljenje traja šest tednov, po potrebi pa se lahko podaljša še za šest tednov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jorveza have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Jorveza upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
During this time the patient should steadily swallow the saliva with the dissolved medicine.
V tem času mora bolnik enakomerno požirati slino z raztopljenim zdravilom.
What benefits of Jorveza have been shown in studies?
Kakšne koristi je zdravilo Jorveza izkazalo v študijah?
What are the risks associated with Jorveza?
Kakšna tveganja so povezana z zdravilom Jorveza?
What is Jorveza and what is it used for?
Kaj je zdravilo Jorveza in za kaj se uporablja?
Why is Jorveza approved?
Zakaj je bilo zdravilo Jorveza odobreno?
It is not intended to provide practical advice on how to use Jorveza.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
It is caused by a large build-up of white blood cells called eosinophils in the lining of the oesophagus.
Povzroča ga veliko kopičenje belih krvnih celic, imenovanih eozinofilci, v steni požiralnika.
The active substance in Jorveza, budesonide, is a corticosteroid medicine.
Zdravilna učinkovina v zdravilu Jorveza, budezonid, je kortikosteroidno zdravilo.
For more information about treatment with Jorveza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Jorveza preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The full EPAR for Jorveza 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 Jorveza je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Because the number of patients with eosinophilic oesophagitis is low, the disease is considered ‘rare', and Jorveza was designated an ‘orphan medicine' (a medicine used in rare diseases) on 5 August
Ker je bolnikov z eozinofilnim ezofagitisom malo, velja ta bolezen za redko, zato je bilo zdravilo Jorveza 5. avgusta 2013 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Jorveza was shown to be effective in one main study involving 88 adults with eosinophilic oesophagitis.
Zdravilo Jorveza se je izkazalo za učinkovito v eni glavni študiji, ki je vključevala 88 odraslih z eozinofilnim ezofagitisom.
The most common side effects with Jorveza (which may affect up to 3 in 10 people) are fungal infections in the mouth, pharynx (throat) and oesophagus.
Najpogostejši neželeni učinki zdravila Jorveza (ki se lahko pojavijo pri največ 3 bolnikih od 10) so glivične okužbe ust, žrela in požiralnika.
For the full list of all side effects and restrictions with Jorveza, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Jorveza glejte navodilo za uporabo.
For practical information about using Jorveza, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Jorveza naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Eosinophilic oesophagitis is inflammation of the oesophagus (the food-pipe that leads from the mouth to the stomach), which causes symptoms including dysphagia (difficulty swallowing) and obstruction of the oesophagus.
Eozinofilni ezofagitis je vnetje požiralnika (cevk, ki vodi hrano od ust do želodca), ki povzroča simptome, vključno z disfagijo (oteženim požiranjem) in obstrukcijo požiralnika.
Jorveza benefits patients with eosinophilic oesophagitis by improving the symptoms of the disease and reducing the excess of eosinophils.
Zdravilo Jorveza koristi bolnikom z eozinofilnim ezofagitisom tako, da izboljša simptome bolezni in zmanjša presežek eozinofilcev.
Jorveza was compared with placebo (a dummy treatment).
Zdravilo Jorveza so primerjali s placebom (zdravilom brez zdravilne učinkovine).
How does Jorveza work?
Kako zdravilo Jorveza deluje?
Jorveza can only be obtained with a prescription and treatment should be started by a doctor experienced with diagnosing and treating eosinophilic oesophagitis.
Predpisovanje in izdaja zdravila Jorveza je le na recept, zdravljenje pa mora uvesti zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem eozinofilnega ezofagitisa.
After Jorveza dissolves in the mouth, the saliva carries it to the oesophagus where it reduces the inflammation and relieves the symptoms of eosinophilic oesophagitis.
Ko se zdravilo Jorveza raztopi v ustih, po slini potuje v požiralnik, kjer zmanjšuje vnetje in blaži simptome eozinofilnega ezofagitisa.
How is Jorveza used?
Kako se zdravilo Jorveza uporablja?
Jorveza is a medicine used to treat adults with eosinophilic oesophagitis.
Zdravilo Jorveza se uporablja za zdravljenje odraslih z eozinofilnim ezofagitisom.
Jorveza contains the active substance budesonide.
Zdravilo Jorveza vsebuje zdravilno učinkovino budezonid.
Subcutaneous or intravenous use powder: multidose vial (glass); solvent: ampoule (glass)
prašek in vehikel za raztopino za injiciranje prašek: večodmerna viala (steklo); vehikel: ampula (steklo)
Solution 5000 IU/ml)
raztopina 5000 i.e./ml)
solvent: 10 ml (reconst.
vehikel: 10 ml (rekonst.
50000 IU Powder and solvent for solution for injection
4 napolnjene injekcijske brizge
Romania GEROT PHARMAZEUTIKA Ges.m.b.H.
Romunija GEROT PHARMAZEUTIKA Ges.m.b.H.
Generis Farmacêutica, S.A. Rua João de Deus, 19 Amadora
Portugalska Generis Farmacêutica, S.A. Rua João de Deus, 19
Tecnifar - Indústria Técnica Farmacêutica, S.A.
Portugalska Tecnifar - Indústria Técnica Farmacêutica, S.A.
Austria sanofi-aventis GmbH SATURN Tower, Vienna DC Leonard-Bernstein-Straße
Avstrija sanofi-aventis GmbH SATURN Tower, Vienna DC Leonard-Bernstein-Straße
Sanofi-Aventis Bulgaria EOOD
Bolgarija Sanofi-Aventis Bulgaria EOOD
Romania Sanofi-Aventis France 1-13 Boulevard Romain Rolland
Romunija Sanofi-Aventis France 1-13 Boulevard Romain Rolland
Via Scarlatti Domenico, 31 20124 Milano Italy
Via Scarlatti Domenico, 31 20124 Milano Italy valprojska kislina, natrijev valproat
Sandoz Pharmaceuticals d.d
Slovaška Sandoz Pharmaceuticals d.d
ARENA GROUP S.A. Str. Ştefan Mihăileanu nr.
Str. Ştefan Mihăileanu nr.
Lithuania Orion Corporation Orionintie 1 A
Slovaška Orion Corporation Orionintie 1 A
Sanofi-Aventis zrt.
Madžarska Sanofi-Aventis zrt.
Sanofi-Aventis Slovakia s r.o.
Slovaška Sanofi-Aventis Slovakia s r.o.
Prolonged-release capsule
Kapsula s podaljšanim sproščanjem
Gastro-resistant capsule
Gastrorezistentna kapsula
DEPAKINE CHRONO (SPHERE) 1000 mg/sachet Coated granules in sachet
DEPAKINE CHRONO (SPHERE) 1000 mg/sachet Obložena zrnca v vrečici
Gastro-resistant capsule, soft
Gastrorezistentna kapsula, mehka
Romania Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Romunija Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Germany Ratiopharm GmbH Graf-Arco-Strasse 3
Slovaška Ratiopharm GmbH Graf-Arco-Strasse 3
SI-1000 Ljubljana Slovenia
1000 Ljubljana
500-1000 mg Modified-release granules
500-1000 mg Zrnca z prirejenim sproščanjem
Intravenous Use
Intravenska uporaba
Gastro-resistant capsule, hard
Gastrorezistentna kapsula, trda
Lithuania G.L.
Madžarska G.L.
Magnesium valproate
Italy magnezijev valproat
104 25 Stockholm Sweden
104 25 Stockholm Sweden valprojska kislina natrijev valproat
Sweden Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Slovaška Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Coated granules in sachet
Obložena zrnca v vrečici
Solution for injection/concentra te for solution for infusion
Raztopina za injiciranje/koncentr at za raztopino za infundiranje
Valproic acid VALPROATE SODIUM SANDOZ 500MG
NATRIJEV VALPROAT SANDOZ 500MG
Film-coated tablet Oral Use
Obložena tableta Peroralna uporaba